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Rule

Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2

Action

Final Rule.

Summary

This final rule specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments. In addition, it specifies payment adjustments under Medicare for covered professional services and hospital services provided by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use of certified EHR technology (CEHRT) and other program participation requirements. This final rule revises certain Stage 1 criteria, as finalized in the July 28, 2010 final rule, as well as criteria that apply regardless of Stage.

Unified Agenda

 

Table of Contents Back to Top

Tables Back to Top

DATES: Back to Top

Effective dates: This final rule is effective on November 5, 2012, with the exception of the definition of “meaningful EHR user” in § 495.4 and the provisions in § 495.6(f), § 495.6(g), § 495.8, § 495.102(c), and part 495 subpart D, which are effective September 4, 2012.

Applicability dates: Sections 495.302, 495.304, and 495.306 are applicable beginning payment year 2013.

FOR FURTHER INFORMATION CONTACT: Back to Top

Elizabeth Holland, (410) 786-1309, or Robert Anthony, (410) 786-6183, EHR Incentive Program issues or Administrative appeals process issues.David Koppel, (410) 786-3255, for Medicaid Incentive Program issues.Frank Szeflinski, (303) 844-7119, for Medicare Advantage issues.Travis Broome, (214) 767-4450, Medicare payment adjustment issues.Douglas Brown, (410) 786-0028, or Maria Michaels, (410) 786-2809 for Clinical quality measures issues.

SUPPLEMENTARY INFORMATION: Back to Top

Acronyms Back to Top

ARRAAmerican Recovery and Reinvestment Act of 2009

AACAverage Allowable Cost (of CEHRT)

ACOAccountable Care Organization

AIUAdopt, Implement, Upgrade (CEHRT)

CAHCritical Access Hospital

CAHPSConsumer Assessment of Healthcare Providers and Systems

CCNCMS Certification Number

CDSClinical Decision Support

CEHRTCertified Electronic Health Record Technology

CFRCode of Federal Regulations

CHIPChildren's Health Insurance Program

CHIPRAChildren's Health Insurance Program Reauthorization Act of 2009

CMSCenters for Medicare & Medicaid Services

CPOEComputerized Provider Order Entry

CQMClinical Quality Measure

CYCalendar Year

EHRElectronic Health Record

EPEligible Professional

EPOExclusive Provider Organization

FACAFederal Advisory Committee Act

FFPFederal Financial Participation

FFYFederal Fiscal Year

FFSFee-For-Service

FQHCFederally Qualified Health Center

FTEFull-Time Equivalent

FYFiscal Year

HEDISHealthcare Effectiveness Data and Information Set

HHSDepartment of Health and Human Services

HIEHealth Information Exchange

HITHealth Information Technology

HITPCHealth Information Technology Policy Committee

HIPAAHealth Insurance Portability and Accountability Act of 1996

HITECHHealth Information Technology for Economic and Clinical Health Act

HMOHealth Maintenance Organization

HOSHealth Outcomes Survey

HPSAHealth Professional Shortage Area

HRSAHealth Resource and Services Administration

IAPDImplementation Advance Planning Document

ICRInformation Collection Requirement

IHSIndian Health Service

IPAIndependent Practice Association

ITInformation Technology

LOINCLogical Observation Identifiers and Codes System

MAMedicare Advantage

MACMedicare Administrative Contractor

MAOMedicare Advantage Organization

MCOManaged Care Organization

MITAMedicaid Information Technology Architecture

MMISMedicaid Management Information Systems

MSAMedical Savings Account

NAACNet Average Allowable Cost (of CEHRT)

NCQANational Committee for Quality Assurance

NCVHSNational Committee on Vital and Health Statistics

NPINational Provider Identifier

NPRMNotice of Proposed Rulemaking

ONCOffice of the National Coordinator for Health Information Technology

PAHPPrepaid Ambulatory Health Plan

PAPDPlanning Advance Planning Document

PCPPrimary Care Provider

PECOSProvider Enrollment, Chain, and Ownership System

PFFSPrivate Fee-For-Service

PHOPhysician Hospital Organization

PHRPersonal Health Record

PHSPublic Health Service

PHSAPublic Health Service Act

PIHPPrepaid Inpatient Health Plan

POSPlace of Service

PPOPreferred Provider Organization

PQRSPhysician Quality Reporting System

PSOProvider Sponsored Organization

RHCRural Health Clinic

RPPORegional Preferred Provider Organization

SAMHSASubstance Abuse and Mental Health Services Administration

SMHPState Medicaid Health Information Technology Plan

TINTax Identification Number

Table of Contents Back to Top

I. Executive Summary and Overview

A. Executive Summary

1. Purpose of Regulatory Action

a. Need for the Regulatory Action

b. Legal Authority for the Regulatory Action

2. Summary of Major Provisions

a. Stage 2 Meaningful Use Objectives and Measures

b. Reporting on Clinical Quality Measures (CQMs)

c. Payment Adjustments and Exceptions

d. Modifications to Medicaid EHR Incentive Program

e. Stage 2 Timeline Delay

3. Summary of Costs and Benefits

B. Overview of the HITECH Programs Created by the American Recovery and Reinvestment Act of 2009

II. Provisions of the Proposed Regulations and Analysis of and Responses to Public Comments

A. Definitions Across the Medicare FFS, Medicare Advantage, and Medicaid Programs

1. Uniform Definitions

2. Meaningful EHR User

3. Definition of Meaningful Use

a. Considerations in Defining Meaningful Use

b. Changes to Stage 1 Criteria for Meaningful Use

c. State Flexibility for Stage 2 of Meaningful Use

d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)

(1) Discussion of Whether Certain EPs, Eligible Hospitals or CAHs can meet all Stage 2 Meaningful Use Objectives Given Established Scopes of Practice

(2) EPs Practicing in Multiple Practices/Locations

(3) Discussion of the Reporting Requirements of the Measures Associated with the Stage 2 Meaningful Use Objectives

B. Reporting on Clinical Quality Measures Using Certified EHRs Technology by Eligible Professionals, Eligible Hospitals, and Critical Access Hospitals

1. Time Periods for Reporting Clinical Quality Measures

2. Certification Requirements for Clinical Quality Measures

3. Criteria for Selecting Clinical Quality Measures

4. Clinical Quality Measures for Eligible Professionals

a. Statutory and Other Considerations

b. Clinical Quality Measures for Eligible Professionals for CY 2013

c. Clinical Quality Measures for Eligible Professionals Beginning With CY 2014

5. Reporting Methods for Clinical Quality Measures for Eligible Professionals

a. Reporting Methods for Medicaid EPs

b. Reporting Methods for Medicare EPs in CY 2013

c. Reporting Methods for Medicare EPs Beginning With CY 2014

d. Group Reporting Option for Medicare and Medicaid Eligible Professionals Beginning With CY 2014

6. Clinical Quality Measures for Eligible Hospitals and Critical Access Hospitals

a. Statutory and Other Considerations

b. Clinical Quality Measures for Eligible Hospitals and CAHs for FY 2013

7. Reporting Methods for Eligible Hospitals and Critical Access Hospitals

a. Reporting Methods in FY 2013

b. Reporting Methods Beginning With FY 2014

c. Electronic Reporting of Clinical Quality Measures for Medicaid Eligible Hospitals

C. Demonstration of Meaningful Use and Other Issues

1. Demonstration of Meaningful Use

a. Common Methods of Demonstration in Medicare and Medicaid

b. Methods for Demonstration of the Stage 2 Criteria of Meaningful Use

c. Group Reporting Option of Meaningful Use Core and Menu Objectives and Associated Measures for Medicare and Medicaid EPs Beginning With CY 2014

2. Data Collection for Online Posting, Program Coordination, and Accurate Payments

3. Hospital-Based Eligible Professionals

4. Interaction With Other Programs

D. Medicare Fee-for-Service

1. General Background and Statutory Basis

2. Payment Adjustment Effective in CY 2015 and Subsequent Years for EPs Who Are Not Meaningful Users of CEHRT for an Applicable Reporting Period

a. Applicable Payment Adjustments in CY 2015 and Subsequent Calendar Years for EPs Who Are Not Meaningful Users of CEHRT

b. EHR Reporting Period for Determining Whether an EP Is Subject to the Payment Adjustment for CY 2015 and Subsequent Calendar Years

c. Exception to the Application of the Payment Adjustment to EPs in CY 2015 and Subsequent Calendar Years

d. HPSA Bonus Technical Change

e. Payment Adjustment Not Applicable to Hospital-Based EPs

3. Incentive Market Basket Adjustment Effective in FY 2015 and Subsequent Years for Eligible Hospitals That Are Not Meaningful EHR Users for an Applicable Reporting Period

a. Applicable Market Basket Adjustment for Eligible Hospitals Who Are Not Meaningful EHR Users for FY 2015 and Subsequent FYs

b. EHR Reporting Period for Determining Whether a Hospital is Subject to the Market Basket Adjustment for FY 2015 and Subsequent FYs

c. Exception to the Application of the Market Adjustment to Hospitals in FY 2015 and Subsequent FYs

d. Application of Market Basket Adjustment in FY 2015 and Subsequent FYs to a State Operating Under a Payment Waiver Provided by Section 1814(B)(3) of the Act

4. Reduction of Reasonable Cost Reimbursement in FY 2015 and Subsequent Years for CAHs That Are Not Meaningful EHR Users

a. Applicable Reduction of Reasonable Cost Payment Reduction in FY 2015 and Subsequent Years for CAHs That Are Not Meaningful EHR Users

b. EHR Reporting Period for Determining Whether a CAH Is Subject to the Applicable Reduction of Reasonable Cost Payment in FY 2015 and Subsequent Years

c. Exception to the Application of Reasonable Cost Payment Reductions to CAHs in FY 2015 and Subsequent FYs

5. Administrative Review Process of Certain Electronic Health Record Incentive Program Determinations

E. Medicare Advantage Organization Incentive Payments

1. Definition (§ 495.200)

2. Identification of Qualifying MA Organizations, MA-EPs and MA-Affiliated Eligible Hospitals (§ 495.202)

3. Incentive Payments to Qualifying MA Organizations for Qualifying MA EPs and Qualifying MA-Affiliated Eligible Hospitals (§ 495.204)

a. Amount Payable to a Qualifying MA Organization for Its Qualifying MA EPs

b. Increase in Incentive Payment for MA EPs Who Predominantly Furnish Services in a Geographic Health Professional Shortage Area (HPSA)

4. Avoiding Duplicate Payments

5. Payment Adjustments Effective in 2015 and Subsequent MA Payment Adjustment Years (§ 495.211).

6. Reconsideration Process for MA Organizations

F. Revisions and Clarifications to the Medicaid EHR Incentive Program

1. Net Average Allowable Costs

2. Eligibility Requirements for Children's Hospitals

3. Medicaid Professionals Program Eligibility

a. Calculating Patient Volume Requirements

b. Practices Predominately

4. Medicaid Hospital Incentive Payment Calculation

a. Discharge Related Amount

b. Acute Care Inpatient Bed Days and Discharges for the Medicaid Share and Discharge- Related Amount

c. Hospitals Switching States

5. Hospital Demonstrations of Meaningful Use—Auditing and Appeals

6. State Flexibility for Stage 2 of Meaningful Use

7. State Medicaid Health Information Technology Plan (SMHP) and Implementation Advance Planning Document (IAPD)

a. Frequency of Health Information Technology (HIT) Implementation Advanced Planning Document (IAPD) Updates

b. Requirements of States Transitioning From HIT Planning Advanced Planning Documents (P-APDs) to HIT IAPDs

III. Waiver of Delay in Effective Date

IV. Collection of Information Requirements

A. ICR Regarding Demonstration of Meaningful Use Criteria (§ 495.6 and § 495.8)

B. ICRs Regarding Qualifying MA Organizations (§ 495.210)

C. ICRs Regarding State Medicaid Agency and Medicaid EP and Hospital Activities (§ 495.332 Through § 495.344)

V. Regulatory Impact Analysis

A. Statement of Need

B. Overall Impact

C. Anticipated Effects

1. Overall Effects

a. Regulatory Flexibility Analysis and Small Entities

(1) Number of Small Entities

(2) Conclusion

b. Small Rural Hospitals

c. Unfunded Mandates Reform Act

d. Federalism

2. Effects on Eligible Professionals, Eligible Hospitals, and CAHs

a. Background and Assumptions

b. Industry Costs and Adoption Rates

c. Costs of EHR Adoption for EPs

d. Costs of EHR Adoption for Eligible Hospitals

3. Medicare Incentive Program Costs

a. Medicare Eligible Professionals (EPs)

b. Medicare Eligible Hospitals and CAHs

c. Critical Access Hospitals (CAHs)

4. Medicaid Incentive Program Costs

a. Medicaid EPs

b. Medicaid Hospitals

5. Benefits For All EPs and All Eligible Hospitals

6. Benefits to Society

7. General Considerations

8. Summary

9. Explanation of Benefits and Savings Calculations

D. Accounting Statement

E. Conclusion

Regulations Text Back to Top

I. Executive Summary and Overview Back to Top

A. Executive Summary

1. Purpose of Regulatory Action

a. Rationale for the Regulatory Action

In this final rule the Secretary of the Department of Health and Human Services (the Secretary) will specify Stage 2 criteria beginning in 2014 that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for an incentive payment, as well as introduce changes to the program timeline and detail Medicare payment adjustments. Recommendations on Stage 2 criteria from the Health IT Policy Committee (HITPC), a Federal Advisory Committee that coordinates industry and provider input regarding the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs were substantially adopted, with consideration of current program data for the Medicare and Medicaid EHR Incentive Programs. Our current program data is derived from two sources. First, data elements from the registration and attestation process of those providers who have already registered and attested to Stage 1 of meaningful use. This includes demographic information about the provider, the Certified EHR Technology (CEHRT) used by the provider and their performance on the meaningful use objectives and measures. Second, we have information from thousands of questions providers submitted about the EHR Incentive Programs. These questions provide insights into the difficulties faced by providers and also into the areas of the EHR Incentive Programs that warrant additional clarification.

b. Legal Authority for the Regulatory Action

The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) amended Titles XVIII and XIX of the Social Security Act (the Act) to authorize incentive payments to EPs, eligible hospitals, and CAHs, and Medicare Advantage (MA) organizations to promote the adoption and meaningful use of CEHRT.

Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the statutory basis for the Medicare incentive payments made to meaningful EHR users. These statutory provisions govern EPs, Medicare Advantage (MA) organizations (for certain qualifying EPs and hospitals that meaningfully use CEHRT), subsection (d) hospitals and critical access hospitals (CAHs) respectively. Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward payment adjustments, beginning with calendar or fiscal year 2015, for EPs, MA organizations, subsection (d) hospitals and CAHs that are not meaningful users of CEHRT for certain associated reporting periods.

Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for Medicaid incentive payments. (There are no payment adjustments under Medicaid). For a more detailed explanation of the statutory basis for the EHR incentive payments, see the Stage 1 final rule (75 FR 44316 through 44317).

2. Summary of Major Provisions

a. Stage 2 Meaningful Use Objectives and Measures

In the Stage 1 final rule we outlined Stage 1 meaningful use criteria, we finalized a separate set of core objectives and menu objectives for EPs, eligible hospitals and CAHs. EPs and hospitals must meet the measure or qualify for an exclusion to all 15 core objectives and 5 out of the 10 menu objectives in order to qualify for an EHR incentive payment. In this final rule, we maintain the same core-menu structure for the program for Stage 2. We are finalizing that EPs must meet the measure or qualify for an exclusion to 17 core objectives and 3 of 6 menu objectives. We are finalizing that eligible hospitals and CAHs must meet the measure or qualify for an exclusion to 16 core objectives and 3 of 6 menu objectives. Nearly all of the Stage 1 core and menu objectives are retained for Stage 2. The “exchange of key clinical information” core objective from Stage 1 was re-evaluated in favor of a more robust “transitions of care” core objective in Stage 2, and the “Provide patients with an electronic copy of their health information” objective was removed because it was replaced by a “view online, download, and transmit” core objective. There are also multiple Stage 1 objectives that were combined into more unified Stage 2 objectives, with a subsequent rise in the measure threshold that providers must achieve for each objective that has been retained from Stage 1.

b. Reporting on Clinical Quality Measures (CQMs)

EPs, eligible hospitals, and CAHs are required to report on specified clinical quality measures in order to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs. This final rule outlines a process by which EPs, eligible hospitals, and CAHs will submit CQM data electronically, reducing the associated burden of reporting on quality measures for providers. EPs will submit 9 CQMs from at least 3 of the National Quality Strategy domains out of a potential list of 64 CQMs across 6 domains. We are recommending a core set of 9 CQMs focusing on adult populations with a particular focus on controlling blood pressure. We are also recommending a core set of 9 CQMs for pediatric populations. EPs should report on these recommended CQMs if they are representative of their clinical practice and patient population. Eligible hospitals and CAHs will submit 16 CQMs from at least 3 of the National Quality Strategy domains out of a potential list of 29 CQMs across 6 domains. For the Medicare EHR Incentive Program, EPs, eligible hospitals, and CAHs in their first year of demonstrating meaningful use must submit their CQM data via attestation, and those beyond their first year must submit their CQM data electronically via a CMS-designated transmission method. For EPs, this includes an aggregate electronic submission or a patient-level electronic submission through the method specified by the Physician Quality Reporting System (PQRS) that would provide one submission for credit in both the PQRS and Medicare EHR Incentive Program. For eligible hospitals and CAHs, this includes an aggregate electronic submission or a patient-level data submission through the method similar to the Medicare EHR Incentive Program Electronic Reporting Pilot, which is proposed for extension in the CY 2013 Hospital Outpatient Prospective Payment System (OPPS) proposed rule (July 30, 2012, 77 FR 45188). For electronic submissions, patient-level data must be submitted using the Quality Reporting Data Architecture (QRDA) Category I format, and aggregate-level data must be submitted using the QRDA Category III format.

c. Payment Adjustments and Exceptions

Medicare payment adjustments are required by statute to take effect in 2015. We are finalizing a process by which payment adjustments will be determined by a prior reporting period. Therefore, we specify that EPs and eligible hospitals that are meaningful EHR users in 2013 will avoid payment adjustment in 2015. Also, if such providers first meet meaningful use in 2014, they will avoid the 2015 payment adjustment, if they are able to demonstrate meaningful use at least 3 months prior to the end of the calendar (for EPs) or fiscal year (for eligible hospitals) and meet the registration and attestation requirement by July 1, 2014 (for eligible hospitals) or October 1, 2014 (for EPs).

We also are finalizing exceptions to these payment adjustments. This final rule outlines four categories of exceptions based on (1) the lack of availability of internet access or barriers to obtaining IT infrastructure; (2) a time-limited exception for newly practicing EPs or new hospitals that will not otherwise be able to avoid payment adjustments; (3) unforeseen circumstances such as natural disasters that will be handled on a case-by-case basis; and (4) (EP only) exceptions due to a combination of clinical features limiting a provider's interaction with patients or, if the EP practices at multiple locations, lack of control over the availability of CEHRT at practice locations constituting 50 percent or more of their encounters.

d. Modifications to Medicaid EHR Incentive Program

We are expanding the definition of what constitutes a Medicaid patient encounter, which is a required eligibility threshold for the Medicaid EHR Incentive Programs. We include encounters for individuals enrolled in a Medicaid program, including Title XXI-funded Medicaid expansion encounters (but not separate Children's Health Insurance Programs (CHIPs)). We also specify flexibility in the lookback period for patient volume to be over the 12 months preceding attestation, not tied to the prior calendar year.

We are also making eligible approximately 12 additional children's hospitals that have not been able to participate to date, despite meeting all other eligibility criteria, because they do not have a CMS Certification Number since they do not bill Medicare.

These changes would take effect beginning with payment year 2013.

e. Stage 2 Timeline Delay

Lastly, we are finalizing a delay in the implementation of the onset of Stage 2 criteria. In the Stage 1 final rule, we established that any provider who first attested to Stage 1 criteria in 2011 would begin using Stage 2 criteria in 2013. This final rule delays the onset of those Stage 2 criteria until 2014, which we believe provides the needed time for vendors to develop CEHRT. We are also introducing a special 3-month EHR reporting period, rather than a full year of reporting, for providers attesting to either Stage 1 or Stage 2 in 2014 in order to allow time for providers to implement newly certified CEHRT. In future years, providers who are not in their initial year of demonstrating meaningful use must meet criteria for 12-month reporting periods. The 3-month reporting period allows providers flexibility in their first year of meeting Stage 2 without warranting any delay for Stage 3. This policy is consistent with CMS's commitment to ensure that Stage 3 occurs on schedule (implemented by 2016).

3. Summary of Costs and Benefits

This final rule is anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under the Executive Order and a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the final rule. The total Federal cost of the Medicare and Medicaid EHR Incentive Programs between 2014 and 2019 is estimated to be $15.4 billion (these estimates include net payment adjustments for Medicare providers who do not achieve meaningful use in 2015 and subsequent years in the amount of $2.1 billion). In this final rule we have not quantified the overall benefits to the industry, nor to EPs, eligible hospitals, or CAHs participating in the Medicare and Medicaid EHR Incentive Programs. Information on the costs and benefits of adopting systems specifically meeting the requirements for the EHR Incentive Programs has not yet been collected and information on costs and benefits overall is limited. Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs, including reductions in medical recordkeeping costs, reductions in repeat tests, decreases in length of stay, increased patient safety, and reduced medical errors. There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs.

TABLE 1—Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the HITECH EHR Incentive Program. (Fiscal year)—(in Billions) Back to Top
Fiscal year Medicare eligible Medicaid eligible Total
Hospitals Professionals Hospitals Professionals
2014 $2.1 $1.9 $0.6 $0.5 $5.10
2015 1.8 1.9 0.4 0.8 4.90
2016 1.2 0.6 0.5 0.8 3.10
2017 0.2 0.1 0.5 0.7 1.50
2018 ^0.1 ^0.2 0.1 0.7 0.50
2019 0.0 ^0.2 0.0 0.5 0.30

B. Overview of the HITECH Programs Created by the American Recovery and Reinvestment Act of 2009

The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) amended Titles XVIII and XIX of the Social Security Act (the Act) to authorize incentive payments to EPs, eligible hospitals, and CAHs, and Medicare Advantage (MA) Organizations to promote the adoption and meaningful use of CEHRT. In the July 28, 2010 Federal Register (75 FR 44313 through 44588) we published a final rule entitled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program,” that specified the Stage 1 criteria that EPs, eligible hospitals, and CAHs must meet in order to qualify for an incentive payment, calculation of the incentive payment amounts, and other program participation requirements (hereinafter referred to as the Stage 1 final rule). (For a full explanation of the amendments made by ARRA, see the Stage 1 final rule (75 FR 44316).) In that final rule, we also detailed that the Medicare and Medicaid EHR Incentive Programs will consist of 3 different stages of meaningful use requirements.

For Stage 1, CMS and the Office of the National Coordinator for Health Information Technology (ONC) worked closely to ensure that the definition of meaningful use of CEHRT and the standards and certification criteria for CEHRT were coordinated. Current ONC regulations may be found at 45 CFR part 170.

For Stage 2, CMS and ONC again worked together to align our regulations.

In the March 7, 2012 Federal Register (77 FR 13698), we published a proposed rule that specified the potential Stage 2 criteria that EPs, eligible hospitals, and CAHs would have to meet in order to qualify for Medicare and/or Medicaid EHR incentive payments (hereinafter referred to as the Stage 2 proposed rule). In addition, the proposed rule —(1) proposed payment adjustments under Medicare for covered professional services and hospital services provided by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use of CEHRT and other program participation requirements; and (2) proposed the revision of certain Stage 1 criteria, as well as criteria that apply regardless of stage.

In the April 18, 2012 Federal Register (77 FR 23193), we published a document that corrected typographical and technical errors in the March 7, 2012 Stage 2 proposed rule.

Simultaneously in the March 7, 2012 Federal Register (77 FR 13832), ONC published its notice of proposed rulemaking titled Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology. The notice of proposed rulemaking proposed revisions to the initial set of standards, implementation specifications, and certification criteria in ONC's July 28, 2010 final rule as well as the adoption of new standards, implementation specifications, and certification criteria.

We urge those interested in this final rule to also review the ONC final rule on standards and implementation specifications for CEHRT. Readers may also visit http://www.cms.hhs.gov/EHRincentiveprograms and http://healthit.hhs.gov for more information on the efforts at the Department of Health and Human Services (HHS) to advance HIT initiatives.

II. Provisions of the Proposed Regulations and Analysis of and Responses to Public Comments Back to Top

We received approximately 6,100 items of timely correspondence in response to our Stage 2 proposed rule published in the March 7, 2012 Federal Register. We received some comments that were outside the scope of the proposed rule and therefore are not addressed in this final rule. Summaries of the timely public comments that are within the scope of the Stage 2 proposed rule and our responses to those comments are set forth in the various sections of this final rule under the appropriate headings. We have generally organized those sections by stating our proposals, summarizing and responding to the timely public comments received, and describing our final policy.

A. Definitions Across the Medicare FFS, Medicare Advantage, and Medicaid Programs

1. Uniform Definitions

As discussed in the proposed rule, in the Stage 1 final rule, we finalized many uniform definitions for the Medicare FFS, Medicare Advantage (MA), and Medicaid EHR incentive programs. These definitions are set forth in part 495 subpart A of the regulations, and we proposed to maintain most of these definitions, including, for example, “Certified EHR Technology (CEHRT),” “Qualified EHR,” “Payment Year,” and “First, Second, Third, Fourth, Fifth, and Sixth Payment Year.” We noted in the Stage 2 proposed rule that our definitions of “CEHRT” and “Qualified EHR” incorporate the definitions adopted by ONC, and to the extent that ONC's definitions are revised, our definitions would also incorporate those changes. For these definitions, we refer readers to ONC's standards and certification criteria final rule that is published elsewhere in this issue of the Federal Register.

We did not receive any comments on our proposal and will continue to use the existing definitions in part 495 subpart A, except where stated otherwise in this final rule.

We stated that we would revise the descriptions of the EHR reporting period to clarify that providers who are demonstrating meaningful use for the first time would have an EHR reporting period of 90 days regardless of payment year. We proposed to add definitions for the applicable EHR reporting period that would be used in determining the payment adjustments, as well as a definition of a payment adjustment year.

A summary of the comments pertaining to the EHR reporting period, the applicable EHR reporting period for determining the payment adjustments, and the definition of a payment adjustment year, as well as our responses to those comments, can be found in sections II.A.3.a and II.D.2 of this final rule.

2. Meaningful EHR User

We proposed to include clinical quality measure reporting as part of the definition of “meaningful EHR user” under § 495.4 instead of as a separate meaningful use objective under § 495.6.

Comment: A few commenters suggested that this change would create confusion, but the majority supported this change to alleviate confusion caused by the current situation. Many comments discussed the specifics of clinical quality measures.

Response: We appreciate the support expressed for the proposal. We continue to believe that separating clinical quality measures from the meaningful use objectives and measures in § 495.6 will reduce confusion and finalize the change as proposed. We address comments on the specifics of clinical quality measures in section II.B of this final rule. While clinical quality measure reporting will no longer be listed as a separate objective and measure in § 495.6, as it is now incorporated in the definition of meaningful EHR user in § 495.4, it remains a condition for demonstrating meaningful use.

We proposed to revise the third paragraph of the definition of meaningful EHR user at § 495.4 to refer specifically to the payment adjustments and read as follows: “(3) To be considered a meaningful EHR user, at least 50 percent of an EP's patient encounters during an EHR reporting period for a payment year (or during an applicable EHR reporting period for a payment adjustment year) must occur at a practice/location or practices/locations equipped with CEHRT.” We did not receive any comments on this revision and we are finalizing it as proposed.

3. Definition of Meaningful Use

a. Considerations in Defining Meaningful Use

In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the Congress identified the broad goal of expanding the use of EHRs through the concept of meaningful use. Section 1903(t)(6)(C) of the Act also requires that Medicaid providers adopt, implement, upgrade or meaningfully use CEHRT if they are to receive incentives under Title XIX. CEHRT used in a meaningful way is one piece of the broader HIT infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety. This vision of reforming the health care system and improving health care quality, efficiency, and patient safety should inform the definition of meaningful use.

As we explained in our Stage 1 meaningful use rule and again in our Stage 2 proposed rule, we seek to balance the sometimes competing considerations of health system advancement (for example, improving health care quality, encouraging widespread EHR adoption, promoting innovation) and minimizing burdens on health care providers given the short timeframe available under the HITECH Act.

Based on public and stakeholder input received during our Stage 1 rule, we laid out a phased approach to meaningful use. Such a phased approach encompasses reasonable criteria for meaningful use based on currently available technology capabilities and provider practice experience, and builds up to a more robust definition of meaningful use as technology and capabilities evolve. The HITECH Act acknowledges the need for this balance by granting the Secretary the discretion to require more stringent measures of meaningful use over time. Ultimately, consistent with other provisions of law, meaningful use of CEHRT should result in health care that is patient centered, evidence-based, prevention-oriented, efficient, and equitable.

Under this phased approach to meaningful use, we update the criteria of meaningful use through staggered rulemaking. We published the Stage 1 final rule (75 FR 44314) on July 28, 2010, and this rule finalizes the criteria and other requirements for Stage 2. We currently are planning at least one additional update, and anticipate finalizing the Stage 3 criteria through additional rulemaking in early 2014 with Stage 3 starting in 2016. The stages represent an initial graduated approach to arriving at the ultimate goal.

  • The Stage 1 meaningful use criteria, consistent with other provisions of Medicare and Medicaid law, focused on electronically capturing health information in a structured format; using that information to track key clinical conditions and communicating that information for care coordination purposes (whether that information is structured or unstructured, but in structured format whenever feasible); implementing clinical decision support tools to facilitate disease and medication management; using EHRs to engage patients and families and reporting clinical quality measures and public health information. Stage 1 focused heavily on establishing the functionalities in CEHRT that will allow for continuous quality improvement and ease of information exchange. By having these functionalities in CEHRT at the onset of the program and requiring that the EP, eligible hospital or CAH become familiar with them through the varying levels of engagement required by Stage 1, we believe we created a strong foundation to build on in later years. Though some functionalities were optional in Stage 1, all of the functionalities are considered crucial to maximize the value to the health care system provided by CEHRT. We encouraged all EPs, eligible hospitals and CAHs to be proactive in implementing all of the functionalities of Stage 1 in order to prepare for later stages of meaningful use, particularly functionalities that improve patient care, the efficiency of the health care system and public and population health. The specific criteria for Stage 1 of meaningful use are discussed in the Stage 1 final rule, published on July 28, 2010 (75 FR 44314 through 44588). We are finalizing certain changes to the Stage 1 criteria in section II.A.3.b. of this final rule.
  • Stage 2: We stated in the Stage 2 proposed rule that our Stage 2 goals, consistent with other provisions of Medicare and Medicaid law, would expand upon the Stage 1 criteria with a focus on ensuring that the meaningful use of EHRs supports the aims and priorities of the National Quality Strategy. Specifically, Stage 2 meaningful use criteria would encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible. Our proposed Stage 2 meaningful use requirements included rigorous expectations for health information exchange including: more demanding requirements for e-prescribing; incorporating structured laboratory results; and the expectation that providers will electronically transmit patient care summaries with each other and with the patient to support transitions in care. Increasingly robust expectations for health information exchange in Stage 2 and Stage 3 would support the goal that information follows the patient. In addition, as we forecasted in the Stage 1 final rule, we proposed that nearly every objective that was optional for Stage 1 would be part of the core for Stage 2.
  • Stage 3: We anticipate that Stage 3 meaningful use criteria will focus on: promoting improvements in quality, safety and efficiency leading to improved health outcomes; focusing on decision support for national high priority conditions; patient access to self-management tools; access to comprehensive patient data through robust, secure, patient-centered health information exchange; and improving population health. For Stage 3, we currently intend to propose higher standards for meeting meaningful use. For example, we intend to propose that every objective in the menu set for Stage 2 be included in Stage 3 as part of the core set. While the use of a menu set allows providers flexibility in setting priorities for EHR implementation and takes into account their unique circumstances, we maintain that all of the objectives are crucial to building a strong foundation for health IT and to meeting the objectives of the HITECH Act. In addition, as the capabilities of HIT infrastructure increase, we may raise the thresholds for these objectives in both Stage 2 and Stage 3.

In the Stage 1 final rule (75 FR 44323), we published the following Table 2 with our expected timeline for the stages of meaningful use.

Table 2—Stage of Meaningful Use Criteria by Payment Year as Finalized in 2010 Back to Top
First payment year Payment year
2011 2012 2013 2014 2015
2011 Stage 1 Stage 1 Stage 2 Stage 2 TBD
2012 Stage 1 Stage 1 Stage 2 TBD
2013 Stage 1 Stage 1 TBD
2014 Stage 1 TBD

We proposed changes to this timeline as well as its extension beyond 2014. As we explained in the Stage 2 proposed rule, under the timeline used in Table 2, an EP, eligible hospital, or CAH that became a meaningful EHR user for the first time in 2011 would need to begin their EHR reporting period for Stage 2 on January 1, 2013 (EP) or October 1, 2012 (eligible hospital or CAH). The HITPC recommended we delay by 1 year the start of Stage 2 for providers who became meaningful EHR users in 2011. We stated in the proposed rule that Stage 2 of meaningful use would require changes to both technology and workflow that cannot reasonably be expected to be completed in the time between the publication of the final rule and the start of the EHR reporting periods as listed in Table 2. We noted the similar concerns we have heard from other stakeholders and agreed that, based on our proposed definition of meaningful use for Stage 2, providers could have difficulty implementing these changes in time. Therefore, we proposed a 1-year extension of Stage 1 of meaningful use for providers who successfully demonstrated meaningful use for 2011. Our proposed timeline through 2021, which we finalize in this rule with a notation of the special EHR reporting period in 2014, is displayed in Table 3. We refer readers to section II.D.2 of this final rule for a discussion of the applicable EHR reporting period that will be used to determine whether providers are subject to payment adjustments.

Table 3—Stage of Meaningful Use Criteria by First Payment Year Back to Top
First payment year Stage of meaningful use
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
*3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months at state option) for Medicaid EPs. All providers in their first year in 2014 use any continuous 90-day EHR reporting period.
2011 1 1 1 *2 2 3 3 TBD TBD TBD TBD
2012 1 1 *2 2 3 3 TBD TBD TBD TBD
2013 1 *1 2 2 3 3 TBD TBD TBD
2014 *1 1 2 2 3 3 TBD TBD
2015 1 1 2 2 3 3 TBD
2016 1 1 2 2 3 3
2017 1 1 2 2 3

We explained in the proposed rule that the Medicare EHR incentive program and the Medicaid EHR incentive program have different rules regarding the number of payment years available, the last year for which incentives may be received, and the last payment year for initiating the program. The last year for which an EP and an eligible hospital or CAH can begin receiving Medicare incentive payments is 2014 and 2015 respectively. These providers would begin in Stage 1 of meaningful use. Medicaid EPs and eligible hospitals can receive a Medicaid EHR incentive payment for “adopting, implementing, and upgrading” (AIU) to CEHRT for their first payment year, which is not reflected in Table 3. For example, a Medicaid EP who earns an incentive payment for AIU in 2013 would have to meet Stage 1 of meaningful use in his or her next 2 payment years (2014 and 2015). The applicable payment years and the incentive payments available for each program are discussed in the Stage 1 final rule.

If we anticipate future criteria beyond Stage 3 of meaningful use, we expect to update Table 3 in the rulemaking for Stage 3, which remains on schedule for implementation in 2016.

Comment: We received numerous comments, which represented a significant majority of all comments received, on the timing of the stages of meaningful use. Commenters asserted that the timeline is too aggressive and will result in many providers being unable to meet Stage 2 of meaningful use, particularly those who first attested in 2011 and 2012. The most common justification for this claim was the lack of sufficient time between the publication of this final rule and the time when a provider who first attested to meaningful use in 2011 or 2012 would have to begin Stage 2 of meaningful use. Some commenters suggested that the time was insufficient regardless of resource constraints, while others suggested that currently vendors of CEHRT lack the necessary capacity to make the necessary upgrades to their CEHRT products and implement them for their customers in time. Commenters also pointed to competing priorities and demands on provider time and resources, such as the transition to ICD-10, the various programs and policies under the Affordable Care Act and other priorities that diminish the time and resources that can be devoted to reaching Stage 2 of meaningful use. Commenters offered several suggestions on how to increase the time available between publication of this final rule and the EHR reporting periods in 2014. The suggestions included using a shorter than full year EHR reporting period in 2014, delaying the start of Stage 2 until 2015 and using a shorter than full year EHR reporting period in 2015, and delaying the start of Stage 2 until 2015 with a full year EHR reporting period. Several commenters suggested a minimum of 18 months is needed, while others suggested longer periods.

Response: While our proposal would provide more than a year between the publication of this final rule and the first day any provider would start their EHR reporting period in 2014 for any stage of meaningful use, we agree that additional time to demonstrate meaningful use in 2014 would be helpful to providers, many of whom will need to upgrade to new technology as well as ensure they are able to meet all of the objectives and measures for Stage 2. In considering what would be an appropriate length of time between publication of this final rule and the start of the EHR reporting periods for providers in 2014 for either Stage 2 or Stage 1, we weighed two primary factors against the comments calling for a delay. The first is that by delaying Stage 2 until 2015, the movement towards improved outcomes that is the main goal of meaningful use would be put off by a full year. This full-year delay would have a ripple effect through the timeline of the stages as providers move along their own timelines across the stages of meaningful use. For this reason, we will not delay Stage 2 until 2015, but instead we are using a 3-month EHR reporting period in 2014 as the first year any provider would attest to Stage 2. The second consideration is the data integrity of meaningful use attestations and clinical quality measure submissions, especially as it relates to our efforts towards alignment with other programs such as PQRS, Medicare Shared Savings Program (SSP), and potentially others. The more robust data set provided by a full year reporting period offers more opportunity for alignment than the data set provided by a shorter reporting period, especially compared across years. By altering the reporting period from year to year the data is less comparable from year to year. However, we agree with commenters that the use of a shorter EHR reporting period in 2014 is necessary to allow sufficient time for vendors to upgrade their CEHRT and for providers to implement it. In an effort to preserve some data validity with similar Medicare quality measurement programs, we are finalizing 3-month quarter EHR reporting periods in 2014 for certain providers that are beyond their first year of meaningful use, rather than any continuous 90-day period within the year as for first-time meaningful users. For more information on alignment with other programs, we refer readers to our discussion on clinical quality measures (see section II.B.1. of this final rule).

While commenters generally suggested a shorter EHR reporting period for the start of Stage 2 in any year rather than just Stage 2 in 2014, we believe that most of the reasons for a shorter period are due to the time constraints for vendor certification, upgrades and provider implementation between publication of this final rule and the beginning of Stage 2 in 2014. Any provider starting Stage 2 after 2014 will have more time and therefore most of the constraints are lifted. We acknowledge that not all constraints go away, but we believe that the balance is sufficiently shifted such that the concerns of data validity and program alignment outweigh the few remaining concerns with a full year EHR reporting period for the provider's first year of Stage 2 if it is after 2014. In addition, since ONC's 2014 Edition certification is for all EHR systems, regardless of the stage of meaningful use the provider using that system is in, there are far fewer implementation concerns after 2014. For example, if a provider begins Stage 2 in 2015, that provider would have been required to use CEHRT (that was certified to the 2014 Edition EHR certification criteria) for the previous year (2014) for Stage 1.

Finally, we considered that for the Medicaid EHR incentive program, EPs work exclusively with the states as they must choose between either the Medicare or Medicaid EHR incentive program. We do not know whether shifting from an EHR reporting period of any continuous 90 days to a 3-month quarter will provide any alignment benefits for Medicaid EPs, and it could introduce system complexity for Medicaid agencies. Therefore, we are maintaining flexibility for states to allow Medicaid EPs to select any continuous 90-day EHR reporting period during 2014 as defined by the state Medicaid program, or, if the state so chooses, any 3-month calendar quarter in 2014. As nearly all hospitals participate in both Medicare and Medicaid, we are using the 3-month quarter EHR reporting period for all hospitals to align both programs.

After consideration of the public comments received, we are modifying our proposal with regard to the EHR reporting periods for EPs, eligible hospitals and CAHs that attest to meaningful use for 2014 for their first year of Stage 2 or their second year of Stage 1. Our final policy is as follows: For 2014, Medicare EPs will attest using an EHR reporting period of January 1, 2014 through March 31, 2014; April 1, 2014 through June 30, 2014; July 1, 2014 through September 30, 2014; or October 1, 2014 through December 31, 2014. For 2014, Medicare and Medicaid eligible hospitals and CAHs will attest using an EHR reporting period of October 1, 2013 through December 31, 2013; January 1, 2014 through March 31, 2014; April 1, 2014 through June 30, 2014; or July 1, 2014 through September 30, 2014. Medicaid EPs will attest using an EHR reporting period of any continuous 90-day period between January 1, 2014 and December 1, 2014 as defined by the state Medicaid program, or, if the state so chooses, any 3-month calendar quarter in 2014.

b. Changes to Stage 1 Criteria for Meaningful Use

We proposed the following changes to the objectives and associated measures for Stage 1:

  • Computerized Provider Order Entry (CPOE)—In 2013 (CY for EPs, FY for eligible hospitals/CAHs), we proposed that providers in Stage 1 could use the alternative denominator of the number of medication orders created by the EP or in the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period (for further explanation of this alternative denominator, see the discussion of the CPOE objective in the Stage 2 criteria section at II.A.3.d. of this final rule).

A provider seeking to meet Stage 1 in 2013 can use either the denominator defined in the Stage 1 final rule or the alternative denominator to calculate the percentage for the CPOE measure. We also proposed to require the alternative denominator for Stage 1 beginning in 2014.

Comment: Commenters both supported and opposed the new denominator for CPOE. Those supporting the proposed denominator did so for its simplicity and greater accuracy for measuring actual CPOE usage. Those opposing the proposed denominator did so either because they were concerned with the burden associated with counting paper or other orders that are never entered into the EHR or because of the potential higher performance required by the proposed denominator.

Response: We proposed the alternative denominator to alleviate the burden associated with measurement, not to create a higher performance threshold. As we stated in the proposed rule, feedback from many providers indicated that the alternative denominator was more easily measurable. In response to concerns from commenters, we are finalizing the alternative denominator for this measure and specify that providers at any year in Stage 1 may elect to use either the denominator defined in the Stage 1 final rule or the alternative denominator to calculate the percentage for the CPOE measure. In response to comments, we are not requiring that the alternative denominator be used beginning in 2014, which will give providers who may find it difficult to measure the flexibility to continue to use the denominator defined in the Stage 1 final rule.

  • Vital Signs—For the objective of record and chart changes in vital signs, the proposed Stage 2 measure would allow an EP to split the exclusion and exclude blood pressure only or height/weight only (for more detail, see the discussion of this objective in the Stage 2 criteria section at II.A.3.d. of the final rule). We proposed an identical change to the Stage 1 exclusion as well, starting in CY 2013. We also proposed changing the age limitations on vital signs for Stage 2 (for more detail, see the discussion of this objective in the Stage 2 criteria section). We proposed an identical change to the age limitations on vital signs for Stage 1, starting in 2013 (CY for EPs, FY for eligible hospitals/CAHs). These changes to the exclusion and age limitations were proposed as an alternative in 2013 to the current Stage 1 requirements but required for Stage 1 beginning in 2014.

Comment: While some commenters suggested that these changes would be confusing, most commenters supported the changes and indicated that they would provide added flexibility for providers who seek to incorporate the recording of this data into their clinical workflow. These commenters also noted that the age change reflects best clinical practices. Some commenters suggested removing BMI and growth charts from the measure since there are no best practices on BMI for patients under 3 years of age and since providers who would not record height and weight would not be able to provide BMI or growth charts.

Response: We appreciate the support for these changes and finalize them as proposed. We also note that BMI and growth charts are not required to meet this measure but are instead a capability provided by CEHRT. Providers who claim the exclusion for height and weight will not have data for CEHRT to create either BMI or growth charts and this will not affect their ability to meet the measure of this objective.

Comment: Some commenters requested clarification on whether providers who provide ancillary services and do not normally record any of these elements as part of their regular scope of practice can claim the exclusion.

Response: If a provider believes that height and weight and/or blood pressure are relevant to their scope of practice, they must record those data elements and cannot qualify for the exclusion. We believe that most providers who provide ancillary services can meet the measure of this objective by obtaining this information from a referring provider and recording the necessary data in their CEHRT.

Comment: Some providers asked for clarification on whether providers who only occasionally record height and weight and/or blood pressure are still permitted to claim the exclusions for this measure.

Response: We recognize that there are situations in which certain providers may only record height and weight and/or blood pressure for a very limited number of patients (for example, high-risk surgical patients or patients on certain types of medication) but do not normally regard these data as relevant to their scope of practice. When a provider does not believe that height and weight and/or blood pressure are typically relevant to their scope of practice but still records these vital signs only in exceptional circumstances, the provider is permitted to claim the exclusions for this measure.

After consideration of the public comments received, we are finalizing the changes to vital signs as proposed. We are making technical corrections to the regulation text at § 495.6(d)(8) and § 495.6(f)(7) to clarify these are alternatives in 2013 and required beginning in 2014.

  • Exchange Key Clinical Information—As noted in the proposed rule, the objective of “capability to exchange key clinical information” has been surprisingly difficult for providers to understand, which has made the objective difficult for most providers to achieve. We solicited comment on several options for this objective that we believed would reduce or eliminate the burden associated with this objective or increase the value of the objective. The first option we considered was removal of this objective. The second option was to require that the test be successful. The third option was to eliminate the objective, but require that providers select either the Stage 1 medication reconciliation objective or the Stage 1 summary of care at transitions of care and referrals objective from the menu set. The fourth option was to move from a test to one case of actual electronic transmission of a summary of care document for a real patient either to another provider of care at a transition or referral or to a patient authorized entity. We proposed the first option to remove this objective and measure from the Stage 1 core set beginning in 2013 (CY for EPs, FY for eligible hospitals/CAHs), but we also stated we would evaluate all four options in light of the public comments we received.

Comment: While we received feedback and support from commenters on all of the proposed options, the majority of commenters supported the elimination of this objective for Stage 1. Some commenters instead supported a more exact definition of data exchange for this measure, and other commenters supported additional elements or additional requirements for exchange to be included as part of the measure. Other proposals included implementing a system that would allow case-by-case reporting of data exchange that would allow CMS to measure successes and failures by provider, vendor, and other elements.

Response: We appreciate the many suggestions from commenters on clarifying data exchange and/or adding requirements to the measure. We also appreciate the suggestion of a case-by-case reporting system for data exchange. However, we are concerned that all of these options would not alleviate but actually increase the burden of this measure for providers by requiring them to document and submit substantially greater information than is currently required by attestation. While such a burden may be justified, we do not believe it is in this case because the Stage 2 requirements for actual electronic exchange of summary of care records create sufficient incentive to begin testing in Stage 1 without there being an explicit meaningful use requirement to do so. Because of these concerns and in reaction to the opinion of most commenters, we are finalizing the removal of this objective and measure for Stage 1 beginning in 2013. Although some commenters suggested removing this objective earlier, we do not believe the timing of publication of this final rule would allow us to implement such a change and allow consistent reporting for all providers in 2012. Therefore, this objective and measure will be removed from the Stage 1 criteria beginning in 2013 (CY for EPs, FY for eligible hospitals and CAHs).

  • View Online, Download, and Transmit—We proposed for Stage 2 a new method for making patient information available electronically, which would enable patients to view online, download, and transmit their health information and hospital admission information. We discuss in the Stage 2 criteria section at II.A.3.d the “view online, download, and transmit” objectives for EPs and hospitals. We noted in the proposed rule that starting in 2014, CEHRT would no longer be certified to the Stage 1 EP and hospital core objectives of providing patients with electronic copies of their health information (§ 495.6(d)(12) and (f)(11)) or the Stage 1 hospital core objective of providing patients with electronic copies of their discharge instructions upon request (§ 495.6(f)(12)), nor would it support the Stage 1 EP menu objective of providing patients with timely electronic access to their health information (§ 495.6(e)(5)). Therefore starting in 2014, for Stage 1, we proposed to replace these objectives with the new “view online, download and transmit” objectives.

Comment: There were a number of commenters who asked for clarifications regarding the requirements of these objectives. Other commenters raised concerns regarding the implementation of these objectives in both Stage 1 and Stage 2.

Response: We discuss the clarifications and concerns raised by commenters in our Stage 2 criteria at II.A.3.d regarding these objectives. Please refer to those discussions for additional information.

Comment: Some commenters supported this change while other commenters disagreed with it. Those who disagreed with the proposed change indicated that providers would not be ready to implement online access to health information in Stage 1, and that it was unlikely that providers could convince more than 50 percent of patients to sign up for online access within the Stage 1 reporting period. These commenters suggested eliminating all of the Stage 1 objectives for providing electronic copies of health information or discharge summaries and not replacing these objectives with the “view, download, and transmit” objectives.

Response: We disagree that the Stage 1 objectives for providing patients with electronic copies of their health information and discharge instructions should be eliminated without replacing these objectives with the “view online, download, and transmit” objectives. We believe patient access to their health information is an important aspect of patient care and engagement, and we further believe that the capabilities of CEHRT in 2014 and beyond will enable providers to make this information available online in a way that does not impose a significant burden on providers.

We note that only the first measure of the “view online, download, and transmit” objectives would be required for Stage 1. This means that providers would only have to make information available online to view online, download, and transmit for more than 50 percent of all unique patients during the EHR reporting period in order to meet the measure. We further clarify that providers are only required to make this information available online to view online, download, and transmit and that patients who do not access the information or would not affect whether or not the provider is able to meet the measure. For Stage 1, providers are not required to meet the second measure of more than 5 percent of patients view online, download, or transmit to a third party their health or hospital admission information. Providers are only required to meet the second measure of the objectives in Stage 2. However, the exclusions for these objectives are available for providers in Stage 1. Therefore, we are finalizing our proposal to replace the existing Stage 1 EP and hospital objectives listed above with the “view online, download, and transmit” objectives beginning in 2014 for Stage 1. We are making a technical correction to the regulations text to clarify that the existing Stage 1 objective at § 495.6(f)(11) is being replaced. We clarify in Table 4 the four existing Stage 1 objectives that are being replaced. We are also making a technical correction to the regulation text to remove the existing exclusion for the objective at § 495.6(f)(12)(iii) beginning in 2014 because the objective that this exclusion applies to is being replaced.

  • Removing CQM Reporting from Stage 1 Objectives—We proposed a revised definition of a meaningful EHR user at § 495.4 which would incorporate the requirement to submit clinical quality measures, as discussed in section II.A.2 of this final rule. We also proposed to remove the objective to submit clinical quality measures from § 495.6 beginning in 2013 for Stage 1 to conform with this change in the definition of a meaningful EHR user.

Comment: While some commenters indicated that this change would be confusing, most commenters supported this change.

Response: We appreciate the support of commenters and believe that removing the objective will actually alleviate confusion. Therefore, as discussed earlier in II.A.2. of this final rule, we are finalizing as proposed, the revised definition of a meaningful EHR user at § 495.4 to include clinical quality measure submission, as well as the removal of this objective from § 495.6 beginning in 2013.

  • Public Health Objectives—For the Stage 1 public health objectives, beginning in 2013, we proposed to add “except where prohibited” to the regulation text in order to encourage all EPs, eligible hospitals, and CAHs to submit electronic immunization data, even when not required by state/local law. Therefore, if they are authorized to submit the data, they should do so even if it is not required by either law or practice. There are a few instances where some EPs, eligible hospitals, and CAHs are prohibited from submitting to a state/local immunization registry. For example, in sovereign tribal areas that do not permit transmission to an immunization registry or when the immunization registry only accepts data from certain age groups (for example, adults).

Comment: Some commenters supported this change while others disagreed with it. A number of commenters interpreted the proposed addition of language as a change to either the measure of the objectives or the exclusions that are currently in place.

Response: As noted in the proposed rule, the addition of this language was intended to ensure that providers who are not required by law or practice to submit data would do so and to make it clear that EPs, eligible hospitals, and CAHs that are prohibited from submitting data would not be required to submit such data. Immunizations was used as a descriptive example in the proposed rule, but this change applies to all Stage 1 public health objectives. The exclusions provided for these objectives in Stage 1 are not affected by the addition of this language and remain in place for all providers. Therefore, we are finalizing the addition of this language as proposed.

  • Menu Set Exclusions Policy—We proposed to change the policy on menu set exclusions for Stage 1 beginning in 2014. Please see section II.A.3.d. of this final rule for a discussion of the proposal and our final policy.

• Electronic Prescribing

Comment: We received comments pointing out that we proposed a new exclusion for electronic prescribing objective for Stage 2 regarding the availability of pharmacies that can accept electronic prescriptions. These commenters noted that if this exclusion was not also made available for Stage 1 then it would create a strange scenario where an EP might have to electronically prescribe during their 2 years of Stage 1 and then meet an exclusion in Stage 2.

Response: We agree that it makes no sense to apply this exclusion to e-prescribing in Stage 2, but not in Stage 1. We consider it an oversight of our proposed rule that we did not include that exclusion in our proposed changes to the Stage 1 criteria. We are finalizing an exclusion for the e-prescribing objective in Stage 2 for any EP who does not have a pharmacy within their organization and there are no pharmacies that accept electronic prescriptions within 10 miles of the EP's practice location at the start of his/her EHR reporting period. We are also finalizing the addition of this exclusion to Stage 1 starting in CY 2013.

Table 4—Stage 1 Changes Back to Top
Stage 1 objective Final changes Effective year (CY/FY)
Use CPOE for medication orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelines Change: Addition of an alternative measure More than 30 percent of medication orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using CPOE 2013 - Onward (Optional).
Generate and transmit permissible prescriptions electronically (eRx) Change: Addition of an additional exclusion Any EP who: does not have a pharmacy within their organization and there are no pharmacies that accept electronic prescriptions within 10 miles of the EP's practice location at the start of his/her EHR reporting period 2013—Onward (Required).
Record and chart changes in vital signs Change: Addition of alternative age limitations More than 50 percent of all unique patients seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have blood pressure (for patients age 3 and over only) and height and weight (for all ages) recorded as structured data 2013 Only (Optional).
Record and chart changes in vital signs Change: Addition of alternative exclusions 2013 Only (Optional).
Any EP who  
(1) Sees no patients 3 years or older is excluded from recording blood pressure;  
(2) Believes that all three vital signs of height, weight, and blood pressure have no relevance to their scope of practice is excluded from recording them;  
(3) Believes that height and weight are relevant to their scope of practice, but blood pressure is not, is excluded from recording blood pressure; or  
(4) Believes that blood pressure is relevant to their scope of practice, but height and weight are not, is excluded from recording height and weight.  
Record and chart changes in vital signs Change: Age limitations on height, weight and blood pressure 2014—Onward (Required).
More than 50 percent of all unique patients seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have blood pressure (for patients age 3 and over only) and height and weight (for all ages) recorded as structured data.  
Record and chart changes in vital signs Change: Changing the age and splitting the EP exclusion 2014—Onward (Required).
Any EP who  
(1) Sees no patients 3 years or older is excluded from recording blood pressure;  
(2) Believes that all three vital signs of height, weight, and blood pressure have no relevance to their scope of practice is excluded from recording them;  
(3) Believes that height and weight are relevant to their scope of practice, but blood pressure is not, is excluded from recording blood pressure; or  
(4) Believes that blood pressure is relevant to their scope of practice, but height and weight are not, is excluded from recording height and weight.  
Capability to exchange key clinical information (for example, problem list, medication list, medication allergies, and diagnostic test results), among providers of care and patient authorized entities electronically Change: Objective is no longer required 2013—Onward (Required).
Report ambulatory (hospital) clinical quality measures to CMS or the states Change: Objective is incorporated directly into the definition of a meaningful EHR user and eliminated as an objective under § 495.6 2013—Onward (Required).
EP and Hospital Objectives: Provide patients with an electronic copy of their health information (including diagnostics test results, problem list, medication lists, medication allergies, discharge summary, procedures) upon request Change: Replace these four objectives with the Stage 2 objective and one of the two Stage 2 measures. 2014—Onward (Required).
EP Objective: Provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the EP.  
EP Measure: More than 50 percent of all unique patients seen by the EP during the EHR reporting period are provided timely (within 4 business days after the information is available to the EP) online access to their health information subject to the EP's discretion to withhold certain information.  
Hospital Objective: Provide patients with an electronic copy of their discharge instructions at time of discharge, upon request Hospital Objective: Provide patients the ability to view online, download, and transmit information about a hospital admission.  
EP Objective: Provide patients with timely electronic access to their health information (including lab results, problem list, medicatiion lists, and allergies) within 4 business days of the information being available to the EP. Hospital Measure: More than 50 percent of all patients who are discharged from the inpatient or emergency department (POS 21 or 23) of an eligible hospital or CAH have their information available online within 36 hours of discharge.  
Public Health Objectives: Change: Addition of “except where prohibited” to the objective regulation text for the public health objectives under § 495.6 2013—Onward (Required).
Stage 1 Policy Changes    
Meeting an exclusion for a menu set objective counts towards the number of menu set objectives that must be satisfied to meet meaningful use Meeting an exclusion for a menu set objective does not count towards the number of menu set objectives that must be satisfied to meet meaningful use. 2014—Onward (Required).

c. State Flexibility for Stage 2 of Meaningful Use

We proposed to offer states flexibility under the Medicaid incentive program with the public health measures in Stage 2, similar to that of Stage 1, subject to the same conditions and standards as the Stage 1 flexibility policy. This applies to the public health measures as well as the measure to generate lists of specific conditions to use for quality improvement, reduction of disparities, research or outreach. We clarify that our proposal included the existing public health measures from Stage 1 as well as the new public health measures proposed for Stage 2.

In addition, we stated that whether a state moved an objective to the core or left it in the menu, states may also specify the means of transmission of the data or otherwise change the public health measure, as long as it does not require EHR functionality above and beyond that which is included in the 2014 ONC EHR certification criteria.

We solicited comments on extending state flexibility as described for Stage 2 of meaningful use and whether this remains a useful tool for state Medicaid agencies.

Comment: Commenters requested clarification of the requirement that states cannot require EHR functionality above and beyond that which is included in the 2014 ONC EHR certification criteria. These commenters point out that the Stage 2 public health measures require capabilities beyond that which is included in the 2014 ONC EHR certification criteria already.

Response: We assume commenters are referring to transmission methods which are not included in 2014 Edition EHR certification criteria adopted by ONC for public health objectives (immunizations, electronically reportable lab results, syndromic surveillance, cancer registries and specialized registries). This limitation applies only to those capabilities and standards included in 2014 ONC EHR certification criteria for a given public health objective. For example, a state could not require a different standard than the one included in 2014 ONC EHR certification criteria. In cases where the 2014 ONC EHR certification criteria are silent, such as the means of transmission for a given public health objective, the state may propose changes to public health measures.

Comment: Several commenters supported extending state flexibility with meaningful use for Stage 2, but requested that CMS provide a clearer definition of state flexibility. Commenters suggested that it would be helpful to EPs and eligible hospitals if states follow a common timeline for establishing state-specific requirements.

Response: We appreciate these comments and would like to clarify that the state flexibility for Stage 2 remains defined the same way as it is defined in Stage 1 at § 495.316 (d)(2) and § 495.322 (f)(2). Given that states are launching their programs at different times and are therefore at different stages in the program lifecycle and process, at this time we do not support the development of a common timeline for establishing state-specific requirements. The parameters remain the same as for Stage 1 and providers are subject to the requirements found in § 495.332. CMS approval of states' requests will include a review of the outlined elements.

After consideration of the public comments received, we are finalizing these provisions as proposed.

d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)

We proposed to continue the Stage 1 concept of a core set of objectives and a menu set of objectives for Stage 2. In the Stage 1 final rule (75 FR 44322), we indicated that for Stage 2, we expected to include the Stage 1 menu set objectives in the core set. We proposed to follow that approach for our Stage 2 core set with two exceptions. We proposed to keep the objective of “capability to submit electronic syndromic surveillance data to public health agencies” in the menu set for EPs. Our experience with Stage 1 is that very few public health agencies have the ability to accept non-emergency or non urgent care ambulatory syndromic surveillance data electronically and those that do are less likely to support EPs than hospitals; therefore we do not believe that current infrastructure supports moving this objective to the core set for EPs. We also proposed to keep the objective of “record advance directives” in the menu set for eligible hospitals and CAHs. As we stated in our Stage 1 final rule (75 FR 44345), we have continuing concerns that there are potential conflicts between storing advance directives and existing state laws.

We proposed new objectives for Stage 2, some of which would be part of the Stage 2 core set and others would make up the Stage 2 menu set, as discussed below with each objective. We proposed to eliminate certain Stage 1 objectives for Stage 2, such as the objective for testing the capability to exchange key clinical information. We proposed to combine some of the Stage 1 objectives for Stage 2. For example, the objectives of maintaining an up-to-date problem list, active medication list, and active medication allergy list would not be separate objectives for Stage 2. Instead, we proposed to combine these objectives with the objective of providing a summary of care record for each transition of care or referral by including them as required fields in the summary of care.

We proposed a total of 17 core objectives and 5 menu objectives for EPs. We proposed that an EP must meet the criteria or an exclusion for all of the core objectives and the criteria for 3 of the 5 menu objectives. This is a change from our current Stage 1 policy where an EP could reduce the number of menu set objectives that the EP would otherwise need to meet by the number of menu set objectives that the EP could exclude. We noted the feedback we received on Stage 1 from providers and health care associations leads us to believe that most EPs had difficulty understanding the concept of deferral of a menu objective in Stage 1. Therefore, we proposed this change for Stage 2, as well as for Stage 1 beginning in 2014, to make the selection of menu objectives easier for EPs. We also proposed this change because we are concerned that under the current Stage 1 requirements some EPs could select and exclude menu objectives when there are other menu objectives they can legitimately meet, thereby making it easier for them to demonstrate meaningful use than EPs who attempt to legitimately meet the full complement of menu objectives. Although we provided the ability to do this in the selection of Stage 1 menu objectives through 2013, we stated that EPs participating in Stage 1 and Stage 2 starting in 2014 should focus solely on those objectives they can meet rather than those for which they have an exclusion. In addition, we noted the exclusions for the Stage 2 menu objectives that we believe would accommodate EPs who are unable to meet certain objectives because of scope of practice. However, just as we signaled in our Stage 1 regulation, we stated our intent to propose in our next rulemaking that every objective in the menu set for Stage 2 (as described later in this section) be included in Stage 3 as part of the core set.

We explained that in the case where an EP meets the criteria for the exclusions for 3 or more of the Stage 2 menu objectives, the EP would have more exclusions than the allowed deferrals. EPs in this situation would attest to an exclusion for 1 or more menu objectives in his or her attestation to meaningful use. In doing so, the EP would be attesting that he or she also meets the exclusion criteria for all of the menu objectives that he or she did not choose. We stated that the same policy would also apply for the Stage 1 menu objectives for EPs beginning in 2014.

We proposed a total of 16 core objectives and 4 menu objectives for eligible hospitals and CAHs for Stage 2. We proposed that an eligible hospital or CAH must meet the criteria or an exclusion for all of the core objectives and the criteria for 2 of the 4 menu objectives. We proposed that the policy for exclusions for EPs discussed in the preceding paragraph would also apply to eligible hospitals and CAHs for Stage 1 beginning in 2014 and for Stage 2.

We received many comments on the appropriateness of individual objectives placement in the core or menu set. We discuss these comments below for each individual objective.

Comment: Commenters expressed concern over the small number of objectives in the menu set. They were concerned that the small number of objectives limited the usefulness of the menu set to providers.

Response: Stage 2 does contain a more specialized and smaller menu set than Stage 1. We see this as a natural result of moving up the staged path towards improved outcomes and adding fewer new objectives. We also see specialization as necessary for meaningful use to be applicable to all EPs. Due to comments received we are adding two objectives for hospitals and one for EPs which will be in the menu, as further explained later in this section.

After consideration of the public comments received, we finalize the concept of a core and menu set for Stage 2.

We finalize a total of 17 core objectives and 6 menu objectives for EPs for Stage 2. We finalize that an EP must meet the criteria or an exclusion for all of the core objectives and the criteria for 3 of the 6 menu objectives unless an exclusion can be claimed for more than 3 of the menu objectives in which case the criteria for the remaining non-excluded objectives must be met.

We finalize a total of 16 core objectives and 6 menu objectives for eligible hospitals and CAHs for Stage 2. We finalize that an eligible hospital or CAH must meet the criteria or an exclusion for all of the core objectives and the criteria for 3 of the 6 menu objectives.

We also finalize our proposal to change the menu set exclusions policy for Stage 1. Beginning in 2014, qualifying for an exclusion from a menu set objective will no longer reduce the number of menu set objectives that an EP or hospital must otherwise satisfy to demonstrate meaningful use for Stage 1. There is an exception for EPs who meet the criteria to exclude five or more of the menu set objectives, in which case the EP must meet the criteria for all of the remaining non-excluded menu set objectives. This exception would not be applicable to hospitals due to the number of hospital menu set objectives that include exclusions.

(1) Discussion of Whether Certain EPs, Eligible Hospitals or CAHs Can Meet All Stage 2 Meaningful Use Objectives Given Established Scopes of Practice

We noted in the proposed rule that we do not believe that any of the proposed new objectives for Stage 2 make it impossible for any EP, eligible hospital or CAH to meet meaningful use. Where scope of practice may prevent an EP, eligible hospital or CAH from meeting the measure associated with an objective, we discussed the barriers and included exclusions in our descriptions of the individual objectives. We proposed to include new exclusion criteria when necessary for new objectives, continue the Stage 1 exclusions for Stage 2, and continue the option for EPs and hospitals to defer some of the objectives in the menu set unless they meet the exclusion criteria for more objectives than they can defer as explained previously.

We recognized in the proposed rule that at the time of publication, our data (derived internally from attestations) only reflected the meaningful use attestations from Medicare providers. There have been no significant changes in the data derived from meaningful use attestations since the publication of the proposed rule.

We did not receive any comments on this provision.

(2) EPs Practicing in Multiple Practices/Locations

We proposed for Stage 2 to continue our policy that to be a meaningful EHR user, an EP must have 50 percent or more of his or her outpatient encounters during the EHR reporting period at a practice/location or practices/locations equipped with CEHRT. An EP who does not conduct at least 50 percent of their patient encounters in any one practice/location would have to meet the 50 percent threshold through a combination of practices/locations equipped with CEHRT. We gave the following in the proposed rule example: if the EP practices at a federally qualified health center (FQHC) and within his or her individual practice at 2 different locations, we would include in our review all 3 of these locations, and CEHRT would have to be available at one location or a combination of locations where the EP has 50 percent or more of his or her patient encounters. If CEHRT is only available at one location, then only encounters at this location would be included in meaningful use assuming this one location represents 50 percent or more of the EP's patient encounters. If CEHRT is available at multiple locations that collectively represent 50 percent or more of the EP's patient encounters, then all encounters from those locations would be included in meaningful use.

In the proposed rule we stated that we have received many inquiries on this requirement since the publication of the Stage 1 final rule. We define patient encounter as any encounter where a medical treatment is provided and/or evaluation and management services are provided. This includes both individually billed events and events that are globally billed, but are separate encounters under our definition. We define a practice/location as equipped with CEHRT if the record of the patient encounter that occurs at that practice/location is created and maintained in CEHRT. This can be accomplished in three ways: CEHRT could be permanently installed at the practice/location, the EP could bring CEHRT to the practice/location on a portable computing device, or the EP could access CEHRT remotely using computing devices at the practice/location. Although it is currently allowed under Stage 1 for an EP to create a record of the encounter without using CEHRT at the practice/location and then later input that information into CEHRT that exists at a different practice/location, we do not believe this process takes advantage of the value CEHRT offers. We proposed not to allow this practice beginning in 2013. We have also received inquiries whether the practice locations have to be in the same state, to which we clarify that they do not. Finally, we received inquiries regarding the interaction with hospital-based EP determination. The determination of whether an EP is hospital-based or not occurs prior to the application of this policy, so only nonhospital-based eligible professionals are included. Furthermore, this policy, like all meaningful use policies for EPs, only applies to outpatient settings (all settings except the inpatient and emergency department of a hospital).

Comment: Some commenters suggested that for EPs practicing in multiple locations that meaningful use attestations should be limited to just reporting on meaningful use for the most prevalent location due to the difficulty in aggregating data across locations.

Response: We continue to believe that for the core measures, aggregating data is not overly burdensome. We allow the numerators and denominators calculated by CEHRT to be summed across an EP's various practice locations.

Comment: We received request for clarification on what to do when an EP is practicing in multiple locations that select different menu objectives to pursue, and the EP does not control this selection.

Response: An EP who does not have the same menu objectives implemented across each of their practice locations equipped with CEHRT would attest to the three menu objectives that represent the greatest number of their patient encounters. For example, if six menu objectives are implemented between two locations, an EP would attest to the three menu objectives implemented at the location where they have the greatest number of encounters during the EHR reporting period. For measures that utilize a percentage threshold, they can limit the denominator to the location or locations that pursued that menu objective.

After consideration of the public comments received, we are finalizing the proposed provisions with the modifications previously discussed.

(3) Discussion of the Reporting Requirements of the Measures Associated With the Stage 2 Meaningful Use Objectives

In our experience with Stage 1, we found the distinction between limiting the denominators of certain measures to only those patients whose records are maintained using CEHRT, but including all patients in the denominators of other measures, to be complicated for providers to implement. We proposed to remove this distinction for Stage 2 and instead include all patients in the denominators of all of the measures associated with the meaningful use objectives for Stage 2. We believe that by the time an EP, eligible hospital, or CAH has reached Stage 2 of meaningful use all or nearly all of their patient population should be included in their CEHRT, making this distinction no longer relevant.

Comment: We received comments that maintain that this distinction is still necessary for Stage 2 because there are situations where significant patient records may still be maintained outside of CEHRT. Examples provided by commenters include worker's compensation or other special contracts for certain patients, specialized departments or units in a hospital for which CEHRT is not tailored and patient requests to keep their records on paper.

Response: We continue to believe that nearly all patient records will be stored in CEHRT by the time a provider reaches Stage 2. However, we acknowledge that if this assertion is correct then there is no practical consequence of maintaining the distinction, while if it is not, removing the distinction could have adverse impacts on providers.

After consideration of the comments, we are not finalizing our proposed change. Instead, we maintain the distinction between measures that include only those patients whose records are maintained using CEHRT and measures that include all patients. Providers may limit the denominator to those patients whose records are maintained using CEHRT for measures with a denominator other than unique patients seen by the EP during the EHR reporting period or unique patients admitted to the eligible hospital's or CAH's inpatient or emergency department during the EHR reporting period.

Comment: Some commenters suggested that the denominators should be limited to either just Medicare-covered patients for those participating in the Medicare EHR Incentive Program or just Medicaid-covered patients for those participating in the Medicaid EHR Incentive Program. Commenters presented two arguments in favor of this suggestion. First, that requiring a provider to include all patients was more burdensome than including just Medicare-covered or Medicaid-covered patients and that this burden was not offset by the incentive payments that are based (for Medicare only) on charges submitted to Medicare. Second, that if identifiable patient data was included in Medicare or Medicaid meaningful use reporting for patient not covered by Medicare or Medicaid this would raise serious privacy concerns and possibly require patient consent. Other commenters were supportive of current denominators that does not account for payers.

Response: We discussed the burden differences between all patients versus patients differentiated by payer in our Stage 1 final rule (75 FR44332). We continue to believe that it is highly unlikely that providers will use different record keeping systems based on payer. Where there are differences in patient populations such as age we account for them directly in the measure not indirectly with payer as a generalized proxy. The burden of breaking out the patients by payer for purposes of meaningful use measurement would have only increased from the publication of the Stage 1 final rule as measurement tools have been designed and implemented to measure patients regardless of payer. If at a future date, the demonstration of meaningful use includes the submission of identifiable patient data we will certainly address the privacy implications of that requirement. However, the Stage 1 objectives and measures and Stage 2 objectives and measures included in this final rule do not require the submission of identifiable patient information. We are not making any changes to this policy in this final rule.

We proposed new objectives that could increase reporting burden. To minimize the burden, we proposed to create a uniform set of denominators that would be used for all of the Stage 2 meaningful use objectives, as discussed later.

Many of our meaningful use objectives use percentage-based measures if appropriate. To provide a check on the burden of reporting of meaningful use, we proposed for Stage 2 to use 1 of 4 denominators for each of the measures associated with the meaningful use objectives. We focused on denominators because the action that moves something from the denominator to the numerator usually requires the use of CEHRT by the provider. These actions are easily tracked by the technology.

The four proposed denominators for EPs are—

  • Unique patients seen by the EP during the EHR reporting period (stratified by age or previous office visit);
  • Number of orders (medication, labs, radiology);
  • Office visits, and
  • Transitions of care/referrals.

Comment: We received many comments supporting our efforts to minimize the variety of denominators. Some commenters argued that any variation (such as by age or orders of different types) should be considered separate denominators.

Response: We appreciate the support for our proposal to minimize the variety of denominators. Our base of four denominators are only modified by information that must be entered into CEHRT in order to meet meaningful use; therefore, we believe that such modifications represent a small burden and are in keeping with our overall goal in minimizing the variety of denominators.

In the proposed rule, we stated that the term “unique patient” means that if a patient is seen or admitted more than once during the EHR reporting period, the patient only counts once in the denominator. Patients seen or admitted only once during the EHR reporting period will count once in the denominator. A patient is seen by the EP when the EP has an actual physical encounter with the patient in which they render any service to the patient. A patient seen through telemedicine will also still count as a patient “seen by the EP.” In cases where the EP and the patient do not have an actual physical or telemedicine encounter, but the EP renders a minimal consultative service for the patient (like reading an EKG), the EP may choose whether to include the patient in the denominator as “seen by the EP” provided the choice is consistent for the entire EHR reporting period and for all relevant meaningful use measures. For example, a cardiologist may choose to exclude patients for whom they provide a one-time reading of an EKG sent to them from another provider, but include more involved consultative services as long as the policy is consistent for the entire EHR reporting period and for all meaningful use measures that include patients “seen by the EP.” EPs who never have a physical or telemedicine interaction with patients must adopt a policy that classifies at least some of the services they render for patients as “seen by the EP,” and this policy must be consistent for the entire EHR reporting period and across meaningful use measures that involve patients “seen by the EP”—otherwise, these EPs will not be able to satisfy meaningful use, as they will have denominators of zero for some measures. In cases where the patient is seen by a member of the EP's clinical staff the EP can include or not include those patients in their denominator at their discretion as long as the decision applies universally to all patients for the entire EHR reporting period and the EP is consistent across meaningful use measures. In cases where a member of the EP's clinical staff is eligible for the Medicaid EHR incentive in their own right (for example, nurse practitioners (NPs) and certain physician assistants (PA)), patients seen by NPs or PAs under the EP's supervision can be counted by both the NP or PA and the supervising EP as long as the policy is consistent for the entire EHR reporting period.

Comment: While generally supporting the concept of a unique patient as a good tool to address the fact that not all meaningful use objectives need be addressed at every patient encounter or rendering of medical service, some commenters expressed concern about the ability to identify unique patients across CEHRTs in situations where an EP practices at multiple locations or in situations where an EP might switch CEHRT during an EHR reporting period.

Response: We agree that determining unique patients across CEHRTs is difficult. When aggregating performance on meaningful use measures across multiple practice locations using different CEHRTs we do not require that it be determined that a patient seen at one location was not also seen at another location. While this could result in the same patient appearing more than once in the denominator of unique patients seen, we believe that the burden of seeking out these patients is greater than any gain in measurement accuracy. Furthermore, it is not possible for a provider to increase only the numerator with this policy as any increase in the numerator would also increase the denominator. Accordingly, we are adopting a final policy that will give EPs who practice at multiple locations or switch CEHRT during the EHR reporting period some flexibility as to the method for counting unique patients in the denominators. We leave it up to the EP to decide for the EHR reporting period whether to count a unique patient across all locations equipped with different CEHRT (for example, 1 patient seen at 3 locations with different CEHRT counts once) or at each location equipped with CEHRT (for example, 1 patient seen at 3 locations with different CEHRT counts thrice). In cases where a provider switches CEHRT products at a single location during the EHR reporting period, they also have the flexibility to count a patient as unique on each side of the switch and not across it (for example, 1 patient seen before the switch and after the switch could be counted once or twice). EPs in these scenarios must choose one of these methods for counting unique patients and apply it consistently throughout the entire EHR reporting period.

With the flexibility for EPs practicing in multiple locations using different CEHRT or switching CEHRT during the EHR reporting period, we otherwise finalize our description of “unique patient” as proposed.

We proposed that an office visit is defined as any billable visit that includes: (1) Concurrent care or transfer of care visits; (2) consultant visits; or (3) prolonged physician service without direct, face-to-face patient contact (for example, telehealth). A consultant visit occurs when a provider is asked to render an expert opinion/service for a specific condition or problem by a referring provider. The visit does not have to be individually billable in instances where multiple visits occur under one global fee.

Comment: We received comments requesting that we establish a list of billing codes that constitute an office visit for purposes of clarity.

Response: We continue to believe that the use of a list of billing codes would inappropriately limit the discretion of EPs that we have built into this measure. We finalize as proposed our description of an office visit and emphasize that there is room for EP discretion in this definition and that the most important consideration in utilizing that discretion is that the policy apply for the entire EHR reporting period and across all patients.

We proposed to describe transitions of care as the movement of a patient from one setting of care (hospital, ambulatory primary care practice, ambulatory specialty care practice, long-term care, home health, rehabilitation facility) to another. Currently, the meaningful use measures that use transitions of care require there to be a receiving provider of care to accept the information. Therefore, a transition home without any expectation of follow-up care related to the care given in the prior setting by another provider is not a transition of care for purpose of Stage 2 meaningful use measures as there is no provider recipient. A transition within one setting of care does not qualify as a transition of care. Referrals are cases where one provider refers a patient to another, but the referring provider maintains their care of the patient as well. Please note that a “referral” as defined here and elsewhere in this final rule is only intended to apply to the EHR Incentive Programs and is not applicable to other Federal regulations.

Comment: We have received many comments that determining when a transition of care occurs is very difficult under our current Stage 1 rule, particularly when the provider is on the receiving end of the transition of care. Commenters suggest that the only reliable way to know if a patient saw another provider is to ask the patient at each encounter and even then this is not guaranteed. Several suggestions were presented to make the definition more precise on both the receiving and transitioning side. They were as follows:—

  • Discharges for eligible hospitals/CAHs and referrals to other providers who do not share the same CEHRT as the EP are very clearly identified and should be the focus of the numerator/denominator.
  • A transition within one setting of care does not qualify as a transition of care. Referral is defined as care “where one provider refers a patient to another, but the referring provider maintains their care of the patient as well.”
  • A patient is referred to another provider (for EPs) or a patient is discharged (for eligible hospitals).
  • Sharing data with health plans.

Response: In reviewing the comments, we agree that a refinement of our transitions of care definition is needed. We also agree with the suggestions to point to specific events that identify a transition of care has occurred without relying entirely on asking the patient. Therefore, we revise our description of transitions of care for the purpose of defining the denominator. For an EP who is on the receiving end of a transition of care or referral, (currently used for the medication reconciliation objective and measure), the denominator includes first encounters with a new patient and encounters with existing patients where a summary of care record (of any type) is provided to the receiving provider. The summary of care record can be provided either by the patient or by the referring/transiting provider or institution. We believe that both of these situations would create information in the CEHRT that can be automatically recorded. For an EP who is initiating a patient transfer to another setting and/or referring a patient to another provider, (currently used for providing summary of care documents at transitions of care), the initiating/referring EP would count the transitions and/or referrals that were ordered by the EP in the measure denominator. If another provider also sees the same patient, only the EP who orders the transition/referral would need to account for this transition for the purpose of this measure. EPs are not responsible for including patient-initiated transitions and referrals that were not ordered by the EP. For example, if the EP creates an order for admission to a nursing home, this transition of care would be counted in the EP's measure denominator. If one of the EP's patients is admitted to a nursing home by another provider, this transition would only have to be counted by the EP who creates the order and not necessarily by other EPs who care for the patient. We want to emphasize that these transitions of care/referral descriptions have been developed for purposes of reducing the provider measurement burden for the EHR Incentive Program and do not necessarily apply to other programs or regulations. We also clarify that these descriptions are minimum requirements. An EP can include in the denominator transitions of care and referrals that fit the broader descriptions of these terms, but are not one of the specific events described previously.

The four proposed denominators for eligible hospitals and CAHs are—

  • Unique patients admitted to the eligible hospital's or CAH's inpatient or emergency department during the EHR reporting period (stratified by age);
  • Number of orders (medication, labs, radiology);
  • Inpatient bed days; and
  • Transitions of care.

We noted in the proposed rule that our explanation of “unique patients” and “transitions of care” for EPs would also apply for eligible hospitals and CAHs.

Comment: Commenters suggested a problem with unique patients could arise if a hospital switched CEHRT during the EHR reporting period.

Response: Our final policy on EPs who switch CEHRT during the EHR reporting period counting unique patients in the denominator would also apply for hospitals in the same situation.

Comment: We have received many comments that determining when a transition of care occurs is very difficult under our Stage 1 regulations, particularly when the provider is on the receiving end of the transition of care. Commenters suggest that the only reliable way to know if a patient saw another provider is to ask the patient at each encounter and even then this is not guaranteed. Several suggestions were presented to make the definition more precise on both the receiving and transitioning side, which we summarized previously in the discussion of the proposed denominators for EPs.

Response: For the same reasons as discussed for EPs, we agree that pointing to specific occurrences is needed to accurately measure this denominator. For transitions of care when the hospital is on the receiving end, (currently used for the medication reconciliation objective and measure), we include all admissions to the inpatient and emergency departments. For transitions of care when the hospital is transitioning the patient, (currently used for providing summary of care documents at transitions of care), we include all discharges from the inpatient department and after admissions to the emergency department when follow-up care is ordered by an authorized provider of the hospital. As with EPs, these are the minimum events that must be included in the denominator for the transitions of care measure. Hospitals can include additional transitions of care that match the full description of transitions of care, but are not one of these specific events.

We proposed that admissions to the eligible hospital or CAH can be calculated using one of two methods currently available under Stage 1 of meaningful use. The observation services method includes all patients admitted to the inpatient department (POS 21) either directly or through the emergency department and patients who initially present to the emergency department (POS 23) and receive observation services. Details on observation services can be found in the Medicare Benefit Policy Manual, Chapter 6, Section 20.6. Patients who receive observation services under both the outpatient department (POS 22) and emergency department (POS 23) should be included in the denominator under this method. The all emergency department method includes all patients admitted to the inpatient department (POS 21) either directly or through the emergency department and all patients receiving services in the emergency department (POS 23).

Comment: Commenters expressed near universal support for the continuance of the two options in defining an admission to the emergency department.

Response: We continue to believe that not all information required by meaningful use may be relevant to all encounters in the emergency department and that this decision is best left to the hospital; therefore, we are finalizing this as proposed.

We proposed that inpatient bed days are the admission day and each of the following full 24-hour periods during which the patient is in the inpatient department (POS 21) of the hospital. For example, a patient admitted to the inpatient department at noon on June 5th and discharged at 2 p.m. on June 7th will be admitted for 2-patient days: the admission day (June 5th) and the 24 hour period from 12 a.m. on June 6th to 11:59 p.m. on June 6th.

We did not receive comments on this proposal. This denominator is not used by the proposed meaningful use objectives and measures nor the finalized objectives and measures.

As discussed later in this section, we are including the menu objective for hospitals of “Provide structured electronic lab results to ambulatory providers”. The measure associated with the objective uses a denominator that was not included in our proposal. The denominator is the number of electronic lab orders received by the hospital from ambulatory providers. For this objective, we use the same description of “laboratory services” as for our Stage 2 CPOE objective: any service provided by a laboratory that could not be provided by a nonlaboratory. We also use the definition of “laboratory” at § 493.2 as for the Stage 2 CPOE objective. Any order for a laboratory service will be considered a lab order. For the order to be considered received electronically, it must be received by the hospital utilizing an electronic transmission method and not through methods such as physical electronic media, electronic fax, paper document or telephone call.

After consideration of public comments, we are finalizing the following denominators for EPs:

  • Unique patients seen by the EP during the EHR reporting period (stratified by age or previous office visit);
  • Number of orders (medication, labs, radiology);
  • Office visits; and
  • Transitions of care/referrals including at a minimum one of the following:

+ + When the EP is the recipient of the transition or referral, first encounters with a new patient and encounters with existing patients where a summary of care record (of any type) is provided to the receiving EP;

++ When the EP is the initiator of the transition or referral, transitions and referrals ordered by the EP.

We are finalizing the following denominators for eligible hospitals and CAHs:

  • Unique patients admitted to the eligible hospital's or CAH's inpatient or emergency department during the EHR reporting period (stratified by age);
  • Number of orders (medication, labs, radiology);
  • Transitions of care including at a minimum one of the following:

++ When the hospital is the recipient of the transition or referral, all admissions to the inpatient and emergency departments,

++ When the hospital is the initiator of the transition or referral, all discharges from the inpatient department and after admissions to the emergency department when follow-up care is ordered by authorized providers of the hospital; and

  • Electronic lab orders received by the hospital from ambulatory providers.

(4) Discussion of the Relationship of Meaningful Use to CEHRT

We proposed to continue our policy of linking each meaningful use objective to certification criteria for CEHRT. As with Stage 1, EPs, eligible hospitals, and CAHs must use the capabilities and standards that are certified to meet the objectives and associated measures for Stage 2 of meaningful use. In meeting any objective of meaningful use, an EP, eligible hospital or CAH must use the capabilities and standards that are included in certification. We noted that in some instances, meaningful use objectives and measures require use that is not directly enabled by certified capabilities and/or standards. In these cases, the EP, eligible hospital and CAH is responsible for meeting the objectives and measures of meaningful use, but the way they do so is not constrained by the capabilities and standards of CEHRT. In the proposed rule we gave the following example: in e-Rx and public health reporting, CEHRT applies standards to the message being sent and enables certain capabilities for transmission in 2014; however, to actually engage in e-Rx or public health reporting many steps must be taken outside of these standards and capabilities such as contacting both parties and troubleshooting issues that may arise through the normal course of business.

Comment: We received many comments that expressed confusion of when the capabilities and standards included in certification must be used and when they do not.

Response: Nearly all of these comments were objective-specific, so we address them at the referenced objective. With each measure we include a universal statement on the applicability of the specific standards and capabilities included in the 2014 edition of certification criteria for EHR technologies and, if applicable, specific allowances for that measure.

After consideration of the public comments received, we are finalizing these provisions as proposed.

(5) Discussion of the Relationship Between a Stage 2 Meaningful Use Objective and Its Associated Measure

We proposed to continue our Stage 1 policy that regardless of any actual or perceived gaps between the measure of an objective and full compliance with the objective (such as a measure threshold of less than 100 percent or a measure designed to account for circumstances where 100 percent compliance in not the intention of the objective), meeting the criteria of the measure means that the provider has met the objective for Stage 2.

We did not receive any comments and we are finalizing these provisions as proposed.

(6) Objectives and Their Associated Measures

(a) Objectives and Measures Carried Over (Modified or Unmodified) From Stage 1 Core Set to Stage 2 Core Set

Proposed Objective: Use computerized provider order entry (CPOE) for medication, laboratory and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelines to create the first record of the order.

In the proposed rule, we outlined the following benefits of CPOE. CPOE improves quality and safety by allowing clinical decision support at the point of the order and therefore influences the initial order decision. CPOE improves safety and efficiency by automating aspects of the ordering process to reduce the possibility of communication and other errors. Consistent with the recommendations of the HIT Policy Committee, we proposed to expand the orders included in the objective to medication (which was included in Stage 1), laboratory, and radiology. We believe that the expansion to laboratory and radiology furthers the goals of the CPOE objective, that such orders are commonly included in CPOE roll outs and that inclusion of the entry of these orders using CPOE is a logical step in the progression of meaningful use. We note that this does not require the electronic transmission of the order.

We proposed to continue to define CPOE as the provider's use of computer assistance to directly enter medical orders (for example, medications, consultations with other providers, laboratory services, imaging studies, and other auxiliary services) from a computer or mobile device. The order is then documented or captured in a digital, structured, and computable format for use in improving safety and efficiency of the ordering process. We further proposed that the CPOE function of CEHRT must be used by the ordering provider or licensed healthcare professionals under his or her direction to create the first record of that order, or it would not count as CPOE. As this proposed objective limits the use of CPOE to the creation of the first record of the order (a more restrictive standard than in Stage 1), we invited public comment on whether the stipulation that the CPOE function be used only by licensed healthcare professionals remains necessary or if CPOE can be expanded to include non-licensed healthcare professionals such as scribes.

Comment: Commenters focused primarily on CPOE's value as the trigger for clinical decision support interventions. It was suggested the term be revised from computerized provider order entry to computerized order evaluation. This focus led to the suggestion by several commenters that as long as the ordering providers “signs” or otherwise authorizes the order before it is carried out this should count for CPOE. These commenters maintain that meaningful use should not dictate any of the processes that lead up to this authorization including who enters the order into CEHRT nor what types of record of the order may exist prior to entry into CEHRT.

Response: We agree that CPOE as the trigger for CDS interventions is the primary value creating function of CPOE. However, we disagree that it is the only one. We believe automating aspects of and/or eliminating steps in the ordering process prior to final authorization of the order does reduce communication and other errors. Furthermore, it is our understanding from both commenters and our own experiences with CEHRT that many EHRs use the entry of the order as the trigger for CDS interventions and either display them again at authorization or do not display them at all at authorization. For these reasons, we continue to focus the definition and measurement of CPOE on when and by whom the order is entered into CEHRT and not on when it is authorized by the ordering provider in CEHRT.

Comment: Commenters stated that the authentication of verbal orders is already covered by the conditions of participation for hospitals at 42 CFR482.24(c)(1)(iii) which states that “[a]ll verbal orders must be authenticated based upon Federal and state law. If there is no state law that designates a specific timeframe for the authentication of verbal orders, verbal orders must be authenticated within 48 hours.” Meaningful use should adopt this same standard.

Response: We are not adopting this standard for two reasons. First, as this is in an incentive program, we do not believe it is logical to base a requirement for meaningful use solely on a condition of participation. Hospitals already must comply with the conditions of participation, so we believe as an incentive program meaningful use should be incentivizing behavior beyond the conditions of participation. Second, as discussed later, we are not limiting the communication of orders prior to CPOE to verbal orders so there is not a direct corollary between this condition of participation and our description of CPOE. Section 482.23(c)(2) also speaks to verbal orders. First, it states, “If verbal orders are used, they are to be used infrequently. Second, it states, “When verbal orders are used, they must only be accepted by persons who are authorized to do so by hospital policy and procedures consistent with Federal and state law.” We discuss who may enter the order later in comment and response, but reiterate our position that meaningful use should incentivize behavior that benefits patients beyond that required by the conditions of participation.

Comment: Commenters objected to our proposal to change our policy regarding CPOE from “the CPOE function should be used the first time the order becomes part of the patient's medical record and before any action can be taken on the order” to “the order created using the EHR must be the first record of that order or it would not count as CPOE”. The commenters stressed that if they used a process that created a record of the order that was not part of the patient's medical record, then the proposed policy requiring this record not be retained is not advisable. The commenters asserted that even if it was not part of the patient's medical record the initial record of the order could be used for quality control purposes.

Response: Our proposed policy change was intended as an evolution from the Stage 1 requirements for CPOE. However, after reviewing the comments received, we agree that requiring an electronic or written order that is not created using the CPOE function of CEHRT to not be retained in order for it to count as CPOE could have unforeseen and possibly detrimental consequences for quality control. We continue to believe that our original proposal would have increased CPOE's ability to improve safety and efficiency and encourage all providers to streamline the ordering process to minimize the number of steps involved. However, we do not have sufficient information to determine whether the gains of the proposal are greater than or less than the potential cost of not retaining written or electronic orders issued before the use of the CPOE function. Therefore, we are not finalizing the proposed revised description of when the CPOE function must be utilized during the ordering process and instead finalize our existing Stage 1 description that the CPOE function should be used the first time the order becomes part of the patient's medical record and before any action can be taken on the order. Based on the questions we have received on CPOE to date, the limiting criterion is the first time the order becomes part of the patient's medical record rather than the limitation of before any action can be taken on the order. The provider must make the determination as to what constitutes the patient's medical record and what does not based on their existing policies and applicable state and Federal law. Our only requirements in this regard are that the determination be made by the provider prior to the start of the EHR reporting period and be uniformly applied.

Comment: We have received many comments on who can enter the order into CEHRT for it to count as CPOE. Four possibilities received comment support. First, only the ordering provider be able to enter the order into CEHRT. Second, any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelines can enter the order into CEHRT. This is the current policy which was proposed to continue. Third, an expansion to any licensed, certified or appropriately credentialed healthcare professional (some commenters replaced medical assistant with healthcare professional) who can enter orders into the medical record per state, local and professional guidelines. Fourth, an expansion to allow anyone, including those commonly referred to as scribes, enter the orders into the medical record per state, local and professional guidelines. We also note that there was some confusion among commenters as to our current limitation and proposal of any licensed healthcare professional using CPOE to create the first entry of the order into the patient's medical record as we received many comments suggesting that nurses should be able to enter the orders. We clarify that nurses who are licensed and can enter orders into the medical record per state, local and professional guidelines may enter the order into CEHRT and have it count as CPOE.

Response: As we did not revise our description of when in the ordering process the CPOE function must be used, we are inclined to not revise our description of who may enter it into CEHRT. However, we are particularly concerned with CPOE usage by EPs in this regard. Many EPs practice without the assistance of other licensed healthcare professionals. These EPs in their comments urged the expansion indicated in the third possibility of credentialed healthcare professionals/medical assistants. We believe that this expansion is warranted and protects the concept that the CDS interventions will be presented to someone with medical knowledge as opposed to a layperson. The concept of credentialed healthcare professionals is over broad and could include an untold number of people with varying qualifications. Therefore, we finalize the more limited description of including credentialed medical assistants. The credentialing would have to be obtained from an organization other than the employing organization. Our responses to earlier comments factored into this decision as well. Based on the public comments received, questions submitted by the public on Stage 1 and demonstrations of CEHRT we have participated in, it is apparent that the prevalent time when CDS interventions are presented is when the order is entered into CEHRT, and that not all EHRs also present CDS when the order is authorized (assuming such a multiple step ordering process is in place). This means that the person entering the order could be required to enter the order correctly, evaluate CDS either using their own judgment or through accurate relay of the information to the ordering provider, and then either make a change to the order based on the CDS intervention or bypass the intervention. We do not believe that a layperson is qualified to do this, and as there is no licensing or credentialing of scribes, there is no guarantee of their qualifications.

Comment: We received comments on a particular category of orders referred to as “protocol” or “standing” orders. The defining characteristic of these orders is that they are not created due to a specific clinical determination by the ordering provider for a given patient, but rather are pre-determined for patients with a given set of characteristics (for example, administer medication X and order lab Y for all patients undergoing a certain procedure or refills for given medication). Commenters maintain that these orders require special treatment in regards to when they are entered into CEHRT and who enters them. Commenters indicate that administrative staff should be allowed to enter them, but not override any CDS interventions that may appear.

Response: We agree that this category of orders warrant different considerations than orders that are due to a specific clinical determination by the ordering provider for a specific patient. We therefore allow providers to exclude orders that are predetermined for a given set of patient characteristics or for a given procedure from the calculation of CPOE numerators and denominators. Note this does not require providers to exclude this category of orders from their numerator and denominator. We foresee two circumstances where a provider would not want to exclude this category of orders. The first is that they disagree that these type of orders warrant different considerations and therefore enter them according to our description of CPOE. The second is providers who are unable to separate them from other orders in their calculation of the denominator and numerator.

Comment: Commenters mostly support the expansion to the laboratory and radiology orders. Three concerns were raised. First, commenters believed that as laboratory and radiology orders were new additions they should have a lower threshold than medication orders. Second, commenters desired a more descriptive definition on what constitutes a laboratory and particularly a radiology order. Third, commenters suggested that laboratory and radiology orders should be delayed for EPs until more laboratory and radiology providers could receive the order electronically.

Response: We discuss the measure separately later in this section and address the comments on the threshold there. We describe laboratory services as any service provided by a laboratory that could not be provided by a non-laboratory. Laboratory is defined at 42 CFR 493.2 as: “a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.” We describe radiologic services as any imaging service that uses electronic product radiation. Electronic product radiation is defined at 21 CFR 1000.3 as: “any ionizing or nonionizing electromagnetic or particulate radiation, or [a]ny sonic, infrasonic, or ultrasonic wave that is emitted from an electronic product as the result of the operation of an electronic circuit in such product.” If the provider desires to include other types of imaging services that do not rely on electronic product radiation they may do so as long as the policy is consistent across all patients and for the entire EHR reporting period. Finally, as we discuss in the next comment and response, electronic transmission of the order is not a requirement for CPOE.

Comment: Some commenters stated that while CPOE is a commonly understood function in the hospital setting, in the ambulatory setting its use is more ambiguous. For medication orders, the difference between CPOE for the medication and e-prescribing the medication is more subtle. The expansion to laboratory and radiology further complicates this in the ambulatory setting as most laboratory and radiology orders are sent to a third party which may or may not be able to receive such orders electronically.

Response: While we agree that the concept of CPOE is a more definitive action in the ordering process in the hospital setting, we believe that it is still integral to the ambulatory setting and serves the same purposes in both settings as a trigger for CDS interventions and as a way to increase the efficiency and safety of the ordering process. CPOE is the entry of the order into the patient's EHR that uses a specific function of CEHRT. It is not how that order is filled or otherwise carried out. For medications, on the ambulatory side CPOE feeds into e-prescribing, and on the hospital side electronic medication administration record may be used, but neither of these are requirements for CPOE. For example, a medication could be entered into CEHRT using CPOE and then be electronically transmitted to a pharmacy. This would be both CPOE and e-prescribing. However, a medication could be entered into CEHRT using CPOE and then a printed copy of the prescription could be generated by CEHRT and given to the patient. This would still be CPOE, but not e-prescribing. Similarly, whether the ordering of laboratory or radiology services using CPOE in fact results in the order being transmitted electronically to the laboratory or radiology provider does not dictate whether CPOE was met. CPOE is a step in a process that takes place in both hospital and ambulatory settings, and we continue to believe it is relevant to both settings.

After consideration of the public comments received, we are modifying this objective for EPs as § 495.6(j)(1)(i) and for eligible hospitals and CAHs at § 495.6(l)(1)(i) to use the same language as Stage 1 (with the addition of laboratory and radiology orders), as we did not finalize our proposed changes to when the order must be entered: “Use computerized provider order entry (CPOE) for medication, laboratory, and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local, and professional guidelines.”

Proposed Measure: More than 60 percent of medication, laboratory, and radiology orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using CPOE.

In Stage 1 of meaningful use, we adopted a measure of more than 30 percent of all unique patients with at least one medication in their medication list seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have at least one medication order entered using CPOE. In the Stage 1 final rule, we adopted a threshold of 60 percent for this measure for Stage 2.

In our proposed rule, we discussed how our experience with Stage 1 has shown that the denominator of all orders created by the EP or in the hospital would not be unduly burdensome for providers and creates a better measurement for CPOE usage, particularly for EPs who infrequently order medications. We explained that the denominator recommended by the HITPC of “patients with at least one type of order” is a proxy measure for the number of orders issued. We asked for comments on whether the barriers to collecting information for our proposed denominator would be greater in a hospital or ambulatory setting. We also requested that commenters suggest different denominators or measures and encouraged any commenter proposing an alternative denominator to discuss whether the proposed threshold or an alternative threshold should be used for this measure and to include any exclusions they believe are necessary based on their alternative denominator.

We also stated in our proposed rule that we believed providers do not roll out CPOE for only one order type, but rather for a package of order types. The HITPC had recommended a percentage threshold for laboratory orders, but a yes/no attestation of one order for radiology (not for both laboratory and radiology, as we mistakenly stated in the proposed rule). We also expressed concerns in the proposed rule about the possibility that an EP, eligible hospital or CAH could create a test environment to issue the one order and not roll out the capability widely or at all. For these reasons, we proposed a percentage threshold for all three types of orders: medication, laboratory, and radiology.

Comment: Commenters both supported and opposed the new denominator for CPOE. Those supporting the proposed denominator did so for its simplicity and greater accuracy for measuring actual CPOE usage. Commenters that opposed the proposed denominator did so for one of two reasons. Either they were concerned with the burden associated with counting paper or other orders that are never entered into CEHRT or they were concerned that the proposed denominator requires much higher performance of CPOE usage. For example, in the hospital setting an inpatient might have 20 orders during a stay. Under the proposed denominator, 13 of those orders would have to be entered using CPOE, while under the current denominator only one order would have to be entered using CPOE. A few commenters opposed the new denominator for both reasons.

Response: In regards to the perceived higher performance of CPOE usage required by switching from the Stage 1 denominator to the Stage 2 proposed denominator, the sole purpose of the proxy measure for CPOE used in Stage 1 was to alleviate the measurement burden, not create a lower level of CPOE usage than implied by the percentage threshold. Therefore, as a more accurate measure is possible, it should reflect the percentage of CPOE use indicated by the established thresholds. In regards to the burden of the measure, we had stated in our proposed rule that the reason we believed we could move to the proposed denominator was feedback from many providers indicating that they could in fact measure the proposed denominator. In addition due to problems associated with the proxy for EPs who have comprehensive medication lists for their patients, but were not the ordering provider for many of those medications some EPs were having to use an alternative measure issued through guidance (https://questions.cms.gov/faq.php?id=5005&faqId=3257) that allowed them to only include patients with medications the EP had ordered. We assume in determining the measures of meaningful use that the patient's medical record conforms to existing Federal and state laws, which we believe would generally require that all orders issued by a provider for a patient become part of the patient's medical record (for example, 42 CFR 482.24(c)(2)(vi)). Therefore, the concept that some orders do not become part of the CEHRT means that the provider is maintaining patient medical records both electronically in CEHRT and outside of CEHRT using either paper charts or another electronic system. When a provider starts their first Stage 2 EHR reporting period, they will have been using CEHRT for at least 15 months. In our proposed rule, we have stated our belief that most providers would have fully transitioned patients' medical records to CEHRT by the time they start Stage 2. However, as discussed previously, we are leaving open the option for limiting certain measures to only those records maintained in CEHRT. As this is one of those measures, there is no reason to change the measure to accommodate patient records not maintained in CEHRT as provider can choose to not include records not maintained in CEHRT in the denominator. Thus, we finalize the denominator as proposed.

Comment: Commenters requested clarification on whether the measure puts all medication, laboratory and radiology orders in the same denominator and therefore it was potentially possible to meet the 60 percent threshold without CPOE being used 60 percent of the time for one or more order type, up to and including the possibility that CPOE may never be used for one or more order type. Many commenters suggested that if all orders were in the same denominator this was not a good measure of the expansion of CPOE to laboratory and radiology and that the orders should be broken out separately. Only a few commenters suggested that the denominator should be the aggregate of all three types of orders.

Response: We agree with the commenters that an aggregate denominator does not best reflect our expansion to laboratory and radiology and therefore create a separate denominator for each order type. This is consistent with the suggestions of the majority of commenters and most accurately reflects the use of CPOE. While CPOE does not require the electronic transmission of the order, many CEHRT will be linked to the technology systems that manage medication, as well as those for laboratories and radiology departments. These systems may be different thereby presenting unique challenges for each order type that could result in differing roll out times and utilization rates. In addition, a provider with a high number of one order type compared to others may even be able to reach a combined threshold without implementing CPOE for one or more of the order types. This would negate the benefits of expanding CPOE to these order types. We have exclusionary criteria for those providers who so infrequently issue an order type that it is not practical to implement CPOE for that order type.

Comment: We received several suggestions on the percentage threshold for medication orders to reduce it below 60 percent. The suggestions ranged from 50 percent to 30 percent. Two reasons were given. First, that 60 percent was simply too high. Second, that the proposed denominator made 30 percent a much higher bar than it was when the proxy was in place and the threshold should not be raised until we have data based on the proposed denominator.

Response: As we stated previously, the purpose of the proxy denominator was not to create a lower bar than CPOE usage at 30 percent, but to address measurement burden. While we agree that the information generated using the proxy denominator for CPOE is different from the finalized denominator, this is only true in a limited set of circumstances, especially for EPs. For it to be different at all, a provider must have ordered more than one medication for a patient during the EHR reporting period. Furthermore, this is most likely limited to providers who see a patient on more than one occasion. We believe it would be highly unlikely that a provider would use CPOE to order one medication and then not use it to order another during the same encounter or admission. For these reasons, we believe that while not a perfect correlation the information gained through Stage 1 attestations. The Stage 1 attestations provide a reasonable basis on which to set the Stage 2 thresholds. We believe it is reasonable to expect the actual use of CPOE to increase from 30 percent in Stage 1 to 60 percent in Stage 2 and consist with the expectations that were finalized in the Stage 1 regulations. Therefore, for medication orders, we finalize the threshold at 60 percent.

Comment: Some commenters maintain that the addition of laboratory and radiology orders to CPOE is a new function and should not be introduced at the same threshold.

Response: Based on the same logic supporting the 60 percent threshold for medication orders (that is, 30 percent is reasonable when CPOE is first introduced for an order type, and 60 percent in the next stage following CPOE introduction), we agree with the commenters that the thresholds should be different. We finalize a threshold of 30 percent for each laboratory and radiology orders.

After consideration of the public comments received, we are splitting the proposed measure into three measures and changing the threshold for radiology and laboratory orders at § 495.6(j)(1)(ii) for EPs and § 495.6(l)(1)(ii) for eligible hospitals and CAHs.

  • More than 60 percent of medication orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using CPOE.
  • More than 30 percent of laboratory orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using CPOE.
  • More than 30 percent of radiology orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using CPOE.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(1).

As discussed in the comment and response section, an EP, eligible hospital or CAH can limit the denominators to only include medication, laboratory and radiology orders for patients whose records are maintained using CEHRT.

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of medication orders created by the EP or authorized providers in the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period.
  • Numerator: The number of orders in the denominator recorded using CPOE.
  • Threshold: The resulting percentage must be more than 60 percent in order for an EP, eligible hospital or CAH to meet this measure.

Exclusion: Any EP who writes fewer than 100 medication orders during the EHR reporting period.

  • Denominator: Number of radiology orders created by the EP or authorized providers in the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period.
  • Numerator: The number of orders in the denominator recorded using CPOE.
  • Threshold: The resulting percentage must be more than 30 percent in order for an EP, eligible hospital or CAH to meet this measure.

Exclusion: Any EP who writes fewer than 100 radiology orders during the EHR reporting period.

  • Denominator: Number of laboratory orders created by the EP or authorized providers in the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period.
  • Numerator: The number of orders in the denominator recorded using CPOE.
  • Threshold: The resulting percentage must be more than 30 percent in order for an EP, eligible hospital or CAH to meet this measure.

Exclusion: Any EP who writes fewer than 100 laboratory orders during the EHR reporting period.

An EP through a combination of meeting the thresholds and/or exclusions must satisfy all three measures for this objective.

A hospital must meet the thresholds for all three measures.

Proposed EP Objective: Generate and transmit permissible prescriptions electronically (eRx).

In the proposed rule, we noted that the use of electronic prescribing has several advantages over having the patient carry the prescription to the pharmacy or directly faxing a handwritten or typewritten prescription to the pharmacy. When the EP generates the prescription electronically, CEHRT can recognize the information and can provide decision support to promote safety and quality in the form of adverse interactions and other treatment possibilities. The CEHRT can also provide decision support that promotes the efficiency of the health care system by alerting the EP to generic alternatives or to alternatives favored by the patient's insurance plan that are equally effective. Transmitting the prescription electronically promotes efficiency and safety through reduced communication errors. It also allows the pharmacy or a third party to automatically compare the medication order to others they have received for the patient. This comparison allows for many of the same decision support functions enabled at the generation of the prescription, but bases them on potentially greater information.

We proposed to continue to define prescription as the authorization by an EP to dispense a drug that will not be dispensed without such authorization. This includes authorization for refills of previously authorized drugs. We proposed to define a permissible prescription as all drugs meeting the definition of prescription not listed as a controlled substance in Schedules II-V http://www.deadiversion.usdoj.gov/schedules/index.html. Although the Drug Enforcement Administration's (DEA) interim final rule on electronic prescriptions for controlled substances (75 FR 16236) removed the Federal prohibition to electronic prescribing of controlled substances, some challenges remain including more restrictive state law and widespread availability of products both for providers and pharmacies that include the functionalities required by the DEA's regulations. We asked for public comments as to whether over the counter (OTC) medicines will be routinely electronically prescribed and proposed to continue to exclude them from the definition of a prescription.

In our proposed rule we discussed several different workflow scenarios are possible when an EP prescribes a drug for a patient. First, the EP could prescribe the drug and provide it to the patient at the same time, and sometimes the EP might also provide a prescription for doses beyond those provided concurrently. Second, the EP could prescribe the drug, transmit it to a pharmacy within the same organization, and the patient would obtain the drug from that pharmacy. Third, the EP could prescribe the drug, transmit it to a pharmacy independent of the EP's organization, and the patient would obtain the drug from that pharmacy. Although each of these scenarios would result in the generation of a prescription, the transmission of the prescription would vary. In the first situation, there is no transmission. In the second situation, the transmission may be the viewing of the generation of the prescription by another person using the same CEHRT as the EP, or it could be the transmission of the prescription from the Certified EHR Technology used by the EP to another system used by the same organization in the pharmacy. In the third situation, the EP's Certified EHR Technology transmits the prescription outside of their organization either through a third party or directly to the external pharmacy. These differences in transmissions create differences in the need for standards. We proposed that only the third situation would require standards to ensure that the transmission meets the goals of electronic prescribing. In the first two scenarios one organization has control over the whole process. In the third scenario, the process is divided between organizations. In that situation, standards can ensure that despite the lack of control the whole process functions reliably. To have successfully e-prescribed, we proposed that the EP needs to use CEHRT as the sole means of creating the prescription, and when transmitting to an external pharmacy that is independent of the EP's organization such transmission must use standards adopted for EHR technology certification.

We did not receive any public comments on this objective, therefore, we are finalizing this objective at § 495.6(j)(2)(i) as proposed.

Proposed EP Measure: More than 65 percent of all permissible prescriptions written by the EP are compared to at least one drug formulary and transmitted electronically using CEHRT.

We proposed a new exclusion for Stage 2 that would allow EPs to exclude this objective if no pharmacies within 25 miles of an EP's practice location at the start of his/her EHR reporting period accept electronic prescriptions. This is 25 miles in any straight line from the practice location independent of the travel route from the practice location to the pharmacy. We stated that EP's practicing at multiple locations would be eligible for the exclusion if any of their practice locations that are equipped with CEHRT meet this criteria. An EP would not be eligible for this exclusion if he or she is part of an organization that owns or operates its own pharmacy within the 25-mile radius regardless of whether that pharmacy can accept electronic prescriptions from EPs outside of the organization. We also proposed an exclusion for EPs who write fewer than 100 prescriptions during the EHR reporting period.

Comment: Most commenters agreed with the exclusion of controlled substances in the denominator. They were concerned about industry readiness as well as potentially conflicting state regulations. Other commenters expressed concerns that specialists (that is, surgeons, psychiatrists) who write prescriptions that are not permissible (that is, controlled substances) would not be able to meet the measure.

Response: We agree with the commenters and will continue to exclude controlled substances from the denominator. However, we are also adding an alternative denominator to provide additional flexibility for EPs who are able to electronically prescribe controlled substances and want to count these prescriptions in the measure.

Comment: Most commenters did not support the inclusion of OTC medicines in this objective, as OTC medicines are not usually intended for the pharmacy to fill. Those commenters who did support it noted that OTC medicines are prescribed often times because it allows patients to use their health care spending accounts to pay for the cost.

Response: After consideration of public comments, we agree with the majority of commenters in that OTC medicines should not be included as a part of this objective. While some OTC medicines are ordered by the EP, the low prevalence of such occurrences means the costs of including them in both measurement and actual e-prescribing outweighs any benefit of inclusion.

Comment: Most commenters thought the proposed threshold was too high or just right. Those who thought it was too high expressed concerns about the abilities of mail-order pharmacies to accept electronic subscriptions. Some commenters suggested lowering the threshold to 50 percent. Other commenters expressed concerns that patients may prefer a paper prescription and suggested excluding those patients from the denominator. The commenters who thought the proposed threshold was “just right” noted that most EPs who successfully demonstrated meaningful use for Stage 1 far exceeded the Stage 1 threshold of 40 percent.

Response: Preliminary analysis of Stage 1 meaningful use attestation data shows that those EPs who successfully attested for this measure exceeded the 40 percent threshold—many reporting thresholds of 80-100 percent. However, the Surescripts Q4 2011 Report suggests that close to 40 percent of physicians who began e-prescribing in 2008 meet the 65 percent threshold. This report only represents the earliest adopters. Based on public comments, we believe the 65 percent threshold we proposed may be unattainable for many EPs and question whether any real difference in provider behavior is achieved with a 65 percent threshold versus a 50 percent threshold. This lower threshold also accounts for patients who may prefer a paper prescription, rather than having their prescription sent to a pharmacy electronically. After consideration of public comments, we are finalizing the threshold for this measure at 50 percent.

Comment: Most commenters supported comparing prescriptions written by the EP to a drug formulary, but not without concern. Many noted that drug formularies are not always readily available, are linked to specific payers, or may not otherwise be readily available.

Response: After review of the public comments, we realize this measure needs to be further clarified. We recognize that not every patient will have a formulary that is relevant for him or her. Therefore, we require not that the CEHRT check each prescription against a formulary relevant for a given patient, but rather that the CEHRT check each prescription for the existence of a relevant formulary. If a relevant formulary is available, then the information can be provided. We believe that this initial check is essentially an on or off function for the CEHRT and should not add to the measurement burden. Therefore, with this clarification of the check we are referring to, we are finalizing the drug formulary check as a component of this measure. We look forward to the day when a relevant formulary is available for every patient. We also modified the measure to use the word “query” instead of “compare” because it better explains the process in which the EP uses the CEHRT to consult the information provided in the formulary.

Comment: Many commenters expressed concerns about patients who request paper copies of their prescriptions and how they would be accounted for in this measure. Commenters also expressed concerns about patients who prefer to use mail-order pharmacies that do not accept eRx.

Response: We have accounted for patient preferences by lowering the threshold for this measure from 65 percent to 50 percent.

Comment: Many commenters expressed concerns that the word “permissible” was omitted from the proposed exclusion for EPs who write fewer than 100 prescriptions during the EHR reporting period.

Response: We agree with commenters in that we inadvertently omitted the word “permissible” from this exclusion. After consideration of public comments, we are finalizing this exclusion as “EPs who write fewer than 100 permissible prescriptions during the EHR reporting period.”

Comment: Many commenters supported this exclusion but expressed concerns about how it was proposed and would be implemented. Some commenters suggested reducing the radius to 10 miles or less in urban areas and leaving it at 25 miles in rural areas. Other commenters suggested revising this exclusion for EPs where less than 20 percent of pharmacies e-prescribe within a 25-mile radius of their office. Other commenters expressed concerns that there may only be a limited number of pharmacies in their geographic area that can accept prescriptions electronically. Yet others suggested including a grace period for EPs in areas where no pharmacies e-prescribe at the beginning of their EHR reporting period, but later begin accepting eRx.

Response: We appreciate the commenters' concerns about this exclusion. We agree with commenters in that a 25-mile radius may be too large. We believe the 10-mile radius is more reasonable as it takes the country's geographic diversity (urban, suburban, rural areas) into account. We are therefore finalizing that if no pharmacies within a 10-mile radius of an EP's practice location at the start of the EHR reporting period accept electronic prescriptions, the EP would qualify for this exclusion, unless the EP is part of an organization that owns or operates a pharmacy within the 10-mile radius. As for patient preference, we agree with commenters that not all patients will want to go to a particular pharmacy just because they accept electronic prescriptions. However, we believe we accounted for patient preference by lowering the threshold for the measure to 50 percent.

After consideration of public comments, we are revising the measure at § 495.6(j)(2)(ii) to read: “More than 50 percent of all permissible prescriptions, or all prescriptions, written by the EP are queried for a drug formulary and transmitted electronically using CEHRT.”

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT at 45 CFR 170.314(b)(3) and 45 CFR 170.314(a)(10).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of prescriptions written for drugs requiring a prescription in order to be dispensed other than controlled substances during the EHR reporting period; or

Number of prescriptions written for drugs requiring a prescription in order to be dispensed during the EHR reporting period.

  • Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary and transmitted electronically using CEHRT.
  • Threshold: The resulting percentage must be more than 50 percent in order for an EP to meet this measure.

Exclusions: Any EP who: (1) Writes fewer than 100 permissible prescriptions during the EHR reporting period; or (2) does not have a pharmacy within their organization and there are no pharmacies that accept electronic prescriptions within 10 miles of the EP's practice location at the start of his/her EHR reporting period.

Consolidated Objective: Maintain an up-to-date problem list of current and active diagnoses.

Consolidated Objective: Maintain active medication list.

Consolidated Objective: Maintain active medication allergy list.

For Stage 2, we proposed to consolidate the objectives for maintaining an up-to-date problem list, active medication list, and active medication allergy list with the Stage 2 objective for providing a summary of care for each transition of care or referral. We stated that we continue to believe that an up-to-date problem list, active medication list, and active medication allergy list are important elements to be maintained in CEHRT. However, the continued demonstration of their meaningful use in Stage 2 would be required by other objectives focused on the transitioning of care of patients removing the necessity of measuring them separately. Providing this information is critical to continuity of care, so we proposed to add these as required fields in the summary of care for the following Stage 2 objective: “The EP, eligible hospital or CAH who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care should provide a summary care record for each transition of care or referral.” We stated that EPs and hospitals would have to ensure the accuracy of these fields when providing the summary of care, which we believe would ensure a high level of compliance in maintaining an up-to-date problem list, active medication list, and active medication allergy list for patients. The required standards for these fields are discussed in the ONC standards and certification final rule published elsewhere in this issue of the Federal Register.

Comment: Overall, we received very few comments on our proposal to consolidate the up-to-date problem list, active medication list, and active medication allergy list objectives. Some commenters opposed our proposal as they believe it would detract from the importance of these items. However, the vast majority of those who commented on this proposal supported the consolidation of these objectives.

Response: After consideration of public comments, we are finalizing the consolidation of these objectives as proposed for the reasons discussed in the proposed rule. The objectives of maintaining an up-to-date problem list, active medication list, and active medication allergy list will be consolidated with the Stage 2 objective for providing a summary of care for each transition of care or referral.

Proposed EP Objective: Record the following demographics: preferred language, gender, race and ethnicity, and date of birth.

Proposed Eligible Hospital/CAH Objective. Record the following demographics: preferred language, gender, race and ethnicity, date of birth, and date and preliminary cause of death in the event of mortality in the eligible hospital or CAH.

We proposed to continue the policy that EPs, eligible hospitals and CAHs collect baseline demographic data for all unique patients in the EHR using OMB standards for race and ethnicity. The proposed rule outlines some of the numerous benefits from recording basic patient demographic information in the EHR, including improved patient-centered care and management of the health of populations. In response to multiple comments from the Stage 1 final rule regarding the preliminary cause of death data element required for eligible hospitals and CAHs, we clarified the following; this element is the preliminary cause of death recorded by the hospital and is not required to be amended when additional information becomes available, there is no specified timeframe for recording this element, and we invited additional public comment regarding these clarifications in the proposed rule. We also asked for public comment on the burden and ability to include additional measures of disability status, gender identity and/or sexual orientation.

Comment: We received many comments suggesting CMS differentiate between the terms sex and gender. One commenter provided the definition that the term sex is used in recording vital health statistics that describe the physiological characteristics at time of birth. The term gender incorporates behaviors, roles, and expectations corresponding to an individual's sex and is generally self reported.

Response: We appreciate this clarification and will incorporate the change in terminology for the final rule using the term sex instead of gender in EP, eligible hospital and CAH objectives for recording demographics. This change in terminology aligns with vital statistic reporting and the HHS final demographic data collection standards published October 31, 2011.

Comment: Several commenters indicated that the collection of race and ethnicity demographic information can be sensitive and patients may be unwilling or uncomfortable reporting this information to the individual collecting demographic data. Other comments supported CMS clarification in the Stage 1 final rule that providers can be allowed to account for patients who decline to provide elements of demographic information. Additional comments suggested that a single system parameter be developed to identify states that prohibit data reporting should be available to the EHR.

Response: If a patient declines to provide information of ethnicity or race or if capturing a patient's ethnicity or race is prohibited by state law, this should be duly noted as structured data in the EHR and this would still count as an entry for the purpose of meeting this measure. A study by the Agency for Healthcare Research and Quality (AHRQ) states that current state prohibitions on the collection of ethnicity and race apply to health plans' collection of data at the time of enrollment. Title VI of the Civil Rights Act of 1964 permits health care organizations to collect race, ethnicity, and preferred language patient data for the purpose of quality improvement.

Comment: Several commenters suggested that CMS use the same definition for race and ethnicity as the Centers for Disease Control and Prevention (CDC) and the United States Census Bureau. Other commenters were concerned about the need to collect data granular enough to identify differences between subpopulations and aligned across government programs.

Response: We recognize that the CDC has developed codes that allow for the mapping of more detailed race and ethnicity categories such as those maintained by the U.S. Bureau of the Census to the less detailed OMB standard. We appreciate that providers may need to collect more granular demographic data to manage their patient populations. For purposes of achieving Stage 2 of meaningful use, we will continue to rely on the OMB standard as a minimum standard for the collection of race and ethnicity data. EPs, eligible hospitals, and CAHs who wish to collect more granular level data on patient race and ethnicity may do so as long as they can map the data to 1 of the 5 races included in the existing OMB standards. The standards associated with the meaningful use objectives and measures are discussed further in the ONC standards and certification criteria final rule and we refer readers to that regulation published elsewhere in this issue of the Federal Register.

Comment: Many commenters agreed with the need to incorporate disability status in EHR technology. However, it was also clear that several of these commenters varied in their definition of disability with interpretations that ranged from physical, mental, occupational, and economic disability status. Commenters also differed regarding the most appropriate location for the capture and storage of disability status data elements within the EHR. Suggestions for where to incorporate disability status data varied (for example; from the demographic objective, to physician notes, and/or the problem list component of the summary of care document). Another commenter suggested that the demographic objective should be limited to collecting data with static values and the active problem list, electronic notes and/or care summary documents that are continually updated would be more appropriate for recording changes in patient disability status.

Response: We wish to clarify that the term disability status used in the proposed rule was meant to be all-encompassing by incorporating both the concepts of physical and cognitive disabilities as well as the concept of functional status limitations that impact an individual's capability to perform activities in different environments. This latter concept incorporates metrics useful for planning and coordination across care settings. Commenters varied in their responses regarding the level of consensus on measurement standards for each of these health status measures. Since publishing the proposed rule we have learned that significant progress has been made regarding the capture of functional status into the consolidated clinical document architecture (C-CDA) standard for summary of care records. The C-CDA Implementation Guide provides the following examples that may be incorporated under functional status; assessments of a patient's language, vision, hearing, activities of daily living, behavior, general function, mobility, self-care status, physical state and cognitive function. [1] The C-CDA standards support the exchange of clinical documents between those involved in the care of a patient and allow for the re-use of clinical data for clinical care giving, public health reporting, quality monitoring, patient safety and clinical trials. This inclusion is addressed more fully under the discussion of the transition of care objective in this final rule.

We strongly support the adoption, implementation and meaningful use of CEHRT for all individuals and the reduction of barriers for persons with disabilities. In finalizing this rule, we also considered the operational challenges that could result from the lack of consensus noted by many commenters to incorporate a physical disability standard measure in the demographic section of CEHRT at this time. As a result, we will not require the collection of disability status data under the demographic objective for Stage 2 of meaningful use. However, we suggest that providers examine the questions developed by the HHS as required by section 4302 of the Affordable Care Act. The questions resulted from an interagency process and are closely aligned to the Census Bureau's American Community Survey and the International Classification of Disability. These questions may be found on the HHS Web site at http://minorityhealth.hhs.gov/templates/content.aspx?ID=9232#1. The answers to these questions could be incorporated as functional status or other data elements in the C-CDA summary of care document mentioned above and discussed more fully in the transition of care objective later in this rule.

We will continue to work with ONC, other federal agencies and seek the advice of the HIT Policy Committee to explore further how disability status could be included in meaningful use Stage 3.

Comments: Many commenters supported the proposed inclusion of recording gender identity and/or sexual orientation as part of the demographic objective. Other commenters suggested that the collection of this information is extremely sensitive and could be considered offensive for some patients especially when collected by administrative staff. Still other commenters did not see the clinical significance of collecting and recording this information in the demographic section of the EHR. Others commenters were against recording gender identity and/or sexual orientation because they did not consider this would provide additional clinical benefit. Still others suggested that the reporting of gender identity or sexual orientation be optional and up to individual clinician judgment whether or not it is appropriate to collect this information.

Similar to the comments for the proposed inclusion of disability status, commenters noted both the data collection challenges and data reporting burden. Many commenters were opposed to the mandatory collection of all three additional measures for Stage 2 of meaningful use and suggested that reporting could be optional.

Response: Considering the lack of consensus for the definition of the concept of gender identity and/or sexual orientation as well as for a standard measure of the concept and where it would be most appropriate to store the data within the EHR, we will await further development of a consensus for the goal and standard of measurement for gender identity and/or sexual orientation. Additionally, we note that many commenters raised concerns as to whether such data collection is necessary for all EPs, eligible hospital, and CAH regardless of specialty.

Comments: Several additional measures were suggested under the demographic objective including; measuring the level of access to and use of the internet, measuring computer literacy, and measuring standardized occupation using established industry codes.

Response: We appreciate the numerous comments suggesting additional demographic information that will allow providers to improve the quality of individual patient centered care as well as population health. We may consider these suggestions further in the development of Stage 3 of meaningful use.

Comment: A minority of commenters recommended removing the preliminary cause of death element altogether from the eligible hospital/CAH objective. Others suggested that the eligible hospital/CAH measure for preliminary cause of death be modified to simply capture whether or not the patient had a cause of death recorded, regardless of when that information was entered into the EHR, because the preliminary cause of death may often be inaccurate since by law the coroner or medical examiner makes the final determination for the patient's death certificate.

Response: We appreciate the suggestion for measure simplification. However, for this measure we want to respect the existing hospital workflow where a clinician evaluates the patient to pronounce the death. This preliminary cause of death is documented by the clinician in the patient's chart. We recognize that these workflows may change as EHR technology develops and becomes more widely adopted and the exchange of health information is able to link to vital statistic reporting. However, for the time being the measure of preliminary cause of death under the demographic objective will remain unchanged.

After consideration of the public comments received, we are modifying the meaningful use objective at § 495.6(j)(3)(i) of our regulations as follows: EPs “Record all of the following demographics: Preferred language, sex, race, ethnicity, and date of birth.”

After consideration of the public comments received, we are modifying the meaningful use objective at § 495.6(l)(2)(i) of our regulations as follows: Eligible hospitals and CAHs “Record all of the following demographics: Preferred language, sex, race, ethnicity, date of birth, date and preliminary cause of death in the event of mortality in the eligible hospital or CAH.”

Proposed Measure: More than 80 percent of all unique patients seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have demographics recorded as structured data.

Comment: Most commenters were supportive of the increased threshold for this measure.

Response: Our analysis of the meaningful use data for Stage 1 found that over 90 percent of EPs, eligible hospitals and CAHs were able to successfully report the demographic measure. Therefore, based on comments and actual performance data we do not foresee a burden in increasing the measure threshold from more than 50 percent in Stage 1 to greater than 80 percent in Stage 2.

After consideration of public comments, we are finalizing this measure for EPs at § 495.6(j)(3)(ii) and for eligible hospitals and CAHs at § 495.6(l)(2)(ii) as proposed.

We further specify that in order to meet this objective and measure an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(3).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

• Denominator: Number of unique patients seen by the EP or admitted to an eligible hospital or CAH inpatient or emergency department (POS 21 or 23) during the EHR reporting period.

• Numerator: The number of patients in the denominator who have all the elements of demographics (or a specific notation if the patient declined to provide one or more elements or if recording an element is contrary to state law) recorded as structured data.

• Threshold: The resulting percentage must be more than 80 percent in order for an EP, eligible hospital or CAH to meet this measure.

If a patient declines to provide one or more demographic elements this can be noted in the CEHRT and the EP or hospital may still count the patient in the numerator for this measure. The required elements and standards for recording demographics and noting omissions because of state law restrictions or patients declining to provide information will be discussed in the ONC standards and certification rule, published elsewhere in this issue of the Federal Register.

Proposed Objective: Record and chart changes in the following vital signs: height/length and weight (no age limit); blood pressure (ages 3 and over); calculate and display body mass index (BMI); and plot and display growth charts for patients 0-20 years, including BMI.

We proposed to continue our policy objective from Stage 1 to collect and record basic vital sign data for patients across health care settings. In the proposed rule, we outlined the benefits of documenting basic vital signs including that the data provides important clinical information on both the patient's current condition as well as the ability to track changes in patient status over time. For Stage 2, we proposed to remove the age restrictions on recording height/length and weight, and also proposed to remove the age restrictions on calculating and displaying BMI and growth charts. In addition, we proposed to modify the Stage 1 blood pressure guideline to align with the American Academy of Pediatrics guideline recommendations to measure blood pressure for children 3 years of age and older. We also proposed to continue our exclusions policy from Stage 1 (with modifications, as discussed below) for EPs who believe that recording and charting vital signs is outside the scope of their practice.

Comment: Several commenters questioned why all providers need to collect vital sign data when this information should be available from a robust health information exchange across providers.

Response: We will continue the Stage 1 meaningful use policy that any method of obtaining height, weight and blood pressure is acceptable for the purpose of this objective as long as the information is recorded as structured data in the CEHRT. As stated in the proposed rule, the vital sign information can be entered into the patient's medical record in a number of ways including: direct entry by the EP, eligible hospital, or CAH; entry by a designated individual from the EP, eligible hospital, or CAH's staff; data transfer from another provider electronically, through an HIE or through other methods; or data entered directly by the patient through a portal or other means. Some of these methods are more accurate than others, and it is up to the EP or eligible hospital to determine the level of accuracy needed to care for their patient and how best to obtain this information. We also look forward to the time when a more robust health information exchange network will allow providers to share relevant data across settings and/or alert providers when additional data should be obtained.

Comment: We received comments requesting that CMS include a statement clarifying which specialties would be included or excluded from this objective.

Response: We appreciate commenter's efforts to clarify this objective. However, we will continue our more general policy from Stage 1 (with modifications, as explained later) of allowing EPs to exclude this objective if they believe recording and charting changes in vital signs is not relevant to their scope of practice. We cannot define the scope of practice and/or interventions necessary for each individual patient and will continue to rely on provider determinations based on individual patient circumstances. Consider a hypothetical example of an elderly patient with multiple chronic conditions that includes depression. When the patient is seen by his behavioral healthcare provider to manage his depression, it is up to that provider to determine whether it would be medically necessary to record and chart the patient's weight in order to manage the patient's care.

After consideration of public comments, we are finalizing this objective for EPs at § 495.6(j)(4)(i) and for eligible hospitals and CAHs at § 495.6(l)(3)(i) as proposed.

Proposed Measure: More than 80 percent of all unique patients seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have blood pressure (for patients age 3 and over only) and height/length and weight (for all ages) recorded as structured data.

We proposed to split the exclusions from Stage 1 such that an EP could choose to record height/length and weight only and exclude blood pressure, or record blood pressure only and exclude height/length and weight. We encouraged comments on this split and whether it should go both ways. We proposed to increase the threshold from more than 50 percent to more than 80 percent for this measure.

Comment: Several commenters agreed with the policy that height/length, weight, and blood pressure do not each need to be updated by a provider neither at every patient encounter nor even once per patient seen during the EHR reporting period.

Response: We will maintain our policy from Stage 1 that it is up to the EP or hospital to determine whether height/length, weight, and blood pressure each need to be updated, the level of accuracy needed to care for their patient, and how best to obtain the vital sign information that will allow for the right care for each patient.

Comment: Another commenter suggested that CMS clarify that the growth charts and BMI are not part of the actual measure for this objective.

Response: We clarify that to satisfy the measure of this objective, the CEHRT must have the capability to calculate BMI and produce growth charts for patients as appropriate. Since BMI and growth charts are only produced when height/length and weight vital sign data are captured in the CEHRT, the measure is limited to these data elements.

Overall commenters supported the added flexibility of our proposal to split the exclusion and allow EPs to record blood pressure only or height/length and weight only. Our analysis of the meaningful use data for Stage 1 found that over 90 percent of EPs, eligible hospitals and CAHs were able to successfully report the vital signs measure. We did not propose additional measure elements that could increase the reporting burden at this time.

After consideration of the public comments received, we are finalizing this measure as proposed for EPs at § 495.6(j)(4)(ii) and for eligible hospitals and CAHs at § 495.6(l)(3)(ii).

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(4). The ability to calculate the measure is included in CEHRT.

To calculate the percentage, CMS and ONC have worked together to define the following:

  • Denominator: Number of unique patients seen by the EP or admitted to an eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period.
  • Numerator: Number of patients in the denominator who have at least one entry of their height/length and weight (all ages) and/or blood pressure (ages 3 and over) recorded as structured data.
  • Threshold: The resulting percentage must be more than 80 percent in order for an EP, eligible hospital, or CAH to meet this measure.
  • Exclusions: Any EP who sees no patients 3 years or older is excluded from recording blood pressure. Any EP who believes that all 3 vital signs of height/length, weight, and blood pressure have no relevance to their scope of practice is excluded from recording them. Any EP who believes that height/length and weight are relevant to their scope of practice, but blood pressure is not, is excluded from recording blood pressure. Any EP who believes that blood pressure is relevant to their scope of practice, but height/length and weight are not, is excluded from recording height/length and weight.

Proposed Objective: Record smoking status for patients 13 years old or older.

We stated in the proposed rule that accurate information on smoking status provides context to a high number and wide variety of clinical decisions, such as immediate needs for smoking cessation or long-term outcomes for chronic obstructive pulmonary disease. Cigarette smoking is a key component to the current Million Hearts Initiative (http://millionhearts.hhs.gov). We did not propose rules on who may record smoking status or how often the record should be updated. In addition, we proposed to continue the age limitation at 13 years old. We also requested comments specifically on the possible inclusion of other forms of tobacco use and second hand smoke.

Comment: We have received comments that assert that the objective is not relevant to a significant number of EPs due to their scope of practice and that it is redundant to the clinical quality measure “National Quality Forum (NQF) 28: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention”. Some of the comments suggest that it should be eliminated and those EPs for whom it is relevant select the CQM.

Response: We disagree that the proposed objective and the clinical quality measure identified by commenters serve the same purpose and therefore only one should be included. The objective seeks to ensure that information on smoking status is included in the patient's record. Furthermore, that the information is stored in a structured format so that it can automatically be identified by CEHRT as smoking status for possible reporting or exchanging. We also note that the clinical quality measure only focuses on patients 18 years or older, while the objective focuses on patients 13 years or older. In addition, many quality measures related to smoking are coupled with follow-up actions by the provider such as counseling. We consider those follow-up actions to be beyond the scope of what we hope to achieve for this objective and would move the objective beyond the scope of practice for many providers. We disagree that the objective is not relevant to EPs seeing patient 13 years old or older. We note that this is intended to inform the provider. The frequency of when the information is updated, detail beyond the standard included in certification of EHR technology and many other factors discussed later are all left up to the provider to decide and fit to their scope of practice and their patient population.

Comment: We received conflicting suggestions in comments regarding the age limitation. These comments can be divided into those suggesting a lower age (as low as 8 to 12), those supporting 13 years old and those who believe it should be raised to 18 to match the clinical quality measures associated with smoking.

Response: It is apparent from the comments that the appropriate age for smoking status is an elusive target highly dependent on the situation. For example, it was suggested in comments that the age be lowered for patients meeting certain characteristics such as parents who smoke or other risk factors, while remaining at 13 for other patients. In our review of the public comments, we do not believe a consensus has been reached on a different age limitation than our Stage 1 age limitation of 13 years old and therefore finalize the age limitation as proposed. As with other meaningful use objectives and measures, this represents a minimum requirement. We encourage each and every provider to evaluate whether their scope of practice and/or patient population calls for collecting smoking status on patients younger than 13 or more detailed information than required by this objective.

Comment: There continues to be strong support for expanding smoking to other forms of tobacco use. Commenters note that other types of tobacco use are supported by the clinical quality measure “NQF 28: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention”.

Response: We refer readers to ONC's standards and certification criteria final rule that is published elsewhere in this issue of the Federal Register for discussions on the adoption of a standard that would support other types of tobacco use. As ONC did not adopt a standard supporting other forms of tobacco use, we do not expand the objective.

Comment: Some commenters expressed strong support for the inclusion of second-hand smoke either as part of this objective or as a separate objective.

Response: We agree with the importance of collecting second-hand smoke information for many EPs and hospitals. However, as with other forms of tobacco use, there is not a standard on which to base the requirement of collection of this information as structured data.

After consideration of the public comments received, we are finalizing this objective as proposed for EPs as § 495.6(j)(5)(i) and for eligible hospitals and CAHs at § 495.6(l)(4)(i).

Proposed Measure: More than 80 percent of all unique patients 13 years old or older seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency departments (POS 21 or 23) during the EHR reporting period have smoking status recorded as structured data.

In our proposed rule, based on Stage 1 data showing performance on this measure far exceeded the measure threshold of more than 50 percent, we proposed a threshold of more than 80 percent for this measure for Stage 2 of meaningful use.

Comment: We received comments asking for clarification on what must be recorded in the EHR and how often for the numerator to be met.

Response: Information on smoking status must be present as structured data using the standard specified at 45 CFR 170.314(a)(11). There is no requirement that the smoking status be entered into the record by a specific person or category of persons, there is no requirement that smoking status be entered into the CEHRT already in the terminology of the standard and there is no requirement on how frequently this information be updated. A patient indicating how many packs he smokes a day on a new patient questionnaire which is then entered by an administrative person and mapped in the CEHRT to one of the responses in the standard is valid for this measure. A physician could also ask a patient detailed questions to determine if the patient is a current smoker, input the information into the CEHRT, and select one of the responses of the standard. ONC has provided a mapping of SNOMED CT® ID to the descriptions at 45 CFR 170.314(a)(11).

Comment: We received a few comments on the threshold. Most were supportive, while others believe it should remain at 50 percent.

Response: Due to our analysis of performance on this measure from Stage 1 and the support received from commenters, we are finalizing the threshold as proposed.

After consideration of public comments, we are finalizing this measure as proposed for EPs at § 495.6(j)(5)(ii) and for eligible hospitals and CAHs at § 495.6(l)(4)(ii).

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(11).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of unique patients age 13 or older seen by the EP or admitted to an eligible hospital's or CAH's inpatient or emergency departments (POS 21 or 23) during the EHR reporting period.
  • Numerator: The number of patients in the denominator with smoking status recorded as structured data.
  • Threshold: The resulting percentage must be more than 80 percent in order for an EP, eligible hospital, or CAH to meet this measure.
  • Exclusion: Any EP, eligible hospital, or CAH that neither sees nor admits any patients 13 years old or older.

CQM Reporting as a Stage 2 Objective—We proposed to add CQM reporting to the definition of “meaningful EHR user” under § 495.4 instead of including it as a separate objective under § 495.6. Accordingly, we did not propose a CQM reporting objective for EPs and hospitals as part of the Stage 2 criteria under § 495.6.

Comment: While some commenters indicated that this change would be confusing, most commenters supported this change.

Response: We appreciate the support of commenters and believe including CQM reporting in the definition of “meaningful EHR user” under § 495.4 will actually alleviate confusion. Therefore, we are not finalizing an objective related to the reporting of CQMs in the Stage 2 criteria for meaningful use under § 495.6. Although CQM reporting is not listed as a separate objective and measure under § 495.6, it remains a condition for demonstrating meaningful use.

Consolidated Objective: Implement drug-drug and drug-allergy interaction checks.

For Stage 2, we proposed to make the objective for “Implement drug-drug and drug-allergy checks” one of the measures of the core objective for “Use clinical decision support to improve performance on high-priority health conditions.” We noted our belief that automated drug-drug and drug-allergy checks provide important information to advise the provider's decisions in prescribing drugs to a patient. Because this functionality provides important clinical decision support that focuses on patient health and safety, we proposed to include this functionality as part of the objective for using clinical decision support.

We discuss comments regarding this consolidation in the discussion of the clinical decision support objective.

Proposed Objective: Use clinical decision support to improve performance on high-priority health conditions.

We proposed to modify the clinical decision support (CDS) objective for Stage 2 such that CDS would be used to improve performance on high-priority health conditions. We stated it would be left to the provider's clinical discretion to select the most appropriate CDS interventions for their patient population. We also proposed that the CDS interventions selected must be related to five or more of the clinical quality measures (CQMs) on which providers would be expected to report. The goal of the proposed CDS objective is for providers to implement improvements in clinical performance for high-priority health conditions that will result in improved patient outcomes.

Comment: A few commenters voiced concern regarding the maturity of the development of clinical decision support systems. Others voiced a misconception that not all CEHRT includes pre-built CDS interventions where both capabilities and content are vendor supplied. The commenter went on to clarify that the CDS interventions must be specific to each provider's requirements. Still others commented on the CMS change in terminology from CDS “rules” to CDS “interventions” increases the range of available interventions.

Response: We recognize commenters' concerns regarding the maturity of CDS systems. Closely linked to the development of EHRs, there are multiple factors impacting the evolution of CDS systems including; the increasing availability and sophistication of information technology in clinical settings, the increasing pace of publication of new evidence-based guidelines for clinical practice and the continual evaluation and improvements of CDS. [2] We clarify that all CEHRT includes CDS interventions. The companion ONC standards and certification criteria final rule published elsewhere in this issue of the Federal Register includes further information regarding the criteria necessary to implement CDS in CEHRT for Stage 2 of meaningful use. With each incremental phase of meaningful use, CDS systems progress in their level of sophistication and ability to support patient care. For Stage 2 of meaningful use, it is our expectation that at a minimum, providers will select clinical decision support interventions to drive improvements in the delivery of care for the high-priority health conditions relevant to their patient population. Continuous quality improvement requires an iterative process in the implementation and evaluation of selected CDS interventions that will allow for ongoing learning and development. In this final rule, we will consider a broad range of CDS interventions that improve both clinical performance and the efficient use of healthcare resources in measuring providers' ability to demonstrate the meaningful use of CEHRT for Stage 2.

After consideration of the public comments received, we are finalizing this objective as proposed for EPs at § 495.6(j)(6)(i) and for eligible hospitals and CAHs at § 495.6(l)(5)(i).

Proposed Measure: We proposed two measures for EPs, eligible hospitals and CAHs for this objective. Both of the measures must be met in order for the provider to satisfy this objective:

1. Implement five clinical decision support interventions related to five or more clinical quality measures at a relevant point in patient care for the entire EHR reporting period; and

2. The EP, eligible hospital, or CAH has enabled and implemented the functionality for drug-drug and drug-allergy interaction checks for the entire EHR reporting period.

We proposed to make the Stage 1 objective for “implement drug-drug and drug-allergy interaction checks” one of the measures of the CDS objective for Stage 2. Based on the HIT Policy Committee's recommendation, we proposed that each CDS intervention must enable providers to review all of the following attributes for the intervention: developer of the intervention, bibliographic citation, funding source of the intervention, and the release or revision date of each intervention. The ONC standards and certification criteria final rule published elsewhere in this issue of the Federal Register provides additional information regarding the incorporation of the CDS in CEHRT. We proposed that providers must implement the CDS intervention at a relevant point in patient care when the intervention can influence clinical decisionmaking before an action is taken on behalf of the patient. We proposed that providers must implement five CDS interventions that they believe will result in improvement in performance for five or more of the clinical quality measures on which they report. If none of the clinical quality measures is applicable to an EP's scope of practice, the EP should implement a CDS intervention that he or she believes will be effective in improving the quality, safety, or efficiency of patient care.

Comment: Many commenters noted that at least one of the CDS interventions implemented should be tied to efficiency goals (for example, reducing the overuse of high-cost procedures).

Response: While we believe that it is entirely possible for a CDS intervention to improve both the quality of care and improve healthcare efficiency, we agree with the suggestion that at least one intervention could be tied directly to improving the efficient use of healthcare resources. In considering whether a CDS intervention increases healthcare efficiency, providers can consider improvements in any healthcare process. Some examples, of CDS interventions that may lead to improvements in healthcare efficiency include, alerts when duplicate tests, procedures or treatments are ordered for the same patient, using clinical guidelines for direct patient care processes, documentation templates to reduce variability in recording and alerting when outside of specified parameters, and using evidence based pre-specified order sets for blood products. Therefore, we are modifying the proposed CDS measure such that four of the CDS interventions are related to four or more CQMs, and the fifth CDS intervention should be related to improving healthcare efficiency. We clarify that any of the five CDS interventions may be related to both CQMs and improving healthcare efficiency.

Comment: Various comments were received in response to the proposed number of CDS interventions that are related to five or more CQMs. One commenter noted the potential for improved provider reporting and user efficiencies due to the inherent measure associations. Several commenters welcomed this improved alignment of CQM measures and reporting between the EHR Incentive Program and other CMS quality programs. Other commenters expressed the difficult burden for specialists and others who may not be able to identify sufficient CQMs related to their patient population. Still other comments suggested that providers could easily implement double the number of proposed CDS interventions.

Response: Overall comments were supportive of the proposed number of CDS interventions and of aligning these interventions with CQM reporting. If none of the clinical quality measures are applicable to an EP's scope of practice, the EP should implement a clinical decision support intervention that he or she believes will be effective in improving the quality, safety or efficiency of patient care. We believe that the proposed clinical quality measures for eligible hospitals and CAHs would provide ample opportunity for implementing clinical decision support interventions related to high-priority health conditions.

Comment: Commenters also supported continuing the requirement for providers to enable and implement drug-drug and drug-allergy interaction checks for the entire reporting period under the new CDS measure. An AHA Survey indicated that 73 percent of hospitals could perform the drug/drug and drug/allergy check, as well as at least one additional clinical decision support function in the Fall of 2011.

Response: We appreciate the commenters' overall support for consolidating this Stage 1 objective into one of the required clinical decision support measures. We also agree that drug-drug and drug-allergy interaction checks are important CDS tools contributing to improvements in patient safety and the overall quality of patient care.

Comment: Additional comments addressed concerns regarding the point at which professionals will be able to exercise clinical judgment about the CDS intervention before action is taken on behalf of the patient. The specific concern is that some interventions are only triggered when an action is about to be taken, and proposed that CMS revise this criterion to “before or at the time an action is taken.”

Response: We agree with the commenter that providers should be allowed the flexibility to determine the most appropriate CDS intervention and timing of the CDS. The CDS measure for EPs, eligible hospitals and CAHs allows this flexibility by allowing the implementation at a “relevant point in patient care.” We clarify that the CDS implementation criterion which allow for CDS implementation at a relevant point in patient care includes interventions that may occur before or at the time an action is taken in the care delivery process.

Comment: Several commenters expressed concern with “alert fatigue” associated with increased use of clinical decision support interventions. These commenters cited studies that suggest that multiple alerts may be disabled or ignored resulting in adverse effects in the quality of care and patient safety.

Response: We recognize that “alert fatigue” is a potential occurrence with the increased use of some types of clinical decision support interventions. However, meaningful use seeks to leverage the capabilities of CEHRT to improve patient care. The selection of CDS interventions should weigh both the potential for unintended consequences including alert fatigue against the benefits of each CDS intervention, and the appropriate selection of an intervention type that interferes minimally with the provider's clinical workflow and cognitive burden. We believe such determinations are best left to providers. CDS is included as a meaningful use objective because we believe that the overall benefit of CDS is to improve patient safety and the quality of care. Therefore, we will continue to require the implementation of clinical decision support interventions in order to achieve meaningful use. Finally, as defined in the ONC standards and certification criteria final rule published elsewhere in this issue of the Federal Register, CDS is “not simply an alert, notification, or explicit care suggestion.” While some alerts may be helpful and necessary, we encourage EPs and hospitals to consider the selection of CDS interventions that are not alerts in order to reduce the burden of alert fatigue. Examples of non-alert CDS may include patient or disease specific order sets, referential decision support (presentation or availability of clinical reference information such as diagnostic guidance, dosing guidelines, or lab value interpretation assistance, or patient or disease specific documentation forms/templates that remind the provider to capture essential historical or physical exam findings for a patient with a certain condition). A common example of a CDS form/template would be a documentation form that is presented for patients with diabetes that includes a required section for the diabetic foot exam, where the same form would be presented for patients without diabetes and with the diabetic foot exam section removed.

Comment: Several commenters requested the flexibility to be able to change CDS interventions at any point during the reporting period so that in effect they would not be implementing the CDS intervention during the entire reporting period. Commenters cited provider uncertainty at the beginning of a reporting period of which CQMs they will ultimately report during the attestation process (for example, due to low counts for the measures). Many commenters requested the additional flexibility for providers to be permitted to implement CDS interventions relevant to any of the finalized panel of clinical quality measures specific to the provider type, even if the provider ultimately chooses different clinical quality measures to report. Commenters requested the opportunity to change CDS interventions during the reporting period and not be penalized for the CDS measure that requires the intervention during the entire reporting period. Commenters also wanted clarification whether they have to align CDS interventions with the same CQM measures reported for meaningful use.

Response: We expect providers to align CDS interventions with CQMs to the extent possible, although we recognize that providers may not know at the beginning of a reporting period which CQMs they will end up selecting to report. Based on the comments, we clarify that EPs and hospitals may implement CDS interventions that are related (as defined in the proposed rule) to any of the clinical quality measures for EPs and hospitals, respectively, and that are finalized for the EHR Incentive Program for the relevant year of reporting. In other words, providers are not required to implement CDS interventions that are related to the specific CQMs that they choose to report for that year. Providers who are not able to identify CQMs that apply to their scope of practice or patient population may implement CDS interventions that they believe are related to high-priority health conditions relevant to their patient population and will be effective in improving the quality, safety or efficiency of patient care. We will require providers to implement a minimum of five CDS interventions for the entire EHR reporting period. The provider may switch between CDS interventions or modify them during the EHR reporting period as long as a minimum of five are implemented for the entire EHR reporting period. We expect that providers may choose to implement a greater number of interventions from which they can select five interventions that have been enabled for the entire EHR reporting period when they attest to meaningful use.

Comment: Several providers recommend to be allowed to use their clinical judgment regarding which clinical decision support interventions would best benefit patients within the scope of their practice.

Response: We thank providers for this comment and want to clarify that in Stage 1; CMS allowed providers significant leeway in determining the clinical support interventions most relevant to their scope of practice. In Stage 2, we will continue to provide the flexibility for providers to identify high-priority health conditions that are most appropriate for CDS. As we stated in the proposed rule, for Stage 2 we will not require the provider to demonstrate actual improvements in performance on clinical quality measures for this objective. Because CQMs focus on high-priority health conditions by definition, to the extent possible, four of the five CDS interventions that are implemented must be related to CQMs. Providers are also reminded that the CDS interventions selected for Stage 2 represent only a floor. We expect that providers will implement many CDS interventions, and providers are free to choose interventions in any domain that is a priority to the EP, eligible hospital or CAH.

Comment: Several commenters voiced concern that CDS interventions must be predetermined at the beginning of an EHR reporting period but providers do not have to choose CQMs until the end of the attestation reporting period. There is concern that providers will be unable to change the CDS interventions if they decide to change the related CQMs in a reporting period.

Response: We proposed alignment with CQMs to facilitate provider reporting and measurement, but as we clarified earlier, providers are allowed the flexibility to implement CDS interventions that are related to any of the CQMs that are finalized for the EHR Incentive Program. They are not limited to the CQMs they choose to report. Providers who are not able to identify CQMs that apply to their scope of practice or patient population may implement CDS interventions that they believe are related to high-priority health conditions relevant to their patient population and will be effective in improving the quality, safety or efficiency of patient care. These high priority conditions must be determined prior to the start of the EHR reporting period in order to implement the appropriate CDS to allow for improved performance. We require a minimum number of CDS interventions, and providers must determine whether a greater number of CDS interventions are appropriate for their patient populations.

Comment: Commenters supported the inclusion of drug-drug and drug-allergy checks noting that they are critical to ensuring the safety of the medications prescribed for patients, and agree with the inclusion of this measure. Other commenters noted the lack of an for EPs who do not prescribe medications and thus would not be able to meet this core set objective.

Response: We received similar feedback after publication of the Stage 1 final rule and after careful consideration of the comments, we will allow an exclusion to this measure for EPs that write fewer than 100 medication orders during the EHR reporting period. We did not include this exclusion as a change to Stage 1 as this is primarily an implementation of a function of CEHRT and there is no requirement to update CEHRT in 2013. This exclusion aligns with the exclusion under the objective CPOE for medication orders discussed earlier in this rule.

Comment: There were several comments regarding the implementation of CDS and the attributes required for each intervention. Commenters did not believe that the information requested in order to support the inclusion of CDS attributes would be available to many providers, particularly for providers in a group practice. Commenters also requested clarification whether these attributes would be required for drug-drug and drug-allergy interactions. Other commenters requested additional clarification regarding the extent that CDS attributes are required when the interventions result from self-generated evidence. Other comments addressed provider concerns regarding the need to purchase additional expensive vendor products and upgrades to incorporate these requirements.

Response: We appreciate the many comments for the proposed CDS attributes. We clarify that the need for inclusion of attributes for each CDS intervention also applies to drug-drug and drug-allergy interventions as well as interventions based on self-generated evidence. The companion ONC standards and certification criteria final rule published elsewhere in this issue of the Federal Register further describes CEHRT requirements for these CDS attributes in order to ensure that all users of CEHRT will have access to this new functionality. After consideration of the public comments and for the reasons discussed earlier, we are modifying the measures for EPs at § 495.6(j)(6)(ii) and for eligible hospitals and CAHs at § 495.6(l)(5)(ii) as follows:

  • Implement five clinical decision support interventions related to four or more clinical quality measures at a relevant point in patient care for the entire EHR reporting period. Absent four clinical quality measures related to an EP, eligible hospital or CAH's scope of practice or patient population, the clinical decision support interventions must be related to high-priority health conditions . It is suggested that one of the five clinical decision support interventions be related to improving healthcare efficiency.
  • The EP, eligible hospital, or CAH has enabled and implemented the functionality for drug-drug and drug-allergy interaction checks for the entire EHR reporting period.

Exclusion: For the second measure, any EP who writes fewer than 100 medication orders during the EHR reporting period.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(8) and (a)(2).

Replaced Objective: Provide patients with an electronic copy of their health information.

Replaced Objective: Provide patients with an electronic copy of their discharge instructions.

For Stage 2, we did not propose the Stage 1 meaningful use objectives for EPs and hospitals to provide patients with an electronic copy of their health information and discharge instructions upon request. As we stated in the proposed rule, the HIT Policy Committee recommended that these objectives be combined with the objectives for view online, download, and transmit. We agreed with the HIT Policy Committee and proposed to replace the Stage 1 objectives above with objectives and measures for Stage 2 that would enable patients to view online and download their health information and hospital admission information. We stated that continued online access to such information is more useful and provides greater accessibility over time and in different health care environments than a single electronic transmission or a one-time provision of an electronic copy, especially when that access is coupled with the ability to download a comprehensive point in time record.

We received no comments that supported the retention of these objectives for Stage 2. Therefore, we are finalizing the replacement of these objectives for EPs, eligible hospitals, and CAHs as proposed. Please refer to the discussions later in this rule regarding view online, download, and transmit objectives for both EPs and eligible hospitals and CAHs for more information about the Stage 2 objectives that replace these Stage 1 objectives.

Proposed EP Objective: Provide clinical summaries for patients for each office visit.

In the proposed rule, we outlined the following benefits of providing clinical summaries for patients for each office visit: A summary of an office visit provides patients and their families with a record of the visit. This record can prove to be a vital reference for the patient and their caregivers about their health and actions they should be taking to improve their health. Without this reference, the patient must either recall each detail of the visit, potentially missing vital information, or contact the provider after the visit. Certified EHR technology enables the provider to create a summary easily and in many cases instantly. This capability removes nearly all of the barriers that exist when using paper records.

As noted in the proposed rule, clinical summaries for each office visit are important because without this reference the patient must either recall each detail of the visit, potentially missing vital information, or contact the provider after the visit. We also noted that this is a meaningful use requirement, which does not override an individual's broader right under HIPAA to access his or her health information. Providers must continue to comply with all applicable requirements under the HIPAA Privacy Rule, including the access provisions of 45 CFR 164.524. However, none of the HIPAA access requirements preclude an EP from releasing electronic copies of clinical summaries to their patients as required by this meaningful use provision. For Stage 2, we proposed this as a core objective for EPs.

Comment: Some commenters believed that this objective should be eliminated because the same information would be made available through the objective to “Provide patients the ability to view online, download, and transmit their health information.” Other commenters suggested combining these objectives with a concomitant rise in the measure threshold.

Response: While it is true that there may be overlap between the information in the clinical summary and the information made available through the objective to “Provide patients the ability to view online, download, and transmit their health information,” we believe the clinical summary after an office visit serves a different purpose than online access to health information. A summary of an office visit provides patients and their families with a record of the visit and specific lab tests or specific follow-up actions and treatment related to the visit. While this information is certainly part of the patient's overall electronic health record, the clinical summary serves to highlight information that is relevant to the patient's care at that particular moment. Therefore, we decline to eliminate or combine the objective.

After consideration of the public comments, we are finalizing the meaningful use objective for EPs at § 495.6(j)(11)(i) as proposed.

Proposed EP Measure: Clinical summaries provided to patients within 24 hours for more than 50 percent of office visits.

In the proposed rule, we proposed to maintain several policies regarding this objective from Stage 1. As we stated, for purposes of meaningful use, an EP could withhold information from the clinical summary if they believe substantial harm may arise from its disclosure through an after-visit clinical summary. An EP could also choose whether to offer the summary electronically or on paper by default, but at the patient's request must make the other form available. The EP could select any modality (for example, online, CD, USB) as their electronic option and would not have to accommodate requests for different modalities. We also stated in the proposed rule that we do not believe it would be appropriate for an EP to charge the patient a fee for providing the summary. Finally, we stated that when a single consolidated summary is provided for an office visit that lasts for several consecutive days, or for an office visit where a patient is seen by multiple EPs, that office visit must be counted only once in both the numerator and denominator of the measure. We are finalizing all of these policies for Stage 2 as proposed.

Comment: Many commenters suggested that the measure should be changed from “24 hours” to “1 business day.” Other commenters believed that this timeframe was too short, especially for specialty providers who might not come into the office every day, and suggested either changing the timeframe to 48 hours or reverting to the 72-hour measure of Stage 1. Another commenter noted that delays past 24 hours can sometimes occur outside of the provider's control—for example, in the case of new patients where the provider might not have access to adequate previous records.

Response: We believe that Certified EHR technology enables the provider to create a summary with the required information easily and in most cases instantly. The feedback we have received on this objective in Stage 1 through discussions with providers indicates that most providers make this clinical summary available as patients leave the office visit, and we expect this workflow to continue for most providers. Therefore a longer timeframe of 48 or 72 hours should not be necessary for providing clinical summaries. We also note that the clinical summary contains information relevant to the patient's office visit and therefore the EP should not need to include information from previous records for most patients. However, we believe the threshold of more than 50 percent of office visits allows EPs to meet the measure of this objective despite these challenges for a small number of patients. We also agree that the measure should be changed from “24 hours” to “1 business day” since all providers may not have staff available to issue clinical summaries prior to the close of a work week or the beginning of a Federal holiday. Therefore, we are finalizing the change from “24 hours” to “1 business day.”

Comment: A number of commenters raised questions regarding the provision of the clinical summary. They asked whether the summary should be given automatically to each patient or whether offering the summary at the end of an office visit was sufficient to meet the measure. Commenters also asked whether patients who refused a copy of the clinical summary should be counted in the numerator of the measure.

Response: It is the intention of this objective that clinical summaries be automatically given to patients within 1 business day of an office visit. However, we do recognize that some patients may decline a physical copy of their clinical summary. In the event that a clinical summary is offered to and subsequently declined by the patient, that patient may still be included in the numerator of the measure. We note that the clinical summary must be offered to the patient; a passive indication of the clinical summary's availability (for example, a sign at the reception desk, a note in form, etc.) would not serve as offering the clinical summary and those patients could not be counted in the numerator of the measure. However, the clinical summary does not necessarily need to be printed before being offered to the patient.

Comment: Commenters asked whether making clinical summaries available on a patient portal or as part of the objective to “Provide patients the ability to view online, download, and transmit their health information” would meet the measure of this objective. Some commenters suggested that patients should be permitted to demand an electronic copy of clinical summaries where an EP has chosen to provide them in hard copy form.

Response: We are continuing our policy from Stage 1 that the clinical summary can be provided through a patient portal or through other electronic means to satisfy this measure. A clinical summary provided through the same means that the provider makes other patient information available to meet the objective to “Provide patients the ability to view online, download, and transmit their health information” would also meet the measure of this objective. As stated previously, an EP can choose whether to offer the summary electronically or on paper by default, but at the patient's request must make the other form available. The EP could select any modality (for example, online, CD, USB) as their electronic option and would not have to accommodate requests for different electronic modalities.

Comment: Some commenters suggested that this measure should be based on the number of unique patients seen by the EP instead of office visits. Other commenters suggested that the threshold for the measure should be reduced.

Response: We do not agree that the measure should be based on unique patients. The purpose of the clinical summary is to provide patients and their authorized representatives with a record of an office visit and specific lab tests or specific follow-up actions and treatment related to that visit. Nor do we agree that the percentage threshold of this measure should be reduced. We note that the threshold for this measure in Stage 1 was also 50 percent; any reduction would constitute a step backward for the meaningful use of this capability.

Comment: Some commenters suggested that EPs should be permitted to charge a fee for provision of a clinical summary.

Response: Because the clinical summary is meant to summarize the office visit and any lab tests, follow-up actions, or treatments related to that visit, we do not believe it is appropriate for an EP to charge patients additional fees for its provision. Also, because this is a meaningful use requirement for the incentivized provider and not a response to a patient request, we do not believe it is appropriate for an incentivized provider to charge the patient. This is consistent with our position for this objective in Stage 1 (75 FR 44358).

Comment: Commenters suggested that clinical summaries provided to patient-authorized representatives should also be counted for this measure.

Response: We agree that the provision of a clinical summary to a patient-authorized representative should also be counted, and we have amended the measure accordingly.

Comment: Many commenters believed that the list of required elements to be included in the clinical summary was excessive and not useful to the patient. Commenters suggested that the list be shortened or left to the provider's discretion. Additionally, many commenters asked for clarification on whether certain fields could be left blank and still permit the EP to meet the measure of this objective. Finally, a number of commenters suggested that this objective should focus on whether the summary is provided and not on required information since CEHRT cannot distinguish between information not provided in a clinical summary because it is not relevant or because a provider has exercised discretion to withhold it.

Response: This measure is focused on the provision of the clinical summary. The clinical summary represents a patient's current care and health as a snapshot in time. When provided, we believe it can significantly improve a patient's overall awareness of the care they are receiving as well as any conditions they may need to manage between office visits. The required information listed at the end of this section are provided as a way to standardize and prioritize for the purposes of EHR technology certification the minimum amount of information that must be available to EPs to select. Further, we believe that the information in this minimum list is the most applicable and beneficial to improving patient care. This is a list of information, not a particular structure or format for the summary handed to the patient.

We have no requirements on the design of the summary just the information that must be present if it is in the CEHRT. The design of the summary should reflect the context of the visit. For example, the information of future appointments, referrals to other providers, future scheduled tests, and clinical instructions could all appear in a section of the summary called “Next steps”. If all of these information areas were empty then “next steps” could just be none and all the feeding information elements would be covered. Alternatively, if the summary is provided on letterhead that includes the office location and the provider's name that information does not have to be repeated in the text of the summary. We cannot emphasize enough that this is required information for the summary not a particular required structure for the summary. We do not believe that the list of required information imposes an undue burden on providers because CEHRT will be able to automatically generate the clinical summary with at least all of the required information. In ONC's rule it has included in the certification criterion that correlates to this objective the capability for end-users to customize (for example, edit) the clinical summary to make it more relevant to the patient encounter.

In circumstances where there is no information available to populate one or more of the fields previously listed, either because the EP can be excluded from recording such information (for example, vital signs) or because there is no information to record (for example, no medication allergies or laboratory tests), an indication that the information is not available in the clinical summary would meet the measure of this objective. The feedback we have received on this objective in Stage 1 through discussions with providers indicates that the absence of information in the clinical summary sometimes offers an opportunity for reconciliation of misinformation; for example, if “no medication allergies” is listed but the patient has one, he or she may communicate that to the provider, thus improving the quality of the data in the EHR. We do note that the measure of this objective already focuses on provision of the clinical summary and is not specific to the information which is provided within the clinical summary; the list of required elements is meant to standardize the information given to patients, not to create an additional measure for the objective.

We also refer providers to our discussion of what constitutes an office visit. Many of the concerns we have heard regarding this summary are the result of misunderstandings about what constitutes an office visit. For example, in some cases removing sutures or giving allergy shots do not represent an office visit if that is the only service provided.

Comment: Commenters asked for clarification on “current problem list and any updates,” “current medication list and any updates,” and “current medication allergy list and any updates,” since updates would be included in any current problem list. They suggested simplifying these requirements to “current problem list;” “current medication list;” and “current medication allergy list”.

Response: We agree that including the language “and any updates” is redundant since a current problem, medication, or medication allergy list would already include updated information. We are amending this language in the list of required elements below. However, the clinical summary should include both a current problem list and any diagnosis specifically related to the office visit as separate fields. The diagnosis related to the office visit should be expressed in the “Reason for the patient's visit” field, though it may also be included in the current problem list. We note that this is consistent documentation available in the Consolidated Clinical Document Architecture (CDA), which defines the “Reason for the patient's visit” field as the provider's description of the reason for visit and the “Chief complaint field” as the patient's own description.

Comment: Commenters asked for clarification on “vital signs and any updates” and suggested simplifying this requirement to “Vitals taken during visit”.

Response: While we agree that vital signs taken during the visit would be most useful in the clinical summary, we also recognize that all vital signs may not be updated at each office visit. Therefore, we are amending this language to “Vital signs taken during the visit (or other recent vital signs)” in the list of required elements below.

Comment: Commenters asked us to clarify if the requirement relating to the inclusion of laboratory test results applies only to test results available at the time of the office visit or to test results that become available after the clinical summary is issued.

Response: By laboratory test results, we mean for the clinical summary to include results that are available at the time the clinical summary is issued to the patient. As we stated in the proposed rule, clinical summaries can quickly become out of date due to information not available to the EP at the end of the visit. The most common example of this is laboratory test results. We believe that EPs should make this information known to the patient when the results are available, but do not require that a new clinical summary must be issued when information needs to be updated.

Comment: Commenters asked us to clarify if the list of diagnostic tests pending indicates diagnostic tests that have been scheduled or diagnostic tests for which results are not yet available.

Response: Diagnostic tests pending refers to diagnostic tests that have been performed but for which results are not yet available. Laboratory or diagnostic tests that have been scheduled but not yet performed should be recorded under “Future scheduled tests” in the list of required elements later in this section.

Comment: Some commenters asked us to define clinical instructions. Other commenters asked if the instructions included as part of the care plan were redundant with the “clinical instructions” element in the list of required information.

Response: By clinical instructions we mean care instructions for the patient that are specific to the office visit. Although we recognize that these clinical instructions at times may be identical to the instructions included as part of the care plan, we also believe that care plans may include additional instructions that are meant to address long-term or chronic care issues, whereas clinical instructions specific to the office visit may be related to acute patient care issues. Therefore, we maintain these as separate items in the list of required elements later.

Comment: A commenter noted that future appointments and future scheduled tests might be stored in a scheduling system that is separate from CEHRT and suggested that if the information is not available in CEHRT that the EP be excluded from having to provide it as part of the clinical summary.

Response: As noted previously, in circumstances where there is no information available to populate one or more of the fields previously listed, either because the EP can be excluded from recording such information (for example, vital signs) or because there is no information to record (for example, no medication allergies or laboratory tests), an indication that the information is not available in the clinical summary would meet the measure of this objective. This would also be true if the information is not accessible through CEHRT.

Comment: Commenters asked for clarification regarding demographics “maintained by EP.” Specifically, they asked whether the EP was required to enter demographics or whether these could be maintained by a member of his or her staff.

Response: By demographics we mean the demographics maintained within CEHRT. We do not intend to specify that only the EP can enter such information into the EHR; demographic information can be entered into CEHRT by any person or through any electronic interface with another system. Therefore, we are amending the language to “Demographic information maintained within CEHRT” in our list of required elements later in this section.

Comment: In regard to the inclusion of “care plan field” in the list of required information, some commenters believed that the wording was overly prescriptive since CEHRT could utilize multiple fields to structure care plans. Other commenters requested a more detailed definition of care plan.

Response: We agree that the language proposed could be viewed as prescriptive, and we do not intend to limit the inclusion of the care plan to a single field. Therefore, we are amending the language to “Care plan field(s), including goals and instructions” in our list of required elements below. However, we decline to provide an alternate definition that would limit the information in the care plan. We believe that the definition we proposed in the proposed rule is sufficient to allow for the inclusion of a variety of care plans in the clinical summary. For purposes of the clinical summary, we define a care plan as the structure used to define the management actions for the various conditions, problems, or issues. A care plan must include at a minimum the following components: problem (the focus of the care plan), goal (the target outcome) and any instructions that the provider has given to the patient. A goal is a defined target or measure to be achieved in the process of patient care (an expected outcome).

Comment: Some commenters asked for clarification about what is meant by patient decision aids.

Response: By patient decision aids we mean any educational resource or tool that the provider believes can inform patient decisions about their own care. An example is an educational handout on the pros and cons of having surgery for a particular condition.

Comment: Some commenters noted that because EHRs capture medical data, they will produce clinical summaries with medical terminology, whereas patients should receive summaries with nonmedical terminology and descriptions of both medications and lab test results that are easy to read and contain actionable items.

Response: While we agree that clinical summaries with nonmedical terminology and extended descriptions would be most beneficial to patients, we also believe that the utility of this objective must be balanced against the potential burden it places on EPs. Since clinical summaries can be automatically generated from existing data in CEHRT, this removes significant workflow barriers to providing a summary for patients. We believe that requiring providers or their staff to render all information in the clinical summary into nonmedical terms at this time would impose a significant burden on providers and reduce the number of clinical summaries that providers make available to patients, thereby reducing the effectiveness of this objective. However, we note that most of the information that is required as part of the clinical summary should be easily understandable by most patients. Also, there is nothing to prevent an EP from providing additional information if he or she believes it would be more effective for the overall quality of patient care. We further note that we anticipate that the capabilities of CEHRT may soon allow for the provision of non-medical terminology and extended descriptions and we are considering adding this requirement in future stages of meaningful use.

Comment: One commenter noted that the clinical summary contains a vast amount of protected health information (PHI) which could be compromised if patients discard the clinical summary insecurely. The commenter suggested requiring the clinical summary only for those patients who affirm they want it to eliminate any provider responsibility for security of the information.

Response: We do not believe that making protected health information available to patients in any way compromises either patients or providers. On the contrary, we believe that offering this information is critical to improving the overall quality of patient care by offering specific follow-up instructions, test results, and care plan information to patients so that they can actively participate in their own care. We believe that providers can take steps to inform patients about the need to securely dispose of PHI, and we further note that making clinical summaries available electronically through an online portal or other means can be used to keep such PHI secure. Therefore, we decline to change the measure for this objective.

After consideration of the public comments, we are finalizing the meaningful use measure for EPs as “Clinical summaries provided to patients or patient-authorized representatives within 1 business day for more than 50 percent of office visits” at § 495.6(j)(11)(ii).

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT at 45 CFR 170.314(e)(2).

We clarify that the following information (or an indication that there is no information available) is required to be part of the clinical summary for Stage 2:

  • Patient name.
  • Provider's name and office contact information.
  • Date and location of the visit.
  • Reason for the office visit.
  • Current problem list.
  • Current medication list.
  • Current medication allergy list.
  • Procedures performed during the visit.
  • Immunizations or medications administered during the visit.
  • Vital signs taken during the visit (or other recent vital signs).
  • Laboratory test results.
  • List of diagnostic tests pending.
  • Clinical instructions.
  • Future appointments.
  • Referrals to other providers.
  • Future scheduled tests.
  • Demographic information maintained within CEHRT (sex, race, ethnicity, date of birth, preferred language).
  • Smoking status
  • Care plan field(s), including goals and instructions.
  • Recommended patient decision aids (if applicable to the visit).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of office visits conducted by the EP during the EHR reporting period.
  • Numerator: Number of office visits in the denominator where the patient or a patient-authorized representative is provided a clinical summary of their visit within 1 business day.
  • Threshold: The resulting percentage must be more than 50 percent in order for an EP to meet this measure.

• Exclusion: Any EP who has no office visits during the EHR reporting period.

Removed Objective: Capability to exchange key clinical information.

In Stage 2, we proposed to move to actual use cases of electronic exchange of health information through the following objective: “The EP, eligible hospital or CAH who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care should provide summary care record for each transition of care or referral.” We also proposed to remove this objective for Stage 1 as well, but requested comments on other options. Please refer to the section titled “Changes to Stage 1” at II.A.3.b. of this final rule for details of the options considered. We are finalizing the removal of this objective as proposed in favor of the more robust, actual use case of electronic exchange through a summary of care record following each transition of care or referral. We believe that this actual use case is not only easier for providers to understand but it is also more beneficial because it contributes directly to the care of the patient through enhanced coordination between providers. A prudent provider will be preparing and testing to conduct actual exchange prior to the start of Stage 2 during their Stage 1 EHR reporting periods.

Proposed Objective: Protect electronic health information created or maintained by the CEHRT through the implementation of appropriate technical capabilities.

In the proposed rule, we outlined the following benefits of protecting health information: Protecting electronic health information is essential to all other aspects of meaningful use. Unintended and/or unlawful disclosures of personal health information could diminish consumers' confidence in EHRs and electronic health information exchange. Ensuring that health information is adequately protected and secured will assist in addressing the unique risks and challenges that may be presented by electronic health records.

Comment: A number of commenters supported the continued inclusion of this objective, yet several commenters requested the elimination of this objective as redundant to HIPAA regulations.

Response: We believe that it is crucial that EPs, eligible hospitals, and CAHs evaluate the privacy and security implications of CEHRT as part of the EHR Incentive Programs, particularly as they pertain to 45 CFR 164.308(a)(1) and the protection and safeguarding of personal health information in general. Therefore, we retain this objective and measure for meaningful use in the final rule.

After consideration of the public comments, we are finalizing the meaningful use objective for EPs at § 495.6(j)(16)(i) and eligible hospitals and CAHs at § 495.6(l)(15)(i) as proposed.

Proposed Measure: Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data at rest in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies as part of the provider's risk management process.

In the proposed rule, we explained that this measure is the same as in Stage 1 except that we specifically address the encryption/security of data is that is stored in CEHRT (data at rest). Due to the number of breaches reported to HHS involving lost or stolen devices, the HIT Policy Committee recommended specifically highlighting the importance of an entity's reviewing its encryption practices as part of its risk analysis. We agree that this is an area of security that appears to need specific focus. Recent HHS analysis of reported breaches indicates that almost 40 percent of large breaches involve lost or stolen devices. Had these devices been encrypted, their data would have been secured. It is for these reasons that we specifically call out this element of the requirements under 45 CFR 164.308(a)(1) for the meaningful use measure. We did not propose to change the HIPAA Security Rule requirements, or require any more than is required under HIPAA. We only emphasize the importance of an EP or hospital including in its security risk analysis an assessment of the reasonable and appropriateness of encrypting electronic protected health information as a means of securing it, and where it is not reasonable and appropriate, the adoption of an equivalent alternative measure.

We proposed this measure because the implementation of CEHRT has privacy and security implications under 45 CFR 164.308(a)(1). A review must be conducted for each EHR reporting period and any security updates and deficiencies that are identified should be included in the provider's risk management process and implemented or corrected as dictated by that process.

In the proposed rule, we emphasized that our discussion of this measure and 45 CFR 164.308(a)(1) is only relevant for purposes of the meaningful use requirements and is not intended to supersede what is separately required under HIPAA and other rulemaking. Compliance with the HIPAA requirements is outside of the scope of this rulemaking. Compliance with 42 CFR Part 2 and state mental health privacy and confidentiality laws is also outside the scope of this rulemaking. EPs, eligible hospitals or CAH affected by 42 CFR Part 2 should consult with the Substance Abuse and Mental Health Services Administration (SAMHSA) or state authorities.

Comment: Some commenters asked if the Stage 2 requirements for this objective contradict earlier Stage 1 requirements and HIPAA regulations. Specifically, the addition of addressing encryption/security of data at rest to the measure was raised as a concern.

Response: We do not believe that the Stage 2 measure of this objective contradicts either the Stage 1 measure or current HIPAA regulations. As noted in the proposed rule, this measure is the same as in Stage 1 except that we specifically highlight the encryption/security of data that is stored in CEHRT (data at rest). Recent HHS analysis of reported breaches indicates that almost 40 percent of large breaches (breaches affecting 500 or more individuals) involve lost or stolen devices. Had these devices been encrypted, their data would have been secured. It is for these reasons that we specifically call out this requirement under 45 CFR 164.308(a)(1). We did not propose to change the HIPAA Security Rule requirements, or require any more under this measure than is required under HIPAA. We only emphasize the importance of an EP or hospital including in its security risk analysis an assessment of the reasonable and appropriateness of encrypting electronic protected health information as a means of securing it, and where it is not reasonable and appropriate, the adoption of an equivalent alternative measure.

Comment: Several commenters asked for clarification of what constitutes an acceptable security risk analysis. Commenters also asked if the security risk analysis required in the measure should apply to health data stored in data centers with physical security.

Response: We did not propose to change the HIPAA Security Rule requirements or impose additional requirements under this measure than those required under HIPAA. A review must be conducted for each EHR reporting period and any security updates and deficiencies that are identified should be included in the provider's risk management process and implemented or corrected as dictated by that process. We refer providers to the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data at rest in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), of the HIPAA Security Rule for compliance. The HHS Office for Civil Rights (OCR) has issued guidance on conducting a security risk assessment pursuant to the HIPAA Security Rule (http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf). The scope of the security risk analysis for purposes of this meaningful use measure applies only to data created or maintained by CEHRT. This measure does not apply to data centers that are not part of CEHRT. However, we note that such data centers may be subject to the security requirements under 45 CFR 164.308(a)(1) and refer providers to the HIPAA Security Rule for compliance information.

Comment: One commenter asked if the measure of the objective required hospitals to report on data encryption methods.

Response: No, eligible hospitals and CAHs are not required to report to CMS or the states on specific data encryption methods used. However, they are required to address the encryption/security of data at rest in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3).

Compliance with 42 CFR Part 2 and state mental health privacy and confidentiality laws is also outside the scope of this rulemaking. EPs, eligible hospitals or CAH affected by 42 CFR Part 2 should consult with the Substance Abuse and Mental Health Services Administration (SAMHSA) or state authorities.

We are making a change in this final rule to the language of “data at rest” to specify our intention of data that is stored in CEHRT. After consideration of the public comments, we are finalizing the meaningful use measure as “Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data stored in CEHRT in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies as part of the provider's risk management process” for EPs “at § 495.6(j)(16)(ii) and eligible hospitals and CAHs at § 495.6(l)(15)(ii).

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(d)(1) through 170.314(d)(8).

(b) Objectives and Measures Carried Over (Modified or Unmodified) from Stage 1 Menu Set to Stage 2 Core Set

We signaled our intent in the Stage 1 final rule to move the objectives from the Stage 1 menu set to the Stage 2 core set. The HIT Policy Committee also recommended that we move all of these objectives to the core set for Stage 2. We proposed to include in the Stage 2 core set all of the objectives and associated measures from the Stage 1 menu set, except for the objective “capability to submit electronic syndromic surveillance data to public health agencies” for EPs, which will remain in the menu set for Stage 2. As discussed later, we also proposed to modify and combine some of these objectives and associated measures for Stage 2—

Consolidated Objective: Implement drug formulary checks.

For Stage 2, we proposed to include this objective within the core objective for EPs “Generate and transmit permissible prescriptions electronically (eRx)” and the menu objective for eligible hospitals and CAHs of “Generate and transmit permissible discharge prescriptions electronically (eRx).” We believe that drug formulary checks are most useful when performed in combination with e-prescribing, where such checks can allow the EP or hospital to increase the efficiency of care and benefit the patient financially. We address the comments related to these proposals and state our final policy in the discussions of the eRx objectives for EPs and hospitals.

Proposed Objective: Incorporate clinical lab test results into CEHRT as structured data.

We propose to continue the policy from Stage 1 to incorporate clinical lab test results into CEHRT as structured data. We believe this measure contributes to the exchange of health information between providers of care, facilitates the sharing of information with patients and their designated representatives, and may reduce order entry errors which will contribute to patient care improvements.

We did not receive any comments for this objective. We are finalizing the meaningful use objective for EPs at § 495.6(j)(7)(i) and eligible hospitals and CAHs at § 495.6(l)(6)(i) as proposed.

Proposed Measure: More than 55 percent of all clinical lab tests results ordered by the EP or by authorized providers of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) during the EHR reporting period whose results are either in a positive/negative or numerical format are incorporated in CEHRT as structured data.

We proposed to increase the measure threshold from more than 40 percent for Stage 1 to more than 55 percent for Stage 2. We also solicited public comment regarding the feasibility of continuing to account for individual lab tests separately from group and panel tests. In addition, we solicited comment on whether standards and other capabilities would allow for the expansion of this measure to include all quantitative lab results.

Comment: Many of the commenters voiced their concern that not all EHRs are capable of splitting out individual test results from panel tests and that it would not be feasible to require this for Stage 2 of meaningful use. Other commenters suggested modifying the current measure to use the number of laboratory test results in the EHR as the numerator and the total laboratory test results from the Lab Information System as the denominator. Others questioned the validity of the current measure that counts orders in the denominator and results in the numerator. Another comment is that not all providers have access to a lab interface system and not all lab interfaces are compatible.

Response: We appreciate the many comments and suggestions submitted regarding this measure which were carefully considered as we developed the final regulation. Some commenters questioned the measure validity suggesting that the measure is imperfect since the numerator and denominator are incongruent. However, in considering the broader policy goal underlying this measure (to incorporate lab results into CEHRT in a standard format) the measure needs to be broad enough to allow providers to incorporate laboratory orders and results from multiple service providers. By incorporating all lab orders (whether panel or individual) in the denominator, and all lab test results in the numerator, providers will be able to capture structured lab data from a broad range of provider laboratory information systems into the CEHRT. We understand that the most likely scenario is that the denominator of total lab orders (if panel orders are counted as one) will be less than the numerator of laboratory results because results are provided for each individual test rather than by panel. Therefore, it is highly unlikely that the measure would impact a provider's ability to meet the increased threshold in this scenario.

Providers will need to continue to report individual lab test results recorded as structured data in the numerator, and in the denominator report all individual lab-tests ordered whether or not they are ordered individually or as part of a panel or group lab order. For example, one panel order of ten individual lab tests could be counted as 1 or 10 lab tests ordered in the denominator depending on the system that is used to incorporate this data into the CEHRT. We will monitor provider experience with this measure as technological capacity for the reporting and exchange of lab data continues to evolve.

Comment: Other commenters mentioned uncertainty regarding the proper vocabulary to use for the incorporation of lab test results in a structured format. Several commenters went on to mention that there is not one current vocabulary that encompasses all types of tests. Another comment proposed that CMS work to amend the clinical laboratory improvement amendments (CLIA) to require hospital labs to report results in standard vocabulary such as the Logical Observation Identifiers Names and Codes System (LOINC) by the time Stage 2 is implemented in 2014.

Response: We refer readers to the ONC standards and certification criteria final rule published elsewhere in this issue of the Federal Register for vocabulary specifications.

Comment: Many commenters were confused by the clarification CMS provided in the proposed rule for expanding the measure to all quantitative results (all results that can be compared on as a ratio or on a difference scale). Comments were mixed on whether this measure should include all types of lab tests that produce quantitative results. One commenter suggested CMS should allow ordinal responses for the measure since that is what LOINC uses as the response rather than counting test results with either a positive, negative or numeric response since operationally, counting tests based on whether or not they have two allowed answer choices is difficult, where counting tests based on whether the LOINC code for them had a Scale of QN or Ord would be quite simple. Another commenter suggested most people would assume that “numeric/quantitative tests” would include decimals and whole numbers as well as results reported in a range (for example, >7.4 or <150) and ratios such as also titer levels (for example, 1:128).

Response: We appreciate the number of comments regarding an expansion of the existing measure as well as further clarification. Based on both CMS and companion ONC comments received, we clarify that the measure incorporate all numeric/quantitative tests that report whole or decimal numbers. The structured data for the numeric/quantitative test results may include positive or negative affirmations and/or numerical format that would include a reference range of numeric results and/or ratios.

Comment: Most commenters agreed that the increase measure threshold is appropriate. One commenter referenced a recent AHA survey that found “60 percent of hospitals could perform this function in Fall 2011 at the raised threshold”.

Response: Our analysis of the Stage 1 attestation data shows that 91.5 percent of EPs and 95 percent of eligible hospitals and CAHs were able to successfully demonstrate meaningful use for this measure. Therefore, combined with the AHA survey data results, we will adopt the proposed threshold of 55 percent or more for this measure.

After consideration of the public comments received, we modify the measure for EPs at § 495.6(j)(7)(ii) and eligible hospitals and CAHs at § 495.6(l)(6)(ii) to:

More than 55 percent of all clinical lab tests results ordered by the EP or by authorized providers of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) during the EHR reporting period whose results are either in a positive/negative affirmation or numerical format are incorporated in CEHRT as structured data.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(b)(5).

  • Denominator: Number of lab tests ordered during the EHR reporting period by the EP or by authorized providers of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) whose results are expressed in a positive or negative affirmation or as a number.
  • Numerator: Number of lab test results which are expressed in a positive or negative affirmation or as a numeric result which are incorporated in CEHRT as structured data.
  • Threshold: The resulting percentage must be more than 55 percent in order for an EP, eligible hospital, or CAH to meet this measure.
  • Exclusion: Any EP who orders no lab tests where results are either in a positive/negative affirmation or numeric format during the EHR reporting period.

There is no exclusion available for eligible hospitals and CAHs because we do not believe any hospital will ever be in a situation where its authorized providers have not ordered any lab tests for admitted patients during an EHR reporting period.

Proposed Objective: Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach.

In the proposed rule, we outlined the following benefits of generating lists of patients by specific conditions: Generating patient lists is the first step in proactive management of populations with chronic conditions and is critical to providing accountable care. The ability to look at a provider's entire population or a subset of that population brings insight that is simply not available when looking at patients individually. Small variations that are unnoticeable or seem insignificant on an individual basis can be magnified when multiplied across a population. A number of studies have shown that significant improvements result merely due to provider awareness of population level information. We believe that many EPs and eligible hospitals will use these reports in combination with one of the selected quality measures and decision support interventions to improve quality for a high priority issue (for example, identify patients who are in the denominator for a measure, but not the numerator, and in need of an intervention). The capabilities and variables used to generate the lists are defined in the ONC standards and certification final rule published elsewhere in this issue of the Federal Register; not all capabilities and variables must be used for every list.

We have combined the comments and responses for this objective with the measure below. After consideration of the public comments, we are finalizing the meaningful use objective for EPs at § 495.6(j)(8)(i) and eligible hospitals and CAHs at § 495.6(l)(7)(i) as proposed.

Proposed Measure: Generate at least one report listing patients of the EP, eligible hospital, or CAH with a specific condition.

We proposed to continue our Stage 1 policies for this measure. The objective and measure do not dictate the specific report(s) that must be generated, as the EP, eligible hospital, or CAH is best positioned to determine which reports are most useful to their care efforts. The report used to meet the measure can cover every patient or a subset of patients. We believe there is no EP, eligible hospital, or CAH that could not benefit their patient population or a subset of their patient population by using such a report to identify opportunities for quality improvement, reductions in disparities of patient care, or for purposes of research or patient outreach; therefore, we did not propose an exclusion for this measure. The report can be generated by anyone who is on the EP's or hospital's staff during the EHR reporting period. We also solicited comment on whether a measure that either increases the number and/or frequency of the patient lists will further the intent of this objective.

Comment: Most commenters voiced support for the objective and measure and wish it to remain unchanged in the final rule, although some commenters stated that the measure should only require demonstration that a list can be created and not require a certain number of patient lists until the needs to create certain patient lists are better ascertained.

Response: We appreciate the support for this objective, and we note that the measure of the objective remains unchanged from Stage 1. Demonstration only of the capability to generate lists of patients by specific conditions would represent a step backward from the Stage 1 measure, therefore we do not agree that this would be an appropriate measure for Stage 2. We also believe there is ample evidence to support the use of patient lists in a variety of quality improvement efforts.

Comment: Some commenters suggested that the measure requirements should be increased, either to require more than one report be generated during the EHR reporting period or to require that the report generated is linked to one of the EP's or eligible hospital's clinical decision support interventions. Another commenter suggested that the measure should indicate how the list should be used.

Response: We believe that moving the objective from the menu set to the core represents an adequate increase for Stage 2. We also continue to believe that an EP, eligible hospital, or CAH is best positioned to determine which reports are most useful to their care efforts. Therefore, we do not propose to direct certain reports be created or link reports to clinical decision support interventions at this time.

Comment: Some commenters suggested that lists should be generated according to specific clinical conditions or include specific elements, such as demographics, to aid analysis. One commenter wanted to know whether EPs retain flexibility in deciding the lists they generate, particularly in coordinating public health activities with state and local public health departments and Medicaid agencies. Another commenter suggested that the measure of the objective specify the continuous use of the report throughout the EHR reporting period.

Response: As noted previously, we are continuing our policy from Stage 1 that an EP, eligible hospital, or CAH is best positioned to determine which reports are most useful to their care efforts. Therefore, we do not propose to direct certain reports be created, nor do we require that specific conditions or elements be required for the reports. Also, we do not set requirements for the frequency of use of the report.

Comment: A commenter asked us to clarify whether the EP must generate the patient list or if the patient list could be generated by a member of the EP's staff in order to meet the measure.

Response: For this and most meaningful use objectives, we do not specify how information must be entered into CEHRT or who must complete the required action to meet the measure. Therefore an EP or a member of the EP's staff could generate the list and meet this measure. The exception to this rule is for computerized provider order entry (CPOE) of medication, laboratory, and radiology orders, which must be entered by a licensed healthcare professional per state, local, and professional guidelines.

After consideration of the public comments, we are finalizing the meaningful use measure for EPs at § 495.6(j)(8)(ii) and eligible hospitals and CAHs at § 495.6(l)(7)(ii) as proposed.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(14).

Proposed EP Objective: Use clinically relevant information to identify patients who should receive reminders for preventive/follow-up care.

In the proposed rule, we described the following benefits of this objective. By proactively reminding patients of preventive and follow-up care needs, EPs can increase compliance. These reminders are especially beneficial when long time lapses may occur as with some preventive care measures and when symptoms subside, but additional follow-up care is still required.

We also proposed to revise this objective for Stage 2 to “Use clinically relevant information to identify patients who should receive reminders for preventive/follow-up care” based on the HITPC recommendation. An EP should use clinically relevant information stored within the CEHRT to identify patients who should receive reminders. We believe that the EP is best positioned to decide which information is clinically relevant for this purpose.

Comment: A commenter stated that the language in the proposed objective is in conflict with the proposed measure. The proposed objective is to “Use clinically relevant information to identify patients who should receive reminders for preventive/follow-up,” with no indication that the reminder be sent. However, the proposed measure refers to “patient who had an office visit and were sent a reminder, per patient preference.”

Response: We agree with the commenter that the objective as proposed only speaks to the identification of the need for the reminder and that the proposed measure requires that the reminder be sent. The value of this objective is created when the reminder is sent to the patient and therefore, we revise the objective accordingly.

Comment: Commenters requested request clarification of the operative definition of “reminder.” Remembering to keep the appointment is an important first step to follow-up and preventive care and therefore should be counted.

Response: We believe that reminders should be limited to new actions that need to be taken not of actions that are already taken. For example, a reminder to schedule your next mammogram is a reminder to take action, while a reminder that your next mammogram is scheduled for next week is a reminder of action already taken. If we were to allow for reminders of existing scheduled appointments then every provider could meet this objective and measure without any patient ever learning new information. So we clarify that reminders for preventive/follow-up care should be for care that the patient is not already scheduled to receive. Reminders are not necessarily just to follow up with the reminding EP. Reminders for referrals or to engage in certain activities are also included in this objective and measure.

After consideration of the public comments received, we are modifying the objective at § 495.6(j)(9)(i) to “Use clinically relevant information to identify patients who should receive reminders for preventive/follow-up care and send these patients the reminders, per patient preference.”

Proposed EP Measure: More than 10 percent of all unique patients who have had an office visit with the EP within the 24 months prior to the beginning of the EHR reporting period were sent a reminder, per patient preference.

In Stage 1, the measure of this objective was limited to more than 20 percent of all patients 65 years old or older or 5 years old or younger. Rather than raise the threshold for this measure, the HIT Policy Committee recommended lowering the threshold but extending the measure to all active patients. We proposed to apply the measure of this objective to all unique patients who have had an office visit with the EP within the 24 months prior to the beginning of the EHR reporting period. We believe this not only identifies the population most likely to consist of active patients, but also allows the EP flexibility to identify patients within that population who can benefit most from reminders. We solicited comments on the appropriateness of this timeframe. We also recognize that some EPs may not conduct face-to-face encounters with patients but still provide treatment to patients. These EPs could be unintentionally prevented from meeting this core objective under the measure requirements, so we proposed an exclusion for EPs who have no office visits in order to accommodate such EPs. Patient preference refers to the method of providing the reminder.

Comment: Commenters expressed concern that even with the proposed revisions many patients in the denominator might not require a reminder. One example given was some colonoscopies are done on a schedule of once every ten years. Another example provided was specialists who see some patients only for one-time consults. Suggestions by commenters to deal with patients in the denominator who do not require reminders involve either much more precise measurement such as tracking and following up when CEHRT identifies the need for a patient reminder, to specific exclusions of certain visit types in the measure or to move the requirement to the menu set. Others suggested that providers who do not typically send reminders be sent granted exclusions.

Response: We agree that not every active patient will require a reminder during the EHR reporting period, which is why the threshold is far below 100 percent. We believe that a low threshold of 10 percent is the best way to account for the contextually specific reasons a patient might not be sent a reminder. We proposed an exclusion for EPs who would typically not send reminders, specifically those without office-based visits. This may not include all providers who do not typically send reminders, but as an exclusion must contain definitive criteria we believe it is a good exclusion. We did not receive in comments precise criteria for an alternative exclusion.

Comment: We received many comments as to what constitutes an active patient in a practice. Many voiced the opinion that given the 24 month look back period in a typical practice, many patients would have moved to another practice. One suggestion given for an alternate way to count patients was to change the definition of “active patients” to be either three or more visits in 24 months or two or more visits in 12 months. Other commenters recommended that the time limitation be removed.

Response: We proposed active patients as a method to limit the denominator to patients more likely to require a reminder. The goal is to limit the denominator as much as possible without excluding patients who should receive a reminder. After reviewing the comments, we change the look back to patients with at least two office visits in the last 24 months. We believe this better establishes a relationship between the provider and the EP. This would account for those specialists that do not have continuing relationships with their patients, but rather hand their care back to the referring provider.

Comment: Several commenters raised concerns with the requirement that it be per patient preference. They asked for clarification on the definition of “per patient preference.” Specifically commenters asked if patient preference referred to whether the patient wanted reminders or what method of communication they wanted to receive the reminders. Second, clarification is requested on how providers should document these preferences. Third, there is concern that an insufficient number of patients will have their preferences recorded at the start of the EHR reporting period and if so, any method of communication should suffice for those patients.

Response: We clarify that patient preference is the method of communication that patients prefer to receive their reminders such as (but not limited to) by mail, by phone or by secure messaging. Given the look back period associated with this measure, we agree that it is not feasible to have all patient preferences recorded prior to the start of the EHR reporting period. Therefore, we clarify that reminders must be sent using the preferred communication medium only when it is known by the provider. This is limited to the type of communication (phone, mail, secure messaging, etc.) and does not extend to other constraints like time of day. Patients may decline to provide their preferred communication medium in which case the provider may select the communication medium. A patient may also decline to receive reminders. We believe that this will be rare enough that combined with the 10 percent through, patients declining to receive reminders will not affect the ability of an EP to meet this measure. It is our expectation that providers will begin to collect this information and that in the future as the look back period catches up to the publication of this final rule it will become possible to require that all reminders be sent per patient preference. We do not specify how things are documented beyond the capabilities and standards included in CEHRT.

After consideration of the public comments received, we are modifying the measure at § 495.6(j)(9)(ii) to “More than 10 percent of all unique patients who have had 2 or more office visits with the EP within the 24 months before the beginning of the EHR reporting period were sent a reminder, per patient preference when available.”

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(14).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

• Denominator: Number of unique patients who have had two or more office visits with the EP in the 24 months prior to the beginning of the EHR reporting period.

• Numerator: Number of patients in the denominator who were sent a reminder per patient preference when available during the EHR reporting period.

• Threshold: The resulting percentage must be more than 10 percent in order for an EP to meet this measure.

• Exclusion: Any EP who has had no office visits in the 24 months before the EHR reporting period.

Proposed EP Objective: Provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the EP.

In the proposed rule, we stated that the goal of this objective was to allow patients easy access to their health information as soon as possible so that they can make informed decisions regarding their care or share their most recent clinical information with other health care providers and personal caregivers as they see fit. In addition, we noted that this objective aligns with the Fair Information Practice Principles (FIPPs), [3] in affording baseline privacy protections to individuals. [4] In particular, the principles include Individual Access (patients should be provided with a simple and timely means to access and obtain their individually identifiable information in a readable form and format). We indicated that this objective replaces the Stage 1 core objective for EPs of “Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, medication allergies) upon request” and the Stage 1 menu objective for EPs of “Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, and allergies) within 4 business days of the information being available to the EP.” The HIT Policy Committee recommended making this a core objective for Stage 2 for EPs, and we agreed with their recommendation consistent with our policy of moving Stage 1 menu objectives to the core set for Stage 2. Consistent with the Stage 1 requirements, we noted that the patient must be able to access this information on demand, such as through a patient portal or personal health record (PHR). However, we noted that providers should be aware that while meaningful use is limited to the capabilities of CEHRT to provide online access there may be patients who cannot access their EHRs electronically because of their disability. Additionally, other health information may not be accessible. Finally, we noted that providers who are covered by civil rights laws must provide individuals with disabilities equal access to information and appropriate auxiliary aids and services as provided in the applicable statutes and regulations.

Comment: Some commenters suggested that this objective should be part of the menu set instead of a core objective for Stage 2. This would permit EPs who do not believe they can meet the measure at this time to select different objectives.

Response: We do not agree that this objective should be part of the menu set. We proposed this objective as part of the core for EPs because it is intended to replace the previous Stage 1 core objective of “Provide patients with an electronic copy of their health information upon request” and the Stage 1 menu objective of “Provide patients with timely electronic access to their health information.” Although CEHRT will provide added capabilities for this objective, we do not believe the objective itself is sufficiently different from previous objectives to justify placing it in the menu set. Also, we believe that patient access to their electronic health information is a high priority for the EHR Incentive Programs and this objective best provides that access in a timely manner.

Comment: Some commenters expressed the opinion that this objective should not be included as part of meaningful use and was more appropriately regulated under HIPAA and through the Office for Civil Rights.

Response: We do not agree that this objective should not be included in meaningful use. Although we recognize that many issues concerning the privacy and security of electronic health information are subject to HIPAA requirements, we believe that establishing an objective to provide online access to health information is within the regulatory purview of the EHR Incentive Programs and consistent with the statutory requirements of meaningful use.

Comment: Some commenters suggested that this objective should be combined with the objective to “Provide clinical summaries for patients after each office visit” since much of the information provided in these objectives is identical.

Response: While it is true that there may be overlap between the information provided in the clinical summary and the information made available through this objective, we believe the clinical summary after an office visit serves a different purpose than online access to health information. A summary of an office visit provides patients and their families with a record of the visit and specific lab tests or specific follow-up actions and treatment related to the visit. While this information is certainly part of the patient's overall electronic health record, the clinical summary serves to highlight information that is relevant to the patient's care at that particular moment. Therefore, we decline to combine the two objectives.

After consideration of the public comments, we are finalizing the meaningful use objective for EPs at § 495.6(j)(10)(i) as proposed.

Proposed EP Measures: We proposed two measures for this objective, both of which must be satisfied in order to meet the objective:

More than 50 percent of all unique patients seen by the EP during the EHR reporting period are provided timely (within 4 business days after the information is available to the EP) online access to their health information subject to the EP's discretion to withhold certain information.

More than 10 percent of all unique patients seen by the EP during the EHR reporting period (or their authorized representatives) view, download or transmit to a third party their health information.

Exclusions: Any EP who neither orders nor creates any of the information listed for inclusion as part of this measure may exclude both measures. Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude only the second measure.

As we stated in the proposed rule, transmission can be any means of electronic transmission according to any transport standard(s) (SMTP, FTP, REST, SOAP, etc.). However, the relocation of physical electronic media (for example, USB, CD) does not qualify as transmission although the movement of the information from online to the physical electronic media will be a download.

Comment: Some commenters suggested that the timeframe for the first measure should be expanded to 7 days, since the data required to be provided in order to meet the measure of this objective would sometimes be incomplete only 4 days after the patient's visit. Other commenters suggested the timeline for the first measure should be shortened to 2 business days or 24 hours.

Response: We do not agree that the timeframe for the measure should be lengthened. In the Stage 1 menu objective of “Provide patients with timely electronic access to their health information,” we established the measure for providing access within 4 business days. Also, we believe that most of the information required by this measure, except for lab tests, will be readily available within the specified time period. However, we also believe that 24 hours or 2 business days would not provide adequate time to make all information available online. Therefore, we maintain the requirement of making information available within 4 business days.

Comment: Some commenters asked for clarification on whether online access had to be made available using CEHRT or if the information could be made available through other means (patient portal, PHR, etc.).

Response: Both of the measures for this objective must be met using CEHRT. Therefore, for the purposes of meeting this objective, the capabilities provided by a patient portal, PHR, or any other means of online access and that would permit a patient or authorized representative to view, download, or transmit their personal health information would have to be certified in accordance with the certification requirements adopted by ONC. We refer readers to ONC's standards and certification criteria final rule that is published elsewhere in this issue of the Federal Register.

Comment: A commenter asked how long data should be made available online before it can be removed. In a related topic, another commenter asked which provider would be responsible for excluding data from sharing when multiple providers share CEHRT.

Response: It is the goal of this objective to make available to the patient both current and historical health information. Therefore, we would anticipate that the data should be available online on an ongoing basis. However, an EP may withhold or remove information from online access if they believe substantial harm may arise from its disclosure online. In regard to withholding data and which provider should be responsible for making the determination when multiple providers share CEHRT, we would expect that providers sharing the CEHRT would make a joint determination regarding the information to be withheld. Therefore, we leave this decision to the providers' discretion.

Comment: Some commenters asked for clarification on how access by the patient is defined.

Response: We define access as having been given when the patient possesses all of the necessary information needed to view, download, or transmit their information. This could include providing patients with instructions on how to access their health information, the Web site address they must visit for online access, a unique and registered username or password, instructions on how to create a login, or any other instructions, tools, or materials that patients need in order to view, download, or transmit their information.

Comment: Some commenters suggested that patients under the age of 18 should not have the same access to the same information to which adult patients have access and requested a separate list of required elements for patients under the age of 18.

Response: An EP may decide that online access is not the appropriate forum for certain health information for patients under the age of 18. Within the confines of the laws governing guardian access to medical records for patients under the age of 18, we would defer to the EP's judgment regarding which information should be withheld for such patients. In lieu of providing online access to patients under the age of 18, EPs could provide online access to guardians for patients under the age of 18, in accordance with state and local laws, in order to meet the measure of this objective. Providing online access to guardians in accordance to state and local laws would be treated the same as access for patients, and guardians could then be counted in the numerator of the measure. We recognize that state and local laws may restrict the information that can be made available to guardians, and in these cases such information can be withheld and the patient could still be counted in the numerator of the measure. No requirement of meaningful use supersedes any Federal, State or local law regarding the privacy of a person's health information.

Comment: Some commenters suggested that specialists should transmit information to the patient's primary care provider rather than providing online access to information in order to reduce the number of portals a patient must visit, which could cause confusion.

Response: We believe that much of this information will be transmitted between providers as part of the summary of care record following a transition of care. However, we also believe there is value to the patient in having online access to this information for all providers they visit, including specialists. Therefore, we maintain this measure for all EPs.

Comment: Many commenters voiced objections to the second measure of this objective and the concept of providers being held accountable for patient actions. The commenters believed that while providers could be held accountable for making information available online to patients, providers could not control whether patients actually accessed their information. Many commenters also noted that the potential barriers of limited internet access, computer access, and patient engagement with health IT for certain populations (for example, rural, elderly, lower income, visually impaired, non-English-speaking, etc.) might make the measure impossible to meet for some providers. There were also a number of comments stating that metrics used to track views or downloads can be misleading and are not necessarily the most accurate measure of patient usage. Commenters suggested a number of possible solutions to allow providers to overcome these barriers, including eliminating the percentage threshold of the measure or requiring providers to offer and track patient access but not requiring them to meet a percentage measure in order to demonstrate meaningful use. However, some commenters believed that the measure was a reasonable and necessary step to ensure that providers had accountability for engagement of their patients in use of electronic health information and integration of it into clinical practice. In addition, commenters pointed to the unique role that providers can play in encouraging and facilitating their patients' and their families' use of online tools.

Response: While we recognize that EPs cannot directly control whether patients access their health information online, we continue to believe that EPs are in a unique position to strongly influence the technologies patients use to improve their own care, including viewing, downloading, and transmitting their health information online. We believe that EPs' ability to influence patients coupled with the low threshold of more than 10 percent of patients having viewed online, downloaded, or transmitted to a third party the patient's health information make this measure achievable for all EPs.

We recognize that certain patient populations face greater challenges in online access to health information. We address the potential barrier of limited Internet access in the comment regarding a broadband exclusion below. We address the potential barrier to individuals with disabilities through ONC's rules requiring that EHRs meet web content accessibility standards. While we agree that excluding certain patient populations from this requirement would make the measure easier for EPs to achieve, we do not know of any reliable method to quantify these populations for each EP in such a way that we could standardize exclusions for each population. We also decline to eliminate the percentage threshold of this measure because we do not believe that a simple yes/no attestation for this objective is adequate to encourage a minimum level of patient usage. However, in considering the potential barriers faced by these patient populations, we agree that it would be appropriate to lower the proposed threshold of this measure to more than 5 percent of unique patients who view online, download, or transmit to a third party the patient's health information. In addition, we are concerned that blanket exclusions for certain disadvantaged populations could serve to extend existing disparities in electronic access to health information and violate civil rights laws. All entities receiving funds under this program are subject to civil rights laws. For more information about these laws and their requirements (see http://www.hhs.gov/ocr/civilrights/index.html). We believe that this lower threshold, combined with the broadband exclusion detailed in the response that follow, will allow all EPs to meet the measure of this objective.

Comment: Some commenters suggested an alternate definition of the second measure based on the number of patients seen within the last 2 years that access their health information online.

Response: We believe that the current numerator and denominator for this measure encourage the active online access by patients of their health information. We further believe that broadening the time period of this measure to patients seen within the last 2 years does not encourage both EPs and current patients to use online access to health information in the active management of their care, which is one of the goals of the EHR Incentive Programs. Therefore, we decline to adopt this suggested alternate definition.

Comment: Some commenters asked for clarification on how view is defined.

Response: We define view as the patient (or authorized representative) accessing their health information online.

Comment: Some commenters noted that the potential financial burden of implementing an online patient portal to provide patients online access to health information. These commenters noted the added time burden for staff in handling the additional patient use of online resources, which may increase costs through the hiring of additional staff, as well as the need to modify their existing workflow to accommodate additional online messages from patients. Some commenters also believed that there would be an additional cost for sharing content before standards exist for content types and formats.

Response: We do not believe that implementing online access for patients imposes a significant burden on providers. While we note that in some scenarios it may be possible for an EP to receive reimbursement from private insurance payers for online messaging, we acknowledge that EPs are generally not reimbursed for time spent responding to electronic messaging. However, it is also true that EPs are generally not reimbursed for other widely used methods of communication with patients (for example, telephone). As we noted in the proposed rule, many providers have seen a reduction in time responding to inquires and less time spent on the phone through the use of health IT, including online messages from patients. We expect the same will be true for online access to health information by reducing continuous requests for health records, test results, and other pertinent patient information. Finally, we believe that the standards established for this objective by ONC will serve as a content standard that will allow this information to be more easily transmitted and uploaded to another certified EHR, thereby reducing additional costs.

Comment: Some commenters noted that patient engagement could occur effectively with or without online access, and patients should be encouraged to use any method (for example, telephone, internet, traditional mail) that suits them. These commenters noted that engagement offline reduces both the need and value for engagement online.

Response: We agree that patient engagement can occur effectively through a variety of media, and we also believe that electronic access to health information can be an important component of patient engagement. We do not believe that offline engagement reduces the need for online access, as patients may opt to access information in a variety of ways. Because of the variety of ways that patients/families may access information, we keep the threshold for this measure low. We also note that online access to health information can enhance offline engagement—for example, patients could download information from an office visit with their primary care provider to bring with them for a consult with a specialist—which is one of the primary goals of the EHR Incentive Programs.

Comment: Some commenters expressed concern that vendors would not be able to make these capabilities available as part of CEHRT in time for the beginning of Stage 2.

Response: Many CEHRT vendors already make patient portals available that would meet the certification criteria and standards required for this measure. In fact, many vendors have already incorporated these capabilities into their CEHRT products in order to meet the measure of the Stage 1 objective to “Provide patients with timely electronic access to their health information.” Although the Stage 2 measure requires some additional capabilities, we believe vendors will be able to make these capabilities available in time for the beginning of Stage 2.

Comment: Some commenters requested clarification on the exclusion regarding an EP “who neither orders nor creates any of the information listed for inclusion as part of this measure may exclude both measures.” Because the list of required elements for this measure includes the patient's name, provider's name, and office contact information, these commenters suggested that no EP could qualify for this exclusion.

Response: We amend the wording of the exclusion to accommodate providers who do not order or create any of the information listed, except for patient name, provider name, and office contact information.

Comment: Some commenters suggested that basing an exclusion on the broadband data available from the FCC Web site (www.broadband.gov) was suspect since the data originates from vendors.

Response: The broadband data made available from the FCC was collected from over 3,400 broadband providers nationwide. This data was then subject to many different types of analysis and verification methods, from drive testing wireless broadband service across their highways to meeting with community leaders to receive feedback. Representatives met with broadband providers, large and small, to confirm data, or suggest changes to service areas, and also went into the field looking for infrastructure to validate service offerings in areas where more information was needed. Therefore, we believe the data is appropriate for the exclusion to this measure. We note that since publication of our proposed rule the Web site has changed to www.broadbandmap.gov and the speed used has changed from 4Mbps to 3Mbps. We are updating our exclusion to reflect these changes.

Comment: Some commenters believe that broadband exclusions should be based on the patients' locations instead of the providers, since county-level data may not be granular enough to capture all areas of low broadband availability within a particular region.

Response: Although we agree that a broadband exclusion based primarily on the individual locations of each patient seen would be more accurate, we do not believe that there is any method of making this determination for every patient without placing an undue burden on the provider. We continue to believe that limited broadband availability in the EP's immediate practice area, coupled with the low threshold of this measure, adequately serves as an acceptable proxy for determining areas where online access can present a challenge for patients. Therefore, we retain the broadband exclusion as proposed.

Comment: Some commenters requested a clarification of the required element of “Any additional known care team members beyond the referring or transitioning provider and the receiving provider.”

Response: With this element we mean for providers to indicate the names and contact information for any other health care professionals known to the EP. This could include referring providers, receiving providers, or any other provider inside or outside the EP's practice that provides care to the patient. We are amending the language for this required element to “Any known care team members.”

Comment: Some commenters suggested that growth charts should not be included for either download or transmission, since these charts are simply visualizations of the height and weight data elements.

Response: We believe that growth charts can be a useful tool for both patients and providers, especially in instances where a patient may elect to download or transmit their health information to another provider. Therefore, we require them to be included to meet the measure of this objective.

Comment: One commenter suggested that images should not be included in the list of required elements to be provided to patients online. They cited specific difficulties in image viewing online, as well as concerns over file size.

Response: We note the commenter's concerns and further note that images are not among the required elements to meet the measure of this objective.

After consideration of the public comments, we finalize the first meaningful use measure for EPs as proposed at § 495.6(j)(10)(ii)(A). We finalize the second meaningful use measure for EPs as “More than 5 percent of all unique patients seen by the EP during the EHR reporting period (or their authorized representatives) view, download or transmit to a third party their health information” at § 495.6(j)(10)(ii)(B). We finalize the following exclusions for EPs at § 495.6(j)(10)(iii): “Any EP who neither orders nor creates any of the information listed for inclusion as part of both measures, except for “Patient name” and “Provider's name and office contact information,” may exclude both measures;” “Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 3Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude only the second measure”.

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT at 45 CFR 170.314(e)(1).

To calculate the percentage of the first measure for providing patient with timely online access to health information, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of unique patients seen by the EP during the EHR reporting period.
  • Numerator: The number of patients in the denominator who have timely (within 4 business days after the information is available to the EP) online access to their health information.
  • Threshold: The resulting percentage must be more than 50 percent in order for an EP to meet this measure.

For the second measure for reporting on the number of unique patients seen by the EP during the EHR reporting period (or their authorized representatives) who view, download or transmit health information, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of unique patients seen by the EP during the EHR reporting period.
  • Numerator: The number of unique patients (or their authorized representatives) in the denominator who have viewed online, downloaded, or transmitted to a third party the patient's health information.
  • Threshold: The resulting percentage must be more than 5 percent in order for an EP to meet this measure.
  • Exclusions: Any EP who neither orders nor creates any of the information listed for inclusion as part of both measures, except for “Patient name” and “Provider's name and office contact information,” may exclude both measures. Any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 3Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude only the second measure.

In order to meet this objective, the following information must be made available to patients electronically within 4 business days of the information being made available to the EP:

  • Patient name.
  • Provider's name and office contact information.
  • Current and past problem list.
  • Procedures.
  • Laboratory test results.
  • Current medication list and medication history.
  • Current medication allergy list and medication allergy history.
  • Vital signs (height, weight, blood pressure, BMI, growth charts).
  • Smoking status.
  • Demographic information (preferred language, sex, race, ethnicity, date of birth).
  • Care plan field(s), including goals and instructions, and
  • Any known care team members including the primary care provider (PCP) of record.

As we stated in the proposed rule, this is not intended to limit the information made available by the EP. An EP can make available additional information and still align with the objective. In circumstances where there is no information available to populate one or more of the fields previously listed, either because the EP can be excluded from recording such information (for example, vital signs) or because there is no information to record (for example, no medication allergies or laboratory tests), the EP may have an indication that the information is not available and still meet the objective and its associated measure. Please note that while some of the information made available through this measure is similar to the information made available in the summary of care document that must be provided following transitions of care or referrals, the list of information above is specific to the view online, download, and transmit objective. Patients and providers have different information needs and contexts, so CMS has established separate required fields for each of these objectives.

Proposed Objective: Use clinically relevant information from Certified EHR Technology to identify patient-specific education resources and provide those resources to the patient.

In the proposed rule, we explained that providing clinically relevant education resources to patients is a priority for the meaningful use of CEHRT. Based on our experience with this objective in Stage 1, we are clarifying that while CEHRT must be used to identify patient-specific education resources, these resources or materials do not have to be stored within or generated by the CEHRT. We are aware that there are many electronic resources available for patient education materials, such as through the National Library of Medicine, that can be queried via CEHRT (that is, specific patient characteristics are linked to specific consumer health content). The EP or hospital should utilize CEHRT in a manner where the technology suggests patient-specific educational resources based on the information stored in the CEHRT. Certified EHR technology is certified to use the patient's problem list, medication list, or laboratory test results to identify the patient-specific educational resources. The EP or hospital may use these elements or additional elements within CEHRT to identify educational resources specific to patients' needs. The EP or hospital can then provide these educational resources to patients in a useful format for the patient (such as, electronic copy, printed copy, electronic link to source materials, through a patient portal or PHR).

In the Stage 1 final rule (75 FR 44359), we included the phrase “if appropriate” in the objective so that the EP or the authorized provider in the hospital could determine whether the education resource was useful and relevant to a specific patient. Consistent with the recommendations of the HIT Policy Committee, we proposed to remove the phrase “if appropriate” from the objective for Stage 2 because we do not believe that any EP or hospital will have difficulty identifying appropriate patient-specific education resources for the low percentage of patients required by the measure of this objective.

We also recognized that providing education materials at literacy levels and cultural competency levels appropriate to patients is an important part of providing patient-specific education. However, we continue to believe that there is not currently widespread availability of such materials and that such materials could be difficult for EPs and hospitals to identify for their patients.

Comment: Many commenters sought clarification on the meaning of the term “identified by CEHRT.” They questioned how the CEHRT would identify resources and whether the education resources had to be stored in the CEHRT or if it could contain links to the materials.

Response: We clarified in the proposed rule (77 FR 13720) that while CEHRT must be used to identify patient-specific education resources, these resources or materials do not have to be stored within or generated by the Certified EHR Technology. We refer readers to ONC's standards and certification criteria final rule that is published elsewhere in this issue of the Federal Register which describes the capabilities and standards that CEHRT must include. For patient-specific education materials, this includes a general functional capability to identify educational materials as well as a capability to do so using the HL7 Context-aware Information Retrieval “Infobutton” standard. This measure requires that an EP or hospital use the capabilities CEHRT includes to identify patient education materials. To clarify, although CEHRT will include the ability to identify education materials using the HL7 Infobutton standard, such capability alone does not need to be used in order to be counted in the numerator (that is, the general capability to identify education materials also counts towards the numerator).

After reviewing the public comments, we finalize the objective for EPs at § 495.6(j)(12)(i) and for eligible hospitals and CAHs at § 495.6(l)(9)(i) as proposed.

Proposed EP Measure: Patient-specific education resources identified by Certified EHR Technology are provided to patients for more than 10 percent of all office visits by the EP.

In the proposed rule, we noted that the Stage 1 measure for this objective for EPs was “More than 10 percent of all unique patients seen by the EP are provided patient-specific education resources.” Because we proposed this as a core objective for Stage 2, we proposed to modify the measure for EPs to “Patient-specific education resources identified by CEHRT are provided to patients for more than 10 percent of all office visits by the EP.” We recognized that some EPs may not conduct face-to-face encounters with patients but still provide treatment to patients. These EPs could be prevented from meeting this core objective under the previous measure requirements, so we proposed to alter the measure to account for office visits rather than unique patients seen by the EP. We also proposed an exclusion for EPs who have no office visits in order to accommodate such EPs.

The resources will have to be those identified by CEHRT. If resources are not identified by CEHRT and provided to the patient then it will not count in the numerator. We do not intend through this requirement to limit the education resources provided to patient to only those identified by CEHRT. We proposed the threshold at only 10 percent for this reason. We believe that the 10 percent threshold both ensures that providers are using CEHRT to identify patient-specific education resources and is low enough to not infringe on the provider's freedom to choose education resources and to which patients these resources will be provided. The education resources will need to be provided prior to the calculation and subsequent attestation to meaningful use.

Comment: Many commenters expressed concerns about the availability of resources that would be available at the appropriate literacy level for their patient populations. Some stated that there is a dearth of low-literacy materials available as most education sites are geared toward college-educated patients; others stated that most materials are designed to be appropriate for a broad spectrum of literacy levels. Some commenters expressed concerns about the lack of resources available for non-English speaking patients. Yet other commenters were unclear as to what appropriate sources of patient-specific education would be. Some commenters expressed concerns that another alert within the system may create physician fatigue.

Response: We understand the commenters concerns that the educational materials identified by the CEHRT may not be appropriate for certain patients. To accommodate these concerns, we are maintaining the threshold for this measure at 10 percent. As we stated in our proposed rule and in the Stage 1 Final Rule, we account for these concerns by maintaining a low threshold for this objective.

Comment: Some commenters expressed concerns that the CEHRT, not the provider, would “choose” which educational resources would be provided to the patient.

Response: We cannot define the scope of practice and/or appropriate educational resources to be shared with each individual patient and will continue to rely on provider determinations based on individual patient circumstances.

Comment: Many commenters were concerned that the denominator for the EP measure included the number of office visits by the EP during the EHR reporting period. Commenters agreed with the rationale that EPs might not have the opportunity to provide educational materials to a patient if the patient has not had an office visit with the EP, however, commenters also stated that if an EP has a series of office visits with a patient, it might not be appropriate to provide education at each visit (for example, a patient with heart disease or high blood pressure that would see the EP multiple times during the EHR reporting period). To avoid the potential for presenting redundant information to patients, commenters suggested that the denominator be based on unique patients with office visits. This is consistent with the denominator for eligible hospitals, as that denominator is based on unique patients admitted. Additionally, commenters noted that counting unique patients is more appropriate to account for patient-specific education resources that are not provided in the context of an office visit, such as reference materials available from a portal or PHR about a patient's medications, conditions, or lab results.

Response: We agree with commenters in that counting unique patients with office visits during the EHR reporting period for EPs, rather than office visits, is a more appropriate denominator for this measure. A patient with a chronic disease, such as diabetes or heart disease, may have multiple office visits with an EP during the EHR reporting period. While providing educational resources for these patients is important, presenting the same materials each office visit may prove to be redundant. We encourage EPs to refer educational resources to their patients with multiple visits during the EHR reporting period at their discretion.

Additionally, we do maintain that EPs with no office visits during the EHR reporting period can be excluded from this measure. Therefore, we are finalizing the denominator for this measure as the “Number of unique patients with office visits seen by the EP during the EHR reporting period.”

Comment: Most commenters agreed that 10 percent was a reasonable threshold for this measure as it was proposed.

Response: We agree with commenters and are finalizing 10 percent as the threshold for this measure. It will remain unchanged from Stage 1.

After reviewing the public comments, we are finalizing the measure for EPs at § 495.6(j)(12)(ii) as “Patient-specific education resources identified by CEHRT are provided to patients for more than 10 percent of all unique patients with office visits seen by the EP during the EHR reporting period.”

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(15).

To calculate the percentage for EPs, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of unique patients with office visits seen by the EP during the EHR reporting period.
  • Numerator: Number of patients in the denominator who were provided patient-specific education resources identified by the Certified EHR Technology.
  • Threshold: The resulting percentage must be more than 10 percent in order for an EP to meet this measure.
  • Exclusion: Any EP who has no office visits during the EHR reporting period.

Proposed Eligible Hospital/CAH Measure: More than 10 percent of all unique patients admitted to the eligible hospital's or CAH's inpatient or emergency departments (POS 21 or 23) are provided patient-specific education resources identified by Certified EHR Technology.

After consideration of public comments, we are finalizing the measure for eligible hospitals and CAHs at § 495.6(l)(9)(ii) as proposed.

We further specify that in order to meet this objective and measure, an eligible hospital or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(15).

To calculate the percentage for hospitals, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of unique patients admitted to the eligible hospital's or CAH's inpatient or emergency departments (POS 21 or 23) during the EHR reporting period.
  • Numerator: Number of patients in the denominator who are subsequently provided patient-specific education resources identified by CEHRT.
  • Threshold: The resulting percentage must be more than 10 percent in order for an eligible hospital or CAH to meet this measure.

Proposed Objective: The EP, eligible hospital or CAH who receives a patient from another setting of care or provider of care or believes an encounter is relevant should perform medication reconciliation.

In the proposed rule we outlined the following benefits of this objective. Medication reconciliation allows providers to confirm that the information they have on the patient's medication is accurate. This not only assists the provider in their direct patient care, it also improves the accuracy of information they provide to others through health information exchange.

In the proposed rule, we noted that that when conducting medication reconciliation during a transition of care, the EP, eligible hospital or CAH that receives the patient into their care should conduct the medication reconciliation. We reiterated that the measure of this objective does not dictate what information must be included in medication reconciliation. Information included in the process of medication reconciliation is appropriately determined by the provider and patient. In the proposed rule we defined medication reconciliation as the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage, frequency, and route, by comparing the medical record to an external list of medications obtained from a patient, hospital or other provider. We proposed that the electronic exchange of information is not a requirement for medication reconciliation.

Comment: Commenters requested that the definition of medication reconciliation should specifically mention over-the-counter medications, vitamins, herbal or other alternative care medications in the definition.

Response: We believe our term medications is expansive and not limiting. We in no way limit what any provider chooses to include or not include in their conduct of a medication reconciliation. As we are focused on the use of CEHRT to assist in medication reconciliation it is not our intent to develop a definitive definition of what medication reconciliation is.

Comment: Commenters stated that the objective is so reliant on health information exchange that it should not be moved to core until health information exchange capability increases.

Response: Robust health information exchange is certainly of great assistance to medication reconciliation. However, it is not required for medication reconciliation. Nor is electronic health information exchange the only way EHRs can assist with medication reconciliation. So while we believe that medication reconciliation will become easier as health information exchange capability increases, it is not a prerequisite to performing medication reconciliation.

After consideration of the comments received, we are finalizing this objective as proposed for EPs at § 495.6(j)(13)(i) and for eligible hospitals and CAHs at § 495.6(l)(10)(i).

Proposed Measure: The EP, eligible hospital or CAH performs medication reconciliation for more than 65 percent of transitions of care in which the patient is transitioned into the care of the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23).

In the proposed rule, we stated that although the HITPC recommended maintaining this threshold at 50 percent we believed that due to this measure's role in information exchange that we seek to promote through meaningful use a higher measure was appropriate. Based on the performance of providers in Stage 1, we proposed to raise the measure to 65 percent.

Comment: If as stated in the proposed rule “the majority chose to defer this measure in Stage 1,” commenters asserted that this is insufficient information to justify raising the threshold to 65 percent and move the objective to core. Other commenters assert that any measure that moves from menu to core should maintain its Stage 1 threshold regardless of the particular measure's rate of deferral.

Response: After considering the arguments for lowering the threshold to 50 percent and the lack of robust data in support of the proposed threshold, we do lower the threshold to 50 percent. For this measure in particular, we agree that since most providers chose to defer this measure in Stage 1 the information available on performance from Stage 1 meaningful EHR users is not as robust as for other objectives and measures. We do not agree with the comment that all objectives that move from menu to core should maintain the same threshold. We believe such a blanket policy would be arbitrary and not properly account for the information available for each objective and measure. For example, if most Stage 1 meaningful EHR users had reported on this measure, there would be a robust data set of performance on which to judge a threshold. A blanket policy would ignore such information.

Comment: The denominator of transitions of care during the EHR reporting period for which the provider is the receiving part of the transition is imprecise and therefore difficult to determine, especially when neither the transitioning provider or patient notifies the provider of the transition.

Response: We addressed this comment earlier in this section in our discussion of meaningful use denominators and provided a minimum set of specific actions that would indicate a transition of care has occurred.

Comment: While the objective speaks to relevant encounters, these are not included in the measure. This makes measurement difficult for those providers that conduct medication reconciliation at more than just transitions of care. If providers were allowed to include these encounters in the measure, measurement would both be easier and more representative of the actual use of CEHRT by the provider.

Response: We continue to believe that what is a relevant encounter is to variable to be included in the measure for all providers. However, a provider who institutes a policy for medication reconciliation at encounters encompassing more than just the minimum actions defined by the transitions of care denominator can include those encounters in their denominator and if medication reconciliation is conducted at the encounter in the numerator as well.

After consideration of the comments, we are modifying the threshold of the measure for EPs at § 495.6(j)(13)(ii) and for eligible hospitals and CAHs at § 495.6(l)(10)(ii). The EP, eligible hospital or CAH performs medication reconciliation for more than 50 percent of transitions of care in which the patient is transitioned into the care of the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23).

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(b)(4).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of transitions of care during the EHR reporting period for which the EP or eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) was the receiving party of the transition.
  • Numerator: The number of transitions of care in the denominator where medication reconciliation was performed.
  • Threshold: The resulting percentage must be more than 50 percent in order for an EP, eligible hospital or CAH to meet this measure.
  • Exclusion: Any EP who was not the recipient of any transitions of care during the EHR reporting period.

Proposed Objective: The EP, eligible hospital or CAH who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care provides a summary care record for each transition of care or referral.

In the proposed rule, we outlined the following benefits of this objective. By assuring lines of communication between providers caring for the same patient, all of the providers of care can operate with better information and more effectively coordinate the care they provide. Electronic health records, especially when linked directly or through health information exchanges, reduce the burden of such communication. The purpose of this objective is to ensure a summary of care record is provided to the receiving provider when a patient is transitioning to a new provider or has been referred to another provider while remaining under the care of the referring provider.

In the proposed rule, we proposed to eliminate the Stage 1 objective for the exchange of key clinical information for Stage 2 and instead include such information as part of the summary of care when it is a part of the patient's electronic record. We also proposed to incorporate two separate Stage 2 recommendations from the HIT Policy Committee as required fields in the summary of care record—

  • Record care plan fields, including goals and instructions, for at least 10 percent of transitions of care; and
  • Record team member, including primary care practitioner, for at least 10 percent of patients.

ONC also proposed in their standards and certification criteria rule (77 FR 13848 to include these as standard fields required to populate the summary of care document so CEHRT will be able to include this information. We provided a description of a “care plan” as well as the minimum components it must include for purposes of meaningful use, although we recognized that the actual content would be dependent on the clinical context. We asked for comments on both our description of a care plan and whether a description is necessary for purpose of meaningful use.

We proposed certain elements that are listed in the proposed rule (77 FR 13722) to be included in the summary care document. In circumstances where there is no information available on an element, either because the EP, eligible hospital or CAH can be excluded from recording such information or because there is no information to record, the EP, eligible hospital or CAH may leave the field(s) blank and still meet the objective and its associated measure.

In addition, we proposed that all summary of care documents used to meet this objective must include the following:

  • An up-to-date problem list of current and active diagnoses.
  • An active medication list, and
  • An active medication allergy list.

We proposed that all summary of care documents must contain the most recent and up-to-date information on these three elements to count in the numerator. We proposed to define problem list as a list of current and active diagnoses. We solicited comment on whether the problem list should be extended to include, “when applicable, functional and cognitive limitations” or whether a separate list should be included for functional and cognitive limitations. We proposed to define an up-to-date problem list as a list populated with the most recent diagnoses known by the EP or hospital. We proposed to define active medication list as a list of medications that a given patient is currently taking. We proposed to define active medication allergy list as a list of medications to which a given patient has known allergies. We proposed to define allergy as an exaggerated immune response or reaction to substances that are generally not harmful. In the event that there are no current or active diagnoses for a patient, the patient is not currently taking any medications, or the patient has no known medication allergies, confirmation of no problems, no medications, or no medication allergies would satisfy the measure of this objective. Note that the inclusion and verification of these elements in the summary of care record replaces the Stage 1 objectives for “Maintain an up-to-date problem list,” “Maintain active medication list,” and “Maintain active medication allergy list.”

Comment: Commenters suggested that the required data for each type of referral and transitions varies and that rather than creating a list of elements, the provider should decide what is needed.

Response: While we agree that tailoring the summary of care document for each referral and transition of care is desirable, we disagree that this means a list of basic elements that should be in each summary of care documents is not appropriate. We note that most organizations that try and tackle the issue of summary of care documents have required fields, core sets or other nomenclature for elements that they believe should be in all summary of care documents. For example, the CDA architecture used as the standard for the summary of care document contains required and optional fields. The American College of Physicians in their Neighborhood Model uses a core data set. None of these organizations intend for their list of elements to be limiting and nor do we intend our list to be limiting, but rather serve as a minimum. In our proposed rule we went further and said that if the provider does not have the information available to populate one or more of the fields listed, either because they can be excluded from recording such information (for example, vital signs) or because there is no information to record (for example, laboratory tests), the provider may leave the field(s) blank. The only exception to this is the problem list, medication list, and medication allergy list. Therefore, we are including a list of elements in this final rule.

Comment: Commenters stated that their understanding is that if any of the fields specifically for problem list, medication list, or allergy list is blank (meaning no entry of problems, medications or allergies nor an indication that it is known by the provider that the patient has no problems, medication or allergies), the EP or hospital will not meet the measure, but that if any other information is blank, the EP or hospital will still meet the measure. Please clarify whether this is a correct understanding of the proposal.

Response: This understanding of our proposed rule is generally correct. The problem list, medication list and medication allergy list must also either contain problems, medications and medication allergy or a specific notation that the patient has none. Leaving the field entirely blank with no entry whatsoever would not meet the measure. However, in cases where the provider does not have the information available to populate one or more of the other fields listed, either because they can be excluded from recording such information (for example, vital signs) or because there is no information to record (for example, laboratory tests), the provider may leave the field(s) blank. Note this does not allow a provider to disable a listed field from being generated by the CEHRT, but rather allows for when the CEHRT does not contain information on which to generate an entry for the field.

Comment: Some commenters suggested the substitution of past medical history for historical problem list in the list of required elements, since past medical history could provide additional information valuable to patient care.

Response: CMS' Evaluation and Management Services Guide defines a past medical history as the patient's past “experiences with illnesses, operations, injuries and treatments” (see http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf, p. 11). In our proposed rule, we referred to “current and historical problem list” as this is more concrete and standards based than the definition for past medical history. We believe the concept of past medical history is inclusive of current and historical problem list. We understand that providers are more familiar with the term past medical history and will evaluate expanding historical problem list to past medical history for Stage 3. However, for Stage 2, we are finalizing current and historical problem list. For summary of care documents at transitions of care we encourage providers to send a list of items that he or she believes to be pertinent and relevant to the patient's care, rather than a list of all problems, whether they are active or resolved, that have ever populated the problem list. While a current problem list should always be included, the provider can use his or her judgment in deciding which items historically present on the problem list, PMHx list (if it exists in CEHRT), or surgical history list are included given the clinical circumstances.

Comment: Commenters stated that it is too burdensome to determine whether the problem list, medication list and medication allergy list are included in each summary of care document.

Response: We disagree that this is too burdensome. We note that in Stage 1 measuring the completeness of the problem list, medication list and medication allergy list is already a requirement. Summary of care documents are generated by the CEHRT based on the information available to it. Therefore, there are only two causes of error that would have to be discovered to make the determination of whether the problem list, medication list and medication allergy list are included. The problem list, medication list and medication allergy list do not contain information for a given patient and/or there is an error in the generation of the summary of care document. This discovery constitutes the burden of this measure. We have already noted that the ability to know whether the lists contain information is already a Stage 1 measure. The second issue is prevalent in nearly every meaningful use measure that requires CEHRT to generate a measurement so that burden is already integral to meaningful use.

Comment: Commenters stated that the different descriptions of problem list throughout the proposed rule create confusion. The four terms used are “an up-to-date problem list of current and active diagnoses”, “problem list”, “Current problem list and any updates to it” and “problem list maintained by the hospital on the patient”. CMS should use this term uniformly. Furthermore, the limitation of the problem list to only current and active diagnoses is inconsistent with how problem lists are used and historical problems should also be included.

Response: We only proposed one definition of the base term “problem list”, which is a list of current and active diagnoses. We then use descriptors to tailor the term to the objective in which it is being utilized. For example, “up-to-date” means that the problem list in the CEHRT is populated with the most recent diagnoses known by the EP or hospital. The description used for office visit summary “Current problem list and any updates to it” was intended to separate problems that were known before the visit and those that were determined during the visit. We agree that our limitation of the “problem list” to just current and active diagnoses is unnecessarily limiting. The C-CDA, which is the standard adopted for EHR technology certification, for summary of care documents states that “at a minimum, all pertinent current and historical problems should be listed”. We revise our definition of “problem list” to include historical problems. This is a minimum. We do not limit the provider to just including diagnoses on the problem list. We agree that there should be just one definition of the base term “problem list”; however, we disagree that the same list is appropriate for every case especially with the addition of the historical problems. Some objectives call for the current problem list which includes only those diagnoses of problems currently affecting the patient. Other objectives call for the current and historical problem list, which would include problems currently affecting the patient as well as those that have been resolved. For purposes of clarity, we are consolidating across all of the meaningful use objectives to just two descriptions of our term “problem list”: “current problem list” and “current and historical problem list.” This consolidation also removes the need for a separate item of past relevant diagnosis as these would be included in a historical problem list. We define active medication list as a list of medications that a given patient is currently taking. We define active medication allergy list as a list of medications to which a given patient has known allergies. We define allergy as an exaggerated immune response or reaction to substances that are generally not harmful. Information on problems, medications, and medication allergies could be obtained from previous records, transfer of information from other providers (directly or indirectly), diagnoses made by the EP or hospital, new medications ordered by the EP or in the hospital, or through querying the patient. In the event that there are no current or active diagnoses for a patient, the patient is not currently taking any medications, or the patient has no known medication allergies, confirmation of no problems, no medications, or no medication allergies would satisfy the measure of this objective.

Comment: Many commenters recommended against any specification of problem list content regarding functional and cognitive limitations citing insufficient consensus around the appropriate classification of these functions. Commenters also stated that if included, functional and cognitive limitations should be further defined.

Response: As noted earlier in this final rule under the demographic objective, we wish to clarify that both the concepts of physical and cognitive disabilities as well as the concept of functional limitations that impact an individual's capability to perform activities were included in our description of disability status for the purpose of this rule. The latter concept is a common metric for care planning and care coordination across settings because knowledge of a patient's abilities (for example, functional and/or cognitive status) are also necessary for clinical practice. While many commenters noted the lack of consensus for the terms and standards necessary to support the inclusion of disability, functional and cognitive status assessment and observations into the Consolidated CDA for summary of care records, we understand that this standard was updated to include section- and data-entry level templates that can describe a patient's functional and cognitive status. However, we agree that there are insufficient definitions for disability, functional and cognitive status assessment and observations to include them as part of the problem list. Therefore, we are including “functional status, including functional, cognitive and disability” as a separate element in the summary of care document.

Comment: In regard to the inclusion of “care plan field” in the list of required information, some commenters believed that the wording was overly prescriptive since CEHRT could utilize multiple fields to structure care plans. Other commenters requested a more detailed definition of care plan and/or the standards that are available or required.

Response: We agree that the language proposed could be viewed as prescriptive, and we do not intend to limit the inclusion of the care plan to a single field. Therefore, we are amending the language to “Care plan field(s), including goals and instructions” in our list of required elements below. However, we decline to provide an alternate definition that would limit the information in the care plan. We believe that the definition we proposed in the proposed rule is sufficient to allow for the inclusion of a variety of care plans in the clinical summary. For purposes of the clinical summary, we define a care plan as the structure used to define the management actions for the various conditions, problems, or issues. A care plan must include at a minimum the following components: Problem (the focus of the care plan), goal (the target outcome), and any instructions that the provider has given to the patient. A goal is a defined target or measure to be achieved in the process of patient care (an expected outcome).

Comment: Commenters stated that while the care team members are clearly important data elements and key to clinical coordination, they recommended further research into true standards to support these elements before any requirements are imposed.

Response: Our proposal is to include “Any additional known care team members beyond the referring or transitioning provider and the receiving provider”. We believe that the ability to identify providers is well established. We note that there is no requirement to identify the role of each provider which we would agree are not well established beyond PCP and referring provider. We also note that this is only for cases when the other care team members are known by the transitioning provider. These allowances are sufficient to accommodate the current standard limitations and therefore we finalize as proposed.

Comment: As referrals are included in the denominator as well as transitions of care, the summary of care document should include the reason for the referral.

Response: We agree with this comment and add reason for referral for EPs. The reason for the referral is the clinical question the referring provider wants answered for a consultation or the procedure to be performed. If the consultation is more open ended, then a brief summary of the case details pertinent to referral suffices.

After consideration of the comments, all summary of care documents used to meet this objective must include the following information if the provider knows it:

  • Patient name.
  • Referring or transitioning provider's name and office contact information (EP only).
  • Procedures.
  • Encounter diagnosis.
  • Immunizations.
  • Laboratory test results.
  • Vital signs (height, weight, blood pressure, BMI).
  • Smoking status.
  • Functional status, including activities of daily living, cognitive and disability status.
  • Demographic information (preferred language, sex, race, ethnicity, date of birth).
  • Care plan field, including goals and instructions.
  • Care team including the primary care provider of record and any additional known care team members beyond the referring or transitioning provider and the receiving provider.
  • Discharge instructions (Hospital Only).
  • Reason for referral (EP only).

In circumstances where there is no information available to populate one or more of the fields listed previously, either because the EP, eligible hospital or CAH can be excluded from recording such information (for example, vital signs) or because there is no information to record (for example, laboratory tests), the EP, eligible hospital or CAH may leave the field(s) blank and still meet the objective and its associated measure.

In addition, all summary of care documents used to meet this objective must include the following in order to be considered a summary of care document for this objective:

  • Current problem list (Providers may also include historical problems at their discretion),
  • Current medication list, and
  • Current medication allergy list.

An EP or hospital must verify these three fields for current problem list, current medication list, and current medication allergy list are not blank and include the most recent information known by the EP or hospital as of the time of generating the summary of care document.

After consideration of public comments, we are finalizing this objective for EPs at § 495.6(j)(14)(i) and for eligible hospitals and CAHs at § 495.6(l)(11)(i) as proposed.

Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy both measures in order to meet the objective:

The EP, eligible hospital or CAH that transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 65 percent of transitions of care and referrals.

The EP, eligible hospital or CAH that transitions or refers their patient to another setting of care or provider of care electronically transmits a summary of care record using CEHRT to a recipient with no organizational affiliation and using a different CEHRT vendor than the sender for more than 10 percent of transitions of care and referrals.

First Measure: We proposed that if the provider to whom the referral is made or to whom the patient is transitioned has access to the medical record maintained by the referring provider, then the summary of care record would not need to be provided and that patient should not be included in the denominators of the measures of this objective. We stated in the proposed rule that different settings within a hospital using the same CEHRT would have access to the same information, so providing a clinical care summary for transfers within the hospital would not be necessary.

Comment: If as stated in the proposed rule “the majority chose to defer this measure in Stage 1”, commenters asserted this is insufficient information to justify raising the threshold to 65 percent and move the objective to core. Other commenters assert that any measure that moves from menu to core should maintain its Stage 1 threshold regardless of the particular measure's rate of deferral.

Response: After considering the arguments for lowering the threshold to 50 percent and the lack of a robust data set in support of the proposed threshold, we do lower the threshold to 50 percent. For this measure in particular, we agree that since most providers chose to defer this measure in Stage 1 the information available on performance from Stage 1 meaningful EHR users is not as robust as for other objectives and measures. We do not agree with the comment that all objectives that move from menu to core should maintain the same threshold. We believe such a blanket policy would be arbitrary and not properly account for the information available for each objective and measure. For example, if most Stage 1 meaningful EHR users had reported on this measure, there would be a robust data set of performance on which to judge a threshold. A blanket policy would ignore such information.

Comment: Commenters questioned and requested clarification on situations where the recipient of the transition or referral is using the same instance of CEHRT or otherwise has access to the CEHRT of the transitioning or referring provider. Some of these commenters acknowledged our proposal to address this situation were also split between support for our proposal to exclude these from the denominator versus allowing them to be in the denominator and numerator of both measures. Also commenters expressed concern on whether this was a measurable constraint. Finally, commenters requested clarification on whether our proposal applied to one or both measures.

Response: We proposed that if the provider to whom the referral is made or to whom the patient is transitioned has access to the medical record maintained by the referring provider, then the summary of care record would not need to be provided and that patient should not be included in the denominators of the measures of this objective. We believe that different settings within a hospital using CEHRT would have access to the same information, so providing a clinical care summary for transfers within the hospital would not be necessary. This is a continuance of our current Stage 1 policy. In response to comments, this policy applies to both measures. We clarify the first sentence that access to the medical record could be through several mechanisms. Some providers will be in the same organization and share CEHRT outright. Other providers might grant remote access to their CEHRT to providers not sharing their same CEHRT. We do not limit the mechanisms through which access is granted. We disagree that this access should count in the denominator or numerator of either measure. A summary of care document generated by CEHRT conforms to specific standards and could in many cases be automatically integrated into the recipient's CEHRT. Access provides no such capability. For this reason, we finalize our policy of excluding these transitions and referrals from the denominator. However, if a transitioning or referring provider provides both access and a summary of care document to providers outside their organization and wishes to include them in their denominator and as appropriate their numerator, they can do so. Finally, while we agree that it some cases it may be difficult to determine whether the recipient has access to the sender's CEHRT. We do not believe that we should remove an accommodation due to measurement difficulties. It is acceptable for a provider to include these transitions and referrals in the denominator, but only if a summary of care document is provided would it count in the numerator.

Comment: Commenters stated that there are some providers who may engage in a small number of transitions of care and referrals and the implementation burden of this objective is too high to require of those with only a small number. This is particularly true as the requirement for electronic health information exchange is introduced.

Response: We have previously allowed for a more than zero, but less than 100 exclusion for our other objective requiring electronic health information exchange (eRx); therefore, in response to these comments we will apply that policy to this objective and measure as well and raise the exclusion from zero to less than 100 transitions of care and referrals. Transitions of care and referrals are additive so someone with 50 transitions of care and 75 referrals would not qualify for the exclusion.

After consideration of public comments, we are revising the measure for EPs at § 495.6(j)(14)(ii)(A) and for eligible hospitals and CAHs at § 495.6(l)(11)(ii)(A) to “The EP, eligible hospital or CAH that transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 50 percent of transitions of care and referrals.”

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(b)(l) and (b)(2)(i).

To calculate the percentage of the first measure, CMS and ONC have worked together to define the following for this objective:

• Denominator: Number of transitions of care and referrals during the EHR reporting period for which the EP or eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) was the transferring or referring provider.

• Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was provided.

• Threshold: The percentage must be more than 50 percent in order for an EP, eligible hospital, or CAH to meet this measure.

• Exclusion: Any EP who transfers a patient to another setting or refers a patient to another provider less than 100 times during the EHR reporting period is excluded from all three measures.

Second Measure: For Stage 2, we proposed the additional second measure for electronic transmittal because we believe that the electronic exchange of health information between providers will encourage the sharing of the patient care summary from one provider to another and the communication of important information that the patient may not have been able to provide, which can significantly improve the quality and safety of referral care and reduce unnecessary and redundant testing. Use of common standards can significantly reduce the cost and complexity of interfaces between different systems and promote widespread exchange and interoperability. In acknowledgement of this, ONC has included certain transmission protocols in the proposed 2014 Edition EHR certification criteria.

These protocols would allow every provider with CEHRT to have the tools in place to share critical information when patients are discharged or referred, representing a critical step forward in exchange and interoperability. Accordingly, we proposed to limit the numerator for this second measure to only count electronic transmissions which conform to the transport standards proposed for adoption at 45 CFR 170.202 of the ONC standards and certification criteria rule.

To meet the second measure of this objective, we proposed that a provider must use CEHRT to create a summary of care document with the required information according to the required standards and electronically transmit the summary of care document using the transport standards to which its CEHRT has been certified. No other transport standards beyond those proposed for adoption as part of certification would be permitted to be used to meet this measure.

In the proposed rule, we acknowledged the benefits of requiring the use of consistently implemented transport standards nationwide, but at the same time want to be cognizant of any unintended consequences of this approach. ONC requested comments on whether equivalent alternative transport standards exist to the ones ONC proposes to exclusively permit for certification. These comments are addressed in the ONC standards and certification final rule published elsewhere in this issue of the Federal Register. We noted in the proposed rule that the use of USB, CD-ROM, or other physical media or electronic fax would not satisfy the measures for electronic transmittal of a summary of care record. We discussed in the proposed rule, in lieu of requiring solely the transmission capability and transport standard(s) included in a provider's CEHRT to be used to meet this measure, also permitting a provider to count electronic transmissions in the numerator if the provider electronically transmits summary of care records to support patient transitions using an organization that follows Nationwide Health Information Network (NwHIN) specifications (http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__nhin_resources/1194). This could include those organizations that are part of the NwHIN Exchange as well as any organization that is identified through a governance mechanism ONC would establish through regulation. We requested public comment on whether this additional flexibility should be added to our proposed numerator limitations.

In the proposed rule we raised another potential concern that another transport standard emerges after CMS' and ONC's rules are finalized that is not adopted in a final rule by ONC as part of certification, but nonetheless accomplishes the objective in the same way. To mitigate this concern, ONC indicated in its proposed rule that it would pursue an off-cycle rulemaking to add as an option for certification transport standards that emerge at any time after these proposed rules are finalized in order to keep pace with innovation and thereby allow other transport standards to be used and counted as part of this measure's numerator. We asked for comments on how these standards will further the goal of true health information exchange.

Additionally, in order to foster standards based-exchange across organizational and vendor boundaries, we proposed to further limit the numerator by only permitting electronic transmissions to count towards the numerator if they are made to recipients that are—(1) not within the organization of the transmitting provider; and (2) do not have CEHRT from the same EHR vendor.

We proposed these numerator limitations because, in collaboration with ONC, our experience has shown that one of the biggest barriers to electronic exchange is the adoption of numerous different transmission methods by different providers and vendors. Thus, we explained that it would be prudent for Stage 2 to include these more specific requirements and conformance to open, national standards as it will cause the market to converge on those transport standards that can best and most readily support electronic health information exchange and avoid the use of proprietary approaches that limit exchange among providers. We recognized that because the 2011 Edition EHR certification criteria did not include specific transport standards for transitions of care, some providers and vendors implemented their own methods for Stage 1 to engage in electronic health information exchange, some of which would no longer be an acceptable means of meeting meaningful use if this proposal were finalized.

Therefore, in order to determine a reasonable balance that makes this measure achievable yet significantly advance interoperability and electronic exchange, we asked for comment on the following concerns stakeholders may have relative to the numerator limitations we proposed previously.

We discussed a potential concern related to the feasibility of meeting this proposed measure if an insufficient number of providers in a given geographic location (because of upgrade timing or some other factor) have EHR technology certified to the transport standards ONC has proposed to adopt. For example, a city might have had a widely adopted health information exchange organization that still used another standard than those proposed for adoption by ONC. While it is not our intent to restrict providers who are engaged in electronic health information exchange via other transport standards, we believe requiring the use of a consistent transport standard could significantly further our overarching goals for Stage 2.

We recognized that this limitation extends beyond the existing parameters set for Stage 1, which specified that providers with access to the same medical record do not include transitions of care or referrals among themselves in either the denominator or the numerator. We recognized that this limitation could severely limit the pool of eligible recipients in areas where one vendor or one organizational structure using the same EHR technology has a large market share and may make measuring the numerator more difficult. We sought comment on the extent to which this concern could potentially be mitigated with an exclusion or exclusion criteria that account for these unique environments. We believe the limitation on organizational and vendor affiliations is important because even if a network or organization is using the standards, it does not mean that a network is open to all providers. Certain organizations may find benefits, such as competitive advantage, in keeping their networks closed, even to those involved in the care of the same patient. We believe this limitation will help ensure that electronic transmission of the summary of care record can follow the patient in every situation.

Even without the addition of the proposed exclusions under the proposed measure, CEHRT would need to be able to distinguish between (1) electronic transmissions sent using standards and those that are not, (2) transmission that are sent to recipients with the same organizational affiliation or not, and (3) transmissions that are sent to recipients using the same EHR vendor or not. ONC sought comment in their proposed certification rule as to the feasibility of this reporting requirement for CEHRT.

Despite the possible unintended consequences of the parameters we proposed for the numerator, in the proposed rule we stated that we believed that these limitations would help ensure that electronic health information exchange proceeds at the pace necessary to accomplish the goals of meaningful use. We asked for comments on all these points and particularly suggestions that would both push electronic health information exchange beyond what is proposed and minimize the potential concerns expressed previously.

The HIT Policy Committee recommended different thresholds for EPs and hospitals for the electronic transmission measure, with a threshold of only 25 instances for EPs. However, we proposed a percentage-based measure is attainable for both EPs and eligible hospitals/CAHs and better reflects the actual meaningful use of technology. It also provides a more level method for measurement across EPs. We asked for comments on whether there are significant barriers in addition to those discussed above to EPs meeting the 10 percent threshold for this measure.

Comment: There were several comments that doubted that the technology will be ready for providers to meet this measure. They did not believe there is enough vendor support to create, customize, and implement the changes necessary to meet the new measure. Commenters expressed concern that many of the technologies, from EHRs to HIEs and transmission standards, needed to enable electronic health information exchange currently do not exist.

Response: We disagree that it is premature to include this measure for Stage 2. We note that as an incentive program it is expected that the requirements will reach beyond what is commonplace today. Many organizations and providers are successfully engaged in electronic health information exchange today and by including this measure in meaningful use those established practices will be adopted by a greater number of providers.

Comment: A commenter suggested that ONC's certification rule was the appropriate place to ensure cross-vendor interoperability, not the Stage 2 measures and objectives.

Response: While we agree that meaningful use should be enabled by the capabilities included in certification, the concept of meaningful use is to incentivize the use of such capabilities not just the acquisition of them.

Comment: Commenters expressed two concerns on the limitation on the numerator that limited it to recipients with no organizational affiliation and using a different CEHRT vendor. First, there was concern that in some markets an organization or CEHRT vendor may control such a significant share of the market that meeting 10 percent is not possible. Second, even if the 10 percent threshold was feasible in a given market, one organization or CEHRT vendor may have enough market share that the provider's referral patterns would inappropriately be influenced to give preference to those using different CEHRT vendors or outside their organizations. Commenters support appropriate information exchange between all providers, where clinically relevant, regardless of provider affiliations, but have these concerns on our proposed measure for this objective. Commenters presented several different solutions including removing one or both limitations, replacing the limitations with an error reporting system for instances where electronic health information exchange fails, moving the limitations to the denominator and providing exclusions for areas of high vendor or organizational market penetrations.

Response: We agree that the measure as proposed runs both risks stated by commenters. Of the solutions presented by commenters, one directly alleviates both of these concerns. In drafting the final rule, we considered moving the limitations from the numerator to the denominator of the measure, both concerns are addressed. For example, if a provider makes 500 referrals during the EHR reporting period, 400 of which are to providers that either are affiliated with the same organization or use the same CEHRT vendor, then only 100 referrals are even eligible for the proposed numerator. This creates a bar that is much higher than 10 percent, as 50 percent of the eligible instances must be electronically transmitted to meet the proposed measure in this example, which we agree has the possibility of influencing referral patterns. However, applying the limitations of “no organizational affiliation” and “different CEHRT vendor” to the denominator instead of the numerator would result, in this example, in a denominator of 100 referrals instead of 500 and a true 10 percent threshold. There would be no need to change referral patterns as there would be no negative effect on the threshold for having a referral partner either in the same organization or using the same CEHRT vendor. We firmly believe that this solution is the best measure of the type of health information exchange that we proposed to target and that is supported in principle by nearly all commenters. However, we are not including this solution in the final rule as explained in the response to the next set of comments. Instead, we are removing the organizational and vendor limitations from this measure solely due to the burden of making these determinations for measurement.

Comment: Many commenters expressed concern over the ability to measure this objective especially the organization and vendor limitations. Commenters who were providers expressed concern over the ability of their CEHRT vendor to measure this objective, while vendors of CEHRT expressed concern over the ability of providers to measure the objective. Combined, it appears that neither the provider nor the vendor believed they could even measure on their own and had concerns on their partners on which they placed their hopes for measurement.

Response: In the proposed rule we determined that the CEHRT would have to be able to make three determinations to successfully calculate the numerator for this measure: (1) Electronic transmissions sent using standards and those that are not; (2) transmissions that are sent to recipients with the same organizational affiliation or not; and (3) transmissions that are sent to recipients using the same EHR vendor or not. We stated that ONC will seek comment in their proposed certification rule as to the feasibility of this reporting requirement for certified EHR technologies. ONC received comments similar to ours that making the determinations for the numerator was infeasible particularly in regard to the organizational and vendor limitations. Therefore, we are removing the organizational and vendor limitations from this measure solely due to the burden of making these determinations for measurement. Commenters did not suggest difficulties with determining that the electronic transmission was sent using the specified standards. Therefore, we finalize the stipulation that CEHRT be used, including its accompanying standards for this measure (“measure 2”).

However, we are not abandoning all efforts to ensure that cross vendor electronic exchange is possible for all meaningful EHR users in Stage 2. As discussed in the prior comment and response, the only reason we are not finalizing the stipulations on the denominator is the measurement burden. We believe that a third measure is needed that reduces the burden relative to the proposed measure, but still ensures that all providers have implemented CEHRT in a way that enables them to electronically exchange summary of care documents with a recipient using EHR technology designed by a different vendor. Therefore, we have added a third measure (“measure 3”) that requires providers to use their CEHRT to either—

  • Conduct one or more successful electronic exchanges of a summary of care document, which is counted in measure 2 with a recipient who has EHR technology designed by a different EHR technology developer than the sender's EHR technology certified to 45 CFR 170.314(b)(2); or
  • Conduct one or more successful tests with the CMS designated test EHR during the EHR reporting period.

For the first option in measure 3, the sender must verify that the recipient's technology used to receive the summary of care record was not designed by the same EHR technology developer that designed the sender's EHR technology certified to 45 CFR 170.314(b)(2).

With respect to the second option in measure 3, and recognizing past difficulties and lessons learned from a “test” oriented measure in Stage 1, we have collaborated with ONC and NIST to initiate a project that would result in a public facing (hosted online) “test EHR” with which EPs, eligible hospitals, and CAHs could engage in electronic exchange. We expect that most providers will satisfy the first option in the normal course of meeting measure 2. However, in those rare instances where that does not occur this other second option would give every EP, eligible hospital, or CAH an alternative method to meet measure 3 with minimal burden by successfully testing electronic exchange with the CMS-designated test EHR. If this second option is used, we clarify that the use of test information about a fictional patient that would be identical in form to what would be sent about an actual patient (for example, “dummy data”) must be used for the purposes of conducting a test with the CMS-designated test EHR. Providers that use the same EHR technology certified to 45 CFR 170.314(b)(2) and share a network for which their organization either has operational control or license to use can conduct one test that covers all providers in the organization. For example, if a large group of EPs with multiple physical locations use the same EHR technology certified to 45 CFR 170.314(b)(2) and those locations are connected using a network that the group has either operational control of or license to use, then a single test would cover all EPs in that group. Similarly, if a provider uses an EHR technology that is hosted (cloud-based) on the developer's network, then a single test would allow all EPs, eligible hospitals and CAHs using the EHR technology that is hosted (cloud-based) on the developer's network to meet the measure.

While making this does impose a burden on the provider, we believe the burden is outweighed by the benefits of ensuring that every provider who becomes a meaningful EHR user is capable of exchanging a summary of care document electronically regardless of who developed the sender's EHR and the recipient's EHR.

We also seek to note for readers that while we have significantly reduced this objective's burden from what we proposed in measure 2, we continue to believe that making vendor to vendor standards-based exchange attainable for all meaningful EHR users is of paramount importance. In that regard, and as we look toward meaningful use Stage 3, we will monitor the ease with which EPs, eligible hospitals, and CAHs engage in electronic exchange, especially across different vendors EHRs. If we do not see sufficient progress or that continued impediments exist such that our policy goals for standards-based exchange are not being met, we will revisit these more specific measurement limitations and consider other policies to strengthen the interoperability requirements included in meaningful use as well as consider other policies and regulations through which the Department could effect the outcome we seek. Finally, we also intend to consider future meaningful use requirements that increase expectations for standards-based exchange and make information that is exchanged more searchable and usable for a broad array of clinical purposes imperative to care improvement. We envision that these requirements would rely on metadata tagging as well as more dynamic methods of electronic health information exchange.

Comment: Commenters expressed support for including in this measure's numerator electronic transmissions enabled by query-based exchange models, including organizations using NwHIN Exchange specifications. The commenters indicated that NwHIN Exchange specifications are appropriate for exchange use cases not covered as well by the Direct standards, and use of either standard should be counted. This is particularly important in cases where the summary is pulled instead of pushed. Providers and organizations that are part of the NwHIN Exchange or other organizations using these standards should receive credit for those exchanges in meeting interoperability measures.

Response: In Stage 2, all providers should be able to use CEHRT to share summary of care records in a “push” manner to support safe transitions and informed referrals. “Pull” (query) transactions can also support these goals. By “pull” transactions we refer to instances where the receiving provider retrieves the summary of care document from a location outside their own CEHRT as opposed to “push” transactions where the referring or transitioning provider sends the summary of care document to the receiving provider. Thus, such transactions should be counted towards the numerator of the provider initiating the transitions or referrals when the recipient (the provider “receiving” the transition or referral) actually receives or downloads the patient's summary of care record relevant to the transition or referral. The act of uploading the summary of care record to a repository that can be queried by the recipient—without validation that this query in fact occurred will not be sufficient to count towards the numerator. While we acknowledge that there may not be a simple, universal way for this to be measured, we believe it is important to make this accommodation for those who elect to engage in this form of exchange. Therefore, we are revising the second measure to include in the sending provider's numerator instances where the recipient receives the summary of care record via exchange facilitated by an organization that is an NwHIN Exchange participant or in a manner that is consistent with the governance mechanism ONC establishes for the nationwide health information network. The referring or transitioning provider would use their CEHRT to generate a summary of care document and to provide it an organization that is a NwHIN Exchange participant or in a manner that is consistent with the governance mechanism ONC establishes for the nationwide health information network. More information on NwHIN Exchange participants is available at http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__nhin_exchange/1407. ONC issued a request for information regarding a governance mechanism for the nationwide health information network that is available at 77 FR 28543.

After considering the comments received, we are modifying the second measure for EPs at § 495.6(j)(14)(ii)(B) and for eligible hospitals and CAHs at § 495.6(l)(11)(ii)(B) to “The EP, eligible hospital or CAH that transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 10 percent of such transitions and referrals either (a) electronically transmitted using CEHRT to a recipient or (b) where the recipient receives the summary of care record via exchange facilitated by an organization that is a NwHIN Exchange participant or in a manner that is consistent with the governance mechanism ONC establishes for the nationwide health information network.”

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(b)(l) and (b)(2).

To calculate the percentage of the second measure, CMS and ONC have worked together to define the following for this objective:

• Denominator: Number of transitions of care and referrals during the EHR reporting period for which the EP or eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) was the transferring or referring provider.

• Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was a) electronically transmitted using CEHRT to a recipient or b) where the recipient receives the summary of care record via exchange facilitated by an organization that is a NwHIN Exchange participant or in a manner that is consistent with the governance mechanism ONC establishes for the nationwide health information network. The organization can be a third-party or the sender's own organization.

• Threshold: The percentage must be more than 10 percent in order for an EP, eligible hospital or CAH to meet this measure.

• Exclusion: Any EP who transfers a patient to another setting or refers a patient to another provider less than 100 times during the EHR reporting period is excluded from all three measures.

Third Measure: After considering the comments received, we are adding a third measure for EPs at § 495.6(j)(14)(ii)(C) and for eligible hospitals and CAHs at § 495.6(l)(11)(ii)(C) to “An EP, eligible hospital or CAH must satisfy one of the two following criteria:

  • Conducts one or more successful electronic exchanges of a summary of care document, which is counted in “measure 2” (for EPs the measure at § 495.6(j)(14)(ii)(B) and for eligible hospitals and CAHs the measure at § 495.6(l)(11)(ii)(B)) with a recipient who has EHR technology that was designed by a different EHR technology developer than the sender's EHR technology certified to 45 CFR 170.314(b)(2); or
  • Conducts one or more successful tests with the CMS designated test EHR during the EHR reporting period.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(b)(2).

• Exclusion: Any EP who transfers a patient to another setting or refers a patient to another provider less than 100 times during the EHR reporting period is excluded from all three measures.

(c) Public Health Objectives

General Public Health Discussion

In the proposed rule, due to similar considerations among the public health objectives, we discussed them together. Some Stage 2 public health objectives are proposed to be in the core set while others are proposed to be in the menu set. Each objective is identified as either core or menu in the following discussion.

  • Capability to submit electronic data to immunization registries or immunization information systems except where prohibited, and in accordance with applicable law and practice.
  • Capability to submit electronic reportable laboratory results to public health agencies, except where prohibited, and in accordance with applicable law and practice.
  • Capability to submit electronic syndromic surveillance data to public health agencies, except where prohibited, and in accordance with applicable law and practice.
  • Capability to identify and report cancer cases to a state cancer registry except where prohibited, and in accordance with applicable law and practice.
  • Capability to identify and report specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice.

We proposed the following requirements, which will apply to all of the public health objectives and measures. We proposed that actual patient data is required for the meaningful use measures that include ongoing submission of patient data.

We discussed in the proposed rule situations where PHAs partner with health information exchange (HIE) organizations to facilitate the submission of public health data electronically from EHRs. As we stated in guidance for Stage 1, (see FAQ #10764 at: https://questions.cms.hhs.gov) we clarified that such arrangements with HIE organizations, if designated by the PHA to simply transport the data, but not transforming content or message format (for example, HL7 format), are acceptable for the demonstration of meaningful use. Alternatively, if the intermediary is serving as an extension of the EP, eligible hospital or CAH's CEHRT and performing capabilities for which certification is required (for example, transforming the data into the required standard), then that functionality must be certified in accordance with the certification program established by ONC. In this situation, the EP, eligible hospital or CAH must still ensure the accomplishment of ongoing submission of reports to the actual immunization information system or registry (whether performed by the intermediary or not), except in situations when the PHA has explicitly designated delivery of reports to the intermediary as satisfying these requirements.

We proposed that an eligible provider is required to utilize the transport method or methods supported by the PHA in order to achieve meaningful use.

Unlike in Stage 1, under our proposed Stage 2 criteria a failed submission will not meet the objective. An eligible provider must either have successful ongoing submission or meet an exclusion criterion.

We stated in the proposed rule that we expect that CMS, CDC and PHAs will establish a process where PHAs will be able to provide letters affirming that the EP, eligible hospital or CAH was able to submit the relevant public health data to the PHA. This affirmation letter could then be used by the EP, eligible hospital or CAH for the Medicare and Medicaid meaningful use attestation systems, as well as in the event of any audit. We requested comments on challenges to implementing this strategy.

We proposed to accept a yes/no attestation and information indicating to which PHA the public health data were submitted to support each of the public health meaningful use measures.

Comment: Commenters asked for clarification of ongoing submission; additionally, due to the amount of time needed to prepare for submission of data, commenters asked for clarification on the timing to determine if a public health authority has the capacity to accept electronic data for ongoing submission. Other commenters noted that being “in queue” or in the process of validation for ongoing submission should count as meeting this measure. Commenters also noted that credit should be given for having moved into ongoing submission during Stage 1.

Response: To clarify the timing issue, the EP or hospital must determine if the PHA has the capacity to accept electronic data using the specification prescribed by ONC for the public health information for the objectives of meaningful use within the first 60 days of the EHR reporting period. If the PHA does not have the capacity to accept reporting (including situations when the PHA accepts electronic data but states it lacks capacity to enroll the EP, eligible hospital or CAH during that reporting period), the EP or hospital can claim an exclusion for this measure related to the data that cannot be accepted. In determining whether the PHA has the capacity, CMS anticipates developing a centralized repository for this information, including a deadline for the PHA to submit information. If the PHA fails to provide information to this centralized repository by the deadline, the provider could claim the exclusion. In the event, that we are unable to develop a centralized repository, providers will make the determination of PHA capacity by working directly with the PHA as is currently the case for Stage 1 of meaningful use. If the PHA does have the capacity, the measure may be satisfied through any of the following general public health criteria:

  • Ongoing submission was already achieved for an EHR reporting period in a prior year and continues throughout the current EHR reporting period using either the current standard at 45 CFR 170.314(f)(1) and (f)(2) or the standards included in the 2011 Edition EHR certification criteria adopted by ONC during the prior EHR reporting period when ongoing submission was achieved.
  • Registration with the PHA or other body to whom the information is being submitted of intent to initiate ongoing submission was made by the deadline (within 60 days of the start of the EHR reporting period) and ongoing submission was achieved.
  • Registration of intent to initiate ongoing submission was made by the deadline and the EP or hospital is still engaged in testing and validation of ongoing electronic submission.
  • Registration of intent to initiate ongoing submission was made by the deadline and the EP or hospital is awaiting invitation to begin testing and validation.

The measure will not be met if the provider—

  • Fails to register their intent by the deadline; or
  • Fails to participate in the on-boarding process as demonstrated by failure to respond to the PHA written requests for action within 30 days on two separate occasions.

Comment: Several commenters expressed concern that no data transport mechanism was included in the Stage 2 rule and/or EHR certification. Some expressed concern that the lack of a standard may result in EPs paying more for interfaces than received in incentive payments. Other commenters supported including no transport mechanism to allow maximum flexibility for public health authorities.

Response: While we understand the concern of supporting multiple transport mechanisms, in order for data to flow to public health authority, vendors must support the transport mechanism utilized by the public health authority to which the EP or hospital reports. Public health authorities have moved to standardize transport mechanisms where feasible, and Health Information Exchanges are often facilitating the transport of data to public health. We stand by our policy that allows public health authorities to dictate the transport mechanism in their jurisdiction. Further, we clarify that this is independent of the EHR certification criteria as EHR certification does not address transport for public health objectives.

Comment: Commenters suggested that the expectation that public health agencies provide affirmation letters is too restrictive in accomplishing the goal of established a record of communication between the provider and the PHA. They maintain that there are simpler and less burdensome ways such as automated acknowledgment messages from immunization submissions.

Response: We agree that our proposal requiring it must be a letter is too restrictive and revise our expectation to allow for any written communication (which may be in electronic format) from the PHA affirming that the EP, eligible hospital or CAH was able to submit the relevant public health data to the PHA.

Comment: Commenters requested greater clarification on what is meant by ongoing submission. Some suggested that it be transitioned to a percentage measurement as with other objectives of meaningful use.

Response: We do not agree that a transition to a percentage measurement best serves the public health objectives. First, a percentage measure would only be applicable to those engaged in ongoing submission, and as indicated in an earlier response, we are allowing four different situations to meet the measure. Second, we believe that the requirement to submit information would be under applicable law, the agreements between the provider and PHA, or through meaningful use which requires submissions except where prohibited, so it is not necessary for meaningful use to monitor the already mandated submission. For greater clarification, we describe successful ongoing submission as electronic submission of reportable data during the normal course of a provider's operations. This is not to say all data that is reportable is sent to the PHA. A provider who is submitting any reportable data during their normal course of their operations is engaged in ongoing submission. A provider that can only submit reportable data in a test environment or other circumstance that is not part of their normal operations would not be engaged in ongoing submission.

Where a measure states “in accordance with applicable law and practice,” this reflects that some public health jurisdictions may have unique requirements for reporting and that some may not currently accept electronic data reports. In the former case, the proposed criteria for this objective will not preempt otherwise applicable state or local laws that govern reporting. In the latter case, EPs, eligible hospitals, and CAHs will be excluded from reporting.

Comment: Several commenters requested the removal of “except where prohibited” from the objective, while others expressed support for this phrase. Those that did not support note that CMS does not have the authority to direct reporting if not required by law or regulations, while supporters applauded CMS for supporting reporting where allowed but not required by law. Several commenters suggested removing the phrase “in accordance with applicable law,” while other commenters wrote in support of the addition of the phrase.

Response: We disagree with the commenters suggesting removal of these phrases and will keep them as part of the final rule. The phrase “except where prohibited” is meant to allow exemptions from reporting for providers who cannot by law report to the public health authority within their jurisdiction. For example, a sovereign Indian Nation may not be permitted to report immunization registry data to the public health authority in their jurisdiction. The phrase is meant to encourage reporting if a provider is authorized to do so. The “in accordance with applicable law” phrase allows public health authorities to utilize their existing laws and regulations for reporting.

Proposed Objective: Capability to submit electronic data to immunization registries or immunization information systems except where prohibited, and in accordance with applicable law and practice.

We proposed to include this objective in the Stage 2 core set for EPs, eligible hospitals and CAHs as recommended by the HITPC. We discussed in the proposed rule that the Stage 1 objective and measure acknowledged that our nation's public health IT infrastructure is not universally capable of receiving electronic immunization data from CEHRT, either due to technical or resource readiness. Immunization programs, their reporting providers and federal funding agencies, such as the CDC, ONC, and CMS, have worked diligently since the passage of the HITECH Act in 2009 to facilitate EPs, eligible hospitals and CAHs ability to meet the Stage 1 measure. We proposed for Stage 2 to take the next step from testing to requiring actual submission of immunization data. In order to achieve improved population health, providers who administer immunizations must share that data electronically, to avoid missed opportunities or duplicative vaccinations. Stage 3 is likely to enhance this functionality to permit clinicians to view the entire immunization registry/immunization information system record and support bi-directional information exchange.

We proposed that the threshold for Stage 2 should move from simply testing the electronic submission of immunization data (with follow-up submission if the test is successful) to ongoing submission. However, we asked for comments on the challenges that moving this objective from the menu set to the core set would present for EPs and hospitals.

Comment: Some commenters suggested that the term immunization information systems was all encompassing making the inclusion of immunization registries redundant.

Response: We agree that an information system could include registries; however, we do not believe that modifying the objective serves a distinct purpose and could confuse those accustomed to the term immunization registries.

Comment: Commenters, although supportive of moving immunization registry reporting from menu to core, expressed concern that PHAs did not have the capacity to accept electronic data from additional providers.

Response: We agree that not all PHAs will have the resources to onboard providers for immunization registry reporting. The final rule allows for an EP or hospital to be excluded from the measure if they operate in a jurisdiction for which no immunization registry is capable of accepting data. We further clarify that this exception applies not only if the technical capacity to receive the data does not exist, but also if the resources are not available within the public health authority to initiate ongoing submission with the EP or hospital. We also permit (as earlier stated) an EP or hospital to meet the measure so long as they have registered to submit and are either still in the process of testing and validation (within the time limits established earlier), or are still awaiting an invitation to begin submission.

Comment: Numerous commenters encouraged the inclusion of bidirectional exchange of data with immunization registries. Many commenters noted that the EP or eligible hospital cannot take advantage of rich data and clinical decision support contained within an immunization registry without bidirectional exchange.

Response: While we agree that the need for bidirectional data exchange is clear, this measure aligns more with the goals of Stage 3 meaningful use stated in the proposed rule. Additionally, the standards and mechanisms for bidirectional data exchange need to be more standardized across public health authorities.

After consideration of the public comments received, we are finalizing this objective for EPs at § 495.6(j)(15)(i) and for eligible hospitals and CAHs at § 495.6(l)(12)(i) as proposed.

Proposed Measure: Successful ongoing submission of electronic immunization data from CEHRT to an immunization registry or immunization information system for the entire EHR reporting period.

Comment: Many commenters noted the lack of national standards for the collection of immunization data with specific examples such as CVS versus MVX coding vocabularies and also noted the need for centralized data collection at a national level. Commenters noted that the lack of standardization results in cost-prohibitive compliance with this measure.

Response: We agree that during the implementation of Stage 1 reporting of immunization data, the need for a more harmonized standard for immunization reporting was highlighted. To address this issue, the option of using version HL7 2.3.1 versus 2.5.1 for certification was removed and now only an HL7 2.5.1 message can be used for Stage 2 reporting of immunization data. The implementation guide for HL7 2.5.1 has been updated to remove much of the variability across states for immunization registry reporting. However, if EPs prior to CY 2014 and eligible hospitals and CAHs prior to FY2014 have achieved successful ongoing submission using EHR technology certified to the 2011 Edition EHR certification criteria (HL7 2.3.1 only) it is acceptable to continue this ongoing submission and meet the Stage 2 measure for as long as HL7 2.3.1 continues to be accepted by the immunizations information system or immunization registry. EPs and eligible hospitals and CAHs conducting submissions using HL7 2.5.1 will be able to get their arrangement certified to the 2014 Edition EHR certification criteria.

After consideration of the public comments received, we are finalizing this measure at for EPs at 495.6(j)(15)(ii) and for eligible hospitals and CAHs at 495.6(l)(12)(ii) as proposed, but we modify the exclusions to conform with the general criteria for public health objectives and to address redundancy in two of the proposed exclusions. In the general criteria for public health objectives section we established a centralized repository of information about PHA capacity. If a PHA does not provide capacity information to this repository in time for it to be made available to providers at the start of their EHR reporting period, then the providers in that PHA's jurisdiction will meet the modified exclusion. We proposed two exclusions: (1) The EP, eligible hospital or CAH operates in a jurisdiction for which no immunization registry or immunization information system is capable of receiving electronic immunization data in the specific standards required for CEHRT at the start of their EHR reporting period; and (2) the EP, eligible hospital or CAH operates in a jurisdiction for which no immunization registry or immunization information system is capable of accepting the version of the standard that the EP, eligible hospital or CAH's CEHRT can send at the start of their EHR reporting period. In both cases the limitation is the ability of the immunization registry or immunization information system to receive immunization data in the standards required by ONC for EHR certification in 2014. Therefore, we are combining these exclusions.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(f)(1) and (f)(2). However, if EPs prior to CY 2014 and eligible hospitals and CAHs prior to FY 2014 have achieved successful ongoing submission using EHR technology certified to the 2011 Edition EHR certification criteria (HL7 2.3.1 only), it is acceptable to continue this ongoing submission and meet the Stage 2 measure for as long as HL7 2.3.1 continues to be accepted by the immunizations information system or immunization registry. We note that our decision to continue to permit the use of EHR technology certified to the 2011 Edition EHR certification criteria is a special circumstance and emphasize that EPs, eligible hospitals, and CAHs will still need EHR technology certified to the 2014 Edition EHR certification criteria in order to meet the CEHRT definition beginning with the FY/CY 2014 EHR reporting period.

  • Exclusions: Any EP, eligible hospital or CAH that meets one or more of the following criteria may be excluded from this objective: (1) The EP, eligible hospital or CAH does not administer any of the immunizations to any of the populations for which data is collected by their jurisdiction's immunization registry or immunization information system during the EHR reporting period; (2) the EP, eligible hospital or CAH operates in a jurisdiction for which no immunization registry or immunization information system is capable of accepting the specific standards required for CEHRT at the start of their EHR reporting period (3) the EP, eligible hospital or CAH operates in a jurisdiction where no immunization registry or immunization information system provides information timely on capability to receive immunization data; or (4) the EP, eligible hospital or CAH operates in a jurisdiction for which no immunization registry or immunization information system that is capable of accepting the specific standards required by CEHRT at the start of their EHR reporting period can enroll additional EPs, eligible hospitals or CAHs.

The second exclusion will not apply if an entity designated by the immunization registry or immunization information system can receive electronic immunization data submissions. For example, if the immunization registry cannot accept the data directly or in the standards required by CEHRT, but if it has designated a Health Information Exchange to do so on their behalf and the Health Information Exchange is capable of accepting the information in the standards required by CEHRT, the provider could not claim the second exclusion.

Proposed Eligible Hospital/CAH Objective: Capability to submit electronic reportable laboratory results to public health agencies, except where prohibited, and in accordance with applicable law and practice.

We proposed that this objective is in the Stage 2 core set for eligible hospitals and CAHs. The same rationale for the proposed changes between this proposed objective and that of Stage 1 are discussed earlier under the immunization registry objective. Please refer to that section for details on our proposals in this regard.

Comment: Commenters, although supportive of moving electronic laboratory reporting from menu to core, expressed concern that PHAs did not have the capacity to accept electronic data from additional providers.

Response: We agree that not all PHAs will have the resources to onboard providers for electronic laboratory reporting. The final rule allows for an EP, eligible hospital or CAH to be excluded from the measure if they operate in a jurisdiction for which no public health authority is capable of accepting electronic laboratory data. We further clarify that this exception applies not only if the technical capacity to receive the data does not exist, but also if the resources are not available within the public health authority to initiate ongoing submission with the EP, eligible hospital or CAH. We also permit (as earlier stated) an EP, eligible hospital or CAH to meet the measure so long as they have registered to submit and are either still in the process of testing and validation, or are still awaiting an invitation to begin submission.

Comment: Many commenters noted that lack of standards for reporting electronic laboratory data to public health authorities and also noted the variety of transport methods needed to support reporting to public health.

Response: ONC has adopted an updated implementation guide for electronic laboratory reporting from EHR technology in its 2014 Edition EHR certification criteria. Additionally, the Centers for Disease Control and Prevention in coordination with the Council of State and Territorial Epidemiologists have created the national Reporting Condition Mapping Table (http://www.cdc.gov/EHRmeaningfuluse/rcmt.html) that provides further guidance on appropriate vocabularies usable for reportable conditions across the country for reporting of ELR data.

Comment: Several commenters wrote in favor of expansion of this requirement to be inclusive of the surveillance of healthcare associated infections (HAI).

Response: While we agree that the reporting of healthcare associated infections is a critical part of public health surveillance, the methods and standards for reporting this information require very different standards for electronic laboratory reporting of reportable conditions. This measure aligns more with the goals of Stage 3 meaningful use.

Comment: Numerous commenters suggested that Electronic Laboratory Reporting is outside the scope of EHRs and should be excluded from the objectives. These commenters note that laboratory information systems (LIMS) already have ELR capabilities, and most EHRs do not. One commenter expressed concern that reporting from both laboratories and providers may cause duplicate reporting of a single case. The same commenter stated that many LIMS systems already have functionality to identify which laboratory results need to be reported to public health, which EHRs do not, and that building that capability into EHRs would be duplicative and burdensome.

Response: We disagree with the statement that ELR is “outside the scope of EHRs and should be excluded” because we share ONC's broad interpretation of the term EHR technology. Eligible Hospitals can choose to report data directly from any kind of EHR technology that has been certified to the certification criteria adopted by ONC. This could include EHR technology from a single EHR technology developer, a separate modularly certified component such as a LIMS certified as an EHR Module, or the technical capability offered by an HIE that is certified as an EHR Module for electronic laboratory reporting.

After consideration of the public comments, we are finalizing this objective for eligible hospitals and CAHs at 495.6(l)(13)(i) as proposed.

Proposed Eligible Hospital/CAH Measure: Successful ongoing submission of electronic reportable laboratory results from CEHRT to a public health agency for the entire EHR reporting period as authorized, and in accordance with applicable State law and practice.

Please refer to the general public health discussion regarding use of intermediaries.

Most comments received related to this measure have been addressed in the discussion of public health objectives in general or in the discussion of the objective associated with this measure.

Comment: Commenters pointed out that the proposed measure includes the statement “as authorized, and in accordance with applicable State law and practice.” Some commenters believed the phrase was simply redundant to the objective and was inconsistent with the other public health measures. Other commenters expressed concern that the addition of the phrase implied a more restrictive measure than other public health measures particularly with the limit to state law as opposed to just law.

Response: We agree with commenters that this phrase is redundant to the objective and may introduce confusion. Therefore, we are revising this measure to remove the phrase and make it consistent with the other public health measures.

Based on consideration of those comments, we are modifying this measure for eligible hospitals and CAHs at § 495.6(l)(13)(ii) to successful ongoing submission of electronic reportable laboratory results from CEHRT to a public health agency for the entire EHR reporting period.” We also modify the exclusions to conform with the general criteria for public health objectives. In the general criteria for public health objectives, we plan to establish a centralized repository of PHA capacity information. If a PHA does not provide capacity information to this repository in time for it to be made available to providers at the start of their EHR reporting period, then the providers in that PHA's jurisdiction will meet the modified exclusion. If the repository is not established, the eligible hospital or CAH must consult their PHA jurisdiction for guidance.

We further specify that in order to meet this objective and measure, an eligible hospital or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(f)(4).

  • Exclusions: The eligible hospital or CAH that meets one or more of the following criteria may be excluded from this objective: (1) operates in a jurisdiction for which no public health agency is capable of receiving electronic reportable laboratory results in the specific standards required for Certified EHR Technology at the start of the EHR reporting period; (2) operates in a jurisdiction where no public health agency provides information timely on capability to receive electronic reportable laboratory results or (3) the eligible hospital or CAH operates in a jurisdiction for which no public health agency that is capable of accepting the specific standards required by CEHRT at the start of their EHR reporting period can enroll additional eligible hospitals or CAHs.

Proposed Objective: Capability to submit electronic syndromic surveillance data to public health agencies except where prohibited, and in accordance with applicable law and practice.

We proposed that this objective is in the Stage 2 core set for eligible hospitals and CAHs and the Stage 2 menu set for EPs. The Stage 1 objective and measure acknowledged that our nation's public health IT infrastructure is not universally capable of receiving syndromic surveillance data from CEHRT, either due to technical or resource readiness. Given public health IT infrastructure improvements and new implementation guidance, for Stage 2, we proposed that this objective and measure be in the core set for hospitals and in the menu set for EPs. It is our understanding from hospitals and the CDC that many hospitals already send syndromic surveillance data. The CDC has issued the PHIN Messaging Guide for Syndromic Surveillance: Emergency Department and Urgent Care Data [http://www.cdc.gov/ehrmeaningfuluse/Syndromic.html] as cited in the ONC final rule on EHR standards and certification. However, per the CDC and a 2010 survey completed by the Association of State and Territorial Health Officials (ASTHO), very few public health agencies are currently accepting syndromic surveillance data from ambulatory, non-hospital providers, and there is no corresponding implementation guide at the time of this final rule. CDC is working with the syndromic surveillance community to develop a new implementation guide for ambulatory and inpatient discharge reporting of syndromic surveillance information, which it expects will be available in the spring 2013. We anticipate that Stage 3 might include syndromic surveillance for EPs in the core set if the collection of ambulatory syndromic data becomes a more standard public health practice in the interim.

The HIT Policy Committee recommended making this a core objective for Stage 2 for EPs and hospitals. However, we did not propose to adopt their recommendation for EPs. We specifically invited comment on the proposal to leave syndromic surveillance in the menu set for EPs, while requiring it in the core set for eligible hospitals and CAHs.

Comment: Commenters noted that keeping the objective as menu for EPs is still problematic as most public health agencies are unable to accept the data. Commenters also expressed that for providers that are already reporting this objective, it makes sense to keep it as a menu set option.

Response: We agree that although not all public health authorities are able to accept syndromic surveillance data from Eligible Professionals, since many EPs already report this measure and some public health authorities have the ability to accept this data, the measure will remain as a menu set option.

Comment: Commenters noted that moving the objective as core is premature due to public health readiness. Commenters also expressed that for hospitals that have already reporting this objective, it makes sense to move the measure to core.

Response: We agree that not all public health authorities are able to accept syndromic surveillance data from hospitals; however, our exclusion criteria addresses this situation. Since many hospitals already report this measure and many public health authorities have the ability to accept this data, the measure will remain as core. If there are no public health authorities for the hospitals to report syndromic surveillance data to, the hospital can claim an exemption.

Comment: Many commenters noted that lack of standards for reporting syndromic surveillance data to public health authorities.

Response: While a single national implementation guide exists for syndromic surveillance data of emergency department data from hospitals, currently an implementation guide does not exist for syndromic surveillance reporting from the eligible professional. The Centers for Disease Control and Prevention is working in conjunction with the International Society for Disease Surveillance and draft guidance is currently available for the reporting of ambulatory based syndromic surveillance.

Comment: Several comments expressed concern about the level of reporting. Concern was expressed from entities with multiple locations that would need to report by facility or provider lever rather than as an organization.

Response: Currently public health departments that collect syndromic surveillance data streamline the data collection process and collect data at an organization or facility level depending on the provider. Syndromic surveillance data is not collected at the provider level, although attestation would be at the provider level where reporting by a single organization or facility could count for multiple providers.

After consideration of the public comments received, we are finalizing this objective for EPs in the menu set at § 495.6(k)(3)(i) and for eligible hospitals and CAHs in the core set at § 495.6(l)(14)(i) as proposed.

Proposed Measure: Successful ongoing submission of electronic syndromic surveillance data from CEHRT to a public health agency for the entire EHR reporting period.

All comments received related to this measure have been addressed in the discussion of public health objectives in general or in the discussion of the objective associated with this measure. After consideration of these public comments, we are finalizing this measure as proposed for EPs in the menu set at § 495.6(k)(3)(ii) and for eligible hospitals and CAHs in the core set at § 495.6(l)(14)(ii) as proposed, but we modify the exclusions to conform with the general criteria for public health objectives and to address redundancy in two of the proposed exclusions. In the general criteria for public health objectives, we plan to establish a centralized repository of PHA capacity information. If a PHA does not provide capacity information to this repository in time for it to be made available to providers at the start of their EHR reporting period, then the providers in that PHA's jurisdiction will meet the modified exclusion. We proposed two exclusions: (1) The EP, eligible hospital, or CAH operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data in the specific standards required for Certified EHR Technology at the start of their EHR reporting period; and (2) the EP, eligible hospital, or CAH operates in a jurisdiction for which no public health agency is capable of accepting the version of the standard that the EP's, eligible hospital's or CAH's CEHRT can send at the start of their EHR reporting period. In both cases the limitation is the ability of the PHA to receive syndromic surveillance data in the standards required by ONC for EHR certification in 2014. Therefore, we are combining these exclusions.

We expect that the CDC will be issuing (in Spring 2013) the CDC PHIN Messaging Guide for Ambulatory Syndromic Surveillance and we may rely on this guide to determine which categories of EPs will not collect such information.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(f)(3). However, if EPs prior to CY 2014 and eligible hospitals and CAHs prior to FY 2014 have achieved successful ongoing submission using EHR technology certified to the 2011 Edition EHR certification criteria (HL7 2.3.1 only), it is acceptable to continue this ongoing submission and meet the Stage 2 measure for as long as HL7 2.3.1 continues to be accepted by the PHA in that jurisdiction. We note that our decision to continue to permit the use of EHR technology certified to the 2011 Edition EHR certification criteria is a special circumstance and emphasize that EPs, eligible hospitals, and CAHs will still need EHR technology certified to the 2014 Edition EHR certification criteria in order to meet the CEHRT definition beginning with the FY/CY 2014 EHR reporting period.

  • Exclusions: Any EP, eligible hospital or CAH that meets one or more of the following criteria may be excluded from this objective: (1) the EP is not in a category of providers that collect ambulatory syndromic surveillance information on their patients during the EHR reporting period; (2) the eligible hospital or CAH does not have an emergency or urgent care department; (3) the EP, eligible hospital, or CAH operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data in the specific standards required by CEHRT at the start of their EHR reporting period; (4) the EP, eligible hospital or CAH operates in a jurisdiction where no public health agency provides information timely on capability to receive syndromic surveillance data; or (5) the EP, eligible hospital or CAH operates in a jurisdiction for which no public health agency that is capable of accepting the specific standards required by CEHRT at the start of their EHR reporting period can enroll additional EPs, eligible hospitals or CAHs.

As was described under the immunization registry measure, the third and fourth exclusions do not apply if the PHA has designated an HIE organization or other intermediary to collect this information on its behalf and that intermediary can do so in the specific Stage 2 standards and/or the same standard as the provider's CEHRT. An urgent care department delivers ambulatory care, usually on an unscheduled, walk-in basis, in a facility dedicated to the delivery of medical care, but not classified as a hospital emergency department. Urgent care centers are primarily used to treat patients who have an injury or illness that requires immediate care but is not serious enough to warrant a visit to an emergency department. Often urgent care centers are not open on a continuous basis, unlike a hospital emergency department, which will be open at all times.

(d) New Core and Menu Set Objectives and Measures for Stage 2

We proposed the following objectives for inclusion in the core set for Stage 2: “Provide patients the ability to view online, download, and transmit information about a hospital admission” and “Automatically track medication orders using an electronic medication administration record (eMAR)” for hospitals; “Use secure electronic messaging to communicate with patients” for EPs. We proposed all other new objectives for inclusion in the menu set for Stage 2. While the HIT Policy Committee recommended making all objectives mandatory and eliminating the menu option, we believe a menu set is necessary for some of these new objectives in order to give providers an opportunity to implement new technologies and make changes to workflow processes and to provide maximum flexibility for providers in specialties that may face particular challenges in meeting new objectives.

Proposed Objective: Imaging results and information are accessible through CEHRT.

In the proposed rule, we outlined the following benefits for this objective. Making the image that results from diagnostic scans and accompanying information accessible through CEHRT increases the utility and efficiency of both the imaging technology and the CEHRT. The ability to share the results of imaging scans will likewise improve the efficiency of all health care providers and increase their ability to share information with their patients. This will reduce the cost and radiation exposure from tests that are repeated solely because a prior test is not available to the provider.

We stated in the proposed rule that most of the enabling steps to incorporating imaging relate to the certification of EHR technologies. As with the objective for incorporating lab results, we encourage the use of electronic exchange to incorporate imaging results into the CEHRT, but in absence of such exchange it is acceptable to manually add the image and accompanying information to CEHRT.

Comment: Some commenters expressed concerns over the ability of CEHRT to store the images.

Response: We did not propose that CEHRT store the images. Storing the images natively in CEHRT is one way to make them accessible through CEHRT, but there are many other ways.

Comment: Commenters stated that unless a HIE organization existed to facilitate imaging exchange, building out an unique interface for each imaging provider is cost prohibitive. Second, commenters were concerned that because stand-alone radiology centers are not subject to the EHR Incentive Program they may not agreeing to provide their images electronically to the provider through their EHR. These commenters therefore suggest that it is premature to include this objective.

Response: We agree that many advances in infrastructure are needed to fully enable this objective. We believe that from publication of this final rule to the start of Stage 2 significant progress will be made in part due to the inclusion of this objective in Stage 2. We do agree that these improvements in infrastructure will vary based on local conditions such as the presence of HIEs, the willingness of radiology centers to link to EHRs, and other factors and note that is a primary reason for this being a menu objective. We will also consider these comments below in relation to setting the threshold for the measure.

Comment: The resolution required for viewing imaging for diagnostic purposes requires specific hardware which would be cost prohibitive for all EPs. CMS should clarify that the image can be of any resolution.

Response: We do not impose limitations on the resolution of the image. To the extent this is a concern, it would be a capability of CEHRT not a requirement of meaningful use.

Comment: Commenters requested clarification on whether both the image itself and the accompanying results and information must be available, or just one or the other.

Response: The objective as proposed was intended to convey that the image itself is the result and that narratives/explanations and other information would be the additional information. Due to the many comments we received requesting clarification, we are revising the objective for clarity.

Comment: Commenters requested a more specific definition of imaging.

Response: We believe that imaging is a well understood term in the provider community. However, we agree that a more specific definition is required for purposes of measuring meaningful use. We adopt the description of radiology services from the Stage 2 CPOE objective as the minimum description of imaging. Providers are free to use a more expansive definition of imaging.

After review of the comments, we are revising the objective for EPs at 495.6 (k)(1)(i) and for eligible hospitals and CAHs at 495.6(m)(2)(i) to “Imaging results consisting of the image itself and any explanation or other accompanying information are accessible through CEHRT.”

Proposed Measure: More than 40 percent of all scans and tests whose result is one or more images ordered by the EP or by an authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) during the EHR reporting period are accessible through CEHRT.

For Stage 2, we did not propose the image or accompanying information (for example, radiation dose) be required to be structured data. Images and imaging results that are scanned into the CEHRT may be counted in the numerator of this measure. We defined accessible as either incorporation of the image and accompanying information into CEHRT or an indication in CEHRT that the image and accompanying information are available for a given patient in another technology and a link to that image and accompanying information. Incorporation of the image means that the image and accompanying information is stored by the CEHRT. We did not propose that meaningful use would impose any additional retention requirements on the image. A link to the image and accompanying information means that a link to where the image and accompanying information is stored is available in CEHRT. This link must conform to the certification requirements associated with this objective in the ONC final rule published elsewhere in this issue of the Federal Register. We encouraged comments on the necessary level of specification and what those specifications should be to define accessible and what constitutes a direct link.

Comment: Commenters suggested that the proposed threshold of 40 percent was too high given the dependency on the image provider and electronic exchange infrastructure discussed in the objective. The most popular suggested threshold was 10 percent. Commenters also suggested that an exclusion be created for providers who have no access to electronic images. A few of the commenters pointed to the lack of an imaging provider that could make electronic images available. Others were concerned that when a provider uses multiple imaging providers, 40 percent might be too high of a threshold even if at least one imaging provider that could make electronic images available.

Response: After reviewing the comments, we agree that 40 percent is too high of a threshold for this measure and revise it to 10 percent. Providers, especially EPs, may use many imaging providers, and we do not want an EP to have to defer this objective simply because they have three imaging providers, and the one allowing electronic access represents less than 40 percent of their orders. The comment regarding complete lack of an imaging provider that could make electronic images available speaks to the need for an exclusion. In considering an exclusion for those providers who have no access to electronic images, we take into account that it is a menu objective and also that there may be providers who fall into a situation where access is more than zero, but less than 10 percent. In regards to the menu, while it is true that a provider may defer this measure, the number of measures in the menu set are fewer and more specialized than in Stage 1. Furthermore, as an exclusion no longer counts towards meeting a menu objective, we are not concerned providers would choose this objective only to exclude it. For this reason, we are finalizing an exclusion for providers who have no access to electronic images. For those who cannot meet the 10 percent threshold even with access to an imaging provider who makes electronic images available, deferral remains a possibility as well as shifting more orders to imaging providers that do allow electronic access.

Comment: Several commenters disagreed with the proposed exclusion for EPs and believed it was inconsistent with the objective. These commenters believe the objective is intended for EPs who order imaging, whether or not they interpret the imaging studies themselves. These commenters suggested changing the exclusion to “Any EP who orders (less than 100/50/no) diagnostic scans or tests whose result is an image during the EHR reporting period”.

Response: Our intention with the proposed exclusion was to distinguish between ordering providers who have need of the image and those that do not. Based on the comments the need to view the image depends on a combination of factors including previous experiences with the type of image, the imaging facility, the circumstances of the patient, whether a similar image has been ordered before for the patient and the reading clinician. Given the wide variety of factors, we agree that it is not possible to create a distinct line between ordering providers who need the image and those that do not. We believe this line can be partly drawn by adopting the exclusion recommended by comments with a high count of 100. This is both consistent with our other objectives and as a high number indicates a particular benefit to the provider as well as increasing the likelihood that factors align for the ordering provider to need the image.

Comment: Commenters stated that the use of the term “scan” is confusing and unnecessary. Scan frequently applies to actions and concepts other than certain types of imaging procedures.

Response: We agree that the term scan has multiple uses, as any scan would be an image and could be classified as a test. Therefore, we remove the word scan from the measure as duplicative.

After reviewing the comments, we modify the measure for EPs at § 495.6 (k)(1)(ii) and for eligible hospitals and CAHs at § 495.6(m)(2)(ii) to: More than 10 percent of all tests whose result is one or more images ordered by the EP or by an authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) during the EHR reporting period are accessible through CEHRT.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(12).

To calculate the percentage, CMS and ONC have worked together to define the following for this measure:

  • Denominator: Number of tests whose result is one or more images ordered by the EP or by an authorized provider on behalf of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 and 23) during the EHR reporting period.
  • Numerator: The number of results in the denominator that are accessible through CEHRT.
  • Threshold: The resulting percentage must be more than 10 percent in order to meet this measure.
  • Exclusion: Any EP who orders less than 100 tests whose result is an image during the EHR reporting period; or

Any EP who has no access to electronic imaging results at the start of the EHR reporting period.

No access means that none of the imaging providers used by the EP provide electronic images and any explanation or other accompanying information that are accessible through their CEHRT at the start of the EHR reporting period.

We solicited comments on a potential second measure for this objective that would encourage the exchange of imaging and results between providers. We considered a threshold of 10 percent of all scans and tests whose result is one or more images ordered by the EP or by an authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) during the EHR reporting period and accessible through CEHRT also be exchanged with another provider of care.

Comment: While most commenters agree with the principle of exchange of images among providers of care, they nearly all agreed that this measure would be premature for Stage 2 due to infrastructure concerns. Some suggested that it be considered for Stage 3 as a logical next step from our proposed Stage 2 measure.

Response: Given the comments, we are not including this measure in our final rule. We will consider the input provided when we develop our proposal for Stage 3.

Proposed Objective: Record patient family health history as structured data

In the proposed rule, we noted that every provider currently requests a family health history from the patient in order to obtain it. However, EHRs can allow the patient to contribute directly to the record and allow the record to be shared among providers, thereby greatly increasing the efficiency of collecting family health histories. Family health history is a major risk indicator for a variety of chronic conditions for which effective screening and prevention tools are available.

Comment: Commenters generally supported the inclusion of recording family health history as a menu set measure for EPs, eligible hospitals and CAHs, while some suggested deferring the measure until Stage 3 when they expect more robust standards will be available. Some commenters also suggested family health history is best collected by primary care physicians, not hospitals. Others still suggested modifying this objective to allow for the use of unstructured data.

Response: ONC has adopted standards requiring CEHRT to be able to use SNOMED-CT or the HL7 Pedigree standard to record a patient's family health history. We refer readers to ONC's standards and certification criteria final rule that is published elsewhere in this issue of the Federal Register. As a readily available standard is being adopted, we are maintaining this objective as proposed and including it in the menu set. We continue to believe that family history is part of regular physician and hospital workflow—even if it's collected at a very high level. While it may primarily be the physicians working in the hospital that consider this information, these same physicians typically use the hospital EHR when evaluating their hospitalized patients so having this information in the hospital EHR is just as important as having it in the physician's own EHR. We will also finalize the exclusion for EPs who have no office visits during the EHR reporting period to account for scope of practice concerns and the common collection of this information directly from patients.

After consideration of public comments, we are finalizing this objective for EPs at § 495.6 (k)(2)(i) and for eligible hospitals and CAHs at § 495.6(m)(3)(i) as proposed.

Proposed Measure: More than 20 percent of all unique patients seen by the EP, or admitted to the eligible hospital or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have a structured data entry for one or more first-degree relatives.

We proposed to adopt the definition of first degree relative used by the National Human Genome Research Institute of the National Institutes of Health. A first degree relative is a family member who shares about 50 percent of their genes with a particular individual in a family. First degree relatives include parents, offspring, and siblings. We considered other definitions, including those that address both affinity and consanguinity relationships and encourage comments on this definition. We noted that this is a minimum and not a limitation on the health history that can be recorded. We did not propose a time limitation on the indication that the family health history has been reviewed. The recent nature of this capability in EHRs will impose a de facto limitation on review to the recent past.

We proposed an exclusion to this measure for EPs who have no office visits during the EHR reporting period. We believe that EPs who do not have office visits will not have the face-to-face contact with patients necessary to obtain family health history information.

Comment: Many commenters wondered why recording family health history was limited to first-degree relatives. They noted that a patient's grandparents or other relatives may have equally relevant medical information that should be included in the EHR. Other commenters pointed out that not all patients may know their family health history, particularly patients who were adopted, and suggested including a code for “unknown” or “not relevant.” They noted that in some cultures, the patient may not be willing to provide the data or that the data they have may be unreliable (such as informal adoptions in Native American tribes).

Response: While information about second degree relatives may be useful for some diagnoses and conditions, we believe collecting medical history from first degree relatives is the floor, not the ceiling and encourage providers to collect additional information as they see fit. Additionally, we understand concerns about patients who may not know their family history. In these situations, we would find it acceptable for the provider to record the patient's family history as “unknown.” Either a structured data entry of “unknown” or any structured data entry identified as part of the patient's family history and conforming to the standards of CEHRT at 45 CFR 170.314(a)(13) must be in the provider's CEHRT for the patient to count in the numerator.

Comment: Some commenters suggested we introduce this measure with a lower threshold as this is a new requirement, but did not specify a threshold. They noted that providers who might have previously captured family history might not have that in a structured format or not coded against the standards chosen for CEHRT. This history would have to be redocumented.

Response: We proposed a low threshold of 20 percent. As this measure is not reliant on other organizations and providers the way imaging is we do not believe that is necessary to lower the threshold further.

Comment: Some commenters suggested this measure may not apply to certain specialty providers (for example, Urgent Care, Orthopedics) and suggested including an exclusion.

Response: We proposed an exclusion to this measure for EPs who have no office visits during the EHR reporting period. We continue to believe that EPs who do not have office visits would not have the face-to-face contact with patients necessary to obtain family health history information. However, this exclusion may not apply to certain specialty providers (like the aforementioned). We continue believe that recording family health history, regardless of specialty, is can be an important indicator for chronic conditions. Additionally, as this measure is being finalized as part of the menu set, providers are not required to report on this objective.

After consideration of public comments, we are finalizing the measure for EPs at § 495.6(k)(2)(ii) and for eligible hospitals and CAHs at § 495.6(m)(3)(ii) to “More than 20 percent of all unique patients seen by the EP, or admitted to the eligible hospital or CAH's inpatient or emergency department (POS 21 or 23), during the EHR reporting period have a structured data entry for one or more first-degree relatives”.

We are finalizing the exclusion as proposed at § 495.6(k)(2)(iii).

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(13).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

• Denominator: Number of unique patients seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency departments (POS 21 or 23) during the EHR reporting period.

• Numerator: The number of patients in the denominator with a structured data entry for one or more first-degree relatives.

• Threshold: The resulting percentage must be more than 20 percent in order to meet this measure.

• Exclusion: Any EP who has no office visits during the EHR reporting period.

Proposed EP Objective: Capability to identify and report cancer cases to a state cancer registry, except where prohibited, and in accordance with applicable law and practice.

We outlined the following benefits of this objective in the proposed rule. Reporting to cancer registries by EPs would address current underreporting of cancer, especially certain types. In the past most cancers were diagnosed and/or treated in a hospital setting and data were primarily collected from this source. However, medical practice is changing rapidly and an increasing number of cancer cases are never seen in a hospital or are cared for primarily in the outpatient setting. Data collection from EPs presents new challenges since the infrastructure for reporting is less mature than it is in hospitals. Certified EHR technology can address this barrier by identifying reportable cancer cases and treatments to the EP and facilitating electronic reporting either automatically or upon verification by the EP.

We proposed to include “except where prohibited and in accordance with applicable law and practice” because we want to encourage all EPs to submit cancer cases, even in rare cases where they are not required to by state/local law. Legislation requiring cancer reporting by EPs exists in 49 states with some variation in specific requirements, per the 2010 Council of State and Territorial Epidemiologists (CSTE) State Reportable Conditions Assessment (SRCA) (http://www.cste.org/dnn/ProgramsandActivities/PublicHealthInformatics/StateReportableConditionsQueryResults/tabid/261/Default.aspx).” If EPs are authorized to submit, they should do so even if it is not required by either law or practice.” In accordance with applicable law and practice” reflects that some public health jurisdictions may have unique requirements for reporting, and that some may not currently accept electronic provider reports. In the former case, the proposed criteria for this objective would not preempt otherwise applicable state or local laws that govern reporting. In the latter case, eligible professionals would be exempt from reporting.

Comment: Nearly all commenters who wrote in support of the objective stated that the rule would decrease reporting burden for EPs because cancer diagnosis reporting in mandatory in most states. One commenter noted that the rule may increase compliance with mandatory reporting by reducing time and effort needed to submit cancer diagnosis report. Also, it was noted that incorporation of cancer reporting in meaningful use Stage 2 for eligible providers will improve completeness and quality of cancer reporting. Conversely, several of the commenters who recommended moving the objective to Stage 3 or remove the objective completely stated that inclusion of this object would place undue burden on EPs, especially because primary care providers rarely report to cancer registries. A commenter noted that the necessary EHR functionality currently exists primarily in oncology specialty EHRs, and EPs may be required to purchase additional modules to meet this object, and further states that this would be cost-prohibitive to EPs who only rarely diagnose cancer. One commenter suggested that the detailed reporting requirements would be too time-consuming for most EPs. Another commenter questions if responsibility for reporting cases, or presumptive cases, would shift to primary care providers. Other commenters suggest that the objective should be removed until such time that a national central repository can be established to simplify point-to-point connections.

Response: We agree that inclusion of this requirement is likely to reduce reporting burden for those already required to report to cancer registries. We also agree with commenters that this objective is not relevant to all providers. For those EPs who do not meet the proposed exclusion of not diagnosing or directly treating cancer, yet are not already under a requirement to report to cancer registries, we note that this is a menu objective and can be deferred. Between the proposed exclusions and the option to defer, we do not believe the measure imposes a reporting burden on providers who would not normally report to cancer registries.

Comment: The objectives of specialized registries and cancer registries reporting should be combined.

Response: In review of comments we found no compelling reason to change our proposal. No commenter disputed that the reporting to cancer registries has different level of existing reporting requirements and supporting standards than other specialized registries.

Comment: One commenter suggested changing the final rule to read, “public health central cancer registry” to clearly distinguish them from hospital-based cancer registries.

Response: We agree that the term public health central cancer registry is better than just cancer registries and more inclusive than just state cancer registries as used in the proposed objective, but not the proposed measure.

After consideration of the public comments received, we are modifying this objective for EPs at § 495.6 (k)(4)(i) to “Capability to identify and report cancer cases to a public health central cancer registry, except where prohibited, and in accordance with applicable law and practice.”

Proposed EP Measure: Successful ongoing submission of cancer case information from CEHRT to a cancer registry for the entire EHR reporting period.

Comment: Commenters are concerned that under the proposed menu set providers will be required to choose one of: (1) Syndromic surveillance; (2) submitting to cancer registries; or (3) submitting to specialty registries if they do not meet the exclusions for all three. The commenters believe that CMS should be providing physicians with a legitimate selection of menu set measures from which to choose.

Response: Stage 2 does contain a more specialized and smaller menu set than Stage 1. We see this as a natural result of moving up the staged path towards improved outcomes. We also see it as necessary for meaningful use to be applicable to all EPs. We use exclusions to ensure that only those EPs who create reportable data have the obligation under meaningful use to report it so this would not be a barrier to meeting meaningful use. Furthermore, we added an objective to the menu set in this final rule for EPs so it is no longer true that an EP would be required to pick one of the three menu objectives mentioned by commenters.

After consideration of the public comments received, we are modifying this measure for EPs at § 495.6 (k)(4)(ii) to “Successful ongoing submission of cancer case information from CEHRT to a public health central cancer registry for the entire EHR reporting period” and modify the exclusions to conform with the general criteria for public health objectives.

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT 45 CFR 170.314(a), (c)(l), (f)(5), and (f)(6).

  • Exclusions: Any EP that meets at least 1 of the following criteria may be excluded from this objective: (1) The EP does not diagnose or directly treat cancer; (2) the EP operates in a jurisdiction for which no public health agency is capable of receiving electronic cancer case information in the specific standards required for CEHRT at the beginning of their EHR reporting period; (3) the EP operates in a jurisdiction where no PHA provides information timely on capability to receive electronic cancer case information; (4) the EP operates in a jurisdiction for which no public health agency that is capable of receiving electronic cancer case information in the specific standards required for CEHRT at the beginning of their EHR reporting period can enroll additional EPs.

Proposed EP Objective: Capability to identify and report specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice.

In the proposed rule, we outlined the following benefits of this objective. We believe that reporting to registries is an integral part of improving population and public health. The benefits of this reporting are not limited to cancer reporting. We include cancer registry reporting as a separate objective because it is more mature in its development than other registry types, not because other reporting is excluded from meaningful use. We have included this objective to provide more flexibility in the menu objectives that EPs can choose. We believe that specialized registry reporting could provide many EPs with meaningful use menu option that is more aligned with their scope of practice.

Comment: The overwhelming majority of individuals and groups who commented on this objective expressed concern about the lack of specificity of this objective. Their concerns include: (1) Lack of specificity of the potential types of registries make planning for vendors and EPs very difficult; (2) lack of information about who would define which registries may be included; (3) leaving dozens or hundreds of possibilities; (4) lack of clarity as to the definition of 'specialized registry; (5) lack of standards for many registries; (6) or potential of needing to comply with standards not identified in the proposed rule; and (7) lack of public health readiness to accept data from EHRs.

Response: The purpose of this objective and measure is to give meaningful use credit to those EPs who are engaged in ongoing submission with specialized registries. It is not expected that every EP will select this objective and measure from the menu nor even that every EP will have the capability to submit to a specialized registry. We are purposefully general in our description of specialized registry because we do not wish to exclude certain registries in an attempt to be more specific. The only limitation we place on our description of specialized registries is that the specialized registry cannot be duplicative of any of the other registries included in other meaningful use objectives and measures. This means that an EP cannot meet the immunization, syndromic surveillance or cancer objectives and this objective by reporting to the same registry. EPs who either do not wish to participate with a specialized registry or cannot overcome the barriers to doing so can defer or exclude this measure as their situation warrants.

Comment: Commenters expressed support for expansion of the requirement to streamline and improve surveillance of healthcare-associated infections (HAIs), with the goal of improving patient care and safety.

Response: A registry that is focused on healthcare associated infections could certainly be considered a specialized registry.

After consideration of the public comments received, we are finalizing this objective for EPs at § 495.6 (k)(5)(i) as proposed.

Proposed EP Measure: Successful ongoing submission of specific case information from CEHRT to a specialized registry for the entire EHR reporting period.

Comment: Since the lack of specificity and named standards make it difficult to select this measure from the menu set, the actual viable measures available in the menu set are reduced to four and burdensome for providers who may need to pay for interfaces, costing the EPs extra time and money above the cost of the CEHRT.

Response: Stage 2 does contain a more specialized and smaller menu set than Stage 1. We see this as a natural result of moving up the staged path towards improved outcomes. We also see it as necessary for meaningful use to be applicable to all EPs. We include exclusions that allow for those providers who do not create reportable data so every provider who would is required to report public health data would have public health data to report. Furthermore, we added an objective to the menu in this final rule for EPs so it is no longer true that an EP would be required to pick one of the three menu objectives. The purpose of this measure is to provide meaningful use credit to those providers engaged in the beneficial use of CEHRT of participating in specialized registries. Other EPs can either meet the exclusions or defer this objective and thereby avoid the burden of compliance with this objective.

Comment: Given the large number of specialized registries, many of which have national scope, the exclusions are rendered meaningless.

Response: We agree with this comment, and for purposes of the exclusion only, we limit it to registries sponsored by national specialty societies and specialized registries maintained by PHAs. We believe this provides needed limitations on the exclusions. This limitation does not apply to the specialized registries that can be used to satisfy the measure as the benefits are not limited only to reporting to registries operated by Public Health Agencies or national medical specialty organizations. Specialized registries operated by patient safety organizations and quality improvement organizations also enable knowledge generation or process improvement regarding the diagnosis, therapy and prevention of various conditions that affect a population.

After consideration of the public comments received, we are finalizing this measure for EPs at § 495.6 (k)(5)(ii) as proposed, but we modify the exclusions to conform with the general criteria for public health objectives and in response to comments.

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT 45 CFR 170.314(f)(5) and (f)(6).

• Exclusions: Any EP that meets at least 1 of the following criteria may be excluded from this objective: (1) The EP does not diagnose or directly treat any disease associated with a specialized registry sponsored by a national specialty society for which the EP is eligible, or the public health agencies in their jurisdiction; (2) the EP operates in a jurisdiction for which no specialized registry sponsored by a public health agency or by a national specialty society for which the EP is eligible is capable of receiving electronic specific case information in the specific standards required by CEHRT at the beginning of their EHR reporting period; (3) the EP operates in a jurisdiction where no public health agency or national specialty society for which the EP is eligible provides information timely on capability to receive information into their specialized registries ; or (4) the EP operates in a jurisdiction for which no specialized registry sponsored by a public health agency or by a national specialty society for which the EP is eligible that is capable of receiving electronic specific case information in the specific standards required by CEHRT at the beginning of their EHR reporting period can enroll additional EPs.

Proposed EP Objective: Use secure electronic messaging to communicate with patients on relevant health information.

In the proposed rule, we outlined the following benefits of using secure electronic messaging to communicate with patients: Electronic messaging (for example, email) is one of the most widespread methods of communication for both businesses and individuals. The inability to communicate through electronic messaging may hinder the provider-patient relationship. Electronic messaging is very inexpensive on a transactional basis and allows for communication even when the provider and patient are not available at the same moment in time. The use of common email services and the security measures that may be used when they are sent may not be appropriate for the exchange of protected health information. Therefore, the exchange of health information through electronic messaging requires additional security measures while maintaining its ease of use for communication. While email with the necessary safeguards is probably the most widely used method of electronic messaging, for the purposes of meeting this objective, secure electronic messaging could also occur through functionalities of patient portals, PHRs, or other stand-alone secure messaging applications.

We proposed this as a core objective for EPs for Stage 2. The additional time made available for Stage 2 implementation made possible the inclusion of some new objectives in the core set as proposed in the proposed rule. We chose to identify objectives that address critical priorities of the country's National Quality Strategy (NQS) (http://www.healthcare.gov/law/resources/reports/quality03212011a.html), with a focus on one for EPs and one for hospitals.

For EPs, secure electronic messaging is critically important to two NQS priorities—

  • Ensuring that each person/family is engaged as partners in their care; and
  • Promoting effective communication and coordination of care.

Secure messaging could make care more affordable by using more efficient communication vehicles when appropriate. Specifically, research demonstrates that secure messaging has been shown to improve patient adherence to treatment plans, which reduces readmission rates. Secure messaging has also been shown to increase patient satisfaction with their care. Secure messaging has been named as one of the top ranked features according to patients. Also, despite some trepidation, providers have seen a reduction in time responding to inquires and less time spent on the phone. We specifically sought comment on whether there may be special concerns with this objective in regards to behavioral health.

Comment: Some commenters noted that patient engagement and enhanced patient-provider communications facilitated by an EHR are important goals, and secure messaging between EPs and patients is an appropriate objective to consider for Meaningful Use criteria.

Response: We appreciate the commenters support of this objective and agree that electronic patient-provider communication is important to improving the overall quality of patient care.

Comment: Some commenters suggested that this objective should be part of the menu set instead of a core objective for Stage 2. This would permit EPs who do not believe they can meet the measure at this time to select different objectives.

Response: As we noted in the proposed rule, we placed this objective in the core because we believe it addresses critical priorities of the country's National Quality Strategy (NQS) (http://www.healthcare.gov/law/resources/reports/quality03212011a.html): Ensuring that each person/family is engaged as partners in their care; and promoting effective communication and coordination of care. We also believe that secure messaging could make care more affordable by using more efficient communication vehicles when appropriate. Specifically, research demonstrates that secure messaging has been shown to improve patient adherence to treatment plans, which reduces readmission rates (see Rosenberg SN, Shnaiden TL, Wegh AA, Juster IA (2008) “Supporting the patient's role in guideline compliance: a controlled study” American Journal of Managed Care 14(11):737-44; Gustafson DH, Hawkins R, Boberg E, Pingree S, Serlin RE, Graziano F, Chan CL (1999) “Impact of a patient-centered, computer-based health information/support system” American Journal of Preventive Medicine 16(1):1-9). Secure messaging has also been shown to increase patient satisfaction with their care (see Ralston JD, Carrell D, Reid R, Anderson M, Moran M, Hereford J (2007) “Patient Web services integrated with a shared medical record: patient use and satisfaction” Journal of the American Medical Informatics Association 14(6):798-806). Therefore, we are leaving this as a core objective for EPs for Stage 2.

Comment: Several commenters responded to our question about whether there were special concerns about implementing this objective for behavioral health patients. These commenters indicated that they did not believe this objective posed a special concern and that it would help behavioral health patients obtain needed support from clinicians.

Response: We appreciate the feedback from commenters regarding behavioral health.

After consideration of the public comments, we are finalizing the meaningful use objective for EPs at § 495.6(j)(17)(i) as proposed.

Proposed EP Measure: A secure message was sent using the electronic messaging function of CEHRT by more than 10 percent of unique patients seen by the EP during the EHR reporting period.

Comment: Many commenters voiced objections to the measure of this objective and the concept of providers being held accountable for patient actions. The commenters believed that while providers could be held accountable for making electronic messaging capabilities available to patients and encouraging patients to use electronic messaging, they could not control whether patients actually utilized electronic messaging. However, some commenters believed that the measure was a reasonable and necessary step to require vendors to make electronic messaging tools more widely available and for providers to incorporate electronic messaging into clinical practice. In addition, commenters pointed to the unique role that providers can play in encouraging and facilitating their patients' and their families' use of secure messaging.

Response: While we recognize that EPs cannot directly control whether patients use electronic messaging, we continue to believe that EPs are in a unique position to strongly influence the technologies patients use to improve their own care, including secure electronic messaging. We believe that EPs' ability to influence patients coupled with the low threshold make this measure achievable for all EPs.

Comment: Other commenters did not object to the principle of providers being held accountable for patient actions but noted that the potential barriers of limited internet access, computer access, and electronic messaging platforms for certain populations (for example, rural, elderly, lower income, visually impaired, non-English-speaking, etc.) might make the measure impossible to meet for some providers. Commenters suggested a number of possible solutions to allow providers to overcome these barriers: granting exclusions for certain patient populations, lowering the proposed threshold of the measure, or eliminating the percentage threshold of the measure.

Response: We recognize that certain patient populations face greater challenges in utilizing electronic messaging. We address the potential barrier of limited internet access in the comment regarding a broadband exclusion below. While we agree that excluding certain patient populations from this requirement would make the measure easier for EPs to achieve, we do not know of any reliable method to quantify these populations for each EP in such a way that we could standardize exclusions for each population. In addition, we are concerned that blanket exclusions for certain disadvantaged populations could serve to extend existing disparities in electronic access to health information. We also decline to eliminate the percentage threshold of this measure because we do not believe that a simple yes/no attestation for implementation of electronic messaging is adequate to encourage a minimum level of patient usage. However, in considering the potential barriers faced by these patient populations, we agree that it would be appropriate to lower the proposed threshold of this measure to more than 5 percent of unique patients sending an electronic message. We believe that this lower threshold, combined with the broadband exclusion detailed in the response below, will allow all EPs to meet the measure of this objective.

Comment: Several commenters suggested that the exclusion for FCC-recognized areas with under 50 percent broadband availability, which was proposed in the objective to “Provide patients the ability to view online, download, and transmit their health information,” should be extended to the electronic messaging objective.

Response: We agree that the infrastructure required for electronic messaging is similar to the infrastructure required for successful usage of an online patient portal as described in the objective to “Provide patients the ability to view online, download, and transmit their health information.” Therefore, we believe an exclusion to this measure based on the availability of broadband is appropriate and are finalizing the exclusion in the language below. We note that since publication of our proposed rule the Web site has changed to www.broadbandmap.gov and the speed used has changed from 4Mbps to 3Mbps. We updated our exclusion.

Comment: Some commenters expressed concern about including all patients seen by the EP in the denominator and suggested limiting the denominator instead to patients who have indicated secure electronic messaging as their communication preference. Other commenters suggested the denominator should not be limited to patients seen by the EP and should also include patients who make inquiries or who attempt to make an appointment with the EP during the reporting period.

Response: We do not agree that limiting the denominator to patients who have indicated secure electronic messaging as their communication preference is appropriate. The purpose of the measure is for EPs to promote wider use of electronic messaging as a regular communication vehicle for their patients, and we are concerned that limiting the denominator in the manner suggested would not lead to an increase in the promotion or usage of electronic messaging as an important communication vehicle between patients and providers. We also do not agree that expanding the denominator to patients not seen by the EP during the reporting period is appropriate. Another purpose of the measure is for secure messaging to include clinically relevant information, and we do not believe that patients seeking introductory information or making an appointment are likely to include clinically relevant information in secure messaging.

Comment: Some commenters noted that patients whose only office visit with an EP occurs near the end of the reporting period might not be able to send an electronic message in time to be included in the numerator of the measure.

Response: While we agree that patients with a single office visit near the end of the reporting period may not utilize electronic messaging and be eligible for inclusion in the numerator of the measure during the EHR reporting period, we believe that the threshold of this measure will be sufficiently low to permit EPs to meet the measure even without the participation of these patients.

Comment: Several commenters requested clarification on the definition of a secure message.

Response: We define a secure message as any electronic communication between a provider and patient that ensures only those parties can access the communication. This electronic message could be email or the electronic messaging function of a PHR, an online patient portal, or any other electronic means. However, we note that the secure message also must use the electronic messaging function of CEHRT in order to qualify for the measure of this objective.

Comment: Some commenters suggested that EPs or patients should be permitted to use an electronic messaging function that is not part of CEHRT in order to meet the measure.

Response: We believe that allowing patients to use multiple electronic messaging functions in order to communicate with the provider under this measure could create confusion for the EP and potentially lead to electronic messages that are missed or not responded to. We also believe that by encouraging patients to use the electronic messaging function that is part of CEHRT EPs can better ensure that electronic messages are sent securely to protect patient's health information. Finally, we are concerned that CEHRT would not be able to track electronic messaging that is not part of the EHR, which would place an extra burden for reporting on EPs in meeting this measure. For all of these reasons, we require that patients use the electronic messaging function that is part of CEHRT in order to be included in the measure of this objective.

Comment: Commenters agreed with our decision not to include in the definition for this measure “relevant health information.” Commenters did not believe CEHRT could support the categorization of electronic messages in a way that would satisfy such a requirement.

Response: We appreciate the support offered by commenters. As we stated in the proposed rule, the secure messages sent should contain relevant health information specific to the patient in order to meet the measure of this objective. We believe the EP is the best judge of what health information should be considered relevant in this context. We do not specifically include the term “relevant health information” in the measure because we believe the provider is best equipped to determine whether such information is included. We agree that it would be too great a burden for CEHRT to determine whether the information in the secure message has such information.

Comment: Some commenters expressed concerns that we did not propose to measure provider response to patient electronic messaging. These commenters believed that the proposed measure places too much focus on patient messaging and should instead focus on communication between patient and provider. Some commenters suggested that the measure be modified for responsiveness of an EP or staff to patient messaging rather than the proposed percentage of patients who send a secure message.

Response: As we stated in the proposed rule, there is an expectation that the EP would respond to electronic messages sent by the patient, although we do not specify the method of response or require the EP to document his or her response for this measure. We decline to specify the method of provider response because we believe it is best left to the provider's clinical judgment to decide the course of action which should be taken in response to the patient's electronic message. An EP or staff member could decide that a follow-up telephone call or office visit is more appropriate to address the concerns raised in the electronic message. Therefore, we decline to alter the measure to include provider response.

Comment: Commenters asked for clarification as to whether the EP had to respond personally to electronic messaging or whether members of the EP's staff could respond. Commenters also asked for clarification regarding whether or not messages sent by a patient-authorized representative would be recorded in this measure.

Response: There is not an expectation that the EP must personally respond to electronic messages to the patient. Just as an EP's staff respond to telephone inquiries or conduct office visits on behalf of the EP, staff could also respond to electronic messages from the patient. We also intend for electronic messages sent by a patient-authorized representative to be included in the measure of this objective and have modified the language of the measure below accordingly.

Comment: Some commenters raised concerns regarding the security of electronic messaging, specifically citing instances where family members might have access to the patient's account or elderly patients who would not know how to use a computer and would have to give account access to a caregiver. Other commenters raised concerns regarding their liability in providing access to such information or in responding to an electronic message.

Response: We do not believe that secure electronic messaging poses greater risks to exposure of protected health information than other mediums such as telephone messaging, paper records, etc. In some cases secure electronic messaging can provide even greater protection of health information. We note that many patients grant access to health information to family members and caregivers to facilitate care, and we expect the same access to continue with secure electronic messaging. Nor do we believe that secure electronic messaging exposes providers to greater liability (for example, in areas of privacy protection or malpractice) than other mediums such as telephone, mail, paper records, etc. Previous research has demonstrated that better patient-provider communication reduces the likelihood of malpractice claims being filed.

Comment: Some commenters noted that the potential financial burden of implementing securing messaging as a part of their clinical or administrative workflow. These commenters noted that EPs are not reimbursed for the time spent responding to electronic messages and that it can be time consuming for an EP to have multiple exchanges with a patient via email.

Response: We do not believe that implementing electronic messaging imposes a significant burden on providers. While we note that in some scenarios it may be possible for an EP to receive reimbursement from private insurance payers for online messaging, we acknowledge that EPs are generally not reimbursed for time spent responding to electronic messaging. However, it is also true that EPs are generally not reimbursed for other widely used methods of communication with patients (for example, telephone). As we noted in the proposed rule, many providers have seen a reduction in time responding to inquires and less time spent on the phone through the use of electronic messaging. In addition, we note that EPs themselves do not have to respond to electronic messages personally and can delegate this task to staff, just as many EPs currently delegate telephone exchanges with patients to staff.

After consideration of the public comments, we are finalizing the meaningful use measure for EPs as “A secure message was sent using the electronic messaging function of CEHRT by more than 5 percent of unique patients (or their authorized representatives) seen by the EP during the EHR reporting period” at § 495.6(j)(17)(ii) and the exclusion for EPs as “Any EP who has no office visits during the EHR reporting period, or any EP who conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 3Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period” at § 495.6(j)(17)(iii).

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT at 45 CFR 170.314(e)(3).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

• Denominator: Number of unique patients seen by the EP during the EHR reporting period.

  • Numerator: The number of patients or patient-authorized representatives in the denominator who send a secure electronic message to the EP that is received using the electronic messaging function of CEHRT during the EHR reporting period.
  • Threshold: The resulting percentage must be more than 5 percent in order for an EP to meet this measure.
  • Exclusion: Any EP who has no office visits during the EHR reporting period, or any EP who conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 3Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period.

Proposed Eligible Hospital/CAH Objective: Automatically track medications from order to administration using assistive technologies in conjunction with an electronic medication administration record (eMAR).

In the proposed rule, we outlined the following benefits of automatically tracking medications with eMAR: eMAR increases the accuracy of medication administration thereby increasing both patient safety and efficiency. The HIT Policy Committee has recommended the inclusion of this objective for hospitals in Stage 2, and we proposed this as a core objective for eligible hospitals and CAHs. The additional time made available for Stage 2 implementation makes possible the inclusion of some new objectives in the core set. eMAR is critically important to making care safer by reducing medication errors which may make care more affordable. eMAR has been shown to lead to significant improvements in medication-related adverse events within hospitals with associated decreases in cost. eMAR cuts in half the adverse drug event (ADE) rates for non-timing medication errors, according to a study published in the New England Journal of Medicine (Poon et al., 2010, Effect of Bar-Code Technology on the Safety of Medication Administration http://www.nejm.org/doi/abs/10.1056/NEJMsa0907115?query=NC). A study done to evaluate cost-benefit of eMAR (Maviglia et al., 2007, Cost-Benefit Analysis of a Hospital Pharmacy Bar Code Solution http://archinte.ama-assn.org/cgi/content/full/167/8/788) demonstrated that associated ADE cost savings allowed hospitals to break even after 1 year and begin reaping cost savings going forward.

We proposed to define eMAR as technology that automatically documents the administration of medication into CEHRT using electronic tracking sensors (for example, radio frequency identification (RFID)) or electronically readable tagging such as bar coding). The specific characteristics of eMAR for the EHR Incentive Programs will be further described in the ONC standards and certification criteria final rule published elsewhere in this issue of the Federal Register.

By its very definition, eMAR occurs at the point of care so we did not propose additional qualifications on when it must be used or who must use it.

Comment: Some commenters suggested that this should be a menu objective for Stage 2.

Response: As we stated in the proposed rule, we believe that eMAR is critically important to making care safer by reducing medication errors which may also make care more affordable. eMAR has been shown to lead to significant improvements in medication-related adverse events within hospitals with associated decreases in cost. Therefore, we believe that the benefits to patient safety from eMAR warrant the inclusion of this as a Stage 2 core objective for eligible hospitals and CAHs.

After consideration of the public comments, we are finalizing the meaningful use objective for eligible hospitals and CAHs at § 495.6(l)(16)(i) as proposed.

Proposed Eligible Hospital/CAH Measure: More than 10 percent of medication orders created by authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period are tracked using eMAR.

Comment: A number of commenters questioned whether the measure should apply to at least one instance of the administration of a dose connected with a medication order or whether each individual dose connected with a medication order should be included in the measure. Some commenters believed that a single instance of administration of a dose should constitute fulfillment of the measure, while others believed that all doses administered rather than orders administered would be a more precise and meaningful measurement.

Response: We believe that including each individual dose connected with a medication order through this measure could yield denominators that are very large. However, we believe that the benefits to patient safety from eMAR are seen when all doses of a medication order are tracked. Therefore, we clarify that we include in the numerator of this objective medication orders for which all doses are tracked using eMAR, and we are amending the measure language below to reflect this clarification. If a medication is ordered but not all doses of the medication are tracked using eMAR, then that order may not be included in the numerator of the measure.

Comment: Some commenters raised the concern that certain rural and low volume hospitals might face undue financial burden in implementing this objective and proposed an exclusion for hospitals with either a limited number of inpatient beds or a low average inpatient volume. Some commenters suggested there should be an exclusion for very small hospitals for whom eMAR could be a prohibitively expensive undertaking. Other commenters noted that the difficulties in implementing eMAR were outweighed by the significant benefits to patient safety.

Response: We agree with commenters who suggested that the potential benefits to patient safety of eMAR are significant. While we agree that certain hospitals may face challenges in implementing eMAR on a wider scale, we believe that the low threshold for this measure lessens the burden associated with implementation of eMAR for most rural and low volume hospitals. We also note that CEHRT will include eMAR capabilities, so the primary barrier to implementation for most hospitals will be workflow.

However, we are also concerned that very small hospitals may have local technical support and training issues that may make an automated eMAR solution actually less effective than other approaches. We also believe that very small hospitals will have fewer health care professionals involved in the process of medication administration and fewer patients for whom duplicative orders could present an issue, which would also make an eMAR solution less effective. Therefore, we believe these hospitals would not benefit from eMAR as much as larger facilities and are finalizing an exclusion for these hospitals. Any hospital with an average daily inpatient census of fewer than 10 patients may be excluded from meeting the measure of this objective. For purposes of this exclusion, we define an average daily inpatient census as the total number of patients admitted during the previous calendar year divided by 365 (or 366 if the previous calendar year is a leap year).

Comment: Some commenters stated that the percentage threshold of this measure should be replaced with the implementation of eMAR in one ward or unit of the hospital to limit burdensome measurement requirements. Other commenters argued that changing the measure to one ward or unit of the hospital would introduce ambiguity regarding what constitutes a ward or unit, while a percentage threshold would allow hospitals the flexibility to implement eMAR capabilities on a limited basis.

Response: We believe that the low threshold of this objective does not impose burdensome measurement requirements on hospitals, especially since we do not anticipate a significant difference in the way CEHRT will measure eMAR usage regardless of where it is implemented. We agree that limiting the measure to implementation in a single ward or unit could introduce ambiguity regarding the precise definition of ward or unit, especially since some hospitals combine the locations and workflows of certain units. We further note that the percentage threshold does allow hospitals to implement eMAR in a limited capacity, and that a hospital could potentially meet the low measure of this objective by implementing in a single ward or unit or by implementing in several smaller wards or units that combine to yield more than 10 percent of medication orders created during the EHR reporting period. We believe the percentage measure of this objective yields maximum flexibility for a hospital to implement eMAR in a way that is clinically relevant to its individual workflow.

Comment: Some commenters requested clarification on whether eMAR could be implemented solely in portions of an inpatient department or solely in portions of an emergency department in order to meet the measure, as opposed to implementing eMAR in both the inpatient and emergency departments.

Response: As stated previously, we have attempted to provide maximum flexibility for a hospital to implement eMAR in a way that is clinically relevant to its individual workflow. Therefore, we do not require that eMAR is implemented in both inpatient and emergency departments in order to meet this measure, only that more than 10 percent of medication orders created by authorized providers of either the inpatient or emergency department (POS 21 or 23) during the EHR reporting period are tracked using eMAR. Hospitals could implement eMAR in the inpatient department, the emergency department, or both departments in order to meet the threshold of this measure.

After consideration of the public comments, we modify the meaningful use measure as “More than 10 percent of medication orders created by authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period for which all doses are tracked using eMAR” for eligible hospitals and CAHs at § 495.6(l)(16)(ii) and finalize the exclusion as “Any eligible hospital or CAH with an average daily inpatient census of fewer than 10 patients” at § 495.6(l)(16)(iii).

We further specify that in order to meet this objective and measure, an eligible hospital or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(16).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

• Denominator: Number of medication orders created by authorized providers in the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period.

• Numerator: The number of orders in the denominator for which all doses are tracked using eMAR.

• Threshold: The resulting percentage must be more than 10 percent in order for an eligible hospital or CAH to meet this measure.

• Exclusion: Any hospital with an average daily inpatient census of fewer than ten (10) patients.

Proposed Eligible Hospital/CAH Objective: Generate and transmit permissible discharge prescriptions electronically (eRx)

In the proposed rule, we outlined the following benefits of electronic prescribing: The use of electronic prescribing has several advantages over having the patient carry the prescription to the pharmacy or directly faxing a handwritten or typewritten prescription to the pharmacy. When the hospital generates the prescription electronically, CEHRT can recognize the information and can provide decision support to promote safety and quality in the form of adverse interactions and other treatment possibilities. The CEHRT can also provide decision support that promotes the efficiency of the health care system by alerting the EP to generic alternatives or to alternatives favored by the patient's insurance plan that are equally effective. Transmitting the prescription electronically promotes efficiency and safety through reduced communication errors. It also allows the pharmacy or a third party to automatically compare the medication order to others they have received for the patient. This comparison allows for many of the same decision support functions enabled at the generation of the prescription, but bases them on potentially greater information.

We have combined the comments and responses for this objective with the measure below. After consideration of the public comments, we are finalizing the meaningful use objective for eligible hospitals and CAHs at § 495.6(m)(4)(i) as proposed.

Proposed Eligible Hospital/CAH Measure: More than 10 percent of hospital discharge medication orders for permissible prescriptions (for new or changed prescriptions) are compared to at least one drug formulary and transmitted electronically using CEHRT.

Comment: Most commenters voiced support for this as a menu set item, with some commenters noting that the threshold for this measure should remain low for Stage 2 because of the difficulty of using electronic prescribing for all prescriptions, including controlled substances.

Response: We appreciate the support for this objective, and we note that the measure of the objective for eligible hospitals and CAHs for Stage 2 is set at more than 10 percent of all discharge medication orders for permissible prescriptions. We believe this sets a sufficiently low threshold that would allow most hospitals to achieve this measure and eliminates the inclusion of controlled substances, which are not included as permissible prescriptions for the purposes of this measure.

Comment: Most commenters noted that distinguishing new and altered prescriptions from refills would be unnecessarily burdensome for hospitals.

Response: Although we had initially proposed to limit this measure to only new and altered prescriptions because we believed that hospitals would not issue refill prescriptions, we agree with the commenters that distinguishing refills from new and altered prescriptions could be unnecessarily burdensome for hospitals. Therefore, we are not imposing this limitation and include new, altered, and refill prescriptions in the measure of discharge medication orders for permissible prescriptions.

Comment: Some commenters expressed concerns about patient requests for paper prescriptions instead of electronic prescriptions.

Response: We believe that the more than 10 percent of discharge medication orders threshold is sufficiently low to accommodate patient requests for paper prescriptions and still allow most, if not all, hospitals to meet the measure of this objective.

Comment: Some commenters asked whether prescriptions electronically transmitted to in-house pharmacies should be included in the measure and if the standards specified by ONC for this measure would apply to these transmissions.

Response: We are continuing the policy from Stage 1 that prescriptions transmitted electronically within an organization (the same legal entity) would be counted in the measure and would not need to use the standards specified by ONC for this objective. However, a hospital's CEHRT must meet all applicable certification criteria and be certified as having the capability of meeting external transmission requirements. In addition, the EHR that is used to transmit prescriptions within the organization would need to be CEHRT.

The hospital would include in the numerator and denominator both types of electronic transmission (those within and outside the organization) for the measure of this objective. We further clarify that for purposes of counting discharge prescriptions “generated and transmitted electronically,” we considered the generation and transmission of prescriptions to occur simultaneously if the prescriber and dispenser are the same person and/or are accessing the same record in an integrated EHR to create an order in a system that is electronically transmitted to an internal pharmacy.

Comment: Some commenters asked for clarification regarding whether drug-formulary checks had to be enabled for the entire EHR reporting period, as required by the Stage 1 measure.

Response: No. The Stage 1 objective for drug-formulary checks has been combined with this Stage 2 objective for generating and transmitting permissible discharge prescriptions electronically. Although the measure of the Stage 1 objective required the capability for drug-formulary checks to be enabled for the entire reporting period, the measure of the Stage 2 objective specifies drug-formulary checks should be performed for more than 10 percent of hospital discharge medication orders for permissible prescriptions. We recognize that not every patient will have a formulary that is relevant for him or her. Therefore, we require not that the EHR check each prescription against a formulary relevant for a given patient, but rather that the EHR check each prescription for the existence of a relevant formulary. If a relevant formulary is available, then the information can be provided. We believe that this initial check is essentially an on or off function for the EHR and should not add to the measurement burden. Therefore, with this clarification of the check we are referring to, we are finalizing the drug formulary check as a component of this measure. We look forward to the day when a relevant formulary is available for every patient. We modified the measure to use the word query instead of compare.

Comment: Some commenters asked whether the measure of this objective applied to inpatient departments, emergency departments, or both.

Response: We specify that the measure of this objective applies to medication orders for patients discharged from either the inpatient (POS 21) department, the emergency department, or both the inpatient and emergency departments of an eligible hospital or CAH during the EHR reporting period.

Comment: One commenter asked for clarification of whether a patient for whom no relevant drug formularies are available could be counted in the numerator of the measure if the discharge prescription for that patient is generated and transmitted electronically. Another commenter suggested that patients for whom no relevant formularies are available should not be counted in the measure.

Response: As noted in the proposed rule, we believe that the inclusion of the comparison to at least one drug formulary enhances the efficiency of the healthcare system when clinically appropriate and cheaper alternatives may be available. In the event that a relevant formulary is unavailable for a particular patient and medication combination, a discharge prescription that is generated and electronically transmitted should still be included in the numerator of the measure. We do not agree that prescriptions for patients for whom relevant formularies are unavailable should be excluded from this measure.

Comment: Several commenters believed that the exclusion based on the availability of a pharmacy capable of receiving electronic prescriptions within 25 miles of the hospital's location was not adequate for all areas, particularly rural areas. Some commenters suggested that 10 miles is a more appropriate distance.

Response: We appreciate the commenters' concerns about this exclusion. As stated in the proposed rule, we recognize that certain areas may not have widespread availability of electronic prescribing in all pharmacies, we believe that most hospitals will be able to fulfill electronic prescriptions through an internal pharmacy. However, we agree with commenters that basing the exclusion on a 25-mile radius could place a significant burden on patients to travel to fill prescriptions, especially in rural areas. Therefore, we are finalizing a 10-mile radius at the start of the EHR reporting period. Hospitals that do not have an internal pharmacy and that are located 10 miles from a pharmacy that can receive electronic prescriptions at the start of the EHR reporting period would be able to claim the exclusion for this measure. We also believe that the low threshold of more than 10 percent of discharge prescriptions transmitted electronically would make it possible for all hospitals to meet this measure.

Comment: Some commenters requested for clarification of whether CEHRT would provide the capability to determine the availability of a pharmacy capable of receiving electronic prescriptions within 25 miles of the hospital's location.

Response: CEHRT will not provide the capability to determine whether a hospital meets the exclusion for this measure. As stated in the previous response, we are finalizing the exclusion for the availability of a pharmacy capable of receiving electronic prescriptions within 10 miles of the hospital's location. Therefore, eligible hospitals and CAHs may use their own resources to make a determination regarding the availability of a pharmacy capable of receiving electronic prescriptions within 10 miles of the hospital's location.

After consideration of the public comments, we modify the meaningful use measure for eligible hospitals and CAHs as “More than 10 percent of hospital discharge medication orders for permissible prescriptions (for new, changed, and refilled prescriptions) are queried for a drug formulary and transmitted electronically using CEHRT” at § 495.6(m)(4)(ii) and we modify the exclusion for eligible hospitals and CAHs at § 495.6(m)(4)(iii) by changing the radius from 25 miles to 10 miles.

We further specify that in order to meet this objective and measure, an eligible hospital or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(10) and (b)(3).

To calculate the percentage, CMS and ONC have worked together to define the following for this objective:

• Denominator: Number of new, changed, or refill prescriptions written for drugs requiring a prescription in order to be dispensed other than controlled substances for patients discharged during the EHR reporting period.

• Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary and transmitted electronically.

• Threshold: The resulting percentage must be more than 10 percent in order for an eligible hospital or CAH to meet this measure.

• Exclusion: Any eligible hospital or CAH that does not have an internal pharmacy that can accept electronic prescriptions and is not located within 10 miles of any pharmacy that accepts electronic prescriptions at the start of their EHR reporting period.

Proposed Eligible Hospital/CAH Objective: Provide patients the ability to view online, download, and transmit information about a hospital admission.

In the proposed rule, we noted that studies have found that patients engaged with computer based information sources and decision support show improvement in quality of life indicators, patient satisfaction and health outcomes. (Ralston, Carrell, Reid, Anderson, Moran, & Hereford, 2007) (Gustafson, Hawkins, Bober, S, Graziano, & CL, 1999) (Riggio, Sorokin, Moxey, Mather, Gould, & Kane, 2009) (Gustafson, et al., 2001). In addition, we noted that this objective aligns with the FIPPs, [5] in affording baseline privacy protections to individuals. We stated that we believe this information is integral to the Partnership for Patents initiative and reducing hospital readmissions. While this objective does not require all of the information sources and decision support used in these studies, having a set of basic information available advances these initiatives. The ability to have this information online means it is always retrievable by the patient, while the download function ensures that the patient can take the information with them when secure internet access is not available. However, providers should be aware that while meaningful use is limited to the capabilities of CEHRT to provide online access, there may be patients who cannot access their EHRs electronically because of their disability. Additionally, other health information may not be accessible. Finally, we noted that providers who are covered by civil rights laws must provide individuals with disabilities equal access to information and appropriate auxiliary aids and services as provided in the applicable statutes and regulations.

We proposed this as a core objective for hospitals for Stage 2. We also specified in the proposed rule the information that must be made available as part of the objective, although we noted hospitals could choose to provide additional information (77 FR 13730).

Comment: Some commenters suggested that this objective should be part of the menu set instead of a core objective for Stage 2. This would permit eligible hospitals and CAHs that do not believe they can meet the measure at this time to select different objectives.

Response: We do not agree that this objective should be part of the menu set. We proposed this objective as part of the core for eligible hospitals and CAHs because it is intended to replace the previous Stage 1 core objective of “Provide patients with an electronic copy of their health information upon request” and the Stage 1 core objective of “Provide patients with an electronic copy of their discharge information.” Although CEHRT will provide added capabilities for this objective, we do not believe the objective itself is sufficiently different from previous objectives to justify placing it in the menu set. Also, we believe that patient access to their discharge information is a high priority for the EHR Incentive Programs and this objective best provides that access in a timely manner.

Comment: Some commenters expressed the opinion that this objective should not be included as part of meaningful use and was more appropriately regulated under HIPAA and through the Office for Civil Rights.

Response: We do not agree that this objective should not be included in meaningful use. Although we recognize that many issues concerning the privacy and security of information online are subject to HIPAA requirements, we believe that establishing an objective to provide online access to health information is within the regulatory purview of the EHR Incentive Programs and consistent with the statutory requirements of meaningful use.

After consideration of the public comments, we are finalizing the meaningful use objective for eligible hospitals and CAHs at § 495.6(l)(8)(i) as proposed.

Proposed Eligible Hospital/CAH Measure: There are 2 measures for this objective, both of which must be satisfied in order to meet the objective.

More than 50 percent of all patients who are discharged from the inpatient or emergency department (POS 21 or 23) of an eligible hospital or CAH have their information available online within 36 hours of discharge.

More than 10 percent of all patients who are discharged from the inpatient or emergency department (POS 21 or 23) of an eligible hospital or CAH view, download or transmit to a third party their information during the EHR reporting period.

Comment: A commenter questioned how long data should be made available online before it can be removed.

Response: It is the goal of this objective to make available to the patient both current and historical health information regarding hospital discharges. Therefore, we would anticipate that the data should be available online on an ongoing basis. However, an eligible hospital or CAH may withhold or remove information from online access for purposes of meaningful use if they believe substantial harm may arise from its disclosure online.

Comment: Some commenters asked for clarification on whether online access had to be made available using CEHRT or if the information could be made available through other means (patient portal, PHR, etc.).

Response: Both of the measures for this objective must be met using CEHRT. Therefore, for the purposes of meeting this objective, the capabilities provided by a patient portal, PHR, or any other means of online access and that would permit a patient or authorized representative to view, download, or transmit their personal health information would have to be certified in accordance with the certification requirements adopted by ONC. We refer readers to ONC's standards and certification criteria final rule that is published elsewhere in this issue of the Federal Register.

Comment: Some commenters asked for clarification on how access by the patient is defined.

Response: We define access as having been given when the patient possesses all of the necessary information needed to view, download, or transmit their discharge information. This could include providing patients with instructions on how to access their health information, the Web site address they must visit for online access, a unique and registered username or password, instructions on how to create a login, or any other instructions, tools, or materials that patients need in order to view, download, or transmit their discharge information.

Comment: Some commenters suggested that patients under the age of 18 should not have the same access to the same information to which adult patients have access and requested a separate list of required elements for patients under the age of 18.

Response: An eligible hospital or CAH may decide that online access is not the appropriate forum for certain health information for patients under the age of 18. Within the confines of the laws governing guardian access to medical records for patients under the age of 18, we would defer to the eligible hospital's or CAH's judgment regarding which information should be withheld for such patients. In lieu of providing online access to patients under the age of 18, eligible hospitals or CAHs could provide online access to guardians for patients under the age of 18, in accordance with state and local laws, in order to meet the measure of this objective. Providing online access to guardians in accordance to state and local laws would be treated the same as access for patients, and guardians could then be counted in the numerator of the measure. We recognize that state and local laws may restrict the information that can be made available to guardians, and in these cases such information can be withheld and the patient could still be counted in the numerator of the measure.

Comment: Many commenters voiced objections to the second measure of this objective and the concept of providers being held accountable for patient actions. The commenters believed that while providers could be held accountable for making information available online to patients, providers could not control whether patients actually accessed their information. Many commenters also noted that the potential barriers of limited internet access, computer access, and patient engagement with health IT for certain populations (for example, rural, elderly, lower income, non-English-speaking, etc.) might make the measure impossible to meet for some providers. There were also a number of comments stating that metrics used to track views or downloads can be misleading and are not necessarily the most accurate measure of patient usage. Commenters suggested a number of possible solutions to allow providers to overcome these barriers, including eliminating the percentage threshold of the measure or requiring providers to offer and track patient access but not requiring them to meet a percentage measure in order to demonstrate meaningful use. However, some commenters believed that the measure was a reasonable and necessary step to ensure that providers had accountability for engagement of their patients in use of electronic health information and integration of it into clinical practice. In addition, commenters pointed to the unique role that providers can play in encouraging and facilitating their patients' and their families' use of online tools.

Response: While we recognize that eligible hospitals and CAHs cannot directly control whether patients access their health information online, we continue to believe that eligible hospitals and CAHs are in a unique position to strongly influence the technologies patients use to improve their own care, including viewing, downloading, and transmitting their health information online. We believe that the eligible hospital's or CAH's ability to influence patients coupled with the low threshold of more than 10 percent of patients who view online, download, or transmit to a third party their information make this measure achievable for all eligible hospitals and CAHs.

We recognize that certain patient populations face greater challenges in online access to information. We address the potential barrier of limited internet access in the comment regarding a broadband exclusion below. We address the potential barrier to individuals with disabilities through ONC's rules requiring that EHRs meet disability accessibility standards. While we agree that excluding certain patient populations from this requirement would make the measure easier for eligible hospitals and CAHs to achieve, we do not know of any reliable method to quantify these populations for each eligible hospital and CAH in such a way that we could standardize exclusions for each population. We also decline to eliminate the percentage threshold of this measure because we do not believe that a simple yes/no attestation for this objective is adequate to encourage a minimum level of patient usage. However, in considering the potential barriers faced by these patient populations, we agree that it would be appropriate to lower the proposed threshold of this measure to more than 5 percent of unique patients who view online, download, or transmit to a third party their information. In addition, we are concerned that blanket exclusions for certain disadvantaged populations could serve to extend existing disparities in electronic access to information and violate civil rights laws. All entities receiving funds under this program are subject to civil rights laws. For more information about these laws and their requirements (see http://www.hhs.gov/ocr/civilrights/index.html). We believe that this lower threshold, combined with the broadband exclusion detailed in the response later in this section, will allow all eligible hospitals and CAHs to meet the measure of this objective.

Comment: Some commenters suggested making the numerator and denominator language for this measure consistent with the language used for this measure for EPs.

Response: We agree that there are some slight variations in language between the measure for EPs and the measure for hospitals. To the extent possible, we have harmonized the language between both.

Comment: Some commenters asked for clarification on how view is defined.

Response: We define view as the patient (or authorized representative) accessing their health information online.

Comment: Some commenters noted that the potential financial burden of implementing an online patient portal to provide patients online access to discharge information. These commenters noted the added time burden for staff in handling the additional patient use of online resources, which may increase costs through the hiring of additional staff, as well as the need to modify their existing workflow to accommodate potential online messages from patients. Some commenters also believed that there would be an additional cost for sharing content before standards exist for content types and formats.

Response: As noted in the proposed rule, studies have found that patients engaged with computer based information sources and decision support show improvement in quality of life indicators, patient satisfaction and health outcomes (see Rosenberg SN, Shnaiden TL, Wegh AA, Juster IA (2008) “Supporting the patient's role in guideline compliance: a controlled study” American Journal of Managed Care 14(11):737-44; Gustafson DH, Hawkins R, Boberg E, Pingree S, Serlin RE, Graziano F, Chan CL (1999) “Impact of a patient-centered, computer-based health information/support system” American Journal of Preventive Medicine 16(1):1-9; Ralston JD, Carrell D, Reid R, Anderson M, Moran M, Hereford J (2007) “Patient web services integrated with a shared medical record: patient use and satisfaction” Journal of the American Medical Informatics Association 14(6):798-806). We believe that the information provided as part of this measure is integral to the Partnership for Patents initiative and reducing hospital readmissions. We do not believe that implementing online access for patients imposes a significant burden, financial or otherwise, on providers. While we note that in some scenarios it may be possible for an eligible hospital or CAH to receive reimbursement from private insurance payers for online messaging, we acknowledge that eligible hospitals and CAHs are generally not reimbursed for time spent responding to electronic messaging. However, it is also true that eligible hospitals and CAHs are generally not reimbursed for other widely used methods of communication with patients (for example, telephone). In addition, it will be part of the capability of CEHRT to automatically populate most of the list of required elements to meet this measure, which significantly reduces the administrative burden of providing this information. Finally, we believe that the standards established for this objective by ONC will serve as a content standard that will allow this information to be more easily transmitted and uploaded to another certified EHR, thereby reducing the cost of sharing information.

Comment: Some commenters noted that patient engagement could occur effectively with or without online access, and patients should be encouraged to use any method (for example, telephone, internet, traditional mail) that suits them. These commenters noted that engagement offline reduces both the need and value for engagement online.

Response: We agree that patient engagement can occur effectively through a variety of media, and we also believe that electronic access to discharge information can be an important component of patient compliance and improving longitudinal care. We do not believe that offline engagement reduces the need for online access, as patients may opt to access information in a variety of ways. Because of the variety of ways that patients/families may access information, we keep the threshold for this measure low. Measuring other means of accessing health information is beyond the scope of the EHR Incentive Programs. We also note that online access to health information can enhance offline engagement—for example, patients could download information from a hospital admission to bring with them for a consult on follow-up care—which is one of the primary goals of the EHR Incentive Programs.

Comment: Some commenters expressed concern that vendors would not be able to make these capabilities available as part of CEHRT in time for the beginning of Stage 2.

Response: Many CEHRT vendors already make patient portals available that would meet the certification criteria and standards required for this measure. Although the Stage 2 eligible hospital/CAH measure requires some additional required elements and fields capabilities, we believe vendors will be able to make these capabilities available in time for the beginning of Stage 2.

Comment: Some commenters suggested that basing the exclusion on the broadband data available from the FCC Web site (www.broadband.gov) was suspect since the data originates from vendors.

Response: The broadband data made available from the FCC was collected from over 3,400 broadband providers nationwide. This data was then subject to many different types of analysis and verification methods, from drive testing wireless broadband service across their highways to meeting with community leaders to receive feedback. Representatives met with broadband providers, large and small, to confirm data, or suggest changes to service areas, and also went into the field looking for infrastructure to validate service offerings in areas where more information was needed. Therefore, we believe the data is appropriate for the exclusion to this measure. We note that since publication of our proposed rule the Web site has changed to www.broadbandmap.gov and the speed used has changed from 4Mbps to 3Mbps. We are updating our exclusion to reflect these changes.

Comment: Some commenters believe that broadband exclusions should be based on the patients' locations instead of the providers, since county-level data may not be granular enough to capture all areas of low broadband availability within a particular region.

Response: Although we agree that a broadband exclusion based primarily on the individual locations of each patient seen would be more accurate, we do not believe that there is any method of making this determination for every patient without placing an undue burden on the provider. We continue to believe that limited broadband availability in the eligible hospital's or CAH's immediate practice area, coupled with the low threshold of this measure, adequately serves as an acceptable proxy for determining areas where online access can present a challenge for patients. Therefore, after consideration of the public comments received, we are finalizing the broadband exclusion as proposed.

Comment: Some commenters suggested that the required element of “Problem list maintained by the hospital on the patient” should be made consistent with the required element in the objective of the same name and changed to “Problem list.” Other commenters asked for clarification of “Relevant past diagnoses known by the hospital” and how this element differs from “Problem list.”

Response: We agree that this language should be made standard. By “Relevant past diagnoses known by the hospital” we mean to indicate historical entries in the patient's problem list. Therefore, we are eliminating the “Relevant past diagnoses” element and modifying the problem list element to “Current and past problem list” in the list of required elements below.

Comment: Some commenters suggested that displaying all historical medications for each patient under the required element of “Medication list maintained by the hospital on the patient (both current admission and historical)” would be too burdensome for hospitals. These commenters suggested amending the required element to only the active medication list maintained by CEHRT. They also expressed confusion over the use of the term “current admission” since the information for this measure would be posted after the patient's discharge.

Response: We believe that just as providing a historical problem list for the patient can be useful, so too can providing a historical list of all medications. To clarify the intention of this objective, we are modifying the language in the list of required elements below to read “Active medication list and medication history. Current admission referred to the admission and subsequent discharge that places the patient in the denominator for this measure.

Comment: Some commenters suggested that “Laboratory test results (available at discharge)” could result in a large number of test results that could be confusing to patients. They suggested limiting this required element to a subset of lab results of a particular type or lab results from the last 24 hours of admission.

Response: We believe that a list of all laboratory test results can be beneficial to longitudinal care, therefore, we decline to modify this required element either by type of lab result or by any time period beyond those lab test results available at discharge.

Comment: Some commenters suggested that the required element of “Care transition summary and plan for next provider of care (for transitions other than home)” should be made consistent with the required element in the objective of the same name and changed to “Care plan field, including goals and instructions.” Some commenters also suggested that care transition plans are more appropriate for providers than patients.

Response: By “care transition summary and plan for next provider of care” we mean for eligible hospitals and CAHs to include both the care plan field(s), including goals and instructions, and a copy of the summary of care document that hospitals must generate and provide for the core objective of “The eligible hospital or CAH that transitions their patient to another setting of care or provider of care or refers their patient to another provider of care should provide summary care record for each transition of care or referral.” While we believe that the summary of care documents are best exchanged directly with the provider to whom the hospital is transitioning care or referring the patient, we also believe that providing an electronic copy with discharge information will ensure that the provider can easily access the information after the transition of referral. We have modified the language in the list of required elements below to reflect this.

After consideration of the public comments received, we are finalizing the first meaningful use measure for eligible hospitals and CAHs at § 495.6(l)(8)(ii)(A) as proposed. We are modifying the second meaningful use measure for eligible hospitals and CAHs to be “More than 5 percent of all patients (or their authorized representatives) who are discharged from the inpatient or emergency department (POS 21 or 23) of an eligible hospital or CAH view, download or transmit to a third party their information during the EHR reporting period” at § 495.6(l)(8)(ii)(B), and the exclusion for eligible hospitals and CAHs at § 495.6(l)(8)(iii) as “Any eligible hospital or CAH that is located in a county that does not have 50 percent or more of its housing units with 3Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period is excluded from the second measure.”

We further specify that in order to meet this objective and measure, an eligible hospital or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(e)(1).

To calculate the percentage of the first measure for providing patients timely access to discharge information, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of unique patients discharged from an eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period.
  • Numerator: The number of patients in the denominator whose information is available online within 36 hours of discharge.
  • Threshold: The resulting percentage must be more than 50 percent in order for an eligible hospital or CAH to meet this measure.

To calculate the percentage of the second measure for reporting on the number of unique patients discharged from an eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period (or their authorized representatives) who view, download or transmit health information, CMS and ONC have worked together to define the following for this objective:

  • Denominator: Number of unique patients discharged from an eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period.
  • Numerator: The number of unique patients (or their authorized representatives) in the denominator who have viewed online, downloaded, or transmitted to a third party the discharge information provided by the eligible hospital or CAH.
  • Threshold: The resulting percentage must be more than 5 percent in order for an eligible hospital or CAH to meet this measure.
  • Exclusion: Any eligible hospital or CAH will be excluded from the second measure if it is located in a county that does not have 50 percent or more of its housing units with 3Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period.

The following information must be available to satisfy the objective and measure:

  • Patient name.
  • Admit and discharge date and location.
  • Reason for hospitalization.
  • Care team including the attending of record as well as other providers of care.
  • Procedures performed during admission.
  • Current and past problem list.
  • Current medication list and medication history.
  • Current medication allergy list and medication allergy history.
  • Vital signs at discharge.
  • Laboratory test results (available at time of discharge).
  • Summary of care record for transitions of care or referrals to another provider.
  • Care plan field(s), including goals and instructions.
  • Discharge instructions for patient.
  • Demographics maintained by hospital (sex, race, ethnicity, date of birth, preferred language).
  • Smoking status.

As noted in the proposed rule, this is not intended to limit the information made available by the hospital. A hospital can make available additional information and still align with the objective. Please note that while some of the information made available through this measure is similar to the information made available in the summary of care document that must be provided following transitions of care or referrals, the list of information above is specific to the view online, download, and transmit objective. Patients and providers have different information needs and contexts, so CMS has established separate required fields for each of these objectives.

Proposed Eligible Hospital/CAH Objective: Record whether a patient 65 years old or older has an advance directive.

In our proposed rule, we noted that the HIT Policy Committee recommended making this a core objective and also requiring eligible hospitals and CAHs to either store an electronic copy of the advance directive in the CEHRT or link to an electronic copy of the advance directive. However, we proposed to maintain this objective as part of the menu set for Stage 2, and we did not propose the requirement of an electronic copy or link to the advance directive. As we stated in our Stage 1 final rule (75 FR 44345), we have continuing concerns that there are potential conflicts between storing advance directives and existing state laws. Also, we believe that because of state law restrictions, an advance directive stored in an EHR may not be actionable. Finally, we believe that eligible hospitals and CAHs may have other methods of satisfying the intent of this objective at this time, although we recognize that these workflows may change as EHR technology develops and becomes more widely adopted. Therefore, we did not propose to adopt the HIT Policy Committee's recommendations for this objective.

The HIT Policy Committee has also recommended the inclusion of this objective for EPs in Stage 2. In our Stage 1 final rule (75 FR 44345), we indicated our belief that many EPs will not record this information under current standards of practice and will only require information about a patient's advance directive in rare circumstances. We continue to believe this is the case and that creating a list of specialties or types of EPs that will be excluded from the objective will be too cumbersome and still might not be comprehensive. Therefore, we did not propose the recording of the existence of advance directives as an objective for EPs in Stage 2. However, we solicited public comment on this decision and encouraged commenters to address specific concerns regarding scope of practice and ease of compliance for EPs. And we note that nothing in this rule compels the use of advance directives.

Comment: While some commenters supported the HIT Policy Committee's recommendations, many recommended that we keep this measure as part of the menu set. We received several comments about a link or copy of the advance directives, and these commenters generally supported our proposal of not including this as part of the objective.

Response: While we appreciate the commenters support and the HITPC's reiteration of their recommendation, neither the HITPC nor other commenters provided new information that would address our concerns regarding conflicting state laws.

Comment: While most commenters agreed that this objective should not be extended to EPs at this time, a select few suggested adding it as part of the menu set.

Response: We are not extending this objective to EPs. Our belief that many EPs would not record this information under current standards of practice was supported by commenters. Also, we continue to believe that creating a list of specialties or types of EPs that would be excluded from the objective would be too cumbersome and would not be comprehensive.

After consideration of public comments, we are finalizing this objective for eligible hospitals and CAHs at § 495.6(m)(1)(i) as proposed.

Proposed Eligible Hospital/CAH Measure: More than 50 percent of all unique patients 65 years old or older admitted to the eligible hospital's or CAH's inpatient department (POS 21) during the EHR reporting period have an indication of an advance directive status recorded as structured data.

In the proposed rule, we explained that the calculation of the denominator for the measure of this objective is limited to unique patients age 65 or older who are admitted to an eligible hospital's or CAH's inpatient department (POS 21). Patients admitted to an emergency department (POS 23) should not be included in the calculation. As we discussed in our Stage 1 final rule (75 FR 44345), we believe that this information is a level of detail that is not practical to collect on every patient admitted to the eligible hospital's or CAH's emergency department, and therefore, have limited this measure only to the inpatient department of the hospital.

Comment: A commenter indicated that nearly 70 percent of hospitals could meet this measure in Fall 2011.

Response: Data collected from Stage 1 attestations shows that less than 15 percent of hospitals deferred this measure.

After consideration of public comments, we are finalizing this measure for eligible hospitals and CAHs at § 495.6(m)(1)(ii) as proposed. We are maintaining the exclusion for any eligible hospital or CAH that admits no patients age 65 years old or older during the EHR reporting period.

We further specify that in order to meet this objective and measure, an EP must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(17).

  • Denominator: Number of unique patients age 65 or older admitted to an eligible hospital's or CAH's inpatient department (POS 21) during the EHR reporting period.
  • Numerator: The number of patients in the denominator who have an indication of an advance directive status entered using structured data.
  • Threshold: The resulting percentage must be more than 50 percent in order for an eligible hospital or CAH to meet this measure.
  • Exclusion: Any eligible hospital or CAH that admits no patients age 65 years old or older during the EHR reporting period.

(f) HIT Policy Committee Recommended Objectives Discussed in the Proposed Rule Without Proposed Regulation Text

We did not propose these objectives for Stage 2 as explained at each objective, but we solicited comments on whether these objectives should be incorporated into Stage 2.

Hospital Objective: Provide structured electronic lab results to eligible professionals.

Although the HITPC recommended this as a core objective for Stage 2 for hospitals, we did not propose this objective for the following reasons as explained in the proposed rule. Although hospital labs supply nearly half of all lab results, they are not the predominant vendors for providers who do not share or cannot access their technology. Independent and office laboratories provide over half of the labs in this market. We stated that we were concerned that imposing this requirement on hospital labs would unfairly disadvantage them in this market. Furthermore, not all hospitals offer these services so it would create a natural disparity in meaningful use between those hospitals offering these services and those that do not. Finally, all other aspects of meaningful use in Stage 1 and Stage 2 focus on the inpatient and emergency departments of a hospital. This objective is not related to these departments, and in fact excludes services provided in these departments. We asked for comments on both the pros and cons of this objective and whether it should be considered for this final rule as recommended by the HITPC.

Comment: Nearly all of the commenters that supported the inclusion of this objective based their support wholly or in part on the concept that the benefits of hospitals providing structured electronic lab results outweigh the costs of doing so. They point to specific benefits, such as making it more likely that EPs will be able to meet the meaningful use measure of incorporating clinical lab-test results into CEHRT as structured data, as well as more general benefits of structured electronic results.

Response: The large number of commenters in support of this objective and the associated benefits they identified make a compelling case for inclusion. In particular, inclusion of this objective will enable EPs to incorporate laboratory test results into the CEHRT as structured data, which in turn adds to the ability of CEHRT to provide CDS and to calculate clinical quality measures. In addition, this objective will improve consistency in the market by incentivizing the use of the uniform standard for laboratory exchange transactions included in CEHRT as established in ONC's certification criteria at (ONC reference once available). However, the benefits identified are somewhat tempered by the makeup of the commenters supporting the inclusion of this objective, who are usually those who stand to benefit (EPs, patient advocates and others), whereas those who did not support inclusion are usually those who would bear the burden (hospitals and vendors). We summarize and respond to the comments in opposition later. However, due to the strong disagreements among commenters about the inclusion of this objective, and also concern for market impact discussed in the comments later, we will include it in the menu set of Stage 2 and not in the core set as recommended by the HITPC and supported by some of the commenters.

Comment: Several commenters questioned the applicability of this objective to meaningful use. Most stated that it was not applicable for several reasons. First, commenters asserted it is beyond the statutory authority of the Medicare EHR Incentive Program, which is established in sections of the statute that govern payment for hospital inpatient services, whereas laboratory services are paid under a different payment system. Second, as meaningful use is currently constrained to the inpatient and emergency departments, it would be inconsistent to expand it to include lab results for patients that are not admitted to either the inpatient or emergency department of the hospital. Third, systems used by hospitals to process and send laboratory results are not traditionally considered part of CEHRT, and including those systems in CEHRT could have many unintended consequences and costs.

Response: We believe the statute supports a definition of meaningful use that is not limited to actions taken within the inpatient department of a hospital. The meaningful use incentive payments and payment adjustments for Medicare eligible hospitals are established in sections of the Act that are under the hospital inpatient prospective payment system (IPPS) (sections 1886(n) and 1886(b)(3)(B)(ix) of the Act, respectively). However, the statutory definition of a “meaningful EHR user” under section 1886(n)(3) of the Act does not constrain the use of CEHRT to the inpatient department of the hospital. The definition requires in part that an eligible hospital must use CEHRT “for the electronic exchange of health information to improve the quality of health care, such as promoting care coordination” (section 1886(n)(3)(A)(ii)), which the objective of providing structured electronic lab results to ambulatory providers would support. Moreover, the majority of hospital objectives for Stages 1 and 2 of meaningful use take into account actions performed in the emergency department as well as the inpatient department. In the Stage 1 final rule, we indicated that we may consider applying the Stage 2 criteria more broadly to all hospital outpatient settings beyond the emergency department (75 FR 44322). One of the primary reasons not to include outpatient settings in meaningful use for hospitals is the potential for overlap with settings where EPs typically would use CEHRT. We believe there is minimal risk of such overlap with this objective, as it involves a function that is controlled by the hospital, and for which EPs are a recipient and not a provider of information. In regards to the third reason identified by commenters, CEHRT and meaningful use already include the ability to report electronic lab results to public health agencies, so consequences and costs of such inclusion should have already occurred. The impact of including these systems in certification is addressed in the ONC regulation published elsewhere in this issue of the Federal Register.

Comment: A few commenters supported this objective because they believe that hospital labs have lagged behind independent labs in providing electronic results.

Response: We agree that hospital lab reporting should be included as a menu set objective, but without actual data demonstrating lags by hospitals in laboratory exchange with ambulatory providers, we do not find this to be a compelling reason to include the objective as part of the core set.

Comment: Commenters believed this objective is inappropriate because the meaningful use regulations do not apply to commercial clinical laboratories, leading to an adverse market impact for hospitals in competition with others that process laboratory results for physician offices. The operational impacts of this objective are significant. In the absence of functional health information exchanges, hospitals would need to create and maintain separate, system-to-system interfaces with each physician office that receives laboratory results electronically, at considerable cost and effort. The transition to using standardized code sets in laboratories that must continue to function is challenging and burdensome, particularly for small hospitals.

Response: For these reasons, we include this objective and measure in the menu set. Those hospitals that see competitive benefits in providing electronic lab results to ambulatory providers may wish to select this as a menu set objective. Those who believe that building out the capability to provide electronic lab results is not beneficial in their competitive market environments can defer the objective. Similarly, those hospitals that consider the burden too high can defer this objective.

After consideration of public comments, we are including this objective in the menu set for eligible hospitals and CAHs at § 495.6(m)(6)(i) as “Provide structured electronic lab results to ambulatory providers.”

For each objective, we outline the benefits expected from that objective. We did not include these benefits in our proposed rule and we are adding them to this final rule. Hospitals sending structured lab results electronically to EPs using CEHRT and in accordance with designated standards will directly enhance the ability of EPs to meet meaningful use objectives, including incorporating laboratory test results into the EHR as structured data, generating lists of patients with particular conditions, utilizing clinical decision support, and enhancing the ability to calculate clinical quality measures. The addition of this objective will help improve consistency in the market, in contrast to today's environment in which inconsistencies in interface requirements are hindering the delivery of structured hospital lab results to ambulatory EHRs. This objective will also benefit hospitals by creating a uniform standard for laboratory exchange transactions, which will eliminate variation, reducing interface costs and time to deploy.

Hospital Measure: Hospital labs send (directly or indirectly) structured electronic clinical lab results to the ordering provider for more than 40 percent of electronic lab orders received.

The measure for this objective recommended by the HIT Policy Committee is that 40 percent of clinical lab test results electronically sent by an eligible hospital or CAH will need to be done so using the capabilities CEHRT. This measure requires that in situations where the electronic connectivity between an eligible hospital or CAH and an EP is established, the results electronically exchanged are done so using CEHRT. To facilitate the ease with which this electronic exchange may take place, ONC proposed that for certification, ambulatory EHR technology will need to be able to incorporate lab test results formatted in the same standard and implementation specifications to which inpatient EHR technology will need to be certified as being able to create.

Comment: Some commenters who support this objective raised concerns that small hospitals might not be able to comply due to the burden involved and suggest an unspecified exclusion for them.

Response: By including this objective as a menu set item, those hospitals that view lab reporting to ambulatory practices as too burdensome can defer this measure.

Comment: Some commenters supporting the measure indicated that they would like to see hospital reference labs that are already providing electronic lab results to ordering providers “grandfathered” into the measure.

Response: There are two reasons that a hospital providing electronic lab results already would need special consideration. First, they are not using the standards of CEHRT where available. Second, they may not have gotten the system they use certified. As it is meaningful use of CEHRT we do not believe that we should include exceptions to the use of CEHRT in meaningful use. We do not believe that providers must “rip and replace” existing systems. Existing systems that support the standards of CEHRT can be certified for inclusion and those that do not support the standards can defer the objective until they upgrade to the standards of CEHRT.

Comment: Commenters expressed concern that if the objective is included in meaningful use that the threshold is unattainable. They noted that for a hospital to send electronic lab results the EP must be able to receive electronic results and that current adoption rates do not indicate that 40 percent of EPs will be able to receive electronic lab results.

Response: The measure uses a denominator of electronic lab orders received so this consideration is already built into the measure. However, we do agree with commenters that 40 percent is a high threshold for this completely new measure as it is dependent on electronic health exchange. For the final measure we reduce the threshold to 20 percent. While we considered lowering the threshold to 10 percent, the denominator limitation that the lab order must be received electronically already limits the measure to those ordering providers capable of submitting electronic orders and implies at least some electronic health information exchange has been established between the hospital and the ordering provider.

After considering the comments, we are finalizing this measure for eligible hospitals and CAHs at § 495.6(m)(6)(ii) as “Hospital labs send structured electronic clinical lab results to the ordering provider for more than 20 percent of electronic lab orders received.”

In order to be counted in the numerator, the hospital would need to use CEHRT to send laboratory results to the ambulatory provider in a way that has the potential for electronic incorporation of those results as structure data. Methods that have no potential for automatic incorporation such as “portal view” do not count in the numerator. We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(b)(6).

  • Denominator: The number of electronic lab orders received.
  • Numerator: The number of structured clinical lab results sent to the ordering provider.
  • Threshold: The resulting percentage must be greater than 20 percent.

EP Objective/Measure: Record patient preferences for communication medium for more than 20 percent of all unique patients seen during the EHR reporting period.

We proposed that this requirement is better incorporated with other objectives that require patient communication and is not necessary as a standalone objective.

Commenters were supportive of the incorporation of this objective and we continue to believe that it is better incorporated; therefore, we are finalizing this provision as proposed.

Objective/Measure: Record care plan goals and patient instructions in the care plan for more than 10 percent of patients seen during the reporting period.

We proposed that this requirement is better incorporated with other objectives that require summary of care documents and is not necessary as a standalone objective.

Commenters were supportive of the incorporation of this objective as proposed and we continue to believe that it is better incorporated; therefore, we are finalizing this provision as proposed.

Objective/Measure: Record health care team members (including at a minimum PCP, if available) for more than 10 percent of all patients seen during the reporting period; this information can be unstructured.

We proposed that this requirement is better incorporated with other objectives that require summary of care documents and is not necessary as a standalone objective.

Commenters were supportive of the incorporation of this objective as proposed and we continue to believe that it is better incorporated; therefore, we are finalizing as proposed.

Objective/Measure: Record electronic notes in patient records for more than 30 percent of office visits.

In the proposed rule, we encouraged public comment regarding the inclusion of this objective/measure. We noted that narrative entries are considered an important component of patient records and complement the structured data captured in CEHRT. We also noted our understanding that electronic notes are already widely used by providers and therefore may not need to include this as a meaningful use objective.

Comment: Commenters agreed that existing technology has the capability to capture notes in an electronic form for inclusion in the patient record. Other commenters mentioned that not all CEHRT in use currently include the capability to incorporate narrative clinical documentation.

Response: We reiterate the statement in the proposed rule regarding the important contribution of narrative clinical documentation in the patient record. In light of the comments that not all CEHRT currently has the capability to incorporate this clinical documentation, we agree to incorporate this functionality to record electronic notes as an additional menu objective for Stage 2 of meaningful use. The ONC standards and certification criteria final rule associated with this objective/measure is published elsewhere in this issue of the Federal Register. We believe that inclusion of electronic patient notes to the meaningful use menu objectives is another incremental step towards maximizing the potential of EHR technology.

Comment: The HIT Policy Committee commented that this objective/measure should apply to both EPs, eligible hospitals and CAHs because some certified EHRs do not have clinical documentation and because they believe that a complete record (including progress notes) is required to deliver high quality, efficient care.

Response: We agree and are adopting this objective in the menu set for Stage 2 for EPs, eligible hospitals and CAHs in order to allow providers access to the most accurate and complete patient information available electronically to support quality of care efforts across patient care settings.

Comment: A commenter suggested that if this objective/measure becomes part of the final rule it will require a clear definition of how notes are defined and who may create, edit and sign them in order to be included in the measure numerator. Other commenters requested clarification of the term electronic note and whether it would include nursing notes, flow sheets, operative reports, discharge summaries, consults, etc. in addition to basic progress notes.

Response: For this objective, we have determined that any EP as defined for the Medicare or Medicaid EHR Incentive Programs, or an authorized provider of the eligible hospital's or CAH's inpatient or emergency departments (POS 21 or 23) may author, edit, and provide an electronic signature for the electronic notes in order for them to be considered for this measure. We further define electronic notes as electronic progress notes for the purpose of this measure. We will rely on providers own determinations and guidelines defining when progress notes are necessary to communicate individual patient circumstances and for coordination with previous documentation of patient observations, treatments and/or results in the electronic health record.

Comment: Many commenters agreed with the inclusion of the text searchable certification requirement and agreed that portions of clinical notes are already being collected electronically. The HIT Policy Committee recommended inclusion of this measure because some certified EHRs do not have clinical documentation, and believe that the benefit of a complete patient record, including progress notes, is required to deliver high quality, efficient care. Several commenters were opposed to the inclusion of this additional measure in order to limit the number of reporting objectives.

Response: Based on the multiple reasons stated in this preamble we agree with the benefits of including the electronic progress notes measure in the menu set for the Stage 2 meaningful use objectives. We envision continued technological advances in the capture and processing of text and diagrammatic data such as research of natural language processing. We also believe there is added value in collecting both narrative data and structured data in the EHR and using that information to track key clinical conditions and communicating that information for care coordination purposes. Therefore, we are including this objective/measure to record electronic notes in the patient records for more than 30 percent of office visits or unique patients admitted to an eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) as was originally recommended by the HITPC.

After consideration of public comments, we are finalizing this objective for EPs at § 495.6(k)(6)(i) and for eligible hospitals and CAHs at § 495.6(m)(5)(i) as “Record electronic notes in patient records.”

We are adding the measure for EPs at § 495.6(k)(6)(ii) and for eligible hospitals and CAHs at § 495.6(m)(5)(ii) of our regulations to include this new measure:

EP Menu Measure: Enter at least one electronic progress note created, edited and signed by an EP for more than 30 percent of unique patients with at least one office visit during the EHR reporting period. Electronic progress notes must be text-searchable. Non-searchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable text notes under this measure.

Eligible Hospital/CAH Menu Measure: Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH's inpatient or emergency department during the EHR reporting period. Electronic progress notes must be text-searchable. Non-searchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable text notes under this measure.

We further specify that in order to meet this objective and measure, an EP, eligible hospital, or CAH must use the capabilities and standards of CEHRT at 45 CFR 170.314(a)(9).

To calculate the percentage, CMS and ONC have worked together to define the following for these measures:

  • Denominator: Number of unique patients with at least one office visit during the EHR reporting period for EPs or admitted to an eligible hospital or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period.
  • Numerator: The number of unique patients in the denominator who have at least one electronic progress note from an eligible professional or authorized provider of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) recorded as text-searchable data.
  • Threshold: The resulting percentage must be more than 30 percent in order for an EP, eligible hospital or CAH to meet this measure.
Table B5—Stage 2 Objectives and Measures Back to Top
Health outcomes policy priority Stage 2 objectives Stage 2 measures
Eligible professionals Eligible hospitals and CAHs
CORE SET      
Improving quality, safety, efficiency, and reducing health disparities Use computerized provider order entry (CPOE) for medication, laboratory and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelines Use computerized provider order entry (CPOE) for medication, laboratory and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelines More than 60 percent of medication, 30 percent of laboratory, and 30 percent of radiology orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using CPOE.
Generate and transmit permissible prescriptions electronically (eRx) More than 50 percent of all permissible prescriptions, or all prescriptions written by the EP and queried for a drug formulary and transmitted electronically using CEHRT.
Record the following demographics: • Preferred language • Sex • Race • Ethnicity • Date of birth Record the following demographics: • Preferred language • Sex • Race • Ethnicity • Date of birth • Date and preliminary cause of death in the event of mortality in the eligible hospital or CAH. More than 80 percent of all unique patients seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have demographics recorded as structured data.
Record and chart changes in vital signs: • Height/length • Weight • Blood pressure (age 3 and over) • Calculate and display BMI • Plot and display growth charts for patients 0-20 years, including BMI Record and chart changes in vital signs: • Height/length • Weight • Blood pressure (age 3 and over) • Calculate and display BMI • Plot and display growth charts for patients 0-20 years, including BMI More than 80 percent of all unique patients seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have blood pressure (for patients age 3 and over only) and height/length and weight (for all ages) recorded as structured data.
Record smoking status for patients 13 years old or older Record smoking status for patients 13 years old or older More than 80 percent of all unique patients 13 years old or older seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency departments (POS 21 or 23) during the EHR reporting period have smoking status recorded as structured data.
Use clinical decision support to improve performance on high-priority health conditions Use clinical decision support to improve performance on high-priority health conditions 1. Implement five clinical decision support interventions related to four or more clinical quality measures at a relevant point in patient care for the entire EHR reporting period. Absent four clinical quality measures related to an EP, eligible hospital or CAH's scope of practice or patient population, the clinical decision support interventions must be related to high-priority health conditions. It is suggested that one of the five clinical decision support interventions be related to improving healthcare efficiency. 2. The EP, eligible hospital, or CAH has enabled and implemented the functionality for drug and drug allergy interaction checks for the entire EHR reporting period.
Incorporate clinical lab-test results into Certified EHR Technology as structured data. Incorporate clinical lab-test results into Certified EHR Technology as structured data More than 55 percent of all clinical lab tests results ordered by the EP or by authorized providers of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) during the EHR reporting period whose results are either in a positive/negative affirmation or numerical format are incorporated in Certified EHR Technology as structured data.
Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach. Generate at least one report listing patients of the EP, eligible hospital or CAH with a specific condition.
Use clinically relevant information to identify patients who should receive reminders for preventive/follow-up care and send these patients the reminder, per patient preference More than 10 percent of all unique patients who have had two or more office visits with the EP within the 24 months before the beginning of the EHR reporting period were sent a reminder, per patient preference when available.
Automatically track medications from order to administration using assistive technologies in conjunction with an electronic medication administration record (eMAR). More than 10 percent of medication orders created by authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period for which all doses are tracked using eMAR.
Engage patients and families in their health care Provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the EP. 1. More than 50 percent of all unique patients seen by the EP during the EHR reporting period are provided timely (within 4 business days after the information is available to the EP) online access to their health information subject to the EP's discretion to withhold certain information. 2. More than 5 percent of all unique patients seen by the EP during the EHR reporting period (or their authorized representatives) view, download, or transmit to a third party their health information.
Provide patients the ability to view online, download, and transmit information about a hospital admission. 1. More than 50 percent of all patients who are discharged from the inpatient or emergency department (POS 21 or 23) of an eligible hospital or CAH have their information available online within 36 hours of discharge. 2. More than 5 percent of all patients (or their authorized representatives) who are discharged from the inpatient or emergency department (POS 21 or 23) of an eligible hospital or CAH view, download or transmit to a third party their information during the reporting period.
Provide clinical summaries for patients for each office visit Clinical summaries provided to patients or patient-authorized representatives within 1 business day for more than 50 percent of office visits.
Use Certified EHR Technology to identify patient-specific education resources and provide those resources to the patient Use Certified EHR Technology to identify patient-specific education resources and provide those resources to the patient Patient-specific education resources identified by CEHRT are provided to patients for more than 10 percent of all unique patients with office visits seen by the EP during the EHR reporting period. More than 10 percent of all unique patients admitted to the eligible hospital's or CAH's inpatient or emergency departments (POS 21 or 23) are provided patient-specific education resources identified by Certified EHR Technology.
Use secure electronic messaging to communicate with patients on relevant health information A secure message was sent using the electronic messaging function of Certified EHR Technology by more than 5 percent of unique patients (or their authorized representatives) seen by the EP during the EHR reporting period.
Improve care coordination The EP who receives a patient from another setting of care or provider of care or believes an encounter is relevant should perform medication reconciliation. The eligible hospital or CAH who receives a patient from another setting of care or provider of care or believes an encounter is relevant should perform medication reconciliation The EP, eligible hospital or CAH performs medication reconciliation for more than 50 percent of transitions of care in which the patient is transitioned into the care of the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23).
The EP who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care provides a summary care record for each transition of care or referral The eligible hospital or CAH who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care provides a summary care record for each transition of care or referral 1. The EP, eligible hospital, or CAH that transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 50 percent of transitions of care and referrals. 2. The EP, eligible hospital or CAH that transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 10% of such transitions and referrals either—(a) electronically transmitted using CEHRT to a recipient or (b) where the recipient receives the summary of care record via exchange facilitated by an organization that is a NwHIN Exchange participant or in a manner that is consistent with the governance mechanism ONC establishes for the nationwide health information network. 3. An EP, eligible hospital or CAH must satisfy one of the two following criteria: (A) Conducts one or more successful electronic exchanges of a summary of care document, as part of which is counted in “measure 2” (for EPs the measure at § 495.6(j)(14)(ii)(B) and for eligible hospitals and CAHs the measure at § 495.6(l)(11)(ii)(B)) with a recipient who has EHR technology that was developed designed by a different EHR technology developer than the sender's EHR technology certified to 45 CFR 170.314(b)(2); or (B) Conducts one or more successful tests with the CMS designated test EHR during the EHR reporting period.
Improve population and public health Capability to submit electronic data to immunization registries or immunization information systems except where prohibited, and in accordance with applicable law and practice Capability to submit electronic data to immunization registries or immunization information systems except where prohibited, and in accordance with applicable law and practice Successful ongoing submission of electronic immunization data from Certified EHR Technology to an immunization registry or immunization information system for the entire EHR reporting period.
Capability to submit electronic reportable laboratory results to public health agencies, except where prohibited, and in accordance with applicable law and practice Successful ongoing submission of electronic reportable laboratory results from Certified EHR Technology to public health agencies for the entire EHR reporting period.
Capability to submit electronic syndromic surveillance data to public health agencies, except where prohibited, and in accordance with applicable law and practice Successful ongoing submission of electronic syndromic surveillance data from Certified EHR Technology to a public health agency for the entire EHR reporting period.
Ensure adequate privacy and security protections for personal health information Protect electronic health information created or maintained by the Certified EHR Technology through the implementation of appropriate technical capabilities Protect electronic health information created or maintained by the Certified EHR Technology through the implementation of appropriate technical capabilities Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data stored in CEHRT in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies as part of the provider's risk management process.
MENU SET      
Improving quality, safety, efficiency, and reducing health disparities Record whether a patient 65 years old or older has an advance directive More than 50 percent of all unique patients 65 years old or older admitted to the eligible hospital's or CAH's inpatient department (POS 21) during the EHR reporting period have an indication of an advance directive status recorded as structured data.
Imaging results consisting of the image itself and any explanation or other accompanying information are accessible through Certified EHR Technology. Imaging results consisting of the image itself and any explanation or other accompanying information are accessible through Certified EHR Technology. More than 10 percent of all tests whose result is one or more images ordered by the EP or by an authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 and 23) during the EHR reporting period are accessible through Certified EHR Technology.
Record patient family health history as structured data Record patient family health history as structured data More than 20 percent of all unique patients seen by the EP or admitted to the eligible hospital or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period have a structured data entry for one or more first-degree relatives.
Generate and transmit permissible discharge prescriptions electronically (eRx) More than 10 percent of hospital discharge medication orders for permissible prescriptions (for new, changed, and refilled prescriptions) are queried for a drug formulary and transmitted electronically using Certified EHR Technology.
Record electronic notes in patient records Record electronic notes in patient records Enter at least one electronic progress note created, edited and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period. Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH's inpatient or emergency department during the EHR reporting period. Electronic progress notes must be text-searchable. Non-searchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable text notes under this measure.
Provide structured electronic lab results to ambulatory providers Hospital labs send structured electronic clinical lab results to the ordering provider for more than 20 percent of electronic lab orders received.
Improve Population and Public Health Capability to submit electronic syndromic surveillance data to public health agencies, except where prohibited, and in accordance with applicable law and practice Successful ongoing submission of electronic syndromic surveillance data from Certified EHR Technology to a public health agency for the entire EHR reporting period.
Capability to identify and report cancer cases to a public health central cancer registry, except where prohibited, and in accordance with applicable law and practice. Successful ongoing submission of cancer case information from CEHRT to a public health central cancer registry for the entire EHR reporting period.
Capability to identify and report specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice. Successful ongoing submission of specific case information from Certified EHR Technology to a specialized registry for the entire EHR reporting period.

B. Reporting on Clinical Quality Measures Using Certified EHR Technology by Eligible Professionals, Eligible Hospitals, and Critical Access Hospitals

The following sections address CQMs reporting requirements using CEHRT. These include: EHR technology certification requirements; criteria for CQM selection; time periods for reporting CQMs; issues related to specifications for CQMs and transmission formats; reporting options and CQMs for EPs; reporting methods for EPs; reporting options and CQMs for eligible hospitals and CAHs; and reporting methods for eligible hospitals and CAHs.

1. Time Periods for Reporting CQMs

This section addresses the reporting periods and submission periods as they relate to reporting CQMs only. For a summary of the reporting and submission periods proposed for CQMs, please refer to Table 5 in the Stage 2 proposed rule (77 FR 13742).

We proposed that the reporting period for CQMs, which is the period during which data collection or measurement for CQMs occurs, would continue to track with the EHR reporting periods for the meaningful use objectives and measures:

  • EPs: January 1 through December 31 (calendar year).
  • Eligible Hospitals and CAHs: October 1 through September 30 (federal fiscal year).
  • EPs, eligible hospitals, and CAHs in their first year of meaningful use for Stage 1, any continuous 90-day period within the calendar year (CY) or federal fiscal year (FY), respectively.

To avoid a payment adjustment, Medicare EPs and eligible hospitals that are in their first year of demonstrating meaningful use in the year immediately preceding any payment adjustment year would have to ensure that their 90-day EHR reporting period ends at least 3 months before the end of the CY or FY, and that all submission is completed by October 1 or July 1, respectively. For more information on payment adjustments, see section II.D. of this final rule.

The submission period is the time during which EPs, eligible hospitals, and CAHs may submit CQM information. We proposed the submission period for CQM data generally would be the 2 months immediately following the end of the EHR reporting period as follows:

  • EPs: January 1 through February 28.
  • Eligible Hospitals and CAHs: October 1 through November 30.
  • EPs, eligible hospitals, and CAHs in their first year of Stage 1: Anytime after the end of their 90-day EHR reporting period until the end of the 2 months immediately following the end of the CY or FY, respectively. However, for purposes of avoiding the payment adjustments, Medicare EPs and eligible hospitals that are in their first year of demonstrating meaningful use in the year immediately preceding a payment adjustment year must submit their CQM data no later than October 1 (EPs) or July 1 (eligible hospitals) of such preceding year.

Comment: Several commenters stated that the first year of a new stage for reporting CQMs should only require a 90-day or 180-day reporting period instead of a 365-day reporting period.

Response: We agree that vendors, EPs, eligible hospitals, and CAHs may need more time to develop, test, and implement EHR technology certified to the 2014 Edition EHR certification criteria and to be able to meet the CQM reporting requirements that we proposed beginning in 2014. Therefore, for the reasons discussed in this section, we are modifying the reporting periods for CQMs in 2014 to match the EHR reporting periods that we are finalizing for 2014. By using 3-month quarters as the reporting periods in 2014 for providers that are beyond their first year of demonstrating meaningful use instead of requiring a full year as proposed, we allow vendors and health care providers as much as 9 months more time to program, develop, and implement CEHRT, and meet the requirements for meaningful use in 2014. We note that the 3-month quarter reporting period is only applicable for 2014. For 2015 and subsequent years, we are finalizing our proposal of a full year reporting period for EPs, eligible hospitals and CAHs that are beyond their first year of demonstrating meaningful use. We have selected 3-month quarters rather than any continuous 90-day period to promote more ready comparisons of data. This is particularly important for eligible hospitals and CAHs since many of the CQMs that we are finalizing for 2014 and subsequent years are also used in the CMS Hospital IQR Program. We have indicated our desire to transition the CMS Hospital IQR Program to collecting EHR-based quality data. Having data from hospitals for comparable quarter timeframes as used for the CMS Hospital IQR Program will be beneficial for comparing chart abstracted data with data derived from CEHRT and will facilitate data collection mode for potential future usage for Hospital Compare public reporting and the CMS Hospital Value Based Purchasing programs.

After consideration of the public comments received, we are finalizing the reporting and submission periods as follows. The reporting period for CQMs generally will be the same as an EP's, eligible hospital's, or CAH's respective EHR reporting period for the meaningful use objectives and measures, with the exceptions discussed later in this section. Please note that Medicare EPs who choose to report CQMs through the options we are finalizing that rely on other CMS programs (namely, Option 2—PQRS (see section II.B.6.c. of this final rule) and the group reporting options—Physician Quality Reporting System (PQRS) and Accountable Care Organizations (ACOs) (see section II.B.6.d. of this final rule) would be subject to the reporting periods for CQMs established for those programs. As an example using CY 2014, for Medicare EPs who choose to submit CQMs under Option 2 (PQRS EHR Reporting Option) for purposes of satisfying the CQM reporting component of meaningful use, the reporting periods for the PQRS EHR reporting that fall within CY 2014 would apply. Medicaid EPs and eligible hospitals must submit CQM data for a reporting period that is the same as their EHR reporting period using the reporting methods and submission periods specified by their state Medicaid agency.

In 2013, the reporting period for CQMs will continue to be an EP's, eligible hospital's or CAH's respective EHR reporting period. The submission period will be the 2 months immediately following the end of the CY or FY, respectively (EPs: January 1 through February 28, 2014; eligible hospitals and CAHs: October 1 through November 30, 2013). EPs, eligible hospitals and CAHs in their first year of meaningful use may submit CQM data anytime after the end of their 90-day EHR reporting period until the end of the 2 months immediately following the end of the CY or FY, respectively.

Beginning in 2014 and in subsequent years, for EPs, eligible hospitals and CAHs that are in their first year of meaningful use, the reporting period for CQMs will be their respective 90-day EHR reporting period, and they must submit CQM data by attestation. The submission period will be anytime after the end of their respective 90-day EHR reporting period until the end of the 2 months immediately following the end of the CY or FY, respectively. However, for purposes of avoiding a payment adjustment, Medicare EPs and eligible hospitals that are in their first year of demonstrating meaningful use in the year immediately preceding a payment adjustment year must submit their CQM data no later than October 1 (EPs) or July 1 (eligible hospitals) of such preceding year. We note that these deadlines do not apply to CAHs. For more details on submission deadlines specific to CAHs, please refer to section II.D.4. of this final rule.

Beginning in 2014 and in subsequent years, EPs, eligible hospitals and CAHs that are beyond their first year of meaningful use must electronically submit CQM data unless the Secretary lacks the capacity to accept electronic submission. In the unlikely event that the Secretary does not have the capacity to accept electronic submission, then consistent with sections 1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii) of the Act, we would continue to accept attestation as a method of reporting CQMs. We would inform the public of this fact by publishing a notice in the Federal Register and providing instructions on how CQM data should be submitted to us. For additional details on the reporting methods for EPs, please refer to sections II.B.6.c. and II.B.6.d. of this final rule, and for the reporting methods for eligible hospitals and CAHs, please refer to section II.B.8.b. of this final rule. The reporting periods for CQMs in 2014 for EPs, eligible hospitals, and CAHs that are beyond their first year of meaningful use are as follows:

  • EPs, eligible hospitals and CAHs may report CQM data for the full CY or FY 2014, respectively, if desired. Alternatively, they may report CQM data for the 3-month quarter(s) that is/are their respective EHR reporting period.

++ For EPs, the 3-month quarters are as follows:

—January 1, 2014 through March 31, 2014

—April 1, 2014 through June 30, 2014

—July 1, 2014 through September 30, 2014

—October 1, 2014 through December 31, 2014

++ For eligible hospitals and CAHs, the 3-month quarters are as follows:

—October 1, 2013 through December 31, 2013

—January 1, 2014 through March 31, 2014

—April 1, 2014 through June 30, 2014

—July 1, 2014 through September 30, 2014

In all cases of electronic submission, the submission period will be the 2 months immediately following the end of the CY or FY, respectively. This submission period will apply regardless of whether an EP, eligible hospital or CAH reports CQM data for the full CY or FY, respectively, or only for a 3-month quarter:

  • EPs: January 1, 2015 through February 28, 2015.
  • Eligible Hospitals and CAHs: October 1, 2014 through November 30, 2014.

The reporting periods for CQMs in 2015 and in subsequent years for EPs, eligible hospitals, and CAHs that are beyond their first year of meaningful use will be the full CY or FY, respectively. For EPs, we expect to accept a single annual submission. For eligible hospitals and CAHs, we expect to align with the submission frequency of the Hospital IQR program for electronic reporting of CQMs.

We summarize the reporting and submission periods beginning with CY/FY 2014 for EPs, eligible hospitals, and CAHs reporting CQMs via attestation in Table 5 and reporting CQMs electronically in Table 6.

Table 5—Reporting and Submission Periods for EPs, Eligible Hospitals and CAHs in Their First Year of Meaningful Use Submitting CQMs via Attestation Beginning With CY/FY 2014 Back to Top
Provider type Reporting period for first year of meaningful use (Stage 1) Submission period for first year of meaningful use (Stage 1)*
*For purposes of avoiding a payment adjustment, Medicare EPs and eligible hospitals that are in their first year of demonstrating meaningful use in the year immediately preceding a payment adjustment year must submit their CQM data no later than October 1 (EPs) or July 1 (eligible hospitals) of such preceding year.
EP 90 consecutive days Anytime immediately following the end of the 90-day reporting period, but no later than February 28 of the following calendar year.
Eligible Hospital/CAH 90 consecutive days Anytime immediately following the end of the 90-day reporting period, but no later than November 30 of the following fiscal year.
Table 6—Reporting and Submission Periods for EPs, Eligible Hospitals and CAHs Beyond Their First Year of Meaningful Use Submitting CQMs Electronically Beginning With CY/FY 2014 Back to Top
Provider type Optional reporting period in 2014* Reporting period for subsequent years of meaningful use (stage 1 and subsequent stages) Submission period for subsequent years of meaningful use (stage 1 and subsequent stages)*
*NOTE: The optional quarter reporting periods have the same submission period as a full year reporting period for electronic submission.
EP Calendar year quarter: January 1-March 31 April 1-June 30 July 1-September 30 October 1-December 31 1 calendar year (January 1-December 31) 2 months following the end of the reporting period (January 1-February 28).
Eligible Hospital/CAH Fiscal year quarter October 1-December 31 January 1-March 31 April 1-June 30 July 1-September 30 1 Fiscal year (October 1-September 30) 2 months following the end of the reporting period (October 1-November 30).

2. EHR Technology Certification Requirements for Reporting of CQMs

ONC adopts certification criteria for EHR technology and proposed a 2014 Edition of certification criteria in a proposed rule (77 FR 13832). As such, we proposed to require that CEHRT, as defined by ONC, must be used by EPs, eligible hospitals, and CAHs to satisfy their CQM reporting requirements (77 FR 13743). We proposed that CQM reporting methods could include the following:

  • Aggregate reporting methods (EPs, eligible hospitals, and CAHs):

++ Attestation

++ Electronic submission

  • Patient-level reporting methods:

++ The PQRS EHR reporting option, the group reporting options for PQRS, the Medicare SSP or Pioneer ACOs (note: these are reporting methods for EPs)

++ The manner similar to the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot for Eligible Hospitals and CAHs.

For the attestation and aggregate electronic reporting methods, we proposed that EPs, eligible hospitals, and CAHs must only submit CQMs that their EHR technology had been certified to “incorporate and calculate” (45 CFR 170.314(c)(2) in ONC's rule). For example, if an EP's CEHRT was certified to calculate CQMs #1 through #9, and the EP submitted CQMs #1 through #8 and #25, the EP would not have met the meaningful use requirement for reporting CQMs because his/her CEHRT was not certified to calculate CQM #25. For the attestation and aggregate electronic reporting methods, we proposed that CEHRT must be certified to the “reporting” certification criterion proposed for adoption by ONC at 45 CFR 170.314(c)(3) and which focused on EHR technology's capability to create and transmit a standard aggregate XML-based file that CMS can electronically accept.

Comment: Most commenters supported the requirement that EHR technology certified to the 2014 Edition EHR certification criteria should be able to capture, accurately calculate and transmit CQM data. Many of these commenters pointed out EHR technology certified to the 2011 Edition EHR certification criteria did not produce accurate results and was not explicitly tested and certified for accurate CQM calculation. As a result of experiences in Stage 1, some commenters recommended requiring that EHR technologies be able to calculate all measures finalized by CMS in order to be certified rather than requiring only one CQM to be certified, as was proposed by ONC to satisfy the Base EHR definition. Others supported EHR technology's output of data to another product for calculation or output in the Quality Reporting Data Architecture (QRDA) format. Many commenters also supported consistency among EHR technologies based on certification and adequate testing of the systems during certification, including use of test data. One commenter recommended closer oversight of vendors by ONC and a remediation process for vendors who do not properly implement CEHRT.

Many commenters stated that the specific XML-based format required by CMS for CQM reporting should be incorporated into ONC's certification criteria. One commenter suggested that all vendors focus on codified data collection and provide complete CCD extractions to another system (such as PopHealth) and allow that system to manage the calculations and data tables as well as provide the extraction of data for a QRDA report, stating that this method would save time and money because it would not require testing each individual EHR product. Another commenter supported the use of CQM definitions that include standards for technical and electronic specifications that allow for interoperability across EHRs and consistent use among end users.

Response: Comments on EHR technology certification requirements are outside the scope of this final rule and are addressed in ONC's Standards and Certification Criteria (S&CC) final rule published elsewhere in this issue of the Federal Register. ONC has addressed the CQM requirements for the Base EHR definition, the standards necessary for the submission of CQM data to CMS, and has made other conforming revisions to the proposed certification criteria in response to public comments received.

Comment: Several commenters stated that it was unrealistic to expect the transition to EHR technology certified to the 2014 Edition EHR certification criteria to be feasible for all EPs and all eligible hospitals and CAHs at the same time. These commenters explained that EHR vendors would need to develop, test, distribute upgraded products, and provide user support for a large number of clients in a short amount of time. Furthermore, EPs, eligible hospitals, and CAHs would need to devote time and resources as well as have qualified staff to purchase and implement the upgraded technology, including testing the system and training staff, which may include designing new clinical workflows. The commenters requested a more reasonable approach to transitioning to the upgraded technology that would ensure proper implementation and avoid compromising patient safety.

Response: We acknowledge that the transition to upgraded EHR technology will be a challenge for all parties involved. Due to several interrelated factors addressed by ONC and CMS to relieve regulatory burden in our respective final rules, we have respectively included certain new flexibilities for EPs, eligible hospitals, and CAHs in order to allow for a more reasonable transition to the upgraded technology. ONC has decided to finalize a more flexible CEHRT definition for the EHR reporting periods in FY/CY 2013, which would permit EPs, eligible hospitals, and CAHs to use EHR technology that has been certified only to the 2014 Edition EHR certification criteria.

For EPs, eligible hospitals, and CAHs that seek to use EHR technology certified only to the 2014 Edition EHR certification criteria in FY/CY 2013, we note that EHR technology certified to these criteria reflect the new set of CQMs we adopt in this rule for reporting beginning with FY/CY 2014. We also note that the reporting requirements in FY/CY 2013 are otherwise the same as for FY/CY 2011 and 2012, including reporting on the CQMs that were finalized in the July 28, 2010 Stage 1 final rule. For EPs, the reporting schema for CY 2013 will remain 3 core or alternate core CQMs, and 3 additional CQMs, as explained in section II.B.5.b. of this final rule. We note that EHR technology certified to the 2014 Edition certification criteria will exclude the three CQMs that we are removing from the list of EP CQMs for reporting beginning in CY 2014 (NQF 0013, 0027, 0084). NQF 0013 is in the list of core CQMs in the Stage 1 final rule, but just as in the case where one of the core CQMs would not apply to an EP's scope of practice or unique patient population, EPs can select one CQM from the list of alternate core CQMs to replace NQF 0013. Therefore, in order to meet the CQM reporting criteria for meaningful use in CY 2013, EPs who seek to use EHR technology certified only to the 2014 Edition EHR certification criteria could only select from CQMs that are included in both the Stage 1 and Stage 2 final rules. For eligible hospitals and CAHs, the reporting schema for FY 2013 will remain all 15 of the CQMs finalized for reporting in FYs 2011 and 2012 because all CQMs that were included in the Stage 1 final rule are also included in the Stage 2 final rule.

Comment: Most commenters stated that CQM exceptions (allowable reason for non-performance of a quality measure for patients that meet the denominator criteria and do not meet the numerator criteria) should be incorporated into the CQM certification requirements. Many commenters also stated that EPs should not be penalized if it is later determined that a vendor has not met the certification requirement as it would be burdensome and expensive to then purchase additional certified modules and modify workflows after an existing EHR is determined to be non-certified. The same commenters believed that EPs should have an exemption from CQM reporting requirements of meaningful use until measures have been tested and vendors have shown they have met the certification requirements.

Some commenters requested delaying implementation of CQMs that require information from Labor and Delivery information systems until they are certified. One commenter stated that EHR technology should be based on the 2011 Edition EHR certification criteria. Another commenter stated that very few vendors are providing QI measure data integrity and error-checking algorithms, citing the information in FAQ 10839 which includes that CMS does not require providers to record all clinical data in their CEHRT but that providers should report the CQM data exactly as it is generated as output from CEHRT.

Response: We do not agree with the suggestion that EHR technology should based on the 2011 Edition EHR certification criteria. The 2014 Edition EHR certification criteria are significantly enhanced compared to 2011 Edition and we believe that it is important for EPs, eligible hospitals and CAHs to adopt, implement, and use EHR technology based on the updated certification criteria. We expect that the enhancements in the 2014 Edition certification criteria will address the accuracy of outputs from CEHRT.

We agree generally with the rest of the comments. All CQMs included in this final rule will have electronic specifications available at or around the time of publication. Certification requirements are outside the scope of this rule. We refer readers to ONC's S&CC final rule published elsewhere in this issue of the Federal Register for information of certification requirements for items such as CQM exceptions. We discuss the testing of CQM specifications in section II.B.4. of this final rule. We encourage EPs, eligible hospitals and CAHs to refer to the Certified HIT Products List when selecting an EHR product (http://oncchpl.force.com/ehrcert). We also encourage EPs, eligible hospitals, and CAHs to discuss their intent to participate in the EHR Incentive Programs with their vendors, and for vendors to communicate intentions related to certification of a product with EPs, eligible hospitals or CAHs.

After consideration of the public comments received, we are finalizing the proposals related to EHR technology certification requirements for reporting of CQMs subject to the discussion earlier. They include:

  • The data reported to CMS for CQMs must originate from an EP's, eligible hospital's, or CAH's CEHRT that has been certified to “capture and export” in accordance with 45 CFR 170.314(c)(1) and “electronic submission” in accordance with 45 CFR 170.314(c)(3).
  • For attestation and the aggregate electronic reporting methods, the only CQMs that can be reported are those for which an EP's, eligible hospital's, or CAH's CEHRT has been certified to “import and calculate” in accordance with 45 CFR 170.314(c)(2).
  • In FY/CY 2013, if an EP, eligible hospital, or CAH seeks to use EHR technology certified only to the 2014 Edition EHR certification criteria for reporting CQMs, they can only report those CQMs that are included in both the Stage 1 and Stage 2 final rules. For EPs, this would exclude the option of reporting NQF 0013, 0027, 0084 from the CQMs in the Stage 1 final rule. Since NQF 0013 is a core CQM in the Stage 1 final rule, EPs would select one of the alternate core CQMs to replace it. All 15 CQMs for eligible hospitals and CAHs in the Stage 1 final rule are included in the Stage 2 final rule.

3. Criteria for Selecting CQMs

We solicited comment on a wide-ranging list of 125 potential CQMs for EPs and 49 potential CQMs for eligible hospitals and CAHs. We stated that we expected to finalize only a subset of these proposed CQMs. We discussed several criteria that we used to select the proposed CQMs.

In the proposed rule, we stated our commitment to align quality measurement and reporting among our programs (for example, IQR, PQRS, CHIPRA, ACO programs). We noted that our alignment efforts focus on several fronts including using the same measures for different programs, standardizing the measure development and electronic specification processes across CMS programs, coordinating quality measurement stakeholder involvement efforts, and identifying ways to minimize multiple submission requirements and mechanisms. In the proposed rule, we gave the example that we are working toward allowing CQM data submitted via CEHRT by EPs, eligible hospitals and CAHs to apply to other CMS quality reporting programs. A longer-term vision would be hospitals and clinicians reporting through a single, aligned mechanism for multiple CMS programs. We stated our belief that the alignment options proposed for PQRS/EHR Incentive Program would be a first step toward such a vision.

Comment: There was strong support for aligning CQMs and reporting mechanisms across multiple quality reporting programs as well as alignment with the goals of the National Quality Strategy and the HIT Policy Committee recommendations. However, some commenters addressed utility of the CQMs within the EHR Incentive Program as follows:

  • Removal of measures that are not included under other quality reporting programs.
  • Alignment in other areas such as specifications, reporting methods and to whom measures are reported.
  • Concern that the penalties that will be applied in 2015, given the many problems that were encountered implementing Stage 1 CQMs.
  • Administrative burden required by multiple submission requirements and multiple reporting mechanisms. Where possible, one commenter encouraged CMS to promote and/or mandate similar action for state, accreditation body, and private payer reporting.

Response: We appreciate the comments received and have made every effort to accommodate the concerns by aligning quality reporting for EPs with the PQRS EHR Reporting Option and establishing an infrastructure for eligible hospitals and CAHs that could be used by IQR and other hospital reporting programs to electronically report CQMs.

We continue to explore how data intermediaries and state Medicaid Agencies could participate in and further enable these quality measurement and reporting alignment efforts, while meeting the needs of multiple Medicare and Medicaid programs (for example, ACO programs, Dual Eligible initiatives, Medicaid shared savings efforts, CHIPRA and Affordable Care Act measure sets). Through these efforts, we intend to lessen provider burden and harmonize with our data exchange priorities.

In addition to statutory requirements for EPs (see section II.B.5.a. of this final rule), eligible hospitals (see sections II.B.7.a. of this final rule), and CAHs (see section II.B.7.a. of this final rule), we relied on other criteria to select the proposed CQMs for EPs, eligible hospitals, and CAHs such as measures that can be technically implemented within the capacity of the CMS infrastructure for data collection, analysis, and calculation of reporting and performance rates. This includes measures that are ready for implementation, such as those with developed specifications for electronic submission that have been used in the EHR Incentive Program or other CMS quality reporting initiatives, or that will be ready soon after the expected publication of the final rule in 2012. This also includes measures that can be most efficiently implemented for data collection and submission.

Comment: There were several comments on infrastructure regarding quality measures, the selection of quality measures, challenges of implementing EHRs and the lack of coordination between measure developers and software vendors. These comments included the following:

  • CQMs require data that is not coded in a structured format within the EHRs and thus require significant resources and effort, including specialized coding and training, in order to build CQMs within the EHR systems that can produce accurate results.
  • CMS should only include measures which have been sufficiently field tested and validated. The National Qualify Forum's (NQF) Quality Data Model (QDM) and Measure Authoring Tool (MAT) have not been sufficiently tested to ensure valid and accurate EHR CQM calculations.
  • A general lack of communication between vendors and measure stewards.

There were also several comments providing additional recommendations for selecting quality measures, including CQMs that:

  • Can be automatically abstracted from an EHR.
  • Rely on data that is considered viable and accurate.
  • Definitively support quality care improvement.
  • Align with current quality programs.

Response: The CQMs that we are finalizing for reporting beginning with 2014 have either undergone feasibility testing in EHR systems and clinical settings or were finalized in the Stage 1 final rule for reporting in 2011 and 2012 and specifications have been updated based on experiences with reporting those CQMs. In addition, ONC's 2014 Edition certification criteria explicitly require that the data elements be captured for certification (see 45 CFR 170.314(c), as discussed in ONC's final rule). We have taken into account the recommendations of commenters in our selection of the CQMs finalized for reporting beginning in 2014, and we are finalizing measures that align with current clinical quality programs as well as definitively support quality care improvements.

Comment: Commenters pointed out the limitations of current CQMs in addressing longitudinal patient care management and population health.

Response: We are finalizing CQMs for EPs, eligible hospitals, and CAHs that will have electronic specifications available at or around the time of publication of the final rule and also meet the selection criteria described in this rule. We agree with the importance of the clinical quality measurement goals mentioned by the commenters and are working with measure stewards and measure developers to create a broader set of electronic CQMs that would address these goals.

We also identified the following as criteria used in selecting CQMs:

  • CQMs that can be technically implemented within the capacity of the CMS infrastructure for data collection, analysis, and calculation of reporting and performance rates. This includes CQMs that are ready for implementation, such as those with developed specifications for electronic submission that have been used in the EHR Incentive Program or other CMS quality reporting initiatives, or that will be ready soon after the expected publication of the final rule in 2012. This also includes CQMs that can be most efficiently implemented for data collection and submission.
  • CQMs that support CMS and HHS priorities for improved quality of care for people in the United States, which are based on the March 2011 report to the Congress, “National Strategy for Quality Improvement in Health Care” (National Quality Strategy, NQS) (http://www.healthcare.gov/law/resources/reports/nationalqualitystrategy032011.pdf) and the Health Information Technology Policy Committee's (HITPC's) recommendations (http://healthit.hhs.gov/portal/server.pt?open=512&amp;objID=1815&amp;parentname=CommunityPage&amp;parentid=7&amp;mode=2&amp;in_hi_userid=11113&amp;cached=true).
  • CQMs that address known gaps in quality of care, such as measures in which performance rates are currently low or for which there is wide variability in performance, or that address known drivers of high morbidity and/or cost for Medicare and Medicaid.
  • CQMs that address areas of care for different types of EPs (for example, Medicare- and Medicaid-eligible physicians, and Medicaid-eligible nurse-practitioners, certified nurse-midwives, dentists, physician assistants).

In an effort to align the CQMs used within the EHR Incentive Program with the goals of CMS and HHS, the NQS, and the HITPC's recommendations, we have assessed all proposed CQMs against six domains based on the NQS's six priorities, which were further developed by the HITPC Workgroups, as follows:

  • Patient and Family Engagement. These are CQMs that reflect the potential to improve patient-centered care and the quality of care delivered to patients. They emphasize the importance of collecting patient-reported data and the ability to impact care at the individual patient level as well as the population level through greater involvement of patients and families in decision making, self care, activation, and understanding of their health condition and its effective management.
  • Patient Safety. These are CQMs that reflect the safe delivery of clinical services in both hospital and ambulatory settings and include processes that would reduce harm to patients and reduce burden of illness. These measures should enable longitudinal assessment of condition-specific, patient-focused episodes of care.
  • Care Coordination. These are CQMs that demonstrate appropriate and timely sharing of information and coordination of clinical and preventive services among health professionals in the care team and with patients, caregivers, and families in order to improve appropriate and timely patient and care team communication.
  • Population and Public Health. These are CQMs that reflect the use of clinical and preventive services and achieve improvements in the health of the population served and are especially focused on the leading causes of mortality. These are outcome-focused and have the ability to achieve longitudinal measurement that will demonstrate improvement or lack of improvement in the health of the US population.
  • Efficient Use of Healthcare Resources. These are CQMs that reflect efforts to significantly improve outcomes and reduce errors. These CQMs also impact and benefit a large number of patients and emphasize the use of evidence to best manage high priority conditions and determine appropriate use of healthcare resources.
  • Clinical Processes/Effectiveness. These are CQMs that reflect clinical care processes closely linked to outcomes based on evidence and practice guidelines.

We solicited comments on these domains, and whether they would adequately align with and support the breadth of CMS and HHS activities to improve quality of care and health outcomes.

Comment: Many commenters supported the NQS initiative. Many commenters stated that the domains were imprecise and some CQMs can be placed in multiple domains. Some commenters recommended that the Care Coordination domain include pre- and post-acute care providers and that the CQMs be carefully assigned to the appropriate domains.

Response: We appreciate the supportive comments with respect to the NQS. We agree with commenters that certain CQMs do not fit in only a single domain. When we considered CQMs for selection, we also considered to what extent a domain is already represented in the meaningful use objectives and measures, which use performance thresholds. For example, in the area of care coordination, to be a meaningful EHR user, a provider must provide a summary of care record for more than 50 percent of their transitions of care and referrals. In addition, in the area of patient and family engagement, to be a meaningful EHR user a provider must make patients' health information available to them and potentially their caregivers and families and is responsible for ensuring that at least 5 percent of their patients or their caregivers and families actually access that information. For these reasons, we are relaxing the requirement to report CQMs in each domain as discussed in section II.B.5.c. of this final rule for EP reporting requirements and II.B.7.c. of this final rule for eligible hospital and CAH reporting requirements.

We stated in the proposed rule that we also considered the recommendations of the Measure Applications Partnership (MAP) for inclusion of CQMs. The MAP is a public-private partnership convened by the National Quality Forum (NQF) for the primary purpose of providing input to HHS on selecting performance measures for public reporting. The MAP published draft recommendations in their Pre-Rulemaking Report on January 11, 2012 (http://www.qualityforum.org/map/), which includes a list of, and rationales for, all the CQMs that the MAP did not support. The MAP did not review the CQMs for 2011 and 2012 that were previously adopted for the EHR Incentive Program in the Stage 1 final rule. We stated in the proposed rule that we included some of the CQMs not supported by the MAP in Tables 7 (EPs) and 8 (eligible hospitals and CAHs) to ensure alignment with other CMS quality reporting programs, address recommendations by other Federal advisory committees such as the HITPC, and support other quality goals such as the Million Hearts Campaign. We also stated that we included some CQMs to address specialty areas that may not have had applicable CQMs in the Stage 1 final rule.

We stated in the proposed rule that we anticipated that only a subset of these CQMs would be finalized. We stated that in considering which measures to finalize, we would take into account public comment on the CQMs themselves and the priorities listed previously. We also stated that we intended to prioritize CQMs in order to align with and support to the extent possible the measurement needs of CMS program activities related to quality of care, delivery system reform, and payment reform, especially the following:

  • Encouraging the use of outcome measures, which provide foundational data needed to assess the impact of these programs on population health.
  • Measuring progress in preventing and treating priority conditions, including those affecting a large number of CMS beneficiaries or contributing to a large proportion of program costs.
  • Improving patient safety and reducing medical harm.
  • Capturing the full range of populations served by CMS programs.

Comment: Several commenters support the inclusion of CQMs recommended by the MAP. A commenter supported CQMs which are both MAP evaluated and NQF endorsed. Another commenter raised concern that CMS did not have enough time to consider the MAP recommendations as the CQMs published in the proposed rule differ from those recommended by the MAP. Some commenters were concerned that limiting the CQMs to MAP-supported and/or NQF-endorsed CQMs would discourage CQM innovation and the creation of novel CQMs and those that cover more specialties.

Response: We carefully considered the MAP recommendations and took NQF endorsement status into consideration when making our CQM selections for reporting beginning with 2014. In order to align with other quality reporting programs and address recommendations by other Federal advisory committees, such as the HITPC, as well as consider CQMs endorsed by other multistakeholder groups, we considered CQMs that were not supported by the MAP. After consideration of the public comments received, we are finalizing the policies on criteria for selecting CQMs as proposed.

4. CQM Specification

We stated in the proposed rule that we do not intend to use notice and comment rulemaking as a means to update or modify CQM specifications. In general, it is the role of the measure steward to make changes to a CQM in terms of the initial patient population, numerator, denominator, and potential exclusions. We recognized that it may be necessary to update CQM specifications after they have been published to ensure their continued relevance, accuracy, and validity. Measure specifications updates may include administrative changes, such as adding the NQF endorsement number to a CQM, correcting faulty logic, adding or deleting codes as well as providing additional implementation guidance for a CQM.

These changes would be described in full through supplemental updates to the electronic specifications for EHR submission provided by CMS. We stated that measures would be tracked on a version basis as updates to those CQMs are made, and we would require EPs, eligible hospitals, and CAHs to submit the versions of the CQMs as identified on our Web site.

We stated in the proposed rule that the complete CQM specifications would be posted on our Web site (https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp) at or around the time of the final rule. In order to assist the public in considering the proposed CQMs, we published tables titled “Proposed CQMs for 2014 CMS EHR Incentive Programs for Eligible Professionals” and “Proposed CQMs for 2014 CMS EHR Incentive Programs for Eligible Hospitals and CAHs” on this Web site. These tables contain additional information for the EP, eligible hospital, and CAH CQMs, respectively, which may not be found on the NQF Web site. We noted that some of the CQMs were still being developed and that the additional descriptions provided in the tables may still change before the final rule is published. We noted that the titles and descriptions for the CQMs included in these tables were updated by the measure stewards and therefore may not match the information provided on the NQF Web site.

We proposed that, under certain circumstances, it may be necessary to remove a CQM from the EHR Incentive Programs between rulemaking cycles. We stated in the proposed rule that when there is reason to believe the continued collection of a CQM as it is currently specified raises potential patient safety concerns and/or is no longer scientifically valid, we would take immediate action to remove the CQM from the EHR Incentive Programs and not wait for the next rulemaking cycle. Likewise, we stated if a CQM undergoes a substantive change by the measure steward between rulemaking cycles such that the measure's intent has changed, we would remove the measure immediately from the EHR Incentive Programs until the next rulemaking cycle when we could propose the revised CQM for public comment. Under this proposed policy, we would promptly remove such CQMs from the set of CQMs available for EPs or eligible hospitals and CAHs to report under the EHR Incentive Programs, confirm the removal or propose the revised CQM, in the next EHR Incentive Programs rulemaking cycle, and notify providers (EPs, eligible hospitals, and CAHs) and the public of our decision to remove the CQM(s) through the usual communication channels (memos, email notification, web site postings).

Comment: Numerous commenters indicated the importance of having CQM specifications and implementation guides as soon as possible. Several commenters pointed out that CQMs without electronic specifications should be re-tooled as eMeasures prior to inclusion in meaningful use.

Response: We will provide complete CQM specifications at or around the time of the publication of this final rule on our Web site (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/ElectronicSpecifications.html). All of the CQMs that we are finalizing will be fully specified.

Comment: Many commenters noted that more than 6 months is needed to deploy and adequately test upgrades that may affect clinician workflows and patient safety. Other commenters stated that software developers need at least 18 to 24 months to alter their systems and allow for installation of software to complete process updates, development, testing, error checks, training, and roll-out before the reporting periods begin. Multiple commenters requested notification and a scheduled approach to making changes to CQM specifications. Commenters suggested that CMS post the CQMs and updates in one place for easy reference.

Response: We understand health care providers and software developers need sufficient time to accommodate CQM specification updates. However, we must balance this with our policy priority for CQMs to remain consistent with clinical practice guidelines and any new scientific data related to efficacy. To address the timing concerns mentioned by commenters, we expect to make the updated specifications, which will be tracked on a version basis, publicly available through our Web site (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/ElectronicSpecifications.html) approximately 6 months in advance of the beginning of the CY and FY for EPs and hospitals, respectively. We will make every effort to have updated specifications made available earlier and ensure that measure updates are limited in scope. In the event that we remove CQMs between rulemakings, we will post this information on the same Web site and notify the public through listserv and any additional communication channels that may be appropriate.

Comment: Many commenters stated that CQM specifications should not have to be updated in CEHRT during the period for which the EHR product is certified. Some commenters pointed out the burden and complexity of supporting multiple versions of the CQMs concurrently (that is, the specifications authorized for use within the current reporting period, and the updated specifications intended for implementation in the following reporting period).

Response: CQM specifications are updated to maintain alignment with current clinical guidelines and ensure that the CQM remains relevant and actionable within the clinical care setting. We believe the benefits of having the ability to update specifications more frequently than the rulemaking cycle for the EHR Incentive Programs outweighs the burden and complexity identified by commenters.

As a result of aligning with other quality reporting programs (for example, PQRS), the CQMs and specifications are being used in multiple programs. If we do not have the ability to update specifications annually, then our respective programs may no longer align. Furthermore, without having the ability to update the specifications at least annually, the CQMs could become obsolete and would not adequately reflect current best practices. The majority of the administrative changes expected in the annual specification updates would reflect updates that vendors would routinely push to their clients' EHR technologies (for example, drug code updates).

We did not receive any comments on our proposed policy to remove CQMs between rulemaking cycles under certain circumstances.

After consideration of the public comments received, we are finalizing the following policies on CQM specifications. Updates to CQM specifications may be provided annually approximately 6 months in advance of the FY/CY for hospitals and EPs, respectively. Providers will not be required to use the updated specifications for purposes of submitting the CQMs for the EHR Incentive Program unless specified in future rulemaking. We note that EPs choosing to submit CQMs through another quality reporting program (for example, PQRS) would need to use the updated specifications if required by the other program. We are finalizing the policy on removing CQMs between rulemaking cycles under certain circumstances as proposed. In the event that one or more CQMs are removed between rulemakings, the number of CQMs that an EP, eligible hospital, or CAH must report would be reduced by the number of CQMs removed. For example, if one EP CQM was removed from the set of CQMs finalized for EPs in Table 7, EPs would only be required to submit 8 CQMs instead of 9. Likewise, if a hospital CQM is removed from the set of CQMs finalized in Table 8, eligible hospitals and CAHs would only be required to submit 15 CQMs instead of 16. The requirement that the CQMs submitted cover at least 3 domains will remain the same unless all CQMs for a particular domain have been eliminated. EPs that are not affected by such a removal of a CQM between rulemakings and could report on other CQMs are expected to continue reporting on 9 CQMs. Likewise, eligible hospitals and CAHs that are not affected and could report on other CQMs are expected to continue reporting on 16 CQMs.

5. CQMs for EPs

(a) Statutory and Other Considerations

Sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C) of the Act provide for the reporting of CQMs by EPs as part of demonstrating meaningful use of CEHRT. For further explanation of the statutory requirements, we refer readers to the discussion in our proposed and final rules for Stage 1 (75 FR 1870 through 1902 and 75 FR 44380 through 44435, respectively).

Under sections 1848(o)(1)(D)(iii) and 1903(t)(8) of the Act, the Secretary must seek, to the maximum extent practicable, to avoid duplicative requirements from federal and state governments for EPs to demonstrate meaningful use of CEHRT under Medicare and Medicaid. Therefore, to meet this requirement, we continued our practice from Stage 1 of proposing CQMs that would apply for both the Medicare and Medicaid EHR Incentive Programs, as listed in sections II.B.5.b. and II.B.5.c. of this final rule.

Section 1848(o)(2)(B)(iii) of the Act requires that in selecting CQMs for EPs, and in establishing the form and manner of reporting, the Secretary shall seek to avoid redundant or duplicative reporting otherwise required, including reporting under subsection (k)(2)(C) (that is, reporting under the PQRS). Consistent with that requirement, we proposed to select CQMs for EPs for the EHR Incentive Programs that align with other quality reporting programs mentioned in the proposed rule (77 FR 13745). We stated in the proposed rule that when a CQM is included in more than one CMS quality reporting program and is reported using CEHRT, we would seek to avoid requiring EPs to report the same CQM to separate programs through multiple transactions or mechanisms.

Section 1848(o)(2)(B)(i)(I) of the Act requires the Secretary to give preference to CQMs endorsed by the entity with a contract with the Secretary under section 1890(a) (namely, the NQF). We proposed CQMs for EPs for 2013, 2014, and 2015 (and potentially subsequent years) that reflect this preference, although we note that the Act does not require the selection of NQF endorsed CQMs for the EHR Incentive Programs. CQMs listed in this final rule that do not have an NQF identifying number are not NQF endorsed, but are included in this final rule with the intent of eventually obtaining NQF endorsement of those CQMs determined to be critical to our program.

We stated our intent to increase the total number of CQMs for EPs to include areas such as behavioral health, dental care, long-term care, special needs populations, and care coordination. We proposed new pediatric CQMs, an obstetric CQM, behavioral/mental health CQMs, CQMs related to HIV medical visits and antiretroviral therapy, two oral health CQMs, as well as other CQMs that address NQS goals. Although we did not propose additional CQMs in the areas of long-term and post-acute care due to the lack of electronic specifications, we stated that we would continue to develop or identify CQMs for these areas for future years. We received public comments related to statutory and other considerations. We have responded to those comments in later sections of this final rule, including comments related to form and manner and the clinical areas covered by specific CQMs (see sections II.B.6.c. or II.B.6.d. of this final rule).

(b) CQMs for EPs for CY 2013

We proposed that for the EHR reporting periods in CY 2013, EPs must submit data for the CQMs that were finalized in the Stage 1 final rule for CYs 2011 and 2012 (75 FR 44398 through 44411, Tables 6 and 7). We stated that we expected to post updates to the CQMs' electronic specifications on the EHR Incentive Program Web site at least 6 months prior to the start of CY 2013. As required by the Stage 1 final rule, EPs must report on 3 core or alternate core CQMs, plus 3 additional CQMs. We referred readers to the discussion in the Stage 1 final rule for further explanation of the requirements for reporting those CQMs (75 FR 44398 through 44411).

We received no public comments and are finalizing these proposals for EPs for CY 2013. We have posted updates to the CQM specifications on the EHR Incentive Program Web site (https://www.cms.gov/apps/ama/license.asp?file=/QualityMeasures/Downloads/QMEPSupplemental.zip) and note that they will be optional with respect to CY 2013 reporting.

(c) CQMs and Reporting Options for EPs Beginning with CY 2014

(i) Reporting Options

We proposed two reporting options that would begin in CY 2014 for Medicare and Medicaid EPs, as described as follows: Options 1 and 2. We proposed the CQMs listed in Table 8 of the proposed rule (77 FR 13749 through 13757) for all EPs (Medicare and Medicaid) for the EHR reporting periods in CYs 2014, 2015, and potentially subsequent years, regardless of whether an EP is in Stage 1 or Stage 2 of meaningful use. We stated that the policies and CQMs proposed for CYs 2014 and 2015 would continue to apply in CY 2016 and subsequent years until a new rule is published. Therefore, we referred to CQMs that apply ”beginning with” or ”beginning in” CY 2014. We stated that for Medicaid EPs, although the reporting method for CQMs may vary by state, the set of CQMs from which to select would be the same as for Medicare EPs. We stated that Medicare EPs who are in their first year of Stage 1 may report CQMs by attestation.

For Option 1, we proposed two alternatives (Options 1a and 1b), but stated that we intended to finalize only a single method. We proposed that Medicare EPs who participate in both the PQRS EHR reporting option and the EHR Incentive Program may choose Option 2 instead of Option 1.

  • Option 1a: We proposed that EPs would select and report 12 CQMs from those listed in Table 8 of the proposed rule (77 FR 13749 to 13757), including at least 1 CQM from each of the 6 domains, which are described in section II.B.3. of this final rule. EPs would select the CQMs that best apply to their scope of practice and/or unique patient population. If an EP's CEHRT does not contain patient data for at least 12 CQMs, then the EP must report the CQMs for which there is patient data and report the remaining required CQMs as ”zero denominators” as displayed by the EPs CEHRT. If there are no CQMs applicable to the EP's scope of practice or unique patient populations, EPs must still report 12 CQMs even if zero is the result in either the numerator and/or the denominator of the CQM. If all applicable CQMs have a value of zero from their CEHRT, then EPs must report any 12 of the CQMs. We noted one advantage of this approach is that EPs can choose CQMs that best fit their practice and patient populations. However, because of the large number of CQMs to choose from, this approach would result in fewer EPs reporting on any given CQM, and likely only a small sample of patient data represented in each CQM. We proposed that EPs would submit the CQM data in an XML-based format on an aggregate basis reflective of all patients without regard to payer.
  • Option 1b: We proposed that EPs would report 11 “core” CQMs listed in Table 6 of the proposed rule (77 FR 13746 to 13747), plus 1 “menu” CQM from Table 8 of the proposed rule (77 FR 13749 to 13757). We noted that the ”core” CQM set reflected the national priorities outlined in section II.B.3. of the proposed rule. EPs would select 1 CQM to report from the “menu” set based on their respective scope of practice and/or unique patient population. We explained one advantage of this approach is that quality data would be collected on a smaller set of CQMs, so the resulting data for each CQM would represent a larger number of patients and therefore could be more accurate. However, this approach could mean that more CQMs are reported with zero denominators (if they are not applicable to certain practices or populations), making the data less comprehensive. We stated that the policy on reporting ”zeros” in the numerator and/or denominator of a CQM, as discussed previously under Option 1a, would also apply for Option 1b.
  • Option 2: Submit and satisfactorily report CQMs under the PQRS's EHR Reporting Option.

We proposed that Medicare EPs who participate in both the PQRS EHR reporting option and the EHR Incentive Program may choose Option 2 instead of Option 1. In order to streamline quality reporting options for EPs participating in both programs, we proposed that Medicare EPs who submit and satisfactorily report PQRS CQMs under the PQRS's EHR reporting option using CEHRT would satisfy the CQM reporting requirement under the Medicare EHR Incentive Program. We referred readers to 42 CFR 414.90 and the CY 2012 Medicare PFS final rule with comment period (76 FR 73314) for more information about the existing requirements of the PQRS and stated that EPs who choose this Option 2 would be required to comply with any changes to the requirements of the PQRS that may apply in future years.

Comment: Many commenters preferred Option 1a instead of 1b since it offers more flexibility and a larger selection of CQMs, especially for specialties including surgery, otolaryngology, urology, and psychiatry. However, they also indicated that it would be difficult to report 1 CQM from each of the 6 domains that apply to their scope of practice and/or unique patient population.

Other commenters supported Option 1b over 1a as long as it limits the number of CQMs to those that vendors would be required to support. A few commenters suggested removing the “one menu CQM” requirement entirely.

Many commenters suggested a modification of Options 1a and 1b to require reporting a specific number of core CQMs (fewer than the 11 proposed) and a specific number of menu CQMs (more than 1 as proposed) along with some changes to the domain requirement. Many commenters suggested a reporting option requiring EPs to report 6 clinically relevant CQMs covering at least 2 domains, and if no CQMs are clinically relevant for an EP, they must demonstrate zeros in the denominator for 6 CQMs covering at least 2 domains. A few commenters suggested requiring up to 9 CQMs covering a range of 2 to 4 domains. One commenter also advocated for the retention of all three reporting options (1a, 1b, and 2) so that EPs could select the one most appropriate to their practice.

Response: We agree that a modified approach for Option 1 would provide a more optimal reporting schema for most EPs. In our modified approach, we included the positive and minimized the negative components of each of the two proposed options where possible. The Option 1 that we are finalizing (as explained in detail later) decreases the number of CQMs that EPs must select to report, decreases the total number of domains required to be covered among the selected CQMs, recommends but does not require reporting from a “core” set of CQMs, and offers specialist EPs the flexibility to select CQMs that are applicable to their scope of practice.

We note the following CQMs in the finalized recommended core sets for adults and children were included in the proposed core set: NQF 0018, 0022, 0024, 0028, 0418, and TBD—Closing the referral loop: receipt of specialist report.

Comment: We also received many comments on Option 2. Numerous commenters supported Option 2, including the submission of CQM data via the PQRS program and receiving credit for both PQRS and meaningful use. However, some of these commenters indicated that not all EPs qualify to participate in PQRS. Another concern was that the patient population reported differs between the two programs in that PQRS requires reporting on Medicare patients only, whereas meaningful use reflects all patients without regard to payer.

Response: For the reporting of CQMs, we are finalizing Option 2 as proposed in order to reduce reporting burden on EPs who participate in both programs and attain the goal of alignment with the PQRS EHR reporting option. EPs who do not participate in PQRS may submit CQMs for the EHR Incentive Program using Option 1. Regardless of whether an EP chooses Option 1 or Option 2 for CQM reporting, we note that all EPs must also report the meaningful use objectives and measures through attestation, as well as meet all other meaningful use requirements.

We acknowledge that under the PQRS, only Medicare patient information is submitted. In general, our preference is to measure quality at the all patient level, based on samples of all patient data (that is, patients that meet the denominator criteria of each reported CQM). We believe this provides a better assessment of overall care quality rendered by EPs. However, although meaningful use reflects all patients without regard to payer, we believe Option 2 is appropriate because it is a step in the direction of the longer-term goal of a single, aligned mechanism for multiple CMS programs.

After consideration of the public comments received, and for the reasons discussed earlier, we are finalizing two reporting options beginning with CY 2014 for EPs in all stages of meaningful use. These options will continue to apply in the event that we have not engaged in another round of rulemaking by CY 2016.

Option 1: Report 9 CQMs covering at least 3 domains.

Medicare and Medicaid EPs selecting this reporting option will be required to submit a total of 9 CQMs covering at least 3 domains from Table 7. We expect EPs would select the CQMs that best apply to their scope of practice and/or unique patient population. For this reporting option, CQMs will be submitted on an aggregate basis reflective of all patients without regard to payer. We are not requiring the submission of a core set of CQMs, but we identify two recommended core sets, one for adults and one for children, that we encourage EPs to report to the extent those CQMs are applicable to an EP's scope of practice and patient population. If an EP's CEHRT does not contain patient data for at least 9 CQMs covering at least 3 domains, then the EP must report the CQMs for which there is patient data and report the remaining required CQMs as “zero denominators” as displayed by the EP's CEHRT. If there are no CQMs applicable to the EP's scope of practice and patient population, EPs must still report 9 CQMs even if zero is the result in either the numerator or the denominator of the measure. If all applicable CQMs have a value of zero from their CEHRT, then EPs must report any 9 CQMs from Table 7.

Option 2: Submit and satisfactorily report CQMs under the PQRS's EHR Reporting Option.

Under this option, Medicare EPs who participate in both the PQRS and the Medicare EHR Incentive Program will satisfy the CQM reporting component of meaningful use if they submit and satisfactorily report PQRS CQMs under the PQRS's EHR reporting option using CEHRT. EPs choosing to report under this option for purposes of the Medicare EHR Incentive Program will be subject to the reporting periods established for the PQRS EHR reporting option, which may be different from their EHR reporting period for the meaningful use objectives and measures. For example, in CY 2014, an EP who is beyond his or her first year of meaningful use will have a 3-month quarter EHR reporting period for the meaningful use objectives and measures, but the reporting periods for the PQRS EHR reporting option that fall within CY 2014 would apply for purposes of reporting CQMs. We emphasize that EPs who are in their first year of demonstrating meaningful use in the year immediately preceding a payment adjustment year cannot choose this Option 2 for reporting CQMs for the EHR Incentive Program. For purposes of avoiding a payment adjustment, they must submit their CQM data by attestation no later than October 1 of such preceding year. For more information on the requirements of the PQRS, we refer readers to 42 CFR 414.90 and the CY 2013 Medicare PFS proposed rule (77 FR 44805 through 44988). EPs who choose this option to satisfy the CQM reporting component of meaningful use under the Medicare EHR Incentive Program will be required to comply with any changes to the PQRS that may apply in future years.

(ii) CQMs

We proposed to remove three CQMs beginning with CY 2014 for EPs at all stages of meaningful use for the following reasons:

  • NQF # 0013—The measure steward did not submit this CQM to the NQF for continued endorsement. We included other CQMs that address high blood pressure and hypertension in Table 8 in the proposed rule.
  • NQF #0027—We determined this CQM is very similar to NQF #0028 a and b; therefore, to avoid duplication, we proposed to only retain NQF # 0028 a and b.
  • NQF #0084—The measure steward did not submit this CQM to the NQF for continued endorsement. Additionally, CMS has decided to remove this CQM because there are other FDA-approved anticoagulant therapies available in addition to Warfarin. We proposed to replace this measure, pending availability of electronic specifications, with NQF #1525—Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy.

We did not receive public comments and are finalizing the elimination of measures NQF #0013, NQF #0027, and NQF #0084 beginning with CY 2014 for EPs at all stages of meaningful use. We proposed to replace NQF #0084 with NQF #1525, which was determined to contain data elements that were difficult to capture in EHRs after additional feasibility testing. Therefore, we are implementing an Adverse Drug Events CQM to replace NQF #0084:

Title: ADE Prevention and Monitoring: Warfarin Time in Therapeutic Range.

Description: Average percentage of time in which individuals with atrial fibrillation who are on chronic anticoagulation have International Normalized Ratio (INR) test results within the therapeutic range during the measurement period.

For a list of all the CQMs proposed for EPs to report for the EHR Incentive Programs beginning with CY 2014, please refer to Table 8 in the Stage 2 proposed rule (77 FR 13749 to 13757). We stated that we expected to finalize only a subset of the CQMs listed in Table 8 based on public comments and the priorities discussed in section II.B.3. of the proposed rule.

We noted that some of these CQMs had not yet been submitted for consensus endorsement consideration or were under review for endorsement consideration by the NQF. We stated that we expect that any measure proposed in Table 8 for inclusion beginning with CY 2014 would be submitted for endorsement consideration by the measure steward. Because measure specifications may need to be updated more frequently than our expected rulemaking cycle will allow for, we stated that we would provide updates to the specifications at least 6 months prior to the beginning of the calendar year for which the measures would be required, and we expected to update specifications annually.

Comment: Many commenters indicated support for CMS's efforts to include CQMs that are broadly applicable across primary care and specialist EPs. However, many commenters also stated that most of the proposed CQMs apply to primary care practices and preventive medicine and requested more CQMs that apply to specialist practices or to adjust the reporting requirements to match the number of clinically available CQMs for nonprimary care EPs. Another commenter requested pediatricians be excluded from having to report on CQMs for patients older than 18 years old rather than having to demonstrate zero denominators on a population that does not apply to them.

Many commenters stated that there were too many CQMs, citing issues with implementation of such a large set of measures as well as diluting the impact of quality measurement. Some of these commenters believed that CMS should focus on a smaller set of CQMs to refine for accuracy in implementation. They also did not believe that they should have to build CQMs into their CEHRT if those CQMs did not apply to their scope of practice because those CQMs would only yield zero denominators. Some suggested alternatives to building out all CQMs included allowing EPs to attest to having a low denominator, such as 25 or fewer patients, or for CMS to assign the primary care or specialty fields that each CQM applies to, whereby EPs whose field is not listed for a particular CQM would be exempt from reporting that CQM.

Many of the proposed EP CQMs received support from the public. Some commenters gave feedback on specific proposed CQMs, including questions on the feasibility of reporting the CQM, issues with specific requirements of the CQM, and preferences for preventative CQMs. A few commenters did not support finalizing CQMs that were not NQF endorsed. We also received suggestions for additional CQMs that were not included in the list of 125 proposed EP CQMs. A few commenters expressed concern about the lack of transparency in the development of the CQMs.

Response: We stated in the Stage 2 proposed rule that we would be finalizing a subset of the proposed CQMs. We convened a Quality Measures Task Force (QMTF), which is made up of stakeholders from across the Department and includes representation from different quality reporting programs. Through the QMTF and with senior leadership, we considered public comments, feasibility of the electronic specifications to be captured in EHRs, and the goals stated in section II.B.3. of this final rule when selecting the finalized list of EP CQMs. By including such a large representation of stakeholders, we believe that we have prioritized CQMs that align with other programs, which includes CQMs that are not used in other programs currently but could be implemented in other programs as they include more electronically specified CQMs in their respective CQM lists. This will move us closer to our longer-term goal of having a single, aligned mechanism for CQM reporting.

Since the measure stewards are responsible for any information that affects the requirements of the CQM, we have shared the feedback on specific CQMs with the respective measure stewards. Consideration of both evidence and expert consensus are integral parts of the NQF's measure endorsement process. More information on this Consensus Development Process is available on the NQF Web site: http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx. Although we give preference to CQMs that have been endorsed by NQF, section 1848(o)(2)(B)(i)(I) of the Act does not require the selection of NQF-endorsed CQMs for the EHR Incentive Program. Please refer to section II.B.3. of this final rule for the discussion on criteria for inclusion of a CQM.

We appreciate the commenters' suggestions for additional CQMs that apply to specialties that may not have been as represented in the measure set as primary care or preventative medicine. Although we cannot in this final rule select CQMs that were not proposed in the proposed rule, we will consider the suggested CQMs for future inclusion. As for the commenters' request to adjust the reporting requirements or exclude certain specialties from reporting certain CQMs, we believe that our policy on allowing “zero denominators” to be reported allows specialists to meet the CQM reporting requirements of meaningful use and is a continuation of our policy from the Stage 1 final rule.

Comment/Response: Table 7 summarizes the public comments received on specific proposed EP CQMs and the CMS rationale (that is, our response to the CQM-specific comment(s)) for finalizing or not finalizing the CQM for reporting beginning with CY 2014.

Table 7—Summary of EP CQM-Specific Comments and Rationale To Finalize or Not Finalize the CQM Back to Top
CQM No. Commenters support finalization Commenters do not support finalization Finalized Rationale
# NQF endorsement includes a consensus development process that takes into account clinical guidelines and scientific evidence. NQF describes its consensus development process at http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx.
NQF 0002 No comments No comments Yes Addresses efficient use of resources; alignment with other programs.
NQF 0004 Supports measure Privacy concerns; concerned that it could be difficult to implement Yes Addresses high priority agency goals and aligns with other quality reporting programs. We retained NQF 0004 in order to represent the important issue of alcohol or other drug dependence treatment in our measure set. We also believe that through our collaboration with ONC, we have addressed the issues associated with data collection.
NQF 0018 Public comment supports measure No comments Yes Supports high priority goals (controlling high blood pressure).
NQF 0022 No comments Measure is not supported by evidence Yes Addresses patient safety. NQF requires clinical evidence supporting a measure in order to achieve NQF endorsement.
NQF 0024 Support for measure but evidence only for overweight, obese, or underweight children and not ideal weight Contains data elements that are difficult to capture as structured data Yes Supports high priority goals (weight assessment, nutrition, physical activity for children); received strong public support. Based on industry standards, CMS is collaborating with other federal agencies and private organizations to standardize data elements.
NQF 0028 Support for measure Concerns about capturing discrete data Yes Supports high priority goals (tobacco use cessation); alignment with other programs.
NQF 0031 No comments Does not align with current clinical guidelines for frequency of screening Yes This CQM is currently NQF endorsed. # This is a high priority prevention measure for breast cancer.
NQF 0032 No comments Does not align with current clinical guidelines for frequency of screening Yes This CQM is currently NQF endorsed # and will be updated for consistency with clinical guidelines as discussed earlier in this section. This is a high priority prevention measure for cervical cancer.
NQF 0033 No comments Does not align with current clinical guidelines for frequency of screening Yes This CQM is currently NQF endorsed # and will be updated for consistency with clinical guidelines as discussed earlier in this section. This is a high priority prevention measure.
NQF 0034 No comments Does not align with current clinical guidelines Yes This CQM is currently NQF endorsed # and will be updated for consistency with clinical guidelines as discussed earlier in this section. This is a high priority prevention measure.
NQF 0036 No comments Duplicative of other measures (duplicate measure not included) Yes Addresses high priority agency goals and aligns with other quality reporting programs. Some aspects of this measure may be considered duplicative of other CQMs, however we believe that there are unique aspects of this CQM that are important to measure.
NQF 0038 Supports measures to reduce rate of Hepatitis B No comments Yes Supports public health goals.
NQF 0041 Support for measure No evidence to support influenza vaccinations for all patients; Concerns about capturing discrete data and accounting for alternative delivery locations Yes This CQM is currently NQF endorsed. # This is a high priority prevention measure. Delivery of the vaccine should be captured in the EHR even if it was delivered in an alternate location.
NQF 0043 Support for measure Concerns about capturing discrete data and accounting for alternative delivery locations Yes Alignment with PQRS/ACOs/NCQA-PCMH Accreditation. This is a high priority prevention measure. Delivery of the vaccine should be captured in the EHR even if it was delivered in an alternate location. Passed feasibility testing for the data elements needed.
NQF 0052 Support with suggestions for improvements No comments Yes Addresses efficient use of resources.
NQF 0055 No comments Inconsistent with evidence Yes This CQM is currently NQF endorsed. # This is a high priority prevention measure.
NQF 0056 Support for measure Concerns about ability to collect discrete data Yes Supports high priority goals (diabetes); alignment with other programs. Passed feasibility testing for the data elements needed.
NQF 0059 Support for measure No comments Yes Supports high priority goals (diabetes); alignment with other programs.
NQF 0060 Support for measure Concern that this measure is untested in a pediatric population Yes Supports high priority goals (diabetes, pediatric population).
NQF 0062 Supports measure No comments Yes Supports high priority goals (diabetes); alignment with other programs.
NQF 0064 Supports measure as a way to monitor overuse and non-evidence based therapies No comments Yes Supports high priority goals (diabetes); alignment with other programs.
NQF 0068 Support for measure No comments Yes Supports high priority goals (heart disease); alignment with other programs.
NQF 0069 No comments No comments Yes Addresses efficient use of resources; alignment with other programs.
NQF 0070 Support for measure No comments Yes Supports high priority goals (heart disease); alignment with other programs.
NQF 0075 Support for measure Denominator is complex and ability to capture prior year data is questioned Yes Supports high priority goals (heart disease); alignment with other programs. We are also collaborating very closely with the ONC to ensure that these data are captured within CEHRT.
NQF 0081 Support for measure No comments Yes Supports high priority goals (heart disease); alignment with other programs.
NQF 0083 Support for measure No comments Yes Supports high priority goals (heart disease); alignment with other programs.
NQF 0086 Support for measure Does not advance quality of care Yes This CQM is currently NQF endorsed. #
NQF 0088 Supports measure Concerned about ability to transmit data between providers Yes Supports high priority goals (diabetes); alignment with other programs. Data is not required to be electronically transmitted between providers.
NQF 0089 Supports measure Does not advance quality of care; Concerned about ability to transmit data between providers Yes This CQM is currently NQF endorsed. # Communication between eye specialist and the physician who manages diabetes care is important. Data is not required to be electronically transmitted between providers.
NQF 0101 Support for measure Concerns about ability to collect discrete data Yes Addresses patient safety. Passed feasibility testing for the data elements required.
NQF 0104 Support for measure Duplicative of other measures; Concerns about ability to collect discrete data Yes Supports public health goals; alignment with other programs. Duplicative measures have not been finalized. Takes initial steps toward collecting discrete data.
NQF 0105 Support for measure Concerns about suggesting pharmacotherapy over other treatment options Yes This CQM is currently NQF endorsed. #
NQF 0108 No comments No comments Yes Addresses pediatric population.
NQF 0110 Support for measure Concerns about complexity and confidentiality; Concerns about ability to collect discrete data Yes We are collaborating very closely with the ONC to ensure that these data are captured within CEHRT.
NQF 0384 Support for measure Concerns about ability to collect discrete data Yes Addresses patient engagement; alignment with other programs.
NQF 0385 Supports measure Concerns about ability to collect discrete data Yes Addresses high priority agency goals and aligns with other quality reporting programs.
NQF 0387 Support for measure Concerns about ability to collect discrete data Yes Addresses high priority agency goals and aligns with other quality reporting programs.
NQF 0389 Support for measure Concerns about complexity; Concerns about ability to collect discrete data Yes We are collaborating very closely with the ONC to ensure that these data are captured within CEHRT.
NQF 0403 Support for measure Concerns about ability to document AIDS status Yes Addresses high priority agency goals and aligns with other quality reporting programs.
NQF 0405 Support for measure Concerns about agreement with current clinical guidelines Yes This CQM is currently NQF endorsed # and will be updated for consistency with clinical guidelines as discussed earlier in this section.
TBD (proposed as NQF 0407—HIV/AIDS RNA Control) Support for measure Concerns about ability to collect discrete data Yes Alignment with other programs. This CQM will be updated for consistency with the clinical guidelines as discussed earlier in this section.
NQF 0418 Support for assessment of depression Concern that patient refusal of screening could count against EP; Concerns about ability to collect discrete data Yes Supports public health goals; alignment with other programs. We also recognize that patients may refuse the treatments measured within this CQM, but there are no performance thresholds established for the EHR Incentive Program.
NQF 0419 Support for measure with concerns about ability to capture discrete data Too check-boxy and does not advance quality of care Yes This CQM is currently NQF endorsed. #
NQF 0421 Support for measure Too check-boxy and does not advance quality of care; Concerns about ability to collect discrete data Yes Supports public health goals. Alignment with PQRS/ACOs/UDS. This CQM is currently NQF endorsed. # Passed feasibility testing for the data elements needed.
NQF 0564 Supports measure that targets high priority condition to Medicare population and will add substantial value to the clinical quality measure set No comments Yes Addresses patient safety; alignment with other programs.
NQF 0565 Supports measure that targets high priority condition to Medicare population and will add substantial value to the clinical quality measure set No comments Yes Alignment with other programs.
NQF 0608 No comments No comments Yes Addresses high priority agency goals.
NQF 0710 Supports measure concept but concerned metric is too high Privacy concerns Yes Addresses high priority agency goals. To protect patient confidentiality and adhere to HIPAA requirements, CMS and all contractors for CMS are held to maintaining and abiding by the IT Security Policy in the transmission of electronic data.
NQF 0712 Supports measure Privacy concerns; Concerns about ability to collect discrete data Yes Addresses high priority agency goals and takes initial steps towards collecting accurate discrete data. To protect patient confidentiality and adhere to HIPAA requirements, CMS and all contractors for CMS are held to maintaining and abiding by the IT Security Policy in the transmission of electronic data.
TBD (proposed as 1335 Children dental) Supports measure Concerns about collecting data via EHR and required changes to workflow; Concerns about ability to collect discrete data Yes Addresses child health and dental measures not previously included in program. We are collaborating very closely with the ONC to ensure that these data are captured within CEHRT.
NQF 1365 Support for measure Concerns about ability to collect discrete data Yes Supports public health goals; alignment with other programs. Duplicative measures have not been finalized. Takes initial steps toward collecting discrete data.
NQF 1401 No comments Concerns about linking measure to age of child when measure relates to maternal depression and ability to capture discrete data Yes Addresses public health goals. We are collaborating very closely with the ONC to ensure that these data are captured within CEHRT.
TBD (proposed as 1419 Primary caries prevention) Support if revised to clarify numerator and denominator Concerns about whether measure reflects standard of care for medical providers Yes Addresses child health and dental measures not previously included in program. Received strong public support. The CQM is currently NQF endorsed for medical providers. #
TBD (LDL) Supports measure Not NQF endorsed; Concerns about ability to collect discrete data Yes Addresses high priority goal (high cholesterol); Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
TBD (Fasting LDL) Supports measure Not NQF endorsed; Concerns about ability to collect discrete data Yes Addresses high priority goal (high cholesterol); Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
TBD (Dementia) Supports measure Not NQF endorsed; Concerns about ability to collect discrete data Yes Addresses high priority agency goals and takes initial steps towards collecting accurate discrete data; Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
TBD (Hypertension) No comments No comments Yes Addresses high priority goal (hypertension).
TBD (Closing referral loop) Supports as an example of a core measure Concerns about ability to capture data exchange; not NQF endorsed Yes Addresses care coordination; Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
TBD (FSA knee) Supports measure Not NQF endorsed; Concerns about ability to collect discrete data Yes Addresses functional status assessment and patient engagement; Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
TBD (FSA hip) Supports measure Not NQF endorsed; Concerns about ability to collect discrete data Yes Addresses functional status assessment and patient engagement; Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
TBD (FSA complex) Supports measure Not NQF endorsed; Concerns about ability to collect discrete data Yes Addresses functional status assessment and patient engagement; Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
TBD (ADE) Supports Not NQF endorsed; Concerns about ability to collect discrete data Yes Addresses patient safety; Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
TBD (HBP followup) No comments Measure focuses on limited population; not NQF endorsed Yes Addresses high priority goals (hypertension); Though we gave preference to NQF endorsement, some measures selected that were not NQF endorsed based on their measurement of high priority conditions.
NQF 0001 Supports measure Does not advance quality of care; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0012 Measure could be adapted to use EHRs to create more accurate quality measures No comments No Measure no longer supported by measure steward.
NQF 0014 No comments Does not advance quality of care No Measure no longer supported by measure steward.
NQF 0045 No comments Measure is untested in part of population age range; focus on communications instead of outcomes No Difficulty ensuring accurate and standard data collected.
NQF 0046 Supports measure Concerns about ability to collect discrete data No Difficulty ensuring accurate and standard data collected.
NQF 0047 Supports measure Measure is complicated; concern about lack of look back period No Difficulty ensuring accurate and standard data collected.
NQF 0048 Supports measure with suggested changes No comments No Difficulty ensuring accurate and standard data collected.
NQF 0050 Supports measure Does not advance quality of care; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0051 Supports measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0058 No comments Definition of condition too restrictive No Concur with public comment that acute bronchitis is too restrictive for an antibiotic overuse CQM. Seek to limit measure set to reduce burden.
NQF 0061 Support for measure No comments No Redundant with other measures assessing condition (e.g., NQF 0018).
NQF 0066 Support for measure Measure contains two diagnoses and should separated into two measures; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0067 Support for measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0073 Support for measure and suggestion to adapt to further exploit EHRs No comments No Redundant with other measures assessing condition (e.g., NQF 0018).
NQF 0074 Support for measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0097 Support for measure Measure does not advance quality of care, too “check boxy,” reconciling across care settings; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0098 Support for measure Measure is vague; ability to capture discrete data; need standardized tool for assessment; no evidence interventions support outcomes No Concur with public comment and complexity associated with collecting discrete data.
NQF 0100 Support for measure No evidence interventions support outcomes; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0102 Support for measure Concerns about ability to collect discrete data and calculate measure No Concur with public comment and complexity associated with collecting discrete data.
NQF 0103 Support for measure; harmonize with other measures Does not advance quality of care; privacy issues; Concerns about ability to collect discrete data No Concur with concerns in public comments.
NQF 0106 Support for measure Measure is too complex; concerns about ability to collect discrete data No Concur with concerns in public comments that the measure is too complex; and agree with the concerns about ability to collect discrete data.
NQF 0107 No comments Duplicative of other measures No Concur with concerns in public comments that it is duplicative of other measures.
NQF 0112 Support for measure Measure is too complex; privacy issues; vague; concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0239 Support for measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
Former NQF 0246 Support for measure Does not advance quality of care; not NQF endorsed; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0271 Support for measure Questions if appropriate for ambulatory setting; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0312 Support for measure Measure is vague No Difficulty ensuring accurate and standard data collected.
NQF 0321 Support for measure No comments No Complexity associated with collecting discrete data.
NQF 0322 Support for measure Measure is vague; concerns about ability to capture discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0323 Support for measure Interoperability concerns No Concur with public comment and complexity associated with collecting discrete data.
NQF 0382 Support for measure Concerns about ability to capture numerator data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0383 Support for measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0388 Support for measure Concerns about ability to collect discrete data No Measure retired by steward.
NQF 0399 Support for measure No comments No Seek to limit measure set to reduce burden.
NQF 0400 Support for measure No comments No Seek to limit measure set to reduce burden.
NQF 0401 Support for measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0406 Support for measure Concerns about keeping up-to-date with changing guidelines No Concur with concerns from public comments with concerns about keeping up-to-date with changing guidelines.
NQF 0507 Support for measure Does not advance quality of care No Concur with public comment and complexity associated with collecting discrete data.
NQF 0508 Support for measure Inability to capture screening results as discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0510 Support for measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0513 Support for measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0519 Support for measure Does not advance quality of care; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0561 Support for measure; supports care coordination and alignment with PQRS Does not advance quality of care; Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting discrete data.
NQF 0562 Support for measure Concerns about ability to collect discrete data; important measure of overuse No Concur with public comment and complexity associated with collecting discrete data.
NQF 0575 Support for measure with reasonable target regarding potential adverse effects of tight diabetes control No comments No Concur with concerns in public comments regarding potential adverse effects of tight diabetes control.
NQF 0711 Supports measure concept but concerned metric is too high Potentially duplicative; privacy issues No Concur with concerns in public comments about potentially duplicative measure; and privacy issues.
NQF 1525 Support for measure Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Risk Assessment for Falls) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Plan of Care for Falls) Support for measure Not NQF endorsed; questions evidence base for plan of care for falls No Concur with public comment and complexity associated with collecting these discrete data.
TBD (ADK: BP Mgmt) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (ADK: ESA) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Wound Wet to Dry) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Dementia Staging) Support for measure Not NQF endorsed; does not advance quality of care. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Dementia FSA) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Dementia Safety) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Dementia Driving) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Dementia Caregiver) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Wound Compression) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (RA: FSA) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Glaucoma) No comments Not NQF endorsed No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Wound Diabetic) Support for measure Not NQF endorsed. Concerns about ability to collect discrete data No Concur with public comment and complexity associated with collecting these discrete data.
TBD (Hypertension: BPM) No comments Not NQF endorsed; questions appropriateness due to narrow population No Prefer CQMs on the topic of hypertension with NQF endorsement.

After consideration of the public comments received and the CQM selection criteria discussed, we are finalizing the list of 64 CQMs for EPs included in Table 7. We note that the CQMs that do not have a CQM number in Table 7 are those that are not NQF endorsed. EPs will identify these CQMs by the eMeasure ID and version number that will be included in the CQM specifications that will be made available on our Web site.

We also note that three of the CQMs listed with a CQM number of TBD in Table 7 were proposed with NQF numbers but are changed to “TBD” in this final rule as follows:

  • NQF 0407 is now HIV/AIDS: RNA control for Patients with HIV
  • NQF 1335 is now Children who have dental decay or cavities
  • NQF 1419 is now Primary Caries Prevention Intervention as Part of Well/Ill Child Care as Offered by Primary Care Medical Providers

NQF 0407 referenced antiretroviral therapy as the means for RNA control. This CQM is scheduled for NQF review and, due to changing clinical guidelines regarding therapies, significant change in this measure is expected. Due to the nature of HIV/AIDS, the virus mutates frequently, necessitating frequent changes in clinical guidelines with respect to treatments. By respecifying the CQM to remove antiretroviral therapy as the specific treatment and only focus on the outcome of RNA control, the intent of this CQM remains the same. The respecified CQM will be submitted to NQF for endorsement. NQF 1335 was endorsed as population-based CQMs rather than individual provider-level CQMs and will be respecified to include individual provider reporting, and NQF 1419 was endorsed at the individual provider level but only for primary care physicians and will be respecified to include dental providers. Both will undergo additional testing, and the results for each CQM will be submitted to NQF to determine whether the respecification warrants a new NQF number. However, the intent of each of these CQMs will remain the same as proposed.

The CQMs finalized in the recommended core sets are included in Table 7 and are denoted with a “*” for adult populations (9 CQMs) and “**” for pediatric populations (9 CQMs). We believe this approach supports the NQS and provides flexibility for specialists whose scope of practice may not be adequately represented in the proposed core CQM set. Controlling blood pressure has been and continues to be a high priority goal in many national health initiatives, including the Million Hearts campaign. Therefore, we emphasize the importance of reporting NQF #0018 as a primary recommended core CQM. We will monitor reporting on NQF #0018 and consider ways to increase its reporting. This may include, through future rulemaking, requiring EPs in relevant specialties such as primary care and cardiovascular care to report this CQM. We note that the designation of being recommended for the adult population or pediatric population does not limit an EP from reporting the CQM only for those populations as long as the patients still fit the criteria to be included in the measure (for example, the CQM numbered “TBD—Closing the referral loop: receipt of specialist report” is designated as a recommended core CQM for adult populations, but it can apply to pediatric populations as well).

Table 8—CQMs Finalized for Medicare and Medicaid EPs Beginning with CY 2014 Back to Top
CQM No. CQM title and description Measure steward and contact information Other quality measure programs that use the same CQM*** New CQM Domain
* Recommended Adult Core CQMs for EPs.
** Recommended Pediatric Core CQMs for EPs.
*** PQRS = Physician Quality Reporting System.
EHR PQRS = Physician Quality Reporting System's Electronic Health Record Reporting Option.
CHIPRA = Children's Health Insurance Program Reauthorization Act.
HEDIS = Healthcare Effectiveness Data and Information Set.
ACA 2701 = Affordable Care Act section 2701.
NCQA-PCMH = National Committee for Quality Assurance—Patient Centered Medical Home.
Group Reporting PQRS = Physician Quality Reporting System's Group Reporting Option.
UDS = Uniform Data System (Health Resources Services Administration).
ACO = Accountable Care Organization (Medicare Shared Savings Program).
NQF 0002** Title: Appropriate Testing for Children with Pharyngitis Description: Percentage of children 2-18 years of age who were diagnosed with pharyngitis, ordered an antibiotic and received a group A streptococcus (strep) test for the episode. National Committee for Quality Assurance (NCQA) Contact information: www.ncqa.org EHR PQRS, CHIPRA Efficient Use of Healthcare Resources.
NQF 0004 Title: Initiation and Engagement of Alcohol and Other Drug Dependence Treatment Description: Percentage of patients 13 years of age and older with a new episode of alcohol and other drug (AOD) dependence who received the following. Two rates are reported. NCQA Contact Information: www.ncqa.org EHR PQRS, HEDIS, state use, ACA 2701, NCQA-PCMH Recognition Clinical Process/Effectiveness.
a. Percentage of patients who initiated treatment within 14 days of the diagnosis.        
b. Percentage of patients who initiated treatment and who had two or more additional services with an AOD diagnosis within 30 days of the initiation visit.        
NQF 0018* Title: Controlling High Blood Pressure Description: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90mmHg) during the measurement =period. NCQA Contact Information: www.ncqa.org EHR PQRS, ACO, Group Reporting PQRS, UDS Clinical Process/Effectiveness.
NQF 0022* Title: Use of High-Risk Medications in the Elderly Description: Percentage of patients 66 years of age and older who were ordered high-risk medications. Two rates are reported. NCQA Contact Information: www.ncqa.org PQRS New Patient Safety
a. Percentage of patients who were ordered at least one high-risk medication.        
b. Percentage of patients who were ordered at least two different high-risk medications.        
NQF 0024** Title: Weight Assessment and Counseling for Nutrition and Physical Activity for Children and Adolescents NCQA Contact information: www.ncqa.org EHR PQRS, UDS Population/Public Health.
Description: Percentage of patients 3-17 years of age who had an outpatient visit with a Primary Care Physician (PCP) or Obstetrician/Gynecologist (OB/GYN) and who had evidence of the following during the measurement period. Three rates are reported        
• Percentage of patients with height, weight, and body mass index (BMI) percentile documentation        
• Percentage of patients with counseling for nutrition        
• Percentage of patients with counseling for physical activity        
NQF 0028* Title: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention. Description: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS, ACO, Group Reporting PQRS, UDS Population/Public Health.
NQF 0031 Title: Breast Cancer Screening Description: Percentage of women 40-69 years of age who had a mammogram to screen for breast cancer. NCQA Contact Information: www.ncqa.org EHR PQRS, ACO, Group Reporting PQRS, ACA 2701, HEDIS, state use, NCQA-PCMH Recognition Clinical Process/Effectiveness.
NQF 0032 Title: Cervical Cancer Screening Description: Percentage of women 21-64 years of age, who received one or more Pap tests to screen for cervical cancer. NCQA Contact Information: www.ncqa.org EHR PQRS, ACA 2701, HEDIS, state use, NCQA-PCMH Recognition, UDS Clinical Process/Effectiveness.
NQF 0033** Title: Chlamydia Screening for Women Description: Percentage of women 16-24 years of age who were identified as sexually active and who had at least one test for chlamydia during the measurement period. NCQA Contact Information: www.ncqa.org EHR PQRS, CHIPRA, ACA 2701, HEDIS, state use, NCQA-PCMH Recognition Population/Public Health.
NQF 0034 Title: Colorectal Cancer Screening Description: Percentage of adults 50-75 years of age who had appropriate screening for colorectal cancer. NCQA Contact Information: www.ncqa.org EHR PQRS, ACO, Group Reporting PQRS, NCQA-PCMH Recognition Clinical Process/Effectiveness.
NQF 0036** Title: Use of Appropriate Medications for Asthma Description: Percentage of patients 5-64 years of age who were identified as having persistent asthma and were appropriately prescribed medication during the measurement period. NCQA Contact Information: www.ncqa.org EHR PQRS Clinical Process/Effectiveness.
NQF 0038** Title: Childhood Immunization Status Description: Percentage of children 2 years of age who had four diphtheria, tetanus and acellular pertussis (DTaP); three polio (IPV), one measles, mumps and rubella (MMR); three H influenza type B (HiB); three hepatitis B (Hep B); one chicken pox (VZV); four pneumococcal conjugate (PCV); one hepatitis A (Hep A); two or three rotavirus (RV); and two influenza (flu) vaccines by their second birthday. NCQA Contact Information: www.ncqa.org EHR PQRS, UDS Population/Public Health.
NQF 0041 Title: Preventative Care and Screening: Influenza Immunization Description: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS, ACO, Group Reporting PQRS Population/Public Health.
NQF 0043 Title: Pneumonia Vaccination Status for Older Adults Description: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine. NCQA Contact Information: www.ncqa.org EHR PQRS, ACO, Group Reporting PQRS, NCQA-PCMH Recognition Clinical Process/Effectiveness.
NQF 0052* Title: Use of Imaging Studies for Low Back Pain Description: Percentage of patients 18-50 years of age with a diagnosis of low back pain who did not have an imaging study (plain X-ray, MRI, CT scan) within 28 days of the diagnosis. NCQA Contact Information: www.ncqa.org EHR PQRS Efficient Use of Healthcare Resources.
NQF 0055 Title: Diabetes: Eye Exam Description: Percentage of patients 18-75 years of age with diabetes who had a retinal or dilated eye exam by an eye care professional during the measurement period or a negative retinal exam (no evidence of retinopathy) in the 12 months prior to the measurement period. NCQA Contact Information: www.ncqa.org EHR PQRS, Group Reporting PQRS Clinical Process/Effectiveness.
NQF 0056 Title: Diabetes: Foot Exam Description: Percentage of patients aged 18-75 years of age with diabetes who had a foot exam during the measurement period. NCQA Contact Information: www.ncqa.org EHR PQRS, Group Reporting PQRS Clinical Process/Effectiveness.
NQF 0059 Title: Diabetes: Hemoglobin A1c Poor Control Description: Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c >9.0% during the measurement period. NCQA Contact Information: www.ncqa.org EHR PQRS, ACO, Group Reporting PQRS, UDS Clinical Process/Effectiveness.
NQF 0060 Title: Hemoglobin A1c Test for Pediatric Patients Description: Percentage of patients 5-17 years of age with diabetes with an HbA1c test during the measurement period. NCQA Contact Information: www.ncqa.org New Clinical Process/Effectiveness.
NQF 0062 Title: Diabetes: Urine Protein Screening Description: The percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy during the measurement period. NCQA Contact Information: www.ncqa.org EHR PQRS, Group Reporting PQRS Clinical Process/Effectiveness.
NQF 0064 Title: Diabetes: Low Density Lipoprotein (LDL) Management Description: Percentage of patients 18-75 years of age with diabetes whose LDL-C was adequately controlled (<100 mg/dL) during the measurement period. NCQA Contact Information: www.ncqa.org PQRS, Group Reporting PQRS Clinical Process/Effectiveness.
NQF 0068 Title: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic Description: Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (IVD) during the measurement period, and who had documentation of use of aspirin or another antithrombotic during the measurement period. NCQA Contact Information: www.ncqa.org EHR PQRS, ACO, Group Reporting PQRS Clinical Process/Effectiveness.
NQF 0069 ** Title: Appropriate Treatment for Children with Upper Respiratory Infection (URI) Description: Percentage of children 3 months-18 years of age who were diagnosed with upper respiratory infection (URI) and were not dispensed an antibiotic prescription on or three days after the episode. NCQA Contact Information: www.ncqa.org PQRS, NCQA-PCMH Recognition New Efficient Use of Healthcare Resources.
NQF 0070 Title: Coronary Artery Disease (CAD): Beta-Blocker Therapy—Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF <40%) Description: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who also have a prior MI or a current or prior LVEF <40% who were prescribed beta-blocker therapy. AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS, NCQA-PCMH Recognition Clinical Process/Effectiveness.
NQF 0075 Title: Ischemic Vascular Disease (IVD): Complete Lipid Panel and LDL Control Description: Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (IVD) during the measurement period, and who had a complete lipid profile performed during the measurement period and whose LDL-C was adequately controlled (<100 mg/dL). NCQA Contact Information: www.ncqa.org EHR PQRS, ACO, Group Reporting PQRS Clinical Process/Effectiveness.
NQF 0081 Title: Heart Failure (HF): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD) AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS, Group Reporting PQRS, NCQA-PCMH Recognition Clinical Process/Effectiveness
Description: Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (LVEF) <40% who were prescribed ACE inhibitor or ARB therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge        
NQF 0083 Title: Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) Description: Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (LVEF) <40% who were prescribed beta-blocker therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge. AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS, ACO, Group Reporting PQRS Clinical Process/Effectiveness.
NQF 0086 Title: Primary Open Angle Glaucoma (POAG): Optic Nerve Evaluation Description: Percentage of patients aged 18 years and older with a diagnosis of POAG who have an optic nerve head evaluation during one or more office visits within 12 months. AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS Clinical Process/Effectiveness.
NQF 0088 Title: Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of Retinopathy Description: Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed which included documentation of the level of severity of retinopathy and the presence or absence of macular edema during one or more office visits within 12 months. AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS Clinical Process/Effectiveness.
NQF 0089 Title: Diabetic Retinopathy: Communication with the Physician Managing Ongoing Diabetes Care Description: Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed with documented communication to the physician who manages the ongoing care of the patient with diabetes mellitus regarding the findings of the macular or fundus exam at least once within 12 months. AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS Clinical Process/Effectiveness.
NQF 0101 Title: Falls: Screening for Future Fall Risk Description: Percentage of patients 65 years of age and older who were screened for future fall risk during the measurement period. AMA-PCPI Contact Information: cpe@ama-assn.org; NCQA Contact Information: www.ncqa.org PQRS, ACO, Group Reporting PQRS New Patient Safety.
NQF 0104 Title: Major Depressive Disorder (MDD): Suicide Risk Assessment Description: Percentage of patients aged 18 years and older with a new diagnosis or recurrent episode of MDD who had a suicide risk assessment completed at each visit during the measurement period. AMA-PCPI Contact Information: cpe@ama-assn.org PQRS New Clinical Process/Effectiveness.
NQF 0105 Title: Anti-depressant Medication Management Description: Percentage of patients 18 years of age and older who were diagnosed with major depression and treated with antidepressant medication, and who remained on antidepressant medication treatment. Two rates are reported. NCQA Contact Information: www.ncqa.org EHR PQRS, HEDIS, state use, ACA 2701 Clinical Process/Effectiveness.
a. Percentage of patients who remained on an antidepressant medication for at least 84 days (12 weeks)        
b. Percentage of patients who remained on an antidepressant medication for at least 180 days (6 months)        
NQF 0108** Title: ADHD: Follow-Up Care for Children Prescribed Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Description: Percentage of children 6-12 years of age and newly dispensed a medication for attention-deficit/hyperactivity disorder (ADHD) who had appropriate follow-up care. Two rates are reported. NCQA Contact Information: www.ncqa.org New Clinical Process/Effectiveness.
a. Percentage of children who had one follow-up visit with a practitioner with prescribing authority during the 30-Day Initiation Phase        
b. Percentage of children who remained on ADHD medication for at least 210 days and who, in addition to the visit in the Initiation Phase, had at least two additional follow-up visits with a practitioner within 270 days (9 months) after the Initiation Phase ended        
NQF 0110 Title: Bipolar Disorder and Major Depression: Appraisal for alcohol or chemical substance use Description: Percentage of patients with depression or bipolar disorder with evidence of an initial assessment that includes an appraisal for alcohol or chemical substance use. Center for Quality Assessment and Improvement in Mental Health (CQAIMH) Contact Information: www.cqaimh.org; cqaimh@cqaimh.org NCQA-PCMH Recognition New Clinical Process/Effectiveness.
NQF 0384 Title: Oncology: Medical and Radiation—Pain Intensity Quantified Description: Percentage of patient visits, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantified. AMA-PCPI Contact Information: cpe@ama-assn.org PQRS New Patient and Family Engagement.
NQF 0385 Title: Colon Cancer: Chemotherapy for AJCC Stage III Colon Cancer Patients Description: Percentage of patients aged 18 through 80 years with Stage III colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy within the 12-month reporting period. AMA-PCPI Contact Information: cpe@ama-assn.org; American Society of Clinical Oncology (ASCO): www.asco.org; National Comprehensive Cancer Network (NCCN): www.nccn.org EHR PQRS Clinical Process/Effectiveness.
NQF 0387 Title: Breast Cancer: Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer Description: Percentage of female patients aged 18 years and older with Stage IC through IIIC, ER or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting period. AMA-PCPI Contact Information: cpe@ama-assn.org; ASCO: www.asco.org; NCCN: www.nccn.org EHR PQRS Clinical Process/Effectiveness.
NQF 0389 Title: Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low Risk Prostate Cancer Patients Description: Percentage of patients, regardless of age, with a diagnosis of prostate cancer at low risk of recurrence receiving interstitial prostate brachytherapy, OR external beam radiotherapy to the prostate, OR radical prostatectomy, OR cryotherapy who did not have a bone scan performed at any time since diagnosis of prostate cancer. AMA-PCPI Contact Information: cpe@ama-assn.org EHR PQRS Efficient Use of Healthcare Resources.
NQF 0403 Title: HIV/AIDS: Medical Visit Description: Percentage of patients, regardless of age, with a diagnosis of HIV/AIDS with at least two medical visits during the measurement year with a minimum of 60 days between each visit. AMA-PCPI Contact Information: cpe@ama-assn.org; NCQA Contact Information: www.ncqa.org New Clinical Process/Effectiveness.
NQF 0405 Title: HIV/AIDS: Pneumocystis jiroveci pneumonia (PCP) Prophylaxis Description: Percentage of patients aged 6 weeks and older with a diagnosis of HIV/AIDS who were prescribed Pneumocystis jiroveci pneumonia (PCP) prophylaxis. AMA-PCPI Contact Information: cpe@ama-assn.org; NCQA Contact Information: www.ncqa.org PQRS, NCQA-PCMH Recognition New Clinical Process/Effectiveness.
TBD (proposed as NQF 0407) Title: HIV/AIDS: RNA control for Patients with HIV Description: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS, with at least two visits during the measurement year, with at least 60 days between each visit, whose most recent HIV RNA level is <200 copies/mL. NCQA Contact Information: www.ncqa.org PQRS New Clinical Process/Effectiveness.
NQF 0418*** Title: Preventive Care and Screening: Screening for Clinical Depressionand Follow-Up Plan Description: Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen. Centers for Medicare and Medicaid Services (CMS) 1-888-;734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139; Quality Insights of Pennsylvania (QIP) Contact Information: www.usqualitymeasures.org EHR PQRS, ACO, Group Reporting PQRS New Population/Public Health.
NQF 0419* Title: Documentation of Current Medications in the Medical Record Description: Percentage of specified visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications to the best of his/her knowledge and ability. This list must include ALL prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. Centers for Medicare and Medicaid Services (CMS) 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139; QIP Contact Information: www.usqualitymeasures.org PQRS, EHR PQRS New Patient Safety.
NQF 0421* Title: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Description: Percentage of patients aged 18 years and older with a calculated BMI in the past six months or during the current reporting period documented in the medical record AND if the most recent BMI is outside of normal parameters, a follow-up plan is documented within the past six months or during the current reporting period. Normal Parameters: Age 65 years and older BMI ≥23 and <30. Age 18-64 years BMI ≥18.5 and <25. Centers for Medicare and Medicaid Services (CMS) 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139; QIP Contact Information: www.usqualitymeasures.org EHR PQRS, ACO, Group Reporting PQRS, UDS Population/Public Health.
NQF 0564 Title: Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional Surgical Procedures Description: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and had any of a specified list of surgical procedures in the 30 days following cataract surgery which would indicate the occurrence of any of the following major complications: retained nuclear fragments, endophthalmitis, dislocated or wrong power IOL, retinal detachment, or wound dehiscence. AMA-PCPI Contact Information: cpe@ama-assn.org; NCQA Contact Information: www.ncqa.org PQRS New Patient Safety.
NQF 0565 Title: Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery Description: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and no significant ocular conditions impacting the visual outcome of surgery and had best-corrected visual acuity of 20/40 or better (distance or near) achieved within 90 days following the cataract surgery. AMA-PCPI Contact Information: cpe@ama-assn.org; NCQA Contact Information: www.ncqa.org PQRS New Clinical Process/Effectiveness.
NQF 0608 Title: Pregnant women that had HBsAg testing Description: This measure identifies pregnant women who had a HBsAg (hepatitis B) test during their pregnancy. Ingenix Contact Information: www.ingenix.com New Clinical Process/Effectiveness.
NQF 0710 Title: Depression Remission at Twelve Months Description: Adult patients age 18 and older with major depression or dysthymia and an initial PHQ-9 score >9 who demonstrate remission at twelve months defined as PHQ-9 score less than 5. This measure applies to both patients with newly diagnosed and existing depression whose current PHQ-9 score indicates a need for treatment. Minnesota Community Measurement (MNCM) Contact Information: www.mncm.org; info@mncm.org New Clinical Process/Effectiveness.
NQF 0712 Title: Depression Utilization of the PHQ-9 Tool Description: Adult patients age 18 and older with the diagnosis of major depression or dysthymia who have a PHQ-9 tool administered at least once during a 4 month period in which there was a qualifying visit. MNCM Contact Information: www.mncm.org; info@mncm.org New Clinical Process/Effectiveness.
TBD ** Title: Children who have dental decay or cavities Description: Percentage of children ages 0-20, who have had tooth decay or cavities during the measurement period. Maternal and Child Health Bureau, Health Resources and Services Administration http://mchb.hrsa.gov/ New Clinical Process/Effectiveness.
NQF 1365 Title: Child and Adolescent Major Depressive Disorder: Suicide Risk Assessment Description: Percentage of patient visits for those patients aged 6 through 17 years with a diagnosis of major depressive disorder with an assessment for suicide risk. AMA-PCPI Contact Information: cpe@ama-assn.org New Patient Safety.
NQF 1401 Title: Maternal depression screening Description: The percentage of children who turned 6 months of age during the measurement year, who had a face-to-face visit between the clinician and the child during child's first 6 months, and who had a maternal depression screening for the mother at least once between 0 and 6 months of life. NCQA Contact Information: www.ncqa.org New Population/Public Health.
TBD Title: Primary Caries Prevention Intervention as Offered by Primary Care Providers, including Dentists Description: Percentage of children, age 0-20 years, who received a fluoride varnish application during the measurement period. University of Minnesota Contact Information: www.umn.edu New Clinical Process/Effectiveness.
TBD Title: Preventive Care and Screening: Cholesterol—Fasting Low Density Lipoprotein (LDL-C) Test Performed Description: Percentage of patients aged 20 through 79 years whose risk factors have been assessed and a fasting LDL-C test has been performed. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139; QIP Contact Information: www.usqualitymeasures.org EHR PQRS New Clinical Process/Effectiveness.
TBD Title: Preventive Care and Screening: Risk-Stratified Cholesterol—Fasting Low Density Lipoprotein (LDL-C) Description: Percentage of patients aged 20 through 79 years who had a fasting LDL-C test performed and whose risk-stratified fasting LDL-C is at or below the recommended LDL-C goal. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139; QIP Contact Information: www.usqualitymeasures.org EHR PQRS New Clinical Process/Effectiveness.
TBD Title: Dementia: Cognitive Assessment Description: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12 month period. AMA-PCPI Contact Information: cpe@ama-assn.org PQRS New Clinical Process/Effectiveness.
TBD Title: Hypertension: Improvement in blood pressure Description: Percentage of patients aged 18-85 years of age with a diagnosis of hypertension whose blood pressure improved during the measurement period. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139 New Clinical Process/Effectiveness.
TBD* Title: Closing the referral loop: receipt of specialist report Description: Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139 New Care Coordination.
TBD Title: Functional status assessment for knee replacement Description: Percentage of patients aged 18 years and older with primary total knee arthroplasty (TKA) who completed baseline and follow-up (patient-reported) functional status assessments. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139 New Patient and Family Engagement.
TBD Title: Functional status assessment for hip replacement Description: Percentage of patients aged 18 years and older with primary total hip arthroplasty (THA) who completed baseline and follow-up (patient-reported) functional status assessments. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139 New Patient and Family Engagement.
TBD* Title: Functional status assessment for complex chronic conditions Description: Percentage of patients aged 65 years and older with heart failure who completed initial and follow-up patient-reported functional status assessments. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139 New Patient and Family Engagement.
TBD Title: ADE Prevention and Monitoring: Warfarin Time in Therapeutic Range Description: Average percentage of time in which individuals with atrial fibrillation who are on chronic anticoagulation have International Normalized Ratio (INR) test results within the therapeutic range during the measurement period. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139 New Patient Safety.
TBD Title: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented Description: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure AND a recommended follow-up plan is documented based on the current blood pressure (BP) reading as indicated. CMS 1-888-734-6433 or http://questions.cms.hhs.gov/app/ask/p/21,26,1139; QIP Contact Information: www.usqualitymeasures.org PQRS, EHR PQRS, Group Reporting PQRS, ACO New Population/Public Health.

6. Reporting Methods for CQMs for EPs

(a) Reporting Methods for Medicaid EPs

For Medicaid EPs, we stated in the proposed rule that states are, and will continue in Stage 2 to be, responsible for determining whether and how electronic reporting would occur, or whether they wish to continue to allow reporting through attestation. If a state does require such electronic reporting, the state is responsible for sharing the details of the process with its provider community. We stated that we anticipate that whatever means states have deployed for capturing Stage 1 CQMs electronically would be similar for reporting in CY 2013. However, we note that subject to our prior approval, this is within the states' purview. Beginning in CY 2014, we proposed that the states would establish the method and requirements, subject to CMS prior approval, for the electronic capture and reporting of CQMs from CEHRT.

Comment: Commenters suggested unified Medicaid CQM reporting to reduce the burden on EPs operating in multiple states.

Response: For the purposes of the Medicaid EHR Incentive Program, EPs report CQMs to the state making the EHR incentive payment. However, data from all practice locations that are equipped with CEHRT will be used for reporting CQMs, even if the practice locations are in different states.

After consideration of the public comments received, we are finalizing the policies for electronic reporting of CQMs for Medicaid EPs as proposed. As part of certification for EHR technology, ONC is including testing for data capture, CQM calculation, and electronic submission. For CQMs, this includes certification criteria for the QRDA Category I (QRDA-I) and QRDA Category III (QRDA-III) transmission formats. We expect the states that have electronic reporting options for CQMs might choose to adopt QRDA-I for patient-level data and/or QRDA-III for aggregate data as the form in which EPs would report CQM data. By adopting the same QRDA-I and/or QRDA-III that CMS is requiring for CQM reporting, the states would be able to leverage the development of the specifications by CMS and the industry as well as the testing done by ONC for certification of EHR technology. This would reduce the burden on EHR vendors to implement and test different specifications.

(b) Reporting Methods for Medicare EPs in CY 2013

In the Stage 2 proposed rule, we did not propose any reporting methods for Medicare EPs in 2013. However, in the CY 2013 Medicare PFS proposed rule (77 FR 44988), we proposed that EPs may continue to report by attestation CQM results as calculated by CEHRT, as they did for 2011 and 2012. For further explanation of reporting CQMs by attestation, please see the Stage 1 final rule (75 FR 44430 through 44434). We also proposed in the CY 2013 Medicare PFS proposed rule (77 FR 44988) to continue the voluntary electronic reporting pilot for CQMs (the PQRS—Medicare EHR Incentive Pilot) for 2013, which we had previously established for 2012. We expect to finalize in the CY 2013 Medicare PFS final rule the reporting methods that would apply in 2013 for EPs participating in the Medicare EHR Incentive Program.

(c) Reporting Methods for Medicare EPs Beginning With CY 2014

Under section 1848(o)(2)(A)(iii) of the Act, EPs must submit information on the CQMs selected by the Secretary “in a form and manner specified by the Secretary” as part of demonstrating meaningful use of CEHRT. We proposed that Medicare EPs who are in their first year of Stage 1 may report CQMs through attestation for a continuous 90-day EHR reporting period. We proposed that Medicare EPs who choose Option 1 for reporting CQMs would submit through an aggregate reporting method, which would require the EP to log into a CMS-designated portal and submit through an upload process data produced as output from their CEHRT in an XML-based format specified by CMS. We proposed that Medicare EPs who choose to report CQMs as described in Option 2 would submit in accordance with the requirements of the PQRS program.

Comment: We received several comments on the proposal to use an XML-based format for transmitting aggregate results. Those commenters were generally in favor of using an aggregate XML and that the technical structure aligns with the PQRS registry reporting option. One commenter noted that the aggregate-level standard QRDA-III is not currently mature. Some commenters indicated a preference that the aggregate reporting method should only require submission of one data file instead of multiple files, citing that submitting multiple files is onerous and may not be manageable due to the number of files EPs would need to upload.

Response: We acknowledge that there is currently no consensus standard for the electronic transmission of aggregate results of CQMs. However, the 2014 Edition certification criteria adopt the QRDA-III specification. As a result, we expect to be able to receive data submitted using the QRDA-III specification.

We proposed to consider an “interim submission” option for Medicare EPs who are in their first year of Stage 1 and who participate in PQRS. Under this option, EPs would submit the PQRS CQM data for a continuous 90-day EHR reporting period, and the data must be received no later than October 1 to meet the requirements of the EHR Incentive Program. We proposed that the EP would report the remainder of his/her CQM data by the deadline specified for PQRS in order to meet the requirements of the PQRS program. We solicited public comment on this potential option.

Comment: Many commenters indicated the proposed interim submission option for Medicare EPs in their first year of Stage 1 is unclear and would involve a prohibitive amount of effort. The commenters also suggested removing this option. Other commenters supported the interim submission option.

Response: This option was intended to accommodate Medicare EPs who are demonstrating meaningful use for the first time in 2014 and want to choose Option 2 (the PQRS EHR reporting option) for reporting CQMs. As proposed, however, it would require two submissions. We agree with the commenters that the “interim submission option” is complex and potentially burdensome. We are not finalizing the interim submission option.

After consideration of the public comments received, we are finalizing the following reporting methods for Medicare EPs beginning in CY 2014:

  • Option 1: Aggregate reporting through a CMS-designated electronic transmission method using CEHRT.

The format required for aggregate reporting will be the QRDA-III, which is an XML-based format. The electronic transmission method for aggregate reporting differs from reporting via attestation in that the QRDA-III report would be generated by the EPs CEHRT and transmitted electronically rather than the aggregate results manually input into the Registration and Attestation system. EPs who are in their first year of Stage 1 must report CQMs under Option 1 through attestation (please refer to the Stage 1 final rule for an explanation of reporting CQMs through attestation (75 FR 44430 through 44434)). Consistent with section 1848(o)(2)(B)(ii) of the Act, in the unlikely event that the Secretary does not have the capacity to receive CQM data electronically, EPs who are beyond the first year of Stage 1 may continue to report aggregate CQM results through attestation.

  • Option 2: Patient-level reporting via PQRS through the transmission methods established for the PQRS EHR-based reporting mechanisms and using CEHRT.

Please refer to 42 CFR 414.90 and the CY 2013 Medicare PFS proposed rule (77 FR 44988) for more information on the PQRS.

(d) Group Reporting Option for Medicare and Medicaid EPs Beginning With CY 2014

For Stage 1, EPs were required to report the CQMs on an individual basis and did not have an option to report the CQMs as part of a group practice. Under section 1848(o)(2)(A) of the Act, the Secretary may provide for the use of alternative means for EPs furnishing covered professional services in a group practice (as defined by the Secretary) to meet the requirements of meaningful use. Beginning with CY 2014, we proposed three group reporting options to allow EPs within a single group practice to report CQM data on a group level. We proposed that all three methods would be available for Medicare EPs, while only the first one would be possible for Medicaid EPs, at states' discretion.

We proposed each of these options as an alternative to reporting CQM data as an individual EP under the proposed options and reporting methods discussed earlier in this rule. These group reporting options would only be available for reporting CQMs for purposes of the EHR Incentive Program and only if all EPs in the group are beyond the first year of Stage 1. EPs would not be able to use these group reporting options for any of the other meaningful use objectives and associated measures in the EHR Incentive Programs.

The three group reporting options that we proposed for EPs are as follows:

  • Two or more EPs, each identified with a unique NPI associated with a group practice identified under one tax identification number (TIN) may be considered an EHR Incentive Group for the purposes of reporting CQMs for the Medicare EHR Incentive Program. This group reporting option would only be available for electronic reporting of CQMs and would not be available for those EPs in their first year of Stage 1. The CQMs reported under this option would represent all EPs within the group. EPs who choose this group reporting option for CQMs would have to individually satisfy the objectives and associated measures for their respective stage of meaningful use. We proposed that states may also choose this option to accept group reporting for CQMs, based upon a predetermined definition of a “group practice,” such as sharing one TIN.
  • Medicare EPs participating in the Medicare SSP and the testing of the Pioneer ACO model who use CEHRT to submit ACO measures in accordance with the requirements of the Medicare SSP would be considered to have satisfied their CQM reporting requirement as a group for the Medicare EHR Incentive Program. The Medicare SSP does not require the use of CEHRT. However, all CQM data would have to be extracted from CEHRT in order for the EP to qualify for the Medicare EHR Incentive Program if an EP intends to use this group reporting option. EPs would have to individually satisfy the objectives and associated measures for their respective stage of meaningful use, in addition to submitting CQMs as part of an ACO. EPs who are part of an ACO but do not enter the data used for reporting the CQMs (which excludes the survey tool or claims-based measures that are collected to calculate the quality performance score in the Medicare SSP) into CEHRT would not be able to meet meaningful use requirements. For more information about the requirements of the Medicare SSP, see 42 CFR 425 and the November 2, 2011 final rule (76 FR 67802). EPs who use this group reporting option for the Medicare EHR Incentive Program would be required to comply with any changes to the Medicare SSP that may apply in the future. EPs would be required to be part of a group practice (that is, two or more EPs, each identified with a unique NPI associated with a group practice identified under one TIN) to be able to use this group reporting option.
  • Medicare EPs who satisfactorily report PQRS CQMs using CEHRT under the PQRS Group Practice Reporting Option (GPRO), would be considered to have satisfied their CQM reporting requirement as a group for the Medicare EHR Incentive Program. For more information about the PQRS GPRO, see 42 CFR 414.90 and the CY 2012 Medicare PFS final rule (76 FR 73314) and CY 2013 Medicare PFS proposed rule (77 FR 44805 through 44807). EPs who use this group reporting option for the Medicare EHR Incentive Program would be required to comply with any changes to the PQRS GPRO that may apply in the future and would have to individually satisfy the objectives and associated measures for their respective stage of meaningful use.

Comment: We received numerous comments on the proposed group reporting options. Generally, most commenters supported including group reporting. Many commenters indicated group reporting options are consistent with the intent of many of the measures and would promote a more patient focused healthcare experience. A commenter requested clarification regarding whether group reporting was confined to CQMs or other objectives in meaningful use as well. Other commenters requested more detail on how new EPs or EPs leaving group practices might affect reporting and validation. Commenters indicated the requirement that only EPs beyond Stage 1 be able to use this option be eliminated because new providers join practices frequently. A commenter requested that new members of a practice be able to report at the same level that the group is currently reporting. Many commenters requested greater specificity in the final rule and clarification whether all EPs under the same TIN need to submit as a group, or if some can submit as a group and others individually. A commenter recommended that not all EPs under the same TIN should have to have access to CEHRT at all group practice locations. Other commenters stated that the proposed option for group reporting is complex and suggested the files submitted contain only data related to providers within the group or practice that have met the measures. A commenter indicated that the addition of multiple reporting options has made it exceedingly difficult for providers already presented with multiple reporting options across state and federal programs.

Response: We agree with commenters as to the benefits of reporting and measurement at the group level. We believe it can lessen the complexity and burden of reporting and also promote a greater patient focus. Group level reporting can avoid the need for multiple professionals in the same practice to report the same information on single patient that they may each treat. It can promote team work and the recognition that quality care often depends on interplay of multiple professionals rather that solely on a particular individual professional. Therefore, we agree that we should include the option of group reporting of CQMs for the EHR Incentive Program.

With respect to applicability to measures other than CQMs, as proposed the group reporting options in section II.B.6.d. of the proposed rule (77 FR 13758) would apply only to CQM reporting and not to other meaningful use objectives and associated measures. EPs reporting CQMs under a group reporting option must still attest to the meaningful use objectives and associated measures individually or through the batch reporting process we are finalizing in section II.C.1.c of this final rule to successfully demonstrate meaningful use.

As for the three options for group reporting we proposed, we agree with the potential for complexity of group reporting under which different individuals within a group would be treated differently, such as the proposed requirement that all EPs in the group must be beyond their first year of meaningful use. We believe that this would be complex and difficult to operationalize, so we are not finalizing this requirement. We note that for the group reporting option under PQRS and for professionals participating in the Medicare SSP and the testing of the Pioneer ACO model, all individuals within a group are treated as being part of the group for the purposes of quality reporting.

As a result, for the Medicare EHR Incentive Program, we are finalizing the following two group reporting options for the purposes of CQM reporting:

  • Medicare EPs participating in the Medicare SSP and the testing of the Pioneer ACO model who use CEHRT to submit ACO CQMs in accordance with the requirements of the Medicare SSP would be considered to have satisfied their CQM reporting requirement as a group for the Medicare EHR Incentive Program.
  • Medicare EPs who satisfactorily report PQRS CQMs using CEHRT under the PQRS GPRO would be considered to have satisfied their CQM reporting requirement as a group for the Medicare EHR Incentive Program. Under the CY 2013 Medicare PFS proposed rule, additional group reporting options are proposed. We note that the proposed claims and registry options for GPRO, which do not involve the use of CEHRT, would not satisfy the CQM reporting requirement for the EHR Incentive Program. However, the options for GPRO involving the use of CEHRT, which include submissions from CEHRT directly to CMS or through a data intermediary to CMS, could satisfy the CQM reporting requirement for the EHR Incentive Program. Under the PQRS GPRO, CQM submission is at the group level, not at the level of any individual EP that is part of the group. Each individual EP who is a member of the group would meet the CQM reporting requirement for the EHR Incentive Program if the group meets the requirements for PQRS, with the exception of the EPs in the group who are in their first year of demonstrating meaningful use as noted later in this section.

We do not finalize any additional requirements beyond those of the programs themselves for group reporting, with the exception that the group must use CEHRT in connection with submitting CQMs. Although a group may include EPs that are demonstrating meaningful use for the first time, we emphasize that these EPs cannot use either of these group reporting options for reporting CQMs for the EHR Incentive Program. CQM data collected by EPs that are part of a group and are in their first year of demonstrating meaningful use could still be part of the group's collective data submission. However, for purposes of avoiding a payment adjustment, EPs who are in their first year of demonstrating meaningful use in the year immediately preceding a payment adjustment year must individually submit their CQM data by attestation no later than October 1 of such preceding year. We encourage EPs who would like to use the group reporting options beginning in 2014 to become meaningful EHR users in 2013. Please see section II.D.2. of this final rule for more details on payment adjustments.

For the Medicaid EHR Incentive Program, the states will have the option to allow group reporting of CQMs through an update to their State Medicaid HIT plan, which must describe how they would address the issue of EPs who switch group practices during an EHR reporting period.

7. CQMs for Eligible Hospitals and Critical Access Hospitals

(a) Statutory and Other Considerations

Sections 1886(n)(3)(A)(iii) and 1903(t)(6)(C) of the Act provide for the reporting of CQMs by eligible hospitals and CAHs as part of demonstrating meaningful use of CEHRT. For further explanation of the statutory requirements, we refer readers to the discussion in our Stage 1 proposed and final rules (75 FR 1870 through 1902 and 75 FR 44380 through 44435, respectively).

Section 1886(n)(3)(B)(i)(I) of the Act requires the Secretary to give preference to CQMs that have been selected for the purpose of applying section 1886(b)(3)(B)(viii) of the Act (that is, measures that have been selected for the Hospital Inpatient Quality Reporting (IQR) Program) or that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act (namely, the NQF). We proposed CQMs for eligible hospitals and CAHs for 2013, 2014, and 2015 (and potentially subsequent years) that reflect this preference, although we note that the Act does not require the selection of such CQMs for the EHR Incentive Programs. CQMs listed in this final rule that do not have an NQF identifying number are not NQF endorsed.

Under section 1903(t)(8) of the Act, the Secretary must seek, to the maximum extent practicable, to avoid duplicative requirements from federal and state governments for eligible hospitals and CAHs to demonstrate meaningful use of CEHRT under Medicare and Medicaid. Therefore, to meet this requirement, we proposed to continue our practice from Stage 1 of proposed CQMs that would apply for both the Medicare and Medicaid EHR Incentive Programs.

In accordance with CMS and HHS quality goals as well as the HHS National Quality Strategy recommendations, the hospital CQMs that we proposed beginning with FY 2014 can be categorized into the following six domains, which are described in section II.B.3. of this final rule:

  • Patient & Family Engagement.
  • Patient Safety.
  • Care Coordination.
  • Population & Public Health.
  • Efficient Use of Healthcare Resources.
  • Clinical Process/Effectiveness.

The selection of CQMs we proposed for eligible hospitals and CAHs was based on statutory requirements, the HITPC's recommendations, alignment with other CMS and national hospital quality measurement programs such as the Joint Commission, the Medicare Hospital Inpatient Quality Reporting (IQR) Program and Hospital Value-Based Purchasing (HVBP) Program, the National Quality Strategy (NQS), and other considerations discussed in sections II.B.7.b. and II.B.7.c. of the proposed rule.

Section 1886(n)(3)(B)(iii) of the Act requires that in selecting measures for eligible hospitals and CAHs, and in establishing the form and manner of reporting, the Secretary shall seek to avoid redundant or duplicative reporting with reporting otherwise required. In consideration of the importance of alignment with other measure sets that apply to eligible hospitals and CAHs, we analyzed the Hospital IQR Program, hospital CQMs used by state Medicaid agencies, and the Joint Commission's hospital CQMs when selecting the proposed CQMs to be reported under the EHR Incentive Program. Furthermore, as we noted in the proposed rule, we placed emphasis on those CQMs that are in line with the NQS and the HITPC's recommendations.

Comment: Many commenters supported alignment of measure sets and reporting methods with other quality reporting programs and agency goals, such as Hospital IQR Program, HVBP, and NQS. These commenters commended CMS's intentions to reduce duplicative requirements between programs, prevent hospitals from calculating both electronic and paper-based reports for the same CQMs, avoid confusion and move towards a single, aligned quality reporting mechanism. However, several commenters requested that we provide a timeline for these alignment efforts as well as additional clarification regarding how we intend to pursue and achieve alignment across quality report programs and what this means operationally for eligible hospitals and CAHs. One commenter requested that we also align with the Center for Disease Control and Prevention's (CDC's) National Healthcare Safety Network (NHSN) to make hospital acquired infections (HAI) a national healthcare priority. Other commenters requested that we seek alignment and accuracy in other areas of quality measurement, including electronic specifications, data reporting methodologies, and vendor certification requirements. One commenter also urged that we continuously align electronic specifications for all CQMs across quality reporting programs as measure stewards update and maintain their CQMs.

Response: We appreciate the supportive comments regarding alignment. Our principal goals in alignment of the Hospital IQR, and the Medicare and Medicaid EHR Incentive Programs are to: (1) Provide a single set of CQMs for hospital reporting; (2) to the extent possible, avoid duplicate reporting by hospitals by using a single submission for multiple purposes as appropriate; and (3) transition from manual chart abstraction to automated extraction and electronic reporting based on the use of EHR technology.

In the FY 2012 Inpatient Prospective Payment Systems/Long-Term Care Hospital Prospective Payment System (IPPS/LTCH PPS) proposed rule (76 FR 25893), we stated our intention to explore mechanisms for Hospital IQR Program data collection using EHRs, and gave FY 2015 as an example of when hospitals might be able to switch to EHR-based reporting of manually chart-abstracted Hospital IQR measures. The CQMs we are finalizing beginning in 2014 for reporting under the EHR Incentive Program are electronically specified versions of current IQR chart abstracted CQMs. The 2015 target date would allow for at least 1 year of electronic submission of CQMs through the EHR Incentive Program prior to our targeted date to begin EHR-based reporting for IQR. We must assess any data collection mode differences between EHR-based reporting and chart abstracted measures using a diverse and robust sample of hospitals before proposing in rulemaking to use EHR data collection in the Hospital IQR program. Among other factors, our ability to transition to EHR-based reporting for IQR will depend on whether EHR-based reporting is accurate and reliable. Our goal would be to phase out manual chart abstraction for hospital reporting.

We did not propose the IQR CQMs on HAI for the EHR Incentive Program. Hospitals may electronically submit HAI information to the CDC, although this is not required. Information of electronic submission through the NHSN can be found at http://www.cdc.gov/nhsn/CDA_eSurveillance.html. NHSN data is based on surveillance data rather than chart abstraction. We will consider the NHSN measures for the EHR Incentive Program in future years.

(b) CQMs for Eligible Hospitals and CAHs for FY 2013

For the EHR reporting periods in FY 2013, we proposed to require that eligible hospitals and CAHs submit information on each of the 15 CQMs that were finalized for FYs 2011 and 2012 in the Stage 1 final rule (75 FR 44418 through 44420). We refer readers to the discussion in the Stage 1 final rule for further explanation of the requirements for reporting those CQMs (75 FR 44411 through 44422).

We did not receive any public comments on our proposals, and we are finalizing the CQMs for FY 2013 as proposed.

(c) CQMs for Eligible Hospitals and CAHs Beginning With FY 2014

(i) Reporting Options

We proposed to require eligible hospitals and CAHs to report 24 CQMs from a menu of 49 CQMs beginning with FY 2014, including at least 1 CQM from each of the following 6 domains, which are discussed in section II.B.3. of this final rule:

  • Patient and Family Engagement.
  • Patient Safety.
  • Care Coordination.
  • Population and Public Health.
  • Efficient Use of Healthcare Resources.
  • Clinical Process/Effectiveness.

For the remaining CQMs, we proposed that eligible hospitals and CAHs would select and report CQMs that best apply to their patient mix. We solicited comments on the number of CQMs and the appropriateness of the CQMs and domains for eligible hospitals and CAHs.

Comment: A few commenters stated that the requirement to report 24 CQMs was too difficult and adds to the administrative burden placed on eligible hospitals and CAHs, especially rural hospitals. Many commenters suggested that CQM reporting requirement beginning with 2014 remain at 15 CQMs due to the number of issues experienced by hospitals when implementing the Stage 1 CQMs, although other commenters stated that requiring up to 18 CQMs would be reasonable. A few commenters noted that CQMs were not evenly distributed among the 6 domains, making the requirement to report at least one CQM from each domain difficult for some hospitals. One commenter recommended that if a domain did not have at least 4 CQMs eligible hospitals and CAHs should not be required to report that domain. Multiple commenters stated that eligible hospitals and CAHs in Stage 1 in FY 2014 may have difficulty meeting the CQM requirement beginning in 2014 and recommend that the Stage 1 CQMs meet the requirements for those hospitals. Alternatively, the commenters recommended that if the CQMs beginning in 2014 are required, that the number of CQMs being reported be reduced for the eligible hospitals and CAHs in Stage 1 beginning in FY 2014. One commenter stated that CQM requirements failed to align with other meaningful use objectives.

Response: We acknowledge that increasing the number of CQMs required to be reported from 15 in 2011, 2012, and 2013 to 24 beginning in 2014 increases implementation burden on hospitals. We have stated our intention to implement EHR-based reporting of CQMs in other quality reporting programs, such as the Hospital IQR Program. One purpose of our proposal to increase the number of CQMs reported electronically for the EHR Incentive Program is to create an electronic reporting infrastructure that we can also use for other quality reporting programs. We also acknowledge that the requirement of reporting 24 CQMs for hospitals in their first year of Stage 1 in 2014 is a significan