Skip to Content
Rule

Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010

Action

Final Rule With Comment Period.

Summary

This final rule with comment period implements changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also implements or discusses certain provisions of the Medicare Improvements for Patients and Providers Act of 2008. (See the Table of Contents for a listing of the specific issues addressed in this rule.)

This final rule with comment period also finalizes the calendar year (CY) 2009 interim relative value units (RVUs) and issues interim RVUs for new and revised codes for CY 2010. In addition, in accordance with the statute, it announces that the update to the physician fee schedule conversion factor is −21.2 percent for CY 2010, the preliminary estimate for the sustainable growth rate for CY 2010 is −8.8 percent, and the conversion factor (CF) for CY 2010 is $28.4061.

 

Table of Contents Back to Top

Tables Back to Top

DATES: Back to Top

Effective Dates: With the exception of the provisions of § 414.68 and § 414.210(e)(5), this final rule is effective on January 1, 2010. The provisions of § 414.68 are effective on October 30, 2009, and the provisions of § 414.210(e)(5) are effective on July 1, 2010.

Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 29, 2009.

ADDRESSES: Back to Top

In commenting, please refer to file code CMS-1413-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions under the “More Search Options” tab.

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare Medicaid Services, Department of Health and Human Services, Attention: CMS-1413-FC, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare Medicaid Services, Department of Health and Human Services, Attention: CMS-1413-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses:

a. For delivery in Washington, DC—

Centers for Medicare Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

b. For delivery in Baltimore, MD—

Centers for Medicare Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

FOR FURTHER INFORMATION CONTACT: Back to Top

Rick Ensor, (410) 786-5617, for issues related to practice expense methodology.

Craig Dobyski, (410) 786-4584, for issues related to geographic practice cost indices and malpractice RVUs.

Ken Marsalek, (410) 786-4502, for issues related to the physician practice information survey and the multiple procedure payment reduction.

Regina Walker-Wren, (410) 786-9160, for issues related to the phasing out of the outpatient mental health treatment limitation.

Diane Stern, (410) 786-1133, for issues related to the physician quality reporting initiative and incentives for e-prescribing.

Lisa Grabert, (410) 786-6827, for issues related to the Physician Resource Use Feedback Program.

Colleen Bruce, (410) 786-5529, for issues related to value-based purchasing.

Sandra Bastinelli, (410) 786-3630, for issues related to the implementation of accreditation standards.

Jim Menas, (410) 786-4507, for issues related to teaching anesthesia services.

Sarah McClain, (410) 786-2994, for issues related to the coverage of cardiac rehabilitation services.

Dorothy Shannon, (410) 786-3396, for issues related to payment for cardiac and pulmonary rehabilitation services.

Roya Lotfi, (410) 786-4072, for issues related to the coverage of pulmonary rehabilitation.

Jamie Hermansen, (410) 786-2064, for issues related to kidney disease patient education programs.

Terri Harris, (410) 786-6830, for issues related to payment for kidney disease patient education.

Brijet Burton, (410) 786-7364, for issues related to the compendia for determination of medically-accepted indications for off-label uses of drugs and biologicals in an anti-cancer chemotherapeutic regimen.

Henry Richter, (410) 786-4562, or Lisa Hubbard, (410) 786-5472, for issues related to renal dialysis provisions and payments for end-stage renal disease facilities.

Cheryl Gilbreath, (410) 786-5919, for issues related to payment for covered outpatient drugs and biologicals.

Edmund Kasaitis, (410) 786-0477, or Bonny Dahm, (410) 786-4006, for issues related to the Competitive Acquisition Program (CAP) for Part B drugs.

Pauline Lapin, (410) 786-6883, for issues related to the chiropractic services demonstration BN issue.

Monique Howard, (410) 786-3869, for issues related to CORF conditions of coverage.

Roechel Kujawa, (410) 786-9111, for issues related to ambulance services.

Anne Tayloe Hauswald, (410) 786-4546, for clinical laboratory issues.

Troy Barsky, (410) 786-8873, or Roy Albert, (410) 786-1872, for issues related to physician self-referral.

Christopher Molling, (410) 786-6399, or Anita Greenberg, (410) 786-4601, for issues related to the repeal of transfer of title for oxygen equipment.

Michelle Peterman, (410) 786-2591, or Iffat Fatima, (410) 786-6709 for issues related to the grandfathering provisions of the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition Program.

Ralph Goldberg, (410) 786-4870, or Heidi Edmunds, (410) 786-1781, for issues related to the damages process caused by the termination of contracts awarded in 2008 under the DMEPOS Competitive Bidding program.

Diane Milstead, (410) 786-3355, or Gaysha Brooks, (410) 786-9649, for all other issues.

SUPPLEMENTARY INFORMATION: Back to Top

Submitting Comments: We welcome comments from the public on the following issues: interim relative value units (RVUs) for selected codes identified in Addendum C; the physician self-referral designated health services (DHS) codes listed in Tables 31 and 32; services for consideration for the Five-Year Review of work RVUs for services as discussed in section II.P., and information concerning services provided under arrangement as discussed in section II.N.2.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Table of Contents Back to Top

To assist readers in referencing sections contained in this preamble, we are providing a table of contents. Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the Code of Federal Regulations (CFR). Information on the regulation's impact appears throughout the preamble, and therefore, is not discussed exclusively in section XIII. of this final rule with comment period.

I. Background

A. Development of the Relative Value System

1. Work RVUs

2. Practice Expense Relative Value Units (PE RVUs)

3. Resource-Based Malpractice (MP) RVUs

4. Refinements to the RVUs

5. Adjustments to RVUs Are Budget Neutral

B. Components of the Fee Schedule Payment Amounts

C. Most Recent Changes to the Fee Schedule

II. Provisions of the Final Regulation and Analysis of the Public Comments

A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)

1. Practice Expense Methodology

a. Data Sources for Calculating Practice Expense

b. Allocation of PE to Services

c. Facility and Non-Facility Costs

d. Services With Technical Components (TCs) and Professional Components (PCs)

e. Transition Period

f. PE RVU Methodology

2. PE Revisions for CY 2010

a. SMS and Supplemental Survey Background

b. Physician Practice Information Survey (PPIS)

c. Equipment Utilization Rate

d. Miscellaneous PE Issues

e. AMA RUC PE Recommendations for Direct PE Inputs

f. Practice Expense for Intranasal Vaccine Administration Codes (CPT Codes 90467, 90468, 90473, and 90474)

B. Geographic Practice Cost Indices (GPCIs): Locality Discussion

1. Update—Expiration of 1.0 Work GPCI Floor

2. Payment Localities

C. Malpractice Relative Value Units (RVUs)

1. Background

2. Methodology for the Revision of Resource-Based Malpractice RVUs

D. Medicare Telehealth Services

1. Requests for Adding Services to the List of Medicare Telehealth Services

2. Submitted Requests for Addition to the List of Telehealth Services

a. Health and Behavior Assessment and Intervention (HBAI)

b. Nursing Facility Services

c. Critical Care Services

d. Other Requests

e. Summary: Result of Evaluation of 2010 Requests

3. Other Issues

E. Specific Coding Issues Related to the Physician Fee Schedule

1. Canalith Repositioning

2. Payment for an Initial Preventive Physical Examination (IPPE)

3. Audiology Codes: Policy Clarification of Existing CPT Codes

4. Consultation Services

F. Potentially Misvalued Codes Under the Physician Fee Schedule

1. Valuing Services Under the Physician Fee Schedule

2. High Cost Supplies

3. Review of Services Often Billed Together and the Possibility of Expanding the Multiple Procedure Payment Reduction (MPPR) to Additional Nonsurgical Services

4. AMA RUC Review of Potentially Misvalued Services

a. Site of Service

b. “23-Hour” Stay

c. AMA RUC Review of Potentially Misvalued Codes for CY 2010

5. PE Issues—Arthoscopy

6. Establishing Appropriate Relative Values for Physician Fee Schedule Services

G. Issues Related to the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)

1. Section 102: Elimination of Discriminatory Copayment Rates for Medicare Outpatient Psychiatric Services

2. Section 131(b): Physician Payment, Efficiency, and Quality Improvements—Physician Quality Reporting Initiative (PQRI)

3. Section 131(c): Physician Resource Use Measurement and Reporting Program

4. Section 131(d): Plan for Transition to Value-Based Purchasing Program for Physicians and Other Practitioners

5. Section 132: Incentives for Electronic Prescribing (E-Prescribing)—The E-Prescibing Incentive Program

6. Section 135: Implementation of Accreditation Standards for Suppliers Furnishing the Technical Component (TC) of Advanced Diagnostic Imaging Services

7. Section 139: Improvements for Medicare Anesthesia Teaching Programs

8. Section 144(a): Payment and Coverage Improvements for Patients With Chronic Obstructive Pulmonary Disease and Other Conditions—Cardiac Rehabilitation Services

9. Section 144(a): Payment and Coverage Improvements for Patients With Chronic Obstructive Pulmonary Disease and Other Conditions—Pulmonary Rehabilitation Services

10. Section 144(b): Repeal of Transfer of Title for Oxygen Equipment

11. Section 152(b): Coverage of Kidney Disease Patient Education Services

12. Section 153: Renal Dialysis Provisions

13. Section 182(b): Revision of Definition of Medically-Accepted Indication for Drugs; Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen

H. Part B Drug Payment

1. Average Sales Price (ASP) Issues

2. Competitive Acquisition Program (CAP) Issues

I. Provisions Related to Payment for Renal Dialysis Services Furnished by End-Stage Renal Disease (ESRD) Facilities

J. Discussion of Chiropractic Services Demonstration

1. Background

2. Analysis of Demonstration

3. Payment Adjustment

K. Comprehensive Outpatient Rehabilitation Facilities (CORF) and Rehabilitation Agency Issues

L. Ambulance Fee Schedule: Technical Correction to the Rural Adjustment Factor Regulations (§ 414.610)

M. Clinical Laboratory Fee Schedule: Signature on Requisition

N. Physician Self-Referral

1. General Background

2. Physician Stand in the Shoes

3. Services Provided “Under Arrangements” (Services Performed by an Entity Other Than the Entity That Submits the Claim): Solicitation of Comments

O. Durable Medical Equipment-Related Issues

1. Damages to Suppliers Awarded a Contract Under the Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (Medicare DMEPOS Competitive Bidding Program) Caused by the Delay of the Program

2. Notification to Beneficiaries for Suppliers Regarding Grandfathering

P. Five-Year Refinement of Relative Value Units

Q. Other Issues—Therapy Caps

III. Refinement of Relative Value Units for Calendar Year 2010 and Response to Public Comments on Interim Relative Value Units for 2009

A. Summary of Issues Discussed Related to the Adjustment of Relative Value Units

B. Process for Establishing Work Relative Value Units for the Physician Fee Schedule

C. Work Relative Value Unit Refinements of Interim Relative Value Units

D. Interim 2009 Codes

E. Establishment of Interim Work Relative Value Units for New and Revised Physician's Current Procedural Terminology (CPT) Codes and New Healthcare Common Procedure Coding System Codes (HCPCS) for 2010 (Includes Table Titled “AMA RUC Recommendations and CMS' Decisions for New and Revised 2010 CPT Codes”)

F. Discussion of Codes and AMA RUC Recommendations

G. Additional Coding Issues

H. Establishment of Interim PE RVUs for New and Revised Physician's Current Procedural Terminology (CPT) Codes and New Healthcare Common Procedure Coding System (HCPCS) Codes for 2010

IV. Physician Self-Referral Prohibition: Annual Update to the List of CPT/HCPCS Codes

A. General

B. Annual Update to the Code List

V. Physician Fee Schedule Update for CY 2010

A. Physician Fee Schedule Update

B. The Percentage Change in the Medicare Economic Index (MEI)

C. The Update Adjustment Factor (UAF)

VI. Allowed Expenditures for Physicians' Services and the Sustainable Growth Rate (SGR)

A. Medicare Sustainable Growth Rate

B. Physicians' Services

C. Preliminary Estimate of the SGR for 2010

D. Revised Sustainable Growth Rate for 2009

E. Final Sustainable Growth Rate for 2008

F. Calculation of 2010, 2009, and 2008 Sustainable Growth Rates

VII. Anesthesia and Physician Fee Schedule Conversion Factors for CY 2010

A. Physician Fee Schedule Conversion Factor

B. Anesthesia Conversion Factor

VIII. Telehealth Originating Site Facility Fee Payment Amount Update

IX. Provisions of the Final Rule

X. Waiver of Proposed Rulemaking and Delay in Effective Date

XI. Collection of Information Requirements

XII. Response to Comments

XIII. Regulatory Impact Analysis

Regulation Text

Addendum A—Explanation and Use of Addendum B

Addendum B—Relative Value Units and Related Information Used in Determining Medicare Payments for CY 2010

Addendum C—Codes With Interim RVUs

Addendum D—2010 Geographic Adjustment Factors (GAFs)

Addendum E—2010 Geographic Practice Cost Indices (GPCIs) by State and Medicare Locality

Addendum F—CY 2010 ESRD Wage Index for Non-Urban Areas Based on CBSA Labor Market Areas

Addendum G—CY 2010 ESRD Wage Index for Urban Areas Based on CBSA Labor Market Areas

Addendum H—CPT/HCPCS Imaging Codes Defined by Section 5102(b) of the DRA

Addendum I—List of CPT/HCPCS Codes Used To Define Certain Designated Health Services Under Section 1877 of the Social Security Act

Acronyms Back to Top

In addition, because of the many organizations and terms to which we refer by acronym in this final rule with comment period, we are listing these acronyms and their corresponding terms in alphabetical order below:

AAAnesthesiologist assistant

AACVPRAmerican Association of Cardiovascular and Pulmonary Rehabilitation

AANAAmerican Association of Nurse Anesthetists

ABMSAmerican Board of Medical Specialties

ABNAdvanced Beneficiary Notice

ACCAmerican College of Cardiology

ACGMEAccreditation Council on Graduate Medical Education

ACLSAdvanced cardiac life support

ACRAmerican College of Radiology

AEDAutomated external defibrillator

AFROCAssociation of Freestanding Radiation Oncology Centers

AHAAmerican Heart Association

AHFS-DIAmerican Hospital Formulary Service—Drug Information

AHRQ[HHS'] Agency for Healthcare Research and Quality

AMAAmerican Medical Association

AMA-DEAmerican Medical Association Drug Evaluations

AMPAverage manufacturer price

AOAccreditation organization

AOAAmerican Osteopathic Association

APAAmerican Psychological Association

APTAAmerican Physical Therapy Association

ARRAAmerican Recovery and Reinvestment Act (Pub. L. 111-5)

ASCAmbulatory surgical center

ASPAverage sales price

ASRTAmerican Society of Radiologic Technologists

ASTROAmerican Society for Therapeutic Radiology and Oncology

ATAAmerican Telemedicine Association

AWPAverage wholesale price

BBABalanced Budget Act of 1997 (Pub. L. 105-33)

BBRA[Medicare, Medicaid and State Child Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)

BIPAMedicare, Medicaid, and SCHIP Benefits Improvement Protection Act of 2000 (Pub. L. 106-554)

BLSBasic Life support

BNBudget neutrality

BPMBenefit Policy Manual

CABGCoronary artery bypass graft

CADCoronary artery disease

CAHCritical access hospital

CAHEACommittee on Allied Health Education and Accreditation

CAPCompetitive acquisition program

CBICCompetitive Bidding Implementation Contractor

CBPCompetitive Bidding Program

CBSACore-Based Statistical Area

CFConversion factor

CfCConditions for Coverage

CFRCode of Federal Regulations

CKDChronic kidney disease

CLFSClinical laboratory fee schedule

CMACalifornia Medical Association

CMHCCommunity mental health center

CMPCivil money penalty

CMSCenters for Medicare Medicaid Services

CNSClinical nurse specialist

CoPCondition of participation

COPDChronic obstructive pulmonary disease

CORFComprehensive Outpatient Rehabilitation Facility

COSCost of service

CPEPClinical Practice Expert Panel

CPIConsumer Price Index

CPI-UConsumer price index for urban customers

CPRCardiopulmonary resuscitation

CPT[Physicians'] Current Procedural Terminology (4th Edition, 2002, copyrighted by the American Medical Association)

CRCardiac rehabilitation

CRNACertified registered nurse anesthetist

CRPCanalith repositioning

CRTCertified respiratory therapist

CSWClinical social worker

CYCalendar year

DEADrug Enforcement Agency

DHSDesignated health services

DMEDurable medical equipment

DMEPOSDurable medical equipment, prosthetics, orthotics, and supplies

DOQDoctor's Office Quality

DOSDate of service

DRADeficit Reduction Act of 2005 (Pub. L. 109-171)

DSMTDiabetes self-management training

E/MEvaluation and management

EDIElectronic data interchange

EEGElectroencephalogram

EHRElectronic health record

EKGElectrocardiogram

EMGElectromyogram

EMTALAEmergency Medical Treatment and Active Labor Act

EOGElectro-oculogram

EPOErythopoeitin

ESRDEnd-stage renal disease

FAXFacsimile

FDAFood and Drug Administration (HHS)

FFSFee-for-service

FR Federal Register

GAFGeographic adjustment factor

GAOGeneral Accounting Office

GEMGenerating Medicare [Physician Quality Performance Measurement Results]

GFRGlomerular filtration rate

GPOGroup purchasing organization

GPCIGeographic practice cost index

HACHospital-acquired conditions

HBAIHealth and behavior assessment and intervention

HCPACHealth Care Professional Advisory Committee

HCPCSHealthcare Common Procedure Coding System

HCRISHealthcare Cost Report Information System

HDRTHigh dose radiation therapy

HH PPSHome Health Prospective Payment System

HHAHome health agency

HHRGHome health resource group

HHS[Department of] Health and Human Services

HIPAAHealth Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191)

HITHealth information technology

HITECHHealth Information Technology for Economic and Clinical Health Act (Title IV of Division B of the Recovery Act, together with Title XIII of Division A of the Recovery Act)

HITSPHealthcare Information Technology Standards Panel

HIVHuman immunodeficiency virus

HOPDHospital outpatient department

HPSAHealth Professional Shortage Area

HRSAHealth Resources Services Administration (HHS)

IACSIndividuals Access to CMS Systems

ICDInternational Classification of Diseases

ICFIntermediate care facilities

ICRIntensive cardiac rehabilitation

ICRInformation collection requirement

IDTFIndependent diagnostic testing facility

IFCInterim final rule with comment period

IMRTIntensity-Modulated Radiation Therapy

IPPEInitial preventive physical examination

IPPSInpatient prospective payment system

IRSInternal Revenue Service

ISOInsurance services office

IVDIschemic Vascular Disease

IVIGIntravenous immune globulin

IWPUTIntra-service work per unit of time

JRCERTJoint Review Committee on Education in Radiologic Technology

KDEKidney disease education

LCDLocal coverage determination

MAMedicare Advantage

MA-PDMedicare Advantage—Prescription Drug Plans

MAVMeasure Applicability Validation

MCMPMedicare Care Management Performance

MDRDModification of Diet in Renal Disease

MedCACMedicare Evidence Development and Coverage Advisory Committee (formerly the Medicare Coverage Advisory Committee (MCAC))

MedPACMedicare Payment Advisory Commission

MEIMedicare Economic Index

MIEA-TRHCAMedicare Improvements and Extension Act of 2006 (that is, Division B of the Tax Relief and Health Care Act of 2006 (TRHCA) (Pub. L. 109-432)

MIPPAMedicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275)

MMAMedicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)

MMSEAMedicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173)

MNTMedical nutrition therapy

MOCMaintenance of certification

MPMalpractice

MPPRMultiple procedure payment reduction

MQSAMammography Quality Standards Act of 1992 (102)

MRAMagnetic resonance angiography

MRIMagnetic resonance imaging

MSAMetropolitan statistical area

NBRCNational Board for Respiratory Care

NCDNational Coverage Determination

NCQDISNational Coalition of Quality Diagnostic Imaging Services

NDCNational drug code

NFNursing facility

NISTANational Institute of Standards and Technology Act

NPNurse practitioner

NPINational Provider Identifier

NPPNonphysician practitioner

NQFNational Quality Forum

NRCNuclear Regulatory Commission

OACT[CMS'] Office of the Actuary

OBRAOmnibus Budget Reconciliation Act

ODFOpen door forum

OGPEOxygen generating portable equipment

OIGOffice of Inspector General

OMBOffice of Management and Budget

ONC[HHS'] Office of the National Coordinator for Health IT

OPPSOutpatient prospective payment system

OSCAROnline Survey and Certification and Reporting

PAPhysician assistant

PATPerformance assessment tool

PCProfessional component

PCIPercutaneous coronary intervention

PDPPrescription drug plan

PEPractice expense

PE/HRPractice expense per hour

PEACPractice Expense Advisory Committee

PERCPractice Expense Review Committee

PFSPhysician Fee Schedule

PGP[Medicare] Physician Group Practice

PHIProtected health information

PHPPartial hospitalization program

PIM[Medicare] Program Integrity Manual

PLIProfessional liability insurance

POAPresent on admission

POCPlan of care

PPIProducer price index

PPISPhysician Practice Information Survey

PPSProspective payment system

PPTAPlasma Protein Therapeutics Association

PQRIPhysician Quality Reporting Initiative

PRPulmonary rehabilitation

PRAPaperwork Reduction Act

PSAPhysician scarcity areas

PTPhysical therapy

PTCAPercutaneous transluminal coronary angioplasty

PVBPPhysician and Other Health Professional Value-Based Purchasing Workgroup

RARadiology assistant

RBMARadiology Business Management Association

RFARegulatory Flexibility Act

RHCRural health clinic

RIARegulatory impact analysis

RNRegistered nurse

RNACReasonable net acquisition cost

RPARadiology practitioner assistant

RRTRegistered respiratory therapist

RUC[AMA's Specialty Society] Relative (Value) Update Committee

RVURelative value unit

SBASmall Business Administration

SGRSustainable growth rate

SLPSpeech-language pathology

SMS[AMA's] Socioeconomic Monitoring System

SNFSkilled nursing facility

SORSystem of record

SRSStereotactic radiosurgery

STARSServices Tracking and Reporting System

TCTechnical Component

TINTax identification number

TRHCATax Relief and Health Care Act of 2006 (Pub. L. 109-432)

TTOTranstracheal oxygen

UPMCUniversity of Pittsburgh Medical Center

USDEUnited States Department of Education

USP-DIUnited States Pharmacopoeia—Drug Information

VBPValue-based purchasing

WAMPWidely available market price

I. Background Back to Top

Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services.” The Act requires that payments under the physician fee schedule (PFS) are based on national uniform relative value units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense (PE), and malpractice expense. Before the establishment of the resource-based relative value system, Medicare payment for physicians' services was based on reasonable charges.

A. Development of the Relative Value System

1. Work RVUs

The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (101), and OBRA 1990, (101). The final rule, published on November 25, 1991 (56 FR 59502), set forth the fee schedule for payment for physicians' services beginning January 1, 1992. Initially, only the physician work RVUs were resource-based, and the PE and malpractice RVUs were based on average allowable charges.

The physician work RVUs established for the implementation of the fee schedule in January 1992 were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original physician work RVUs for most codes in a cooperative agreement with the Department of Health and Human Services (DHHS). In constructing the code-specific vignettes for the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the Federal government, and obtained input from numerous physician specialty groups.

Section 1848(b)(2)(B) of the Act specifies that the RVUs for anesthesia services are based on RVUs from a uniform relative value guide, with appropriate adjustment of the conversion factor (CF), in a manner to assure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. We established a separate CF for anesthesia services, and we continue to utilize time units as a factor in determining payment for these services. As a result, there is a separate payment methodology for anesthesia services.

We establish physician work RVUs for new and revised codes based on our review of recommendations received from the American Medical Association's (AMA) Specialty Society Relative Value Update Committee (RUC).

2. Practice Expense Relative Value Units (PE RVUs)

Section 121 of the Social Security Act Amendments of 1994 (103), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physician's service beginning in 1998. We were to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs.

Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), amended section 1848(c)(2)(C)(ii) of the Act to delay implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from charge-based PE RVUs to resource-based RVUs.

We established the resource-based PE RVUs for each physicians' service in a final rule, published November 2, 1998 (63 FR 58814), effective for services furnished in 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, resource-based PE RVUs did not become fully effective until 2002.

This resource-based system was based on two significant sources of actual PE data: the Clinical Practice Expert Panel (CPEP) data; and the AMA's Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of physicians, practice administrators, and nonphysicians (for example, registered nurses (RNs)) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physician's service in both the office setting and out-of-office setting. We have since refined and revised these inputs based on recommendations from the RUC. The AMA's SMS data provided aggregate specialty-specific information on hours worked and PEs.

Separate PE RVUs are established for procedures that can be performed in both a nonfacility setting, such as a physician's office, and a facility setting, such as a hospital outpatient department. The difference between the facility and nonfacility RVUs reflects the fact that a facility typically receives separate payment from Medicare for its costs of providing the service, apart from payment under the PFS. The nonfacility RVUs reflect all of the direct and indirect PEs of providing a particular service.

Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

In the Calendar Year (CY) 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating PE RVUs beginning in CY 2007 and provided for a 4-year transition for the new PE RVUs under this new methodology.

3. Resource-Based Malpractice (MP) RVUs

Section 4505(f) of the BBA amended section 1848(c) of the Act requiring us to implement resource-based malpractice (MP) RVUs for services furnished on or after 2000. The resource-based MP RVUs were implemented in the PFS final rule published November 2, 1999 (64 FR 59380). The MP RVUs were based on malpractice insurance premium data collected from commercial and physician-owned insurers from all the States, the District of Columbia, and Puerto Rico.

4. Refinements to the RVUs

Section 1848(c)(2)(B)(i) of the Act requires that we review all RVUs no less often than every 5 years. The first Five-Year Review of the physician work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The second Five-Year Review was published in the CY 2002 PFS final rule with comment period (66 FR 55246) and was effective in 2002. The third Five-Year Review of physician work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. (Note: Additional codes relating to the third Five-Year Review of physician work RVUs were addressed in the CY 2008 PFS final rule with comment period (72 FR 66360).)

In 1999, the AMA's RUC established the Practice Expense Advisory Committee (PEAC) for the purpose of refining the direct PE inputs. Through March 2004, the PEAC provided recommendations to CMS for over 7,600 codes (all but a few hundred of the codes currently listed in the AMA's Current Procedural Terminology (CPT) codes). As part of the CY 2007 PFS final rule with comment period (71 FR 69624), we implemented a new methodology for determining resource-based PE RVUs and are transitioning it over a 4-year period.

In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the first Five-Year Review of the MP RVUs (69 FR 66263).

5. Adjustments to RVUs Are Budget Neutral

Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.

As explained in the CY 2009 PFS final rule with comment period (73FR 69730), as required by section 133(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), the separate budget neutrality (BN) adjustor resulting from the third Five-Year Review of physician work RVUs is being applied to the CF beginning with CY 2009 rather than the work RVUs.

B. Components of the Fee Schedule Payment Amounts

To calculate the payment for every physicians' service, the components of the fee schedule (physician work, PE, and MP RVUs) are adjusted by a geographic practice cost index (GPCI). The GPCIs reflect the relative costs of physician work, PE, and malpractice expense in an area compared to the national average costs for each component.

RVUs are converted to dollar amounts through the application of a CF, which is calculated by CMS' Office of the Actuary (OACT).

The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as:

Payment = [(RVU work × GPCI work) + (RVU PE × GPCI PE) + (RVU malpractice × GPCI malpractice)] × CF.

C. Most Recent Changes to the Fee Schedule

The CY 2009 PFS final rule with comment period (73 FR 69726) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized the CY 2008 interim RVUs and implemented interim RVUs for new and revised codes for CY 2009 to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. The CY 2009 PFS final rule with comment period also addressed other policies, as well as certain provisions of the MIPPA.

As required by the statute, and based on section 131 of the MIPPA, the CY 2009 PFS final rule with comment period also announced the following for CY 2009: the PFS update of 1.1 percent, the initial estimate for the sustainable growth rate of 7.4 percent, and the conversion factor (CF) of $36.0666.

II. Provisions of the Final Regulation Back to Top

In response to the CY 2010 PFS proposed rule (74 FR 33520) we received approximately 16,500 timely public comments. These included comments from concerned citizens, individual physicians, health care workers, professional associations and societies, manufacturers and Congressmen. The majority of the comments addressed proposals related to the MIPPA provisions concerning teaching anesthesiology and cardiac and pulmonary rehabilitation, the physician practice information survey (PPIS), and the impact of the proposed rule on specific specialties. To the extent that comments were outside the scope of the proposed rule, they are not addressed in this final rule with comment period.

A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)

Practice expense (PE) is the portion of the resources used in furnishing the service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages but excluding malpractice expenses, as specified in section 1848(c)(1)(B) of the Act.

Section 121 of the Social Security Amendments of 1994 (103), enacted on October 31, 1994, required CMS to develop a methodology for a resource-based system for determining PE RVUs for each physician's service. Until that time, PE RVUs were based on historical allowed charges. This legislation stated that the revised PE methodology must consider the staff, equipment, and supplies used in the provision of a variety of medical and surgical services in various settings beginning in 1998. The Secretary has interpreted this to mean that Medicare payments for each service would be based on the relative PE resources typically involved with furnishing the service.

The initial implementation of resource-based PE RVUs was delayed from January 1, 1998, until January 1, 1999, by section 4505(a) of the BBA. In addition, section 4505(b) of the BBA required that the new payment methodology be phased in over 4 years, effective for services furnished in CY 1999, and fully effective in CY 2002. The first step toward implementation of the statute was to adjust the PE values for certain services for CY 1998. Section 4505(d) of the BBA required that, in developing the resource-based PE RVUs, the Secretary must—

  • Use, to the maximum extent possible, generally-accepted cost accounting principles that recognize all staff, equipment, supplies, and expenses, not solely those that can be linked to specific procedures and actual data on equipment utilization.
  • Develop a refinement method to be used during the transition.
  • Consider, in the course of notice and comment rulemaking, impact projections that compare new proposed payment amounts to data on actual physician PE.

In CY 1999, we began the 4-year transition to resource-based PE RVUs utilizing a “top-down” methodology whereby we allocated aggregate specialty-specific practice costs to individual procedures. The specialty-specific PEs were derived from the American Medical Association's (AMA's) Socioeconomic Monitoring Survey (SMS). In addition, under section 212 of the BBRA, we established a process extending through March 2005 to supplement the SMS data with data submitted by a specialty. The aggregate PEs for a given specialty were then allocated to the services furnished by that specialty on the basis of the direct input data (that is, the staff time, equipment, and supplies) and work RVUs assigned to each CPT code.

For CY 2007, we implemented a new methodology for calculating PE RVUs. Under this new methodology, we use the same data sources for calculating PE, but instead of using the “top-down” approach to calculate the direct PE RVUs, under which the aggregate direct and indirect costs for each specialty are allocated to each individual service, we now utilize a “bottom-up” approach to calculate the direct costs. Under the “bottom up” approach, we determine the direct PE by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide each service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are based on our review of recommendations received from the AMA's Relative Value Update Committee (RUC). For a more detailed explanation of the PE methodology, see the Five-Year Review of Work Relative Value Units Under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

Note:

In section II.A.1 of this final rule with comment period rule, we discuss the current methodology used for calculating PE. In section II.A.2. of this final rule with comment period, which contains PE proposals for CY 2010, we summarize and respond to comments on our proposal to use data from the AMA Physician Practice Information Survey (PPIS) in place of the AMA's SMS survey data and supplemental survey data that is currently used in the PE methodology, as well as our proposal concerning equipment utilization assumptions.

1. Practice Expense Methodology

a. Data Sources for Calculating Practice Expense

The AMA's SMS survey data and supplemental survey data from the specialties of cardiothoracic surgery, vascular surgery, physical and occupational therapy, independent laboratories, allergy/immunology, cardiology, dermatology, gastroenterology, radiology, independent diagnostic testing facilities (IDTFs), radiation oncology, and urology are currently used to develop the PE per hour (PE/HR) for each specialty. For those specialties for which we do not have PE/HR, the appropriate PE/HR is obtained from a crosswalk to a similar specialty.

The AMA developed the SMS survey in 1981 and discontinued it in 1999. Beginning in 2002, we incorporated the 1999 SMS survey data into our calculation of the PE RVUs, using a 5-year average of SMS survey data. (See the CY 2002 PFS final rule with comment period (66 FR 55246).) The SMS PE survey data are adjusted to a common year, 2005. The SMS data provide the following six categories of PE costs:

  • Clinical payroll expenses, which are payroll expenses (including fringe benefits) for nonphysician clinical personnel.
  • Administrative payroll expenses, which are payroll expenses (including fringe benefits) for nonphysician personnel involved in administrative, secretarial, or clerical activities.
  • Office expenses, which include expenses for rent, mortgage interest, depreciation on medical buildings, utilities, and telephones.
  • Medical material and supply expenses, which include expenses for drugs, x-ray films, and disposable medical products.
  • Medical equipment expenses, which include depreciation, leases, and rent of medical equipment used in the diagnosis or treatment of patients.
  • All other expenses, which include expenses for legal services, accounting, office management, professional association memberships, and any professional expenses not previously mentioned in this section.

In accordance with section 212 of the BBRA, we established a process to supplement the SMS data for a specialty with data collected by entities and organizations other than the AMA (that is, those entities and organizations representing the specialty itself). (See the Criteria for Submitting Supplemental Practice Expense Survey Data interim final rule with comment period (65 FR 25664).) Originally, the deadline to submit supplementary survey data was through August 1, 2001. In the CY 2002 PFS final rule (66 FR 55246), the deadline was extended through August 1, 2003. To ensure maximum opportunity for specialties to submit supplementary survey data, we extended the deadline to submit surveys until March 1, 2005 in the Revisions to Payment Policies Under the Physician Fee Schedule for CY 2004 final rule with comment period (68 FR 63196) (hereinafter referred to as CY 2004 PFS final rule with comment period).

The direct cost data for individual services were originally developed by the Clinical Practice Expert Panels (CPEP). The CPEP data include the supplies, equipment, and staff times specific to each procedure. The CPEPs consisted of panels of physicians, practice administrators, and nonphysicians (for example, RNs) who were nominated by physician specialty societies and other groups. There were 15 CPEPs consisting of 180 members from more than 61 specialties and subspecialties. Approximately 50 percent of the panelists were physicians.

The CPEPs identified specific inputs involved in each physician's service provided in an office or facility setting. The inputs identified were the quantity and type of nonphysician labor, medical supplies, and medical equipment. The CPEP data has been regularly updated by various RUC committees on PE.

b. Allocation of PE to Services

Currently, the aggregate level specialty-specific PEs are derived from the AMA's SMS survey and supplementary survey data. For CY 2010, we discuss in section II.A.2. of this final rule with comment period how a new data source, PPIS, will be used. To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.

(i) Direct costs. The direct costs are determined by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide the service. The costs of these resources are calculated from the refined direct PE inputs in our PE database. These direct inputs are then scaled to the current aggregate pool of direct PE RVUs. The aggregate pool of direct PE RVUs can be derived using the following formula: (PE RVUs × physician CF) × (average direct percentage from survey PE/HR data)).

(ii) Indirect costs. Currently, the SMS and supplementary survey data are the sources for the specialty-specific aggregate indirect costs used in our PE calculations. For CY 2010, we discuss in section II.A.2. of this final rule with comment period how a new data source, PPIS, will be used. We then allocate the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the physician work RVUs. For calculation of the 2010 PE RVUs, we use the 2008 procedure-specific utilization data crosswalked to 2010 services. To arrive at the indirect PE costs—

  • We apply a specialty-specific indirect percentage factor to the direct expenses to recognize the varying proportion that indirect costs represent of total costs by specialty. For a given service, the specific indirect percentage factor to apply to the direct costs for the purpose of the indirect allocation is calculated as the weighted average of the ratio of the indirect to direct costs (based on the survey data) for the specialties that furnish the service. For example, if a service is furnished by a single specialty with indirect PEs that were 75 percent of total PEs, the indirect percentage factor to apply to the direct costs for the purposes of the indirect allocation would be (0.75/0.25) = 3.0. The indirect percentage factor is then applied to the service level adjusted indirect PE allocators.
  • We currently use the specialty-specific PE/HR from the SMS survey data, as well as the supplemental surveys for cardiothoracic surgery, vascular surgery, physical and occupational therapy, independent laboratories, allergy/immunology, cardiology, dermatology, radiology, gastroenterology, IDTFs, radiation oncology, and urology. (Note: For radiation oncology, the data represent the combined survey data from the American Society for Therapeutic Radiology and Oncology (ASTRO) and the Association of Freestanding Radiation Oncology Centers (AFROC)). As discussed in the CY 2008 PFS final rule with comment period (72 FR 66233), the PE/HR survey data for radiology is weighted by practice size. For CY 2010, we discuss in section II.A.2. of this final rule with comment period how a new data source, PPIS, will be used. We incorporate this PE/HR into the calculation of indirect costs using an index which reflects the relationship between each specialty's indirect scaling factor and the overall indirect scaling factor for the entire PFS. For example, if a specialty had an indirect practice cost index of 2.00, this specialty would have an indirect scaling factor that was twice the overall average indirect scaling factor. If a specialty had an indirect practice cost index of 0.50, this specialty would have an indirect scaling factor that was half the overall average indirect scaling factor.
  • When the clinical labor portion of the direct PE RVU is greater than the physician work RVU for a particular service, the indirect costs are allocated based upon the direct costs and the clinical labor costs. For example, if a service has no physician work and 1.10 direct PE RVUs, and the clinical labor portion of the direct PE RVUs is 0.65 RVUs, we would use the 1.10 direct PE RVUs and the 0.65 clinical labor portions of the direct PE RVUs to allocate the indirect PE for that service.

c. Facility and Non-Facility Costs

Procedures that can be furnished in a physician's office, as well as in a hospital or facility setting have two PE RVUs: facility and non-facility. The non-facility setting includes physicians' offices, patients' homes, freestanding imaging centers, and independent pathology labs. Facility settings include hospitals, ambulatory surgical centers (ASCs), and skilled nursing facilities (SNFs). The methodology for calculating PE RVUs is the same for both facility and non-facility RVUs, but is applied independently to yield two separate PE RVUs. Because the PEs for services provided in a facility setting are generally included in the payment to the facility (rather than the payment to the physician under the PFS), the PE RVUs are generally lower for services provided in the facility setting.

d. Services With Technical Components (TCs) and Professional Components (PCs)

Diagnostic services are generally comprised of two components: a professional component (PC) and a technical component (TC), both of which may be performed independently or by different providers. When services have TCs, PCs, and global components that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global components, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.)

e. Transition Period

As discussed in the CY 2007 PFS final rule with comment period (71 FR 69674), the change to the PE methodology was implemented over a 4-year period. In CY 2010, the transition period for the change to the PE methodology is complete and PE RVUs will be calculated based entirely on the current methodology.

f. PE RVU Methodology

The following is a description of the PE RVU methodology. While there are some changes to the data sources, the methodology remains the same.

(i) Setup File

First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/non-facility place of service level, and the specialty-specific survey PE per physician hour data.

(ii) Calculate the Direct Cost PE RVUs

Sum the costs of each direct input.

Step 1: Sum the direct costs of the inputs for each service. The direct costs consist of the costs of the direct inputs for clinical labor, medical supplies, and medical equipment. The clinical labor cost is the sum of the cost of all the staff types associated with the service; it is the product of the time for each staff type and the wage rate for that staff type. The medical supplies cost is the sum of the supplies associated with the service; it is the product of the quantity of each supply and the cost of the supply. The medical equipment cost is the sum of the cost of the equipment associated with the service; it is the product of the number of minutes each piece of equipment is used in the service and the equipment cost per minute. The equipment cost per minute is calculated as described at the end of this section.

Apply a BN adjustment to the direct inputs.

Step 2: Calculate the current aggregate pool of direct PE costs. To do this, multiply the current aggregate pool of total direct and indirect PE costs (that is, the current aggregate PE RVUs multiplied by the CF) by the average direct PE percentage from the SMS and supplementary specialty survey data. For CY 2010, we discuss in section II.A.2. of this final rule with comment period how a new data source, PPIS, will be used.

Step 3: Calculate the aggregate pool of direct costs. To do this, for all PFS services, sum the product of the direct costs for each service from Step 1 and the utilization data for that service.

Step 4: Using the results of Step 2 and Step 3 calculate a direct PE BN adjustment so that the aggregate direct cost pool does not exceed the current aggregate direct cost pool and apply it to the direct costs from Step 1 for each service.

Step 5: Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the Medicare PFS CF.

(iii) Create the Indirect PE RVUs

Create indirect allocators.

Step 6: Based on the SMS and supplementary specialty survey data, calculate direct and indirect PE percentages for each physician specialty. For CY 2010, we discuss in section II.A.2. of this final rule with comment period how a new data source, PPIS, will be used.

Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, we are calculating the direct and indirect percentages across the global components, PCs, and TCs. That is, the direct and indirect percentages for a given service (for example, echocardiogram) do not vary by the PC, TC and global component.

Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVU, the clinical PE RVU, and the work RVU.

For most services the indirect allocator is:

indirect percentage * (direct PE RVU/direct percentage) + work RVU.

There are two situations where this formula is modified:

  • If the service is a global service (that is, a service with global, professional, and technical components), then the indirect allocator is: indirect percentage * (direct PE RVU/direct percentage) + clinical PE RVU + work RVU.
  • If the clinical labor PE RVU exceeds the work RVU (and the service is not a global service), then the indirect allocator is: indirect percentage * (direct PE RVU/direct percentage) + clinical PE RVU.

Note:

For global services, the indirect allocator is based on both the work RVU and the clinical labor PE RVU. We do this to recognize that, for the professional service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVU and the clinical labor PE RVU. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.

For presentation purposes in the examples in the Table 1, the formulas were divided into two parts for each service. The first part does not vary by service and is the indirect percentage * (direct PE RVU/direct percentage). The second part is either the work RVU, clinical PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVU exceeds the work RVU (as described earlier in this step.)

Apply a BN adjustment to the indirect allocators.

Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the current aggregate pool of PE RVUs by the average indirect PE percentage from the physician specialty survey data. This is similar to the Step 2 calculation for the direct PE RVUs.

Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service. This is similar to the Step 3 calculation for the direct PE RVUs.

Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. This is similar to the Step 4 calculation for the direct PE RVUs.

Calculate the Indirect Practice Cost Index.

Step 12: Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.

Step 13: Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service.

Step 14: Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors as under the current methodology.

Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty-specific indirect scaling factor by the average indirect scaling factor for the entire PFS.

Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global components, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC and global component.)

Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVU.

(iv) Calculate the Final PE RVUs.

Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17.

Step 19: Calculate and apply the final PE BN adjustment by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required primarily because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (See “Specialties excluded from ratesetting calculation” below in this section.)

(v) Setup File Information

  • Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties such as midlevel practitioners paid at a percentage of the PFS, audiology, and low volume specialties from the calculation. These specialties are included for the purposes of calculating the BN adjustment.
  • Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
  • Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
  • Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVU. For example, the professional service code 93010 is associated with the global code 93000.
  • Payment modifiers: Payment modifiers are accounted for in the creation of the file. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier.
  • Work RVUs: The setup file contains the work RVUs from this proposed rule.

(vi) Equipment cost per minute

The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1−(1/((1 + interest rate) ** life of equipment)))) + maintenance)

Where:

minutes per year= maximum minutes per year if usage were continuous (that is, usage = 1); 150,000 minutes.

usage= equipment utilization assumption; 0.9 for certain expensive diagnostic equipment (see section II.A.2. of this final rule with comment period rule) and 0.5 for others.

price= price of the particular piece of equipment.

interest rate= 0.11.

life of equipment= useful life of the particular piece of equipment.

maintenance= factor for maintenance; 0.05.

Note:

To illustrate the PE calculation, in Table 1 we have used the conversion factor (CF) of $28.3769 which is the CF effective January 1, 2010 as published in this final rule with comment period.

BILLING CODE 4120-01-P

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

BILLING CODE 4120-01-C

2. PE Revisions for CY 2010

a. SMS and Supplemental Survey Background

Currently, we use PE/HR obtained from the SMS surveys from 1995 through 1999. For several specialties that collected additional PE/HR data through a more recent supplemental survey, we accepted and incorporated these data in developing current PE/HR values.

While the SMS survey was not specifically designed for the purpose of establishing PE RVUs, we found these data to be the best available at the time. The SMS was a multi-specialty survey effort conducted using a consistent survey instrument and method across specialties. The survey sample was randomly drawn from the AMA Physician Masterfile to ensure national representativeness. The AMA discontinued the SMS survey in 1999.

As required by the BBRA, we also established a process by which specialty groups could submit supplemental PE data. In the May 3, 2000 interim final rule entitled, Medicare Program; Criteria for Submitting Supplemental Practice Expense Survey Data, (65 FR 25664), we established criteria for acceptance of supplemental data. The criteria were modified in the CY 2001 and CY 2003 PFS final rules with comment period (65 FR 65380 and 67 FR 79971, respectively). We currently use supplemental survey data for the following specialties: cardiology; dermatology; gastroenterology; radiology; cardiothoracic surgery; vascular surgery; physical and occupational therapy; independent laboratories; allergy/immunology; independent diagnostic testing facilities (IDTFs); radiation oncology; medical oncology; and urology.

Because the SMS data and the supplemental survey data are from different time periods, we have historically inflated them by the MEI to help put them on as comparable a time basis as we can when calculating the PE RVUs. This MEI proxy has been necessary in the past due to the lack of contemporaneous, consistently collected, and comprehensive multispecialty survey data.

b. Physician Practice Information Survey (PPIS)

The AMA has conducted a new survey, the PPIS, which was expanded (relative to the SMS) to include nonphysician practitioners (NPPs) paid under the PFS. The PPIS, administered in CY 2007 and CY 2008, was designed to update the specialty-specific PE/HR data used to develop PE RVUs.

The AMA and our contractor, The Lewin Group (Lewin), analyzed the PPIS data and calculated the PE/HR for physician and nonphysician specialties, respectively. The AMA's summary worksheets and Lewin's final report are available on the CMS Web site at http://www.cms.gov/PhysicianFeeSched/. (See AMA PPIS Worksheets 1-3 and Lewin Group Final Report PPIS.) We also included a table in the proposed rule showing the current indirect PE/HR based on SMS and supplemental surveys, the PPIS indirect PE/HR, and the indirect cost percentages of total costs (74 FR 33530 through 33531).

The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs using a consistent survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS has gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available to date.

As noted, the BBRA required us to establish criteria for accepting supplemental survey data. Since the supplemental surveys were specific to individual specialties and not part of a comprehensive multispecialty survey, we had required that certain precision levels be met in order to ensure that the supplemental data was sufficiently valid, and acceptable for use in the development of the PE RVUs. Because the PPIS is a contemporaneous, consistently collected, and comprehensive multispecialty survey, we do not believe similar precision requirements are necessary and we did not propose to establish them for the use of the PPIS data.

For physician specialties, the PPIS responses were adjusted for non-response bias. Non-response bias is the bias that results when the characteristics of survey respondents differ in meaningful ways, such as in the mix of practice sizes, from the general population. The non-response adjustment was developed based on a comparison of practice size and other characteristic information between the PPIS survey respondents and data from the AMA Masterfile (for physician specialties) or information from specialty societies (for non-physician specialties). For six specialties (chiropractors, clinical social workers, nuclear medicine, osteopathic manipulative therapy, physical therapy, and registered dietitians) such an adjustment was not possible due to a lack of available characteristic data. The AMA and Lewin have indicated that the non-response weighting has only a small impact on PE/HR values.

Under our current policy, various specialties without SMS or supplemental survey data have been crosswalked to other similar specialties to obtain a proxy PE/HR. For specialties that were part of the PPIS for which we currently use a crosswalked PE/HR, we proposed instead to use the PPIS-based PE/HR. We also proposed to continue current crosswalks for specialties that did not participate in PPIS.

Supplemental survey data on independent labs, from the College of American Pathologists, was implemented for payments in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing IDTFs, was blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments in CY 2007. Neither IDTFs, nor Independent Labs, participated in the PPIS. Therefore, we proposed to continue using the current PE/HR that was developed using their supplemental survey data.

We did not propose to use the PPIS data for reproductive endocrinology, sleep medicine, and spine surgery since these specialties are not separately recognized by Medicare and we do not know how to blend this data with Medicare recognized specialty data. We sought comment on this issue.

We did not propose changes to the manner in which the PE/HR data are used in the current PE RVU methodology. We proposed to update the PE/HR data itself based on the new survey. We proposed to utilize the PE/HR developed using PPIS data for all Medicare recognized specialties that participated in the survey for payments effective January 1, 2010. The impact of using the new PPIS-based PE/HR is discussed in the Regulatory Impact Analysis in section XIII. of this final rule with comment period.

The following is a summary of the public comments received on the PPIS survey and our responses.

Comment: MedPAC was generally supportive of the use of the PPIS survey data, stating:

Ensuring the accuracy of PE payments is important given that close to half of all payments under the physician fee schedule are associated with practice expense. The Commission has repeatedly raised concerns that the specialty-specific cost data that CMS uses to derive PE RVUs are not current for most specialties, which might lead to payments becoming inaccurate over time. Compared with the multiple data sources that CMS currently relies on for practice cost information, the PPIS is a step forward because: (1) It reflects current practice patterns and costs; (2) it measures costs of nearly all physician and nonphysician specialties; and (3) it uses a standard protocol for all specialty groups that was designed to derive PE RVUs. However, CMS should provide more information about the PPIS's response rate and representativeness. We are also concerned that CMS has not laid out options for ensuring the accuracy of PE RVUs in the long term. As a future step, CMS should consider alternatives for collecting specialty-specific cost data or options to decrease the reliance on such data.

Response: We agree with MedPAC that the PPIS is a step forward compared to the data sources currently used in the development of the PE RVUs.

With respect to additional information on the PPIS survey, the AMA has continued to respond to requests from the individual specialty societies for additional data analysis as they have done since the PPIS results were first released. We have also performed further analyses in response to comments received on the proposed rule. The results of these analyses are available on our Web site (described later in this section) and have not changed our conclusion that the PPIS is the most comprehensive, multi-specialty, contemporaneous, consistently collected PE data source available.

We also agree with MedPAC that it is appropriate to consider the future of the PE RVUs moving forward. We did not propose any changes to the methodology in conjunction with the use of the PPIS data. However, we seek comments from other stakeholders on the issues raised by MedPAC for the future. In particular, we seek comments regarding MedPAC's suggestion that we consider alternatives for collecting specialty-specific cost data or options to decrease the reliance on such data. For example, MedPAC stated that “CMS should consider if Medicare or provider groups should sponsor future data collection efforts, if participation should be voluntary (such as surveys) or mandatory (such as cost reports), and whether a nationally representative sample of practitioners would be sufficient for either a survey or cost reports.” MedPAC also stated that one option for decreasing the reliance on specialty-specific cost data would be the elimination of specialty-specific cost pools from the method used to derive indirect PE RVUs. We would address any changes through future rulemaking.

Comment: In addition to MedPAC, numerous specialty groups and individual physicians and practitioners supported utilizing the PPIS data. The commenters included family practice, general practice, geriatrics, pediatrics, internal medicine, obstetrics and gynecology, general surgery, infectious disease, emergency medicine, psychiatry, anesthesiology, colorectal surgery, dermatology, endocrinology, gastroenterology, neurology, neurosurgery, ophthalmology, optometry, orthopedic surgery, osteopathic physicians, otolaryngology, pathology, physical medicine and rehabilitation, physical and occupational therapy, plastic surgery, podiatry, pulmonary disease, spine surgery, thoracic surgery, transplant surgery, and vascular surgery.

Those in favor of using the PPIS data made one or more of the following points:

  • PPIS was a nationally representative survey providing the most up-to-date and comprehensive data available from 51 specialties. It was a highly scientific and controlled undertaking, using a survey instrument that the AMA took great care to design, test, and implement.
  • Seventy organizations contributed to the costs of the survey and agreed to take responsibility for communicating and publicizing the effort in order to enhance response rates. All groups had ample time to review and provide input and received monthly updates on response rates for their group.
  • PPIS followed the exacting criteria that CMS has established for gathering this type of data and for producing results that are acceptable for submission. The AMA worked with CMS's contractor to ensure that all data met these criteria and were analyzed consistently across the various physicians and practitioner specialties. Any data that did not meet the criteria such as response outliers were excluded.
  • The vast majority of the data currently used are completely outdated. MedPAC and GAO have been calling on CMS to update PE payments. The annual update of such data is inadequate to capture the true changes in practice costs that physicians have experienced over the years.
  • Supplemental survey data from a limited number of specialties have caused significant distortions and misallocations of PE payments, and provided an unfair advantage to some specialties. Many organizations were unable to submit supplemental survey data due to the high cost of gathering the data.
  • Concurrently and uniformly collected data will correct payment imbalances caused by the supplemental surveys. Due to BN, this leads to a shift in payment to some specialties at the expense of others. The new data will reduce the payment gap between primary care and other specialties.
  • Blending PPIS data with existing data would preserve distortions and continue utilization of data that are more than 10 years old for some groups.

Response: We appreciate the support of this broad-based and diverse mix of primary care, surgical, and other nonsurgical specialties for our proposal. We agree with the commenters that the PPIS is the most comprehensive, multi-specialty, contemporaneous, consistently collected PE data source available.

Comment: There were also many specialty groups and individual physicians and practitioners strongly opposed to the use of the PPIS data. The commenters included representatives of the specialties of cardiology, radiation oncology, medical oncology, interventional radiology, hematology, nuclear medicine, urology, rheumatology, and dieticians. Those opposed to using the PPIS data made one or more of the following points:

  • Some commenters stated that data were not collected in a contemporaneous, consistent, and comprehensive way;
  • Some commenters stated that the PPIS should be subject to the same level of analysis as the supplemental surveys to assess accuracy and precision. The commenters also indicated that the survey did not meet the target goal for useable responses. The commenters stated that the low response rates, for some specialties, means that the data are not representative of the specialties' PEs. The commenters also stated that specialty societies should be given the names of the survey respondents, especially those that failed to fully complete the survey, so they could be contacted;
  • Some commenters stated that there was not adequate transparency in the PPIS survey process and that there was insufficient information provided about the survey methodology and process;
  • Some commenters stated that CMS should withdraw the proposal and take the time necessary to adequately examine the data submitted by AMA, consider changes to the PE methodology, and solicit public input on the validity of the data and the most appropriate way to integrate this data into the PFS; and
  • Some commenters stated that if PPIS data is used, it should be blended with supplemental survey data and/or phased in over a number of years.

Response: The PPIS uses a consistent survey instrument and methodology across all specialty and health care professional groups. The sample was drawn from the AMA's Physician Masterfile, which is a listing of all member and non-member physicians in the United States. The survey was conducted in conjunction with national medical specialty societies and other health care professionals, representing 51 specialties and health professions in order to maximize the overall response rate. Respondents could submit information through multiple modalities, including telephone, fax, and Web-based reporting.

The survey was conducted by external contractors. In 2007 the PPIS project was contracted to the Gallup Organization. In late 2007 the AMA transitioned the survey effort to dmrkynetec, formally Doane Marketing Research, to complete the project. Dmrkynetec conducted the majority of the specialty level surveys that were previously implemented by CMS. Dmrkynetec used the same survey instruments as did the Gallup Organization in order that survey data collected by Gallup could be appropriately merged in the dmrkynetec data collection.

The survey methodology was highly consistent with the prior SMS methodology because only small deviations were allowed to accommodate practice style differences across the various groups surveyed. The PPIS was conducted in accordance with known conventions governing PE collection activities. One hundred completed surveys for each specialty was set as a goal for the PPIS, but was not a minimum requirement. More than 7,000 surveys were collected for 51 physicians, non MD/DO specialties, and health professions. For the majority of specialties, at least 100 surveys were collected.

The AMA provided specialty groups with information on the survey throughout the survey process. Monthly progress reports were issued on response rates. Due to confidentiality agreements with the AMA and participating specialty groups, raw survey data was not distributed to CMS or the specialty groups. However, this does not mean that analysis was not performed on the PPIS data.

In conjunction with publication of the proposed rule, we posted information on our Web site on physician response rates, precision and PE/HR. In addition, we posted Lewin's report entitled, “Physician Practice Information Survey (PPIS) Data Submitted for 2010: Non-MD/DO and Health Professionals Practice Information” (June 19, 2009). This report includes information on the PPIS survey process as well as the methodology for determining the PE/HR.

As noted earlier in our response to the MedPAC comment, the AMA has continued to respond to requests from the individual specialty societies for additional data analysis, as they have done since the PPIS results were first released. In response to comments received on the proposed rule, we have also performed additional analyses of summary data supplied by the AMA, the supplemental survey, and cardiology, urology, and radiology groups. This additional analysis indicates that while the PE/HR for these specialties differs between the data sources reviewed for certain practice sizes, these differences do not validate the commenters' conclusion that the PPIS data is invalid. We continue to believe that the PPIS is the most appropriate data source available for the development of resource-based PE RVUs. To view this analysis, please see our Web site at http://www.cms.hhs.gov/PhysicianFeeSched/. (At this Web site, Go to “PFS Federal Regulation Notices” tab, and then chose “CMS-1413-P.” Lewin's original report is listed under the CY 2010 PFS proposed rule page. The additional AMA information and analysis of the PPIS is available at http://www.ama-assn.org/go/ppisurvey.

We disagree with some commenters that the same precision requirements that applied to the individual specialty supplemental surveys should apply to the broad multispecialty contemporaneous PPIS. Each individual specialty supplemental survey was being used alongside the multispecialty contemporaneous SMS survey data for all the other specialties. This is not the case for the PPIS data. We proposed to use the PPIS data in its entirety for all Medicare recognized specialties, with the exception of two supplier specialties that did not participate in the PPIS. Precision requirements were appropriate, and required by the BBRA, in the context of the selective acceptance of individual supplemental surveys, but are not necessary in the context of the much broader adoption of the PPIS data.

We also disagree that we should blend the supplemental survey data with the PPIS data. One of the advantages of the PPIS data is precisely that it is contemporaneous and collected in a consistent, broad multi-specialty manner. Blending this data with the supplemental survey data weakens the advantage of using the PPIS data, as was pointed out by commenters who favored its use.

However, we do recognize that some specialties experience significant payment reductions with the use of the PPIS data. Given the magnitude of these payment reductions for some specialties, we agree with commenters who suggested a transition to the new PE RVUs developed using the PPIS data. Historically, we have provided for 4-year transitions when we have significantly altered the PE methodology. While we did not propose any changes to the methodology in the proposed rule, we are persuaded by commenters that the use of the new PPIS data has a sufficiently significant impact to warrant the use of such a transition. In light of the comments received and our past practice, we are finalizing a 4-year transition (75/25, 50/50, 25/75, 0/100) from the current PE RVUs to the PE RVUs developed using the new PPIS data.

Comment: Some commenters that supported the use of the PPIS data and some who opposed its use claimed that Medicare pays only 51 percent of direct costs. Commenters maintained that the PE methodology results in the underpayment of procedures with high direct costs, and will shift procedures from the office to the higher cost hospital setting.

Response: The purpose of the resource-based PE methodology is to develop RVUs within the overall PFS BN requirements. We are unaware of any independent analysis that indicates that Medicare pays 51 percent of direct costs as a result of these BN requirements. In the PE methodology, there is a scaling factor applied in the development of the direct PE portion of the PE RVUs and there is a scaling factor applied in the development of the indirect PE portion. We believe that commenters may be misinterpreting the scaling factor applied in the development of the direct cost portion of the PE RVUs.

The PPIS data indicated a significant decrease in the percentage of PEs that are attributable to direct PEs and a corresponding increase in the percentage that are attributable to indirect PEs. The incorporation of the PPIS data, therefore, results in a decrease in the scaling factor applied in the development of the direct cost portion of the PE methodology from its current value of 0.63 to its new value of 0.51 and a corresponding increase in the scaling factor applied in development of the indirect cost portion. As stated earlier, the PPIS is the most comprehensive, multi-specialty, contemporaneous, consistently collected source of PE data. The PPIS data indicates that direct costs are a smaller proportion of total PE costs for almost every single specialty surveyed (see Table 2). We are incorporating this result into our methodology and disagree with commenters that this empirically based decrease in the scaling factor for the direct cost portion of the PE RVU using the PPIS survey data is inappropriate.

Comment: The American Society of Clinical Oncology (ASCO) noted that section 303 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) (MMA) added section 1848(c)(2)(H) of the Act, which requires us to use their supplemental survey submitted in 2003 for oncology drug administration services.

Response: We have reviewed the MMA provision and agree that, as amended, section 1848(c)(2)(H)(i) of the Act requires that we continue to use the supplemental survey data for oncology. We have revised the PE/HR for medical oncology, hematology, and hematology/oncology to reflect the continued use of these supplemental survey data.

Comment: Several commenters indicated that PPIS data for reproductive endocrinology, sleep medicine, and spine surgery should not be used because they are not separately recognized specialties by Medicare and it is difficult to blend this data with data from specialties that are recognized. Other commenters disagreed and recommended weights we could use to blend the PPIS data with the data from the recognized specialties for certain services.

Some commenters encouraged us to make these Medicare-recognized specialties because they perform work that is separate and apart from their parent specialty, require additional training, and have separate liability issues. Other commenters opposed the recognition of separate specialties for these groups, indicating that they are not markedly different from their parent specialties.

Response: We did not specifically solicit comments on whether reproductive endocrinology, sleep medicine, and spine surgery should be separately recognized Medicare specialties, nor did we make such a proposal. Specialties seeking such recognition must make a formal request using our existing process. (See the CMS Internet-Only Medicare Claims Processing Manual, 100, Chapter 26, Section 10.8, Requirements for Specialty Codes.)

We did consider the comments on blending in the PPIS data for the above physician groups as suggested by some commenters. However, we are more persuaded by the commenters who indicated that determining the correct blend would be difficult. We are reluctant to assign utilization weights to the mix of specialties that perform these services in the absence of actual claims data. We suggest that the commenters who wish us to use the PPIS data for these groups apply for a specialty code using our normal process. If approved, the claims data associated with the new specialty code could be used to incorporate the PPIS survey data for that specialty.

Comment: A group of commenters indicated that they were precluded from participating in the PPIS. Some commenters representing portable x-ray suppliers indicated that an inability to participate in the PPIS resulted in an inappropriately low crosswalk for their specialty to radiology.

Response: We did not exclude any specialty from participating in PPIS. Individual specialties made the decision whether to participate. However, we agree with the commenters representing portable x-ray suppliers that radiology may not be the most appropriate crosswalk for their specialty given the relatively low amount of physician time in the services performed by the specialty. In light of these comments, we are changing the PE/HR crosswalk for portable x-ray suppliers to IDTF, a specialty similar with respect to the physician time issue.

Comment: As noted earlier, commenters representing freestanding radiation oncology centers are opposed to the use of the PPIS data. However, if CMS were to use the PPIS data, these commenters requested that CMS adjust the PE/HR used for freestanding radiation oncology centers by eliminating the weighting of the data and by eliminating 21 survey responses whose physician hour information was missing from the data and imputed. The commenters also requested that we update the weights used to blend the hospital-based and freestanding radiation oncology center survey data based on more recent claims data.

Response: We agree with the commenters that it would be more consistent with the methodology used for other specialties to remove the 21 survey responses whose physician hour information was missing from the data and imputed. We also agree it is more appropriate to update the weights used to blend the hospital-based and freestanding radiation oncology center survey data based on more recent claims data. However, we disagree that it is appropriate to eliminate the weighting of the survey data, especially with the 21 observations with imputed physician practice hours removed from the survey sample respondent mix. Consistent with the weighting methodology for other physician specialties, we applied the AMA Masterfile weights to the data. More details on our analysis of this comment can be found on our Web site.

Comment: Some commenters indicated that since, by statute, registered dieticians are paid 85 percent of what a physician would be paid for providing medical nutrition therapy services, the PPIS survey data for registered dieticians should not be used in calculation of PE RVUs; and that we should, therefore, base the RVUs for these services only on the physician specialties that provide the service.

Response: We agree with commenters that, under the current PE methodology, the PPIS survey data for registered dieticians should not be used in the calculation of PE RVUs since they are paid 85 percent of what a physician would be paid for providing the service. To include them in the PE calculation would influence the rate setting to include what the services would be paid if performed by registered dieticians and not strictly on what the payment rate would be if provided by physicians. We will crosswalk the specialty of registered dietician to the “all physician” PE/HR rate.

In summary, based on the decisions described above, Table 2 shows the indirect PE/HR for the specialties that have PPIS survey data that we are adopting to calculate the PE RVUs. Also shown for these specialties is the previous indirect PE/HR used to calculate the PE RVUs. Note that for oncology, clinical laboratories, and IDTFs we are continuing to use the supplemental survey data as described above. Consistent with our past practice, the previous indirect PE/HRs for these specialties have been updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS survey data.

Table 2—Indirect PE/HR for the Specialties That Have PPIS Survey Data Back to Top
Specialty Previous indirect PE/HR Final rule indirect PE/HR Previous indirect % Final rule indirect %
All Physicians $59.04 86.36 67 74
Allergy and Immunology 153.29 162.68 62 67
Anesthesiology 19.76 29.36 56 82
Audiology 59.04 72.17 67 85
Cardiology 131.02 88.04 56 65
Cardiothoracic Surgery 61.75 67.83 68 83
Chiropractor 49.60 65.33 69 86
Clinical Laboratory (Billing Independently) 66.46 68.32 37 37
Clinical Psychology 29.07 20.07 90 93
Clinical Social Work 29.07 17.80 90 97
Colon Rectal Surgery 53.93 90.84 77 80
Dermatology 158.49 184.62 70 70
Emergency Medicine 36.85 38.36 88 94
Endocrinology 49.60 84.39 69 73
Family Medicine 52.79 90.15 62 76
Gastroenterology 101.30 96.78 70 75
General Practice 52.79 78.59 62 69
General Surgery 53.93 82.73 77 82
Geriatrics 49.60 54.14 69 74
Hand Surgery 98.56 148.78 72 77
Independent Diagnostic Testing Facilities 466.16 501.45 50 51
Internal Medicine 49.60 84.02 69 76
Interventional Pain Medicine 59.04 156.79 67 70
Interventional Radiology 118.48 82.56 58 81
Medical Oncology 141.84 145.81 59 59
Nephrology 49.60 66.00 69 80
Neurology 66.05 110.39 74 87
Neurosurgery 89.64 115.76 86 87
Nuclear Medicine 118.48 39.80 58 77
Obstetrics/Gynecology 69.74 99.32 67 67
Ophthalmology 103.28 170.07 65 70
Optometry 59.04 88.02 67 77
Oral Surgery (Dentist only) 96.01 173.19 71 65
Orthopaedic Surgery 98.56 131.40 72 81
Osteopathic Manipulative Therapy 59.04 53.93 67 93
Otolaryngology 96.01 141.54 71 75
Pain Medicine 59.04 122.42 67 70
Pathology 59.80 74.98 70 74
Pediatrics 51.52 76.27 62 69
Physical Medicine and Rehabilitation 84.92 110.13 71 84
Physical Therapy 35.17 57.26 65 84
Plastic Surgery 99.32 134.81 67 74
Podiatry 59.04 74.76 67 82
Psychiatry 29.07 30.10 90 94
Pulmonary Disease 44.63 55.26 76 74
Radiation Oncology (Hospital Based Freestanding) 114.00 165.10 50 57
Radiology 118.48 95.60 58 71
Rheumatology 84.92 98.08 71 67
Urology 119.57 97.01 69 73
Vascular Surgery 60.10 83.98 63 73

c. Equipment Utilization Rate

As part of the PE methodology associated with the allocation of equipment costs for calculating PE RVUs, we currently perform these calculations with an equipment usage assumption of 50 percent. In the CY 2008 PFS proposed rule (72 FR 38132), we noted that if the assumed equipment usage percentage is set too high, the result would be an insufficient allowance at the service level for the practice costs associated with equipment. If the assumed equipment usage percentage is set too low, the result would be an excessive allowance for the practice costs of equipment at the service level. We acknowledged that the current 50 percent usage assumption does not capture the actual usage rates for all equipment, but stated that we did not believe that we had strong empirical evidence to justify any alternative approaches.

In the CY 2008 PFS final rule with comment period, we summarized comments received on this issue. Commenters' recommendations about making adjustments to the 50 percent utilization rate assumption varied. Some commenters recommended that we do nothing until stronger empirical evidence is available. Other commenters recommended a decrease in the utilization assumption while others recommended an increase in the utilization assumption. We agreed with the commenters that the equipment utilization rate should continue to be examined for accuracy. We indicated that we would continue to monitor the appropriateness of the equipment utilization assumption, and evaluate whether changes should be proposed in light of the data available.

In the CY 2010 PFS proposed rule (74 FR 33532), we acknowledged that since the publication of the CY 2008 PFS final rule with comment period, MedPAC addressed this issue in its March 2009 Report to Congress (see http://www.medpac.gov/documents/Mar09_EntireReport.pdf). In part of its discussion, MedPAC stated:

In 2006, the Commission sponsored a survey by NORC of imaging providers in six markets, which found that MRI and CT machines are used much more than the 25 hours per week that CMS assumes (Table 2B-6). According to data from this survey, MRI scanners are used 52 hours per week, on average (median of 46 hours), and CT machines are operated 42 hours per week, on average (median of 40 hours) (NORC 2006). Although the survey results are not nationally representative, they are representative of imaging providers in the six markets included in the survey. We also analyzed data from a 2007 survey of CT providers by IMV, a market research firm (IMV Medical Information Division 2008). IMV data are widely used in the industry and have also appeared in published studies (Baker et al. 2008, Baker and Atlas 2004). Using IMV's data on 803 nonhospital CT providers (imaging centers, clinics, and physician offices), we calculated that the average provider uses its CT scanner 50 hours per week, which is twice the number CMS assumes. The IMV survey also found that nonhospital providers increased the average number of procedures per CT machine by 31 percent from 2003 to 2007, which indicates that providers either used their machines more hours per day or performed more scans per hour (IMV Medical Information Division 2008) (p. 108).

In the proposed rule, we stated that the studies cited by MedPAC indicated that the current equipment usage rate assumption is significantly understated, especially with respect to the types of high cost equipment that were the subject of the studies. The current 50 percent utilization rate translates into about 25 hours per week out of a 50-hour work week. The median value of 46 hours for Magnetic Resonance Imaging equipment from the first study cited by MedPAC is equivalent to a utilization rate of 92 percent on a 50-hour week. For Computed Tomography scanners, averaging the value from the first study of 40 hours per week and the value from the second study of 50 hours per week yields 45 hours and is equivalent to a 90 percent utilization rate on a 50-hour work week. Therefore, in the CY 2010 PFS proposed rule, we proposed to increase the equipment usage rate to 90 percent for all services containing equipment that cost in excess of $1 million dollars. We stated that the studies cited by MedPAC suggested that physicians and suppliers would not typically make huge capital investments in equipment that would only be utilized 50 percent of the time. We stated that we would continue to explore data sources regarding the utilization rates of equipment priced at less than $1 million dollars, but we did not propose a change in the usage rate for this less expensive equipment.

The following is a summary of the public comments received and our responses.

Comment: We received comments supporting our proposal to apply a 90 percent equipment utilization rate to expensive equipment priced at more than $1 million and comments opposing our proposal. MedPAC stated:

“The Commission supports CMS's proposal as it applies to diagnostic imaging machines that cost more than $1 million, and we encourage CMS to explore increasing the equipment use factor for diagnostic imaging machines that cost less than $1 million. MedPAC did not contemplate applying the policy to radiation therapy machines.”

Commenters supporting our proposal cited the MedPAC studies and the rationale we provided in the proposed rule.

Commenters opposing our proposal stated that the Balanced Budget Act of 1997 (BBA) directed CMS to “utilize, to the maximum extent practicable, generally accepted cost accounting principles which: (1) Recognize all staff, equipment, supplies and expense, not just those which can be tied to specific procedures; and (2) use actual data on equipment utilization and other key assumptions.” The commenters stated that the equipment usage proposal violates this provision of the BBA since we lacked sufficient empirical justification for the change. The commenters indicated that the National Opinion Research Center survey data, which was one data source used by MedPAC, was not nationally representative, and was never intended to determine equipment usage rates.

Some commenters referenced information submitted by the Radiology Benefit Management Association (RBMA) based on a survey of its members. The commenters stated that the information supported maintaining a 50 percent utilization usage rate assumption for diagnostic imaging equipment. The commenters also stated that the information indicated differences in utilization rates between rural and urban areas and that our proposal would create access issues, especially in rural areas.

In MedPAC's comment letter, it agreed with CMS that “decreasing PE RVUs for expensive diagnostic imaging services should not affect access to care in rural areas.”

The AMA submitted summary equipment utilization data from the PPIS survey on MRI, CT, angiography, IMRT, and gamma camera. It stated that although there was a relatively small sample size, the survey responses suggest that equipment utilization varies depending on the type of equipment involved. The AMA requested that we allow specialty societies to provide data supporting lower utilization rates, if appropriate. It stated that this would allow for varying equipment utilization rate assumptions depending on the type of equipment being used, rather than a single utilization assumption.

Some commenters indicated that even if the available data did indicate a higher utilization rate for certain types of diagnostic equipment, we should not apply the change to all types of expensive diagnostic equipment. For example, we should not apply the usage rate to new imaging technology.

Some commenters requested that we not change the equipment usage rate assumption to 90 percent for any equipment until additional data sources can be identified. The commenters suggested that the equipment usage rate policy should not be limited to increasing usage rate assumptions but should also include potentially decreasing equipment usage rate assumptions when appropriate.

If we were to implement a higher utilization rate, some commenters suggested that the change be phased in over a number of years.

Response: We appreciate all of the comments received on this issue. At the time that we published the proposed rule, we had the data on MRI and CT from the MedPAC analysis. We indicated that the MedPAC studies suggested that physicians and suppliers would not typically make significant capital investments in equipment that would only be utilized 50 percent of the time. Commenters opposed to our proposal have questioned both the validity of the MedPAC analysis for CT and MRI and extrapolation of this data to all expensive equipment, particularly therapeutic equipment. While we are persuaded by PPIS data on angiography, IMRT, and Gamma Camera that the extrapolation of the MRI and CT data to all expensive equipment may be inappropriate, we disagree with commenters who indicated that we do not have an empirical basis for applying a 90 percent usage rate to MRIs and CTs.

As described earlier, the MedPAC analysis was performed on two data sources for different types of equipment. The first data source was the survey done by NORC for MRIs and CTs. The second data source was the IMV data for CT scans. With respect to MRIs and CTs, we have now also received summary information from the RBMA and summary PPIS survey data from the AMA. The PPIS survey data results for MRIs (n=97) and CTs (n=86) are consistent with the findings from the MedPAC studies on MRIs and CTs. However, the data from the RBMA (17 members submitted a total of 46 center surveys) indicates a lower utilization rate for CT and MRI.

As we have described in section II.A.2.b. of this final rule with comment, the PPIS is the best available data source currently available on PEs. Given the corroboration of the MedPAC analysis by the PPIS data, we are confident that we are using the best data currently available on the utilization of MRIs and CTs (90 percent), consistent with the BBA requirement that we use actual data on equipment utilization.

We are open to receiving more comprehensive data than the responses of 16 RBMA members on this issue from the RBMA or other members of the public. We will evaluate any data submitted for consideration in future rulemaking.

We continue to agree with the MedPAC analysis and comment indicating that decreasing the PE payments for expensive diagnostic imaging services should not affect access to care in rural areas.

We also agree with commenters that it would be appropriate to transition the new PE RVUs developed using the higher 90 percent utilization rate for MRIs and CTs. As discussed elsewhere in this final rule, we are providing for a 4-year transition (25/75, 50/50, 75/25, 100/0) to the new PE RVUs.

As indicated above, we are not finalizing our proposal to increase the utilization rate assumption for expensive equipment other than MRIs and CTs, including therapeutic equipment. We are finalizing our proposal to increase the utilization rate to 90 percent for expensive diagnostic equipment priced at more than $1 million.

d. Miscellaneous PE Issues

As we have discussed in the past rulemaking (see the CY 2007 and CY 2008 PFS final rules with comment period (71 FR 69647 and 72 FR 66236, respectively), we continue to have concerns about the issue of PE RVUs for services which are utilized 24 hours a day/7 days a week, such as certain monitoring systems. For example, the PE equipment methodology was not developed with this type of 24/7 equipment in mind. As stated in the CY 2010 PFS proposed rule (74 FR 33532), we are continuing to analyze the issue of PEs for services, which are utilized 24 hours a day/7 days a week to identify any modifications to our methodology that would address the specific “constant use” issues associated with these services. Services that are currently contractor priced in CY 2009 would remain contractor priced in CY 2010. We also indicated that any proposed changes will be communicated through future rulemaking.

Comments: We received three comments regarding the proposal to continue to contractor price these services. All three commenters supported the establishment of a national price for cardiac outpatient telemetry. The commenters also indicated that they believe they were the only ones that should be billing these codes.

Response: We will finalize our proposal to continue to contractor price these services in 2010 so that we may conduct further analysis. Any proposed changes will be communicated through future rulemaking.

As discussed in the proposed rule, (74 FR 33532) we received comments regarding the PE direct cost inputs (for example, supply costs and the useful life of the renewable sources) related to the high dose radiation therapy (HDRT) and placement CPT codes (CPT codes 77785, Remote afterloading high dose rate radionuclide brachytherapy; 1 channel, 77786, Remote afterloading high dose rate radionuclide brachytherapy; 2-12 channels, 77787, Remote afterloading high dose rate radionuclide brachytherapy; over 12 channels). Based on our review of these codes and comments received, we requested that the AMA RUC consider these CPT codes for additional review.

Comment: The AMA RUC reviewed these CPT codes based on our request and recommended revisions to the clinical labor staff type, supplies, and equipment. The AMA RUC also recommended further discussion between the specialty and CMS regarding a resolution regarding the useful life of Iridium-192 source. The AMA RUC and other commenters stated that the useful life of the Iridium-192 source is 70 to 90 days. However, many commenters stated that physician offices enter into 1 year contracts for its replacement.

Several commenters supported the AMA RUC's recommended changes to the practice expense inputs for these codes. The commenters agreed that certain direct PE inputs were previously omitted.

Response: We accept the AMA RUC's recommendations regarding the direct PE inputs for these CPT codes. Based on the comments received and further analysis, we are changing the useful life of the Iridium-192 source from 5 years to 1 year and it will be considered as equipment. We are also revising the direct PE inputs for clinical labor staff type, supplies, and equipment.

e. AMA RUC Recommendations for Direct PE Inputs

The AMA RUC provided recommendations for PE inputs for the codes listed in Table 3 (74 FR 33532).

Table 3—Codes With AMA RUC PE Recommendations Back to Top
CPT1code Description
1CPT codes and descriptions are Copyright 2009 American Medical Association.
37183 Remove hepatic shunt (tips).
47382 Percut ablate liver rf.
50200 Biopsy of kidney.
55873 Cryoablate prostate.
93025 Microvolt t-wave assess.

In the proposed rule, we stated that we were in agreement with the AMA RUC recommendations for the direct PE inputs for the codes listed in Table 3 and proposed to adopt these for CY 2010.

Comment: Several commenters stated that it did not appear that we had adopted the AMA RUC recommendations for these codes. Commenters requested that we review their direct PE inputs to determine if we had adopted the RUC's recommendations.

Response: We have reviewed the direct PE inputs for these codes and it appears that some were omitted in error. We have now updated the PE inputs for these codes consistent with the RUC recommendation.

f. Practice Expense for Intranasal Vaccine Administration Codes (CPT Codes 90467, 90468, 90473, and 90474)

Comment: We received a comment from a manufacturer that the payment for the intranasal vaccine administration codes (represented by CPT codes 90467, 90468, 90473, and 90474) is approximately half the rate of the injected vaccine administration codes (represented by CPT codes 90465, 90466, 90471, and 90472). The commenter stated that the apparent source of the difference is the clinical staff time inputs of the PE component of the RVUs for these codes. The commenter noted that these codes are used to administer the intranasal form of the influenza vaccine to healthy individuals between 2 to 49 years of age.

Response: We responded to a similar comment in the CY 2008 PFS final rule with comment period (72 FR 66242). At that time, we stated that a manufacturer had expressed concern that the PE RVUs for intranasal administration of vaccines (CPT codes 90467/8 and 90473/4) are inappropriately low and should be equalized to the injectable immunization administration PE RVUs. The commenter stated that when the codes were re-evaluated in 2004 there was not enough experience in the office to fully understand the time associated with providing an intranasal vaccine. The commenter stated that specialty organizations have indicated that this issue is worth reexamining and indicated that they had been encouraged to communicate with the AMA RUC in support of equalizing payment for the codes. In our response we stated that we appreciated the commenter's concerns about the disparity in the PE RVUs for the intranasal and injectable immunization administration procedures. To the extent that these concerns related to the direct PE inputs, we encouraged the commenters to work with the specialty organizations to determine if it was appropriate to bring these codes forward for further AMA RUC review.

The AMA RUC reviewed the immunization administration services (CPT codes 90465 through 90474) in February 2008. It recommended similar PE inputs for the intramuscular and intranasal immunization administration codes. In the CY 2009 PFS final rule with comment period (73 FR 38512), we stated that we accepted all of the AMA RUC recommendations, except for inclusion of the clinical staff time related to quality activities for the codes. In the CY 2009 PFS final rule with comment period (73 FR 69736), we stated that we had reexamined the issue and that there was evidence to support the inclusion of QA time in this case. We revised the PE database to reflect QA time for these codes.

B. Geographic Practice Cost Indices (GPCIs): Locality Discussion

1. Update—Expiration of 1.0 Work GPCI Floor

Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (that is, work, PE and malpractice). While requiring that the PE and malpractice GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the physician work GPCIs reflect only one-quarter of the relative cost differences compared to the national average.

Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. This section also specifies that if more than 1 year has elapsed since the last GPCI revision, we must phase in the adjustment over 2 years, applying only one-half of any adjustment in each year. As discussed in the CY 2009 PFS final rule with comment period (73 FR 69740), the CY 2009 adjustment to the GPCIs reflected the fully implemented fifth comprehensive GPCI update. We noted that a 1.0 work GPCI floor was enacted and implemented for CY 2006, and was set to expire on June 30, 2008. We also noted that section 134 of the MIPPA extended the 1.0 work GPCI floor from July 1, 2008, through December 31, 2009. Additionally, section 1848(e)(1)(G) of the Act, as amended by section 134(b) of the MIPPA, set a permanent 1.5 work GPCI floor in Alaska for services furnished beginning January 1, 2009. Therefore, as required by the MIPPA, beginning on January 1, 2010, the 1.0 work GPCI floor will be removed. However, the 1.5 work GPCI floor for Alaska will remain in place. See Addenda D and E of this final rule for the GPCIs and summarized geographic adjustment factors (GAFs), respectively.

Comment: A few commenters urged us to make the 1.0 work GPCI floor permanent.

Response: With regard to the 1.0 work GPCI floor, we do not have the authority to extend this provision beyond December 31, 2009. As explained in the CY 2010 PFS proposed rule (74 FR 33533), section 134 of the MIPPA only extended the 1.0 work GPCI floor from July 1, 2008, through December 31, 2009.

2. Payment Localities

a. Background

As stated above in this section, section 1848(e)(1)(A) of the Act requires us to develop separate GPCIs to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (this is, work, PE, and malpractice). Payments under the PFS are based on the relative resources involved in furnishing physicians' services, and are adjusted for differences in relative resource costs among payment localities using the GPCIs. As a result, PFS payments vary between localities.

The current PFS locality structure was developed and implemented in 1997. There are currently 89 localities including 37 higher-cost areas; 16 Rest of State areas (comprising the remaining counties not located in a higher-cost area within a State); 34 Statewide areas; and Puerto Rico and the Virgin Islands which are designated as “territory-wide” localities. The development of the current locality structure is described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and the subsequent final rule (61 FR 59494).

As we have frequently noted, any changes to the locality configuration must be made in a budget neutral manner within a State and can lead to significant redistributions in payments. For many years, we have not considered making changes to localities without the support of a State medical association in order to demonstrate consensus for the change among the professionals whose payments would be affected (with some increasing and some decreasing). However, we have recognized that, over time, changes in demographics or local economic conditions may lead us to conduct a more comprehensive examination of existing payment localities.

Payment Locality Approaches Discussed in the CY 2008 PFS Proposed Rule

For the past several years, we have been involved in discussions with California physicians and their representatives about recent shifts in relative demographics and economic conditions among a number of counties within the current California payment locality structure. In the CY 2008 PFS proposed and final rules with comment period, we described three potential options for changing the payment localities in California (72 FR 38139 and 72 FR 66245, respectively).

After reviewing the comments on these options, we decided not to proceed with implementing any of them at that time. We explained that there was no consensus among the California medical community as to which, if any, of the options would be most acceptable. We also received suggestions from the Medicare Payment Advisory Commission (MedPAC) for developing changes in payment localities for the entire country and other States expressed interest in having their payment localities reconfigured as well. In addition, other commenters wanted us to consider a national reconfiguration of localities rather than just making changes one State at a time. Because of the divergent views expressed in comments, we explained in the CY 2008 PFS final rule with comment period that we intended to conduct a thorough analysis of potential approaches to reconfiguring localities and would address this issue again in future rulemaking.

Interim Study of Alternative Payment Localities Under the PFS

As a follow-up to the CY 2008 PFS final rule with comment period, we contracted with Acumen, LLC (Acumen), to conduct a preliminary study of several options for revising the payment localities on a nationwide basis. The contractor's interim report was posted on the CMS Web site on August 21, 2008, and we requested comments from the public. The report entitled, “Review of Alternative GPCI Payment Locality Structures,” is still accessible from the CMS PFS Web page under the heading “Interim Study of Alternative Payment Localities under the PFS.” The report may also be accessed directly from the following link: http://www.cms.hhs.gov/PhysicianFeeSched/10_Interim_Study.asp#TopOfPage. We accepted comments on the interim report through November 3, 2008. The alternative locality configurations discussed in the report are described briefly below in this section.

Option 1: CMS Core Based Statistical Area (CBSA) Payment Locality Configuration

This option uses the Office of Management and Budget (OMB's) Metropolitan Statistical Area (MSA) designations for the payment locality configuration. MSAs would be considered as urban CBSAs. Micropolitan Areas (as defined by OMB) and rural areas would be considered as non-urban (rest of State) CBSAs. This approach would be consistent with the inpatient hospital prospective payment system (IPPS) pre-reclassification CBSA assignments and with the geographic payment adjustments used in other Medicare payment systems. This option would increase the number of localities from 89 to 439.

Option 2: Separate High Cost Counties From Existing Localities (Separate Counties)

Under this approach, higher cost counties are removed from their existing locality structure and they would each be placed into their own locality. This option would increase the number of localities from 89 to 214 using a 5 percent GAF differential to separate high cost counties.

Option 3: Separate MSAs From Statewide Localities (Separate MSAs)

This option begins with Statewide localities and creates separate localities for higher cost MSAs (rather than removing higher cost counties from their existing locality as described in option 2). This option would increase the number of localities from 89 to 130 using a 5 percent GAF differential to separate high cost MSAs.

Option 4: Group Counties Within a State Into Locality Tiers Based on Costs (Statewide Tiers)

This option creates tiers of counties (within each State) that may or may not be contiguous but share similar practice costs. This option would increase the number of localities from 89 to 140 using a 5 percent GAF differential to group similar counties into Statewide tiers.

Additionally, as discussed in the interim locality study report, our contractor, Acumen, applied a “smoothing” adjustment to the current PFS locality structure, as well as to each of the alternative locality configurations (except option 4: Statewide Tiers). The “smoothing” adjustment was applied to mitigate large payment differences (or payment “cliffs”) between adjacent counties. Since large payment differences between adjacent counties could influence a physician's decision on a practice location (and possibly impact access to care), the “smoothing” adjustment was applied to ensure that GAF differences between adjacent counties do not exceed 10 percent. (For more information on the “smoothing” adjustment see the interim locality study report on the PFS Web page via the link provided above).

b. Summary of Public Comments on Interim Locality Study Report

In the CY 2009 PFS proposed rule (73 FR 38514), we encouraged interested parties to submit comments on the options presented both in the proposed rule and in the interim report posted on our Web site. We also requested comments and suggestions on other potential alternative locality configurations (in addition to the options described in the report). Additionally, we requested comments on the administrative and operational issues associated with the various options under consideration. We also emphasized that we would not be proposing any changes to the current PFS locality structure for CY 2009 and that we would provide extensive opportunities for public comment before proposing any change.

In the CY 2010 PFS proposed rule (74 FR 33533), we noted that approximately 200 industry comments were submitted on the alternative locality options discussed in the CY 2009 PFS proposed rule and on the interim locality study report. Comments were submitted from various specialty groups, medical societies, state medical associations, individual practitioners, and beneficiaries. Commenters generally commended us for acknowledging the need to reconfigure PFS payment localities and expressed support for our study of alternative locality configurations. Some urged us to expedite any changes while other commenters requested that we take a cautious approach.

Several commenters who supported the adoption of an MSA-based PFS locality structure suggested that option 3 could be used as a transition to the CMS CBSA locality configuration (option 1). Many commenters from the State of California supported option 3 (Separate High Cost MSAs) because the commenters believe it would improve payment accuracy (over the current locality configuration) and mitigate possible payment reductions to rural areas as compared to option 1 (CMS CBSA) and option 4 (Statewide Tiers. Because of the payment reductions to rural areas, most commenters did not support option 4 (Statewide Tiers).

Many commenters also acknowledged the significant redistribution of payments that would occur under each option and requested that we minimize the payment discrepancy between urban and rural areas to ensure continued access to services. One medical association stated that “budget neutral redistributions would only exacerbate an already flawed and under-funded Medicare PFS” and suggested that States with a Statewide locality be given the option of remaining a Statewide locality. The commenter also requested that we continue our policy of allowing any State the option of converting to a Statewide locality.

For a more detailed discussion of the comments submitted on the interim locality study, see the CY 2010 PFS proposed rule (74 FR 33534).

We did not make a specific proposal for changing the PFS locality structure in the CY 2010 PFS proposed rule. As noted by the commenters and reflected in the report, significant payment redistribution would occur if a nationwide change in the PFS locality configuration were undertaken. All four of the potential alternative payment locality configurations reviewed in the report would increase the number of localities and separate higher cost, typically urban areas from lower cost, typically rural “Rest of State” areas. In general, payments to urban areas would increase while rural areas would see a decrease in payment under each of the options studied because they would no longer be grouped with higher cost “urbanized” areas. We intend to continue our review of the suggestions made by the commenters and consider the impact of each of the potential alternative locality configurations.

Comment: We received some comments on the locality discussion from various specialty groups and medical societies. A few commenters expressed support for our decision to defer proposing changes to the PFS locality reconfiguration and recommended that we continue pursuing a cautious approach. One State Medical Association stated that it is hopeful that the Congress will provide a method to update all payment localities in a manner that prevents cuts to payments in lower-cost counties. However, in the event the Congress does not provide additional funding to hold lower cost counties harmless, the commenter supports a PFS locality configuration based on MSAs. Another commenter noted that the redistribution of payments could have a negative impact on access to care. The commenter stated that geographic location should not be a detriment as to whether a physician can provide care to a Medicare beneficiary. One specialty group stated that changes in localities should only be made to improve the relative accuracy of Medicare payment. In the event we make a proposal to change the PFS locality structure, the commenter urged us to provide sufficient data for the public to ascertain the impact on specific geographic areas.

Response: We agree that a nationwide locality reconfiguration requires a cautious approach and will carefully consider the commenter's suggestion regarding an MSA-based locality configuration. We would also like to thank the public again for the many thoughtful comments on the interim locality study report entitled, “Review of Alternative GPCI Payment Locality Structures”. A final report will be posted to the CMS Web site after further review of the studied alternative locality approaches. As explained in the CY 2010 PFS proposed rule, we are not proposing changes in the PFS locality structure at this time. In the event we decide to make a specific proposal for changing the locality configuration, we would provide data on the impact of the changes. We would also provide extensive opportunities for public input (for example, Town Hall meetings or Open Door Forums, as well as opportunities for public comments afforded by the rulemaking process).

C. Malpractice Relative Value Units (RVUs)

1. Background

Section 1848(c) of the Act requires that each service paid under the PFS be comprised of three components: Work, PE, and malpractice. From 1992 to 1999, malpractice RVUs were charge-based, using weighted specialty-specific malpractice expense percentages and 1991 average allowed charges. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 4505(f) of the BBA required us to implement resource-based malpractice RVUs for services furnished beginning in 2000. Initial implementation of resource-based malpractice RVUs occurred in 2000. The statute also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. The first review and update of resource based malpractice RVUs was addressed in the CY 2005 PFS final rule (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule (70 FR 70153). In the CY 2010 PFS proposed rule, we proposed to implement the second review and update of malpractice RVUs.

2. Methodology for the Revision of Resource-Based Malpractice RVUs

The proposed malpractice RVUs were developed by Acumen, LLC (Acumen) under contract to us (74 FR 33537).

The methodology used in calculating the proposed second review and update of resource-based malpractice RVUs largely parallels the process used in the CY 2005 update. The calculation requires information on malpractice premiums, linked to the physician work conducted by different specialties that furnish Medicare services. Because malpractice costs vary by State and specialty, the malpractice premium information must be weighted geographically and across specialties. Accordingly, the malpractice expense RVUs that we proposed are based upon three data sources:

  • Actual CY 2006 and CY 2007 malpractice premium data.
  • CY 2008 Medicare payment data on allowed services and charges.
  • CY 2008 Geographic adjustment data for malpractice premiums.

Similar to the previous update of the resource-based malpractice expense RVUs, we proposed to revise the RVUs using specialty-specific malpractice premium data because they represent the actual malpractice expense to the physician. In addition, malpractice premium data are widely available through State Departments of Insurance. We proposed to use actual CY 2006 and CY 2007 malpractice premium data because they are the most current data available (CY 2008 malpractice premium data were not consistently available during the data collection process). Accounting for market share, three fourths of all included rate filings were implemented in CY 2006 and CY 2007. The remaining rate filings were implemented in CY 2003 through CY 2005 but still effective in CY 2006 and CY 2007. Carriers submit rate filings to their State Departments of Insurance listing the premiums and other features of their coverage. The rate filings include an effective date, which is the date the premiums go into effect. Some States require premium changes to be approved before their effective date; others just require the rate filings to be submitted. We attempted to capture at least 2 companies and at least 50 percent of the market share, starting with the largest carriers in a State.

The primary determinants of malpractice liability costs continue to be physician specialty, level of surgical involvement, and the physician's malpractice history. We collected malpractice premium data from 49 States and the District of Columbia for all physician specialties represented by major insurance providers. Rate filings were not available through Departments of Insurance in Mississippi or Puerto Rico. Premiums were for $1 million/$3 million, mature, claims-made policies (policies covering claims made, rather than services furnished during the policy term). A $1 million/$3 million liability limit policy means that the most that would be paid on any claim is $1 million and that the most that the policy would pay for several claims over the timeframe of the policy is $3 million. We collected data from commercial and physician-owned insurers and from joint underwriting associations (JUAs). A JUA is a State government-administered risk pooling insurance arrangement in areas where commercial insurers have left the market. Adjustments were made to reflect mandatory surcharges for patient compensation funds (PCFs) (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) in States where PCF participation is mandatory. We sought to collect premium data representing at least 50 percent of physician malpractice premiums paid in each State as identified by State Departments of Insurance and by the National Association of Insurance Commissioners (NAIC).

Rather than select the top 20 physician specialties as we did when the malpractice RVU were originally established and updated, we included premium information for all physician and surgeon specialties, and risk classifications available in the collected rate filings. Most insurance companies provided crosswalks from insurance service office (ISO) codes to named specialties; we matched these crosswalks to CMS specialty codes. We also preserved information obtained regarding surgery classes, which are categorizations that affect premium rates. For example, many insurance companies grouped general practice physicians into nonsurgical, minor-surgical and major-surgical classes, each with different malpractice premiums. Some companies provided additional surgical subclasses; for example, distinguishing general practice physicians that conducted obstetric procedures, which further impacted malpractice rates. We standardized this information to CMS specialty codes.

We proposed a resource based methodology for developing malpractice RVUs for technical component (TC) services (for example diagnostic tests). Currently, the MP RVUs for TC services and the TC portion of global services are based on historical allowed charges and have not been made resource based due to a lack of available malpractice premium data for nonphysician suppliers. Over the last few years, we have requested malpractice premium data for nonphysician suppliers, but had not received any data prior to last year. In response to our request in last year's rulemaking cycle, one commenter did provide information on one of the largest insurance companies that provides liability insurance for medical physicists employed by imaging facilities. After our contractor, Acumen, verified the medical physicist premium information submitted in response to last year's proposed rule, we proposed to use the medical physicist premium data as a proxy for the malpractice premiums paid by all entities providing TC services; primarily independent diagnostic testing facilities (IDTFs).

Other than the change in methodology for developing malpractice RVUs for TC services, our proposed methodology for updating malpractice RVUs conceptually followed the same approach, with some minor refinements, used to originally develop the resource based malpractice RVUs in CY 2000 and used in the CY 2005 update. These refinements included an expansion in the malpractice premium data collection to include additional specialties, a distinction between major and minor surgical risk factors, and a proposal to use the malpractice risk factor of the specialty that performs a given service the most (dominant specialty) for services with less than 100 occurrences. We solicited comments on our proposed methodology for updating the malpractice RVUs and posted the Acumen report, “Interim Report on Malpractice RVUs for the CY 2010 Medicare Physician Fee Schedule Proposed Rule” on the CMS Web site. The interim report on Malpractice RVUs for the CY 2010 PFS proposed rule and Malpractice premium amounts and risk factors by specialty, which was produced by Acumen, LLC under contract to CMS, is accessible from the CMS PFS Web page under the heading “Interim Report on Malpractice RVUs for the CY 2010 Medicare PFS Proposed rule.” The report and malpractice premiums may also be accessed directly on the CMS Web site at http://www.cms.hhs.gov/PhysicianFeeSched/05_Malpractice_Report.asp#TopOfPage.

A more detailed explanation of our proposed malpractice RVU update can be found in the CY 2010 PFS proposed rule (74 FR 33537).

We received over 250 industry comments on the CY 2010 proposed malpractice RVU update.

Comment: Many commenters commended us for employing an expanded data collection that included premium information for all physician specialties, rather than just the top 20 Medicare physician specialties. Commenters also applauded our use of the most current PLI premium data available from State filings.

Response: We agree with the commenters that the use of the most current PLI data and the expanded data collection is appropriate.

Comment: Some commenters supported the use of medical physicist data as a proxy for developing malpractice RVUs for TC services. The commenters expressed their belief that using medical physicist data provide a better reflection of PLI premiums paid by entities furnishing TC services than the current charge-based approach or cross-walking to physician specialties. Many commenters did not support the proposed change to resource-based MP RVUs for TC services because premium amounts paid by medical physicists were used as a proxy for all entities furnishing TC services. The commenters objected to our proposed use of medical physicist data, stating that the use of this data will result in inappropriately low MP RVUs for the affected services. The commenters indicated that we should use premium data from the suppliers of these TC services, such as IDTFs and audiologists. Some commenters requested that we work with the Radiology Business Management Association (RBMA) to obtain PLI premium information for IDTFs. Other suppliers of TC services, including suppliers of imaging services and remote cardiac monitoring services, also submitted liability policy information. Several commenters requested that we use the current charge-based malpractice RVUs until data from TC suppliers can be collected.

Response: We appreciate all the comments received on this issue. While we agree with the commenters who stated that the medical physicist data provide a better reflection of PLI premiums paid by entities furnishing TC services than the current charge-based approach or crosswalking to physician specialties, we also agree with the commenters who indicated that we should use premium data from the suppliers of these services, if the data are available and meet the same standards as the other premium data collected for use in the development of the malpractice RVUs. As noted earlier, we have repeatedly requested PLI data sources for suppliers of TC services. Our proposal for TC services was based on the first verifiable data source provided to us. In the comment period, alternative PLI sources were recommended for use with the TC services. In some circumstances, the information submitted by the commenters included insurance coverage beyond the scope of the malpractice RVUs (for example, property liability, errors and omissions liability) and/or coverage limits beyond the $1 million/$3 million coverage malpractice premium collection parameters used for professional services. However, these same commenters also submitted the names of several insurance companies who provide malpractice insurance for IDTFs. We contacted these insurance companies in an attempt to collect premium data for the suppliers of TC services. We were able to verify the premium information for IDTFs consistent with the information collected for physician specialties. Therefore, we are using this verified premium data in the calculation of the malpractice RVUs for TC services.

Comment: Many commenters stated that all services have some level of malpractice risk and that it was inappropriate for CMS to allow rounding to result in zero malpractice RVUs for some services.

Response: After considering the comments on this issue, we agree that it would be inappropriate for services to receive zero payment for malpractice due to rounding. These services will be assigned 0.01 malpractice RVUs for CY 2010.

Comment: One commenter did not support the use of work RVUs to account for differences in risk-of-service for drug administration services and that these services were being inappropriately penalized in the malpractice risk allocation.

Response: When developing the current resource-based PE RVU methodology, we received similar comments since the work RVUs are also a component of the indirect PE allocation. In response to those comments, we modified the resource-based PE methodology to allow the allocation to be done using the greater of the clinical labor involved in the service or the work RVUs. In light of similar comments on this issue in the malpractice allocation, we will make a similar modification. Specifically, we will use the greater of the clinical labor involved in the service or the work RVUs in the malpractice allocation.

Comment: The AMA RUC and other commenters requested that we use the generally lower malpractice survey data from the Physician Practice Information Survey (PPIS) for NPPs instead of crosswalking NPPs to the lowest physician specialty (allergy/immunology). One commenter also noted that the average premiums collected for diagnostic radiology were lower than the average reported premium from the AMA PPIS data.

Response: The resource-based malpractice RVUs are based on verifiable PLI premium data. We do not believe it would be appropriate to base the malpractice RVUs for nonphysician specialties or selected specialties on survey data and use premium data for all other specialties. Therefore, we do not agree with the commenters who suggested the use of survey data for NPPs or selected specialties.

Comment: The AMA RUC and two other commenters requested that we crosswalk gynecologic oncology to general surgery and surgical oncology (instead of crosswalking it to medical oncology) because gynecologic oncologists are predominantly cancer surgeons.

Response: We agree with the commenters and will crosswalk gynecologic oncology to general surgery premium data.

Comment: Some commenters raised questions about our proposal to crosswalk maxillofacial surgery and oral surgery to allergy/immunology. The commenters suggested that we use PLI data collected from the American Association of Maxillofacial Surgery (AAOMS) or the PPIS data instead of crosswalking to the lowest physician specialty.

Response: As noted earlier, the resource-based malpractice RVUs are based on verifiable premium data. We do not agree with the commenters who suggested the use of unverified maxillofacial surgery and oral surgery PLI information. However, we do agree that it would be more appropriate to use a surgical specialty's premium data rather than allergy/immunology premium data for surgical specialties. Therefore, we will crosswalk these specialties to the similar specialty of plastic surgery.

Comment: Some commenters did not support using the global surgery indicator for assigning the major or minor risk factor to surgical procedures. The commenters stated that using this methodology for determining the surgical class will not adequately address all the instances in which a surgical procedure should be classified as major. The commenters requested that we work with PLI insurance companies and the AMA RUC to determine a more comprehensive definition of major and minor surgical classifications. One commenter requested that we assign the surgical risk factor to injection procedures performed during cardiac catheterization as described by CPT codes 93501 through 93572.

Response: For the original implementation of resource-based MP RVUs (CY 2000), we assigned one of two risk factors to each service based on code range: surgery and nonsurgery (the surgery risk factor did not distinguish between major and minor). This methodology of assigning risk factors to specific services was also used in the first Five-Year Review. For the second malpractice RVU update, we proposed to assign each service code to one of the following three risk factors: Nonsurgical; minor surgical; and major surgical (74 FR 33539). Risk factor classes for each service were assigned based on procedure code ranges and whether or not the service had a 90-day global period. The 90-day global period was used to assign surgical codes to major surgery.

After consideration of the comments, we will not finalize our proposal but will continue to use our current approach for assigning risk factors to individual services while we study this issue further. We will consider the request to assign the surgical risk factor to injection procedures as part of our further study and would propose any changes through future rulemaking.

As is done under the current methodology, we will continue to assign each service to either a nonsurgical or surgical risk factor based on CPT code ranges: Surgery (CPT code range 10000 through 69999; 92980 through 92998; 93501 through 93536; 92973 through 92974; 93501 through 93533; 93580 through 93581; 93600 through 93613; 93650 through 93652; 92975; 92980 through 92998; 93617 through 93641); and nonsurgery (all other CPT codes). Consistent with current practice, the surgery risk factor would not distinguish between major and minor.

Comment: While commenters agreed with most of our proposed claims based dominant specialty designations for codes with less than 100 allowed services, the commenters disagreed with our proposal for some services. The commenters believe that the claims have been miscoded, resulting in erroneous specialty designations.

Response: Service specific malpractice RVUs are determined based on the weighted average risk factor(s) of the specialties that furnish the service. For rarely-billed Medicare services (that is, when allowed services are less than 100), we proposed to use the risk factor of the dominant specialty as reflected in our claims data. In the past, we had used all the specialties performing these low volume services as reflected in our claims data. Approximately 2,000 services met the criteria for “low volume.” The dominant specialty for each ‘low volume’ service was determined from CY 2008 Medicare claims data.

By using the dominant specialty from our claims data to assign the specialty for these low volume services, we attempted to strike a balance between our preference for the empirical, objective use of all of our claims data in the development of the malpractice RVUs and the desire of commenters to override our claims data for these low volume services using less objective criteria. After careful consideration of the comments, we continue to believe that a more balanced approach between the complete reliance on all of the specialties in our claims data and the subjective review of each low volume service is the most appropriate way of approaching the development of malpractice RVUs for these low volume services. We disagree with the commenters that we should override the dominant specialty from the claims data with the recommended specialty. Therefore, we will finalize our proposal to use Medicare claims data to assign a dominant specialty to low volume services.

D. Medicare Telehealth Services

1. Requests for Adding Services to the List of Medicare Telehealth Services

Section 1834(m)(4)(F) of the Act defines telehealth services as professional consultations, office visits, and office psychiatry services, and any additional service specified by the Secretary. In addition, the statute requires us to establish a process for adding services to or deleting services from the list of telehealth services on an annual basis.

In the December 31, 2002 Federal Register (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services. This process provides the public with an ongoing opportunity to submit requests for adding services. We assign any request to make additions to the list of Medicare telehealth services to one of the following categories:

  • Category #1: Services that are similar to professional consultations, office visits, and office psychiatry services. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter. We also look for similarities in the telecommunications system used to deliver the proposed service, for example, the use of interactive audio and video equipment.
  • Category #2: Services that are not similar to the current list of telehealth services. Our review of these requests includes an assessment of whether the use of a telecommunications system to deliver the service produces similar diagnostic findings or therapeutic interventions as compared with the face-to-face “hands on” delivery of the same service. Requestors should submit evidence showing that the use of a telecommunications system does not affect the diagnosis or treatment plan as compared to a face-to-face delivery of the requested service.

Since establishing the process, we have added the following to the list of Medicare telehealth services: psychiatric diagnostic interview examination; ESRD services with two to three visits per month and four or more visits per month (although we require at least one visit a month to be furnished in-person “hands on”, by a physician, clinical nurse specialist (CNS), nurse practitioner (NP), or physician assistant (PA) to examine the vascular access site); individual medical nutrition therapy; neurobehavioral status exam; and follow-up inpatient telehealth consultations.

Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, requests submitted before the end of CY 2009 are considered for the CY 2011 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation you wish us to consider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requestors should be advised that any information submitted is subject to disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, visit our Web site at http://www.cms.hhs.gov/telehealth/.

2. Submitted Requests for Addition to the List of Telehealth Services

We received requests in CY 2008 to add the following services as Medicare telehealth services effective for CY 2010: (1) Health and behavior assessment and intervention (HBAI) procedures; and (2) nursing facility services. In addition, we received a number of requests to add services that we did not approve as Medicare telehealth services in previous PFS rules. These requested services include critical care services; initial and subsequent hospital care; group medical nutrition therapy; diabetes self-management training; speech and language pathology services; and physical and occupational therapy services.

In the CY 2010 PFS proposed rule (74 FR 33543), we responded to these requests. We proposed to add individual HBAI services to the list of Medicare telehealth services, and we proposed to revise our regulations at § 410.78 and § 414.65 accordingly. We proposed to revise § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.40(c). We proposed to revise § 410.78 to specify that the G-codes for follow-up inpatient telehealth consultations (as described by HPCPCS codes G0406 through G0408) include follow-up telehealth consultations furnished to beneficiaries in hospitals and SNFs. We did not propose to add group HBAI, family-with-patient HBAI, nursing facility services, critical care services, or any of the other requested services to the list of Medicare telehealth services. The following is a summary of the discussion from the proposed rule, a summary of comments we received, and our responses.

a. Health and Behavior Assessment and Intervention (HBAI)

The American Psychological Association (APA) submitted a request to add HBAI services (as described by HCPCS codes 96150 through 96154) to the list of approved telehealth services. The APA asked us to evaluate and approve HBAI services as a Category #1 service because they are comparable to the psychotherapy services currently approved for telehealth.

As discussed in the CY 2010 PFS proposed rule (74 FR 33543), clinical psychologists furnish HBAI services to beneficiaries to help them manage or improve their behavior in response to physical problems. Elements of HBAI services typically include interviewing, observing, and counseling beneficiaries to help them modify their behavior. These elements are also common to the office psychiatry services currently approved for telehealth. In the proposed rule, we stated that we believe the interaction between a practitioner and a beneficiary receiving individual HBAI services (as described by HCPCS codes 96150 through 96152) is similar to the assessment and counseling elements of the individual office psychiatry services currently approved for telehealth. Therefore, we proposed to revise § 410.78 and § 414.65 to include individual HBAI services as Medicare telehealth services.

With regard to group HBAI (as described by HCPCS code 96153) or family-with-patient HBAI (as described by HCPCS code 96154), we noted that group services are not currently approved as Medicare telehealth services. Group counseling services have a different interactive dynamic between the physician or practitioner and his or her patients as compared to individual services. Since the interactive dynamic for group HBAI services is not similar to that for individual HBAI services or any other approved telehealth services, we stated that we do not believe that group HBAI or family-with-patient HBAI services should be considered as Category #1 requests. To be considered as a Category #1 request, a service must be similar to the current list of Medicare telehealth services. (See 70 FR 45787 and 70157, and 73 FR 38516 and 69743). Instead, we believe that group HBAI and family-with-patient HBAI must be evaluated as Category #2 services. Accordingly, we need to evaluate whether these are services for which telehealth can be an adequate substitute for a face-to-face encounter. The requestor did not submit evidence suggesting that the use of a telecommunications system to deliver these services would produce similar diagnostic findings or therapeutic interventions as compared to the face-to-face delivery of these services. Therefore, we did not propose to add group HBAI (as described by HCPCS code 96153) or family-with-patient HBAI (as described by HCPCS code 96154) to the list of approved Medicare telehealth services.

Comment: The APA stated that it was pleased that we proposed to add individual HBAI to the list of approved telehealth services and that it may wish to resume the discussion of adding other HBAI services in the future. Other commenters were also pleased that we proposed to add individual HBAI to the list of approved telehealth services. However, they disagreed with our proposal not to add the other HBAI services to the list of approved Medicare telehealth services. The commenters noted that CMS has no evidence that it is not appropriate to furnish group services via telehealth. In addition, the commenters believe that the involvement of family members in patient counseling can often be critical in developing an appropriate plan of care.

Response: Office psychiatry services currently approved for telehealth are individual rather than group services. There are no group services approved for telehealth. In order to add services for Medicare telehealth that are not similar to the existing list of Medicare telehealth services, we evaluate comparative studies to assess whether the use of an interactive audio and video telecommunications system is an adequate substitute for the in-person (face-to-face) delivery of the requested service. Requestors did not submit sufficient comparative analyses showing that the use of a telecommunications system is an adequate substitute for group counseling services furnished in person.

b. Nursing Facility Services

Section 149 of the MIPPA added SNFs as telehealth originating sites effective for services furnished on or after January 1, 2009. We received a request from the American Telemedicine Association (ATA) to add subsequent nursing facility care; nursing facility discharge services; and other nursing facility services to the list of approved telehealth services. The Center for Telehealth and e-Health Law submitted a request to add the same nursing facility services and indicated its support of ATA's request. We also received a request from the Marshfield Clinic to add the same services requested by the ATA, plus the initial nursing facility care services.

The procedure codes included in these requests are used to report evaluation and management (E/M) services furnished onsite to patients in SNFs. The requestors drew analogies to the E/M services currently approved for Medicare telehealth, and they provided evidence in support of their belief that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of this type of care.

As discussed in the CY 2010 PFS proposed rule (74 FR 33543), the long-term care regulations at § 483.40 require that residents of SNFs receive initial and periodic personal visits. These regulations insure that at least a minimal degree of personal contact between a physician or a qualified NPP and a resident is maintained, both at the point of admission to the facility and periodically during the course of the resident's stay. We believe that these Federally-mandated visits should be conducted in-person, and not as Medicare telehealth services. We proposed to revise § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.40(c).

We reviewed the use of telehealth for each of the subcategories of nursing facility services included in these requests. We identified the E/M services that fulfill Federal requirements for personal visits under § 483.40 and we did not propose to add any procedure codes that are used exclusively to describe these Federally-mandated visits.

Initial Nursing Facility Care

The initial nursing facility care procedure codes (as described by HCPCS codes 99304 through 99306) are used to report the initial E/M visit in a SNF or NF that fulfills Federally-mandated requirements under § 483.40(c). We did not propose to add the initial nursing facility care services (as described by HCPCS codes 99304 through 99306) to the list of approved Medicare telehealth services because these procedure codes are used exclusively to describe E/M services that fulfill Federal requirements for personal visits under § 483.40.

Subsequent Nursing Facility Care

The subsequent nursing facility care procedure codes (as described by HCPCS codes 99307 through 99310) are used to report either a Federally-mandated periodic visit under § 483.40(c), or any E/M visit, prior to and after the initial physician visit, that is reasonable and medically necessary to meet the medical needs of the individual resident. In the past, we have not added hospital E/M visits to the list of approved Medicare telehealth services because of our concern regarding the use of telehealth for the ongoing E/M of a high-acuity hospital inpatient. (See 69 FR 47511, 69 FR 66276, 72 FR 38144, 72 FR 66250, 73 FR 38517, and 73 FR 69745.) Many residents of SNFs also require medically complex care, and we have similar concerns about allowing physicians or NPPs to furnish E/M visits via telehealth to residents of SNFs.

The complexity of care required by many residents of SNFs may be significantly greater than the complexity of care generally associated with patients receiving the office visits approved for telehealth. Accordingly, we do not consider E/M visits furnished to residents of SNFs similar to the office visits on the current list of Medicare telehealth services. Therefore, we believe the use of subsequent nursing facility care for medically necessary E/M visits that are in addition to Federally-mandated periodic personal visits must be evaluated as a Category #2 service.

We evaluated whether these are services for which telehealth can be an adequate substitute for a face-to-face encounter. The requestors submitted supporting documentation to demonstrate that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of this type of care. However, we did not receive sufficient comparative analysis or other compelling evidence to demonstrate that furnishing E/M visits via telehealth to residents of SNFs is an adequate substitute for the face-to-face encounter between the practitioner and the resident, especially in cases where the resident requires medically complex care. We were also concerned that one study demonstrated that services provided via telehealth do not elicit adequate participation in informed medical decision-making from residents with low to moderate illness when compared to face-to-face encounters. We determined that telehealth is not an adequate substitute for the face-to-face delivery of E/M visits to residents of SNFs. Therefore, we did not propose to add subsequent nursing facility care services to the list of approved Medicare telehealth services.

Nursing Facility Discharge Day Management

The nursing facility discharge day management codes (as described by HCPCS codes 99315 and 99316) are used to report an E/M visit that prepares a resident for discharge from a nursing facility. We note that there is no Medicare Part B requirement to furnish and bill an E/M visit in preparation for a resident's discharge from a SNF. However, if a physician or qualified NPP bills a Nursing Facility Discharge Services code, we believe that a face-to-face encounter will better insure that the resident is prepared for discharge. We do not have evidence that nursing facility discharge services furnished via telehealth are equivalent to face-to-face provision of this service. We did not propose to add the nursing facility discharge day management services to the list of approved Medicare telehealth services.

Other Nursing Facility Service

In 2006, CPT added a procedure code for Other Nursing Facility Service (CPT code 99318) to describe an annual nursing facility assessment. An annual assessment is not one of the required visits under the long-term care regulations at § 483.40. For Medicare purposes, this code can be used in lieu of a Subsequent Nursing Facility Care code to report a Federally-mandated periodic personal visit furnished under § 483.40(c). An annual assessment visit billed using CPT code 99318 does not represent a distinct benefit service for Medicare Part B physician services, and it cannot be billed in addition to the required number of Federally-mandated periodic personal visits. Under Medicare Part B, we cover this procedure code if the visit fully meets the CPT code 99318 requirements for an annual nursing facility assessment. In order to cover and pay for this service, we also require that this annual assessment falls on the 60-day mandated visit cycle. We did not propose to add the other nursing facility care services described by this code to the list of approved Medicare telehealth services because this code is payable by Medicare only if the visit is substituted for a Federally-mandated visit under § 483.40(c). We believe all of the Federally-mandated periodic visits must be conducted in person.

Follow-up Inpatient Consultations

Prior to 2006, follow-up inpatient consultations (as described by CPT codes 99261 through 99263) were approved telehealth services. In 2006, the CPT Editorial Panel of the American Medical Association (AMA) deleted the codes for follow-up inpatient consultations. In the hospital setting, the AMA advised practitioners to bill for services that would previously have been billed as follow-up inpatient consultations using the procedure codes for subsequent hospital care (as described by CPT codes 99231 through 99233). In the nursing facility setting, the AMA advised practitioners to bill for these services using the procedure codes for subsequent nursing facility care (as described by CPT codes 99307 through 99310).

In the CY 2009 PFS final rule with comment period (73 FR 69745), we created follow-up inpatient telehealth consultation codes (as described by HCPCS codes G0406 through G0408) to furnish care to hospital inpatients, and we added these G-codes to the list of Medicare telehealth services. These HCPCS codes are limited to the range of services included in the scope of the previous CPT codes for follow-up inpatient consultations, and the descriptions limit the use of such services for telehealth.

In the CY 2010 PFS proposed rule (74 FR 33547), we stated that if the former codes for follow-up consultations (as described by CPT codes 99261 through 99263) still existed, these procedure codes would also be available to practitioners providing follow-up consultations via telehealth to SNF patients. Although we did not receive a public request to add follow-up inpatient consultations for SNF patients to the list of approved Medicare telehealth services, we stated that we also recognized a need to establish a method for practitioners to provide these services. For CY 2010, we proposed to revise § 410.78 to specify that the G-codes for follow-up inpatient telehealth consultations (as described by HCPCS codes G0406 through G0408) include follow-up inpatient telehealth consultations furnished to beneficiaries in SNFs, as well as in hospitals. The HCPCS codes clearly designate these services as follow-up consultations provided via telehealth, and not as subsequent care used for E/M visits. Utilization of these codes for patients in SNFs will facilitate payment for these services, as well as enable us to monitor whether the codes are used appropriately. (See the CMS Internet-Only Medicare Claims Processing Manual, Pub. 100-04, Chapter 12, Section 190, for the definition of follow-up inpatient telehealth consultations.)

The following is a summary of the comments we received regarding our proposed decisions on Nursing Facility Services.

Comment: Commenters supported our proposal to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.40(c). Commenters also supported our proposal to expand the definition of Follow-Up Inpatient Telehealth Consultations (as described by HCPCS codes G0406-G0408) to allow their use for residents of SNFs. Commenters noted that this change would be a positive step towards increasing access to care for Medicare beneficiaries in rural areas.

Some commenters disagreed with our proposal not to add Nursing Facility Services to the list of approved Medicare telehealth services. Commenters acknowledged Congressional intent expressed in section 413 of the MMA that the use of telehealth should not be a substitute for the Federally-mandated periodic personal visits required under § 483.40(c). All commenters agreed with our proposal not to add any procedure codes that are used exclusively to describe these Federally-mandated visits. Commenters stated that they believed that the Congress intended to allow the use of telehealth to furnish E/M medically necessary visits onsite to residents of SNFs that are in addition to Federally-mandated periodic personal visits. Some commenters also noted that due to health professional shortages in rural areas, many SNFs lack essential onsite services. Some commenters believe adding nursing facility visits to the list of approved telehealth services will improve the quality of care furnished to residents of SNFs. Commenters also noted that not adding nursing facility visits to the list of approved Medicare telehealth services will not prevent the use of telehealth to furnish services to residents of SNFs, including those residents requiring medically complex care. These same residents could be transported to physicians' offices or hospitals where they could receive similar E/M visits via telehealth.

Response: We did not receive sufficient comparative analysis or other compelling evidence to demonstrate that furnishing E/M visits via telehealth to residents of SNFs is an adequate substitute for the face-to-face encounter between the practitioner and the resident, especially in cases where the resident requires medically complex care. We are further concerned that the use of telehealth may not elicit adequate participation from residents of SNFs in making informed medical decisions with their clinicians when compared to face-to-face encounters.

We agree with the commenters who noted that expanding the definition of Follow-Up Inpatient Telehealth Consultations (G0406-G0408) to allow their use for residents of SNFs will increase access to care for Medicare beneficiaries in rural areas. We believe the availability of inpatient consultations to furnish care via telehealth to residents of SNFs is consistent with the addition of SNFs as approved telehealth originating sites. Physicians and NPPs who furnish inpatient consultations via telehealth complement the care provided by the SNF and furnished onsite by the attending physician or physician of record.

c. Critical Care Services

In the CY 2009 PFS final rule with comment period (73 FR 69744), we did not add critical care services to the list of approved Medicare telehealth services. In 2009, Philips Healthcare submitted an expanded request to add critical care services to the list of approved Medicare telehealth services. It stated that critical care services can be approved as a Category #1 service based on their similarity to the inpatient consultation services currently approved for Medicare telehealth. The requestor also stated that many of the components of critical care are similar to a high-level inpatient consultation service, which is currently approved for Medicare telehealth. Common components include obtaining a patient history, conducting an examination, and engaging in complex medical decision-making for patients who may be severely ill. Because we classified critical care as a Category #2 service last year, the requestor also submitted evidence to support its belief that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of this type of care.

In the CY 2010 PFS proposed rule (74 FR 33548), we stated that remote critical care services are different than the telehealth delivery of critical care (as described by HCPCS codes 99291 and 99292). We did not propose adding critical care services (as described by HCPCS codes 99291 and 99292) to the list of approved Medicare telehealth services. We reiterated that our decision not to add critical care services to the list of approved telehealth services does not preclude physicians from furnishing telehealth consultations to critically ill patients.

Comment: A commenter disagreed with our proposal not to add critical care services to the list of approved Medicare telehealth services. The commenter submitted a new study to support its belief that these services are comparable to critical care furnished in-person. The commenter asserted that the role of the intensivist, whether in-person or remotely, is to provide the required expertise and ability to direct onsite clinical staff to perform any necessary hands-on intervention, not necessarily to effectuate them personally. To support this, the commenter submitted a vignette describing critical care services, including an analysis detailing the types of services furnished when critical care (as described by HCPCS codes 99291 and 99292) was billed by a sample of intensivists. The commenter noted that the critical care services included in this sample did not require hands-on intervention.

Another commenter who submitted the CY 2009 request submitted descriptions of telestroke technology to support the assertion that the elements of a stroke-related neurological assessment performed by a neurologist are effectively the same whether furnished in-person or via telehealth. The commenter acknowledges that some telestroke services satisfy the criteria for billing consultations via telehealth, but noted that the payment is less than the same neurological assessment furnished in-person and billed as a critical care service. The commenter requested that we consider adding critical care services to the list of approved Medicare telehealth services when the underlying diagnosis is stroke-related.

Response: We continue to believe that remote critical care services are different from the telehealth delivery of critical care services (as described by HCPCS codes 99291 and 99292). The AMA created remote critical care tracking codes. Such codes track utilization of a service, facilitating data collection on, and assessment of, new services and procedures. We believe that the data collected for these tracking codes will help provide useful information on how to best categorize and value remote critical care services in the future.

We did not find the studies submitted during the comment period persuasive that telehealth can be an adequate substitute for the face-to-face delivery of critical care services (as described by HCPCS codes 99291 and 99292). As described in these studies, the role of the physician furnishing remote critical care services includes monitoring patients and directing on-site staff to intervene, as necessary. Within the current standards of practice, we believe that critical care services (as described by HCPCS codes 99291 and 99292) require the physical presence of a physician who is available to furnish any hands-on intervention. We continue to believe that remote critical care services are different services than the telehealth delivery of critical care (as described by HCPCS codes 99291 and 99292). As noted above, we believe that the data collected for the remote critical care tracking codes will help provide useful information on how to best categorize and value remote critical care services in the future.

d. Other Requests

We received a number of requests to add services that we reviewed and did not accept in previous PFS Rules. The following are brief summaries of our discussions from the proposed rule, summaries of comments received, and our responses.

Initial and Subsequent Hospital Care

We received a request to add initial hospital care (as described by HCPCS codes 99221 through 99223) and subsequent hospital care (as described by HCPCS codes 99231 through 99233) to the list of approved Medicare telehealth services. In response to previous requests, we did not add initial or subsequent hospital care to the list of approved telehealth services because of our concern regarding the use of telehealth for the ongoing E/M of a high-acuity hospital inpatient. (See 69 FR 47510 and 66276, 72 FR 38144 and 66250, and 73 FR 38517 and 69745.) We did not receive any new information with this request that would alter our previous decision. Therefore, we did not propose adding initial hospital care or subsequent hospital care to the list of approved Medicare telehealth services. We did not receive any comments on this proposal.

Group Medical Nutrition Therapy Services

We received a request to add group medical nutrition therapy (MNT) services (as described by HCPCS codes G0271 and 97804) to the list of approved Medicare telehealth services. In response to a previous request, we did not add group MNT to the list of approved telehealth services because we believe that group services are not appropriately delivered through telehealth. (See 70 FR 45787 and 70157.) We did not receive any new information with this request that would alter our previous decision. Therefore, we did not propose adding group MNT to the list of approved Medicare telehealth services. We did not receive any comments on this proposal.

Diabetes Self-Management Training (DSMT)

We received a request to add diabetes self-management training (DSMT) (as described by HCPCS codes G0108 and G0109) to the list of approved telehealth services. In response to previous requests, we did not add DSMT to the list of approved telehealth services because of the statutory requirement that DSMT include teaching beneficiaries to self-administer injectable drugs. Furthermore, DSMT is often performed in group settings and we believe that group services are not appropriately delivered through telehealth. (See 70 FR 45787 and 70157, and 73 FR 38516 and 69743.) We did not receive any new information with this request that would alter our previous decision. Therefore, we did not propose to add DSMT to the list of approved Medicare telehealth services.

Comment: We received two comments opposing our proposal not to add DSMT to the list of approved Medicare telehealth services. The American Association of Diabetes Educators (AADE) agrees that telehealth is not an appropriate venue for initial DSMT when it includes teaching beneficiaries to self-administer injectable drugs. One commenter submitted studies to support its belief that the use of a telecommunications system was equivalent to the face-to-face delivery of follow-up DSMT.

Response: We believe that skill-based training, such as teaching patients how to inject insulin, would be difficult to accomplish effectively without the physical presence of the teaching practitioner. We disagree that this training element should be carved out of individual DSMT for purposes of providing Medicare telehealth services. The training involved in teaching beneficiaries the skills necessary for the self-administration of injectable drugs is a key component of this statutorily described benefit (and therefore inherent in the codes that describe DSMT). We continue to believe that it would not be appropriate to add individual follow-up DSMT to the list of approved Medicare telehealth services.

Speech and Language Pathology Services

We received a request to add various speech and language pathology services to the list of approved telehealth services. Speech-language pathologists are not permitted under current law to furnish and receive payment for Medicare telehealth services. Therefore, we did not propose to add any speech and language pathology services to the list of approved Medicare telehealth services. (For further discussion, see 69 FR 47512 and 66276, and 71 FR 48995 and 69657.)

Comment: The American Speech-Language Hearing Association (ASHA) commented that telehealth has been successfully applied to speech-language pathology and audiology services. ASHA requested that CMS support expansion of Medicare telehealth coverage for speech-language pathologists in communications with Congress. The American Academy of Audiology commented on the shortage of audiologists in rural areas. The group requested that we use our administrative authority to add audiology services to the list of approved Medicare telehealth services.

Response: It is not within our administrative authority to pay speech-language pathologists and audiologists for services furnished via telehealth. The statute authorizes the Secretary to pay only for telehealth services furnished by a physician or a practitioner as those terms are defined in the statute.

Physical and Occupational Therapy Services

We received a request to add various physical and occupational therapy services to the list of approved Medicare telehealth services. The statute does not authorize Medicare payment to physical and occupational therapists for Medicare telehealth services. Therefore, we did not propose to add any physical and occupational therapy services to the list of approved Medicare telehealth services. (For further discussion, see 71 FR 48995 and 69657.)

e. Summary: Result of Evaluation of 2010 Requests

We will finalize our proposal to add the individual HBAI services (as described by HCPCS codes 96150 through 96152) and not to add group HBAI (as described by HCPCS code 96153) or family-with-patient HBAI (as described by HCPCS code 96154) to the list of approved Medicare telehealth services. We will also finalize our proposal to add individual HBAI services to the list of approved Medicare telehealth services at § 410.78 and § 414.65.

We will finalize our proposal to revise § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.40(c). We will finalize our proposal not to add Nursing Facility Services (as described by HCPCS codes 99304 through 99318) to the list of approved Medicare telehealth services. We will also finalize our proposal to revise § 410.78 to specify that the G-codes for follow-up inpatient telehealth consultations (as described by HPCPCS codes G0406 through G0408) include follow-up telehealth consultations furnished to beneficiaries in hospitals and SNFs.

We will finalize our proposals not to add critical care services (as described by HCPCS codes 99291 and 99292) or any of the other requested services to the list of approved Medicare telehealth services.

3. Other Issues

We received other comments on matters related to Medicare telehealth services that were not the subject of proposals in the CY 2010 PFS proposed rule. We thank the commenters for sharing their views and suggestions. Because we did not make any proposals regarding these matters, we do not generally summarize or respond to such comments in this final rule. However, we have chosen to summarize and respond to the following comments in order to furnish more information.

Comment: The American Society of Nephrology requested clarification on whether Medicare would pay for kidney disease patient education furnished via telehealth. Other commenters specifically requested that we add kidney disease patient education services to the list of approved telehealth services.

Response: Kidney disease patient education services are not approved Medicare telehealth services. Any interested parties may submit requests to add services to the list of Medicare telehealth services. Requests submitted before the end of CY 2009 will be considered for the CY 2011 PFS proposed rule. Requestors should be advised that each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requestor wishes us to consider as we review the request. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to directly mail these requests, visit our Web site at http://www.cms.hhs.gov/telehealth.

Comment: We received a few comments that questioned our criteria and process for reviewing requests to add to the list of approved Medicare telehealth services. The commenters stated that our standards interfere with appropriate physician medical judgment under section 1801 of the Act. One commenter noted that since the standards are not specified in regulation text, we can change them without formal rulemaking.

Response: Our established criteria and process for reviewing requests to add to the list of approved Medicare telehealth services were subject to full notice and comment procedures in the CY 2003 PFS proposed and final rules. Since we did not make any proposals relating to the criteria or process, any potential revisions to the process for adding or deleting services from the list of approved Medicare telehealth services are outside the scope of this final rule.

Comment: We received a request to provide a list of physician services that can be furnished without an in-person examination.

Response: General guidance regarding physician services that can be furnished by visualizing some aspect of the patient's condition without an in-person examination is provided in the CMS Internet-Only Medicare Benefits Policy Manual, Pub. 100-02, Chapter 15, § 30.

E. Specific Coding Issues Related to the Physician Fee Schedule

1. Canalith Repositioning

In 2008, the CPT Editorial Panel created a new code for canalith repositioning (CRP). This procedure is a treatment for vertigo which involves therapeutic maneuvering of the patient's body and head in order to use the force of gravity to redeposit the calcium crystal debris in the semicircular canal system.

In the CY 2009 PFS final rule with comment period (73 FR 69896), new CPT code 95992, Canalith repositioning procedure(s) (e.g., Epley maneuver, Semont maneuver), per day, was assigned the bundled status indicator (B). We explained that this procedure previously was billed as part of an evaluation and management (E/M) service or under a number of CPT codes, including CPT code 97112, Therapeutic procedure, one or more areas, each 15 minutes; neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, and/or proprioception for sitting and/or standing activities. We also explained that because neurologists and therapists are the predominant providers of this service to Medicare patients (each at 22 percent), it was assigned as a “sometimes therapy” service under the therapy code abstract file.

After publication of the CY 2009 PFS final rule with comment period, we received comments on this issue from an organization representing physical therapists, as well as others expressing opposition to our decision to bundle the new code. Commenters stated that they believe that our decision to bundle CPT code 95992 was flawed since physical therapists are unable to bill E/M services. One commenter also stated that therapists would be precluded from using another code for billing for this service because CPT correct coding instructions require that the provider/supplier select the procedure that most accurately defines the service provided.

Based upon the commenters' feedback, we realized that we had failed to address how therapists would bill for the service since they cannot bill E/M services. In order to address this situation so that access to this service would not be impacted we released a MedLearn article informing PTs to continue using one of the more generally defined “always therapy” CPT codes (97112) as a temporary measure. See http://www.cms.hhs.gov/transmittals/downloads/R1691CP.pdf and http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6397.pdf.

In response to the concerns raised and upon additional review of this issue in the CY 2010 PFS proposed rule, we proposed to change the status indicator for this code from B (Bundled) to I (Not valid for Medicare purposes). We proposed that physicians would continue to be paid for CRP as a part of an E/M service. Physical therapists would continue to use one of the more generally defined “always therapy” CPT codes (97112). We stated that we believe that this will enable beneficiaries to continue to receive this service while at the same time it will address our concerns about the potential for duplicate billing for this service to the extent that this service is paid as a part of an E/M service. As a result of this proposal, CPT code 95992 would be removed as a “sometimes” therapy code from the therapy code list.

The following is a summary of the comments we received regarding the canalith repositioning proposal.

Comment: Some commenters stated that the canalith repositioning treatment requires 20 minutes of intraservice time as valued by the AMA RUC and that the pre-time was specifically removed because the service is typically performed with an E/M code. The commenters also stated that they believe we expected physicians to forgo payment for CRP and asked that we pay it separately from an E/M service. The commenters requested that CMS recognize the service as separate and distinct from an E/M service.

Response: As we stated in the CY PFS final rule (73 FR 69896) canalith repositioning has been billed using E/M codes and therapy service codes in the past and we believe it should continue to be billed this way. Physicians will continue to be paid for the work performed when CRP is billed using E/M codes.

Comment: Some commenters opposed designating CPT code 95992 as not valid for Medicare purposes. The commenters stated that the code was developed to describe and value CRP and that it should be utilized. Another commenter stated that it is not consistent with CPT coding principles to direct therapists to use a less specific code.

Response: As stated in the CY 2010 PFS proposed rule we initially decided to bundle this code, but upon further review proposed to change the status indicator to “I” (not valid for Medicare purposes). Physicians will continue to be paid for CRP as part of an E/M service. Physical therapists will continue to use an “always therapy” CPT code as they have in the past. The code will be removed from the “sometimes” therapy list. This change will address our concerns about the potential for duplicate billing of this service while still allowing physicians and therapists to perform the service.

Comment: Some commenters are concerned that audiologists have no way to bill for CRP. They requested that CMS reconsider allowing payment to audiologists for this treatment.

Response: Audiological tests are covered under the benefit category for other diagnostic tests. There is no statutory authority to allow audiologists to bill Medicare for treatment services, such as CRP. CRP may be covered under the benefit category for physician services or physical therapy services. If covered as a physician service, it may be furnished incident to a physician's service by any qualified staff.

We will finalize our proposal to designate CPT code 95992 as “I”, not valid for Medicare purposes. We will also remove it from the “sometimes” therapy code list in order to allow therapists to bill appropriately for the service, using one of the more generally defined “always therapy” codes.

2. Payment for an Initial Preventive Physical Examination (IPPE)

In the CY 2010 PFS proposed rule, we proposed to increase the payment for an initial preventive physical examination (IPPE) furnished face-to-face with the patient and billed with HCPCS code G0402, Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment beginning January 1, 2010. The IPPE service includes a broad array of components and focuses on primary care, health promotion, and disease prevention.

Section 101(b) of the MIPPA changed the IPPE benefit by adding to the IPPE visit the measurement of an individual's body mass index and, upon an individual's consent, end-of-life planning. Section 101(b) of the MIPPA also removed the screening electrocardiogram (EKG) as a mandatory service of the IPPE.

In order to implement this MIPPA provision, in the CY 2009 PFS final rule with comment period (73 FR 69870), we created HCPCS code G0402 as a new HCPCS code and retained, on an interim basis, the work RVUs of 1.34 assigned to HCPCS code G0344, the code that was previously used to bill for the IPPE. While we did not believe the revisions to the IPPE required by MIPPA impacted the work RVUs associated with this service, we solicited public comments on this issue, as well as suggested valuations of this service to reflect resources involved in furnishing the service. (For a summary of the comments received on the CY 2009 PFS final rule with comment period, see the CY 2010 PFS proposed rule (74 FR 33549)).

Based on a review of the comments received on the CY 2009 PFS final rule with comment period and upon further evaluation of the component services of the IPPE, we stated in the CY 2010 PFS proposed rule that we believe the services, in the context of work and intensity, contained in HCPCS code G0402 are most equivalent to those services contained in CPT code 99204, Evaluation and management new patient, office or other outpatient visit, and proposed increasing the work RVUs for HCPCS code G0402 to 2.30 effective for services furnished beginning on January 1, 2010.

The following is a summary of the comments we received regarding the proposed increase to the payment for the IPPE billed with HCPCS code G0402.

Comment: All commenters strongly supported CMS' proposal to increase the payment for the IPPE. Commenters believe that the CY 2010 payment will fairly account for the services rendered.

Response: We are finalizing our proposal to increase the work RVUs for the IPPE to 2.30 effective for services furnished beginning January 1, 2010.

3. Audiology Codes: Policy Clarification of Existing CPT Codes

In the CY 2009 PFS final rule with comment period (73 FR 69890), we noted that the AMA RUC reviewed and recommended work RVUs for 6 audiology codes with which we agreed (that is, CPT codes 92620, 92621, 92625, 92626, 92627, and 92640). We also noted that in the Medicare program, audiology services are covered under the diagnostic test benefit and that some of the work descriptors for these services include “counseling,” “potential for remediation,” and “establishment of interventional goals.”

Since audiology services fall under the diagnostic test benefit, aspects of services that are therapeutic or management activities are not payable to audiologists. This distinction is of particular importance since CPT codes 92620, 92621, 92626, 92627, and 92640 are “timed” codes. These codes are billed based on the actual time spent furnishing the service.

We noted that we do not believe these aspects fit within the diagnostic test benefit. We solicited comments on this issue. For a summary of the comments received and our responses to those comments, see the CY 2010 PFS proposed rule (74 FR 33550).

The following is summary of the comments we received regarding the policy clarification of existing CPT codes for audiology services.

Comment: We received additional comments reiterating the comments to which we had responded previously in the proposed rule that “counseling,” “potential for remediation,” and “establishment of interventional goals” were part of the diagnostic test and were not therapeutic or management activities. Other commenters agreed with the clarification as it was presented in the proposed rule.

Response: After a careful consideration of all the comments, we are finalizing the clarification of audiology services with respect to CPT codes 92620, 92621, 92625, 92626, 92627, 92640, and other audiologist services as discussed in the proposed rule. Although we understand that test results are sometimes appropriately and briefly conveyed to the patient at the time of the diagnostic test, any therapeutic activities or activities that should be billed as E/M services associated with these audiology codes are not payable to audiologists because they do not fall within the benefit category under which these tests are covered.

4. Consultation Services

a. Background

The current physician visit and consultation codes were developed by the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel in November 1990. A consultation service is an evaluation and management (E/M) service furnished to evaluate and possibly treat a patient's problem(s). It can involve an opinion, advice, recommendation, suggestion, direction, or counsel from a physician or qualified NPP at the request of another physician or appropriate source. (See the Internet-Only Medicare Claims Processing Manual, Pub. 100-04, chapter 12, § 30.6.10 A for more information.) A consultation service must be documented and a written report given to the requesting professional. Currently, consultation services are predominantly billed by specialty physicians. Primary care physicians infrequently furnish these services.

The required documentation supports the accuracy and medical necessity of a consultation service that is requested and provided. Medicare pays for a consultation service when the request and report are documented as a consultation service, regardless of whether treatment is initiated during the consultation evaluation service. (See the Internet-Only Medicare Claims Processing Manual, Pub. 100-04, chapter 12, § 30.6.10 B.) A consultation request between professionals may be done orally by telephone, face-to-face, or by written prescription brought from one professional to another by the patient. The request must be documented in the medical record.

In the Physician Fee Schedule Final Rule issued June 5, 1991, (56 FR 25828) we stated that the agency's goal for the development of the new visit and consultation codes was that they meet two criteria: (1) They should be used reliably and consistently by all physicians and carriers; that is, the same service should be coded the same way by different physicians; and (2) they should be defined in a way that enables us to properly crosswalk the new codes to the relative values for the Harvard vignettes so valid RVUs for work are assigned to the new codes.

Based on requests from the physician community to clarify our consultation payment policy and to provide consultation examples, we convened an internal workgroup of medical officers within CMS (then called the Health Care Financing Administration, or HCFA) and revised the payment policy instructions in August 1999 in the Medicare Claims Processing Manual (at § 30.6.10 as cited above). We provided examples of consultation services and examples of clinical scenarios that did not satisfy Medicare criteria for consultation services. Without explicit instructions for every possible clinical scenario outlined in national policy instructions or in AMA coding definitions or coding instructions, the local policy interpretations by Medicare contractors were not universally equivalent or acceptable to the physician community and resulted in denials in different localities. Some Medicare contractors would consider a consultation service with treatment to be an initial visit rather than a consultation thus resulting in a denial for the billed consultation. We clarified in the 1999 revision that Medicare would pay for a consultation whether treatment was initiated at the consultation visit or not. The physician community has stated that terms such as referral, transfer and consultation, used interchangeably by physicians in clinical settings, confuse the actual meaning of a consultation service and that interpretation of these words varies greatly among members of that community as some label a transfer as a referral and others label a consultation as a referral. Although we clarified the terms referral and consultation in the 1999 revision, there was disagreement with our policy by physicians in the health care community and by AMA CPT staff. We provided our documentation guidance so physicians would be in compliance with our payment policy. The consultation definition in the AMA CPT simply stated that the consultant's opinion or other information must be communicated to the requesting physician.

Additional manual revisions in both January and September 2001 (at § 30.6.10 as cited above) clarified that NPPs can both request and furnish consultation services within their scope of practice and licensure requirements. We continued to explain our documentation requirements to the physician community through our Medicare contractors and in our discussions with the AMA CPT staff. Under our current policy and in the AMA CPT definition, a consultation service must have a request from another physician or other professional and be followed by a report to the requesting professional. The AMA CPT definition does not state that the request must be written in the requesting physician's medical record. However, we require the request to be documented in the requesting physician's plan of care in the medical record as a condition for Medicare payment. The E/M documentation guidelines which apply to all E/M visits or consultations (http://www.cms.hhs.gov/MLNEdWebGuide/25_EMDOC.asp) clearly state that when referrals are made, consultations are requested, or advice is sought, the medical record should indicate to whom and where the referral or consultation is made or from whom the advice is requested. Our Medicare contractors are responsible for reviewing and paying consultation claims when submitted. When there is a question that triggers a review of a consultation service, our Medicare contractors will look at both the requesting physician's medical record (where the request should be noted) and the consultant's medical record where the consultation is reported and at the report generated for the requesting physician. Medicare contractors do not look for evidence of documentation on every claim, only when there is a concern raised during random sampling or during a specific audit performed by a contractor. The AMA CPT coding manual, which is not a payment manual, does not specify these requirements, and, therefore, as we understand it, many physicians do not agree with the CMS policy.

In March 2006, the Office of the Inspector General (OIG) published a report entitled, “Consultations in Medicare: Coding and Reimbursement” (OEI-09-02-00030). The stated purpose of the report was to assess whether Medicare's payments for consultation services were appropriate. While the OIG study was being conducted, we continued our ongoing discussions with the AMA CPT staff for potential changes to the consultation definition and guidance in CPT. The findings in the OIG report (based on claims paid by Medicare in 2001) indicated that Medicare allowed approximately $1.1 billion more in 2001 than it should have for services that were billed as consultations. Approximately 75 percent of services paid as consultations did not meet all applicable program requirements (per the Medicare instructions) resulting in improper payments. The majority of these errors (47 percent of the claims reviewed) were billed as the wrong type or level of consultation. The second most frequent error was for services that did not meet the definition of a consultation (19 percent of the claims reviewed). The third category of improperly paid claims was a lack of appropriate documentation (9 percent of the claims reviewed). The OIG recommended that CMS, through our Medicare contractors, should educate physicians and other health care practitioners about Medicare criteria and proper billing for all types and levels of consultations with emphasis on the highest levels and follow-up inpatient consultation services.

We agreed with the OIG findings that additional education would help physicians understand the differences in the requirements for a consultation service from those for other E/M services. With each additional revision from 1999 until the OIG study began, we continually educated physicians through the guidance provided by our Medicare contractors. However, there remained discrepancies with unclear and ambiguous terms and instructions in the AMA CPT definition of a consultation, transfer of care and documentation, and the feedback from the physician community that indicated they disagreed with Medicare guidance.

Prior to the official publication of the OIG report, we issued a Medlearn Matters article, effective January 2006, to educate the physician community about requirements and proper billing for all types and levels of consultation services as requested by the OIG in their report. The Medlearn Matters article reflected the manual changes we made in 2006 and the AMA CPT coding changes as noted below. (This article and related documents can be accessed at http://www.cms.hhs.gov/MLNMattersArticles/2005MMA/itemdetail.asp?filterType=nonefilterByDID=-99sortByDID=7sortOrder=ascendingitemID=CMS053630intNumPerPage=2000.)

Our consultation policy revisions continued as a work-in-progress over several years as disagreements were raised by the physician community. We continued to work with AMA CPT coding staff in an attempt to have improved guidance for consultation services in the CPT coding definition. In looking at physician claims data (for example, the low usage of confirmatory consultation services) and in response to concerns from the physician community regarding how to correctly use the follow-up consultation codes, the AMA CPT Editorial Panel chose to delete some of the consultation codes for 2006. The Follow-Up Inpatient Consultation codes (CPT codes 99261 through 99263) and the Confirmatory Consultation codes (CPT codes 99271 through 99275) were deleted. During our ongoing discussions, the AMA CPT staff maintained that physicians did not fully understand the use of these codes and historically submitted them inappropriately for payment as was reflected in the OIG study.

We issued a manual revision in the Medicare Claims Processing Manual (at § 30.6.10 as cited above) simultaneously with the publication of AMA CPT 2006 coding changes removing the follow-up consultation codes, and instructed physicians to use the existing subsequent hospital care code(s) and subsequent nursing facility care codes for visits following a consultation service. The confirmatory consultation codes (which were typically used for second opinions) were also removed and we instructed physicians to use the existing E/M codes for a second opinion service. We further clarified the documentation requirements by making it easier to document a request for a consultation service from another physician and to submit a consultation report to the requesting professional. Again, physicians stated that a consultant has no control over what a requesting or referring physician writes in a medical record, and that they should not be penalized for the behavior of others. However, our consultation policy instructions apply to all physicians, whether they request a consultation or furnish a consultation. As noted above, documentation by both the requesting physician and the physician who furnishes the consultation is required under the E/M documentation guidelines. The E/M documentation guidelines have been in use since 1995. In our discussions with the AMA CPT staff and physician groups, and national physician open door conference calls, we have emphasized that the requesting physician medical record is not reviewed unless there is a specific audit or random sampling performed. The physician furnishing the consultation service should document in the medical record from whom a request is received.

We continue to hear from the AMA and from specific national physician specialty representatives that physicians are dissatisfied with Medicare documentation requirements and guidance that distinguish a consultation service from other E/M services such as transfer of care. CPT has not clarified transfer of care. Many physician groups disagree with our requirements for documentation of transfer of care. Interpretation differs from one physician to another as to whether transfer of care should be reported as an initial E/M service or as a consultation service.

Despite our efforts, the physician community disagrees with Medicare interpretation and guidance for documentation of transfer of care and consultation. The existing consultation coding definition in the AMA CPT definition has been ambiguous and confusing for certain clinical scenarios and without a clear definition of transfer of care. The CPT consultation codes are used by physicians and qualified NPPs to identify their services for Medicare payment. There has been an absence of any guidance in the AMA CPT consultation coding definition that distinguishes a transfer of care service (when a new patient visit is billed) from a consultation service (when a consultation service is billed). Although Medicare has provided guidance, there has continued to be disagreement with our policy from AMA CPT staff and some members of the physician community. Because of the disparity between AMA coding guidance and Medicare policy, some physicians have stated that they have difficulty in choosing the appropriate code to bill. The payment for both inpatient consultation and office/outpatient consultation services is higher than for initial hospital care and new patient office/outpatient visits. However, the associated physician work is clinically similar. Many physicians contend that there is more work involved with a new patient visit than a consultation service because of the post work involvement with a new patient. The payment for a consultation service has been set higher than for initial visits because a written report must be made to the requesting professional. However, all medically necessary Medicare services require documentation in some form in a patient's medical record. Over the past several years, some physicians have asked CMS to recognize the provision of the consultation report via a different form of communication in lieu of a written letter report to the requesting physician so as to lessen any paperwork burden on physicians. We have eased the consultation reporting requirements by lessening the required level of formality and permitting the report to be made in any written form of communication, (including submission of a copy of the evaluation examination taken directly from the medical record and submitted without a letter format) as long as the identity of the physician who furnished the consultation is evident. Although preparation and submission of the consultant's report is no longer the major defining aspect of consultation services, the higher payment has remained. (See the Internet-Only Medicare Claims Processing Manual, Pub. 100-04, chapter 12, § 30.6.10 F.)

Both AMA CPT coding rules and Medicare Part B payment policy have always required that there is only one admitting physician of record for a particular patient in the hospital or nursing facility setting. (AMA CPT 2009, Hospital Inpatient Services, Initial Hospital Care, p.12) This physician has been the only one permitted to bill the initial hospital care codes or initial nursing facility codes. All other physicians must bill either the subsequent hospital care codes, subsequent nursing facility care codes or consultation codes. (See the Internet-Only Medicare Claims Processing Manual, Pub. 100-04, chapter 12, § 30.6.9.1 G.)

Beginning January 1, 2008, we ceased to recognize office/outpatient consultation CPT codes for payment of hospital outpatient visits (72 FR 66790 through 66795). Instead, we instructed hospitals to bill a new or established patient visit CPT code, as appropriate to the particular patient, for all hospital outpatient visits. Regardless of all of our efforts to educate physicians on Medicare guidance for documentation, transfer of care, and consultation policy, disagreement in the physician community prevails.

b. Summary of CY 2010 Proposal

In the CY 2010 PFS proposed rule (74 FR 33551), we proposed, beginning January 1, 2010, to budget neutrally eliminate the use of all consultation codes (inpatient and office/outpatient codes for various places of service except for telehealth consultation G-codes) by increasing the work RVUs for new and established office visits, increasing the work RVUs for initial hospital and initial nursing facility visits, and incorporating the increased use of these visits into our PE and malpractice RVU calculations.

We noted that section 1834(m) of the Act includes “professional consultations” (including the initial inpatient consultation codes “as subsequently modified by the Secretary”) in the definition of telehealth services. We recognize that consultations furnished via telehealth can facilitate the provision of certain services and/or medical expertise that might not otherwise be available to a patient located at an originating site. Therefore, for CY 2010, we proposed to create HCPCS codes specific to the telehealth delivery of initial inpatient consultations. The purpose of these codes would be solely to preserve the ability for practitioners to provide and bill for initial inpatient consultations delivered via telehealth. These codes are intended for use by practitioners when furnishing services that meet Medicare requirements relating to coverage and payment for telehealth services. Practitioners would use these codes to submit claims to their Medicare contractors for payment of initial inpatient consultations provided via telehealth. The proposed HCPCS codes would be limited to the range of services included in the scope of the CPT codes for initial inpatient consultations, and the descriptions would be modified to limit the use of such services for telehealth. The HCPCS codes would clearly designate these as initial inpatient consultations provided via telehealth, and not initial hospital care or initial nursing facility care used for inpatient visits. Utilization of these codes would allow us to provide payment for these services, as well as enable us to monitor whether the codes are used appropriately.

We also stated that, if we create HCPCS G-codes specific to the telehealth delivery of initial inpatient consultations, then we would crosswalk the RVUs for these services from the RVUs for initial hospital care (as described by CPT codes 99221 through 99223). We believed this is appropriate because a physician or practitioner furnishing a telehealth service is paid an amount equal to the amount that would have been paid if the service had been furnished without the use of a telecommunication system. Since physicians and practitioners furnishing initial inpatient consultations in a face-to-face encounter to hospital inpatients must continue to utilize initial hospital care codes (as described by CPT codes 99221 through 99223), we believe it is appropriate to set the RVUs for the proposed inpatient telehealth consultation G-codes at the same level as for the initial hospital care codes.

We considered creating separate G-codes to enable practitioners to bill initial inpatient telehealth consultations when furnished to residents of SNFs and crosswalking the RVUs to initial nursing facility care (as described by CPT codes 99304 through 99306). For the sake of administrative simplicity, if we create HCPCS G-codes specific to the telehealth delivery of initial inpatient consultations, they will be defined in § 410.78 and in our manuals as appropriate for use to deliver care to beneficiaries in hospitals or skilled nursing facilities.

We stated in the CY 2010 PFS proposed rule that if we adopt this proposal, we would then make corresponding changes to our regulations at § 410.78 and § 414.65. In addition, we would add the definition of these codes to the CMS Internet-Only Medicare Benefit Policy Manual, Pub. 100-02, Chapter 15, Medicare Claims Processing Manual, Pub. 100-04, Chapter 12, Section 190.

Outside the context of telehealth services, physicians will bill an initial hospital care or initial nursing facility care code for their first visit during a patient's admission to the hospital or nursing facility in lieu of the consultation codes these physicians may have previously reported. The initial visit in a skilled nursing facility and nursing facility must be furnished by a physician except as otherwise permitted as specified in § 483.40(c)(4). In the nursing facility setting, an NPP who is enrolled in the Medicare program, and who is not employed by the facility, may perform the initial visit when the State law permits this. (See this exception in the Internet-Only Medicare Claims Processing Manual, Pub. 100-04, chapter 12, § 30.6.13 A). An NPP, who is enrolled in the Medicare program, is permitted to report the initial hospital care visit or new patient office visit, as appropriate, under current Medicare policy.

Because of an existing CPT coding rule and current Medicare payment policy regarding the admitting physician, we will create a modifier to identify the admitting physician of record for hospital inpatient and nursing facility admissions. For operational purposes, this modifier will distinguish the admitting physician of record who oversees the patient's care from other physicians who may be furnishing specialty care. The admitting physician of record will be required to append the specific modifier to the initial hospital care or initial nursing facility care code which will identify him or her as the admitting physician of record who is overseeing the patient's care. Subsequent care visits by all physicians and qualified NPPs will be reported as subsequent hospital care codes and subsequent nursing facility care codes.

We believe that the rationale for a differential payment for a consultation service is no longer supported because documentation requirements are now similar across all E/M services. To be consistent with OPPS policy, as noted above, we will pay only new and established office or other clinic visits under the PFS.

We proposed that this change would be implemented in a budget neutral manner, meaning it would not increase or decrease PFS expenditures. We proposed to make this change budget neutral for the work RVUs by increasing the work RVUs for new and established office visits by approximately 6 percent to reflect the elimination of the office consultation codes and the work RVUs for initial hospital and facility visits by approximately 2 percent to reflect the elimination of the facility consultation codes. We crosswalked the utilization for the office consultation codes into the office visits and the utilization of the hospital and facility consultation codes into the initial hospital and facility visits. We proposed that this change would be made budget neutral in the PE and malpractice RVU methodologies through the use of the new work RVUs and the crosswalked utilization.

We solicited comments on the proposal to eliminate payment for all consultation services codes under the PFS and to allow all physicians to bill, in lieu of a consultation service code, an initial hospital care visit or initial nursing facility care visit for their first visit during a patient's admission to the hospital or nursing facility. Additionally, we solicited comments on the proposal to create HCPCS G-codes to identify the telehealth delivery of initial inpatient consultations.

We received many comments on our proposal. MedPAC also commented on our proposal. The following is a summary of the comments we received regarding the discussion of the proposed changes to consultation services and our responses.

Comment: One commenter noted that “there may be both advantages and disadvantages to this proposal,” but urged that we refrain from finalizing it for January 1, 2010. The commenter expressed concerns about whether there would be sufficient time to educate physicians who currently employ the consultation codes in order to avoid “a flood of claim denials and appeals.” Other commenters raised similar concerns about whether there would be adequate time to educate physicians and billing personnel about the change and to assess the effects of the proposal.

Response: We agree that adoption of this proposal would call for appropriate measures to educate physicians and billing personnel about the change. However, we do not believe that the requisite educational efforts are extensive and complex enough as to warrant delaying implementation of the proposal. Essentially, the proposal would require physicians to cease submitting the consultation codes on their Medicare claims, and to employ the appropriate visit codes in their place. The determination of the appropriate visit code would be made solely on the basis of the existing rules and guidelines for the use of these codes, without any reference to the guidelines that have been employed for the use of the consultation codes. The guidelines for use of the visit codes are well established and well known and used by nearly all physicians. It is not necessary to develop any complicated coding crosswalk or guidelines for translating the consultation code requirements for purposes of applying the visit codes. The major effects of the provision may actually simplify coding because physicians will use the office and hospital visit codes in place of consultations and will not have to determine whether the requirements to bill a consult are met. For these reasons, we believe the proposal should be implemented beginning January 1, 2010.

Comment: Some commenters urged delay or deferral of the proposal in order to allow time to determine whether the new CPT definition of “transfer of care” that goes into effect for 2010 would address concerns about the use of consultation codes. Other commenters stated more generally that the proposed change is not the appropriate way to resolve the confusion about using consultation codes versus patient visits.

Response: As we discussed in presenting our proposal, the confusion and disagreement about the proper use of the consultation codes have persisted for a long time. We discussed in detail our efforts over a period of years to clarify the guidelines and to resolve the persistent disagreements. As a result of this experience, we are skeptical that any further changes in guidelines or definitions would resolve these issues. We appreciate the efforts by the CPT committee to develop a new definition of transfer of care. However, we do not believe that this new definition will clarify all the ambiguities and resolve all the differences about the appropriate use of these codes.

As we stated when we implemented the PFS in 1992, one of our goals for the development of new visit and consultation codes was that they should be used reliably and consistently by all physicians and carriers, that is, that the same service should be coded the same way by different physicians. In addition, as we discussed in the CY 2010 PFS proposed rule, we believe that the confusion and disagreement about the use of the consultation codes have produced a situation in which that goal is far from being met.

As we also discussed in the proposed rule, we believe that a good deal of this confusion and disagreement arises from the use of terms such as referral, transfer, and consultation which are used sometimes interchangeably and sometimes inconsistently, by physicians in clinical settings.

The divergent interpretations and uses of these terms have served to confuse the meaning of a consultation service, as some label a transfer as a referral while others label a consultation as a referral. Even with the new definition of “transfer of care,” we foresee many clinical situations in which two physicians may not agree as to whether the referral was for consultation or transfer of care, and it may be difficult to resolve the issue based upon the conflicting interpretations reflected in the two physicians' medical records.

Comment: A number of commenters recommended a delay in order to develop alternative approaches on this issue. The commenters recommended that we revise the consultation codes or provide additional payments to physicians who provide thorough consultation reports to referring physicians.

Response: As we discussed in the proposed rule, we have considered numerous approaches to the issues posed by the use of the consultation codes over a period of years, and we have adopted some measures in an attempt to resolve those issues. We believe that, if there any other realistic and reasonable resolution to the issues surrounding the consultation codes, it would have emerged by now during the discussions that we have recounted above. The specific proposal mentioned by the commenter would have us pay more to physicians that provide thorough consultation reports to the referring physicians. However, we previously have tried to resolve the issues surrounding consultations in part by revising the documentation requirements, with the result that the documentation requirements for consultation codes have been reduced to the point where there is no longer a sufficient difference between the requirements for consultations and those for visits to justify a payment differential. The commenter's idea would have us return to increasing documentation requirements to receive higher payment for providing a thorough consultation report. We believe that any attempt to increase documentation requirements again to justify a payment differential will lead to objections from some physicians, and that it would be very difficult or impossible to define the requirements for a “detailed report” with sufficient precision to justify the provision of an additional payment.

Comment: Other commenters disagreed with our assessment that there is no substantial difference in work between consultations and visits. The commenters observed that consultations necessarily involve more complex cases that the referring physician is unable to treat. Furthermore, the commenters stated that these services require greater cognitive work and more complex medical decision making. Several commenters emphasized that consultation services required greater knowledge and expertise, acquired through additional training and experience, than is required for initial hospital and office visits. The preparation of a written report to the referring physician also requires additional time, regardless of the format in which the report is provided. One commenter expressed disagreement with our statement that “the higher work value for consultations is entirely related to the provision of a written report to the requesting physicians.” However, other commenters agreed with our assessment that there is no substantial difference in work between consultations and visits.

Response: To some degree, greater complexity and cognitive effort may be relative to the training and specialization of the physician. A case that presents clinical complexity and complex medical decision-making for one physician may be relatively simple and straightforward to another physician because of their repeated experience evaluating the same or similar problems. Evaluation and management services, although similar in the types of activities that occur during the encounter, may vary widely in the types of conditions being evaluated. The major difference between the work of a hospital or office visit and a consultation is that the patient has been referred to the consultant to obtain a specialized opinion. However, with the requirements lessened upon the consultant, the actual work done during the encounter with a patient for a consultation or an office or hospital visit has become harder to distinguish in terms of clinical complexity and medical decisionmaking. Further, many physicians contend that a new patient office visit may actually require more work than a consultation service because of the post work involvement with a new patient. As we discussed in the proposed rule, the documentation requirements for consultation services have been reduced to the point where it is difficult to justify a payment differential between consultations and new visits. Therefore, for these reasons, we support the view of those commenters who contend that in most cases, there is no substantial difference in work between consultations and visits.

Comment: Several commenters objected to the proposal on the grounds that it constitutes an unprecedented elimination of a set of CPT codes widely used by large numbers of physicians. Some commenters also stated that the proposal circumvents the CPT and AMA RUC processes.

Response: We do not agree that discontinuing the use of these codes for Medicare purposes is unprecedented. On the contrary, our proposal follows existing program precedent. As we noted in the proposed rule, beginning January 1, 2008, we ceased to recognize office/outpatient consultation CPT codes for payment of hospital outpatient visits (72 FR 66790 through 66795). Instead, we instructed hospitals to bill a new or established patient visit CPT code, as appropriate to the particular patient, for all hospital outpatient visits. We also do not believe that we have in any way circumvented the existing CPT and AMA RUC processes. We described in the CY 2010 PFS proposed rule the numerous attempts that we have made to resolve the relevant issues with AMA CPT staff. Despite all of our efforts to devise and implement relevant guidance, and educate physicians regarding documentation, transfer of care, and consultation policy, there is still substantial disagreement and inconsistency within the physician community regarding these issues.

Comment: Some commenters stated that the overall payment decreases that various specialists would face as a result of the proposed change are unwarranted.

Response: In making the proposal to eliminate use of the consultation codes under the PFS, it has not been our intention to increase or to decrease overall payments for any group or groups of physicians. Rather, our intent has been to provide for correct and consistent coding for services provided by physicians, as well as to provide for appropriate payment for the specific services that have been billed using the consultation codes, specifically, as well as the evaluation and management codes. It is in the nature of any budget neutral payment system for changes such as this to have a somewhat differential impact on various groups of providers and/or practitioners. In this particular case, we do not believe that these impacts are disproportionate to the goals we have sought to achieve in making and finalizing this proposal. It is important to keep in mind that, while elimination of the differential payment for consultation services will have a greater negative impact on some physician specialties than on others, all physicians will benefit from the budget neutral increase in the payment levels for the visit codes.

For more information on the impact of the changes in this rule, see section XIII. of this final rule with comment period.

Comment: Some commenters objected to our failure to increase the bundled payments for post-operative visits occurring over a 10-day or 90-day global period. For example, one major specialty society recommended extending the incremental work RVU increase to the E/M codes that are built into the 10-day and 90-day global codes. “Arbitrarily changing the work RVUs for some E/M codes without adjusting the E/M components of other procedural codes undermines the relative value scale on which physician payment is based.” The commenters otherwise supported the proposal, but strongly recommended that the global codes be increased for the sake of consistency. However, some other commenters who supported the proposal urged us to maintain this position in the final rule on the grounds that these services, by their very nature, were never billed as consultations.

Response: Payment for major surgeries includes bundled payment for the related post-operative visits occurring over a 10-day or 90-day global period. Historically, when payments for new and established office visits were increased after the third Five-Year Review, we also increased the bundled payments for these post-operative visits in the global period. However, we did not propose to increase the payments for the major surgeries to reflect the increase in the visits. We agree with those commenters who contended that consistency requires that we increase the bundled payments for these services proportionately in order to account for the increase in the visits that are incorporated into these bundles. We have accordingly increased the payments for those services in conjunction with finalizing our proposal to eliminate use of the consultation codes in the PFS. However, the increases in the payments for these services due specifically to this change are quite small because visits are a relatively small proportion of the total global payment amount.

Comment: A few commenters objected that we did not make available the crosswalk we used to relate the consultation codes to visit codes for purposes of ensuring BN. Other commenters expressed concerns about the assumptions we used in crosswalking the consultation codes to existing E/M codes. For example, one commenter stated that, for E/M services, a physician must consider three elements (extent of history obtained, extent of examination performed, and complexity of medical decision making) in determining the appropriate code level. However, for subsequent hospital care or hospital outpatient E/M services, only two of these three elements are necessary. In contrast, all three elements must be considered in determining the appropriate coding level for consultation services, both initial and follow-up consultations. There is no established patient visit code or subsequent hospital care code that adequately describes the work of consultation codes (CPT codes 99245 and 99255) when a patient is seen for follow-up consultation. One of these commenters noted that while there are five consultation codes, there are only three initial visit codes, and expressed concern that it would be difficult for physicians to accurately employ the visit codes for the services previously billed under the consultation codes. Another commenter observed that none of the E/M codes reflect the face-to-face times reflected in the highest level consultation codes (for example, 80 minutes for CPT code 99245 and 110 minutes for CPT code 99255). Still other commenters took issue with some elements of the destination mapping in our crosswalk, for example, the assumption that 50 percent of the cases represented as office consultation code (CPT code 99245) would be coded as a new patient office visit code (CPT code 99205), and 50 percent as an established patient office visit code (CPT code 99215).

Response: We made the relevant crosswalk available on our Web site at http://www.cms.hhs.gov/PhysicianFeeSched/PFSFRN/itemdetail.asp?filterType=nonefilterByDID=-99sortByDID=4sortOrder=descendingitemID=CMS1223902intNumPerPage=10.

As we have noted above, we did not develop that crosswalk for purposes of providing any guidelines or principles for using the visit codes in place of the consultation codes that physicians have employed prior to the implementation of this proposal. Rather, the crosswalk was developed solely for purposes of making the requisite BN calculations. For purposes of coding specific cases, adoption of this proposal will essentially require physicians to cease submitting the consultation codes on their Medicare claims, and to employ the appropriate visit codes in their place. The determination of the appropriate visit code should be made solely on the basis of the existing rules and guidelines for the use of the relevant visit codes (for example, office visit or inpatient visit), without any reference to the guidelines that have been employed for the use of the consultation codes. The guidelines for use of the visit codes are well established and well understood. Therefore, we do not believe that it is necessary to provide any coding crosswalk or guidelines for translating the consultation code requirements into the appropriate visit codes. Commenters are correct that while there are five consultation codes, there are only three initial visit codes, that none of the E/M codes reflect the face-to-face times reflected in the highest level consultation codes, and various other differences between the two sets of codes. Nevertheless, it remains possible to determine the appropriate visit code for the services in question by applying the appropriate guidelines and requirements for using those codes. There are, for example, legitimate coding measures to take into account face-to-face times over and above the times specified in the relevant visit codes. Since we ordinarily refrain from providing coding advice in this context, we recommend that physicians, coders, and billing personnel consult the appropriate manuals and coding authorities about how to make the appropriate coding determinations for services previously coded under the consultation codes.

In crosswalking the codes for purposes of making the requisite BN calculations, we employed the same estimating techniques that we normally employ in such calculations. In the absence of concrete data on certain factors in the calculation, we also employed standard assumptions that are appropriate in a system based on averages. For example, office consultation CPT code 99245 was employed to report consultations provided to new or established patients in a physician's office or other ambulatory setting. For purposes of making the BN calculations, it was necessary to apportion the utilization of that code between the separate office visit codes for new patients (CPT code 99205) and established patients (CPT code 99215). In the absence of concrete data on the number of new and established patients reported under CPT 99245, we employed the standard technique of assuming that half the patients were new patients, and half the patients were established patients. Such an assumption minimizes the range of potential error and negative impacts in a system based of averages. Similarly, with respect to the new or established patient initial inpatient consultation codes such as CPT code 99251, it was necessary to apportion the utilization estimates between inpatient visits in a hospital setting and in nursing homes. In this case, we believe that there would be far fewer consultation visits in nursing homes than in the inpatient hospital setting. Therefore, we adopted a standard assumption that 70 percent of the cases would be in inpatient hospitals (CPT initial hospital inpatient visit code 99221) and 30 percent in nursing homes (CPT initial nursing care facility visit code 99304). We employed similar assumptions throughout the crosswalk.

Comment: Several commenters maintained that we had not adequately responded to the OIG report about the use of consultation codes prior to developing this proposal. These commenters noted that the majority of the billing errors detected by the OIG were created by lack of documentation and/or services that did not meet the definition of consultation, and that the OIG recommended education and outreach to physicians to reduce such errors. The commenters recommended that we not proceed with the proposal until we can demonstrate that education and outreach efforts cannot improve the situation.

Response: Prior to the official publication of the OIG report, we issued a Medlearn Matters article, effective January 2006, to educate the physician community about requirements and proper billing for all types and levels of consultation services as requested by the OIG in their report. The Medlearn Matters article reflected the manual changes we made in 2006 and the AMA CPT coding changes as noted below. We have also answered numerous questions and inquiries regarding the use of these codes at open door forums and other settings.

With each additional revision from 1999 until the OIG study began, we made repeated efforts to educate physicians through the guidance provided by, and through, our Medicare contractors. However, there were continued discrepancies with unclear and ambiguous terms and instructions in the AMA CPT consultation coding definition, transfer of care and documentation, and the feedback from the physician community indicated they disagreed with Medicare guidance. Despite our best, these disagreements and misunderstandings among the physician community with Medicare interpretations and guidance relating to documentation of transfer of care and consultation have continued.

Comment: A number of commenters expressed concern about the effects of this proposal on coordination of payment between CMS and other payers. The commenters believe that if other payers continue to recognize consultation codes, the result could be confusion, erroneous billings, and serious delays or even denials of payment.

Response: We do not have the authority to determine which services will be recognized and paid by other third party payers. Some payers may choose to adopt this policy subsequent to this final rule. In cases where other payers do not adopt this policy, physicians and their billing personnel will need to take into consideration that Medicare will no longer recognize consultation codes submitted on bills, whether those bills are for primary or secondary payment. In those cases where Medicare is the primary payer, physicians must submit claims with the appropriate visit code in order to receive payment from Medicare for these services. In these cases, physicians should consult with the secondary payers in order to determine how to bill those services in order to receive secondary payment. In those cases where Medicare is the secondary payer, physicians and billing personnel will first need to determine whether the primary payer continues to recognize the consultation codes. If the primary payer does continue to recognize those codes, the physician will need to decide whether to bill the primary payer using visit codes, which will preserve the possibility of receiving a secondary Medicare payment, or to bill the primary payer with the consultation codes, which will result in a denial of payment for invalid codes.

Comment: One commenter stated that we had not responded to several letters over the last few years requesting clarification of the confusion over consultation and transfer of care, and providing suggested language to clarify the confusion. In addition, the commenter stated that the agency has never responded to a request that the contractors suspend audits of consultation services pending resolution of the confusion.

Response: We have received many similar requests and suggestions regarding the confusion over consultation and transfer of care over many years. We have continuously discussed these issues in the appropriate forums, including proposed and final rules, manual instructions, Medlearn matters articles, and meetings of the AMA CPT Committee. We recounted this extensive history in the proposed rule. As for the status of audits of consultation services, we generally do not discuss the specific audit measures and priorities that we are currently pursuing. In general, the goal of medical review is to identify, through analysis of data and evaluation of other information, program vulnerabilities concerning coverage and coding made by individual providers and to take the necessary action to prevent or address the identified vulnerabilities.

Comment: A few commenters stated that it was inconsistent to continue separate payment for consultation services under the telehealth benefit, but to discontinue them in other contexts in which physician services are provided. Some commenters also stated that discontinuing the consultation codes may be contrary to the statute. Specifically, section 1845(c)(5) of the Act, states:

Coding.—The Secretary shall establish a uniform coding system for the coding of all physician services. The Secretary shall provide for an appropriate coding structure for visits and consultations. The Secretary may incorporate the use of time in the coding for visits and consultations. The Secretary, in establishing such coding system, shall consult with the Physician Payment Review Commission and other organizations representing physicians.

Response: We note that section 1845(c)(5) of the Act calls for the Secretary to provide for “an appropriate coding structure for visits and consultations.” We believe the use of the adjective “appropriate” indicates that the statute is granting the Secretary discretion to determine the structure of coding for these services. For the reasons given above and in our proposed rule, we believe that we are creating an appropriate coding structure for visits and consultations by employing a set of codes that accurately describes, and permits appropriate payment for, those services. We also note that discontinuing the use of the consultation codes does not imply discontinuing payment for consultation services, but only discontinuing the payment differential between consultations and visits. These services will continue to be reported, coded, and paid under the PFS. On the other hand, as we noted previously, section 1834(m) of the Act merely states that the definition of telehealth services includes “professional consultations,” and points to the initial inpatient consultation codes (“as subsequently modified by the Secretary”) as part of the coding structure for such services. We believe it is more consistent with legislative intent, as expressed in this provision, to retain the separate recognition of consultation services in the context of telehealth services. We believe that we have appropriately exercised the Secretary's discretion under section 1845(c)(5) of the Act in eliminating the consultation codes under the PFS, while at the same time respecting the legislative intent underlying section 1834(m) of the Act for separate recognition of consultation services in the context of telehealth.

Comment: MedPAC commented that the proposed change “seems an appropriate policy response” to the relaxation of documentation requirements. However, the Commission noted that:

* * * reduced consultation documentation may not sufficiently meet the needs of the requesting physician, and thus not help achieve the goals and benefits of well-coordinated care. While CMS' proposed payment policy for consultation may be appropriate in the light of current practice, in the future, the agency may wish to consider whether to increase the requirements for consultations in order to better coordinate care and increase consultation payments commensurately.

Other commenters expressed similar concerns that the elimination of the consultation codes might financially discourage coordination of care and communication among physicians.

Response: We appreciate MedPAC's evaluation that our proposal has merit as a response to the reduction in the documentation requirements for consultation services. We also agree with MedPAC that promoting effective coordination of care must be an essential goal of our payment systems. However, we are not aware of any evidence that the reduced consultation documentation requirements are currently failing to sufficiently meet the needs of referring physicians, or that the benefits of effective coordination of care are otherwise not being realized as result of these reduced requirements. If we become aware of such evidence in the future, we would certainly consider whether there is an appropriate policy response to promote more effective coordination of care. It is, however, premature to consider what the appropriate responses might be until and unless specific evidence of an issue comes to our attention. Nevertheless, we will certainly be attentive to any concerns that develop about the effects of this policy on the goal of promoting effective coordination of care.

Comment: Many other commenters supported the proposal. The commenters agreed with us that the documentation requirements are now generally similar among consultation services, office visits, and hospital and facility visits. The commenters also agreed that the proposed change would simplify documentation and resolve the confusion surrounding the billing of consultation codes, “transfer of care,” and other matters.

Response: We appreciate the support of the commenters, and we continue to believe that the approach we proposed is the most appropriate policy response to the confusion, disagreement, and problems that have beset the use of the consultation codes under the PFS. Accordingly, we are adopting our proposal in this final rule.

Specifically, beginning January 1, 2010, we will eliminate the use of all consultation codes (inpatient and office/outpatient codes for various places of service except for telehealth consultation G-codes) on a budget neutral basis by increasing the work RVUs for new and established office visits, increasing the work RVUs for initial hospital and initial nursing facility visits, and incorporating the increased use of these visits into our PE and malpractice RVU calculations.

Since section 1834(m) of the Act includes “professional consultations” (including the initial inpatient consultation codes “as subsequently modified by the Secretary”) in the definition of telehealth services, we will not eliminate the use of these codes in the telehealth context. Therefore, for CY 2010, we will create HCPCS codes specific to the telehealth delivery of initial inpatient consultations. Specifically, we are establishing the following HCPCS codes to describe initial inpatient consultations approved for telehealth:

  • G0425, Initial inpatient telehealth consultation, typically 30 minutes communicating with the patient via telehealth.
  • G0426, Initial inpatient telehealth consultation, typically 50 minutes communicating with the patient via telehealth.
  • G0427, Initial inpatient telehealth consultation, typically 70 minutes or more communicating with the patient via telehealth.

The purpose of these codes is solely to preserve the ability for practitioners to provide and bill for initial inpatient consultations delivered via telehealth. These codes are intended for use by practitioners when furnishing services that meet Medicare requirements relating to coverage and payment for telehealth services. Practitioners will use these codes to submit claims to their Medicare contractors for payment of initial inpatient consultations provided via telehealth. The new HCPCS codes will be limited to the range of services included in the scope of the CPT codes for initial inpatient consultations, and the descriptions will limit the use of such services for telehealth. Utilization of these codes will allow us to provide payment for these services, as well as enable us to monitor whether the codes are used appropriately.

As we also stated in the CY 2010 PFS proposed rule, we will crosswalk the RVUs for these services from the RVUs for initial hospital care (as described by CPT codes 99221 through 99223). We believed this is appropriate because a physician or practitioner furnishing a telehealth service is paid an amount equal to the amount that would have been paid if the service had been furnished without the use of a telecommunication system. Since physicians and practitioners furnishing initial inpatient consultations in a face-to-face encounter to hospital inpatients must continue to utilize initial hospital care codes (as described by CPT codes 99221 through 99223), we believe it is appropriate to set the RVUs for the proposed inpatient telehealth consultation G-codes at the same level as for the initial hospital care codes. As we stated in the CY 2010 PFS proposed rule, we also will make corresponding changes to our regulations at § 410.78 and § 414.65. In addition, we will add the definition of these codes to the CMS Internet-Medicare Claims Processing Manual, Pub. 100-04, Chapter 12, Section 190.

Outside the context of telehealth services, physicians will bill an initial hospital care or initial nursing facility care code for their first visit during a patient's admission to the hospital or nursing facility in lieu of the consultation codes these physicians may have previously reported. The initial visit in a skilled nursing facility and nursing facility must be furnished by a physician except as otherwise permitted as specified in § 483.40(c)(4). In the nursing facility setting, an NPP who is enrolled in the Medicare program, and who is not employed by the facility, may perform the initial visit when the State law permits this. (See this exception in the Internet-Only Medicare Claims Processing Manual, Pub. 100-04, chapter 12, § 30.6.13 A). An NPP, who is enrolled in the Medicare program is permitted to report the initial hospital care visit or new patient office visit, as appropriate, under current Medicare policy. Because of an existing CPT coding rule and current Medicare payment policy regarding the admitting physician, we will create a modifier to identify the admitting physician of record for hospital inpatient and nursing facility admissions. For operational purposes, this modifier will distinguish the admitting physician of record who oversees the patient's care from other physicians who may be furnishing specialty care. The admitting physician of record will be required to append the specific modifier to the initial hospital care or initial nursing facility care code which will identify him or her as the admitting physician of record who is overseeing the patient's care. Subsequent care visits by all physicians and qualified NPPs will be reported as subsequent hospital care codes and subsequent nursing facility care codes.

As proposed, this change will be implemented in a budget neutral manner, meaning that it will not increase or decrease aggregate PFS expenditures. We will make this change budget neutral for the work RVUs by increasing the work RVUs for new and established office visits by approximately 6 percent to reflect the elimination of the office consultation codes and the work RVUs for initial hospital and facility visits by approximately 0.3 percent to reflect the elimination of the facility consultation codes. As discussed above, in this final rule we are also increasing the incremental work RVUs for the E/M codes that are built into the 10-day and 90-day global surgical codes. As we did for the CY 2010 PFS proposed rule, we have crosswalked the utilization for the office consultation codes into the office visits and the utilization of the hospital and facility consultation codes into the initial hospital and facility visits. And, as we proposed, this change will be made budget neutral in the PE and malpractice RVU methodologies through the use of the new work RVUs and the crosswalked utilization.

F. Potentially Misvalued Services Under the Physician Fee Schedule

1. Valuing Services Under the Physician Fee Schedule

As explained in the CY 2010 PFS proposed rule (74 FR 33554), the American Medical Association's (AMA) Relative Value System Update Committee (RUC) provides recommendations to CMS for the valuation of new and revised codes, as well as codes identified as misvalued. On an ongoing basis, the AMA RUC's Practice Expense (PE) Subcommittee reviews direct PE (clinical staff, medical supplies, medical equipment) for individual services and examines the many broad and methodological issues relating to the development of PE relative value units (RVUs).

To address concerns expressed by stakeholders with regard to the process we use to price services paid under the PFS, the AMA RUC created the Five-Year Review Identification Workgroup. As we stated in the CY 2009 PFS proposed rule (73 FR 38582), the workgroup identified some potentially misvalued codes through several vehicles. It focused on codes for which there have been shifts in the site of service (site of service anomalies), codes with a high intra-service work per unit of time (IWPUT), high volume codes, new technology designation, and shifts from practice expense to work. We also identified other methods that the AMA RUC could undertake to assist in identifying potentially misvalued services including reviewing the fastest growing procedures, Harvard-valued codes, and practice expense RVUs. There were 204 potentially misvalued services identified in 2008.

We believe that there are additional steps we can take to address the issue of potentially misvalued services. In the CY 2009 PFS proposed rule, we identified approaches to address this issue including reviewing services often billed together and the possibility of expanding the multiple procedure payment reduction (MPPR) to additional nonsurgical procedures and the update of high cost supplies.

Comment: We received several comments concerning the misvalued code initiative. One commenter, representing a physician specialty organization, expressed concern about the ongoing misuse of intraservice work per unit of time (IWPUT) as a means to determine appropriate work values. The commenter states that IWPUT was never intended to compare intensity or work across specialties and was to be used only as a measure of relativity between codes or in families of codes. Commenters also expressed concern about the need for transparency concerning the development of values for codes, including the review of PE inputs; the need for CMS to consider the underlying reasons why utilization for certain services may increase; and the economic and public health implications of appropriate valuation of services. A commenter also recommended that the agency become more proactive in identifying problematic trends in utilization and in re-evaluating new technology. The commenter recognized that additional resources would be needed and acknowledged that the Congress may need to ensure adequate resources are available but believes that such an investment could result in lower overall costs in the system over the long-term.

Response: We thank the commenters for sharing their concerns and will consider them as we continue examining the valuation of services under the misvalued code initiative.

We also share some the concerns expressed by the commenter with regards to IWPUT, which is a calculation that was used as the primary tool to value physician services for some codes during the third Five-Year Review. This calculation poorly assesses intensity for services that are short in time duration and also services that are short in time duration and of high intensity. The IWPUT has also been used to align procedures within a family of codes. It has value in some instances, such as in validating the RVUs for a given procedure using the building block methodology. However, the IWPUT has not proven to be a valuable tool in evaluating or validating cognitive services. The building block methodology is the accepted methodology used by the AMA RUC and CMS for valuing all physician procedures and services. We believe that the building block methodology should be consistently used when the AMA RUC considers valuation of physician services for its recommendations.

2. High Cost Supplies

In the CY 2010 PFS proposed rule (74 33554), we referenced our CY 2009 PFS proposal concerning updating prices for high cost supplies (73 FR 38582) and (73 FR 69882), and stated that we are continuing to examine alternatives on the best way to obtain accurate pricing information and will propose a revised process in future rulemaking.

The following is a summary of the comments received to date regarding high cost supplies and our response.

Comment: Several commenters expressed support for this initiative. A few commenters were disappointed that we did not propose any new methodologies in the CY 2010 PFS proposed rule.

Commenters were in agreement that we must ensure accurate pricing of supplies, as the cost of supplies plays an important role in the payment calculation for services under the PFS.

Commenters also offered the following suggestions for pricing high cost supplies including:

  • Identify high cost disposable supplies (that is, over $200) with separate HCPCS codes;
  • Use the supply pricing methodology used by the Veterans Administration;
  • Work with specialty societies to obtain invoices for high priced items from a designated group of physicians that are geographically representative; and
  • Work with the industry or physicians directly to get current pricing information.

MedPAC stated it is important for us to update the prices of higher priced supplies on a regular basis as inaccurate prices can distort PE RVUs over time. MedPAC believes that prices drop over time as items diffuse through the market and as other companies begin to produce them, and encouraged us to regularly update information.

A few commenters also recommended that any pricing proposal should be available for public comment through future rulemaking, possibly on an annual basis. This would enable stakeholders to evaluate and provide feedback to the agency on pricing accuracy as well as practical availability of the item itself.

Response: We want to thank the commenters for sharing their suggestions and will take these comments into consideration as we explore the best way to address this issue.

3. Review of Services Often Billed Together and the Possibility of Expanding the Multiple Procedure Payment Reduction (MPPR) to Additional Nonsurgical Procedures

In the CY 2009 PFS final rule with comment period (73 FR 69882), we stated that we planned to perform a data analysis of nonsurgical CPT codes that are often billed together. We stated that we would identify whether there are inequities in PFS payments that are a result of variations between services in the comprehensiveness of the codes used to report the services or in the payment policies applied to each (for example, global surgery and MPPRs). The rationale for the MPPR is that certain clinical labor activities, supplies, and equipment are not performed or furnished twice when multiple procedures are performed. The MPPR currently applies to certain diagnostic and surgical procedures (73 FR 38586). We stated that we would consider developing a proposal either to bundle more services or expand application of the MPPR to additional procedures. Additionally, the Medicare Payment Advisory Committee (MedPAC) requested that we consider duplicative physician work and PE in any expansion of the MPPR.

In the CY 2010 PFS proposed rule (74 FR 33554), we stated that we planned to analyze codes furnished together more than 75 percent of the time, excluding E/M codes. We also stated that we planned to analyze both physician work and PE inputs. If duplications are found, we said that we would consider whether to propose to implement an MPPR or to bundle the services involved. We stated that we would propose any changes through future rulemaking.

Comment: Several commenters did not support the analysis of codes furnished together more than 75 percent of the time. The commenters stated that limiting the review to codes performed together 90 to 95 percent of the time was more appropriate. A few commenters suggested that 75 percent should not be the only criterion we use when considering whether to implement an MPPR or bundle services. Some commenters requested that we postpone our review of services that are often billed together and rely on the work that is being done in this area by the AMA RUC. The commenters believe that the work the AMA RUC is doing will be informative regarding which services should be considered in the future in determining whether to propose to expand the MPPR or to bundle services. The AMA RUC stated that it wants to work with CMS to accurately assess these services.

A few commenters generally supported the analysis of codes furnished together more than 75 percent of the time. One commenter stated that almost all imaging procedures and equipment have become more efficient in recent years allowing more procedures in a given time.

Most commenters were in agreement that this policy should not be expanded until CMS has additional data and there is an opportunity for public comment through future rulemaking.

Response: We appreciate the comments received and will consider these comments as we explore the best way to address this issue. We also look forward to working with the AMA RUC to accurately assess these services.

4. AMA RUC Review of Potentially Misvalued Codes

a. Site of Service

In the CY 2009 PFS final rule with comment period (73 FR 69883), we said that although we would accept the AMA RUC valuation for these site of service anomaly codes for 2009, we indicated that we had concerns about the methodology used by the AMA RUC to review these services because they may have resulted in removal of hospital days and deletion or reallocation of office visits without extraction of the associated RVUs from the valuation of the code. We also stated that we would continue to examine these codes and would consider whether it would be appropriate to propose additional changes in future rulemaking.

In the CY 2010 PFS proposed rule (74 FR 33554), we proposed work RVU changes to several of the codes where the valuation had been adjusted to reflect changes in the site of service but the RVUs had not been extracted by the AMA RUC. The proposed work RVUs were recalculated based upon the AMA RUC-recommended inputs (that is, changes in pre-service and post-service times and associated E/M services). The proposed work RVUs for each CPT code were recalculated using the pre-AMA RUC review work RVUs as a starting point, and adjusted for the addition or extraction of pre-service and post-service times, inpatient hospital days, discharge day management services and outpatient visits as recommended by the AMA RUC.

In addition to the proposed revisions to the AMA RUC-recommended RVUs, we encouraged the AMA RUC to utilize the building block methodology as described in the CY 2007 PFS proposed rule (71 FR 37172) in the future when revaluing codes with site of service anomalies. We recognized that the AMA RUC looks at families of codes and may assign RVUs based on a particular code ranking within the family. However, we stated that we believed that the relative value scale requires each service to be valued based on the resources used in furnishing the service.

We also sought public comment on alternative methodologies that could be used to establish work RVUs for codes that would have a negative valuation under the methodology we utilized to develop proposed revisions to the AMA RUC-recommended values described above.

The following is summary of the comments we received regarding the proposed revisions to the codes with site of service anomalies.

Comment: Some commenters supported CMS' attempt to account for recognized changes in physician work for certain procedures in which the typical site of service has changed. However, other commenters opposed the proposed work RVUs and found the methodology unclear and problematic since some cases resulted in negative work values. Many commenters recommended the acceptance of the AMA RUC recommended values and encouraged CMS to work with them to develop a clearer methodology.

Response: As a result of the comments, we are not finalizing our proposal to change the work RVUs for codes with site of service anomalies that were included in Table 8 of the CY 2010 proposed rule (74 FR 33555). Although we still have concerns about the methodology used by the AMA RUC to review the services, we are accepting the AMA RUC-recommended work RVUs in the interim and request that the AMA RUC utilize the building block methodology to revalue the services listed in Table 4.

TABLE 4—CY 2010 CMS Interim Work RVUs for Site of Service Anomalies Reviewed by the AMA RUC in CY 2009 Back to Top
CPT code1 Descriptor 2009 AMA RUC recommended work RVU CMS decision 2010 CMS interim work RVU2
1All CPT codes copyright 2009 American Medical Association.
22010 CMS Interim Work RVUs may differ from AMA RUC-recommended work RVU due to work increases in 10 and 90 day global codes as a result of the elimination of the consultation codes.
21025 Excision of bone, lower jaw 9.87 Agree 10.03
23415 Release of shoulder ligament 9.07 Agree 9.23
25116 Remove wrist/forearm lesion 7.38 Agree 7.56
42440 Excise submaxillary gland 7.05 Agree 7.13
52341 Cysto w/ureter stricture tx 5.35 Agree 5.35
52342 Cysto w/up stricture tx 5.85 Agree 5.85
52343 Cysto w/renal stricture tx 6.55 Agree 6.55
52344 Cysto/uretero, stricture tx 7.05 Agree 7.05
52345 Cysto/uretero w/up stricture 7.55 Agree 7.55
52346 Cystouretero w/renal strict 8.58 Agree 8.58
52400 Cystouretero w/congen repr 8.66 Agree 8.69
52500 Revision of bladder neck 7.99 Agree 8.14
52640 Relieve bladder contracture 4.73 Agree 4.79
53445 Insert uro/ves nck sphincter 15.21 Agree 15.39
54410 Remove/replace penis prosth 15.00 Agree 15.18
54530 Removal of testis 8.35 Agree 8.46
57287 Revise/remove sling repair 10.97 Agree 11.15
62263 Epidural lysis mult sessions 6.41 Agree 6.54
62350 Implant spinal canal cath 6.00 Agree 6.05
63650 Implant neuroelectrodes 7.15 Agree 7.20
63685 Insrt/redo spine n generator 6.00 Agree 6.05
64708 Revise arm/leg nerve 6.22 Agree 6.36
64831 Repair of digit nerve 9.00 Agree 9.16
65285 Repair of eye wound 14.43 Agree 14.71

b. “23-Hour” Stay

Services that are performed in the hospital outpatient setting and require a stay of less than 24 hours are considered outpatient services. We received recommendations from the AMA RUC for inclusion of inpatient services for services that are typically performed in an outpatient setting.

In the 2010 PFS proposed rule (74 FR 33556), we stated that we believed the use of E/M codes for services rendered in the post-service period for procedures requiring less than a 24-hour hospital stay would result in overpayment for pre- and post-service work that would not be provided. Therefore, we stated that we would not allow an additional E/M service to be billed for care furnished during the post procedure period when care is furnished for an outpatient service requiring less than a 24-hour hospital stay.

The following is summary of the comments we received regarding the proposed revisions to the “23-Hour” stay.

Comment: The majority of commenters disagreed with CMS' proposal because they believed it would result in surgeons not being paid for the work they perform. Commenters urged CMS to engage in a discussion at CPT and/or the AMA RUC regarding alternative E/M coding solutions.

Response: As a result of the comments, we are not finalizing our proposal and will work with CPT and the AMA RUC regarding alternative E/M coding solutions to address our concerns about using inpatient hospital visit codes as a proxy for the work being performed.

c. AMA RUC Review of Potentially Misvalued Codes for CY 2010

We are addressing the AMA RUC's recommendations from the February and April 2009 meetings for potentially misvalued codes in this final rule with comment period in a manner consistent with the way we address other AMA RUC recommendations. Specifically, we completed our own review of the AMA RUC recommendations and we describe the AMA RUC's recommendations, indicate whether or not we accept them, and provide a rationale for our decision in this final rule with comment period. The values for these services are interim values for the next calendar year.

The AMA RUC continued its review of potentially misvalued codes using various screens, including codes with site of anomalies, high IWPUT, high volume, fastest growing procedures, and other CMS requests. For CY 2010, the AMA RUC submitted recommendations for 113 codes. Of those codes 1 was recommended for a reduction in valuation; 7 were recommended for an increase in valuation; 11 were recommended to maintain the same valuation; 45 were referred to CPT for further code clarification, 33 were recommended for PE changes and 16 were recommended for clinical labor revisions.

We have agreed to accept the valuation for these codes for CY 2010 as interim, including the conforming changes to the PE inputs for these codes, as applicable with the exception of CPT 92597, Evaluation for use and/or fitting of voice prosthetic device to supplement oral speech. With the enactment of the MIPPA, speech-language pathologists were able to bill the Medicare program independently as private practitioners effective July 1, 2009. In response, speech-language pathologists requested that the AMA RUC value the work of certain codes. Previously, the work of the speech-language pathologists had been accounted for and paid under the PE component for these codes. CPT code 92597 was evaluated by the AMA RUC, after which the AMA RUC recommended a work RVU of 1.48 based upon a survey that included speech-language pathologists and otolaryngologists, the most frequent providers of the service. The work description for CPT code 92597 includes initial fitting of a prosthesis. The code descriptor for CPT code 31611, Construction of tracheoesophageal fistula and subsequent insertion of an alaryngeal speech prosthesis (eg, voice button, Blom-Singer prosthesis), with a work RVU of 5.92 also includes insertion or fitting of a speech prosthesis. Otolaryngologists perform this service a majority of the time. It appears that both codes include fitting a prosthesis and that there is an overlap of work between CPT codes 92597 and 31611. To account for the overlap of work between these two codes, for CPT code 92597 we have assigned a work RVU value at the 25th percentile, 1.26 work RVUs. We note that the work RVU for CPT code 31611 may not have been reviewed by the RUC since 1995. We invite the RUC to review these two codes and any others for which work may overlap.

We continue to have concerns about the methodology used by the AMA RUC to review services with site of service anomalies. We request that the AMA RUC utilize the building block methodology to revalue these services.

The AMA RUC also recommended that we review claims data for CPT codes 76970, Ultrasound study follow-up (specify), 94450, Breathing response to hypoxia (hypoxia response curve), 94014, Patient-initiated spirometric recording per 30-day period of time; includes reinforced education, transmission of spirometric tracing, data capture, analysis of transmitted data, periodic recalibration and physician review and interpretation, 94015, Patient-initiated spirometric recording per 30-day period of time; recording (includes hook-up, reinforced education, data transmission, data capture, trend analysis, and periodic recalibration) and 94016, Patient-initiated spirometric recording per 30-day period of time; physician review and interpretation only. We will take the AMA RUC's suggestions under consideration and further investigate these claims.

5. PE Issues—Arthoscopy

Previously, the AMA RUC recommended that an arthoscopic procedure (CPT code 29870, Arthroscopy, knee, diagnostic, with or without synovial biopsy (separate procedure)) not be valued in the non-facility setting because they believed the procedure was unsafe to perform outside of the facility setting. In the CY 2008 PFS final rule (72 FR 66238), we deferred proposing non-facility inputs for these types of procedures. We stated that the physicians performing arthroscopic services in the non-facility setting should be given the opportunity to have a multi-specialty review by the AMA RUC.

Comment: We have received many inquiries about why CPT code 29870 was not valued in the non-facility setting. For CY 2010, in response to a request from CMS, the AMA RUC has recommended PE inputs for CPT code 29870.

Response: We accept the AMA RUC's recommended PE inputs for this procedure and are valuing this code in the non-facility setting.

BILLING CODE 4120-01-P

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

BILLING CODE 4120-01-C

6. Establishing Appropriate Relative Values for Physician Fee Schedule Services

In MedPAC's March 2006 Report to Congress, MedPAC made a number of recommendations to improve the review of the relative values for PFS services. Since that time, we have taken significant actions to improve the accuracy of the RVUs. As MedPAC noted in its recent March 2009 Report to Congress, “CMS and the AMA RUC have taken several steps to improve the review process” in the intervening years since those initial recommendations. Many of our efforts to improve the accuracy of RVUs have also resulted in substantial increases in the payments for primary care services.

The original March 2006 recommendation was summarized in the March 2008 Report to Congress:

We also recommended that CMS establish a group of experts, separate from the AMA RUC, to help the agency conduct these and other activities. This recommendation was intended not to supplant the AMA RUC but to augment it. To that end, the panel should include members who do not directly benefit from changes to Medicare's payment rates, such as experts in medical economics and technology diffusion and physicians who are employed by managed care organizations and academic medical centers.

The idea of a group of experts separate from the AMA RUC, to help the agency improve the review of relative values, raises a number of issues. In the proposed rule, we solicited input on specific points concerning the creation of such a group, including:

  • How could input from a group of experts best be incorporated into existing processes of rulemaking and agency receipt of AMA RUC recommendations?
  • What specifically would be the roles of a group of experts (for example, identify potentially misvalued services, provide recommendations on valuation of specified services, review AMA RUC recommendations selected by the Secretary, etc.)?
  • What should be the composition of a group of experts? How could such a group provide expertise on services that clinician group members do not furnish?
  • How would such a group relate to the AMA RUC and existing Secretarial advisory panels such as the Practicing Physician Advisory Committee?

We also requested comments on the resources required to establish and maintain such a group. We stated that we would consider these comments as we consider the establishment of a group of experts to assist us in our ongoing reviews of the PFS RVUs.

Comments: We received comments from many organizations, specialty societies, and groups, including the AMA, the AMA RUC, and MedPAC concerning the creation of a group of experts.

Some commenters expressed support of such a panel. The commenters offered suggestions concerning its establishment and operations. The commenters stated that adequate resources and funding would be needed. The commenters viewed the panel as a vehicle to independently assess the AMA RUC recommendations. Several commenters stressed the importance of including consumers or purchasing representatives on such a panel and that the current process is too narrowly focused on resource costs. Commenters stated there is a need to restructure the payment system so that it appropriately values coordinated care delivery, encourages appropriate use of services, and rewards value and not volume.

Other commenters opposed creation of such a panel. The commenters stated that the current process has been successful, is transparent, and the rulemaking process provides additional oversight of the AMA RUC's recommendations. The commenters also stated that the AMA RUC has the technical knowledge and objective judgment to assist CMS in maintenance of the RVUs and that a superimposed panel would lack its insight. Commenters also stated that the addition of a separate group would increase demands on CMS; create coordination problems; and would be fiscally unsound and imprudent. Commenters noted that CMS and the AMA RUC have made strides in the misvalued codes initiative. Some of the commenters suggested that we consider enhancing the existing refinement panel process used to address the comments received on interim work RVUs (see section III for additional information on this process). Some commenters expressed concern that the refinement panels have not been adequately developed and that there is a lack of transparency.

MedPAC stated there are valid reasons that a panel should be established. It stated that CMS needs a regular source of expertise available to assist in valuing services and that such expertise is not solely the domain of the AMA RUC.

Response: We appreciate all of the comments and suggestions provided regarding the creation of a group of experts. We will take these comments into consideration as we continue to explore this issue.

We also appreciate the comments raised concerning the existing refinement panel process. Any revisions to this process would be discussed in future rulemaking.

G. Issues Related to the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)

This section addresses certain provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). We proposed to revise our policies and regulations as described below in order to conform them to the statutory amendments.

1. Section 102: Elimination of Discriminatory Copayment Rates for Medicare Outpatient Psychiatric Services

Prior to the enactment of the MIPPA, section 1833(c) of the Act provided that for expenses incurred in any calendar year in connection with the treatment of mental, psychoneurotic, and personality disorders of an individual who is not an inpatient of a hospital, only 62½ percent of such expenses are considered to be incurred under Medicare Part B when determining the amount of payment and application of the Part B deductible in any calendar year. This provision is known as the outpatient mental health treatment limitation (the limitation), and has resulted in Medicare paying only 50 percent of the approved amount for outpatient mental health treatment, rather than the 80 percent that is paid for most other outpatient services.

Section 102 of the MIPPA amends the statute to phase out the limitation on recognition of expenses incurred for outpatient mental health treatment, which will result in an increase in the Medicare Part B payment for outpatient mental health services to 80 percent by CY 2014. When this section is fully implemented in 2014, Medicare will pay for outpatient mental health services at the same level as other Part B services. For CY 2010, section 102 of the MIPPA provides that Medicare will recognize 68¾ percent of expenses incurred for outpatient mental health treatment, which translates to a payment of 55 percent of the Medicare-approved amount. Section 102 of the MIPPA specifies that the phase out of the limitation will be implemented as shown in Table 6 provided that the patient has satisfied his or her deductible.

Table 6—Implementation of Section 102 of the MIPPA Back to Top
Calendar year Recognized incurred expenses Patient pays Medicare pays
CY 2009 and prior calendar years 62.50% 50% 50%
CY 2010 and CY 2011 68.75% 45% 55%
CY 2012 75.00% 40% 60%
CY 2013 81.25% 35% 65%
CY 2014 100.00% 20% 80%

At present, § 410.155(c) of the regulations includes examples to illustrate application of the current limitation. We proposed to remove these examples from the regulations and, instead, provided examples in the CY 2010 PFS proposed rule (74 FR 33521), in our manual, and under provider education materials as needed. (See the CY 2010 PFS proposed rule (74 FR 33557) for the examples illustrating the application of the limitation in various circumstances as it is gradually reduced under section 102 of the MIPPA.) Section 102 of the MIPPA did not make any other changes to the outpatient mental health treatment limitation. Therefore, other aspects of the limitation will remain unchanged during the transition period between CYs 2010 and 2014. The limitation will continue to be applied as it has been in accordance with our regulation at § 410.155(b) which specifies that the limitation applies to outpatient treatment of a mental, psychoneurotic, or personality disorder, identified under the International Classification of Diseases (ICD) diagnosis code range 290-319. We use this ICD diagnosis code range, place of service code, and the procedure code to identify services to which the limitation applies.

Additionally, we proposed to make technical corrections to § 410.155(b)(2) in order to update and clarify the services already under these regulations to which the limitation does not apply. We proposed the following technical changes:

  • Under § 410.155(b)(2)(ii), revise the regulation to specify the HCPCS code, M0064 (or any successor code), that represents the statutory exception to the limitation for brief office visits for the sole purpose of monitoring or changing drug prescriptions used in mental health treatment.
  • At § 410.155(b)(2)(iv), we proposed to revise the regulation to add neuropsychological tests and diagnostic psychological tests to the examples of diagnostic services that are not subject to the limitation when performed to establish a diagnosis.
  • Under § 410.155(b)(2)(v), we proposed to revise the regulation to specify the CPT code 90862 (or any successor code) that represents pharmacologic management services to which the limitation does not apply when furnished to treat a patient who is diagnosed with Alzheimer's disease or a related disorder.

Finally, we proposed to add a new paragraph (c) to § 410.155 that provides a basic formula for computing the limitation during the phase-out period from CY 2010 through CY 2013, as well as after the limitation is fully removed from CY 2014 onward.

The following is a summary of the comments we received regarding the proposed implementation of section 102 of the MIPPA.

Comment: All of the comments on section 102 of the MIPPA support the enactment by the Congress and implementation by CMS of this provision that will eventually achieve parity in payment for outpatient mental health services under the Medicare Part B program with the program's payment for other outpatient services. Most of the commenters describe the limitation as discriminatory and inequitable, and believe that it should have been eliminated a long time ago. The majority of the commenters believe that the elimination of the limitation will increase access to outpatient mental health services in the Medicare population. Therefore, elimination of the limitation will have a positive impact on Medicare beneficiaries because they will have to pay less out-of-pocket. Also, commenters believe that physicians and other providers of outpatient mental health care will be “held harmless” with respect to this change because, although they will collect less from the patient, they will ultimately be able to collect from the program the full Medicare approved amount for outpatient mental health services. The commenters that embrace our proposal to implement section 102 of the MIPPA, request that we maintain our proposal in the final rule, and encourage CMS to finalize section 102 of the MIPPA in a timely fashion.

Response: We appreciate the supportive comments received on our proposal to implement section 102 of the MIPPA and the encouragement to finalize our proposal. Also, we are grateful for the offerings made by a few commenters to assist in educating the provider community about section 102 of the MIPPA.

Comment: One commenter opposed two of our technical corrections to current regulations on the limitation at § 410.155(b)(2) and provided suggested changes. Specifically, under § 410.155(b)(2)(iv), we proposed to insert neuropsychological tests along with diagnostic tests that are performed to establish a diagnosis as diagnostic services that are not subject to the limitation. While this commenter has no issue with including neuropsychological tests, the commenter believes that a complete list of services would include outpatient consultation codes, all outpatient new patient and initial visit evaluation and management (E/M) codes, and the psychiatric diagnostic and evaluation interview codes (90801 and 90802). Accordingly, the commenter believes that if we expand the list of identified services not subject to the limitation by inserting neuropsychological tests only, without including the complete listing of services, we could be subjecting services inappropriately to the limitation.

On this particular technical correction, another commenter suggested that we should consider including a definition of “diagnostic services” to provide further guidance to the field on this issue.

The other technical correction that the commenter opposed is the provision under § 410.155(b)(2)(v) that lists medical management services billed under CPT code 90862 (or its successor code), as opposed to psychotherapy, as not being subject to the limitation when furnished to treat a patient who is diagnosed with Alzheimer's disease or a related disorder. The commenter believes that medical management services are not limited to those billed under CPT code 90862, but also includes E/M of a patient with a mental illness using the outpatient E/M codes (CPT codes 99211 through 99215), and in a nursing facility, the subsequent nursing facility care E/M CPT codes (CPT codes 99307 through 99310). Hence, this commenter suggests that the proposed technical correction would unnecessarily and improperly limit the exception to only those instances when CPT code 90862 is billed. This commenter urged that the exception to the limitation for the treatment of a patient who is diagnosed with Alzheimer's disease or a related disorder should continue to include all non-psychotherapy services. Accordingly, this commenter suggested that the current language under regulations should be retained or that new language clarify that any outpatient service including CPT code 90862, E/M codes, and any other non-psychotherapy service provided to a patient with Alzheimer's disease or a related condition is not subject to the limitation.

One commenter who supports our implementation of the MIPPA provision commented that it is appropriate to update the list of services to which the limitation does not apply by specifying HCPCS code M0064, neuropsychological tests and diagnostic psychological tests, as well as CPT code 90862 when reporting services provided to a patient with Alzheimer's disease or a related disorder.

Response: The intent of our technical corrections to § 410.155 was to clarify, not to expand, our current policy. We intended to amend the existing regulations in a way that would update and clarify the already stated policy. Diagnostic psychological and neuropsychological tests are diagnostic services that are excluded from the limitation when performed to establish a diagnosis. The neuropsychological test codes were established years after the CPT codes for diagnostic psychological tests and that is why the reference to neuropsychological tests had not been included under current regulations. Additionally, in the context of psychiatric mental health services, the specific diagnostic services for which we have national policy regarding the limitation are the psychiatric diagnostic services under CPT codes 90801 and 90802, and, the CPT codes for diagnostic psychological and neuropsychological testing. In the absence of national policy concerning application of the limitation to diagnostic services billed under the outpatient consultation codes or the outpatient new patient and initial visit E/M codes, contractors use their discretion in making decisions about whether the limitation should be applied to such services under a variety of circumstances. To list these additional outpatient consultation and E/M codes as suggested by the commenter would represent an expansion of the current regulatory exception at § 410.155(b)(2)(iv).

However, we believe that if we revise the wording under § 410.155(b)(2)(iv) to specify that psychiatric diagnostic services billed under CPT codes 90801 and 90802 (or successor codes) and diagnostic psychological and neuropsychological tests billed under CPT code range 96101 through 96125 (or any successor code range) that are performed to establish a diagnosis are not subject to the limitation, we will address the commenter's concerns. Also, such a change will provide the field with specific guidance on our definition of “diagnostic services” in terms of mental health services.

We agree with the commenter that our technical correction to § 410.155(b)(2)(v) might have been read to restrict application of the exception to CPT code 90862. We will refrain from addressing specifically in the regulation outpatient E/M codes or nursing facility E/M codes. Rather, we will continue to leave in the hands of our contractors decisions as to whether the exception applies for these codes under particular circumstances. We have provided policy guidance to our contractors that medical management services furnished under CPT code 90862 to treat a patient diagnosed with Alzheimer's disease or a related disorder are not subject to the limitation. Therefore, we believe it is consistent with current national policy to amend the regulatory exception under § 410.155(b)(2)(v) to read, “medical management such as that furnished under CPT code 90862 (or its successor code), as opposed to psychotherapy, furnished to a patient diagnosed with Alzheimer's disease or a related disorder.”

We received comments on issues that are outside the scope of our proposals for section 102 of MIPPA. These comments are not addressed in this final rule with comment.

2. Section 131: Physician Payment, Efficiency, and Quality Improvements—Physician Quality Reporting Initiative (PQRI)

a. Program Background and Statutory Authority

The Physician Quality Reporting Initiative (PQRI) is a voluntary reporting program that provides an incentive payment to eligible professionals who satisfactorily report data on quality measures for covered professional services during a specified reporting period. Under section 1848(k)(3)(B) of the Act, the term “eligible professional” means any of the following a: (1) physician; (2) practitioner described in section 1842(b)(18)(C); (3) physical or occupational therapist or a qualified speech-language pathologist; or (4) qualified audiologist. The PQRI was first implemented in 2007 as a result of section 101 of Division B of the Tax Relief and Health Care Act of 2006—the Medicare Improvements and Extension Act of 2006 (Pub. L. 109-432) (MIEA-TRHCA), which was enacted on December 20, 2006. The PQRI was extended and further enhanced as a result of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) (MMSEA), which was enacted on December 29, 2007, and the MIPPA, which was enacted on July 15, 2008. Changes to the PQRI as a result of these laws, as well as information about the PQRI in 2007, 2008, and 2009, are discussed in detail in the CY 2008 PFS proposed rule (72 FR 38196 through 38204), CY 2008 PFS final rule with comment period (72 FR 66336 through 66353), CY 2009 PFS proposed rule (73 FR 38558 through 38575), and CY 2009 PFS final rule with comment period (73 FR 69817 through 69847). In addition, detailed information about the PQRI is available on the CMS Web site at http://www.cms.hhs.gov/PQRI.

We received several comments from the public on the CY 2010 PFS proposed rule related to the PQRI. General comments about the PQRI are addressed immediately below.

Comment: Many commenters supported proposed program changes for 2010, in particular those that make reporting flexible and less burdensome such as changes to the criteria for satisfactory reporting of measures groups (specifically, the removal of the requirement to report on consecutive patients), the proposed electronic health record-based (EHR-based) reporting mechanism, and the group practice reporting option.

Response: We appreciate the commenters' support of the changes proposed for the 2010 PQRI, many of which are finalized herein. We agree with commenters that many of the changes that we are finalizing for the 2010 PQRI, including the ones listed above, provide eligible professionals with greater flexibility and make reporting less burdensome.

Comment: Several commenters suggested that we consider and recommend to the Congress a modified version of the proposed option presented by the Senate Finance Committee in the April 29, 2009, “Description of Policy Options, Transforming the Health Care Delivery System: Proposals to Improve Patient Care and Reduce Health Care Costs” to add a new participation option allowing eligible professionals to receive PQRI incentive payments for 3 successive years if, on a triennial (every 3 year) basis, the eligible professional: (1) participates in a qualified American Board of Medical Specialties (ABMS) certification known as the Maintenance of Certification (MOC), or equivalent programs; and (2) completes a qualified MOC practice assessment. Such practice assessments typically consist of the use of performance measures to evaluate practice activities, which includes documentation of evidence of practice changes to improve quality, and re-evaluation to determine the effect of a change in the practice process or structure of care.

Response: Section 1848(m)(1) of the Act specifies the PQRI incentive amount for each program year and how the incentive payment amount is to be calculated for each reporting period during the program year. We do not have the authority to change how the incentive payment amount is determined and, therefore, cannot continue payments beyond the authorized program year.

With respect to the commenters' suggestion to provide PQRI incentive payments to eligible professionals who participate in an ABMS MOC program and complete a qualified MOC practice assessment, section 1848(m)(3)(A) of the Act dictates the criteria that eligible professionals must meet in order to be treated as satisfactorily submitting data on quality measures. These criteria include the reporting, by eligible professionals, of quality data on a standardized set of national consensus-based measures. For years after 2009, section 1848(m)(3)(D) of the Act gives us the discretion to revise the criteria for satisfactorily submitting data on quality measures. The proposed criteria for 2010, which did not explicitly include the option suggested by the commenters, were discussed in the CY 2010 PFS proposed rule (74 FR 33565 through 33569). We believe that basing criteria for satisfactory reporting solely on participation in an ABMS MOC and completion of a qualified MOC practice assessment without the submission of PQRI measures results would defeat the ability of CMS to analyze and compare eligible professional performance based on a standardized set of measures. PQRI is not based upon such qualifications, but rather on the submission of data on quality measures to measure eligible professional performance.

However, to the extent that ABMS member certification boards collect information on PQRI quality measures from eligible professionals, the ABMS member boards may qualify as registries under the PQRI and report such information to CMS on behalf of eligible professionals. Currently, one of the ABMS member boards has qualified as a CMS PQRI registry and successfully submitted data on PQRI measures on behalf of eligible professionals. This would allow eligible professionals to concurrently participate in an ABMS MOC and PQRI.

Comment: Several commenters suggested that we expand our education and outreach efforts so that professionals can gain a better understanding of the program, coding, and how to participate satisfactorily. Specifically, commenters suggested that we:

  • Publish a list of professions that have participated in PQRI.
  • Communicate potential incentive amounts that could be earned by an individual participant.
  • Work with the AMA and other national stakeholder organizations to increase education and outreach for professionals about the requirements for satisfactorily reporting under various options.
  • Use provider-neutral language, such as “clinician” or “provider” in describing the array of eligible professionals.

Response: We value the input received from stakeholders and participants who have provided constructive feedback and have collaborated with us to disseminate educational PQRI materials to eligible professionals in the health care community. We will continue to work with national and regional stakeholder organizations to educate their members on program requirements for satisfactory reporting.

We also plan to continue to host monthly national provider calls in which we expect to provide guidance on specific topics, including having our PQRI subject matter experts available to answer questions on the PQRI. Information about upcoming calls can be obtained from the CMS Sponsored Calls page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/04_CMSSponsoredCalls.asp#TopOfPage. We will continue to make PQRI educational materials and other resources available on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI as well. Updated educational materials and resources for the 2010 PQRI will be made available as soon as possible following publication of this final rule with comment period. Where appropriate, we will consistently use inclusive terminology such as “eligible professionals” rather than “physicians” in PQRI educational resources and related documents. We encourage eligible professionals to visit this Web site and to review the frequently asked questions (FAQs) found on this Web site. Eligible professionals are also encouraged to join the physician listserv to obtain periodic updates about the PQRI. Instructions for joining the listserv can be found at https://list.nih.gov/archives/physicians-1.html.

Finally, we anticipate conducting and publishing an evaluation of the 2008 PQRI similar to the “PQRI 2007 Reporting Experience” posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/Downloads/PQRI2007ReportFinal12032008CSG.pdf. Although we have not yet finalized the operational details of our evaluation strategy, we expect the report to include participation rates by specialty/profession, associated trends in clinical performance and beneficiary outcomes, and other observable impacts on participants, the Medicare program, and beneficiaries.

Comment: Several commenters requested that we provide more detailed educational resources well in advance of the 2010 PQRI start date and provide enough lead time so that electronic systems may be updated to allow data capture for new or revised 2010 PQRI measures.

Response: We agree with the commenters that it is desirable to provide final measure specifications and other educational resources sufficiently in advance of the start of a new program year to allow reasonable time for professionals to analyze new or revised reporting options and measures, and implement any needed changes in their office workflows so that they may accurately capture and satisfactorily submit data on a selection of measures applicable to their practice. We are aware that such lead time would also help the eligible professionals' specialty or professional societies to prepare to support the professionals' selection of relevant measures. Having detailed information on measures available in advance also enhances the ability of vendors (such as practice-management software, billing services, and electronic health record vendors) to support professionals' successful implementation of revised data capture processes for the measures. We are targeting finalization and publication of the detailed specifications for all 2010 PQRI measures on the CMS Web site, by November 15, 2009, but no later than December 31, 2009. The detailed specifications include instructions for reporting and identifying the circumstances in which each measure is applicable. The specifications for measures in the final listing for the 2010 PQRI, including a measure's title, remain potentially subject to corrections until the start of the 2010 reporting period. We are also committed to making other educational resources for the 2010 PQRI available on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI as quickly as possible after publication of this final rule with comment period.

As discussed below, to assist eligible professionals who may need additional time to make updates to their electronic systems or practice workflows, we also are finalizing a 6-month reporting period beginning July 1, 2010, for claims-based reporting of individual measures. Thus, the 6-month reporting period will be available for both those who wish to report individual measures, as well as measures groups through claims or a qualified registry.

Comment: Some commenters requested that we provide detailed data used to determine that a professional failed to report on 80 percent of eligible cases and to inform them about what they need to do to rectify errors.

Response: We considered recommendations about PQRI participant feedback reports as part of an ongoing dialogue with the stakeholder and participant community. We convened a multi-specialty focus group and have revised the design and content of the 2008 PQRI feedback reports, which were recently released. These revised feedback reports include more detailed information at the individual eligible professional level than was provided in the 2007 PQRI feedback reports.

Comment: Several commenters stated that the 2007 feedback reports were too difficult to obtain, did not provide sufficient detailed information to allow correction, and were not available on an interim basis to prevent eligible professionals from making the same errors in the following program year.

Response: To address concerns expressed about our secure method used to obtain the feedback reports (which requires eligible professionals to register and obtain an Individuals Authorized Access to CMS Computer Services, or IACS, account), we identified an alternative feedback report request process for individual eligible professionals requesting NPI level reports, which allows an individual participant to obtain his or her own feedback report through their carrier or MAC after providing appropriate identification. Information about this new process is available on the PQRI section of the CMS Web site and was discussed on the October 15, 2009, PQRI national provider call.

We have assessed the feasibility of providing some type of interim feedback report to participants. We have determined, however, detailed, accurate, participant-level interim feedback reports cannot be provided in an appropriately secure access environment. However, given that the most prevalent underlying reasons for failure to meet incentive eligibility are due to (1) failure by the professional to identify and report on at least 80 percent of denominator-eligible cases for the measures selected, and (2) quality data code errors due to incorrect or insufficient coding, we have determined that an aggregate-level quality data submission error report could be published on a quarterly basis on the PQRI section of the CMS Web site, to provide information on the types of submission errors found for each measure. Following the posting of the “PQRI 2007 Reporting Experience” report, we have continued to post updated error reports on a quarterly basis on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI.

Comment: Several commenters who participated in the 2008 PQRI have commented on the lack of timely feedback reports and incentive payments.

Response: For claims-based reporting, PQRI analysis of individual professionals' claims begins after the conclusion of the program year when all claims have been processed. Conducting individual-level analysis on a portion of a professional's claims during the program year would result in inaccurate data and presents a significant expense to CMS. We acknowledge participating professionals' need for interim information on the accuracy of their quality reporting through claims. Therefore, we have posted aggregate-level information on the PQRI section of the CMS Web site on a quarterly basis describing quality-data code submission errors that we observe on claims for each PQRI measure and anticipate continuing to do so in the future.

In addition, many registries provide interim feedback to their clients. Therefore, eligible professionals who participate in PQRI through a qualified registry may be able to receive interim feedback from the registry and have the opportunity to correct those errors prior to the program year data submission deadline.

Comment: Several commenters requested that we establish a formal appeals process for those professionals who participate in PQRI but do not qualify for the incentive payment.

Response: Section 1848(m)(5)(e) of the Act provides that with respect to the PQRI there shall be no administrative or judicial review under section 1869, section 1879, or otherwise of (1) The determination of measures applicable to services furnished by eligible professionals; (2) the determination of satisfactory reporting; and (3) the determination of any incentive payment. Since 2007, we have addressed inquiries about the PQRI through the question-and-answer sessions held during monthly PQRI national provider calls and open door forums. More recently, a dedicated Help Desk has been implemented to respond to participants' inquiries related to all aspects of the PQRI, including assisting eligible professionals in understanding why they did not receive a PQRI incentive payment. The Help Desk is available from 7 a.m. to 7 p.m. CT and can be reached by phone at (866) 288-8912 or via e-mail at qnetsupport@sdps.org.

Comment: Several commenters expressed the need to evaluate the impact of PQRI and make evaluation results available to stakeholders. Some commenters stated that an evaluation of outcomes achieved is needed before deciding whether to expand the program, impose penalties, or make participation mandatory. One commenter noted that such an evaluation is needed to restore confidence in the PQRI since the program's validity within the eligible professional community has been compromised due to the PQRI being rushed. Other commenters urged us to provide medical specialty organizations with the PQRI data files so that they may perform an independent analysis to assist CMS to improve the clinical appropriateness of physician quality measures and better understand or correct potential barriers to satisfactory reporting.

Response: We have conducted and published an evaluation of the 2007 PQRI and have posted the “PQRI 2007 Reporting Experience” on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/Downloads/PQRI2007ReportFinal12032008CSG.pdf. We anticipate conducting a similar evaluation of the 2008 PQRI and expect to include participation rates by specialty/profession, associated trends in clinical performance and beneficiary outcomes, and other observable impacts on participants, the Medicare program, and beneficiaries. Although we have not yet finalized the operational details of our evaluation strategy for the 2008 PQRI and beyond, we do anticipate making the results of the evaluation, at the national level, available to the public. We also may make publicly available the results of such analyses aggregated at other meaningful levels (for example, State, specialty, or profession). We do not at this time plan to make results publicly available in a format or with content that would enable identification of individual professionals or specific practices' reporting or performance results.

Comment: Several commenters urged CMS to expand PQRI in a manner that would allow participation by therapy professionals who practice in institutional settings such as hospitals, rehabilitation facilities, and skilled nursing facilities and submit their individual National Provider Identifier (NPI) either through claims or through registry-based reporting.

Response: As we stated in the CY 2008 PFS final rule with comment period (74 FR 69820 through 69821), we agree with the goal of offering the opportunity to participate in PQRI to as many eligible professionals as feasible and practical, consistent with the statutory requirements. Except for group practices participating in the group practice reporting option, which begins in 2010, the determination of satisfactory reporting and the calculation of any earned incentive payment amount must be determined at the individual professional level, regardless of the method of reporting quality data. For therapy professionals who practice in institutional settings, we cannot make the determination of satisfactory reporting and calculate earned incentive payment amounts at the individual eligible professional level without extensive modifications to the claims processing systems of CMS and providers, which would represent a material administrative burden to us and to providers. It would also require modifications to the industry standard claims formats, which would require substantial time to effect through established processes and structures that we do not maintain or control. We have also found that most institutions that employ therapists do not tie the individual therapist to the service rendered to an individual patient. Instead, therapists are hired for a fixed number of hours per day per week. In this case, there are no provider identifiers available to use in processing these claims.

Comment: Several commenters indicated that we should convert PQRI from a pay-for-reporting program to a pay-for performance program, stating that reporting on quality measures is not sufficient and that consumers need performance data for informed choice based on quality and value.

Response: Our plans for a report to Congress on transitioning to a physician value-based purchasing program are discussed in section II.G.4. of this final rule with comment period.

Comment: Some commenters expressed concern that the impact analysis of the estimated costs for participation by professionals for claims-based, registry-based, and EHR-based reporting contained in the CY 2010 PFS proposed rule (74 FR 33664 through 33665) are too low or inaccurate and should be rectified in the final rule. One commenter noted that one estimate of the cost for a practice to participate in PQRI ranges from $55,000 to $1.3 million. Other commenters cited an example from a practice with 1 full-time eligible professional and 1 part-time eligible professional where it was determined that the cost for claims-based reporting in PQRI was $1,780 per year, or $1,186 per eligible professional. Some commenters suggested that we conduct a survey of successful PQRI participants and/or data submission vendors to determine all participation costs and publish survey results in future rules.

Response: As stated in the CY 2010 PFS proposed rule (74 FR 33664), individual eligible professionals and group practices may have different processes for integrating the PQRI into their practices' work flows. Therefore, it is difficult for us to accurately quantify the cost burden because it would vary with each eligible professional by the number of measures applicable to the eligible professional, the number of measures on which an eligible professional chooses to report, the complexity of the measure(s) chosen by the eligible professional, the eligible professional's patient population and how frequently the professional's selected measure(s) apply to the professional's patient population, the eligible professional's familiarity, understanding, and experience with the PQRI, and the reporting option selected by the eligible professional. To be able to provide any cost estimates we had to use certain assumptions with respect to the number of measures reported on and the number of reporting instances per eligible professional. Given that practices vary in size and patient population, these assumptions will not hold true for every practice participating in PQRI and some practices' costs associated with PQRI participation will exceed the estimates provided in our cost estimates while other practices will have costs below our estimates. We cannot assess the examples offered by commenters without additional information on the number of measures reported by each eligible professional in the practice and the number of reporting instances per eligible professional. We will consider, however, the commenters' suggestions for future years but believe that it would be unlikely that we would be able to obtain a representative sample of survey respondents given the many variables that impact participation costs.

Comment: A specific concern cited by commenters with respect to the impact analysis was that reliance on historical data from the Physician Voluntary Reporting Program (PVRP) is inappropriate and does not take into consideration the development and maintenance of new workflows necessary to participate in PQRI and the new measure, measure specification changes and reporting option changes that occur on an annual basis.

Response: Information from the PVRP was used solely for developing cost estimates for participation in PQRI through the claims-based reporting mechanism; not through other reporting mechanisms. To develop our cost estimates for claims-based reporting, we applied information from PVRP on how much time it takes one eligible professional, in a median practice, to report one measure one time through claims to our assumptions. We recognize that the PVRP cost estimates are historical, but we do not believe that the process for reporting measures through claims has changed significantly from PVRP to PQRI in a way to considerably change the amount of time it takes one eligible professional to report one measure one time through claims. However, for our impact analysis, we did use a higher average practice labor cost than what was indicated in the information from the PVRP (that is, we used $55 per hour instead of $50 per hour) to account for increases in labor costs over time (74 FR 33655).

Comment: Other commenters had specific concerns about the estimates provided for participation in PQRI via registries. Some commenters offered anecdotal information that the annual cost to one practice of participating in a specific registry is approximately $3,000. Another commenter believed that more than 5 minutes is needed for an eligible professional to authorize a registry to submit quality measure results and numerator and denominator data on their behalf. Other commenters were concerned that our estimate of $1,500 to $5,000 to purchase an EHR product was too low. One commenter noted that EHR systems have capital costs of over $1 million per year. Another commenter noted that researchers recently found that it would cost about $124,000 for a single doctor or small practice to upgrade to EHRs over 5 years.

Response: We appreciate the input from commenters and have taken the additional information provided by commenters into consideration to revise the estimates associated with registry and EHR reporting where appropriate in sections XIII.E.2 and XI. of this final rule with comment period.

For registry reporting, however, we note that many registries offer additional services beyond what is required to participate in PQRI. In the example provided by commenters, it is not clear whether those costs that are not related to reporting PQRI quality measure results and numerator and denominator data on PQRI measures have been taken into consideration and excluded. Our impact analysis is limited to the incremental cost of participating in PQRI.

b. Incentive Payments for the 2010 PQRI

For 2010, section 1848(m)(1)(B) of the Act authorizes the Secretary to provide an incentive payment equal to 2.0 percent of the estimated total Medicare Part B PFS allowed charges (based on claims submitted not later than 2 months after the end of the reporting period) for all covered professional services furnished during the reporting period for 2010. Although PQRI incentive payments are only authorized through 2010 under section 1848(m)(1)(A) of the Act, section 1848(k)(2)(C) of the Act provides for the use of consensus-based quality measures for the PQRI for 2010 and subsequent years.

The PQRI incentive payment amount is calculated using estimated Medicare Part B PFS allowed charges for all covered professional services, not just those charges associated with the reported quality measures. “Allowed charges” refers to total charges, including the beneficiary deductible and coinsurance, and is not limited to the 80 percent paid by Medicare or the portion covered by Medicare where Medicare is secondary payer. Amounts billed above the PFS amounts for assigned and non-assigned claims will not be included in the calculation of the incentive payment amount. In addition, since, by definition under section 1848(k)(3)(A) of the Act, “covered professional services” are limited to services for which payment is made under, or is based on, the PFS and which are furnished by an eligible professional, other Part B services and items that may be billed by eligible professionals but are not paid under or based upon the Medicare Part B PFS are not included in the calculation of the incentive payment amount.

Under section 1848(m)(6)(C) of the Act, the “reporting period” for the 2008 through 2011 PQRI is defined to be the entire year, but the Secretary is authorized to revise the reporting period for years after 2009 if the Secretary determines such “revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden.”

We are also required by section 1848(m)(5)(F) of the Act to establish alternative criteria for satisfactorily reporting and alternative reporting periods for registry-based reporting and for reporting measures groups. Therefore, eligible professionals who meet the alternative criteria for satisfactorily reporting for registry-based reporting and for reporting measures groups for the 2010 alternative reporting periods for registry-based reporting and for reporting measures groups will also be eligible to earn an incentive payment equal to 2.0 percent of the estimated total Medicare Part B PFS allowed charges for all covered professional services furnished by the eligible professional during the alternative reporting periods for 2010 PQRI registry-based reporting or for reporting measures groups.

Prior to 2010, the PQRI was an incentive program in which determination of whether an eligible professional satisfactorily reported quality data was made only at the individual professional level, based on the NPI. Although the incentive payments were made to the practice(s) represented by the Tax Identification Number (TIN) to which payments are made for the individual professional's services, there were no incentive payments made to the group practice based on a determination that the group practice, as a whole, satisfactorily reported PQRI quality measures data. To the extent individuals (based on the individuals' NPIs) satisfactorily reported data on PQRI quality measures that were associated with more than one practice or TIN, the determination of whether an eligible professional satisfactorily reported PQRI quality measures data was made for each unique TIN/NPI combination. Therefore, the incentive payment amount was calculated for each unique TIN/NPI combination and payment was made to the holder of the applicable TIN.

However, section 1848(m)(3)(C)(i) of the Act requires that by January 1, 2010, the Secretary establish and have in place a process under which eligible professionals in a group practice (as defined by the Secretary) shall be treated as satisfactorily submitting data on quality measures for the PQRI for covered professional services for a reporting period, if, in lieu of reporting measures under subsection (k)(2)(C), the group practice reports measures determined appropriate by the Secretary, such as measures that target high-cost chronic conditions and preventive care, in a form and manner, and at a time, specified by the Secretary. Therefore, beginning with the 2010 PQRI, group practices that satisfactorily submit data on quality measures also would be eligible to earn an incentive payment equal to 2.0 percent of the estimated total Medicare Part B PFS allowed charges for all covered professional services furnished by the group practice during the applicable reporting period. As required by section 1848(m)(3)(C)(iii) of the Act, payments to a group practice by reason of the process described above would be in lieu of the PQRI incentive payments that would otherwise be made to eligible professionals in the group practice for satisfactorily submitting data on quality measures. Therefore, an individual eligible professional who is participating in the group practice reporting option as a member of a group practice would not be able to separately earn a PQRI incentive payment as an individual eligible professional under that same TIN (that is, for the same TIN/NPI combination).

The following is summary of the comments we received regarding the 2010 PQRI incentive payment amount.

Comment: One commenter expressed support of the proposed extension of the PQRI incentive related to the group practice reporting option.

Response: We appreciate the commenter's support of the extension of the PQRI incentive to group practices.

Commenter: One commenter expressed a concern that the PQRI incentive payment is calculated as a percentage of the total Medicare billing of the individual eligible professional. The commenter expressed concern that for an equal amount of relative value unit work, eligible professionals in lower GPCI localities will receive as much as 38 percent less PQRI payment for the same work, time, and effort used in providing quality care than eligible professionals in higher GPCI localities. The commenter suggested that PQRI incentive payment calculations should not be geographically adjusted and recommended that we change the basis of the incentive to RVUs rather than dollars billed to Medicare.

Response: While we acknowledge the effect of the GPCI on the calculation of the PQRI incentive amount, we do not have authority to change the basis for the calculation of the incentive amount, which is defined by section 1848(m)(1) of the Act.

Comment: A commenter requested clarification on whether radiopharmaceuticals are included in the PQRI and electronic prescribing incentive payments (see section II.G.5. of this final rule with comment period for further discussion of the E-Prescribing Incentive Program).

Response: Medicare Part B PFS allowed charges for radiopharmaceuticals have been included for determining the PQRI and electronic prescribing incentive payments. Radiopharmaceuticals are included as part of section 1861(s)(4) of the Act, which is incorporated into the list of PFS services cited in section 1848(j)(3) of the Act, and therefore, are part of the PQRI and electronic prescribing incentive calculations.

The relevant radiopharmaceutical codes are paid on the basis of invoices submitted by physicians. Such invoices are considered similar to contractor priced items or services. In addition, radiopharmaceuticals are classified as A codes (A9500-A9699) which inadvertently have not previously been included in Addendum B. Commencing with CY 2010, radiopharmaceuticals will be included in Addendum B as MPFSDB covered charges.

Furthermore, FAQ 8545, which can be accessed via the PQRI section of the CMS Web site, states that for “PQRI participants who report satisfactorily, radiopharmaceuticals furnished as part of a covered professional service will be included in the basis of total Medicare Part B PFS allowed charges on which the incentive is calculated.”

No changes in radiopharmaceutical payment will be necessary. Payment will continue to be contractor-priced on the basis of invoices under the physician fee schedule.

c. 2010Reporting Periods for Individual Eligible Professionals

As we indicated above, section 1848(m)(6)(C) of the Act defines “reporting period” for 2010 to be the entire year. Section 1848(m)(6)(C)(ii) of the Act, however, authorizes the Secretary to revise the reporting period for years after 2009, if the Secretary determines such revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden. In addition, section 1848(m)(5)(F) of the Act requires, for 2008 and subsequent years, the Secretary to establish alternative reporting periods for reporting groups of measures and for registry-based reporting.

In the CY 2010 PFS proposed rule (74 FR 33560), we proposed that the 2010 PQRI reporting period for the reporting of individual PQRI quality measures through claims or a qualified EHR would be the entire year (that is, January 1, 2010 through December 31, 2010). We also proposed to retain the 2 alternative reporting periods from the 2008 and 2009 PQRI for reporting measures groups and for registry-based reporting: (1) the entire year; and (2) a 6-month reporting period beginning July 1.

We solicited comments on these proposals and the decision not to propose a 6-month reporting period for claims-based reporting of individual PQRI quality measures. The following is a summary of the comments received regarding the proposed reporting periods.

Comment: Although a majority of the commenters supported the proposed reporting periods, we received several comments requesting that CMS retain or add a 6-month reporting period for claims-based reporting of individual measures. Many commenters requested this additional reporting period because they believe that doing so would encourage PQRI participation by allowing more time for eligible professionals to implement PQRI into their practice workflows and providing an opportunity for those who are hesitant to continue participating in PQRI until they receive feedback from the previous year to do so as well. Many commenters noted that reporting measures groups or reporting through a registry is not an option for them. Other commenters suggested that we maintain the 6-month reporting period for claims-based reporting of individual measures to maintain flexibility and uniformity in reporting periods for all PQRI reporting options to reduce confusion since many eligible professionals already believe that they can start claims-based reporting of individual measures in July.

Some commenters also requested that we have a 6-month reporting period for claims-based reporting of individual measures for situations in which an eligible professional who was planning to report through an alternative reporting mechanism may have to revert to claims-based reporting during the year, such as when an eligible professional's EHR system requires re-installation or significant maintenance or upgrades or when it takes longer for a practice to acquire a new EHR system than anticipated.

Response: Although many commenters requested that we “retain” the 6-month reporting period for claims-based reporting of individual measures, we would like to clarify there was no 6-month reporting period for claims-based reporting of individual quality measures available for either the 2008 or 2009 PQRI. In the 2008 and 2009 PQRI, the 6-month reporting period beginning July 1 was only available to eligible professionals who chose to report on measures groups or chose registry-based reporting (of either individual measures or measures groups). Prior to 2010 we did not have the authority to change the reporting period for claims-based reporting of individual measures, which is defined by section 1848(m)(6)(C)(i)(II) of the Act to be the entire year for 2008, 2009, 2010, and 2011. The only program year in which the reporting period was defined by statute to be the 6-month period beginning July 1 was the 2007 PQRI.

However, as a result of the compelling arguments presented by commenters, we will exercise our authority under section 1848(m)(6)(C)(ii) of the Act to revise the reporting period for the 2010 PQRI. Thus, in addition to the 12-month reporting period beginning January 1, 2010, we are finalizing a 6-month reporting period beginning July 1, 2010, available for claims-based reporting of individual measures for the 2010 PQRI.

Comment: One commenter supported not adding a 6-month reporting period for claims-based reporting of individual measures based on the assumption that we would eliminate claims-based reporting after 2010.

Response: As we stated in the CY 2010 PFS proposed rule (74 FR 33561), our ability to reduce or eliminate our reliance on claims-based reporting is contingent on there being an adequate number and variety of registries available and/or EHR reporting options. Since it is unlikely that there will be an adequate number of measures available for EHR reporting in 2011 for us to solely rely on registry and EHR reporting, we anticipate continuing to offer claims-based reporting options for the PQRI beyond 2010. Therefore, for the reasons discussed above, we believe that a 6-month reporting period for claims-based reporting of individual measures should be available to the extent that claims-based reporting of individual measures continues to be an available option for eligible professionals.

Comment: One commenter requested that we provide a “clarifying definition of the term `qualified' ” with respect to the proposed 2010 PQRI reporting periods. The commenter noted that there is a similar term in industry use and a definition would help to avoid confusion.

Response: We are unclear as to how the term “qualified” relates to the PQRI reporting periods and believe that the commenter may be referring to our use of the term “qualified” with respect to registry and EHR reporting. As proposed for the 2010 PQRI (74 FR 33563 through 33565), for purposes of the PQRI, a “qualified” registry is one that has self-nominated to be able to submit PQRI quality measures results and numerator and denominator data on PQRI quality measures or measures groups on behalf of eligible professionals and that has been vetted by CMS to ensure the registry's meets certain technical and other requirements. Similarly, a “qualified” EHR vendor is one that has self-nominated to have one or more of its EHR products vetted by CMS to ensure that the product(s) meets certain technical and other requirements. Eligible professionals who wish to submit PQRI measures via an EHR may only use qualified EHR products to do so.

For the reasons discussed above and based on the comments, for 2010, we will retain a 12-month reporting period beginning January 1, 2010, which will be available for all reporting mechanisms and regardless of whether an individual eligible professional chooses to report on 2010 PQRI individual measures or measures groups. In addition, we are adopting a 6-month reporting beginning July 1, 2010, for claims-based and registry-based reporting of 2010 PQRI individual measures or measures groups. This 6-month reporting period will not be available for EHR-based reporting in 2010. Once we have additional experience with EHR reporting in PQRI we may consider including a 6-month reporting period for EHR reporting in future years.

In addition, an eligible professional who satisfactorily reports 2010 PQRI measures or measures groups through claims or a qualified registry for the 6-month reporting period will qualify to earn a PQRI incentive payment equal to 2.0 percent of his or her total estimated Medicare Part B PFS allowed charges for covered professional services furnished between July 1, 2010 and December 31, 2010 only. As required by section 1848(m)(1)(A) of the Act, the incentive payment will be calculated based on the eligible professional's charges for covered professional services furnished during the applicable reporting period only.

d. 2010 PQRI Reporting Mechanisms for Individual Eligible Professionals

When the PQRI was first implemented in 2007, there was only 1 reporting mechanism available to submit data on PQRI quality measures. For the 2007 PQRI, the only way that eligible professionals could submit data on PQRI quality measures was by reporting the appropriate quality data codes on their Medicare Part B claims (claims-based reporting). For the 2008 PQRI, we added a second reporting mechanism as required by section 1848(k)(4) of the Act, so that eligible professionals could submit data on PQRI quality measures to a qualified PQRI registry and request the registry to submit PQRI quality measures results and numerator and denominator data on the 2008 PQRI quality measures or measures groups on their behalf (registry-based reporting). For the 2009 PQRI, we retained the 2 reporting mechanisms used in the 2008 PQRI (that is, claims-based reporting and registry-based reporting) for reporting individual PQRI quality measures and for reporting measures groups.

To promote the adoption of EHRs, we also conducted limited testing of a third reporting mechanism for the 2008 and 2009 PQRI, which was the submission of clinical quality data extracted from an EHR, or the EHR-based reporting mechanism. No incentive payment was available to those eligible professionals who participated in testing the EHR-based reporting mechanism.

For the 2010 PQRI, we proposed to retain the claims-based reporting mechanism and the registry-based reporting mechanism. In addition, we proposed to accept PQRI quality measure data extracted from a qualified EHR product (that is, an EHR successfully completing the 2009 EHR Testing Program) for a limited subset of the proposed 2010 PQRI quality measures, as identified in Table 20 of the CY 2010 PFS proposed rule, contingent upon the successful completion of our 2009 EHR data submission testing process and a determination based on that testing process that accepting data from EHRs on quality measures for the 2010 PQRI is practical and feasible. We solicited comments on the proposed reporting mechanisms for the 2010 PQRI, including the proposal to add an EHR-based reporting mechanism to the 2010 PQRI, contingent upon the successful completion of our 2009 EHR data submission testing process and a determination that accepting data from EHRs on quality measures for the 2010 PQRI is practical and feasible.

We also discussed in the CY 2010 PFS proposed rule how we may consider significantly limiting the claims-based mechanism of reporting clinical quality measures for the PQRI after 2010. We solicited comments on our intent to lessen our reliance on the claims-based reporting mechanism for the PQRI beyond 2010.

The following is a summary of the comments received with regard to the proposed 2010 PQRI reporting mechanisms and our intent to lessen reliance on the claims-based reporting mechanism for the PQRI beyond 2010.

Comment: A majority of the commenters agreed with our reasons for lessening our reliance of claims-based reporting, supported alternative reporting mechanisms, or agreed that we should eventually transition away from claims-based reporting. At the same time, however, many of these same commenters urged us to reconsider limiting or eliminating claims-based reporting in 2011. Many commenters noted that claims-based reporting is currently the only option available for many eligible professionals and is the only reporting mechanism that is available to all eligible professionals. Other commenters cited claims-based reporting as the most convenient and cost-effective reporting mechanism available to eligible professionals, particularly solo practitioners and those in small practices. Also, the commenters noted that the EHR-based reporting mechanism initially will only be available on a limited basis so we should wait until EHR-based reporting becomes well established before transitioning away from claims-based reporting.

Response: We acknowledge the commenters' concerns that prematurely eliminating the claims-based reporting mechanism could create barriers to participation. While our goal continues to be to eventually phase-out claims-based reporting, our ability to reduce or eliminate our reliance on claims-based reporting is contingent on there being an adequate number and variety of registries available and/or EHR reporting options. As we stated previously, since it is unlikely that there will be an adequate number of measures available for EHR reporting in 2011 for us to completely eliminate the claims-based reporting mechanism, we anticipate continuing to offer claims-based reporting options for the PQRI beyond 2010. We may, however, avoid introducing new claims-based measures and increasingly limit the circumstances in which claims-based reporting is an available reporting mechanism in order to encourage wider adoption of registry or EHR-based reporting.

Comment: One commenter recommended that, as we move towards reducing reliance on claims-based reporting for PQRI and increase registry-based and EHR-based options, we require registries and EHR vendors to seek and obtain a license to use the measures from the measure developers.

Response: PQRI measure specifications are developed in consultation with the measure developers and are made available to the public via posting on the PQRI section of the CMS Web site. Registries must use the PQRI measure specifications posted on the PQRI section of the CMS Web site to calculate reporting or performance unless otherwise stated. Similarly, eligible professionals who choose to participate in PQRI via the EHR-based reporting mechanism must use PQRI measure specifications to do so. We believe use of these measure specifications, regardless of the method by which quality data is submitted to PQRI for analysis, ensures consistent use and reporting of the measures.

Comment: One commenter expressed concern that registry and EHR-based reporting may not account for changes in patient condition over the course of the reporting period, and suggested reporting options be restructured so that results submitted using any method for a given patient population and a specific time period are identical.

Response: Regardless of the reporting mechanism an eligible professional selects to participate in PQRI, measure specifications and instructions for reporting a measure are consistent across mechanisms. If the measure specifications are analyzed properly by a registry or EHR vendor, the results should be very close or identical to the results for claims-based reporting, as the commenter requested.

Comment: Several commenters recommended uniform data submission deadlines be established across all reporting mechanisms. The commenter noted specifically that the proposed deadline for submission of data on PQRI quality measures for EHR-based reporting and for registry reporting was March 31, 2011 while the proposed deadline for submission of data on PQRI quality measures for other reporting mechanisms was February 28, 2011.

Response: We agree that the deadline for submission of data on PQRI quality measures for EHR-based reporting should be consistent with the deadline for submission of data on PQRI quality measures for claims-based reporting. Therefore, eligible professionals participating in the 2010 PQRI via EHR reporting or claims reporting will be required to submit all data on 2010 PQRI quality measures by no later than February 28, 2011 in order for the data to be included in the 2010 PQRI data analysis. Whereas CMS receives the raw data elements from eligible professionals for EHR and claims-based reporting and calculates the eligible professionals' reporting and performance results, registries must calculate and submit eligible professionals' quality measure reporting and performance results to us. In implementing registry-based reporting for the 2008 PQRI, we determined that a February deadline for submission of data on PQRI quality measures would be insufficient for registries to collect the data from their participants, calculate PQRI quality measure results, and submit the quality measure results and numerator and denominator data to CMS. Thus, registries are given additional time beyond February 28, 2011, to submit their data on behalf of participating eligible professionals. Eligible professionals participating in the 2010 PQRI via registry reporting should check with their selected registry regarding the registry's deadline for submission of data on PQRI quality measures from eligible professionals.

For the reasons discussed above and based on the comments received, as well as our experience with the EHR testing process to date, we are finalizing the option for an eligible professional to be able to choose to report data on 2010 PQRI quality measures through claims, through a qualified registry, or through a qualified EHR product (contingent on there being a qualified 2010 EHR product). Depending on which PQRI individual quality measures or measures groups an eligible professional selects, however, one or more of the 2010 reporting mechanisms may not be available for reporting a particular 2010 PQRI individual quality measure or measures group. The 2010 reporting mechanism(s) through which each 2010 PQRI individual quality measure and measures group can be reported is identified in Tables 11 through 27 of this final rule with comment period.

Regardless of the reporting mechanism chosen by an eligible professional, there is no requirement for the eligible professional to sign up or register to participate in the PQRI. However, there may be some requirements for participation through a specific reporting mechanism that are unique to that particular reporting mechanism. In addition to the criteria for satisfactory reporting of individual measures and measures groups described in sections II.G.2.e. and II.G.2.f. of this final rule with comment period, eligible professionals must ensure that they meet all requirements for their chosen reporting mechanism as described in sections II.G.2.d.1. through II.G.2.d.3. of this final rule.

(1) Final Requirements for Individual Eligible Professionals Who Choose the Claims-Based Reporting Mechanism

For eligible professionals who choose to participate in the 2010 PQRI by submitting data on individual quality measures or measures groups through the claims-based reporting mechanism, we proposed that the eligible professional would be required to submit the appropriate PQRI quality data codes on the professionals' Medicare Part B claims. As in previous years, an eligible professional would be permitted to start submitting the quality data codes for the eligible professional's selected individual PQRI quality measures or measures group at any time during 2010. Please note, however, that as required by section 1848(m)(1)(A) of the Act, all claims for services furnished between January 1, 2010 and December 31, 2010, would need to be processed by no later than February 28, 2011, to be included in the 2010 PQRI analysis.

We did not receive any comments specific to the requirements for individual eligible professionals who choose claims-based reporting. Therefore, we are finalizing the requirements as proposed. Eligible professionals should refer to the “2010 PQRI Implementation Guide” to facilitate satisfactory reporting of quality data codes for 2010 PQRI individual measures on claims and to the “Getting Started with 2010 PQRI Reporting of Measures Groups” to facilitate satisfactory reporting of quality data codes for 2010 PQRI measures groups on claims. By no later than December 31, 2009, both of these documents will be posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri.

(2) Final Requirements for Individual Eligible Professionals Who Choose the Registry-Based Reporting Mechanism

In order to report quality measures results and numerator and denominator data on the 2010 PQRI individual quality measures or measures group through a qualified clinical registry, we proposed that eligible professionals would need to enter into and maintain an appropriate legal arrangement with a qualified 2010 PQRI registry. Such arrangements would provide for the registry's receipt of patient-specific data from the eligible professional and the registry's disclosure of quality measures results and numerator and denominator data on PQRI quality measures or measures groups on behalf of the eligible professional to CMS. Thus, the registry would act as a Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) (HIPAA) Business Associate and agent of the eligible professional. Such agents are referred to as “data submission vendors.” The “data submission vendors” would have the requisite legal authority to provide clinical quality measures results and numerator and denominator data on individual quality measures or measures groups on behalf of the eligible professional for the PQRI. The registry, acting as a data submission vendor, would submit CMS-defined registry-derived measures information to the CMS designated database for the PQRI, using a CMS-specified record layout. The record layout will be provided to the registry by CMS.

To maintain compliance with applicable statutes and regulations, our program and its data system must maintain compliance with the HIPAA requirements for requesting, processing, storing, and transmitting data. Eligible professionals that conduct HIPAA covered transactions also would need to maintain compliance with the HIPAA requirements.

We proposed that eligible professionals choosing to participate in PQRI by submitting quality measures results and numerator and denominator data on PQRI individual quality measures or measures groups through the registry-based reporting mechanism for 2010 would be required to select a qualified PQRI registry and submit information on PQRI individual quality measures or measures groups to the selected registry in the form and manner and by the deadline specified by the registry (74 FR 33562).

In addition to meeting the above proposed requirements specific to registry-based reporting, we proposed that eligible professionals who choose to participate in PQRI through the registry-based reporting mechanism would need to meet the relevant criteria proposed for satisfactory reporting of individual measures or measures groups that all eligible professionals must meet in order to qualify to earn a 2010 PQRI incentive payment (74 FR 33563).

The following is a summary of the comments we received regarding the proposed requirements for individual eligible professionals who choose the registry-based reporting mechanism for the 2010 PQRI.

Comment: We received multiple comments requesting that we not wait until the qualified 2009 registries successfully submit their 2009 PQRI data to publish the list of qualified registries for 2010 PQRI. Commenters suggested that approved registries and the vetting of the self-nominated registries must occur earlier in the reporting year to allow eligible providers time to review and select an appropriate registry for their needs. A few commenters suggested that the list of eligible registries be made available prior to the start of the reporting period and one commenter recommended these registries be announced at least one month prior to the reporting period. Another commenter suggested the delay in listing qualified registries for 2010 PQRI would penalize 2009 qualified registries and could lead to an unintended consequence of decreasing the number of participating eligible professionals in 2010.

Response: We understand the concern posed by the commenters. We make every effort to increase the likelihood of successful data submission to PQRI on behalf of eligible professionals from qualified registries. While we cannot guarantee that a qualified registry will be able to send the quality measure data on behalf of their eligible professionals, a thorough vetting process has been established in order to qualify new registries. Part of this process includes determining the success of the 2009 PQRI registries with respect to their data submission. As in 2009, we are again requiring a self-nomination process for registries wishing to submit quality measures results and numerator and denominator data on 2010 PQRI quality measures or measure groups on behalf of eligible professionals for services furnished during the applicable reporting periods in 2010. Similar to previous years, the 2010 PQRI registry self-nomination process is based on a registry meeting specific technical and other requirements. While we strive to announce the qualified 2010 registries in advance of our target date, the selection process to determine qualified registries for 2010 PQRI is time-consuming. We anticipate posting the complete list of qualified 2010 registries as soon as we have completed vetting the registries interested in participating in the 2010 PQRI and identified the qualified registries for the 2010 PQRI. We expect to post the qualified registries no later than Summer 2010. In an attempt to address the commenters' requests, however, we do intend to post the names of the successful 2008 registries who intend to continue their participation in the 2010 PQRI. As stated in the CY 2010 PFS proposed rule (74 FR 33562 through 33563), this initial list of 2010 qualified registries will be available on the Web site by no later than December 31, 2009.

Comment: One commenter suggested we consider implementing a registry submission process that allows registries to demonstrate the recording and feedback of quality information, rather than go through a cumbersome method to transform the data for submission to CMS. The commenter noted that the current registry requirements appear to be designed in a way that would allow registry data to be transformed to claims data.

Response: We believe the commenter is reacting to the fact that the PQRI originated as a claims-based quality reporting program and he or she believes that registry requirements are still being designed to allow registry data to be transformed to claims data. We do not require registries to transform the quality data that they collect into a claims data format, as such a requirement would be overly prescriptive. In accordance with the registry qualifications set forth in section II.G.2.d.4. of this final rule with comment period, registries may collect and analyze data on PQRI measures and measures groups on behalf of eligible professionals pursuing incentive payment for the 2010 PQRI in any manner they deem appropriate for successful business operations. Therefore, an eligible professional who chooses registry-based reporting must submit data on PQRI quality measures or measures groups in whatever manner that is required by his or her selected qualified registry.

Comment: A commenter suggested that individual eligible professionals and small practices be offered a mechanism by which registry data could be cross-referenced with claims data to see if any other provider has supplied the appropriate care. The commenter remarked that this would allow eligible professionals to participate in registry-based reporting even if they do not have access to the quality information needed to report.

Response: The PQRI does not allow for one eligible professional's data to be “cross-referenced” with other eligible professional's data at the individual eligible professional level. This is however, consistent with one of the benefits of the physician group option method of PQRI reporting, which will start in 2010 and is discussed in further detail in section II.G.2.g. of this final rule with comment period. Satisfactory participation in PQRI for individuals looks at reporting rates at the individual TIN/NPI level.

As a result of the comments, we are finalizing the requirements for individual eligible professionals who choose the registry-based reporting mechanism as proposed (74 FR 33562 through 33563) and discussed above.

We will post on the PQRI section of the CMS Web site at http://www.cms.hhs.gov a list of qualified registries for the 2010 PQRI, including the registry name, contact information, and the 2010 measure(s) and/or measures group(s) for which the registry is qualified and intends to report. As proposed in the CY 2010 PFS proposed rule (74 FR 33562 through 33563), we will post the names of 2010 PQRI qualified registries in 2 phases. In either event, even though a registry is listed as “qualified,” we cannot guarantee or assume responsibility for the registry's successful submission of PQRI quality measures results and numerator and denominator data on PQRI quality measures or measures groups on behalf of eligible professionals.

In the first phase, we will post, by December 31, 2009, a list of those registries qualified for the 2010 PQRI based on: (1) Being a qualified registry for the 2008 and 2009 PQRI that successfully submitted 2008 PQRI quality measures results and numerator and denominator data on the quality measures; (2) having received a letter indicating their continued interest in being a PQRI registry for 2010; and (3) the registry's compliance with the 2010 PQRI registry requirements. By posting this first list of qualified registries for the 2010 PQRI, we seek to make available the names of registries that can be qualified at the start of the 2010 reporting period.

In the second phase, we will complete posting of the list of qualified 2010 registries as soon as we have completed vetting the additional registries interested in participating in the 2010 PQRI and identified the qualified registries for the 2010 PQRI, which we anticipate will be completed by no later than Summer 2010. An eligible professional's ability to report PQRI quality measures results and numerator and denominator data on PQRI quality measures or measures groups using the registry-based reporting mechanism should not be impacted by the complete list of qualified registries for the 2010 PQRI being made available after the start of the reporting period. First, registries will not begin submitting eligible professionals' PQRI quality measures results and numerator and denominator data on the quality measures or measures groups to CMS until 2011. Second, if an eligible professional decides that he or she is no longer interested in submitting quality measures results and numerator and denominator data on PQRI individual quality measures or measures group through the registry-based reporting mechanism after the complete list of qualified registries becomes available, this does not preclude the eligible professional from attempting to meet the criteria for satisfactory reporting through another 2010 PQRI reporting mechanism.

The process and requirements that will be used to determine whether a registry is qualified to submit quality measures results and numerator data on PQRI quality measures or measures groups on an eligible professional's behalf in 2010 are described in section II.G.2.d.4. of this final rule with comment period.

(3) Requirements for Individual Eligible Professionals Who Choose the EHR-Based Reporting Mechanism

For eligible professionals who choose to participate in the 2010 PQRI by submitting data on individual quality measures through the EHR-based reporting mechanism, the requirements we proposed associated with EHR-based reporting other than meeting the criteria for satisfactory reporting of individual measures were to: (1) select a qualified EHR product and (2) submit clinical quality data extracted from the EHR to a CMS clinical data warehouse (74 FR 33563). Provided that our 2009 EHR data submission testing process is successful, we proposed to begin accepting submission of clinical quality data extracted from “qualified” EHRs on January 1, 2010, or as soon thereafter as is technically feasible. We proposed that eligible professionals will have until March 31, 2011, to complete data submission through qualified EHRs for services furnished during the 2010 PQRI reporting period.

We did not propose any option to report measures groups through EHR-based reporting on services furnished during 2010. Because EHR-based reporting to CMS of data on quality measures would be new to PQRI for 2010, we proposed, for EHR-based reporting, to make available only the criteria applicable to reporting of individual PQRI measures. The criteria applicable to reporting of measures groups were not proposed to be available for EHR-based reporting for 2010.

The following is a summary of the comments we received regarding the proposed requirements for individual eligible professionals who choose the EHR-based reporting mechanism.

Comment: Some commenters urged CMS to conduct extensive education and outreach prior to implementation of EHR reporting for PQRI.

Response: We agree that it is necessary to educate eligible professionals regarding this new reporting mechanism prior to implementation. We anticipate doing so through PQRI National Provider Calls, or other CMS-sponsored calls, and through educational materials to be posted on the PQRI section of CMS Web site once qualified EHR vendors have been identified for the 2010 PQRI.

Comment: One commenter noted his or her expectation that the 2009 EHR Testing Program would be a success. Another commenter suggested we include a discussion of the 2009 EHR submission testing experience in this final rule.

Response: We appreciate the positive comment and anticipate the ongoing 2009 EHR data submission testing process will be a success. However, we have not completed the final beta test as of the writing of this final rule with comment period and therefore, we are unable to discuss the results of the testing process in this final rule with comment period.

Comment: Many commenters supported further expanding reporting mechanisms and moving forward with accepting quality measures data through EHRs for the PQRI program. Several commenters were pleased with our proposal to accept PQRI quality measure data extracted from qualified EHRs in 2010 and one commenter urged us to quickly finalize testing for the EHR-based reporting mechanism and allow participation in 2010 PQRI through the use of qualified EHRs. One commenter indicated the use of EHR data submission will result in the reporting of more robust quality measures.

Response: We encourage the adoption and use of EHRs and are appreciative of the commenters' support. We believe EHR-based reporting will enhance the quality of PQRI data reported by eligible professionals participating in the PQRI program and, compared to claims-based reporting, will relieve some of the reporting burden on eligible professionals.

Comment: One commenter remarked that all eligible professionals should have the option to report measures through an EHR. Similarly, another commenter indicated opposition to the decision to limit EHR based reporting initially to a narrow subset of the universe of approved quality measures.

Response: We have selected 10 measures which can be reported from an EHR in this initial phase of quality data reporting from EHRs for PQRI. As we gain experience accepting quality measures data electronically, we will evaluate the feasibility of expanding the list of measures for which we have this capability.

Comment: A commenter suggested we allow hospital EHR systems to qualify as a reporting method for PQRI, as some eligible professionals are employed in a hospital facility which may be using an EHR (for example, Registered Dietitians).

Response: To the extent that a hospital utilizes an EHR system that is “qualified” for the 2010 PQRI, eligible professionals employed by the hospital can participate in the 2010 PQRI by submitting PQRI quality measures data extracted from the hospital's EHR system. We do not place restrictions on who can self-nominate to have one or more of their EHR products become qualified PQRI EHR products as long as the vendor successfully completes the self-nomination process described in section II.G.2.d.5. of this final rule with comment period.

Comment: One commenter concurred that we cannot assume responsibility for the successful submission of data from an eligible professional's EHRs.

Response: As discussed in the proposed rule (74 FR 33563), we cannot assume responsibility for the successful submission of data from any eligible professional's EHR. It is each EHR vendor's responsibility to ensure that it has updated its EHR product(s) to facilitate PQRI quality measures data submission.

Comment: One commenter recommended a more streamlined approach to simplify the reporting criteria and time-periods for EHR users, by allowing EHR users to report on all their patients throughout the year.

Response: For satisfactory PQRI reporting via a qualified EHR, we are requiring all PQRI quality data to be submitted at one time. This will allow us to finish the infrastructure development and will also allow CMS and eligible professionals to avoid redundant reporting by inadvertently submitting data previously reported. Also, we believe one-time reporting is more convenient for eligible professionals.

Comment: One commenter commended CMS for acknowledging the Health Information Technology for Economic and Clinical Health (HITECH) Act and its focus on EHR implementation for incentive payments, meaningful use, and quality reporting. Some commenters suggested that we align initiatives in response to the health information technology (HIT) incentives and with applicable provisions in the HITECH Act regarding EHR certification requirements (that is, HITECH requires eligible professionals to use certified technology) so that eligible professionals can follow similar qualification and/or certification requirements as they prepare for quality reporting for both PQRI and the HITECH Act incentive programs. Another commenter remarked that EHR systems may require reinstallation or significant maintenance/upgrades to meet “meaningful use” criteria, which could potentially take months to achieve. Coordinating reporting standards may help minimize preparation and reporting requirements for program participants. Another commenter suggested we advocate to the Certification Commission of Health Information Technology for the inclusion of PQRI reporting capabilities in the certification criteria.

Response: Any EHR quality data submission will be required to comply with all current regulations regarding security and privacy. “Meaningful use” criteria will be reviewed as they are finalized and we will endeavor to align our work in the future, as appropriate. However, since meaningful use criteria have not yet been finalized, this comment is currently beyond the scope of this final rule with comment period.

Comment: One commenter remarked that an EHR is a tool that allows physicians to improve work flow and efficiency by electronically documenting data, however it does not, in all cases, have a quality feedback loop for providers. One commenter recommended that we provide back to the submitter, feedback on the extracted data that is received and then that feedback should be provided back to the eligible professional. The commenter also suggested we require that this process include return receipt for the data content prior to scoring for PQRI participation and calculation of incentive payment.

Response: With regard to a “feedback loop,” we note that the EHR data submission process is such that the eligible professional will know if the file he or she sent to us has been successfully submitted and accepted. A file which is not accepted will be returned with an error code. We note, however, that successful submission of a data file does not indicate that the eligible professional met the criteria for satisfactory reporting; it just indicates that we received the data file that was sent to us.

As is the case for other eligible professionals participating in PQRI, eligible professionals submitting their quality data through an EHR will receive a feedback report from us that will be accessible in the same manner as other feedback reports we provide for other reporting mechanisms.

As a result of the comments and our experience thus far with the ongoing 2009 EHR Testing Program, eligible professionals who choose the EHR-based reporting mechanism for the 2010 PQRI will be required to (in addition to meeting the criteria for satisfactory reporting of individual measures):

  • Have a qualified EHR product;
  • Have an active IACS user account that will be used to submit clinical quality data extracted from the EHR to a CMS clinical data warehouse;
  • Submit a test file containing real or dummy clinical quality data extracted from the EHR to a CMS clinical data warehouse via IACS between July 1, 2010 and September 30, 2010 (if technically feasible); and
  • Submit a file containing the eligible professional's 2010 PQRI clinical quality data extracted from the EHR for the entire reporting period (that is January 1, 2010 through December 31, 2010) via IACS between January 1, 2011 through February 28, 2011.

As stated above, however, the 2009 EHR Testing Program is still ongoing. Since only EHR vendors that self-nominated to participate in the 2009 EHR Testing Program and successfully complete the 2009 EHR Testing Program will be considered qualified EHR vendors for the 2010 PQRI, there is no guarantee that there will be any qualified EHR vendors available for the 2010 PQRI. In addition, as we complete the 2009 EHR Testing Program and are better able to determine what is technically feasible, the actual dates on which eligible professionals are required to submit their test files and/or to begin submitting the actual 2010 PQRI data are subject to change.

As stated above, we also cannot assume responsibility for the successful submission of data from eligible professionals' EHRs. Any eligible professional who chooses to submit PQRI data extracted from an EHR should contact the EHR product's vendor to determine if the product is qualified and has been updated to facilitate PQRI quality measures data submission. Such professionals also should begin attempting submission soon after the opening of the clinical data warehouse in order to assure the professional has a reasonable period of time to work with his or her EHR and/or its vendor to correct any problems that may complicate or preclude successful quality measures data submission through that EHR. As we indicated above, data submission for the 2010 PQRI will need to be completed by February 28, 2011.

The specifications for the electronic transmission of the 2010 PQRI measures identified in Table 14 of this final rule as being available for EHR-based reporting in 2010 are posted on Alternative Reporting Mechanisms page of the PQRI section of the CMS Web site.

(4) Qualification Requirements for Registries

For the 2010 PQRI, we proposed to require a self-nomination process for registries wishing to submit 2010 PQRI quality measures or measures groups on behalf of eligible professionals for services furnished during the applicable reporting periods in 2010 (74 FR 33563). The proposed registry self-nomination process for the 2010 PQRI would be based on a registry meeting specific technical and other requirements.

To be considered a qualified registry for purposes of submitting individual quality measures and measures groups on behalf of eligible professionals who choose to report using this reporting mechanism under the 2010 PQRI, we proposed that a registry would need to:

  • Be in existence as of January 1, 2009;
  • Be able to collect all needed data elements and calculate results for at least 3 measures in the 2010 PQRI program (according to the posted 2010 PQRI Measure Specifications);
  • Be able to calculate and submit measure-level reporting rates by TIN/NPI;
  • Be able to calculate and submit, by TIN/NPI, a performance rate (that is, the percentage of a defined population who receive a particular process of care or achieve a particular outcome) for each measure on which the TIN/NPI reports;
  • Be able to separate out and report on Medicare Part B FFS patients;
  • Provide the name of the registry;
  • Provide the reporting period start date the registry will cover;
  • Provide the reporting period end date the registry will cover;
  • Provide the measure numbers for the PQRI quality measures on which the registry is reporting;
  • Provide the measure title for the PQRI quality measures on which the registry is reporting;
  • Report the number of eligible instances (reporting denominator);
  • Report the number of instances of quality service performed (numerator);
  • Report the number of performance exclusions;
  • Report the number of reported instances, performance not met (eligible professional receives credit for reporting, not for performance);
  • Be able to transmit this data in a CMS-approved XML format. We expect that this CMS-specified record layout will be substantially the same as for the 2008 and 2009 PQRI. This layout will be provided to registries in 2010;
  • Comply with a CMS-specified secure method for data submission, such as submitting its data in an XML file through an IACS user account;
  • Submit an acceptable “validation strategy” to CMS by March 31, 2010. A validation strategy ascertains whether eligible professionals have submitted accurately and on at least the minimum number (80 percent) of their eligible patients, visits, procedures, or episodes for a given measure. Acceptable validation strategies often include such provisions as the registry being able to conduct random sampling of their participants' data, but may also be based on other credible means of verifying the accuracy of data content and completeness of reporting or adherence to a required sampling method;
  • Enter into and maintain with its participating professionals an appropriate Business Associate agreement that provides for the registry's receipt of patient-specific data from the eligible professionals, as well as the registry's disclosure of quality measure results and numerator and denominator data on behalf of eligible professionals who wish to participate in the PQRI program;
  • Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the registry has authorized the registry to submit quality measures results and numerator and denominator data to CMS for the purpose of PQRI participation. This documentation must be obtained at the time the eligible professional signs up with the registry to submit PQRI quality measures data to the registry and must meet any applicable laws, regulations, and contractual business associate agreements;
  • Provide CMS access (if requested) to review the Medicare beneficiary data on which 2010 PQRI registry-based submissions are founded;
  • Provide the reporting option (reporting period and reporting criteria) that the eligible professional has satisfied or chosen; and
  • Provide CMS a signed, written attestation statement via mail or e-mail which states that the quality measure results and numerator and denominator data provided to CMS are accurate and complete (74 FR 33563 through 33564).

With respect to the submission of 2010 measure results and numerator and denominator data on measures groups, we proposed to retain in 2010 the following registry requirements from the 2009 PQRI:

  • Indicate the reporting period chosen for each eligible professional who chooses to submit data on measures groups;
  • Base reported information on measures groups only on patients to whom services were furnished during the 12-month reporting period of January through December 2010 or the 6-month reporting period of July 2010 through December 2010;
  • Agree that the registry's data may be inspected by CMS under our oversight authority if non-Medicare patients are included in the patient sample;
  • Be able to report data on all of the measures in a given measures group and on either 30 patients from January 1 through December 31, 2010 (note this patient sample must include some Medicare Part B FFS beneficiaries) or on 80 percent of applicable Medicare Part B FFS patients for each eligible professional (with a minimum of 15 patients during the January 1, 2010 through December 31, 2010 reporting period or a minimum of 8 patients during the July 1, 2010 through December 31, 2010 reporting period); and
  • Be able to report the number of Medicare FFS patients and the number of Medicare Advantage patients that are included in the patient sample for a given measures group (74 FR 33564).

In addition to the above requirements, we proposed the following new requirements for registries for the 2010 PQRI:

  • Registries must have at least 25 participants;
  • Registries must provide at least 1 feedback report per year to participating eligible professionals;
  • Registries must not be owned and managed by an individual locally-owned single-specialty group (in other words, single-specialty practices with only 1 practice location or solo practitioner practices would be prohibited from self-nominating to become a qualified PQRI registry);
  • Registries must participate in ongoing 2010 PQRI mandatory support conference calls hosted by CMS (approximately 1 call per month), including an in-person registry kick-off meeting to be held at CMS headquarters in Baltimore, MD;
  • Registries must provide a flow and XML of a measure's calculation process for each measure type that the registry intends to calculate; and
  • Registries must use PQRI measure specifications to calculate reporting or performance unless otherwise stated (74 FR 33654).

The following is summary of the comments we received regarding the proposed qualification requirements and self-nomination process for registries for the 2010 PQRI.

Comment: We received several comments supporting many of the proposed qualification requirements for registries. A number of commenters agreed with the proposed requirement that registries must have a minimum of 25 participants. Similarly, one commenter remarked that the rationale for restricting a single practice site or solo practitioners from becoming a qualified registry is unclear and suggested that such entities should not be prohibited from becoming a qualified registry if they otherwise meet the requirements.

Response: We appreciate the supportive comments and believe that the additional requirements will improve registry based reporting. We limited registry participation to registries with at least 25 participants to conserve both CMS and eligible professionals' resources. Every registry goes through a vetting process which includes providing a sample measure flow illustrating how that registry will calculate an example of each type of measure it plans to submit to CMS. Additionally, registries must send in a sample XML file per the CMS specifications. This process occurs over a 2-3 month period and requires resources on the part of CMS, as well as the potential registry. Finally, a mandatory in-person registry kick-off meeting is held each year at CMS headquarters in Baltimore, MD. We believe the time and expense for a solo practitioner or single practice site to go through these steps would be prohibitive for most practitioners or practice sites. We do not believe that a majority of solo practitioners or single practice sites do not have the information technology (IT) staffing and resources needed to successfully complete the vetting process. Furthermore, we do not have the resources to provide IT support to such entities.

Comment: Numerous commenters strongly supported the requirement for registries to provide at least one feedback report per year to participating eligible professionals. Several commenters suggested the feedback reports from registries be issued to eligible professionals at some point during the reporting year so as to allow practices to assess their performance both on reporting and on performance, which may inform and promote internal quality improvement. One commenter stated providing eligible professionals with access to feedback reports during the reporting year would allow more accurate assessment of their performance before the close of the reporting period.

Response: We agree that the requirement for registries to provide at least one feedback report per year is an essential tool for quality improvement and must be provided to participating eligible professionals. The information contained within feedback reports will allow the eligible professional to assess the quality of care they provided to their patients during the specific reporting timeframe of the report. Furthermore the report may provide information for the promotion of internal quality improvement. While we will not require registries to provide more than the minimum number of feedback reports per year (one) to participating eligible professionals, we would be supportive of such a decision by a registry.

Comment: One commenter recommended we develop an audit program for registry vendors, as the PQRI program moves away from claims-based reporting. The commenter suggested eligible professionals participating in the PQRI look to CMS for assurance that registry vendors are regularly inspected for quality.

Response: As we gain more experience with registry submission, we would expect to further specify through rulemaking qualification requirements for registries that may include more comprehensive validation requirements. As we evaluate our policies, we plan to continue a dialogue with stakeholders to discuss opportunities for program efficiency and flexibility.

As a result of the comments, we are finalizing the 2010 qualification requirements for registries as proposed (74 FR 33563 through 33565).

We will post the 2010 PQRI registry requirements, including the exact date by which registries that wish to qualify for 2010 must submit a self-nomination letter and instructions for submitting the self-nomination letter, on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI by November 15, 2009. We anticipate that new registries that wish to self-nominate for 2010 will be required to do so by January 31, 2010.

We are finalizing our proposal (74 FR 33563 through 33565) that registries that were “qualified” for 2009 and wish to continue to participate in 2010 will not need to be “re-qualified” for 2010 unless they are unsuccessful at submitting 2009 PQRI data (that is, fail to submit 2009 PQRI data per the 2009 PQRI registry requirements). Registries that are “qualified” for 2009 and wish to continue to participate in 2010 were required to indicate their desire to continue participation for 2010 by submitting a letter to CMS indicating their continued interest in being a PQRI registry for 2010 and their compliance with the 2010 PQRI registry requirements by no later than October 31, 2009. Instructions regarding the procedures for submitting this letter were provided to qualified 2009 PQRI registries on the 2009 PQRI registry support conference calls.

If a qualified 2009 PQRI registry fails to submit 2009 PQRI data per the 2009 PQRI registry requirements, the registry will be considered unsuccessful at submitting 2009 PQRI data and will need to go through the full self-nomination process again to participate in the 2010 PQRI. By March 31, 2010, registries that are unsuccessful submitting quality measures results and numerator and denominator data for 2009 will need to be able to meet the 2010 PQRI registry requirements and go through the full vetting process again.

As stated in the proposed rule, the above registry requirements will apply not only for the purpose of a registry qualifying to report 2010 PQRI quality measure results and numerator and denominator data on PQRI individual quality measures or measures groups, but also for the purpose of a registry qualifying to submit the proposed electronic prescribing measure for the 2010 E-Prescribing Incentive Program (see section II.G.5. of this final rule with comment period.

(5) Qualification Requirements for EHR Vendors and Their Products

As stated in the proposed rule (74 FR 33565), we proposed that EHR products listed on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI as a “qualified” EHR product (that is, the name of the vendor software product and the version that is qualified), would be available for the product's users to submit quality data to CMS directly from their system for the 2010 PQRI. We also proposed that we would post this list of qualified EHR vendors and products upon completion of the 2009 EHR Testing Program. We anticipate the 2009 EHR Testing Program will be complete in early 2010.

Vendors' EHR products that are listed as “qualified” products were selected because the vendor self-nominated to participate in the 2009 EHR Testing Program and demonstrated that their products met the “Requirements for Electronic Health Record (EHR) Vendors to Participate in the 2009 PQRI EHR Testing Program” that were posted on the Alternative Reporting Mechanisms page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/20_Reporting.asp#TopOfPage on December 31, 2008. Additionally, a vendor's EHR system must be updated according to the Draft 2010 EHR specifications posted on the Alternative Reporting Mechanisms page of the PQRI section of the CMS Web site in order for an EHR vendor and its product to be qualified to submit information on 2010 PQRI measures.

As stated in the proposed rule (74 FR 33565), we proposed that the EHR vendor requirements described above would apply not only for the purpose of a vendor's EHR product being qualified for the purpose of the product's users being able to submit data extracted from the EHR for the 2010 PQRI, but also for the purpose of a vendor's EHR product being qualified for the purpose of the product's users being able to electronically submit data extracted from the EHR for the electronic prescribing measure for the 2010 E-Prescribing Incentive Program.

The following is a summary of the comments received regarding the proposed 2010 EHR vendor qualification requirements and/or process.

Comment: One commenter recommended we implement an ongoing qualification process for new vendors and systems to enable inclusion of vendors that did not self-nominate or did not exist prior to the reporting year.

Response: Currently there is an ongoing qualification process for new EHR vendors and their products. EHR vendors interested in enabling their customers to submit data on PQRI that is extracted from their customers' EHRs must complete the EHR vendor quality data submission qualification process to be considered. For the 2010 PQRI, we will consider those EHR vendors who successfully completed the 2009 EHR Testing Program to be qualified for purposes of the 2010 PQRI. We will list the vendors qualified for the 2010 PQRI on the PQRI section of the CMS Web site upon completion of the 2009 PQRI EHR Testing Process. We anticipate completing the 2009 PQRI EHR Testing Process in early 2010.

During 2010, we expect to use a similar self-nomination process described in the “Requirements for Electronic Heath Record (EHR) Vendors to Participate in the 2009 PQRI EHR Testing Program” posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/20_Reporting.asp#TopOfPage to qualify additional vendors for the 2011 PQRI. This document is subject to modification for the 2011 EHR self-nomination process. In any case, a vendor must self-nominate no later than January 31, 2010 to be eligible to participate in the 2011 PQRI Testing Process in 2010. Sometime in 2010, those EHR products that meet all of the EHR vendor requirements will be listed on the PQRI section page of the CMS Web site at http://www.cms.hhs.gov/PQRI as a “qualified” EHR product, which indicates that the vendor's product's users may submit quality data to CMS for the 2011 PQRI or subsequent years.

Comment: Some commenters commended the establishment of electronic standards for EHR-based reporting.

Response: We appreciate the supportive comments regarding the establishment of standard qualification requirements for EHR reporting.

Comment: A few of commenters expressed concern regarding the criteria set forth to rigidly define “qualified” EHRs. These concerns stem from the fact that some EHR products are developed for health care professionals specific to their needs (such as physical therapists, oncologists, etc.). Another commenter remarked that vendors for specialty-specific EHR products, such as oncology-specific EHR products, should not have to adjust their software to comply with certification procedures designed for a general ambulatory system. This commenter stated that the goal of EHRs should be to contain comprehensive information relevant to each patient's condition, their treatment plan and outcomes, but in some cases, specific terminology and data collection to support the eligible professional.

Response: We recognize that some EHR products have been designed to accommodate specific specialties, however, we are unclear how this would prevent the EHR product from meeting the EHR qualification requirements other than that there are no measures available for reporting via EHR. As we analyze the EHR reporting mechanism for 2010, we will consider expanding the measures available for electronic submission in the future.

Comment: One commenter recommended that we develop an audit program for EHR vendors, as the PQRI moves away from claims-based reporting. The commenter suggested eligible professionals participating in the PQRI look to CMS for assurance that vendors are regularly inspected for quality.

Response: Ensuring that vendors meet and perform properly would fall under the purview of their certifying body, which is currently CCHIT (if the product is CCHIT certified). During the qualification process (in which we conduct testing to ensure that the EHR can extract and transmit the necessary quality data elements), we evaluate the vendor and their program to see if the system is capable of performing the necessary tasks required for quality reporting to us for PQRI.

Comment: One commenter noted that some practitioners do not have authority under state law to prescribe medications, and thus products developed to meet the needs of these eligible professionals need not incorporate electronic prescribing functionality at this time.

Response: We recognize the concerns cited by the commenter and note that PQRI does not require qualified EHRs to have an electronic prescribing module in order for eligible professionals to participate in the PQRI via a qualified EHR. We believe the commenter is referring to the idea of “meaningful use” with respect to requiring an electronic prescribing module in the EHR system for purposes of the HITECH Act incentive programs. The issue of “meaningful use” is beyond the scope of this rule.

As previously stated above, only EHR vendors that self-nominated to participate in the 2009 EHR Testing Program and successfully complete the 2009 EHR Testing Program will be considered qualified EHR vendors for the 2010 PQRI. There is no guarantee that there will be any qualified EHR vendors available for the 2010 PQRI since the 2009 EHR Testing Program is still ongoing.

During 2010, we expect to use the self-nomination process described in the “Requirements for Electronic Health Record (EHR) Vendors to Participate in the 2009 PQRI EHR Testing Program” posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/20_AlternativeReportingMechanisms.asp#TopOfPage, to qualify additional EHR vendors and their EHR products to submit quality data extracted from their EHR products to the CMS clinical quality data warehouse for program years after 2010. We anticipate that the requirements will be similar to those used to qualify EHR products for the 2009 PQRI EHR Testing Program, but they may be modified based on the results of our 2009 EHR testing. Any updates to the EHR vendor requirements, which would be based on our experience with the 2009 EHR Testing Program and would be non-substantive in nature, will be made December 15, 2009, and will be posted on the PQRI section of CMS Web site at http://www.cms.hhs.gov/PQRI. As stated previously, any EHR vendor interested in having one or more of their EHR products “qualified” to submit quality data extracted from their EHR products to the CMS clinical quality data warehouse for 2011 and subsequent years must submit their self-nomination letter by January 31, 2010. Instructions for submitting the self-nomination letter will be provided in the 2011 EHR vendor requirements. At the conclusion of this process, those EHR products that meet all of the EHR vendor requirements will be listed on the PQRI section of the CMS Web site as a “qualified” EHR product, which indicates that the product's users may submit quality data to CMS for the 2011 PQRI or subsequent years.

e. Criteria for Satisfactory Reporting of Individual Quality Measures for Individual Eligible Professionals

As discussed in the proposed rule (74 33565 through 33568), for years after 2009, section 1848(m)(3)(D) of the Act authorizes the Secretary, in consultation with stakeholders and experts, to revise the criteria for satisfactorily reporting data on quality measures. Based on this authority and the input we have received from stakeholders via the invitation to submit suggestions for the 2010 PQRI reporting options posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI in April 2009, we proposed 3 criteria for satisfactory reporting of individual PQRI quality measures for 2010. In an effort to continue to be consistent with the criteria of satisfactory reporting used in prior PQRI program years, we proposed to retain the following 2 criteria with respect to satisfactorily reporting data on individual quality measures in circumstances where 3 or more individual quality measures apply to the services furnished by an eligible professional:

  • Report on at least 3 2010 PQRI measures; and
  • Report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.

These criteria would apply to all 2010 PQRI reporting mechanisms available for reporting individual PQRI quality measures.

If an eligible professional has fewer than 3 PQRI measures that apply to the professional's services, then the professional would be able to meet the criteria for satisfactorily reporting data on individual quality measures by meeting the following 2 criteria:

  • Reporting on all measures that apply to the services furnished by the professional (that is 1 to 2 measures); and
  • Reporting each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.

We proposed that, as in previous years, these criteria for satisfactorily reporting data on fewer than 3 individual quality measures would be available for the claims-based reporting mechanism only. An eligible professional who has fewer than 3 PQRI measures that apply to the professional's services would not be able to meet the criteria for satisfactory reporting by reporting on all applicable measures (that is, 1 or 2 measures) through the registry-based or EHR-based reporting mechanisms.

We also proposed that an eligible professional who reports on fewer than 3 measures through the claims-based reporting mechanism in 2010 may be subject to the Measure Applicability Validation (MAV) process, which allows us to determine whether an eligible professional should have reported quality data codes for additional measures. When an eligible professional reports on fewer than 3 measures, we proposed to review whether there are other closely related measures (such as those that share a common diagnosis or those that are representative of services typically provided by a particular type of professional). If an eligible professional who reports on fewer than 3 measures in 2010 reports on a measure that is part of an identified cluster of closely related measures and did not report on any other measure that is part of that identified cluster of closely related measures, then the professional would not qualify to receive a 2010 PQRI incentive payment. Additional information on the MAV process can be found on the Analysis and Payment page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI.

In addition to the above criteria related to the number of measures on which an eligible professional would be required to report and the frequency of reporting, we proposed a third criterion for satisfactory reporting of individual measures. Based on our authority to revise the criteria for satisfactory reporting under section 1848(m)(3)(D) of the Act, we proposed (74 FR 33566) that an eligible professional also be required to report data on at least one individual measure on a minimum number of Medicare Part B FFS patients seen during the reporting period, as detailed below.

Regardless of the reporting mechanism chosen by the eligible professional, we proposed (74 FR 33567) that the minimum patient sample size for reporting individual quality measures be 15 Medicare Part B FFS patients for the 12-month reporting period. An eligible professional would need to meet this minimum patient sample size requirement for at least one measure on which the eligible professional chooses to report. Similarly, for the 6-month reporting period (which was proposed to be available for registry-based reporting only), we proposed that the minimum patient sample size for reporting on individual quality measures be 8 Medicare Part B FFS patients seen during the 6-month reporting period. An eligible professional would need to meet this minimum patient sample size requirement for at least one measure on which the eligible professional chooses to report.

We solicited comments on the proposal to add a minimum patient sample size criterion to the criteria for satisfactory reporting of data on individual quality measures. In addition, we solicited comments on the specific thresholds proposed for the 12-month reporting period (which was proposed to be available for claims-based, registry-based, and EHR-based reporting) and for the 6-month reporting period (which was proposed to be available for registry-based reporting only) for reporting individual quality measures.

The following is summary of the comments we received regarding the criteria for satisfactory reporting of individual quality measures for individual eligible professionals.

Comment: We received several comments supporting the proposed minimum patient sample size requirement for PQRI reporting of individual measures (that is, at least 15 patients for at least 1 measure for the 12-month reporting period and at least 8 patients for at least 1 measure for the 6-month reporting period). A few commenters supported the proposed minimum patient sample requirement only if eligible professionals are required to meet the proposed threshold(s) for only 1 measure on which they report. Many commenters remarked that the minimum patient sample size requirement would encourage eligible professionals to select more applicable measures while discouraging eligible professionals from selectively reporting measures that are not representative of the types of services they normally provide in their practice. The commenters also remarked that the minimum sample size requirements will enhance the scientific validity of eligible professionals' performance results.

Response: We agree with the reasons cited by commenters for why the minimum patient sample size requirement is important. However, analysis of preliminary data from the 2008 PQRI indicates that a significant number of eligible professionals who would otherwise meet the criteria for satisfactory reporting would be adversely impacted by the addition of a minimum patient sample size requirement to the criteria for satisfactory reporting of individual measures by individual eligible professionals. Therefore, we are not finalizing the proposed minimum patient sample requirement. We will reconsider adding a minimum patient sample requirement to the criteria for satisfactory reporting of individual measures for future years upon further analysis of the PQRI data.

Comment: We also received comments requesting that we withdraw the proposed minimum patient sample requirement. The commenters were concerned that this requirement would create a participation barrier for certain eligible professionals, such as those who treat patients with rare conditions, those with small practices, and/or those with relatively few Medicare patients.

Response: For the reasons stated above and based on the commenters' concerns that such a requirement would create participation barriers for certain eligible professionals, we are not finalizing the proposed minimum patient sample size requirement for the PQRI reporting options for individual measures reporting. However, upon further analysis of the PQRI data, we will reconsider adding a minimum patient sample requirement to the criteria for satisfactory reporting of individual measures and explore other means of enhancing the PQRI criteria for satisfactory reporting for future years.

Comment: A majority of commenters believed that the proposed minimum patient sample size thresholds were appropriate. Some commenters, however, believed that the thresholds should be lowered to 10 or 15 for the 12-month reporting period and 6 for the 6-month reporting period. Other commenters believed that the thresholds should be higher, such as 25 or 30 for the 12-month reporting period.

Response: As stated previously, we are not finalizing the proposed minimum patient sample size requirement for reporting of 2010 PQRI individual measures. As we reassess this requirement for future years, we anticipate that we will continue to monitor the PQRI data on an ongoing basis and reassess the thresholds as needed for future years.

Comment: One commenter suggested that we reconsider allowing registry-based reporting for fewer than 3 measures, primarily to encourage eligible professionals to transition to registry-based reporting, as the claims-based option becomes phased out. This option may also allow greater flexibility for the program.

Response: We appreciate the intent of this comment, however, as in previous years, satisfactorily reporting data on fewer than 3 individual quality measures will only be available for the claims-based reporting mechanism. While we have received similar comments in the past, we continue to believe that permitting an eligible professional to report fewer than 3 measures through the registry-based reporting mechanism, (if fewer than 3 measures apply to him or her) would be inefficient at this time. Analytically it would be difficult to implement in that if an eligible professional submits fewer than 3 measures via registries, we would not know whether the eligible professional did so because only 2 measures applied to him or her or because the registry only accepts data for 2 of the provider's measures and he or she is reporting their third measure via claims. We also look for the most favorable method of reporting (that is, did the eligible professional report via a different method for a longer reporting period as well as whether an eligible professional satisfactorily reported under a different reporting option if he or she did not satisfactorily report for a particular reporting option). Accepting fewer than 3 measures from registries would increase the amount of cross-checking already required and makes it impractical to implement the commenter's suggestions at this time. Should the claims-based reporting mechanism be removed entirely from the PQRI program at some point in the future, we may revisit the issue of allowing registries to submit data for eligible professionals on fewer than 3 measures.

Comment: One commenter remarked that limiting EHR-based reporting to reporting on individual measures would limit the ability of some eligible professionals to report on the measures most relevant to them by eliminating one reporting mechanism (such as electronic reporting of the back pain measures for spine care).

Response: The EHR reporting mechanism for PQRI is still in an early development phase. This mechanism will be closely examined in the future, and may be expanded as appropriate. We believe that the first set of measures specified electronically have broad appeal in that they deal with common conditions such as diabetes and prevention.

Comment: Some commenters recommended significant changes to the criteria for satisfactory reporting that would not be consistent with the criteria for satisfactory reporting for prior years. For example, one commenter recommended that as the PQRI moves forward, the definition of satisfactory reporting should not be determined by what the commenter believed were somewhat arbitrary formulas but rather by accurate data that is able to reflect the ways in which a provider attempted to relay the quality of their patient care. Another commenter recommended that CMS phase out the existing process by which participating professionals select the measures on which they will be report. Instead CMS should assign each participating individual eligible professional with sets of measures for high volume conditions, based on services provided to their patient population. Similarly, another commenter recommended more criteria to guide measure selection by eligible professionals and that we require eligible professionals to report on 6 measures.

Response: We agree with commenters that as the PQRI matures, we will need to reassess the criteria for satisfactory reporting so that the information that we collect becomes more representative of the quality of care provided by eligible professionals. We also generally agree with the goals cited by the commenters, but have concerns that the specific suggestions offered by the commenters are not operationally practical and feasible when we take into account the vast numbers of eligible professionals and the diversity of their practices.

In addition, we believe that such significant changes should occur gradually. The criteria for satisfactory reporting are specifically defined under section 1848(m)(3)(A) of the Act. With the authority under section 1848(m)(3)(D) of the Act to revise the criteria for satisfactory reporting for years after 2009, we have started to move towards the direction recommended by commenters with the introduction of the minimum patient sample size requirement for individual measures reporting for the 2010 PQRI. In addition, the new PQRI group practice reporting option also moves the PQRI towards the direction recommended by commenters in that we assign participating group practices both the measures and patients on which they are required to report. We will consider additional changes to the criteria for satisfactory reporting for 2011 and beyond and look forward to receiving stakeholder input on how we can revise the criteria for satisfactory reporting in an operationally practical and feasible manner to achieve the goals cited by commenters.

Comment: One comment was received with respect to the MAV, which allows us to determine whether an eligible professional should have reported quality data codes for additional measures when an eligible professional submits fewer than 3 individual PQRI measures. The commenter requested that CMS provide updates on newly identified clusters of closely related measures that will be employed in the MAV for 2010.

Response: No changes are planned for the MAV process for 2010. Additional information on the MAV process are listed on the Analysis and Payment page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI. However, we are contemplating some changes to the clusters of closely related measures based on the addition or removal of measures in the 2010 PQRI or the fact that certain measures included in these clusters will become registry-only measures for 2010. For example, if measures in an existing cluster are retired for the 2010 PQRI or are made registry-only then the cluster will be revised or deleted as appropriate.

Based on the new 2010 PQRI measures, the only new clusters being contemplated are a second preventive cluster, 2 new anesthesia care clusters, an ear care cluster, and an Ischemic Vascular (IVD) cluster. The second preventive cluster would consist of the following 2 measures: (1) Measure #114 Preventive Care and Screening: Inquiry Regarding Tobacco Use and (2) Measure #115 Preventive Care and Screening: Advising Smokers and Tobacco Users to Quit. The first anesthesia care cluster would consist of 2 measures: (1) Measure #30 Perioperative Care: Timely Administration of Prophylactic Parenteral Antibiotics and (2) Measure #76 Prevention of Catheter-Related Bloodstream Infections (CRBI): Central Venous Catheter (CVC) Insertion Protocol. The second anesthesia care cluster would consist of Measure #76 and the new Perioperative Temperature Management measure. For both of the anesthesia care clusters, however, the MAV would not apply if an eligible professional reports only Measure #76. Measure # 76 is a broadly applicable measure that encompasses services often provided by eligible professionals for whom Measure #30 and the Perioperative Temperature Management measure do not apply such as intensivists, hospitalists, internists, and emergency physicians. The ear care cluster would consist of the 3 new referral for otologic evaluation measures listed in Table 13 of this final rule. The IVD cluster would consist of the following 4 new PQRI measures:

  • Ischemic Vascular Disease (IVD): Blood Pressure Management Control;
  • Ischemic Vascular Disease (IVD): Complete Lipid Profile;
  • Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL-C) Control; and
  • Ischemic Vascular Disease (IVD): Use of Aspirin or Another Anti-Thrombotic.

By no later than December 31, 2009, we will post the final MAV process for 2010 and the final 2010 MAV clusters on the Analysis and Payment page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/25_AnalysisAndPayment.asp#TopOfPage.

After considering the comments and the new 6-month reporting period for claims-based reporting of individual PQRI quality measures that we are adding to the 2010 PQRI at the request of commenters, the final 2010 criteria for satisfactory reporting of data on individual PQRI quality measures are summarized in Table 7 and are arranged by reporting mechanism and reporting period. The criteria for satisfactory reporting for claims-based reporting of individual PQRI quality measures for the 6-month reporting period are consistent with the criteria for satisfactory reporting of individual PQRI quality measures.

For the 2010 PQRI, there are a total of 5 reporting options, or ways, in which an eligible professional may meet the criteria for satisfactory reporting on individual quality measures. Each reporting option consists of the criteria for satisfactory reporting such data and results on individual quality measures relevant to a given reporting mechanism and reporting period. While eligible professionals may potentially qualify as satisfactorily reporting individual quality measures under more than one of the reporting criteria, reporting mechanisms, and/or for more than one reporting period, only one incentive payment will be made to an eligible professional based on the longest reporting period for which the eligible professional satisfactorily reports.

Table 7—2010 Criteria for Satisfactory Reporting of Data on Individual PQRI Quality Measures, by Reporting Mechanism and Reporting Period Back to Top
Reporting mechanism Reporting criteria Reporting period
Claims-based reporting • Report at least 3 PQRI measures, or 1-2 measures if less than 3 measures apply to the eligible professional; and January 1, 2010-December 31, 2010.
• Report each measure for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measure applies.  
Claims-based reporting • Report at least 3 PQRI measures, or 1-2 measures if less than 3 measures apply to the eligible professional; and July 1, 2010-December 31, 2010.
• Report each measure for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measure applies.  
Registry-based reporting • Report at least 3 PQRI measures; and January 1, 2010-December 31, 2010.
• Report each measure for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measure applies.  
Registry-based reporting • Report at least 3 PQRI measures; and July 1, 2010-December 31, 2010.
• Report each measure for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measure applies.  
EHR-based reporting • Report at least 3 PQRI measures; and January 1, 2010-December 31, 2010.
• Report each measure for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measure applies.  

f. Proposed Criteria for Satisfactory Reporting Measures Groups for Individual Eligible Professionals

For the 2010 PQRI, we proposed 2 basic sets of criteria for satisfactory reporting on a measures group (74 FR 33568). Both sets of criteria would apply to the claims-based and registry-based reporting mechanism. We did not propose to make the EHR-based reporting mechanism available for reporting on measures groups in 2010.

The first set of proposed criteria, which we proposed to make available for either the 12-month or 6-month reporting period in 2010, would be consistent with the 2009 criteria for satisfactory reporting of measures groups through registry-based reporting, which require the reporting of at least 1 measures group for at least 80 percent of patients to whom the measures group applies during the applicable reporting period (with reporting required on a minimum number of Medicare Part B FFS patients commensurate with the reporting period duration). In the 2009 PQRI, there was a requirement under these criteria to report each measures group on at least 30 Medicare Part B FFS patients for the 12-month reporting period and at least 15 Medicare Part B FFS patients for the 6-month reporting period for registry-based reporting of measures groups. For the 2010 PQRI, we proposed to revise the requirement by making these criteria applicable to both registry-based and claims-based reporting and to change the number of Medicare Part B FFS patients on which an eligible professional would be required to report a measures group. We proposed to require an eligible professional who chooses to report on measures groups based on reporting on 80 percent of applicable patients to report on a minimum of 15 Medicare Part B FFS patients for the 12-month reporting period and a minimum of 8 Medicare Part B FFS patients for the 6-month reporting period, regardless of whether the eligible professional chooses to report the measures group through claims-based reporting or registry-based reporting.

The second set of proposed criteria, which we proposed to make available for the 12-month reporting period only, would be based on reporting on a measures group on a specified minimum number of patients (74 FR 33568). The second set of criteria would require reporting on at least 1 measures group for at least 30 patients seen between January 1, 2010 and December 31, 2010 to whom the measures group applies. Unlike the 2009 PQRI, which required that eligible professionals report on consecutive patients (that is, patients seen in order, by date of service), the 30 patients on which an eligible professional would need to report a measures group for 2010 would not need to be consecutive patients. The eligible professional would be able to report on any 30 unique patients seen during the reporting period to which the measures group applies. As in previous years, we proposed that for 2010, the patients, for claims-based reporting, would be limited to Medicare Part B FFS patients. For registry-based reporting, however, we proposed that the patients could include some, but not be exclusively, non-Medicare Part B FFS patients.

We solicited comments on our proposal to make the criteria for satisfactory reporting of measures groups more consistent with those proposed for reporting individual measures, including our proposal to revise the minimum sample size requirement related to satisfactory reporting on measures group through the registry-based reporting mechanism so that the criteria for satisfactory reporting of measures groups, regardless of reporting mechanism, would be identical to those proposed for reporting individual measures. We also solicited comments on our proposal to allow eligible professionals to report on measures groups on any 30 patients rather than a consecutive patient sample.

The following is summary of the comments we received regarding the criteria for satisfactory reporting measures groups for individual eligible professionals.

Comment: A few commenters agreed with the proposal to make the criteria for satisfactory reporting of measures groups more consistent with those proposed for reporting individual measures. One commenter cited that doing so makes the program more accessible and improves the commenter's ability to educate their members.

Response: We agree that making the criteria for satisfactory reporting of measures groups more consistent with those proposed for reporting individual measures should facilitate participation and enhance education efforts. For the reasons cited in section II.G.2.e. of this final rule with comment period, we are not finalizing our proposal to add a minimum patient sample requirement to the criteria for satisfactory reporting of individual measures. For the 2010 PQRI criteria for satisfactory reporting of measures groups, however, we will retain the minimum patient sample size requirement for those eligible professionals who choose to report on measures groups based on reporting on 80 percent of applicable patients and will finalize the lower thresholds for the minimum patient sample size requirement proposed for 2010.

Comment: We received numerous comments in support of our proposal to allow eligible professionals to report on measures groups on any 30 patients rather than a consecutive patient sample.

Response: We appreciate the commenters' positive feedback and hope that this change will make measures group reporting a more attractive option for eligible professionals.

Comment: A few commenters were opposed to removing the requirement that the 30 patients be consecutive. A few commenters expressed that reporting of measures groups on consecutive patients reduces opportunities for selectively reporting patients or cases with more favorable results or would result in reporting on non-representative patient samples. Another commenter suggested the CMS eliminate the option of reporting on 30 patients through claims altogether or allow eligible professionals to report on non-consecutive patients but require a reporting period within which the 30 patients must be selected.

Response: We believe that retaining the option to report on 30 patients provides an incentive to eligible professionals to consider reporting measures groups instead of individual PQRI measures. As we have stated previously, we believe that measures groups enable a more comprehensive assessment of patient care for a given clinical condition or focus by addressing several aspects of care for that particular clinical condition or focus. Because we believe that measures groups may often provide more meaningful information about the care being furnished to Medicare beneficiaries than individual measures reported in isolation, we would like to encourage measures group reporting where possible.

With respect to commenters' concerns that removing the requirement that eligible professionals report on 30 patients, we reiterate that we believe that it would be difficult for eligible professionals to selectively choose which patients to report on since they must report on multiple measures for a given clinical condition or focus. We will, however, continue to monitor the PQRI data to determine whether this needs to be reassessed in future years.

Comment: We received some comments supporting the proposed revisions to the minimum patient sample size requirement for PQRI reporting of measures group (that is, reducing the thresholds from reporting at least 30 patients for at least 1 measures group for the 12-month reporting period and at least 15 patients for at least 1 measures group for the 6-month reporting period to 15 and 8 patients, respectively). Some commenters also remarked that the proposed thresholds were reasonable and appropriate. One commenter, however, remarked that the proposed thresholds were not adequate.

Response: We are finalizing the thresholds as proposed to provide eligible professionals with fewer than 30 patients an opportunity to report on PQRI measures groups for 2010. As identified in Table 8, the new minimum patient sample size thresholds for measures groups reporting for the 2010 PQRI will be 15 patients for at least 1 measures group for the 12-month reporting period and 8 patients for at least 1 measures group for the 6-month reporting period.

As suggested by another commenter, however, we will continue to monitor the PQRI data on an ongoing basis to determine whether the criteria for satisfactory reporting of measures groups, including the minimum patient sample size requirements, need to be re-evaluated for future years.

After considering the comments and for the reasons discussed previously, the final 2010 criteria for satisfactory reporting of data on measures groups are summarized in Table 8 and are arranged by reporting mechanism and reporting period. Accordingly, there are a total of 6 reporting options, or ways in which an eligible professional may meet the criteria for satisfactory reporting of measures groups for the 2010 PQRI. Each reporting option consists of the criteria for satisfactory reporting relevant to a given reporting mechanism and reporting period. As stated previously, while eligible professionals may potentially qualify as satisfactorily reporting on measures groups under more than one of the reporting criteria, reporting mechanisms, and/or for more than one reporting period, only one incentive payment will be made to an eligible professional based on the longest reporting period for which the eligible professional satisfactorily reports. Similarly, an eligible professional could also potentially qualify for the PQRI incentive payment by satisfactorily reporting both individual measures and measures groups. However, only one incentive payment will be made to the eligible professional based on the longest reporting period for which the professional satisfactorily reports.

Table 8—2010 Criteria for Satisfactory Reporting on Measures Groups, by Reporting Mechanism and Reporting Period Back to Top
Reporting mechanism Reporting criteria Reporting period
Claims-based reporting • Report at least 1 PQRI measures group; January 1, 2010—December 31, 2010.
• Report each measures group for at least 30 Medicare Part B FFS patients.  
Claims-based reporting • Report at least 1 PQRI measures group; January 1, 2010—December 31, 2010.
• Report each measures group for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; and  
• Report each measures group on at least 15 Medicare Part B FFS patients seen during the reporting period to which the measures group applies.  
Claims-based reporting • Report at least 1 PQRI measures group; July 1, 2010-December 31, 2010.
• Report each measures group for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; and  
• Report each measures group on at least 8 Medicare Part B FFS patients seen during the reporting period to which the measures group applies.  
Registry-based reporting • Report at least 1 PQRI measures group; January 1, 2010-December 31, 2010.
• Report each measures group for at least 30 patients. Patients may include, but may not be exclusively, non-Medicare Part B FFS patients.  
Registry-based reporting • Report at least 1 PQRI measures group; January 1, 2010-December 31, 2010.
• Report each measures group for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; and  
• Report each measures group on at least 15 Medicare Part B FFS patients seen during the reporting period to which the measures group applies.  
Registry-based reporting • Report at least 1 PQRI measures group; July 1, 2010-December 31, 2010.
• Report each measures group for at least 80% of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; and  
• Report each measures group on at least 8 Medicare Part B FFS patients seen during the reporting period to which the measures group applies.  

g. Reporting Option for Satisfactory Reporting on Quality Measures by Group Practices

As discussed above, for 2010, incentive payments will be available to group practices based on the determination that the group practice, as a whole (that is, for the TIN), satisfactorily reports on PQRI quality measures for 2010. If, however, an individual eligible professional is affiliated with a group practice participating in the group practice reporting option and the group practice satisfactorily reports under the group practice reporting option, the eligible professional will not be eligible to earn a separate PQRI incentive payment for 2010 on the basis of his or her satisfactorily reporting PQRI quality measures data at the individual level under that same TIN (that is, for the same TIN/NPI combination).

(1) Definition of “Group Practice”

As stated in the proposed rule (74 FR 33570), section 1848(m)(3)(C)(i) of the Act authorizes the Secretary to define “group practice.” For purposes of determining whether a group practice satisfactorily submits PQRI quality measures data, we proposed that a “group practice” would consist of a physician group practice, as defined by a single TIN, with at least 200 or more individual eligible professionals (as identified by Individual NPIs) who have reassigned their billing rights to the TIN. We solicited comments on the proposed definition of “group practice” and our proposal to limit initial implementation of the PQRI group practice reporting option in 2010 to practices with 200 or more individual eligible professionals.

We also proposed to require group practices to complete a self-nomination process and to meet certain technical and other requirements in order to participate in the 2010 PQRI through the group practice reporting option (74 FR 33570). Group practices interested in participating in the 2010 PQRI through the group practice reporting option would be required to submit a self-nomination letter to CMS requesting to participate in the 2010 PQRI group practice reporting option. The following is a summary of the comments received regarding the proposed definition of “group practice” and the proposed self-nomination requirements.

Comment: Several commenters requested that we consider allowing smaller group practices to participate in this reporting option. Commenters were concerned that defining a group practice as 200 or more eligible professionals will lead to inaccurate data and further bias. Commenters encouraged us to look for ways to make the option more accessible for most group practices, including those that are not large group practices. Commenters requested that we consider whether in the future smaller group practice sizes should be allowed to participate in this option. Commenters also requested an alternative reporting option that uses statistical sampling for primary care oriented group practices that report measures only applicable to primary care physicians.

Response: We are appreciative of the commenters' thoughtful and constructive feedback and will take these concerns into consideration as we further develop the group practice reporting option. However, the group practice reporting option draws from the experiences of the Physician Group Practice (PGP) demonstration and the Medicare Care Management Performance (MCMP) demonstration. Each of these demonstrations included physician groups, but of different sizes. The PGP demonstration, which the group practice reporting option statistical sampling method is primarily modeled after, has been successful. We recognize that the group practice size of 200 or more individual eligible professionals limits participation. The inclusion of smaller group practices that is those with less than 200 individual eligible professionals, in the group practice reporting option was not proposed at this time because we believe it is unlikely that the smaller groups would be able to achieve 411 assigned Medicare beneficiaries per disease module or preventive care measure that we use under the demonstration. We will use this initial implementation year to further develop and refine aspects of the group practice reporting option and anticipate adapting and expanding this option to group practices less than 200 individual eligible professionals in future program years.

Comment: Several commenters were supportive of the group practice reporting option and thought that the group level data would be more meaningful. Commenters expressed that they are pleased to see the group practice reporting option which has many benefits and that CMS has taken a logical step of initially basing the group reporting process on the PGP and MCMP demonstrations. A commenter stated that group practice reporting option encourages voluntary reporting and promotes better care coordination and a team-based approach to care. One commenter suggested that the group practice reporting option reduces the significant resources which practices currently need to report measures. Another commenter stated the group practice reporting option allows for increased provider participation and greater transparency in the healthcare provided to Medicare beneficiaries and suggested that the group practice reporting option will bring greater attention to a range of important therapeutic areas.

Response: The group practice reporting option is based on certain aspects of the PGP and the MCMP demonstrations. As defined, the group practice reporting option is intended for large physician groups to report on the high-cost chronic care quality measures for the specific disease modules and preventive care.

Comment: A few commenters supported the proposal for public reporting of group practices' performance results. One commenter, however, did so with the caveat that CMS monitors the results to ensure that there are no unintended consequences.

Response: We appreciate the commenters' positive feedback. As we have stated previously, it is our desire to be able to move towards public reporting of performance results for physicians and other eligible professionals. We believe that public reporting of group practice performance results provides an opportunity to move towards achieving that goal with PQRI data.

Comment: Several commenters were opposed to public reporting of the group practices' PQRI performance results because they believe:

  • The reporting process for group practices needs to be further tested to ensure that there are no problems when we implement this process into PQRI, that validity and accuracy of the measures as a reflection of performance, and that there are no unintended consequences;
  • CMS does not have specific authority from the Congress to post performance results;
  • Doing so would be premature and discourage groups from participating in this option;
  • Many issues identified in the CMS Issue Paper: Development of a Plan to Transition to a Medicare Value-Based Purchasing Program for Physician and Other Professional Services should be addressed prior to public reporting of performance results. Once addressed, public reporting of performance results should be conducted for all PQRI participants, not just group practices;

For similar reasons, other commenters requested that we delay public reporting of the group practices' performance results for at least 1 year or wait until we are fully satisfied with the reliability and validity of the performance data collected from group practices.

Response: Section 1848(m)(3)(C) of the Act requires us to establish a process under which eligible professionals in a group practice shall be treated as satisfactorily submitting data on PQRI quality measures and provides the Secretary with the discretion to determine how to set up this process. For group practices that choose to participate in the PQRI, participation in the group practice reporting option is voluntary. Group practices have a choice as to whether they wish to participate in PQRI with each eligible professional in the group participating individually using one of the reporting options available to individual eligible professionals or to participate as a group through the group practice reporting option.

Furthermore, we believe that public reporting of performance information at the group level does not present some of the same issues that public reporting of performance information at the individual eligible professional would. For example, as we stated in the CY 2010 PFS proposed rule, no performance results would be calculated based on small denominator sizes due to the reporting criteria for the group practice reporting option, which require that group practices report each disease module or preventive care measure under the group practice reporting option for 411 patients. Nevertheless, we take note of the importance of working through the concerns raised by commenters about publicly posting groups' performance results, especially commenters' concerns about doing so in the first year of implementation of the group practice reporting option and the importance of giving participating group practices an opportunity to review their results from the first year of the group practice reporting option before any information is publicly reported. Therefore, we are not finalizing our proposal to require group practices that wish to utilize the group practice reporting option in 2010 to agree to have their PQRI performance results publicly reported. In addition, we will not report any 2010 group practice performance results publicly except as otherwise required by law and will limit public reporting of information on the PQRI group practice reporting for 2010 to the information required by section 1848(m)(5)(G)(i) of the Act (that is, the names of group practices that satisfactorily submitted data on 2010 PQRI quality measures). Instead, we will consider implementing public reporting of group practices' performance results in the 2011 PQRI program year.

For the reasons discussed above and based on these comments, a group practice, for purposes of finalizing the 2010 PQRI group practice reporting option, a group practice will consist of a single TIN with at least 200 or more individual eligible professionals (as identified by Individual NPIs) who have reassigned their billing rights to the TIN. Additionally, the TIN and all Individual NPIs must be established Medicare providers.

To participate in the 2010 PQRI group practice reporting option, a group practice will be required to submit a self-nomination letter indicating the group practice's interest in participating in the 2010 PQRI group practice reporting option. Also, the letter must be accompanied by an electronic file submitted in a format specified by CMS (such as, a Microsoft Excel file) that includes the group practice's TIN and the Individual NPI numbers, name of the group practice, and names of all eligible professionals who will be participating as part of the group practice (that is, all Individual NPI numbers, which are established Medicare providers and associated with the group practice's TIN), a single point of contact for handling administrative issues as well as a single point of contact for technical support purposes. In addition, the self-nomination letter must also indicate the group practice's compliance with the following requirements:

  • Have an active IACS user account;
  • Agree to attend and participate in all mandatory training sessions; and
  • Have billed Medicare Part A and Part B on or after January 1, 2009 and prior to October 29, 2009.

The final participation requirements listed above for group practices, including instructions for submitting the self-nomination letter and other requested information, will be posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI by November 15, 2009. Group practices that wish to self-nominate for 2010 will be required to do so by January 31, 2010. Upon receipt of the self-nomination letters we will assess whether the participation requirements were met by each self-nominated group practice using 2009 Medicare claims data.

As discussed further in section II.G.5. of this final rule, participation in the E-Prescribing Incentive Program is voluntary for group practices selected to participate in the PQRI group practice reporting option. However, we are requiring group practices to participate in the PQRI group practice reporting option in order to be eligible to participate in the electronic prescribing group practice reporting option. Therefore, a group practice that wishes to participate in both the PQRI group practice reporting option and the electronic prescribing group practice reporting must notify CMS of its desire to do so at the time that it self-nominates to participate in the PQRI group practice reporting option.

(2) Process for Physician Group Practices to Participate as Group Practices and Criteria for Satisfactory Reporting Data on Quality Measures by Group Practices

For physician groups selected to participate in the PQRI group practice reporting option for 2010, we proposed (74 FR 33570) the reporting period would be the 12-month reporting period beginning January 1, 2010. We proposed that group practices would be required to submit information on these measures using a data collection tool based on the data collection tool used in CMS' MCMP demonstration and the quality measurement and reporting methods used in CMS' PGP demonstration. We proposed that physician groups selected to participate in the 2010 PQRI through the group practice reporting option would be required to report on a common set of 26 NQF-endorsed quality measures that are based on measures currently used in the MCMP and/or PGP demonstration and that target high-cost chronic conditions and preventive care.

As part of the data submission process, we proposed that, beginning in 2011, each group practice would be required to report quality measures with respect to services furnished during the 2010 reporting period (that is, January 1, 2010 through December 31, 2010) on an assigned sample of Medicare beneficiaries. We proposed to analyze the January 1, 2010 through October 29, 2010 (that is, the last business day of October 2010) National Claims History (NCH) file to assign Medicare beneficiaries to each physician group practice using the same patient assignment methodology used in the PGP demonstration.

We solicited comments on our proposal to adopt the PGP demonstration's quality measurement and reporting methods for the PQRI group practice reporting option. We specifically requested comments on the proposed patient assignment methodology and our proposal to use a data collection tool based on the one used in the MCMP demonstration as the reporting mechanism for physician groups selected to participate in the PQRI group practice reporting option.

We also proposed 2 criteria for satisfactory reporting of quality measures by a physician group (74 FR 33571). First, the physician group would be required to report completely on all of the proposed modules and measures listed in Table 34 of the proposed rule (74 FR 33588). Second, the physician group would be required to report completely on the first 411 consecutively assigned and ranked Medicare beneficiaries per disease module or preventive care measure.

The following is a summary of the comments we received regarding the proposed reporting option for satisfactory reporting on quality measures by group practices under PQRI.

Comment: One commenter was troubled by our proposal to model the PQRI group practice reporting option on the PGP demonstration since only half of PGP participants earned the incentive payment in the 3rd year of the demonstration. Another commenter noted that transitioning from individual eligible professional reporting to group practice reporting and from pay-for-reporting to pay-for-performance are major and challenging steps.

Response: Although we are planning to model the data collection and sampling process for the PQRI group practice reporting option after the PGP demonstration, we reiterate that the PQRI group practice reporting option is distinct from the PGP demonstration. The requirements to qualify for the incentive for PQRI are different from the requirements to qualify for an incentive payment under the demonstration. Whereas the PGP demonstration is a pay-for-performance demonstration, the PQRI group practice reporting option, like the remainder of the PQRI program, is solely a pay-for-reporting program. Group practices will qualify for a PQRI incentive payment based on meeting the reporting criteria. The PQRI incentive is not based on the group practice's performance on the measures nor on cost savings.

Comment: Several Commenters were concerned with the proposed patient assignment methodology. A few commenters asked CMS to reconsider requirements in order to refine the attribution methodology. One commenter opposed the retrospective attribution. One commenter suggested that we limit the E/M visits to primary care physicians selected other specialists, such as endocrinologists and cardiologists, who frequently provide and coordinate care for Medicare beneficiaries. Another commenter recommended the following refinements: (1) Use claims that have the CPT code for “established” patients only; (2) use claims that show the place of service code 11 (the code for office visits); and (3) require that the patients have had at least two office visits during the year in order to get into the sample.

Response: For the group practice reporting option, the patient sample will be based on Medicare Part B claims submitted by the group practices' TIN for services provided from January 1, 2010 through October 29, 2010. Only claims appearing in CMS NCH by October 29, 2010, will be considered in the patient sampling and assignment processes. Patients will be assigned to the group practice if they receive the plurality of their Office or Other Outpatient E/M services from the practice. The assigned patients who are selected for quality reporting must have received Office or Other Outpatient E/M services from the practice at least two times in the 10-month period. Furthermore, part-year and managed care patients will not be considered since we have incomplete claims for these individuals and groups may not have had sufficient time to impact the quality of their care. The retrospective attribution will allow CMS to more accurately assign patients using Medicare Part B claims that have been submitted by the group practices' TIN and processed into the NCH.

Comment: One commenter stated that the eligible professionals' affiliation with a group practice will dictate participation. A commenter asked us to allow group practices the flexibility to decide at any stage in the reporting process whether they want to continue with the group reporting process.

Response: The group practice reporting option provides an additional method of participating in PQRI. We do not dictate participation in PQRI, nor do we dictate whether an eligible professional participates in PQRI as an individual or as part of a group. PQRI is a voluntary program. The decision to participate in PQRI is at the discretion of the eligible professional. The eligible professional may participate in PQRI under multiple unique TIN/NPI combinations. An eligible professional may also report via more than one reporting option. The eligible professional cannot, however, receive a duplicate incentive payment for the same TIN/NPI combination.

The eligible professional can receive separate incentive payments by participating and qualifying under one or more unique TIN/NPI combinations. For example, if an eligible professional with TIN/NPI 003/001 participates in the group practice reporting option for one practice and also participates as an individual using TIN/NPI 005/001 the eligible professional can qualify and earn a separate incentive payment for both TIN/NPI combinations because this is under a different TIN/NPI combination. In the event that a group practice is unsuccessful with the group practice reporting option, we will not conduct analysis to determine if the TIN/NPI qualified and is incentive eligible for other methods of PQRI participation. There is no appeals process for PQRI.

Comment: One commenter asked that we provide a mechanism for allowing group practices to deselect patients who have been assigned to the group practice.

Response: We understand that due to circumstances out of the groups' control (that is, death, unable to locate a medical record, etc.) that the group practice may not be able to report completely on 100 percent of the first 411 consecutively ranked assigned patient sample. The reporting tool allows for exclusions in certain instances and the group will not be required to populate the tool when these circumstances arise. In order to accommodate for such issues, each group practice will be assigned an over sample of patients, which will assure that the group practice reports completely on 411 consecutively assigned patients per disease module and preventive care measure to report on. The experience from the PGP demonstration has shown that this sampling method provides a sufficient number of assigned patients in the event that the deselection of assigned patients is warranted.

Comment: One commenter specifically supported using the Performance Assessment Tool (PAT), which is the data collection tool used in the PGP and MCMP demonstrations and proposed for use in PQRI group practice reporting option. Another commenter supports using the PAT and applauds quick turnaround time we anticipate for providing pre-populated results to practices.

Response: We appreciate the commenters' support for the data collection tool. We anticipate providing the selected group practices with a pre-populated data collection tool. Data fields will be pre-populated based on Medicare claims and demographic information for dates of service between January 1, 2010 and October 29, 2010. This tool will be modeled after the PAT currently in use for the MCMP program, with some modifications. The tool will require, at a minimum, standard PC image with Microsoft Office and Microsoft Access software installed and minimum software configurations for the group practices to successfully complete the data collection tool. The data collection tool may potentially provide a high level feedback (submission) report to the group practice, including such information as percentage of patients that have been completed in the sample and percentage of positive measure results. These features will allow the group practices to verify data prior to submitting it to us. We reserve the right to audit the data submitted by the group practices.

Comment: One commenter stated that only those group practices that have participated in the PGP demonstration will be successful in completing the tool and participating in the group practice reporting option.

Response: Group practices participating in the PGP demonstration will not be allowed to participate in the PQRI group practice reporting option in 2010. We acknowledge that there will be a learning period needed to become familiar with and to complete the tool. Group practices that are selected to participate in the PQRI group practice reporting option will be required to attend mandatory training sessions. Prior to these mandatory training sessions, we anticipate providing the group practices with a sample tool to become familiar with its functionality and reporting process. Additionally, we may establish periodic conference calls with the group practices, with most calls being held during the tool data entry period, to provide technical support to practices. The group practices will be required to designate administrative and technical points of contact to streamline and assist with communication.

Comment: One commenter stated that it would be challenging for group practices to report on 26 measures.

Response: We disagree that it would be challenging for group practices to report on 26 measures. We will be prepopulating the data collection tool that will be used for the PQRI group practice reporting option with claims and other demographic information on the group practices' assigned Medicare beneficiaries prior to sending the data collection tool to the groups to complete. Furthermore, we believe the burden of reporting the 26 measures is outweighed by the potential incentive payment. Completion of this data collection tool on all 26 measures for the required number of patients essentially qualifies the group practice for an incentive payment equal to 2.0 percent of the group practice's estimated total Medicare Part B PFS allowed charges for services furnished during the reporting period.

For the reasons discussed above and after taking into consideration the comments, we are finalizing the process group practices will be required to use to report data on quality measures for the 2010 PQRI as a group practice and the associated criteria for satisfactory reporting of data on quality measures by group practices, which are summarized in Table 9. Group practices participating in PQRI as a group practice will be required to report on all of the measures listed in Table 28 of this final rule with comment period. These quality measures are grouped into preventive care measures and four disease modules: diabetes; heart failure; coronary artery disease; and hypertension.

Although the process for physician groups to participate in PQRI as a group practice incorporates some characteristics and methods from the PGP demonstration and the MCMP demonstration, the PQRI group practice reporting option is a separate program with its own specifications and methodology from the PGP and MCMP demonstration programs. The reporting process for the group practice reporting option, including the use of a data collection tool as the reporting mechanism, will not be available to individual eligible professionals participating in the 2010 PQRI.

As stated in the proposed rule (74 FR 33570 through 33571), we will analyze the January 1, 2010 through October 29, 2010, NCH file to assign Medicare beneficiaries to each physician group practice using the same patient assignment methodology used in the PGP demonstration. Assigned beneficiaries will be limited to those Medicare FFS beneficiaries with Medicare Parts A and B for whom Medicare is the primary payer. Assigned beneficiaries will not include Medicare Advantage enrollees. A beneficiary will be assigned to the physician group that provides the plurality of a beneficiary's office or other outpatient E/M allowed charges (based on Medicare Part B claims submitted for the beneficiary for dates of services between January 1, 2010 and October 29, 2010). Beneficiaries with only 1 visit to the group practice between January 1, 2010 and October 29, 2010, will be eliminated from the group practice's assigned patient sample. For inclusion in the sample, beneficiaries will be required to have at least 2 visits to the group practice between January 1, 2010 and October 29, 2010.

Once the beneficiary assignment has been made for each physician group during the fourth quarter of 2010, we will provide each physician group selected to participate in the group practice reporting option with access to a database (that is, a data collection tool) that will include the group's assigned beneficiary samples and the quality measures listed in Table 28. We will prepopulate the data collection tool with the assigned beneficiaries' demographic and utilization information based on all of their Medicare claims data. We intend to provide the selected physician groups with access to this prepopulated database by no later than the first quarter of 2011. The physician group will be required to populate the remaining data fields necessary for capturing quality measure information on each of the assigned beneficiaries. Numerators for each of the quality measures will include all beneficiaries in the denominator population who also satisfy the quality performance criteria for that measure. Denominators for each quality measure will include a sample of the assigned beneficiaries who meet the eligibility criteria for that disease module or each preventive care quality measure. All of the assigned patients' inpatient, outpatient, and physician claims will be used in determining clinical eligibility for each module. Identical to the sampling method used in the PGP demonstration, the random sample must consist of at least 411 assigned beneficiaries. If the pool of eligible assigned beneficiaries is less than 411, then the group practice must report on 100 percent, or all, of the assigned beneficiaries to satisfactorily participate in the group practice reporting option. For each disease module or preventive care measure, the physician group will be required to report information on the assigned patients in the order in which they appear in the group's sample (that is, consecutively).

Table 9—2010 Process for Physician Group Practices To Participate as Group Practices and Criteria for Satisfactory Reporting of Data on Quality Measures by Group Practices Back to Top
Reporting mechanism Reporting criteria Reporting period
• A pre-populated data collection tool provided by CMS • Report on all measures included in the data collection tool (26 measures); and January 1, 2010-December 31, 2010.
• Complete the tool for the first 411 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each disease module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 411, then report on 100% of assigned beneficiaries  

h. Statutory Requirements and Other Considerations for 2010 PQRI Measures

(1) Statutory Requirements for 2010 PQRI Measures

As discussed in the proposed rule (74 FR 33571 through 33572), the statutory requirements with respect to the use of quality measures for the 2010 PQRI are different from the statutory requirements for previous program years. For purposes of reporting data on quality measures for covered professional services furnished during 2010 and subsequent years for the PQRI, subject to the exception noted below, section 1848(k)(2)(C)(i) of the Act, as added by MIPPA, requires that the quality measures shall be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under subsection 1890(a) of the Act (that is, the National Quality Forum, or NQF). In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the NQF, however, section 1848(k)(2)(C)(ii) of the Act authorizes the Secretary to specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary, such as the AQA alliance.

Finally, section 1848(k)(2)(D) of the Act requires that for each 2010 PQRI quality measure, “the Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish.”

(2) Other Considerations for Measures Selected for Inclusion in the 2010 PQRI

Based on the statutory requirements described above, we stated in the CY 2010 PFS proposed rule (74 FR 33572 through 33573) that we proposed to apply the following considerations with respect to the selection of 2009 PQRI quality measures for inclusion in the 2010 PQRI quality measure set:

  • Where some 2009 PQRI quality measures have been endorsed by the NQF and others have not, those 2009 PQRI quality measures that have been specifically considered by NQF for possible endorsement, but NQF has declined to endorse it, will not be included in the 2010 PQRI quality measure set (that is, we will retire the measure for 2010).
  • In circumstances where no NQF-endorsed measure is available, we will exercise the exception under section 1848 (k)(2)(C)(ii) of the Act. Under these circumstances, a 2009 PQRI quality measure that previously (that is, prior to January 31, 2009) has been adopted by the AQA will meet the requirements under the Act and it would be appropriate for eligible professionals to use the measure to submit quality measures data and/or quality measures results and numerator and denominator data on quality measures, as appropriate.
  • Although we are not including any 2009 PQRI measures that have not been endorsed by the NQF or adopted by the AQA in the final 2010 PQRI quality measure set, we acknowledge that section 1848(k)(C)(ii) of the Act provides an exception to the requirement that the Secretary select measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF) as long as an area or medical topic for which a feasible and practical NQF-endorsed measure is not available has been identified and due consideration has been given to measures that have been endorsed by the NQF and/or, prior to January 31, 2009, adopted by the AQA.
  • The statutory requirements under section 1848(k)(2)(C) of the Act, subject to the exception noted above, require only that the measures be selected from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) (that is, the NQF) and are silent with respect to how the measures that are submitted to the NQF for endorsement were developed. The basic steps for developing measures applicable to physicians and other eligible professionals prior to submission of the measures for endorsement may be carried out by a variety of different organizations. We do not believe there needs to be any special restrictions on the type or make up of the organizations carrying out this basic development of physician measures, such as restricting the initial development to physician-controlled organizations. Any such restriction would unduly limit the basic development of quality measures and the scope and utility of measures that may be considered for endorsement as voluntary consensus standards.
  • 2009 PQRI measures that were part of the 2007 and/or 2008 PQRI in which the 2007 and 2008 PQRI analytics indicate a lack of significant reporting and usage were not considered for inclusion in the 2010 PQRI.

In addition to reviewing the 2009 PQRI measures and previously retired measures, for purposes of developing the proposed 2010 PQRI measures, we reviewed and considered measure suggestions including comments received in response to the CY 2009 PFS proposed rule and final rule with comment period. Additionally, suggestions and input received through other venues, such as an invitation for measures suggestions posted on the PQRI section of the CMS Web site in February 2009 were also reviewed and considered for purposes of our development of the list of proposed 2010 PQRI quality measures. All measures and measures groups reviewed for potential inclusion in the 2010 PQRI measure set are listed in the “Table of 2010 Measure Suggestions” posted on the Statute/Regulations/Program Instructions page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/05_StatuteRegulationsProgramInstructions.asp#TopOfPage.

With respect to the selection of new measures (that is, measures that have never been selected as part of a PQRI quality measure set for 2009 or any prior year), we stated in the CY 2010 PFS proposed rule (74 FR 33572 through 33573) that we would apply the following considerations, which include many of the same considerations applied to the selection of 2009 PQRI quality measures for inclusion in the 2010 PQRI quality measure set described above:

  • High Impact on Healthcare.

+ Measures that are high impact and support CMS and HHS priorities for improved quality and efficiency of care for Medicare beneficiaries. These current and long term priority topics include: prevention; chronic conditions; high cost and high volume conditions; elimination of health disparities; healthcare-associated infections and other conditions; improved care coordination; improved efficiency; improved patient and family experience of care; improved end-of-life/palliative care; effective management of acute and chronic episodes of care; reduced unwarranted geographic variation in quality and efficiency; and adoption and use of interoperable HIT.

+ Measures that are included in, or facilitate alignment with, other Medicare, Medicaid, and CHIP programs in furtherance of overarching healthcare goals.

  • NQF Endorsement.

+ Measures must be NQF-endorsed by July 1, 2009, in order to be considered for inclusion in the 2010 PQRI quality measure set.

+ Although we did not propose to include any new measures that were not endorsed by the NQF by July 1, 2009 in the final 2010 PQRI quality measure set, we acknowledge that section(k)(2)(C)(ii) of the Act provides an exception to the requirement that the Secretary select measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF). As long as an area or medical topic for which a feasible and practical NQF-endorsed measure is not available has been identified and due consideration has been given to measures that have been adopted by the AQA or other consensus organization identified by the Secretary.

+ The statutory requirements under section 1848(k)(2)(C) of the Act, subject to the exception noted above, require only that the measures be selected from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) (that is, the NQF) and are silent with respect to how the measures that are submitted to the NQF for endorsement were developed. The basic steps for developing measures applicable to physicians and other eligible professionals prior to submission of the measures for endorsement may be carried out by a variety of different organizations. We do not believe there needs to be any special restrictions on the type or make up of the organizations carrying out this basic development of physician measures, such as restricting the initial development to physician-controlled organizations. Any such restriction would unduly limit the basic development of quality measures and the scope and utility of measures that may be considered for endorsement as voluntary consensus standards. The requirements under section 1848(k)(2)(C) of the Act pertain only to the selection of measures and not to the development of measures.

  • Address Gaps in PQRI Measure Set.

+ Measures that increase the scope of applicability of the PQRI measures to services furnished to Medicare beneficiaries and expand opportunities for eligible professionals to participate in PQRI. We seek to achieve broad ability to assess the quality of care furnished to Medicare beneficiaries, and ultimately to compare performance among professionals. We seek to increase the circumstances where eligible professionals have at least three measures applicable to their practice and measures that help expand the number of measures groups with at least four measures in a group.

+ Measures of various aspects of clinical quality including outcome measures, where appropriate and feasible, process measures, structural measures, efficiency measures, and measures of patient experience of care.

Other considerations that we proposed to apply to the selection of measures for 2010, regardless of whether the measure is a 2009 PQRI measure or not, were:

  • Measures that are functional, which is to say 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 leads to preference for measures that reflect readiness for implementation, such as those that are currently in the 2009 PQRI program or have been through testing. The purpose of measure testing is to reveal the measure's strengths and weaknesses so that the limitations can be addressed and the measure refined and strengthened prior to implementation. For new measures, preference is given to those that can be most efficiently implemented for data collection and submission. Therefore, any measures that have been found to be technically impractical to report because they are analytically challenging due to any number of factors, including those that are claims-based, have not been included in the 2010 PQRI. For example, in some cases, we are replacing existing 2009 PQRI measures with updated and improved measures that are less technically challenging to report.
  • For some measures that are useful, but where data submission is not feasible through all otherwise available PQRI reporting mechanisms, a measure may be included for reporting solely through specific reporting mechanism(s) in which its submission is feasible. For example, we proposed to limit reporting of some measures that previously were available for claims-based reporting and registry-based reporting to registry-based reporting only because they were technically challenging to report and/or analyze through the claims-based reporting mechanism (74 FR 33579 through 33580).

We also reviewed 33 measures that have been retired from the PQRI in previous years using the considerations for selecting measures for the 2010 PQRI discussed above (74 FR 33573). None were found to be eligible for inclusion in the 2010 PQRI quality measure set because they did not meet the criteria described above.

We solicited comments on the implication of including or excluding any given measure or measures in the final 2010 PQRI quality measure set and to our approach in selecting measures. As we stated in the proposed rule, we recognize that some commenters may also wish to recommend additional measures for inclusion in the 2010 PQRI measures that we did not propose (74 FR 33573). While we may consider such recommended measures for inclusion in future measure sets for PQRI and/or other programs to which such measures may be relevant, we will not be able to consider such additional measures for inclusion in the 2010 measure set.

(3) Summary of Comments and Responses

The following is a summary of the comments we received regarding the statutory requirements and other considerations for the selection of 2010 PQRI measures.

Comment: Some commenters appreciated our continued efforts to expand the PQRI quality measure set with measures that are scientifically valid and minimize eligible professional burden. In order to promote the provisions that reflect up-to-date care for beneficiaries as the program matures, these commenters urged us to revise its quality measures regularly to reflect current guidelines.

Response: We appreciate these supportive comments regarding our continued efforts to expand the PQRI quality measure set. As the program evolves, we will continue to consider more effective processes to update and/or revise the PQRI quality measure set to reflect the most current guidelines of care.

Comment: Several commenters supported our proposal to only use quality measures that have been endorsed by the NQF, thereby ensuring a rigorous evaluation of the measures by multiple stakeholders and providing an opportunity for public comment from those various stakeholders. These commenters suggested the utilization of NQF endorsed measures reflect areas that are common to providers, allow for appropriate measurement of services provided in Medicare, and provide a thorough standardized review framework. One commenter, however, was unclear whether NQF or consensus organization endorsement or adoption is required for all suggested measures for 2010 or 2011 or whether the Secretary can suggest measures of her own accord when measures do not already exist with this endorsement.

Response: We appreciate the commenters' supportive feedback and agree with the points raised by the commenters with respect to the benefits of NQF endorsement. As we stated above, subject to the exception under section 1848(k)(2)(C)(ii) of the Act, measures selected for the 2010 PQRI are required by section 1848(k)(2)(C)(i) of the Act to be endorsed by Secretary. Section 1848(k)(2)(C)(ii) of the Act authorizes us to select measures for the 2010 PQRI and subsequent years that have not been endorsed by the NQF in a specified area or medical topic for which a feasible and practical measure has not been so endorsed as long as we give due to consideration to measures that have been endorsed or adopted by other consensus organizations identified by the Secretary.

Comment: One commenter notes that the proposed rule makes allowance for measures used in the 2009 PQRI that have not been endorsed by the NQF but were previously approved by the AQA. The commenter believes that for new measures, NQF endorsement should be a requirement not only for the PQRI measures but also for measures for the hospital outpatient quality data reporting program, or HOP QDRP. While the underlying statutes for both reporting programs differ, the commenter believes CMS has the discretion to adopt a consistent policy with respect to NQF endorsement.

Response: As discussed previously, the requirements for measures selected for the PQRI are defined in statute. The requirements for other quality data reporting programs are beyond the scope of this rule.

Comment: Some commenters recommended that we require NQF endorsement not only of individual measures, but also NQF endorsement of measures groups.

Response: When we create measures groups, we only utilize individual measures that meet statutory requirements. All measures in current measures groups meet the statutory requirements. We are unaware of any efforts by NQF to review groups of measures for separate endorsement. Section 1848(m)(5)(F) of the Act required us to establish alternative criteria for satisfactorily reporting and alternative reporting periods for reporting groups of measures for 2008 and subsequent years but did not establish any additional limitations on the discretion of the Secretary.

Comment: Some commenters urged us to recognize additional consensus organizations to endorse quality measures for the PQRI. The commenters suggested we recognize measure development organizations such as the American Medical Association's Physician Consortium for Performance Improvement (AMA-PCPI) or the National Committee for Quality Assurance (NCQA) as consensus endorsement organizations.

Response: MIPPA modified the requirements for measure selection by the Secretary for PQRI as previously described. Further, as we stated in response to similar comments in previous years, we are unaware of other consensus organizations that are comparable to the NQF in terms of meeting the formal requirements of the NTTAA or of organizations other than AQA that do not strictly meet the requirements of the National Institute of Standards and Technology Act (NISTA), as amended by the NTTAA but that feature the breadth of stakeholder involvement in the consensus process necessary to meet the intent of the Act.

Comment: One commenter suggested that the measure development process should not be restricted to physician-controlled organizations but that the measure development process must include relevant physician input due to their expertise in the subject areas.

Response: We are in agreement that while physician expertise is an important ingredient in measure development and in the consensus process, physicians should not be in complete control of the process of measure development. Any such restriction would unduly limit the basic development of physician quality measures.

Comment: A few commenters did not believe that endorsement or adoption by the NQF or the AQA, respectively, was a necessary condition for inclusion of a measure in the PQRI for 2010 or subsequent years. One commenter urged us to use measures from other nationally recognized sources in areas for which NQF-endorsed measures are not available on the condition that the measures are expedited through the NQF endorsement process.

Response: We agree that NQF endorsement or AQA adoption is not a necessary condition for all measures included in the PQRI quality measure set. As stated previously, section 1848(k)(2)(C)(ii) of the Act does permit us to select measures for the 2010 PQRI and subsequent years that have not been endorsed by the NQF in a specified area or medical topic for which a feasible and practical measure has not been so endorsed as long as we give due consideration to measures that have been endorsed or adopted by other consensus organizations identified by the Secretary.

We proposed to exercise this authority for 2010 in the CY 2010 PFS proposed rule (74 FR 33576 through 33579) by proposing to include in the 2010 PQRI several 2009 PQRI measures that had not yet achieved NQF endorsement but that were AQA adopted. As we stated in the proposed rule, we would include such measures in the 2010 PQRI as long as a measure had not been reviewed by the NQF prior to July 1, 2009 and specifically declined for endorsement.

We are also exercising this authority with respect to our decision to finalize 3 proposed new measures (that is, Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear; Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear within the Previous 90 days; and Referral for Otologic Evaluation for Patients with History of Sudden or Rapidly Progressive Hearing Loss) that were neither NQF endorsed prior to July 1, 2009 nor AQA adopted prior to January 31, 2009. We decided to finalize these 3 measures despite the lack of consensus endorsement or adoption due to the lack of measures available for audiologists to report on. Audiologists are a new a category of eligible professionals that were added to the list of professionals eligible to participate in the PQRI beginning with the 2009 PQRI.

We stress, however, that inclusion of measures that are not NQF endorsed or AQA adopted is an exception to the requirement under section 1848(k)(2)(C)(i) of the Act that measures be endorsed by the NQF. Therefore, we do believe that this exception authority should be exercised in very limited circumstances, such as when few or no measures are available for a particular specialty or category of eligible professionals to report.

Comment: Several commenters suggested what the PQRI quality measure set should focus on and how the PQRI quality measure set should evolve. One commenter believes the PQRI quality measure set should evolve with the development of better clinical evidence and a greater understanding of the benefit-cost tradeoffs of particular services and treatments. Another commenter urged us to adopt quality measures that would address the existing gaps in quality and that focus on services with the potential to deliver high value to Medicare beneficiaries and to avoid services that may have little or no value to beneficiaries, such as high-cost or high-volume services. One commenter suggested additional criteria that should be utilized in the selection of measures, which include selecting: (1) More outcome and resource use measures; (2) care coordination measures; (3) measures addressing appropriateness of care which deliver high value to Medicare patients; (4) measures that allow for assessing and reporting on disparities of care. Some commenters also believe the measures selected for PQRI should not reward eligible professionals for providing marginally effective care or care that is already routinely furnished.

Response: In the 2010 PFS proposed rule, we listed the considerations that we applied for the selection of proposed 2010 PQRI quality measures. As described above, many of these considerations reflect the commenters' suggestions, particularly our focus on:

  • Measures with high impact on healthcare.
  • Measures that support CMS and HHS priorities for improved quality and efficiency of care for Medicare beneficiaries (such as, prevention; chronic conditions; high cost and high volume conditions; elimination of health disparities; healthcare-associated infections and other conditions; improved care coordination; improved efficiency; improved patient and family experience of care; improved end-of-life/palliative care; effective management of acute and chronic episodes of care; reduced unwarranted geographic variation in quality and efficiency; and adoption and use of interoperable HIT).
  • Measures that are included in, or facilitate alignment with, other Medicare, Medicaid, and CHIP programs in furtherance of overarching healthcare goals.
  • Measures that address gaps in the PQRI measure set in order to increase the scope of applicability of the PQRI measures to services furnished to Medicare beneficiaries and expand opportunities for eligible professionals to participate in PQRI.

Comment: Some commenters encouraged us to identify and add more quality measures and to develop interim opportunities for eligible professionals that have a dearth of available measures to participate in PQRI. One commenter specifically recommended that we expand the number of measures to reflect all types of services provided to all beneficiaries.

Response: Despite our efforts to expand the PQRI quality measure set to increase the scope of applicability of the PQRI measures to services furnished to Medicare beneficiaries and expand opportunities for eligible professionals to participate in PQRI, we are aware that there remains some gaps in the PQRI quality measure set. However, we largely depend on the development of measures by professional organizations and other measure developers. Although we had significant involvement in the development of measures applicable to eligible professionals at the start of the PQRI, ideally we would not need to be closely involved in the development of clinician-level quality measures but would select from measures that meet the statutory requirements. Thus, we encourage professional organizations and other measure developers to fund and develop measures that address some of the gaps identified by the commenters.

Comment: Some commenters recommended we utilize data from previous reporting periods to determine the appropriateness and effectiveness of the measures. The commenters recommended that we continually evaluate and revise the criteria for measure selection to ensure measures align with clinical practice and can be reported with minimal administrative burden.

Response: We will continue to evaluate data from previous reporting periods to assess the appropriateness and effectiveness of the PQRI measures. We will also continue to work with measure developers to urge alignment of the PQRI measures with clinical practice as the program evolves and matures.

i. The Final 2010 PQRI Quality Measures for Individual Eligible Professionals

For 2010, we proposed that final PQRI quality measures would be selected from 153 of the 2009 PQRI measures and the measures listed in the “Table of 2010 Measure Suggestions” posted on the Statute/Regulations/Program Instructions page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/05_StatuteRegulationsProgramInstructions.asp# TopOfPage. We proposed to include a total of 176 measures (this includes both individual measures and measures that are part of a proposed 2010 measures group) on which individual eligible professionals can report for the 2010 PQRI (74 FR 33574 through 33587, and 39032). In addition, we proposed to retire 7 measures because they did not meet one or more of the considerations for selection of proposed 2010 measures (74 FR 33574). In addition we proposed 13 measures groups for the 2010 PQRI (74 FR 33582 through 33587).

The following is a summary of the comments received on the 2010 PQRI measures in general and comments on the measures from the 2009 PQRI not proposed for inclusion in the 2010 PQRI, which are addressed below. Comments specific to measures proposed for inclusion in the 2010 PQRI are addressed in sections II.G.2.i.1. through II.G.2.i.5. below.

Comment: Several commenters requested or recommended that we make readily available on an ongoing basis more detailed information on the measure development process and on measures in development.

Response: We agree that it is desirable for the public to have information on the measures development process and measures in development. To this end, we have developed a standardized process to be used for CMS contracted measures development. This standardized process is detailed in the “Measures Management System Blueprint” found on the CMS Web site at http://www.cms.hhs.gov/apps/QMIS/mmsBlueprint.asp.

As stated previously, however, we largely depend on the development of measures by professional organizations and other measure developers for the PQRI. Many major measures developers follow a similar process for the measures that they develop, in that they publish measures and specifications during development and seek public comment. Both the NQF and AQA also publish measures and specifications during their consensus processes and seek public comment.

Comment: Numerous commenters requested final measure specifications for the 2010 PQRI be published as far in advance of the beginning of the reporting period as possible, and that more detailed information about measures proposed or finalized for use in PQRI be published at the same time as or in advance of future rulemaking.

Response: We agree with the commenters that it is desirable to provide final measure specifications sufficiently in advance of the reporting period to allow reasonable time for professionals to analyze new or revised measures and implement any needed changes in their office workflows to accurately capture and successfully submit data on a selection of measures applicable to their practice on which they can act to improve the quality of the services they furnish.

Having detailed information on measures available in advance of the reporting period also enhances the ability of vendors (such as practice management software, billing services, and electronic health records vendors) to support professionals' successful implementation of revised data-capture processes for the measures. Our intent is to provide the final list of 2010 PQRI measures and the detailed measures specifications on the PQRI section of the CMS Web site by November 15, 2009, but no later than December 31, 2009. These detailed specifications will include instructions for reporting and identifying the circumstances in which each measure is applicable. The detailed technical specifications for measures in the final listing for the 2010 PQRI remain potentially subject to corrections until the start of the 2010 reporting period, as we stated in the proposed rule.

Comment: One commenter supported removal from the PQRI quality measure set for 2010 and 2009 PQRI measure that was part of the 2007 and/or 2008 PQRI for which the 2007 and 2008 PQRI analytics indicate a lack of significant reporting and usage. The commenter remarked that continued review and revision of the measures list will help to refine the process and validity of the program and reduce undue burden on participants, increasing meaningful participation.

Response: We appreciate the commenter's constructive feedback and agree that it is necessary to review and revise the PQRI quality measure set on an ongoing basis as we gain more experience with particular measures and/or new measures become available to replace existing measures.

We are unclear, however, with respect to the commenter's remark that continued revision of the PQRI quality measure set will reduce undue burden on participants. Although there are several measures available in the PQRI quality measure set, participants are not required, nor are they expected to, report on all measures included in the PQRI quality measure set. As discussed further in sections II.G.2.e. and II.G.2.f. above, an individual eligible professional generally needs to report on only 3 individual 2010 PQRI quality measures or 1 2010 PQRI measures group in order to meet the criteria for satisfactory reporting for 2010.

Comment: Some commenters specifically suggested that Measure #143 Oncology: Medical and Radiation—Pain Intensity Quantified and Measure #144 Oncology: Medical and Radiation Plan of Care for Pain be retained for the 2010 PQRI because they believe the measures address quality of life issue for patients with cancer. One commenter requested that if the measures are analytically challenging as claims-based measures, we retain the measures as registry-only measures instead.

Response: We only proposed to retire these measures because they were too complex to calculate via claims. Based on the commenter's suggestion to retain these measures as registry-only measures for the 2010 PQRI, we are finalizing and including them in the measures listed in “Table 11: 2010 Measures Selected From the 2009 PQRI Quality Measure Set Available for Registry-based Reporting Only.”

Comment: One commenter requested that Measure #94 Otitis Media with Effusion (OME): Diagnostic Evaluation—Assessment of Tympanic Membrane Mobility and Measure #95 Otitis Media with Effusion (OME) Hearing Testing not be retired since audiologists were just added to the list of eligible professionals with the 2009 PQRI and there are few measures on which they can report. The commenter requested that we retain both measures for at least an additional year to reassess the level of use since PQRI reporting, for audiologists, is a new process that requires extensive training.

Response: We agree that in order to provide audiologists with opportunities to participate in the PQRI, it is necessary to retain at least one of these measures for at least another year. Thus, we have decided to retain Measure #94 Otitits Media with Effusion (OME): Diagnostic Evaluation—Assessment of Tympanic Membrane Mobility and retire only Measure #95 Otitis Media with Effusion (OME) Hearing Testing for 2010. Measure #94, in conjunction with the 3 new measures developed by the Audiology Quality Consortium (AQC) listed in Table 13, will provide audiologists with at least 4 measures on which they can report for the 2010 PQRI.

Comment: One commenter was not clear on which measure was being proposed to replace Measure #34 Stroke and Stroke Rehabilitation: Tissue Plasminogen Activator (tPA) Considered and requested that CMS not retire Measure #34 until clarification is provided. Another commenter, however, supported the retirement of Measure #34 and CMS' decision to replace this measure with the proposed new Stroke and Stroke Rehabilitation: Thrombolytic Therapy measure (see Table 19 of the CY 2010 PFS proposed rule).

Response: As indicated by the commenter, we are replacing Measure #34 with the Stroke and Stroke Rehabilitation: Thrombolytic Therapy measure listed in Table 13 of this final rule with comment period.

Comment: One commenter expressed support for a proposed revision of Measure #11 for 2010 PQRI that expands the eligible denominator patient population.

Response: We wish to clarify that at the request of the measure developer, we are retiring Measure #11 and replacing it with the proposed new NQF-endorsed measure: Stenosis Management in Cardiac Imaging Studies (see Table 13 of this final rule with comment period).

Based on the criteria discussed above and our review of these comments, we are retiring the 4 measures listed in Table 10 and are including the 175 individual measures listed in Tables 11 through 13 in the final 2010 PQRI individual quality measure set. We are also including 13 measures groups in the final 2010 PQRI quality measure set, which are listed in Tables 15 through 27. The individual measures selected for the 2010 PQRI can be categorized as follows:

(1) 2010 Individual Quality Measures Selected From the 2009 PQRI Quality Measures Set Available for Claims-based Reporting and Registry-Based Reporting;

(2) 2010 Individual Quality Measures Selected From the 2009 PQRI Quality Measures Set Available for Registry-based Reporting Only;

(3) New Individual Quality Measures Selected for 2010; and

(4) 2010 Measures Available for EHR-based Reporting.

Table 10—2009 PQRI Quality Measures Not Included in the 2010 PQRI Back to Top
Measure No. Measure title
11 Stroke and Stroke Rehabilitation: Carotid Imaging Reporting.
34 Stroke and Stroke Rehabilitation: Tissue Plasminogen Activator (tPA)Considered.
95 Otitis Media with Effusion (OME): Hearing Testing.
152 Coronary Artery Disease (CAD): Lipid Profile in Patients with CAD.

(1) 2010 Individual Quality Measures Selected From the 2009 PQRI Quality Measures Set Available for Claims-based Reporting and Registry-based Reporting

We proposed to include in the 2010 PQRI quality measure set 116 of the 2009 PQRI measures, which would be available for either claims-based reporting or registry-based reporting as individual quality measures (74 FR 33574 through 33579). We also noted that one of the proposed measures, Measure #46 Medication Reconciliation: Reconciliation After Discharge from an Inpatient Facility, is reportable through the registry-based reporting mechanism only in the 2009 PQRI. However, for the 2010 PQRI, we proposed to make this measure available for either claims-based reporting or registry-based reporting.

These 116 proposed measures did not include any measures that were proposed to be included as part of the 2010 Back Pain measures group. Similar to the 2009 PQRI, we proposed that any 2010 PQRI measure that is included in the Back Pain measures group would not be reportable as individual measures through claims-based reporting or registry-based reporting.

The following is a summary of the comments received on the 116 proposed measures selected from the 2009 PQRI quality measure set.

Comment: We received numerous comments in support of the 2009 PQRI quality measures proposed for inclusion in the 2010 PQRI. Several commenters supported the retention of all the 2009 PQRI measures proposed for 2010. Other commenters supported inclusion of specific 2009 PQRI measures in the 2010 PQRI. Measures on which we received specific support include:

  • Measure #1 Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus;
  • Measure #2 Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control in Diabetes Mellitus;
  • Measure #3 Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus;
  • Measure #9 Major Depressive Disorder (MDD): Antidepressant Medication During Acute Phase for Patients with MDD;
  • Measure #18 Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of Retinopathy;
  • Measure #19 Diabetic Retinopathy: Communication with the Physician Managing On-going Diabetes Care;
  • Measure #67 Myelodysplastic Syndrome (MDS) and Acute Leukemias: Baseline Cytogenetic Testing Performed on Bone Marrow;
  • Measure #68 Myelodysplastic Syndrome (MDS): Documentation of Iron Stores in Patients Receiving Erythopoietin Therapy;
  • Measure #102 Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low-Risk Prostate Cancer Patients;
  • Measure #104 Prostate Cancer: Adjuvant Hormonal Therapy for High-Risk Prostate Cancer Patients;
  • Measure #105 Prostate Cancer: Three-Dimensional (3D) Radiotherapy;
  • Measure #106 Major Depressive Disorder (MDD): Diagnostic Evaluation;
  • Measure #107 Major Depressive Disorder (MDD): Suicide Risk Assessment;
  • Measure #110 Preventive Care and Screening: Influenza Immunization for Patients ≥50 Years Old;
  • Measure #111 Preventive Care and Screening: Pneumonia Vaccination for Patients 65 Years and Older;
  • Measure #112 Preventive Care and Screening: Screening Mammography;
  • Measure #113 Preventive Care and Screening: Colorectal Cancer Screening;
  • Measure #114 Preventive Care and Screening: Inquiry Regarding Tobacco Use;
  • Measure #115 Preventive Care and Screening: Advising Smokers and Tobacco Users to Quit;
  • Measure #117 Diabetes Mellitus: Dilated Eye Exam in Diabetic Patient;
  • Measure #119 Diabetes Mellitus: Urine Screening for Microalbumin or Medical Attention for Nephropathy in Diabetic Patients;
  • Measure #124 Health Information Technology (HIT): Adoption/Use of Electronic Health Records (EHR);
  • Measure #126 Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy-Neurological Evaluation;
  • Measure #127 Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention—Evaluation of Footwear;
  • Measure #134 Screening for Clinical Depression and Follow-Up Plan;
  • Measure #136 Melanoma: Follow-Up Aspects of Care;
  • Measure #137 Melanoma: Continuity of Care—Recall System;
  • Measure #138 Melanoma: Coordination of Care;
  • Measure #156 Oncology: Radiation Dose Limits to Normal Tissues; and
  • Measure #163 Diabetes Mellitus: Foot exam.

Response: All 116 of the proposed measures listed in Table 17 of the proposed rule (74 FR 33575 through 33579), including all of the measures specifically supported by commenters, have been finalized for the 2010 PQRI, and are included in Table 11.

Comment: One commenter commended CMS on the format of Table 17 of the proposed rule (74 FR 33575 through 33579) which clearly stated the status of NQF endorsement, AQA adoption, and the measure developer for each proposed measure. The commenter encouraged us to use this format in future rules.

Response: We appreciate the positive feedback on the newly formatted tables in the proposed rule.

Comment: One commenter urged us to finalize the proposed new measures related to age-related macular degeneration, osteoporosis, and cancer care and to work with the community to ensure these measures are appropriately reported.

Response: We note that the measures referenced by the commenter are existing 2009 PQRI measures that will be included for 2010 PQRI. As noted previously, we have developed an education and outreach plan that is continuously expanding in scope in our efforts to educate eligible professionals on the nuances of the PQRI, including educating eligible professionals and office staff on appropriate reporting of the PQRI measures.

Comment: Several commenters recommended changes to specific quality measures' titles, definitions, and detailed specifications or coding. Many of these recommendations were based on alternative interpretations of clinical evidence or concerns about the utility of the measures. Some requests were specifically concerned that measures be expanded to include specific professionals to whom the measure may be applicable such as physical therapists, audiologists, and hospitalists.

Specifically, one commenter suggested that in order to maximize the impact of Measure #1 Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus, the PQRI specification should continue to require a performance period of 12 months and reporting that identifies whether A1c control is good (that is, A1c ≤ 7.0 percent), moderate (that is, A1c ≤ 9.0 percent, but 7.0 percent), or poor (that is, A1c 9.0 percent).

Another commenter suggested that audiologists should be included in Measure #154 Falls: Risk Assessment. The commenter noted that audiologists are consulted to provide vestibular rehabilitation that results in improved quality of care for these patients and reduces unnecessary and excessive cost.

Another commenter requested that Measure #52 Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation needs to be re-evaluated and CMS should consider modifying this measure or creating a new one that addresses the appropriate use of LABA.

We received one comment regarding Measure #158 Carotid Endarterectomy: Use of Patch During Conventional Carotid Endarterectomy, expressing concern that there is no reliable data, controlled or otherwise, that shows that use of patch graft results in better outcomes.

Finally, one commenter suggested that the following proposed 2010 measures selected from the 2009 PQRI quality measure set available for either claims-based reporting or registry-based reporting may not promote quality care because they do not adequately address concerns of patient groups that rely on plasma derived treatments such as those with primary immune deficiency or alpha-1 antitrypsin deficiency:

  • Measure #51 Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation;
  • Measure #64 Asthma: Asthma Assessment;
  • Measure #65 Treatment for Children with Upper Respiratory Infection (URI): Avoidance of Inappropriate Use;
  • Measure #110 Preventive Care and Screening: Influenza Immunization for Patients ≥ 50 Years Old; and
  • Measure #126 Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy—Neurological Evaluation.

The commenter suggested that we focus on aligning these measures with accepted clinical practices for patients that rely on plasma-derived treatments.

Response: Health care quality measures are currently developed by a variety of organizations and used by a variety of governmental and nongovernmental, and public-private initiatives which have various and at times differing priorities and programmatic needs for quality measures. As reflected by the considerations for identifying proposed PQRI quality measures described above, we are committed to having a broad and robust set of quality measures for the PQRI. However, we largely depend on the development of measures by professional organizations and other measure developers. Although we had significant involvement in the development of measures applicable to eligible professionals at the start of the PQRI, currently we are not directly involved in the development of clinician-level quality measures for PQRI, but do select from measures that meet the statutory requirements and other considerations described above.

Quality measures that have completed the consensus processes of NQF or AQA have a designated party (generally the measure developer/owner) who has accepted responsibility for maintaining the measure. In general, it is the role of the measure owner, developer, or maintainer to make substantive changes to a measure, including any updates to the measure to reflect the current clinical evidence such as the changes suggested by the commenters above. The measure maintainer and/or the developer/owner of a measure included in the final set of quality measures selected for the 2010 PQRI is identified as the “Measure Developer” in Tables 11 through 28. In addition, NQF has, for its endorsed measures, an established maintenance process which may be accessed. The Secretary is required to provide opportunities for public comment on selected measures and do so through notice and comment rulemaking. We do not, however, use notice and comment rulemaking as a means to update or modify measure specifications. We retain the ability to update or modify specifications to the measures until December 31, 2009.

After that date, there will be no changes to the measure for the 2010 reporting period(s).

Comment: One commenter was concerned about the potential retention of claims-based reporting for Measure #124 Health Information Technology (HIT): Adoption/Use of Electronic Health Records (EHR). The commenter assumes that if an eligible professional had an EHR, he or she would be able to submit this type of data directly from the EHR rather through claims. This also appears to conflict with the statement that Measure #124 is proposed to be an EHR measure. The commenter requests further clarification.

Response: As reflected in Tables 11 and 14, Measure #124 is available for reporting via claims, a qualified registry, or a qualified EHR for the 2010 PQRI. We decided to continue to allow eligible professionals to report Measure #124 via claims for the 2010 PQRI because we do not anticipate that there will be a sufficient number of qualified EHR vendors for the 2010 PQRI to permit a majority of those who adopt and use an EHR to report this measure via their EHR.

Comment: One commenter supported the proposal that Measure #46 Medication Reconciliation: Reconciliation After Discharge from an Inpatient Facility would be available for claims and registry reporting since registries reported difficulty capturing the required information for the 2009 PQRI.

Response: We agree. As such, Measure #46 is listed in Table 11 as a measure that is available for claims and registry reporting in the 2010 PQRI.

Comment: With respect to Measure #52 Chronic Obstructive Pulmonary Disease (COPD): Bronchodilator Therapy, one commenter pointed out that Medicare DMERC coverage criteria for LABA are not consistent with clinical guidelines.

Response: Medicare coverage policy is beyond the scope of this section of the final rule. Questions or concerns about Medicare coverage policy should be directed to CMS_caginquiries@cms.hhs.gov.

For the reasons discussed above and based on the comments received, we are finalizing in the 2010 PQRI quality measure set the 116 2009 PQRI measures that were proposed to be available in the 2010 PQRI for claims and registry reporting identified in Table 11. In addition, Table 11 includes 1 2009 PQRI measure that was proposed for retirement in 2010 and 2 2009 PQRI measures that were proposed to be available for registry reporting only (see sections II.G.2.i. and II.G.2.i.2., respectively, of this final rule for further details). The 119 individual 2009 PQRI measures selected for inclusion in the 2010 PQRI quality measure set as individual quality measures for either claims-based reporting or registry-based reporting are listed by their Measure Number and Title in Table 11, along with the name of the measure's developer/owner. The PQRI Measure Number is a unique identifier assigned by CMS to all measures in the PQRI measure set. Once a PQRI Measure Number is assigned to a measure, it will not be used again to identify a different measure, even if the original measure to which the number was assigned is subsequently retired from the PQRI measure set. A description of the measures listed in Table 11 can be found in the “2009 PQRI Quality Measures List,” which is available on the Measures and Codes page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI.

BILLING CODE 4120-01-P

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

BILLING CODE 4120-01-C

Please note that detailed measure specifications, including the measure's title, for 2009 individual PQRI quality measures may have been updated or modified during the NQF endorsement process or for other reasons prior to 2010. The 2010 PQRI quality measure specifications for any given individual quality measure may, therefore, be different from specifications for the same quality measure used for 2009. Specifications for all 2010 individual PQRI quality measures, whether or not included in the 2009 PQRI program, must be obtained from the specifications document for 2010 individual PQRI quality measures, which will be available on the PQRI section of the CMS Web site on or before December 31, 2009.

(2) 2010 Individual Quality Measures Selected From the 2009 PQRI Quality Measures Set Available for Registry-Based Reporting Only

We proposed to select 26 registry-only individual measures from the 2009 PQRI for the 2010 PQRI (74 FR 33579 through 33580). Nine of the 26 proposed measures were previously available for either claims-based reporting or registry-based reporting. We solicited comments on our proposal to increase the number of registry-only measures for the 2010 PQRI.

The following is a summary of the comments received on the 26 proposed registry-only measures.

Comment: We received one comment in support of the following registry-only measures:

  • Measure #136 Melanoma: Follow-Up Aspects of Care;
  • Measure #137 Melanoma: Continuity of Care—Recall System; and
  • Measure #138 Melanoma: Coordination of Care.

Response: We appreciate the commenters' positive feedback. These final measures are listed in Table 12 as 2009 PQRI measures selected for the 2010 PQRI available for registry reporting only.

Comment: We received several comments regarding the proposed reporting mechanism(s) available for proposed 2010 measures. There were several recommendations that the following 2009 PQRI quality measures, which were available for claims or registry reporting in the 2009 PQRI, should not be limited to registry reporting for the 2010 PQRI:

  • Measure #83 Hepatitis C: Testing for Chronic Hepatitis C—Confirmation of Hepatitis C Viremia;
  • Measure #136 Melanoma: Follow-Up Aspects of Care;
  • Measure #137 Melanoma: Continuity of Care—Recall System;
  • Measure #138 Melanoma: Coordination of Care;
  • Measure #139 Cataracts: Comprehensive Preoperative Assessment for Cataract Surgery with Intraocular Lens (IOL) Placement; and
  • Measure #141 Primary Open-Angle Glaucoma (POAG): Reduction of Intraocular Pressure (IOP) by 15 percent OR Documentation of a Plan of Care.

The primary reason cited by commenters for opposing limiting certain measures to registry reporting is the lack of an available registry.

Response: With respect to the limited availability of registries for certain eligible professionals, we reiterate that there are qualified registries in our 2009 PQRI program that do report all of the PQRI measures. These registries are accepting eligible professionals who wish to sign up as new clients of the registry. While we acknowledge that there may be costs associated with participating through registries, we note that the decision to participate via a registry is voluntary.

We do, however, agree with commenters' concerns about limiting Measures #139 and #141 to registry reporting. These measures were first introduced in the PQRI quality measure set for the 2009 PQRI and are currently available for claims and registry reporting for 2009. Keeping these measures as measures available for claims and registry reporting for 2010 will allow us to collect more data to analyze the measures' feasibility via claims reporting. Therefore, the measures are listed in Table 11 of this final rule with comment period as 2009 PQRI measures selected for the 2010 PQRI that are available for registry and claims reporting.

Comment: Some commenters were specifically opposed to continuing to limit Measure #174 Pediatric End-Stage Renal Disease (ESRD): Plan of Care for Inadequate Hemodialysis to registry reporting for the 2010 PQRI. Specifically, the commenters suggested that CMS permit claims-based reporting of the measure for 2010 since there are only two pediatric ESRD measures included in PQRI for 2010. One of the pediatric ESRD measures, Measure #175 Pediatric ESRD Influenza Immunization Measure, was proposed to be available for either claims or registry reporting. Because eligible professionals must report on at least 3 measures when using the registry-based reporting mechanism, the commenter felt that making Measure #174 registry only will exclude pediatric nephrologists from participating in the PQRI. In addition, a registry is not available for pediatricians who participate in small academic departments.

Response: The commenter is correct in that eligible professionals who wish to have a qualified registry submit PQRI measure results and numerator and denominator data on PQRI quality measures are required to report at least 3 PQRI quality measures when reporting on individual quality measures or to report all measures in at least 1 measure group when reporting on measure groups. Measure #174 Pediatric End-Stage Renal Disease (ESRD): Plan of Care for Inadequate Hemodialysis was registry only for 2009 PQRI. Due to complexities surrounding the timing of the expected quality action (once per month) this measure will remain registry only for the 2010 PQRI.

However, in response to the commenters' concern that there are only 2 2010 PQRI measures that apply to pediatric nephrologists and only 1 of them (that is, Measure #175) is available for claims-based reporting, eligible professionals who have fewer than 3 applicable measures can still participate in the 2010 PQRI via claims. Such eligible professionals would need to report on all applicable measures that are available for claims-based reporting via claims and meet the appropriate criteria for satisfactory reporting of individual measures in order to qualify for a 2010 PQRI incentive payment.

For the reasons discussed above and based on the comments received, we are finalizing in the 2010 PQRI quality measure set 24 of the 26 proposed 2009 PQRI measures identified in Table 18 of the proposed rule for registry reporting only. As stated above, 2 of the 26 2009 PQRI measures that were proposed to be available for registry reporting only for the 2010 PQRI (that is, Measure #139 and Measure #141), will be available for both registry and claims reporting in the 2010 PQRI and are listed in Table 11 of this final rule with comment period. In addition, we are also retaining 2 2009 PQRI measures that were proposed for retirement for 2010, but we are limiting reporting of these measures to registry reporting for the 2010 PQRI. The 26 2009 PQRI measures selected for the 2010 PQRI that are available for registry reporting only are listed in Table 12 of this final rule with comment period. The 26 individual 2009 PQRI measures selected for inclusion in the 2010 PQRI quality measure set as individual quality measures for registry-based reporting only are listed by their Measure Number and Title in Table 12, along with the name of the measure's developer/owner. A description of the measures listed in Table 12 can be found in the “2009 PQRI Quality Measures List,” which is available on the Measures and Codes page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI. Measures that were available for either claims-based reporting or registry-based reporting in the 2009 PQRI but are available for registry-based reporting only in the 2010 PQRI are identified by an asterisk (*) in Table 12.

Table 12—2010 Measures Selected From the 2009 PQRI Quality Measure Set Available for Registry-based Reporting Only Back to Top
Measure Number Measure title Measure developer
* Individual 2009 PQRI measures that were available for both claims-based and registry-based reporting but will be available for registry-based reporting only for the 2010 PQRI.
5 Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD)* AMA-PCPI
7 Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI) AMA-PCPI
8 Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD)* AMA-PCPI
33 Stroke and Stroke Rehabilitation: Anticoagulant Therapy Prescribed for Atrial Fibrillation at Discharge AMA-PCPI/NCQA
81 End-Stage Renal Disease (ESRD): Plan of Care for Inadequate Hemodialysis in ESRD Patients AMA-PCPI
82 End-Stage Renal Disease (ESRD): Plan of Care for Inadequate Peritoneal Dialysis AMA-PCPI
83 Hepatitis C: Testing for Chronic Hepatitis C—Confirmation of Hepatitis C Viremia* AMA-PCPI
118 Coronary Artery Disease (CAD): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Patients with CAD and Diabetes and/or Left Ventricular Systolic Dysfunction (LSVD)* AMA-PCPI
136 Melanoma: Follow-Up Aspects of Care* AMA-PCPI/NCQA
137 Melanoma: Continuity of Care—Recall System* AMA-PCPI/NCQA
138 Melanoma: Coordination of Care* AMA-PCPI/NCQA
143 Oncology: Medical and Radiation—Pain Intensity Quantified* AMA-PCPI
144 Oncology: Medical and Radiation—Plan of Care for Pain* AMA-PCPI
159 HIV/AIDS: CD4+ Cell Count or CD4+ Percentage AMA-PCPI/NCQA
160 HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis AMA-PCPI/NCQA
161 HIV/AIDS: Adolescent and Adult Patients with HIV/AIDS Who Are Prescribed Potent Antiretroviral Therapy AMA-PCPI/NCQA
162 HIV/AIDS: HIV RNA Control After Six Months of Potent Antiretroviral Therapy AMA-PCPI/NCQA
164 Coronary Artery Bypass Graft (CABG): Prolonged Intubation (Ventilation) STS
165 Coronary Artery Bypass Graft (CABG): Deep Sternal Wound Infection Rate STS
166 Coronary Artery Bypass Graft (CABG): Stroke/Cerebrovascular Accident (CVA) STS
167 Coronary Artery Bypass Graft (CABG): Postoperative Renal Insufficiency STS
168 Coronary Artery Bypass Graft (CABG): Surgical Re-exploration STS
169 Coronary Artery Bypass Graft (CABG): Antiplatelet Medications at Discharge STS
170 Coronary Artery Bypass Graft (CABG): Beta-Blockers Administered at Discharge STS
171 Coronary Artery Bypass Graft (CABG): Lipid Management and Counseling STS
174 Pediatric End-Stage Renal Disease (ESRD): Plan of Care for Inadequate Hemodialysis AMA-PCPI

Although we are designating certain measures as registry-only measures, we cannot guarantee that there will be a registry qualified to submit each registry-only measure for 2010. We rely on registries to self-nominate and identify the types of measures for which they would like to be qualified to submit quality measures results and numerator and denominator data on quality measures. If no registry self-nominates to submit measure results and numerator and denominator data on a particular type of measure for 2010, then an eligible professional would not be able to report that particular measure type.

We note also that detailed measure specifications, including a measure's title, for 2009 PQRI quality measures may have been updated or modified during the NQF endorsement process or for other reasons prior to 2010. Therefore, the 2010 PQRI quality measure specifications for any given quality measure may be different from specifications for the same quality measure used for 2009. Specifications for all 2010 individual PQRI quality measures, whether or not included in the 2009 PQRI program, must be obtained from the specifications document for 2010 individual PQRI quality measures, which will be available on the PQRI section of the CMS Web site on or before December 31, 2009.

(3) New Individual Quality Measures Selected for 2010

We proposed to include in the 2010 PQRI quality measure set 30 measures that were not included in the 2009 PQRI quality measures provided that each measure obtains NQF endorsement by July 1, 2009 and its detailed specifications are completed and ready for implementation in PQRI by August 15, 2009. Besides having NQF endorsement, we proposed that the development of a measure is considered complete for the purposes of the 2010 PQRI if by August 15, 2009—(1) the final, detailed specifications for use in data collection for PQRI have been completed and are ready for implementation, and (2) all of the Category II Current Procedural Terminology (CPT II) codes required for the measure have been established and will be effective for CMS claims data submission on or before January 1, 2010.

Due to the complexity of their measure specifications, we proposed that 24 of these 30 measures would be available as registry-only measures for the 2010 PQRI. The remaining 6 measures were proposed to be available for reporting through either claims-based reporting or registry-based reporting.

The following is a summary of the comments received on the 30 new individual quality measures proposed for 2010.

Comment: We received numerous comments in support of the proposed additional quality measures for 2010 PQRI. Several commenters stated that these measures “continue to build upon potential gaps that exist in the prevention and management of chronic conditions.” One commenter was pleased to see the use of evidence-based clinical quality measures in the 2010 PQRI proposed measures. Comments were received specifically in support of the following measures:

  • Functional Communication—Spoken Language Comprehension;
  • Functional Communication—Attention;
  • Functional Communication—Memory;
  • Functional Communication—Motor Speech;
  • Functional Communication—Reading;
  • Functional Communication—Spoken Language Expression;
  • Functional Communication—Writing;
  • Functional Communication—Swallowing;
  • Perioperative Temperature Management;
  • Oncology: Cancer Stage Documented;
  • Cataracts: 20/40 or Better Visual Acuity within 90 days following Cataract Surgery;
  • Cataracts: Complications within 30 days following Cataract Surgery requiring Additional Surgical;
  • Ischemic Vascular Disease (IVD): Blood Pressure Management Control;
  • Stenosis Management in Cardiac Imaging Studies;
  • Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear;
  • Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear within the Previous 90 days;
  • Referral for Otologic Evaluation for Patients with a History of Sudden or Rapidly Progressive Hearing Loss;
  • Coronary Artery Disease (CAD): Symptom and Activity Assessment;
  • Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL-Cholesterol;
  • Heart Failure: Left Ventricular Function (LVF) Assessment;
  • Heart Failure: Patient Education; and
  • Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation.

Response: We appreciate the commenters' support and are finalizing all of the 30 proposed new measures, which are identified in Table 13 of this final rule with comment period.

Comment: We received many comments opposed to limiting one or more new measures proposed for the 2010 PQRI to registry reporting, including the 2 new proposed cataract measures and the 11 new proposed cardiology measures. The commenters suggested that the measures be available for both claims-based and registry reporting for the 2010 PQRI so that practices may choose the best reporting option for them. One commenter also remarked that we should resolve any analytic reporting difficulties with claims-based reporting of these measures internally and not place the burden on eligible professionals.

Response: While we proposed that 19 of the 30 proposed new measures would be available for registry reporting only for 2010 PQRI, we agree, after consideration of the comments received, that it would be feasible to make some of these measures available for either claims or registry reporting. Therefore, the following measures originally proposed for registry only reporting will be available for either claims or registry reporting for the 2010 PQRI:

  • Ischemic Vascular Disease (IVD): Blood Pressure Management Control.
  • Ischemic Vascular Disease (IVD): Complete Lipid Profile.
  • Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL-C) Control.
  • Ischemic Vascular Disease (IVD): Use of Aspirin or Another Anti-Thrombotic.

The measure specifications developed by the measure developer for the remaining 15 measures are too complex for claims-based reporting.

Based on the reasons discussed above and comments received, we are finalizing in the 2010 PQRI quality measure set all of 30 proposed 2010 PQRI measures identified in Table 19 of the proposed rule. Please note that 4 measures that were proposed to be available for registry only will be made available for either registry or claims reporting in the 2010 PQRI. These measures are:

  • Ischemic Vascular Disease (IVD): Blood Pressure Management Control;
  • Ischemic Vascular Disease (IVD): Complete Lipid Profile;
  • Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL-C) Control; and
  • Ischemic Vascular Disease (IVD): Use of Aspirin or Another Anti-Thrombotic.

The titles of the 30 additional, or new, PQRI measures for 2010 are listed in Table 13 along with the name of the measure developer and the reporting mechanism(s) available (that is, whether the measure will be reportable using claims, registries, or both).

Table 13—New Individual Quality Measures Selected for 2010 Back to Top
Measure title NQF Endorsement status as of 5/1/09 AQA Adoption status as of 1/31/09 Measure developer Reporting mechanism(s)
Stroke and Stroke Rehabilitation: Thrombolytic Therapy Yes No American Heart Association (AHA)/American Stroke Association (ASA) Registry.
Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear Pending NQF review No Audiology Quality Consortium (AQC) Claims, Registry.
Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear within the Previous 90 days Pending NQF review No AQC Claims, Registry.
Referral for Otologic Evaluation for Patients with a History of Sudden or Rapidly Progressive Hearing Loss Pending NQF review No AQC Claims, Registry.
Cataracts: 20/40 or Better Visual Acuity within 90 days Following Cataract Surgery Pending NQF review Yes AMA-PCPI/NCQA Registry.
Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional Surgical Procedures Pending NQF review Yes AMA-PCPI/NCQA Registry.
Perioperative Temperature Management Yes Yes AMA-PCPI Claims, Registry.
Oncology: Cancer Stage Documented Yes Yes AMA-PCPI/ASCO Claims, Registry.
Stenosis Measurement in Carotid Imaging Studies Yes Yes AMA-PCPI/NCQA Claims, Registry.
Coronary Artery Disease (CAD): Symptom and Activity Assessment Yes No AMA-PCPI Registry.
Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL-Cholesterol Yes No AMA-PCPI Registry.
Heart Failure: Left Ventricular Function (LVF) Assessment Yes No AMA-PCPI Registry.
Heart Failure: Patient Education Yes No AMA-PCPI Registry.
Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation Yes No AMA-PCPI Registry.
Ischemic Vascular Disease (IVD): Blood Pressure Management Control Yes No NCQA Claims, Registry.
Ischemic Vascular Disease (IVD): Complete Lipid Profile Yes No NCQA Claims, Registry.
Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL-C) Control Yes No NCQA Claims, Registry.
Ischemic Vascular Disease (IVD): Use of Aspirin or Another Anti-thrombotic Yes No NCQA Claims, Registry.
HIV/AIDS: Sexually Transmitted Disease Screening for Chlamydia and Gonorrhea Yes No AMA-PCPI/NCQA Registry.
HIV/AIDS: Screening for High Risk Sexual Behaviors Yes No AMA-PCPI/NCQA Registry.
HIV/AIDS: Screening for Injection Drug Use Yes No AMA-PCPI/NCQA Registry.
HIV/AIDS: Sexually Transmitted Disease Screening for Syphilis Yes No AMA-PCPI/NCQA Registry.
Functional Communication Measure—Spoken Language Comprehension Yes No American Speech Language Hearing Association (ASHA) Registry.
Functional Communication Measure—Attention Yes No ASHA Registry.
Functional Communication Measure—Memory Yes No ASHA Registry.
Functional Communication Measure—Motor Speech Yes No ASHA Registry.
Functional Communication Measure—Reading Yes No ASHA Registry.
Functional Communication Measure—Spoken Language Expression Yes No ASHA Registry.
Functional Communication Measure—Writing Yes No ASHA Registry.
Functional Communication Measure—Swallowing Yes No ASHA Registry.

We note also that we are finalizing the following new measures for the 2010 PQRI even though they are still pending NQF endorsement and were not AQA adopted as of January 31, 2009:

  • Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear;
  • Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear within the Previous 90 days; and
  • Referral for Otologic Evaluation for Patients with a History of Sudden or Rapidly Progressive Hearing Loss. As stated above, we are exercising our exception authority under section 1848(k)(2)(C)(ii) of the Act due to the lack of available measures for audiologists. Measures for audiologists represent a specific area for which there are a dearth of measures that have been endorsed by the NQF and/or adopted by the AQA.

(4) 2010 Individual Quality Measures Available for EHR-Based Reporting

We proposed to accept PQRI data from EHRs for a limited subset (10) of the proposed 2010 PQRI quality measures, contingent upon the successful completion of our 2009 EHR data submission testing process and a determination that accepting data from EHRs on quality measures for the 2010 PQRI is practical and feasible (74 FR 33582).

The following is a summary of the comments received on the proposed electronic submission of these 10 measures.

Comment: One commenter requested that the 2010 EHR measure specifications be released in an expedited fashion so that vendors may properly configure their software in time for the 2010 PQRI.

Response: We agree with the commenter that vendors need sufficient time to adapt their products to support EHR-based capture and submission of data for PQRI measures. To that end, the specifications for the electronic transmission of 2010 PQRI measures were posted on the QualityNet Web site in April 2009 and were updated and reposted in July and September 2009 on the Alternative Reporting Mechanisms page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/20_AlternativeReportingMechanisms.asp#TopOfPage.

We should note that only eligible professionals using EHR systems that have been “qualified” by CMS by virtue of passing our self-nomination and testing process will be able to report their quality data to CMS via their EHR.

Comment: Several comments voiced support for EHR-based reporting of Measure #124, Measure #112, and Measure #113. One commenter was disappointed that no measures relevant to oncology were proposed to be available for 2010 PQRI EHR reporting. Another commenter recommended that the new CAD and heart failure measures proposed for 2010 PQRI registry only reporting also be available for EHR reporting for 2010. One commenter recommended that any potential retooling of measures for reporting through EHRs should not undermine the scientific basis of the measure.

Response: We appreciate the commenters' support for EHR-based reporting of measures. However, the number of measures available for EHR reporting is limited because in order for measures to be available for EHR-based reporting, measure specifications for the electronic reporting of those measures must be available. We will consider adding new measures for future PQRI program years as specifications become available. The retooling of measures will not change the intent of the measure. We believe that all PQRI measures are evidence-based and consistent with standards of care.

Comment: One commenter suggested that increasing the number of PQRI measures is discriminatory to those that cannot or have not incorporated electronic prescribing due to expense of initiating EHRs and electronic prescribing for small provider offices.

Response: With respect to practices that have not implemented technology that would allow for participation in PQRI via an EHR, there are other 2010 PQRI reporting options available for such practices. There are a total of 125 individual quality measures available for claims or registry reporting for the 2010 PQRI. In addition, 8 of the 13 2010 PQRI measures groups are available for claims or registry reporting (see section II.G.2.i.5. of this final rule with comment period for discussion of the final 2010 PQRI measures groups). The remaining 50 individual PQRI quality measures and 4 measures groups are available for registry reporting in 2010.

With respect to practices that have not implemented technology that would allow for electronic prescribing, we reiterate that the E-Prescribing Incentive Program is a separate and distinct incentive program for eligible professionals. Participation in the E-Prescribing Incentive Program is voluntary and is not required for participation in the 2010 PQRI. Details of the 2010 E-Prescribing Incentive Program can be found in section II.G.5. of this final rule with comment period.

Based on the reasons discussed above and the comments received, we are finalizing the option of accepting clinical quality data extracted from qualified EHRs on all 10 of the proposed 2010 PQRI quality measures identified in Table 20 of the proposed rule. The final 2010 measures available for EHR-based reporting are identified in Table 14 of this final rule with comment period.

Table 14—2010 Measures Available for EHR-Based Reporting Back to Top
Measure No. Measure title NQF endorsement status as of 5/1/09 AQA adoption status as of 1/31/09 Measure developer
1 Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus Yes Yes NCQA
2 Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control in Diabetes Mellitus Yes Yes NCQA
3 Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus Yes No NCQA
5 Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD) Yes Yes AMA-PCPI
7 Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI) Yes Yes AMA-PCPI
110 Preventive Care and Screening: Influenza Immunization for Patients ≥ 50 Years Old Yes No AMA-PCPI
111 Preventive Care and Screening: Pneumonia Vaccination for Patients 65 Years and Older Yes Yes NCQA
112 Preventive Care and Screening: Screening Mammography Yes Yes NCQA
113 Preventive Care and Screening: Colorectal Cancer Screening Yes Yes NCQA
124 Health Information Technology (HIT): Adoption/Use of Electronic Health Records (EHR) Yes Yes CMS/QIP

(5) Measures Selected for Inclusion in 2010 Measures Groups

We proposed to retain the 7 2009 PQRI measures groups for the 2010 PQRI: (1) Diabetes Mellitus; (2) CKD; (3) Preventive Care; (4) CABG; (5) Rheumatoid Arthritis; (6) Perioperative Care; and (7) Back Pain (74 FR 33582 through 33587). As in 2009, we proposed the CABG measures group would be reportable through the registry-based reporting mechanism only for 2010 while the remaining 6 2009 PQRI measures groups would be reportable through either claims-based reporting or registry-based reporting for the 2010 PQRI.

In addition to the 7 measures groups that we proposed to retain from the 2009 PQRI, we proposed 6 new measures groups for the 2010 PQRI, for a total of 13 CY 2010 measures groups. The 6 new measures groups proposed for the 2010 PQRI were: (1) Coronary Artery Disease (CAD); (2) Heart Failure; (3) Ischemic Vascular Disease (IVD); (4) Hepatitis C; (5) Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS); and (6) Community Acquired Pneumonia (CAP). Since many of the 6 new measures groups proposed for 2010 contained proposed new registry-only measures, only 8 proposed 2010 measures groups would be reportable through either claims-based reporting or registry-based reporting: Diabetes Mellitus; CKD; Preventive Care; Perioperative Care; Rheumatoid Arthritis; Back Pain; Hepatitis C; and Community Acquired Pneumonia. We solicited comments on our proposal to limit claims-based reporting of measures groups in 2010.

Finally, we also proposed that except for the measures included in the Back Pain measures group, the measures included in any proposed 2010 measures group would be reportable either as individual measures or as part of a measures group. Similar to the 2009 PQRI, we proposed that the measures proposed for inclusion in the Back Pain measures group would be reportable only as part of a measures group and not as individual measures in 2010.

The measures proposed for inclusion in each of the proposed 2010 measures groups were identified in Tables 21 through 33 of the CY 2010 PFS proposed rule (74 FR 33582 through 33587).

The following is a summary of the comments received on the proposed 2010 measures groups.

Comment: We received several comments in support of the proposed 2010 PQRI measures groups. Specifically, we received comments in support of the Preventive Care, CAP, HIV/AIDS, Hepatitis C, Rheumatoid Arthritis, IVD, and Heart Failure measures groups. Some commenters also commended CMS for the inclusion of specific measures in certain measures groups.

Response: We appreciate the commenters' feedback. As identified in Tables 15 through 27 of this final rule with comment period, we are finalizing all of the 13 proposed 2010 PQRI measures groups. No changes were made to the measures included in the measures groups. However, as a result of 4 measures proposed for inclusion in the IVD measures group that were proposed to be registry only measures now being available for either claims or registry reporting, the IVD measures group will also be available for either claims or registry reporting.

Comment: Some commenters suggested changes to our definition of “measures group.” One commenter urged us to reduce the number of measures required for reporting a measure group to a minimum of 3 measures. Another commenter requested that we define “measures group” to be any 3 measures. One commenter recommended that we implement measures groups with complex denominators to allow for reporting on measures that have an associated impact on patient care and positive outcomes.

Response: As stated in the CY 2010 PFS proposed rule (74 FR 33568), “measures group” has been previously defined as a subset of 4 or more PQRI measures that have a particular clinical condition or focus in common. The denominator definition and coding of the measures groups identifies the condition or focus that is shared across the measures within a particular measures group. If we change this definition as suggested by commenters, then there would be no difference in terms of reporting measures groups and reporting PQRI individual quality measures since eligible professionals who choose to report on individual PQRI quality measures are already generally required to report on 3 measures. The only exception that permits eligible professionals to report on fewer than 3 measures is when an eligible professional has fewer than 3 applicable measures. For eligible professionals in this situation, the only option is to report applicable measures via claims.

Comment: One commenter recommended that we monitor Measure #115 Preventive Care and Screening: Advising Smokers and Tobacco Users to Quit for the CAD measures group for “appropriate conclusion as more evidence is released which will show whether advising smokers to quit increases the chances that they actually will quit.”

Response: We assume that that the commenter is requesting that we monitor Measure #115 for appropriate inclusion in CAD the measures groups. As with all measures and measures groups selected for inclusion in the PQRI quality measure set, we will continue to monitor the appropriateness of including Measure #115 in the CAD measures group on an ongoing basis for future program years.

Comment: One commenter recommended that claims-based reporting be available for all measures groups. Other commenters recommended that claims-based reporting be available for specific measures groups, such as the CAD, IVD, Heart Failure, HIV/AIDS measures groups.

Response: The following 2010 PQRI measures groups will be reportable only via registry-based reporting: (1) CABG; (2) CAD; (3) Heart Failure; and (4) HIV/AIDS. These measures groups will be registry-only because they include individual 2010 PQRI registry-only measures that cannot be feasibly specified for claims based reporting.

Although we proposed that the IVD measures group would also be registry-only for 2010, we determined, based on comments that it is feasible to make the proposed registry-only measures proposed for inclusion in the IVD measures group available for either claims or registry reporting for 2010. Therefore, the IVD measures group will be available for either claims or registry reporting.

Comment: Some commenters recommended the addition of specific codes to particular measures that were proposed for inclusion in a measures group. Specifically, one commenter recommended the addition of 2 physical therapy codes to the back pain measures for the proposed Back Pain measures group. Another commenter recommended the addition of inpatient codes for the measures proposed for inclusion in the CAP measures group.

Response: As stated previously, it is generally the role of the measure owner, developer, or maintainer to make substantive changes to a measure. The addition of physical therapy codes would mean that it is appropriate to hold such professionals accountable for the measure, which we believe constitutes such a substantive issue. The measure maintainer and/or the developer/owner of a measure included in the final set of 2010 PQRI measures groups is identified as the “Measure Developer” in Tables 15 through 27 of this final rule with comment period. In addition, NQF has, for its endorsed measures, an established maintenance process which may be accessed. Both venues would be available to seek such substantive changes to the measures. Although we are required by section 1848(k)(2)(D) of the Act to give the public an opportunity to provide input on the selection of PQRI measures and do so via notice and comment rulemaking, we do not use notice and comment rulemaking as a means to make substantive changes to measures nor to update or modify measure specifications. We retain the ability to update or modify specifications to the measures until December 31, 2009. After that date, there will be no changes to the measure for the 2010 reporting period(s).

Based on the reasons discussed above and comments received, we are finalizing the following proposed 2010 measures groups: (1) Diabetes Mellitus; (2) CKD; (3) Preventive Care; (4) CABG; (5) Rheumatoid Arthritis; (6) Perioperative Care; (7) Back Pain; (8) CAD; (9) Heart Failure; (10) IVD; (11) Hepatitis C; (12) HIV/AIDS; and (13) CAP. The following 4 measures groups are reportable through the registry-based reporting mechanism only: (1) CABG; (2) CAD; (3) Heart Failure; and (4) HIV/AIDS. The IVD measures group is no longer limited to registry only reporting since 4 measures included in the group that were proposed to be registry-only measures are now available for either claims or registry reporting for 2010 (see section II.G.2.i.2. above).

The measures selected for inclusion in each of the 2010 measures groups are identified in Tables 15 through 27 of this final rule with comment period. Some measures selected for inclusion in these 6 measures group are current 2009 individual PQRI measures. The title of each such measure is preceded with its PQRI Measure Number in Tables 15 through 27. As stated previously, the PQRI Measure Number is a unique identifier assigned by CMS to all measures in the PQRI measure set. Once a PQRI Measure Number is assigned to a measure, it will not be used again, even if the measure is subsequently retired from the PQRI measure set. Measures that are not preceded by a number (in other words, those preceded by “TBD”) in Tables 15 through 27 were never part of a PQRI measure set prior to 2010. A number will be assigned to such measures for 2010.

In addition, some measures selected for inclusion in some of these measures groups for 2010 were not included in the measures groups in 2009. The 2009 measures selected for inclusion in a 2010 measures group that were not included in the measures group for 2009 are identified with an asterisk (*).

We also note that the proposed 2010 Heart Failure measures group included the measure Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation, which is not included in the final 2010 Heart Failure measures group. The measure does not meet the common denominator criteria for the Heart Failure measures group because it requires an additional denominator code for atrial fibrillation. This additional code is not in the other 7 measures included in the Heart Failure measures group. As stated previously, measures groups must have a particular condition or focus in common, as identified by the denominator definition and coding of the measures group.

As with measures group reporting in the 2008 and 2009 PQRI, each eligible professional electing to report a group of measures for 2010 must report all measures in the group that are applicable to each patient or encounter to which the measures group applies at least up to the minimum number of patients required by the applicable reporting criteria. The measures selected for the Back Pain measures group continue to be reportable only as part of a measures group and not as individual measures for the 2010 PQRI. Measures selected for inclusion in all other 2010 PQRI measures groups are reportable either as individual measures or as part of a measures group.

BILLING CODE 4120-01-P

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

[Graphic not available; view image of printed page]

BILLING CODE 4120-01-C

We note that the specifications for measures groups do not necessarily contain all the specification elements of each individual measure making up the measures group. This is based on the need for a common set of denominator specifications for all the measures making up a measures group in order to define the applicability of the measures group. Therefore, the specifications and instructions for measures groups will be provided separately from the specifications and instructions for the individual 2010 PQRI measures. We will post the detailed specifications and specific instructions for reporting measures groups on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI by no later than December 31, 2008.

Additionally, the detailed measure specifications and instructions for submitting data on those 2010 measures groups that were also included as 2009 PQRI measures groups may be updated or modified prior to 2010. Therefore, the 2010 PQRI measure specifications for any given measures group could be different from specifications and submission instructions for the same measures group used for 2009. These measure specification changes do not materially impact the intended meaning of the measures or the strength of the measures.

(6) Request for Public Comment on Measure Suggestions for Future PQRI Quality Measure Sets

In the CY 2010 PFS proposed rule (74 FR 33587), we invited commenters to submit suggestions for individual quality measures and measures groups (that is, suggestions for new measures groups and/or suggestions for the composition of measures groups) for consideration for possible inclusion in the proposed set of quality measures for use in the 2011 PQRI. We asked individuals or organizations submitting suggestions to provide us with the following information:

  • Requestor contact information, such as name and title, organization/practice name, phone number and e-mail address;
  • Measure title;
  • Measure description;
  • Measure owner/developer;
  • NQF endorsement status, including the date of endorsement or anticipated endorsement (if not NQF-endorsed) and type of endorsement (for example, time-limited endorsement);
  • AQA adoption status, including date of AQA adoption or anticipated AQA adoption;
  • Preferred PQRI reporting option for the suggested measure(s) (that is, claims, registry, registry-only, measures group, measures group only, EHRs); and
  • The measure specifications.

The following is summary of the comments we received regarding suggestions for individual quality measures and measures groups (that is, suggestions for new measures groups and/or suggestions) for the 2011 PQRI.

Comment: Several commenters suggested quality measures or measures groups for the 2010 PQRI in addition to the quality measures and measures groups for individual eligible professionals we had proposed in Tables 19 through 33 of the CY 2010 PFS proposed rule (74 FR 33575 through 33587).

Response: We have not included in this final rule with comment period for the 2010 PQRI any individual quality measures that were not identified in the CY 2010 PFS proposed rule as proposed 2010 PQRI measures. As discussed above in this final rule with comment period, we are obligated by section 1848(k)(2)(D) of the Act to give eligible professionals an opportunity to provide input during the selection of measures for the 2010 PQRI and subsequent years. Eligible professionals have not had an opportunity to provide input on measures recommended for selection via comments on the proposed rule that were not specifically included in the proposed rule. Thus, such additional measures recommended via comments on the proposed rule cannot be included in the 2010 PQRI quality measure set. However, we have captured these recommendations and will have them available for consideration in identifying measure sets for future years' PQRI and other initiatives to which those measures may be pertinent.

Comment: As we requested in the CY 2010 PFS proposed rule (74 FR 33587), several commenters suggested quality measures or measures groups for the 2011 PQRI.

Response: We have captured these recommendations. To the extent information provided is complete (that is, includes the measure or measure group details requested in the proposed rule), we will consider the commenters' recommendations in identifying measure sets for future years' PQRI and other initiatives to which those measures may be pertinent. As we stated in the CY 2010 PFS proposed rule, suggesting individual measures or measures for new or proposed measures groups does not mean that the measure(s) or measures group(s) will be included in the proposed or final sets of measures or measures groups of any proposed or final rules that address the 2011 PQRI. We will determine what individual measures and measures group to include in the proposed set of quality measures, and after a period of public comment, we will make the final determination with regard to the final set of quality measures for the 2011 PQRI.

Comment: Some commenters urged us to expand the opportunities for measures to be presented to CMS for potential inclusion in the PQRI. One commenter elaborated that the process to develop and endorse measures takes a considerable amount of time and measure developers should have greater opportunities to bring measures forward. The commenter also requested that we review the process by which PQRI measures are selected to ensure transparency and greater communication with measure developers. The commenter stated that currently the process leaves little opportunity for the measure developer to dialogue with CMS if the measure is denied. The commenter believes we should provide feedback on suggested measures prior to publication of the proposed rule.

Response: We understand the commenters' concerns. As stated previously, we largely depend on the development of measures by professional organizations and other measure developers. As such, we depend on the measure developers and other stakeholders to bring forth potential measures to our attention. We are continuing to look for ways to improve the process for allowing stakeholders to bring forth suggested measures and are considering some changes in the process future years PQRI. For example, in addition to our invitation to submit suggestions for measures and measures groups for potential inclusion in the 2011 PQRI contained in CY 2010 PFS proposed rule (74 FR 33587), we are considering a Call for 2011 Measures that will allow stakeholders to submit additional measures and/or measures groups suggestions for the 2011 PQRI after publication of this final rule followed by a listening session in early 2010 to promote a dialogue with stakeholders with respect to the measure or measures group suggestions we receive.

j. 2010 PQRI Quality Measures for Physician Groups Selected To Participate in the Group Practice Reporting Option

We proposed that physician groups selected to participate in the 2010 PQRI group practice reporting option would be required to report on 26 measures (74 FR 33587). These measures are NQF-endorsed measures currently collected as part of the PGP and/or MCMP demonstrations.

The following is summary of the comments we received regarding the proposed 2010 PQRI Quality Measures for physician groups selected to participate in the PQRI group practice reporting option.

Comment: Some commenters suggested that we broaden the scope of measures so that the measures would be applicable to specialty care such as emergency medicine, gastroenterology, and surgical specialties. A few commenters felt that group practices are being required to report on too many measures. Several commenters believe that it is appropriate for CMS to first implement the group practice reporting option by focusing on the high-cost chronic conditions and preventive care reflected by the proposed measures.

Response: We recognize that the measures largely apply to primary care. However, as required by statute, the measures shall target high-cost chronic conditions and preventive care. This reporting option is for group practices with 200 or more eligible professionals. On average, these group practices typically have 20,000 patients assigned to each group practice. Each group practice will be required to complete the data collection tool on a total of no more than 3,699 consecutively assigned and ranked patients, which is 411 patients per disease module and preventive care measure. Thus, the number of measures is considered to be equitable for practices with this volume of patients and eligible professionals. We will continue to evaluate the number and types of measures and modules for future program years.

Comment: We received some comments in support of the proposed measures for the group practice reporting option. A few commenters expressed support for specific proposed measures, including:

  • Measure #1 Diabetes Mellitus: Hemoglobin A1c Poor Control;
  • Measure #5 Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD);
  • Measure #6 Coronary Artery Disease (CAD): Oral Antiplatelet Therapy Prescribed for Patients with CAD;
  • Measure #7 Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI);
  • Measure #8 Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD); Measure #118 Coronary Artery Disease (CAD): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Patients with CAD and Diabetes and/or Left Ventricular Systolic Dysfunction (LVSD);
  • Heart Failure: Left Ventricular Function (LVF) Testing;
  • Heart Failure: Left Ventricular Function (LVF) Assessment;
  • Heart Failure: Weight Measurement;
  • Heart Failure: Patient Education;
  • Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation; and
  • Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL-Cholesterol.

Response: We appreciate the commenters support. The final measures for physician groups participating in the 2010 PQRI group practice reporting option are identified in Table 28.

Comment: One commenter noted that the 2 proposed hypertension measures (Hypertension (HTN): Blood Pressure Control and Hypertension (HTN): Plan of Care) are not included in the larger list of 2010 PQRI measures for individual eligible professionals. The commenter recommended that we include these 2 measures as 2010 PQRI individual quality measures for individual eligible professionals.

Response: The commenter is correct; these 2 measures are not available to individual eligible professionals to report for the 2010 PQRI. Since these measures were not proposed to be included in the 2010 PQRI quality measure set for individual eligible professionals, however, we are unable to add them to the PQRI quality measure set for individual quality measures for 2010. As stated previously, section 1848(k)(2)(D) of the Act requires us to give the public an opportunity to provide input on the selection of measures for the PQRI, which we accomplish through notice and comment rulemaking. Since these measures have not been placed before the public as potential measures for individual eligible professionals for the 2010 PQRI, eligible professionals and other stakeholders have not had an opportunity to provide input on the inclusion of these 2 measures in the 2010 PQRI quality measure set for individual eligible professionals.

Comment: The measure developer/owner of the Heart Failure: Weight measurement measure requested that we remove the measure from the group reporting option since the measure owner's measure workgroup is planning to retire the measure from its heart failure measure set in the upcoming months.

Response: We value the input of the measure developer/owner. Furthermore, we look to the measure developer/owner to maintain and update measures based on the standards of care and evidence base. We believe, however, that the Heart Failure: Weight Measurement measure targets a high-cost chronic condition. The measure is a valuable measure in the evaluation of patients with heart failure and continues to have a significant impact on the care and improvement in outcomes. Additionally, the measure has undergone the scientific rigor of achieving consensus endorsement by the NQF. Therefore, we will retain this measure, as proposed, in the group practice reporting option. The final measure specifications for the group practice reporting option will be posted on the CMS Web site http://www.cms.hhs.gov/pqri no later than December 31, 2009.

Comment: One commenter noted that measure developer listed in the proposed rule for the “Preventive Care: Blood Pressure Management” measure was incorrect and should be corrected in the final rule.

Response: The measure title was incorrectly listed as “Preventive Care: Blood Pressure Management.” The correct title is “Hypertension: Blood Pressure Measurement.” This correction is reflected in Table 28.

Based on the reasons discussed above and after considering the comments, for the 2010 PQRI, group practices selected to participate in the PQRI group practice reporting option will be required to report on all measures listed in Table 28. To the extent that a measure is an existing PQRI measure available for reporting by individual eligible professionals, the Measure Title is preceded by the measure's PQRI Measure Number. If there is no number in the PQRI Measure Number column of the table, then the measure is not an existing PQRI measure and will be added to the 2010 PQRI for purposes of the group practice reporting option.

A separate measures specifications manual and other supporting documents will be available for group practices participating in the 2010 PQRI group practice reporting option. We anticipate that the group practice measures specifications manual will be available by November 15, 2009 on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI.

Table 28—Measures for Physician Groups Participating in the 2010 PQRI Group Practice Reporting Option Back to Top
PQRI Measure No. Measure title Measure developer
1 Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus NCQA
2 Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control NCQA
3 Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus NCQA
5 Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD) AMA-PCPI
6 Coronary Artery Disease (CAD): Oral Antiplatelet Therapy Prescribed for Patients with CAD AMA-PCPI
7 Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI) AMA-PCPI
8 Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) AMA-PCPI
110 Preventive Care and Screening: Influenza Immunization for Patients ≥ 50 Years Old AMA-PCPI
111 Preventive Care and Screening: Pneumonia Vaccination for Patients 65 Years and Older NCQA
112 Preventive Care and Screening: Screening Mammography NCQA
113 Preventive Care and Screening: Colorectal Cancer Screening NCQA/AMA-PCPI
117 Diabetes Mellitus: Dilated Eye Exam in Diabetic Patient NCQA
118 Coronary Artery Disease (CAD): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) for Patients with CAD and Diabetes and/or Left Ventricular Systolic Dysfunction (LVSD) AMA-PCPI
119 Diabetes Mellitus: Urine Screening for Microalbumin or Medical Attention for Nephropathy in Diabetic Patients NCQA
163 Diabetes Mellitus: Foot Exam NCQA
TBD Diabetes Mellitus: Hemoglobin A1c Testing NCQA
TBD Diabetes Mellitus: Lipid Profile NCQA
TBD Heart Failure: Left Ventricular Function (LVF) Testing CMS
TBD Heart Failure: Left Ventricular Function (LVF) Assessment AMA-PCPI
TBD Heart Failure: Weight Measurement AMA-PCPI
TBD Heart Failure: Patient Education AMA-PCPI
TBD Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation AMA-PCPI
TBD Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL-Cholesterol AMA-PCPI
TBD Hypertension: Blood Pressure Measurement AMA-PCPI
TBD Hypertension (HTN): Blood Pressure Control CMS/NCQA
TBD Hypertension (HTN): Plan of Care AMA-PCPI

k. Public Reporting of PQRI Data

Section 1848(m)(5)(G) of the Act, as added by the MIPPA, requires the Secretary to post on the CMS Web site, in an easily understandable format, a list of the names of eligible professionals (or group practices) who satisfactorily submitted data on quality measures for the PQRI and the names of the eligible professionals (or group practices) who are successful electronic prescribers. In accordance with section 1848(m)(5)(G) of the Act, we stated in the CY 2010 PFS proposed rule (74 FR 33588 through 33589) our intent to make public the names of eligible professionals and group practices that satisfactorily submit quality data for the 2010 PQRI on the Physician and Other Health Care Professionals Directory. In addition to posting the information required by section 1848(m)(5)(G) of the Act, for those group practices that are selected to participate in PQRI under the group practice reporting option, we also proposed to make the group practices' PQRI performance rates publicly available, for each of the measures. We solicited comments regarding our proposal to publicly report group practices' PQRI performance results.

The following is summary of the comments we received regarding the public reporting of PQRI data required under section 1848(m)(5)(G)(i) of the Act and our proposal to publicly report group practices' PQRI performance results.

Comment: We received some comments in support of public reporting of either the information required by section 1848(m)(5)(G)(i) of the Act or all PQRI measure results, including individual eligible professionals' performance results. One commenter stated that CMS needs to articulate a clear and aggressive path forward, with short-term benchmarks and a goal of having publicly available, actionable performance and cost information for all participating Medicare clinicians.

Response: We appreciate the commenters' support. As we have stated previously, we believe that public reporting of group practices' PQRI performance results represents an opportunity to make strides towards the goal of being able to make quality information about physicians and other healthcare professionals publicly available.

Comment: One commenter encouraged the use of composite measures to help increase the reliability of individual eligible professionals' performance data.

Response: At this time we have no plans to publicly release individual eligible professionals' performance data. Additional refinements to the PQRI are likely needed as the program matures.

Comment: One commenter recommended that CMS also publicly report the names of eligible professionals who choose not to participate in the PQRI. The commenter stated that the willingness (or lack thereof) of clinicians to participate in performance measurement and reporting should be publicly recognized.

Response: We disagree that such information would be useful to consumers since there are several valid reasons why an eligible professional may choose to not participate in a voluntary initiative, such as the PQRI. Consumers may potentially misinterpret the lack of participation to mean that an eligible professional is not interested in providing quality care.

Comment: Many commenters were opposed to releasing any other data on PQRI until issues with the Physician and Other Health Care Professional Directory are addressed and corrected. Some of the issues cited by commenters include, the lack of accurate provider listings, poor and difficult to find disclaimer information regarding participation in PQRI, and poor user instructions. Many comments, in particular, requested that the disclaimer that was provided with the list of 2007 PQRI participants be updated and made more prominent.

Response: We appreciate the comments and plan to make improvements to the Directory with respect to reporting PQRI participation.

Comment: Many commenters were opposed to releasing any additional PQRI information, including the information required under section 1848(m)(5)(G)(i) of the Act, because of issues with the PQRI itself. Some of the concerns cited by commenters include the following:

  • The errors identified with the 2007 PQRI have compromised the program's validity within the participant community;
  • The program's plans to transition away from claims-based reporting may force eligible professionals who satisfactorily reported in the past to stop doing so;
  • The potential for consumers to misunderstand the significance of the information being publicly reported since there are still many valid reasons why an eligible professional may not have participated or may have participated but was not considered a satisfactory reporter.

One commenter suggested that we consider alternative data sets for public reporting such as Board certification, CAHPS data, and/or a physician or other health care professional's participation in a registry. Other commenters requested that a formal evaluation of the 2007 and 2008 PQRI be conducted before releasing any participation, reporting, or performance rates.

Response: As required by section 1848(m)(5)(G)(i) of the Act, we must, at a minimum, make public the names of eligible professionals and group practices that satisfactorily submit quality data for the 2010 PQRI on the Physician and Other Health Care Professionals Directory. We anticipate that the names of individual eligible professionals and group practices that satisfactorily submit quality data for the 2010 PQRI will not be made available any earlier than in 2011 after the 2010 incentive payments are paid. In an attempt to address commenters' concerns, we will make information about the intended uses and/or limitations of the information being presented in the form of a disclaimer available on the Web site as well. To the extent that additional information derived from the PQRI, is made public we would also take such concerns into account.

Comment: Several commenters provided recommendations for CMS to consider with respect to publicly reporting PQRI information, including the information required by section 1848(m)(5)(G)(i) of the Act. These suggestions include the following:

  • Establishing a process that allows for prior review and comment before data are made public and that allows for any comments received to be included with the publicly reported data;
  • Establishing an appeals process with regard to any data that is to be publicly reported;
  • Providing information outlining the data's potential uses and limitations;
  • Providing information that clearly and specifically states that information about whether an eligible professional is a satisfactory reporter does not necessarily indicate that higher quality care was or will be provided by those eligible professionals (or group practices) who qualified to earn PQRI incentive payments;
  • Providing better access to and more timely feedback;
  • Avoiding characterization of the names of satisfactory reporters as comparative quality information; and
  • Giving eligible professionals an opportunity to explain why they are not participating.

Response: We appreciate the commenters' valuable input. We believe that many of these suggestions have already been addressed. For example, eligible professionals have an opportunity to review their reporting and performance results via the feedback reports that are made available to all participating eligible professionals at the time that incentive payments are released for a particular program year. As discussed previously, we have also created an alternate process to make it easier for eligible professionals to obtain their feedback reports and created a dedicated Help Desk that is available to assist eligible professionals who have any concerns about the information contained in their feedback reports. All information that is publicly reported will also be accompanied by appropriate disclaimers that address the information's potential uses and limitations, including the fact that an eligible professional or group practice is listed as having satisfactorily reported PQRI quality measures does not necessarily indicate that he or she provides higher quality care than those who did not participate or those who participated but did not do so satisfactorily.

Comment: Several commenters provided recommendations for CMS to consider specifically with respect to our proposal to publicly report group practices' PQRI performance results. These suggestions include the following:

  • Providing group practices the opportunity to suppress their data;
  • Precisely defining what performance data CMS plans to post; and
  • Conducting and publishing an evaluation of PQRI on its impact on quality of care before selecting measures for public reporting.

Response: As stated in the CY 2010 PFS proposed rule (74 FR 33589), we proposed to make the group practices' performance rates for each of the PQRI group practice reporting option measures public for each group selected to participate in PQRI group practice reporting option. We proposed to attribute the performance rates to the entire group and will not post any information with respect to the performance of individual eligible professionals other than, potentially, to identify the individual eligible professionals that were associated with the group during the reporting period.

As stated in section II.G.2.g.1. above, however, we have taken the commenters' concerns about publicly reporting the group practices' performance results in the first year of implementation of the PQRI group practice reporting option into consideration. We are not finalizing our proposal to require group practices that wish to utilize the group practice reporting option in 2010 to agree to have their PQRI performance results publicly reported. In addition, we will not report any 2010 group practice performance results publicly at all except as otherwise required by law and will limit public reporting of information on the PQRI group practice reporting to the information required by section 1848(m)(5)(G)(i) of the Act (that is, the names of group practices that satisfactorily submitted data on PQRI quality measures). Instead, we will consider implementing public reporting of group practices' performance results in the 2011 PQRI program year.

Comment: Many commenters were opposed to the public reporting of any PQRI information beyond what is specifically required by section 1848(m)(5)(G)(i) of the Act. These concerns include the following:

  • CMS only has the specific authority to publicly report the information required by section 1848(m)(5)(G)(i) of the Act;
  • There continue to be substantial gaps in the PQRI quality measure set that may create a barrier to participation in PQRI;
  • The value of PQRI data is questionable since there has been no formal evaluation of the PQRI to determine its impact on the quality of care, whether it allows for fair and meaningful comparisons of performance on eligible professionals, and whether it is valid; and
  • PQRI is not available to all specialties.

Response: Other than the information required by section 1848(m)(5)(G)(i) of the Act, the only PQRI information that we contemplated making public is the PQRI performance results for group practices selected to participate in the PQRI group practice reporting option (that is, group practices that have agreed to have their PQRI performance results publicly reported as a condition of utilizing the group practice reporting option). As stated above, we have taken commenters' concerns into consideration and have decided to defer implementation of public reporting of group practices' performance results until the 2011 PQRI program year.

Comment: One commenter requested clarification of the term “satisfactorily submitted.” The commenter recommended that we exercise flexibility until there is a guarantee that we can accurately collect and analyze the submission of quality data codes.

Response: We do not believe we have the authority to flexibly define the term “satisfactorily submitted.” Section 1848(m) of the Act clearly considers any eligible professional or group practice who satisfies the criteria for satisfactory reporting, as defined in sections II.G.2.e. through II.G.2.g. of this final rule with comment period, to be an eligible professional or group practice who qualifies for an incentive payment. Furthermore, section 1848(m)(5)(G) of the Act clearly requires us to post the names of eligible professionals or group practices that satisfactorily submitted data on PQRI quality measures.

After considering the comments above, we intend to post the names of eligible professionals who: (1) Submit data on the 2010 PQRI quality measures through one of the reporting mechanisms available for the 2010 PQRI; (2) meet one of the proposed satisfactory reporting criteria of individual measures or measures groups for the 2010 PQRI; and (3) qualify to earn a PQRI incentive payment for covered professional services furnished during the applicable 2010 PQRI reporting period for purposes of satisfying the requirements under section 1848(m)(5)(G)(i) of the Act, on the Physician and Other Health Care Professionals Directory.

Similarly, for purposes of satisfying the requirements under section 1848(m)(5)(G)(i) of the Act with respect to group practices, on the Physician and Other Health Care Professionals Directory, we intend to post the names of group practices that: (1) Submit data on the 2010 PQRI quality measures through the proposed group practice reporting option; (2) meet the proposed criteria for satisfactory reporting under the group practice reporting option; and (3) qualify to earn a PQRI incentive payment for covered professional services furnished during the applicable 2010 PQRI reporting period for group practices.

We do not intend to make performance rates for group practices participating in the 2010 PQRI group practice reporting option publicly available but anticipate publicly reporting group practices' performance results for the 2011 PQRI program year.

We anticipate that information with respect to quality data submitted for the 2010 PQRI (that is, the names of individual eligible professionals and group practices that satisfactorily report in 2010) will not be available until after the 2010 incentive payments are paid in 2011.

3. Section 131(c): Physician Resource Use Measurement and Reporting Program

a. Statutory Authority

As required under section 1848(n) of the Act, as added by section 131(c) of the MIPPA, we established and implemented by January 1, 2009, the Physician Resource Use Measurement Reporting Program for purposes of providing confidential reports to physicians that measure the resources involved in furnishing care Medicare beneficiaries. Section 1848(n) of the Act also authorizes CMS to include information on the quality of care furnished to Medicare beneficiaries by a physician or group of physicians.

b. Background

As stated in the CY 2009 PFS final rule with comment period (73 FR 69866), the Program would consist of multiple phases. We included a summary of the activities of phase I of the Program in the CY 2009 PFS final rule with comment period (73 FR 69866 through 69869). In addition to discussing phase I of the Program, we also highlighted the activities of several other initiatives, including Medicare Value-Based Purchasing (VBP) programs and demonstrations and related activities undertaken by the MedPAC and the Government Accountability Office (GAO). We refer readers to the CY 2009 PFS final rule with comment period (73 FR 69866 through 69869) for a detailed discussion of these activities.

In the CY 2009 PFS final rule with comment period (73 FR 69866 through 69869), we finalized, on an interim basis, the following parameters for phase I of the Program: (1) Use of both per capita and episode of care methodologies for resource use measurement; (2) cost of service category analysis (for example, imaging services or inpatient admissions); (3) use of 4 calendar years of claims data; (4) focus on high cost and/or high volume conditions; (5) reporting to physician specialties relevant to the selected focal conditions; (6) focus on physicians practicing in certain geographic areas, and (7) low, median, and high cost benchmarks.

In the CY 2010 PFS proposed rule (74 FR 33589 through 33591), we summarized the comments received from the CY 2009 PFS final rule with comment period and our responses. Further, we made the following proposals in the CY 2010 PFS proposed rule (74 FR 33591): (1) Reporting on quality measures in addition to resource use measures, and (2) reporting to groups of physicians in addition to individual physicians.

c. Phase I of the Program

As indicated above, the Program consists of multiple phases. Under this approach, each phase of the Program will inform future phases of the Program. We refer readers to the CY 2009 PFS final rule with comment period (73 FR 69866 through 69869) for a description of phase I Program activities. Using the parameters that were finalized on an interim basis, we have disseminated approximately 310 resource use reports (a sample report is available at http://rurinfo.mathematica-mpr.com/) to physicians in 13 geographic regions (74 FR 33590). In the proposed rule, we solicited public comments on the interim final Program parameters.

Commenters supported the Program parameters that were finalized on an interim basis in the CY 2009 PFS final rule (73 FR 69866 through 69869). Our summary of those comments and our responses are contained in the CY 2010 PFS proposed rule (74 FR 33589 through 33591). Accordingly, we are finalizing the interim final Program parameters.

In addition to the eight conditions finalized on an interim basis in the CY 2009 PFS final rule(74 FR 33590), we solicited public comment on adding diabetes as an episode of care.

Comment: Commenters supported including diabetes as one of the selected episodes of care for the Program.

Response: We are finalizing adding diabetes to the episode of care analysis in the Program.

In the CY 2010 PFS proposed rule (74 FR 33591), we referred readers to the following Web site to review a de-identified sample of the resource use reports disseminated to physicians: http://rurinfo.mathematica-mpr.com/. We solicited public comment on the resource use report used in phase I of the Program.

Comment: Commenters supported dissemination of feedback reports both in hard copy and electronically.

Response: We intend to offer both hard copy and electronic delivery of feedback reports in the Program.

Comment: Commenters supported electronic reports that allow user-driven data drilldown capability to the claim level.

Response: We intend to explore the feasibility of such drill-down capability.

Comment: A few commenters suggested that additional cost of service categories (described on pages 30 and 34-35 at http://rurinfo.mathematica-mpr.com/) should be included in the feedback reports. Additional categories mentioned included: prescribed drugs, costs due to infections, and specific information on diagnostic tests and services.

Response: We intend to explore the feasibility of these additional cost of service categories in the future.

Comment: A few commenters suggested capturing hospital readmissions as a measure in the feedback reports.

Response: We are committed to closely monitoring hospital readmissions in the Medicare program. We intend to explore the feasibility of capturing readmissions in the physician group feedback reports in the future.

Comment: A few commenters stated that some of the benchmarks used in the reports were too broad in order to make meaningful peer comparisons.

Response: We are committed to refining the benchmarks used in the Program to ensure meaningful peer comparisons. We note that there is a trade-off between statistical precision and narrow benchmarks. For additional discussion on this statistical topic, we refer readers to the CY 2010 PFS proposed rule (74 FR 33590 through 33591). Further, we note that the broad geographic benchmarks provide additional value to CMS by informing policymakers of measurement variation across geographic regions.

Comment: A few commenters mentioned that eligible professionals would appreciate knowing each beneficiary that was assigned to them. Further, physicians would appreciate knowing which other physicians were also providing care to the beneficiaries assigned to them.

Response: To the extent it is practicable, we are committed to providing physicians with information that targets specific performance areas. We intend to explore the feasibility of providing this detailed level of data.

Comment: One commenter requested that CMS pursue a robust evaluation of the risk adjustment methodology (pages 29 and 32 at http://rurinfo.mathematica-mpr.com/) used in the Program.

Response: We are committed to conducting further research to refine the risk adjustment rules currently being applied in the Program. Determining how to accurately adjust for patient risk factors is a priority for CMS.

Comment: One commenter suggested that we make the minimum thresholds for patients and episodes that are needed for statistical accuracy used in the Program publicly available.

Response: We are committed to making the methodologies used in the Program transparent. We are currently exploring the feasibility of publicly posting the minimum thresholds for patients and episodes used in the Program on our Web site.

Comment: A few commenters suggested that additional outreach and education is needed to help eligible professionals understand the reports. Further, commenters suggested including a task in the next Quality Improvement Organization (QIO) scope of work to assist physicians with interpreting their reports.

Response: We are committed to providing technical assistance to eligible professionals to aide in the understanding of the reports. We intend to explore the feasibility of including a task to provide technical assistance in understanding the reports in the QIO 10th scope of work.

Comment: One commenter questioned how E/M codes included in surgical bundle payments are used to inform CMS' designated attribution methodologies.

Response: We are committed to pursuing further research in order to refine the designated attribution rules currently being applied in the Program. Determining how to accurately attribute surgical bundles is a priority for CMS.

Comment: One commenter requested that CMS raise the minimum of 10 percent of E/M costs used to assign a patient or episode to a physician.

Response: In addition to setting the minimum threshold at 10 percent, we will test some higher minimum thresholds. We note that one of the goals of this Program is to provide confidential feedback reports to as many physicians as possible. One of the trade-offs to raising the minimum threshold is that fewer physicians may qualify to receive a feedback report.

Comment: Several commenters strongly supported CMS' use of the multiple proportional attribution rule (pages 26-27 and 33 at http://rurinfo.mathematica-mpr.com/).

Response: We will continue to examine the utility of this attribution rule and test others.

In the CY 2010 PFS proposed rule, we referred readers to two publicly available Web sites for commercial episode grouper vendors regarding transparency of their methodologies (74 FR 33591). We solicited public comment on the use of proprietary products to measure episodes of care in the Program.

Comment: Many commenters were in favor of CMS only using a Medicare-specific public domain episode grouper in the Program.

Response: To the greatest extent practicable, we are committed to ensuring all methodologies used in the Program are transparent. We intend to explore the feasibility of using a Medicare-specific public domain episode grouper in the Program. We refer readers to (74 FR 48979 through 48980) for an announcement regarding an upcoming public listening session that CMS is hosting to discuss this topic.

d. Phase II of the Program

For phase II, we proposed to expand the Program in ways that that targets specific performance areas for physicians. We proposed to add reporting to groups of physicians, recognizing that many physicians practice in arrangements other than solo practices. We noted that group level reporting will be more likely to resolve the sample size issues that arise when individual physicians have too few Medicare beneficiaries with specific conditions to generate statistically significant information. We solicited public comment on potential types of groups including the following: (1) Formally-established single or multi-specialty group practices; (2) physicians practicing in defined geographic regions; and (3) physicians practicing within facilities or larger systems of care.

Comment: Commenters supported reporting to groups of physicians, including all categories listed above, in addition to individual physicians. A few commenters questioned how CMS would define groups. Commenters did not offer a definition of group reporting, however. One commenter asked us to include accountable care organizations (ACOs) in the definition of the “group.”

Response: We are finalizing our proposal to include group reporting. Since no explicit definition of group practice was suggested through public comment, for purposes of this Program, we are finalizing the following definition of group practice: more than one physician practicing medicine together. We choose this definition because we want to recognize groups of physicians as entities that are separate and distinct from individual physicians. We are defining a group as two or more physicians both to recognize groups as separate and distinct from individual physicians and to ensure that we have the broadest possible definition of a group so that all physicians could potentially be provided with resource use reports. If groups were to be defined more narrowly, it is possible that some physicians would not be subject to the resource use reporting because they are neither working in solo practice as an individual physician or part of a practice that meets our definition of a group.

This definition applies to the following groups: (1) Formally-established single or multi-specialty group practices; (2) physicians practicing in defined geographic regions; and (3) physicians practicing within facilities or larger systems of care. With respect to ACOs, the term is not defined at this time in either the law or regulations but to the extent that the ACO includes more than one physician, the physicians in the ACO would constitute a group for resource use reporting. We are therefore, finalizing the definition for group practices and these three types of groups of physicians.

Phase I of the Program focused on providing confidential feedback on resource use measures. Section 1848(n)(1)(A) of the Act states that the Secretary may also include information on the quality of care furnished to Medicare beneficiaries by physicians (or groups of physicians) in the feedback reports. Providing physicians with feedback on both quality and cost of care better captures the value of the care provided. Including quality measures in the Program is consistent with the direction for other CMS VBP initiatives. We solicited public comments on the use of PQRI, GEM, and other aggregate quality measures to be used in the Physician Resource Use Measurement and Reporting Program.

Comment: Commenters were unanimously supportive of including quality measures, in addition to resource use measures in the Program.

Response: We are finalizing our proposal to include quality measures in the Program.

Comment: Commenters were in support of using both PQRI and GEM measures to capture quality of care. Some commenters cited the new nature of both PQRI and GEM measures as an area of concern and recommended caution in using these quality measures until the measures become more mature.

Response: Though we recognize that both the measures used in the PQRI and claims-based measures calculated without submission of quality data codes from physicians (such as GEM measures) will continue to mature over time, we intend to include them in the Program. Including these quality measures will allow us to gain more experience reporting performance metrics to eligible professionals on a confidential basis.

Comment: In addition to the use of PQRI and GEM measures, commenters also encouraged reporting of structure and outcome measures (outside of those currently included in the PQRI Program). Commenters stated that specialty societies and other measure developers should be encouraged to speed the development of these types of measures.

Response: We are committed to capturing all aspects of performance, including process, structure, and outcomes measures. As additional measures become available, we will examine the utility of such measures as an additional aspect of reporting in this Program.

Comment: A few commenters expressed that quality data should closely relate to the episodes of care that are targeted in the Program.

Response: We are committed to working collaboratively with measure developers on pairing quality measures with episodes of care.

Comment: A few commenters recommended that the time period represented by the quality and cost measures should overlap.

Response: To the greatest extent practicable, we are committed to recognizing overlapping measurement time periods between quality and cost measures in this Program.

Comment: A few commenters suggested capturing quality data from registries.

Response: We are committed to allowing the collection of quality measures from data contained within clinical registries. We refer readers to section II.G.2. of this final rule with comment period that discusses the PQRI for additional discussion on the use of registries to collect quality data.

e. General Comments

In addition to the areas where we specifically solicited comments, we also received several general comments.

Comment: Some commenters expressed concern about the use of the data contained within the feedback reports for purposes beyond confidential reporting. One commenter strongly encouraged CMS to publicly report the data contained within the feedback reports.

Response: Section 1848(n) of the Act currently provides the authority to use the information contained within the feedback reports on a confidential basis only.

Comment: One commenter suggested integrating the reporting of resource use measures into Maintenance of Certification programs.

Response: CMS is committed to working collaboratively with stakeholders on various mechanisms and programs to increase the value of care delivered to beneficiaries. We refer readers to section II.G.2. of this final rule with comment period that discusses the PQRI for additional discussion of this suggestion.

Comment: One commenter suggested that the feedback reports be used to provide information on geographic variations in the delivery of specific services.

Response: We are committed to monitoring and addressing geographic variations in the delivery of services. As mentioned above, we plan to explore group level reporting, which may include reporting to physicians within a specified geographic group.

Comment: One commenter strongly encouraged CMS to expand the number of reports delivered beyond the 310 delivered in Phase I of the Program.

Response: We are committed to providing feedback to as many physicians as our resources will allow. We intend to explore the feasibility of providing more reports in the Program.

4. Section 131(d): Plan for Transition to Value-Based Purchasing Program for Physicians and Other Practitioners

a. Background

Value-based purchasing uses payment incentives and transparency to increase the value of care by rewarding providers for higher quality and more efficient services and for publicly reporting performance information. Section 131(d) of the MIPPA requires the Secretary to develop a plan to transition to a value-based purchasing (VBP) program for Medicare payment for covered professional services made under, or based on, the PFS. Section 131(d) of the MIPPA also states that by May 1, 2010, the Secretary shall submit a report to the Congress, containing the plan, together with recommendations for such legislation and administrative action as the Secretary determines appropriate. The Secretary, through the Physician and Other Health Professional VBP (PVBP) Workgroup, submitted a progress letter to Congress on January 8, 2009 detailing the progress made on the PVBP plan for physicians and other professionals.

Currently, Medicare health professional payments are based on quantity of services and procedures provided, without recognition of quality or efficiency. Under various authorities, we have pursued the implementation of building blocks to support the establishment of a VBP program for health professionals. These include initiatives in the following major topic areas: quality and efficiency measurement and reporting, approaches for aligning incentives with providing higher quality care instead of higher volume of care, care coordination, prevention, and health information technology (HIT). The following are examples of the initiatives specifically relevant to physicians and other health professionals:

  • Pay for reporting of quality measurement data instituted under the Physician Quality Reporting Initiative (PQRI);
  • Resource use reports comparing overall costs, as well as costs for treatment across episodes of care, as required by the Physician Resource Use Measurement and Reporting Program; and
  • Demonstration projects including the Physician Group Practice demonstration of a shared savings model, gainsharing demonstrations, medical home and other care coordination and disease management demonstrations, and the Acute Care Episodes demonstration of a bundled payment model.

We are fully committed to implementing VBP incentives to drive quality improvement and greater efficiency for services furnished to Medicare beneficiaries.

b. Approach to Plan Development

We have created an internal cross-component team, the PVBP Steering Committee (formerly referred to as PVBP Workgroup), to lead development of the PVBP plan. Four Subgroups were established to address the major sections of the Plan: measures; incentives; data strategy and infrastructure; and public reporting. The PVBP Steering Committee was tasked with reviewing the state-of-the-art in performance-based payment for physicians, including relevant Medicare programs and demonstrations and private sector initiatives; preparing an Issues Paper to present program objectives and design principles; engaging stakeholders and obtaining input on program design; and developing the PVBP Plan and Report to Congress. A similar approach was used in the development of the CMS Hospital VBP Plan.

To guide the planning process, the PVBP Steering Committee adopted the following goal to improve Medicare beneficiary health outcomes and experience of care by using payment incentives and transparency to encourage higher quality, more efficient professional services. In pursuit of this goal, the Workgroup has defined the following objectives:

  • Promote evidence-based medicine through measurement, payment incentives, and transparency.
  • Reduce fragmentation and duplication through accountability across settings, alignment of measures and incentives across settings, better care coordination for smoother transitions, and attention to episodes of care.
  • Encourage effective management of chronic disease by improving early detection and prevention, focusing on preventable hospital readmissions, and emphasizing the importance of advanced care planning and appropriate end-of-life care.
  • Accelerate the adoption of effective, interoperable HIT, including clinical registries, e-prescribing, and electronic health records.
  • Empower beneficiaries to make value-based health care choices, and encourage health professionals to improve the value of care they provide by disseminating information designed to help them change their practice patterns to improve performance.

The goal and objectives were captured in an Issues Paper that was posted on the CMS Web site on November 24, 2008, in preparation for the December 9, 2008 Listening Session which was held at CMS headquarters. The Issues Paper included questions seeking public input on key design considerations. The Issues Paper is available on the CMS Web site at http://www.cms.hhs.gov/PhysicianFeeSched/downloads/PhysicianVBP-Plan-Issues-Paper.pdf. Nearly 500 stakeholders participated in the day-long Listening Session. We received both verbal and written comments that are informing the design of the PVBP Plan. Stakeholder input from this Listening Session is summarized in the proposed rule (74 FR 33592 through 33593).

c. Next Steps in Plan Development

Building on input from the Listening Session on the Issues Paper topics, the PVBP Steering Committee has begun to develop potential recommendations for inclusion in the Report to Congress. The first step is to design various approaches for performance-based payment that will address the planning goal and objectives for different practice arrangements. This design process will include identifying appropriate measures and incentive structures, considering the necessary data infrastructure, and addressing public reporting options. Consideration will be given to approaches that:

(1) Overlay the current PFS, such as differential fee schedule payments based on measured performance;

(2) Address multiple levels of accountability, including individual health professionals, as well as larger care teams or organizations made up of a variety of health professionals and facilities; and

(3) Promote more integrated care through shared savings models and bundled payment arrangements.

In the proposed rule, we solicited public comment on the development of the PVBP plan and Report to Congress. We specifically requested for comments on two topics: (1) the appropriate level at which to hold practitioners accountable (for example, individuals or groups); and (2) appropriate data submission mechanisms. We received comments on these topics, as well as comments on other issues we should consider when developing the PVBP Report to Congress. The following is summary of the comments we received regarding section 131(d) of the MIPPA.

Comment: Regarding the appropriate level at which to hold practitioners accountable, commenters were supportive of our intention for the PVBP plan to recognize multiple levels of accountability ranging from individual practitioners to larger organizations. Commenters recognized that a “one size fits all” approach would not be appropriate. One commenter suggested conducting a series of demonstrations and pilots to help further explore this issue. Commenters also urged us to design the program to allow participation by practitioners other than physicians.

Response: We plan to continue to explore ways to measure and incentivize practitioners for higher value care at multiple levels of accountability, including possible demonstrations and pilots to test and analyze the effectiveness of certain practice arrangements and payment systems. We recognize that the Congress intended the PVBP plan to be broader than physicians, and the PVBP Steering Committee is considering approaches that allow for participation by a wide variety of health care practitioners.

Comment: Regarding the appropriate methods for data submission, commenters overwhelmingly supported the adoption and use of interoperable electronic health records. Commenters suggested that the CMS PVBP Steering Committee coordinate with the Office of the National Coordinator for Health IT (ONC) to align PVBP incentives for electronic health records with the recently enacted HITECH incentives for health IT adoption. Commenters also recognized the role of registries in data submission. In addition, commenters urged us to carefully consider procedural protections for practitioners, such as allowing their review of their own data before submission to CMS.

Response: The CMS PVBP Steering Committee is exploring ways to encourage the use of interoperable health IT systems, including registries, as part of the PVBP plan. We have been actively engaged with ONC on how to align any PVBP incentives for health IT with the HITECH provisions and will continue to work closely with ONC. We recognize the importance of the accuracy and validity of electronically submitted data, and are exploring ways to incorporate data review processes for practitioners into the PVBP plan recommendations.

Comment: Several commenters were concerned with the relationship between the PVBP plan and the current Medicare payment system. Commenters stated that the current Medicare payment system is flawed in that it does not align incentives across providers and settings, and a PVBP plan that simply overlays the existing system will not be sufficient to re-align incentives to provide higher value care.

Response: In developing the PVBP plan, we are considering both short-term and long-term recommendations. Short-term recommendations may include changes within the current payment system. Such changes, though, would be interim steps toward implementing a more long-term approach for comprehensive payment reform.

Comment: Commenters urged us to not limit the Report to Congress to recommendations for only performance-based incentive payments. Commenters suggested the plan recommend a wide range of incentives for activities such as improving beneficiary health outcomes, patient experience of care, efficient performance of services, and use of electronic health IT such as registries or e-prescribing. Commenters also urged us to recommend using the PVBP plan to encourage high quality care by being actionable on the part of all practitioners.

Response: We are considering recommending a variety of different activities within the PVBP plan, taking into account what is more feasible in the short-term versus the long-term. We are also considering what program activities are likely to be the most meaningful and actionable for practitioners, both in the short-term and long-term.

Comment: Commenters urged CMS to gain experience with confidential feedback reporting of quality and resource use before using the information for either payment or public reporting. One commenter suggested that any public reporting under the PVBP plan should be geared toward consumer decision-making.

Response: We are considering a variety of program activities, including confidential feedback reports, public reporting, and incentive payments. The PVBP Steering Committee is carefully analyzing the options for each of these activities.

Comment: Several commenters mentioned that encouraging successful management of chronic disease is essential to any PVBP plan. Commenters mentioned medical home care models and the important role they can play in promoting integrated care and reducing costs.

Response: We recognize the importance of managing chronic disease, and are currently conducting a demonstration of the medical home concept. Findings from this demonstration may be used to inform plan development.

Comment: Commenters urged us to use the PVBP plan to increase efficiency and slow cost growth in the Medicare program. Commenters specifically mentioned shared savings models and encouraged us to further explore how to incorporate appropriate shared savings principles into the plan. There was no consensus among the comments regarding whether a PVBP plan should include shared savings or gainsharing. However, some commenters cautioned that a PVBP plan should not be viewed solely as a method to slow cost growth.

Response: We recognize the importance of both slowing cost growth and maintaining beneficiary access to high quality care. The PVBP plan will carefully explore program activities that accomplish both of these goals.

Comment: We received input on several issues related to the appropriate measurement of eligible professionals in a PVBP program. Commenters suggested we recommend only transparent evidence-based measures that are vetted by physician groups and endorsed by a national consensus-based organization. Commenters also suggested we recommend strategically selecting measures to address gaps in quality, or those related to high-cost and/or high-volume services. Measures used in the program should not be “topped out,” but still have significant room for improvement collectively across the Medicare program. In addition, commenters urged us to recommend the use of both quality and resource use information, and to report both domains of measures together in order to give a fuller picture of an eligible professional's performance. Commenters urged us to consider incorporating a broad range of quality measures into the PVBP program, including patient experience, clinical outcomes, disparities, care coordination, and structural measures such as the adoption of health IT.

Response: The PVBP Steering Committee is carefully considering what measures to recommend for which program activities (that is, incentive payment, confidential feedback, public reporting). We recognize the potential for the PVBP plan to address gaps in quality and high-cost and/or high volume services, and the importance of recommending the use of both quality and resource use information and the value to eligible professionals of providing this information together. We also recognize the importance of recommending the use of a broad array of measures. Many of the types of measures mentioned by commenters have not yet been fully developed. Therefore, short-term recommendations for the PVBP plan cannot include them, but long-term recommendations may encourage their development and use.

Comment: Commenters supported tying a portion of payment to an eligible professional's performance, and stated that participants should not be rewarded simply for reporting data to CMS. Commenters stated that the PVBP plan should reward both attainment of specified levels of performance, and improvement over time. Commenters also suggested that such incentive payments should be aimed toward breaking down the payment silos that currently exist between Medicare Parts A and B.

Response: Whether to reward eligible professionals for performance, and not merely participation is a key design option that the PVBP Steering Committee is considering for the PVBP plan. The Steering Committee will also carefully discuss whether to recommend paying incentives for attainment, improvement, or both.

Comment: Commenters stressed the importance of risk-adjustment, especially if performance data is used to make incentive payments.

Response: We recognize that risk-adjustment is essential and we are exploring methods for its incorporation into the PVBP plan.

Comment: Commenters commended CMS for involving stakeholders in PVBP plan development, and encouraged CMS to continue to involve stakeholders as plan development proceeds. Commenters urged CMS to ensure that any PVBP plan does not impede the evolution of medical practice, discourage innovation, or interfere with practitioner-patient decision-making.

Response: We appreciate the opportunity to hear from stakeholders regarding plan recommendations, and we value the input stakeholders have provided thus far. We are carefully considering options and taking an iterative approach to PVBP plan development to avoid the potential pitfalls mentioned by commenters.

We received other comments that were outside the scope of the proposed rule, and are therefore not discussed in this final rule with comment period.

5. Section 132: Incentives for Electronic Prescribing (E-Prescribing)—The E-Prescribing Incentive Program

a. Program Background and Statutory Authority

As described in the CY 2010 PFS proposed rule (74 FR 33593 through 33600), section 1848(m)(2) of the Act, as amended by section 132 of the MIPPA, promotes the use of electronic prescribing by authorizing incentive payments to eligible professionals or group practices who are “successful electronic prescribers.” This E-Prescribing Incentive Program is expected to encourage significant expansion of the use of electronic prescribing by authorizing a combination of financial incentives and payment adjustment and is separate from, and in addition to, any incentive payment that eligible professionals may earn through the PQRI program. Individual eligible professionals do not have to participate in PQRI in order to participate in the E-Prescribing Incentive Program (and vice versa).

For 2010, which is the second year of the E-Prescribing Incentive Program, the Secretary is authorized to provide successful electronic prescribers, as defined in section 1848(m)(3)(B) of the Act and further discussed below in this section, an incentive payment equal to 2.0 percent of the total estimated Medicare Part B PFS allowed charges (based on claims submitted not later than 2 months after the end of the reporting period) for all covered professional services furnished during the 2010 reporting period. Covered professional services are defined under the statute to be services for which payment is made under, or is based on, the PFS and which are furnished by an eligible professional. The applicable electronic prescribing percent (2.0 percent) authorized for the 2010 E-Prescribing Incentive Program is the same as that authorized for the 2009 E-Prescribing Incentive Program.

We received several comments from the public on the CY 2010 PFS proposed rule related to the E-Prescribing Incentive Program. General comments about the E-Prescribing Incentive Program are addressed immediately below.

Comment: One commenter was opposed to making any changes to the E-Prescribing Incentive Program for 2010, but a majority of the comments voiced their support for the changes proposed for the 2010 E-Prescribing Incentive Program and discussed below.

Response: Although we understand the commenter's desire to keep the program the same in 2010, we believe that this would defeat our attempts to simplify the E-Prescribing Incentive Program and reduce the reporting burden for eligible professionals.

Comment: Some comments recommended that we conduct significant education and outreach activities, especially with respect to the changes for 2010, and that we promote the program by making participation information, as well as information about potential incentive payment amounts available.

Response: We value the input received from stakeholders and participants who have provided constructive feedback and have collaborated with us to disseminate educational materials about the E-Prescribing Incentive Program to eligible professionals in the health care community. We anticipate that ongoing education and outreach efforts will continue to evolve with the program. We will continue to work with national and regional stakeholder organizations to educate their members on program requirements for successful reporting, especially the changes that will be implemented for 2010, as discussed below. We also plan to continue to host monthly national provider calls in which we expect to provide guidance on specific topics, including having our E-Prescribing Incentive Program subject matter experts available to answer questions. Information about upcoming calls can be obtained from the CMS Sponsored Calls page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/04_CMSSponsoredCalls.asp#TopOfPage. We will also continue to make educational materials and other resources available on the E-Prescribing Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/erxincentive. We encourage eligible professionals to visit this Web site and to review the frequently asked questions found on this Web site. Eligible professionals are also encouraged to join our physician listserv to obtain periodic updates about the E-Prescribing Incentive Program. Instructions for joining the listserv can be found at https://list.nih.gov/archives/physicians-l.html.

Comment: One commenter recommended that we promote the program by making participation information, as well as information about potential incentive payment amounts available.

Response: Once the 2009 program year is complete, we anticipate conducting an evaluation of the 2009 E-Prescribing Incentive Program reporting experience at an aggregate level and posting a national summary report similar to the “PQRI 2007 Reporting Experience” report found at http://www.cms.hhs.gov/PQRI/Downloads/PQRI2007ReportFinal12032008CSG.pdf.

With respect to the suggestion to make information about potential incentive payment amounts available, we are concerned that doing so may be misleading since incentive payments will differ for each eligible professional based on his or her Medicare Part B PFS allowed charges for covered professional services. We believe that information such as the mean incentive payment amount released in the “PQRI 2007 Reporting Experience” report could serve the same purpose.

Comment: Many commenters expressed a desire for the Drug Enforcement Agency (DEA) to permit electronic prescribing of controlled substances. Commenters noted that until electronic prescribing of controlled substances is permitted, eligible professionals may be reluctant to adopt electronic prescribing technology due to work flow issues and the need to utilize two processes (electronic and written) for generating prescriptions.

Response: We are aware of the current limitation for electronic prescribing of controlled substances. Actions taken or that may be taken by the DEA are beyond our purview. However, we have taken this limitation into consideration in establishing the 2010 criteria for determining a successful electronic prescriber.

Comment: Some commenters suggested that we obtain data on electronic prescribing from pharmacies rather than eligible professionals or that we should also be holding pharmacies or pharmacy networks accountable for ensuring accurate, timely, and consistent transmission of electronic prescribing data.

Response: As established by MIPPA, the E-Prescribing Incentive Program is an incentive program specifically for eligible professionals, as defined by section 1848(k)(3)(B) of the Act, based on information submitted by eligible professionals. Additionally, section 1848(m)(3)(B)(iv) of the Act authorizes the use of Part D data, which reflects information submitted by pharmacies to Part D plan sponsors. As we explained in the CY 2010 PFS proposed rule (74 FR 33595), however, the accuracy and completeness of the Part D data with respect to whether a prescription was submitted electronically is unknown since Part D plan sponsors will not be required to start submitting this information until 2010. Should we rely on Part D data in the future, we anticipate that we will no longer need eligible professionals to submit data on their electronic prescribing activities to us.

Comment: One commenter was concerned that the E-Prescribing Incentive Program will include a penalty, or payment adjustment, to begin in 2012 and requested that we, in consultation with stakeholders, define in a timely manner how we intend to use the case-by-case, significant hardship penalty exemption authority.

Response: We believe the commenter is referring to section 1848(a)(5)(B) of the Act, which permits the Secretary, on a case-by-case basis, to exempt an eligible professional from the application of the payment differential if the Secretary “determines, subject to annual renewal that compliance with the requirement for being a successful electronic prescriber would result in a significant hardship.” This hardship exemption is to be used at the discretion of the Secretary.

As we stated in the CY 2009 PFS proposed rule (74 FR 33549), we will discuss the application of the payment adjustment in future notice and comment rulemaking. We will address the circumstances under which the hardship exemption applies at that time.

Comment: One commenter recommended that we provide a participation option for eligible professionals who predominately practice in skilled nursing facilities. The commenter is concerned that many such professionals are currently unable to participate in the E-Prescribing Incentive Program because the facility's prescribing systems generate orders to an internal pharmacy and, for reasons unspecified by the commenter, do not meet the full definition of a qualified electronic prescribing system.

Response: Since the commenter did not describe what aspects of the definition of “qualified” electronic prescribing system a skilled nursing facility's electronic prescribing system fails to meet, it is not entirely clear how the fact that a facility's electronic prescribing system generates orders to an internal pharmacy alone would prevent the facility's system from meeting the definition of a “qualified” electronic prescribing system. In an attempt to provide eligible professionals who predominately practice in skilled nursing facilities with more opportunities to participate in the E-Prescribing Incentive Program, however, we are expanding the scope of the electronic prescribing measure's denominator codes to include professional services outside the professional office and outpatient setting. The expanded codes include professional services furnished in skilled nursing facilities and in the home care setting. To be considered a successful electronic prescriber, eligible professionals need only to report 25 separate electronic prescribing events during the reporting period. To qualify for the electronic prescribing incentive payment, a successful electronic prescriber must have 10 percent of their Medicare Part B PFS allowed charges for covered professional services be comprised of the codes in the denominator of the measure. The electronic prescribing system used for these 25 electronic prescribing events must have all of the functionalities listed in the measure's specifications and described in section II.G.5.c.3. below.

Comment: One commenter was concerned that the incentive payment favors prescribers who typically bill high-cost services since the incentive payment is based on Medicare Part B PFS allowed charges. The commenter suggested that the incentive payment should be a flat-rate bonus or a bonus payment that rewards medication management.

Response: We appreciate the comment; however, we do not have the authority to change the basis for the calculation of the incentive payment amount, which is defined in section 1848(m)(2)(A) of the Act.

b. The 2010 Reporting Period for the E-Prescribing Incentive Program

Section 1848(m)(6)(C)(i)(II) of the Act defines “reporting period” for the 2010 E-Prescribing Incentive Program to be the entire year. Section 1848(m)(6)(C)(ii) of the Act, however, authorizes the Secretary to revise the reporting period for years after 2009 if the Secretary determines such revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden. In the CY 2010 PFS proposed rule (74 FR 33594 through 33595), we proposed that the 2010 E-Prescribing Incentive Program reporting period would be the entire calendar year (January 1, 2010-December 31, 2010).

Comment: A majority of commenters supported the proposed reporting period. One commenter, however, recommended two 6-month reporting periods, because this would allow eligible professionals who are able to implement electronic prescribing in their practice by the middle of 2010 to still benefit from the incentive for 2010.

Response: We do not believe that adoption and implementation of an electronic prescribing system after the start of the 2010 reporting period would necessarily preclude an individual eligible professional from being able to qualify for the incentive payment. The 25 electronic prescribing events required to meet the criteria for successful electronic prescriber for 2010 (see section II.G.5.c. below) can be reported at any time during the 2010 reporting period.

After considering these comments, we are finalizing the entire calendar year as the 2010 reporting period for the E-Prescribing Incentive Program. Successful electronic prescribers will be eligible to receive an incentive payment equal to 2.0 percent of the total estimated Medicare Part B PFS allowed charges (based on claims submitted by no later than February 28, 2011) for all covered professional services furnished January 1, 2010 through December 31, 2010.

c. Criteria for Determination of Successful Electronic Prescriber for Eligible Professionals

Under section 1848(m)(3)(B) of the Act, in order to qualify for the incentive payment, an eligible professional must be a “successful electronic prescriber,” which the Secretary is authorized to identify using 1 of 2 possible criteria. One criterion, under section 1848(m)(3)(B)(ii) of the Act, is based on the eligible professional's reporting, in at least 50 percent of the reportable cases, on any electronic prescribing quality measures that have been established under the physician reporting system, under subsection 1848(k) of the Act (which, as noted previously, we have named “PQRI” for ease of reference) and are applicable to services furnished by the eligible professional during a reporting period. We applied this criterion in 2009. However, for years after 2009, section 1848(m)(3)(D) of the Act permits the Secretary in consultation with stakeholders and experts to revise the criteria for submitting data on electronic prescribing measures under section 1848(3)(B)(ii) of the Act.

The second criterion, under section 1848(m)(3)(B)(iii) of the Act, is based on the electronic submission by the eligible professional of a sufficient number (as determined by the Secretary) of prescriptions under Part D during the reporting period. If the Secretary decides to use the latter standard, then, in accordance with section 1848(m)(3)(B)(iv) of the Act, the Secretary is authorized to use Part D drug claims data to assess whether a “sufficient” number of prescriptions have been submitted by eligible professionals. However, under section 1848(m)(3)(B)(i) of the Act, if the standard based on a sufficient number (as determined by the Secretary) of electronic Part D prescriptions is applied for a particular reporting period, then the standard based on the reporting on electronic prescribing measures would no longer apply.

For 2010, we proposed to continue to require eligible professionals to report on the electronic prescribing measure used in the 2009 E-Prescribing Incentive Program to determine whether an eligible professional is a successful electronic prescriber, but we proposed to modify the measure's specifications and to use modified reporting criteria based on the authority provided under section 1848(m)(3)(D) of Act, as discussed below.

(1) Reporting the Electronic Prescribing Measure

For 2010, we proposed to make 3 reporting mechanisms available to individual eligible professionals to report the electronic prescribing measure. First, we proposed to retain the claims-based reporting mechanism that is used in the 2009 E-Prescribing Incentive Program. In addition, similar to the PQRI, for the E-Prescribing Incentive Program, we proposed to implement a registry-based reporting mechanism and, depending on whether we finalize the proposed EHR-based reporting mechanism for PQRI, we also proposed that an EHR-based reporting mechanism be available for the electronic prescribing measure.

We proposed that only registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals for the 2010 PQRI would be qualified to submit measure results and numerator and denominator data on the electronic prescribing measure on behalf of eligible professionals for the 2010 E-Prescribing Incentive Program. Similarly, we proposed that only EHR products “qualified” to potentially be able to submit clinical quality data extracted from the EHR to CMS for the 2010 PQRI would be considered “qualified” for the purpose of an eligible professional potentially being able to submit data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program.

We solicited comments on our proposal to provide alternatives to the claims-based reporting mechanism for reporting the electronic prescribing measure, as well as on our proposal to limit the registries and EHR products qualified to submit the electronic prescribing measure for the 2010 E-Prescribing Incentive Program to those that are qualified registries and EHR products, respectively, for the 2010 PQRI.

All commenters supported having alternatives to the claims-based reporting mechanism for reporting the electronic prescribing measure. All commenters were also in agreement that only registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals for the 2010 PQRI and EHR products “qualified” to submit clinical quality data extracted from the EHR to CMS for the 2010 PQRI be considered “qualified” for the purpose of an eligible professional being able to submit data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program. Based on these comments, we are finalizing our proposal that for the 2010 E-Prescribing Incentive Program, eligible professionals will be able to choose whether to submit data on the electronic prescribing measure through claims, a qualified registry, or a qualified EHR product.

Only registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals for the 2010 PQRI will be qualified to submit measure results and numerator and denominator data on the electronic prescribing measure on behalf of eligible professionals for the 2010 E-Prescribing Incentive Program. We will post a list of qualified registries for the 2010 E-Prescribing Incentive Program on the E-Prescribing Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/ERXIncentive when we post the list of qualified registries for the 2010 PQRI on the PQRI section of the CMS Web site (see section II.G.2. of this final rule with comment period). Not all registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals for the 2010 PQRI will be qualified to submit quality measure results and numerator and denominator data on the electronic prescribing measure. That is to say that PQRI qualified registries may not wish to be qualified to submit all measures. The electronic prescribing measure is reportable by an eligible professional any time he or she bills for one of the procedure codes for Part B covered professional services included in the measure's denominator. Some registries that self-nominate to become a qualified registry for PQRI may not choose to self-nominate to become a qualified registry for submitting measures that require reporting at each eligible visit, such as the electronic prescribing measure. Therefore, we cannot guarantee that there will be a registry willing to submit the electronic prescribing measure on behalf of eligible professionals. Registries will need to indicate their desire to qualify to submit measure results and numerator and denominator data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program at the time that they submit their self-nomination letter for the 2010 PQRI.

Similarly, only EHR products “qualified” to submit clinical quality data extracted from the EHR to CMS for the 2010 PQRI will be considered “qualified” for the purpose of an eligible professional being able to submit data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program. As stated in section II.G.2.d.3. of this final rule with comment period, 2009 EHR Testing Program is underway. Therefore, we cannot guarantee that any of the EHR vendors that self-nominated to have one or more of their EHR products “qualified” for the PQRI will successfully complete the testing process and therefore, be eligible for participation as a qualified EHR vendor the E-Prescribing Incentive Program. An EHR vendor will need to indicate its intention to have one or more of their EHR products qualified for the purpose of an eligible professional potentially being able to submit data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program at the time that they are being vetted for the 2010 PQRI. We will post a list of qualified EHR vendors and products for the 2010 E-Prescribing Incentive Program on the E-Prescribing Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/ERXIncentive when we post the list of qualified EHR vendors and products for the 2010 PQRI on the PQRI section of the CMS Web site (see section II.G.2. of this final rule with comment period). We anticipate completing the 2009 PQRI EHR Testing Program in early 2010.

(2) The Reporting Denominator for the Electronic Prescribing Measure

The electronic prescribing measure, similar to the PQRI measures, has 2 basic elements, which include: (1) a reporting denominator that defines the circumstances when the measure is reportable; and (2) a reporting numerator.

The denominator for the electronic prescribing measure consists of specific billing codes for covered professional services. The measure becomes reportable when any one of these procedure codes is billed by an eligible professional for Part B covered professional services. As initially required under section 1848(k)(2)(A)(ii) of the Act, and further established through rulemaking and under section 1848(m)(2)(B) of the Act, we may modify the codes making up the denominator of the electronic prescribing measure. As such, we proposed to expand the scope of the denominator codes for 2010 to covered professional services outside the professional office and outpatient setting, such as professional services furnished in skilled nursing facilities or the home care setting. We proposed to add the following CPT codes to the denominator of the electronic prescribing measure for 2010: 90862, 99304; 99305; 99306; 99307; 99308; 99309; 99310; 99315; 99316; 99341; 99342; 99343; 99344; 99345; 99347; 99348; 99349; and 99350. We solicited comments on the proposed changes to codes identified for the electronic prescribing measure denominator.

The following is a summary of the comments we received regarding the proposed denominator codes for the 2010 electronic prescribing measure.

Comment: Many commenters supported the proposed expansion of the electronic prescribing measure's denominator codes. However, some commenters noted that a subset of home care physicians will not be able to participate in the E-Prescribing Incentive Program without the addition of codes for domiciliary care visits in the measure's denominator.

Response: We appreciate the commenters' support of the proposed denominator codes. Based on comments indicating that some eligible professionals exclusively make domiciliary care visits, we are adding the following codes to the electronic prescribing measure's denominator for 2010: 99324 through 99328; 99334 through 99337; and 99346.

Comment: Other commenters suggested additional codes for inclusion in the measure's denominator, including an annual nursing facility assessment code (CPT code 99318) in lieu of CPT codes 99307 through 99310, inpatient evaluation and management (E/M) codes, codes for professional services furnished in renal dialysis facilities (CPT codes 90951 through 90970 for outpatient dialysis), and interactive psychotherapy codes (CPT codes 90810 through 90815).

Response: With respect to commenters' suggestions to add other denominator codes that were not proposed, we do not believe it is necessary to expand the denominator codes to include the suggested codes. As we stated previously, the electronic prescribing measure becomes reportable when any one of the procedure codes included in the measure's denominator is billed by an eligible professional for Part B covered professional services. Eligible professionals only need to have 10 percent of their Medicare Part B PFS allowed charges for covered professional services be comprised of the codes in the denominator of the measure and meet the criteria for determining a successful electronic prescriber to qualify to earn an electronic prescribing incentive payment. The incentive payment amount, however, will be calculated based on all of the eligible professional's total estimated Medicare Part B PFS allowed charges for covered professional services, including the services reflected in the suggested codes if such services are Medicare Part B PFS covered professional services.

Accordingly, we are finalizing the following denominator codes for the 2010 electronic prescribing measure: 90862; 99304; 99305; 99306; 99307; 99308; 99309; 99310; 99315; 99316; 99324; 99325; 99326; 99327; 99328; 99334; 99335; 99336; 99337; 99341; 99342; 99343; 99344; 99345; 99346; 99347; 99348; 99349; and 99350. There are no diagnosis codes in the measure's denominator and there are no age/gender requirements in order for a patient to be included in the measure's denominator (that is, reporting of the electronic prescribing measure is not further limited to certain ages or a specific gender). Eligible professionals are not required to report this measure in all cases in which the measure is reportable. Eligible professionals who do not bill for one of the procedure codes for Part B covered professional services included in the measure's denominator will have no occasion to report the electronic prescribing measure.

By December 31, 2009, we will post the final specifications of the measure on the “E-Prescribing Measure” page of the E-Prescribing Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/ERXIncentive.

(3) Qualified Electronic Prescribing System—Required Functionalities and Part D E-Prescribing Standards

To report the electronic prescribing measure in 2010, we proposed that the eligible professional must report one of the measure's numerator “G” codes (74 FR 33597). However, when reporting any of the G-codes for purposes of qualifying for the incentive payment for electronic prescribing in 2010, we proposed that the professional must have and regularly use a “qualified” electronic prescribing system, as defined in the electronic prescribing measure specifications.

Required Functionalities for a “Qualified” Electronic Prescriber System. We proposed (74 FR 33596 through 33597) that what constitutes a “qualified” electronic prescribing system is based upon certain required functionalities that the system can perform (74 FR 33596 through 33597). As currently specified in the electronic prescribing measure for 2009, a “qualified” electronic prescribing system would be one that can:

(a) Generate a complete active medication list incorporating electronic data received from applicable pharmacies and PBMs, if available.

(b) Allow eligible professionals to select medications, print prescriptions, electronically transmit prescriptions, and conduct alerts (written or acoustic signals to warn the prescriber of possible undesirable or unsafe situations including potentially inappropriate dose or route of administration of a drug, drug-drug interactions, allergy concerns, or warnings and cautions). This functionality must be enabled.

(c) Provide information related to lower cost, therapeutically appropriate alternatives (if any). The ability of an electronic prescribing system to receive tiered formulary information, if available, would suffice for this requirement for 2010 and until this function is more widely available in the marketplace.

(d) Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan (if available).

Part D Electronic Prescribing Standards. Section 1848(m)(3)(B)(v) of the Act specifies that to the extent practicable, in determining whether an eligible professional is a successful electronic prescriber, “the Secretary shall ensure that eligible professionals utilize electronic prescribing systems in compliance with standards established for such systems pursuant to the Part D Electronic Prescribing Program under section 1860D-4(e)” of the Act. The Part D standards for electronic prescribing systems establish which electronic standards Part D sponsors, providers, and dispensers must use when they electronically transmit prescriptions and certain prescription related information for Part D covered drugs that are prescribed for Part D eligible individuals. To be a qualified electronic prescribing system under the current E-Prescribing Incentive Program, electronic systems must convey the information listed above under (a) through (d) using the standards currently in effect for the Part D electronic prescribing program. Additional Part D electronic prescribing standards were implemented April 1, 2009. These latest Part D electronic prescribing standards, and those that had previously been adopted, can be found on the CMS Web site at http://www.cms.hhs.gov/eprescribing.

To ensure that eligible professionals utilize electronic prescribing systems that meet these requirements, the electronic prescribing measure requires that those functionalities required for a “qualified” electronic prescribing system utilize the adopted Part D electronic prescribing standards. The Part D electronic prescribing standards relevant to the four functionalities for a “qualified” system in the electronic prescribing measure, described above and listed as (a), (b), (c), and (d), currently are:

(a) Generate medication list—Use the National Council for Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8, Release 1, October 2005 (hereinafter “NCPDP SCRIPT 8.1”) Medication History Standard;

(b) Transmit prescriptions electronically—Use the NCPDP SCRIPT 8.1 for the transactions listed at § 423.160(b)(2);

(c) Provide information on lower cost alternatives—Use the NCPDP Formulary and Benefits Standard, Implementation Guide, Version 1, Release 0 (Version 1.0), October 2005 (hereinafter “NCPDP Formulary and Benefits 1.0”);

(d) Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan—use:

(1) NCPDP Formulary and Benefits 1.0 for communicating formulary and benefits information between prescribers and plans;

(2) Accredited Standards Committee (ASC) X12N 270/271—Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, Washington Publishing Company, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010A1, October 2002, Washington Publishing Company, 004010X092A1 for communicating eligibility information between the plan and prescribers;

(3) NCPDP Telecommunication Standard Specification, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 for communicating eligibility information between the plan and dispensers.

There are, however, Part D electronic prescribing standards that are in effect for functionalities that are not commonly utilized at this time. Such functionalities are not currently required for a “qualified” system under the E-Prescribing Incentive Program. One example is Rx Fill Notification, which is discussed in the Part D electronic prescribing final rule (73 FR 18918, 18926). For purposes of the 2010 Electronic Prescribing Program and incentive payments, we did not propose to require that an electronic prescribing system contain all functionalities for which there are available Part D electronic prescribing standards. For those required functionalities described above, we proposed that a “qualified” system must use the adopted Part D electronic prescribing standards for electronic messaging.

The following is a summary of the comments we received regarding the proposed required functionalities and Part D electronic prescribing standards for a qualified electronic prescribing system for 2010.

Comment: Many commenters supported the list of required functionalities for what constitutes a “qualified” system.

Response: We appreciate the commenters' positive feedback. We believe the list of required functionalities leverage many of the potential advantages to electronic prescribing, such as, but not limited to, improving patient safety and quality of care, improving formulary adherence, and providing access to patient's medication history.

Comment: One commenter requested clarification with respect to qualification (b) above, which requires that the functionality to allow eligible professionals to select medications, print prescriptions, electronically transmit prescriptions, and conduct alerts be enabled. The commenter recommended that we clarify in the final rule that “ `printing prescriptions' from a qualified electronic prescribing system does not meet the criteria for `creating' or `generating' an e-prescription.”

Response: All functionalities required of a “qualified” electronic prescribing system must be enabled. As noted by the commenter, printed prescriptions, however, do not qualify as an electronic prescribing event. In order for a prescription to be considered an electronic prescribing event, the prescription must be transmitted electronically using the applicable standards and the prescriber's system must warn the prescriber of possible undesirable or unsafe situations.

Comment: One commenter recommended that we clearly articulate how we will align the definition of being a “successful electronic prescriber” with the forthcoming “meaningful use” definition related to health information technology. Particularly, commenter recommended that the standards should come together in 2011 to promote the objective that for BOTH sets of incentives clinicians:

  • Use computerized physician order entry (CPOE) for all orders;
  • Implement drug/drug, drug/allergy, drug/formulary checks;
  • Generate and transmit permissible prescriptions electronically;
  • Maintain active medication lists; and
  • Maintain active medication allergy lists.

The commenter is concerned that in the absence of greater alignment, the electronic prescribing standard will be inconsistent with the proposed meaningful use definition, and could undermine that definition and confuse clinicians.

Response: CMS is actively working internally and with external agencies, such as the Office of the National Coordinator (ONC) on meaningful use and its implications relative to our PQRI and E-prescribing Incentive Programs. Guidance on the definition of “meaningful use” is beyond the scope of this rule and will be provided in separate notice and comment rulemaking specifically addressing meaningful use.

Comment: One commenter recommended that CMS provide a list of qualified systems in order to assist eligible professionals with accurately selecting a system.

Response: We are unable to provide this information since we do not vet electronic prescribing systems to ensure that the systems have all of the required functionalities. Eligible professionals should be able to assess whether a system is qualified by going through the list of required functionalities and asking the system's vendor whether the system is capable of doing all of the required functionalities.

After considering the comments, we are finalizing as the required functionalities for a qualified electronic prescribing system for 2010 those outlined in the section above entitled “Required Functionalities for a `Qualified' Electronic Prescribing System.” In addition, for each required functionality of a qualified system, the system must use the adopted Part D electronic prescribing standards for electronic messaging listed above in the section entitled “Part D Electronic Prescribing Standards.”

There are other aspects of the functionalities for a “qualified” system that are not dependent on electronic messaging and are part of the software of the electronic prescribing system, for which Part D standards for electronic prescribing do not pertain and are not required for purposes of the E-Prescribing Incentive Program. For example, the requirements in qualification (b) listed above that require the system to allow professionals to select medications, print prescriptions, and conduct alerts are functions included in the particular software, for which Part D standards for electronic messaging do not apply.

We are aware that there are significant numbers of eligible professionals who are interested in earning the incentive payment, but currently do not have an electronic prescribing system. The electronic prescribing measure does not require the use of any particular system or transmission network; only that the system be a “qualified” system having the functionalities described above based on Part D electronic prescribing standards. If the professional does not have general access to an electronic prescribing system in the practice setting, there is nothing to report and the eligible professional would not be able to participate in the E-Prescribing Incentive Program.

(4) The Reporting Numerator for the Electronic Prescribing Measure

Currently, to report for an applicable case where 1 of the denominator codes is billed for Part B covered professional services, an eligible professional must report 1 of 3 G-codes specified in the electronic prescribing measure.

For 2010, we proposed to modify the first G-code (G8443) to indicate that at least 1 prescription in connection with the visit billed was electronically prescribed (74 FR 33597). In addition, we proposed to eliminate the 2 remaining G-codes from the measure's numerator: G8445: Qualified E-prescribing System Available, but no Prescription(s) were Generated During the Encounter; and G8446: E-prescribing System Available, but not Used for One or More Prescriptions Due to Patient/System Reasons. We solicited comments on the proposed modifications to the electronic prescribing measure numerator.

The following is a summary of the comments we received regarding the proposed reporting numerator for the electronic prescribing measure for 2010.

Comment: A majority of commenters supported simplification of the measure's numerator to only 1 G-code. However, one commenter was opposed to the elimination of both the G8445 and G8446 codes, while other commenters were specifically opposed to the elimination of the G8446 code. The commenters believed that continued reporting is needed for cases in which an eligible professional would have electronically prescribed had electronic prescribing been possible, such as electronic prescribing of controlled substances.

Response: We are finalizing our proposal to modify the G-codes for the electronic prescribing measure. Since we are revising the criteria for determining that an eligible professional is a successful electronic prescriber to assess the actual number of electronic prescribing events (with the minimum threshold of 25 events) during the reporting period rather than assessing the percentage of eligible cases on which an eligible professional reported the measure, we believe it is no longer necessary to require eligible professionals to report the measure to us for cases where an eligible professional would have electronically prescribed but electronic prescribing was not possible or that no prescriptions were generated.

Comment: One commenter requested clarification on whether the revised G8443 code indicates at least one prescription “generated” by a qualified system or indicates at least one prescription “sent electronically.”

Response: The new G-code for 2010 indicates that at least 1 prescription created during the encounter was generated and transmitted electronically using a qualified electronic prescribing system.

Comment: Another commenter suggested that instead of modifying the G-code to indicate that at least 1 prescription in connection with the visit billed was electronically prescribed, we should modify the G-code to indicate that “at least 1 electronic prescription submitted for all qualified prescriptions for this visit.” This would allow eligible professionals to report the G-code in all of the following circumstances: (1) All prescriptions were transmitted electronically; (2) some prescriptions were transmitted electronically; other prescriptions did not qualify for electronic transmittal; and (3) no prescriptions were submitted or qualified for electronic transmittal. The commenter was concerned that the proposed single G-code approach would not allow measure rates to be calculated as the numerator would not include visits for which no qualified prescriptions were submitted. The commenter further recommended that the measure rate calculations exclude instances where there were qualified prescriptions, but no prescriptions were transmitted electronically.

Response: We appreciate the commenter's feedback. However, before eligible professionals can begin using electronic prescribing technology, they must first adopt the technology. Since, as we discussed in the CY 2010 PFS proposed rule (74 FR 33593), rates for the adoption and use of electronic prescribing technology by eligible professionals are still low and 2010 is only the second year of this incentive program, our goal for the 2010 E-Prescribing Incentive Program is to focus on increasing eligible professionals' adoption of electronic prescribing technology. We believe that this will be facilitated by administering the E-Prescribing Incentive Program in a way that does not create an unnecessarily large reporting burden on eligible professionals in order to qualify for the incentive.

The criteria for successful reporting we are finalizing for 2010 are designed to reward those eligible professionals who demonstrate that they have adopted a qualified electronic prescribing system and actually used the system in a substantial way to electronically prescribe. In this context, the reporting of information as to circumstances where a professional did not electronically prescribe is not pertinent. Additionally, although it may be of interest to measure the proportion of prescribing events that are electronic, we do not believe such detail at the individual or group practice level is of sufficient value to warrant the high burden of reporting such information. We do note that in the future the use of Part D claims data may allow this information to be collected without the necessity for professionals to specifically report such details.

Accordingly, for the 2010 electronic prescribing measure, we are finalizing the following numerator G-code: Gxxxx: At least 1 prescription created during the encounter was generated and transmitted electronically using a qualified electronic prescribing system.

A new G-code will be assigned by CMS to the above code for 2010 and will be included in the measure's specifications, which we will post on the “E-Prescribing Measure” page of the E-Prescribing Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/ERXIncentive. We will post by no later than December 31, 2009, the final electronic prescribing measure specifications for 2010.

Because the electronic prescribing quality measure will apply only when an eligible professional furnishes services indicated by one of the codes included in the measure's denominator, for claims-based reporting, for example, it will not be necessary for an eligible professional to report G-codes for the electronic prescribing measure on claims not containing one of the denominator codes. However, if reporting a G-code, the G-code data submission will only be considered valid if it appears on the same Medicare Part B claim containing one of the electronic prescribing quality measure's denominator codes.

In addition, if the eligible professional submits a Medicare Part B claim containing one of the electronic prescribing measure's denominator codes, he or she can report the numerator G-code only when the eligible professional furnishes services indicated by one of the G-codes included in the measure's numerator. That is, only when at least 1 prescription created during the encounter was generated and transmitted electronically using a qualified electronic prescribing system.

(5) Criteria for Successful Reporting of the Electronic Prescribing Measure

As discussed above, section 1848(m)(3)(B)(ii) of the Act specifies that an eligible professional shall be treated as a successful electronic prescriber for a reporting period based on the eligible professional's reporting of the electronic prescribing measure in at least 50 percent of applicable cases. For 2010, however, we proposed to exercise our authority under section 1848(m)(3)(D) of the Act to revise the criteria for submitting data on the electronic prescribing measure (74 FR 33598). For 2010, rather than requiring that the electronic prescribing measure be reported for a certain proportion of reportable cases, we proposed to make the determination of whether an eligible professional is a successful electronic prescriber based on a count of the number of times (minimum threshold of 25) an eligible professional reports that at least one prescription created during the encounter was generated using a qualified electronic prescribing system. We solicited comments on the proposed criteria for determination of successful electronic prescriber.

The following is a summary of the comments we received regarding the proposed criteria for determination of successful electronic prescriber for the 2010 E-Prescribing Incentive Program.

Comment: A majority of commenters supported the changes proposed for the criteria for the determination of successful electronic prescriber for 2010 and the proposed threshold for reporting the electronic prescribing measure at least 25 times during the reporting period. Some commenters, however, expressed concern that the proposed threshold may be insufficient to ensure that electronic prescribing is fully adopted into the prescriber's clinical practice and workflow since some eligible professionals may be able to meet this threshold in a matter of a few days or weeks.

Some commenters suggested that in lieu of a fixed threshold, we establish a percent threshold based upon the percent of eligible cases in 2009. Another commenter suggested that if an eligible professional has an electronic prescribing system, he or she should be using the system for all prescriptions. Other commenters suggested a threshold of 250-500 electronic prescribing events during the reporting period.

Response: We appreciate the commenters' feedback, and believe that lowering this requirement simplifies the reporting burden, which would encourage more eligible professionals to participate in this incentive program, and more importantly, to adopt an electronic prescribing system.

We agree with commenters that some eligible professionals may be able to meet the criteria for successful reporting in a matter of a few days or weeks. However, in establishing the threshold of 25 electronic prescribing events, we also took into account the many valid circumstances that would prevent eligible professionals who have adopted a qualified electronic prescribing system from having 25 electronic prescribing events during the calendar year and variations in practice characteristics. In addition to the patient-related, system-related, or legal reasons that were formerly addressed by reporting the G8446 code for the measure, some eligible professionals may have few opportunities to report the electronic prescribing measure since they generate a low volume of prescriptions, have few Medicare patients, infrequently provide the services included in the measure's denominator, or a combination of these factors.

Comment: Other commenters were concerned that the proposed changes to the criteria for determining a successful electronic prescriber, while lower than the 2009 criteria, would make it more difficult to qualify for the electronic prescribing incentive payment. The commenters were concerned that the impact on eligible professionals will vary depending on the percentage of Medicare patients in their practice and the volume of prescriptions generated by the practice. For some practices 25 electronic prescriptions could be achieved in a matter of days but for other practices it may be difficult or impossible to achieve this threshold. One commenter suggested that lowering the reporting threshold from 25 to 15 may be enough to get an eligible professional to adopt and use an electronic prescribing system and to recognize its superiority. Other commenters suggested that we retain the criteria to report the electronic prescribing measure on 50 percent of applicable cases instead.

Response: As we stated previously, we have taken the commenters' concerns into consideration in establishing the proposed threshold of 25 electronic prescribing events. On average, we believe an eligible professional would need to have 2 to 3 electronic prescribing events per month to be considered a successful electronic prescriber. We believe that this is achievable by a majority of eligible professionals. However, we will monitor the 2010 E-Prescribing Incentive Program results and take the commenters' recommendation into consideration as we develop the criteria for future years.

Comment: Some commenters recommended that we allow for alternative reporting to accommodate those who may not be able to electronically prescribe at least 25 times due to state or federal laws and regulations that do not allow electronic prescribing for narcotics or other controlled substances.

Response: As stated previously, we have taken into account the many valid circumstances that would prevent eligible professionals who have adopted a qualified electronic prescribing system from having 25 electronic prescribing events during the calendar year, including state or federal laws and regulations that do not allow electronic prescribing for narcotics or other controlled substances, when we established the proposed threshold of 25 electronic prescribing events. Therefore, we do not believe that it is necessary to establish alternative reporting criteria for such eligible professionals.

Comment: One commenter recommended that, for eligible professionals who practice in a nursing facility and other institutional settings, the determination of successful electronic prescriber should be made by measuring the electronic management of prescription drugs instead of measuring adoption and use of a qualified electronic prescribing system. The commenter recommends that eligible professionals be required to submit, with each eligible CPT code, a HCPCS code verifying that all prescription medications for the patient were electronically reviewed prior to the submission of the claims. This would continue to incentivize eligible professionals, who are prescribing schedule drugs, or working in a facility which does not provide access to electronic prescribing or the internet, for electronically managing patients' drugs.

Response: We are unclear as to how incentivizing eligible professionals for electronically managing patients' drugs encourages the adoption and use of electronic prescribing technology. In contrast, the proposed criteria for determining a successful electronic prescriber encourage the adoption and use of electronic prescribing technology by requiring eligible professionals to report to us that they have used a qualified electronic prescribing system during the reporting period. Therefore, we are not adopting the commenter's recommendation.

Comment: One commenter recommended that we institute a “floor” or minimum number of prescriptions that must be prescribed in order to even be assessed for the electronic prescribing incentive. This would protect consultants or proceduralists who do not prescribe medications from being assessed a payment adjustment in future years.

Response: We believe that such a floor is already addressed by the limitation required under section 1848(m)(2)(B) of the Act. In order to avoid being subject to the limitation for 2010 and qualify to earn an electronic prescribing incentive payment, eligible professionals who meet the criteria for successful electronic prescriber must have at least 10 percent of their Medicare Part B PFS allowed charges for covered professional services comprised of the codes in the denominator of the electronic prescribing measure. In addition, we note that under section 1848(m)(2)(B) of the Act, eligible professionals who are subject to the limitation would not be subject to the payment adjustment.

Comment: One commenter recommended that we apply the proposed criteria for determining a successful electronic prescriber for 2010 to the 2009 E-Prescribing Incentive Program so that those eligible professionals who reported that they electronically prescribed at least 25 times in 2009 would also be eligible to receive a 2009 electronic prescribing incentive payment.

Response: We do not have the authority to change the criteria for determining a successful electronic prescriber for 2009. Section 1848(m)(3)(D) of the Act does not authorize us to revise the criteria for submitting data on electronic prescribing measures specified under subparagraph (B)(ii) until years after 2009. Additionally, even if we had the authority to modify the criteria for determining a successful electronic prescriber for 2009, we could not do so retrospectively.

Comment: Some commenters urged us to use our authority under section 1848(m)(3)(B)(iv) of the Act to utilize Part D claims to determine if eligible professionals are prescribing a sufficient number of prescriptions electronically. The commenters noted that this would be a more efficient means of capturing the information needed by us for determining whether an eligible professional is a successful electronic prescriber. One commenter stressed that it is necessary for us to overcome our concerns about the use of a certain number of Part D prescribing events as a basis for the incentive payment in time for implementation of the meaningful use criteria in 2011.

Response: We agree that using Part D claims to determine if eligible professionals are prescribing a sufficient number of prescriptions electronically could potentially be a more efficient means of capturing the information needed by us for determining whether an eligible professional is a successful electronic prescriber and we anticipate that we would do so as soon as it is practical to do so. As we stated in the CY 2010 PFS proposed rule (74 FR 33595), however, the accuracy and completeness of the Part D data with respect to whether a prescription was submitted electronically by an individual eligible professional is unknown since that information will not be collected on the Part D claims, until 2010. During 2010 we anticipate evaluating the adequacy of Part D data to determine the feasibility of its use for determining whether an eligible professional qualifies as a successful electronic prescriber. In the meantime, we are implementing alternative reporting mechanisms (that is, registry and EHR reporting) for reporting the electronic prescribing measure in 2010 in an effort to provide more flexibility to eligible professionals.

After considering the comments, for 2010, an eligible professional will be required to report the electronic prescribing measure at least 25 times during the reporting period for purposes of meeting the criteria for successful electronic prescriber and qualifying to earn the electronic prescribing incentive (subject to the limitation required under section 1848(m)(2)(B) of the Act). In other words, an eligible professional will be required to report that he or she electronically prescribed at least 25 times during the reporting period for services indicated by one of the codes included in the measure's denominator.

As stated previously, by December 31, 2009, we will post the final specifications of the measure on the “E-Prescribing Measure” page of the E-Prescribing Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/ERXIncentive.

d. Determination of the 2010 Incentive Payment Amount for Individual Eligible Professionals Who Are Successful Electronic Prescribers

Section 1848(m)(2)(B) of the Act imposes a limitation on the electronic prescribing incentive payment. The Secretary is authorized to choose 1 of 2 possible criteria for determining whether or not the limitation applies to a successful electronic prescriber. The first criterion, under section 1848(m)(2)(B)(i) of the Act, is based upon whether the Medicare Part B allowed charges for covered professional services to which the electronic prescribing quality measure applies are less than 10 percent of the total Medicare Part B PFS allowed charges for all covered professional services furnished by the eligible professional during the reporting period. The second criterion, under section 1848(m)(2)(B)(ii) of the Act, is based on whether the eligible professional submits (both electronically and nonelectronically) a sufficient number (as determined by the Secretary) of prescriptions under Part D (which can, again, be assessed using Part D drug claims data). If the Secretary decides to use the latter criterion, then, in accordance with section 1848(m)(2)(B) of the Act, the criterion based on the reporting on electronic prescribing measures would no longer apply. The statutory limitation also applies with regard to the future application of the payment adjustment.

Based on our proposal to make the determination of whether an eligible professional is a “successful electronic prescriber” based on submission of the electronic prescribing measure, we proposed to apply the criterion under section 1848(m)(2)(B)(i) of the Act for the limitation for the 2010 E-Prescribing Incentive Program.

The following is a summary of the comments we received regarding the proposed criterion for the limitation.

Comment: Although the commenters acknowledged that the limitation on the electronic prescribing incentive payment is required by law, a few commenters were opposed to the 10 percent threshold because certain types of eligible professionals would be unlikely to meet the 10 percent threshold.

Response: Unfortunately, we do not have the authority to change the 10 percent threshold, since the threshold is required by section 1848(m)(2)(B)(i) of the Act. In an effort to allow more eligible professionals to potentially qualify for the incentive payment, however, we have expanded the denominator of the electronic prescribing measure. Despite the requirement that 10 percent or more of an eligible professional's charges must be comprised of codes in the denominator, preliminary information from the 2009 E-Prescribing Incentive Program indicates that over 90 percent of eligible professionals who have prescribing privileges do not appear to be affected by the limitation. We believe that expanding the denominator of the measure will further reduce the percentage of eligible professionals who will be subject to the limitation.

Comment: One commenter requested that we make available to individual eligible professionals the percentage of their prior year's Medicare charges that resulted from the codes included in the electronic prescribing measure's denominator specifications since many eligible professionals may not have the time or analytic tools necessary to make the determination of whether they are likely to meet the 10 percent threshold prior to making the decision on whether to electronically prescribe.

Response: Unfortunately, we do not have the resources to calculate and provide feedback to eligible professionals regarding the composition of their charges. Most electronic billing systems, however, will have this functionality and should be able to provide eligible professionals who use such billing systems with this information.

Since, as discussed above, we are finalizing for 2010 our proposal to make the determination of whether an eligible professional is a “successful electronic prescriber” based on submission of the electronic prescribing measure, we also are finalizing our proposal to analyze the claims submitted by the eligible professional at the TIN/NPI level to determine whether the 10 percent threshold is met in determining the receipt of an electronic prescribing incentive payment for 2010 by an eligible professional. This calculation is expected to take place in the first quarter of 2011 and will be performed by dividing the eligible professional's total 2010 Medicare Part B PFS allowed charges for all such covered professional services submitted for the measure's denominator codes by the eligible professional's total Medicare Part B PFS allowed charges for all covered professional services (as assessed at the TIN/NPI level). If the result is 10 percent or more, then the statutory limitation will not apply and a successful electronic prescriber will qualify to earn the electronic prescribing incentive payment. If the result is less than 10 percent, then the statutory limitation will apply and the eligible professional will not earn an electronic prescribing incentive payment—even if he or she electronically prescribes and reports a G-code indicating that he or she generated and transmitted a prescription electronically at least 25 times for those eligible cases that occur during the 2010 reporting period. Although an individual eligible professional may decide to conduct his or her own assessment of how likely this statutory limitation is expected to apply to him or her before deciding whether or not to report the electronic prescribing measure, an individual eligible professional may report the electronic prescribing measure without regard to the statutory limitation for the incentive payment.

e. Reporting Option for Satisfactory Reporting of the Electronic Prescribing Measure by Group Practices

In the CY 2010 PFS proposed rule (74 FR 33599 through 33600), we discussed making incentive payments to group practices based on the determination that the group practice, as a whole (that is, the TIN), is a successful electronic prescriber for 2010, as required under section 1848(m)(3)(C)(i) of the Act. In addition, we noted that section 1848(m)(3)(C)(iii) of the Act requires that payments to a group practice by reason of the process established under section 1848(m)(3)(C)(i) of the Act shall be in lieu of the payments that would otherwise be made under this subsection to eligible professionals in the group practice for being a successful electronic prescriber.

(1) Definition of “Group Practice”

Section 1848(m)(3)(C)(i) of the Act authorizes the Secretary to define “group practice.” For purposes of determining whether a group practice is a successful electronic prescriber, we proposed that a “group practice” would consist of a physician group practice, as defined by a TIN, with at least 200 or more individual eligible professionals (or, NPIs) who have reassigned their billing rights to the TIN (74 FR 33599). In addition, we proposed to limit the group practices eligible to participate in the 2010 E-Prescribing Incentive Program through the group practice reporting option to those group practices selected to participate in the PQRI group practice reporting option.

The following is a summary of the comments received regarding our proposed definition of “group practice”.

Comment: Several commenters urged CMS to permit small and mid-sized group practices with fewer than 200 eligible professionals to participate in the group practice reporting option. One commenter requested that we reconsider the 200 individual eligible professional thresholds for the definition of a group practice or that we at least offer an alternative reporting option that uses a statistical sampling model for primary care oriented group practices.

Response: We recognize that the proposed required group practice size of 200 or more individual eligible professionals limits participation. As stated in the proposed rule (74 FR 33599), for 2010, we would like to limit the number of groups participating in the group practice reporting option until we get further experience with the group practice reporting option. Therefore, we are not adopting the commenters' suggestion to permit small and mid-sized group practices with fewer than 200 eligible professionals to participate in the group practice reporting option and are finalizing the definition of “group practice” for the electronic prescribing group practice reporting option as proposed.

In order for a group practice to participate in the electronic prescribing group practice reporting option for 2010, the group practice must be one that is selected to participate in the PQRI group practice reporting option, which requires that group practices have 200 or more eligible professionals. Group practices cannot solely participate in the electronic prescribing group practice reporting option. A group practice can choose to participate in: (1) both the PQRI group practice reporting option and the electronic prescribing group practice reporting option; (2) the PQRI group practice reporting option but participate in the E-Prescribing Incentive Program as individual eligible professionals; or (3) the PQRI group practice reporting option but not participate in the E-Prescribing Incentive Program at all.

We will use this initial implementation year to explore and refine the group practice reporting option and anticipate expanding this option to group practices with less than 200 individual eligible professionals in future program years.

Comment: A commenter urged us to keep PQRI and the E-Prescribing Incentive programs separate and distinct for group practices wishing to participate in the PQRI group practice reporting option.

Response: The PQRI and E-Prescribing Incentive Programs are separate and distinct incentive programs with different program requirements. However, in order for a group practice to participate in the electronic prescribing group practice reporting option, one of the participation requirements is that the group practice must be one that is selected to participate in the PQRI group practice reporting option. As stated previously, a group practice can choose to participate in: (1) Both the PQRI group practice reporting option and the electronic prescribing group practice reporting option; (2) the PQRI group practice reporting option but participate in the E-Prescribing Incentive Program as individual eligible professionals; or (3) the PQRI group practice reporting option but not participate in the E-Prescribing Incentive Program at all. Therefore, participation in the E-Prescribing Incentive Program, whether as a group practice or at the individual eligible professional level, is optional for those group practices selected to participate in the PQRI group practice reporting option.

For those group practices who choose to participate in both the PQRI and electronic prescribing group practice reporting option, it is important to note that the electronic prescribing measure is not reportable using the PQRI group practice reporting option data collection tool. The electronic prescribing measure is reportable via the same reporting mechanisms that are available to individual eligible professionals participating in the 2010 E-Prescribing Incentive Program (that is claims, a qualified registry, or a qualified EHR).

Comment: A commenter had concerns that some group practices will have difficulty ramping up for participation in both the PQRI and electronic prescribing group practice reporting options between now and January 1, 2010.

Response: As we stated previously, participation in the electronic prescribing group practice reporting option by group practices selected to participate in the PQRI group practice reporting option is optional. To the extent that a group practice chooses to participate in both programs' group practice reporting options, it does not need to be ready to begin the PQRI and electronic prescribing group practice reporting options between now and January 1, 2010. As stated in section II.G.2. of this final rule with comment period, we are requiring interested group practices that meet the criteria to self-nominate by January 31, 2010 and indicate to us whether the practice wishes to participate in just the PQRI group practice reporting option or both the PQRI and electronic prescribing group practice reporting option. The reporting periods for both programs are the same (that is, January 1, 2010 through December 31, 2010), the data submission timelines, however, are different.

In an attempt to ensure the group practices have sufficient time to become acclimated to the PQRI group practice reporting option, for the 2010 PQRI, the group practice will be notified of the selection decision to participate in the PQRI group practice reporting option no later than the second quarter of 2010. Training on the data collection tool is projected to be provided in the third quarter of 2010. The group practice will not be expected to complete and return the data collection tool until the end of the first quarter of 2011.

For the 2010 E-Prescribing Incentive Program, we proposed requiring that reporting of the electronic prescribing measure by group practices would occur under the same data submission timeline as reporting of the electronic prescribing measure by individual eligible professionals. The proposed reporting mechanisms for the electronic prescribing measure would be the same regardless of whether an eligible professional is participating individually or as a group practice. Furthermore, the electronic prescribing measure was not proposed to be reportable via the PQRI group practice reporting option data collection tool.

To summarize, based on these comments, for purposes of the 2010 E-Prescribing Incentive Program, we are finalizing a group practice reporting option that will consist of “group practice” being defined as a TIN with at least 200 or more individual eligible professionals (as identified by NPIs) who have reassigned their billing rights to the TIN and who are participating in the 2010 PQRI group practice reporting option. Therefore, unlike individual eligible professionals who are not required to participate in the PQRI, to be eligible to earn an electronic prescribing incentive in 2010, group practices that wish to participate in the electronic prescribing group practice reporting option will be required to participate in the PQRI group practice reporting option. Participation in the E-Prescribing Incentive Program, including participation in the electronic prescribing group practice reporting option is, however, optional for group practices that are participating in PQRI under the group practice reporting option. If a group practice wishes to participate in the 2010 E-Prescribing Incentive Program under the group practice reporting option, it must indicate its desire to do so at the time that the group practice self-nominates to participate in the 2010 PQRI group practice reporting option. There is no need for group practices to indicate their intent to participate in the 2010 E-Prescribing Incentive Program as individual eligible professionals when the group practice self-nominates to participate in the 2010 PQRI group practice reporting option.

Group practices interested in participating in the 2010 PQRI through the group practice reporting option are required to submit a self-nomination letter to CMS, requesting to participate in the 2010 PQRI group practice reporting option. Instructions for submitting the self-nomination letter will be posted on the PQRI section of the CMS Web site by November 15, 2009. A group practice that wishes to participate in the E-Prescribing Incentive Program group practice reporting option will be notified of the selection decision to participate in the E-Prescribing Incentive Program at the same time that it is notified of the selection decision for the PQRI group practice reporting option.

In addition to meeting the eligibility requirements discussed in section II.G.5.e.1. of this final rule with comment period, a group practice that wishes to participate in the 2010 E-Prescribing Incentive Program under the group practice reporting option will also have to indicate how it intends to report the electronic prescribing measure. That is, the group practice will need to indicate in its self-nomination letter which reporting mechanism the group practice intends to use for purposes of participating in the 2010 E-Prescribing Incentive Program group practice reporting option.

(2) Process for Group Practices to Participate as Group Practices and Criteria for Successful Reporting of the Electronic Prescribing Measure by Group Practices

For group practices selected to participate in the electronic prescribing group practice reporting option for 2010, we proposed the reporting period would be January 1, 2010 to December 31, 2010 (74 FR 33599 through 33600).

We proposed that physician groups selected to participate in the 2010 E-Prescribing Incentive Program through the group practice reporting option would be able to choose to report the electronic prescribing measure through the claims-based, the registry-based, or, contingent upon us finalizing this reporting mechanism for the 2010 PQRI, the EHR-based reporting mechanism.

In order for a group practice to be considered a successful electronic prescriber, we proposed that the group practice would have to report that at least 1 prescription during an encounter was generated using a qualified electronic prescribing system in at least 2,500 instances during the reporting period. We solicited comments on the proposed criteria for determining whether a group practice is a successful electronic prescriber. We also invited feedback on our underlying assumptions.

Section 1848(m)(2)(B) of the Act specifies that the limitation on the applicability of the electronic prescribing incentive applies to group practices as well as individual eligible professionals. Therefore, in determining whether a group practice will receive an electronic prescribing incentive payment for 2010 by meeting the proposed reporting criteria described above, we would determine whether the 10 percent threshold is met based on the claims submitted by the group practice.

The following is a summary of the comments we received regarding the proposed process for group practices to participate as group practices and criteria for successful reporting of the electronic prescribing measure by group practices.

Comment: One commenter agrees with CMS' assumptions and proposals for group reporting and believed it is reasonable to set criteria for successful electronic prescribing using the 2,500 threshold. Conversely, one commenter believed that 2,500 electronic prescribing events during the reporting period is too low a threshold for group practices and suggested that the threshold should be 25,000 to 50,000 electronic prescribing instances during the reporting period per group practice. One commenter believed that CMS should retain the 50 percent rule and thinks that establishing a numerical target of 2,500 electronic prescribing instances during the reporting period creates an unbalanced incentive depending on practice type, size, and percent Medicare patient mix. Another commenter stated that the electronic prescribing group practice reporting option should not be different for a group practice versus an individual eligible professional.

Response: By establishing a reporting threshold of 2,500 electronic prescribing events per reporting period per group practice, we desired to implement a threshold that is obtainable and demonstrates that the group practice has adopted and is using a qualified electronic prescribing system. Also, by establishing this threshold, we sought to reduce reporting burden. A numerical target of reporting 2,500 electronic prescribing events per reporting period will provide a tangible goal for the group practices to achieve. As stated previously, we are making every effort to promote the adoption of electronic prescribing by making participation both practical and operational so that group practices may achieve successful reporting. In establishing the threshold of 2,500 electronic prescribing events, we had to take into account not only all the circumstances that we discussed above with respect to the threshold for individual eligible professionals that could prevent a group practice who has adopted a qualified electronic prescribing system from having 2,500 electronic prescribing events during the calendar year but also the fact that the impact of these circumstances will vary depending on the types of specialties that are affiliated with each group practice.

Comment: A commenter expressed that the proposed method of calculating whether the limitation applies to a group practice will prevent most large multi-specialty group practices from being able to use the electronic prescribing group practice reporting option.

Response: We do not have the authority to change the basis for determining the applicability of the limitation. If we are making the determination of successful electronic prescriber based on reporting the electronic prescribing measure, section 1848(m)(2)(B) of the Act specifies that the limitation will apply if the Medicare Part B PFS allowed charges for all covered professional services furnished by the group practice for the codes to which the electronic prescribing quality measure applies are less than 10 percent of the total of the Medicare Part B PFS allowed charges for all covered professional services furnished by the group practice.

For the reasons mentioned above and after considering the comments, we are finalizing for the 2010 E-Prescribing Incentive Program the group practice reporting option discussed above. Specifically, group practices will be required to report the 2010 electronic prescribing measure at least 2,500 times during the reporting period in order for the group practice to be considered a successful electronic prescriber.

Group practices will be able to choose to report the electronic prescribing measure through claims, a qualified registry, or qualified EHR product. As discussed for individual eligible professionals, only registries and EHR products qualified to participate in the 2010 PQRI will be qualified for purposes of the 2010 electronic prescribing group practice reporting option.

In addition, in determining whether a group practice will receive an electronic prescribing incentive payment for 2010 by meeting the reporting criteria described above, we will determine whether the 10 percent threshold is met based on our analysis of the claims submitted by the group practice during the reporting period. This calculation is expected to take place in the first quarter of 2011 and will be determined by dividing the group practice's total 2010 Medicare Part B PFS allowed charges for all covered professional services submitted for the measure's denominator codes by the group practice's total Medicare Part B PFS allowed charges for all covered professional services. If the result is 10 percent or more, then the statutory limitation will not apply and a group practice that is determined to be a successful electronic prescriber will qualify to earn the electronic prescribing incentive payment. If the result is less than 10 percent, then the statutory limitation will apply and the group practice will not qualify to earn the electronic prescribing incentive payment.

f. Public Reporting of Names of Successful Electronic Prescribers

Section 1848(m)(5)(G) of the Act requires the Secretary to post on the CMS Web site, in an easily understandable format, a list of the names of eligible professionals (or group practices) who satisfactorily submit data on quality measures for the PQRI and the names of the eligible professionals (or group practices) who are successful electronic prescribers. As required by section 1848(m)(5)(G) of the Act, we proposed to make public the names of eligible professionals and group practices who are successful electronic prescribers for the 2010 E-Prescribing Incentive Program on the Physician and Other Health Care Professionals Directory.

The following is summary of the comments we received regarding requirements under section 1848(m)(5)(G) of the Act with respect to the E-Prescribing Incentive Program.

Comment: Some commenters supported public reporting of the names of successful electronic prescribers. One commenter, in particular, noted that public reporting of the names of successful electronic prescribers will assist health plans in identifying such entities for related requirements in Medicare Advantage and Part D and help private health plans identify those that may need to be encouraged or assisted with electronic prescribing.

Response: We are pleased to have commenters' support for our efforts to make information about eligible professionals' adoption and use of electronic prescribing technology publicly available. We agree that such information may be relevant and useful to a broad audience.

Comment: Many commenters urged us to post only the information required by section 1848(m)(5)(G) of the Act, that is, the names of individual eligible professionals and group practices who are successful electronic prescribers.

Response: As we stated in the CY 2010 PFS proposed rule (74 FR 33600), we proposed to make public only the names of eligible professionals and group practices who are successful electronic prescribers. We do not anticipate posting any other information with respect to the E-Prescribing Incentive Program at this time.

Comment: Other commenters recognized that we are statutorily required to carry out public reporting of the names of successful electronic prescribers but are, nevertheless, opposed to publicly releasing the names of successful electronic prescribers or urged us to delay releasing such information until the public has a better understanding of the details of the E-Prescribing Incentive Program. Some of the concerns specifically cited by commenters include the following:

  • The E-Prescribing Incentive Program is voluntary and excludes many eligible professionals;
  • A formal independent evaluation of the E-Prescribing Incentive Program's processes and an analysis and validation of the data gathered needs to be conducted prior to any information being publicly released;
  • CMS needs to provide eligible professionals with better access and feedback to the quality data they report (especially feedback on why they failed to report successfully) before the release of any information;
  • There is little to be gained from this effort since eligible professionals and patients do not fully understand the details of the program and are still learning about this program;
  • Patients may not understand the purpose for posting this information since the program is still new; and
  • The criteria for becoming a successful electronic prescriber are changing from 2009 to 2010.

Response: We are appreciative of the commenters' thoughtful and constructive feedback and will take these concerns into consideration as we further develop our plans for publicly reporting information from the E-Prescribing Incentive Program. While we understand the commenters' concerns, we note that section 1848(m)(5)(G) of the Act requires us to list the names of individual eligible professionals and group practices who are successful electronic prescribers in an easily understandable format on our Web site. As such, it is our intent to identify the eligible professionals and group practices who are successful electronic prescribers for the 2010 E-Prescribing Incentive Program for posting in 2011. We note that we anticipate conducting an evaluation of the E-Prescribing Incentive Program and making the national evaluation results public through an experience report similar to the “PQRI 2007 Reporting Experience” report that we posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/Downloads/PQRI2007ReportFinal12032008CSG.pdf.

Comment: A few commenters stressed the importance of including appropriate and prominent disclaimers or other statements on our Web site that provides information about the E-Prescribing Incentive Program and specifically state that there are valid reasons why an eligible professional may not have been a successful electronic prescriber for 2010.

Response: We agree with the commenters on the importance of including disclaimers and other information on the Web site that explains the E-Prescribing Incentive Program and its goals and the limitations of the data being reported (such as the fact that there are valid reasons why an eligible professional may not have been a successful electronic prescriber). Thus, it is our intent to include such language and disclaimers on the Web site similar to what was displayed with the 2007 PQRI participation information that was publicly released on the Physician and Other Health Care Professionals Directory in December 2008. We also anticipate being able to update the Physician and Other Health Care Professionals Directory to display the relevant disclaimers more prominently.

Comment: Some commenters recommended that eligible professionals and group practices have an opportunity to review their electronic prescribing results before those results are made public, including access to information about why they were not able to successfully report this data, and that we continue to work with eligible professionals on the sensitive issues that surround this concept.

Response: Eligible professionals and group practices will have an opportunity to review their electronic prescribing results via the detailed, confidential feedback reports that will be made available to all eligible professionals and group practices who participle in the E-Prescribing Incentive Program. Eligible professionals and group practices will have an opportunity to obtain their feedback reports prior to any information about their success being publicly released.

Eligible professionals who have concerns about their results or any other information included on their feedback reports are encouraged to contact the QualityNet Help Desk at (866) 288-8912 or qnetsupport@sdps.org for assistance.

Comment: One commenter recommended that we also publicly report the names of eligible professionals who choose to not participate in the E-Prescribing Incentive Program.

Response: We do not believe it will be meaningful to the public to know the names of those eligible professionals who choose not to participate in the E-Prescribing Incentive Program. As some commenters noted, the E-Prescribing Incentive Program is a voluntary incentive program and many eligible professionals who have adopted and use a qualified electronic system have valid reasons for not participating. For example, some eligible professionals may not provide the services included in the electronic prescribing measure's denominator and, therefore, would not have an opportunity to report the measure. Other professionals may know, based on the prior year's charges, that they are unlikely to meet the statutory limitation under section 1848(m)(2)(B) of the Act that would allow them to be eligible to qualify to earn the electronic prescribing incentive payment. Therefore, such eligible professionals would most likely opt to not participate in the E-Prescribing Incentive Program even if they are electronically prescribing.

After considering the comments, we will publicly report the names of eligible professionals and group practices who are successful electronic prescribers for the 2010 E-Prescribing Incentive Program on the Physician and Other Health Care Professionals Directory. We anticipate that the names of individual eligible professionals and group practices who are successful electronic prescribers for the 2010 E-Prescribing Incentive Program will be available in 2011 after the 2010 incentive payments are paid.

Although we stated in the CY 2009 PFS proposed rule (74 FR 33600) and the CY 2008 PFS final rule with comment period (73 FR 69852) that we intended to post the names of individual eligible professionals who meet the criteria for successful electronic prescriber and for whom the limitation does not apply (in other words, eligible professionals who qualify to earn an incentive payment), we would like to clarify that for purposes of publicly reporting the names of individual eligible professionals on the Physician and Other Health Care Professionals Directory, section 1848(m)(5)(G) of the Act requires only that the Secretary post the names of eligible professionals (or group practices) who are successful electronic prescribers. Therefore, with respect to the 2010 E-Prescribing Incentive Program we intend to post the names of individual eligible professionals who report the electronic prescribing measure at least 25 times during the 2010 reporting period for patient encounters included in the measure's denominator, without regard to whether the limitation applied to the eligible professional and without regard to whether the eligible professional actually qualified to earn an incentive payment. In addition, since the PQRI and the E-Prescribing Incentive Program are two separate incentive programs and individual eligible professionals are not required to participate in both programs to earn an incentive under either program, we point out that it is possible for an eligible professional who participates in both incentive programs to be listed both as an individual eligible professional who satisfactorily submits data on quality measures for the PQRI and is a successful electronic prescriber under the E-Prescribing Incentive Program. Likewise, an individual eligible professional may be listed as an individual eligible professional who satisfactorily submits data on quality measures for the PQRI but not as a successful electronic prescriber under the E-Prescribing Incentive Program (or vice versa) even if he or she participated in both incentive programs.

Similarly, for purposes of publicly reporting the names of group practices, on the Physician and Other Health Care Professionals Directory, we intend to post the names of group practices who report the electronic prescribing measure at least 2,500 times during the 2010 reporting period for patient encounters included in the measure's denominator without regard to whether the limitation applied to the group practice or whether the group practice actually qualified to earn an incentive payment. Although any group practice participating in the E-Prescribing Incentive Program under the group practice reporting option would have had to also participate in the PQRI group practice reporting option, the criteria for satisfactory reporting of PQRI measures for group practices are different from the criteria for successful reporting of the electronic prescribing measure by group practices. Therefore, it is possible for a group practice to be listed as a group practice that satisfactorily submits data on quality measures for the PQRI but not as a successful electronic prescriber under the E-Prescribing Incentive Program, or vice versa.

6. Section 135: Implementation of Accreditation Standards for Suppliers Furnishing the Technical Component (TC) of Advanced Diagnostic Imaging Services

Section 1834(e) of the Act, as added by section 135(a) of the MIPPA, requires that beginning January 1, 2012, Medicare payment may only be made for the technical component (TC) of advanced diagnostic imaging services for which payment is made under the fee schedule established in section 1848(b) of the Act to a supplier who is accredited by an accreditation organization (AO) designated by the Secretary.

a. Accreditation Requirement

In the proposed rule, we proposed criteria for designating organizations to accredit suppliers furnishing the TC of advanced diagnostic imaging services as specified in section 1834(e) of the Act. In addition, we proposed the required procedures to ensure that the criteria used by an AO meets minimum standards for each imaging modality in § 414.68.

We did not propose any substantive standards that suppliers furnishing the TC of advanced imaging would have to meet. We have chosen to utilize clinical guidelines that are already accepted by the experienced accreditation organizations already performing accreditation. We believe that the suppliers should be able to assimilate these new accreditation requirements very easily into their medical practice.

We will be designating organizations based on, at minimum, their ability to meet the requirements set forth in the statute. In addition, in this rule we have described the components that any organization must have in order to be considered for designated status.

As proposed, the CMS-designated AO would apply standards that set qualifications for medical personnel who are not physicians but who furnish the TC. The standards would describe the qualifications and responsibilities of medical directors and supervising physicians. including the following: recognizing whether a particular medical director or supervising physician received training in advanced imaging services in a residency program; and has attained, through experience, the necessary expertise to be a medical director or supervising physician; has completed any continuing medical education courses related to advanced imaging services; or has met such other standards as the Secretary determines appropriate.

In addition, the standards would require suppliers to: (1) Establish and maintain a quality control program to ensure the technical quality of diagnostic images produced by the supplier; (2) ensure the equipment used meets performance specifications; and (3) ensure safety of personnel. While the statute authorizes the Secretary to establish as criteria for accreditation any other standards or procedures the Secretary determines appropriate, we did not propose to establish other standards or procedures.

In the proposed rule, we also stated that we expect to publish a notice to solicit applications from entities for the purposes of becoming a designated AO the same day that this final rule with comment period is issued. We still expect to meet the January 1, 2010 statutory deadline in order to designate organizations to accredit suppliers furnishing the TC of advanced diagnostic imaging services by waiving the 60-day delay in the imaging accreditation provisions in the final rule.

We believe that we have furnished enough detail in the proposed rule, in addition to receiving extensive comments from prospective AOs, so that AOs will find that 30 days is sufficient time to respond to the solicitation.

b. Accreditation for Suppliers

Section 1834(e) of the Act requires the Secretary to designate and approve AOs to accredit suppliers of the TC of advanced diagnostic imaging services. To promote consistency in accrediting providers and suppliers throughout the Medicare program, we proposed to review existing procedures for the application, selection, and oversight of AOs detailed at 42 CFR part 488, subparts A and D, and apply them (with appropriate revisions) to organizations accrediting suppliers of the TC of advanced diagnostic imaging services. We proposed modifications to the existing part 488 requirements to meet the specialized needs of the advanced imaging industry. These modifications would require an independent AO applying for approval as a designated AO to include in their application:

  • A detailed description of how the organization's accreditation criteria satisfy the statutory standards at section 1834(e)(3) of the Act, specifically:

+ Qualifications of medical personnel who are not physicians and who furnish the TC of advanced diagnostic imaging services;

+ Qualifications and responsibilities of medical directors and supervising physicians, such as training in advanced diagnostic imaging services in a residency program, expertise obtained through experience, or continuing medical education courses;

+ Procedures to ensure the safety of persons who furnish the TC of advanced diagnostic imaging services and individuals to whom such services are furnished;

+ Procedures to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by the supplier.

  • An agreement to conform accreditation requirements to any changes in Medicare statutory requirements in section 1834(e) of the Act.
  • Information to demonstrate the AO's knowledge and experience in the advanced diagnostic imaging arena.
  • The organization's proposed fees for accreditation for each modality in which the organization intends to offer accreditation and any plans for reducing the burden and cost of accreditation to small and rural suppliers.
  • Any specific documentation requirements and attestations requested by CMS as a condition of designation under this part.

If, after review of an AO's submission of information, we determined that additional information was necessary to make a determination for approval or denial of the AO's application to be designated as an AO for suppliers of the TC of advanced diagnostic imaging services, the organization would be notified and afforded an opportunity to provide the additional information. We could visit the organization's offices to verify representations made by the organization in its application, including, but not limited to, review of documents and interviews with the organization's staff. The AO would receive a formal notice from CMS stating whether the request for designation was approved or denied. If approval was denied, the notice would include the basis for denial and outline the reconsideration procedures. We would make every effort to issue a final decision no more than 30 calendar days from the time the completed reapplication was received by CMS. An AO could withdraw its application for designation under section 1834(e) of the Act at any time before the formal notice of approval is received. An AO that was notified that its request for designation was denied could request reconsideration in accordance with § 488.201 through § 488.211 in Subpart D. Any AO whose request for designation was denied could resubmit its application if the organization (1) Revised its accreditation program to address the rationale for denial of its previous request; (2) provided reasonable assurance that its accredited companies meet applicable Medicare requirements; and (3) resubmitted the application in its entirety. If an AO requested a reconsideration of a denial, it could not submit a new application for the type of modality that is at issue in the reconsideration until the reconsideration was final.

A panel would evaluate all proposals from AOs seeking designation under section 1834(e) of the Act using existing CMS survey and certification processes, similar to those established at § 488.4.

c. Payment Rules for Suppliers of the TC of Advanced Diagnostic Imaging Services (§ 414.68)

We would implement at § 414.68 the statutory requirement of section 1834(e) of the Act that all suppliers of the TC of advanced diagnostic imaging services be accredited by a CMS-designated AO by January 1, 2012 for payments made under the fee schedule established under section 1848(b). In § 414.68(a), we proposed to define the following:

  • “Accredited supplier” would mean a supplier that has been accredited by a CMS-approved AO.
  • “Advanced Diagnostic Imaging Services” would mean diagnostic magnetic resonance imaging, computed tomography, nuclear medicine, and positron emission tomography. We did not propose to include other diagnostic imaging services in this definition under section 1834(e)(1)(B)(ii) of the Act.
  • “CMS-approved accreditation organization” would mean an independent AO designated by CMS to perform the accreditation function established in section 1834(e) of the Act.

d. Ongoing Responsibilities of CMS-Approved Accreditation Organizations

We proposed to require a CMS-approved AO to perform several activities on an ongoing basis. The organization would provide to CMS in written form and on an ongoing basis all of the following:

  • Copies of all accreditation surveys of specific suppliers along with any survey-related information that we may require (including corrective action plans and summaries of CMS requirements that were not met).
  • Notice of all accreditation decisions.
  • Notice of all complaints related to suppliers of the TC of advanced diagnostic imaging service.
  • Information about any suppliers of the TC of advanced diagnostic imaging service for which the accrediting organization has denied the supplier's accreditation status.
  • Notice of any proposed changes in its accreditation standards or requirements or survey process. If the organization implemented the changes before or without CMS approval, we could withdraw approval of the AO.
  • Written notice of any deficiencies and adverse actions implemented by the CMS-approved AO against an accredited supplier of the TC of advanced diagnostic imaging within 2 days of identifying such deficiencies, if the deficiencies pose immediate jeopardy to a beneficiary or to the general public.
  • Written notice of the withdrawal to all accredited suppliers within 10 days of CMS' notice to withdraw approval of the AO.
  • Summary data specified by CMS related to the past year's accreditation activities and trends, on an annual basis.

In addition, the AO would permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.

e. Continuing CMS Oversight of CMS-Approved Accreditation Organizations

We proposed to add § 414.68 to establish specific criteria and procedures for continuing oversight and for withdrawing approval of an approved AO.

(1) Validation Audits

We proposed to audit the accredited organizations in order to validate the survey accreditation process of approved AOs in the TC of advanced imaging. The audits would be conducted on a representative sample of suppliers who have been accredited by a particular accrediting organization or in response to allegations of supplier noncompliance with the standards. When conducted on a representative sample basis, we proposed that the audit would be comprehensive and address all of the standards or would focus on a specific standard in issue. When conducted in response to an allegation, we proposed to specify that the CMS team or our contractor would audit for any standard that we determined was related to the allegations. We also proposed to require a supplier selected for a validation audit to authorize the validation audit to occur and authorize the CMS team or our contractor to monitor the correction of any deficiencies found through the validation audit. If a supplier selected for a validation audit failed to comply with the requirements at § 414.68, the supplier would no longer meet the Medicare requirements and, under this proposal, the supplier's accreditation for the TC of the advanced medical imaging would be revoked.

We proposed that a CMS team or our contractor would conduct an audit of an accredited organization, examine the results of the AO's own survey procedure onsite, or observe the AO's survey, in order to validate the organization's accreditation process. At the conclusion of the review, we would identify any accreditation programs for which validation audit results indicated the following:

  • A 10 percent or greater rate of disparity between findings by the AO and findings by CMS or our contractor on standards that did not constitute immediate jeopardy to patient health and safety if not met;
  • Any disparity between findings by the AO and findings by CMS or our contractor on standards that constituted immediate jeopardy to patient health and safety if not met; or
  • There were widespread or systemic problems in the organization's accreditation process such that the accreditation no longer provided assurance that suppliers met or exceeded the Medicare requirements, irrespective of the rate of disparity.

(2) Notice of Intent To Withdraw Approval for Designating Authority

As proposed, if a validation audit, onsite observation, or our concerns with the ethical conduct (that impacted the health and safety of the beneficiary) of an AO suggest that the AO was not meeting the requirements of § 414.68, we would provide the organization written notice of our intent to withdraw approval of the AO's designating authority.

(3) Withdrawal of Approval for Designating Authority

We proposed to withdraw approval of an AO at any time if we determined that:

  • Accreditation by the organization no longer provided sufficient assurance that the suppliers of the TC of advanced imaging meet the requirements of section 1834(e) of the Act and the failure to meet those requirements could pose an immediate jeopardy to the health and safety of Medicare beneficiaries;
  • Conditions at an imaging supplier accredited by an AO constituted a significant hazard to the public health; or
  • The AO failed to meet its obligations for application and reapplication procedures.

(4) Reconsideration

We proposed to implement requirements similar to those set out under 42 CFR part 488 without substantive changes, as the requirements have been utilized for the health care providers covered under 42 CFR part 488 since 1992. We proposed that an AO dissatisfied with a determination that its accreditation requirements did not provide or do not continue to provide reasonable assurance that the suppliers accredited by the AO met the applicable standards would be entitled to a reconsideration. We also proposed to reconsider any determination to deny, remove, or not renew the approval of the designating authority to AOs if the AO filed a written request for reconsideration through its authorized officials or through its legal representative.

We proposed to require the AO to file the request for reconsideration within 30 calendar days after the issuance of CMS notice of an adverse determination or non-renewal. We proposed to require the request for reconsideration to specify the findings or issues with which the AO disagreed and the reasons for the disagreement. A requestor could withdraw its request for reconsideration at any time before the issuance of a reconsideration determination. In response to a request for reconsideration, we would provide the accrediting organization the opportunity for an informal hearing that would be conducted by a hearing officer appointed by the CMS Administrator and provide the accrediting organization the opportunity to present, in writing and in person, evidence or documentation to refute the determination to deny approval, or to withdraw or not renew its designating authority.

As proposed, we would provide written notice of the time and place of the informal hearing at least 10 business days before the scheduled date. The informal reconsideration hearing would be open to CMS and the organization requesting the reconsideration, including authorized representatives, technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts), and legal counsel. The hearing would be conducted by the hearing officer, who would receive testimony and documents related to the proposed action. Testimony and other evidence could be accepted by the hearing officer. However, the normal evidentiary exclusions applicable in Federal courts would not apply to these hearings. The hearing officer would not have the authority to compel by subpoena the production of witnesses, papers, or other evidence. Within 45 calendar days of the close of the hearing, the hearing officer would present the findings and recommendations to the accrediting organization that requested the reconsideration. The written report of the hearing officer would include separate numbered findings of fact and the legal conclusions of the hearing officer. The hearing officer's decision would be final.

The following is a summary of the comments we received regarding