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Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements

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Start Preamble Start Printed Page 80170

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule.

SUMMARY:

This major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes changes related to the Medicare Shared Savings Program, requirements for Medicare Advantage Provider Networks, and provides for the release of certain pricing data from Medicare Advantage bids and of data from medical loss ratio reports submitted by Medicare health and drug plans. In addition, this final rule expands the Medicare Diabetes Prevention Program model.

DATES:

These regulations are effective on January 1, 2017.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Jessica Bruton, (410) 786-5991, for issues related to identification of potentially misvalued services and any physician payment issues not identified below.

Gail Addis, (410) 786-4522, for issues related to diabetes self-management training.

Jaime Hermansen, (410) 786-2064, for issues related to moderate sedation coding and anesthesia services.

Roberta Epps, (410) 786-4503, for issues related to PAMA section 218(a) policy and the transition from traditional x-ray imaging to digital radiography.

Ann Marshall, (410) 786-3059, for primary care issues related to chronic care management (CCM), burden reduction, telehealth services and evaluation and management services.

Emily Yoder, (410) 786-1804, for issues related to resource intensive services, telehealth services and other primary care issues.

Lindsey Baldwin, (410) 786-1694, for primary care issues related to behavioral health integration services.

Geri Mondowney, (410) 786-4584, and Donta Henson, (410) 786-1947, for issues related to geographic practice cost indices.

Michael Soracoe, (410) 786-6312, for issues related to the target and phase-in provisions, the practice expense methodology, impacts, conversion factor, and the valuation of pathology and surgical procedures.

Pamela West, (410) 786-2302, for issues related to therapy.

Patrick Sartini, (410) 786-9252, for issues related to malpractice RVUs, radiation treatment, mammography and other imaging services.

Kathy Bryant, (410) 786-3448, for issues related to collecting data on resources used in furnishing global services.

Donta Henson, (410) 786-1947, for issues related to ophthalmology services.

Corinne Axelrod, (410) 786-5620, for issues related to rural health clinics or federally qualified health centers.

Simone Dennis, (410) 786-8409, for issues related to FQHC-specific market basket.

JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, for issues related to appropriate use criteria for advanced diagnostic imaging services.

Robin Usi, (410) 786-0364, for issues related to open payments.

Sean O'Grady, (410) 786-2259, or Julie Uebersax, (410) 786-9284, for issues related to release of pricing data from Medicare Advantage bids and release of medical loss ratio data submitted by Medicare Advantage organizations and Part D sponsors.

Sara Vitolo, (410) 786-5714, for issues related to prohibition on billing qualified Medicare beneficiary individuals for Medicare cost-sharing.

Michelle Peterman, (410) 786-2591, for issues related to Accountable Care Organization (ACO) participants who report PQRS quality measures separately.

Katie Mucklow, (410) 786-0537 or John Spiegel, (410) 786-1909, for issues related to Provider Enrollment Medicare Advantage Program.

Jen Zhu, (410) 786-3725, Carlye Burd, (410) 786-1972, or Nina Brown, (410) 786-6103, for issues related to Medicare Diabetes Prevention Program model expansion.

Rabia Khan or Terri Postma, (410) 786-8084 or ACO@cms.hhs.gov, for issues related to the Medicare Shared Savings Program.

Kimberly Spalding Bush, (410) 786-3232, or Fiona Larbi, (410) 786-7224, for issues related to Value-based Payment Modifier and Physician Feedback Program.

Lisa Ohrin Wilson, (410) 786-8852, or Gabriel Scott, (410) 786-3928, for issues related to physician self-referral updates.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary and Background

A. Executive Summary

B. Background

II. Provisions of the Final Rule for PFS

A. Determination of Practice Expense Relative Value Units (PE RVUs)

B. Determination of Malpractice Relative Value Units (MRVUs)

C. Medicare Telehealth Services

D. Potentially Misvalued Services Under the Physician Fee Schedule

1. Background

2. Progress in Identifying and Reviewing Potentially Misvalued Codes

3. Validating RVUs of Potentially Misvalued Codes

4. CY 2017 Identification and Review of Potentially Misvalued Services

5. Valuing Services That Include Moderate Sedation as an Inherent Part of Furnishing the Procedure

6. Collecting Data on Resources Used in Furnishing Global Services

E. Improving Payment Accuracy for Primary Care, Care Management Services, and Patient-Centered Services

F. Improving Payment Accuracy for Services: Diabetes Self-Management Training (DSMT)

G. Target for Relative Value Adjustments for Misvalued Services

H. Phase-In of Significant RVU Reductions

I. Geographic Practice Cost Indices (GPCIs)

J. Payment Incentive for the Transition From Traditional X-Ray Imaging to Digital Radiography and Other Imaging Services

K. Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap

L. Valuation of Specific Codes

M. Therapy Caps

III. Other Provisions of the Final Rule for PFS

A. Chronic Care Management (CCM) and Transitional Care Management (TCM) Supervision Requirements in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

B. FQHC-Specific Market Basket

C. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

D. Reports of Payments or Other Transfers of Value to Covered Recipients: Summary of Public Comments

E. Release of Part C Medicare Advantage Bid Pricing Data and Part C and Part D Medical Loss Ratio (MLR) DataStart Printed Page 80171

F. Prohibition on Billing Qualified Medicare Beneficiary Individuals for Medicare Cost-Sharing

G. Recoupment or Offset of Payments to Providers Sharing the Same Taxpayer Identification Number

H. Accountable Care Organization (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately

I. Medicare Advantage Provider Enrollment

J. Expansion of the Diabetes Prevention Program (DPP) Model

K. Medicare Shared Savings Program

L. Value-Based Payment Modifier and Physician Feedback Program

M. Physician Self-Referral Updates

N. Designated Health Services

IV. Collection of Information Requirements

V. Regulatory Impact Analysis

Regulations Text

Acronyms

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

A1c Hemoglobin A1c

AAA Abdominal aortic aneurysms

ACO Accountable care organization

AMA American Medical Association

ASC Ambulatory surgical center

ATA American Telehealth Association

ATRA American Taxpayer Relief Act (Pub. L. 112-240)

AWV Annual wellness visit

BBA Balanced 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)

BLS Bureau of Labor Statistics

CAD Coronary artery disease

CAH Critical access hospital

CBSA Core-Based Statistical Area

CCM Chronic care management

CEHRT Certified EHR technology

CF Conversion factor

CG-CAHPS Clinician and Group Consumer Assessment of Healthcare Providers and Systems

CLFS Clinical Laboratory Fee Schedule

CoA Certificate of Accreditation

CoC Certificate of Compliance

CoR Certificate of Registration

CNM Certified nurse-midwife

CP Clinical psychologist

CPC Comprehensive Primary Care

CPEP Clinical Practice Expert Panel

CPT [Physicians] Current Procedural Terminology (CPT codes, descriptions and other data only are copyright 2015 American Medical Association. All rights reserved.)

CQM Clinical quality measure

CSW Clinical social worker

CT Computed tomography

CW Certificate of Waiver

CY Calendar year

DFAR Defense Federal Acquisition Regulations

DHS Designated health services

DM Diabetes mellitus

DSMT Diabetes self-management training

eCQM Electronic clinical quality measures

ED Emergency Department

EHR Electronic health record

E/M Evaluation and management

EMT Emergency Medical Technician

EP Eligible professional

eRx Electronic prescribing

ESRD End-stage renal disease

FAR Federal Acquisition Regulations

FDA Food and Drug Administration

FFS Fee-for-service

FQHC Federally qualified health center

FR Federal Register

FSHCAA Federally Supported Health Centers Assistance Act

GAF Geographic adjustment factor

GAO Government Accountability Office

GPCI Geographic practice cost index

GPO Group purchasing organization

GPRO Group practice reporting option

GTR Genetic Testing Registry

HCPCS Healthcare Common Procedure Coding System

HHS [Department of] Health and Human Services

HOPD Hospital outpatient department

HPSA Health professional shortage area

IDTF Independent diagnostic testing facility

IPPE Initial preventive physical exam

IPPS Inpatient Prospective Payment System

IQR Inpatient Quality Reporting

ISO Insurance service office

IT Information technology

IWPUT Intensity of work per unit of time

LCD Local coverage determination

MA Medicare Advantage

MAC Medicare Administrative Contractor

MACRA Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10)

MAP Measure Applications Partnership

MAPCP Multi-payer Advanced Primary Care Practice

MAV Measure application validity [process]

MCP Monthly capitation payment

MedPAC Medicare Payment Advisory Commission

MEI Medicare Economic Index

MFP Multi-Factor Productivity

MIPPA Medicare Improvements for Patients and Providers Act (Pub. L. 110-275)

MMA Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003)

MP Malpractice

MPPR Multiple procedure payment reduction

MRA Magnetic resonance angiography

MRI Magnetic resonance imaging

MSA Metropolitan Statistical Areas

MSPB Medicare Spending per Beneficiary

MU Meaningful use

NCD National coverage determination

NCQDIS National Coalition of Quality Diagnostic Imaging Services

NP Nurse practitioner

NPI National Provider Identifier

NPP Nonphysician practitioner

NQS National Quality Strategy

OACT CMS's Office of the Actuary

OBRA ’89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)

OBRA ’90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508)

OES Occupational Employment Statistics

OMB Office of Management and Budget

OPPS Outpatient prospective payment system

OT Occupational therapy

PA Physician assistant

PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)

PAMPA Patient Access and Medicare Protection Act (Pub. L. 114-115)

PC Professional component

PCIP Primary Care Incentive Payment

PE Practice expense

PE/HR Practice expense per hour

PEAC Practice Expense Advisory Committee

PECOS Provider Enrollment, Chain, and Ownership System

PFS Physician Fee Schedule

PLI Professional Liability Insurance

PMA Premarket approval

PPM Provider-Performed Microscopy

PQRS Physician Quality Reporting System

PPIS Physician Practice Expense Information Survey

PPS Prospective Payment System

PT Physical therapy

PT Proficiency Testing

PT/INR Prothrombin Time/International Normalized Ratio

PY Performance year

QA Quality Assessment

QC Quality Control

QCDR Qualified clinical data registry

QRUR Quality and Resources Use Report

RBRVS Resource-based relative value scale

RFA Regulatory Flexibility Act

RHC Rural health clinic

RIA Regulatory impact analysis

RUC American Medical Association/Specialty Society Relative (Value) Update Committee

RUCA Rural Urban Commuting Area

RVU Relative value unit

SBA Small Business Administration

SGR Sustainable growth rate

SIM State Innovation Model

SLP Speech-language pathology

SMS Socioeconomic Monitoring System

SNF Skilled nursing facility

TAP Technical Advisory Panel

TC Technical component

TIN Tax identification number

TCM Transitional Care Management

UAF Update adjustment factor

UPIN Unique Physician Identification Number

USPSTF United States Preventive Services Task Force

VBP Value-based purchasing

VM Value-Based Payment Modifier

Addenda Available Only Through the Internet on the CMS Web Site

The PFS Addenda along with other supporting documents and tables referenced in this final rule are available through the Internet on the CMS Web site at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. Click on the link on the left side of the screen titled, Start Printed Page 80172“PFS Federal Regulations Notices” for a chronological list of PFS Federal Register and other related documents. For the CY 2017 PFS Final Rule, refer to item CMS-1654-F. Readers who experience any problems accessing any of the Addenda or other documents referenced in this rule and posted on the CMS Web site identified above should contact Jessica Bruton at (410) 786-5991.

CPT (Current Procedural Terminology) Copyright Notice

Throughout this final rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2015 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary and Background

A. Executive Summary

1. Purpose

This major final rule revises payment polices under the Medicare Physician Fee Schedule (PFS) and makes other policy changes related to Medicare Part B payment. These changes will be applicable to services furnished in CY 2017. In addition, this final rule includes the following provisions: Payment policy changes for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs); expansion of the Medicare Diabetes Prevention Program model; policy changes related to the Medicare Shared Savings Program; and release of pricing data submitted to CMS by Medicare Advantage (MA) organizations; and medical loss ratio reports submitted by MA plans and Part D plans. These additional policies are addressed in section III. of this final rule.

2. Summary of the Major Provisions

The statute requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: Work, practice expense (PE); and malpractice (MP) expense; and, that we establish by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major final rule, we establish RVUs for CY 2017 for the PFS, 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, as well as changes in the statute. In addition, this final rule includes summaries of public comments and final policies regarding:

  • Potentially Misvalued Codes.
  • Telehealth Services.
  • Establishing Values for New, Revised, and Misvalued Codes.
  • Target for Relative Value Adjustments for Misvalued Services.
  • Phase-in of Significant RVU Reductions.
  • Chronic Care Management (CCM) and Transitional Care Management (TCM) Supervision Requirements in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
  • FQHC-Specific Market Basket.
  • Appropriate Use Criteria for Advanced Diagnostic Imaging Services.
  • Reports of Payments or Other Transfers of Value to Covered Recipients: Solicitation of Public Comments.
  • Release of Part C Medicare Advantage Bid Pricing Data and Part C and Part D Medical Loss Ratio (MLR) Data.
  • Prohibition on Billing Qualified Medicare Beneficiary Individuals for Medicare Cost-Sharing.
  • Recoupment or Offset of Payments to Providers Sharing the Same Taxpayer Identification Number.
  • Accountable Care Organization (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately.
  • Medicare Advantage Provider Enrollment.
  • Expansion of the Diabetes Prevention Program (DPP) Model.
  • Medicare Shared Savings Program.
  • Value-Based Payment Modifier and the Physician Feedback Program.
  • Physician Self-referral Updates.
  • Designated Health Services.

3. Summary of Costs and Benefits

The statute requires that annual adjustments to PFS RVUs may not cause annual estimated expenditures to differ by more than $20 million from what they would have been had the adjustments not been made. If adjustments to RVUs would cause expenditures to change by more than $20 million, we must make adjustments to preserve budget neutrality. These adjustments can affect the distribution of Medicare expenditures across specialties. In addition, several changes in this final rule will affect the specialty distribution of Medicare expenditures. When considering the combined impact of work, PE, and MP RVU changes, the projected payment impacts would be small for most specialties; however, the impact would be larger for a few specialties.

We have determined that this major final rule is economically significant. For a detailed discussion of the economic impacts, see section VI. of this final rule.

B. Background

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 PFS relies on national relative values that are established for work, PE, and MP, which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the RVUs into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). The final rule published on November 25, 1991 (56 FR 59502) set forth the first fee schedule used for payment for physicians' services.

We note that throughout this major final rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for services furnished to Medicare beneficiaries.

1. Development of the Relative Values

a. Work RVUs

The work RVUs established for the initial fee schedule, which was implemented on January 1, 1992, were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining 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.

As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion Start Printed Page 80173of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalk to key reference or similar codes, and magnitude estimation. More information on these issues is available in that rule.

b. Practice Expense RVUs

Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, 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 physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services.

Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA) delayed 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 the charge-based PE RVUs to the resource-based PE RVUs.

We established the resource-based PE RVUs for each physicians' service in a final rule, published on November 2, 1998 (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 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. (These data sources are described in greater detail in the CY 2012 final rule with comment period (76 FR 73033).

Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office. The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incurred by the facility. Thus, payment associated with those facility resources is not made under the PFS.

Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) 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 CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.

c. Malpractice RVUs

Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' malpractice insurance premium data from all the states, the District of Columbia, and Puerto Rico. For more information on MP RVUs, see section II.B.2. of this final rule.

d. Refinements to the RVUs

Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently. We completed five-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012.

Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.

In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.

In addition to the five-year reviews, beginning for CY 2009, CMS and the RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, that require the agency to periodically Start Printed Page 80174identify, review and adjust values for potentially misvalued codes.

e. Application of Budget Neutrality to Adjustments of RVUs

As described in section VI.C. of this final rule, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures did not increase or decrease by more than $20 million.

2. Calculation of Payments Based on RVUs

To calculate the payment for each service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services. The GPCIs reflect the relative costs of work, PE, and MP 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 based on a statutory formula by CMS's 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 MP × GPCI MP)] × CF.

3. Separate Fee Schedule Methodology for Anesthesia Services

Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia conversion factor, in a manner to ensure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate conversion factor for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality.

4. Most Recent Changes to the Fee Schedule

Section 220(d) of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) (PAMA) added a new subparagraph (O) to section 1848(c)(2) of the Act to establish an annual target for reductions in PFS expenditures resulting from adjustments to relative values of misvalued codes. If the estimated net reduction in expenditures for a year is equal to or greater than the target for that year, the provision specifies that reduced expenditures attributable to such adjustments shall be redistributed in a budget-neutral manner within the PFS. The provision specifies that the amount by which such reduced expenditures exceed the target for a given year shall be treated as a reduction in expenditures for the subsequent year for purposes of determining whether the target for the subsequent year has been met. The provision also specifies that an amount equal to the difference between the target and the estimated net reduction in expenditures, called the target recapture amount, shall not be taken into account when applying the budget neutrality requirements specified in section 1848(c)(2)(B)(ii)(II) of the Act. The PAMA amendments originally made the target provisions applicable for CYs 2017 through 2020 and set the target for reduced expenditures at 0.5 percent of estimated expenditures under the PFS for each of those 4 years.

Subsequently, section 202 of the Achieving a Better Life Experience Act of 2014 (Division B of Pub. L. 113-295, enacted December 19, 2014) (ABLE) accelerated the application of the target, amending section 1848(c)(2)(O) of the Act to specify that target provisions apply for CYs 2016, 2017, and 2018; and setting a 1 percent target for reduced expenditures for CY 2016 and a 0.5 percent target for CYs 2017 and 2018. The implementation of the target legislation was finalized in the CY 2016 PFS final rule with comment period, and revisions are discussed in section II.G. of this final rule.

Section 1848(c)(7) of the Act, as added by section 220(e) of the PAMA, specified that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased in over a 2-year period. Section 220(e) of the PAMA required the phase-in of RVU reductions of 20 percent or more to begin for 2017. Section 1848(c)(7) of the Act was later amended by section 202 of the ABLE Act to require instead that the phase-in must begin in CY 2016. The implementation of the phase-in legislation was finalized in the CY 2016 PFS final rule with comment period and revisions in this year's rulemaking are discussed in section II.H. of this final rule.

II. Provisions of the Final Rule for PFS

A. Determination of Practice Expense (PE) Relative Value Units (RVUs)

1. Overview

Practice expense (PE) is the portion of the resources used in furnishing a 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. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.

2. Practice Expense Methodology

a. Direct Practice Expense

We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that 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 generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to 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).Start Printed Page 80175

b. Indirect Practice Expense per Hour Data

We use survey data on indirect PEs incurred per hour worked in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (NPPs) paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS 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. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.

When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.

Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.

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

Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data.

We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.

Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in the PPIS. However, beginning in CY 2010, we changed the PE/HR crosswalk for portable X-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more similar to each other for work time.

For registered dietician services, the resource-based PE RVUs have been calculated in accordance with the final policy that crosswalks the specialty to the “All Physicians” PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and discussed in more detail in the CY 2011 PFS final rule with comment period (75 FR 73183). We have incorporated the available utilization data for interventional cardiology, which became a recognized Medicare specialty during 2014. We finalized the use of a proxy PE/HR value for interventional cardiology in the CY 2016 final rule with comment period (80 FR 70892), as there are no PPIS data for this specialty, by crosswalking the PE/HR from Cardiology, since the specialties furnish similar services in the Medicare claims data.

Comment: A commenter questioned the validity of the PPIS survey data since it is nearly 10 years old. Several other commenters stated that CMS' estimated per-minute labor cost inputs are lower than actual labor costs.

Response: We have previously identified several concerns regarding the underlying data used in determining PE RVUs in the CY 2014 PFS final rule (78 FR 74246-74247). Even when we first incorporated the survey data into the PE methodology, many in the community expressed serious concerns over the accuracy of this or other PE surveys as a way of gathering data on PE inputs from the diversity of providers paid under the PFS. However, we currently lack another source of comprehensive data regarding PE costs, and as a result, we continue to believe that the PPIS survey data is the best data currently available. We continue to seek the best broad-based, auditable, routinely-updated source of information regarding PE costs.

c. Allocation of PE to Services

To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.

(1) Direct Costs

The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.

(2) Indirect Costs

Section II.A.2.b. of this final rule describes the current data sources for specialty-specific indirect costs used in our PE calculations. We allocated 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 work RVUs. We also incorporated the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows:

  • For a given service, we used the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is Start Printed Page 80176calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represented 25 percent of total costs for the specialties that furnished the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
  • Next, we added the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
  • Next, we incorporated the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.

(3) Facility and Nonfacility Costs

For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs: Facility, and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.

(4) 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). The PC and TC may be furnished independently or by different providers, or they may be furnished together as a “global” service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)

(5) PE RVU Methodology

For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct interested readers to the file called “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our Web site under downloads for the CY 2017 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. This file contains a table that illustrates the calculation of PE RVUs as described below for individual codes.

(a) 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/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys.

(b) 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.

Step 2: Calculate the aggregate pool of direct PE costs for the current year. We set the aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to current aggregate work RVUs and the proposed aggregate work RVUs.

Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregate direct costs for all services from Step 1 and the utilization data for that service.

Step 4: Using the results of Step 2 and Step 3, use the conversion factor to calculate a direct PE scaling factor to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling factor to the direct costs for each service (as calculated in Step 1).

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 CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs, as long as the same CF is used in Step 4 and Step 5. Different CFs will result in different direct PE scaling factors, but this has no effect on the final direct cost PE RVUs since changes in the CFs and changes in the associated direct scaling factors offset one another.

(c) Create the Indirect Cost PE RVUs

Create indirect allocators.

Step 6: Based on the survey data, calculate direct and indirect PE percentages for each physician specialty.

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, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service.

We use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. As we stated in the CY 2016 final rule with comment period (80 FR 70894), we believe that the 3-year average will mitigate the need to use dominant or expected specialty instead of the claims data. Because we incorporated CY 2015 claims data for use in the CY 2017 proposed rates, we believe that the finalized PE RVUs associated with the CY 2017 PFS final rule provide a first opportunity to determine whether service-level overrides of claims data are necessary. Currently, in the development of PE RVUs we apply only the overrides that also apply to the MP RVU calculation. Since the proposed PE RVUs include a new year of claims into the 3-year average for the first time, we solicited comment on the proposed CY 2017 PFS rates and whether or not the incorporation of a new year of utilization data into a 3-year average mitigates the need for alternative service-level overrides such as a claims-based approach (dominant specialty) or stakeholder-recommended approach Start Printed Page 80177(expected specialty) in the development of PE (and MP) RVUs for low-volume codes. Prior year RVUs are available at several locations on the PFS Web site located at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​.

Comment: Several commenters contended that even a multi-year average of claims data to determine the mix of specialties that furnish the services creates distortions and wide variability for low volume services, particularly those services with fewer than 100 annual Medicare claims. Commenters stated that low volume codes that use a specialty override appear to have stable PE and MP RVUs, while other low volume codes without overrides continue to shift from year to year. Given these fluctuations, commenters suggested that CMS implement service-level overrides to determine the specialty mix for these low volume procedures. These commenters provided a list of nearly 2000 codes and suggested specialty overrides.

Response: We appreciate commenters' interest in relatively stable PE and MP RVUs and for continuing to highlight the challenges faced when determining the specialty allocation for low volume services. Since we did not make a proposal regarding specialty overrides for low volume services, we do not believe that it would be appropriate to establish overrides for several thousand codes at this time. However, given the continued concerns, we will consider the issue, including these specific recommendations, for future rulemaking.

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 RVUs; the clinical labor PE RVUs; and the work RVUs.

For most services the indirect allocator is: Indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.

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 PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs.
  • If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: Indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.

(Note: For global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVUs and the clinical labor PE RVUs. 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 download file called “Calculation of PE RVUs under Methodology for Selected Codes”, 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 RVUs/direct percentage).
  • The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).

Apply a scaling adjustment to the indirect allocators.

Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 8 by the average indirect PE percentage from the survey data.

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.

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.

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 work time for the service, and the specialty's utilization for the service across all services furnished by the specialty.

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

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 service, 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 service.)

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 RVUs.

(d) Calculate the Final PE RVUs

Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the sum of steps 5 and 17 of to the proposed aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS account for the fact that certain specialties are excluded from the calculation of PE RVUs but included in maintaining overall PFS budget neutrality. (See “Specialties excluded from ratesetting calculation” later in this section.)

(e) Setup File Information

  • Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain NPPs paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1.

Table 1—Specialties Excluded From Ratesetting Calculation

Specialty codeSpecialty description
49Ambulatory surgical center.
50Nurse practitioner.
51Medical supply company with certified orthotist.
52Medical supply company with certified prosthetist.
53Medical supply company with certified prosthetist-orthotist.
54Medical supply company not included in 51, 52, or 53.
55Individual certified orthotist.
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56Individual certified prosthetist.
57Individual certified prosthetist-orthotist.
58Medical supply company with registered pharmacist.
59Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc.
60Public health or welfare agencies.
61Voluntary health or charitable agencies.
73Mass immunization roster biller.
74Radiation therapy centers.
87All other suppliers (e.g., drug and department stores).
88Unknown supplier/provider specialty.
89Certified clinical nurse specialist.
96Optician.
97Physician assistant.
A0Hospital.
A1SNF.
A2Intermediate care nursing facility.
A3Nursing facility, other.
A4HHA.
A5Pharmacy.
A6Medical supply company with respiratory therapist.
A7Department store.
B2Pedorthic personnel.
B3Medical supply company with pedorthic personnel.
  • 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 RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
  • Payment modifiers: Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. 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. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 2 details the manner in which the modifiers are applied.

Table 2—Application of Payment Modifiers to Utilization Files

ModifierDescriptionVolume adjustmentTime adjustment
80, 81, 82Assistant at Surgery16%Intraoperative portion.
ASAssistant at Surgery—Physician Assistant14% (85% * 16%)Intraoperative portion.
50 or LT and RTBilateral Surgery150%150% of work time.
51Multiple Procedure50%Intraoperative portion.
52Reduced Services50%50%.
53Discontinued Procedure50%50%.
54Intraoperative Care onlyPreoperative + Intraoperative Percentages on the payment files used by Medicare contractors to process Medicare claimsPreoperative + Intraoperative portion.
55Postoperative Care onlyPostoperative Percentage on the payment files used by Medicare contractors to process Medicare claimsPostoperative portion.
62Co-surgeons62.5%50%.
66Team Surgeons33%33%.

We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.

For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.

  • Work RVUs: The setup file contains the work RVUs from this final rule.

(6) Equipment Cost Per Minute

The equipment cost per minute is calculated as:

Start Printed Page 80179

(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); generally 150,000 minutes.

usage = variable, see discussion below.

price = price of the particular piece of equipment.

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

maintenance = factor for maintenance; 0.05.

interest rate = variable, see discussion below.

Usage: We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act.

Stakeholders have often suggested that particular equipment items are used less frequently than 50 percent of the time in the typical setting and that CMS should reduce the equipment utilization rate based on these recommendations. We appreciate and share stakeholders' interest in using the most accurate assumption regarding the equipment utilization rate for particular equipment items. However, we believe that absent robust, objective, auditable data regarding the use of particular items, the 50 percent assumption is the most appropriate within the relative value system. We welcome the submission of data that illustrates an alternative rate.

Maintenance: This factor for maintenance was finalized in the CY 1998 PFS final rule (62 FR 33164).

We continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items.

Comment: One commenter stated that the cost of maintaining imaging equipment exceeds the cost of general medical equipment, and that for imaging modalities the median maintenance cost is approximately 10 percent of the equipment purchase price. The commenter stated that the current 5 percent equipment maintenance rate continues to be an inadequate and outdated reflection of actual maintenance costs. The commenter also stated that information on maintenance costs is readily available to CMS through both public and private sources. The commenter did not identify these sources.

Response: As we previously stated in the CY 2016 final rule with comment period (80 FR 70897), we agree with the commenter that we do not believe the annual maintenance factor for all equipment is exactly 5 percent, and we concur that the current rate likely understates the true cost of maintaining some equipment. We also believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding sources of data containing equipment maintenance rates, commenters were unable to identify an auditable, robust data source that could be used by CMS on a wide scale. As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining maintenance factor, we do not believe that we have sufficient information at present to adopt a variable maintenance factor for equipment cost per minute pricing. We continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items.

Interest Rate: In the CY 2013 PFS final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation. The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life). The interest rates are listed in Table 3. (See 77 FR 68902 for a thorough discussion of this issue.) We did not propose any changes to these interest rates for CY 2017.

Table 3—SBA Maximum Interest Rates

PriceUseful lifeInterest rate (%)
<$25K<7 Years7.50
$25K to $50K<7 Years6.50
>$50K<7 Years5.50
<$25K7+ Years8.00
$25K to $50K7+ Years7.00
>$50K7+ Years6.00

d. Changes to Direct PE Inputs for Specific Services

This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2017 direct PE input database, which is available on our Web site under downloads for the CY 2017 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

(1) PE Inputs for Digital Imaging Services

Prior to the CY 2015 PFS rulemaking cycle, the RUC provided a recommendation regarding the PE inputs for digital imaging services. Specifically, the RUC recommended that we remove supply and equipment items associated with film technology from a previously specified list of codes since these items were no longer typical resource inputs. The RUC also recommended that the Picture Archiving and Communication System (PACS) equipment be included for these imaging services since these items are typically used in furnishing imaging services. However, since we did not receive any invoices for the PACS system prior to that year's proposed rule, we were unable to determine the appropriate pricing to use for the inputs. For CY 2015, we finalized our proposal to remove the film supply and equipment items, and to create a new equipment item as a proxy for the PACS workstation as a direct expense (79 FR 67561-67563). We used the price associated with ED021 (computer, desktop, w-monitor) to price the new item, ED050 (PACS Workstation Proxy), pending receipt of invoices to facilitate pricing specific to the PACS workstation. Subsequent to establishing payment rates for CY 2015, we received information from several stakeholders regarding pricing for items related to the digital acquisition and storage of images. We received invoices from one stakeholder that facilitated a proposed price update for the PACS workstation in the CY 2016 PFS proposed rule, and we updated the price for the PACS workstation to $5,557 in the CY 2016 PFS final rule with comment period (80 FR 70899).

In addition to the workstation used by the clinical staff for acquiring the images and furnishing the technical component (TC) of the services, a stakeholder also submitted more detailed information regarding a workstation used by the practitioner interpreting the image in furnishing the professional component (PC) of many of these services.

As we stated in the CY 2015 PFS final rule with comment period (79 FR 67563), we generally believe that workstations used by these practitioners are more accurately considered indirect costs associated with the PC of the service. However, we understand that the professional workstations for interpretation of digital images are similar in principle to some of the previous film inputs incorporated into the global and technical components of the codes, such as the view box equipment. Given that the majority of these services are reported globally in the nonfacility setting, we believe it is appropriate to include these costs as direct inputs for the associated HCPCS codes. Based on our established Start Printed Page 80180methodology in which single codes with professional and technical components are constructed by assigning work RVUs exclusively to the professional component and direct PE inputs exclusively to the technical components, these costs would be incorporated into the PE RVUs of the global and technical component of the HCPCS code.

We stated in the CY 2016 PFS final rule with comment period that the costs of the professional workstation may be analogous to costs related to the use of film previously incorporated as direct PE inputs for these services. We also solicited comments on whether including the professional workstation as a direct PE input for these codes would be appropriate, given that the resulting PE RVUs would be assigned to the global and technical components of the codes. Commenters responded by indicating their approval of the concept of a professional PACS workstation used for interpretation of digital images. We received invoices for the pricing of a professional PACS workstation, as well as additional invoices for the pricing of a mammography-specific version of the professional PACS workstation. The RUC also included these new equipment items in its recommendations for the CY 2017 PFS rulemaking cycle.

Based on our analysis of submitted invoices, we proposed to price the professional PACS workstation (ED053) at $14,616.93. We did not propose a change in price for the current technical PACS workstation (ED050), which will remain at a price of $5,557.00.

The price of the professional PACS workstation is based upon individual invoices submitted for the cost of a PC Tower ($1531.52), a pair of 3 MP monitors ($10,500.00 in total), a keyboard and mouse ($84.95), a UPS power backup devices for TNP ($1098.00), and a switch for PACS monitors/workstations ($1402.46).

We proposed to add the professional PACS workstation to many CPT codes in the 70000 series that use the current technical PACS workstation (ED050) and include professional work for which such a workstation would be used. We did not propose to add the equipment item to add-on codes since the base codes would include minutes for the item. We also did not propose to add the item to codes that are therapeutic in nature, as the professional PACS workstation is intended for use in diagnostic services. We therefore did not propose to add the item to codes in the Radiation Therapy section (77261 through 77799) or the Nuclear Medicine Cardiology section (78414-78499). We also did not propose to add the item to image guidance codes where the dominant provider is not a radiologist (77002, 77011, 77071, 77077, and 77081) according to the most recent year of claims data, since we believe a single workstation would be more typical in those cases. We identified approximately 426 codes to which we proposed to add a professional PACS workstation. Please see Table 4 for the full list of affected codes.

For the professional PACS workstation, we proposed to assign equipment time equal to the intraservice work time plus half of the preservice work time associated with the codes, since the work time generally reflects the time associated with the professional interpretation. We proposed half of the preservice work time for the professional PACS workstation because we do not believe that the practitioner would typically spend all of the preservice work period using the equipment. For older codes that do not have a breakdown of physician work time by service period, and only have an overall physician work time, we proposed to use half the total work time as an approximation of the intraservice work time plus one half of the preservice work time. In our review of services that contained an existing PACS workstation and had a breakdown of physician work time, we found that half of the total time was a reasonable approximation for the value of intraservice work time plus one half of preservice work time where no such breakdown existed. We also considered using an equipment time formula of the physician intraservice time plus 1 minute (as a stand-in for the physician preservice work time). We solicited public comment on the most accurate equipment time formula for the professional PACS workstation.

We solicited public comment on the proposed list of codes that would incorporate the professional PACS workstation. We were interested in public comment on the codes for which a professional PACS workstation should be included, and whether one of these professional workstations should be included for codes outside the 70000 series. In cases within the 70000 series where radiologists are not the typical specialty reporting the code, such as CPT codes 77002 and 77011, we asked whether it would be appropriate to add one of the professional PACS workstations to these services.

The following is a summary of the comments we received on the proposed addition of the professional PACS workstation, the pricing of the workstation, the list of codes that would incorporate the professional PACS workstation, and the equipment minutes to assign to the workstation.

Comment: Commenters supported the general concept of the professional PACS workstation and its addition to the proposed list of codes. Commenters stated that the professional PACS workstation is an essential component of diagnostic imaging procedures due to the switch from film to digital technology, and the professional workstation would be an appropriate inclusion as a direct PE input for these services.

Response: We appreciate the support from the commenters for the addition of the professional PACS workstation.

Comment: Many commenters addressed the subject of the proper pricing of the professional PACS workstation. Several commenters requested that CMS increase the price of the workstation to include a third and fourth monitor (for speech recognition) priced at $1,715.98, an Admin Monitor (the extra working monitor) priced at $279.27, and a Powerscribe Microphone priced at $424.00. Commenters stated that speech recognition equipment is typical for a professional PACS workstation, and that physicians typically employed a monitor with greater resolution than what would be typically used for other purposes (such as for electronic health records). Related comments contended that the proposed pricing of the workstation remained significantly less than what the average imaging facility spends on PACS technology. Other commenters disagreed with these sentiments and supported the pricing of the professional PACS workstation at the proposed rate of $14,616.93.

Response: We appreciate the feedback from the commenters regarding the proper pricing of the professional PACS workstation. When proposing a price for the professional PACS workstation, we did not include the cost of the additional monitors and the Powerscribe microphone because these items represent indirect costs under the established PE methodology and the functionality would unlikely have been included in the previously existing film inputs the professional PACS workstation is replacing. Generally, we believe that monitors used to access electronic health records and microphones used for dictation are often used by practitioners who furnish a range a PFS services, are not allocable to particular services or patients, and therefore, are included in the administrative cost category of practice expense, and therefore, are allocated to Start Printed Page 80181individual codes through indirect PE RVUs.

Comment: Many commenters stated that CMS should expand the list of codes with a professional PACS workstation. Commenters generally focused on three of the criteria proposed by CMS: The exclusion of the workstation from add-on services, the exclusion of therapeutic (as opposed to diagnostic) services, and the exclusion of codes outside the 70000 series. Commenters stated that add-on codes should be incorporated into the professional PACS workstation list, as they require additional time to perform, and therefore, more time with the technical PACS workstation for the technician, as well as additional time for the review and interpretation performed by the physician using the professional PACS workstation. Commenters also indicated that many therapeutic services would also require a professional PACS workstation, and disagreed with limiting the workstation to diagnostic services only. Finally, commenters supplied extensive lists of additional codes, both inside and outside of the 70000 series, where they stated that the inclusion of a professional PACS workstation was warranted.

Response: We appreciate the feedback from the commenters in helping to define the criteria for inclusion of the professional PACS workstation, along with more specific recommendations about which codes should include the workstation. After considering these comments, we will be adding the professional PACS workstation to additional suggested codes. We took the following into account in making these additions:

  • We did not add the professional PACS workstation to any code that currently lacks a technical PACS workstation (ED050) or lacks a work RVU. We continue to believe that procedures which do not include a technical workstation, or do not have physician work, would not require a professional workstation.
  • We did not add the professional PACS workstation to add-on codes. Because the base codes include equipment minutes for the workstation, we continue to believe it would be duplicative to add additional equipment time for the professional PACS workstation in the add-on code.
  • We agree with commenters that because the clinical utility of the PACS workstation is not necessarily limited to diagnostic services, there may be therapeutic codes where it would be reasonable to assume its use to be typical. We believe that in these specific cases, the use of the professional PACS workstation has been established to be typical for the code in question by the specialties furnishing the service, as a result of the evidence provided in the comments submitted in response to our proposal. We have added the workstation to many of the therapeutic codes requested by commenters, specifically codes listed outside the 70000 series, where use of the professional PACS station is typical.
  • Within the 70000 series, we reviewed each of the codes submitted by commenters. Most of these codes did not fall within one of the categories where we proposed to add the professional PACS workstation in the proposed rule: They lacked a technical PACS workstation, they were add-on codes, or they were diagnostic procedures for which radiology is not the dominant specialty providing the service. We continue to believe that the professional PACS workstation should not be added to codes that do not fall into these categories, since we believe that the image must be captured in order to for it to be interpreted, that the use of the PACS workstation in the base code reported with add-on codes would accurately capture the associated resources used, and that the PACS professional workstation is only typically used by radiologists. Based on comments, we are adding the professional workstation to only one code in the 70000 series, CPT code 73562, as it includes a technical PACS workstation, is not an add-on code, and is typically furnished by radiologists.
  • For codes in the 80000 and 90000 series, we are concerned about whether it is appropriate to include the technical PACS workstation into many of these services. PACS workstations were created for imaging purposes, but many of these services that include a technical PACS workstation do not appear to make use of imaging. Although we are not removing the technical PACS workstation from these codes at this time, we do not believe that a professional PACS workstation should be added to these procedures. We will consider the inclusion of both PACS workstations for future rulemaking.

Comment: Several commenters addressed the topic of equipment time for the professional PACS workstation. Commenters requested that CMS allocate the entire preservice physician work time associated with the codes, as opposed to the proposed half of the preservice physician work time. Commenters stated that although certain physician work activities in the preservice period may not directly involve the professional workstation, even when the physician is engaged in these parallel work activities, the professional workstation is “open” to the patient at hand and cannot be used for other patients. Commenters also disagreed with the proposal to use half the total time for older codes in which there is no separation of preservice and intraservice period times. Commenters stated that using the entire physician work time would be the best option since there is no accurate way to estimate the service period times, and that it would avoid potential confusion in equipment formulas in the future.

Response: We continue to believe that the professional PACS workstation is more accurately assigned equipment time by using half of the preservice physician work time rather than the full preservice physician work time. As we stated in the proposed rule, we do not believe that the practitioner would typically spend all of the preservice work period using the equipment. Commenters agreed that the physician may not need the professional workstation for the full preservice period, but contended that the equipment would be “open” and unavailable for use by other physicians or for other patients. We disagree with this argument on clinical practice and methodological grounds. We do not agree that the professional PACS workstation would necessarily be unavailable for use by other physicians when the physician in question is not using the machine, Additionally, we note that the number of minutes assigned to the predecessor film inputs did not generally include the full number of pre-service minutes. Finally, our PE methodology is based on the resources typically used to furnish the procedure, and we typically assign time for equipment items based on when it cannot be used by another practitioner or for another patient due to its use in the given procedure. We continue to believe that half of the preservice physician work time (along with the full physician intraservice work time) is a good approximation of the time in the preservice period that the professional PACS workstation will typically be in use. As we stated in the proposed rule, we do not believe that the practitioner would typically spend all of the preservice time using the equipment, and would also spend preservice time on other activities, such as scrubbing and dressing, for example.

For older codes where there is no breakdown of work time values by service period, we do not agree with commenters that the professional PACS workstation should use the total work time. The comments do not provide a Start Printed Page 80182persuasive rationale for using the total work time instead of our proposed alternative, developed for consistency with codes for which we do have work time breakdowns by service period. Therefore, in the absence of service period work time detail, we continue to believe that half of the total work time is a reasonable proxy for the small number of old codes affected by this issue. We are not concerned about the potential for confusion in the future with differing equipment time formulas, as the addition of the professional PACS workstation to these codes is a one-time inclusion that will not affect the future review of this equipment.

Finally, we believe that there is a difference in the pattern of equipment usage for the professional PACS workstation between diagnostic and therapeutic codes. Generally, the intraservice work for diagnostic imaging codes describes the review of images, while the intraservice work for therapeutic services describes a broader range of activities. Therefore, although we used an equipment formula of half the preservice physician work time and the full intraservice physician work time for the diagnostic procedures, we do not believe that this same time formula would be appropriate for therapeutic procedures since the professional PACS workstation would not be in use during the intraservice portion of these services. Therefore, we will use an equipment time formula of half the preservice physician work time and half the postservice physician work time for the therapeutic codes to which we are adding a professional PACS workstation, which we believe is more consistent with the descriptions of work for the codes in question. Consistent with our ongoing efforts to improve payment accuracy for these costs, we seek recommendations from the RUC and other stakeholders on a more precise allocation methodology for equipment minutes for these procedures.

After consideration of comments received, we are finalizing our proposal to add a professional PACS workstation (ED053) to the equipment database and price it at the proposed rate of $14,616.93. We are dividing the codes that will contain a professional PACS workstation into diagnostic and therapeutic categories. For diagnostic codes, we are assigning equipment minutes equal to half the preservice physician work time and the full intraservice physician work time. For the relatively smaller group of diagnostic codes with no service period time breakdown, we are assigning equipment time equal to half of the total physician work time. For therapeutic codes, we are assigning equipment minutes equal to half the preservice physician work time and half the postservice physician work time for the second group. There are no therapeutic codes on our current list which lack a service period time breakdown. The following table lists all of the codes that include a professional PACS workstation for CY 2017, along with the equipment minutes for the workstation.

Table 4—Codes With Professional PACS Workstation in the Direct PE Input Database

HCPCSProcedure typeED053 Minutes
10030Therapeutic23
10035Therapeutic15
19081Therapeutic19
19083Therapeutic17
19085Therapeutic19
19281Therapeutic18
19283Therapeutic19
19285Therapeutic18
19287Therapeutic19
22510Therapeutic32
22511Therapeutic32
22513Therapeutic32
22514Therapeutic32
32555Therapeutic19
32557Therapeutic19
36221Therapeutic34
36222Therapeutic34
36223Therapeutic34
36224Therapeutic34
36225Therapeutic34
36226Therapeutic34
36251Therapeutic31
36252Therapeutic31
36253Therapeutic31
36254Therapeutic31
36598Therapeutic13
37184Therapeutic30
37187Therapeutic25
37188Therapeutic23
37191Therapeutic22
37192Therapeutic23
37193Therapeutic23
37197Therapeutic26
37220Therapeutic34
37221Therapeutic34
37224Therapeutic34
37225Therapeutic34
37226Therapeutic34
37227Therapeutic34
37228Therapeutic34
37229Therapeutic34
37230Therapeutic34
37231Therapeutic34
37236Therapeutic31
37238Therapeutic31
37241Therapeutic26
37242Therapeutic31
37243Therapeutic38
37244Therapeutic38
47531Therapeutic20
47532Therapeutic22
47533Therapeutic26
47534Therapeutic26
47535Therapeutic19
47536Therapeutic16
47537Therapeutic19
47538Therapeutic22
47539Therapeutic26
47540Therapeutic26
47541Therapeutic26
49083Therapeutic18
49405Therapeutic28
49406Therapeutic28
49407Therapeutic28
49418Therapeutic27
49440Therapeutic29
49441Therapeutic29
49442Therapeutic29
49446Therapeutic22
49450Therapeutic20
49451Therapeutic20
49452Therapeutic20
49460Therapeutic20
49465Therapeutic13
50382Therapeutic28
50384Therapeutic24
50385Therapeutic27
50386Therapeutic25
50387Therapeutic22
50389Therapeutic15
50430Therapeutic23
50431Therapeutic20
50432Therapeutic25
50433Therapeutic25
50434Therapeutic23
50435Therapeutic18
50693Therapeutic25
50694Therapeutic25
50695Therapeutic25
58340Therapeutic7
62302Therapeutic17
62303Therapeutic17
62304Therapeutic17
62305Therapeutic18
70015Diagnostic12
70030Diagnostic3
70100Diagnostic3
70110Diagnostic4
70120Diagnostic3
70130Diagnostic4
70134Diagnostic4
70140Diagnostic3
70150Diagnostic4
70160Diagnostic3
70190Diagnostic3
70200Diagnostic4
70210Diagnostic3
70220Diagnostic4
70240Diagnostic3
70250Diagnostic4
70260Diagnostic7
70300Diagnostic2
70310Diagnostic3
70320Diagnostic3
70328Diagnostic3
70330Diagnostic22
70332Diagnostic6
70336Diagnostic20
70350Diagnostic3
70355Diagnostic5
70360Diagnostic3
70370Diagnostic4
70371Diagnostic9
Start Printed Page 80183
70380Diagnostic3
70390Diagnostic5
70450Diagnostic12
70460Diagnostic15
70470Diagnostic18
70480Diagnostic13
70481Diagnostic13
70482Diagnostic14
70490Diagnostic13
70491Diagnostic13
70492Diagnostic14
70540Diagnostic14
70542Diagnostic19
70543Diagnostic19
70544Diagnostic13
70545Diagnostic18
70546Diagnostic18
70547Diagnostic13
70548Diagnostic20
70549Diagnostic25
70551Diagnostic21
70552Diagnostic23
70553Diagnostic28
70554Diagnostic43
71010Diagnostic4
71015Diagnostic3
71020Diagnostic4
71021Diagnostic4
71022Diagnostic4
71023Diagnostic5
71030Diagnostic4
71034Diagnostic5
71035Diagnostic3
71100Diagnostic5
71101Diagnostic4
71110Diagnostic4
71111Diagnostic5
71120Diagnostic3
71130Diagnostic3
71250Diagnostic18
71260Diagnostic17
71270Diagnostic13
71275Diagnostic28
71550Diagnostic15
71551Diagnostic30
71552Diagnostic28
71555Diagnostic33
72020Diagnostic3
72040Diagnostic4
72050Diagnostic6
72052Diagnostic6
72070Diagnostic4
72072Diagnostic3
72074Diagnostic3
72080Diagnostic3
72081Diagnostic6
72082Diagnostic7
72083Diagnostic8
72084Diagnostic9
72100Diagnostic4
72110Diagnostic6
72114Diagnostic6
72120Diagnostic4
72125Diagnostic18
72126Diagnostic12
72127Diagnostic12
72128Diagnostic18
72129Diagnostic12
72130Diagnostic12
72131Diagnostic18
72132Diagnostic12
72133Diagnostic12
72141Diagnostic23
72142Diagnostic26
72146Diagnostic23
72147Diagnostic26
72148Diagnostic23
72149Diagnostic26
72156Diagnostic28
72157Diagnostic28
72158Diagnostic28
72159Diagnostic31
72170Diagnostic5
72190Diagnostic3
72191Diagnostic28
72192Diagnostic12
72193Diagnostic12
72194Diagnostic12
72195Diagnostic30
72196Diagnostic26
72197Diagnostic30
72198Diagnostic28
72200Diagnostic3
72202Diagnostic3
72220Diagnostic3
72240Diagnostic19
72255Diagnostic18
72265Diagnostic18
72270Diagnostic23
72275Diagnostic36
72285Diagnostic9
72295Diagnostic9
73000Diagnostic3
73010Diagnostic3
73020Diagnostic3
73030Diagnostic5
73040Diagnostic6
73050Diagnostic3
73060Diagnostic4
73070Diagnostic3
73080Diagnostic4
73085Diagnostic6
73090Diagnostic3
73092Diagnostic3
73100Diagnostic4
73110Diagnostic4
73115Diagnostic6
73120Diagnostic4
73130Diagnostic4
73140Diagnostic3
73200Diagnostic18
73201Diagnostic11
73202Diagnostic12
73206Diagnostic35
73218Diagnostic25
73219Diagnostic25
73220Diagnostic30
73221Diagnostic23
73222Diagnostic23
73223Diagnostic35
73225Diagnostic31
73501Diagnostic4
73502Diagnostic5
73503Diagnostic6
73521Diagnostic5
73522Diagnostic6
73523Diagnostic7
73525Diagnostic6
73551Diagnostic4
73552Diagnostic5
73560Diagnostic4
73562Diagnostic5
73564Diagnostic6
73565Diagnostic4
73580Diagnostic6
73590Diagnostic4
73592Diagnostic3
73600Diagnostic4
73610Diagnostic4
73615Diagnostic6
73620Diagnostic4
73630Diagnostic4
73650Diagnostic3
73660Diagnostic3
73700Diagnostic18
73701Diagnostic11
73702Diagnostic12
73706Diagnostic35
73718Diagnostic20
73719Diagnostic25
73720Diagnostic30
73721Diagnostic23
73722Diagnostic24
73723Diagnostic32
73725Diagnostic33
74000Diagnostic4
74010Diagnostic3
74020Diagnostic4
74022Diagnostic4
74150Diagnostic14
74160Diagnostic17
74170Diagnostic21
74174Diagnostic33
74175Diagnostic28
74176Diagnostic25
74177Diagnostic28
74178Diagnostic33
74181Diagnostic15
74182Diagnostic28
74183Diagnostic35
74185Diagnostic33
74210Diagnostic5
74220Diagnostic5
74230Diagnostic12
74240Diagnostic7
74241Diagnostic7
74245Diagnostic9
74246Diagnostic7
74247Diagnostic18
74249Diagnostic9
74250Diagnostic5
74251Diagnostic33
74260Diagnostic6
74261Diagnostic43
74262Diagnostic48
74263Diagnostic42
74270Diagnostic7
74280Diagnostic23
74283Diagnostic19
74290Diagnostic4
74400Diagnostic18
74410Diagnostic6
74415Diagnostic6
74430Diagnostic4
74440Diagnostic5
74455Diagnostic4
74485Diagnostic6
Start Printed Page 80184
74710Diagnostic4
74712Diagnostic68
74740Diagnostic5
75557Diagnostic45
75559Diagnostic58
75561Diagnostic50
75563Diagnostic66
75571Diagnostic13
75572Diagnostic25
75573Diagnostic38
75574Diagnostic35
75600Diagnostic6
75605Diagnostic11
75625Diagnostic11
75630Diagnostic13
75635Diagnostic50
75658Diagnostic13
75705Diagnostic20
75710Diagnostic11
75716Diagnostic13
75726Diagnostic11
75731Diagnostic11
75733Diagnostic13
75736Diagnostic11
75741Diagnostic13
75743Diagnostic16
75746Diagnostic11
75756Diagnostic11
75791Diagnostic33
75809Diagnostic5
75820Diagnostic7
75822Diagnostic11
75825Diagnostic11
75827Diagnostic11
75831Diagnostic11
75833Diagnostic14
75840Diagnostic11
75842Diagnostic14
75860Diagnostic11
75870Diagnostic11
75872Diagnostic11
75880Diagnostic7
75885Diagnostic14
75887Diagnostic14
75889Diagnostic11
75891Diagnostic11
75893Diagnostic6
75901Diagnostic11
75902Diagnostic13
75962Diagnostic6
75966Diagnostic13
75978Diagnostic6
75984Diagnostic8
75989Diagnostic12
76000Diagnostic3
76010Diagnostic3
76080Diagnostic6
76098Diagnostic3
76100Diagnostic6
76101Diagnostic6
76102Diagnostic6
76120Diagnostic5
76376Diagnostic8
76380Diagnostic10
76390Diagnostic28
76506Diagnostic10
76536Diagnostic12
76604Diagnostic9
76700Diagnostic14
76705Diagnostic11
76706Diagnostic13
76770Diagnostic13
76775Diagnostic11
76776Diagnostic13
76800Diagnostic14
76801Diagnostic18
76805Diagnostic18
76811Diagnostic35
76813Diagnostic23
76815Diagnostic8
76816Diagnostic18
76817Diagnostic13
76818Diagnostic35
76819Diagnostic28
76820Diagnostic13
76821Diagnostic13
76825Diagnostic45
76826Diagnostic11
76830Diagnostic13
76831Diagnostic30
76856Diagnostic13
76857Diagnostic10
76870Diagnostic10
76872Diagnostic20
76873Diagnostic40
76881Diagnostic18
76885Diagnostic20
76886Diagnostic15
76936Diagnostic71
76942Diagnostic19
76970Diagnostic8
77012Diagnostic11
77014Diagnostic9
77021Diagnostic53
77053Diagnostic5
77054Diagnostic5
77058Diagnostic50
77059Diagnostic55
77072Diagnostic3
77074Diagnostic5
77075Diagnostic6
77076Diagnostic12
77084Diagnostic15
78012Diagnostic8
78013Diagnostic13
78014Diagnostic13
78015Diagnostic31
78016Diagnostic49
78018Diagnostic29
78070Diagnostic13
78071Diagnostic18
78072Diagnostic23
78075Diagnostic38
78102Diagnostic18
78103Diagnostic22
78104Diagnostic20
78135Diagnostic48
78140Diagnostic40
78185Diagnostic16
78190Diagnostic40
78195Diagnostic30
78201Diagnostic16
78202Diagnostic20
78205Diagnostic20
78206Diagnostic25
78215Diagnostic13
78216Diagnostic22
78226Diagnostic13
78227Diagnostic18
78230Diagnostic19
78231Diagnostic23
78232Diagnostic28
78258Diagnostic27
78261Diagnostic21
78262Diagnostic25
78264Diagnostic13
78265Diagnostic18
78266Diagnostic23
78278Diagnostic18
78290Diagnostic18
78291Diagnostic31
78300Diagnostic15
78305Diagnostic22
78306Diagnostic11
78315Diagnostic11
78320Diagnostic24
78579Diagnostic8
78580Diagnostic13
78582Diagnostic15
78597Diagnostic13
78598Diagnostic13
78600Diagnostic16
78601Diagnostic18
78605Diagnostic21
78606Diagnostic22
78607Diagnostic29
78610Diagnostic10
78630Diagnostic24
78635Diagnostic36
78645Diagnostic32
78647Diagnostic15
78650Diagnostic40
78660Diagnostic16
78700Diagnostic17
78701Diagnostic18
78707Diagnostic22
78708Diagnostic32
78709Diagnostic40
78710Diagnostic21
78740Diagnostic30
78761Diagnostic20
78800Diagnostic28
78801Diagnostic32
78802Diagnostic24
78803Diagnostic43
78804Diagnostic35
78805Diagnostic25
78806Diagnostic23
78807Diagnostic37
79440Diagnostic24
G0106Diagnostic24
G0120Diagnostic24
G0297Diagnostic18
G0365Diagnostic20
G0389Diagnostic9

(2) Standardization of Clinical Labor Tasks

As we noted in the CY 2015 PFS final rule (79 FR 67640-67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of Start Printed Page 80185clinical labor minutes for the preservice, service, and postservice periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this improvement would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.

In the following paragraphs, we address a series of issues related to clinical labor tasks, particularly relevant to services currently being reviewed under the misvalued code initiative.

(a) Clinical Labor Tasks Associated With Digital Imaging

In CY 2015 PFS rulemaking, we noted that the RUC recommendation regarding inputs for digital imaging services indicated that, as each code is reviewed under the misvalued code initiative, the clinical labor tasks associated with digital technology (instead of film) would need to be addressed. When we reviewed that recommendation, we did not have the capability of assigning standard clinical labor times for the hundreds of individual codes since the direct PE input database did not previously allow for comprehensive adjustments for clinical labor times based on particular clinical labor tasks. Therefore, consistent with the recommendation, we proposed to remove film-based supply and equipment items but maintain clinical labor minutes that were assigned based on film technology.

As noted in the paragraphs above, we continue to improve the direct PE input database by specifying for each code the minutes associated with each clinical labor task. Once completed, this work would allow adjustments to be made to minutes assigned to particular clinical labor tasks related to digital technology that occur in multiple codes, consistent with the changes that were made to individual supply and equipment items. In the meantime, we believe it would be appropriate to establish standard times for clinical labor tasks associated with all digital imaging services for purposes of reviewing individual services at present, and for possible broad-based standardization once the changes to the direct PE input database facilitate our ability to adjust time across services. During the CY 2016 PFS rulemaking cycle, we proposed appropriate standard minutes for five different clinical labor tasks associated with services that use digital imaging technology. In the CY 2016 PFS final rule with comment period (80 FR 70901), we finalized appropriate standard minutes for four of those five activities, which are listed in Table 5.

Table 5—Clinical Labor Tasks Associated With Digital Imaging Technology

Clinical labor taskTypical minutes
Availability of prior images confirmed2
Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist2
Review examination with interpreting MD2
Exam documents scanned into PACS. Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue1

We did not finalize standard minutes for the activity “Technologist QC's images in PACS, checking for all images, reformats, and dose page.” We agreed with commenters that this task may require a variable length of time depending on the number of images to be reviewed. We stated that it may be appropriate to establish several different standard times for this clinical labor task for a low/medium/high quantity of images to be reviewed, in the same fashion that the clinical labor assigned to clean a surgical instrument package has two different standard times depending on the use of a basic pack (10 minutes) or a medium pack (30 minutes). We solicited public comment and feedback on this subject, with the anticipation of including a proposal in the CY 2017 proposed rule.

We received many comments suggesting that this clinical labor activity should not have a standard time value. Commenters stated that the number of minutes varies significantly for different imaging modalities; and the time is not simply based on the quantity of images to be reviewed, but also the complexity of the images. The commenters recommended that time for this clinical labor activity should be assigned on a code by code basis. We agree with the commenters that the amount of clinical labor needed to check images in a PACS workstation may vary depending on the service. However, we do not believe that this precludes the possibility of establishing standards for clinical labor tasks as we have done in the past by creating multiple standard times, for example, those assigned to cleaning different kinds of scopes. We continue to believe that the use of clinical labor standards provides greater consistency among codes that share the same clinical labor tasks and can improve relativity of values among codes. We proposed to establish a range of appropriate standard minutes for the clinical labor activity, “Technologist QCs images in PACS, checking for all images, reformats, and dose page.” These standard minutes will be applied to new and revised codes that make use of this clinical labor activity when they are reviewed by us for valuation. We proposed 2 minutes as the standard for the simple case, 3 minutes as the standard for the intermediate case, and 4 minutes as the standard for the complex case. We proposed the simple case of 2 minutes as the standard for the typical procedure code involving routine use of imaging. These values are based upon a review of the existing minutes assigned for this clinical labor activity; we have determined that 2 minutes is the Start Printed Page 80186duration for most services and a small number of codes with more complex forms of digital imaging have higher values. We proposed to use 2 minutes for services involving routine X-rays (simple), 3 minutes for services involving CTs and MRIs (intermediate), and 4 minutes for the most highly complex services, which would exceed these more typical cases. We solicited comments regarding the most accurate category—simple, intermediate, or complex for existing codes, and in particular what criteria might be used to identify complex cases systematically.

The following is summary of the comments we received regarding the ongoing standardization of clinical labor tasks, and our specific proposal regarding the clinical labor task, “Technologist QCs images in PACS, checking for all images, reformats, and dose page.”

Comment: Many commenters restated their opposition to the principle of establishing standard values for clinical labor tasks. Commenters contended that clinical labor tasks were highly variable across different specialties, that the standardization process would disrupt the relativity of direct PE inputs across the PFS, and that the proposed standard times were too low and underestimated the staffing time needed to carry out the tasks in question. Commenters stressed that each code should be evaluated on an individual basis. One commenter expressed support for the overall concept regarding efforts to streamline the time for clinical labor activities.

Response: We note the objections raised by the commenters to the process of standardizing time values for clinical labor tasks. However, as we have stated previously, we believe the establishment of standards can provide greater consistency among codes that share the same clinical labor tasks, as well as improve relativity of values among codes. We also note that we do evaluate each code on an individual basis for direct PE inputs, and establishing clinical labor standards assists in that process of individual review. We continue to allow clinical labor times above the standard values for individual services, provided that there is a compelling rationale to explain why that particular service requires additional clinical labor time above and beyond the standard. We believe that establishing a range of standard minutes for this particular digital imaging clinical labor task will provide clarity and help maintain relativity across a wide range of imaging services.

Comment: One commenter requested a broad study of the actual clinical labor times associated with digital imaging.

Response: We appreciate the importance of incorporating robust, auditable, and routinely updated data sources for use in the determination of RVUs. We welcome stakeholder information on the availability of such data, while we continue to consider the best means of acquiring such data.

Comment: Several commenters addressed our specific proposal for the clinical labor task, “Technologist QCs images in PACS, checking for all images, reformats, and dose page.” Commenters requested that, short of no standard times at all, the establishment of categories for this clinical labor task should be as follows: Simple (2 min); intermediate (3 min), complex (4 min) and highly complex (5 min).

Response: We appreciate the suggestion from the commenters to adopt a categorization system very similar to our proposal, with the addition of an extra category for highly complex services valued at 5 minutes. We agree with this addition to our proposal, as it will allow for additional specificity in classifying different types of imaging services, including those that are unusually complex. However, we note that we proposed to define the simple case of 2 minutes as the standard for the typical procedure code involving routine use of imaging, and we believe only a small number of codes with more complex forms of digital imaging would typically involve more time for the task. We proposed to use 2 minutes for services involving routine X-rays (the simple case), and 3 minutes for services involving CTs and MRIs (the intermediate case). We seek recommendations from the RUC and other stakeholders and we intend to request feedback from commenters through future rulemaking to assist in identifying what we believe would be the small number of services that fall into the complex (4 min) and highly complex (5 min) categories, and the specific basis used to set the two categories apart from one another. In the meantime, we will consider individual codes on a case by case basis for this clinical labor task.

After considering the comments received, we are finalizing a range of appropriate standard minutes for the clinical labor activity, “Technologist QCs images in PACS, checking for all images, reformats, and dose page” as follows: Simple (2 min); intermediate (3 min), complex (4 min) and highly complex (5 min). We are also finalizing our criteria for determining the simple and intermediate categories as proposed.

(b) Pathology Clinical Labor Tasks

As with the clinical labor tasks associated with digital imaging, many of the currently assigned times for the specialized clinical labor tasks associated with pathology services are not consistent across codes. In reviewing past RUC recommendations for pathology services, we have not identified information that supports the judgment that the same tasks take significantly more or less time depending on the individual service for which they are performed, especially given the high degree of specificity with which the tasks are described. We continue to believe that, in general, a clinical labor task will tend to take the same amount of time to perform for one individual service as the same clinical labor task when it is performed in a clinically similar service.

Therefore, we developed standard times for clinical labor tasks that we have used in finalizing direct PE inputs in recent years, starting in the CY 2012 PFS final rule with comment period (76 FR 73213). These times were based on our review and assessment of the current times included for these clinical labor tasks in the direct PE input database. We proposed in the CY 2016 PFS proposed rule to establish standard times for a list of 17 clinical labor tasks related to pathology services, and solicited public feedback regarding our proposed standards. Many commenters stated in response to our proposal that they did not support the standardization of clinical labor activities across pathology services. Commenters stated that establishing a single standard time for each clinical labor task was infeasible due to the differences in batch size or number of blocks across different pathology procedures. Several commenters indicated that it might be possible to standardize across codes with the same batch sizes, and urged us to consider pathology-specific details, such as batch size and block number, in the creation of any future standard times for clinical labor tasks related to pathology services.

As we stated in the CY 2016 PFS proposed rule, we developed the proposed standard times based on our review and assessment of the current times included for these clinical labor tasks in the direct PE input database. We believe that, generally speaking, clinical labor tasks with the same description are comparable across different pathology procedures. We believe this to be true based on the comparability of clinical labor tasks in Start Printed Page 80187non-pathology services, as well as the high degree of specificity with which most clinical labor tasks for pathology services are described relative to clinical labor tasks associated with other PFS services. We concurred with commenters that accurate clinical labor times for pathology codes may be dependent on the number of blocks or batch size typically used for each individual service. However, we also believe that it is appropriate and feasible to establish “per block” standards or standards varied by batch size assumptions for many clinical labor activities that would be comparable across a wide range of individual services. We have received detailed information regarding batch size and number of blocks during review of individual pathology services on an intermittent basis in the past. We requested regular submission of these details on the PE worksheets supplied by the RUC as part of the review process for pathology services, as a means to assist in the determination of the most accurate direct PE inputs.

We also stated our belief that many of the clinical labor activities for which we proposed to establish standard times were tasks that do not depend on number of blocks or batch size. Clinical labor activities such as “Clean room/equipment following procedure” and “Dispose of remaining specimens” would typically remain standard across different services without varying by block number or batch size, with the understanding that additional time may be required above the standard value for a clinical labor task that is part of an unusually complex or difficult service. As a result, we ultimately finalized standard times for 6 of the 17 proposed clinical labor activities in the CY 2016 final rule with comment period (80 FR 70902). We have listed the finalized standard times in Table 6. We are taking no further action on the remaining 11 clinical labor activities in this final rule, pending further action by the RUC (see below).

Table 6—Standard Times for Clinical Labor Tasks Associated With Pathology Services

Clinical labor taskStandard clinical labor time (minutes)
Accession specimen/prepare for examination4
Assemble and deliver slides with paperwork to pathologists0.5
Assemble other light microscopy slides, open nerve biopsy slides, and clinical history, and present to pathologist to prepare clinical pathologic interpretation0.5
Clean room/equipment following procedure (including any equipment maintenance that must be done after the procedure)1
Dispose of remaining specimens, spent chemicals/other consumables, and hazardous waste1
Prepare, pack and transport specimens and records for in-house storage and external storage (where applicable)1

We remain committed to the process of establishing standard clinical labor times for tasks associated with pathology services. This may include establishing standards on a per-block or per-batch basis, as we indicated during the previous rulemaking cycle. However, we are aware that the PE Subcommittee of the RUC is currently working to standardize the pathology clinical labor activities they use in making their recommendations. We believe the RUC's efforts to narrow the current list of several hundred pathology clinical labor tasks to a more manageable number through the consolidation of duplicative or highly similar activities into a single description may serve PFS relativity and facilitate greater transparency in PFS ratesetting. We also believe that the RUC's standardization of pathology clinical labor tasks would facilitate our capacity to establish standard times for pathology clinical labor tasks in future rulemaking. Therefore, we did not propose any additional changes to clinical labor tasks associated with pathology services.

(3) Equipment Recommendations for Scope Systems

During our routine reviews of direct PE input recommendations, we have regularly found unexplained inconsistencies involving the use of scopes and the video systems associated with them. Some of the scopes include video systems bundled into the equipment item, some of them include scope accessories as part of their price, and some of them are standalone scopes with no other equipment included. It is not always clear which equipment items related to scopes fall into which of these categories. We have also frequently found anomalies in the equipment recommendations, with equipment items that consist of a scope and video system bundle recommended, along with a separate scope video system. Based on our review, the variations do not appear to be consistent with the different code descriptions.

To promote appropriate relativity among the services and facilitate the transparency of our review process, during review of recommended direct PE inputs for the CY 2017 PFS proposed rule, we developed a structure that separates the scope and the associated video system as distinct equipment items for each code. Under this approach, we proposed standalone prices for each scope, and separate prices for the video systems that are used with scopes. We would define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system is the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. We understand that there may be other accessories associated with the use of scopes; we proposed to separately price any scope accessories, and individually evaluate their inclusion or exclusion as direct PE inputs for particular codes as usual under our current policy based on whether they are typically used in furnishing the services described by the particular codes.

We also proposed standardizing refinements to the way scopes have been defined in the direct PE input database. We believe that there are four general types of scopes: Non-video scopes; flexible scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and rigid scopes would typically be paired with one of the video scope systems, while the non-video scopes would not. The Start Printed Page 80188flexible scopes can be further divided into diagnostic (or non-channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We plan to propose input prices for these equipment items through future rulemaking.

We proposed these changes only for the reviewed codes that make use of scopes; this applies to the codes in the Flexible Laryngoscope family (CPT codes 31572, 31573, 31574, 31575, 31576, 31577, 31578, 31579) (see section II.L) and the Laryngoplasty family (CPT codes 31551, 31552, 31553, 31554, 31580, 31584, 31587, 31591, 31592) (see section II.L) along with updated prices for the equipment items related to scopes utilized by these services. We also solicited comment on this separate pricing structure for scopes, scope video systems, and scope accessories, which we could consider proposing to apply to other codes in future rulemaking.

The following is a summary of the comments we received on this separate pricing structure for scopes, scope video systems, and scope accessories.

Comment: Many commenters addressed our general proposal to reclassify scopes and their related equipment items. Commenters expressed their support for the decision to remove the scopes from the proposed scope packages, and the proposed definition of the scope video system based on the current endoscopy video system equipment item (ES031). There were no comments opposing the general principle behind reclassifying scopes and scope equipment.

Response: We appreciate the support from the commenters for the broad project to clarify these issues related to scopes.

Comment: Many commenters also requested that CMS delay implementing the scope proposal until additional time could be devoted to the subject. Several commenters asked CMS to wait to make any changes until the RUC could form a PE Subcommittee to address this issue. For codes with proposed CY 2017 values, commenters urged CMS to adopt the RUC-recommended direct PE inputs instead of the proposed direct PE inputs, pending anticipated RUC recommendations on the subject. Another commenter requested that CMS make no change for CY 2017 for any endoscopy procedures until proper identification of the capital and disposable cost inputs could be confirmed.

Response: We appreciate commenters' interests in making certain that there is appropriate opportunity for stakeholders to provide feedback and recommendations on the reclassification of scopes and related scope equipment. This was our primary rationale for limiting proposed changes regarding these kinds of inputs to codes reviewed for the current CY 2017 rule cycle, that is, the Flexible Laryngoscope and Laryngoplasty families of codes. Because these codes are under current review; however, we believe that they should be valued according to a scheme that accurately describes the scope equipment typically used in the services. As a result, we continue to believe that our proposed classification system for scopes is the more sound methodology to use for valuation of these two families of codes for CY 2017. However, we note that we would expect to include examination of these codes as part of any broader proposal we would make regarding scope equipment items, in response to new recommendations on the subject.

We look forward to receiving recommendations from the upcoming RUC PE Subcommittee regarding scopes and related scope equipment items. We note that in order for these recommendations to be considered for CY 2018 rulemaking, we would need to receive these recommendations by the same February deadline for the submission of recommendations on code valuations.

Comment: Many commenters disagreed with the CMS proposal to price the endoscopy video system (ES031) at a price of $15,045.00. Some commenters stated that CMS should use the submitted invoices for the pricing of this equipment, which recommended a price of $49,400.00. One commenter stated that the proposed amount did not accurately reflect the current price of GI endoscopy video systems. Another commenter stated that CMS had defined the endoscopy video system as containing five items: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. However, the commenter pointed out that CMS had not included a price for the digital capture device, which the commenter stressed was a significant part of the overall cost and needed to be included in the equipment's pricing. The commenter submitted a series of new invoices for endoscopy video system and requested that CMS incorporate them into the pricing of the equipment.

Response: We appreciate the feedback from the commenters about pricing, especially the submission of new data in the form of additional invoices. We agree that the cost of a digital capture device should be included in the cost of the endoscopy video system; it was our belief that the digital capture device was included in the cost of the processor. We appreciate the clarification from the commenters indicating that this is not the case, and that the digital capture device is a separately priced component of the video system. As a result, we are averaging the price of the digital capture device on the two submitted invoices and pricing it at $18,346.00. We will add this into the overall cost of the endoscopy video system.

For the other four components of the video system, we are finalizing the prices as proposed. The invoices submitted for these components indicate that they are different forms of equipment with different product IDs and different prices. For example, our price for the processor comes from a “Video Processor with keyboard & video cable” (CV-180) as opposed to the newly submitted invoice for a “Viscera Elite Video System” (OTV-S190). These are two distinct equipment items, and we do not have any data to indicate that the equipment on the newly submitted invoices is more typical in its use than the equipment that we are currently using to price the endoscopy video system.

Therefore, we are finalizing the price of the endoscopy video system at $33,391.00, based on component prices of $9,000.00 for the processor, $18,346.00 for the digital capture device, $2,000.00 for the monitor, $2,295.00 for the printer, and $1,750.00 for the cart.

Comment: A few commenters also addressed the pricing of related scope accessories. They stated that the proposed price for the fiberscope, flexible, rhinolaryngoscopy (ES020) was decreased by 33 percent based on one unrepresentative invoice and that this price undervalued the actual cost. Similarly, commenters stated that the proposed price for the stroboscopy system (ES065) at $19,100 was much lower than the manufacturer average invoice pricing. The proposed prices for the channeled and non-channeled flexible video rhinolaryngoscopes (ES064 and ES063 respectively) were also both two to three times lower than the manufacturer's average invoice price. One commenter submitted additional invoices for pricing these scopes and scope accessories.Start Printed Page 80189

Response: We appreciate the submission of this additional pricing data for review. Although many commenters stated that the price of the stroboscopy system was too low, only one commenter supplied additional invoices for the same equipment item that we defined in the proposed rule, the StrobeLED system, and these invoices reflected lower prices than the one we had proposed. These invoices reflected prices of $16,431.00 and $15,000.00. We are averaging these together with our previously submitted price of $19,100.00 for the stroboscopy system, which results in a new price of $16,843.87.

When we reviewed the invoices for the channeled and non-channeled flexible video rhinolaryngoscopes (ES064 and ES063 respectively), we found that the product numbers indicated that these were different equipment items than the scopes that we priced in the proposed rule. As we mentioned for the pricing of the endoscopy video system, we have no data to indicate that use of these particular rhinolaryngoscopes would be typical, as opposed to the rhinolaryngoscopes that we proposed to use to establish prices in the proposed rule. As a result, we are maintaining our current prices for these scopes pending the submission of additional information.

We similarly found that the invoices with recommended price increases for the endoscope, rigid, sinoscopy (ES013) from the current price of $2,414.17 to $4,024.00 and for the videoscope, colonoscopy (ES033) from $23,650.00 to $37,273.00 related to different equipment items that we do not believe are a better reflection of the typical case than the item we currently use. We did not propose to make price changes for these scopes, and we have not incorporated these equipment items into the new scope classification system. As we stated previously, we are currently limiting the scope changes to the CPT codes under review for CY 2017 and their associated equipment items. We will consider pricing changes for the rest of the scopes and associated scope equipment as part of the broader scope reclassification and pricing effort in future rulemaking.

We received invoices for a series of equipment items listed as “other capital inputs not included in CMS estimate” as part of this collection of invoices. Since these equipment items were not included in the original recommendations or our proposed valuations for the Flexible Laryngoscope and Laryngoplasty families of codes, we are not adding them to our equipment database at this time. We will consider the addition of these equipment items as part of the broader recommendations from the RUC PE Subcommittee on the scope classification project.

We did not receive an invoice or other data to support a change in the pricing of the fiberscope, flexible, rhinolaryngoscopy (ES020).

Comment: Many commenters objected to the use of a vendor quote for pricing of the scope equipment. Commenters requested that specialty societies should also be allowed to submit quotes for pricing as they are easier to obtain than paid invoices. Commenters also stated that the use of vendor prices created transparency issues and asked CMS to explain why they are appropriate to use rather than invoices supplied by specialties. One commenter stated that a single invoice was not an adequate sample to use as a pricing input for many types of endoscopic equipment.

Response: We are always interested in investigating multiple data sources for use in pricing supplies and equipment, provided that the information can be verified as accurate. We agree with the commenter that a single voluntarily submitted invoice may not be an adequate source for making wide ranging pricing decisions. We prefer to have pricing information from multiple data sources whenever possible, which may include information obtained from vendors of medical supplies and equipment. We continue to believe that there are risks of bias in submission of price quotes used for purposes of ratesetting. However, given the way we use these prices in the current ratesetting methodologies, we believe the risk of bias is located in submission of overstated, not understated prices. Therefore, we believe it is reasonable to assume that practitioners would generally be able acquire particular items at the prices vendors submit to CMS.

After consideration of comments received, we are finalizing our proposals as detailed in the proposed rule, with the updated prices for the endoscopy video system and the stroboscopy system.

(4) Technical Corrections to Direct PE Input Database and Supporting Files

Subsequent to the publication of the CY 2016 PFS final rule with comment period, stakeholders alerted us to several clerical inconsistencies in the direct PE database. We proposed to correct these inconsistencies as described below and reflected in the CY 2017 direct PE input database displayed on our Web site under downloads for the CY 2017 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

For CY 2017, we proposed the following technical corrections:

  • For CPT codes 72081-72084, a stakeholder informed us that the equipment time for the PACS workstation (ED050) should be equal to the clinical labor during the service period; the equipment time formula we used for these codes for CY 2016 erroneously included 4 minutes of preservice clinical labor. We agree with the stakeholder that the PACS workstation should use the standard equipment time formula for a PACS workstation for these codes. As a result, we proposed to refine the ED050 equipment time to 21 minutes for CPT code 72081, 36 minutes for CPT code 72082, 44 minutes for CPT code 72083, and 53 minutes for CPT code 72084 to reflect the clinical labor time associated with these codes. This same commenter also indicated that a number of clinical labor activities had been entered in the database in the incorrect service period for CPT codes 37215, 50432, 50694, and 72081. These clinical labor activities were incorrectly listed in the “postservice” period instead of the “service post” period. We proposed to make these technical corrections as well so that the minutes are assigned to the appropriate service period within the direct PE input database.
  • Another stakeholder alerted us that ileoscopy CPT codes 44380, 44381 and 44382 did not include the direct PE input equipment item called the Gomco suction machine (EQ235) and indicated that this omission appeared to be inadvertent. We agreed that it was. We have included the item EQ235 in the final direct PE input database for CPT code 44380 at a time of 29 minutes, for CPT code 44381 at a time of 39 minutes, and CPT code 44382 at a time of 34 minutes.

The PE RVUs displayed in Addendum B on our Web site were calculated with the inputs displayed in the CY 2017 direct PE input database.

Comment: One commenter expressed support for the proposed technical corrections to these services.

Response: We appreciate the support from the commenter. After consideration of comments received, we are finalizing these technical corrections.

Comment: Several commenters contacted CMS during the comment period after noticing that six services where CMS proposed to accept the refinement panel work RVU did not contain the updated work RVU in the Start Printed Page 80190Addendum B file for the proposed rule. These commenters requested that CMS address these discrepancies.

Response: We appreciate the assistance from the commenters in recognizing these discrepancies. We have corrected them and assigned the refinement panel work RVUs to the six services in question.

Comment: One commenter stated that there were potential technical errors in the clinical labor inputs for CPT codes 88329, 88331, 88360, and 88361.

Response: We have reviewed these codes and they do not contain technical errors. The clinical labor inputs were adjusted in the CY 2016 rule cycle as a result of CMS refinement (80 FR 70981-70983).

(5) Restoration of Inputs

Several of the PE worksheets included in the RUC recommendations for CY 2016 contained time for the equipment item “xenon light source” (EQ167). Because there appeared to be two special light sources already present (the fiberoptic headlight and the endoscope itself) in the services for which this equipment item was recommended by the RUC, we believed that the use of only one of these light sources would be typical and proposed to remove the xenon light equipment time. In the CY 2016 PFS final rule with comment period, we restored the xenon light (EQ167) and removed the fiberoptic headlight (EQ170) with the same number of equipment minutes for CPT codes 30300, 31295, 31296, 31297, and 92511.

We received comments expressing approval for the restoration of the xenon light. However, the commenters also stated that the two light sources were not duplicative, but rather, both a headlight and a xenon light source are required concurrently for otolaryngology procedures when scopes are utilized. The commenters requested that the fiberoptic headlight be restored to these codes.

We agreed with the commenters that the use of both light sources would be typical for these procedures. Therefore, we proposed in the CY 2017 proposed rule to add the fiberoptic headlight (EQ170) to CPT codes 30300, 31295, 31296, 31297, and 92511 at the same number of equipment minutes as the xenon light (EQ167).

Comment: One commenter expressed appreciation for the CMS proposal to restore the fiberoptic headlight to the codes in question. The commenter also stated that it had supplied invoices for LED lights, which are significantly less expensive than the xenon light source, as it was this commenter's understanding that xenon lights are no longer the typical light source for these procedures and they are no longer widely available for purchase from vendors. The commenter expressed support for retaining the xenon light as the standard light source line item for all endoscopy codes if that remained CMS' preference.

Response: We appreciate the support for our proposal from the commenter, as well as the submission of additional information regarding the typical light source for these procedures. We will add the LED light source to our equipment database at the submitted invoice price of $1,915.00. However, we will not replace the xenon light with the LED light at this time, as we believe the subject deserves further consideration. We will consider proposing this change in future rulemaking.

Comment: We received new invoices for the xenon light equipment from a different commenter which averaged out to a price of $12,298.00.

Response: We are finalizing our proposed price of $7,000.00 for the xenon light source. Since we received a comment stating that xenon lights are no longer a typical light source for procedure use, and that they have been supplanted by the use of LED lights, we are viewing the current input as a proxy item, and therefore, do not believe that it would be appropriate to increase the cost of the xenon light source at this time. We will consider making a proposal to address this subject in future rulemaking.

After consideration of comments received, we are finalizing our proposal to add the fiberoptic headlight (EQ170) to CPT codes 30300, 31295, 31296, 31297, and 92511 at the same number of equipment minutes as the xenon light (EQ167).

(6) Updates to Prices for Existing Direct PE Inputs

In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2017, we proposed the following price updates for existing direct PE inputs:

Several commenters wrote to discuss the price of the Antibody Estrogen Receptor monoclonal (SL493). We received information including three invoices with new pricing information regarding the SL493 supply. We proposed to use this information to propose for the supply item SL493 a price of $14.00 per test, which is the average price based on the invoices that we received in total for the item.

Comment: Several commenters supported the proposed price increase and urged CMS to finalize the proposal.

Response: We appreciate the support from the commenters. After consideration of comments received, we are finalizing the price of the Antibody Estrogen Receptor monoclonal (SL493) supply at $14.00 as proposed.

We also proposed to update the price for two supplies in response to the submission of new invoices. The proposed price for “antigen, venom” supply (SH009) reflects an increase from $16.67 to $20.14 per milliliter, and the proposed price for “antigen, venom, tri-vespid” supply (SH010) reflects an increase from $30.22 to $44.05 per milliliter.

Comment: Several commenters stated that they strongly supported the proposed price updates for antigen supplies and urged CMS to finalize the proposal.

Response: We appreciate the support from the commenters. After consideration of comments received, we are finalizing the price of the “antigen, venom” (SH009) and “antigen, venom, tri-vespid” (SH010) supplies as proposed.

We proposed to remove the laser tip, diffuser fiber supply (SF030) and replace it with the laser tip, bare (single use) supply (SF029) for CPT code 31572 (formerly placeholder code 317X1). We did not propose a price change for the SF030 supply.

Comment: In reference to CPT code 52648, a commenter stated that the price for the laser tip, diffuser fiber supply (SF030) was decreasing from $850 to $197.50. The commenter stated that the methodology for this adjustment was opaque, unanticipated, and not proposed for comment in the proposed rule. The commenter stated that the $850 supply cost would be more appropriate for the laser tip, diffuser fiber supply.

Response: We stated in the CY 2017 proposed rule (81 FR 46247) that we did not believe that the submitted invoice for the laser tip, diffuser supply at $197.50 was current enough to establish a new price for the supply. As a result, we proposed to remove the laser tip, diffuser fiber supply (SF030) and replaced it with the laser tip, bare (single use) supply (SF029) for CPT code 31572 (Laryngoscopy, flexible; with ablation or destruction of lesion(s) with laser, unilateral), as we did not believe that it was appropriate to use a supply with an outdated invoice. However, we inadvertently set the price of the laser tip, diffuser fiber supply to Start Printed Page 80191$197.50 in the proposed direct PE input database in contradiction of our written proposal. We apologize for the confusion caused by this error. In the final direct PE input database, we are restoring the price of the laser tip, diffuser fiber supply to $850.00, since we did not intend to propose a change the price of this supply. We are also requesting the submission of additional current pricing information for the laser tip, diffuser fiber supply, given the significant difference between the $197.50 and $850.00 prices.

Comment: A commenter submitted two invoices containing pricing data for a Cook Biopsy device.

Response: While we appreciate the submission of this pricing information from the commenter, we are unable to determine which supply or equipment item these invoices were in reference to. The invoices were not mentioned in the text of the commenter's letter. We request that invoices submitted for pricing updates should contain clear documentation regarding the item in question: its name, the CMS supply/equipment code that it references (if any), the unit quantity if the item is shipped in boxes or batches, and any other information relevant for pricing.

We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often these invoices are submitted in conjunction with the RUC-recommended values for the codes. For CY 2017, we note that some stakeholders have submitted invoices for new, revised, or potentially misvalued codes after the February deadline established for code valuation recommendations. To be considered for a given year's proposed rule, we generally need to receive invoices by the same February deadline. In similar fashion, we generally need to receive invoices by the end of the comment period for the proposed rule in order to consider them for supply and equipment pricing in the final rule for that calendar year. Of course, we consider invoices submitted as public comments during the comment period following the publication of the proposed rule when relevant for services with values open for comment, and will consider any other invoices received after February and/or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices as finalized in the CY 2011 final rule with comment period (75 FR 73205).

(7) Radiation Treatment Delivery Practice Expense RVUs

Comment: Several commenters noticed that there was a 10 percent decrease in the proposed Non Facility PE RVUs for HCPCS code G6011 despite proposed changes in direct PE inputs. Commenters requested an explanation for why this decrease was taking place, and referenced section 3 of the Patient Access and Medicare Protection Act (PAMPA) (Pub. L. 114-115, enacted December 18, 2015), which requires CMS to maintain the associated “definitions, units, and inputs” for certain radiation treatment and related services for CY 2017 and CY 2018. Several commenters stated that they believed that this decrease in the PE RVU was in violation of section 1848(c)(2)(C)(i-ii) of the Act (added by section 3 of the PAMPA), which requires inputs for these services to remain unchanged for CY 2017 and 2018.

Response: We agree with the commenters that we did not propose to change any of the direct PE inputs for HCPCS code G6011, and we understand the proposed change in the nonfacility PE RVUs would generally not be expected absent a corresponding change in direct PE inputs. However, the change in the PE RVU for HCPCS code G6011 is caused by a significant shift in the specialties furnishing the service in the Medicare claims data. In the claims data we used to establish the PE RVUs for CY 2016, dermatology furnished 51 percent of the services, while radiation oncology furnished 43 percent. The most recent claims data reflects a major shift, with radiation oncology now furnishing about 85 percent of the services and dermatology only about 6 percent. The decrease in the PE RVU between CY 2016 and CY 2017 resulted from this shift in specialty mix, as the specialties actually furnishing the service, reflected in the claims data, have a higher percentage of direct PE relative to indirect PE, and therefore, a lower percentage of indirect PE, than the specialties that were previously furnishing the service in the claims data. In other words, consistent with the established methodology for allocating indirect PE to services, a specialty mix with a lower percentage of indirect PE results in fewer indirect PE RVUs being allocated and a lower overall PE RVU for the code even though the direct PE inputs have remained the same. This kind of shift is relatively unusual outside of low-volume codes, but it is consistent with our established methodology for allocating indirect PE to services. We believe that in many cases, the change in specialty utilization for a particular service would warrant a re-examination of the direct PE inputs for the service under the misvalued code initiative. Given the statutory provision that prohibits us from changing the direct PE inputs prior to CY 2019 or considering these services as potentially misvalued, we will consider this issue further for future rulemaking.

We recognize that this change would be unanticipated, but we do not believe there is a straightforward, transparent way to offset the change since the statutory provision requires that we maintain the direct inputs for the PE RVUs. We note that this change is unique among the radiation therapy and related imaging codes where the maintenance of inputs has generally resulted in payment rate stability for these services.

B. Determination of Malpractice Relative Value Units (RVUs)

1. Overview

Section 1848(c) of the Act requires that each service paid under the PFS be composed of three components: Work, PE, and malpractice (MP) expense. As required by section 1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are resource based. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 1848(c)(2)(B)(i) of the Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. In the CY 2015 PFS final rule with comment period, we implemented the third review and update of MP RVUs. For a comprehensive discussion of the third review and update of MP RVUs see the CY 2015 proposed rule (79 FR 40349 through 40355) and final rule with comment period (79 FR 67591 through 67596).

To determine MP RVUs for individual PFS services, our MP methodology is comprised of three factors: (1) Specialty-level risk factors derived from data on specialty-specific MP premiums incurred by practitioners, (2) service level risk factors derived from Medicare claims data of the weighted average risk factors of the specialties that furnish each service, and (3) an intensity/complexity of service adjustment to the service level risk factor based on either the higher of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were only updated once every 5 years, except in the case of new and revised codes.

As explained in the CY 2011 PFS final rule with comment period (75 FR Start Printed Page 8019273208), MP RVUs for new and revised codes effective before the next 5-year review of MP RVUs were determined either by a direct crosswalk from a similar source code or by a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code. For the modified crosswalk approach, we adjust (or scale) the MP RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work RVU (or, if greater, the difference in the clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code were 10 percent higher than the work RVU for its source code, the MP RVU for the revised code would be increased by 10 percent over the source code MP RVU. Under this approach, the same risk factor is applied for the new/revised code and source code, but the work RVU for the new/revised code is used to adjust the MP RVUs for risk.

In the CY 2016 PFS final rule with comment period (80 FR 70906 through 70910), we finalized a policy to begin conducting annual MP RVU updates to reflect changes in the mix of practitioners providing services (using Medicare claims data), and to adjust MP RVUs for risk for intensity and complexity (using the work RVU or clinical labor RVU). We also finalized a policy to modify the specialty mix assignment methodology (for both MP and PE RVU calculations) to use an average of the 3 most recent years of data instead of a single year of data. We stated that under this approach, the specialty-specific risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews.

For CY 2016, we did not propose to discontinue our current approach for determining MP RVUs for new/revised codes. For the new and revised codes for which we proposed work RVUs and PE inputs, we also published the proposed MP crosswalks used to determine their MP RVUs. We address comments regarding valuation of new and revised codes in section II.L of this final rule, which makes clear the codes with interim final values for CY 2016 had newly proposed values for CY 2017, all of which were again open for comment. The MP crosswalks for new and revised codes with interim final values were established in the CY 2016 PFS final rule with comment period; we proposed these same crosswalks in the CY 2017 PFS proposed rule.

2. Updating Specialty Specific Risk Factors

The proposed CY 2017 GPCI update (eighth update), discussed in section II.E of this final rule, reflects updated MP premium data, collected for the purpose of proposing updates to the MP GPCIs. Although we could have used the updated MP premium data obtained for the purposes of the proposed eighth GPCI update to propose updates to the specialty risk factors used in the calculation of MP RVUs, this would not be consistent with the policy we previously finalized in the CY 2016 PFS final rule with comment period. In that rule, we indicated that the specialty-specific risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews. Additionally, consistent with the statutory requirement at section 1848(e)(1)(C) of the Act, only one half of the adjustment to MP GPCIs would be applied for CY 2017 based on the new MP premium data. As such, we did not think it would be appropriate to propose to update the specialty risk factors for CY 2017 based on the updated MP premium data that is reflected in the proposed CY 2017 GPCI update. Therefore, we did not propose to update the specialty-risk factors based on the new premium data collected for the purposes of the 3-year GPCI update for CY 2017 at this time. However, we solicited comment on whether we should consider doing so, perhaps as early as for 2018, prior to the fourth review and update of MP RVUs that must occur no later than CY 2020.

The following is summary of the comments we received on whether we should consider updating the specialty-risk factors based on the new premium data collected for the purposes of the 3-year GPCI update, perhaps as early as for 2018, prior to the fourth review and update of MP RVUs that must occur no later than CY 2020.

Comment: We received few comments regarding this issue. Some commenters, including the RUC, recommended that CMS use the updated MP premium data collected as part of the CY 2017 GPCI update in the creation of the MP RVUs for CY 2017. One commenter stated that CMS should follow its normal process to update MP RVUs for CY 2020. Another commenter supported the technical and policy changes that CMS made related to the MP RVUs for the CY 2016 PFS, and appreciated CMS' reluctance to change direction a year later and use the updated malpractice premium data gathered for the purpose of the GPCI update, in advance of the next 5-year review of the MP RVUs, to propose updates to the specialty risk factors used in the calculation of MP RVUs. The commenter suggested that CMS consider using the updated data to update the specialty-risk factors in the MP RVU methodology as early as CY 2018, noting that by CY 2018, the adjustment of the malpractice GPCIs would be complete, so the potential disconnect in the use of the updated premium data would no longer be an issue.

Response: We appreciate the commenters' feedback. In response to the commenters who recommended that CMS use the updated MP premium data collected as part of the CY 2017 GPCI update in the creation of the MP RVUs for CY 2017, we reiterate that we did not propose to update the specialty-risk factors based on the new premium data collected for the purposes of the 3-year GPCI update for the CY 2017 MP RVUs. Instead, we solicited comment on whether we should consider doing so prior to the next 5-year interval, perhaps as early as for CY 2018. We will consider the possibility of using the updated MP data to update the specialty risk factors used in the calculation of the MP RVUs prior to the next 5-year update in future rulemaking.

Comment: One commenter stated that CPT code 93355 should be added to the MP RVUs Invasive Cardiology Outside of Surgical Range list so that the surgical risk factor is applied when calculating the MP RVU.

Response: We did not previously propose to include this code on the list of Invasive Cardiology Outside of Surgical Range when we updated MP risk factors for CY 2015 and we did not propose the change in the CY 2017 PFS proposed rule. We will consider that request for future rulemaking in conjunction with the next update of MP risk factors.

C. Medicare Telehealth Services

1. Billing and Payment for Telehealth Services

Several conditions must be met for Medicare to make payments for telehealth services under the PFS. The service must be on the list of Medicare telehealth services and meet all of the following additional requirements:

  • The service must be furnished via an interactive telecommunications system.
  • The service must be furnished by a physician or other authorized practitioner.
  • The service must be furnished to an eligible telehealth individual.Start Printed Page 80193
  • The individual receiving the service must be located in a telehealth originating site.

When all of these conditions are met, Medicare pays a facility fee to the originating site and makes a separate payment to the distant site practitioner furnishing the service.

Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth services to include professional consultations, office visits, office psychiatry services, and any additional service specified by the Secretary, when furnished via a telecommunications system. We first implemented this statutory provision, which was effective October 1, 2001, in the CY 2002 PFS final rule with comment period (66 FR 55246). We established a process for annual updates to the list of Medicare telehealth services as required by section 1834(m)(4)(F)(ii) of the Act in the CY 2003 PFS final rule with comment period (67 FR 79988).

As specified at § 410.78(b), we generally require that a telehealth service be furnished via an interactive telecommunications system. Under § 410.78(a)(3), an interactive telecommunications system is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

Telephones, facsimile machines, and stand-alone electronic mail systems do not meet the definition of an interactive telecommunications system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the Act allows the use of asynchronous “store-and-forward” technology when the originating site is part of a federal telemedicine demonstration program in Alaska or Hawaii. As specified in § 410.78(a)(1), asynchronous store-and-forward is the transmission of medical information from an originating site for review by the distant site physician or practitioner at a later time.

Medicare telehealth services may be furnished to an eligible telehealth individual notwithstanding the fact that the practitioner furnishing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual is an individual enrolled under Part B who receives a telehealth service furnished at a telehealth originating site.

Practitioners furnishing Medicare telehealth services are reminded that these services are subject to the same non-discrimination laws as other services, including the effective communication requirements for persons with disabilities of section 504 of the Rehabilitation Act and language access for persons with limited English proficiency, as required under Title VI of the Civil Rights Act of 1964. For more information, see http://www.hhs.gov/​ocr/​civilrights/​resources/​specialtopics/​hospitalcommunication.

Practitioners furnishing Medicare telehealth services submit claims for telehealth services to the MACs that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner who furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been paid if the service had been furnished without the use of a telecommunications system.

Originating sites, which can be one of several types of sites specified in the statute where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system, are paid a facility fee under the PFS for each Medicare telehealth service. The statute specifies both the types of entities that can serve as originating sites and the geographic qualifications for originating sites. With regard to geographic qualifications, § 410.78(b)(4) limits originating sites to those located in rural health professional shortage areas (HPSAs) or in a county that is not included in a metropolitan statistical area (MSA).

Historically, we have defined rural HPSAs to be those located outside of MSAs. Effective January 1, 2014, we modified the regulations regarding originating sites to define rural HPSAs as those located in rural census tracts as determined by the Federal Office of Rural Health Policy of the Health Resources and Services Administration (HRSA) (78 FR 74811). Defining “rural” to include geographic areas located in rural census tracts within MSAs allows for broader inclusion of sites within HPSAs as telehealth originating sites. Adopting the more precise definition of “rural” for this purpose expands access to health care services for Medicare beneficiaries located in rural areas. HRSA has developed a Web site tool to provide assistance to potential originating sites to determine their geographic status. To access this tool, see the CMS Web site at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

An entity participating in a federal telemedicine demonstration project that has been approved by, or received funding from, the Secretary as of December 31, 2000 is eligible to be an originating site regardless of its geographic location.

Effective January 1, 2014, we also changed our policy so that geographic status for an originating site would be established and maintained on an annual basis, consistent with other telehealth payment policies (78 FR 74400). Geographic status for Medicare telehealth originating sites for each calendar year is now based upon the status of the area as of December 31 of the prior calendar year.

For a detailed history of telehealth payment policy, see 78 FR 74399.

2. Adding Services to the List of Medicare Telehealth Services

As noted previously, in the CY 2003 PFS final rule (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. Under this process, we assign any qualifying request to make additions to the list of telehealth services to one of two categories. Revisions to criteria that we use to review requests in the second category were finalized in the CY 2012 PFS final rule (76 FR 73102). The two categories are:

  • Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth 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, a practitioner who is present with the beneficiary in the originating site. We also look for similarities in the telecommunications system used to deliver the 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 service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient. Submitted evidence should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary Start Printed Page 80194improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit does not include minor or incidental benefits.

Some examples of clinical benefit include the following:

  • Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.
  • Treatment option for a patient population without access to clinically appropriate in-person treatment options.
  • Reduced rate of complications.
  • Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
  • Decreased number of future hospitalizations or physician visits.
  • More rapid beneficial resolution of the disease process treatment.
  • Decreased pain, bleeding, or other quantifiable symptom.
  • Reduced recovery time.

For the list of telehealth services, see the CMS Web site at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html. 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, qualifying requests submitted before the end of CY 2016 will be considered for the CY 2018 proposed rule. Each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes 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, requesters should be advised that any information submitted is subject to public 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, see the CMS Web site at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

3. Submitted Requests To Add Services to the List of Telehealth Services for CY 2017

Under our existing policy, we add services to the telehealth list on a category 1 basis when we determine that they are similar to services on the existing telehealth list for the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 final rule with comment period (76 FR 73098), we believe that the category 1 criteria not only streamline our review process for publicly requested services that fall into this category, but also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.

We received several requests in CY 2015 to add various services as Medicare telehealth services effective for CY 2017. The following presents a discussion of these requests, and our decisions regarding additions to the CY 2017 telehealth list. Of the requests received, we found that four services were sufficiently similar to ESRD-related services currently on the telehealth list to qualify on a category 1 basis. Therefore, we proposed to add the following services to the telehealth list on a category 1 basis for CY 2017:

  • CPT codes 90967 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients younger than 2 years of age; 90968 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 2-11 years of age; 90969 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 12-19 years of age); and 90970 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 20 years of age and older).

As we indicated in the CY 2015 final rule with comment period (80 FR 41783), for the ESRD-related services (CPT codes 90963-90966) added to the telehealth list for CY 2016, the required clinical examination of the catheter access site must be furnished face-to-face “hands on” (without the use of an interactive telecommunications system) by a physician, CNS, NP, or PA. This requirement also applies to CPT codes 90967-90970.

While we did not receive a specific request, we also proposed to add two advance care planning services to the telehealth list. We have determined that these services are similar to the annual wellness visits (HCPCS codes G0438 & G0439) currently on the telehealth list:

  • CPT codes 99497 (advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to-face with the patient, family member(s), or surrogate); and 99498 (advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional; each additional 30 minutes (list separately in addition to code for primary procedure)).

We also received requests to add services to the telehealth list that do not meet our criteria for Medicare telehealth services. We did not propose to add the following procedures for observation care, emergency department visits, critical care E/M, psychological testing, and physical, occupational and speech therapy, for the reasons noted:

a. Observation Care: CPT Codes—

  • 99217 (observation care discharge day management (this code is to be utilized to report all services provided to a patient on discharge from “observation status” if the discharge is on other than the initial date of “observation status.” To report services to a patient designated as “observation status” or “inpatient status” and discharged on the same date, use the codes for observation or inpatient care services [including admission and discharge services, 99234-99236 as appropriate.]));
  • 99218 (initial observation care, per day, for the evaluation and management of a patient which requires these three key components: A detailed or comprehensive history; a detailed or comprehensive examination; and medical decision making that is straightforward or of low complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the problem(s) requiring admission to “observation status” are of low severity. Typically, 30 minutes are spent at the bedside and on the patient's hospital floor or unit);
  • 99219 (initial observation care, per day, for the evaluation and management of a patient, which requires these three key components: A comprehensive history; a comprehensive examination; and medical decision making of moderate complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the problem(s) requiring admission to “observation status” are of moderate severity. Start Printed Page 80195Typically, 50 minutes are spent at the bedside and on the patient's hospital floor or unit);
  • 99220 (initial observation care, per day, for the evaluation and management of a patient, which requires these three key components: A comprehensive history; a comprehensive examination; and medical decision making of high complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the problem(s) requiring admission to “observation status” are of high severity. Typically, 70 minutes are spent at the bedside and on the patient's hospital floor or unit);
  • 99224 (subsequent observation care, per day, for the evaluation and management of a patient, which requires at least two of these three key components: Problem focused interval history; problem focused examination; medical decision making that is straightforward or of low complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the patient is stable, recovering, or improving. Typically, 15 minutes are spent at the bedside and on the patient's hospital floor or unit);
  • 99225 (subsequent observation care, per day, for the evaluation and management of a patient, which requires at least two of these three key components: An expanded problem focused interval history; an expanded problem focused examination; medical decision making of moderate complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 25 minutes are spent at the bedside and on the patient's hospital floor or unit);
  • 99226 (subsequent observation care, per day, for the evaluation and management of a patient, which requires at least two of these three key components: A detailed interval history; a detailed examination; medical decision making of high complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the patient is unstable or has developed a significant complication or a significant new problem. Typically, 35 minutes are spent at the bedside and on the patient's hospital floor or unit);
  • 99234 (observation or inpatient hospital care, for the evaluation and management of a patient including admission and discharge on the same date, which requires these three key components: A detailed or comprehensive history; a detailed or comprehensive examination; and medical decision making that is straightforward or of low complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually the presenting problem(s) requiring admission are of low severity. Typically, 40 minutes are spent at the bedside and on the patient's hospital floor or unit);
  • 99235 (observation or inpatient hospital care, for the evaluation and management of a patient including admission and discharge on the same date, which requires these three key components: A comprehensive history; a comprehensive examination; and medical decision making of moderate complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually the presenting problem(s) requiring admission are of moderate severity. Typically, 50 minutes are spent at the bedside and on the patient's hospital floor or unit);
  • 99236 (observation or inpatient hospital care, for the evaluation and management of a patient including admission and discharge on the same date, which requires these three key components: A comprehensive history; a comprehensive examination; and medical decision making of high complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually the presenting problem(s) requiring admission are of high severity. Typically, 55 minutes are spent at the bedside and on the patient's hospital floor or unit);

The request to add these observation services referenced various studies supporting the use of observation units. The studies indicated that observation units provide safe, cost effective care to patients that need ongoing evaluation and treatment beyond the emergency department visit by having reduced hospital admissions, shorter lengths of stay, increased safety and reduced cost. Additional studies cited indicated that observation units reduce the work load on emergency department physicians, and reduce emergency department overcrowding.

In the CY 2005 PFS proposed rule (69 FR 47510), we considered a request but did not propose to add the observation CPT codes 99217-99220 to the list of Medicare telehealth services on a category two basis for the reasons described in that rule. The most recent request did not include any information that would cause us to question the previous evaluation under the category one criterion, which has not changed, regarding the significant differences in patient acuity between these services and services on the telehealth list. While the request included evidence of the general benefits of observation units, it did not include specific information demonstrating that the services described by these codes provided clinical benefit when furnished via telehealth, which is necessary for us to consider these codes on a category two basis. Therefore, we did not propose to add these services to the list of approved telehealth services.

b. Emergency Department Visits: CPT Codes—

  • 99281 (emergency department visit for the evaluation and management of a patient, which requires these three key components: A problem focused history; a problem focused examination; and straightforward medical decision making. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the presenting problem(s) are self-limited or minor);
  • 99282 (emergency department visit for the evaluation and management of a patient, which requires these three key components: An expanded problem focused history; an expanded problem focused examination; and medical decision making of low complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the presenting problem(s) are of low to moderate severity);Start Printed Page 80196
  • 99283 (emergency department visit for the evaluation and management of a patient, which requires these three key components: An expanded problem focused history; an expanded problem focused examination; and medical decision making of moderate complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the presenting problem(s) are of moderate severity);
  • 99284 (emergency department visit for the evaluation and management of a patient, which requires these three key components: A detailed history; a detailed examination; and medical decision making of moderate complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the presenting problem(s) are of high severity, and require urgent evaluation by the physician, or other qualified health care professionals but do not pose an immediate significant threat to life or physiologic function); and
  • 99285 (emergency department visit for the evaluation and management of a patient, which requires these three key components within the constraints imposed by the urgency of the patient's clinical condition and mental status: A comprehensive history; a comprehensive examination; and medical decision making of high complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and family's needs. Usually, the presenting problem(s) are of high severity and pose an immediate significant threat to life or physiologic function).

In the CY 2005 PFS proposed rule (69 FR 47510), we considered a request but did not propose to add the emergency department visit CPT codes 99281-99285 to the list of Medicare telehealth services for the reasons described in that rule.

The current request to add the emergency department E/M services stated that the codes are similar to outpatient visit codes (CPT codes 99201-99215) that have been on the telehealth list since CY 2002. As we noted in the CY 2005 PFS final rule, while the acuity of some patients in the emergency department might be the same as in a physician's office; we believe that, in general, more acutely ill patients are more likely to be seen in the emergency department, and that difference is part of the reason there are separate codes describing evaluation and management visits in the Emergency Department setting. The practice of emergency medicine often requires frequent and fast-paced patient reassessments, rapid physician interventions, and sometimes the continuous physician interaction with ancillary staff and consultants. This work is distinctly different from the pace, intensity, and acuity associated with visits that occur in the office or outpatient setting. Therefore, we did not propose to add these services to the list of approved telehealth services on a category one basis.

The requester did not provide any studies supporting the clinical benefit of managing emergency department patients with telehealth which is necessary for us to consider these codes on a category two basis. Therefore, we did not propose to add these services to the list of approved telehealth services on a category two basis.

Many requesters of additions to the telehealth list urged us to consider the potential value of telehealth for providing beneficiaries access to needed expertise. We note that if clinical guidance or advice is needed in the emergency department setting, a consultation may be requested from an appropriate source, including consultations that are currently included on the list of telehealth services.

c. Critical Care Evaluation and Management: CPT Codes—

  • 99291 (critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes); and 99292 (critical care, evaluation and management of the critically ill or critically injured patient; each additional 30 minutes (list separately in addition to code for primary service).

We previously considered and rejected adding these codes to the list of Medicare telehealth services in the CY 2009 PFS final rule (74 FR 69744) on a category 1 basis because, due to the acuity of critically ill patients, we did not believe critical care services are similar to any services on the current list of Medicare telehealth services. In that rule, we said that critical care services must be evaluated as category 2 services. Because we considered critical care services under category 2, we needed to evaluate whether these are services for which telehealth can be an adequate substitute for a face-to-face encounter, based on the category 2 criteria at the time of that request. We had no evidence suggesting that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of this type of care.

The American Telemedicine Association (ATA) submitted a new request for CY 2016 that cited several studies to support adding these services on a category 2 basis. To qualify under category 2, we would need evidence that the service furnished via telehealth is still described accurately by the requested code and produces a clinical benefit for the patient via telehealth. However, in reviewing the information provided by the ATA and a study titled, “Impact of an Intensive Care Unit Telemedicine Program on Patient Outcomes in an Integrated Health Care System,” published July 2014 in JAMA Internal Medicine, which found no evidence that the implementation of ICU telemedicine significantly reduced mortality rates or hospital length of stay, which could be indicators of clinical benefit. Therefore, we stated that we do not believe that the submitted evidence demonstrates a clinical benefit to patients. Therefore, we did not propose to add these services on a category 2 basis to the list of Medicare telehealth services for CY 2016 (80 FR 71061).

This year, requesters cited additional studies to support adding critical care services to the Medicare telehealth list on a category 2 basis. Eight of the studies dealt with telestroke and one with teleneurology. Telestroke is an approach that allows a neurologist to provide remote treatment to vascular stroke victims. Teleneurology offers consultations for neurological problems from a remote location. It may be initiated by a physician or a patient, for conditions such as headaches, dementia, strokes, multiple sclerosis and epilepsy.

However, according to the literature, the management of stroke via telehealth requires more than a single practitioner and is distinct from the work described by the above E/M codes, 99291 and 99292. One additional study cited involved pediatric patients, while another noted that the Department of Defense has used telehealth to provide critical care services to hospitals in Guam for many years. Another reference study indicated that consulting intensivists thought that telemedicine consultations were superior to telephone consultations. In all of these cases, we believe the evidence demonstrates that interaction between these patients and distant site practitioners can have clinical benefit. Start Printed Page 80197However, we do not agree that the kinds of services described in the studies are those that are included in the above critical care E/M codes 99291 and 99292. We note that CPT guidance makes clear that a variety of other services are bundled into the payment rates for critical care, including gastric intubations and vascular access procedures among others We do not believe these kinds of services are furnished via telehealth. Public comments, included cited studies, can be viewed at https://www.regulations.gov/​#!documentDetail;​D=​CMS-2015-0081-0002. Therefore, we did not propose to add CPT codes 99291 or 99292 to the list of Medicare telehealth services for CY 2017.

However, we are persuaded by the requests that we recognize the potential benefit of critical care consultation services that are furnished remotely. We note that there are currently codes on the telehealth list that could be reported when consultation services are furnished to critically ill patients. In consideration of these public requests, we recognize that there may be greater resource costs involved in furnishing these services relative to the existing telehealth consultation codes. We also agree with the requesters that there may be potential benefits of remote care by specialists for these patients. For these reasons, we think it would be advisable to create a coding distinction between telehealth consultations for critically ill patients, for example stroke patients, relative to telehealth consultations for other hospital patients. Such a coding distinction would allow us to recognize the additional resource costs in terms of time and intensity involved in furnishing such services, under the conditions where remote, intensive consultation is required to provide access to appropriate care for the critically ill patient. We recognize that the current set of E/M codes, including current CPT codes 99291 and 99292, may not adequately describe such services because current E/M coding presumes that the services are occurring in-person, in which case the expert care would be furnished in a manner described by the current codes for critical care.

Therefore, we proposed to make payment through new HCPCS codes G0508 and G0509, initial and subsequent, used to describe critical care consultations furnished via telehealth. This new coding would provide a mechanism to report an intensive telehealth consultation service, initial or subsequent, for the critically ill patient, such as a stroke patient, under the circumstance when a qualified health care professional has in-person responsibility for the patient but the patient benefits from additional services from a distant-site consultant specially trained in providing critical care services. We proposed limiting these services to once per day per patient. Like the other telehealth consultations, these services would be valued relative to existing E/M services.

More details on the new coding (G0508 and G0509) and valuation for these services are discussed in section II.L. of this final rule and the final RVUs for this service are included in Addendum B of this final rule, including a summary of the public comments we received and our responses to the comments. Like the other telehealth consultation codes, we proposed that these services would be added to the telehealth list and would be subject to the geographic and other statutory restrictions that apply to telehealth services.

d. Psychological Testing: CPT Codes—

  • 96101 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, e.g., MMPI, Rorschach, WAIS), per hour of the psychologist's or physician's time, both face-to-face time administering tests to the patient and time interpreting these test results and preparing the report);
  • 96102 psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, e.g., MMPI and WAIS), with qualified health care professional interpretation and report, administered by technician, per hour of technician time, face-to-face);
  • 96118 Neuropsychological testing (e.g., Halstead-Reitan neuropsychological battery, Wechsler memory scales and Wisconsin card sorting test), per hour of the psychologist's or physician's time, both face-to-face time administering tests to the patient and time interpreting these test results and preparing the report); and,
  • 96119 Neuropsychological testing (e.g., Halstead-Reitan neuropsychological battery, Wechsler memory scales and Wisconsin card sorting test), with qualified health care professional interpretation and report, administered by technician, per hour of technician time, face-to-face).

Requesters indicated that there is nothing in the Minnesota Multiphasic Personality Inventory (MMPI), the Rorschach inkblot test, the Wechsler Adult Intelligence Scale (WAIS), the Halstead-Reitan Neuropsychological Battery and Allied Procedures, or the Wisconsin Card Sorting Test (WCST), that cannot be done via telehealth nor is different than neurological tests done for Parkinson's disease, seizure medication side effects, gait assessment, nor any of the many neurological examinations done via telehealth with the approved outpatient office visit and inpatient visit CPT codes currently on the telehealth list. As an example, requesters indicated that the MPPI is administered by a computer, which generates a report that is interpreted by the clinical psychologist, and that the test requires no interaction between the clinician and the patient.

We previously considered the request to add these codes to the Medicare telehealth list in the CY 2015 final rule with comment period (79 FR 67600). We decided not to add these codes, indicating that these services are not similar to other services on the telehealth list because they require close observation of how a patient responds. We noted that the requesters did not submit evidence supporting the clinical benefit of furnishing these services via telehealth so that we could evaluate them on a category 2 basis. While we acknowledge that requesters believe that some of these tests require minimal, if any, interaction between the clinician and patient, we disagree. We continue to believe that successful completion of the tests listed as examples in these codes require the clinical psychologist to closely observe the patient's response, which cannot be performed via telehealth. Some patient responses, for example, sweating and fine tremors, may be missed when the patient and examiner are not in the same room. Therefore, we did not propose to add these services to the list of Medicare telehealth services for CY 2017.

e. Physical and Occupational Therapy and Speech-Language Pathology Services: CPT Codes—

  • 92507 (treatment of speech, language, voice, communication, and auditory processing disorder; individual); and, 92508 (treatment of speech, language, voice, communication, and auditory processing disorder; group, 2 or more individuals); 92521 (evaluation of speech fluency (e.g., stuttering, cluttering)); 92522 (evaluation of speech sound production (e.g., articulation, phonological process, apraxia, dysarthria)); 92523 (evaluation of speech sound production (e.g., articulation, phonological process, apraxia, dysarthria); with evaluation of language comprehension and expression Start Printed Page 80198(e.g., receptive and expressive language)); 92524 (behavioral and qualitative analysis of voice and resonance); (evaluation of oral and pharyngeal swallowing function); 92526 (treatment of swallowing dysfunction or oral function for feeding); 92610 (evaluation of oral and pharyngeal swallowing function); CPT codes 97001 (physical therapy evaluation); 97002 (physical therapy re-evaluation); 97003 (occupational therapy evaluation); 97004 (occupational therapy re-evaluation); 97110 (therapeutic procedure, 1 or more areas, each 15 minutes; therapeutic exercises to develop strength and endurance, range of motion and flexibility); 97112 (therapeutic procedure, 1 or more areas, each 15 minutes; neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, or proprioception for sitting or standing activities); 97116 (therapeutic procedure, 1 or more areas, each 15 minutes; gait training (includes stair climbing)); 97532 (development of cognitive skills to improve attention, memory, problem solving (includes compensatory training), direct (one-on-one) patient contact, each 15 minutes); 97533 (sensory integrative techniques to enhance sensory processing and promote adaptive responses to environmental demands, direct (one-on-one) patient contact, each 15 minutes); 97535 (self-care/home management training (e.g., activities of daily living (adl) and compensatory training, meal preparation, safety procedures, and instructions in use of assistive technology devices/adaptive equipment) direct one-on-one contact, each 15 minutes); 97537 (community/work reintegration training (e.g., shopping, transportation, money management, avocational activities or work environment/modification analysis, work task analysis, use of assistive technology device/adaptive equipment), direct one-on-one contact, each 15 minutes); 97542 (wheelchair management (e.g., assessment, fitting, training), each 15 minutes); 97750 (physical performance test or measurement (e.g., musculoskeletal, functional capacity), with written report, each 15 minutes); 97755 (assistive technology assessment (e.g., to restore, augment or compensate for existing function, optimize functional tasks and maximize environmental accessibility), direct one-on-one contact, with written report, each 15 minutes); 97760 Orthotic(s) management and training (including assessment and fitting when not otherwise reported), upper extremity(s), lower extremity(s) and/or trunk, each 15 minutes); 97761 (prosthetic training, upper and lower extremity(s), each 15 minutes); and 97762 (checkout for orthotic/prosthetic use, established patient, each 15 minutes).

The statute defines who is an authorized practitioner of telehealth services. Physical therapists, occupational therapists and speech-language pathologists are not authorized practitioners of telehealth under section 1834(m)(4)(E) of the Act, as defined in section 1842(b)(18)(C) of the Act. Because the above services are predominantly furnished by physical therapists, occupational therapists and speech-language pathologists, we do not believe it would be appropriate to add them to the list of telehealth services at this time. One requester suggested that we can add telehealth practitioners without legislation, as evidenced by the addition of nutritional professionals. However, we do not believe we have such authority and note that nutritional professionals are included as practitioners in the definition at section 1834(b)(18)(C)(vi) of the Act, and thus, are within the statutory definition of telehealth practitioners. Therefore, we did not propose to add these services to the list of Medicare telehealth services for CY 2017.

In summary, we proposed to add the following codes to the list of Medicare telehealth services beginning in CY 2017 on a category 1 basis:

  • ESRD-related services 90967 through 90970. The required clinical examination of the catheter access site must be furnished face-to-face “hands on” (without the use of an interactive telecommunications system) by a physician, CNS, NP, or PA.
  • Advance care planning (CPT codes 99497 and 99498).
  • Telehealth Consultations for a Patient Requiring Critical Care Services (G0508 and G0509).

The following is summary of the comments we received regarding the proposed addition of services to the list of Medicare telehealth services:

Comment: Many commenters supported one or more of our proposals to add ESRD-related services (CPT codes 90967, 90968, 90969 and 90970) and advance care planning services (CPT codes 99497 and 99498) to the list of Medicare telehealth services for CY 2017.

Response: We appreciate the commenters' support for the proposed additions to the list of Medicare telehealth services. After consideration of the public comments received, we are finalizing our proposal to add these services to the list of Medicare telehealth services for CY 2017 on a category 1 basis.

Comment: Many commenters also supported the proposal to make payment through new codes, initial and subsequent, used to describe critical care consultations furnished via telehealth. Commenters indicated that the codes will improve patient outcomes and quality of care.

Response: We thank the commenters for their support. We believe the new coding G0508 and G0509 would provide a mechanism to report an intensive telehealth consultation service, initial or subsequent, for the critically ill patient, for example a stroke patient, under the circumstance when a qualified health care professional has in-person responsibility for the patient but the patient benefits from additional services from a distant-site consultant specially trained in furnishing critical care services. After consideration of the public comments received, we are finalizing our proposal to add these critical care consultation services to the list of Medicare telehealth services for CY 2017 on a category 1 basis. We are finalizing these services as limited to once per day per patient.

We are also finalizing our proposal to make payment for these critical care consultation services through new codes G0508 and G0509, initial and subsequent, used to describe critical care consultations furnished via telehealth. More details on the new coding and valuation for these services are discussed in section II.L. of this final rule and the final RVUs for this service are included in Addendum B of this final rule. Like the other telehealth consultation codes, we proposed and are finalizing that these services would be added to the telehealth list and would be subject to the geographic and other statutory restrictions that apply to telehealth services.

Comment: Several commenters agreed with our decision not to add psychological and neuropsychological testing services to the telehealth list, noting that the face-to-face contact between the psychologist or technician and the beneficiary is critical for detecting behaviors related to test taking, such as movements or other nonverbal signals that could be missed by using current telehealth media.

A few commenters disagreed with our decision not to add psychological and neuropsychological testing services. Commenters cited general benefits, such as increased access to care, improved health outcomes, and as a remedy to address provider shortages. One commenter maintained that the requested codes are similar to many Start Printed Page 80199neurological examinations done via telehealth with the approved outpatient office visit and inpatient visit CPT codes currently on the telehealth list.

Response: As noted above, we previously considered the request to add these codes to the telehealth list, on a category 1 basis, in the CY 2015 final rule with comment period (79 FR 67600). We decided not to add these codes, indicating that these services are not similar to other services on the telehealth list because they require close observation of how a patient responds. Commenters provided no evidence of clinical benefit, which is necessary to support adding these services on a category 2 basis. Therefore, we are not adding these services to the list of Medicare list telehealth services for CY 2017.

Comment: A few commenters disagreed with our decision not to add observation care and emergency department visits. Commenters cited general benefits, such as improved quality of care, reduced physician workload, reduced emergency department overcrowding, and reduced shortage of available specialty services. Concerning CPT codes 99281-99283, one commenter indicated that none of these codes include what is categorized as a “detailed” or “comprehensive” history or exam; none of these codes include complexity in medical decision making that is categorized as “high;” and none of these codes include presenting problems of “high” or “high severity/immediate significant threat to life or physiological function.”

Response: As noted above, we previously considered and rejected adding these codes to the list of Medicare telehealth services in the CY 2005 PFS final rule (69 FR 66276) on a category 1 basis because of the difference in typical patient acuity relative to any services on the current list of Medicare telehealth services. While CPT codes 99281-99283 may not include a detailed or comprehensive history or exam or a high level of medical decision making, we do not agree that these codes are similar to outpatient visit codes (CPT codes 99201-99215) currently on the list of Medicare telehealth services. As previously stated, more acutely ill patients are more likely to be seen in the emergency department, and that difference is part of the reason there are separate codes describing evaluation and management visits in the Emergency Department setting. The work in an Emergency Department setting is distinctly different from the pace, intensity, and acuity associated with visits that occur in the office or outpatient setting. Commenters provided no evidence of clinical benefit for these services when furnished via telehealth specifically, which is necessary to support adding these services on a category 2 basis. Therefore, we are not adding these services to the list of Medicare telehealth services for CY 2017.

We remind stakeholders that if consultative telehealth services are required for patients where emergency department or observation care services would ordinarily be reported, multiple codes describing consultative services are currently on the telehealth list and can be used to bill for such telehealth services.

Comment: Concerning various services primarily furnished by physical therapists, occupational therapists, and speech-language pathologists, commenters recognized that a statutory change is required to allow such services to be added to the list of Medicare telehealth services.

Response: We appreciate commenters recognizing the statutory limitation on adding these services. Therefore, we are not adding these services to the list of Medicare telehealth services for CY 2017.

4. Place of Service (POS) Code for Telehealth Services

We have received multiple requests from various stakeholders to establish a POS code to identify services furnished via telehealth. These requests have come from other payers, but may also be related to confusion concerning whether to use the POS where the distant site physician is located or the POS where the patient is located. The process for establishing POS codes is managed by the POS Workgroup within CMS, is available for use by all payers, and is not contingent upon Medicare PFS rulemaking. We noted in the CY 2017 proposed rule (81 FR 46184) that, if such a POS code were created, in order to make it valid for use in Medicare, we would have to determine the appropriate payment rules associated with the code. Therefore, we proposed how a POS code for telehealth would be used under the PFS with the expectation that, if such a code is available, it would be used as early as January 1, 2017. We proposed that the physicians or practitioners furnishing telehealth services would be required to report the telehealth POS code to indicate that the billed service is furnished as a telehealth service from a distant site. As noted below, since the publication of the CY 2017 proposed rule, the telehealth POS code has been created.

Our requirement for physicians and practitioners to use the telehealth POS code to report that telehealth services were furnished from a distant site would improve payment accuracy and consistency in telehealth claims submission. Currently, for services furnished via telehealth, we have instructed practitioners to report the POS code that would have been reported had the service been furnished in person. However, some practitioners use the POS where they are located when the service is furnished, while others use the POS corresponding to the patient's location.

Under the PFS, the POS code determines whether a service is paid using the facility or non-facility practice expense relative value units (PE RVUs). The facility rate is paid when a service is furnished in a location where Medicare is making a separate facility payment to an entity other than the physician or practitioner that is intended to reflect the facility costs associated with the service (clinical staff, supplies and equipment). We note that in accordance with section 1834(m)(2)(B) of the Act, the payment amount for the telehealth facility fee paid to the originating site is a national fee, paid without geographic or site of service adjustments that generally are made for payments to different kinds of Medicare providers and suppliers. In the case of telehealth services, we believe that facility costs (clinical staff, supplies, and equipment) associated with furnishing the service would generally be incurred by the originating site, where the patient is located, and not by the practitioner at the distant site. The statute requires Medicare to pay a fee to the site that hosts the patient. This is analogous to the circumstances under which the facility PE RVUs are used to pay for services under the PFS. Therefore, we proposed to use the facility PE RVUs to pay for telehealth services reported by physicians or practitioners with the telehealth POS code. We note that there are only three codes on the telehealth list with a difference greater than 1.0 PE RVUs between the facility PE RVUs and the non-facility PE RVUs. We did not anticipate that this proposal would result in a significant change in the total payment for the majority of services on the telehealth list. Moreover, many practitioners already use a facility POS when billing for telehealth services (those that report the POS of the originating site where the beneficiary is located). The policy to use the telehealth POS code for telehealth services would not affect payment for Start Printed Page 80200telehealth services for these practitioners.

The POS code for telehealth would not apply to originating sites billing the facility fee. Originating sites are not furnishing a service via telehealth since the patient is physically present in the facility. Accordingly, the originating site would continue to use the POS code that applies to the type of facility where the patient is located.

We also proposed a change to § 414.22(b)(5)(i)(A) that addresses the PE RVUs used in different settings. These revisions would improve clarity regarding our current policies. Specifically, we proposed to amend this section to specify that the facility PE RVUs are paid for practitioner services furnished via telehealth under § 410.78. In addition, we proposed a change to resolve any potential ambiguity and clarify that payment under the PFS is made at the facility rate (facility PE RVUs) when services are furnished in a facility setting paid by Medicare, including in off-campus provider based departments. As proposed, the regulation reflected the policy being proposed, for CY 2017 only, to pay the physician the nonfacility rate for services furnished in an off-campus provider based department that was not excepted under section 603 of the Bipartisan Budget Act of 2015. Finally, to streamline the existing regulation, we also proposed to delete § 414.32 of our regulation that refers to the calculation of payments for certain services prior to 2002.

The following is summary of the comments we received regarding the proposal to use a POS code for services furnished via telehealth:

Comment: Many commenters supported the proposal to use the POS code for telehealth, indicating that it would clarify and simplify billing requirements, improve payment accuracy and consistency in telehealth claims submissions, and provide more reliable data regarding telehealth services.

Response: We appreciate the support for this proposal.

Comment: One commenter asked us to reconsider the proposal, noting that the AMA's CPT Editorial Panel has adopted a telehealth modifier for those medical services that are currently covered telehealth services by Medicare or other payers, which obviates the need for the POS code.

Response: The POS code was requested by other payers, and we continue to believe that adopting it for use in the Medicare program would provide consistency in reporting and identifying services furnished via telehealth. We have had longstanding HCPCS modifiers for telehealth. While these modifiers were not adopted by CPT, they have been available for use by other payers. Despite the availability of these HCPCS modifiers noting telehealth services, payers have requested creation of the new POS code. Therefore, we do not understand why introduction of a new CPT modifier as opposed to a HCPCS modifier would obviate the need for a POS code. Instead, we agree with other payers that the POS code would provide consistency in reporting and identifying services furnished via telehealth, since it eliminates the need for service-specific rules regarding appropriate POS reporting for telehealth services.

Comment: Another commenter stated that use of the POS code, or originating site restrictions, would place additional administrative barriers for telepsychiatric access.

Response: We note that the POS is a required field on the professional claim, regardless of whether the service is furnished via telehealth. Since a selection needs to be made, we believe that requiring the selection of a specific code is no more burdensome than requiring the claim to specify the POS appropriate to either the setting of the telehealth patient or the setting of the distant site practitioner. The POS code does not entail any new originating site restrictions.

Comment: Various commenters asked for clarification of the following:

  • Whether the POS code would replace the GT modifier.
  • Whether the description of telehealth as a service furnished via an interactive audio and video telecommunications system applies to the POS code as it does to the GT modifier.
  • How to ensure proper payment when the distant site practitioner is at a facility, but the patient is not.

Response: Under current policy, use of the GT and GQ modifiers certifies that the service meets the telehealth requirements, and would continue to be required. The POS code would be used in addition to the GT and GQ modifiers. We did not propose to implement a change in the requirement to use either the GT and GQ modifier because at the time of the proposed rule, we did not know whether the telehealth POS code would be made effective for January 1, 2017. However, because under our proposal the POS code would serve to identify telehealth services furnished under section 1834(m) of the Act via an interactive audio and video telecommunications system, we believe that we should consider eliminating the required use of the GT and GQ telehealth modifiers, and we may revisit this question through future rulemaking. Like the modifiers, use of the POS code certifies that the service meets the telehealth requirements. Distant site providers will be paid using the facility PE RVUs, regardless of their location. The setting of the patient does not affect the payment to the distant site provider.

Comment: Commenters also asked for clarification that the proposal to adopt the telehealth POS relates solely to payment, and not to licensure requirements. The commenter noted that practitioners who furnish telehealth services must adhere to the standard of care and licensure rules, regulations and laws of the state where the patient is located, just as the practitioner would in a traditional face-to-face encounter.

Response: The commenters are correct that the purpose of our POS proposal is to assist in determining proper payment. It will also help us to accurately track telehealth utilization and spending. The proposal to adopt the telehealth POS code has no bearing on state licensure requirements or other state regulations. We appreciate the commenters' request for clarification.

Comment: Several commenters supported the proposal to use the facility PE RVUs for telehealth services. One commenter said paying some telehealth services at non-facility rates creates undesirable financial incentives to prefer telehealth services over services that are furnished in person at the originating site.

Response: We appreciate the support for the proposal and agree with the commenter's articulation regarding the importance of developing payment rates that reflect the relative resource costs of furnishing the services and that do not create unintended financial incentives.

Comment: Many other commenters opposed the proposal. Commenters stated that it would result in lower fees for telehealth services furnished by psychologists. Commenters also stated that PE costs increase for services furnished via telehealth due to the costs of HIPAA-compliant telecommunication equipment.

One commenter remarked that use of a POS code should not be the basis for reducing payments and that many codes would experience a significant payment change. The commenter noted that a 1.0 RVU reduction would result in a $36 payment reduction for the service. One commenter stated CMS should propose budget neutral PE and originating site fees, based on data, for CY 2018. One commenter noted that there are no facility PE RVUs for several codes.Start Printed Page 80201

Response: We do not believe that use of the telehealth POS code produces a significant payment change in the vast majority of circumstances. For distant site practitioners who are already paid using the facility PE RVUs and for services where there is no payment difference between the facility and non-facility PE RVUs, there will be no change in payment as a result of the telehealth POS code.

There is utilization data for 56 of the 81 codes on the telehealth list. For these codes, 20 are not paid differently based on site of service, and 27 codes are paid differently by fewer than 0.5 RVUs. There are only three codes on the telehealth list with a difference greater than 1.0 PE RVUs between the facility PE RVUs and the non-facility PE RVUs.

Concerning psychotherapy and psychological testing services, we note that for the vast majority of psychiatric services the difference between the two rates is very small. For example, the difference between the facility and non-facility national rates for 45 minutes of psychotherapy is 0.02 RVUs per service: Less than $1.00. The differences between the facility PE RVUs and non-facility PE RVUS ranges from 0.01-0.03 RVUs for nine of the psychological testing codes on the Medicare telehealth list, and 0.12 RVUs lower for two other codes. We do not consider these reductions significant, nor do we have any evidence that practice expense costs are greater for furnishing such services via telehealth than for furnishing a face-to-face service. Commenters provided no evidence that practice expense costs for services furnished via telehealth are greater, due to the requirement for HIPAA-compliant equipment, than for furnishing in-person services, even in the facility setting.

There are a few HCPCS codes on the telehealth list that do not have a calculated facility PE RVU. For these services, the non-facility PE RVUs would serve as a proxy, and therefore, there would be no payment change for these codes.

Finally, we note that the originating site facility fee is established by statute (section 1834(m)(2)(B) of the Act) and is not affected by this proposal.

We note that we believe that payment using the facility PE RVUs for telehealth services is consistent our belief that the direct practice expense costs are generally incurred at the location of the beneficiary and not by the distant site practitioner. After reviewing the current list of telehealth services in the context of the comments, we continue to believe this is accurate.

After consideration of the public comments received, we are finalizing our proposal to use the POS code for telehealth and to use the facility PE RVUs to pay for telehealth service reported by physicians or practitioners with the telehealth POS code for CY 2017. However, we understand commenters' concerns and will consider the concerns regarding use of the facility payment rate as we monitor utilization of telehealth services. We will welcome information from stakeholders regarding any potential unintended consequences of the payment policy. We will also consider the applicability of the facility rate to any codes newly added to the list of telehealth services.

We have updated the POS code list on our Web site at https://www.cms.gov/​Medicare/​Coding/​place-of-service-codes/​Place_​of_​Service_​Code_​Set.html to include POS 02: Telehealth (Descriptor: The location where health services and health related services are provided or received, through telecommunication technology). The new code will be used for services furnished on or after January 1, 2017.

We are finalizing proposed revisions to our regulation at § 414.22(b)(5)(i)(A) that addresses the PE RVUs used in different settings as described above, except that we are not finalizing the proposed change that would have resulted in the payment of the nonfacility rate for services furnished in off-campus provider based departments that are not excepted under Section 603 of the Bipartisan Budget Act of 2015 since we are finalizing that payments to such non-excepted PBDs will be made under the PFS. In a separate interim final rule with comment period issued in conjunction with the CY 2017 OPPS/ASC final rule with comment period (see Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Certain Off-Campus Outpatient Departments of a Provider; Hospital Value-Based Purchasing (VBP) Program; Establishment of Physician Fee Schedule Payment Rates for Nonexcepted Items and Services Billed by Applicable Departments of a Hospital), we are finalizing other payment policies for nonexcepted items and services furnished by such non-excepted off-campus provider based departments. Accordingly, physicians furnishing services in such provider-based departments will continue to be paid the facility rate. We are also finalizing the proposal to delete § 414.32 of our regulation that refers to the calculation of payments for certain services prior to 2002.

We remind the public that we are currently soliciting requests to add services to the list of Medicare telehealth services. To be considered during PFS rulemaking for CY 2018, these requests must be submitted and received by December 31, 2016. Each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requester 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 mail these requests, we refer readers to the CMS Web site at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

5. Telehealth Originating Site Facility Fee Payment Amount Update

Section 1834(m)(2)(B) of the Act establishes the Medicare telehealth originating site facility fee for telehealth services furnished from October 1, 2001 through December 31, 2002, at $20.00. For telehealth services furnished on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The originating site facility fee for telehealth services furnished in CY 2016 is $25.10. The MEI increase for 2017 is 1.2 percent and is based on the most recent historical update through 2016Q2 (1.6 percent), and the most recent historical MFP through calendar year 2015 (0.4 percent). Therefore, for CY 2017, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $25.40. The Medicare telehealth originating site facility fee and the MEI increase by the applicable time period is shown in Table 6.

Table 6—The Medicare Telehealth Originating Site Facility Fee and MEI

[Increase by the applicable time period]

Time periodMEI increaseFacility fee
10/01/2001-12/31/2002N/A$20.00
01/01/2003-12/31/20033.020.60
01/01/2004-12/31/20042.921.20
01/01/2005-12/31/20053.121.86
01/01/2006-12/31/20062.822.47
01/01/2007-12/31/20072.122.94
01/01/2008-12/31/20081.823.35
01/01/2009-12/31/20091.623.72
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01/01/2010-12/31/20101.224.00
01/01/2011-12/31/20110.424.10
01/01/2012-12/31/20120.624.24
01/01/2013-12/31/20130.824.43
01/01/2014-12/31/20140.824.63
01/01/2015-12/31/20150.824.83
01/01/2016-12/31/20161.125.10
01/01/2017-12/31/20171.225.40

D. Potentially Misvalued Services Under the Physician Fee Schedule

1. Background

Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) to the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.

As discussed in section II.B. of this final rule, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Medicare Payment Advisory Commission (MedPAC), and others. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by the law. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting System (PQRS) databases. In addition to considering the most recently available data, we also assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.

In its March 2006 Report to the Congress (http://www.medpac.gov/​documents/​reports/​Mar06_​EntireReport.pdf?​sfvrsn=​0), MedPAC discussed the importance of appropriately valuing physicians' services, noting that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, “When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” We believe services can also become overvalued when PE declines. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PE rises.

As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/​documents/​reports/​march-2009-report-to-congress-medicare-payment-policy.pdf?​sfvrsn=​0), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories:

  • Codes that have experienced the fastest growth.
  • Codes that have experienced substantial changes in practice expenses.
  • Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.
  • Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.
  • Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
  • Codes that have not been subject to review since implementation of the fee schedule.
  • Codes that account for the majority of spending under the physician fee schedule.
  • Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.
  • Codes for which there may be a change in the typical site of service since the code was last valued.
  • Codes for which there is a significant difference in payment for the same service between different sites of service.
  • Codes for which there may be anomalies in relative values within a family of codes.
  • Codes for services where there may be efficiencies when a service is furnished at the same time as other services.
  • Codes with high intra-service work per unit of time.
  • Codes with high practice expense relative value units.
  • Codes with high cost supplies.
  • Codes as determined appropriate by the Secretary.

Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of Start Printed Page 80203any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the physician fee schedule.

2. Progress in Identifying and Reviewing Potentially Misvalued Codes

To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well.

Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed over 1,671 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period (76 FR 73052 through 73055). In the CY 2012 PFS final rule with comment period, we finalized our policy to consolidate the review of physician work and PE at the same time (76 FR 73055 through 73958), and established a process for the annual public nomination of potentially misvalued services.

In the CY 2013 PFS final rule with comment period, we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes”). In CY 2009, we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes (73 FR 38589). In the fourth Five-Year Review (76 FR 32410), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time).

In the CY 2016 PFS final rule with comment period, we finalized for review a list of potentially misvalued services, which included eight codes in the neurostimulators analysis-programming family (CPT 95970-95982). We also finalized as potentially misvalued 103 codes identified through our screen of high expenditure services across specialties.

3. Validating RVUs of Potentially Misvalued Codes

Section 1848(c)(2)(L) of the Act requires the Secretary to establish a formal process to validate RVUs under the PFS. The Act specifies that the validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may include validation of the pre-, post-, and intra-service components of work. The Secretary is directed, as part of the validation, to validate a sampling of the work RVUs of codes identified through any of the 16 categories of potentially misvalued codes specified in section 1848(c)(2)(K)(ii) of the Act. Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes, including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the validation of RVUs of services.

In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS proposed rule (76 FR 42790), we solicited public comments on possible approaches, methodologies, and data sources that we should consider for a validation process. A summary of the comments along with our responses are included in the CY 2011 PFS final rule with comment period (75 FR 73217) and the CY 2012 PFS final rule with comment period (73054 through 73055).

We contracted with two outside entities to develop validation models for RVUs.

Given the central role of time in establishing work RVUs and the concerns that have been raised about the current time values used in rate setting, we contracted with the Urban Institute to develop empirical time estimates based on data collected from several health systems with multispecialty group practices. The Urban Institute collected data by directly observing the delivery of services and through the use of electronic health records for services selected by the contractor in consultation with CMS and is using this data to produce objective time estimates. We expect the final Urban Institute report will be made available on the CMS Web site later this year.

The second contract is with the RAND Corporation, which used available data to build a validation model to predict work RVUs and the individual components of work RVUs, time and intensity. The model design was informed by the statistical methodologies and approach used to develop the initial work RVUs and to identify potentially misvalued procedures under current CMS and RUC processes. RAND consulted with a technical expert panel on model design issues and the test results. The RAND report is available under downloads on the Web site for the CY 2015 PFS final rule with comment period at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices-Items/​CMS-1612-FC.html.

After posting RAND's report on the models and results on our Web site, we received comments indicating that the models did not adequately address global surgery services due to the lack of available data on included visits. Therefore, we modified the RAND contract to include the development of G-codes that could be used to collect data about post-surgical follow-up visits on Medicare claims to meet the requirements in section 1848(c)(8)(B) of the Act regarding collection of data on global services. Our discussion related to this data collection requirement is in section II.D.6. Also, the data from this project would provide information that would allow the time for these services to be included in the model for validating RVUs.Start Printed Page 80204

4. CY 2017 Identification and Review of Potentially Misvalued Services

a. 0-Day Global Services That Are Typically Billed With an Evaluation and Management (E/M) Service With Modifier 25

Because routine E/M is included in the valuation of codes with 0-, 10-, and 90-day global periods, Medicare only makes separate payment for E/M services that are provided in excess of those considered included in the global procedure. In such cases, the physician would report the additional E/M service with Modifier 25, which is defined as a significant, separately identifiable E/M service performed by the same physician on the day of a procedure above and beyond other services provided or beyond the usual preservice and postservice care associated with the procedure that was performed. Modifier 25 allows physicians to be paid forE/M services that would otherwise be denied as bundled.

In reviewing misvalued codes, both CMS and the RUC have often considered how frequently particular codes are reported with E/M codes to account for potential overlap in resources. Some stakeholders have expressed concern with this policy especially with regard to the valuation of 0-day global services that are typically billed with a separate E/M service with the use of Modifier 25. For example, when we established our valuation of the osteopathic manipulative treatment (OMT) services, described by CPT codes 98925-98929, we did so with the understanding that these codes are usually reported withE/M codes.

For our CY 2017 proposal (81 FR 46187), we investigated Medicare claims data for CY 2015 and found that 19 percent of the codes that described 0-day global services were billed over 50 percent of the time with an E/M with Modifier 25. Since routine E/M is included in the valuation of 0-day global services, we believed that the routine billing of separate E/M services may have indicated a possible problem with the valuation of the bundle, which is intended to include all the routine care associated with the service.

In the proposed rule (81 FR 46187), we stated that reviewing the procedure codes typically billed with an E/M with Modifier 25 may be one avenue to appropriate valuation for these services. Therefore, we developed and proposed a screen for potentially misvalued codes that identified 0-day global codes billed with an E/M 50 percent of the time or more, on the same day of service, with the same physician and same beneficiary. We included a list of codes with total allowed services greater than 20,000. There are 83 codes that met the proposed criteria for the screen and were proposed as potentially misvalued. We also sought comment regarding additional ways to address appropriate valuations for all services that are typically billed with an E/M with Modifier 25.

The following is the summary of the comments we received.

Comment: Several commenters disagreed with CMS' assertion that there is a possible valuation problem with the bundle when an E/M with Modifier 25 is typically reported on the same day of service as a 0-day global procedure. Commenters stated that billing an E/M with Modifier 25 pays physicians for the justifiable and appropriate services they render to patients; allowing for a patient-centered approach to care. Some commenters considered the possibility that there could be fraudulent billing practices when reporting an E/M with Modifier 25 and a few offered various solutions for rectifying the problem from a program integrity perspective. For example, one commenter suggested that further education on the appropriate use of Modifier 25 or penalty for misuse would be effective alternatives to combat inappropriate billing while another commenter suggested investigating the diagnosis coding for services.

Commenters overwhelmingly opposed any change to billing policies or standard valuation for 0-day services that are billed with an E/M with Modifier 25.

Response: We appreciate commenters' perspective on this issue. While we understand the commenters' views, since routine E/M is included in the valuation of 0-day global services we continue to believe that the routine billing of separate E/M services may still indicate a possible problem with the valuation of the global period or the assignment of the global period for particular codes, given that the period is intended to include all the routine care associated with the service. As discussed below, we are finalizing some of the 0-day global services as potentially misvalued. We will also continue to consider this issue for future rulemaking.

Comment: Several commenters expressed appreciation for the identification of an objective screen and reasonable query. While some commenters were accepting of the screen as proposed, others stated their preference for the screen to be withdrawn entirely or limited in scope, with some commenters suggesting the screen be limited to the codes that met the criteria and for which the overlap had not already been considered by the RUC in developing recommended values. Several thousand commenters suggested withdrawing or limiting the scope of this screen, particularly as it pertains to the OMT codes.

Response: Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(K) of the Act identifies several categories of services as potentially misvalued, including codes for services where there may be efficiencies when a service is furnished at the same time as other services, along with codes as determined appropriate by the Secretary. Based on the comments received, we understand that stakeholders would have us identify as potentially misvalued only those individual codes with obvious overlapping resource costs when typically reported with an E/M, rather than consider the issue of misvaluation of the global period more broadly. In response to these comments, we are finalizing the use of our screen for 0-day global services that are typically billed with an E/M with Modifier 25 as a mechanism for identifying services that are potentially misvalued.

Because we recognize that the primary purpose in displaying lists of misvalued codes in rulemaking has been to seek recommendations regarding appropriate valuation from stakeholders, including the RUC, for 2017 we are only identifying the services for which we believe there might be the kind of misvaluation the RUC and the medical specialty societies recognize. Based on the comments from these organizations, we believe that for codes reviewed in the past 5 years, the RUC has already addressed that kind of misvaluation. In other words, commenters have made clear that external review of these services is likely to be limited to clear overlap in resource costs, but will not address the broader concerns we have about developing rates for services that include routine E/M when evaluation and management is also routinely separately reported. As a result, we will continue to consider that issue for future rulemaking. We note that we are required under statute to improve the valuation of the 10- and 90-day global periods, and therefore, we will consider this issue in that context, as well.

Comment: While some commenters supported our review of the 83 codes that were proposed as potentially Start Printed Page 80205misvalued through the screen, the majority of commenters, including the RUC, stated that the codes detailed in Table 7 did not meet the criteria for the screen because they were either reviewed in the last 5 years and/or are not typically reported with an E/M, and therefore, should be removed. While commenters largely disagreed on the list of proposed codes, most agreed that the services they believed met the screen criteria should be reviewed.

Table 7—Codes Requested To Be Removed From the List of Potentially Misvalued Services

HCPCSLong descriptor
11000Removal of inflamed or infected skin, up to 10% of body surface.
11100Biopsy of single growth of skin and/or tissue.
11300Shaving of 0.5 centimeters or less skin growth of the trunk, arms, or legs.
11301Shaving of 0.6 centimeters to 1.0 centimeters skin growth of the trunk, arms, or legs.
11302Shaving of 1.1 to 2.0 centimeters skin growth of the trunk, arms, or legs.
11305Shaving of 0.5 centimeters or less skin growth of scalp, neck, hands, feet, or genitals.
11306Shaving of 0.6 centimeters to 1.0 centimeters skin growth of scalp, neck, hands, feet, or genitals.
11307Shaving of 1.1 to 2.0 centimeters skin growth of scalp, neck, hands, feet, or genitals.
11310Shaving of 0.5 centimeters or less skin growth of face, ears, eyelids, nose, lips, or mouth.
11311Shaving of 0.6 centimeters to 1.0 centimeters skin growth of face, ears, eyelids, nose, lips, or mouth.
11312Shaving of 1.1 to 2.0 centimeters skin growth of face, ears, eyelids, nose, lips, or mouth.
11740Removal of blood accumulation between nail and nail bed.
11900Injection of up to 7 skin growths.
11901Injection of more than 7 skin growths.
12001Repair of wound (2.5 centimeters or less) of the scalp, neck, underarms, trunk, arms and/or legs.
12002Repair of wound (2.6 to 7.5 centimeters) of the scalp, neck, underarms, genitals, trunk, arms and/or legs.
12004Repair of wound (7.6 to 12.5 centimeters) of the scalp, neck, underarms, genitals, trunk, arms and/or legs.
12011Repair of wound (2.5 centimeters or less) of the face, ears, eyelids, nose, lips, and/or mucous membranes.
12013Repair of wound (2.6 to 5.0 centimeters) of the face, ears, eyelids, nose, lips, and/or mucous membranes.
17250Application of chemical agent to excessive wound tissue.
20550Injections of tendon sheath, ligament, or muscle membrane.
20552Injections of trigger points in 1 or 2 muscles.
20553Injections of trigger points in 3 or more muscles.
20600Aspiration and/or injection of small joint or joint capsule.
20604Arthrocentesis, aspiration and/or injection, small joint or bursa (eg, fingers, toes); with ultrasound guidance, with permanent recording and reporting.
20605Aspiration and/or injection of medium joint or joint capsule.
20606Arthrocentesis, aspiration and/or injection, intermediate joint or bursa (eg, temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bursa); with ultrasound guidance, with permanent recording and reporting.
20610Aspiration and/or injection of large joint or joint capsule.
20611Arthrocentesis, aspiration and/or injection, major joint or bursa (eg, shoulder, hip, knee, subacromial bursa); with ultrasound guidance, with permanent recording and reporting.
20612Aspiration and/or injection of cysts.
29125Application of non-moveable, short arm splint (forearm to hand).
29515Application of short leg splint (calf to foot).
30901Simple control of nose bleed.
30903Complex control of nose bleed.
31231Diagnostic examination of nasal passages using an endoscope.
31238Control of nasal bleeding using an endoscope.
31500Emergent insertion of breathing tube into windpipe cartilage using an endoscope.
31575Diagnostic examination of voice box using flexible endoscope.
31579Examination to assess movement of vocal cord flaps using an endoscope.
31645Aspiration of lung secretions from lung airways using an endoscope.
32551Removal of fluid from between lung and chest cavity, open procedure.
32554Removal of fluid from chest cavity.
40490Biopsy of lip.
46600Diagnostic examination of the anus using an endoscope.
51701Insertion of temporary bladder catheter.
51702Insertion of indwelling bladder catheter.
51703Insertion of indwelling bladder catheter.
56605Biopsy of external female genitals.
57150Irrigation of vagina and/or application of drug to treat infection.
57160Fitting and insertion of vaginal support device.
58100Biopsy of uterine lining.
64418Injection of anesthetic agent, collar bone nerve.
65222Removal of foreign body, external eye, cornea with slit lamp examination.
67810Biopsy of eyelid.
67820Removal of eyelashes by forceps.
68200Injection into conjunctiva.
69100Biopsy of ear.
69200Removal of foreign body from ear canal.
69210Removal of impact ear wax, one ear.
69220Removal of skin debris and drainage of mastoid cavity.
92511Examination of the nose and throat using an endoscope.
92941Insertion of stent, removal of plaque and/or balloon dilation of coronary vessel during heart attack, accessed through the skin.
92950Attempt to restart heart and lungs.
Start Printed Page 80206
98925Osteopathic manipulative treatment to 1-2 body regions.
98926Osteopathic manipulative treatment to 3-4 body regions.
98927Osteopathic manipulative treatment to 5-6 body regions.
98928Osteopathic manipulative treatment to 7-8 body regions.
98929Osteopathic manipulative treatment to 9-10 body regions.

Response: After considering the comments received, we are significantly reducing the number of codes identified as potentially misvalued. We agree with commenters that the majority of the codes that we are not finalizing have been recently reviewed. Due to a drafting error in the proposed rule, we stated that we had exempted codes that had been reviewed in the past 5 years. While that exclusion has been standard for many other misvalued code screens, we did not intend to apply it in this case, given our concerns with the valuation of the global period when E/M visits are routinely reported at the same time. As displayed in the proposed rule, the list of codes reflected our intention to include codes that have been recently reviewed. Regardless, we understand based on comments that any review by stakeholders for recently reviewed codes would be likely to result in similar valuation. Therefore, we do not believe that we should include codes reviewed in the past 5 years on this list of misvalued codes, given the limited nature of the likely review. Regarding the accuracy of which of the codes are typically reported with E/M codes, we note that our review included analysis was based on more recent, full claims data than had yet been made public. In the interest of transparency, we are finalizing the list of services based on the publically available data.

Table 8—List of Potentially Misvalued Services Identified Through the Screen for 0-Day Global Services That Are Typically Billed With an Evaluation and Management (E/M) Service With Modifier 25

HCPCSLong descriptor
11755Biopsy of finger or toe nail.
20526Injection of carpal tunnel.
20551Injections of tendon attachment to bone.
20612Aspiration and/or injection of cysts.
29105Application of long arm splint (shoulder to hand).
29540Strapping of ankle and/or foot.
29550Strapping of toes.
43760Change of stomach feeding, accessed through the skin.
45300Diagnostic examination of rectum and large bowel using an endoscope.
57150Irrigation of vagina and/or application of drug to treat infection.
57160Fitting and insertion of vaginal support device.
58100Biopsy of uterine lining.
64405Injection of anesthetic agent, greater occipital nerve.
64455Injections of anesthetic and/or steroid drug into nerve of foot.
65205Removal of foreign body in external eye, conjunctiva.
65210Removal of foreign body in external eye, conjunctiva or sclera.
67515Injection of medication or substance into membrane covering eyeball.
G0168Wound closure utilizing tissue adhesive(s) only.
G0268Removal of impacted cerumen (one or both ears) by physician on same date of service as audiologic function testing.

b. End-Stage Renal Disease Home Dialysis Services (CPT Codes 90963 Through 90970)

In the CY 2004 PFS final rule with comment period (68 FR 63216), we established new Level II HCPCS G-codes for end-stage renal disease (ESRD) services and established payment for those codes through monthly capitation payment (MCP) rates. For ESRD center-based patients, payment for the G-codes varied based on the age of the beneficiary and the number of face-to-face visits furnished each month (for example, 1 visit, 2-3 visits and 4 or more visits). We believed that many physicians would provide 4 or more visits to center-based ESRD patients and a small proportion will provide 2-3 visits or only one visit per month. Under the MCP methodology, to receive the highest payment, a physician would have to provide at least four ESRD-related visits per month. However, payment for home dialysis MCP services only varied by the age of beneficiary. Although we did not initially specify a frequency of required visits for home dialysis MCP services, we stated that we expect physicians to provide clinically appropriate care to manage the home dialysis patient.

The CPT Editorial Panel created new CPT codes to replace the G-codes for monthly ESRD-related services, and we accepted the new codes for use under the PFS in CY 2009. The CPT codes created were 90963-90966 for monthly ESRD-related services for home dialysis patient and CPT codes 90967-90970 for dialysis with less than a full month of services.

In a GAO report titled “END-STAGE RENAL DISEASE Medicare Payment Refinements Could Promote Increased Use of Home Dialysis” dated October 2015, http://www.gao.gov/​products/​GAO-16-125, the GAO stated that experts and stakeholders they interviewed indicated that home dialysis could be clinically appropriate for at least half of patients. Also, at a meeting in 2013, the chief medical officers of 14 dialysis facility chains jointly estimated that a realistic target for home dialysis would be 25 percent of dialysis patients. The GAO noted that CMS data showed that about 10 percent of adult Medicare dialysis patients use home dialysis as of March 2015.Start Printed Page 80207

In the report, the GAO noted that CMS intended for the existing payment structure to create an incentive for physicians to prescribe home dialysis, because the monthly payment rate for managing the dialysis care of home patients, which requires a single in-person visit, was approximately equal to the rate for managing and providing two to three visits to ESRD center-based patients. However, GAO found that, in 2013, the rate of $237 for managing home patients was lower than the average payment of $266 and maximum payment of $282 for managing ESRD center-based patients. The GAO stated that this difference in payment rates may discourage physicians from prescribing home dialysis.

Physician associations and other physicians GAO interviewed stated that the visits with home patients are often longer and more comprehensive than in-center visits; this is in part because physicians may conduct visits with individual home patients in a private setting, but they may be able to more easily visit multiple in-center patients on a single day as they receive dialysis. The physician associations GAO interviewed also said that they may spend a similar amount of time outside of visits to manage the care of home patients and that they are required to provide at least one visit per month to perform a complete assessment of the patient.

It is important to note that, as stated in the CY 2011 PFS final rule with comment period (75 FR 73296), we believe that furnishing monthly face-to-face visits is an important component of high quality medical care for ESRD patients being dialyzed at home and generally would be consistent with the current standards of medical practice. However, we also acknowledged that extenuating circumstances may arise that make it difficult for the MCP physician (or NPP) to furnish a visit to a home dialysis patient every month. Therefore, we allow Medicare contractors the discretion to waive the requirement for a monthly face-to-face visit for the home dialysis MCP service on a case-by-case basis, for example, when the MCP physician's (or NPP's) notes indicate that the MCP physician (or NPP) actively and adequately managed the care of the home dialysis patient throughout the month.

The GAO recommended, and we agreed, that CMS examine Medicare policies for monthly payments to physicians to manage the care of dialysis patients and revise them if necessary to ensure that these policies are consistent with our goal of encouraging the use of home dialysis among patients for whom it is appropriate. Therefore, we proposed to identify CPT codes 90963 through 90970 as potentially misvalued codes based on the volume of claims submitted for these services relative to those submitted for facility ESRD services.

The following is summary of the comments we received.

Comment: Commenters supported the proposal to identify these codes as potentially misvalued and supported CMS' goal of encouraging the use of home dialysis among patients for whom it is appropriate. Some commenters suggested we establish parity between payment for four ESRD-related visits per month for in-center dialysis patients and payment for the care of home dialysis patients for an entire month. One commenter cautioned that CMS should also consider factors other than payment that play a critical role in whether a patient decides to use a home dialysis modality as outlined in a recent GAO report and requested that CMS work closely with nephrologists on this issue. One commenter encouraged CMS to focus on incentives for the adult population separately from pediatrics as they see no benefit from reanalysis of the pediatric home and daily dialysis CPT codes 90963-90965 and 90967-90969.

Response: We appreciate all of the comments and agree that CPT codes 90963 through 90970 should be identified as potentially misvalued. After considering the comments, we are finalizing the addition of CPT codes 90963 through 90970 to the list of potentially misvalued codes. We will also continue to consider these issues for future rulemaking.

c. Direct PE Input Discrepancies

i. Appropriate Direct PE Inputs Involved in Procedures Involving Endoscopes

In the proposed rule (81 FR 46190), we stated that stakeholders had raised concerns about potential inconsistencies with the inputs and the prices related to endoscopic procedures in the direct PE database. Upon review, we noted that there are 45 different pieces of endoscope related-equipment and 25 different pieces of endoscope related-supplies that are currently associated with these services. Relative to other kinds of equipment items in the direct PE input, these items are much more varied and used for many fewer services. Given the frequency with which individual codes can be reviewed and the importance of standardizing inputs for purposes of maintaining relativity across PFS services, we believed that this unusual degree of variation was likely to result in code misvaluation. To facilitate efficient review of this particular kind of misvaluation, and because we believed that stakeholders would prefer the opportunity to contribute to such standardization, we requested that stakeholders like the AMA RUC review and make recommendations on the appropriate endoscopic equipment and supplies typically provided in all endoscopic procedures for each anatomical body region, along with their appropriate prices.

The following is summary of the comments we received.

Comment: Many commenters stated that the RUC is the appropriate resource for the review of appropriate direct PE inputs involved in procedures involving endoscopes and urged CMS to work with the RUC to address this issue. Additionally, the RUC stated that due to the complexity of this issue and the need to incorporate input from various specialty societies that the RUC planned to form a workgroup of the PE subcommittee to review the issue.

Response: We appreciate the comments and will review any recommendation provided to us by the RUC for use in future rulemaking, consistent with our normal review processes.

ii. Appropriate Direct PE Inputs in the Facility Post-Service Period When Post-Operative Visits Are Excluded

In the proposed rule (81 FR 46190), we identified a potential inconsistency in instances where there are direct PE inputs included in the facility postservice period even though post-operative visit is not included in a service. We identified 13 codes affected by this issue and stated that we were unclear if the discrepancy was caused by inaccurate direct PE inputs or inaccurate post-operative data in the work time file. We requested that stakeholders including the AMA RUC review these discrepancies and provide their recommendations on the appropriate direct PE inputs for the codes.

The following is summary of the comments we received.

Comment: The RUC stated that for CPT codes 21077 (Impression and preparation of eye socket prosthesis), 21079 (Impression and custom preparation of temporary oral prosthesis), 21080 (Impression and custom preparation of permanent oral prosthesis), 21081 (Impression and custom preparation of lower jaw bone prosthesis), 21082 (Impression and custom preparation of prosthesis for Start Printed Page 80208roof of mouth enlargement), 21083 (Impression and custom preparation of roof of mouth prosthesis), and 21084 (Impression and custom preparation of speech aid prosthesis) the practice expense time in the postservice period in the facility setting is completely distinct from the physician post-operative visit and that time must be accounted for the manufacture and fitting of the prosthetics. The RUC stated that the following codes all had inaccurate post-operative data in the work time file and provided recommendations on appropriate post-operative visits: CPT codes 28636 (Insertion of hardware to foot bone dislocation with manipulation, accessed through the skin), 28666 (Insertion of hardware to toe joint dislocation with manipulation, accessed through the skin), 43652 (Incision of vagus nerves of stomach using an endoscope), 47570 (Connection of gall bladder to bowel using an endoscope), and 66986 (Exchange of lens prosthesis). Additionally, another commenter stated that CPT code 46900 (Chemical destruction of anal growths) also had inaccurate post-operative data in the work time file and provided a recommendation on the appropriate post-operative visit.

Response: We thank stakeholders for their comments. We will review the recommendations provided to us by the AMA RUC and other commenters and will consider for future rulemaking, consistent with our normal review processes.

d. Insertion and Removal of Drug Delivery Implants—CPT Codes 11981 and 11983

In the proposed rule (81 FR 46190), we stated that stakeholders had urged CMS to create new coding describing the insertion and removal of drug delivery implants for buprenorphine hydrochloride, formulated as a 4 rod, 80 mg, long acting subdermal drug implant for the treatment of opioid addiction. The stakeholders suggested that current coding describing insertion and removal of drug delivery implants was too broad and that new coding was needed to account for specific additional resource costs associated with particular treatment. We identified existing CPT codes 11981 (Insertion, non-biodegradable drug delivery implant), 11982 (Removal, non-biodegradable drug delivery implant), and 11983 (Removal with reinsertion, non-biodegradable drug delivery implant) as potentially misvalued codes and sought comment and information regarding whether the current resource inputs in work and practice expense for the codes appropriately accounted for variations in the service relative to which devices and related drugs are inserted and removed.

The following is summary of the comments we received.

Comment: One commenter stated that CMS should create distinct codes and payment levels for a four-rod implant as opposed to the one-rod implant detailed in CPT codes 11981-11983. In contrast, another commenter stated that the identified codes adequately describe the work and practice expense for drug implant delivery and removal services. Additionally, another commenter stated the codes should be removed from the potentially misvalued list. The RUC stated that a coding change proposal had been submitted for the services under the CPT process and that the RUC anticipated providing relevant recommendations for CY 2018.

Response: We thank stakeholders for their comments. We will review new coding and recommended valuations for future rulemaking, consistent with our normal review processes.

5. Valuing Services That Include Moderate Sedation as an Inherent Part of Furnishing the Procedure

The CPT manual identifies more than 400 diagnostic and therapeutic procedures (listed in Appendix G) for which the CPT Editorial Panel has determined that moderate sedation is an inherent part of furnishing the procedure. In developing RVUs for these services, we include the relative resources associated with moderate sedation in the valuation since the CPT codes include moderate sedation as an inherent part of the procedure. Therefore, practitioners only report the procedure code when furnishing the service. Endoscopic procedures constitute a significant portion of the services identified in Appendix G. In the CY 2015 PFS proposed rule (79 FR 40349), we noted that it appeared that practice patterns for endoscopic procedures were changing, with anesthesia increasingly being separately reported for these procedures, meaning that the relative resources associated with sedation were no longer incurred by the practitioner reporting the Appendix G procedure. We indicated that, in order to reflect apparent changes in medical practice, we were considering establishing a uniform approach to the appropriate valuation of all Appendix G services for which moderate sedation is no longer inherent, rather than addressing the issue at the procedure level as individual codes are revalued. We solicited public comment on approaches to the appropriate valuation of these services.

In the CY 2016 PFS proposed rule (80 FR 41707), we again solicited public comment and recommendations on approaches to address the appropriate valuation of moderate sedation related to Appendix G services. Following our comment solicitation, the CPT Editorial Panel created CPT codes for separately reporting moderate sedation services in association with the elimination of Appendix G from the CPT manual for CY 2017. This coding change would provide for payment for moderate sedation services only in cases where they are furnished. In addition to providing recommended values for the new codes used to separately report moderate sedation, the RUC provided a methodology for revaluing all services previously identified in Appendix G, without moderate sedation, in order to make appropriate corresponding adjustments for the procedural services. The RUC recommended this methodology to address moderate sedation valuation generally instead of recommending that it be addressed as individual codes are reviewed. The RUC's recommended methodology would remove work RVUs for moderate sedation from Appendix G codes based on a code-level assessment of whether the procedures are typically furnished to straightforward patients or more difficult patients. Based on its recommended methodology, the RUC recommended removal of fewer RVUs from each of the procedural services than it recommended for valuing the moderate sedation services. If we were to use the RUC-recommended values for both the moderate sedation codes and the Appendix G procedural codes without refinement, overall payments for these procedures, when moderate sedation is furnished, would increase relative to the current payment.

We direct readers to section II.L. of this final rule, which includes more detail regarding our valuation of the new moderate sedation codes, our methodology for revaluation of the procedural codes previously identified in Appendix G, and discussion and responses to the public comments we received regarding our proposal. We believe that the RVUs assigned under the PFS should reflect the overall relative resources of PFS services, regardless of how many codes are used to report the services. Therefore, our methodology for valuation of Appendix G procedural services maintains current resource assumptions for the procedures when furnished with moderate sedation and redistributes the RVUs associated with moderate sedation (previously Start Printed Page 80209included in the Appendix G procedural codes) to other PFS services. We believe that this methodology for revaluation of Appendix G services without moderate sedation is consistent with our general principle that the overall relative resources for the procedures do not change based solely on changes in coding.

We also noted in the CY 2017 PFS proposed rule that stakeholders presented information to CMS regarding specialty group survey data for physician work. The stakeholders shared survey results for physician work involved in furnishing moderate sedation that demonstrated a significant bimodal distribution between procedural services furnished by gastroenterologists (GI) and procedural services furnished by other specialties. Since we believe that gastroenterologists furnish the highest volume of services previously identified in Appendix G, and services primarily furnished by gastroenterologists prompted the concerns that led to our identification of changes in medical practice and potentially duplicative payment for these codes, we have addressed the variations between GI and other specialties in our review of the new moderate sedation CPT codes and their recommended values. We again direct readers to section II.L. of this final rule where we discuss our establishment of an endoscopy-specific moderate sedation G-code that augments the new CPT codes for moderate sedation, the public comments we received, and our finalized valuations reflecting the differences in the physician survey data between GI and other specialties.

6. Collecting Data on Resources Used in Furnishing Global Services

a. Background

(1) Current Payment Policy for Global Packages

Under the PFS, certain services, such as surgery, are valued and paid for as part of global packages that include the procedure and the services typically furnished in the periods immediately before and after the procedure. For each of these global packages, we establish a single PFS payment that includes payment for particular services that we assume to be typically furnished during the established global period. There are three primary categories of global packages that are labeled based on the number of post-operative days included in the global period: 0-day; 10-day; and 90-day. The 0-day global packages include the surgical procedure and the pre-operative and post-operative services furnished by the physician on the day of the service. The 10-day global packages include these services and, in addition, visits related to the procedure during the 10 days following the day of the procedure. The 90-day global packages include the same services as the 0-day global codes plus the pre-operative services furnished one day prior to the procedure and post-operative services during the 90 days immediately following the day of the procedure. Section 40.1 of Chapter 12 of the Claims Processing Manual (Pub. 100-04) defines the global surgical package to include the following services related to the surgery when furnished during the global period by the same physician or another practitioner in the same group practice:

  • Pre-operative Visits: Pre-operative visits after the decision is made to operate beginning with the day before the day of surgery for major procedures and the day of surgery for minor procedures;
  • Intra-operative Services: Intra-operative services that are normally a usual and necessary part of a surgical procedure;
  • Complications Following Surgery: All additional medical or surgical services required of the surgeon during the post-operative period of the surgery because of complications that do not require additional trips to the operating room;
  • Post-operative Visits: Follow-up visits during the post-operative period of the surgery that are related to recovery from the surgery;
  • Post-surgical Pain Management: By the surgeon; and
  • Miscellaneous Services: Items such as dressing changes; local incisional care; removal of operative pack; removal of cutaneous sutures and staples, lines, wires, tubes, drains, casts, and splints; insertion, irrigation and removal of urinary catheters, routine peripheral intravenous lines, nasogastric and rectal tubes; and changes and removal of tracheostomy tubes.

In the CY 2015 PFS proposed and final rules we extensively discussed the problems with accurate valuation of 10- and 90-day global packages. Our concerns included the fact that we do not use actual data on services furnished to update the rates, questions regarding the accuracy of our current assumptions about typical services, whether we will be able to adjust values on a regular basis to reflect changes in the practice of medicine and health care delivery, and how our global payment policies affect what services are actually furnished (79 FR 67582 through 67585). In finalizing a policy to transform all 10- and 90-day global codes to 0-day global codes in CY 2017 and CY 2018, respectively, to improve the accuracy of valuation and payment for the various components of global packages, including pre- and post-operative visits and the procedure itself, we stated that we were adopting this policy because it is critical that PFS payment rates be based upon RVUs that reflect the relative resources involved in furnishing the services. We also stated our belief that transforming all 10- and 90-day global codes to 0-day global packages would:

  • Increase the accuracy of PFS payment by setting payment rates for individual services that more closely reflect the typical resources used in furnishing the procedures;
  • Avoid potentially duplicative or unwarranted payments when a beneficiary receives post-operative care from a different practitioner during the global period;
  • Eliminate disparities between the payment for E/M services in global periods and those furnished individually;
  • Maintain the same-day packaging of pre- and post-operative physicians' services in the 0-day global packages; and
  • Facilitate the availability of more accurate data for new payment models and quality research.

(2) Data Collection & Revaluation of Global Packages Required by MACRA

Section 523(a) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) added section 1848(c)(8)(A) of the Act, which prohibits the Secretary from implementing the policy, described above, that would have transformed all 10-day and 90-day global surgery packages to 0-day global packages.

Section 1848(c)(8)(B) of the Act, which was also added by section 523(a) of the MACRA, requires us to collect data to value surgical services. Section 1848(c)(8)(B)(i) of the Act requires us to develop, through rulemaking, a process to gather information needed to value surgical services from a representative sample of physicians, and requires that the data collection begin no later than January 1, 2017. The collected information must include the number and level of medical visits furnished during the global period and other items and services related to the surgery and furnished during the global period, as appropriate. This information must be reported on claims at the end of the global period or in another manner specified by the Secretary. Section 1848(c)(8)(B)(ii) of the Act requires that, Start Printed Page 80210every 4 years, we reassess the value of this collected information; and allows us to discontinue the collection of this information if the Secretary determines that we have adequate information from other sources to accurately value global surgical services. Section 1848(c)(8)(B)(iii) of the Act specifies that the Inspector General shall audit a sample of the collected information to verify its accuracy. Section 1848(c)(9) of the Act (added by section 523(b) of the MACRA) authorizes the Secretary, through rulemaking, to delay up to 5 percent of the PFS payment for services for which a physician is required to report information under section 1848(c)(8)(B)(i) of the Act until the required information is reported.

Section 1848(c)(8)(C) of the Act, which was also added by section 523(a) of the MACRA, requires that, beginning in CY 2019, we must use the information collected as appropriate, along with other available data, to improve the accuracy of valuation of surgical services under the PFS.

(3) Public Input

As noted above, section 1848(c)(8)(C) of the Act mandates that we use the collected data to improve the accuracy of valuation of surgery services beginning in 2019. We described in the CY 2015 PFS final rule (79 FR 67582 through 67591) the limitations and difficulties involved in the appropriate valuation of the global packages, especially when the resources and the related values assigned to the component services are not defined. To gain input from stakeholders on implementation of this data collection, we sought comment on various aspects of this task in the CY 2016 proposed rule (80 FR 41707 through 41708). We solicited comments from the public regarding the kinds of auditable, objective data (including the number and type of visits and other services furnished during the post-operative period by the practitioner furnishing the procedure) needed to increase the accuracy of the valuation and payment for 10- and 90-day global packages. We also solicited comment on the most efficient means of acquiring these data as accurately and efficiently as possible. For example, we sought information on the extent to which individual practitioners or practices may currently maintain their own data on services furnished during the post-operative period, and how we might collect and objectively analyze those data and use the results for increasing the accuracy of the values beginning in CY 2019.

We received many comments in response to the comment solicitation in the CY 2016 proposed rule regarding potential methods of valuing the individual components of the global surgical package. A large number of comments expressed strong support for our proposal to hold an open door forum or town hall meetings with the public. In response, we held a national listening session on January 20, 2016. Prior to the listening session, the topics for which guidance was being sought were sent electronically to those who registered for the session and made available on our Web site. The topics were:

  • Capturing the types of services typically furnished during the global period.
  • Determining the representative sample for the claims-based data collection.
  • Determining whether we should collect data on all surgical services or, if not, which services should be sampled.
  • Potential for designing data collection elements to interface with existing infrastructure used to track follow-up visits within the global period.
  • Consideration of using the 5 percent withhold until required information is furnished to encourage reporting.

The 658 participants in the national listening session provided valuable information on this task. A written transcript and an audio recording of this session are available at https://www.cms.gov/​Outreach-and-Education/​Outreach/​NPC/​National-Provider-Calls-and-Events-Items/​2016-01-20-MACRA.html.

b. Data Collection Required To Accurately Value Global Packages

Resource-based valuation of individual physicians' services is a critical foundation for Medicare payment to physicians. It is essential that the RVUs under the PFS be based as closely and accurately as possible on the actual resources used in furnishing specific services to make appropriate payment and preserve relativity among services. For global surgical packages, this requires using objective data on all of the resources used to furnish the services that are included in the package. Not having such data for some components may significantly skew relativity and create unwarranted payment disparities within the PFS.

The current valuations for many services valued as global packages are based upon the total package as a unit rather than by determining the resources used in furnishing the procedure and each additional service/visit and summing the results. As a result, we do not have the same level of information about the components of global packages as we do for other services. To value global packages accurately and relative to other procedures, we need accurate information about the resources—work, PEs and malpractice—used in furnishing the procedure, similar to what is used to determine RVUs for all services. In addition we need the same information on the post-operative services furnished in the global period (and pre-operative services the day before for 90-day global packages). Public comments about our CY 2015 proposal to value all global services as 0-day global services and pay separately for additional post-operative services when furnished indicated that there were no reliable data available on the value of the underlying procedure that did not also incorporate the value of the post-operative services, reinforcing our view that more data are needed across the board.

While we believe that most of the services furnished in the global period are visits for follow-up care, we do not have accurate information on the number and level of visits typically furnished because those billing for global services are not required to submit claims for post-operative visits. A May 2012 Office of Inspector General (OIG) report, titled Cardiovascular Global Surgery Fees Often Did Not Reflect the Number of Evaluation and Management Services Provided (http://oig.hhs.gov/​oas/​reports/​region5/​50900054.pdf) found that for 202 of the 300 sampled cardiovascular global surgeries, the Medicare payment rates were based on a number of visits that did not reflect the actual number of services provided. Specifically, physicians provided fewer services than the visits included in the payment calculation for 132 global surgery services and provided more services than were included in the payment calculations for 70 services. Similar results were found in OIG reports titled “Musculoskeletal Global Surgery Fees Often Did Not Reflect The Number Of Evaluation And Management Services Provided” (http://oig.hhs.gov/​oas/​reports/​region5/​50900053.asp) and “Review of Cataract Global Surgeries and Related Evaluation and Management Services, Wisconsin Physicians Service Insurance Corporation Calendar Year 2003, March 2007.” (http://oig.hhs.gov/​oas/​reports/​region5/​50600040.pdf).

Claims data plays a major role in PFS ratesetting. Specifically, Medicare claims data are a primary driver in the allocation of indirect PE RVUs and MP RVUs across the codes used by Start Printed Page 80211particular specialties, and in making overall budget neutrality and relativity adjustments. In most cases, a claim must be filed for all visits. Such claims provide information such as the place of service, the type and, if relevant, the level of the service, the date of the service, and the specialty of the practitioner furnishing the services. Because we have not required claims reporting of visits included in global surgical packages, we do not have any of this information for the services bundled in the package.

In addition to the lack of information about the number and level of visits actually furnished, the current global valuations rely on crosswalks to E/M visits, based upon the assumption that the resources, including work, used in furnishing pre- and post-operative visits are similar to those used in furnishing E/M visits. We are unaware of any studies or surveys that verify this assertion. Although we generally value the visits included in global packages using the same direct PE inputs as are used for E/M visits, for services for which the RUC recommendations include specific PE inputs in addition to those typically included for E/M visits, we generally use the additional inputs in the global package valuation. In contrast, when a visit included in a global package would use fewer resources than a comparable E/M service, the RUC generally does not include recommendations to decrease the PE inputs of the visit included in the global package, and we have not generally made comparable reductions. Another inconsistency with our current global package valuation approach is that even though we effectively assume that the E/M codes are appropriate for valuing pre- and post-operative services, the indirect PE inputs used for calculating payments for global services are based upon the specialty mix furnishing the global service, not the specialty mix of the physicians furnishing the E/M services, resulting in a different valuation for the E/M services contained in global packages than for separately billable E/M services. There is a critical need to obtain complete information if we are to value global packages accurately and in a way that preserves relativity across the fee schedule.

In response to the requirement of section 1848(c)(8)(B)(i) of the Act that we develop, through rulemaking, a process to gather information needed to value surgical services, we proposed a rigorous data collection effort to provide us the data needed to accurately value the 4,200 codes with a 10- or 90-day global period. Using our authority under sections 1848(c)(2)(M) and (c)(8)(B)(i) of the Act, we proposed to gather the data needed to determine how to best structure global packages with post-operative care that is typically delivered days, weeks or months after the procedure and whether there are some procedures for which accurate valuation for packaged post-operative care is not possible. Finally, we indicated that these data would provide useful information to assess the resources used in furnishing pre- and post-operative care in global periods. To accurately do so, we need to know the volume and costs of the resources typically used.

We proposed a three-pronged approach to collect timely and accurate data on the frequency of and the level of pre- and post-operative visits and the resources involved in furnishing the pre-operative visits, post-operative visits, and other services for which payment is included in the global surgical payment. By analyzing these data, we would not only have the most comprehensive information available on the resources used in furnishing these services, but also would be able to determine the appropriate packages for such services. Specifically, the proposal included:

  • A requirement for claims-based reporting about the number and level of pre- and post-operative visits furnished for 10- and 90-day global services.
  • A survey of a representative sample of practitioners about the activities involved in and the resources used in providing a number of pre- and post-operative visits during a specified, recent period of time, such as two weeks.
  • A more in-depth study, including direct observation of the pre- and post-operative care delivered in a small number of sites, and a separate survey module for practitioners practicing in ACOs.

The information collected and analyzed through the activities would be the first comprehensive look at the volume and level of services in a global period, and the activities and inputs involved in furnishing global services. The data from these activities would ultimately inform our revaluation of global surgical packages as required by statute.

To expand awareness of the proposal for data collection, we held a national listening session in which CMS reviewed the proposal for participants. Subsequent to this national listening session, we held a town hall meeting at the CMS headquarters in which participants, in person and virtual, shared their views on the proposal with CMS. The transcript from these town halls is available on the CMS Web site with the CY 2017 final rule downloads.

(1) Statutory Authority for Data Collection

As described in this section of the final rule, section 1848(c)(8)(B)(i) of the Act requires us to develop, through rulemaking, a process to gather information needed to value surgical services from a representative sample of physicians. The statute requires that the collected information include the number and level of medical visits furnished during the global period and other items and services related to the surgery and furnished during the global period, as appropriate.

In addition, section 1848(c)(2)(M) of the Act, which was added to the Act by section 220 of the PAMA, authorizes the Secretary to collect or obtain information on resources directly or indirectly related to furnishing services for which payment is made under the PFS. Such information may be collected or obtained from any eligible professional or any other source. Information may be collected or obtained from surveys of physicians, other suppliers, providers of services, manufacturers, and vendors. That section also authorizes the Secretary to collect information through any other mechanism determined appropriate. When using information gathered under this authority, the statute requires the Secretary to disclose the information source and discuss the use of such information in the determination of relative values through notice and comment rulemaking.

As described in this section of the final rule, to gain information to assist CMS in determining the appropriate packages for global services and to revalue those services, CMS needs more information on the resources used in furnishing such services. Through the claims-based data collection and the study we are finalizing in this final rule, we would have better information about the actual number of services furnished to Medicare beneficiaries to use in valuation for these codes than has been typically available, such as from RUC surveys that reflect practitioner's estimates of the number of services typically furnished. We anticipate that such efforts would inform how to more regularly collect data on the resources used in furnishing physicians' services. To the extent that such mechanisms prove valuable, they may be used to collect data for valuing other services. To achieve this significant data collection, we proposed to collect data under the authority of both section 1848(c)(8)(B) and (c)(2)(M) of the Act.Start Printed Page 80212

(2) Claims-Based Data Collection

We proposed a claims-based data collection that would have required all those providing 10- or 90-day global services to report on services furnished during the global period using a series of G-codes specially created for this purpose, beginning January 1, 2017.

In response to the comments submitted on the proposal, we are finalizing a claims-based data collection that differs from this proposal in the following significant ways:

  • CPT code 99024 will be used for reporting post-operative services rather than the proposed set of G-codes. Reporting will not be required for pre-operative visits included in the global package or for services not related to patient visit.
  • Reporting will be required only for services related to codes reported annually by more than 100 practitioners and that are reported more than 10,000 times or have allowed charges in excess of $10 million annually.
  • Practitioners are encouraged to begin reporting post-operative visits for procedures furnished on or after January 1, 2017, but the mandatory requirement to report will be effective for services related to global procedures furnished on or after July 1, 2017.
  • Only practitioners who practice in groups with 10 or more practitioners in Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island will be required to report. Practitioners who only practice in smaller practices or in other geographic areas are encouraged to report data, if feasible.

Given that the data collection will be limited to only some states, a subset of global services, and only to those who practice in larger practices the information collected through claims for global packages services will not parallel the claims data that are available in pricing other PFS services. However, we believe that the information collected through this data collection will be a significant improvement over the information currently available to value these services and will be supplemented with information obtained through other mechanisms.

In the following sections, we discuss the comments on each element of our data collection proposal, our responses and our final decision.

(a) Information To Be Reported

A key element of claims-based reporting is using codes that appropriately reflect the services furnished. In response to the comment solicitation in the CY 2016 PFS proposed rule and the input received via the January 2016 listening session, we received numerous recommendations for the information to be reported on claims. The most frequently recommended approach was for practitioners to report the existing CPT code for follow-up visits included in the surgical package (CPT 99024—Postoperative follow-up visit, normally included in the surgical package, to indicate that an E/M service was performed during a postoperative period for a reason(s) related to the original procedure). Others suggested using this code for outpatient visits and using length of stay data to estimate the number of inpatient visits during the global period. In response to our concerns that CPT code 99024 would provide only the number of visits and not the level of visits as required by the statute, one commenter suggested using modifiers in conjunction with CPT code 99024 to indicate the level of the visit furnished. Others recommended using existing CPT codes for E/M visits to report post-operative care. One commenter suggested that CMS analyze data from a sample of large systems and practices that are using electronic health records that require entry of some CPT code for every visit to capture the number of post-operative visits. After noting that the documentation requirements and PEs required for post-operative visits differ from those of E/M visits outside the global period, one commenter encouraged us to develop a separate series of codes to capture the work of the post-operative services and to measure, not just estimate, the number and complexity of visits during the global period.

Other commenters opposed the use of a new set of codes or the use of modifiers to report post-operative visits. Commenters also noted several issues for us to consider in developing data collection mechanisms, including that many post-operative services do not have CPT codes to bill separately, that surgeons perform a wide range of collaborative care services, and that patient factors, including disease severity and comorbidities, influence what post-operative care is furnished.

To assist us in determining appropriate coding for claims-based reporting, we added a task to the RAND validation contract for developing a model to validate the RVUs in the PFS, which was awarded in response to a requirement in the Affordable Care Act. Comments that we received on the validation report suggested the models did not adequately address global surgery services due to the lack of available data on visits included in the global package. Therefore, we modified the validation contract to include the development of G-codes that could be used to collect data about post-surgical follow-up visits on Medicare claims for valuing global services under MACRA so that this time could be included in the model for validating RVUs.

To inform its work on developing coding for claims-based reporting, the contractor conducted interviews with surgeons and other physicians/non-physician practitioners (NPP) who provide post-operative care. A technical expert panel (TEP), convened by the contractor, reviewed the findings of the interviews and provided input on how to best capture care provided in the post-operative period on claims.

In summarizing the input from the interviews and the TEP, the contractor indicated that several considerations were important in developing a claims-based method for capturing post-operative services. First, a simple system to facilitate reporting was needed. Since it was reported that a majority of post-operative visits are straightforward, the contractor found that a key for any proposed system is identifying the smaller number of complex post-operative visits. Another consideration was not using the existing CPT E/M structure to capture postoperative care because of concerns that E/M codes are inadequately designed to capture the full scope of post-operative care and that using such codes might create confusion. Another consideration was that the TEP was most enthusiastic about a set of codes that used site of care, time, and complexity to report visits. The contractor also believed it was important to distinguish—particularly in the inpatient setting—between circumstances where a surgeon is providing primary versus secondary management of a patient. Finally, a mechanism for reporting the postoperative care occurs outside of in-person visits and by clinical staff was needed. The report noted that in the inpatient setting in particular, surgeons spend considerable time reviewing test results and coordinating care with other practitioners.

After reviewing various approaches, a set of time-based, post-operative visit codes that could be used for reporting care provided during the post-operative period was recommended.

The recommended codes distinguish services by the setting of care and whether they are furnished by a physician/NPP or by clinical staff. All codes are intended to be reported in 10-minute increments. A copy of the report Start Printed Page 80213is available on the CMS Web site under downloads for the CY 2017 PFS proposed rule with comment period at http://www.cms.gov/​physicianfeesched/​downloads/​.

We proposed the following no-pay codes be used for reporting on claims the services actually furnished but not paid separately because they are part of global packages.

Table 9—Proposed Global Service Codes

InpatientGXXX1Inpatient visit, typical, per 10 minutes, included in surgical package.
GXXX2Inpatient visit, complex, per 10 minutes, included in surgical package.
GXXX3Inpatient visit, critical illness, per 10 minutes, included in surgical package.
Office or Other OutpatientGXXX4Office or other outpatient visit, clinical staff, per 10 minutes, included in surgical package.
GXXX5Office or other outpatient visit, typical, per 10 minutes, included in surgical package.
GXXX6Office or other outpatient visit, complex, per 10 minutes, included in surgical package.
Via Phone or InternetGXXX7Patient interactions via electronic means by physician/NPP, per 10 minutes, included in surgical package.
GXXX8Patient interactions via electronic means by clinical staff, per 10 minutes, included in surgical package.

(i) Coding for Inpatient Global Service Visits

Our proposal included three codes for reporting inpatient pre- and post-operative visits that distinguish the intensity involved in furnishing the services. Under this proposal, visits that involve any combination or number of the services listed in Table 10, which were recommended by the contractor as those in a typical visit, would be reported using GXXX1. Based on the findings from the interviews and the TEP, the report indicated that the vast majority of inpatient post-operative visits would be expected to be reported using GXXX1.

Table 10—Activities Included in Typical Visit (GXXX1 & GXXX5)

Review vitals, laboratory or pathology results, imaging, progress notes.
Take interim patient history and evaluate post-operative progress.
Assess bowel function.
Conduct patient examination with a specific focus on incisions and wounds, post-surgical pain, complications, fluid and diet intake.
Manage medications (for example, wean pain medications).
Remove stitches, sutures, and staples.
Change dressings.
Counsel patient and family in person or via phone.
Write progress notes, post-operative orders, prescriptions, and discharge summary.
Contact/coordinate care with referring physician or other clinical staff.
Complete forms or other paperwork.

Under our proposal, inpatient pre- and post-operative visits that are more complex than typical visits but do not qualify as critical illness visits would be coded using GXXX2 (Inpatient visit, complex, per 10 minutes, included in surgical package). To report this code, the practitioner would be required to furnish services beyond those included in a typical visit and have documentation that indicates what services were provided that exceeded those included in a typical visit. In the proposed rule, we noted some circumstances that might merit the use of the complex visit code are secondary management of a critically ill patient where another provider such as an intensivist is providing the primary management, primary management of a particularly complex patient such as a patient with numerous comorbidities or high likelihood of significant decline or death, management of a significant complication, or complex procedures outside of the operating room (For example, significant debridement at the bedside).

The highest level of inpatient pre- and post-operative visits, critical illness visits (GXXX3—Inpatient visit, critical illness, per 10 minutes, included in surgical package) would be reported when the physician is providing primary management of the patient at a level of care that would be reported using critical care codes if it occurred outside of the global period. This involves acute impairment of one or more vital organ systems such that there is a high probability of imminent or life threatening deterioration in the patient's condition.

Similar to how time is now counted for the existing CPT critical care codes, we proposed that all time spent engaged in work directly related to the individual patient's care would count toward the time reported with the inpatient visit codes; this includes time spent at the immediate bedside or elsewhere on the floor or unit, such as time spent with the patient and family members, reviewing test results or imaging studies, discussing care with other staff, and documenting care.

(ii) Coding for Office and Other Outpatient Global Services Visits

For the three codes in our proposal that would be used for reporting post-operative visits in the office or other outpatient settings, codes, time would be defined as the face-to-face time with patient, which reflects the current rules for time-based outpatient codes.

Like GXXX1, GXXX5 (Office or other outpatient visit, typical, per 10 minutes, included in surgical package) would be used for reporting any combination of activities in Table 10 under our proposal.

We proposed only face-to-face time spent by the practitioner with the patient and their family members would count toward the time reported with the office visit codes.

(iii) Coding for Services Furnished via Electronic Means

Services that are furnished via phone, the internet, or other electronic means outside the context of a face-to-face visit would be reported using GXXX7 when furnished by a practitioner and GXXX8 when provided by clinical staff under our proposal. We proposed that practitioners would not report these services if they are furnished the day before, the day of, or the day after a visit as we believe these would be included in the pre- and post-service activities in the typical visit. However, we proposed that these codes be used to report non-face-to-face services provided by clinical staff prior to the primary procedure since global surgery codes are typically valued with assumptions regarding pre-service clinical labor time. Given that some practitioners have indicated that services they furnish commonly include activities outside the face-to-face service, we believed it was important to capture information about those activities in both the pre- and post-service periods. We also believed these requirements to report on clinical Start Printed Page 80214labor time are consistent with and no more burdensome than those used to report clinical labor time associated with chronic care management services, which similarly describe care that takes place over more than one patient encounter.

In addition, we proposed for services furnished via interactive telecommunications that meet the requirements of a Medicare telehealth service visit, the appropriate global service G-code for the services would be reported with the GT modifier to indicate that the service was furnished “via interactive audio and video telecommunications systems.”

(iv) Rationale for Use of G-Codes

After considering the contractor report, the comments in response to the comment solicitation in the CY 2016 proposed rule and other stakeholder input that we have received, and our needs for data to fulfill our statutory mandate and to value surgical services appropriately, we proposed this new set of codes because we believe it provides us the most robust data upon which to determine the most appropriate way and amounts to pay for PFS surgical services. We noted that these proposed codes would provide data of the kind that can reasonably collected through claims data and that reflect what we believe are key issues in the valuation of post-operative care—where the service is provided, who furnishes the service, its relative complexity, and the time involved in the service.

We solicited public comments about all aspects of these codes, including the nature of the services described, the time increment, and any other areas of interest to stakeholders. We noted particular interest in any pre- or post-operative services furnished that could not be appropriately captured by these codes. We solicited comments on whether the proposed codes were appropriate for collecting data on pre-operative services. We also sought comment on any activities that should be added to the list of activities in Table 10 to reflect typical pre-operative visit activities.

(v) Alternative Approach to Coding

In making the proposal for G-codes, we noted that many stakeholders had expressed strong support for the use of CPT code 99024 (Postoperative follow-up visit, normally included in the surgical package, to indicate that an evaluation and management service was performed during a post-operative period for a reason(s) related to the original procedure) to collect data on post-operative care. In response to stakeholders noting that practitioners are familiar with this existing CPT code and the burden on practitioners would be minimized by only having to report that a visit occurred, not the level of the visit, we noted that we did not believe that this code alone would provide the information that we need for valuing surgical services nor do we believe it alone can meet the statutory requirement that we collect data on the number and level of visits. Given the strong support for the use of CPT code 99024, we solicited comments specifically on how we could use this code to capture the statutorily required data on the number and level of visits and the data that we would need to value global services in the future.

We also discussed in the proposed rule our concern that using CPT code 99024 with modifiers to indicate to which of the existing levels of E/M codes the visit corresponds may not accurately capture what drives greater complexity in post-operative visits. We noted that as outlined in the contractor's report, E/M billing requirements are built upon complexity in elements such as medical history, review of systems, family history, social history, and how many organ systems are examined. In the context of a post-operative visit, many of these elements may be irrelevant. The contractor's report also notes that there was significant concern from interviewees and the expert panel about documentation that is required for reporting E/M codes. Specifically, they stated that documentation requirements for surgeons to support the relevant E/M visit code would place undue administrative burden on surgeons given that many surgeons currently use minimal documentation when they provide a postoperative visit. We also noted that to value surgical packages accurately we need to understand the activities involved in furnishing post-operative care and as discussed above, we lack information that would demonstrate that activities involved in post-operative care are similar to those in E/M services. In addition, the use of modifiers to report levels of services is more difficult to operationalize than using unique HCPCS codes. However, we sought comments on whether, and if so, why, practitioners would find it easier to report CPT code 99024 with modifiers corresponding to the proposed G-code levels rather than the new G-codes, as proposed. We also sought comment on whether practitioners would find it difficult to use this for pre-operative visits since the CPT code descriptor specifically defines it as a “post-operative follow-up” service.

We also sought comment on whether time of visits could alone be a proxy for the level of visit. If pre- and post-operative care varies only by the time the practitioner spends on care so that time could be a proxy for complexity of the service, then we could use the reporting of CPT code 99024 in 10-minute increments to meet the statutory requirement of collecting claims-based data on the number and level of visits. In addition to comments on whether time is an accurate proxy for level of visit, we solicited comment on the feasibility and desirability of reporting CPT code 99024 in 10-minute increments.

The following is a summary of the comments that we received on our proposal to use G-codes for reporting the services furnished during the pre- and post-operative periods of 10- and 90-day global services.

Comment: Many commenters offered critiques of the G-codes. Most objected to reporting using the proposed G-codes. Some commenters raised concerns with the code definitions. These included: Lack of alignment with clinical workflow, failure to adequately account for variation in complexity and medical decision-making, and use of the term “typical” to define visits in a different way than the term is generally used in PFS valuations. One commenter suggested that CMS should require care plans for outpatient visits in the post-operative period. It was also suggested that the complex visit code could be improved by using a term other than “complex” in the definition. A commenter questioned whether that vast majority of cases would be complex instead of “typical,” since the definition of “complex” included management of a patient with multiple comorbidities and most Medicare beneficiaries have multiple comorbidities. A commenter also suggested that CMS refine the G-codes to distinguish physician visits from NPP visits. In addition, several commenters objected to the proposed G-codes for on-line and telephone services because they believed it would be nearly impossible to track these data and extremely burdensome to do so. Commenters indicated that the G-codes were not well-defined overall and should not be used without testing to determine their validity.

Response: We appreciate the detailed comments on the design of the G-codes and the concerns regarding their limitations in appropriately reflecting the services furnished in 10- and 90-day global periods. These comments provide information for how the G-codes could Start Printed Page 80215be modified to better reflect services furnished in global periods, however, as is discussed at the outset of this section, we are not using the proposed G-codes for this data collection effort.

Comment: Most commenters objected to using codes based on time increments and the proposed 10-minute increments, specifically. Some stated that reporting of services by time did not reflect the way surgeons practiced and would divert practitioners from patient care. One commenter stated that it was not feasible for practitioners to collect time data for every task that they or their clinical staff performed. Another stated that requesting physicians and/or their staff to use a stop-watch to, in effect, conduct time and motion studies for all their non-operating room patient care activities is an incredible burden. Another stated that reporting time in 10-minute increments “is untenable,” noting that, except for a few specialties, physicians do not think of providing care in terms of timed increments. The commenter added that surgeons, in particular, are not accustomed to reporting time for all pre- and post-operative visits and to do so would be a huge disruption to workflow. In addition to objections about the burden of reporting time data, some commenters objected to the use of time data as a factor in valuations.

Three organizations commented that it was appropriate to collect time data, but recommended that we do so based upon 15-minute increments as these were more familiar to physicians than the proposed 10-minue increments. In addition, some other groups, including MedPAC, agreed that data on time was needed for valuations.

Response: Time is a key factor in valuing physician services under the physician fee schedule. Section 1848(c)(1) of the Act defines the work component as the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service. We also note that time-based codes are used by practitioners for a range of services in the PFS including psychotherapy, anesthesiology and critical care services. Critical care services are notable because these services are likely to be furnished intermittently as many commenters suggested is typical for post-operative follow-up services. Since issues have not been raised about the difficulty of using the current critical care codes, it is unclear why reporting of time would be burdensome and disruptive of care in this area. We have no reason to believe the documentation of time is more difficult or burdensome for those furnishing 10- and 90-day global services than for other practitioners. However, based on the comments, it is clear that many practitioners would perceive reporting of time involved in furnishing these services to be a significant increase in burden relative to existing practice. Before implementing a change considered by so many to be so burdensome, we are exploring other ways of obtaining information that can be used to improve the accuracy of valuing these services. Accordingly, we are not finalizing, at this time, the requirement to use time-based codes.

Comment: Many commenters stated that the use of these codes would be costly, requiring extensive education of practitioners and staff and necessitating updates to EHR systems and billing software. Some also noted the cost of processing additional claims. Many commenters noted that this would be particularly difficult as this additional administrative burden would come at the same time practitioners are adjusting the Merit-based Incentive Payment System (MIPS). One commenter provided the results of a survey of surgical practitioners in 20 specialties in which 30 percent of respondents stated that the cost of integrating the new G-codes into their practice would cost more than $100,000 and only about 10 percent stated that it would cost less than $25,000.

Some commenters expressed specific concern about the documentation burden that would come from using these codes. On the other hand, other commenters suggested that providers of visits during the global surgical services should be held to the same documentation standards as providers of E/M services. One stated that the “administrative burden on surgeons should be no different and certainly no less than that on non-surgeons when it comes to documenting a visit with a patient. If many surgeons currently use minimal documentation when they provide a post-operative visit that is no excuse for expecting the same inadequate level of documentation going forward. To require anything less than the same level of documentation for all clinicians providing E/M services would be irresponsible and unfair and would defeat the very purpose of documenting the actual types and extent of these services in the post-operative period.”

Response: The need for accurate, complete and useful data must be balanced with administrative burden and cost. We articulated that using a select number of G-codes based on time would impose a burden on providers, but that burden is necessary for us to comply with the statutory requirement to gather the data necessary to value global procedures. We note that CPT routinely incorporates more than 100 new codes in annual updates, and for this reason we did not anticipate that the inclusion of eight new G-codes was likely to present significant challenges to EHR systems or other infrastructure. Based on the comments we received, however, it is clear that the majority of stakeholders believe the burden is much greater than we had assumed. In general, we agree with commenters that comparable documentation is appropriate for all physicians furnishing and being paid by Medicare for similar services.

Comment: Several commenters noted that the difficulties of using these codes would affect the accuracy of the data reported. One commenter stated that the G-code proposal would be impossible to implement and “at the very least” would yield incomplete and unreliable results.

Response: We agree with commenters that implementation burden is an important consideration in determining how practitioners should report on care provided in the post-operative period and that if practitioners find the reporting requirements to be excessive and require great expenditures to incorporate into their practice, the accuracy of the data could be undermined. We considered this in determining the final policy described below.

Comment: Some commenters criticized the proposed G-codes because they were not directly linked to E/M codes or comparable to existing E/M codes. On the other hand, some commenters preferred the codes describing such visits not be linked or comparable to E/M codes to avoid confusion or unintentional, inappropriate payments. One commenter stated that the follow-up work performed within the global periods and the continuity work performed by cognitive physicians should not be represented by the same codes. Another commenter stated that the care required by a patient recovering from a procedure is fundamentally different from the typical follow-up of an established outpatient or inpatient, especially when there are multiple simultaneous interacting conditions, a single metastable chronic illness, or one or more acute exacerbated chronic illnesses that requires inpatient care and expertise.

Response: Commenters' belief that the work in follow-up visits included in the global package is not necessarily well described by the work of current E/M Start Printed Page 80216codes is worth exploring. Current data does not allow us to determine the validity of these commenters' assertion but given its importance, we believe it is critical to gather data on whether follow-up visits provided in the post-operative period are different than other E/M services. To the extent the services in the post-operative period are different from other E/M services, it would not make sense to use E/M codes in valuing global services as is ostensibly the case under the current process the RUC uses in developing recommended values for PFS services.

Comment: Most commenters supported using CPT codes, rather than the proposed G-codes. A few pointed to the existing E/M codes, but most recommended that any claims-based reporting use CPT code 99024, an existing CPT code that describes post-operative services in a global period. Commenters noted that since this is a current CPT code the administrative burden would be much less than that associated with using the proposed new G-codes. These commenters suggest that practitioners are likely already familiar with the code, some already use it to track services within their practice, and some others already report it to other payers. Also, they suggest that because EHR and billing systems already include CPT code 99024, it will be less costly to implement than the proposal. Some also preferred using CPT code 99024 because unlike the proposed G-codes it does not require the reporting of time units.

Most commenters disagreed that time could be a proxy for the complexity of the visit and objected to reporting time for the same reasons discussed above. These commenters did not agree that CPT code 99024 could be reported in time units as a proxy for collecting the required information about the level of visits.

Three organizations disagreed, however, stating that time is a sufficient proxy for work relativity in post-operative visits and that the number units of CPT code 99024 could reflect the complexity involved. These commenters recommended reporting data in 15-minute intervals, rather than the proposed 10-minute increments, stating that physicians are familiar with 15-minute increments and thus the use of 15-minute increments would greatly reduce the administrative burden. They recommended that CMS clearly define how time is to be reported and suggested that the 8-minute rule is already a familiar concept that could be used.

Many commenters suggested that other approaches, such as a survey, clinical registries, or on-line portals be used to collect data on level of visits.

Several commenters stated that CMS should not collect data on the level of visits based on these commenters' perspective that there is no problem with the level of visits currently used in the valuation of global packages. One commenter pointed out that only 1 percent of all established patient office visits used in valuing 10-day and 90-day global surgery packages have a visit level above a CPT code 99213. Another commenter suggested that the survey be used to collect data on the level of visits. Others suggested that RUC surveys be used to measure level of visits.

Response: We understand that stakeholders believe that using CPT code 99024 rather than the proposed G-codes will significantly lower administrative burden and lower costs related to the collection of this data. We do not have data showing that the level of visits used in valuation of global packages are correct or incorrect; to the best of our knowledge, this has never been assessed outside of the RUC process. While the current valuations for global packages rely primarily on CPT codes 99212 and 99213 for the visit component, we do not agree that this means that the levels are accurate. Further, as some commenters have made clear, there is not consensus among stakeholders that the post-operative visits are equivalent to other E/M visits. Additionally, the relationship between the number and level of visits assumed to be in the global period and the overall work RVUs for the global codes is often unclear. For all of these reasons, we disagree with commenters that we do not need to collect data on the level of services.

In addition to the statutory reference to collecting data on the level of visits, we believe that code valuations can be more accurate with more complete information. While we continue to believe that data only on the number of visits furnished would not provide data on both the number and level of visits needed for valuation of services, data on the number of visits alone is an important input in valuing global packages and having accurate data on the number of visits could be a useful first step in analyzing the global packages.

After considering the comments, we are finalizing a requirement to report post-operative visits furnished during 10- and 90-day global periods. However, rather than using the proposed set of G-codes for this reporting, we are requiring that CPT code 99024 be used to report such visits. We will not, at this time, require time units or modifiers to distinguish levels of visits to be reported. Since this code is specifically limited to post-operative care, we are only requiring reporting of post-operative visits. We expect that the reporting of this information through Medicare claims will provide us with information about the actual number of visits furnished during the post-operative periods for many services reported using global codes. Because the number of visits is a major factor in valuation of global services, we believe that examination of such information, when available, can improve the accuracy of the global codes. The use of a simple code that practitioners are familiar with should facilitate the submission of accurate information. We expect practitioners to note the visit in the medical chart documenting the post-operative visit.

Since CPT code 99024 will only provide data on the number of visits and no data on the level or resources used in furnishing the visit, we believe this is only the first step in gathering the data required by Section 1848(c)(8). The proposed G-codes could have provided information to better understand the resources used in furnishing services during global periods and in valuation of such services assuming that they could be accurately reported. However, widespread concerns from groups representing the practitioners that would be reporting these services, including concerns about the burdens regarding and the inability of physicians to track time and the need to learn a new 8-code coding system, persuade us that we should pursue less burdensome ways of obtaining information. We will assess whether these methods will lead to the collection of necessary data, including data on time and intensity, of these services.

As suggested by commenters, we will explore whether the data collected from the survey that we are conducting, which is discussed later in this preamble, can provide information on the level of visits and other resources needed to value surgical services accurately. Stakeholders should be aware that since this a new approach for collecting data, and one that has not been used previously, we are concerned that additional or different reporting will be necessary to collect data on the number and level of visits and other information needed to value surgical services as required by Section 1848(c)(8).Start Printed Page 80217

b. Reporting of Claims

We proposed that the G-codes detailed above would be reported for services related to and within 10- and 90-day global periods for procedures furnished on or after January 1, 2017. Services related to the procedure furnished following recovery and otherwise within the relevant global period would be required to be reported. These codes would be included on claims filed through the usual process. Through this mechanism, we would collect all of the information reported on a claim for services, including information about the practitioner, service furnished, date of service, and the units of service. By not imposing special reporting requirements on these codes, we proposed to allow practitioners the flexibility to report the services on a rolling basis as they are furnished or to report all of the services on one claim once all have been furnished, as long as the filed claims meet the requirements for filing claims.

We did not propose any special requirements for inclusion of additional data on claims that could be used for linking the post-operative care furnished to a particular service. To use the data reported on post-operative visits for analysis and valuation, we proposed to link the data reported on post-operative care to the related procedure using date of service, practitioner, beneficiary, and diagnosis. While we believed this approach to matching would allow us to accurately link the preponderance of G-codes to the related procedure, we sought comment on the extent to which post-operative care may not be appropriately linked to related procedures whether we should consider using additional variables to link these aspects of the care, and whether additional data should be required to be reported to enable a higher percentage of matching.

The following is summary of the comments we received on our proposal to require reporting on pre- and post-operative care associated with all procedures with 10- and 90-day global periods.

Comment: Many commenters objected to the proposal to require reporting on post-operative services for all 10- or 90-day global services. Some suggested that many of the global services are low volume and have little impact on Medicare spending. It was also noted that it would be difficult to obtain a meaningful sample of low-volume services. Others discussed the burden of reporting on all services. The RUC recommended that CMS only require reporting on services that are furnished by more than 100 providers and that either are furnished more than 10,000 times or have allowed charges of more than $10 million annually to obtain meaningful data for valuation. The RUC noted that many procedures were infrequently furnished and thus useful data would not be obtained. This position was supported by a significant number of commenters. In response to the stated concern about having complete data when more than one surgical service is furnished during the global period, a commenter pointed out that a review of the 2014 Medicare 5 percent sample file shows that, two surgical global codes are performed on the same date of service, by the same physician, only 18 percent of the time.

Response: The commenters are correct that the vast majority of 10- and 90-day procedures are furnished infrequently and thus have little effect on Medicare expenditures or direct impact on the valuations of other services under the PFS. We proposed to collect data on all procedures since we believed the data we collected would be more accurate if physicians reported on all services as it would be routine and would not have required physicians to determine at each pre- and post-operative visit whether or not reporting the service was required. Moreover, as pointed out by commenters, we believe that reporting on all applicable services would have provided more complete data when multiple surgeries occurred during the global period.

Having specific data on all procedures would provide specific information for each service that Medicare pays for using a global period. In assessing the likely benefit of the additional data as compared to the burden of reporting based on the comments we received, we agree with commenters that collecting the data from high volume/high cost procedures could provide adequate information to improve the accuracy of valuation of global packages overall. Even if all practitioners reported data on all procedures, it is likely that we would not receive enough data on low-volume services for the data to be reliable for use in valuations. There are more than 1,500 services that are furnished less than 100 times per year. Because of this, data that we could collect on these services would be extremely limited. We also find that data on services with low volumes are not reliable due to variability from year to year. Since we often value related services by extrapolating data on one service to other services in the family, with adjustments as necessary to reflect variations in the procedure, the data gathered on high-volume services could similarly be used to value low-volume services in the same family. As a result we, believe that the data on high-volume services can improve the accuracy of values for all 10- and 90-day services.

After consideration of the comments, we are implementing a requirement for reporting on services that are furnished by more than 100 practitioners and are either furnished more than 10,000 times or have allowed charges of more than $10 million annually as recommended by the RUC and many other commenters. Under this policy, we estimate that we would collect data on about 260 codes that describe approximately 87 percent of all furnished 10- and 90-day global services and about 77 percent of all Medicare expenditures for 10- and 90-day global services under the PFS. Given that this data would provide information on the codes describing the vast majority of 10- and 90-day global services and expenditures, it will provide significant data for valuation. For 2017, we will use the CY 2014 claims data to determine the codes for which reporting is required and display the list on the CMS Web site. In subsequent years, we will update the list to reflect more recent claims data and publish a list of codes prior to the beginning of the reporting year. The services for which reporting is required will include successor codes to those deleted or modified since CY 2014 for which reporting would have been required if the code had not been deleted or modified.

The following is summary of the comments we received on our proposal to require claims-based reporting for services related to procedures furnished on or after January 1, 2017.

Comments: Many commenters expressed concerns regarding the difficulty of making the changes required to implement this new reporting by January 1, 2017. Some commenters noted that this change was coming at the same time as the new MIPS program. Some commenters stated that the statute required a process to be in place by January 1, 2017, but that CMS has flexibility regarding when to begin the required reporting. Some commenters suggested that CMS consider conducting the proposed survey before implementing any claims-based reporting.

Response: We proposed to begin required reporting on January 1, 2017, based upon the statutory language regarding both the collection and use of the data for revaluation of services. We understand that some practices will need to make modifications to their EHR and billing systems to report this data to Start Printed Page 80218us. We also acknowledge that an opportunity for testing the systems and training will enhance the quality of data that we receive.

After consideration of comments, we are encouraging practitioners to begin reporting data on post-operative services for procedures furnished on or after January 1, 2017. However, the requirement to report will become mandatory for post-operative services related to procedures furnished on or after July 1, 2017 rather than as of January 1, 2017, as proposed. This delay will not negatively impact the use value of the collected data since we expect that data received early in the year might be less complete than data submitted once practitioners adjusted to the requirements. Also, by allowing time for practitioners to adjust EHR and billing software, to test such systems and to train staff, we think the quality of the data will be enhanced by providing flexibility with regard to the effective date of the requirement. Finally, because we are limiting required reporting to high-volume codes, meaningful data for CY 2017 should be available from 6 months of reporting. Our systems can now accept the post-operative visit data so practitioners can begin submitting such claims at any time.

c. Special Provisions for Teaching Physicians

We sought comment on whether special provisions are needed to capture the pre- and post-operative services provided by residents in teaching settings. If the surgeon is present for the key portion of the visit, should the surgeon report the joint time spent by the resident and surgeon with the patient? If the surgeon is not present for the key portion of the visit, should the resident report the service? If we value services without accounting for services provided by residents that would otherwise be furnished by the surgeon in non-teaching settings, subsequent valuations based upon the data we collect may underestimate the resources used, particularly for the types of surgeries typically furnished in teaching facilities. However, there is also a risk of overvaluing services if the reporting includes services that are provided by residents when those services would otherwise be furnished by a physician other than the surgeon, such as a hospitalist or intensivist, and as such, should not be valued in the global package.

Comment: We received only a few comments on this issue. Some commenters suggested using the CMS policies that apply to other services that teaching surgeons report to CMS for the reporting of CPT code 99024. More specifically, when the appropriate conditions are met they would use the GC or GE modifier to identify those services in which surgical residents are involved. One of these suggested that once we have the data we discuss with stakeholders how to use the data involving residents in future valuations. Others suggested that we capture data on resident's time as it could be important for valuation, especially for the more complex cases in a teaching facility setting. Some urged that we provide clear guidance on when the resident's time could be reported. One commenter stated that teaching physicians should be exempt from reporting requirements.

Response: These comments reinforce the importance of collecting data from teaching physicians and to do so using the existing Medicare rules that teaching physicians use in reporting services in which residents are involved in furnishing. Because we are finalizing data collection using CPT code 99024, the issues regarding the reporting of time data are no longer relevant.

After consideration of the comments, we are finalizing a requirement that teaching physicians will be subject to the reporting requirements in the same way that other physicians are. Such physicians should report CPT code 99024 only when the services furnished would meet the general requirements for reporting services and should use the GC or GE modifier as appropriate.

e. Who Reports

In both the comments on the CY 2016 proposed rule and in input from the January 2016 national listening session, there was a great deal of discussion regarding the challenges that we are likely to encounter in obtaining adequate data to support appropriate valuation. Some indicated that a broad sample and significant cooperation from physicians would be necessary to understand what is happening as part of the global surgical package. One commenter suggested that determining a representative sample would be difficult and, due to the variability related to the patient characteristics, it would be easier to have all practitioners report. Many suggested that we conduct an extensive analysis across surgical specialties with a sample that is representative of the entire physician community and covers the broad spectrum of the various types of physician practice to avoid problems that biased or inadequate data collection would cause. Suggestions of factors to account for in selecting a sample include specialty, practice size (including solo practices), practice setting, volume of claims, urban, rural, type of surgery, and type of health care delivery systems. Another commenter pointed out that small sample sizes may lead to unreliable data. Some commenters stated that requiring all practitioners to report this information is unreasonable and would be an insurmountable burden. A participant acknowledged that it would be difficult for practitioners to report on only certain procedures, while another stated that this would not be an administrative burden.

After considering the input of stakeholders on the CY 2016 proposed rule and at the January 2016 national listening session discussed above, we proposed that any practitioner who furnishes a procedure that is a 10- or 90-day global service report the pre- and post-operative services furnished on a claim using the proposed G-codes. We agreed with stakeholders that it would be necessary to obtain data from a broad, representative sample. However, as we struggled to develop a nationally representative sampling approach that would result in statistically reliable and valid data, it became apparent that we do not have adequate information about how post-operative care is delivered, how it varies and, more specifically, what drives variation in post-operative care to develop a sampling frame. In its work to develop the coding used for its study, the contractor found a range of opinions on what drives variation in post-operative care. (The report is available on the CMS Web site under downloads for the CY 2017 PFS proposed rule with comment period at http://www.cms.gov/​physicianfeesched/​downloads/​.) Without information on what drives variation in pre- and post-operative care, we would have to speculate about the factors upon which to base a sample or assume that the variation in such care results from the same variables as are frequently identified for explaining variation in health care and clinical practice. In addition, we expressed concern about whether a sample could provide sufficient volume to value accurately the global package, except in the case of a few high-volume procedures.

In addition to concerns about achieving a statistically representative sample of all practitioners nationally, we noted in the proposed rule significant operational concerns with limiting data collection to a subset of practitioners or a subset of services. These include how to gain sufficient information on practitioners to stratify the sample, how to identify the Start Printed Page 80219practitioners who must report, and for those who practice in multiple settings or with multiple groups in which settings the practitioner would report. We concluded that establishing the rules to govern which post-operative care should be reported based on our proposed G-codes would be challenging for us to develop and difficult for physicians to apply in the limited time between the issuance of the CY 2017 PFS final rule with comment period and the beginning of reporting on January 1, 2017. We do not believe that the same problems apply to the same extent to our final policy to use a single code that already exists to report services described only by codes reported in high volumes. For example, implementation of new sets of codes associated with annual PFS updates are often supported by informational and educational efforts undertaken by national organizations, like the national medical specialty societies. Given that many practitioners are already familiar with CPT code 99024 (as noted by many commenters), the need for such efforts is significantly mitigated.

We also noted in the proposed rule that the more robust the reported data, the more accurate our ultimate valuations can be. We stated that given the importance of data on visits in accurate valuations for global packages, collecting data on all pre- and post-operative visits in the global period is the best way to accurately value surgical procedures with global packages.

We recognized that reporting would require submission of additional claims by those practitioners furnishing global services, but indicated that we believed the benefits of accurate data for valuation of services merited the imposition of this requirement. By using the claims system to report the data, we believed the additional burden would be minimized and referred to stakeholder reports that many practitioners are already required by their practice or health care system to report a code for each visit for internal control purposes and some of these systems already submit claims for these services, which are denied. We noted that requiring only some physicians to report this information, or requiring reporting for only some codes, could actually be more burdensome to physicians than requiring this information from all physicians on all services because of the additional steps necessary to determine whether a report is required for a particular service and adopting a mechanism to assure that data is collected and reported when required. Moreover, we stated that the challenges with implementing a limited approach at the practice level as compared to a requirement for all global services would result in less reliable data being reported.

We noted that as we analyzed the data collected and made decisions about valuations, we would reassess the data needed and what should be required from whom. Through the data collected under our proposal, we indicated that we would have the information to assess whether the post-operative care furnished varies by factors such as specialty, geography, practice setting, and practice size, and thus, the information needed for a sample selection to be representative.

While section 1848(c)(8)(B) of the Act requires us to collect data from a representative sample of physicians on the number and level of visits provided during the global period, we stated that it does not prohibit us from collecting data from a broad set of practitioners. In addition, section 1848(c)(2)(M) of the Act authorizes the collection of data from a wide range of physicians. Given the benefits of more robust data, including avoiding sample bias, obtaining more accurate data, and facilitating operational simplicity, we noted that we believed collecting data on all post-operative care initially is the best way to undertake an accurate valuation of surgical services in the future.

The following is a summary of the comments that we received on our proposal to require all practitioners furnishing 10- or 90-day global services to submit claims for the pre- and post-operative services furnished.

Comment: Commenters overwhelmingly opposed requiring all practitioners to submit claims for postoperative services. Several reasons were cited for the opposition. The most significant reason was the administrative burden and costs to physicians. Many commenters also stated that requiring all practitioners who furnish 10- or 90-day global services to report data is counter to the statute because the statute refers to collection of data from a representative sample of physicians.

One commenter stated that requiring every practitioner to report these codes will be in many ways less representative than a targeted sample, explaining that given the limited time for education, only large, technologically rich practices will have the ability to properly report these services. The commenter noted that this will leave many, smaller or rural practices without the proper education and robust billing systems in place to adequately, if at all, report these G-codes. The commenter also noted that smaller, rural practices have smaller patient populations, which can often be older and sicker than the typical patient seen in a large practice and by creating a complex system that favors one type of practice, the collected data is more likely to be biased rather than representative. Another commenter suggested that a small number of representative practices could provide us with the same level of accuracy as collected data from all physicians.

Response: In response to commenters' opposition to our proposal to require all providers of covered services to report data, we acknowledge that the stakeholders describe a much larger burden from using the G-codes than we anticipated. On the other hand, we also believe that our final policy will result in a much lower burden than the proposed policy would have. As noted above, we are not finalizing the proposed requirements to use the G-codes or the proposed requirement to report on all 10- and 90-day global procedures and thus, we believe that the overall administrative burden is significantly reduced.

We do not agree with commenters that state that we do not have the statutory authority to require reporting by all practitioners furnishing certain services. We point commenters to section 1848(c)(2)(M) of the Act, which authorizes the collection of data to use in valuing PFS services. We continue to believe that section 1848(c)(8) of the Act requires us to collect data that is representative. We also continue to believe that requiring all practitioners to report is more likely to be representative than a sample given our lack of information about what drives variation in post-operative care. However, after considering the information presented by commenters regarding the difficulties that would be placed on many physicians by the proposal, we believe that requiring reporting by all practitioners for CY 2017 may present unforeseen, alternative impediments to the sample being nationally representative of all practitioners, such as practitioners being unable to report data accurately due to constraints of time, finances or technical ability.

Comment: We did not receive any comments on the appropriate sample size. Nor did we receive data on variations in the delivery of post-operative care in response to our concern that we lacked data on how post-operative care was delivered to select a representative sample. Many commenters stated that it was possible to select a representative sample, but none provided details on how to do so.Start Printed Page 80220

Several commenters suggested broadly sampling using the characteristics that are frequently used for health care sampling generally, such as geographic areas, urban and rural, practice types, practice sizes, specialties and academic and non-academic. One commenter recommended that we select a sample using geographical data to identify a sample including practices of all sizes. The commenter suggested, for example, that large hospital-based practices often have practice patterns that are different from the majority of the practicing physicians in suburban and rural areas. Another commenter stated that we should not only collect data from MSAs but also from rural and less urban areas.

One commenter suggested that we consider phasing in the requirement, perhaps starting with larger groups. The commenter stated that through one of these approaches we could avoid “burdening providers with unfunded work that has not yet been tested.”

One commenter suggested that we use a geographic sampling approach similar to that one used for Comprehensive Care for Joint Replacement (CJR) model or the episode payment models proposed for cardiac and surgical hip/femur fraction and modify it to choose a geographic sampling unit of MSAs and non-MSAs.

Response: We agree with commenters that we could select a sample using an approach typically used in health care surveys or in Medicare models and other programs. To the extent that the delivery of post-operative care varies only based upon the criteria we selected, a sample based on being representative for that criteria would be likely to produce valid data.

However, instead of sampling by practice or practitioner or type of service, a geographic approach to sampling (for example, sampling all practitioners in a selected state) could help to alleviate the need to stratify the sample on a long list of criteria. By using broad geographical areas from varied areas of the country, we believe our sample will capture data from practitioners who practice in a variety of settings, single and multispecialty practices, urban and rural, a variety of medical specialties, and practitioners operating in both academic and non-academic institutions. Surgeons interviewed for the G-code development suggested that post-operative care might vary across these dimensions. A geographic approach could also mitigate some of the practical operational barriers. For example, we believe that by having all practitioners in the practice participate in reporting, we avoid concerns about incomplete data when a required reporter furnishes a procedure and another practitioner in the practice furnishes the post-operative visits. A geographic approach also makes it easier to educate practitioners on data collection requirements.

Comment: In response to operational difficulties with a representative sample, such as how to make sure participants were aware of the requirement to report and how to do so, one commenter stated that notifying a small targeted sample is a much smaller task than notifying the entire population of participating Medicare practitioners. They also stated that a targeted approach will encourage open dialogue between the participating practices and CMS, ensuring the data collected are reliable. Others suggested providing compensation for a sample of physicians to submit detailed data, would lead to capturing accurate data because they would more likely to understand and prioritize reporting because of their participation in this type of study.

Response: We disagree that it is operationally easier to notify a small segment of broadly diverse practitioners than the entire population of practitioners unless that small segment has a degree of cohesiveness, such as being in the same geographic area or specialty. We have long appreciated the stakeholder community's collaboration in broad communication efforts. In general, we have found that when something affects a small number of providers it does not receive the same response from entities that are critical for widespread adoption such as associations, who are key purveyors of information, and those developing software systems. We appreciate the suggestion that interaction among those that need to report will facilitate compliance and the quality of the data. With regard to compensation, we note that the statute provided for a 5 percent withhold to encourage compliance and we chose not to propose to implement this provision.

After consideration of the comments, we are finalizing a requirement for reporting that only applies to practitioners in selected states. In addition, those practicing only in small practices are excluded from required reporting. Those not required to report can do so voluntarily and we encourage them to do so.

Geographic Sample

As we noted in the proposed rule, we do not have adequate data on what drives variations in the delivery of pre- and post-operative care to design a sampling methodology that is certain to be representative. We also believe that submission by all practitioners would be consistent with our extensive use of claims data for other PFS services. Additionally, we understand the statute directs us to gather data from more than a select group of practitioners based on any particular attributes, such as gathering data only from “efficient” practices, consistent with longstanding recommendations from MedPAC regarding limiting data collection. We also believed that there were significant operational impairments to data reporting by a limited sample of physicians. In consideration of these factors, we proposed to require reporting by all physicians to make sure that the data we obtained reflected all services furnished. In light of the comments regarding the burden that would be created by requiring reporting by all physicians and the data that was actually needed for valuation, we think that reporting by a subset of practitioners could provide us valuable information on the number of visits typically furnished in global periods. This data could enhance the information we currently use to establish values for these services. While we acknowledge that we believe the data under this less burdensome approach will provide less information than necessary for optimal valuation for these services, we believe that the information on the number of actual visits from a subset of practitioners is preferable to the information on which we currently rely, which is the results of survey data reflecting respondents' assessment of the number of visits considered to be typical.

One commenter suggested that we could develop a geographic sample using a similar approach used by the Center for Medicare and Medicaid Innovation for the Comprehensive Care for Joint Replacement (CJR) or other proposed episode payment models, with an adjustment that would make certain we received data from rural, as well as urban areas. We reviewed these approaches and concluded that such an approach for sample selection could maximize the variability of the sample, mitigate some of our concerns, and provide a robust set of data for consideration.

Commenters suggested a sample should include geographic diversity. Studies show that health care delivery patterns often vary between geographic areas and while we have no specific information that the number of post-operative visits varies by geographic areas, it seems prudent to gather data from a variety of geographic areas to determine if there is such variation and Start Printed Page 80221to account for it in our data collection if it exists. In order to maximize the variability of our limited sample, we are using a methodology that requires reporting from practices in 9 states of various sizes and from various geographic areas of the country. We are using whole states for the geographic areas rather than MSAs as are used for the CJR and proposed for other models for several reasons. First, MSAs are not used for geographic adjustments under the PFS. Indeed, practitioners in most states receive state-wide geographic adjustments under the PFS. Additionally, an MSA-based approach would, by definition, not include large rural areas, something mentioned by many commenters as an important factor in variation in medical practice, and therefore, a critical criterion for sampling. Also, due to a variety of governmental and institutional requirements, the practice of medicine is primarily a state-based activity and thus the use of states will reduce the number of practitioners for whom we have only partial data based on geographic location. In contrast, we believe that practitioners often practice across county lines or in more than one MSA. We also believe that the state-wide approach will be helpful for compliance and education because there are state medical associations in every state and specialty associations in many.

To make sure that we had states of a variety of sizes, we ranked states according to the number of Medicare beneficiaries in each state. We chose the number of Medicare beneficiaries to reflect the general need for Medicare services. We divided states into four groups: The top 5 states in terms of the number of Medicare beneficiaries (group 1); 6th through 15th largest states in terms Medicare beneficiaries (group 2); the 16th through 25th largest states in terms of Medicare beneficiaries (group 3); and all remaining states (26 including the District of Columbia, group 4). The states in each group are:

  • Group 1—California, Florida, New York, Pennsylvania & Texas.
  • Group 2—Georgia, Illinois, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Tennessee, Virginia, and Washington.
  • Group 3—Alabama, Arizona, Indiana, Kentucky, Louisiana, Maryland, Minnesota, Missouri, Wisconsin, and South Carolina.
  • Group 4—Alaska, Arkansas, Colorado, Connecticut, District of Columbia, Delaware, Hawaii, Idaho, Iowa, Kansas, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Oregon, Rhode Island, South Dakota, Utah, Vermont, West Virginia and Wyoming.

We also recorded the Census region for each state using the Census Bureau's nine regions (New England, Middle Atlantic, South Atlantic, East South Central, West South Central, East North Central, West North Central, Mountain, and Pacific). Puerto Rico and other territories were excluded.

To ensure a mix of states in terms of size (measured by number of Medicare beneficiaries), we selected 1 state at random from group 1, followed by 2 states each at random from groups 2 and 3, and lastly 4 states from group four. After each random selection, we eliminated the remaining states in the same Census region from the remaining groups for which selection was pending to maximize geographic variation in the selection of states. In the event that this process resulted in fewer than 9 selected states (for example if none of the three Middle Atlantic states—all in Group 1 and 2—were selected in the first three picks), the last selection(s) were made randomly from states in the remaining Census region from which selections previously had not been made.

Practitioners located in the following states who meet the criteria for required reporting will be required to report the data discussed in this section of the final rule:

  • Florida.
  • Kentucky.
  • Louisiana.
  • Nevada.
  • New Jersey.
  • North Dakota.
  • Ohio.
  • Oregon.
  • Rhode Island.

Exclusion for Practitioners in Small Practices

In response to comment about the burden of our proposed requirement and the concern that the burden would result in the submission of data of poor quality, we are exempting practitioners who only practice in practices with fewer than 10 practitioners from the reporting. Based upon the comments, we believe larger practices are more likely to currently require practitioners to track all visits and often use CPT code 99024 to do so. Moreover, larger practices are more likely to have coding and billing staff that can more easily adapt to this claims-based requirement. The combination of experience with reporting CPT code 99024 and the staff and resource base to devote to developing the infrastructure for such reporting will result in greater accuracy from such practitioners. By excluding practitioners who only practice in practices with fewer than 10 practitioners, we estimate that about 45 percent of practitioners will not be required to report. In defining small practices, we reviewed other programs. We chose 10 practitioners as the threshold for reporting as practices of this size are large enough to support coding and billing staff, which will make this reporting less burdensome. Also, this is the same threshold used by the value-based modifier program for its phase-in of a new requirement because of concerns about the burden of small practices.

For this purpose, we define practices as a group of practitioners whose business or financial operations, clinical facilities, records, or personnel are shared by two or more practitioners. For the purposes of this reporting requirement, such practices do not necessarily need to share the same physical address; for example, if practitioners practice in separate locations but are part of the same delivery system that shares business or financial operations, clinical facilities, records, or personnel, all practitioners in the delivery system would be included when determining if the practice includes at least 10 practitioners. Because qualified non-physician practitioners may also furnish procedures with global periods, the exception for reporting post-operative visits applies only to practices with fewer than ten physicians and qualified non-physician practitioners regardless of specialty. We are including all practitioners and specialties in the count because the exception policy uses practice size as a proxy for the likely ability of the practice to meet the reporting requirements without undue administrative burden. We recognize that physicians and qualified non-physician practitioners furnish services under a variety of practice arrangements. In determining whether a practitioner qualifies for the exception based on size of the practice, all physicians and qualified non-physician practitioners that furnish services as part of the practice should be included. This would include all practitioners, regardless of whether they are furnishing services under an employment model, a partnership model, or an independent contractor model under which they practice as a group and share facility and other resources but continue to bill Medicare independently instead of reassigning benefits. We also recognize that practice size can fluctuate over the year and anticipate that practices will determine their eligibility for the exception based Start Printed Page 80222on their expected staffing. Generally, practitioners in short-term locum tenens arrangements would not be included in the count of practitioners. When practitioners are also providing services in multiple settings, the count may be adjusted to reflect the estimated proportion of time spent in the group practice and other settings.

Although this policy excludes a significant number of practitioners, a majority of the global procedures furnished will be included in the reporting requirements and thus we will have data on a majority of services.

Several commenters also expressed concern that data from small practices be included to have complete information. If those practicing in small practices are motivated to report and either have the infrastructure to do so in place or the resources to develop such infrastructure, then, taken together, these attributes would minimize concerns with accuracy of data from small practices. Accordingly, we are encouraging, but not requiring, small practices to report the visits. As we collect data, we will explore mechanisms to appropriately use the voluntarily submitted claims data. Analysis of this and other data we are able to procure will allow us to assess whether the number of post-operative visits varies based upon the size of practice. To the extent that it does and that we do not have adequate data on the practice patterns in small practices from voluntarily submitted data and other sources, we will reconsider for future notice and comment rulemaking the exemption of practitioners in small practices from the reporting requirements.

The claims data received from practitioners in these states will provide more information about the number of visits typically provided in post-operative periods than is available from any other source. Through analysis of this data, we hope to learn more about what drives variations in the delivery of post-operative care. Many of the characteristics that were suggested by commenters, such as size of practice, type of practice, geographic, urban/rural, academic, hospital based, specialty, etc., will be able to be evaluated using the claims data. Moreover, we hope to be able to stratify the data received based upon comparisons to the national characteristics so that the submitted claims data can contribute to improved valuation of PFS services.

In summary, our claims-based data collection policy requires that, for procedures furnished on or after July 1, 2017, practitioners who practice in practices that includes of 10 or more practitioners in Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island will be required to report on claims data on post-operative visits furnished during the global period of a specified procedure using CPT code 99024. The specified procedures are those that are furnished by more than 100 practitioners and either are nationally furnished more than 10,000 times annually or have more than $10 million in annual allowed charges. The final list of codes subject to required reporting will be available on the CMS Web site. Although required reporting begins for global procedures furnished on or after July 1, 2017, we encourage all practitioners to begin reporting for procedures furnished on or after January 1, 2017, if feasible. Similarly, we encourage those practicing in practices with fewer than 10 practitioners to report data if they can do so.

(1) Survey of Practitioners

We agreed with commenters on the CY 2016 proposed rule and at the listening session that we need more information than is currently provided on claims and that we should utilize a number of different data sources and collection approaches to collect the data needed to assess and revalue global surgery services. In addition to the claims-based reporting, we proposed to survey a large, national sample of practitioners and their clinical staff in which respondents would report information about approximately 20 discrete pre-operative and post-operative visits and other global services like care coordination and patient training. This sample would be stratified based upon specialty and geography, as well as by physician volume (procedures billed) and practice setting. The proposed survey would produce data on a large sample of pre-operative and post-operative visits and is being designed so that we could analyze the data collected in conjunction with the claims-based data that we would be collecting. We expect to obtain data from approximately 5,000 practitioners.

We noted that, if our proposal was finalized, RAND would develop and conduct this survey. RAND would also assist us in collecting and analyzing data for this survey and the claims-based data. While the primary data collection would be via a survey instrument, semi-structured interviews would be conducted and direct observations of post-operative visits would occur in a small number of pilot sites to inform survey design, validate survey results, and collect information that is not conducive to survey-based reporting.

Our proposed sampling approach would sample practitioners rather than specific procedures or visits to streamline survey data collection and minimize respondent burden. Specifically, we will use a random sample from a frame of practitioners who billed Medicare for more than a minimum threshold of surgical procedures with a 10- or 90-day global period (for example, 200 procedures) in the most recent available prior year of claims data. The sampling frame would provide responses from approximately 5,000 practitioners, stratified by specialty, geography, and practice type. Based upon preliminary analysis, we believe this number of participants will allow us to collect information on post-operative care following the full range of CPT level-2 surgical procedure code groups. For many common types of post-operative visits, we anticipate a standard deviation of the time distribution at around 9 minutes. To achieve a 95 percent confidence intervals with a width of 2 minutes, we would need 311 reported post-operative visits per procedure/procedure group. The most comprehensive approach would be to sample sufficient practitioners to observe 311 post-operative visits for each HCPCS procedure, but this approach would be cost- and time-prohibitive. Since post-operative care following similar procedures may involve similar activities and times even if there are differences in the number of visits, we proposed to sample differentially by specialty to maximize our ability to estimate attributes of post-operative care for the largest range of procedures.

Sample sizes for each specialty will be determined on the basis of number of procedures billed by the specialty and number of practitioners billing, assuming a uniform distribution of procedures across the year, an average of 2 post-operative visits by each patient and an equal distribution of procedures across practitioners within a specialty. If the procedure represented only 5 percent of total billed procedures for the specialty, we could expect only one of 20 visits sampled and reported by each practitioner would be for the particular procedure, and thus we would need to sample 311 practitioners within the specialty to achieve the target precision level on estimated post-operative visit time.

We propose targeting 311 reporting practitioners from each specialty which is the only specialty contributing at least 5 percent of billings for any one Start Printed Page 80223procedure group code, defined as procedures sharing a CPT level 2 heading. For other specialties, the target will be defined by the maximum value of 311 divided by the number of specialties contributing at least 5 percent for any procedure group code for which that specialty contributes. The target sample size for a specialty will be capped at 25 percent of the eligible practitioners within the specialty. For example, if a specialty contributed to two procedure group codes, one of which had four contributing specialties and the other had three contributing specialties, the specialty of interest would have a target of 104 reporting practitioners (which is driven by the procedure group code that is tied to three specialties). These guidelines will target at least 311 reporting practitioners for each procedure group code, and result in a total target sample size of 4,872 providers. A smaller sample size would reduce the precision of estimates from the survey and more importantly risk missing important differences in post-operative care for specific specialties or following different types of surgical procedures. We expect a response rate in excess of 50 percent. Given this response rate (and some uncertainty in this response rate estimate), we will need to approach at least 9,722 practitioners for our target of 4,872 practitioners. Should the response rate be lower than expected, we will continue to sample in waves until we reach the target of approximately 4,872 practitioners. Non-response bias will be assessed by comparing available characteristics of non-respondents (for example, practice type, geography, procedure volume etc.) to those of respondents.

We did not propose that respondents report on the entire period of post-operative care for individual patients, as a 90-day follow-up window (for surgeries currently with a 90-day global period) is too long to implement practically in this study setting and would be more burdensome to practitioners. Instead, we proposed to collect information on a range of different post-operative services resulting from surgeries furnished by the in-sample practitioner prior to or during a fixed reporting period.

Practitioners will be asked to describe 20 post-operative visits furnished to Medicare beneficiaries or other patients during the reporting period. The information collected through the survey instrument, which will be developed based upon direct observation and discussions in a small number of pilot sites, will include contextual information to describe the background for the post-operative care, including, for example:

  • Procedure codes(s) and date of service for procedure upon which the global period is based.
  • Procedure place of service.
  • Whether or not there were complications during or after the procedure.
  • The number in sequence of the follow-up visit (for example, the first visit after the procedure).

The survey instrument will also collect information on the visit in question including, for example:

  • Which level of visit using existing billing codes.
  • Specific face-to-face and non-face-to-face activities furnished on the day of the visit.
  • The total time spent on face-to-face and non-face-to-face activities on the day of the visit.
  • Direct practice expense items used during the visit, for example supplies like surgical dressings and clinical staff time.

Finally, the instrument will ask respondents to report other prior or anticipated care furnished to the patient by the practice outside of the context of a post-operative visit, for example non-face-to-face services.

The survey approach will complement the claims data collection by collecting detailed information on the activities, time, intensity, and resources involved in delivering global services. The resulting visit-level survey data would allow us to explore in detail the variation in activities, time, intensity, and resources associated with global services within and between physicians and procedures, and would help to validate the information gathered through claims. A summary of the work that RAND would be doing is available on the CMS Web site under downloads for the CY 2017 PFS proposed rule with comment period at http://www.cms.gov/​physicianfeesched/​downloads/​.

The following is a summary of the comments that we received on our proposal to conduct a survey of practitioners furnishing 10- and 90-day global services to obtain information about the face-to-face activities and other activities included in post-operative care.

Comment: Most commenters were generally supportive of the survey effort and noted that the provider survey will collect useful information on the level of visits, as well as important contextual detail that will not be available from the claims-based reporting. One commenter stated that a limited approach through surveys of physicians and practices looking at a targeted selection of services, and using CPT code 99024 for the claims based component would yield meaningful and actionable data for the agency and stakeholders.

Response: We agree that the survey portion of the data collection approach will provide useful information on level and context. The survey will complement claims-based reporting and will provide us with important information on non-face-to-face activities and other activities that are not reported with CPT code 99024.

Comment: One commenter pointed out challenges in survey response and in estimating time for visits by aggregating practitioner time estimates for specific activities.

Response: While we have not finalized the design of the survey instrument, we are aware of challenges in collecting detailed time estimates for specific activities. We do not intend to sum estimated times for specific activities to arrive at a total duration for the visit. We also recognize the challenges related to survey response rates and are working with our contractor accordingly.

Comment: Several commenters suggested that the survey effort should not target all 4,200 procedure codes.

Response: The survey component of the data collection effort is not designed to collect information on visits following all global procedure codes. Rather, we expect the sample to be stratified by specialty and to result in a sufficient qualitative data to address key procedures in each specialty furnishing procedures with global periods.

Comment: Some commenters believed that the purpose of the direct observation component of the data collection effort was unclear.

Response: The direct observation component will consist of external observers capturing the activities conducted in a sample of post-operative visits at a small number of practices. It is designed to provide additional context to inform future data collection efforts and to gauge where the practitioner survey does or does not capture the full range of activities. It is not a data collection activity per se.

After consideration of the comments, we are finalizing our proposal to conduct a survey of practitioners to gain information on post-operative activities to supplement our claims-based data collection as proposed. We expect that the survey will be in the field mid-2017.

(2) Required Participation in Data Collection

Using the authority we are provided under sections 1848(c)(8) and Start Printed Page 802241848(c)(2)(M) of the Act, we proposed to require all practitioners who furnish a 10- or 90-day global service to submit a claim(s) providing information on all services furnished within the relevant global service period in the form and manner described in this section of the final rule, beginning with surgical or procedural services furnished on or after January 1, 2017. We also proposed to require participation by practitioners selected for the broad-based survey through which we proposed to gather additional data needed to value surgical services, such as the clinical labor and equipment involved that cannot be efficiently collected on claim (see below).

Given the importance of the proposed survey effort, making sure that we get valid data is critical. By eliminating the bias that would be associated with using only data reported voluntarily, we stated that we expected to get more accurate and representative data. In addition to the potential bias inherent in voluntary surveys, we expressed concern that relying on voluntary data reporting would limit the adequacy of the volume of data we obtain, would require more effort to recruit participants, and may make it impossible to obtain data for valuation for CY 2019 as required by the statute.

Based on our previous experience with requesting voluntary cooperation in data collection activity, voluntary participation poses a significant challenge in collection and use of data. Specifically, the Urban Institute's work (under contract with us) to validate work RVUs by conducting direct observation of the time it took to furnish certain elements of services paid under the physician fee schedule provides evidence of this challenge. (See https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Downloads/​RVUs-Validation-Urban-Interim-Report.pdf for an interim report that describes challenges in securing participation in voluntary data collection.) Similarly, we routinely request invoices on equipment and supplies that are used in furnishing PFS services and often receive no more than one invoice. These experiences support the idea that mandatory participation in data collection activities is essential if we are to collect valid and unbiased data.

Section 1848(a)(9) of the Act authorizes us, through rulemaking, to withhold payment of up to 5 percent of the payment for services on which the practitioner is required to report under section 1848(c)(8)(B)(i) of the Act until the practitioner has completed the required reporting. Some commenters opposed the imposition of this payment consequence for failure to report, and others stated that it was too large a penalty. While withholding a portion of payment would encourage practitioners to report the required information, we did not propose to implement this option for CY 2017. We stated that requiring physicians to report the information on claims, combined with the incentive to report complete information so that revaluations of payment rates for global services are based on accurate data, would result in compliance with the reporting requirements. However, we noted that if we find that compliance with required claims-based reporting is not acceptable, we would consider in future rulemaking imposing up to a 5 percent payment withhold as authorized by the statute.

Consistent with the requirements of section 1848(c)(2)(M) of the Act, should the data collected under this requirement be used to determine RVUs, we will disclose the information source and discuss the use of such information in such determination of relative values through future notice and comment rulemaking.

The following is a summary of the comments we received on our proposal to require reporting in the claims-based survey and participation in the survey.

Comment: Many commenters objected overall to the administrative burden of our proposal and questioned the need for some of the data we were proposing to collect, primarily through the claims-based reporting, and made many recommendations for less burdensome data collection to achieve our goals. Some objected to any claims-based reporting at this time. A few recommended a different approach that involved collecting information from a small number of practices that agree to participate and that we pay such practices for participation. However, none recommended that we go forward with data collection on a totally voluntary basis. Some indicated concern that practitioners would not provide required information.

Response: We appreciate the many ideas for how to improve our data collection effort, particularly those that provided information on how to collect the information that we need while imposing a lower administrative burden on practitioners.

Comment: A few commenters supported our not proposing to implement the 5 percent withhold until claims on the post-operative care were submitted.

Response: We appreciate the support of commenters.

After considering the comments, we are finalizing our proposal to require participation in the claims-based reporting. It should be noted, however, due to our modifying the requirement to apply only to those identified as part of the geographic sample, on selected procedures, using one code, and exempting those practicing in groups with fewer than 10 practitioners, as discussed above, the impact of the requirement is significantly reduced overall, including for the subset of practitioners who will have to report under the finalized requirements.

We are not implementing the statutory provision that authorizes a 5 percent withhold of payment for the global services until claims are filed for the post-operative care, if required. We reiterate that should we find that compliance with required claims-based reporting limits confidence in the use of the information for improving the accuracy of payments for the global codes, we would consider in future rulemaking imposing up to a 5 percent payment withhold as authorized by the statute.

(3) Data Collection From Accountable Care Organizations (ACOs)

We are particularly interested in knowing whether physicians and practices affiliated with ACOs expend greater time and effort in providing post-operative global services in keeping with their goal of improving care coordination for their assigned beneficiaries. ACOs are organizations in which practitioners and hospitals voluntarily come together to provide high-quality and coordinated care for their patients. Because such organizations share in the savings realized by Medicare, their incentive is to minimize post-operative visits while maintaining high quality post-operative care for patients. In addition, we believe that such organizations offer us the opportunity to gain more in-depth information about delivery of surgical services.

We proposed to collect data on the activities and resources involved in delivering services in and around surgical events in the ACO context by surveying a small number of ACOs (Pioneer and Next Generation ACOs). Similar to the approach of the more general practitioner survey, this effort would begin with an initial phase of primary data collection using a range of methodologies in a small number of ACOs; development, piloting, and validation of an additional survey module specific to ACOs. A survey of practitioners participating in approximately 4 to 6 ACOs using the Start Printed Page 80225survey instrument along with the additional ACO-specific module will be used to collect data from on pre- and post-operative visits.

The following is summary of the comments we received about our proposal for data ACO data collection.

Comment: Several commenters supported a separate survey of practitioners participating in ACOs. One commenter agreed with CMS that this data collection effort may provide a unique and useful perspective on the matter at hand. Several commenters indicated that there are likely differences in pre- and post-operative care between practitioners who do participate in ACOs and those that do not. One commenter cautioned against extrapolating information gathered from ACOs to value global surgery services that are provided outside of the ACO setting because ACOs are structured differently than other practice settings and data from ACOs may, therefore, be skewed [and] that ACO participants typically are larger practices and thus would underrepresent smaller or solo practitioners.

Response: We agree that ACOs may be structured differently than other practice settings and that these differences may contribute to variations in the provision of outpatient care. By separately surveying ACOs we will be able to investigate whether there are differences in pre- and post-operative care in ACO settings compared to non-ACO settings.

After consideration of the comments received, we are finalizing our proposal for data collection in ACOs. We recognize and will continue to consider the concerns raised by commenters as we implement this project.

(6) Re-Valuation Based Upon Collected Data

We recognize that the some of the data collection activities being undertaken vary from how information is currently gathered to support PFS valuations for global surgery services. However, we believe the proposed claims-based data collection is generally consistent with how claims data is reported for other kinds of services paid under the PFS. We believe that the authority and requirements included in the statute through the MACRA and PAMA were intended to expand and enhance data that might be available to enhance the accuracy of PFS payments. In the proposed rule, we indicated that because these are new approaches to collecting data and in an area—global surgery—where very little data has previously been collected, we cannot describe exactly how this information would be used in valuing services. What is clear is that the claims-based data would provide information parallel to the kinds of claims-data used in developing RVUs for other PFS services and that by collecting these data, we would know far more than we do now about how post-operative care is delivered and gain insight to support appropriate packaging and valuation. We would include any revaluation proposals based on these data in subsequent notice and comment rulemaking.

Even though we did not make a proposal regarding how future re-valuations would use the data collected under these proposals, we received several comments on such revaluations. The following is summary of the comments we received regarding use of the data we obtain through this three-pronged data collection activity in future re-valuations.

Comment: Some commenters stated that the RUC process worked well to value services and should continue to be used to value these and other services. Some of these objected to any claims-based data collection for a variety of reasons including that it was unlikely to provide valid and reliable data, that the RUC process worked well and should continue to be used, and the that since other codes would not be valued on the basis of similar data use of this data would harm the fee schedule's relativity. Some suggested that we use the data obtained here to identify misvalued codes and refer them to the RUC for further evaluation under the usual process. Some commenters suggested that we not collect any data until we could describe how it would be used.

Response: We believe that the Congress enacted the two data collection provisions included in the Act to further the accuracy of PFS rates by having additional data available to the RUC as it makes recommendations to us and to us to inform our evaluation of those recommendations. We do not believe this data collection was intended to replace the RUC or the processes that have been established over the last two decades for valuing physician services. We agree with commenters that one way the data might be used is to identify potentially misvalued codes for the RUC to evaluate. However, we also stress that we do not agree that the use of claims data to value services within global surgery packages would be inconsistent with the valuation of other PFS services. On the contrary, very few other PFS services include estimated work RVUs based on face-to-face patient encounters over multiple days or months. Outside of these services, work RVUs are estimated per patient encounter (or in other cases over longer periods of time for non-face-to-face work). Therefore, the outer limit of any misvaluation between the estimated typical and the actual is the overall value for a single face-to-face service. Under the global packages, potential misvaluations can range from the difference between the estimated typical services for a full global period and the actual services furnished for a full global period for a given patient. We are not finalizing any provisions regarding valuation of global surgical services. Instead, such issues will be addressed in future rulemaking after we collect data and analyze data.

E. Improving Payment Accuracy for Primary Care, Care Management and Patient-Centered Services

1. Overview

In recent years, we have undertaken ongoing efforts to support primary care and patient-centered care management within the PFS as part of HHS' broader efforts to achieve better care, smarter spending and healthier people through delivery system reform. We have recognized the need to improve payment accuracy for these services over several years, especially beginning in the CY 2012 PFS proposed rule (76 FR 42793) and continuing in each subsequent year of rulemaking. In the CY 2012 proposed rule, we acknowledged the limitations of the current code set that describes evaluation and management (E/M) services within the PFS. For example, E/M services represent a high proportion of PFS expenditures, but have not been recently revalued to account for significant changes in the disease burden of the Medicare patient population and changes in health care practice that are underway to meet the current population's health care needs. These trends in the Medicare population and health care practice have been widely recognized in the provider community and by health services researchers and policymakers alike.[1] We believe the focus of the Start Printed Page 80226health care system has shifted to delivery system reforms, such as patient-centered medical homes, clinical practice improvement, and increased investment in primary and comprehensive care management/coordination services for chronic and other conditions. This shift requires more centralized management of patient needs and extensive care coordination among practitioners and providers, often on a non-face-to-face basis across an extended period of time. In contrast, the current CPT code set is designed with an overall orientation to pay for discrete services and procedural care as opposed to ongoing primary care, care management and coordination, and cognitive services. It includes thousands of separately paid, individual codes, most of which describe highly specialized procedures and diagnostic tests, while there are relatively few codes that describe care management and cognitive services. The term “cognitive services” refers to the type of work that is usually classified and described under the current code set for E/M services, such as the critical thinking involved in data gathering and analysis, planning, management, decision-making, and exercising judgment in ambiguous or uncertain situations.[2] It is often used to describe PFS services that are not procedural or strictly diagnostic in nature. Further, in the past, we have not recognized as separately payable many existing CPT codes that describe care management and cognitive services, viewing them as bundled and paid as part of other services including the broadly drawn E/M codes that describe face-to-face visits billed by physicians and practitioners in all specialties.

This has resulted in minimal service variation for ongoing primary care, care management and coordination, and cognitive services relative to other PFS services, and in potential misvaluation of E/M services under the PFS (76 FR 42793). Some stakeholders believe that there is substantial misvaluation of physician work within the PFS, and that the current service codes fail to capture the range and intensity of nonprocedural physician activities (E/M services) and the “cognitive” work of certain specialties (http://www.nejm.org/​doi/​full/​10.1056/​NEJMp1600999#t=​article).

Recognizing the inverse for specialties that furnish other kinds of services, MedPAC has noted that the PFS allows some specialties to more easily increase the volume of services they provide, and therefore, their revenue from Medicare relative to other specialties, particularly those that spend most of their time providing E/M services. (MedPAC March 2015 Report to the Congress, available at http://www.medpac.gov/​-documents-/​reports). We agree with this analysis, and we recognize that the current set of E/M codes limits Medicare's ability under the PFS to appropriately recognize the relative resource costs of primary care, care management/coordination and cognitive services relative to specialized procedures and diagnostic tests.

In recent years, we have been engaged in an ongoing incremental effort to update and improve the relative value of primary care, care management/coordination, and cognitive services within the PFS by identifying gaps in appropriate payment and coding. These efforts include changes in payment and coding for a broad range of PFS services. This effort is particularly vital in the context of the forthcoming transition to the Quality Payment Program that includes the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) incentives under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015), since MIPS and many APMs will adopt and build on PFS coding, RVUs and PFS payment as their foundation.

In CY 2013, we began by focusing on post-discharge care management and transition of beneficiaries back into the community, establishing new codes to pay separately for transitional care management (TCM) services. Next we finalized new coding and separate payment beginning in CY 2015 for chronic care management (CCM) services provided by clinical staff. In the CY 2016 PFS proposed rule (80 FR 41708 through 41711), we solicited public comments on three additional policy areas of consideration: (1) Improving payment for the professional work of care management services through coding that would more accurately describe and value the work of primary care and other cognitive specialties for complex patients (for example, monthly timed services including care coordination, patient/caregiver education, medication management, assessment and integration of data, care planning); (2) establishing separate payment for collaborative care, particularly, how we might better value and pay for robust inter-professional consultation between primary care physicians and psychiatrists (developing codes to describe and provide payment for the evidence-based psychiatric collaborative care model (CoCM)), and between primary care physicians and other (non-mental health) specialists; and (3) assessing whether current PFS payment for CCM services is adequate and whether we should reduce the administrative burden associated with furnishing and billing these services.

We received substantial feedback on this comment solicitation, which we summarized in the CY 2017 PFS proposed rule and used to develop the following coding and payment proposals for CY 2017 (81 FR 46200 through 46215, and 46263 through 46265):

  • Separate payment for existing codes describing prolonged E/M services without direct patient contact by the physician (or other billing practitioner), and increased payment for prolonged E/M services with direct patient contact by the physician (or other billing practitioner) adopting the RUC-recommended values.[3]
  • New coding and payment mechanisms for behavioral health integration (BHI) services including substance use disorder treatment, specifically three codes to describe services furnished as part of the psychiatric CoCM and one code to address other BHI care models.
  • Separate payment for complex CCM services, reduced administrative burden for CCM, and an add-on code to the visit during which CCM is initiated (the CCM initiating visit) to reflect the work of the billing practitioner in assessing the beneficiary and establishing the CCM care plan.
  • A new code for cognition and functional assessment and care planning, for treatment of cognitive impairment.
  • An adjustment to payment for routine visits furnished to beneficiaries for whom the use of specialized mobility-assistive technology (such as adjustable height chairs or tables, patient lifts, and adjustable padded leg supports) is medically necessary.

We noted that the development of coding for these and other kinds of services across the PFS is typically an iterative process that responds to changes in medical practice and may be best refined over several years, with PFS rulemaking and the development of CPT codes as important parts of that process. We noted with interest that the CPT Editorial Panel and AMA/RUC restructured the former Chronic Care Coordination Workgroup to establish a Start Printed Page 80227new Emerging CPT and RUC Issues Workgroup that we hope will continue to consider the issues raised in this section of our CY 2017 proposed rule. At the time of publication of the proposed rule, we were aware that CPT had approved a code to describe assessment and care planning for treatment of cognitive impairment; however, it would not be ready in time for valuation in CY 2017. Therefore, we proposed to make payment using a G-code (G0505 [4] ) for this service in CY 2017. We were also aware that CPT had approved three codes that describe services furnished consistent with the psychiatric CoCM, but that they would also not be ready in time for valuation in CY 2017. We discuss these services in more detail in the next section of this final rule.

To facilitate separate payment for these services furnished to Medicare beneficiaries during CY 2017, we proposed to make payment through the use of three G-codes (G0502, G0503, and G0504—see below) that parallel the new CPT codes, as well as a fourth G-code (G0507—see below) to describe services furnished using other models of BHI in the primary care setting. We intended for these to be temporary codes and would consider whether to adopt and establish values for the new CPT codes under our standard process, potentially for CY 2018. We anticipated continuing the multi-year process of implementing initiatives designed to improve payment for, and recognize long-term investment in, primary care, care management and cognitive services, and patient-centered services. While we recognized that there may be some overlap in the patient populations for the proposed new codes, we noted that time spent by a practitioner or clinical staff could not be counted more than once for any code (or assigned to more than one patient), consistent with PFS coding conventions. We expressed continued consideration of additional codes for CCM services that would describe the time of the physician or other billing practitioner. We also expressed interest in whether there should be changes under the PFS to reflect additional models of inter-professional collaboration for health conditions, in addition to those we proposed for BHI.

We proposed to pay under the PFS for services described by new coding as follows (please note that the descriptions included for G0502, G0503, and G0504 are from Current Procedural Terminology (CPT®) Copyright 2016 American Medical Association (and we understand from CPT that they will be effective as part of CPT codes January 1, 2018). All rights reserved):

  • G0502: Initial psychiatric collaborative care management, first 70 minutes in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:

++ Outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional;

++ Initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan;

++ Review by the psychiatric consultant with modifications of the plan if recommended;

++ Entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant; and

++ Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies.

  • G0503: Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:

++ Tracking patient follow-up and progress using the registry, with appropriate documentation;

++ Participation in weekly caseload consultation with the psychiatric consultant;

++ Ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers;

++ Additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant;

++ Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies;

++ Monitoring of patient outcomes using validated rating scales; and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment.

  • G0504: Initial or subsequent psychiatric collaborative care management, each additional 30 minutes in a calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional (List separately in addition to code for primary procedure) (Use G0504 in conjunction with G0502, G0503).
  • G0507: Care management services for behavioral health conditions, at least 20 minutes of clinical staff time, directed by a physician or other qualified health care professional time, per calendar month.
  • G0505: Cognition and functional assessment using standardized instruments with development of recorded care plan for the patient with cognitive impairment, history obtained from patient and/or caregiver, by the physician or other qualified health care professional in office or other outpatient setting or home or domiciliary or rest home.
  • G0506: Comprehensive assessment of and care planning by the physician or other qualified health care professional for patients requiring chronic care management services, including assessment during the provision of a face-to-face service (billed separately from monthly care management services) (Add-on code, list separately in addition to primary service).
  • G0501: Resource-intensive services for patients for whom the use of specialized mobility-assistive technology (such as adjustable height chairs or tables, patient lifts, and adjustable padded leg supports) is medically necessary and used during the provision of an office/outpatient evaluation and management visit (Add-on code, list separately in addition to primary procedure).

Regarding the majority of these proposals, the public comments were broadly supportive, some viewing our proposals as a temporary solution to an underlying need to revalue E/M services, especially outpatient E/M. Several commenters recommended that CMS utilize the global surgery data collection effort or another major research initiative to distinguish and revalue different kinds of E/M work. Start Printed Page 80228The commenters made recommendations about the scope and definition of the proposed services, what types of individuals should be able to provide them, and potential alignment and overlap. The commenters agreed with the need to increase the relative value of primary care, care management and other cognitive care under the PFS and minimize administrative burden for such services, while ensuring value to the program and beneficiaries. The public comments raise or inform a number of issues around how to define and pay for care that is collaborative, integrative or continuous, and we discuss the comments in greater detail below.

2. Non-Face-to-Face Prolonged Evaluation Management (E/M) Services

In public comments on the CY 2016 PFS proposed rule, many commenters recommended that CMS should establish separate payment for non-face-to-face prolonged E/M service codes that we currently consider to be “bundled” under the PFS (CPT codes 99358, 99359). The CPT descriptors are:

  • CPT code 99358 (Prolonged evaluation and management service before and/or after direct patient care, first hour); and
  • CPT code 99359 (Prolonged evaluation and management service before and/or after direct patient care, each additional 30 minutes (List separately in addition to code for prolonged service).

Commenters believed that separate payment for these existing CPT codes would provide a means for physicians and other billing practitioners to receive payment that more appropriately accounts for time that they spend providing non-face-to-face care. We agreed that these codes would provide a means to recognize the additional resource costs of physicians and other billing practitioners, when they spend an extraordinary amount of time outside of an E/M visit performing work that is related to that visit and does not involve direct patient contact (such as extensive medical record review, review of diagnostic test results or other ongoing care management work). We also believed that doing so in the context of the ongoing changes in health care practice to meet the current population's health care needs would be beneficial for Medicare beneficiaries and consistent with our overarching goals related to patient-centered care.

These non-face-to-face prolonged service codes are broadly described (although they include only time spent personally by the physician or other billing practitioner) and have a relatively high time threshold (the time counted must be an hour or more beyond the usual service time for the primary or “companion” E/M code that is also billed). They are not reported for time spent in care plan oversight services or other non-face-to-face services that have more specific codes and no upper time limit in the CPT code set. We believed this made these codes sufficiently distinct from the other codes we proposed for CY 2017 as part of our primary care/cognitive care/care management initiative described in this section of our final rule. Accordingly, we proposed to recognize CPT codes 99358 and 99359 for separate payment under the PFS beginning in CY 2017. We noted that time could not be counted more than once towards the provision of CPT codes 99358 or 99359 and any other PFS service. We addressed their valuation in the valuation section of the CY 2017 proposed rule.

Through a drafting error, we stated in the proposed rule that we would require these services to be furnished on the same day by the same physician or other billing practitioner as the companion E/M code. We intended to propose conformity with CPT guidance that requires that time counted towards the codes describe services furnished during a single day directly related to a discrete face-to-face service that may be provided on a different day, provided that the services are directly related to those furnished in a face-to-face visit.

We also solicited public comment on our interpretation of existing CPT guidance governing concurrent billing or overlap of CPT codes 99358 and 99359 with complex CCM services (CPT codes 99487 and 99489) and TCM services (CPT codes 99495 and 99496). Specifically CPT provides, “Do not report 99358, 99359 during the same month with 99487-99489. Do not report 99358, 99359 when performed during the service time of codes 99495 or 99496.” Complex CCM services and TCM services are similar to the non-face-to-face prolonged services in that they include substantial non-face-to-face work by the billing physician or other practitioner. The TCM and CCM codes similarly focus on a broader episode of patient care that extends beyond a single day, although they have a monthly service period and the prolonged service codes do not. We sought public input on the intersection of the non-face-to-face prolonged service codes with CCM and TCM services, and with the proposed add-on code to the CCM initiating visit G0506 (Comprehensive assessment of and care planning for patients requiring CCM services). We also solicited comment regarding how distinctions could be made between time associated with prolonged services and the time bundled into other E/M services, particularly pre- and post-service times, which would continue to be bundled with the other E/M service codes. For all of these services, we expressed concern that there would potentially be program integrity risks as the same or similar non-face-to-face activities could be undertaken to meet the billing requirements for a number of codes. We solicited public comment to help us identify the full extent of program integrity considerations, as well as options for mitigating program integrity risks.

Comment: Many commenters recommended that we adopt the CPT coding provision for CPT codes 99358 and 99359 that allows the prolonged services to be provided on a different day than the companion E/M code. At the same time, several commenters indicated that they request changes to the codes through the established processes of the CPT Editorial Panel. For example, some commenters suggested that CPT codes 99358 and 99359 should be revised so that they have a limited (calendar month) service period or measure shorter time increments (15 minutes). Some commenters recommended that a given physician should not be allowed to report CPT codes 99358 and 99359 for the same beneficiary during the same time he or she reported CCM, TCM, or G0506. These commenters stated that CCM, TCM, and proposed G0506 encompass non-face-to-face care provided to the beneficiary during a given period of time that would be duplicated if the physician is also allowed to report CPT codes 99358 and 99359 during the same time period. Other commenters stated that it would be unusual for G0506 and non-face-to-face prolonged services (CPT codes 99358 and 99359) to be reported for services on the same day, but that both should be allowed if time thresholds are met. To facilitate determination of whether time thresholds are met for various potential code combinations, some commenters recommended that CMS establish a time for G0506 and publish typical times for the companion codes to the prolonged service codes. This would enable practitioners to determine when they have exceeded “usual” or average times for E/M services and may bill prolonged services. Some commenters recommended that CMS provide tables Start Printed Page 80229showing times for E/M visits, CCM, G0506 and prolonged services with specific clinical examples for concurrent billing.

Some commenters believed there might be some overlap between the proposed non-face-to-face prolonged service codes and the post-service work of G0505 (Cognition and functional assessment by the physician or other qualified health care professional in office or other outpatient). Some commenters believed there is a discrepancy between our proposal to allow G0505 to be a companion code to prolonged services, and CPT's intent that G0505 should only be billed on the same day as another E/M visit if they are unrelated.

MedPAC commented that the companion E/M codes should be revalued instead of providing separate payment for prolonged services associated with the companion codes. However, if we finalize as proposed, MedPAC recommended that we clarify what situations the prolonged codes are appropriate for, beyond average times. Another commenter recommended an alternative policy instead of the non-face-to-face prolonged service codes, namely several modifiers and add-on codes to E/M services, associated with increased work RVUs. A typical time for the primary service would not need to be established. This coding schema would focus on visits actively treating patients with four or more chronic conditions; patients with three or more chronic problems introducing an acute problem during their visit; unexpected abnormal studies; and electronic communication after visits with the patient, lab, and other clinicians. One commenter drew a distinction between prolonged service work and care management services, where care management does not include extensive review of medical records, review of diagnostic tests and further discussion with a caregiver.

Response: We appreciate the comments. First, we had intended to propose to adopt the CPT coding provision for CPT codes 99358 and 99359 that allows the prolonged time to be provided on a different day than the companion E/M code, along with the rest of the CPT prefatory language for these codes. Our final policy will adopt the CPT guidance that allows the prolonged time to be reported for time on a different day than the companion E/M code, along with the rest of the CPT prefatory language for CPT codes 99358 and 99359.

Second, the public comments elucidate that it is difficult to assess potential overlap between prolonged services and many other codes because the included services, service periods and timeframes are not aligned. For example, most services paid under the PFS are valued based on assumptions regarding the typical pre-service, intra-service and post-service time, but do not have required thresholds for time spent. It is difficult to distinguish the times associated with these services from the times for codes that include time requirements in their descriptor. It is also difficult to distinguish the time and other work included in codes that generally describe services furnished during one day (prolonged services and E/M visits) with codes that describe time and work over substantially different service periods (such as the calendar month services like CCM or BHI services) or add-on codes with no pre or post-service time (such as G0506). In addition, because portions of many services are likely describing work that is furnished “incident to” a physician's or practitioner's services, the time and effort of the billing practitioner may not be the only relevant time and effort to consider. Moreover, the comments reflect a desire and intent on the part of stakeholders to alter the prolonged service codes in the near future, which would, in turn, alter their intersection with the codes proposed in this section of our 2017 rule and many other codes. The public comments also reflect a lack of consensus regarding appropriate medical practice and reporting patterns for prolonged services in relation to the services described by the CCM, TCM, proposed G0505 and proposed G0506 codes.

Having considered this feedback, we have decided to finalize our proposal for separate payment of the non-face-to-face prolonged service codes (CPT 99358, 99359) and adopt the CPT code descriptors and prefatory language for reporting these services. We stress that we intend these codes to be used to report extended non-face-to-face time that is spent by the billing physician or other practitioner (not clinical staff) that is not within the scope of practice of clinical staff, and that is not adequately identified or valued under existing codes or the 2017 finalized new codes. We appreciate the commenters' suggestion to display the typical times associated with relevant services. We have posted a file that notes the times assumed to be typical for purposes of PFS rate-setting. That file is available on our Web site under downloads for the CY 2017 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. We note that while these typical times are not required to bill the displayed codes, we would expect that only time spent in excess of these times would be reported under a non-face-to-face prolonged service code.

Based on our analysis of comments, we do not believe there is significant overlap between CPT codes 99358 and 99359 and the CCM codes (CPT 99487, 99489, 99490) or our finalized BHI service codes (G0502, G0503, G0504, G0507 discussed below). The work of the billing practitioner in the provision of non-complex CCM and the BHI services is related to the direction of ongoing care management and coordination activities of other individuals, compared to the work of 99358 and 99359 which is described as personally performed and directly related to a face-to-face service. On that basis, we do not believe that there is significant overlap in the description of services or the valuation.

The potential intersection of CPT codes 99358 and 99359 with the complex CCM codes is harder to assess because complex CCM explicitly includes medical decision-making of moderate to high complexity by the billing practitioner, which is not performed by clinical staff. The complex CCM codes, however, only measure or count the time of clinical staff. Similarly, TCM includes moderate to high complexity medical decision-making during the service period as well as a level 4 or 5 face-to-face visit, even though clinical staff may perform a number of other aspects of the service. For CY 2017, for administrative simplicity, we are adopting the CPT provision (and finalizing as proposed) that complex CCM cannot be reported during the same month as non-face-to-face prolonged services, CPT codes 99358 and 99359 (by a single practitioner). Similarly, we are adopting the CPT provision that non-face-to-face prolonged services, CPT codes 99358 and 99359 may not be reported when performed during the service time of TCM (CPT codes 99495 and 99496) (by a single practitioner). We interpret the CPT provision to mean that CPT codes 99358 and 99359 cannot be reported during the TCM 30-day service period, by the same practitioner who is reporting the TCM.

Regarding potential intersection of CPT codes 99358 and 99359 with proposed G0505 (Cognition and functional assessment by the physician or other qualified health care professional in office or other outpatient), we are finalizing our proposal that G0505 be designated as a Start Printed Page 80230companion or “base” E/M code to non-face-to-face prolonged services (CPT codes 99358 and 99359) (see section II.E.5 for a detailed discussion of G0505). That is, for CY 2017 CPT codes 99358 and 99359 may be reported with G0505 as the associated companion code, whether furnished on the same day or a different day. We believe CPT intended the code on which G0505 is modeled to function like a specific E/M service, and that while the specificity of the service explicitly includes care planning unique to the needs of patients with particular conditions, there may well be circumstances where the pre- or post-time for a particular beneficiary may be prolonged. In their current form, the non-face-to-face prolonged service codes exist for the purpose of providing additional payment to account for the biller's additional time related to E/M visits. Therefore, we believe the non-face-to-face prolonged service codes should be reportable when related to E/M services, including those such as G0505 that describe more specific E/M work. We look forward to continued feedback on this issue, including through potential revisions to CPT guidance.

Regarding intersection of CPT codes 99358 and 99359 with G0506, we note that G0506 is already an add-on code to another E/M service (the CCM initiating visit, which can be the AWV/IPPE or a qualifying face-to-face E/M visit). We are providing in section II.E.4.a that at this time (beginning in CY 2017), G0506 will be a code that is only billable one time, at the outset of CCM services. We agree with commenters that it would be unusual for physicians to spend enough time with a given beneficiary on a given day to warrant reporting all three codes (the initiating visit code, G0506, and a prolonged service code). We also believe that a simpler approach is preferable at this time (two related codes for CCM initiation, instead of possibly three). Therefore our final policy for CY 2017 is that prolonged services (whether face-to-face or non-face-to-face) cannot be reported in addition to G0506 in association with a companion E/M code that also qualifies as the CCM initiating visit. In association with the CCM initiating visit, a billing practitioner may choose to report either prolonged services or G0506 (if requirements to bill both prolonged services and G0506 are met), but cannot report both a prolonged service code and G0506.

3. Establishing Separate Payment for Behavioral Health Integration (BHI)

In the CY 2016 PFS final rule with comment period (80 FR 70920), we stated that we believe the care and management for Medicare beneficiaries with behavioral health conditions often requires extensive discussion, information-sharing and planning between a primary care physician and a specialist. In CY 2016 rulemaking, we described that in recent years, many randomized controlled trials have established an evidence base for an approach to caring for patients with behavioral health conditions called the psychiatric Collaborative Care Model (CoCM). We sought information to assist us in considering refinements to coding and payment to address this model in particular. The psychiatric CoCM is one of many models for behavioral health integration or BHI, a term that refers broadly to collaborative care that integrates behavioral health services principally with primary care, but that may also integrate behavioral health care with inpatient and other clinical care. BHI is a team-based approach to care that focuses on integrative treatment of patients with medical and mental or behavioral health conditions. In the CY 2017 proposed rule (81 FR 46203 through 46205), we proposed four new G-codes for BHI services: Three describing the psychiatric CoCM specifically, and one generally describing related models of care.

a. Psychiatric Collaborative Care Model (CoCM)

A specific model for BHI, psychiatric CoCM typically is provided by a primary care team consisting of a primary care provider and a care manager who works in collaboration with a psychiatric consultant, such as a psychiatrist. Care is directed by the primary care team and includes structured care management with regular assessments of clinical status using validated tools and modification of treatment as appropriate. The psychiatric consultant provides regular consultations to the primary care team to review the clinical status and care of patients and to make recommendations. As we previously noted, several resources have been published that describe the psychiatric CoCM in greater detail and assess the impact of the model, including pieces from the University of Washington (http://aims.uw.edu/​), the Institute for Clinical and Economic Review (http://icer-review.org/​announcements/​icer-report-presents-evidence-based-guidance-to-support-integration-of-behavioral-health-into-primary-care/​), and the Cochrane Collaboration (http://www.cochrane.org/​CD006525/​DEPRESSN_​collaborative-care-forpeople-with-depression-and-anxiety). Because this particular kind of collaborative care model has been tested and documented in medical literature, in the CY 2016 proposed rule we expressed particular interest in how coding used to describe PFS services might facilitate appropriate valuation of the services furnished under this model. We solicited public comments to assist us in considering refinements to coding and payment to address this model in particular relative to current coding and payment policies, as well as information related to various requirements and aspects of these services.

After consideration of the comments, we proposed in the CY 2017 PFS proposed rule to begin making separate payment for services furnished using the psychiatric CoCM, beginning January 1, 2017. We were aware that the CPT Editorial Panel, recognizing the need for new coding for services under this model of care, had approved three codes to describe the psychiatric collaborative care that is consistent with this model, but the codes would not be ready in time for valuation in CY 2017. Current CPT coding does not accurately describe or facilitate appropriate payment for the treatment of Medicare beneficiaries under this model of care. For example, under current Medicare payment policy, there is no payment made specifically for regular monitoring of patients using validated clinical rating scales or for regular psychiatric caseload review and consultation that does not involve face-to-face contact with the patient. We believed that these resources are directly involved in furnishing ongoing care management services to specific patients with specific needs, but they are not appropriately recognized under current coding and payment mechanisms. Because PFS valuation is based on the relative resource costs of the PFS services furnished to Medicare beneficiaries, we believed that appropriate coding for these services for CY 2017 will facilitate accurate payment for these and other PFS services. Therefore, we proposed separate payment for services under the psychiatric CoCM using three new G-codes, as detailed below: G0502, G0503, and G0504, which would parallel the CPT codes that are being created to report these services.

The proposed code descriptors were as follows (from Current Procedural Terminology (CPT®) Copyright 2016 American Medical Association (and we understand from CPT that they will be effective as part of CPT codes January 1, 2018). All rights reserved):

  • G0502: Initial psychiatric collaborative care management, first 70 minutes in the first calendar month of Start Printed Page 80231behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:

++ Outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional;

++ Initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan;

++ Review by the psychiatric consultant with modifications of the plan if recommended;

++ Entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant; and

++ Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies.

  • G0503: Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:

++ Tracking patient follow-up and progress using the registry, with appropriate documentation;

++ Participation in weekly caseload consultation with the psychiatric consultant;

++ Ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers;

++ Additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant;

++ Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies;

++ Monitoring of patient outcomes using validated rating scales; and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment.

  • G0504: Initial or subsequent psychiatric collaborative care management, each additional 30 minutes in a calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional (List separately in addition to code for primary procedure) (Use G0504 in conjunction with G0502, G0503).

We stated that we intend these to be temporary codes and would consider whether to adopt and establish values for the associated new CPT codes under our standard process once those codes are active.

We proposed that these services would be furnished under the direction of a treating physician or other qualified health care professional during a calendar month. These services would be furnished when a patient has a diagnosed psychiatric disorder that requires a behavioral health care assessment; establishing, implementing, revising, or monitoring a care plan; and provision of brief interventions. The diagnosis could be either pre-existing or made by the billing practitioner. These services would be reported by the treating physician or other qualified health care professional and include the services of the treating physician or other qualified health care professional, the behavioral health care manager (see description below) who would furnish services incident to services of the treating physician or other qualified health care professional, and the psychiatric consultant (see description below) whose consultative services would be furnished incident to services of the treating physician or other qualified health care professional. We proposed that beneficiaries who are appropriate candidates for care reported using the psychiatric CoCM codes could have newly diagnosed conditions, need help in engaging in treatment, have not responded to standard care delivered in a non-psychiatric setting, or require further assessment and engagement prior to consideration of referral to a psychiatric care setting. Beneficiaries would be treated for an episode of care, defined as beginning when the behavioral health care manager engages in care of the beneficiary under the appropriate supervision of the billing practitioner and ending with:

  • The attainment of targeted treatment goals, which typically results in the discontinuation of care management services and continuation of usual follow-up with the treating physician or other qualified healthcare professional; or
  • Failure to attain targeted treatment goals culminating in referral to a psychiatric care provider for ongoing treatment; or
  • Lack of continued engagement with no psychiatric collaborative care management services provided over a consecutive 6-month calendar period (break in episode).

A new episode of care would start after a break in episode of 6 calendar months or more.

The treating physician or other qualified health care professional would direct the behavioral health care manager and continue to oversee the beneficiary's care, including prescribing medications, providing treatments for medical conditions, and making referrals to specialty care when needed. Medically necessary E/M and other services could be reported separately by the treating physician or other qualified health care professional, or other physicians or practitioners, during the same calendar month. Time spent by the treating physician or other qualified health care professional on activities for services reported separately could not be included in the services reported using G0502, G0503, and G0504. We proposed that the behavioral health care manager would be a member of the treating physician or other qualified health care professional's clinical staff with formal education or specialized training in behavioral health (which could include a range of disciplines, for example, social work, nursing, and psychology) who provides care management services, as well as an assessment of needs, including the administration of validated rating scales,[5] the development of a care plan, provision of brief interventions, ongoing collaboration with the treating physician or other qualified health care professional, maintenance of a registry,[6] all in consultation with a psychiatric consultant. The behavioral health care manager would furnish these services both face-to-face and non-face-to-face, and consult with the psychiatric consultant minimally on a weekly basis. We proposed that the behavioral health care manager would be on-site at the location where the treating physician or other qualified health care professional furnishes services to the beneficiary.

We proposed that the behavioral health care manager may or may not be a professional who meets all the requirements to independently furnish and report services to Medicare. If otherwise eligible, then that individual Start Printed Page 80232could report separate services furnished to a beneficiary receiving the services described by G0502, G0503, G0504, and G0507 in the same calendar month. These could include: Psychiatric evaluation (90791, 90792), psychotherapy (90832, 90833, 90834, 90836, 90837, 90838), psychotherapy for crisis (90839, 90840), family psychotherapy (90846, 90847), multiple family group psychotherapy (90849), group psychotherapy (90853), smoking and tobacco use cessation counseling (99406, 90407), and alcohol or substance abuse intervention services (G0396, G0397). Time spent by the behavioral health care manager on activities for services reported separately could not be included in the services reported using time applied to G0502, G0503, and G0504.

The psychiatric consultant involved in the “incident to” care furnished under this model would be a medical professional trained in psychiatry and qualified to prescribe the full range of medications. The psychiatric consultant would advise and make recommendations, as needed, for psychiatric and other medical care, including psychiatric and other medical diagnoses, treatment strategies including appropriate therapies, medication management, medical management of complications associated with treatment of psychiatric disorders, and referral for specialty services, that are communicated to the treating physician or other qualified health care professional, typically through the behavioral health care manager. The psychiatric consultant would not typically see the patient or prescribe medications, except in rare circumstances, but could and should facilitate a referral to a psychiatric care provider when clinically indicated.

In the event that the psychiatric consultant furnished services to the beneficiary directly in the calendar month described by other codes, such as E/M services or psychiatric evaluation (CPT codes 90791 and 90792), those services could be reported separately by the psychiatric consultant. Time spent by the psychiatric consultant on activities for services reported separately could not be included in the services reported using G0502, G0503, and G0504.

We also noted that, although the psychiatric CoCM has been studied extensively in the setting of specific behavioral health conditions (for example, depression), we received persuasive comments in response to the CY 2016 proposed rule recommending that we not specify particular diagnoses required for use of the codes for several reasons, including that: There may be overlap in behavioral health conditions; there are concerns that there could be modification of diagnoses to fit within payment rules which could skew the accuracy of submitted diagnosis code data; and for many patients for whom specialty care is not available, or who choose for other reasons to remain in primary care, primary care treatment will be more effective if it is provided within a model of integrated care that includes care management and psychiatric consultation.

Comment: The public comments were very supportive of our creation of the three G-codes for CY 2017 to pay for services furnished using the psychiatric CoCM. The commenters offered a number of recommendations regarding valuation of the codes. Some commenters requested additional codes, sought clarification, or presented statements in favor of including the services of practitioners other than psychiatrists, especially psychologists and social workers, within the proposed codes.

Response: We thank the commenters for their support of coding and valuation for services furnished using the psychiatric CoCM, and for their recommendations regarding appropriate valuation. We address the comments on valuation in section II.L of this final rule. We address the comments regarding payment for services of psychologists and social workers below.

Comment: Several commenters expressed concern that making separate payment for psychiatric CoCM for the treatment of mood disorders might result in neglecting treatment for other mental health conditions. Other commenters expressed support for not designating a limited set of eligible behavioral health diagnoses. One commenter stated that requiring a diagnosed behavioral health condition might mean that subclinical issues or undiagnosed behavioral health conditions would be neglected.

Response: We continue to believe that we should not limit billing and payment for the psychiatric CoCM codes to a limited set of behavioral health conditions. As we understand it, the psychiatric CoCM model of care may be used to treat patients with any behavioral health condition that is being treated by the billing practitioner, including substance use disorders. In the Collaborative Care literature reviewed by the Cochrane Collaboration and others, there is stronger evidence of effectiveness and cost-effectiveness for certain behavioral disorders, particularly mood and anxiety disorders, than for others. However, we continue to receive persuasive comments indicating that the psychiatric CoCM is recommended for broader incorporation into clinical practice, and recommending that we not specify the use of the psychiatric CoCM codes for only particular behavioral health diagnoses. Therefore we are not limiting billing and payment for the psychiatric CoCM codes to a specified set of behavioral health conditions.

In response to the public comment regarding whether we should require a diagnosed psychiatric disorder (as opposed to a subclinical or undiagnosed condition), we are clarifying that as described, the services require that there must be a presenting psychiatric or behavioral health condition(s) that, in the clinical judgment of the treating physician or other qualified health professional, warrants “referral” to the behavioral health care manager for further assessment and treatment through provision of psychiatric CoCM services. “Referral” is placed in quotes because the behavioral health care manager may be located in the same practice as the treating physician or other qualified health professional, who in any event provides ongoing oversight and continues to treat the beneficiary. However, the referring diagnosis (or diagnoses) may be either pre-existing or made by the treating physician or other qualified health professional, and we are not establishing any specific list of eligible or included diagnoses or conditions. The treating physician or other qualified health professional may not be qualified or able to fully diagnose all relevant psychiatric or behavioral health condition(s) prior to referring the beneficiary for psychiatric CoCM services. If in the course of providing psychiatric CoCM services, it becomes clear that the referring condition(s) or other diagnoses cannot be addressed by psychiatric CoCM services, then we understand that the beneficiary should be referred for other psychiatric treatment or should continue usual follow-up care with the treating practitioner, because the episode of psychiatric CoCM services ends if there is failure to attain targeted treatment goals after or despite changes in treatment, as indicated. Beneficiaries receiving care reported using the psychiatric CoCM codes may, but are not required to have comorbid chronic or other medical condition(s) that are being managed by the treating practitioner.

Comment: Several commenters who supported payment for the proposed codes for psychiatric CoCM services in primary care settings, raised questions about whether these codes could be Start Printed Page 80233used to bill for services furnished in other settings that are not traditional primary care settings, such as inpatient or long-term care, oncology practices, or emergency departments. Some of these commenters recommended additional new codes to pay for services furnished in these other settings.

Response: The psychiatric CoCM trials and real world implementation have mainly included primary care practice that broadly includes pediatrics, obstetrics/gynecology, and geriatrics as well as family practice and general internal medicine. The psychiatric CoCM has also been used in cardiology and oncology practice, and we believe it could be used in various medical specialty settings, as long as the specialist physician or practitioner is managing the beneficiary's behavioral health condition(s) as well as other medical conditions (for example, cancer, status-post acute myocardial infarction and other conditions where co-morbid depression is common). Accordingly, we are not limiting the code to reporting by only “traditional” primary care specialties. We believe primary care practitioners will most frequently perform the services described by the new psychiatric CoCM codes, but if other specialist practitioners perform these services and meet all of the requirements to bill the code(s), then they may report the psychiatric CoCM codes. We are interested in receiving additional, more specific information from stakeholders regarding which specialties furnish psychiatric CoCM services. We note that we would generally not expect psychiatrists to bill the psychiatric CoCM codes, because psychiatric work is defined as a sub-component of the psychiatric CoCM codes.

Regarding psychiatric CoCM services furnished to inpatients or beneficiaries in long-term care settings such as nursing or custodial care facilities, we note that the forthcoming CPT codes are not limited to office or other outpatient or domiciliary services. Moreover, our goal is to separately identify and pay for psychiatric CoCM services furnished to beneficiaries in any appropriate setting of care, whether inpatient or outpatient, in recognition of the associated time and service complexity. Care of beneficiaries who are admitted to a facility, are in long-term care, or are transitioning among settings during the month may be more complex than the care of other types of patients. While there is some overlap between psychiatric CoCM and CCM services, they are distinct services with differing patient populations, as discussed elsewhere in this section of our final rule. Therefore, we have valued the psychiatric CoCM services in both facility and non-facility settings (see section II.L on valuation). We are not limiting the time that can be counted towards the monthly time requirement to bill the psychiatric CoCM code(s) to time that is spent in the care of an outpatient or a beneficiary residing in the community. However, we also stress that G0502, G0503 and G0504 can only be reported by a treating physician or other qualified health care professional when he or she has directed the psychiatric CoCM service for the duration of time that he or she is reporting it, and has a qualifying relationship with individuals providing the service under his or her direction and control. Also, time and effort that is spent managing care transitions for CCM or TCM patients and that is counted towards reporting TCM or CCM services, cannot also be counted towards reporting any transitional care management activities reported under a BHI service code(s), either the psychiatric CoCM codes or the code describing other BHI services. We welcome additional input from stakeholders regarding appropriate (or inappropriate) sites of service for G0502, G0503 and G0504.

We note that for CY 2017, the facility PE RVU for psychiatric CoCM services will include the indirect PE allocated based on the work RVUs, but no direct PE (which is explicitly comprised of other labor, equipment and supplies). This is because historically, the PFS facility rate for a given professional service assumes that the billing practitioner is not bearing a significant resource cost in labor by other individuals, equipment or supplies. We generally assume that those costs are instead borne by the facility, and are adequately accounted for in a separate payment made to the facility to account for these costs and other costs incurred by the facility for the beneficiary's facility stay. For BHI services and similar care management services such as CCM, we have been considering whether this approach to PFS valuation is optimal because the PFS service, in significant part, may be provided by the behavioral health care manager, clinical staff, or even other physicians under the employment of the billing practitioner or under contract to the billing practitioner. These individuals may provide much of the PFS service remotely, and are not necessarily employees or staff of the facility. Indeed, the BHI services are defined in terms of activities performed by individual(s) other than the billing practitioner and who may not be affiliated with or located within the facility, even though as we discuss below the billing practitioner must also perform certain work. For this type of PFS service, there may be more direct practice expense borne by the billing practitioner even though the beneficiary is located, for part or all of the month, in a facility receiving institutional payment. We plan to consider these issues further in the future.

Comment: One specialty association supported the proposed psychiatric CoCM codes, noting that although few of their members would use these codes, they set an important precedent to recognize interdisciplinary care that requires significant non-face-to-face work. This commenter anticipated that similar code series may be developed in the future to describe complex management in other specialties including neurology, and supported the adoption of language approved at CPT that carefully defined the roles of multiple professionals. Other commenters similarly expressed support for separate payment for additional collaborative care services, including inter-professional consultation in the treatment of other illnesses such as cancer or multiple sclerosis.

Response: We continue to be interested in new coding that describes integrative, collaborative or consultative care among specialties other than primary care and behavioral health/psychiatry. We are especially interested in new coding that describes such care in sufficient detail that distinguishes it from existing service codes, and that would further the appropriate valuation of cognitive services. We will continue to follow any new coding proposals at CPT relevant for the Medicare population. We note that we have followed CPT's lead in finalizing proposed code G0505 for cognitive impairment assessment and care planning (see section II.E.5) as well as for psychiatric CoCM services. BHI is a unique type of service that we believe until now has not been well identified nor appropriately valued under existing codes. BHI is not comprised of mere consultation among professionals and has a unique evidence base, in addition to being recently addressed by forthcoming CPT coding. In addition, given the shortage of available psychiatric and other mental health professionals in many parts of the country, we believe it is important to identify and make accurate payment for models of care that facilitate access to psychiatric and other behavioral health specialty care through innovations in medical practice, like the ones described by these codes.Start Printed Page 80234

Comment: One commenter asked CMS to clarify inclusion of nurse practitioners who are primary care practitioners and, in the specialty of psychiatry, psychiatric nurse practitioners who can perform psychiatric evaluations and treat psychiatric problems.

Response: Nurse practitioners are authorized to independently bill Medicare for their services, and can also bill Medicare for services furnished incident to their services. Therefore, nurse practitioners who furnish the psychiatric CoCM services as described may bill for the psychiatric CoCM codes. Nurse practitioners who meet our final qualifications to serve as the behavioral health care manager may provide the behavioral health care manager services incident to the services of another (billing) practitioner. Nurse practitioners who meet all of our final requirements to serve as the psychiatric consultant may provide the psychiatric consultant services incident to the services of the billing practitioner.

Comment: Regarding the care planning requirements for psychiatric CoCM services, some commenters noted that there is not necessarily value in accumulating or enumerating a number of different types of care plans addressing different aspects of the beneficiary's problems, such as a behavioral or psychiatric care plan, a CCM care plan, and a cognitive impairment care plan (see G0505 in section II.E.5).

Response: While the proposed descriptors for the psychiatric CoCM services referred to an “individualized treatment plan,” not a “care plan,” we proposed in addition that the behavioral health care manager would “develop a care plan.” While any care planning should take into account the whole patient, our intent is that the care planning included in the CCM coding (and G0506, the CCM initiating visit add-on code) will be the most comprehensive in nature, addressing all health issues with particular focus on the multiple chronic conditions being managed by the billing practitioner. In that sense, the CCM care plan is an integrative care plan incorporating more comprehensive health information on all of the beneficiary's health issues, or reconciling care plans of other practitioners. In contrast, the BHI care planning will focus on behavioral health or psychiatric issues, in particular, just as cognitive impairment care planning will focus on cognitive impairment issues, in particular (see section II.E.5). We are not requiring the psychiatric CoCM treating practitioner or behavioral health consultant to perform care planning that incorporates comprehensive health information on all of the beneficiary's health issues or reconciles the care plans of other practitioners, as would be expected for CCM care planning.

We understand that adoption of EHRs may be lower among behavioral health practitioners [7] and note that resources are available to help inform how care plans can support team-based care and BHI.[8] Our understanding from the public comments last year and subsequent discussions with experts on the psychiatric CoCM model of care, is that no specific electronic technology or format is necessary or indispensable to carry out the psychiatric CoCM model of care, or perform the services included in the codes we are creating to describe the services furnished using that model. We believe the format of the behavioral health care plan (or any care plan) is less important than having a process whereby feedback and expertise from all relevant practitioners and providers, whether internal or external to the billing practice, are integrated into the beneficiary's treatment plan and goals; that this plan be regularly assessed and revisited by the practitioner who is assuming an overall care management role for the beneficiary in a given month; that the patient is engaged in the care planning process; and that the care planning be documented in the medical record (as with any required element of any PFS service). We are revising the requirement for care planning by the behavioral health care manager accordingly, that he or she will perform “behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes.”

Comment: A number of commenters recommended that we should not require the behavioral health care manager for the psychiatric CoCM services to be located on site within the primary care practice. The commenters noted that in some settings, particularly rural areas or smaller practices, this may be especially important. Some commenters assumed that there is also a behavioral health care manager for G0507 (discussed below). These commenters compared BHI services (the psychiatric CoCM services and G0507) to CCM and recommended that CMS adopt the same requirements for all the BHI codes as for CCM, regarding supervision, location of a behavioral health care manager, and third party outsourcing.

Response: For the psychiatric CoCM services, we proposed that the behavioral health care manager would be a member of the treating physician or other qualified health care professional's clinical staff, and would be required to be located on site but able to work under general supervision. In addition, we proposed that the behavioral health care manager provides his or her services both face-to-face and non-face-to-face. We believed that services provided using the psychiatric CoCM model of care commonly involve face-to-face interaction between the behavioral health care manager and the beneficiary on appropriate occasions, such as the outset of services (a “warm hand-off” from the treating physician or other qualified health care professional). In addition, whether face-to-face or non-face-to-face, many of the included behavioral health care manager duties could be performed while the treating practitioner is not in the office and could be performed after hours. We note that the behavioral health care manager duties are listed in full above, and include care management services, as well as an assessment of needs, including the administration of validated rating scales, behavioral health care planning, provision of brief interventions, ongoing collaboration with the treating physician or other qualified health care professional, and maintenance of a registry, all in consultation with a psychiatric consultant.

The delivery of the psychiatric CoCM depends, in part, on continuity of care between a given patient and the assigned behavioral health care manager. Also it requires collaboration, integration and ongoing data flow between the behavioral health care manager and the treating practitioner the behavioral health care manager is supporting, as well as with the psychiatric consultant who is usually remotely located under the psychiatric CoCM model of care. As previously discussed, the psychiatric CoCM is an integrative model of care, and in considering our proposal we were concerned that allowing the behavioral health care manager to be located remotely would compromise their ability to collaborate, communicate, and timely treat and share information with the beneficiary and the rest of the care team. We are aware of many care Start Printed Page 80235management companies and health information technology companies that may seek to provide remote care management and related services under all of the new BHI codes, as they have for CCM and similar services recently adopted under the PFS. We received public comments from several such stakeholders that indicated an interest in the provision of BHI services and related health information technology. We understand that there have been successful implementations (positive randomized controlled trials) of the psychiatric CoCM using remote call centers; however, in these implementations, call center staff were not randomly rotated among patients and there was ongoing data flow and connectivity between the behavioral health care manager and the other members of the care team, as well as the patient. Moreover, the behavioral health care manager would presumably have to be on site at least some of the time (even if under general supervision), in order to provide some of their services in-person with the beneficiary.

The fact that we proposed and are finalizing general supervision for the psychiatric CoCM codes as we did for CCM services (see section II.E.3.b) does not mean that general supervision alone suffices to meet the requirements of the psychiatric CoCM for continuity, collaboration and integration among the care team members, including the beneficiary. General supervision means that the service is furnished under the overall direction and control of the practitioner billing the service, but without the presence of the practitioner being required during the performance of the service. This definition does not directly govern where individual(s) providing the service on an incident to basis are located, whether on site or remote. Rather, it governs the location and informs the involvement of the billing practitioner.

For payment purposes, we are assigning general supervision to the psychiatric CoCM codes because we do not believe it is clinically necessary that the professionals on the team who provide services other than the treating practitioner (namely, the behavioral health care manager and the psychiatric consultant) must have the billing practitioner immediately available to them at all times, as would be required under a higher level of supervision. However, general supervision sets the minimum standard for supervision and does not, by itself, meet the requirements we are setting for billing new codes G0502, G0503 and G0504. While certain aspects of psychiatric CoCM services might be furnished under general supervision, we do not believe the general supervision requirement adequately describes the nature of the relationship and interactions of the respective team members for services furnished using the psychiatric CoCM or the codes we are creating to describe those services. Moreover it only directly addresses the physical location of the billing practitioner, not the behavioral health care manager, necessarily.

After considering the public comments, we are not finalizing our proposal that the behavioral health care manager must be a member of the treating physician or other qualified health care professional's clinical staff. As some of the psychiatric CoCM services can be contracted out to a third party (subject to rules discussed below), the contracted individuals are not necessarily employees of the treating practitioner.

Regarding the face-to-face provision of services by the behavioral health care manager, we are requiring that the behavioral health care manager must be available to provide services on a face-to-face basis, but not that face-to-face services must be provided. We are not finalizing the proposed requirement that the behavioral health care manager must be located on site, in order to allow for after-hours or appropriate remote provision of services. However, to ensure clinical integration with the treating practitioner and familiarity and continuity with the beneficiary, which are characteristic of services furnished under the psychiatric CoCM model of care, we are requiring that the behavioral health care manager must have a collaborative, integrated relationship with the rest of the care team members, and be able to perform all of the required elements of the psychiatric CoCM services delineated for the behavioral health care manager. The behavioral health care manager must have the ability to engage the beneficiary outside of regular clinic hours as necessary to perform their duties under the CoCM model, and have a continuous relationship with the beneficiary. This does not mean the behavioral health care manager is necessarily an employee of or always physically located within the practice, nor does it require provision of behavioral health care manager services to the beneficiary on site. The behavioral health care manager may provide his or her services from a remote location that is remote from the billing practitioner or remote from the beneficiary, subject to incident to rules and regulations in 42 CFR 410.26, if he or she has a qualifying relationship with the rest of the care team including the beneficiary, and is available to provide services face-to-face.

We will monitor this issue going forward, not just for the psychiatric CoCM but also for the general BHI service code (G0507) we are finalizing, as well as for TCM and CCM services. As we discuss in the final rule section on CCM below, we are continuing to consider whether outsourcing certain aspects of these services to a third party fragments care, leads to insufficient involvement and oversight of the billing practitioner or results in services that do not actually represent or facilitate continuous, seamless transitional care and other required aspects of these services. We will continue to consider how to best define the continuity of care that is required for services furnished and billed under all of these codes, and whether arrangements for remote provision of services whether by a case management company or another entity increases rather than reduces service fragmentation. Advances in health information technology provide opportunities for remote connectivity and interoperability that may assist and be useful, if not necessary, for reducing care fragmentation. However, remote provision of services by entities having only a loose association with the treating practitioner can detract from continuous, patient-centered care, whether or not those entities employ certified or other electronic technology.

We note that while time spent by the treating practitioner is not explicitly counted for in codes G0502, G0503 and G0504, these codes are valued to include work performed directly by the treating practitioner. The treating practitioner directs the behavioral health care manager and continues to oversee the patient's care, including prescribing medications, providing treatments for medical conditions, and making referrals to specialty care when needed. We are finalizing as proposed that some of these services may be separately billable. However, we wish to emphasize that the treating practitioner must remain involved in ongoing oversight, management, collaboration and reassessment as appropriate to bill the psychiatric CoCM codes.

Comment: We received a number of comments requesting that we allow or recognize pharmacists, especially neurologic or psychiatric pharmacists, or doctoral-level clinical psychologists to serve as the psychiatric consultant. Some commenters were concerned that CMS is advocating pharmacotherapy over psychotherapy by requiring a psychiatric consultant who can prescribe medication.Start Printed Page 80236

Response: We agree with the commenters that there are multiple types of indicated treatment for behavioral health conditions, including psychotherapy and other psychosocial interventions as well as pharmacotherapy that are available and should be offered to beneficiaries receiving psychiatric CoCM services. Our intent is not to inappropriately steer beneficiaries into medication-based treatment, but rather that the psychiatric consultant be able to present and recommend the full range of treatment options including but not limited to medications, and to advise regarding any medications the beneficiary chooses to take. Under the psychiatric CoCM, the psychiatric consultant must be able to prescribe medication. As we discuss in section II.L on valuation of G0502, G0503 and G0504, we agree with the commenters who stated that the role of the psychiatric consultant under these codes is primarily evaluation and management, which is not within the scope of pharmacists or clinical psychologists under Medicare rules. Therefore, we are finalizing the role and qualifications of the psychiatric consultant as proposed. The general BHI code (G0507), which we are finalizing, was intended and may be used to report other models of care, where the beneficiary may not receive E/M services from the consultant and the consultant may only be authorized to provide psychotherapy or consultation regarding medications (see section II.E.3.b).

Comment: We received a number of comments recommending various types of professionals as qualified to serve as the behavioral health care manager, such as licensed clinical social workers (LCSWs) and psychologists.

Response: Unlike CCM and the general BHI service (code G0507), the psychiatric CoCM codes are used to report time that is spent in specified activities performed by a behavioral health care manager having formal education or specialized training in those activities, whether or not the behavioral health care manager is eligible to directly bill Medicare for other services. The behavioral health care manager may or may not be a professional who meets all the requirements to independently furnish and report services to Medicare. The behavioral health care manager must also meet any applicable licensure and state law requirements, which is required under 42 CFR 410.26 for all services provided under the PFS. LCSWs would meet these requirements, as would qualified registered nurses, clinical psychologists and other qualified clinical staff. Time spent by administrative or clerical staff cannot be counted towards the time required to bill G0502, G0503 or G0504.

Evaluation and management services (such as face-to-face E/M visits) may be separately billed during the service period or on the same day as the psychiatric CoCM services, provided time is not counted twice towards the same code.

b. General Behavioral Health Integration (BHI)

We recognize that the psychiatric CoCM is prescriptive and that much of its demonstrated success may be attributable to adherence to a set of elements and guidelines of care. We are finalizing the code set discussed above to pay accurately for care furnished using this specific model of care, given its widespread adoption and recognized effectiveness. However, we note that PFS coding, in general, does not dictate how physicians practice medicine and believe that it should, instead, reflect the practice of medicine. We also recognize that there are primary care practices that are incurring, or may incur, resource costs inherent to treatment of patients with similar conditions based on BHI models of care other than the psychiatric CoCM that may benefit beneficiaries with behavioral health conditions (see, for example, the approaches described at http://www.integration.samhsa.gov/​integrated-care-models). There are a variety of care models ranging from behavioral health professionals embedded within a primary care office for same-day treatment, to remote consultation, to assessment-and-referral (see, for example, http://www.commonwealthfund.org/​publications/​newsletters/​quality-matters/​2014/​august-september/​profiles; and http://www.integration.samhsa.gov/​integrated-care-models). These models of care have tended to arise from clinical practice as opposed to the research environment (http://psychnews.psychiatryonline.org/​doi/​full/​10.1176/​appi.pn.2014.10b25), and include resource costs that differ in various respects from those associated with the psychiatric CoCM.

To recognize the resource costs associated with furnishing such BHI services to Medicare beneficiaries, we also proposed to make payment using a new G-code that describes care management for beneficiaries with behavioral health conditions under other models of care. We believe that the resources associated with such care are not currently adequately recognized under the PFS. The proposed code was G0507 (Care management services for behavioral health conditions, at least 20 minutes of clinical staff time, directed by a physician or other qualified health care professional, per calendar month). We noted that we would expect this code to be refined over time as we receive more information about other BHI models being used and how they are implemented.

We sought stakeholder input on whether we should consider different increments of time for this code, such as a base code plus an add-on code comprised of additional 20 minute increments. We recognized that BHI services furnished under the proposed code may range in resource costs. We believed that appropriate payment for these services would further the refinement and implementation of BHI models of care, and that having utilization data would inform future refinement of the proposed code's valuation.

Comment: The commenters were supportive of new coding to support payment for other BHI models of care. They believed G0507 could be used by some smaller or medium sized practices who could not conform to the strict parameters of the psychiatric CoCM but provide very similar services. They also stated that G0507 would be appropriate to report services furnished under other BHI models of care that may not require psychiatric services. We received a few comments describing particular models of care in great detail; a few commenters referenced the Veterans' Administration BHI care models, the Primary Care Behavioral Health/Behavioral Health Consultation (PCBH/BHC) Model, or general models in place within other health care systems. However, there was consensus among the commenters that another code(s) in addition to the psychiatric CoCM codes would be useful to collect information on how other behavioral health care models are being used and implemented.

Many commenters recommended that CMS provide more of a framework or description of included services and provider types without being unduly burdensome. Some commenters recommended service elements similar to the CCM service elements (continuity of care with a designated member of the care team; a written care plan; a comprehensive assessment of behavioral health or psychiatric and other medical conditions as well as any functional and psychosocial needs, updated as necessary; routine evaluation of patient progress using a tracking system; services should be documented in the medical record and available to other treating professionals). These Start Printed Page 80237commenters recommended that eligible patients should have a diagnosed psychiatric or substance use disorder that requires care management services. Several commenters recommended that BHI payments be tied to the use of behavioral health assessment tools for screening and collection of treatment outcomes throughout the sessions of care in primary care. These commenters believed this would better position behavioral health to benefit from the movement toward value-based payment in the future. Some commenters assumed there is a designated behavioral health care manager for the service described by G0507, and recommended that we adopt similar rules for this care manager as apply for clinical staff providing CCM services.

Response: We continue to believe that another code, or set of BHI codes, in addition to the psychiatric CoCM code set would be useful to pay appropriately for BHI services furnished to Medicare beneficiaries. We also believe that such payment could facilitate our ability to identify and collect data regarding similar or related BHI service models. We agree with the commenters that we should provide more specificity around the services eligible for reporting under this other code(s). One way to do this would be to create codes with tiered times. Some commenters supported such an approach, while others believed it would be premature. At this time, we are not creating multiple levels of codes distinguishing levels of general BHI services using time or any other metric, but we may reconsider this in the future (also see section II.L on G0507 valuation).

Regarding included elements of the general BHI service (G0507), we agree with the commenters that we should be more specific in our definition of this service. We wish to provide greater specificity without being overly prescriptive, since a range of activities may be included in BHI models of care other than the psychiatric CoCM. We believe we should include a core set of service elements that are similar to core elements of the psychiatric CoCM, especially a systematic process for initial assessment and routine follow up evaluation, revising the treatment approach or methods for patients who are not progressing or whose status changes; facilitating and coordinating behavioral health expertise and treatment; and designating a member of the care team with whom the beneficiary has a continuous relationship. We may revisit the included services in future years, but for CY 2017 the required service elements for the general BHI service (G0507) will be:

  • Initial assessment or follow-up monitoring, including the use of applicable validated rating scales;
  • Behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes;
  • Facilitating and coordinating treatment such as psychotherapy, pharmacotherapy, counseling and/or psychiatric consultation; and
  • Continuity of care with a designated member of the care team.

Accordingly, the final code descriptor will be, G0507: Care management services for behavioral health conditions, at least 20 minutes of clinical staff time, directed by a physician or other qualified health care professional, per calendar month, with the following required elements:

  • Initial assessment or follow-up monitoring, including the use of applicable validated rating scales;
  • Behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes;
  • Facilitating and coordinating treatment such as psychotherapy, pharmacotherapy, counseling and/or psychiatric consultation; and
  • Continuity of care with a designated member of the care team.

We are aware of a number of validated rating scales that are available for use for a number of conditions addressed by BHI models of care, such as those described by the Kennedy Forum (see http://thekennedyforum-dot-org.s3.amazonaws.com/​documents/​MBC_​supplement.pdf). We are requiring the use of such scales when applicable to the condition(s) that are being treated. Medication Assisted Treatment (MAT) may be a treatment that is facilitated under the facilitating treatment service element.

Regarding diagnosis, we believe we should specify similar diagnostic criteria for G0507 and the psychiatric CoCM services (G0502, G0503 and G0504). Accordingly we are providing that beneficiaries who are appropriate candidates for services billed under G0507 will have an identified psychiatric or behavioral health condition(s) that requires a behavioral health care assessment, behavioral health care planning, and provision of interventions. Eligible beneficiaries must present with a condition(s) that in the treating practitioner's clinical judgment, warrants the services included in G0507. The presenting condition(s) may be pre-existing or newly diagnosed by the treating practitioner, and may be refined as treatment progresses. Beneficiaries receiving services reported under G0507 may, but are not required to have comorbid chronic or other medical condition(s) that are being managed by the treating practitioner. We are not limiting billing and payment for G0507 to a specified set of behavioral health conditions, because there may be overlap in behavioral health conditions; if we specified only certain diagnoses, practitioners might modify diagnoses to fit within payment rules; and for many beneficiaries for whom specialty care is not available, or who choose for other reasons to remain within primary care, their behavioral health condition(s) can be addressed using a model of integrated care.

Regarding rules for clinical staff, we are clarifying that services included in the code G0507 may be provided directly by the treating practitioner or provided by other qualifying individuals (whom we term “clinical staff”) under his or her direction, during the calendar month service period. Unlike the psychiatric CoCM codes, for G0507 there is not necessarily a specific individual designated as a “behavioral health care manager” with formal or specialized education in providing the services (although there could be). Similarly, there is not necessarily a psychiatric or other behavioral health specialist consultant (although there could be), and we note that G0507 is not valued to explicitly account for such a consultant. We will apply the same definition of the term “clinical staff” that we have applied for CCM to G0507, namely, the CPT definition of this term, subject to the incident to rules and regulations and applicable state law, licensure and scope of practice at 42 CFR 410.26. For G0507, then, we note that the term “clinical staff” will encompass or include a psychiatric or other behavioral health specialist consultant, if the treating practitioner obtains consultative expertise. Clinical staff that provide included services do not have to be employed by the treating practitioner or located on site, necessarily, and may or may not be a professional who is permitted to independently furnish and report services to Medicare. Time spent by administrative or clerical staff cannot be counted towards the time required to bill G0507.

G0507 is valued to include minimal work by the treating practitioner; the bulk of the valuation is based on clinical staff time (see section II.L on valuation). However, we want to emphasize that the Start Printed Page 80238treating practitioner must direct the service, continue to oversee the beneficiary's care, and perform ongoing management, collaboration and reassessment. If the service (or part thereof) is provided incident to the treating practitioner's services, whether on site or remotely, the clinical staff providing services must have a collaborative, integrated relationship with the treating practitioner. They must also have a continuous relationship with the beneficiary.

Evaluation and management services, such as face-to-face E/M visits, may be separately billed during the service period or on the same day as G0507, provided time is not counted twice towards the same code.

For payment purposes, we are categorizing this service as a designated care management service assigned general supervision for purposes of “incident to” billing, because we do not believe it is clinically necessary for the individuals on the team who provide services other than the treating practitioner (namely, clinical staff) to have the treating practitioner immediately available to them at all times, as would be required under a higher level of supervision. However, general supervision sets the minimum standard for supervision and does not, by itself, meet the requirements we are setting for billing new code G0507. While certain aspects of G0507 might be furnished under general supervision, we do not believe the general supervision requirement adequately describes the nature of the relationship and interactions of the respective team members for services furnished using BHI models of care or the codes we are creating to describe those services. Moreover the general supervision requirement only directly addresses the physical location of the treating practitioner, not the location of clinical staff, necessarily.

Comment: Regarding behavioral health care planning, some commenters noted that there is not necessarily value in accumulating or enumerating a number of different types of care plans addressing different aspects of the beneficiary's problems, such as a behavioral or psychiatric care plan, a CCM care plan, and a cognitive impairment care plan (see G0505 in section II.E.5).

Response: While any care planning should take into account the whole patient, our intent is that the care planning included in the CCM coding (and G0506, the CCM initiating visit add-on code) will be the most comprehensive in nature, addressing all health issues with particular focus on the multiple chronic conditions being managed by the treating practitioner. In contrast, the BHI care planning will focus on behavioral health or psychiatric issues, in particular, just as the cognitive impairment care planning will focus on cognitive impairment issues, in particular (see section II.E.5. of this final rule).

However, we understand that adoption of EHRs may be lower among behavioral health practitioners [9] and note that resources are available to help inform how care plans can support team-based care and BHI.[10] While we understand that practitioners, in general, are exploring a wide variety of innovative approaches and tools that facilitate care plan integration across clinical disciplines, at this time, there may not be sufficient adoption of interoperable health IT interoperability among all practitioners and providers treating a given beneficiary to necessarily have a single, master care plan that adequately addresses the progress of the beneficiary in relation to all of these issues. In general, practitioners are encouraged to pursue approaches that integrate health information from multiple sources into a single care plan, but we understand that practitioners may need to create separate documents or the relevant care planning may be documented in another format within the medical record.

We believe the format of the care plan(s) is less important than having a process whereby feedback and expertise from all relevant practitioners and providers, whether internal or external to the billing practice, are integrated into the beneficiary's treatment plan and goals; that this plan be regularly assessed and revisited by the practitioner who is assuming an overall care management role for the beneficiary in a given month; that the patient is engaged in the care planning process; and that the care planning be documented in the medical record (as with any required element of any PFS service). We have framed the care planning service element for G0507 accordingly, “Behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes.”

Comment: We received a few comments recommending codes in addition to the psychiatric CoCM codes that would pay for similar services to inpatients, or for behavioral health services by psychologists to psychologically and medically complex patients in skilled nursing facilities (SNF) and nursing homes. Some of these commenters stated that in SNF and long-term care settings, psychologists work closely with primary care physicians, psychiatrists, nurses, and other consultants to improve outcomes by reducing inappropriate use or dosing of psychotropic medications, improving activities of daily living, and preventing avoidable admissions/falls. These commenters stated that many health systems employ psychologists as BHI team leaders or coordinators, and sought clarification on how psychologist-led teams would operationalize the new BHI codes. These commenters believe that psychology training provides unique skills in facilitating interdisciplinary teams. While they acknowledged that psychologists are not qualified to perform the full range of BHI services and interventions, they believed psychologists should be able to separately report and bill for care coordination and BHI initiation activities.

We received similar comments supporting the addition of psychiatric collaborative care services to the PFS, and other evidence-based models in a variety of primary care-based treatment settings. However, these commenters supported the inclusion of social workers at all levels of licensures as reimbursable providers of these services.

Response: We appreciate the commenters' descriptions of some particular working models of care, and we welcome additional information in this regard. We continue to believe it would be appropriate to have new coding for a range of BHI care models applicable to inpatient as well as outpatient and facility settings. Our goal in separately identifying and paying for BHI services is to prioritize accurate payment for these services, in recognition of the associated time and complexity of the services. We agree that beneficiaries who are admitted to a facility, are in long-term care, or are transitioning among settings during the month are likely to be more complex than other types of patients, and to warrant more- not less- BHI services. Therefore, we have valued G0507 in both facility and non-facility settings (see section II.L on valuation). We are not limiting the time that can be counted towards the monthly time Start Printed Page 80239requirement to bill G0507 to time that is spent in the care of an outpatient or a beneficiary residing in the community. As we provide for the psychiatric CoCM services, G0507 may be reported by specialties that are not “traditional” primary care specialties, if such specialists furnish the included services. However, we stress that G0507 can only be reported by a treating physician or other qualified health care professional when he or she has directed the BHI service for the duration of time that he or she is reporting it, and has a qualifying relationship with individuals providing the service under his or her direction and control. Also, time and effort that is spent managing care transitions for CCM or TCM patients and that is counted towards reporting TCM or CCM services, cannot also be counted towards reporting any transitional care management activities reported under a BHI service code(s). We welcome additional input from stakeholders regarding appropriate (or inappropriate) settings of service for G0507.

Since the BHI initiating visit that is required to bill G0507 is not within the scope of practice of a psychologist or social worker (see below), psychologists and social workers will not be able to report G0507 directly (although a psychiatrist may be able to do so). Psychologists and social workers may provide care management services included in G0507 incident to the services of another (billing) practitioner. They may also provide services that are separately billable during the service period. We appreciate the commenters' support for team-based care, and we recognize the substantial role of various types of mental health professionals within a primary care team. We are interested in receiving additional input from stakeholders as to whether and why behavioral health care management services by a social worker, psychologist or similarly qualified professional should be reportable in its own right, rather than incident to the services of a practitioner authorized to bill Medicare for a BHI initiating visit. Consistent with our recent approaches to making proposals under PFS notice and comment rulemaking, we could consider adopting new coding under a different construct that was not defined as BHI, if stakeholders provided sufficient input on how to design, define and value the services. We would also consider such changes if adopted by the CPT Editorial Panel, per our usual process. BHI integrates behavioral health expertise into evaluation and management care. Therefore G0507 is designed to include services that require the oversight and involvement of a practitioner who can perform evaluation and management services, including facilitation of any needed pharmacotherapy, referral for specialty care, and overall management of the beneficiary's treatment in relation to primary care treatment. We note that G0507 would not be independently billed by psychologists or social workers, though from our understanding of various models of BHI, these professionals seem likely to be participants in team-based care for beneficiaries receiving these services.

c. BHI Initiating Visit

Similar to CCM services (see section II.E.4), we proposed to require an initiating visit for all of the BHI codes (G0502, G0503, G0504 and G0507) that would be billable separate from the BHI services themselves. We proposed that the same services that can serve as the initiating visit for CCM services (see section II.E.4.a. of this final rule) could serve as the initiating visit for the proposed BHI codes. The initiating visit would establish the beneficiary's relationship with the billing practitioner (most aspects of the BHI services would be furnished incident to the billing practitioner's professional services), ensure the billing practitioner assesses the beneficiary prior to initiating care management processes, and provide an opportunity to obtain beneficiary consent (discussed below). We solicited public comment on the types of services that are appropriate for an initiating visit for the BHI codes, and within what timeframe the initiating visit should be conducted prior to furnishing BHI services.

Comment: The commenters were largely supportive of our proposal to allow the same services to qualify for the initiating visit to CCM as for the initiating visit to BHI services. We received a few comments stating that in addition to the qualifying E/M services (or an AWV or IPPE), initiating services should include in-depth psychological evaluations delivered by a psychologist including CPT codes 90791, 96116 or 96118 which, in turn, include care plan development. These commenters agreed that psychologists cannot personally furnish all BHI services (for example, medication reconciliation), but believe psychologists effectively coordinate care and perform other aspects of BHI services as part of a team under current practice models. They believe this approach would be particularly effective for reducing inappropriate use or dosing of psychotropic medications in elderly and complex patients, improving activities of daily living, and preventing avoidable admissions and falls.

Response: We appreciate the commenters' feedback. We agree that psychologists would be qualified to perform care coordination that is included in the psychiatric CoCM codes (G0502, G0503 and G0504) and the general BHI code (G0507) under the direction of a physician or other qualified health care professional. In addition, beneficiaries receiving BHI services under any of those codes may be referred to psychologists for psychotherapy or other services that are separately billable and within the scope of practice of psychologists, as discussed elsewhere in this section of our final rule. However many commenters acknowledged, and we agree, that a BHI initiating visit is necessary. The initiating visit is not, in its entirety, within the scope of psychologist practice. Therefore, we are finalizing our proposal that the same services that qualify as the initiating visit for CCM will also qualify as initiating services for BHI, and they do not include in-depth psychological evaluation by a psychologist. Also, we will require an initiating visit for BHI only for new patients or beneficiaries not seen within a year of commencement of BHI services (the same requirement we are finalizing for CCM, see section II.E.4.a). As more experience is gained with the psychiatric CoCM services and other models of BHI care, we may reassess these provisions.

As discussed above, we are interested in receiving input from stakeholders regarding circumstances other than BHI in which behavioral health care management services by a psychologist, social worker or similarly qualified professional should be reportable in its own right, rather than incident to the services of a practitioner authorized to bill Medicare for a BHI initiating visit.

Comment: Some commenters recommended that CMS establish an add-on code to the initiating visit for BHI services, parallel to G0506 (the proposed add-on code for the CCM initiating visit).

Response: We do not believe we have enough information about practice patterns at this time to create an add-on code to the BHI initiating visit, and we did not propose such a code. We may re-examine this issue in the future.

d. Beneficiary Consent for BHI Services

Commenters to the CY 2016 PFS proposed rule indicated that they did not believe a specific patient consent for BHI services is necessary and indicated that requiring special informed consent Start Printed Page 80240for these services may reduce access due to stigma associated with behavioral health conditions. Instead, the commenters recommended requiring a more general consent prior to initiating these services whereby the beneficiary gives the initiating physician or practitioner permission to consult with relevant specialists, which would include conferring with a psychiatric consultant. Accordingly, we proposed to require a general beneficiary consent to consult with relevant specialists prior to initiating these services, recognizing that applicable rules continue to apply regarding privacy. The proposed general consent would encompass conferring with a psychiatric consultant when furnishing the psychiatric CoCM codes (G0502, G0503, and G0504) or the proposed broader BHI code (G0507). Similar to the proposed beneficiary consent process for CCM services, we proposed that the billing practitioner must document in the beneficiary's medical record that the beneficiary's consent was obtained to consult with relevant specialists including a psychiatric consultant, and that, as part of the consent, the beneficiary is informed that there is beneficiary cost-sharing, including potential deductible and coinsurance amounts, for both in-person and non-face-to-face services that are provided. We solicited stakeholder comments on this proposal.

We recognized that special informed consent could also be helpful in cases when a particular service is limited to being billed by a single practitioner for a particular beneficiary. We did not believe that there are circumstances where it would reasonable for multiple practitioners to be reporting these codes during the same month. However, we did not propose a formal limit at this time. We solicited comment on whether such a limitation would be beneficial or whether there are circumstances under which a beneficiary might reasonably receive BHI services from more than one practitioner during a given month.

Comment: The commenters were largely supportive of our proposal regarding BHI consent, some noting that physician-to-physician communication as well as communication within treatment teams happens routinely, without an extra layer of formal written consent, for other medical conditions. A few commenters intimated that CMS might pursue a single broad consent that could be used across care management services; for example, applying for both CCM and BHI. We did not receive any public comments delineating the circumstances under which it would be appropriate to bill for services furnished using more than one BHI service model per month, or appropriate for more than one practitioner (whether in the same practice or different practices) to bill for services furnished in a BHI care model per month.

Response: We agree with the commenters that physician-to-physician communication as well as communication within treatment teams happens routinely, without an extra layer of formal written consent, for other medical conditions. However there are particular privacy concerns addressed by other rules and regulations for some behavioral health or substance use care. Also we are concerned that beneficiaries should not incur unexpected expenses for care that is largely, or in significant part, non-face-to-face in nature. Finally, there are issues to consider, that we considered for CCM, regarding prevention of duplicative practitioner billing, and whether BHI services can actually be furnished under the direction and control of any given practitioner if for a given service period, more than one practitioner is furnishing BHI services and billing them.

The public comments were supportive of our proposal for a broad consent that could be verbally obtained but must be documented in the medical record, and we are finalizing as proposed. At this time, we do not believe a single consent process for both BHI and CCM is advisable. It is not clear how frequently BHI and CCM would or should be furnished concurrently. BHI and CCM are distinct, separate services, having significant differences in time thresholds, the nature of the services, types of individuals providing the services, and payment and cost sharing amounts. Therefore, at this time, we are maintaining separate consent processes for CCM and BHI, as provided in the respective sections of this final rule. Also, as discussed in section II.E.4 on CCM, CCM and BHI may be billed during the same service period.

It remains unclear whether it would be reasonable and necessary for more than one practitioner (whether in the same practice or different practices) to bill BHI services for a given beneficiary for a given service period, given the lack of public response and input on this issue. It may depend on the conditions(s) being treated and whether specialty care, other than psychiatric or behavioral health specialty care, and primary care are both involved. We are not proposing a formal limit at this time, but we stress that BHI services can only be reported by a treating physician or other qualified health care professional when he or she has obtained the required beneficiary consent, directed the BHI services he or she reports for the duration of time reported, and has a qualifying relationship with individuals providing the reported services under his or her direction and control. We would not expect a single practitioner to furnish care to a given beneficiary under more than one BHI model of care during a given month. Therefore a single practitioner must choose whether to report psychiatric CoCM code(s) (G0502, G0503, and G0504 as applicable) or the general BHI code (G0507) for a given month for a given beneficiary. We remind stakeholders that time cannot be counted more than once towards any code(s), all services must be medically reasonable and necessary, and that beneficiary cost sharing and advance consent apply. We will be monitoring the claims data and studying the utilization patterns. We will continue to assess appropriate reporting patterns, and we expect that potential coding changes by the CPT Editorial Panel may inform this issue.

Comment: We received a number of comments recommending that cost sharing be removed for all care management services, whether through legislative change, demonstration, waiver safe harbor, or designation as preventive services.

Response: We appreciate commenters' concerns and recognize many of the challenges associated with patient cost-sharing for these kinds of services. At this time, we do not have authority to waive cost sharing for the BHI or other care management services. We appreciate the commenters' acknowledgement of our current limitations and we will continue to consider this issue.

e. Summary of Final BHI Policies

Beginning in CY 2017, we are providing separate payment for a range of BHI services. Specifically, we are providing payment for psychiatric CoCM services under the following codes:

  • G0502: Initial psychiatric collaborative care management, first 70 minutes in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:

++ Outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional;

++ Initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan;Start Printed Page 80241

++ Review by the psychiatric consultant with modifications of the plan if recommended;

++ Entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant; and

++ Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies.

  • G0503: Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:

++ Tracking patient follow-up and progress using the registry, with appropriate documentation;

++ Participation in weekly caseload consultation with the psychiatric consultant;

++ Ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers;

++ Additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant;

++ Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies;

++ Monitoring of patient outcomes using validated rating scales; and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment.

  • G0504: Initial or subsequent psychiatric collaborative care management, each additional 30 minutes in a calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional (List separately in addition to code for primary procedure) (Use G0504 in conjunction with G0502, G0503).

These psychiatric CoCM services are reported by the treating physician or other qualified health care professional for services furnished during a calendar month service period. These services may be furnished when a beneficiary has a psychiatric or behavioral health condition(s) that in the treating physician or other qualified health care professional's clinical judgment, requires a behavioral health care assessment; establishing, implementing, revising, or monitoring a care plan; and provision of brief interventions. The diagnosis or diagnoses may be pre-existing or made by the treating physician or other qualified health care professional, and may be refined over time. The psychiatric CoCM services may be furnished to beneficiaries with any psychiatric or behavioral health condition(s) that is being treated by the physician or other qualified health care professional, including substance use disorders. Beneficiaries receiving psychiatric CoCM services may, but are not required to have comorbid chronic or other medical condition(s) that are being managed by the treating practitioner.

Psychiatric CoCM services include the services of the treating physician or other qualified health care professional, the behavioral health care manager (see description below) who provides services incident to services of the treating physician or other qualified health care professional, and the psychiatric consultant (see description below) whose consultative services are furnished incident to services of the treating physician or other qualified health care professional. Time spent by administrative or clerical staff cannot be counted towards the time required to bill the psychiatric CoCM service codes.

Beneficiaries receiving psychiatric CoCM services may have newly diagnosed conditions, need help in engaging in treatment, have not responded to standard care delivered in a non-psychiatric setting, or require further assessment and engagement prior to consideration of referral to a psychiatric care setting. Beneficiaries are treated for an episode of care, defined as beginning when the behavioral health care manager engages in care of the beneficiary under the appropriate supervision of the billing practitioner and ending with:

  • The attainment of targeted treatment goals, which typically results in the discontinuation of care management services and continuation of usual follow-up with the treating physician or other qualified healthcare professional; or
  • Failure to attain targeted treatment goals culminating in referral to a psychiatric care provider for ongoing treatment; or
  • Lack of continued engagement with no psychiatric collaborative care management services provided over a consecutive 6-month calendar period (break in episode).

A new episode of care will start after a break in episode of 6 calendar months or more.

The treating physician or other qualified health care professional directs the behavioral health care manager and continues to oversee the beneficiary's care, including prescribing medications, providing treatments for medical conditions, and making referrals to specialty care when needed. The treating physician or other qualified health care professional must remain involved in ongoing oversight, management, collaboration and reassessment as appropriate to bill the psychiatric CoCM codes.

The behavioral health care manager has formal education or specialized training in behavioral health (which could include a range of disciplines, for example, social work, nursing, and psychology). The behavioral health care manager provides care management services, as well as an assessment of needs, including the administration of validated rating scales; [11] behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes; provision of brief interventions; ongoing collaboration with the treating physician or other qualified health care professional; maintenance of a registry; [12] all in consultation with the psychiatric consultant. The behavioral health care manager is available to provide these services face-to-face and non-face-to-face, and consults with the psychiatric consultant minimally on a weekly basis.

The behavioral health care manager must have a collaborative, integrated relationship with the rest of the care team members, and be able to perform all of the required elements of the service delineated for the behavioral health care manager. The behavioral health care manager must have the ability to engage the beneficiary outside of regular clinic hours as necessary to perform the behavioral health care manager's duties under the psychiatric CoCM model, and must have a continuous relationship with the beneficiary. The behavioral health care manager may or may not be a Start Printed Page 80242professional who meets all the requirements to independently furnish and report services to Medicare. The behavioral health care manager is subject to the incident to rules and regulations and applicable state law, licensure and scope of practice (see 42 CFR 410.26).

The psychiatric consultant is a medical professional trained in psychiatry and qualified to prescribe the full range of medications. The psychiatric consultant advises and makes recommendations, as needed, for psychiatric and other medical care, including psychiatric and other medical diagnoses, treatment strategies including appropriate therapies, medication management, medical management of complications associated with treatment of psychiatric disorders, and referral for specialty services, that are communicated to the treating physician or other qualified health care professional, typically through the behavioral health care manager. The psychiatric consultant does not typically see the beneficiary or prescribe medications, except in rare circumstances, but can and should facilitate referral for direct provision of psychiatric care when clinically indicated. The psychiatric consultant is subject to the incident to rules and regulations and applicable state law, licensure and scope of practice (see 42 CFR 410.26).

Beginning in CY 2017, we are providing separate payment for BHI services furnished under models of care other than the psychiatric CoCM model, under HCPCS code G0507: Care management services for behavioral health conditions, at least 20 minutes of clinical staff time, directed by a physician or other qualified health care professional, per calendar month, with the following required elements:

  • Initial assessment or follow-up monitoring, including the use of applicable validated rating scales;
  • Behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes;
  • Facilitating and coordinating treatment such as psychotherapy, pharmacotherapy, counseling and/or psychiatric consultation; and
  • Continuity of care with a designated member of the care team.

G0507 is reported by the treating physician or other qualified health care professional for services furnished during a calendar month service period. This service may be furnished when the beneficiary has a psychiatric or behavioral health condition(s) that in the treating physician or other qualified health care professional's clinical judgment, requires a behavioral health care assessment, behavioral health care planning, and provision of interventions. The presenting condition(s) may be pre-existing or newly diagnosed by the treating physician or other qualified health care professional, and may be refined over time. Beneficiaries receiving services reported under G0507 may have any psychiatric or behavioral health condition(s) that is being treated by the physician or other qualified health care professional, including substance use disorders. Beneficiaries receiving services reported under G0507 may, but are not required to have comorbid chronic or other medical condition(s) that are being managed by the treating practitioner.

Services reported under G0507 may be provided directly by the treating physician or other qualified health care professional, or provided by clinical staff under his or her direction, during a calendar month service period. For G0507, there is not necessarily a specific individual designated as a “behavioral health care manager” with formal or specialized education in providing the services (although there could be). Similarly, there is not necessarily a psychiatric or other behavioral health specialist consultant (although there could be) and we note that G0507 is not valued to explicitly account for expert consultation. For G0507, the term “clinical staff” means the CPT definition of this term, subject to the incident to rules and regulations and applicable state law, licensure and scope of practice at 42 CFR 410.26. For G0507, then, we note that the term “clinical staff” will encompass or include any psychiatric or other behavioral health specialist consultant that may provide consultative services. Clinical staff providing services are not required to be employed by the treating practitioner or located on site, and these individuals may or may not be a professional permitted to independently furnish and report services to Medicare. Time spent by administrative or clerical staff cannot be counted towards the time required to report G0507. We emphasize that the physician or other qualified health care professional must direct the service, continue to oversee the beneficiary's care, and perform ongoing management, collaboration and reassessment. If the service (or part thereof) is provided incident to services of the treating practitioner, whether on site or remotely, the clinical staff providing services must have a collaborative, integrated relationship with the treating practitioner. They must also have a continuous relationship with the beneficiary.

For all of the BHI service codes (G0502, G0503, G0504 and G0507), we are requiring an initiating visit that is billable separate from the BHI services themselves. The same services that qualify as initiating visits for CCM services can serve as the initiating visit for BHI services (certain face-to-face E/M services including the face-to-face visit required for TCM services, and the AWV or IPPE). The BHI initiating visit establishes the beneficiary's relationship with the treating practitioner (BHI services may be furnished incident to the treating practitioner's professional services); ensures that the treating practitioner assesses the beneficiary prior to initiating care management processes; and provides an opportunity to obtain beneficiary consent (consent may also be obtained outside of the BHI initiating visit, as long as it is obtained prior to commencement of BHI services).

For all of the BHI service codes, we are also requiring prior beneficiary consent, recognizing that applicable rules continue to apply regarding privacy. The consent will include permission to consult with relevant specialists including a psychiatric consultant, and inform the beneficiary that cost sharing will apply to in-person and non-face-to-face services provided. Consent may be verbal (written consent is not required) but must be documented in the medical record.

For payment purposes, we are assigning general supervision to all of the BHI service codes (G0502, G0503, G0504 and G0507). However we note that general supervision does not, by itself, comprise a qualifying relationship between the treating practitioner and other individuals providing BHI services under the incident to relationship. Also we note that we valued BHI services in both facility and non-facility settings. BHI services may be furnished to beneficiaries in any setting of care. Time that is spent furnishing BHI services to a beneficiary who is an inpatient or in any other facility setting during service provision or for any part of the service period may be counted towards reporting a BHI code(s). We refer the reader to our discussion above on this matter, as well as reporting by specialty, intersection with other services, and potential reporting by more than one practitioner for a given beneficiary within a service period. A single practitioner must choose whether to report psychiatric CoCM code(s) (G0502, G0503, and Start Printed Page 80243G0504 as applicable) or the general BHI code (G0507) for a given month (service period) for a given beneficiary.

4. Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management (CCM) Services

Beginning in CY 2015, we implemented separate payment for CCM services under CPT code 99490 (Chronic care management services, at least 20 minutes of clinical staff time directed by a physician or other qualified health professional, per calendar month, with the following required elements:

  • Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient;
  • Chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline;
  • Comprehensive care plan established, implemented, revised, or monitored).

In the CY 2015 final rule with comment period, we finalized a proposal to make separate payment for CCM services as one initiative in a series of initiatives designed to improve payment for, and encourage long-term investment in, care management services (79 FR 67715). In particular, we sought to address an issue raised to us by the physician community, which stated that the care management included in many of the existing E/M services, such as office visits, does not adequately describe the typical non-face-to-face care management work required by certain categories of beneficiaries (78 FR 43337). We began to re-examine how Medicare should pay under the PFS for non-face-to-face care management services that were bundled into the PFS payment for face-to-face E/M visits, being included in the pre- and post-encounter work (78 FR 43337). In proposing separate payment for CCM, we acknowledged that, even though we had previously considered non-face-to-face care management services as bundled into the payment for face-to-face E/M visits, the E/M office/outpatient visit CPT codes may not reflect all the services and resources required to furnish comprehensive, coordinated care management for certain categories of beneficiaries. We stated that we believed that the resources required to furnish complex chronic care management services to beneficiaries with multiple (that is, two or more) chronic conditions were not adequately reflected in the existing E/M codes. Medical practice and patient complexity required physicians, other practitioners and their clinical staff to spend increasing amounts of time and effort managing the care of comorbid beneficiaries outside of face-to-face E/M visits, for example, complex and multidisciplinary care modalities that involve regular physician development and/or revision of care plans; subsequent report of patient status; review of laboratory and other studies; communication with other health care professionals not employed in the same practice who are involved in the patient's care; integration of new information into the care plan; and/or adjustments of medical therapy.

Therefore, in the CY 2014 PFS final rule with comment period, we established a separate payment under the PFS for CPT code 99490 (78 FR 43341 through 43342). We sought to include a relatively broad eligible patient population within the code descriptor, established a moderate payment amount, and established bundled payment for concurrently new CPT codes that were reserved for beneficiaries requiring “complex” CCM services (base CPT code 99487 and its add-on code 99489) (79 FR 67716 through 67719). We stated that we would evaluate the services reported under CPT code 99490 to assess whether the service is targeted to the right population and whether the payment amount is appropriate (79 FR 67719). We remind stakeholders that CMS did not limit the eligible population to any particular list of chronic conditions other than the language in the CPT code descriptor. Accordingly, one or more of the chronic conditions being managed through CCM services could be chronic mental health or behavioral health conditions or chronic cognitive disorders, as long as the chronic conditions meet the eligibility language in the CPT code descriptor for CCM services and the billing practitioner meets all of Medicare's requirements to bill the code including comprehensive, patient-centered care planning for all health conditions.

In finalizing separate payment for CPT code 99490, we considered whether we should develop standards to ensure that physicians and other practitioners billing the service would have the capability to fully furnish the service (79 FR 67721). We sought to make certain that the newly payable PFS code(s) would provide beneficiary access to appropriate care management services that are characteristic of advanced primary care, such as continuity of care; patient support for chronic diseases to achieve health goals; 24/7 patient access to care and health information; receipt of preventive care; patient, family and caregiver engagement; and timely coordination of care through electronic health information exchange. Accordingly, we established a set of scope of service elements and payment rules in addition to or in lieu of those established in CPT guidance (in the CPT code descriptor and CPT prefatory language), that the physician or nonphysician practitioner must satisfy to fully furnish CCM services and report CPT code 99490 (78 FR 74414 through 74427, 79 FR 67715 through 67730, and 80 FR 14854). We established requirements to furnish a preceding qualifying visit, obtain advance written beneficiary consent, use certified electronic health record (EHR) technology to furnish certain elements of the service, share the care plan and clinical summaries electronically, document specified activities, and other items summarized in Table 11 of our CY 2017 proposed rule. For the CCM service elements for which we required use of a certified EHR, the billing practitioner must use, at a minimum, technology meeting the edition(s) of certification criteria that is acceptable for purposes of the EHR Incentive Programs as of December 31st of the calendar year preceding each PFS payment year. (For the CY 2017 PFS payment year, this would mean technology meeting the 2014 edition of certification criteria).

These elements and requirements for separately payable CCM services are extensive and generally exceed those required for payment of codes describing procedures, diagnostic tests, or other E/M services under the PFS. In addition, both CPT guidance and Medicare rules specify that only a single practitioner who assumes the care management role for a given beneficiary can bill CPT code 99490 per service period (calendar month). Because the new CCM service closely overlapped with several Medicare demonstration models of advanced primary care (the Multi-Payer Advanced Primary Care Practice (MAPCP) demonstration and the Comprehensive Primary Care Initiative (CPCI)), we provided that practitioners participating in one of these two initiatives could not be paid for CCM services furnished to a beneficiary attributed by the initiative to their practice (79 FR 67729).

Given the non-face-to-face nature of CCM services, we also sought to ensure that beneficiaries would receive advance notice that Part B cost sharing applies since we currently have no legislative authority to “waive” cost sharing for this service. Also since only one practitioner can bill for CCM each service period, we believed the Start Printed Page 80244beneficiary notice requirement would help prevent duplicate payment to multiple practitioners.

Since the establishment of CPT code 99490 for separate payment of CCM services, in a number of forums and in public comments to the CY 2016 PFS final rule (80 FR 70921), many practitioners have stated that the service elements and billing requirements are burdensome, redundant and prevent them from being able to provide the services to beneficiaries who could benefit from them. Stakeholders have stated that CPT code 99490 is underutilized because it is underpaid relative to the resources involved in furnishing the services, especially given the extensive Medicare rules for payment, and they have suggested a number of potential changes to our current payment rules. Stakeholders continue to believe that many of the CCM payment rules are duplicative, and to recommend that we reduce the rules and expand CCM coding and payment to distinguish among different levels of patient complexity. We also note that section 103 of the MACRA requires CMS to assess and report to Congress (no later than December 31, 2017) on access to CCM services by underserved rural and racial and ethnic minority populations and to conduct an outreach/education campaign that is underway.

The professional claims data for CPT code 99490 show that utilization is steadily increasing but may remain low considering the number of eligible Medicare beneficiaries. To date, approximately 513,000 unique Medicare beneficiaries received the service an average of four times each, totaling $93 million in total payments. Since CPT code 99490 describes a minimum of 20 minutes of clinical staff time spent furnishing CCM services during a month and does not have an upper time limit, and since we currently do not separately pay the other codes in the CCM family of CPT codes (which would provide us with utilization data on the number of patients requiring longer service times during a billing period), we do not know how often beneficiaries required more than 20 minutes of CCM services per month. We also do not know their complexity relative to one another, other than meeting the acuity criteria in the CPT code descriptor. Initial information from practitioner interviews conducted as part of our CCM evaluation efforts indicates that practitioners overwhelmingly meet and exceed the 20-minute threshold time for billing CCM. Typically, these practitioners reported spending between 45 minutes and an hour per month on CCM services for each patient, with times ranging between 20 minutes and several hours per month. CCM beneficiaries tend to exhibit a higher disease burden, are more likely to be dually eligible for Medicare and Medicaid, and are older than the general Medicare fee-for-service population.[13] However, absent multiple levels of CCM coding, we do not have comprehensive data on the relative complexity of the CCM services furnished to beneficiaries.

In light of this stakeholder feedback and our mandate under MACRA section 103 to encourage and report on access to CCM services, we proposed several changes in the payment rules for CCM services. Our primary goal, and our statutory mandate, is to pay as accurately as possible for services furnished to Medicare beneficiaries based on the relative resources required to furnish PFS services, including CCM services. In so doing, we also expect to facilitate beneficiaries' access to reasonable and necessary CCM services that improve health outcomes. First, for CY 2017 we proposed to more appropriately recognize and pay for the other codes in the CPT family of CCM services (CPT codes 99487 and 99489 describing complex CCM), consistent with our general practice to price services according to their relative ranking within a given family of services. We direct the reader to section II.L of this final rule for a discussion of valuation for base CPT code 99487 and its add-on CPT code 99489. The CPT code descriptors are:

  • CPT code 99487—Complex chronic care management services, with the following required elements:

++ Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient;

++ Chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline;

++ Establishment or substantial revision of a comprehensive care plan;

++ Moderate or high complexity medical decision making;

++ 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month.

  • CPT code 99489—Each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure).

As CPT provides, less than 60 minutes of clinical staff time in the service period could not be reported separately, and similarly, less than 30 minutes in addition to the first 60 minutes of complex CCM in a service period could not be reported. We would require 60 minutes of services for reporting CPT code 99487 and 30 additional minutes for each unit of CPT code 99489.

We proposed to adopt the CPT provision that CPT codes 99487, 99489 and 99490 may only be reported once per service period (calendar month) and only by the single practitioner who assumes the care management role with a particular beneficiary for the service period. That is, a given beneficiary would be classified as eligible to receive either complex or non-complex CCM during a given service period, not both, and only one professional claim could be submitted to the PFS for CCM for that service period by one practitioner.

Comment: Several commenters were supportive of separate payment for complex CCM services.

Response: We thank the commenters for their support and are finalizing separate payment for CPT codes 99487 and 99489 as proposed. As finalized, these separate payments for complex CCM services will support care management for the most complex and time-consuming cases of beneficiaries with multiple chronic conditions.

Except for differences in the CPT code descriptors, we proposed to require the same CCM service elements for CPT codes 99487, 99489 and 99490. In other words, all the requirements in Table 11 of our proposed rule would apply, whether the code being billed for the service period is CPT code 99487 (plus CPT code 99489, if applicable) or CPT code 99490. These three codes would differ in the amount of clinical staff service time provided; the complexity of medical decision-making as defined in the E/M guidelines (determined by the problems addressed by the reporting practitioner during the month); and the nature of care planning that was performed (establishment or substantial revision of the care plan for complex CCM versus establishment, implementation, revision or monitoring of the care plan for non-complex CCM). Billing practitioners could consider identifying beneficiaries who require complex CCM services using criteria suggested in CPT guidance (such as number of illnesses, number of medications or repeat admissions or emergency department visits) or the profile of typical patients in the CPT Start Printed Page 80245prefatory language, but these would not comprise Medicare conditions of eligibility for complex CCM.

We proposed several changes to our current scope of service elements for CCM, and proposed that the same scope of service elements, as amended, would apply to all codes used to report CCM services beginning in 2017 (i.e., CPT codes 99487, 99489 and 99490). In particular, we proposed changes in the requirements for the initiating visit, 24/7 access to care and continuity of care, format and sharing of the care plan and clinical summaries, beneficiary receipt of the care plan, beneficiary consent and documentation.

Comment: Commenters were broadly supportive of these proposals. We received several comments recommending changes to the scope of service for non-complex CCM that might improve the distinction between non-complex and complex CCM and inform which “level” of service a given beneficiary is eligible for. For example, these commenters suggested changes to the time included in the code descriptor to reflect two or more time increments for CPT code 99490 using add-on codes, or retaining the current low time threshold while allowing practitioners to choose among certain service elements. Some commenters do not believe CPT code 99490 is intended for beneficiaries who require all the current service elements in a given month, and that only a more limited set of elements is medically necessary for the non-complex population.

Response: We appreciate the commenters' recommendations about how we might better distinguish complex CCM services from non-complex CCM services. The CPT Editorial Panel currently maintains the coding for CCM services. Further changes in codes and/or descriptors may be appropriately addressed by CPT and in subsequent PFS rulemaking.

a. CCM Initiating Visit Add-On Code (G0506)

As provided in the CY 2014 PFS final rule with comment period (78 FR 74425) and subregulatory guidance (available at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Downloads/​Payment_​for_​CCM_​Services_​FAQ.pdf), CCM must be initiated by the billing practitioner during a “comprehensive” E/M visit, AWV or IPPE. This face-to-face, initiating visit is not part of the CCM service and can be separately billed to the PFS, but is required before CCM services can be provided directly or under other arrangements. The billing practitioner must discuss CCM with the patient at this visit. While informed patient consent does not have to be obtained during this visit, the visit is an opportunity to obtain the required consent. The face-to-face visit included in transitional care management (TCM) services (CPT codes 99495 and 99496) qualifies as a “comprehensive” visit for CCM initiation. Levels 2 through 5 E/M visits (CPT codes 99212 through 99215) also qualify; CMS does not require the practice to initiate CCM during a level 4 or 5 E/M visit. However, CPT codes that do not involve a face-to-face visit by the billing practitioner or are not separately payable by Medicare (such as CPT code 99211, anticoagulant management, online services, telephone and other E/M services) do not qualify as initiating visits. If the practitioner furnishes a “comprehensive” E/M, AWV, or IPPE and does not discuss CCM with the patient at that visit, that visit cannot count as the initiating visit for CCM.

We continued to believe that we should require an initiating visit in advance of furnishing CCM services, separate from the services themselves, because a face-to-face visit establishes the beneficiary's relationship with the billing practitioner and most aspects of the CCM services are furnished incident to the billing practitioner's professional services. The initiating visit also ensures collection of comprehensive health information to inform the care plan. We continued to believe that the types of face-to-face services that qualify as an initiating visit for CCM are appropriate. We did not propose to change the kinds of visits that can qualify as initiating CCM visits. However, we proposed to require the initiating visit only for new patients or patients not seen within one year instead of for all beneficiaries receiving CCM services. We believed this would allow practitioners with existing relationships with patients who have been seen relatively recently to initiate CCM services without furnishing a potentially unnecessary E/M visit. We solicited public comment on whether a period of time shorter than one year would be more appropriate.

Comment: The commenters were generally supportive of requiring the CCM initiating visit only for beneficiaries who are new patients or have not been seen in a year. A few commenters suggested a 6-month timeframe, or adopting one year and reconsidering as we gain more experience with CCM. Some commenters misinterpreted our proposal as requiring face-to-face visits every year to periodically reassess the beneficiary or the appropriateness of CCM services. Some recommended a similar coding structure for specialists managing a single condition, in place of prolonged services, or for BHI services.

Response: Our intent was to revise the timeframe for the single CCM initiating visit that is required at the outset of services. We did not propose subsequent “re-initiation” of CCM services or face-to-face reassessment within a given timeframe. We discuss further below that we have some concerns about how to ensure that the billing practitioner remains involved in the beneficiary's care and continually reassesses the beneficiary's care, but at this time we do not believe we should require subsequent face-to-face visits within certain timeframes to address those concerns.

We believe that the proposed one-year timeframe for the single, CCM initiating visit is appropriate for CY 2017, so we are finalizing as proposed. We will require the CCM initiating visit only for new patients or patients not seen within the year prior to commencement of CCM (instead of for all beneficiaries receiving CCM services). We will continue to consider in future years whether a different timeframe is warranted. The goal of our final policy is to allow practitioners with existing relationships with beneficiaries who have been seen relatively recently to initiate CCM services (for the first time) without furnishing a potentially unnecessary E/M visit. Regarding subsequent visits (after CCM services begin), practitioners are already permitted to furnish and separately bill subsequent E/M visits (or AWVs) for beneficiaries receiving CCM services. If a face-to-face reassessment is reasonable and necessary and furnished by the billing practitioner, then he or she may bill an appropriate code describing the face-to-face assessment of a beneficiary to whom they have previously furnished CCM services.

We also proposed for CY 2017 to create a new add-on G-code that would improve payment for services that qualify as initiating visits for CCM services. The code would be billable for beneficiaries who require extensive face-to-face assessment and care planning by the billing practitioner (as opposed to clinical staff), through an add-on code to the initiating visit, G0506 (Comprehensive assessment of and care planning by the physician or other qualified health care professional for patients requiring chronic care management services (billed separately from monthly care management services) (Add-on code, list separately in addition to primary service)).

We proposed that when the billing practitioner initiating CCM personally Start Printed Page 80246performs extensive assessment and care planning outside of the usual effort described by the billed E/M code (or AWV or IPPE code), the practitioner could bill G0506 in addition to the E/M code for the initiating visit (or in addition to the AWV or IPPE), and in addition to the CCM CPT code 99490 (or proposed 99487 and 99489) if all requirements to bill for CCM services are also met. We proposed valuation for G0506 in a separate section of our proposed rule.

The code G0506 would account specifically for additional work of the billing practitioner in personally performing a face-to-face assessment of a beneficiary requiring CCM services, and personally performing CCM care planning (the care planning could be face-to-face and/or non-face-to-face) that is not already reflected in the initiating visit itself (nor in the monthly CCM service code). We believed G0506 might be particularly appropriate to bill when the initiating visit is a less complex visit (such as a level 2 or 3 E/M visit), although G0506 could be billed along with higher level visits if the billing practitioner's effort and time exceeded the usual effort described by the initiating visit code. It could also be appropriate to bill G0506 when the initiating visit addresses problems unrelated to CCM, and the billing practitioner does not consider the CCM-related work he or she performs in determining what level of initiating visit to bill. We believed that this proposal would more appropriately recognize the relative resource costs for the work of the billing practitioner in initiating CCM services, specifically for extensive work assessing the beneficiary and establishing the CCM care plan that is reasonable and necessary, and that is not accounted for in the billed initiating visit or in the unit of the CCM service itself that is billed for a given service period. In addition, we believed this proposal would help ensure that the billing practitioner personally performs and meaningfully contributes to the establishment of the CCM care plan when the patient's complexity warrants it.

Comment: Several commenters were supportive of the add-on code (G0506) to the CCM initiating visit to describe physician assessment and care planning for patients requiring CCM services. Some commenters raised questions about whether G0506 should be a one-time service or could also be billed as an add-on code to subsequent reassessments by the billing practitioner (whether E/M visits or subsequent AWVs).

Response: At this time, we do not believe we should permit billing of G0506 more than once by the billing practitioner for a given beneficiary. G0506 was proposed as an add-on code to the single initiating visit, to help ensure the billing practitioner's assessment and involvement at the outset of CCM services. At this time there are no requirements for the billing practitioner to “re-initiate” CCM services; therefore we do not believe we should create an add-on code for a CCM “re-initiation” service. We would have to define “re-initiation” and develop rules regarding when subsequent E/M visits or AWVs are related to the performance of CCM. We do not believe beneficiaries would understand why they are incurring additional cost sharing for an add-on code to a “re-initiation” visit that has not been required or defined by CMS.

As we stated in the CY 2017 proposed rule, we were very interested in coding that was presented to the CPT Editorial Panel, but not adopted, to create code(s) that would separately identify and account for monthly CCM work by the billing practitioner. Such coding may be a better means of separately identifying and valuing the subsequent work of the billing practitioner after CCM is initiated. We want to establish policies that help ensure that the billing practitioner is not merely handing the beneficiary off to a remote care manager under general supervision while no longer remaining involved in their care. We believe that the practitioner billing CCM services should be actively re-assessing the beneficiary's chronic conditions, reviewing whether treatment goals are being met, updating the care plan, performing any medical decision-making that is not within the scope of practice of clinical staff, performing any necessary face-to-face care, and performing other related work. However, it would be more straightforward to separately identify this CCM-related work under code(s) that in their own right describe it, instead of add-on codes to very broadly drawn E/M codes where it becomes difficult to assess the relationship between the two services. Also for beneficiaries receiving complex CCM, some of this work is explicitly included in the complex CCM service codes (i.e., medical decision-making of moderate to high complexity). Therefore, at this time, G0506 will only serve as an add-on code to describe work performed by the billing practitioner once, in conjunction with the start or initiation of CCM services.

We note that despite the role of the billing practitioner in the initiation and provision of CCM services provided by clinical staff, non-complex CCM (CPT code 99490) is described based on the time spent by clinical staff. Complex CCM (CPT codes 99487 and 99489) similarly counts only clinical staff time, although it also includes complex medical decision-making by the billing practitioner. This raises issues regarding appropriate valuation in the facility setting that we will continue to consider in future rulemaking. The facility PE RVU for CCM includes indirect PE (which is an allocation based on physician work), but no direct PE (which would be comprised of other labor, supplies and equipment). This is because historically, the PFS facility rate assumes that the billing practitioner is not bearing a significant resource cost in labor by other individuals, equipment or supplies. Medicare assumes that those costs are instead borne by the facility and adequately accounted for in a separate payment made to the facility. The PFS non-facility rate generally does include such costs, assuming that the billing practitioner bears the resource costs in clinical and other staff labor, supplies and equipment.

For CCM, we have been considering whether this approach to valuation remains appropriate, because the service, in whole or in significant part, is provided by clinical staff under the direction of the billing practitioner. These individuals may provide the service or part thereof remotely, and are not necessarily employees or staff of the facility. Under this construct, there may be more direct practice expense borne by the billing practitioner that should be separately identified and valued over and above any institutional payment to the facility for its staff and infrastructure. We plan to explore these issues in future rulemaking and consider other approaches to valuation that would recognize the accurate relative resource costs to the billing practitioner for CCM and similar services furnished to beneficiaries who remain or reside in a facility setting during some or all of the service period.

Consistent with general coding guidance, we proposed that the work that is reported under G0506 (including time) could not also be reported under or counted towards the reporting of any other billed code, including any of the monthly CCM services codes. The care plan that the practitioner must create to bill G0506 would be subject to the same requirements as the care plan included in the monthly CCM services, namely, it must be an electronic patient-centered care plan based on a physical, mental, cognitive, psychosocial, functional and environmental (re)assessment and an Start Printed Page 80247inventory of resources and supports; a comprehensive care plan for all health issues. This would distinguish it from the more limited care planning included in the BHI codes G0502, G0503, G0504 or G0507 which focus on behavioral health issues, or the care planning included in G0505 which focuses on cognitive status. We sought public input on potential overlap among these codes and further clinical input as to how the assessments and care planning that is included in them would differ.

We received a number of comments regarding the relationship between proposed G0506, G0505 (Cognition and functional assessment by the physician or other qualified health care professional in office or other outpatient), prolonged non-face-to-face services, and BHI. We address these comments in the sections of this final rule regarding G0505, prolonged non-face-to-face services and BHI services (sections II.E.5, II.E.2 and II.E.3). In brief, we are not allowing G0506 and G0505 to be billed the same day (by a single practitioner). G0506 will not be an add-on code for the BHI initiating visit or BHI services. G0506 will be a one-time service code for CCM initiation, and the billing practitioner must choose whether to report either G0506 or prolonged services in association with CCM initiation (if requirements to bill both are met).

The CCM and BHI service codes differ substantially in potential diagnosis and comorbidity, the expected duration of the condition(s) being treated, the kind of care planning performed (comprehensive care planning versus care planning focused on behavioral/mental health issues), service elements and who performs them, and the interventions the beneficiary needs and receives apart from the CCM and BHI services themselves. The BHI codes include a more focused process than CCM for the clinical integration of primary care and behavioral health/psychiatric care, and for continual reassessment and treatment progression to a target or goal outcome that is specific to mental and behavioral health or substance abuse issues. However there is no explicit BHI service element for managing care transitions or systematic assessment of receipt of preventive services; there is no requirement to perform comprehensive care planning for all health issues (not just behavioral health issues); and there are different emphases on medication management or medication reconciliation, if applicable. In deciding which code(s) to report for services furnished to a beneficiary who is eligible for both CCM and BHI services, practitioners should consider which service elements were furnished during the service period, who provided them, how much time was spent, and should select the code(s) that most accurately and specifically identifies the services furnished without duplicative time counting. Practitioners should generally select the more specific code(s) when an alternative code(s) potentially includes the services provided. We are not precluding use of the CCM codes to report, or count, behavioral health care management if it is provided as part of a broader CCM service by a practitioner who is comprehensively overseeing all of the beneficiary's health issues, even if there are no imminent non-behavioral health needs. However, such behavioral care management activities could not also be counted towards reporting a BHI code(s). If a BHI service code more specifically describes the service furnished (service time and other relevant aspects of the service being equal), or if there is no focus on the health of the beneficiary outside of a narrower set of behavioral health issues, then it is more appropriate to report the BHI code(s) than the CCM code(s). Similarly, it may be more appropriate for certain specialists to bill BHI services than CCM services, since specialists are more likely to be managing the beneficiary's behavioral health needs in relation to a narrow subset of medical condition(s). CCM and BHI services can only be billed the same month for the same beneficiary if all the requirements to bill each service are separately met. We will monitor the claims data, and we welcome further stakeholder input to inform appropriate reporting rules.

b. 24/7 Access to Care, Continuity of Care, Care Plan and Managing Transitions

We proposed several revisions to the scope of service elements of 24/7 Access to Care, Continuity of Care, Care Plan and Managing Transitions. We continued to believe these elements are important aspects of CCM services, but that we should reduce the requirements for the use of specified electronic health information technology (IT) in their provision. In sum, we proposed to retain a core requirement to use a certified electronic health record (EHR), but allow fax to count for electronic transmission of clinical summaries and the care plan; no longer require access to the electronic care plan outside of normal business hours to those providing CCM services; and remove standards for clinical summaries in managing care transitions.

We sought to improve alignment with CPT provisions by removing the requirement for the care plan to be available remotely to individuals providing CCM services after hours. Studies have shown that after-hours care is best implemented as part of a larger practice approach to access and continuity (see for example, the peer-review article available at http://www.ncbi.nlm.nih.gov/​pmc/​articles/​PMC3475839/​). There is substantial local variation in how 24/7 access and continuity of care are achieved, depending on the contractual relationships among practitioners and providers in a particular geographic area and other factors. Care models include various contractual relationships between physician practices and after-hours clinics, urgent care centers and emergency departments; extended primary care office hours; physician call-sharing; telephone triage systems; and health information technology such as shared EHRs and systematic notification procedures (http://www.ncbi.nlm.nih.gov/​pmc/​articles/​PMC3475839/​). Some or all of these may be used to provide access to urgent care on a 24/7 basis while maintaining information continuity between providers.

We recognized that some models of care require more significant investment in practice infrastructure than others, for example resources in staffing or health information technology. In addition, we believed there is room to reduce the administrative complexity of our current payment rules for CCM services to accommodate a range of potential care models. In re-examining what should be included in the CCM scope of service elements for 24/7 Access to Care and Continuity of Care, we believed the CPT language adequately and more appropriately describes the services that should, at a minimum, be included in these service elements. Therefore, we proposed to adopt the CPT language for these two elements. For 24/7 Access to Care, the scope of service element would be to provide 24/7 access to physicians or other qualified health care professionals or clinical staff including providing patients/caregivers with a means to make contact with health care professionals in the practice to address urgent needs regardless of the time of day or day of week. We believed the CPT language more accurately reflects the potential role of clinical staff or call-sharing services in addressing after-hours care needs than our current language does. In addition, the 24/7 access would be for “urgent” needs Start Printed Page 80248rather than “urgent chronic care needs,” because we believed after-hours services typically would and should address any urgent needs and not only those explicitly related to the beneficiary's chronic conditions.

We recognized that health information systems that include remote access to the care plan or the full EHR after hours, or a feedback loop that communicates back to the primary care physician and others involved in the beneficiary's care regarding after-hours care or advice provided, are extremely helpful (http://www.ncbi.nlm.nih.gov/​pmc/​articles/​PMC3475839/​#CR25). They help ensure that the beneficiary receives necessary follow up, particularly if he or she is referred to the emergency department, and follow up after an emergency department visit is required under the CCM element of Management of Care Transitions. Accordingly, we continued to support and encourage the use of interoperable EHRs or remote access to the care plan in providing the CCM service elements of 24/7 Access to Care, Continuity of Care, and Management of Care Transitions. However, adoption of such technology would be optimal not only for CCM services, but also for a number of other PFS services and procedures (including various other care management services), and we have not required adoption of any certified or non-certified health information technology as a condition of payment for any other PFS service. We noted that there are incentives under other Medicare programs to adopt such information technology, and were concerned that imposing too many EHR-related requirements at the service level as a condition of PFS payment could create disparities between these services and others under the fee schedule. Lastly, we recognized that not all after-hours care warrants follow-up or a feedback loop with the practitioner managing the beneficiary's care overall, and that under particular circumstances feedback loops can be achieved through oral, telephone or other less sophisticated communication methods. Therefore, we proposed to remove the requirement that the individuals providing CCM after hours must have access to the electronic care plan.

This proposal reflected our understanding that flexibility in how practices can provide the requisite 24/7 access to care, as well as continuity of care and management of care transitions, for their CCM patients could facilitate appropriate access to these services for Medicare beneficiaries. This proposal was not intended to undermine the significance of standardized communication methods as part of effective care. Instead, we recognized that other CMS initiatives (such as MIPS and APMs under the Quality Payment Program) may be better mechanisms to incentivize increased interoperability of health information systems than conditions of payment assigned to particular services under the PFS. We also anticipated that improved accuracy of payment for care management services and reduced administrative burden associated with billing for them would contribute to practitioners' capacity to invest in the best tools for managing the care of Medicare beneficiaries.

For Continuity of Care, we currently require the ability to obtain successive routine appointments “with the practitioner or a designated member of the care team,” while CPT only references successive routine appointments “with a designated member of the care team.” We do not believe there is any practical difference between these two phrases and therefore proposed to omit the words “practitioner or” from our requirement. The billing practitioner is a member of the CCM care team, so the CPT language already allows for successive routine appointments either with the billing practitioner or another appropriate member of the CCM care team.

Based on review of extensive public comment and stakeholder feedback, we had also come to believe that we should not require individuals providing the beneficiary with the required 24/7 access to care for urgent needs to have access to the care plan as a condition of CCM payment. As discussed above, we believed that in general, provision of effective after-hours care of the beneficiary would require access to the care plan, if not the full EHR. However, we have heard from rural and other practices that remote access to the care plan is not always necessary or possible because urgent care needs after-hours are often referred to a practitioner or care team member who established the care plan or is familiar with the beneficiary. In some instances, the care plan does not need to be available to address urgent patient needs after business hours. In addition, we have not required the use of any certified or non-certified health information technology in the provision of any other PFS services (including various other care management services). We were concerned that imposing EHR-related requirements at the service level as a condition of PFS payment could distort the relative valuation of services priced under the fee schedule. Therefore, we proposed to change the CCM service element to require timely electronic sharing of care plan information within and outside the billing practice, but not necessarily on a 24/7 basis, and to allow transmission of the care plan by fax.

We acknowledged that it is best for practitioners and providers to have access to care plan information any time they are providing services to beneficiaries who require CCM services. This proposal was not intended to undermine the significance of electronic communication methods other than fax transmission in providing effective, continuous care. On the contrary, we believed that fax transmission, while commonly used, is much less efficient and secure than other methods of communicating patient health information, and we encouraged practitioners to adopt and use electronic technologies other than fax for transmission and exchange of the CCM care plan. We continued to believe the best means of exchange of all relevant patient health information is through standardized electronic means. However, we recognized that other CMS initiatives (such as MIPS and APMs under the Quality Payment Program) may be better mechanisms to incentivize increased interoperability of health information systems than conditions of payment assigned to particular services under the PFS. We believed our proposal would still allow timely availability of health information within and outside the practice for purposes of providing CCM, and would simplify the rules governing provision of the service and improve access to the service. The proposed revisions would better align the service with appropriate CPT prefatory language, which may reduce unnecessary administrative complexity for practitioners in navigating the differences between CPT guidance and Medicare rules.

The CCM scope of service element Management of Care Transitions includes a requirement for the creation and electronic transmission and exchange of continuity of care documents referred to as “clinical summaries” (see Table 11 of the CY 2017 PFS proposed rule). We patterned our requirements regarding clinical summaries after the EHR Incentive Program requirement that an eligible professional who transitions their patient to another setting of care or provider of care, or refers their patient to another provider of care, should provide a summary care record for each transition of care or referral. This clinical summary includes demographics, the medication list, medication allergy list, problem list, and a number of other data elements if the Start Printed Page 80249practitioner knows them. As a condition of CCM payment, we required standardized content for clinical summaries (that they must be created/formatted according to certified EHR technology). For the exchange/transport function, we did not require the use of a specific tool or service to exchange/transmit clinical summaries, as long as they are transmitted electronically (this can include fax only when the receiving practitioner or provider can only receive by fax).

Based on review of extensive public comment and stakeholder feedback, we had come to believe that we should not require the use of any specific electronic technology in managing a beneficiary's care transitions as a condition of payment for CCM services. Instead, we proposed more simply to require the billing practitioner to create and exchange/transmit continuity of care document(s) timely with other practitioners and providers. To avoid confusion with the requirements of the EHR Incentive Programs, and since we would no longer require standardized content for the CCM continuity of care document(s), we would refer to them as continuity of care documents instead of clinical summaries. We would no longer specify how the billing practitioner must transport or exchange these document(s), as long as it is done timely and consistent with the Care Transitions Management scope of service element. We welcomed public input on how we should refer to these document(s), noting that CPT does not provide model language specific to CCM services. The proposed term “continuity of care document(s)” draws on CPT prefatory language for TCM services, which CPT provides may include “obtaining and reviewing the discharge information (for example, discharge summary, as available, or continuity of care document).”

Again, this proposal was not intended to undermine the significance of a standardized, electronic format and means of exchange (other than fax) of all relevant patient health information, for achieving timely, seamless care across settings especially after discharge from a facility. On the contrary, we believed that fax transmission, while commonly used, is much less efficient and secure than other methods of communicating patient health information, and we encourage practitioners to adopt and use electronic technologies other than fax for transmission and exchange of continuity of care documents in providing CCM services. We continued to believe the best means of exchange of all relevant patient health information is through standardized electronic means. However, as we discussed above regarding the CCM care plan, we have not applied similar requirements to other PFS services specifically (including various other care management services) and had concerns about how doing so may create disparities between these services and others under the PFS. We also recognized that other CMS initiatives (such as MIPS and APMs under the Quality Payment Program) may be better mechanisms to incentivize increased interoperability of health information systems than conditions of payment assigned to particular services under the PFS.

Comment: Most of the commenters supported our proposed revisions to the health IT use requirements for billing the CCM code. They shared CMS' goal of interoperability but believed the changes were necessary to improve CCM uptake. Some commenters favored hardship exceptions or rural or small practice exceptions instead of changes to the current requirements that would apply to all practitioners alike. Some commenters expressed particular concern about relaxing the current rules in instances where CCM outsourcing reduces clinical integration. These commenters noted that CCM is commonly outsourced to third party companies that provide remote care management services (including after hours) via telephone and online contact only, using staff who have no established relationship with the beneficiary or other members of the care team and have no interaction with the office staff and physicians other than electronic communication. These commenters were concerned that our proposed changes to the health IT requirements for CCM payment would result in little to no oversight or guidance of the third party, and recommended that CMS make the proposed changes cautiously. One of these commenters recommended in addition that CMS should seek to increase access to CCM services and reduce administrative burden by pursuing alignment between the provision of CCM and other programs and incentives, such as the Quality Payment Program. Other commenters recommended further reduction in payment rules, such as removing all requirements to use a certified EHR, or movement away from timed codes that require documentation in short time increments and disrupt workflow.

Response: We continue to believe that other Medicare initiatives and programs (such as MIPS and APMs under the Quality Payment Program) are better suited to advance use of interoperable health IT systems than establishing code-level conditions of payment, unique to CCM or other primary care or cognitive services. We also believe that a hardship, rural or small practice exception would greatly increase rather than decrease administrative complexity for practitioners and CMS, and CCM uptake has been relatively high among solo practices. We believe that reducing code-level conditions of payment is necessary to improve beneficiary access to appropriate CCM services. Therefore, we are finalizing revisions to the CCM scope of service elements as proposed.

However, we appreciate the commenters' feedback that relaxing the health IT use requirements may be of particular concern in situations where CCM is outsourced to a third party, reducing clinical integration. As we discuss in the section of this final rule on BHI services (section II.E.3.b), health IT holds significant promise for remote connectivity and interoperability that may assist and be useful (if not necessary) for reducing care fragmentation. However, we agree that remote provision of services by entities having only a loose association with the treating practitioner can detract from continuous, patient-centered care, whether or not those entities employ certified or other electronic technology. We will continue to consider the potential impacts of remote provision of CCM and similar types of services by third parties. We wish to emphasize for CCM, as we did for BHI services, that while the CCM codes do not explicitly count time spent by the billing practitioner, they are valued to include work performed by the billing practitioner, especially complex CCM. We emphasize that the practitioner billing for CCM must remain involved in ongoing oversight, management, collaboration and reassessment as appropriate to bill CCM services. If there is little oversight by the billing practitioner or a lack of clinical integration between a third party providing CCM and the billing practitioner, we do not believe that the CCM service elements are actually being furnished and therefore, in such cases, the practitioner should not bill for CCM.

Finally, we note that activities undertaken as part of participation in MIPS or an APM under the Quality Payment Program may support the ability of a practitioner to meet our final requirements for the continuity of care document(s) and the electronic care plan.

Comment: Several commenters recommended that we define the proposed term “timely” for the creation and transmission of care plan and care Start Printed Page 80250transitions health information. Several commenters believed that “timely” implies a time period of 30 to 90 days, or believed some third party vendors would interpret the term in this manner.

Response: Our proposal of the term “timely” originated from the use of this term in the CPT prefatory language for Care Management services, which includes, for example, “provide timely access and management for follow-up after an emergency department visit” and “timely access to clinical information.” We do not believe we should specify a timeframe, because it would vary for individual patients and CCM service elements, we are not aware of any clinical standards referencing specific times, and we are seeking to allow appropriate flexibility in how CCM is furnished. We note that dictionary meanings of the term “timely” include quickly; soon; promptly; occurring at a suitable time; done or occurring at a favorable or useful time; opportune. “Timely” does not necessarily imply speed, and means doing something at the most appropriate moment. Therefore we believe “timely” is an appropriate term to use to govern how quickly the health information in question is transmitted or available. We note that even the current requirements for use of specific electronic technology do not necessarily impact how quickly the health information in question is used to inform care, and addition of the word “timely” implies more regarding actual use of the information. We are monitoring CCM uptake and diffusion through claims analysis and are pursuing claims-based outcomes analyses, to help inform whether the service is being provided as intended and improving health outcomes. We believe these evaluation activities will help us assess moving forward whether health information is being shared or made available timely enough under our revised CCM payment policies.

As we stated in the CY 2017 proposed rule, the policy changes for CCM health IT use are not intended to undermine the importance of interoperability or electronic data exchange. These changes are driven by concerns that we have not applied similar requirements to other PFS services specifically, including various other care management services, and that such requirements create disparities between CCM services and other PFS services. We believe that other CMS initiatives may be better mechanisms to incentivize increased use and interoperability of health information systems than conditions of payment assigned to particular services under the PFS. We anticipate that these CCM policy changes will improve practitioners' capacity to invest in the best tools for managing the care of Medicare beneficiaries.

c. Beneficiary Receipt of Care Plan

We proposed to simplify the current requirement to provide the beneficiary with a written or electronic copy of the care plan, by instead adopting the CPT language specifying more simply that a copy of the care plan must be given to the patient or caregiver. While we believe beneficiaries should and must be provided a copy of the care plan, and that practitioners may choose to provide the care plan in hard copy or electronic form in accordance with patient preferences, we do not believe it is necessary to specify the format of the care plan that must be provided as a condition of CCM payment. Additionally, we recognize that there may be times that sharing the care plan with the caregiver (in a manner consistent with applicable privacy and security rules and regulations) may be appropriate.

Comment: The commenters who provided comments on this particular proposal were supportive of it. In particular, several commenters expressed appreciation for appropriate inclusion of caregivers.

Response: We thank the commenters for their support and are finalizing as proposed.

d. Beneficiary Consent

We continue to believe that obtaining advance beneficiary consent to receive CCM services is important to ensure the beneficiary is informed, educated about CCM services, and is aware of applicable cost sharing. We also believe that querying the beneficiary about whether another practitioner is already providing CCM services helps to reduce the potential for duplicate provision or billing of the services. However, we believe the consent process could be simplified, and that it should be left to the practitioner and the beneficiary to decide the best way to establish consent. Therefore, we proposed to continue to require billing practitioners to inform the beneficiary of the currently required information (that is, inform the beneficiary of the availability of CCM services; inform the beneficiary that only one practitioner can furnish and be paid for these services during a calendar month; and inform the beneficiary of the right to stop the CCM services at any time (effective at the end of the calendar month)). However, we proposed to specify that the practitioner could document in the beneficiary's medical record that this information was explained and note whether the beneficiary accepted or declined CCM services instead of obtaining a written agreement.

We also proposed to remove the language requiring beneficiary authorization for the electronic communication of his or her medical information with other treating providers as a condition of payment for CCM services, because under federal regulations that implement the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR 164.506), a covered entity is permitted to use or disclose protected health information for purposes of treatment without patient authorization. Moreover, if such disclosure is electronic, the HIPAA Security Rule requires secure transmission (45 CFR 164.312(e)). In previous regulations we have reminded practitioners that for all electronic sharing of beneficiary information in the provision of CCM services, HIPAA Privacy and Security Rule standards apply in the usual manner (79 FR 67728).

Comment: The commenters were largely supportive of our proposed policy changes. The commenters were supportive of verbal instead of written beneficiary consent if a clear requirement remains to transparently inform the beneficiary about the nature and benefit of the services, applicable cost sharing, and document that this information was conveyed; current written agreements qualify; and practitioners can elect to obtain written consent. Some commenters believed that obtaining written consent might be preferable as a means of resolving who is eligible for payment, if more than one practitioner bills. A few commenters suggested CMS require written educational materials about CCM, or conduct beneficiary outreach and education.

Response: We appreciate the commenters' support and recommendations. We are finalizing changes to the beneficiary consent requirements as proposed and clarifying that a clear requirement remains to transparently inform the beneficiary about the nature and benefit of the services, applicable cost sharing, and to document that this information was conveyed. The final beneficiary consent requirements do not affect any written agreements that are already in place for CCM services, and we note that practitioners can still elect to obtain written consent rather than verbal consent.

e. Documentation

We have heard from practitioners that the requirements to document certain Start Printed Page 80251information in a certified EHR format are redundant because the CCM billing rules already require documentation of core clinical information in a certified EHR format. Specifically, we already require structured recording of demographics, problems, medications and medication allergies, and the creation of a clinical summary record, using a qualifying certified EHR; and that a full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordination and ongoing clinical care. Therefore, we proposed to no longer specify the use of a qualifying certified EHR to document communication to and from home- and community-based providers regarding the patient's psychosocial needs and functional deficits and to document beneficiary consent. We would continue to require documentation in the medical record of beneficiary consent (discussed above) and of communication to and from home- and community-based providers regarding the patient's psychosocial needs and functional deficits.

Comment: Many commenters were supportive of these proposals.

Response: We thank the commenters for their support and are finalizing changes to the documentation requirements as proposed. We continue to encourage practitioners to utilize health IT solutions for obtaining and documenting health information from sources external to their practice, noting that the 2015 edition of ONC certification criteria (see 80 FR 62601) includes criteria which specifically relate to obtaining information from non-clinical sources and the capture of structured data relating to social, psychological, and behavioral attributes.

f. Summary of Final CCM Policies

We are finalizing changes to the CCM scope of service elements discussed above that will apply for both complex and non-complex CCM services beginning in CY 2017. The final CY 2017 service elements for CCM are summarized in Table 11. We believe these changes will retain elements of the CCM service that are characteristic of the changes in medical practice toward advanced primary care, while eliminating redundancy, simplifying provision of the services, and improving access to the services. For payment of complex CCM services beginning in CY 2017, we are adopting the CPT code descriptors for CPT codes 99487 and 99489 as well as the service elements in Table 11. We are providing separate payment for complex CCM (CPT 99487, 99489) using the RUC-recommended payment inputs for those services. We may reconsider the role of health information technology in CCM service provision in future years. We anticipate that improved accuracy of payment for CCM services, and reduced administrative burden associated with billing CCM services, will contribute to practitioners' capacity to invest in the best tools for managing the care of Medicare beneficiaries.

Table 11—Summary of CY 2017 Chronic Care Management Service Elements and Billing Requirements

Initiating Visit—Initiation during an AWV, IPPE, or face-to-face E/M visit (Level 4 or 5 visit not required), for new patients or patients not seen within 1 year prior to the commencement of chronic care management (CCM) services
Structured Recording of Patient Information Using Certified EHR Technology—Structured recording of demographics, problems, medications and medication allergies using certified EHR technology. A full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordination and ongoing clinical care
24/7 Access Continuity of Care:
• Provide 24/7 access to physicians or other qualified health care professionals or clinical staff including providing patients/caregivers with a means to make contact with health care professionals in the practice to address urgent needs regardless of the time of day or day of week
• Continuity of care with a designated member of the care team with whom the beneficiary is able to schedule successive routine appointments
Comprehensive Care Management—Care management for chronic conditions including systematic assessment of the beneficiary's medical, functional, and psychosocial needs; system-based approaches to ensure timely receipt of all recommended preventive care services; medication reconciliation with review of adherence and potential interactions; and oversight of beneficiary self-management of medications
Comprehensive Care Plan:
• Creation, revision and/or monitoring (as per code descriptors) of an electronic patient-centered care plan based on a physical, mental, cognitive, psychosocial, functional and environmental (re)assessment and an inventory of resources and supports; a comprehensive care plan for all health issues
• Must at least electronically capture care plan information, and make this information available timely within and outside the billing practice as appropriate. Share care plan information electronically (can include fax) and timely within and outside the billing practice to individuals involved in the beneficiary's care
• A copy of the plan of care must be given to the patient and/or caregiver
Management of Care Transitions:
• Management of care transitions between and among health care providers and settings, including referrals to other clinicians; follow-up after an emergency department visit; and follow-up after discharges from hospitals, skilled nursing facilities or other health care facilities
• Create and exchange/transmit continuity of care document(s) timely with other practitioners and providers
Home- and Community-Based Care Coordination:
• Coordination with home and community based clinical service providers
• Communication to and from home- and community-based providers regarding the patient's psychosocial needs and functional deficits must be documented in the patient's medical record
Enhanced Communication Opportunities—Enhanced opportunities for the beneficiary and any caregiver to communicate with the practitioner regarding the beneficiary's care through not only telephone access, but also through the use of secure messaging, Internet, or other asynchronous non-face-to-face consultation methods
Beneficiary Consent:
• Inform the beneficiary of the availability of CCM services; that only one practitioner can furnish and be paid for these services during a calendar month; and of their right to stop the CCM services at any time (effective at the end of the calendar month)
• Document in the beneficiary's medical record that the required information was explained and whether the beneficiary accepted or declined the services
Medical Decision-Making—Complex CCM services require and include medical decision-making of moderate to high complexity (by the physician or other billing practitioner)
Start Printed Page 80252

5. Assessment and Care Planning for Patients with Cognitive Impairment (GPPP6)

For CY 2017 we proposed a G-code that would provide separate payment to recognize the work of a physician (or other appropriate billing practitioner) in assessing and creating a care plan for beneficiaries with cognitive impairment, such as from Alzheimer's disease or dementia, at any stage of impairment, G0505 (Cognition and functional assessment using standardized instruments with development of recorded care plan for the patient with cognitive impairment, history obtained from patient and/or caregiver, in office or other outpatient setting or home or domiciliary or rest home). We understand that a similar code was recently approved by the CPT Editorial Panel and is scheduled to be included in the CY 2018 CPT code set. We intended for G0505 to be a temporary code, perhaps for only one year, to be replaced by the CPT code in CT 2018. We will consider whether to adopt and establish relative value units for the new CPT code under our standard process, presumably for CY 2018.

We reviewed the list of service elements that were considered by the CPT Editorial Panel, and proposed the following as required service elements of G0505:

  • Cognition-focused evaluation including a pertinent history and examination.
  • Medical decision making of moderate or high complexity (defined by the E/M guidelines).
  • Functional assessment (for example, Basic and Instrumental Activities of Daily Living), including decision-making capacity.
  • Use of standardized instruments to stage dementia.
  • Medication reconciliation and review for high-risk medications, if applicable.
  • Evaluation for neuropsychiatric and behavioral symptoms, including depression, including use of standardized instrument(s).
  • Evaluation of safety (for example, home), including motor vehicle operation, if applicable.
  • Identification of caregiver(s), caregiver knowledge, caregiver needs, social supports, and the willingness of caregiver to take on caregiving tasks.
  • Advance care planning and addressing palliative care needs, if applicable and consistent with beneficiary preference.
  • Creation of a care plan, including initial plans to address any neuropsychiatric symptoms and referral to community resources as needed (for example, adult day programs, support groups); care plan shared with the patient and/or caregiver with initial education and support.

The proposed valuation of G0505 (discussed in section II.E.1) assumed that this code would include services that are personally performed by the physician (or other appropriate billing practitioner, such as a nurse practitioner or physician assistant) and would significantly overlap with services described by certain E/M visit codes, advance care planning services, and certain psychological or psychiatric service codes that are currently separately payable under the PFS. Accordingly, we proposed that G0505 must be furnished by the physician (or other appropriate billing practitioner) and could not be billed on the same date of service as CPT codes 90785 (Psytx complex interactive), 90791 (Psych diagnostic evaluation), 90792 (Psych diag eval w/med srvcs), 96103 (Psycho testing admin by comp), 96120 (Neuropsych tst admin w/comp), 96127 (Brief emotional/behav assmt), 99201-99215 (Office/outpatient visits new), 99324-99337 (Domicil/r-home visits new pat), 99341-99350 (Home visits new patient), 99366-99368 (Team conf w/pat by hc prof), 99497 (Advncd care plan 30 min), 99498 (Advncd care plan addl 30 min)), since these codes all reflect face-to-face services furnished by the physician or other billing practitioner for related separately billable services that overlap substantially with G0505. In addition, we proposed to prohibit billing of G0505 with other care planning services, such as care plan oversight services (CPT code 99374), home health care and hospice supervision (G0181, G0182), or our proposed add-on code for comprehensive assessment and care planning by the billing practitioner for patients requiring CCM services (GPPP7). We solicited comment on whether there are circumstances where multiple care planning codes could be furnished without significant overlap. We proposed to specify that G0505 may serve as a companion or primary E/M code to the prolonged service codes (those that are currently separately paid, and those we proposed to separately pay beginning in 2017), but were interested in public input on whether there is any overlap among these services. We solicited comment on how to best delineate the post-service work for G0505 from the work necessary to provide the prolonged services code.

We did not believe the services described by G0505 would significantly overlap with proposed or current medically necessary CCM services (CPT codes 99487, 99489, 99490); TCM services (CPT codes 99495, 99496); or the proposed behavioral health integration service codes (HCPCS codes GPPP1, GPPP2, GPPP3, GPPPX). Therefore, we proposed that G0505 could be billed on the same date-of-service or within the same service period as these codes (CPT codes 99487, 99489, 99490, 99495, 99496, and HCPCS codes GPPP1, GPPP2, GPPP3, and GPPPX). There may be overlap in the patient population eligible to receive these services and the population eligible to receive the services described by G0505, but we believed there would be sufficient differences in the nature and extent of the assessments, interventions and care planning, as well as the qualifications of individuals providing the services, to allow concurrent billing for services that are medically reasonable and necessary. We solicited public comment on potential overlap between G0505 and other codes currently paid under the PFS, as well as the other primary care/cognitive services addressed in this section of the final rule.

Comment: Many commenters were supportive of the proposal, including the provisions regarding scope of service elements, conditions of payment, and overlap with other services under the PFS.

Response: We thank commenters for their support of the proposed scope of service, conditions of payment, and overlap with other services under the PFS for G0505. We believe that by improving payment accuracy by paying separately for this service, practitioners will be able to accurately assess patients for cognitive impairment, particularly in early stages.

Comment: We received numerous comments stating that assessment and staging for dementia is very sensitive and should only be conducted by neuropsychologists, who would be unable to bill G0505. Commenters were concerned that untrained professionals conducting assessments for dementia would lead to errors in diagnosis and inappropriate treatment. Commenters encouraged CMS to not finalize this code and maintain the current coding for psychological and neuropsychological assessment or suggested that CMS remove the bullet points associated with medication management or medical decision making so that G0505 could be billed by psychologists.

Response: While we acknowledge and support the work of psychologists and neuropsychologists in the care of Medicare beneficiaries, we continue to Start Printed Page 80253believe that this code describes a distinct PFS service that may be reasonable and necessary in the diagnosis and treatment of a beneficiary's illness. We remind interested stakeholders that we routinely examine the valuation and coding for existing services under the potentially misvalued code initiative, and that there is a the process for public nomination of particular codes. If stakeholders have information to suggest that the current coding for neuropsychological and psychological testing is inaccurate, we welcome nominations under the established process.

Comment: A few commenters encouraged CMS to avoid adopting scope of service elements that are exhaustive as these may create barriers to utilization, while other commenters made the following recommendations regarding the scope of service provisions:

  • Expand scope of service elements related to medication management.
  • Include occupational therapy in the scope of service element pertaining to community resources.
  • Rewrite “Creation of a care plan, including initial plans to address any neuropsychiatric symptoms and referral to community resources as needed (for example, adult day programs, support groups); care plan shared with the patient and/or caregiver with initial education and support” to include “identification of caregiver(s), caregiver knowledge, caregiver needs, social supports, and the willingness and availability of caregiver to voluntarily take on caregiving tasks.”
  • Make sure that non-paid or informal caregivers are included in care planning and provide resources and support for care givers so as to improve care givers ability to provide care for the beneficiary.
  • Require the inclusion of caregiver names in care plan and patients medical record, require that caregivers be assessed for stress and depressive symptoms, as well as care giver skill and education needs.
  • State that consultations with the caregiver are permissible under HIPAA and that such conversations may be necessary in the development of a care plan.
  • Specify that any advance care planning is consistent with beneficiary preference and addresses any palliative care needs of the patient, and include establishment of durable power of attorney.
  • Clarify that diagnosis of dementia is not part of the scope of service by deleting “cognition focused evaluation including pertinent history” from the scope of service.
  • Clarify that “functional assessment” is separate from decision making assessments, and that this is a non-legal assessment of competency.
  • Stipulate that other decision makers should be identified.
  • Consider deleting “use of standardized instruments to stage dementia” because the care plan is the most important aspect of the service and many standardized instruments are not very effective at staging.
  • Clarify that the care plan address both medical and non-medical issues, and includes follow-up scheduling for monitoring and evaluation.
  • Provide a copy of the written care plan to the patient.
  • Refer to the care plan as a “person-centered care plan.”
  • Include evaluation of medical problems including review of lab or imaging tests, review of co-morbidities, especially those which are dependent on self-care, evaluation the risk of falls and recommendations for fall prevention, evaluation of possible elder abuse, and documentation of financial issues, as part of the scope of service.

Response: We appreciate the information provided by commenters on the best practices associated with furnishing this service and would encourage stakeholders to adopt any or all of these scope of service provisions, such as the inclusion of caregivers in care planning. The scope of service for assessment and care planning service for patients with cognitive impairment does not prohibit stakeholders from adopting any additional scope of service provisions which may be beneficial for the treatment of the patient. However, we do not believe that the ability to fully furnish this service and establish an appropriate value for it is contingent on meeting such conditions. Therefore, we do not believe they should be added to the scope of service. We concur with commenters on the necessity of avoiding the imposition of overly burdensome restrictions within the scope of service.

Comment: Some commenters requested that CMS clarify that not all elements in the scope of service need to be provided by the billing practitioner and many can be provided by others incident to the billing practitioner's services. One commenter stated that there are circumstances where the best practitioner to provide a specific service element does not work in the same practice as the billing practitioner, and therefore the billing practitioner should be able to contract out for provision of some aspects, provided that the billing practitioner remain in oversight. Other commenters stated that CMS should make G0505 billable by other practitioners, such as occupational therapists, or community based entities.

Response: G0505 is a service that includes central elements, which must be performed by the billing practitioner subject to established E/M guidelines. Only those practitioners eligible to report E/M services should report this service. Outside of the specified elements, the regular incident-to rules apply consistent with other E/M services. We believe that physicians and eligible non-physician practitioners, such as a nurse practitioners and physician assistants should exclusively bill for this code.

Comment: Many commenters suggested that CMS expand HCPCS code G0505 or pay separately for similar services furnished to patients with other advanced or life threatening illnesses.

Response: We appreciate the comments on other conditions that could benefit from assessment and care planning and will consider these for future rulemaking. We are finalizing the G0505 code to pay separately for the assessment and care plan creation for beneficiaries with cognitive impairment, such as from Alzheimer's disease or dementia, at any stage of impairment.

Comment: Commenters provided many examples of how CMS could develop appropriate quality and outreach measures to ensure appropriate utilization of G0505. Commenters encouraged CMS to closely monitor use of G0505 for a few years following implementation, so as to ascertain whether patient eligibility is an issue in uptake for the code.

Response: We appreciate the information on quality and outreach measures. CMS is engaged in the use of measures to improve quality and access to care. CMS intends to monitor utilization and will consider how conditions of payment align with best practices and quality measures.

Comment: One commenter urged CMS to make the proposed coding and payment changes available to physicians in total cost of care models, such as ACOs and bundled payment programs.

Response: Our proposal relates only to payment for services under the Medicare PFS. We note that the codes and payment amounts that we finalize for services will be available for billing and payment under the PFS for CY 2017. In general, we do not address in this final rule, and instead defer to the policies regarding billing and payment for these services that are applicable within individual Center for Medicare Start Printed Page 80254Medicaid Innovation models and other programs. However, as our policies regarding payment for new primary care codes are applicable beginning in CY 2017, we note that models may need to update their policies to prevent potential duplication of payment between the PFS and the models. For example, where CCM services have been excluded from separate payment under existing models, newly established care management services (including complex CCM, psychiatric CoCM, and BHI) may likewise be excluded.

Comment: One commenter stated that many small practices do not have the infrastructure to support a multi-disciplinary team of practitioners and urged CMS to allow flexibility for solo and small group practices to share resources. The commenter also suggested that CMS offer a one-time incentive for practices to integrate service elements into workflow. Response: In general, the coding under the PFS is intended to describe services as they are furnished and are valued using typical resource costs. We appreciate the concern of commenters regarding access, and we are eager to hear from stakeholders regarding concerns related to access for these and other PFS services.

6. Improving Payment Accuracy for Care of People With Disabilities (GDDD1)

We estimate that about 7 percent of all Medicare beneficiaries have a potentially disabling mobility-related diagnosis (the Medicare-only prevalence is 5.5 percent and the prevalence for Medicare-Medicaid dual eligible beneficiaries is 11 percent), using 2010 Medicare (and for dual eligible beneficiaries, Medicaid) claims data.

When a beneficiary with a mobility-related disability goes to a physician or other practitioner's office for an E/M visit, the resources associated with providing the visit can exceed the resources required for the typical E/M visit. An E/M visit for a patient with a mobility-related disability can require more physician and clinical staff time to provide appropriate care because the patient may require skilled assistance throughout the visit to carefully move and adjust his/her body. Furthermore, an E/M visit for a patient with a mobility-related disability commonly requires specialized equipment such as a wheel chair accessible scale, floor and overhead lifts, a movable exam table, padded leg supports, a stretcher and transfer board. The current E/M visit payment rates, based on an assumption of “typical” resources involved in furnishing an E/M visit to a “typical” patient, do not accurately reflect these additional resources associated with furnishing appropriate care to many beneficiaries with mobility-related disabilities.

When furnishing E/M services to beneficiaries with mobility-related disabilities, practitioners face difficult choices in deciding whether to take the extra time necessary and invest in the required specialized equipment for these visits even though the payment rate for the service does not account for either expense; potentially providing less than optimal care for a beneficiary whose needs exceed the standard appointment block of time in the standard equipped exam room reflected in the current E/M visit payment rate; or declining to accept appointments altogether for beneficiaries who require additional time and specialized equipment.

Each of these scenarios is potentially problematic. The first two scenarios suggest that the quality of care for this beneficiary population might be compromised by assumptions under the PFS regarding relative resource costs in furnishing services to this population. The third scenario reflects an obvious access problem for these beneficiaries. To improve payment accuracy and help ameliorate potential disparity in access and quality for beneficiaries with mobility-related disabilities, we proposed to create a new add-on G-code, effective for CY 2017, to describe the additional services furnished in conjunction with E/M services to beneficiaries with disabilities that impair their mobility:

G0501: Resource-intensive services for patients for whom the use of specialized mobility-assistive technology (such as adjustable height chairs or tables, patient lifts, and adjustable padded leg supports) is medically necessary and used during the provision of an office/outpatient evaluation and management service visit (Add-on code, list separately in addition to primary procedure).

Effective January 1, 2017, we proposed that this add-on code could be billed with new and established patient office/outpatient E/M codes (CPT codes 99201 through 99205, and 99212 through 99215), as well as transitional care management codes (CPT codes 99495 and 99496), when the additional resources described by the code are medically necessary and used in the provision of care. In addition to seeking comment on this proposal, we are also sought comment on other HCPCS codes that may be appropriate base codes for this proposed add-on code, including those describing preventive visits and services. We reminded potential commenters that the rationale for this proposal is based in large part on the broad use and lack of granularity in coding for E/M services relative to other PFS services in conjunction with the additional resources used.

We received many thoughtful comments on this proposal and thank commenters for their input. Comments received are summarized below.

Comment: Most commenters agreed with the proposed rule's statement of disability disparities and discussed a variety challenges that individuals with disabilities face in accessing the health care system. Several of these commenters cited evidence of existing challenges for individuals with mobility-related disabilities, including a lack of physically accessible equipment within physician offices, barriers to communication, and a lack of existing tools to recognize, track, and consistently meet specialized needs. Commenters applauded CMS for offering a concrete proposal with significant funding to meaningfully address this problem and noted that 26 years after passage of the Americans with Disabilities Act, it is alarming that physical and communication barriers in physicians' and other health care professionals' offices still exist across the country. However, some commenters suggested that the root cause and scope of these issues are not well characterized, and suggested that CMS work with stakeholders to conduct additional studies and gain information as to the underlying reasons for barriers to access to care and lower quality scores on certain measures.

Generally, commenters noted that they appreciate CMS' efforts to address health disparities based on disability, and some then supported this proposal as a first step in providing medically necessary services to patients with disabilities, while others recommended that CMS not finalize the proposal and raised legal, access, and equity concerns.

Response: We agree with commenters that individuals with disabilities face additional barriers to access health care, an issue that contributes to widespread disparities in outcomes. We also agree with commenters that the underlying reasons for these disparities are multifaceted and can include payment challenges, physical accessibility and communication barriers, a lack of awareness among health care providers in assessing and fully addressing the needs and preferences of people with disabilities, and others issues. As a result of all these factors, individuals with disabilities can face challenges in scheduling appointments, and in Start Printed Page 80255finding and maintaining a primary care provider, an essential foundation for accessing the health system.

Although there was near universal agreement among commenters regarding problems in health care disparities and barriers to access among individuals with disabilities, there was disagreement about whether establishing payment for code G0501 as proposed was a good solution to help solve these problems. While we believe that improving the payment accuracy of physicians' services is necessary and appropriate, and can help to address the underlying access issues for individuals with disabilities, we also acknowledge that implementation of new or revised payments can result in unanticipated, and potentially undesirable, consequences. Before implementing payment for code G0501, we plan to further analyze and address the concerns raised by commenters. As such, we are not finalizing payment for code G0501 at this time. We appreciate commenters' insights, and our commitment to promoting better primary care for people with disabilities remains strong. Over the next 6 months we will engage with interested beneficiaries, advocates, and practitioners to continue to explore improvements in payment accuracy for care of people with disabilities. We intend to discuss this issue again in future rulemaking.

While we are not finalizing separate payment for code G0501 for CY 2017, we are including the code in the CY 2017 code set as G0501. The HCPCS code G0501 will not be payable under the Medicare PFS for CY 2017, though practitioners will be able to report the code, should they be inclined to do so.

a. Soliciting Comment on Other Coding Changes To Improve Payment Accuracy for Care of People With Disabilities

When furnishing care to a beneficiary with a mobility-related disability, the current E/M visit payment rates may not fully reflect the associated resource costs that are being incurred by practitioners. We recognize that there are other populations for which payment adjustment may be appropriate. Our proposal regarding beneficiaries with mobility-related disabilities reflected the discrete nature of the additional resource costs for this population, the clear lack of differentiation in resource costs regarding particular kinds of frequently-furnished services, and the broad recognition of access problems. We recognize that some physician practices may frequently furnish services to particular populations for which the relative resource costs are similarly systemically undervalued and we sought comment regarding other circumstances where these dynamics can be discretely observed.

Comment: Multiple commenters suggested additional coding changes to improve payment accuracy for services for people with disabilities. Several commenters requested that CMS broaden the scope of G0501 and the codes with which it may be billed, for example by allowing G0501 to be billed with preventive services, such as the Initial Preventive Physical Examination (IPPE) or “Welcome to Medicare Visit”, the Annual Wellness Visit, or other preventive services including those that have been assigned a grade of A or B by the United States Preventive Services Task Force. One commenter suggested that CMS also establish payment for a lower-level, lower payment add-on code for use with patients with a mobility-related disability that may not require the use of specialized equipment. Commenters also suggested that CMS establish certain forms of physician payment incentives, which might more effectively address the accessibility needs of individuals with disabilities and ultimately reduce healthcare disparities. Specifically, one commenter suggested CMS incentivize physicians to establish record-keeping to inquire into patients' accessibility and accommodation needs, record the needs of their patients, and take action to meet those needs over time.

Response: We thank commenters for their thoughtful responses. We reiterate our commitment to addressing disparities for individuals with disabilities and advancing health equity, and will continue to explore and revisit potential solutions for overcoming these significant challenges, including the appropriate changes in payment.

7. Regulation Text

Our current regulations in 42 CFR 410.26(b) provide for an exception to assign general supervision to CCM services (and similarly, for the non-face-to-face portion of TCM services), because these are generally non-face-to-face care management/care coordination services that would commonly be provided by clinical staff when the billing practitioner (who is also the supervising practitioner) is not physically present; and the CPT codes are comprised solely (or in significant part) of non-face-to-face services provided by clinical staff. A number of codes that we proposed to establish for separate payment in CY 2017 under our initiative to improve payment accuracy for primary care and care management are similar to CCM services, in that a critical element of the services is non-face-to-face care management/care coordination services provided by clinical staff or other qualified individuals when the billing practitioner may not be physically present. Accordingly, we proposed to amend 42 CFR 410.26(a)(3) and 410.26(b) to better define general supervision and to assign general supervision not only to CCM services and the non-face-to-face portion of TCM services, but also to proposed codes G0502, G0503, G0504, G0507, CPT code 99487, and CPT code 99489. Instead of adding each of these proposed codes assigned general supervision to the regulation text on an individual basis, we proposed to revise our regulation under 42 CFR 410.26(b)(1) to assign general supervision to the non-face-to-face portion of designated care management services, and we would designate the applicable services through notice and comment rulemaking.

We did not receive any public comments on our proposed regulation text. However we received a number of comments regarding a related proposal to require behavioral health care managers to be located on site. Also for psychiatric CoCM services (G0502, G0503 and G0504), we are finalizing a requirement that the behavioral health care manager is available to perform his or her duties face-to-face and non-face-to-face with the beneficiary. We address these issues at length in the BHI section of this final rule (section II.E.3). Since we are assigning general supervision to psychiatric CoCM behavioral health care manager services that may be provided face-to-face with the beneficiary, we are omitting the phrase “non-face-to-face portion of” in “the non-face-to-face portion of designated care management services.” Accordingly, the final amended regulation text in 42 CFR 410.26(b) assigns general supervision to “designated care management services” that we will designate through notice and comment rulemaking. The services that we are newly designating (finalizing) for general supervision in this final rule are G0502, G0503, G0504, G0507, CPT code 99487 and CPT code 99489. We had initially proposed adding a cross-reference to the existing definition of “general supervision” in current regulations at § 410.32(b)(3)(i), but to better describe general supervision in the context of these services, we are specifying at § 410.26(a)(3) that general supervision means the service is furnished under the physician's (or other practitioner's) Start Printed Page 80256overall direction and control, but the physician's (or other practitioner's) presence is not required during the performance of the service. At § 410.26(b)(5), we specify that, in general, services and supplies must be furnished under the direct supervision of the physician (or other practitioner). Designated care management services can be furnished under general supervision of the physician (or other practitioner) when these services or supplies are provided incident to the services of a physician (or other practitioner). The physician (or other practitioner) supervising the auxiliary personnel need not be the same physician (or other practitioner) who is treating the patient more broadly. However, only the supervising physician (or other practitioner) may bill Medicare for incident to services.

8. CCM Requirements for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).

RHCs and FQHCs have been authorized to bill for CCM services since January 1, 2016, and are paid based on the Medicare PFS national average non-facility payment rate when CPT code 99490 is billed alone or with other payable services on a RHC or FQHC claim. The RHC and FQHC requirements for billing CCM services have generally followed the requirements for practitioners billing under the PFS, with some adaptations based on the RHC and FQHC payment methodologies.

To assure that CCM requirements for RHCs and FQHCs are not more burdensome than those for practitioners billing under the PFS, we proposed revisions for CCM services furnished by RHCs and FQHCs similar to the revisions proposed under the section above entitled, “Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management (CCM) Services” for RHCs and FQHCs. Specifically, we proposed to:

  • Require that CCM be initiated during an AWV, IPPE, or comprehensive E/M visit only for new patients or patients not seen within one year. This would replace the requirement that CCM could only be initiated during an AWV, IPPE, or comprehensive E/M visit where CCM services were discussed.
  • Require 24/7 access to a RHC or FQHC practitioner or auxiliary personnel with a means to make contact with a RHC or FQHC practitioner to address urgent health care needs regardless of the time of day or day of week. This would replace the requirement that CCM services be available 24/7 with health care practitioners in the RHC or FQHC who have access to the patient's electronic care plan to address his or her urgent chronic care needs, regardless of the time of day or day of the week.
  • Require timely electronic sharing of care plan information within and outside the RHC or FQHC, but not necessarily on a 24/7 basis, and expands the circumstances under which transmission of the care plan by fax is allowed. This would replace the requirement that the electronic care plan be available on a 24/7 basis to all practitioners within the RHC or FQHC whose time counts towards the time requirement for the practice to bill the CCM code, and removes the restriction on allowing the care plan to be faxed only when the receiving practitioner or provider can only receive clinical summaries by fax.
  • Require that in managing care transitions, the RHC or FQHC creates, exchanges, and transmits continuity of care document(s) in a timely manner with other practitioners and providers. This would replace the requirements that clinical summaries must be created and formatted according to certified EHR technology, and the requirement for electronic exchange of clinical summaries by a means other than fax.
  • Require that a copy of the care plan be given to the patient or caregiver. This would remove the description of the format (written or electronic) and allows the care plan to be provided to the caregiver when appropriate (and in a manner consistent with applicable privacy and security rules and regulations).
  • Require that the RHC or FQHC practitioner documents in the beneficiary's medical record that all the elements of beneficiary consent (for example, that the beneficiary was informed of the availability of CCM services; only one practitioner can furnish and be paid for these services during a calendar month; the beneficiary may stop the CCM services at any time, effective at the end of the calendar month, etc.) were provided, and whether the beneficiary accepted or declined CCM services. This would replace the requirement that RHCs and FQHCs obtain a written agreement that these elements were discussed, and removes the requirement that the beneficiary provide authorization for the electronic communication of his or her medical information with other treating providers as a condition of payment for CCM services.
  • Require that communication to and from home- and community-based providers regarding the patient's psychosocial needs and functional deficits be documented in the patient's medical record. This would replace the requirement to document this patient health information in a certified EHR format.

We noted that we did not propose an additional payment adjustment for patients who require extensive assessment and care planning as part of the initiating visit, as payments for RHC and FQHC services are not adjusted for length or complexity of the visit.

We stated that we believe these proposed changes would keep the CCM requirements for RHCs and FQHCs consistent with the CCM requirements for practitioners billing under the PFS, simplify the provision of CCM services by RHCs and FQHCs, and improve access to these services without compromising quality of care, beneficiary privacy, or advance notice and consent.

We received 31 comments on the proposed revisions to the CCM requirements for RHCs and FQHCs. The following is a summary of the comments we received:

Comment: Commenters stated that they support CMS's efforts to ensure that CCM requirements for RHCs and FQHCs are not more burdensome than those for practitioners billing under the Medicare PFS.

Response: We appreciate the support of the commenters.

Comment: One commenter sought clarification on the requirements for initiating CCM with patients that have been seen in the RHC within the past year. The commenter asked if CCM could be initiated if the patient had any type of visit within the past year, or if the visit within the past year had to be an AWV, IPPE, or comprehensive E/M visit.

Response: To initiate CCM with a patient that has been seen in the RHC or FQHC within the past year, an AWV, IPPE, or comprehensive E/M visit must have taken place within the past year in the RHC or FQHC that is billing for the CCM service. No other type of visit would meet the requirement for initiating CCM services.

Comment: A few commenters were concerned that RHCs and FQHCs were charging beneficiaries for coinsurance for non-face-to-face services, and recommended that the copayment be waived or that CMS pursue waivers of cost-sharing for care coordination codes. One of these commenters stated that patients are often unwilling to pay the patient share of the CCM services since rural providers often have already been Start Printed Page 80257providing similar services without additional cost to the patients.

Response: As previously stated, we do not have the authority to waive the copayment requirements for CCM services. While many practitioners, including those in rural areas, have always provided some care management services, we believe that payment for CCM services will enable many RHCs and FQHCs to furnish comprehensive and systematic care coordination services that were previously unavailable or only sporadically offered.

Comment: A commenter asked for clarification on how claims for patients in RHCs and FQHCs with pre-existing care management plans should be handled, and suggested that CMS permit claims for services for these patients.

Response: We are not entirely clear what this commenter is suggesting. RHCs and FQHCs that bill for CCM services must develop a comprehensive care plan that includes all the elements previously described and also listed in Table 11. When all the requirements for furnishing CCM services are met, including the development of the comprehensive care plan, the RHC or FQHC would submit a claim for CCM payment using CPT code 99490. Only the time spent furnishing CCM services after CCM is initiated with the patient is counted toward the minimum 20 minutes required for CCM billing. There is no additional payment for a pre-existing care plan, and if a comprehensive care plan that meets the CCM requirements was developed before the initiation of CCM services, the time spent developing the plan would not be counted toward the 20 minute minimum requirement.

Comment: A few commenters requested clarification on whether RHCs and FQHCs could bill the new CCM codes for either complex CCM services (CPT 99487 and 99489) or the separately billable comprehensive CCM assessment and care planning (G0506).

Response: As we noted in the proposed rule, we did not propose to adopt codes to provide for an additional payment for patients who require extensive assessment or care planning because payments for RHC and FQHC services are not adjusted for the length or complexity of the visit. Therefore, the codes identified by the commenters are not separately billable by an RHC or FQHC.

Comment: A few commenters recommended that CMS allow RHCs and FQHCs to bill for the new CCM codes, and to allow safety net providers to bill for preventive services in addition to the all-inclusive rate for RHCs and the PPS rate for FQHCs. The commenters stated that the payment structure for RHCs an