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Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015

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Start Preamble Start Printed Page 67548

AGENCY:

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

ACTION:

Final rule with comment period.

SUMMARY:

This major final rule with comment period addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. See the Table of Contents for a listing of the specific issues addressed in this rule.

DATES:

Effective date: The provisions of this final rule are effective on January 1, 2015, with the exception of amendments to parts 412, 413, and 495 which are effective October 31, 2014.

Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 30, 2014.

Compliance date: The compliance date for new data collection requirements in § 403.904(c)(8) is January 1, 2016.

ADDRESSES:

In commenting, please refer to file code CMS-1612-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

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

1. Electronically. You may submit electronic comments on this regulation to www.regulations.gov. Follow the instructions for “submitting a comment.”

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1612-FC, P.O. Box 8013, Baltimore, MD 21244-8013.

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

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1612-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

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

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

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

b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.

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

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Donta Henson, (410) 786-1947 for any physician payment issues not identified below.

Gail Addis, (410) 786-4522, for issues related to the refinement panel.

Chava Sheffield, (410) 786-2298, for issues related to practice expense methodology, impacts, the sustainable growth rate, conscious sedation, or conversion factors.

Kathy Kersell, (410) 786-2033, for issues related to direct practice expense inputs.

Jessica Bruton, (410) 786-5991, for issues related to potentially misvalued services or work RVUs.

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

Ken Marsalek, (410) 786-4502, for issues related to telehealth services.

Pam West, (410) 786-2302, for issues related to conditions for therapists in private practice or therapy caps.

Ann Marshall, (410) 786-3059, for issues related to chronic care management.

Marianne Myers, (410) 786-5962, for issues related to ambulance extender provisions.

Amy Gruber, (410) 786-1542, for issues related to changes in geographic area designations for ambulance payment.

Anne Tayloe-Hauswald, (410) 786-4546, for issues related to clinical lab fee schedule.

Corinne Axelrod, (410) 786-5620, for issues related to Rural Health Clinics or Federally Qualified Health Centers.

Renee Mentnech, (410) 786-6692, for issues related to access to identifiable data for the Centers for Medicare & Medicaid models.

Marie Casey, (410) 786-7861 or Karen Reinhardt, (410) 786-0189, for issues related to local coverage determination process for clinical diagnostic laboratory tests.

Frederick Grabau, (410) 786-0206, for issues related to private contracting/opt-out.

David Walczak, (410) 786-4475, for issues related to payment policy for substitute physician billing arrangements (locum tenens).

Melissa Heesters, (410) 786-0618, for issues related to reports of payments or other transfers of value to covered recipients.

Alesia Hovatter, (410) 786-6861, for issues related to physician compare.

Christine Estella, (410) 786-0485, for issues related to the physician quality reporting system.

Alexandra Mugge, (410) 786-4457, for issues related to EHR incentive program.

Patrice Holtz, (410) 786-5663, for issues related to comprehensive primary care initiative.

Terri Postma, (410) 786-4169, for issues related to Medicare Shared Savings Program.

Kimberly Spalding Bush, (410) 786-3232, for issues related to value-based modifier and improvements to physician feedback.

Elizabeth Holland, (410) 786-1309, Medicare EHR Incentive Program (Medicare payment adjustments and hardship exceptions).

Elisabeth Myers (CMS), (410) 786-4751, Medicare EHR Incentive Program (Medicare payment adjustments and hardship exceptions).

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of Start Printed Page 67549the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

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

Table of Contents

I. Executive Summary and Background

A. Executive Summary

B. Background

C. Health Information Technology

II. Provisions of the Final Rule With Comment Period for PFS

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

B. Potentially Misvalued Services Under the Physician Fee Schedule

C. Malpractice Relative Value Units (RVUs)

D. Geographic Practice Cost Indices (GPCIs)

E. Medicare Telehealth Services

F. Valuing New, Revised and Potentially Misvalued Codes

G. Establishing RVUs for CY 2015

H. Chronic Care Management (CCM)

I. Therapy Caps for CY 2015

J. Definition of Colorectal Cancer Screening Tests

K. Payment of Secondary Interpretation of Images

L. Conditions Regarding Permissible Practice Types for Therapists in Private Practice

M. Payments for Practitioners Managing Patients on Home Dialysis

N. Sustainable Growth Rate

III. Other Provisions of the Final Rule With Comment Period Regulation

A. Ambulance Extender Provisions

B. Changes in Geographic Area Delineations for Ambulance Payment

C. Clinical Laboratory Fee Schedule

D. Removal of Employment Requirements for Services Furnished “Incident to” Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Visits

E. Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models

F. Local Coverage Determination Process for Clinical Diagnostic Laboratory Tests

G. Private Contracting/Opt-Out

H. Solicitation of Comments on the Payment Policy for Substitute Physician Billing Arrangements

I. Reports of Payments or Other Transfers of Value to Covered Recipients

J. Physician Compare Web Site

K. Physician Payment, Efficiency, and Quality Improvements—Physician Quality Reporting System

L. Electronic Health Record (EHR) Incentive Program

M. Medicare Shared Savings Program

N. Value-Based Payment Modifier and Physician Feedback Program

O. Establishment of the Federally Qualified Health Center Prospective Payment System (FQHC PPS)

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

Q. Interim Final Revisions to the Electronic Health Record (EHR) Incentive Program

IV. Collection of Information Requirements

V. Response to Comments

VI. Waiver of Proposed Rulemaking and Waiver of Delay in Effective Date

VII. 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 with comment period, we are listing these acronyms and their corresponding terms in alphabetical order below:

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)

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)

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

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 2014 American Medical Association. All rights reserved.)

CQM Clinical quality measure

CSW Clinical social worker

CT Computed tomography

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

EHR Electronic health record

E/M Evaluation and management

EP Eligible professional

eRx Electronic prescribing

ESRD End-stage renal disease

FAR Federal Acquisition Regulations

FFS Fee-for-service

FQHC Federally qualified health center

FR Federal Register

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

IPPS Inpatient Prospective Payment System

IQR Inpatient Quality Reporting

ISO Insurance service office

IWPUT Intensity of work per unit of time

LCD Local coverage determination

MA Medicare Advantage

MAC Medicare Administrative Contractor

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

MSSP Medicare Shared Savings Program

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)

PC Professional component

PCIP Primary Care Incentive PaymentStart Printed Page 67550

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

PQRS Physician Quality Reporting System

PPIS Physician Practice Expense Information Survey

PT Physical therapy

PY Performance year

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

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 with comment period 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, “PFS Federal Regulations Notices” for a chronological list of PFS Federal Register and other related documents. For the CY 2015 PFS final rule with comment period, refer to item CMS-1612-FC. 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 donta.henson1@cms.hhs.gov.

CPT (Current Procedural Terminology) Copyright Notice

Throughout this final rule with comment period, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2013 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 with comment period revises payment polices under the Medicare Physician Fee Schedule (PFS) and makes other policy changes related to Medicare Part B payment. These changes are applicable to services furnished in CY 2015.

2. Summary of the Major Provisions

The Social Security Act (the Act) 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 Act 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, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major final rule with comment period, we establish RVUs for CY 2015 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 with comment period includes discussions and proposals regarding:

  • Misvalued PFS Codes.
  • Telehealth Services.
  • Chronic Care Management Services.
  • Establishing Values for New, Revised, and Misvalued Codes.
  • Updating the Ambulance Fee Schedule regulations.
  • Changes in Geographic Area Delineations for Ambulance Payment.
  • Updating the—

++ Physician Compare Web site.

++ Physician Quality Reporting System.

++ Medicare Shared Savings Program.

++ Electronic Health Record (EHR) Incentive Program.

  • Value-Based Payment Modifier and the Physician Feedback Program.

3. Summary of Costs and Benefits

The Act 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 proposed changes would affect the specialty distribution of Medicare expenditures. When considering the combined impact of work, PE, and MP RVU changes, the projected payment impacts are small for most specialties; however, the impact would be larger for a few specialties.

We have determined that this final rule with comment period is economically significant. For a detailed discussion of the economic impacts, see section VII. of this final rule with comment period.

B. Background

Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, “Payment for Physicians' Services.” The system 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 final rule with comment period, 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 Start Printed Page 67551cooperative 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 of 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.

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.C. of this final rule with comment period.

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.

With regard to MP RVUs, we completed five-year reviews of MP that were effective in CY 2005 and CY 2010. This final rule with comment period establishes a five-year review for CY 2015.Start Printed Page 67552

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, which requires the agency to periodically identify, 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 with comment period, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs caused 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 physicians' 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 physician work, PE, and MP in an area compared to the national average costs for each component. (See section II.D. of this final rule with comment period for more information about GPCIs.)

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 CF for a given year is calculated using (a) the productivity-adjusted increase in the Medicare Economic Index (MEI) and (b) the Update Adjustment Factor (UAF), which is calculated by taking into account the Medicare Sustainable Growth Rate (SGR), an annual growth rate intended to control growth in aggregate Medicare expenditures for physicians' services, and the allowed and actual expenditures for physicians' services. 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 assure 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

The CY 2014 PFS final rule with comment period (78 FR 74230) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized many of the CY 2013 interim final RVUs and established interim final RVUs for new and revised codes for CY 2014 to ensure that our payment system is updated to reflect changes in medical practice, coding changes, and the relative values of services. It also implemented section 635 of the American Taxpayer Relief Act of 2012 (Pub. L. 112-240, enacted on January 2, 2013) (ATRA), which revised the equipment utilization rate assumption for advanced imaging services furnished on or after January 1, 2014.

Also, in the CY 2014 PFS final rule with comment period, we announced the following for CY 2014: the total PFS update of −20.1 percent; the initial estimate for the SGR of −16.7 percent; and a CF of $27.2006. These figures were calculated based on the statutory provisions in effect on November 27, 2013, when the CY 2014 PFS final rule with comment period was issued.

The Pathway for SGR Reform Act of 2013 (Pub. L. 113-67, enacted on December 26, 2013) established a 0.5 percent update to the PFS CF through March 31, 2014 and the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) (PAMA) extended this 0.5 percent update through December 31, 2014. As a result, the CF for CY 2014 that was published in the CY 2014 final rule with comment period (78 FR 74230) was revised to $35.8228 for services furnished on or after January 1, 2014 and on or before December 31, 2014. The PAMA provides for a 0.0 percent update to the PFS for services furnished on or after January 1, 2015 and on or before March 31, 2015.

The Pathway for SGR Reform Act extended through March 31, 2014 several provisions of Medicare law that would have otherwise expired on December 31, 2013. The PAMA extended these same provisions further through March 31, 2015. A list of these provisions follows.

  • The 1.0 floor on the work geographic practice cost index
  • The exceptions process for outpatient therapy caps
  • The manual medical review process for therapy services
  • The application of the therapy caps and related provisions to services furnished in HOPDs

In addition, section 220 of the PAMA included several provisions affecting the valuation process for services under the PFS. Section 220(a) of the PAMA amended section 1848(c)(2) of the Act to add a new subparagraph (M). The new subparagraph (M) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types and prices of practice expense inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS. This information may be collected or obtained through surveys of physicians or other suppliers, providers of services, manufacturers, and vendors; surgical logs, billing systems, or other practice or facility records; EHRs; and any other mechanism determined appropriate by the Secretary. If we use this information, we are required to disclose the source and use of the information in rulemaking, and to make available aggregated information that does not disclose individual eligible professionals, group practices, or information obtained pursuant to a nondisclosure agreement. Beginning with fiscal year 2014, the Secretary may compensate eligible professionals for submission of data.Start Printed Page 67553

Section 220(c) of the PAMA amended section 1848(c)(2)(K)(ii) of the Act to expand the categories of services that the Secretary is directed to examine for the purpose of identifying potentially misvalued codes. The nine new categories are as follows:

  • Codes that account for the majority of spending under the PFS.
  • 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 PE RVUs.
  • Codes with high cost supplies.

(See section II.B. of this final rule with comment period for more information about misvalued codes.).

Section 220(i) of the PAMA also requires the Secretary to make publicly available the information we considered when establishing the multiple procedure payment reduction (MPPR) policy for the professional component of advanced imaging procedures. The policy reduces the amount paid for the professional component when two advanced imaging procedures are furnished in the same session. The policy was effective for individual physicians on January 1, 2012 and for physicians in the same group practice on January 1, 2013.

In addition, section 220 of the PAMA includes other provisions regarding valuation of services under the PFS that take effect in future years. Section 220(d) of the PAMA establishes an annual target from CY 2017 through CY 2020 for reductions in PFS expenditures resulting from adjustments to relative values of misvalued services. The target is calculated as 0.5 percent of the estimated amount of expenditures under the fee schedule for the year. If the net reduction in expenditures for the year is equal to or greater than the target for the year, the funds shall be redistributed in a budget-neutral manner within the PFS. The amount by which such reduced expenditures exceed the target for the year shall be treated as a reduction in expenditures for the subsequent year, for purposes of determining whether the target has or has not been met. The legislation includes an exemption from budget neutrality of reduced expenditures if the target is not met. Other provisions of section 220 of the PAMA include a 2-year phase-in for reductions in RVUs of at least 20 percent for potentially misvalued codes that do not involve coding changes, and certain adjustments to the fee schedule areas in California. These provisions will be addressed as we implement them in future rulemaking.

On March 5, 2014, we submitted to MedPAC an estimate of the SGR and CF applicable to Medicare payments for physicians' services for CY 2015, as required by section 1848(d)(1)(E) of the Act. The actual values used to compute physician payments for CY 2015 will be based on later data and are scheduled to be published by November 1, 2014, as part of the CY 2015 PFS final rule with comment period.

C. Health Information Technology

The Department of Health and Human Services (HHS) believes all patients, their families, and their health care providers should have consistent and timely access to patient health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient's care. (HHS August 2013 Statement, “Principles and Strategies for Accelerating Health Information Exchange,” see http://www.healthit.gov/​sites/​default/​files/​acceleratinghieprinciples_​strategy.pdf) HHS is committed to accelerating health information exchange (HIE) through the use of safe, interoperable health information technology (health IT), including electronic health records (EHRs), across the broader care continuum through a number of initiatives: (1) Alignment of incentives and payment adjustments to encourage provider adoption and optimization of health IT and HIE services through Medicare and Medicaid payment policies; (2) adoption of common standards and certification requirements for interoperable HIT; (3) support for privacy and security of patient information across all HIE-focused initiatives; and (4) governance of health information. These initiatives are designed to encourage HIE among health care providers, including professionals and hospitals eligible for the Medicare and Medicaid EHR Incentive Programs and those who are not eligible for the EHR Incentive Programs, and are designed to improve care delivery and coordination across the entire care continuum. For example, the Transition of Care Measure #2 in Stage 2 of the Medicare and Medicaid EHR Incentive Programs requires HIE to share summary records for more than 10 percent of care transitions. In addition, to increase flexibility in the Office of the National Coordinator for Health Information Technology's (ONC) regulatory certification structure, ONC expressed in the 2014 Edition Release 2 final rule (79 FR 54472-73) an intent to propose future changes to the ONC HIT Certification Program that would permit more efficient certification of health IT for other health care settings, such as long-term and post-acute care and behavioral health settings.

We believe that health IT that incorporates usability features and has been certified to interoperable standards can effectively and efficiently help all providers improve internal care delivery practices, support management of patient care across the continuum, and support the reporting of electronically specified clinical quality measures (eCQMs).

II. Provisions of the Proposed Rule for PFS

A. Resource-Based 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 physician's 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.Start Printed Page 67554

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).

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 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).

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 with comment period 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 physician 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 use 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. In other words, the initial indirect allocator is calculated 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 Start Printed Page 67555a total PE RVUs of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
  • Next, we add 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 work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs 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 incorporate 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.

d. Facility and Nonfacility Costs

For procedures that can be furnished in a physician's office, as well as in a hospital or other facility setting, 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. Because 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 in a facility, the facility PE RVUs are generally lower than the nonfacility PE RVUs. Medicare makes a separate payment to the facility for its costs of furnishing a service.

e. 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.)

f. 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).

(1) 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.

(2) 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. Apply a scaling adjustment to the direct inputs.

Step 2: Calculate the aggregate pool of direct PE costs for the current year. This is the product of the current aggregate PE (direct and indirect) RVUs, the CF, and the average direct PE percentage from the survey data used for calculating the PE/HR by specialty.

Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregated 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, calculate a direct PE scaling adjustment 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 2 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.

(3) 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.

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 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 Table 1, the formulas were divided into two parts for each service.

  • The first part does not vary by service and is the indirect percentage (direct PE 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 Start Printed Page 67556the current aggregate pool of PE RVUs 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.

(4) Calculate the Final PE RVUs

Step 18: Add the direct PE RVUs from Step 6 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 results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required to redistribute RVUs from step 18 to all PE RVUs in the PFS, and because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but we note that all specialties are included for purposes of calculating the final BN adjustment. (See “Specialties excluded from ratesetting calculation” later in this section.)

(5) Setup File Information

  • Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners 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.
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 Start Printed Page 67557with 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 (MPPR). 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 the average allowed charge is used when simulating RVUs, and therefore, includes all adjustments. A time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where time units are duplicative.

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

(6) Equipment Cost Per Minute

The equipment cost per minute is calculated as:

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

Where:

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

Maintenance: This factor for maintenance was proposed and finalized during rulemaking for CY 1998 PFS (62 FR 33164). Several stakeholders have suggested that this maintenance factor assumption should be variable. We solicited comments regarding reliable data on maintenance costs that vary for particular equipment items. We received several comments about variable maintenance costs, which we will consider in future rulemaking. We note, however, that we do not believe that high-level summary data from informal surveys constitutes reliable data. Rather than assertions that a particular maintenance rate is typical, multiple invoices containing equipment prices that are accompanied by maintenance contracts would provide support for a maintenance cost other than our currently assumed 5 percent. We continue to seek reliable data about variable maintenance costs, as we consider adjustments to our methodology to accommodate variable maintenance costs.

Per-use Equipment Costs: Several stakeholders have also suggested that our PE methodology should incorporate usage fees and other per-use equipment costs as direct costs. We also solicited comment on adjusting our cost formula to include equipment costs that do not vary based on the equipment time. We received a comment that addressed how to incorporate usage fees and other per-use equipment costs into our methodology, and received several comments that addressed how we should reclassify the anomalous supply inputs removed from the direct PE database. We will consider these comments in future rulemaking, including the way these anomalous supply inputs fit in to any future proposals related to per-use costs.

Interest Rate: In the CY 2013 final rule with comment period (77 FR 68902), we updated the interest rates used in Start Printed Page 67558developing 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.)

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
Start Printed Page 67559

Table 4—Calculation of PE RVUS Under Methodology for Selected Codes

Factor (CF) (2nd part)StepSourceFormula99213 Office visit, est non-facility33533 CABG, arterial, single facility71020 Chest x-ray non-facility71020-TC Chest x-ray, non- facility71020-26 Chest x-ray, non-facility93000 ECG, Complete, non- facility93005 ECG, Tracing non- facility93010 ECG, Report non-facility
(1) Labor cost (Lab)Step 1AMA13.3277.525.745.745.105.10
(2) Supply cost (Sup)Step 1AMA2.987.340.530.531.191.19
(3) Equipment cost (Eqp)Step 1AMA0.170.586.926.920.090.09
(4) Direct cost (Dir)Step 1=(1)+(2)+(3)16.4885.4513.1913.196.386.38
(5) Direct adjustment (Dir. Adj.)Steps 2-4See footnote*0.58980.58980.58980.58980.58980.58980.58980.5898
(6) Adjusted LaborSteps 2-4=Labor * Dir Adj=(1)*(5)7.8645.723.393.393.013.01
(7) Adjusted SuppliesSteps 2-4=Eqp * Dir Adj=(2)*(5)1.764.330.310.310.700.70
(8) Adjusted EquipmentSteps 2-4=Sup * Dir Adj=(3)*(5)0.100.344.084.080.050.05
(9) Adjusted DirectSteps 2-4=(6)+(7)+(8)9.7250.407.787.783.773.77
(10) Conversion Factor (CF)Step 5PFS35.8235.8235.8235.8235.8235.8235.8235.82
(11) Adj. labor cost converted-Step 5=(Lab * Dir Adj)/CF=(6)/(10)0.221.280.090.090.080.08
(12) Adj. supply cost convertedStep 5=(Sup * Dir Adj)/CF=(7)/(10)0.050.120.010.010.020.02
(13) Adj. equipment cost convertedStep 5=(Eqp * Dir Adj)/CF=(8)/(10)0.010.110.11
(14) Adj. direct cost convertedStep 5=(11)+(12)+(13)0.271.410.220.220.110.11
(15) Work RVUSetup FilePFS0.9733.750.220.220.170.17
(16) Dir_pctSteps 6,7Surveys0.250.170.290.290.290.290.290.29
(17) Ind_pctSteps 6,7Surveys0.750.830.710.710.710.710.710.71
(18) Ind. Alloc. Formula (1st part)Step 8See Step 8((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)((14)/(16)*(17)
(19) Ind. Alloc.(1st part)Step 8See 180.826.670.530.530.260.26
(20) Ind. Alloc. Formula (2nd part)Step 8See Step 8(15)(15)(15+11)(11)(15)(15+11)(11)(15)
(21) Ind. Alloc.(2nd part)Step 8See 200.9733.750.310.090.220.250.080.17
(22) Indirect Allocator (1st + 2nd)Step 8=(19)+(21)1.7940.420.840.620.220.510.340.17
(23) Indirect Adjustment (Ind. Adj.)Steps 9-11See Footnote**0.38130.38130.38130.38130.38130.38130.38130.3813
(24) Adjusted Indirect AllocatorSteps 9-11=Ind Alloc * Ind Adj0.6815.410.320.240.080.200.130.06
(25) Ind. Practice Cost Index (IPCI)Steps 12-161.070.750.990.990.990.910.910.91
(26) Adjusted IndirectStep 17= Adj.Ind Alloc * PCI=(24)*(25)0.7311.590.320.240.080.180.120.06
(27) Final PE RVUStep 18=(Adj Dir + Adj Ind) * Other Adj=((14)+(26)) * Other Adj)1.0113.040.540.460.080.290.230.06
Note: PE RVUs in Table 5, row 27, may not match Addendum B due to rounding.
* The direct adj = [current pe rvus * CF * avg dir pct]/[sum direct inputs] = [step2]/[step3].
** The indirect adj = [current pe rvus * avg ind pct]/[sum of ind allocators] = [step9]/[step10].
Note: The use of any particular conversion factor (CF) in Table 5 to illustrate the PE Calculation has no effect on the resulting RVUs.
Note: The Other Adjustment includes an adjustment for the equipment utilization change.
Start Printed Page 67560

3. Changes to Direct PE Inputs for Specific Services

In this section, we discuss other CY 2015 revisions related to direct PE inputs for specific services. The final direct PE inputs are included in the final rule CY 2015 direct PE input database, which is available on the CMS Web site under downloads 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.html.

a. RUC Recommendation for Monitoring Time following Moderate Sedation

We received a recommendation from the RUC regarding appropriate clinical labor minutes for post-procedure moderate sedation monitoring and post-procedure monitoring. The RUC recommended 15 minutes of RN time for one hour of monitoring following moderate sedation and 15 minutes of RN time per hour for post-procedure monitoring (unrelated to moderate sedation). For 17 procedures listed in Table 5, the recommended clinical labor minutes differed from the clinical labor minutes in the direct PE database. We proposed to accept, without refinement, the RUC recommendation to adjust these clinical labor minutes as indicated in Table 5 as “Change to Clinical Labor Time.”

Table 5—Codes With Changes to Post-Procedure Clinical Labor Monitoring Time

CPT CodeCurrent monitoring time (min)RUC recommended total post-procedure monitoring time (min)Change to clinical labor time (min)
32553306030
35471216039
354756030−30
354766030−30
36147183012
371916030−30
475256159
49411306030
50593306030
50200156045
316252015−5
316262515−10
316282515−10
316292515−10
316342515−10
3164510155
3164610155

Comment: We received two comments supporting our proposal to accept the RUC recommendation, without refinement, to adjust the clinical labor minutes as indicated in Table 5. One commenter noted that the RUC recommendation was a more accurate reflection of the monitoring time, particularly for codes 50593 (Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy) and 50200 (Renal biopsy; percutaneous, by trocar or needle), than the current time.

Response: We appreciate commenters' support for our proposal. After consideration of comments received, we are finalizing our proposal to accept, without refinement, the RUC recommendation to adjust the clinical labor minutes as indicated in Table 5 as “Change to Clinical Labor Time.”

b. RUC Recommendation for Standard Moderate Sedation Package

We received a RUC recommendation to modify PE inputs included in the standard moderate sedation package. Specifically, the RUC indicated that several specialty societies have pointed to the need for a stretcher during procedures for which moderate sedation is inherent in the procedure. Although the RUC did not recommend that we make changes to PE inputs for codes at this time, the RUC indicated that its future recommendations would include the stretcher as a direct input for procedures including moderate sedation.

The RUC recommended three scenarios that it would use in the future to allocate the equipment time for the stretcher based on the procedure time and whether the stretcher would be available for other patients to use during a portion of the procedure. Although we appreciate the RUC's attention to the differences in the time required for the stretcher based on the time for the procedure, we believe that one of the purposes of standard PE input packages is to reduce the complexity associated with assigning appropriate PE inputs to individual procedures while, at the same time, maintaining relativity between procedures. Since we generally allocate inexpensive equipment items to the entire service period when they are likely to be unavailable for another use during the full service period, we believe it is preferable to treat the stretcher consistently across services. Therefore, we proposed to modify the standard moderate sedation input package to include a stretcher for the same length of time as the other equipment items in the moderate sedation package. The revised moderate sedation input package will be applied to relevant codes as we review them through future notice and comment rulemaking. In seeking comments on the proposal, we stated that it would be useful to hear stakeholders' views and the reasoning behind them on this issue, especially from those who think that the stretcher, as expressed through the allocation of equipment minutes, should be allocated with more granularity than the equipment costs that are allocated to other similar items.

Comment: We received comments supporting our proposal to add the stretcher to the moderate sedation package, including support to include the stretcher for the same length of time as the other equipment items included in the moderate sedation package since it is used by the patient for the duration Start Printed Page 67561of their recovery and not available to other patients during that time.

Response: We appreciate the commenters' support for our proposal. After consideration of comments received, we are finalizing our proposal to add the stretcher to the moderate sedation package for the same length of time as the other equipment items in the moderate sedation package. We note that we will not apply this change retroactively, but will make the change to the moderate sedation package for codes being finalized for 2015, as well as interim final codes for 2015. For a detailed discussion of the specific codes impacted by this change, we refer readers to sections II.F. of this final rule with comment period.

c. RUC Recommendation for Migration From Film to Digital Practice Expense Inputs

The RUC provided a recommendation regarding the PE inputs for digital imaging services. Specifically, the RUC recommended that we remove a list of supply and equipment items associated with film technology since these items are no longer a typical resource input; these items are detailed in Table 6. The RUC also recommended that the Picture Archiving and Communication System (PACS) equipment be included for these imaging services since these items are now typically used in furnishing imaging services. We received a description of the PACS system as part of the recommendation, which included both items that appear to be direct PE items and items for which indirect PE RVUs are allocated in the PE methodology. As we have previously indicated, items which are not clinical labor, medical supplies, or medical equipment, or are not individually allocable to a particular patient for a particular procedure, are not categorized as direct costs in the PE methodology. Since we did not receive any invoices for the PACS system prior to the proposed rule, we were unable to determine the appropriate pricing to use for the inputs. We proposed to accept the RUC recommendation to remove the film supply and equipment items, and to allocate minutes for a desktop computer (ED021) as a proxy for the PACS workstation as a direct expense. Specifically, for the 31 services that already contain ED021 (computer, desktop, w-monitor), we proposed to retain the time that is currently included in the direct PE input database. For the remaining services that are valued in the nonfacility setting, we proposed to allocate the full clinical labor intraservice time to ED021, except for codes without clinical labor, in which case we proposed to allocate the intraservice work time to ED021. For services valued only in the facility setting, we proposed to allocate the post-service clinical labor time to ED021, since the film supply and/or equipment inputs were previously associated with the post-service period.

Table 6—RUC-Recommended Supply and Equipment Items Removed for Digital Imaging Services

CMS CodeDescription
SK013computer media, dvd.
SK014computer media, floppy disk 1.44mb.
SK015computer media, optical disk 128mb.
SK016computer media, optical disk 2.6gb.
SK022film, 8inx10in (ultrasound, MRI).
SK025film, dry, radiographic, 8in x 10in.
SK028film, fluoroscopic 14 x 17.
SK033film, x-ray 10in x 12in.
SK034film, x-ray 14in x 17in.
SK035film, x-ray 14in x 36in.
SK037film, x-ray 8in x 10in.
SK038film, x-ray 8in x 10in (X-omat, Radiomat).
SK086video tape, VHS.
SK089x-ray developer solution.
SK090x-ray digitalization separator sheet.
SK091x-ray envelope.
SK092x-ray fixer solution.
SK093x-ray ID card (flashcard).
SK094x-ray marking pencil.
SK098film, x-ray, laser print.
SM009cleaner, x-ray cassette-screen.
ED014computer workstation, 3D reconstruction CT-MR.
ED016computer workstation, MRA post processing.
ED023film processor, PET imaging.
ED024film processor, dry, laser.
ED025film processor, wet.
ED027film processor, x-omat (M6B).
ER018densitometer, film.
ER029film alternator (motorized film viewbox).
ER067x-ray view box, 4 panel.

We note that the RUC exempted certain procedures from its recommendation because (a) the dominant specialty indicated that digital technology is not yet typical or (b) the procedure only contained a single input associated with film technology, and it was determined that the sharing of images, but not actual imaging, may be involved in the service. However, we do not believe that the most appropriate approach in establishing relative values for services that involve imaging is to exempt services from the transition from film to digital PE inputs based on information reported by individual specialties. Although we understand that the migration from film technology to digital technology may progress at different paces for particular specialties, we do not have information to suggest that the migration is not occurring for all procedures that require the storage of images. Just as it was appropriate to use film inputs as a proxy for some services for which digital inputs were typical pending these changes in the direct PE input database, we believe it is appropriate to use digital inputs as a proxy for the services that may still use film, pending their migration to digital technology. In addition, since the RUC conducted its collection of information from the specialties over several years, we believe the migration process from film to digital inputs has likely continued over the time period during which the information was gathered, and that the digital PE inputs will reflect typical use of technology for most if not all of these services before the change to digital inputs would take effect beginning January 1, 2015.

We noted that we believed that, for the sake of relativity, we should remove the equipment and supply inputs noted below from all procedures in the direct PE database, including those listed in Table 7. We sought comment on whether the computer workstation, which we proposed to use as a proxy for the PACS workstation, is the appropriate input for the services listed in Table 7, or whether an alternative input is a more appropriate reflection of direct PE costs.

Table 7—Codes Containing Film Inputs But Excluded From the RUC Recommendation

HCPCSShort descriptor
21077Prepare face/oral prosthesis.
28293Correction of bunion.
61580Craniofacial approach skull.
61581Craniofacial approach skull.
61582Craniofacial approach skull.
61583Craniofacial approach skull.
61584Orbitocranial approach/skull.
61585Orbitocranial approach/skull.
61586Resect nasopharynx skull.
64517N block inj hypogas plxs.
64681Injection treatment of nerve.
70310X-ray exam of teeth.
77326Brachytx isodose calc simp.
77327Brachytx isodose calc interm.
77328Brachytx isodose plan compl.
91010Esophagus motility study.
91020Gastric motility studies.
91034Gastroesophageal reflux test.
91035G-esoph reflx tst w/electrod.
91037Esoph imped function test.
91038Esoph imped funct test > 1hr.
91040Esoph balloon distension tst.
91120Rectal sensation test.
91122Anal pressure record.
91132Electrogastrography.
91133Electrogastrography w/test.
92521Evaluation of speech fluency.
Start Printed Page 67562
92523Speech sound lang comprehend.
92524Behavioral qualit analys voice.
92601Cochlear implt f/up exam <7.
92603Cochlear implt f/up exam 7/>.
92611Motion fluoroscopy/swallow.
92612Endoscopy swallow tst (fees).
92614Laryngoscopic sensory test.
92616Fees w/laryngeal sense test.
95800Slp stdy unattended.
95801Slp stdy unatnd w/anal.
95803Actigraphy testing.
95805Multiple sleep latency test.
95806Sleep study unatt&resp efft.
95807Sleep study attended.
95808Polysom any age 1-3> param.
95810Polysom 6/> yrs 4/> param.
95811Polysom 6/>yrs cpap 4/> parm.
95812Eeg 41-60 minutes.
95813Eeg over 1 hour.
95829Surgery electrocorticogram.
95950Ambulatory eeg monitoring.
95953Eeg monitoring/computer.
95954Eeg monitoring/giving drugs.
95955Eeg during surgery.
95956Eeg monitor technol attended.
95957Eeg digital analysis.
96904Whole body photography.
G0270Mnt subs tx for change dx.
G0271Group mnt 2 or more 30 mins.

Finally, we noted that the RUC recommendation also indicated that, given the labor-intensive nature of reviewing all clinical labor tasks associated with film technology, these times would be addressed as these codes are reviewed. We agreed with the RUC that reviewing and adjusting the times for each code would be difficult and labor-intensive since the direct PE input database does not allow for a comprehensive adjustment of the clinical labor time based on changes in particular clinical labor tasks. To make broad adjustments such as this across codes, the PE database would need to contain the time associated with individual clinical labor tasks rather than reflecting only the sum of times for the pre-service period, service period, and post-service period, as it does now. We recognized this situation presents a challenge in implementing RUC recommendations such as this one, and makes it difficult to understand the basis of both the RUC's recommended clinical labor times and our refinements of those recommendations. Therefore, we stated that we were considering revising the direct PE input database to include task-level clinical labor time information for every code in the database. As an example, we referred readers to the supporting data files for the direct PE inputs, which include public use files that display clinical labor times as allocated to each individual clinical labor task for a sample of procedures. We displayed this information as we attempt to increase the transparency of the direct PE database. We stated that we hoped that this modification would enable us to more accurately allocate equipment minutes to clinical labor tasks in a more consistent and efficient manner. Given the number of procedures and the volume of information involved, we sought comments on the feasibility of this approach. We note that we did not propose to make any changes to PE inputs for CY 2015 based on this modification to the design of the direct PE input database.

As discussed in section II.G. of this final rule with comment period, some of the RUC recommendations for 2015 included film items as practice expense inputs. For existing codes, the database from the proposed rule already included the PACS workstation proxy. However, for new services, as with the current items in the database, we have replaced the film items with the PACS workstation proxy. The codes affected by this change are listed in Table 8.

Table 8—Codes Affected by Removal of Film Inputs

HCPCSShort descriptor
22510Perq cervicothoracic inject.
22511Perq lumbosacral injection.
22513Perq vertebral augmentation.
22514Perq vertebral augmentation.
62302Myelography lumbar injection.
62303Myelography lumbar injection.
62304Myelography lumbar injection.
62305Myelography lumbar injection.
71275Ct angiography chest.
72191Ct angiograph pelv w/o&w/dye.
72240Myelography neck spine.
72255Myelography thoracic spine.
72265Myelography l-s spine.
72270Myelogphy 2/> spine regions.
74174Ct angio abd&pelv w/o&w/dye.
74175Ct angio abdom w/o & w/dye.
74230Cine/vid x-ray throat/esoph.
76942Echo guide for biopsy.
93312Echo transesophageal.
93314Echo transesophageal.
93320Doppler echo exam heart.
93321Doppler echo exam heart.
93325Doppler color flow add-on.
93880Extracranial bilat study.
93882Extracranial uni/ltd study.
93886Intracranial complete study.
93888Intracranial limited study.
93895Carotid intima atheroma eval.
93925Lower extremity study.
93926Lower extremity study.
93930Upper extremity study.
93931Upper extremity study.
93970Extremity study.
93971Extremity study.
93975Vascular study.
93976Vascular study.
93978Vascular study.
93979Vascular study.

Comment: We received many comments on our proposal to remove the equipment and supply inputs associated with film technology from the direct PE database. In general, commenters supported our proposal to remove the film inputs from the direct PE database. Some commenters supported our use of the desktop computer as a proxy for the PACS workstation, but other commenters opposed using this item as a proxy. Commenters opposed to using the desktop computer as the proxy item stated that the PACS workstation was significantly more expensive and included greater functionality than a desktop computer. Some commenters opposed our proposal to maintain the current equipment time allocated to the computer desktop for the 31 services that already included this equipment item, suggesting that it was incorrect to eliminate the film inputs without proportionately increasing the proxy time for ED021. Some commenters requested a delay in implementation until stakeholders provide invoices or otherwise work with CMS to identify prices for the PACS items. Some commenters suggested CMS should develop a means to allocate digital technology costs to individual services, even if it is difficult to do so. Another commenter explained that it is difficult for stakeholders to obtain invoices that display prices for individual items, such as the PACS workstation, since the price of the particular items is often bundled with other related equipment and services. Many commenters urged CMS to work with stakeholders to obtain invoices, while other commenters requested that CMS accept the RUC recommendation regarding the PACS workstation.

Response: We appreciate commenters' support for our proposal to incorporate the transition from film to digital imaging technology into the direct PE input database. With regard to the pricing of the PACS workstation, as with all inputs, we would prefer to use actual paid invoices to establish the input price. However, in the absence of invoices demonstrating the actual cost, we believe that use of a proxy to price the appropriate inputs, in this case the PACS workstation, is preferable to Start Printed Page 67563continuing to use inputs that we know are no longer typical. We made the proposal to use the computer, desktop, w-monitor (ED021), priced at $2,501, as a proxy based on our assessment of similar resource costs between the item and the PACS workstation. Although some commenters stated that the item was not an appropriate proxy, these commenters did not provide any evidence to indicate that the resource costs are not similar or to suggest a more appropriate proxy. Nor were any paid invoices submitted. Absent such information, we continue to believe that using the proxy item is the best approach to incorporate the direct PE cost of the digital imaging technology.

With regard to the 31 services that already included the desktop computer as an equipment input, we will include the desktop computer as a proxy for the PACS workstation using the same methodology as for the services that did not previously contain the desktop computer. To clearly differentiate the desktop computer proxy from the desktop computer currently included in these services, and to facilitate accurate replacement of this input when we do receive pricing information, we will create a new equipment item called “desktop computer (proxy for PACS workstation),” which will be allocated to each procedure using the methodology described above.

Comment: Some commenters opposed our removal of the film inputs from services that were not included in the RUC recommendation, but did not provide a rationale for their opposition.

Response: For the reasons we explained in making the proposal and reiterate above, we continue to believe that it is appropriate to remove these items from the direct PE database.

Comment: Some commenters provided specific suggestions regarding the use of digital inputs should CMS decide to move forward with the proposal. Commenters requested that for portable x-ray services, CMS include a flat plate receptor/image capture plate to capture the image, specialized software to process the image, and multiple high definition monitors used by the interpreting radiologist. Commenters provided an invoice for the image capture plate at a price of $25,600 indicating that this item replaces the film as the media to record the image.

Response: We appreciate that commenters provided us with an invoice for the image capture plate. However, services furnished by portable x-ray providers are reported using the same procedure codes as services provided using fixed machines. Since the typical x-ray service is furnished using fixed equipment, we are not including the image capture plate that is associated with portable equipment as an input for the imaging procedure codes. We also do not believe that high definition monitors used by the interpreting radiologist are appropriately included in the technical component of imaging procedures; rather, these are indirect costs associated with the professional component of the service. Therefore, we are not including the high definition monitors as an input for these services. Finally, to determine whether the software is appropriately categorized as a direct PE input, we need more information about the functionality of the software, and whether it is used in furnishing the typical x-ray service (including services furnished using fixed machinery). Until we have information that supports the inclusion of this item as a direct cost, we will not include the software for x-ray services.

Comment: Commenters were supportive of the increased transparency with regard to the direct PE inputs, but several commenters suggested that there may be more feasible approaches to break out the individual clinical labor tasks associated with each portion of the service (pre-service period, service period, and post-service period). The RUC suggested that we post all PE worksheets and supporting materials in code-order on our Web site. Other commenters did not suggest a specific alternative approach to providing detail for the individual clinical labor tasks.

Response: We appreciate the RUC's suggestion regarding the posting of the PE worksheets, but we do not believe that this would enable us to accomplish a comprehensive cross-code analysis and refinement to clinical labor times within the direct PE input database to increase consistency for identical clinical labor tasks between codes. Since we did not receive other suggestions from commenters on an approach to break out the individual clinical labor tasks associated with each service period to enable us to conduct the necessary analysis, we will pursue the approach described in the proposed rule. We will consider the comments submitted and continue to work with interested stakeholders regarding the best approaches to displaying the supporting files. We note that public use files continue to be available in the same format as in previous years, but that additional public use files now display the clinical labor tasks for each service period, providing greater transparency and enabling comparisons across codes. We note that we have refined the file structure based on comments, and we continue to seek input on whether there are additional or alternative ways to display this information to enhance its clarity, and note that there are challenges inherent in the display of this information in a two-dimensional format. We refer readers to the public use files available on the CMS Web site under downloads 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.html

d. Inputs for Digital Mammography Services

Mammography services are currently reported and paid using both CPT codes and G-codes. To meet the requirements of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), we established G-codes for use beginning in CY 2002 to pay for mammography services using new digital technologies (G0202 screening mammography digital; G0204 diagnostic mammography digital; G0206 diagnostic mammography digital). We continued to use the CPT codes for mammography services furnished using film technology (77055 (Mammography; unilateral); 77056 (Mammography; bilateral); 77057 (Screening mammography, bilateral (2-view film study of each breast)). As we discussed previously in this section, the RUC has recommended that all imaging codes, including mammography, be valued using digital rather than film inputs because the use of film is no longer typical. A review of Medicare claims data shows that the mammography CPT codes are billed extremely infrequently, and that the G-codes are billed for the vast majority of mammography claims, confirming the RUC's conclusion that the typical service uses digital technology. As such, we stated that we do not believe there is a reason to continue the separate CPT codes and G-codes for mammography services since both sets of codes would have the same values when priced based upon the typical digital technology. Accordingly, we proposed to delete the mammography G-codes beginning for CY 2015 and to pay all mammography using the CPT codes.

We indicated that, although we believed that the CPT codes should now be used to report all mammography services, we had concerns about whether the current values for the CPT codes accurately reflect the resource inputs associated with furnishing the services. Because the CPT codes have not been recently reviewed and Start Printed Page 67564significant technological changes have occurred since the current values were established, we did not believe it would be appropriate to retain the current values for the CPT codes. Therefore, we proposed to value the CPT codes using the RVUs previously established for the G-codes. We believed these values would be most appropriate since they were established to reflect the use of digital technology, which is now typical.

As discussed in section II.B of this final rule with comment period, we proposed these CPT codes as potentially misvalued and requested that the RUC and other interested stakeholders review these services in terms of appropriate work RVUs, work time assumptions, and direct PE inputs. However, as discussed in section II.B. of this final rule with comment period, we will continue to maintain separate payment rates for film and digital mammography while we consider revaluation of all mammography services. For CY 2015, we will therefore maintain both the G-codes and CPT codes; we will continue using the 2014 RVUs from each of the following codes to price them for 2015: G0202, G0204, G0206, 77055, 77056, and 77057. 2015. We also note that we will continue to pay for film mammography services at the 2014 rates until we revalue the mammography services.

We refer readers to section II.B. of this final rule with comment period, where we address comments received on this proposal.

e. Radiation Treatment Vault

In previous rulemaking (77 FR 68922, 78 FR 74346), we indicated that we included the radiation treatment vault as a direct PE input for several recently reviewed radiation treatment codes for the sake of consistency with its previous inclusion as a direct PE input for some other radiation treatment services, but that we intended to review the radiation treatment vault input and address whether or not it should be included in the direct PE input database for all services in future rulemaking. Specifically, we questioned whether it was consistent with the principles underlying the PE methodology to include the radiation treatment vault as a direct cost given that it appears to be more similar to building infrastructure costs than to medical equipment costs. In response to this discussion, we received comments and invoices from stakeholders who indicated that the vault should be classified as a direct cost. However, upon review of the information received, we believed that the specific structural components required to house the linear accelerator are similar in concept to components required to house other medical equipment such as expensive imaging equipment. In general, the electrical, plumbing, and other building specifications are often unique to the intended functionality of a given building, including costs that are attributable to the specific medical equipment housed in the building, but those building characteristics do not represent direct medical equipment costs in our established PE methodology. Therefore, we believed that the special building requirements indicated for the radiation treatment vault to house a linear accelerator do not represent a direct cost in our PE methodology, and that the vault construction is instead accounted for in the indirect PE methodology, just as the building and infrastructure costs are treated for other PFS services including those with specialized infrastructure costs to accommodate specific equipment. Therefore, we proposed to remove the radiation treatment vault as a direct PE input from the radiation treatment procedures listed in Table 9, because we believed that the vault is not, itself, medical equipment; and therefore, it is accounted for in the indirect PE methodology.

Table 9—HCPCS Codes Affected by Proposed Removal of Radiation Treatment Vault

HCPCSShort descriptor
77373Sbrt delivery.
77402Radiation treatment delivery.
77403Radiation treatment delivery.
77404Radiation treatment delivery.
77406Radiation treatment delivery.
77407Radiation treatment delivery.
77408Radiation treatment delivery.
77409Radiation treatment delivery.
77411Radiation treatment delivery.
77412Radiation treatment delivery.
77413Radiation treatment delivery.
77414Radiation treatment delivery.
77416Radiation treatment delivery.
77418Radiation tx delivery imrt.

Comment: We received many comments regarding our proposal to remove the radiation treatment vault as a direct cost from the radiation treatment delivery codes. Although one commenter supported the proposal, most commenters opposed the proposal. In general, commenters reiterated their rationale for inclusion of the vault as a direct practice expense input, asserting that the vault is necessary for the functioning of the equipment, serves a unique medical need, cannot be separated from the treatment delivered by the linear accelerator, and cannot be repurposed for another use. Commenters also stated that the Internal Revenue Code treats the vault as medical equipment that is separately depreciable from the building itself. For the most part, commenters objected to the removal of the vault given the context of declining Medicare payment for radiation oncology services over the past few years, or in conjunction with the revised radiation treatment code set. Specifically, several commenters suggested that stakeholders cannot provide meaningful comment about the impact of the vault proposal in the context of other pending changes. Some commenters requested a phase-in of any decrease in payment so that providers of radiation therapy services have an opportunity to adjust their practice costs. Several commenters also suggested that the change in payment could exacerbate problems in access to oncology services for Medicare patients.

Response: We appreciate commenters' concerns regarding the proposal to remove the vault as a direct practice expense input. We understand the essential nature of the vault in the provision of radiation therapy services and its uniqueness to a particular piece of medical equipment but are not convinced that either of these factors leads to the conclusion that the vault should be considered medical equipment for purposes of the PE methodology under the PFS. We appreciate the information commenters provided regarding the IRS treatment of the vault under tax laws, but the purposes and goals of the tax code and the PFS PE methodology are different, and, as such, attempts to draw parallels between the two are not necessarily instructive or relevant. We are not finalizing our proposal at this time, but intend to further study the issues raised by the vault and how it relates to our PE methodology.

Comment: A commenter noted that removing the vault as a direct cost also reduces the amount of indirect PE allocated for these procedures, and that this proposal does not shift the vault from direct PE to indirect PE, but rather drops the cost of the vault entirely. Another commenter stated that since the pool of indirect PE RVUs associated with radiation oncology services is fixed, the issue in question is how the indirect costs involved in furnishing treatment services compare to the indirect costs in providing other radiation oncology services.

Response: We understand the concerns of commenters regarding the importance of ensuring that the costs related to the vault are included in the Start Printed Page 67565PE methodology. We want to point out, however, that within the established PE methodology, the allocation of indirect PE to individual codes has significant impact on the PE RVUs that determine Medicare payment for individual services. In other words, we believe it is important for stakeholders to recognize that practice expense costs not included in the direct PE input database contribute to the development of PE RVUs through the data used to allocate indirect PE RVUs. We also want to point out that the pool of indirect PE RVUs is not fixed at the specialty level. Rather, the pool of indirect costs under the entire PFS is maintained from year to year, as delineated in step 11 of the PE methodology above. Therefore, changes in the allocation of indirect PE for particular PFS services based on changes in either direct PE inputs, work RVUs, work time, or utilization data, impacts the amount of indirect PE allocated to all other PFS services, not just those furnished by specialties that furnish that service.

After continued review of the issues pertaining to the vault in the context of the comments, we believe that these issues require further study. Therefore, at this time, we will continue to include the vault as a direct PE input for the services listed in Table 9.

f. Clinical Labor Input Errors

Subsequent to the publication of the CY 2014 PFS final rule with comment period, it came to our attention that, due to a clerical error, the clinical labor type for CPT code 77293 (Respiratory Motion Management Simulation (list separately in addition to code for primary procedure)) was entered as L052A (Audiologist) instead of L152A (Medical Physicist), which has a higher cost per minute. We proposed a correction to the clinical labor type for this service.

Comment: Commenters appreciated our proposal to correct this error.

Response: We appreciate commenters' support for our proposal, and are finalizing the assignment of clinical labor type L152A to code 77293 as proposed. The CY 2015 Direct Practice Expense Input database reflects this correction.

In conducting a routine data review of the database, we also discovered that, due to a clerical error, the RN time allocated to CPT codes 33620 (Apply r&l pulm art bands), 33621 (Transthor cath for stent), and 33622 (Redo compl cardiac anomaly) was entered in the nonfacility setting, rather than in the facility setting where the code is valued. When a service is not valued in a particular setting, any inputs included in that setting are not included in the calculation of the PE RVUs for that service. Therefore, we proposed to move the RN time allocated to these procedures to the facility setting. The PE RVUs listed in Addendum B reflect these technical corrections.

We did not receive any comments on this proposal; therefore, we are finalizing our proposal to move the RN time allocated to these procedures to the facility setting. The CY 2015 Direct Practice Expense Input database reflects this correction.

g. Work Time

Subsequent to the publication of the CY PFS 2014 final rule with comment period, several inconsistencies in the work time file came to our attention. First, for some services, the total work time, which is used in our PE methodology, did not equal the sum of the component parts (pre-service, intra-service, post-service, and times associated with global period visits). The times in the CY 2015 work time file reflect our corrected values for total work time. Second, for a subset of services, the values in the pre-positioning time, pre-evaluation time, and pre-scrub-dress-wait time, were inadvertently transposed. We note that this error had no impact on calculation of the total times, but has been corrected in the CY 2015 work time file. Third, minor discrepancies for a series of interim final codes were identified between the work time file and the way we addressed these codes in the preamble text. Therefore, we have made adjustments to the work time file to reflect the decisions indicated in the preamble text. The work time file is available on the CMS Web site under the supporting data files for the CY 2015 PFS final rule with comment period at http://www.cms.gov/​PhysicianFeeSched/​. Note that for comparison purposes, the CY 2014 work time file is located at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices-Items/​CMS-1600-FC.html.

Comment: A commenter supported our proposal to correct the work times associated with the procedures affected by this proposal.

Response: We appreciate the commenter's support for our proposal. After consideration of the comment received, we are finalizing our proposal to adjust the work time file as proposed. The work time file is available on the CMS Web site under the supporting data files for the CY 2015 PFS final rule with comment period at http://www.cms.gov/​PhysicianFeeSched/​

h. Updates to Price for Existing Direct 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. During 2013, we received a request to update the price of SD216 (catheter, balloon, esophageal or rectal (graded distention test)) from $217 to $237.50. We also received a request to update the price of SL196 (kit, HER-2/neu DNA Probe) from $105 to $144.50. We received invoices that documented updated pricing for each of these supply items. We proposed to increase the price associated with these supply items.

We continue to believe it is important to maintain a periodic and transparent process to update the price of items to reflect typical market prices in our ratesetting methodology, and we continue to study the best way to improve our current process. We remind stakeholders that we have difficulty obtaining accurate pricing information. The goal of the current transparent process is to offer the opportunity for the community to both request supply price updates by providing us copies of paid invoices, and to object to proposed changes in price inputs for particular items by providing additional information about prices available to the practitioner community. We remind stakeholders that PFS payment rates are developed within a budget neutral, relative value system, and any increases in price inputs for particular supply items result in corresponding decreases to the relative values of all other direct PE inputs.

We also received a RUC recommendation to update the prices associated with two supply items. Specifically, the RUC recommended that we increase the price of SA042 (pack, cleaning and disinfecting, endoscope) from $15.52 to $17.06 to reflect the addition of supply item SJ009 (basin, irrigation) to the pack, and increase the price of SA019 (kit, IV starter) from $1.37 to $1.60 to reflect the addition of supply item SA044 (underpad 2 ft. x 3 ft. (Chux)) to the kit. We proposed to update the prices for both of these items based on these recommendations.

Comment: We received several comments regarding our concern about obtaining accurate pricing information for equipment and supply items included in the direct PE database. The RUC indicated that it would continue to work with specialty societies to obtain Start Printed Page 67566paid invoices. A commenter suggested that a sample of paid invoices be obtained from practices and submitted with the PE materials to the RUC, or directly to CMS. Another commenter expressed concern regarding CMS's assertion that invoices are difficult to obtain, given that the RUC process collects lists of resources required to furnish services in the physician office using a standardized process that is typically accompanied by invoices. Another commenter stated that CMS used only the lowest-cost invoice for a particular equipment item since the other invoices included “soft costs,” and that CMS should establish an approach that would allow invoices to be used even if they contain “soft costs.”

Response: We appreciate the RUC's assistance in obtaining paid invoices from the specialty societies. These invoices are helpful in pricing inputs. We disagree that we use the lowest-cost invoice because it had the lowest cost; rather, we often use the lowest-cost invoice because we do not have a method to use invoices that include costs that are not included as part of the equipment costs, so called “soft costs,” within the PE methodology. We do not believe it would serve accuracy or relativity to include as part of the pricing inputs “soft costs” that increase the price of particular supply or equipment items. We would welcome further input on potential approaches for “backing out” these costs.

Comment: One commenter disagreed with CMS's position that the RUC PE Subcommittee's review results in biased or inaccurate resource input costs because the prices are largely maintained in the direct PE input database by CMS.

Response: Although we did not raise this point in the CY 2015 PFS proposed rule, we refer readers to our discussion in previous rulemaking (for example, the CY 2011 PFS final rule with comment period at 75 FR 73250 and the CY 2014 PFS final rule with comment period at 78 FR 74246) regarding issues associated with obtaining appropriate prices for medical equipment and supply items included in the direct PE database. We note that the RUC provides recommendations regarding the use of particular items in furnishing a service, but does not provide CMS with recommendations regarding the prices of direct PE item. Without assigning a price, the input cannot be factored in to our PE RVU methodology. Our price information is almost exclusively anecdotal, and generally updated only through voluntary submission of a small number of invoices from the same practitioners that furnish and are paid for the services that use the particular inputs. Therefore, we continue to believe there is potential for bias in the information we receive.

Comment: In its comment, the RUC suggested that an annual CMS review of paid invoices for high-cost supplies would be appropriate. A commenter referenced comments made on the CY 2014 PFS final rule with comment period, and expressed agreement with those commenters that the provision of pricing information is sensitive because of issues involving proprietary pricing information and price negotiations for individual practitioners. This commenter also agreed with CMS that such information would be less sensitive if it confirmed inputs contained in the direct PE database. However, the commenter noted that requiring paid invoices from this point forward only partially addresses the concern since many existing inputs are not based on paid invoices; specifically, societies working on inputs for new, revised, or potentially misvalued services are disadvantaged in comparison to many existing inputs due to fee schedule relativity. The commenter suggested that CMS may need to undertake a comprehensive review of all direct PE inputs and obtain paid invoices to systematically address its concerns.

Response: We share commenters' concerns that codes that are being reviewed may be disadvantaged relative to codes that contain input prices that may not be based on paid invoices; and note that we rely on the public process to ensure continued relativity within the direct PE inputs. We encourage interested stakeholders to review updates to prices, as well as prices for new items, to ensure that they appear reasonable and current, and to provide us with updated pricing information, particularly regarding high cost supplies that have a greater impact on relativity. We refer readers to section II.F. of this final rule with comment period, in which we detail price updates, as well as establish new prices, for inputs included in new, revised, and potentially misvalued codes.

Comment: We received some comments in support of our proposal to update the price for SL196 (kit, HER-2/neu DNA Probe).

Response: We appreciate the commenters' support for our proposal to update the price for SL196. After publication of our proposal, we obtained new information suggesting that further study of the price of this item is necessary before proceeding to update the input price. Therefore, we are not finalizing our proposal to update the price for SL196, and will consider this matter in future rulemaking.

Comment: We did not receive any comments regarding our proposal to update the price for of SD216 (catheter, balloon, esophageal or rectal (graded distention test)).

Response: We are finalizing the price updates for SD216.

Comment: We received comments in support of the price update to SA019 (kit, IV starter) and SA042 (pack, cleaning and disinfecting, endoscope).

Response: We appreciate the commenters' support for our proposal to update the price for SA019 and SA042. After consideration of comments received, we are finalizing the price updates for SA019 and SA042.

i. New Standard Supply Package for Contrast Imaging

The RUC recommended creating a new direct PE input standard supply package “Imaging w/contrast, standard package” for contrast enhanced imaging, with a price of $6.82. This price reflects the combined prices of the medical supplies included in the package; these items are listed in Table 10. We proposed to accept this recommendation, but sought comment on whether all of the items included in the package are used in the typical case. The CY 2015 direct PE database reflects this change and is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/​PhysicianFeeSched/​.

Table 10—Standard Contrast Imaging Supply Package

Medical supply descriptionSCMS supply codeUnitQuantityPrice
Kit, IV starterSA019Kit1$1.60
Gloves, non-sterileSB022Pair10.084
Start Printed Page 67567
Angiocatheter 14g-24gSC001Item11.505
Heparin lockSC012Item10.917
IV tubing (extension)SC019Foot*31.590
Needle, 18-27gSC029Item10.089
Syringe 20mlSC053Item10.558
Sodium chloride 0.9% inj. bacteriostatic (30ml uou)SH068Item10.700
Swab-pad, alcoholSJ053Item10.013
Total7.06
* The price for SC019 (IV tubing, (extension)) is $0.53 per foot.

Comment: Commenters supported our proposal to create the standard supply package for contrast imaging. Some commenters expressed concern that the proposed supply package did not include the full range of supplies typically used when performing contrast imaging. One commenter stated that, for echocardiography labs that utilize contrast-enhanced ultrasound, additional items are typically part of the contrast imaging supply package, including 2x2 gauze pads, a stopcock, and tape. Another commenter suggested that a power injector should also be included in the standard contrast imaging supply package. Commenters also noted that CMS provided limited information regarding how the prices were assigned to the supply items, and pointed to discrepancies between the direct PE database files and the prices quoted in the table.

Response: We appreciate commenters' support for our proposal. We note that the RUC recommendation for the standard contrast imaging supply package also noted that the inputs for CTA and MRA studies would include the standard contrast imaging supply pack in addition to a stop cock (SC050) and additional tubing. While we acknowledge a commenter's suggestion that additional items may be used when echocardiography labs conduct contrast-enhanced ultrasound studies, we do not have information to suggest that these items are used for other imaging studies, such as CT and MRI contrast-enhanced studies. We would welcome more information on whether these items should be included in the newly created standard contrast imaging kit, as well as whether the power injector is used whenever the other inputs in the standard contrast imaging supply package are used, or whether they are used only in certain instances. We note that the reason for the discrepancy in the price for the IV starter kit is that we proposed to update the price at the same time that we proposed to create a new contrast imaging kit. Since we are finalizing the price update for SA019 (kit, IV starter), we are also finalizing a revised price for the new standard contrast imaging package of $7.06. Finally, we disagree with the commenter's suggestion that CMS provided limited information about the pricing for the items included in the kit, as these items are existing inputs in the direct PE database, and the codes associated with these items were listed in the table in the proposed rule. After consideration of comments received, we are finalizing our proposal to create a standard contrast imaging supply pack, with a revised price of $7.06.

j. Direct PE Inputs for Stereotactic Radiosurgery (SRS) Services (CPT Codes 77372 and 77373)

In the CY 2014 PFS final rule with comment period (78 FR 74245), we summarized comments received about whether CPT codes 77372 and 77373 would accurately reflect the resources used in furnishing the typical SRS delivery if there were no coding distinction between robotic and non-robotic delivery methods. Until now, SRS services furnished using robotic methods were billed using contractor-priced G-codes G0339 (Image-guided robotic linear accelerator based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment), and G0340 (Image-guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment). We indicated that we would consider deleting these codes in future rulemaking.

Most commenters responded that the CPT codes accurately described both services, and the RUC stated that the direct PE inputs for the CPT codes accurately accounted for the resource costs of the described services. One commenter objected to the deletion of the G-codes but did not include any information to suggest that the CPT codes did not describe the services or that the direct PE inputs for the CPT codes were inaccurate. Based on a review of the comments received, we had no indication that the direct PE inputs included in the CPT codes would not reflect the typical resource inputs involved in furnishing an SRS service. Therefore, in the CY 2014 proposed rule we proposed to recognize only the CPT codes for SRS services, and to delete the G-codes used to report robotic delivery of SRS.

Comment: We received several comments regarding our proposal to delete the SRS G-codes. Some commenters supported our proposal, but most opposed our proposal on the grounds that the direct PE inputs included in the CPT codes do not reflect the typical resource inputs used in furnishing robotic SRS services. Some commenters urged CMS to delay this policy change and continue to contractor price the G-codes until a more appropriate solution can be found.

Response: After consideration of the comments regarding the appropriate inputs to use in pricing the SRS services, we have concluded that at this time, we lack sufficient information to make a determination about the appropriateness of deleting the G-codes and paying for all SRS/SBRT services using the CPT codes. Therefore, we will not delete the G-codes for 2015, but will instead work with stakeholders to identify an alternate approach and reconsider this issue in future rulemaking.

k. Inclusion of Capnograph for Pediatric Polysomnography Services

We proposed to include equipment item EQ358, Sleep capnograph, polysomnography (pediatric), for CPT codes 95782 (Polysomnography; younger than 6 years, sleep staging with Start Printed Page 675684 or more additional parameters of sleep, attended by a technologist) and 95783 (Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist). Based upon our understanding that capnography is a required element of sleep studies for patients younger than 6 years, we proposed to allocate this equipment item to 95782 for 602 minutes, and 95783 for 647 minutes. Based on the invoice we received for this equipment item, we proposed to price EQ358 at $4,534.23.

Comment: We received two comments in support of our proposal to include the capnograph in CPT codes 95782 and 95783.

Response: We appreciate commenters' support for our proposal. After consideration of comments received, we are finalizing our proposal to include the capnograph in CPT codes 95782 and 95783.

4. Using OPPS and ASC Rates in Developing PE RVUs

Accurate and reliable pricing information for both individual items and indirect PEs is critical to establish accurate PE RVUs for PFS services. As we have addressed in previous rulemaking, we have serious concerns regarding the accuracy of some of the information we use in developing PE RVUs. In particular, as discussed in the CY 2014 PFS final rule with comment period, we have several longstanding concerns regarding the accuracy of direct PE inputs, including both items and procedure time assumptions, and prices of individual supplies and equipment (78 FR 74248-74250). In addition to the concerns regarding the inputs used in valuing particular procedures, we also noted that the allocation of indirect PE is based on information collected several years ago (as described above) and will likely need to be updated in the coming years.

To mitigate the impact of some of these potentially problematic data used in developing values for individual services, in rulemaking for the CY 2014 PFS, we proposed to limit the nonfacility PE RVUs for individual codes so that the total nonfacility PFS payment amount would not exceed the total combined amount that Medicare would pay for the same code in the facility setting. In developing the proposal, we sought a reliable means for Medicare to set upper payment limits for office-based procedures and believed OPPS and ASC payment rates would provide an appropriate comparison because these rates are based on relatively more reliable cost information in settings with cost structures that generally would be expected to be higher than in the office setting.

We received many comments regarding our proposal, the vast majority of which urged us to withdraw the proposal. Some commenters questioned the validity of our assumption that facilities' costs for providing all services are necessarily higher than the costs of physician offices or other nonfacility settings. Other commenters expressed serious concerns with the asymmetrical comparisons between PFS payment amounts and OPPS/ASC payment amounts. Finally, many commenters suggested revisions to technical aspects of our proposed policy.

In considering all the comments, however, we were persuaded that the comparison of OPPS (or ASC) payment amounts to PFS payment amounts for particular procedures is not the most appropriate or effective approach to ensuring that PFS payment rates are based on accurate cost assumptions. Commenters noted several flaws with the approach. First, unlike PFS payments, OPPS and ASC payments for individual services are grouped into rates that reflect the costs of a range of services. Second, commenters suggested that since the ASC rates reflect the OPPS relative weights to determine payment rates under the ASC payment system, and are not based on cost information collected from ASCs, the ASC rates should not be used in the proposed policy. For these and other reasons raised by commenters, we did not propose a similar policy for the CY 2015 PFS. If we consider using OPPS or ASC payment rates in developing PFS PE RVUs in future rulemaking, we would consider all of the comments received regarding the technical application of the previous proposal.

After thorough consideration of the comments regarding the CY 2014 proposal, we continue to believe that there are various possibilities for leveraging the use of available hospital cost data in the PE RVU methodology to ensure that the relative costs for PFS services are developed using data that is auditable and comprehensively and regularly updated. Although some commenters questioned the premise that the hospital cost data are more accurate than the information used to establish PE RVUs, we continue to believe that the routinely updated, auditable resource cost information submitted contemporaneously by a wide array of providers across the country is a valid reflection of “relative” resources and could be useful to supplement the resource cost information developed under our current methodology based upon a typical case that are developed with information from a small number of representative practitioners for a small percentage of codes in any particular year.

Section 220(a)(1) of the PAMA added a new subparagraph (M) under section 1848(c)(2) of the Act that gives us authority to collect information on resources used to furnish services from eligible professionals (including physicians, non-physician practitioners, PTs, OTs, SLPs and qualified audiologists), and other sources. It also authorizes us to pay eligible professionals for submitting solicited information. We will be exploring ways of collecting better and updated resource data from physician practices, including those that are provider-based, and other non-facility entities paid through the PFS. We believe such efforts will be challenging given the wide variety of practices, and that any effort will likely impose some burden on eligible professionals paid through the PFS regardless of the scope and manner of data collection. Currently, through one of the validation contracts discussed in section II.B. of this final rule with comment period, we have been gathering time data directly from physician practices. Through this project, we have learned much about the challenges for both CMS and the eligible professionals of collecting data directly from practices. Our own experience has shown that is difficult to obtain invoices for supply and equipment items that we can use in pricing direct PE inputs.

Many specialty societies also have noted the challenges in obtaining recent invoices for medical supplies and equipment (78 FR 74249). Further, PE calculations rely heavily on information from the Physician Practice Expense Information Survey (PPIS) survey, which, as discussed earlier, was conducted in 2007 and 2008. When we implemented the results of the survey, 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.

In addition to data collection, section 1848(c)(2)(M) of the Act as added by section 220(a) of the PAMA provides authority to develop and use alternative approaches to establish PE relative values, including the use of data from other suppliers and providers of services. We are exploring the best approaches for exercising this authority, including with respect to use of hospital outpatient cost data. We understand that Start Printed Page 67569many stakeholders will have concerns regarding the possibility of using hospital outpatient cost data in developing PE RVUs under the PFS, and we want to be sure we are aware of these prior to considering or developing any future proposal relying on those data.

Therefore, in the CY 2015 PFS proposed rule (79 FR 40333), we sought comment on the possible uses of the Medicare hospital outpatient cost data (not the APC payment amount) in potential revisions of the PFS PE methodology. This could be as a means to validate or, perhaps, in setting the relative resource cost assumptions within the PFS PE methodology. We noted that the resulting PFS payment amounts would not necessarily conform to OPPS payment amounts since OPPS payments are grouped into APCs, while PFS payments would continue to be valued individually and would remain subject to the relativity inherent in establishing PE RVUs, budget neutrality adjustments, and PFS updates. We expressed particular interest in comments that compare such possibilities to other broad-based, auditable, mechanisms for data collection, including any we might consider under the authority provided under section 220(a) of the PAMA. We urged commenters to consider a wide range of options for gathering and using the data, including using the data to validate or set resource assumptions for only a subset of PFS services, or as a base amount to be adjusted by code or specialty-level recommended adjustments, or other potential uses. We appreciate the many thoughtful comments that we received on whether and how to use the OPPS cost data in establishing PE relative values. We will consider these as we continue to think about mechanisms to improve the accuracy of PE values.

In addition to soliciting comments as noted above, in the CY 2015 proposed rule we stated that we continue to seek a better understanding regarding the growing trend toward hospital acquisition of physicians' offices and how the subsequent treatment of those locations as off-campus provider-based outpatient departments affects payments under PFS and beneficiary cost-sharing. MedPAC continues to question the appropriateness of increased Medicare payment and beneficiary cost-sharing when physicians' offices become hospital outpatient departments, and to recommend that Medicare pay selected hospital outpatient services at PFS rates (MedPAC March 2012 and June 2013 Report to Congress). We noted that we also remain concerned about the validity of the resource data as more physician practices become provider-based. Our survey data reflects the PE costs for particular PFS specialties, including a proportion of practices that may have become provider-based since the survey was conducted. Additionally, as the proportion of provider-based offices varies among physician specialties, so do the relative accuracy of the PE survey data. Our current PE methodology primarily distinguishes between the resources involved in furnishing services in two sites of service: The non-facility setting and the facility setting. In principle, when services are furnished in the non-facility setting, the costs associated with furnishing services include all direct and indirect PEs associated with the work and the PE of the service. In contrast, when services are furnished in the facility setting, some costs that would be PEs in the office setting are incurred by the facility. Medicare makes a separate payment to the facility to account for some portion of these costs, and we adjust PEs accordingly under the PFS. As more physician practices become hospital-based, it is difficult to know which PE costs typically are actually incurred by the physician, which are incurred by the hospital, and whether our bifurcated site-of service differential adequately accounts for the typical resource costs given these relationships. We also have discussed this issue as it relates to accurate valuation of visits within the postoperative period of 10- and 90-day global codes in section II.B.4 of this final rule with comment period.

To understand how this trend is affecting Medicare, including the accuracy of payments made through the PFS, we need to develop data to assess the extent to which this shift toward hospital-based physician practices is occurring. To that end, during CY 2014 rulemaking we sought comment regarding the best method for collecting information that would allow us to analyze the frequency, type, and payment for services furnished in off-campus provider-based hospital departments (78 FR 74427). We received many thoughtful comments. However, the commenters did not present a consensus opinion regarding the options we presented in last year's rule. Based on our analysis of the comments, we stated that we believed the most efficient and equitable means of gathering this important information across two different payment systems would be to create a HCPCS modifier to be reported with every code for physicians' and hospital services furnished in an off-campus provider-based department of a hospital.

We proposed that the modifier would be reported on both the CMS-1500 claim form for physicians' services and the UB-04 (CMS form 1450) for hospital outpatient claims. (We note that the requirements for a determination that a facility or an organization has provider-based status are specified in § 413.65, and we define a hospital campus to be the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office.)

Therefore, we proposed to collect this information on the type and frequency of services furnished in off-campus provider-based departments in accordance with our authority under section 1848(c)(2)(M) of the Act (as added by section 220(a) of the PAMA) beginning January 1, 2015. The collection of this information would allow us to begin to assess the accuracy of the PE data, including both the service-level direct PE inputs and the specialty-level indirect PE information that we currently use to value PFS services. Furthermore, this information would be critical in order to develop proposed improvements to our PE data or methodology that would appropriately account for the different resource costs among traditional office, facility, and off-campus provider-based settings. We also sought additional comment on whether a code modifier is the best mechanism for collecting this service-level information.

Comment: Many commenters agreed on the need to collect information on the frequency, type, and payment of services furnished in off-campus provider-based departments of hospitals, however, several commenters expressed concern that the HCPCS modifier would create additional administrative burden for providers. Many of these commenters stated that the new modifier would require significant changes to hospitals' billing systems, including a separate charge master for outpatient off-campus PBDs and training for staff on how to use the new modifier. Several commenters thought that education and training would be required for physician offices to attach a modifier to services furnished in an off-campus provider-based department. These same commenters suggested that a new place of service (POS) code would be more appropriate for physician billing. Several commenters suggested that CMS Start Printed Page 67570should re-propose a detailed data collection methodology, test it with providers, make adjustments, and allow additional time for implementation.

Response: While we understand commenters' concerns about the additional administrative burden of reporting a new HCPCS modifier, we have weighed the burden of reporting the modifier for each service against the benefit of having data that will allow us to obtain and assess accurate information on the type and frequency of outpatient hospital services furnished in off-campus provider-based departments, and we do not believe that the modifier is excessively burdensome for providers to report. When billing for hospital services, providers must know where services are furnished in order to accurately complete value code 78 of an outpatient claim or item 32 for service location on the practitioner claim. However, as discussed later in this section, we agree that a POS code on the professional claim allows for the same type of data collection as a modifier and would be less burdensome than the modifier for practitioners. We discuss the timeframe for implementation later in this section.

Comment: Some commenters who were concerned about the administrative burden of the new HCPCS modifier suggested several alternative methods for CMS to collect data on services furnished in off-campus provider-based departments. Several of these commenters recommended that CMS consider establishing of a new POS code for professional claims, or for both professional and hospital claims, because they believed this approach would be less administratively burdensome than attaching a modifier to each service reported on the claim that was furnished in an off-campus provider-based department. Some commenters preferred identifying services furnished in provider-based departments on the Medicare cost report (CMS-2552-10). Some commenters suggested using provider numbers and addresses to identify off-campus PBDs, or changing the provider enrollment process to be able to track this data. Yet other commenters suggested creating a new bill type to track off-campus PBD services.

Commenters generally recommended that CMS choose the least administratively burdensome approach that would ensure accurate data collection, but did not necessarily agree on what approach would optimally achieve that result. Some commenters believed that a HCPCS modifier would more clearly identify specific services furnished at off-campus PBDs, and would provide better information about the type and level of care furnished. Some commenters believed that a HCPCS modifier would be the least administratively burdensome approach because hospitals and physicians already report a number of claims-based modifiers. However, other commenters stated that additional modifiers would increase administrative burden because this approach would increase the modifiers that would need to be considered when billing.

Response: With respect to creating a new POS code to obtain data on services furnished in off-campus PBDs of a hospital, we note that POS codes are only reported on professional claims and are not included on institutional claims. Therefore, a POS code could not be easily implemented for hospital claims. However, POS codes are already required to be reported on every professional claim, and POS 22 is currently used when physicians' services are furnished in an outpatient hospital department. (More information on existing POS codes is available on the CMS Web site at http://www.cms.gov/​Medicare/​Coding/​place-of-service-codes/​Place_​of_​Service_​Code_​Set.html).

Though we considered proposing a new POS code for professional claims to collect data on services furnished in the off-campus hospital setting, we note that previous GAO and OIG reports (October 2004 A-05-04-0025, January 2005 A-06-04-00046, July 2010 A-01-09-00503, September 2011 A-01-10-00516) have noted frequent inaccuracies in the reporting of POS codes. Additionally, at the time the proposed rule was developed, we had concerns that using a POS code to report this information might not give us the reliable data we are looking to collect, especially if such data were to be cross-walked with hospital claims for the same service, since the hospital claim would have a modifier, not a POS code. However, we have been persuaded by public comments suggesting that use of a POS code on professional claims would be less administratively burdensome than use of a modifier, and would be more familiar to those involved in practitioner billing. Specifically, since a POS code is already required on every professional claim, we believe that creating a new POS code to distinguish outpatient hospital services that are furnished on the hospital campus versus in an off-campus provider-based department would require less staff training and education than would the use of a modifier on the professional claim. Additionally, professional claims only have space for four modifiers; while a very small percentage of professional claims have four modifiers, required use of an additional modifier for every professional claim could lead to more occurrences where there would not be space for all applicable payment modifiers for a specific service. Unlike institutional claims, we note that a new professional claim is required whenever the place of service changes. That is, even if the same practitioner treats the same patient on the same day in the office and the hospital, the services furnished in the office setting must be submitted on one claim with POS 11 (Office), while those furnished in the outpatient hospital department would be submitted on a separate claim with POS 22 (Outpatient Hospital). Likewise, if a new POS code were to be created for off-campus outpatient provider-based hospital department, a separate claim for services furnished in that setting would be required relative to a claim for outpatient services furnished on the hospital's main campus by the same practitioner to the same patient on the same day. Based on public comments and after further consultation with Medicare billing experts, we believe that use of the POS code on professional claims would be no less accurate than use of a modifier on professional claims in identifying services furnished in off-campus PBDs. In addition, we believe that the POS code would be less administratively burdensome for practitioners billing using the professional claim since a POS code is already required for every professional claim.

With respect to adding new fields to existing claim forms or creating a new bill type, we do not believe that this data collection warrants these measures. We believe that those changes would create greater administrative burden than the proposed HCPCS modifier and POS codes, especially since providers are already accustomed to using modifiers and POS codes. Revisions to the claim form to add new fields or an additional bill type would create significant administrative burden to revise claims processing systems and educate providers that is not necessary given the availability of a modifier and POS codes. Though providers may not be familiar with this new modifier or any new POS code; since these types of codes already exist generally for hospital and professional claims, providers and suppliers should already have an understanding of these types of codes and how to apply them. Finally, we do not believe that expansions to the claim form or use of a new bill type Start Printed Page 67571would provide us with detailed information on exactly which services were furnished in an off-campus PBD versus those furnished on the main campus when those services are furnished on the same day.

We also do not believe that we could accurately determine which services are furnished at off-campus provider-base departments (PBDs) using currently available NPI and facility address data. Hospitals are required to report the nine-digit ZIP code indicating where a service was furnished for purposes of paying properly for physician and anesthesia services paid off the PFS when that ZIP code differs from the master address for the hospital on file in CMS claims systems in value code 78 (pub 100-04, transmittal 1681, February 13, 2009). However, the billing ZIP code for the hospital main campus could be broad enough to incorporate on and off-campus provider-based departments. Further, a ZIP code reported in value code 78 does not allow CMS to distinguish between services furnished in different locations on the same date. Therefore, we do not believe that a comparison of the ZIP code captured in value code 78 and the main campus ZIP code is sufficiently precise.

Finally, while we considered the suggestion that CMS use currently reported Medicare hospital cost report (CMS-2552-10) data to identify services furnished at off-campus PBDs, we note that though aggregate data on services furnished in different settings must be reported through the appropriate cost center, we would not be able to obtain the service-specific level of detail that we would be able to obtain from claims data.

We will take under consideration the suggestion that CMS create a way for hospitals to report their acquisition of physician offices as off-campus PBDs through the enrollment process, although this information, as currently reported, would not allow us to know exactly which services are furnished in off-campus provider based departments and which services are furnished on the hospital's main campus when a hospital provides both on the same day.

Comment: Commenters noted that the proposed modifier would not allow CMS to know the precise location of the off-campus provider-based department for billed services or when services are furnished at different off-campus provider-based locations in the same day.

Response: We agree that neither the proposed modifier nor a POS code provides details on the specific provider-based location for each furnished service. However, we believe that collecting information on the type and frequency of services furnished at all off-campus locations will assist CMS in better understanding the distribution of services between on and off-campus locations.

Comment: MedPAC believed there may be some value in collecting data on services furnished in off-campus provider-based departments to validate the accuracy of site-of-service reporting when the physician's office is off-campus but bills as an outpatient department. MedPAC indicated that any data collection effort should not prevent the development of policies to align payment rates across settings. MedPAC encouraged CMS to seek legislative authority to set equal payment rates across settings for evaluation and management office visits and other select services.

Response: We thank MedPAC for its support of our data collection efforts to learn more about the frequency and types of services that are being furnished in off-campus PBDs.

Comment: Many commenters suggested that providers would not be able to accurately apply the new modifier by the January 1, 2015 implementation timeline and recommended a one-year delay before providers would be required to apply the modifier to services furnished at off-campus PBDs. Some commenters requested only a six-month delay in implementation. Commenters indicated that significant revisions to internal billing processes would require additional time to implement.

Response: Though we believe that the January 1st effective date that applies to most policies adopted in the final rules with comment period for both the PFS and the OPPS would provide sufficient lead time, we understand commenters' concerns with the proposed timeline for implementation given that the new reporting requirements may require changes to billing systems as well as education and training for staff. With respect to the POS code for professional claims, we will request two new POS codes to replace POS code 22 (Hospital Outpatient) through the POS Workgroup and expect that it will take some time for these new codes to be established. Once the revised POS codes are ready and integrated into CMS claims systems, practitioners would be required to use them, as applicable. More information on the availability of the new POS codes will be forthcoming in subregulatory guidance, but we do not expect the new codes to be available prior to July 1, 2015. There will be no voluntary reporting period of the POS codes for applicable professional claims because each professional claim requires a POS code in order to be accepted by Medicare. However, we do not view this to be problematic because we intend to give prior notice on the POS coding changes and, as many public commenters noted, because practitioners are already accustomed to using a POS on every claim they submit.

We also are finalizing our proposal to create a HCPCs modifier for hospital services furnished in an off-campus PBD setting; but we are adopting a voluntary reporting period for the new HCPCS modifier for one year. That is, reporting the new HCPCS modifier for services furnished at an off-campus PBD will not be mandatory until January 1, 2016, in order to allow providers time to make systems changes, test these changes, and train staff on use of the new modifier before reporting is required. We welcome early reporting of the modifier and believe a full year of preparation should provide hospitals with sufficient time to modify their systems for accurate reporting.

Comment: Many commenters expressed concern that this data collection would eventually lead to equalizing payment for similar services furnished in the non-facility setting and the off-campus PBD setting. Several commenters noted that the trend of hospitals acquiring physician practices is due to efforts to better integrate care delivery, and suggested that CMS weigh the benefits of care integration when deciding payment changes. Some commenters suggested that CMS should use the data to equalize payment for similar services between these two settings. These commenters suggest that there is little difference in costs and care between the two settings that would warrant the difference in payment. Several of these commenters highlighted beneficiary cost sharing as one reason for site-neutral payment, noting that the total payment amount for hospital outpatient services is generally higher than the total payment amount for those same services when furnished in a physician's office.

Response: We appreciate the comments received. At this time, we are only finalizing a data collection in this final rule with comment period. We did not propose, and therefore, are not finalizing any adjustment to payments furnished in the off-campus PBD setting.

Comment: Several commenters noted that the CMS proposal would not provide additional information on how a physician practice billed prior to becoming an off-campus PBD, which would be important for analyzing the impact of this trend.Start Printed Page 67572

Response: We agree that, in analyzing the impact of this trend, it is important to understand physician billing patterns that were in place prior to becoming an off-campus PBD, and we will continue to evaluate ways to analyze claims data to gather this information. We believe that collecting data using the additional modifier and POS code as finalized in this rule will be an important tool in furthering this analysis.

Comment: Some commenters suggested that the term “off-campus” needs to be better defined. Commenters asked how billing would occur for hospitals with multiple campuses since the CMS definition of campus references main buildings and does not include remote locations. One commenter also asked whether the modifier is intended to cover services furnished in free-standing emergency departments.

Response: For purposes of the modifier and the POS codes we are finalizing in this final rule with comment period, we define a “campus” using the definition at § 413.65(a)(2) to be the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office, to be part of the provider's campus. We agree with commenters that our intent is to capture data on outpatient services furnished off of the hospital's main campus and off of any of the hospital's other campuses. The term “remote location of a hospital” is defined in our regulations at section 413.65(a)(2). Under the regulation, a “remote location” includes a hospital campus other than the main hospital campus. Specifically, a remote location is “a facility or an organization that is either created by, or acquired by, a hospital that is a main provider for the purposes of furnishing inpatient hospital services under the name, ownership, and financial and administrative control of the main provider . . . .” Therefore, we agree with the commenters that the new HCPCS modifier and the POS code for off-campus PBDs should not be reported for services furnished in remote locations of a hospital. The term “remote location” does not include “satellite” locations of a hospital. However, since a satellite facility is one that provides inpatient services in a building also used by another hospital, or in one or more entire buildings located on the same campus as buildings used by another hospital, the new HCPCS modifier and the POS code for off-campus hospital PBDs should not be reported for services furnished in satellite facilities. Satellite facilities are described in our regulations at § 412.22(h). Accordingly, reporting of the modifier and the POS code that identifies an off-campus hospital PBD would be required for outpatient services furnished in PBDs that are located beyond 250 yards from the main campus of the hospital, excluding services furnished in a remote location or satellite facility of the hospital.

We also appreciate the comment on emergency departments. We do not intend for hospitals to report the new modifier for services furnished in emergency departments. We note that there is already a POS code for the emergency department, POS 23 (emergency room-hospital), and this would continue to be used on professional claims for services furnished in emergency departments. That is, the new POS code for off-campus hospital PBDs that will be created for purposes of this data collection would not apply to emergency department services. Hospitals and practitioners that have questions about which departments are considered to be “off-campus PBDs” should review additional guidance that CMS releases on this policy and work with the appropriate CMS regional office if individual, specific questions remain.

Comment: Several commenters asked for clarification on when to report the modifier for services furnished both on and off-campus on the same day. Commenters provided several scenarios of visits and diagnostic services furnished on the same day.

Response: The location where the service is actually furnished would dictate the use of the modifier and the POS codes, regardless of where the order for services is initiated. We expect the modifier and the POS code for off-campus PBDs to be reported in locations in which the hospital expends resources to furnish the service in an off-campus PBD setting. For example, hospitals would not report the modifier for a diagnostic test that is ordered by a practitioner who is located in an off-campus PBD when the service is actually furnished on the main campus of the hospital. This issue does not impact use of the POS codes since practitioners submit a different claim for each POS where they furnish services for a specific beneficiary.

Comment: A few commenters asked for clarification on whether their entity constitutes a provider-based department.

Response: Provider-based departments are departments of the hospital that meet the criteria in § 413.65.

Comment: A commenter recommended that CMS publish the data it acquires through adoption of this modifier.

Response: Data collected through the new HCPCS modifier would be part of the Medicare Limited Data Set and would be available to the public for purchase along with the rest of the Limited Data Set. Similarly, professional claims data with revised POS coding would be available as a standard analytic file for purchase.

In summary, after consideration of the comments received, we are finalizing our proposal with modifications. For professional claims, instead of finalizing a HCPCS modifier, in response to comments, we will be deleting current POS code 22 (outpatient hospital department) and establishing two new POS codes—one to identify outpatient services furnished in on-campus, remote or satellite locations of a hospital, and another to identify services furnished in an off-campus hospital PBD setting that is not a remote location of a hospital, a satellite location of a hospital or a hospital emergency department. We will maintain the separate POS code 23 (emergency room-hospital) to identify services furnished in an emergency department of the hospital. These new POS codes will be required to be reported as soon as they become available, however advance notice of the availability of these codes will be shared publicly as soon as practicable.

For hospital claims, we are creating a HCPCS modifier that is to be reported with every code for outpatient hospital services furnished in an off-campus PBD of a hospital. This code will not be required to be reported for remote locations of a hospital defined at § 412.65, satellite facilities of a hospital defined at § 412.22(h) or for services furnished in an emergency department. This 2-digit modifier will be added to the HCPCS annual file as of January 1, 2015, with the label “PO,” the short descriptor “Serv/proc off-campus pbd,” and the long descriptor “Services, procedures and/or surgeries furnished at off-campus provider-based outpatient departments.” Reporting of this new modifier will be voluntary for 1 year (CY 2015), with reporting required beginning on January 1, 2016. Additional instruction and provider education will be forthcoming in subregulatory guidance.Start Printed Page 67573

B. Potentially Misvalued Services Under the Physician Fee Schedule

1. Valuing Services Under the PFS

Section 1848(c) of the Act requires the Secretary to determine relative values for physicians' services based on three components: Work, PE, and malpractice. Section 1848(c)(1)(A) of the Act defines the work component to mean, “the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service.” In addition, section 1848(c)(2)(C)(i) of the Act specifies that “the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating physician time and intensity required in furnishing the service.”

Section 1848(c)(1)(B) of the Act defines the PE component as “the portion of the resources used in furnishing the service that reflects the general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses.” Section 1848(c)(2)(C)(ii) of the Act requires that PE RVUs be determined based upon the relative PE resources involved in furnishing the service. (See section II.A. of this final rule with comment period for more detail on the PE component.)

Section 1848(c)(1)(C) of the Act defines the MP component as “the portion of the resources used in furnishing the service that reflects malpractice expenses in furnishing the service.” Section 1848(c)(2)(C)(iii) of the Act specifies that MP expense RVUs shall be determined based on the relative MP expense resources involved in furnishing the service. (See section II.C. of this final rule with comment period for more detail on the MP component.)

2. Identifying, Reviewing, and Validating the RVUs of Potentially Misvalued Services

a. 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) of 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 I.B. of this final rule with comment period, 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 Initiative (PQRI) 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. 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, in addition to taking into account the results of consultations with organizations representing physicians. 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, MedPAC discussed the importance of appropriately valuing physicians' services, noting that “misvalued services can distort the price signals 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, in the intervening years since MedPAC made its initial recommendations, “CMS and the RUC have taken several steps to improve the review process.” Also, since that time the Congress added section 1848(c)(2)(K)(ii) to the Act, which augments our efforts. It directs the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following seven categories:

  • Codes and families of codes for which there has been the fastest growth;
  • Codes and families of codes that have experienced substantial changes in PEs;
  • Codes that are recently established for new technologies or services;
  • 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 which have not been subject to review since the implementation of the RBRVS (the so-called `Harvard-valued codes'); and
  • Other codes determined to be appropriate by the Secretary.

Section 220(c) of the Protecting Access to Medicare Act of 2014 (PAMA) further expanded the categories of codes that the Secretary is directed to examine by adding nine additional categories. These are:

  • Codes that account for the majority of spending under the PFS;
  • 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;Start Printed Page 67574
  • 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 PE RVUs; and
  • Codes with high cost supplies.

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 of the Act 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 any 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.

b. 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 as authorized by statute over the coming 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 1,250 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 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 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, we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 (76 FR 32410). In the CY 2013 final rule with comment period, we identified 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 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 2014 final rule with comment period, we finalized for review a list of potentially misvalued services. We included on the list for review ultrasound guidance codes that had longer procedure times than the typical procedure with which the code is billed to Medicare. We also finalized our proposal to replace missing post-operative hospital E/M visit information and work time for approximately 100 global surgery codes. For CY 2014, we also considered a proposal to limit PFS payments for services furnished in a nonfacility setting when the nonfacility PFS payment for a given service exceeds the combined Medicare Part B payment for the same service when it is furnished in a facility (separate payments being made to the practitioner under the PFS and to the facility under the OPPS). Based upon extensive public comment, we did not finalize this proposal. We address our current consideration of the potential use of OPPS data in establishing RVUs for PFS services, as well as comments received, in section II.B. of this final rule with comment period.

c. 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 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. We provided a summary of the comments along with our responses in the CY 2011 PFS final rule with comment period (75 FR 73217) and the CY 2012 PFS final rule with comment period (76 FR 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 collect time data from several practices for services selected by the contractor in consultation with CMS. These data will be used to develop time estimates. The Urban Institute will use a variety of approaches to develop objective time estimates, depending on the type of service. Objective time estimates will be compared to the current time values used in the fee schedule. The project team will then convene groups of physicians from a Start Printed Page 67575range of specialties to review the new time data and their potential implications for work and the ratio of work to time. The Urban Institute has prepared an interim report, Development of a Model for the Valuation of Work Relative Value Units, which discusses the challenges encountered in collecting objective time data and offers some thoughts on how these can be overcome. This interim report is available on the CMS Web site at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Downloads/​RVUs-Validation-UrbanInterimReport.pdf. Collection of time data under this project has just begun. A final report will be available once the project is complete.

The second contract is with the RAND Corporation, which is using 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 will use a representative set of CMS-provided codes to test the model. RAND consulted with a technical expert panel on model design issues and the test results. We anticipate a report from this project by the end of the year and will make the report available on the CMS Web site.

Descriptions of both projects are available on the CMS Web site at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Downloads/​RVUs-Validation-Model.pdf.

We acknowledge comments received regarding the Urban Institute and RAND projects, but note that we did not solicit comments on these projects because we made no proposals related to them. Any changes to payment policies under the PFS that we might make after considering these reports would be issued in a proposed rule and subjected to public comment before they would be finalized and implemented.

3. CY 2015 Identification and Review of Potentially Misvalued Services

a. Public Nomination of Potentially Misvalued Codes

In the CY 2012 PFS final rule with comment period, we finalized a process for the public to nominate potentially misvalued codes (76 FR 73058). The public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation during the 60-day public comment period following the release of the annual PFS final rule with comment period. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

  • Documentation in the peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following: Technique; knowledge and technology; patient population; site-of-service; length of hospital stay; and work time.
  • An anomalous relationship between the code being proposed for review and other codes.
  • Evidence that technology has changed physician work, that is, diffusion of technology.
  • Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
  • Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.
  • Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
  • Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA NSQIP, STS National Database, and the PQRS databases).
  • National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.

After we receive the nominated codes during the 60-day comment period following the release of the annual PFS final rule with comment period, we evaluate the supporting documentation and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate whether we are proposing each nominated code as a potentially misvalued code.

During the comment period to the CY 2014 final rule with comment period, we received nominations and supporting documentation for four codes to be considered as potentially misvalued codes. Although we evaluated the supporting documentation for two of the nominated codes to ascertain whether the submitted information demonstrated that the code should be proposed as potentially misvalued, we did not identify the other two codes until after the publication of the proposed rule. We apologize for this oversight and will address the nomination of CPT codes 92227 and 92228 in the proposed rule for CY 2016.

We proposed CPT code 41530 (submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session) as potentially misvalued based on public nomination due to a significant decrease in two of the direct PE inputs.

Comment: The commenter that nominated this code as potentially misvalued thanked CMS for proposing this code as potentially misvalued, but indicated that the RUC had made recommendations for this code for CY 2015 and further review was no longer necessary. Another commenter suggested that this code should be removed from the list of potentially misvalued codes since it saves Medicare millions of dollars per year.

Response: The RUC only provided us with recommendations for PE inputs for CPT code 41530. Under our usual process, we value work and PE at the same time and would expect to receive RUC recommendations on both before we revalue this service. We disagree with the commenter's statement that codes that may save money for the Medicare program should not be considered as potentially misvalued. Our aim, consistent with our statutory directive, is to value all services appropriately under the PFS to reflect the relative resources involved in furnishing them. After consideration of public comments, we are finalizing CPT code 41530 as potentially misvalued.

We did not propose CPT code 99174 (instrument-based ocular screening (for example, photoscreening, automated-refraction), bilateral) as potentially misvalued, because it is a non-covered service, and we only consider nominations of active codes that are covered by Medicare at the time of the nomination (see 76 FR 73059).

Comment: Commenters did not disagree with CMS not proposing this code as potentially misvalued, but did raise a variety of comments about the code that were unrelated to our proposal.

Response: We continue to believe that our policy to limit the designation of potentially misvalued to those codes that are covered by Medicare is appropriate, so that we focus our limited resources on those services that have an impact on the Medicare program and its beneficiaries. Therefore, we are not including CPT code 99174 on Start Printed Page 67576our final list of potentially misvalued codes for CY 2015.

b. Potentially Misvalued Codes

(1) Review of High Expenditure Services Across Specialties With Medicare Allowed Charges of $10,000,000 or More

We proposed 68 codes listed in Table 11 as potentially misvalued codes under the newly established statutory category, “codes that account for the majority of spending under the physician fee schedule.” To develop this list, we identified the top 20 codes by specialty (using the specialties used in Table 11) in terms of allowed charges. We excluded those codes that we have reviewed since CY 2009, those codes with fewer than $10 million in allowed charges, and E/M services. E/M services were excluded for the same reason that we excluded them in a similar review for CY 2012. The reason was explained in the CY 2012 final rule with comment period (76 FR 73062 through 73065).

We stated that we believed that a review of the codes in Table 11 is warranted to assess changes in physician work and to update direct PE inputs since these codes have not been reviewed since CY 2009 or earlier. Furthermore, since these codes have significant impact on PFS payment at the specialty level, a review of the relativity of the codes is essential to ensure that the work and PE RVUs are appropriately relative within the specialty and across specialties, as discussed previously. For these reasons, we proposed the codes listed in Table 11 as potentially misvalued.

Table 11—Potentially Misvalued Codes Identified Through the High Expenditure by Specialty Screen

HCPCSShort descriptor
11100Biopsy skin lesion.
11101Biopsy skin add-on.
11730Removal of nail plate.
11750Removal of nail bed.
14060Tis trnfr e/n/e/l 10 sq cm/.
17110Destruct b9 lesion 1-14.
31575Diagnostic laryngoscopy.
31579Diagnostic laryngoscopy.
36215Place catheter in artery.
36475Endovenous rf 1st vein.
36478Endovenous laser 1st vein.
36870Percut thrombect av fistula.
51720Treatment of bladder lesion.
51728Cystometrogram w/vp.
51798Us urine capacity measure.
52000Cystoscopy.
55700Biopsy of prostate.
65855Laser surgery of eye.
66821After cataract laser surgery.
67228Treatment of retinal lesion.
68761Close tear duct opening.
71010Chest x-ray 1 view frontal.
71020Chest x-ray 2vw frontal&latl.
71260Ct thorax w/dye.
73560X-ray exam of knee 1 or 2.
73562X-ray exam of knee 3.
73564X-ray exam knee 4 or more.
74183Mri abdomen w/o & w/dye.
75978Repair venous blockage.
76536Us exam of head and neck.
76700Us exam abdom complete.
76770Us exam abdo back wall comp.
76775Us exam abdo back wall lim.
77263Radiation therapy planning.
77334Radiation treatment aid(s).
78452Ht muscle image spect mult.
88185Flowcytometry/tc add-on.
91110Gi tract capsule endoscopy.
92136Ophthalmic biometry.
92250Eye exam with photos.
92557Comprehensive hearing test.
93280Pm device progr eval dual.
93306Tte w/doppler complete.
93351Stress tte complete.
93978Vascular study.
94010Breathing capacity test.
95004Percut allergy skin tests.
95165Antigen therapy services.
95957Eeg digital analysis.
96101Psycho testing by psych/phys.
96118Neuropsych tst by psych/phys.
96372Ther/proph/diag inj sc/im.
96375Tx/pro/dx inj new drug addon.
96401Chemo anti-neopl sq/im.
96409Chemo iv push sngl drug.
97032Electrical stimulation.
97035Ultrasound therapy.
97110Therapeutic exercises.
97112Neuromuscular reeducation.
97113Aquatic therapy/exercises.
97116Gait training therapy.
97140Manual therapy 1/> regions.
97530Therapeutic activities.
G0283Elec stim other than wound.

Comment: Many commenters disagreed with the high expenditure screen in principle, stating that the frequency with which a service is furnished (and therefore the total expenditures) is not an indication that the service is misvalued. Specifically, commenters explained that many of the services are highly utilized because of the nature of the Medicare beneficiary population, and not because there is abuse or overutilization. Commenters asserted that the current misvalued code screens can produce a redundant list of potentially misvalued codes while failing to identify codes that are being incorrectly reported. Another commenter urged CMS to work with the RUC to ensure that the code lists identified by the misvalued code screens are accurate. A commenter asked CMS to provide justification for including codes with charges greater than $10 million on the potentially misvalued codes list. Some commenters urged us to reconsider including particular families of codes that were reviewed prior to 2009; others asked that CMS exclude all codes that have been reviewed in the last 10 years; and still others requested that we exclude codes that were bundled several years ago. A commenter stated that the emphasis on codes with spending of more than $10 million demonstrates an agenda to cut spending rather than to ensure appropriate payment, and expressed concern that CMS was simply nominating high value services. Commenters recommended that CMS not finalize its proposed list of potentially misvalued codes, and instead develop a more targeted list of codes that are likely to be misvalued (not just potentially misvalued). Commenters wanted CMS to exempt codes when there have not been fundamental changes in the way the services are furnished or there is no indication that their values are inaccurate, so that specialty societies do not have to go through the work of reviewing them.

Several commenters questioned the statutory authority for CMS's proposal. One commenter questioned CMS's authority under the relevant statute to select potentially misvalued codes by specialty. The commenter stated that identifying the top 20 codes by specialty in terms of allowed charges does not appear to align with a direct reading of the relevant statutory authority, which allows CMS to identify codes that account for the majority of spending under the PFS, but does not provide for the identification of codes by specialty. The commenter said that a more direct interpretation of the statutory authority would be to select codes based on allowed charges irrespective of specialty, and then to narrow the universe of codes based upon the top codes in terms of allowed charges. Another commenter believed the proposed screen did not comport with the statutory selection criteria because the majority or near majority of spending under the PFS is for evaluation and management (E/M) codes, which CMS excluded from review. The commenter said that if CMS believes that E/M services should not be reviewed—a position the commenter said they would certainly understand—then such a determination is sufficient to meet the statutory mandate to review codes accounting for the majority of PFS spending, and it would then be Start Printed Page 67577appropriate for CMS and the RUC to focus efforts on other categories of potentially misvalued codes. The commenter urged CMS at the very least to develop a more targeted list of potentially misvalued services in the category of codes accounting for the majority of PFS spending, and to include codes that are likely to be misvalued, not just potentially misvalued.

Response: Potentially misvalued code screens are intended to identify codes that are possibly misvalued. By definition, these screens do not assert that codes are certainly or even likely misvalued. As we discussed in the CY 2012 PFS final rule with comment period (76 FR 73056), the screens serve to focus our limited resources on categories of codes where there is a high risk of significant payment distortions. One goal is to avoid perpetuating payment for the services at a rate that does not appropriately reflect the relative resources involved in furnishing the service. In implementing this statutory provision, we consider whether the codes meeting the screening criteria have a significant impact on payment for all PFS services due to the budget neutral nature of the PFS. That is, if codes meeting the screening criteria are indeed misvalued, they would be inappropriately impacting the relative values of all PFS services. Addressing included codes therefore indirectly addresses other codes that do not meet the screening criteria but are themselves misvalued because high expenditure codes are misvalued. We agree with the commenters that high program expenditures and high utilization have varying causes and do not necessarily reflect misvalued codes. However, we continue to believe that the high expenditure screen is nevertheless an appropriate means of focusing our reviews, ensuring appropriate relativity among PFS services, and identifying services that are either over or undervalued. The high expenditure screen is likely to identify misvalued codes, both directly and indirectly.

Regarding screening for codes by specialty, as we discussed above, the included codes have significant impact on PFS payment at the specialty level, therefore a review of the relativity of the codes is essential to ensure that the work and PE RVUs are appropriately relative within the specialty and across specialties. We mentioned in the CY 2012 final rule with comment period how stakeholders have noted that many of the services previously identified under the potentially misvalued codes initiative were concentrated in certain specialties. To develop a robust and representative list of codes for review, we examine the highest PFS expenditure services by specialty and we identify those codes that have not been recently reviewed (76 FR 73060).

Although we understand commenters' concerns that the screens can produce redundant results, we note that we exempted codes that have been reviewed since 2009 for this very reason. We believe that the practice of medicine can change significantly over a 10-year period, and disagree with commenters' suggestions that no changes would occur over a 10-year period that would significantly affect a procedure's valuation.

Regarding the exclusion of E/M services, we refer the commenters to the extensive discussion in the CY 2012 PFS final rule with comment period (76 FR 73060 through 73065). It is true that E/M services account for significant volume under the PFS, but there are significant issues with reviewing these codes as discussed in the CY 2012 final rule with comment period, and as a result we did not propose to include these codes as potentially misvalued.

Comment: Some commenters suggested other screens that could be used to identify misvalued codes. In addition, even though our proposal only relates to identifying potentially misvalued codes, some commenters commented on our mechanisms for re-valuing misvalued codes.

Response: The only screen for which we made a proposal and sought comments was the high expenditure screen. However, we will consider the suggestions for other screens as we develop proposals in future years. Similarly, our proposal only related to identifying potentially misvalued codes and not how to re-value them if they were finalized as potentially misvalued.

Comment: Several commenters requested that CMS postpone the review of potentially misvalued codes until the revised process we proposed for reviewing new, revised, and potentially misvalued codes is in place.

Response: Although we believe that the revised process for reviewing new, revised, and potentially misvalued codes will improve the transparency of the PFS code review process, we do not believe it is appropriate to postpone the review of all potentially misvalued codes until the new process is implemented. We note that the codes identified in this rule as potentially misvalued would be revalued under the new process, which will be phased in starting for CY 2016 and will apply for all codes revalued for CY 2017.

Comment: Commenters raised several codes that they believed should not be included in the high expenditure screen for a variety of reasons, for example if the code is related to other codes that were recently reviewed and the utilization for the identified service is expected to change significantly as a result of coding changes in the family. Commenters also suggested that codes that have been referred to the CPT Editorial Panel should be excluded from the potentially misvalued codes list.

Response: We acknowledge commenters' suggestion that we exclude particular codes from the screen, but since we are not finalizing a particular list of codes for this screen in this final rule we are not addressing these at this time. We note that we do not agree with commenters that codes that have been referred to CPT by the RUC should be excluded from the potentially misvalued list; rather, we believe that only when these codes are either deleted or revised, and/or we receive new RUC recommendations for re-valuing these codes, would it be appropriate to remove these services from the list.

Comment: A commenter suggested that CMS's high expenditure screen may not account for the fact that many radiology codes have already gone through numerous five-year reviews; have well-established RVUs that are included on the RUC's multispecialty point of comparison (MPC) list; have been included in new, bundled codes; or have PE RVUs that were affected by changes in clinical labor times or equipment utilization assumption changes. The commenter also suggested that the screens do not account for the value that patients receive in terms of better, timelier diagnoses and avoidance of invasive procedures.

Response: We acknowledge that certain types of procedures have been identified through multiple screens; however, we continue to believe that it is appropriate to include most codes that are identified via these screens and not to exclude codes simply because many other procedures furnished by that specialty have already been reviewed. We further note that the presence of codes on the MPC list makes the case for their review more compelling, given their importance in ensuring overall relativity throughout the PFS. With respect to changes in PE RVUs, we note that cross-cutting policies that affect large numbers of codes are aimed at ensuring overall relativity but do not address the inputs associated with each procedure affected by the change. Finally, a code's status as potentially misvalued does not imply Start Printed Page 67578that the service itself is not of inherent value; rather, that its valuation may be inaccurate in either direction.

After considering the comments received, as well as the other proposals we are finalizing, we believe it is appropriate to finalize the high expenditure screen as a tool to identify potentially misvalued codes. However, given the resources required over the next several years to revalue the services with global periods, we believe it is best to concentrate our efforts on these valuations. Therefore, we are not finalizing the codes identified through the high expenditure screen as potentially misvalued at this time. Also, we are not responding to comments at this time regarding whether particular codes should or should not be included in the high expenditure code screen and identified as potentially misvalued codes. We will re-run the high expenditure screen at a future date, and will propose at that time the specific set of codes to be reviewed that meet the high expenditure criteria.

(2) Epidural Injection and Fluoroscopic Guidance—CPT Codes 62310, 62311, 62318, 62319, 77001, 77002 and 77003

For CY 2014, we established interim final rates for four epidural injection procedures, CPT codes 62310 (Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic), 62311 (Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)), 62318 (Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic) and 62319 (Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)). These interim final values resulted in CY 2014 payment reductions from the CY 2013 rates for all four procedures.

In the CY 2014 final rule with comment period (78 FR 74340), we described in detail our interim valuation of these codes. We indicated we established interim final work RVUs for these codes that were less than those recommended by the RUC because we did not believe that the RUC-recommended work RVUs accounted for the substantial decrease in time it takes to furnish these services as reflected in the RUC survey data for these four codes. Since the RUC provided no indication that the intensity of the procedures had changed, we indicated that we believed the work RVUs should reflect the reduction in time. We also established interim final direct PE inputs for these four codes based on the RUC-recommended inputs without any refinement. These recommendations included the removal of the radiographic-fluoroscopy room for CPT codes 62310, 62311, and 62318 and a portable C-arm for CPT code 62319.

In response to the comments we received objecting to the CY 2014 interim final values for these codes, we looked at other injection procedures. Other injection procedures, including some that commenters recommended we use to value these epidural injection codes, include the work and practice expenses of image guidance in the injection code. In the proposed rule, we detailed many of these procedures, which include the image guidance in the injection CPT code. Since our analysis of the Medicare data and comments received on the CY 2014 final rule with comment period indicated that these services are typically furnished with imaging guidance, we believe it would be appropriate for the codes to be bundled and the inputs for image guidance to be included in the valuation of the epidural injection codes as it is for transforaminal and paravertebral codes. We stated that we did not believe the epidural injection codes can be appropriately valued without considering the image guidance, and that bundling image guidance will help assure relativity with other injection codes that include the image guidance. To determine how to appropriately value resources for the combined codes, we indicated that we believed more information is needed. Accordingly, we proposed to include CPT codes 62310, 62311, 62318, and 62319 on the potentially misvalued code list so that we can obtain information to value them with the image guidance included. In the meantime, we proposed to use the CY 2013 input values for CPT codes 62310, 62311, 62318 and 62319 to value these codes for CY 2015. Specifically, we proposed to use the CY 2013 work RVUs and work times.

Because it was clear that inputs that are specifically related to image guidance, such as the radiographic fluoroscopic room, are included in these proposed direct PE inputs for the epidural injection codes, we believed allowing separate reporting of the image guidance codes would overestimate the resources used in furnishing the overall service. To avoid this situation, we also proposed to prohibit the billing of image guidance codes in conjunction with these four epidural injection codes. We stated that we believed our two-tiered proposal to utilize CY 2013 input values for this family while prohibiting separate billing of imaging guidance best ensures that appropriate reimbursements continue to be made for these services, while we gather additional data and input on the best way to value them through codes that include both the injection and the image guidance.

Comment: The commenters did not object to identifying these codes as potentially misvalued and generally agreed with our proposal to revert to the 2013 inputs for CY 2015.

Response: We appreciate support for our proposal.

Comment: Several commenters agreed that it would be appropriate to bundle the image guidance with the epidural procedures. Other commenters suggested that we create both a bundled code and a stand-alone epidural injection code.

Response: We appreciate commenters' support for our proposal to bundle image guidance with the epidural procedures. As part of the review process, consideration can be given to how to best implement bundled codes.

Comment: Other commenters expressed concern that the bundling approach CMS proposed to use until these codes are reviewed did not incorporate the work or time for fluoroscopy. Some requested that we add the payment for fluoroscopic guidance to the epidural injection codes, as we have done in the past for facet joint injections and other services. Commenters requested that we continue to allow the image guidance codes to be separately billed until these services are revalued. Another commenter suggested that it may be premature to prohibit separate billing for image guidance, as there is considerable variation on the Start Printed Page 67579use of fluoroscopic guidance between codes within this family.

Response: We understand commenters' concerns about our proposal to prohibit separate billing for image guidance, and note that these concerns are part of the reason we are referring these codes to the RUC as potentially misvalued. However, given that significant resources are allocated to fluoroscopic guidance within the current injection codes, we do not believe it is appropriate to continue to allow the image guidance to be separately billed while we evaluate these epidural injection codes as potentially misvalued services.

After considering comments received, we are finalizing CPT codes 62310, 62311, 62318, and 62319 as potentially misvalued, finalizing the proposed RVUs for these services, and prohibiting separate billing of image guidance in conjunction with these services.

(3) Neurostimulator Implantation (CPT Codes 64553 and 64555)

We proposed CPT codes 64553 (Percutaneous implantation of neurostimulator electrode array; cranial nerve) and 64555 (Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)) as potentially misvalued after stakeholders questioned whether the codes included the appropriate direct PE inputs when furnished in the nonfacility setting.

Comment: A commenter encouraged CMS to include these codes on the potentially misvalued code list to ensure that they are adequately reimbursed in the nonfacility setting, while another commenter disagreed that the work for CPT codes 64553 and 64555 needed to be reviewed.

Response: In general, when a code is proposed as potentially misvalued, unless we receive information that clearly demonstrates it is not potentially misvalued, we finalize the code as potentially misvalued. When we finalize a code as potentially misvalued, we then review the inputs for the code. As a result of such review, inputs can be adjusted either upward or downward.

We appreciate the support for our proposal expressed by some commenters. Since the commenter opposing the addition of these codes to the potentially misvalued code list did not provide justification for its assertion that the work RVUs for CPT codes 64553 and 64555 did not need to be reviewed, after consideration of comments received, we are finalizing CPT codes 64553 and 64555 as potentially misvalued.

(4) Mammography (CPT Codes 77055, 77056, and 77057, and HCPCS Codes G0202, G0204, and G0206)

Medicare currently pays for mammography services through both CPT codes, (77055 (mammography; unilateral), 77056 (mammography; bilateral) and 77057 (screening mammography, bilateral (2-view film study of each breast)) and HCPCS G-codes, (G0202 (screening mammography, producing direct digital image, bilateral, all views), G0204 (diagnostic mammography, producing direct digital image, bilateral, all views), and G0206 (diagnostic mammography, producing direct digital image, unilateral, all views)). The CPT codes were designed to be used for mammography regardless of whether film or digital technology is used. However, for Medicare purposes, the HCPCS G-codes were created to describe mammograms using digital technology in response to special payment rules for digital mammography included in the Medicare Benefit Improvements and Protection Act of 2000 (BIPA).

The RUC recommended that CMS update the direct PE inputs for all imaging codes to reflect the migration from film-to-digital storage technologies since digital storage is now typically used in imaging services. Review of the Medicare data with regard to the application of this policy to mammography confirmed that virtually all mammography is now digital. As a result, we proposed that CPT codes 77055, 77056, and 77057 be used to report mammography regardless of whether film or digital technology is used, and to delete the HCPCS G-codes G0202, G0204, and G0206. We proposed to establish values for the CPT codes by crosswalking the values established for the digital mammography G-codes for CY 2015. (See section II.B. of this final rule with comment period for more discussion of this policy.) In addition, since the G-code values have not been evaluated since they were created in CY 2002 we proposed to include CPT codes 77055, 77056, and 77057 on the list of potentially misvalued codes.

Comment: With regard to whether the mammography codes should be included on the potentially misvalued codes list, commenters had differing opinions. One commenter stated that the work RVUs for digital mammography are the same as those for analog mammography, and maintained that the BIPA-directed payment for digital mammography of 1.5 times the TC of the analog mammography codes appropriately captures the practice expense resources required for digital mammography. Another commenter stated that digital mammography rates resulted from a statutory construct and do not reflect the actual costs of the digital resources necessary to furnish the services. One commenter noted that moving from the non-resource-based values to resource-based values will result in a significant reduction to the valuation of these services, and that this reduction will result from the resource-based PE methodology, not from the RUC review. Another commenter indicated that the RUC should not survey these codes, but requested that if the RUC does survey these codes, they should not do so until after CMS finalizes the new breast tomosynthesis codes (3D mammography) and film-to-digital transition. Another commenter indicated that CMS needed to consider that three-dimensional (3D) mammography codes involve additional resources over the two-dimensional (2D) mammography codes. A commenter suggested that this proposal fails to take into account the increasing use of tomography.

Response: The commenters' disagreement about whether these codes are misvalued would suggest that a review is warranted. Given that more than a decade has passed since these services were reviewed, we continue to believe that it is appropriate to review the work RVUs for these services. By including these codes on the potentially misvalued code list, we will have information to determine whether the current values are still appropriate. Finally, we anticipate that the survey results for the mammography codes will reflect the equipment that is typically used. We note that until these services are reviewed, we do not have adequate information to respond to the suggestion that the valuation for these services will be significantly reduced. However, we do acknowledge that the PE methodology is not intended to account for the actual costs in furnishing a service; rather, it is required to account for the relative resources in furnishing that service. We also note that there are new CPT codes for reporting mammography using tomosynthesis and we have RUC recommendations for these codes. We believe it is most appropriate to value the mammography code family together, and receipt of RUC recommendations on the other mammography codes will assist us in our review. Accordingly, we are including all mammography codes except those newly created for tomosynthesis on the potentially misvalued code list.

Comment: Although commenters agreed with our assessment that digital Start Printed Page 67580technology has replaced analog mammography as typical, not all agreed that it was appropriate to delete G-codes and use the CPT codes. One commenter supported the deletion of the G-codes. Other commenters suggested that deletion of the G-codes was unnecessary. Another commenter stated that the coding system frequently reflects differences in approach and technique, and that the equipment for analog and digital mammography are different enough to warrant separate reporting so we should not delete the G-codes. Some who supported continuation of the G-codes asked us to delay implementation as they were concerned that other payers would not have time to update their requirements by January 1, 2015. Another commenter applauded CMS's decision to delete the G-codes.

Response: In further consideration of this proposal, we discovered that while the CPT codes for diagnostic mammography apply to mammography, whether film or digital technology is used, the descriptor for the screening mammography CPT code specifically refers to film. In light of this and that fact that we anticipate revaluing these codes when we have the benefit of RUC recommendations for all codes in the family, we believe it is appropriate to continue to recognize both the CPT codes and the G-codes for mammography for CY 2015, as we consider appropriate valuations now that digital mammography is typical. Therefore, we are not finalizing our proposal to delete the G-codes. We are, however, making a change in the descriptors to make clear that the G0202, G0204, and G0206 are specific to 2-D mammography. These codes are to be reported with either G0279 or CPT code 77063 when mammography is furnished using 3-D mammography.

Comment: A commenter requested that CMS ensure reimbursement rates remain adequate to protect access for Medicare beneficiaries. Another commenter suggested that these changes could result in barriers to access for Medicare beneficiaries.

Response: We are strongly supportive of access to mammography for Medicare beneficiaries. As stated elsewhere in this final rule with comment period, we believe that accurate valuation incentivizes appropriate utilization of services.

After consideration of public comments, we are modifying our proposal as follows: We will include CPT codes 77055, 77056, and 77057 on the potentially misvalued codes list; we will continue to recognize G0202, G0204 and G0206 but will modify the descriptors so that they are specific to 2-D digital mammography, and instead of using the digital values we will continue to use the CY 2014 work and PE RVUs to value the mammography CPT codes. We expect that the CPT Editorial Panel will consider the descriptor for screening mammography, CPT code 77057, in light of the prevailing use of digital mammography.

(5) Abdominal Aortic Aneurysm Ultrasound Screening (G0389)

When Medicare began paying for abdominal aortic aneurysm (AAA) ultrasound screening, HCPCS code G0389 (Ultrasound, B-scan and/or real time with image documentation; for abdominal aortic aneurysm (AAA) screening) in CY 2007, we set the RVUs at the same level as CPT code 76775 (Ultrasound, retroperitoneal (e.g., renal, aorta, nodes), B-scan and/or real time with image documentation; limited). We noted in the CY 2007 final rule with comment period that CPT code 76775 was used to report the service when furnished as a diagnostic test and that we believed the service reflected by G0389 used equivalent resources and work intensity to those contained in CPT code 76775 (71 FR 69664 through 69665).

In the CY 2014 proposed rule, we proposed to replace the ultrasound room included as a direct PE input for CPT code 76775 with a portable ultrasound unit based upon a RUC recommendation. Since the RVUs for G0389 were crosswalked from CPT code 76775, the proposed PE RVUs for G0389 in the CY 2014 proposed rule were reduced as a result of this change. However, we did not discuss the applicability of this change to G0389 in the preamble to the proposed rule, and did not receive any comments on G0389 in response to the proposed rule. We finalized the change to CPT code 76775 in the CY 2014 final rule with comment period and as a result, the PE RVUs for G0389 were also reduced.

We proposed G0389 as potentially misvalued in response to a stakeholder suggestion that the reduction in the RVUs for G0389 did not accurately reflect the resources involved in furnishing the service. We sought recommendations from the public and other stakeholders, including the RUC, regarding the appropriate work RVU, time, direct PE input, and malpractice risk factors that reflect the typical resources involved in furnishing the service.

Until we receive the information needed to re-value this service, we proposed to value this code using the same work and PE RVUs we used for CY 2013. We proposed MP RVUs based on the five-year review update process as described in section II.C of this final rule with comment period. We stated that we believe this valuation would ameliorate the effect of the CY 2014 reduction that resulted from the RVUs for G0389 being tied to those for another code while we assess appropriate valuation through our usual methodologies. Accordingly, we proposed a work RVU of 0.58 for G0389 and proposed to assign the 2013 PE RVUs until this procedure is reviewed.

Comment: Many commenters supported our proposal to include this service on the potentially misvalued codes list. Some commenters agreed that the crosswalk used to set rates for this service does not appear to be appropriate at this time, whether due to changes in the way the service is provided, or because the specialty mix has shifted, and suggested that it would be appropriate to establish a Category I CPT code for this service. Another commenter suggested that CMS consider crosswalking G0389 to CPT code 93979 (Duplex scan of aorta, inferior vena cava, iliac vasculature, or bypass grafts; unilateral or limited study). One commenter believed it was unnecessary to survey this code, but recommended that we instead maintain the general ultrasound room as a direct PE input and 2013 PE RVUs.

Response: We appreciate commenters' support for our proposal to include G0389 on the potentially misvalued codes list and are finalizing this proposal. We are finalizing this code as potentially misvalued in large part because we are unsure of the correct valuation. Therefore, we believe it is most appropriate to retain the 2013 inputs until we receive new recommendations, rather than making another change or retaining these inputs indefinitely as commenters suggested.

After consideration of comments received, we are finalizing our proposal to add G0389 to the potentially misvalued codes list, and to maintain the 2013 work and PE RVUs while we complete our review of the code. The MP RVUs will be calculated as discussion in section II.C. of this rule.

(6) Prostate Biopsy Codes—(HCPCS Codes G0416, G0417, G0418, and G0419)

For CY 2014, we modified the code descriptors of G0416 through G0419 so that these codes could be used for any method of prostate needle biopsy services, rather than only for prostate saturation biopsies. The CY 2014 descriptions are:Start Printed Page 67581

  • G0416 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 10-20 specimens).
  • G0417 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 21-40 specimens).
  • G0418 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 41-60 specimens).
  • G0419 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; greater than 60 specimens).

Subsequently, we have discussed prostate biopsies with stakeholders, and reviewed medical literature and Medicare claims data in considering how best to code and value prostate biopsy pathology services. After considering these discussions and information, we believed it would be appropriate to use only one code to report prostate biopsy pathology services. Therefore, we proposed to revise the descriptor for G0416 to define the service regardless of the number of specimens, and to delete codes G0417, G0418, and G0419. We believe that using G0416 to report all prostate biopsy pathology services, regardless of the number of specimens, would simplify the coding and mitigate overutilization incentives. Given the infrequency with which G0417, G0418, and G0419 are used, we did not believe that this was a significant change.

Based on our review of medical literature and examination of Medicare claims data, we indicated that we believe that the typical number of specimens evaluated for prostate biopsies is between 10 and 12. Since G0416 currently is used for between 10 and 12 specimens, we proposed to use the existing values for G0416 for CY 2015, since the RVUs for this service were established based on similar assumptions.

In addition, we proposed G0416 as a potentially misvalued code for CY 2015 and sought public comment on the appropriate work RVUs, work time, and direct PE inputs.

Comment: One commenter supported the elimination of the G-codes as a means of simplifying coding requirements, but other commenters opposed our proposal to consolidate the coding into G0416, disagreeing that this would help establish “straightforward coding and maintain accurate payment” as suggested in the proposed rule. Some commenters suggested that we retain the current codes so that biopsy procedures requiring more than 10 specimens can be reimbursed accurately, and indicated that consolidating the coding would further confuse physicians and their staff who have not yet adapted to the CY 2014 coding changes for these G-codes. Other commenters asserted that these changes threaten to undermine access to high quality pathology services. Commenters also stated that the decision to furnish more extensive pathological analysis is not at the discretion of the pathologist, and the pathologist should not be penalized when he or she receives more cores to analyze.

With respect to our proposing G0416 as potentially misvalued, commenters stated that the recent change to these codes has already been confusing and suggests that there is not a clear understanding of what these codes represent, thus making an assessment of their valuation difficult. Commenters further stated that it is unreasonable to consider this a misvalued code when the payment is already 30 percent below what they think it should be, and that CMS has failed to provide justification for why it is potentially misvalued.

The RUC and others suggested that it would be most accurate to utilize CPT code 88305 (Level IV—surgical pathology, gross and microscopic examination) for the reporting of prostate biopsies and to allow the reporting of multiple units. Given the additional granularity and scrutiny given to CPT code 88305 in the CY 2014 final rule, the commenters indicated that they believe that the agency's intent to establish straightforward coding and accurate payment for these services would be realized with this approach.

Response: Given that the typical analysis of prostate biopsy specimens differs significantly from the typical analyses reported using CPT code 88305, as regards the number of blocks used to process the specimen and thus the amount of work involved, we believe that by distinguishing prostate biopsies from other types of biopsies results in more accurate pricing for prostate biopsies. Since CPT code 88305 was revalued with the understanding that prostate biopsies are billed separately, we believe that allowing CPT code 88305 to be reported in multiple units for prostate biopsies would account for significantly more resources than is appropriate. With respect to the concern about higher numbers of specimens, we note that our claims data on the G-codes shows that the vast majority of the claims used G0416, rather than any of the G-codes for greater numbers of specimens.

After consideration of comments received, we are finalizing our proposal to include G0416 on the potentially misvalued codes list, to modify the descriptor to reflect all prostate biopsies, and to maintain the current value until we receive and review information and recommendations from the RUC. We are also finalizing our proposal to delete codes G0417, G0418, and G0419.

(7) Obesity Behavioral Group Counseling—GXXX2 and GXXX3

Pursuant to section 1861(ddd) of the Act, we added coverage for a new preventive benefit, Intensive Behavioral Therapy for Obesity, effective November 29, 2011, and created HCPCS code G0447 (Face-to-face behavioral counseling for obesity, 15 minutes) for reporting and payment of individual behavioral counseling for obesity. Coverage requirements specific to this service are delineated in the Medicare National Coverage Determinations Manual, Pub. 100-03, Chapter 1, Section 210, available at http://www.cms.gov/​manuals/​downloads/​ncd103c1_​Part4.pdf.

It was brought to our attention that behavioral counseling for obesity is sometimes furnished in group sessions, and questions were raised about whether group sessions could be billed using HCPCS code G0447. To improve payment accuracy, we proposed to create two new HCPCS codes for the reporting and payment of group behavioral counseling for obesity. Specifically, we proposed to create GXXX2 (Face-to-face behavioral counseling for obesity, group (2-4), 30 minutes) and GXXX3 (Face-to-face behavioral counseling for obesity, group (5-10), 30 minutes). We indicated that the coverage requirements for these services would remain in place, as described in the National Coverage Determination for Intensive Behavioral Therapy for Obesity cited above. The practitioner furnishing these services would report the relevant group code for each beneficiary participating in a group therapy session.

Since we believed that the face-to-face behavioral counseling for obesity services described by GXXX2 and GXXX3 would require similar per minute work and intensity as HCPCS code G0447, we proposed work RVUs of 0.23 and 0.10 for HCPCS codes GXXX2 and GXXX3, with work times of 8 minutes and 3 minutes respectively. Since the services described by GXXX2 and GXXX3 would be billed per beneficiary receiving the service, the work RVUs and work time that we proposed for these codes were based upon the assumed typical number of beneficiaries per session, 4 and 9, respectively. Accordingly, we proposed Start Printed Page 67582a work RVU of 0.23 with a work time of 8 minutes for GXXX2 and a work RVU of 0.10 with a work time of 3 minutes for GXXX3. We proposed to use the direct PE inputs for GXXX2 and GXXX3 currently included for G0447 prorated to account for the differences in time and number of beneficiaries, and to crosswalk the malpractice risk factor from HCPCS code G0447 to both HCPCS codes GXXX2 and GXXX3, as we believe the same specialty mix will furnish these services. We requested public comment on the proposed values for HCPCS codes GXXX2 and GXXX3.

Comment: Commenters generally supported our proposal to establish a separate payment mechanism for obesity behavioral group counseling services, but raised several concerns regarding the coding structure and valuation of these services. Commenters stated that the work times were inaccurate, requested that the service be valued based on a smaller number of typical group participants, and questioned the need for two G-codes when group counseling services under the PFS are generally billed with a single G-code. A commenter also stated that the lower payment for larger groups will create disincentives for furnishing this service except when there is a full 10-person group, which could limit access. Commenters suggested that CMS only finalize a single G-code for group counseling for intensive behavioral therapy for obesity, and crosswalk the work RVU and work time for this service from the Medical Nutrition Therapy (MNT) group code.

Response: We appreciate commenters' support for our proposal to provide new codes for group obesity counseling services. After reviewing the comments, we agree that it is reasonable to create a single code for group obesity counseling and crosswalk the work RVU and work time from the MNT group code. The individual code for intensive obesity behavioral therapy and the individual MNT code are valued the same, so in the absence of evidence that group composition is different, we believe it makes sense to use the same values. Therefore, we will crosswalk the work RVU of 0.25 and the work time of 10 minutes to a single new G-code for group obesity counseling, G0473 (Face-to-face behavioral counseling for obesity, group (2-10), 30 minutes).

4. Improving the Valuation and Coding of the Global Package

a. Overview

Since the inception of the PFS, we have valued and paid for certain services, such as surgery, as part of global packages that include the procedure and the services typically furnished in the periods immediately before and after the procedure (56 FR 59502). For each of these codes (usually referred to as global surgery codes), 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 codes include the surgical procedure and the pre-operative and post-operative physicians' services on the day of the procedure, including visits related to the service. The 10-day global codes include these services and, in addition, visits related to the procedure during the 10 days following the procedure. The 90-day global codes 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 the Claims Processing Manual (Pub. 100-04, Chapter 12 Physician/Nonphysician Practitioners) defines the global surgical package to include the following services when furnished during the global period:

  • Preoperative Visits—Preoperative 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 postoperative period of the surgery because of complications that do not require additional trips to the operating room;
  • Postoperative Visits—Follow-up visits during the postoperative period of the surgery that are related to recovery from the surgery;
  • Postsurgical Pain Management—By the surgeon;
  • Supplies—Except for those identified as exclusions; 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.

b. Concerns With the 10- and 90-Day Global Packages

CMS supports bundled payments as a mechanism to incentivize high-quality, efficient care. Although on the surface, the PFS global codes appear to function as bundled payments similar to those Medicare uses to make single payments for multiple services to hospitals under the inpatient and outpatient prospective payment systems, the practical reality is that these global codes function significantly differently than other bundled payments. First, the global surgical codes were established several decades ago when surgical follow-up care was far more homogenous than today. Today, there is more diversity in the kind of procedures covered by global periods, the settings in which the procedures and the follow-up care are furnished, the health care delivery system and business arrangements used by Medicare practitioners, and the care needs of Medicare beneficiaries. Despite these changes, the basic structures of the global surgery packages are the same as the packages that existed prior to the creation of the resource-based relative value system in 1992. Another significant difference between this and other typical models of bundled payments is that the payment rates for the global surgery packages are not updated regularly based on any reporting of the actual costs of patient care. For example, the hospital inpatient and outpatient prospective payment systems (the IPPS and OPPS, respectively) derive payment rates from hospital cost and charge data reported through annual Medicare hospital cost reports and the most recent year of claims data available for an inpatient stay or primary outpatient service.

Because payment rates are based on consistently updated data, over time, payment rates adjust to reflect the average resource costs of current practice. Similarly, many of the new demonstration and innovation models track costs and make adjustments to payments. Another significant difference is that payment for the PFS global packages relies on valuing the combined services together. This means that there are no separate PFS values established for the procedures or the follow-up care, making it difficult to estimate the costs of the individual global code component services.

In the following paragraphs, we address a series of concerns regarding the accuracy of payment for 10- and 90-day global codes, including: The fundamental difficulties in establishing Start Printed Page 67583appropriate relative values for these packages, the potential inaccuracies in the current information used to price global codes, the limitations on appropriate pricing in the future, the potential for global packages to create unwarranted payment differentials among specialties, the possibility that the current codes are incompatible with current medical practice, and the potential for these codes to present obstacles to the adoption of new payment models.

Concerns such as these commonly arise when developing payment mechanisms, for example fee-for-service payment rates, single payments for multiple services, or payment for episodes of care over a period of time. However, in the case of the post-operative portion of the 10- and 90-day global codes, we believe that together with certain unique aspects of PFS rate setting methodology, these concerns create substantial barriers to accurate valuation of these services relative to other PFS services.

(1) Fundamental Limitations in the Appropriate Valuation of the Global Packages With Post-Operative Days

In general, we face many challenges in valuing PFS services as accurately as possible. However, the unique nature of global surgery packages with 10- and 90-day post-operative periods presents additional challenges distinct from those presented in valuing other PFS services. Our valuation methodology for PFS services generally relies on assumptions regarding the resources involved in furnishing the “typical case” for each individual service unlike other payment systems that rely on actual data on the costs of furnishing services. Consistent with this valuation methodology, the RVUs for a global code should reflect the typical number and level of E/M services furnished in connection with the procedure. However, it is much easier to maintain relativity among services that are valued on this basis when each of the services is described by codes of similar unit sizes. In other words, because codes with long post-operative periods include such a large number of services, any variations between the “typical” resource costs used to value the service and the actual resource costs associated with particular services are multiplied. The effects of this problem can be two-fold, skewing the accuracy of both the RVUs for individual global codes and the Medicare payment made to individual practitioners. The RVUs of the individual global service codes are skewed whenever there is any inaccuracy in the assumption of the typical number or kind of services in the post-operative periods. This inaccuracy has a greater impact than inaccuracies in assumptions for non-global codes because it affects a greater number of service units over a period of time than for individually priced services. Furthermore, in contrast to prospective payment systems, such inaccuracies under the PFS are not corrected over time through a ratesetting process that makes year-to-year adjustments based on data on actual costs. For example, if a 90-day global code is valued based on an assumption or survey response that ten post-operative visits is typical, but practitioners reporting the code in fact typically only furnish six visits, then the resource assumptions are overestimated by the value of the four visits multiplied by the number of the times the procedure code is reported. In contrast, when our assumptions are incorrect about the typical resources involved in furnishing a PFS code that describes a single service, any inaccuracy in the RVUs is limited to the difference between the resource costs assumed for the typical service and the actual resource costs in furnishing one individual service. Such a variation between the assumptions used in calculating payment rates and the actual resource costs could be corrected if the payments for packaged services were updated regularly using data on actual services furnished. Medicare's prospective payment systems have more mechanisms in place than the PFS does to adjust over time for such variation To make adjustments to the RVUs to account for inaccurate assumptions under the current PFS methodology, the global surgery code would need to be identified as potentially misvalued, survey data would have to reflect an accurate account of the number and level of typical post-operative visits, and we (with or without a corresponding recommendation from the RUC or others) would have to implement a change in RVUs based on the change in the number and level of visits to reflect the typical service.

These amplified inaccuracies may also occur whenever Medicare pays an individual practitioner reporting a 10- or 90-day global code. Practitioners may furnish a wide range of post-operative services to individual Medicare beneficiaries, depending on individual patient needs, changes in medical practice, and dynamic business models. Due to the way the 10- and 90-day global codes are constructed, the number and level of services included for purposes of calculating the payment for these services may vary greatly from the number and level of services that are actually furnished in any particular case. In contrast, the variation between the “typical” and the actual resource cost for the practitioner reporting an individually valued PFS service is constrained because the practitioner is only reporting and being paid for a specific service furnished on a particular date.

For most PFS services, any difference between the “typical” case on which RVUs are based and the actual case for a particular service is limited to the variation between the resources assumed to be involved in furnishing the typical case and the actual resources involved in furnishing the single specific service. When the global surgical package includes more or a higher level of E/M services than are actually furnished in the typical post-operative period, the Medicare payment is based on an overestimate of the quantity or kind of services furnished, not merely an overestimation of the resources involved in furnishing an individual service. The converse is true if the RVUs for the global surgical package are based on fewer or a lower level of services than are typically furnished for a particular code.

(2) Questions Regarding Accuracy of Current Assumptions

In previous rulemaking (77 FR 68911 through 68913), we acknowledged evidence suggesting that the values included in the post-operative period for global codes may not reflect the typical number and level of post-operative E/M visits actually furnished.

In 2005, the OIG examined whether global surgical packages are appropriately valued. In its report on eye and ocular surgeries, “National Review of Evaluation and Management Services Included in Eye and Ocular Adnexa Global Surgery Fees for Calendar Year 2005” (A-05-07-00077), the OIG reviewed a sample of 300 eye and ocular surgeries, and counted the actual number of face-to-face services recorded in the patients' medical records to establish whether and, if so, how many post-operative E/M services were furnished by the surgeons. For about two-thirds of the claims sampled by the OIG, surgeons furnished fewer E/M services in the post-operative period than were included in the global surgical package payment for each procedure. A small percentage of the surgeons furnished more E/M services than were included in the global surgical package payment. The OIG identified the number of face-to-face services recorded in the medical record, but did not review the medical necessity Start Printed Page 67584of the surgeries or the related E/M services. The OIG concluded that the RVUs for these global surgical packages are too high because they include a higher number of E/M services than typically are furnished within the global period for the reviewed procedures.

Following that report, the OIG continued to investigate E/M services furnished during global surgical periods. In May 2012, the OIG published a report entitled “Musculoskeletal Global Surgery Fees Often Did Not Reflect the Number of Evaluation and Management Services Provided” (A-05-09-00053). For this investigation, the OIG sampled 300 musculoskeletal global surgeries and again found that, for the majority of sampled surgeries, physicians furnished fewer E/M services than were included as part of the global period payment for that service. Once again, a small percentage of surgeons furnished more E/M services than were included in the global surgical package payment. The OIG concluded that the RVUs for these global surgical packages are too high because they include a higher number of E/M services than typically are furnished within the global period for the reviewed procedures.

In both reports, the OIG recommended that we adjust the number of E/M services identified with the studied global surgical payments to reflect the number of E/M services that are actually being furnished. However, since it is not necessary under our current global surgery payment policy for a surgeon to report the individual E/M services actually furnished during the global surgical period, we do not have objective data upon which to assess whether the RVUs for global period surgical services reflect the typical number or level of E/M services that are furnished. In the CY 2013 PFS proposed rule (77 FR 44738), we previously sought public comments on collecting these data. As summarized in the CY 2013 PFS final rule (77 FR 68913) we did not discover a consensus among stakeholders regarding either the most appropriate means to gather the data, or the need for, or the appropriateness of using such data in valuing these services. In response to our comment solicitation, some commenters urged us to accept the RUC survey data as accurate in spite of the OIG reports and other concerns that have been expressed regarding whether the visits included in the global periods reflected the typical case. Others suggested that we should conduct new surveys using the RUC approach or that we should mine hospital data to identify the typical number of visits furnished. Some comments suggested eliminating the 10- and 90-day global codes.

(3) Limitations on Appropriate Future Valuations of 10- and 90-Day Global Codes

Historically, our attempts to adjust RVUs for global services based on changes in the typical resource costs (especially with regard to site of service assumptions or changes to the number of post-surgery visits) have been difficult and controversial. At least in part, this is because the relationship between the work RVUs for the 10- and 90-day global codes (which includes the work RVU associated with the procedure itself) and the number of included post-operative visits in the existing values is not always clear. Some services with global periods have been valued by adding the work RVU of the surgical procedure and all pre- and post-operative E/M services included in the global period. However, in other cases, as many stakeholders have noted, the total work RVUs for surgical procedures and post-operative visits in global periods are estimated as a single value without any explicit correlation to the time and intensity values for the individual service components. Although we would welcome more objective information to improve our determination of the “typical” case, we believe that even if we engaged in the collection of better data on the number and level of E/M services typically furnished during the global periods for global surgery services, the valuation of individual codes with post-operative periods would not be straightforward. Furthermore, we believe it would be important to frequently update the data on the number and level of visits furnished during the post-operative periods in order to account for any changes in the patient population, medical practice, or business arrangements. Practitioners paid through the PFS do not report such data.

(4) Unwarranted Payment Disparities

Subsequent to our last comment solicitation regarding the valuation of the post-operative periods (77 FR 68911 through 68913), some stakeholders have raised concerns that global surgery packages contribute to unwarranted payment disparities between practitioners who do and do not furnish these services. These stakeholders have addressed several ways the 10- and 90-day global packages may contribute to unwarranted payment disparities.

The stakeholders noted that, through the global surgery packages, Medicare pays practitioners who furnish E/M services during post-surgery periods regardless of whether the services are actually furnished, while practitioners who do not furnish global procedures with post-operative visits are only paid for E/M services that are actually furnished. In some cases, it is possible that the practitioner furnishing the global surgery procedure may not furnish any post-operative visits. Although we have policies to address the situation when post-operative care is transferred from one practitioner to another, the beneficiary might simply choose to seek care from another practitioner without a formal transfer of care. The other practitioner would then bill Medicare separately for E/M services for which payment was included in the global payment to the original practitioner. Those services would not have been separately billable if furnished by the original practitioner.

These circumstances can lead to unwarranted payment differences, allowing some practitioners to receive payment for fewer services than reflected in the Medicare payment. Practitioners who do not furnish global surgery services bill and are paid only for each individual service furnished. When global surgery values are based on inaccurate assumptions about the typical services furnished in the post-operative periods, these payment disparities can contribute to differences in aggregate RVUs across specialties. Since the RVUs are intended to reflect differences in the relative resource costs involved in furnishing a service, any disparity between assumed and actual costs results not only in paying some practitioners for some services that are not furnished, it also skews relativity between specialties.

Stakeholders have also pointed out that payment disparities can arise because E/M services reflected in global periods generally include higher PE values than the same services when billed separately. The difference in PE values between separately billed visits and those included in global packages result primarily from two factors that are both inherent in the PFS pricing methodology.

First, there is a different mix of PE inputs (clinical labor/supplies/equipment) included in the direct PE inputs for a global period E/M service and a separately billed E/M service. For example, the clinical labor inputs for separately reportable E/M codes includes a staff blend listed as “RN/LPN/MTA” (L037D) and priced at $0.37 per minute. Instead of this input, some codes with post-operative visits include the staff type “RN” (L051A) priced at a higher rate of $0.51 per minute. For these codes, the higher resource cost Start Printed Page 67585may accurately reflect the typical resource costs associated with those particular visits. However, the different direct PE inputs may drive unwarranted payment disparities among specialties who report global surgery codes with post-operative periods and those that do not. The only way to correct these potential discrepancies under the current system, which result from the specialty-based differences in resource costs, would be to include standard direct PE inputs for these services regardless of whether or not the standard inputs are typical for the specialties furnishing the services.

Second, the indirect PE allocated to the E/M visits included in global surgery codes is higher than that allocated to separately furnished E/M visits. This occurs because the range of specialties furnishing a particular global service is generally not as broad as the range of specialties that report separate individual E/M services. Since the specialty mix for a service is a key factor in determining the allocation of indirect PE to each code, a higher amount of indirect PE can be allocated to the E/M services that are valued as part of the global surgery codes than to the individual E/M codes. Practitioners who use E/M codes to report visits separately are paid based on PE RVUs that reflect the amount of indirect PE allocated across a wide range of specialties, which has the tendency to lower the amount of indirect PE. For practitioners who are paid for visits primarily through post-operative periods, indirect PE is generally allocated with greater specificity. Two significant steps would be required to alleviate the impact of this disparity. First, we would have to identify the exact mathematical relationship between the work RVU and the number and level of post-operative visits for each global code; and second, we would have to propose a significant alteration of the PE methodology in order to allocate indirect PE that does not correlate to the specialties reporting the code in the Medicare claims data.

Furthermore, stakeholders have pointed out that the PE RVUs for codes with 10- or 90-day post-operative periods reflect the assumption that all outpatient visits occur in the higher-paid non-facility office setting, when many of these visits are likely to be furnished in provider-based departments, which would be paid at the lower, PFS facility rate if they were billable separately. As we note elsewhere in this final rule with comment period, we do not have data on the volume of physicians' services furnished in provider-based departments, but public information suggests that it is not insignificant and that it is growing. When these services are paid as part of a global package, there is no adjustment made based on the site of service. Therefore, even though the PFS payment for services furnished in post-operative global periods might include clinical labor, disposable supply, and medical equipment costs (and additional indirect PE allocation) that are incurred by the facility and not the practitioner reporting the service, the RVUs for global codes reflect all of these costs associated with the visits.

(5) Incompatibility of Current Packages With Current Practice and Unreliability of RVUs for Use in New Payment Models

In addition to these issues, the 10- and 90-day global periods reflect a long-established but no longer exclusive model of post-operative care that assumes the same practitioner who furnishes the procedure typically furnishes the follow-up visits related to that procedure. In many cases, we believe that models of post-operative care are increasingly heterogeneous, particularly given the overall shift of patient care to larger practices or team-based environments.

We believe that RVUs used to establish PFS payments are likely to serve as critical building blocks to developing, testing, and implementing a number of new payment models, including those that focus on bundled payments to practitioners or payments for episodes of care. Therefore, we believe it is critical for us to ensure that the PFS RVUs accurately reflect the resource costs for individual PFS services instead of reflecting potentially skewed assumptions regarding the number of services furnished over a long period of time in the “typical” case. To the extent that the 10- and 90-day global periods reflect inaccurate assumptions regarding resource costs associated with individual PFS services, we believe they are likely to be obstacles to a wide range of potential improvements to PFS payments, including the potential incorporation of payment bundling designed to foster efficiency and quality care for Medicare beneficiaries.

c. Proposed Transformation of 10- and 90-Day Global Packages Into 0-Day Global Packages

Although we have marginally addressed some of the concerns noted above with global packages in previous rulemaking, we do not believe that we have made significant progress in addressing the fundamental issues with the 10- and 90-day post-operative global packages. In the context of the misvalued code initiative, we believe it is critical for the RVUs used to develop PFS payment rates reflect the most accurate resource costs associated with PFS services. Based on the issues discussed above, we do not believe we can effectively address the issues inherent in establishing values for the 10- and 90-day global packages under our existing methodologies and with available data. As such, we do not believe that maintaining the post-operative 10-and 90-day global periods is compatible with our continued interest in using more objective data in the valuation of PFS services and accurately valuing services relative to each other. Because the typical number and level of post-operative visits during global periods may vary greatly across Medicare practitioners and beneficiaries, we believe that continued valuation and payment of these face-to-face services as a multi-day package may skew relativity and create unwarranted payment disparities within PFS fee-for-service payment. We also believe that the resource based valuation of individual physicians' services will continue to serve as a critical foundation for Medicare payment to physicians, whether through the current PFS or in any number of new payment models. Therefore, we believe it is critical that the RVUs under the PFS be based as closely and accurately as possible on the actual resources involved in furnishing the typical occurrence of specific services.

To address the issues discussed above, we proposed to retain global bundles for surgical services, but to refine bundles by transforming over several years all 10- and 90-day global codes to 0-day global codes. Medically reasonable and necessary visits would be billed separately during the pre- and post-operative periods outside of the day of the surgical procedure. We propose to make this transition for current 10-day global codes in CY 2017 and for the current 90-day global codes in CY 2018, pending the availability of data on which to base updated values for the global codes.

We believe that transforming all 10- and 90-day global codes to 0-day global codes would:

  • Increase the accuracy of PFS payment by setting payment rates for individual services based more closely upon the typical resources used in furnishing the procedures;
  • Avoid potentially duplicative or unwarranted payments when a beneficiary receives post-operative care Start Printed Page 67586from 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; and
  • Facilitate availability of more accurate data for new payment models and quality research.

As we transition these codes, we would need to establish RVUs that reflect the change in the global period for all the codes currently valued as 10- and 90-day global surgery services. We sought assistance from stakeholders on various aspects of this task. Prior to implementing these changes, we intend to gather objective data on the number of E/M and other services furnished during the current post-operative periods and use those data to inform both the valuation of particular services and the overall budget neutrality adjustments required to implement this proposal. We sought comment on the most efficient means of acquiring accurate data regarding the number of visits and other services actually being furnished by the practitioner during the current post-operative periods. For all the reasons stated above, we do not believe that survey data reflecting assumptions of the “typical case” meets the standards required to measure the resource costs of the wide range of services furnished during the post-operative periods. We acknowledge that collecting information on these services through claims submission may be the best approach, and we would propose such a collection through future rulemaking. However, we are also interested in alternatives. 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 evaluate that data.

We also sought comment on the best means to ensure that allowing separate payment of E/M visits during post-operative periods does not incentivize otherwise unnecessary office visits during post-operative periods. If we adopt this proposal, we intend to monitor any changes in the utilization of E/M visits following its implementation but we also solicited comment on potential payment policies that will mitigate such a change in behavior.

In developing this proposal, we considered several alternatives to the transformation of all global codes to 0-day global codes. First, we again considered the possibility of gathering data and using the data to revalue the 10- and 90-day global codes. While this option would have maintained the status quo in terms of reporting services, it would have required much of the same effort as this proposal without alleviating many of the problems associated with the 10- and 90-day global periods. For example, collecting accurate data would allow for more accurate estimates of the number and kind of visits included in the post-operative periods at the time of the survey. However, this alternative approach would only mitigate part of the potential for unwarranted payment disparities. For example, the values for the visits in the global codes would continue to include different amounts of PE RVUs than separately reportable visits and would continue to provide incentives to some practitioners to minimize patient visits. Additionally, it would not address the changes in practice patterns that we believe have been occurring whereby the physician furnishing the procedure is not necessarily the same physician providing the post-procedure follow up.

This alternative option would also rest extensively on the effectiveness of using the new data to revalue the codes accurately. Given the unclear relationship between the assigned work RVUs and the post-operative visits across all of these services, incorporating objective data on the number of visits to adjust work RVUs would still necessitate extensive review of individual codes or families of codes by CMS and stakeholders, including the RUC. We believe the investment of resources for such an effort would be better made to solve a broader range of problems.

We also considered other possibilities, such as altering our PE methodology to ensure that the PE inputs and indirect PE for visits in the global period were valued the same as separately reportable E/M codes or requiring reporting of the visits for all 10- and 90-day global services while maintaining the 10- and 90-day global period payment rates. However, we believe this option would require all of the same effort by practitioners, CMS, and other stakeholders without alleviating most of the problems addressed in the preceding paragraphs.

We also considered maintaining the status quo and identifying each of the 10- and 90-day global codes as potentially misvalued through our potentially misvalued code process for review as 10- and 90-day globals. Inappropriate valuations of these services has a major effect on the fee schedule due to the percentage of PFS dollars paid through 10- and 90-day global codes (3 percent and 11 percent, respectively), and thus, valuing them appropriately is critical to appropriate valuation and relativity throughout the PFS. Through the individual review approach, we could review the appropriateness of the global period and the accurate number of visits for each service. Yet revaluing all 3,000 global surgery codes through the potentially misvalued codes approach would not address many of the problems identified above. Unless such an effort was combined with changes in the PE methodology, it would only partially address the valuation and accuracy issues and would leave all the other issues unresolved. Moreover, the valuation and accuracy issues that could be addressed through this approach would rapidly be out of date as medical practice continues to change. Therefore, such an approach would be only partially effective and would impede our ability to address other potentially misvalued codes.

We sought stakeholder input on an accurate and efficient means to revalue or adjust the work RVUs for the current 10- and 90-day global codes to reflect the typical resources involved in furnishing the services including both the pre- and post-operative care on the day of the procedure. We believe that collecting data on the number and level of post-operative visits furnished by the practitioner reporting current 10- and 90-day global codes will be important to ensuring work RVU relativity across these services. We also believe that these data will be important to determine the relationship between current work RVUs and current number of post-operative visits, within categories of codes and code families. However, we believe that once we collect those data, there is a wide range of possible approaches to the revaluation of the large number of individual global services, some of which may deviate from current processes like those undertaken by the RUC. To date, the potentially misvalued code initiative has focused on several hundred, generally high-volume codes per year. This proposal requires revaluing a larger number of codes over a shorter period of time and includes many services with relatively low volume in the Medicare population. Given these circumstances, it does not seem practical to survey time and intensity information on each of these procedures. Absent any new survey data regarding the procedures themselves, Start Printed Page 67587we believe that data regarding the number and level of post-service office visits can be used in conjunction with other methods of valuation, such as:

  • Using the current potentially misvalued code process to identify and value the relatively small number of codes that represent the majority of the volume of services that are currently reported with codes with post-operative periods, and then adjusting the aggregate RVUs to account for the number of visits and using magnitude estimation to value the remaining services in the family.
  • Valuing one code within a family through the current valuation process and then using magnitude estimation to value the remaining services in the family.
  • Surveying a sample of codes across all procedures to create an index that could be used to value the remaining codes.

Although we believe these are plausible options for the revaluation of these services, we believed there may be others. Therefore, we sought input on the best approach to achieve this proposed transition from 10- and 90-day, to 0-day global periods, including the timing of the changes, the means for revaluation, and the most effective and least burdensome means to collect objective, representative data regarding the actual number of visits currently furnished in the post-operative global periods. We also solicited comment on whether the effective date for the transition to 0-day global periods should be staggered across families of codes or other categories. For example, while we proposed to transition 10-day global periods in 2017 and 90-day global periods in 2018, we solicited comment on whether we should consider implementing the transition more or less quickly and over one or several years. We also solicited comment regarding the appropriate valuation of new, revised, or potentially misvalued 10- or 90-day global codes before implementation of this proposal.

We received many comments regarding the proposed transition to 0-day global packages. Many commenters expressed support or opposition to the proposal. Some commenters offered direct responses to the topics for which we specifically sought comment, while others raised questions regarding how the transition would be implemented. In the following paragraphs, we summarize and respond to these comments.

Comment: Several commenters supported the proposal, including commenters representing several medical specialty societies and several health systems. Many of these commenters agreed with the reasons presented in the proposal. These commenters agreed that the current structure of the global surgery codes prevents CMS from accurately valuing and paying for these services, even if CMS had necessary visit data available. Many commenters agreed that the current arrangement may lead to unwarranted payment disparities and that the current packages have not evolved with changes in practice and because of this, likely provide unreliable building blocks for new payment methodologies.

In agreeing with the proposal, MedPAC stated that it “is essential that the individual services that make up a bundle have accurate values and that there is a mechanism to ensure that the services that are part of the bundle are not paid separately (unbundling). Otherwise, the payment rate for the entire bundle will be inaccurate.” MedPAC urged CMS to finalize this proposal and plan to use the more accurate valuations to create more accurate bundles in the future.

Response: We appreciate the commenters' support for the proposal, and agree that there are many reasons why the current construction of the global surgery packages is difficult to reconcile with accurate valuation of individual services within the current payment construct of the PFS. We agree that achieving the agency's goal of greater bundling requires accurate valuation of component services in a surgical procedure.

Comment: Some commenters, including several of those representing specialty societies, urged CMS to postpone finalization of the proposal pending the report of stakeholder efforts to conduct a comprehensive analysis of the effect it would have on the provision of surgical care, surgical patients, and the surgeons who care for them.

Response: We share stakeholders' concerns regarding the potential impact of the change on Medicare beneficiaries and practitioners. However, based upon our analysis and the information that stakeholders have provided, we believe delaying the proposal to further study the problems is not warranted given the significant concerns that have been raised with the current construction of the global surgery packages. Instead, as we articulated in making the proposal, we anticipate that further analysis by stakeholders will contribute to implementing the transition in a manner that accurately values and pays for PFS services. We believe that accurate valuation of services furnished to Medicare beneficiaries is overwhelmingly in the best interest of both beneficiaries and those who care for them.

Comment: We received several comments from commenters who opposed our proposal, and in general these commenters shared the concerns of those who urged a delay in finalizing or implementing the proposal. In addition, some commenters who opposed the proposal disputed our contention that the global periods contribute to unwarranted payment disparities, saying that the increased direct and indirect PE and MP RVUs for E/M services furnished in the global surgical post-operative periods accurately account for the increased PE and MP costs of practitioners who furnish these services relative to practitioners who typically furnish separately reportable E/M services.

Response: Just as we do not agree that we should delay addressing significant problems with valuations while we further study the issues, we do not believe these same issues raised by commenters opposing the proposal are impediments to implementation. The issues relating to valuation of global period E/M services using our PE methodology are just one of several important considerations that led us to propose transforming 10- and 90-day global services to 0-day global packages. We continue to believe the proposed transformation to 0-day global packages is a simple and immediate step to improve the valuation of the various services included in surgical care. However, Medicare remains committed to bundled payment as a mechanism for delivery system reform and we will continue to explore the best way to bundle surgical services, including alternatives to the 0-day global surgical bundle.

Comment: Many commenters who opposed the proposal addressed valuation problems that would exist if the proposal were implemented. Some stated that, were CMS to finalize the proposal to pay for post-surgical E/Ms using the same codes, the PE and MP RVUs for the services would be artificially reduced because the data from other specialties would be incorporated. These commenters suggested CMS should consider how to maintain the current differences in payment for these services even if the proposal were finalized. Some commenters suggested that CMS would need to account for the additional practice expense and malpractice costs for post-operative surgical visits.

Response: We develop and establish work, PE, and MP RVUs for specific services to reflect the relative resource costs involved in furnishing the typical Start Printed Page 67588PFS service. In developing the proposal, we noted that by including a significant number of E/Ms in the global periods for surgical services, the PFS ratesetting methodology distinguishes these services from other E/Ms for purposes of developing PE and MP RVUs, potentially to the advantage of particular specialties with higher PE and MP RVUs. In contrast, the work RVUs for individual, separately billed E/M services furnished, for example, by primary care practitioners are valued more generally as individual services, and values are not maintained separately from the work RVUs for E/Ms furnished by other practitioners. Therefore, we do not agree with commenters that Medicare should establish higher PE and MP values for E/M services furnished in the post-surgical period than for other E/M services.

Comment: Several commenters suggested that CMS should not use the OIG reports to generalize its concerns about the provision of surgical care, because the OIG reports represent only a small sample of observations of specific procedures and specialties. Other commenters suggested that the OIG methodology might be flawed because, since CMS does not require documentation of post-operative visits, many practitioners may not document such visits in the medical record.

Response: We do not have any reason to believe that the OIG findings on the global surgical service packages furnished by particular specialties that the OIG reviewed are not generalizable to other global surgery services. Nor did the commenters provide any evidence that the OIG conclusions are likely to be less accurate than the survey estimates that CMS uses to value the services. Finally, having an incorrect number of postoperative visits is only one of the many valuation problems that have been identified for global surgical packages. Additionally, we find the suggestion that physicians do not document medical visits that are occurring in the post-surgical period to be concerning. As a general matter, Medicare does not require documentation to support a billed service beyond information that the physician would normally maintain in the patient's medical record. Even in the absence of billing Medicare or another insurer, we believe that physicians and other practitioners following standard medical practice would document what occurred during a patient encounter in order to ensure the patient's medical history is accurate and up-to-date, and to facilitate continuity in the patient's medical care.

Comment: One commenter asserted that the 90-day global period was created to prevent two behaviors referred to as “fee-splitting” and “itinerant surgery.” According to the commenter, these terms refer to the practice where a surgeon would provide only the surgery and leave postoperative care to other practitioners. The commenter believes these practices are inconsistent with professional standards, and that it is medically necessary and expected by patients that surgeons will evaluate their patients on a daily basis in the hospital and as needed on an outpatient basis during the recovery period.

Response: We do not believe that the global surgical package was designed to ensure or allocate appropriate post-operative care among practitioners. Under Medicare's current global surgery policy, practitioners can agree on the transfer of care during the global period and, in such cases, modifiers are used in order to split the payment between the procedure and the post-operative care. We do not agree that global surgical packages obligate the surgeon to furnish some or all of the post-operative care. Global surgical packages are valued based on the typical service, and we would not expect every surgery to require the same number of follow-up visits. However, we would expect that over a large number of services, the central tendency would reflect the number of visits we included as typical for purposes of valuing the global package; and as discussed above, we have not found that this is necessarily the case. Even if Medicare maintains the 10- and 90-day global surgery packages, there would be no assurance that the surgeon, and not another practitioner, would furnish all or a certain amount of post-operative care (whether by the patient's choice of practitioner or otherwise). The global payment includes payment for post-operative care with the payment for the surgery, which makes it difficult to know whether or by whom the post-operative care was actually furnished unless there is an official transfer of care. We are confident that the surgical community will continue to furnish appropriate care for Medicare beneficiaries irrespective of changes in the structure of payment for surgical services.

Comment: Several commenters stated that if Medicare adopts a policy to pay for post-operative care using E/M codes rather than through a global package, Medicare will likely pay a higher level of E/M visits when they are separately billed than it does currently, as the existing global packages tend to include more lower level E/M services than those that are generally reported.

Response: We acknowledge that the visits assumed in the global packages are generally valued as lower-level visits than are most commonly furnished, as reflected in Medicare utilization data for separately reportable E/Ms. However, this disparity is only pertinent to the proposal if the global packages are inaccurately valued or, if, under the proposed policy, practitioners who furnish these services are likely to inaccurately report the level of E/M service that is actually being furnished. If the former is true, then we believe this supports the proposal to revalue these services. As with every service, we expect physicians to bill the most appropriate E/M codes that reflect the care that is furnished, including for post-operative care.

Comment: One commenter expressed concern that the proposal to require separate billing for postoperative surgical care provides a basis for the eventual denial of payment to one or more of the postoperative care providers, based on the notion that care furnished by other specialties is duplicative of or replaces care furnished by the surgeon. This commenter stated that multiple providers with differing expertise and training are essential to achieve optimal patient outcomes and expressed concern that this proposal will provide disincentives to optimal patient care.

Response: As we stated in the proposal, we believe that there are various models for postoperative care that can often include multiple providers, and this is another important reason why we believe the services with longer global periods should be transformed to 0-day packages to accommodate heterogeneous models of care that optimize patient outcomes.

Comment: One commenter recommended that CMS establish G-codes for three levels of post-operative visits furnished by the original surgeon or another surgeon with the same board certification, as well as a second set of three level G-codes for postoperative visits furnished by another provider. The commenter also suggested that CMS should develop methods to fairly measure the duration of E/M times through which a large sample of surgeons might report the number and intensity of post-operative visits. The commenter also recommended that CMS track E/M services furnished to surgical patients within the global period by a physician other than the operating surgeon, for the same or similar diagnosis, in order to begin to understand what portion of Start Printed Page 67589postoperative visits are being billed outside of the global period.

The RUC informed CMS that it has identified several large hospital-based physician group practices that internally use CPT code 99024 to report each bundled post-operative visit, and therefore data is already being captured for some Medicare providers. The RUC also suggested that CMS may have denied-claims data available for CPT code 99024 via the Medicare claims processing system. The RUC recommends that CMS work with it to explore the availability, usefulness, and appropriateness of these data from group practices and the CMS denied-claims dataset, in order to gather existing, objective data to validate the actual number of post-operative visits for 10-day and 90-day procedures. The RUC also suggested that CMS should consider reviewing Medicare Part A claims data to determine the length of stay for surgical services furnished in the inpatient acute care hospital setting.

MedPAC stated that data collection could take several years, would be burdensome for CMS and providers, and may be inaccurate since providers would have little incentive to report each visit. Furthermore, MedPAC suggested that such data collection would be unnecessary since the current ratesetting methodology already assumes particular numbers of visits. MedPAC suggested that CMS should reduce the RVUs for the 10- and 90-day global services based on the same assumptions currently used to pay for these services.

Several other commenters agreed with the approach advocated by MedPAC (often referred to as “reverse-building block”) to revaluing the services. These commenters stated that since CMS has increased RVUs for these services proportionate to the number of E/M services assumed to be included in the postoperative period, for the sake of relativity, the RVUs attributed to the visits can be fairly removed in order to value the new 0-day global codes. Many of these commenters acknowledged that this approach would result in negative or other anomalous values for many of these codes, but asserted that codes with anomalous values might then be individually reviewed. MedPAC suggested that if specialty societies or the RUC believe that the new values for specific global codes are inaccurate, they could present evidence that the codes are misvalued to CMS, presumably through the potentially misvalued code public nomination process. MedPAC further states that for codes without accurate post-operative assumptions, CMS could calculate interim RVUs for these codes based on the average percent reduction for other global codes in the same family.

Many other commenters were against the reverse-building block approach to revaluation. These commenters stated that backing out the bundled E/M services would be highly inappropriate and methodologically unsound since the services were not necessarily valued using a building-block methodology. Many of these commenters, including the RUC, stated that the amount of post-operative work included in the codes can only be appropriately surveyed, vetted, and valued by the RUC.

Response: We appreciate the concerns of commenters regarding the difficulty of revaluing the global surgery codes as 0-day global packages. As we stated in making the proposal, we believe that such stakeholder input and participation in any revaluation will be critical to the accuracy of the resulting values. We will consider all of these comments as we consider mechanisms for revaluations and as we propose new values for specific services. We believe that the challenges involved in revaluation, such as those articulated by commenters, reinforce our understanding that the current construction of the 10- and 90-day global packages are not a sustainable, long-term approach to the accurate valuation of surgical care. As noted above, we will continue to explore appropriate ways of bundling global surgical services.

Comment: In general, commenters supporting the proposal also supported CMS's proposed timeframe to transition 10-day global codes and 90-day global codes to 0-day global surgical packages by 2017 and 2018, respectively. In contrast, most commenters objecting to, or articulating reservations about, the proposal urged CMS to slow its implementation. Some of these commenters suggested that the process used to establish the current values for these CPT codes is ideal and stated that it would take many years to value the many individual services using the same methodologies.

The RUC stated that there are over 4,200 services within the PFS with a 10-day or 90-day global period, so the scope of the proposal is very large and the transition should be staggered over many years. However, the RUC also pointed out that most of these services have relatively low utilization, as only 268 of them (or 6 percent of 10- or 90-day global surgery services) were performed more than 10,000 times annually based on 2013 Medicare claims data.

Response: We appreciate the concerns of the commenters. We agree with those commenters who urged us to move quickly to value services as accurately as possible. We note that most comments suggesting a delay in revaluation were based on a common underlying view that code-level review of the full set of services by the RUC based on practitioner surveys is the only appropriate way to value the services.

As we stated in making the proposal, we do not believe that surveying practitioners who furnish each of these services is a practical or necessarily advisable approach to appropriate valuation. Regardless of when the proposal is implemented, it seems likely that the number of codes to be revalued is much larger than the number of codes that should or can be surveyed. Through its normal process, the RUC routinely makes annual recommendations regarding several hundred codes, and we acknowledge that thousands of services cannot be valued using the typical RUC process in one year. On the other hand we believe that there are other options for revaluing some of the global surgery codes as 0-day global packages, particularly those of low volume, and we have indicated a willingness to work with the RUC to determine appropriate mechanisms for revaluations. Therefore, although we agree that revaluing such a high number of codes is a significant undertaking, we do not believe that that the required revaluations would represent an undue burden between the present and the proposed implementation dates. We also note that in order to focus efforts on revaluing the global surgery packages, we are not asking the RUC to review the nearly 100 services we proposed as potentially misvalued this year under the high expenditure screen. We continue to remain interested in other potential data sources for accurately valuing PFS services, especially the vast majority of 10- and 90-day global codes for which there is not significant volume. We also urge stakeholders to engage with us to help us understand why alternative approaches to the revaluation of the 10- and 90-day global services would require the kind of delay that was urged based on the assumption that the RUC survey approach would be used for all those services.

Additionally, we request stakeholders, including the CPT Editorial Panel and the RUC, to consider the utility of establishing and maintaining separate coding and national Medicare RVUs for the many procedures that have little to no utilization in the Medicare population. For example, there are over 1,000 10- Start Printed Page 67590and 90-day global codes with fewer than 100 annual services in the Medicare database. Although we recognize that some portion of these services may be utilized more extensively by non-Medicare payers, it is also likely that many of these codes may reasonably be consolidated. We request that appropriate coding for surgical services be considered as part of revaluing global surgery.

Comment: Many commenters expressed concerns that requiring beneficiary coinsurance for each follow-up visit could dissuade beneficiaries from returning for necessary follow-up care and, therefore, adversely affect surgical outcomes. Many of these commenters acknowledged that overall patient liability for the total amount of care could be reduced, depending on revaluation, but stated that paying separate coinsurance for follow-up care can cause patients to perceive the net payments as larger, given the frequency of payment required. These commenters stated that the magnitude of these problems might be directly proportionate to how sick the patient is.

Response: We understand the concerns of the commenters, but do not agree that Medicare beneficiaries are unlikely to appreciate the difference between frequency of payment and overall financial liability. We also note that the significant majority of patient encounters with Medicare practitioners generate some degree of beneficiary liability. While liability could prompt the proportion of beneficiaries without secondary insurance to forgo medically reasonable and necessary care for the treatment of illness or injury, we have no reason to conclude that this would be the case specifically for post-operative care. We do acknowledge that surgeons may need to explain the importance of follow-up care so that patients understand and appreciate how compliance with follow-up care can improve the overall quality of care and outcomes. As noted above, while our proposal is to move to 0-day global packages as a simple, immediate adjustment, the agency remains committed to bundling as a key component of payment system delivery reform, and we will consider beneficiary impact as we further consider the appropriate size and construction of a surgical bundle.

Comment: Several commenters expressed concerns that the proposal would result in disjointed or inadequate care and/or disrupt surgical registry data. These commenters suggested that neither patients nor alternate providers are as qualified to determine whether or not a postoperative visit by the surgeon is necessary.

Response: As discussed above, we do not agree that patients who require the post-operative care of a surgeon are likely to forgo such care if Medicare changes how we pay the surgeon for furnishing that care. Although several commenters expressed these and similar kinds of concerns, none explained how the proposed change in payment would change post operative care. We continue to believe that surgeons will continue to furnish appropriate post operative care to Medicare beneficiaries, and we do not agree that concerns about increased patient liability or disjointed care are warranted.

Comment: Several commenters expressed concerns over other Medicare payment policies related to surgical procedures. Some commenters stated that the current multiple procedure payment reduction policies that apply to all 0-, 10-, and 90-day global codes are only appropriate for 10-day and 90-day globals due to the overlap in resource costs during the post-operative period. Other commenters noted that potential reductions in payment to surgeons to account for the reduced post-operative period would negatively impact practitioners who assist at surgery despite the fact that their professional work and responsibilities have not changed.

Response: We appreciate the issues raised by these commenters. Again, we seek continued input from the stakeholder community regarding these and other issues that need to be considered in order to implement the transition. In the case of the MPPR, we note there are several hundred 0-day global codes where these payment policies currently apply. We are especially interested in understanding why stakeholders do not believe the policies effective for the current 0-day global codes would not similarly be appropriate for the current 10-and 90-day codes that will be revalued as 0-day global codes.

Comment: Many of the commenters who opposed or expressed concern about the proposal urged CMS to consider the extent to which this proposal would increase the administrative burden on CMS, MACs, and providers. Other commenters urged CMS to consider that post-operative visits would be subject to the same documentation requirements and other scrutiny as other separately-reportable PFS services. One commenter representing other payers opposed the proposal due to concerns about predicting the usage of post-operative services.

Response: We considered the administrative burden on both CMS and practitioners who furnish these services in making the proposal. In both cases, we note the administrative burden would be no greater than the burden associated with the vast majority of other services paid through the Medicare PFS. We do not believe that the burden of separately reporting post-operative follow-up visits is particularly or unduly burdensome, given that most office visits paid through the PFS are separately reported under current Medicare policies. In comparison to the number of separately reported visits and other PFS services, the number of visits that likely occur in post-operative periods is relatively small. We do not agree that there are inherent reasons that medically necessary post-operative visits should be exempt from the same documentation and other requirements applicable to other PFS services. We appreciate that changes in Medicare policy may affect other insurers who choose to base their payments on the PFS; however, it is our obligation to set our policies based upon the needs of Medicare and its beneficiaries.

Comment: A few commenters urged CMS to consider the possibility that there could be confusion among practitioners and payers if some payers continue to base payment on the 10- or 90-day post-operative periods.

Response: We believe that payment policies that are appropriate for Medicare may not always be optimal for all payers. However, we seek continued input and analysis from other payers as we engage stakeholders in developing our implementation strategy for the transition of 10- and 90-day global services to 0-day global services.

Comment: Several commenters urged CMS to consult with stakeholders as we develop appropriate plans for the global period transition. These commenters cautioned that the structural reorganization of these services is challenging due to the large set of services that will be impacted and could potentially disrupt well-established payment for certain providers.

Response: We appreciate these recommendations and agree that we should continue to consult with stakeholders regarding the implementation of this proposal.

After consideration of all the comments received regarding this proposal, we are finalizing the proposal to transition and revalue all 10- and 90-day global surgery services with 0-day global periods, beginning with the 10-day global services in CY 2017 and following with the 90-day global services in CY 2018. We note that as we Start Printed Page 67591develop implementation details, including revaluations, we will take into consideration all of the comments we received to our global surgery proposal. We will provide additional details during the CY 2016 rulemaking. We are finalizing a transformation to 0-day global codes because we believe this is the most straightforward way to improve the accuracy of valuation for the various components of global surgical packages, including pre- and post-operative visits and performance of the surgical procedure. However, we remain committed to delivery system reform and ensuring Medicare makes appropriate payment for bundles of services whether our payment covers a period of 0, 10 or 90 days. As we begin revaluation of services as 0-day globals, we will actively assess whether there is a better construction of a bundled payment for surgical services.

We also actively seek the analysis and perspective of all affected stakeholders regarding the best means to revalue these services as 0-day global codes. We urge all stakeholders to engage with us regarding potential means of making the transition as seamless as possible, both for patient care and provider impact. We are considering a wide range of approaches to all details of implementation from revaluation to communication and transition, and we are hopeful that sufficient agreement can be reached among stakeholders on important issues such as revaluation of the global services and appropriate coding for post-operative care. We remain committed to collecting objective data regarding the number of visits typically furnished during post-operative periods and will explore the extant source options presented by commenters as we consider other options as well.

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

The CPT manual includes more than 300 diagnostic and therapeutic procedures, listed in Appendix G, for which CPT has determined that moderate sedation is an inherent part of furnishing the procedure and, therefore, only the single procedure code is appropriately reported when furnishing the service and the moderate sedation. The work of moderate sedation has been included in the work RVUs for these diagnostic and therapeutic procedures based upon their inclusion in Appendix G. Similarly, the direct PE inputs for these services include those inputs associated with furnishing a typical moderate sedation service. To the extent that moderate sedation is typically furnished as part of the diagnostic or therapeutic service, the inclusion of moderate sedation in the valuation of the procedure is appropriate.

In the CY 2014 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. For example, one study showed that while the use of a separate anesthesia professional for colonoscopies and upper endoscopies was just 13.5 percent in 2003, the rate more than doubled to 30.2 percent in 2009. An analysis of Medicare claims data showed that a similar pattern is occurring in the Medicare program. We found that, for certain types of procedures such as digestive surgical procedures, a separate anesthesia service is furnished 53 percent of the time. For some of these digestive surgical procedures, the claims analysis showed that this rate was as high as 80 percent.

Our data clearly indicated that moderate sedation was no longer typical for all of the procedures listed in CPT's Appendix G, and, in fact, the data suggested that the percent of cases in which it is used is declining. For many of these procedures in Appendix G, moderate sedation continued to be furnished. The trend away from the use of moderate sedation toward a separately billed anesthesia service was not universal. We found that it differed by the class of procedures, sometimes at the procedure code level, and continued to evolve over time. Due to the changing nature of medical practice in this area, we noted that we were considering establishing a uniform approach to valuation for all Appendix G services for which moderate sedation is no longer inherent, rather than addressing this issue at the procedure level as individual procedures are revalued.

We sought public comment on approaches to address the appropriate valuation of these services. Specifically, we were interested in approaches to valuing Appendix G codes that would allow Medicare to pay accurately for moderate sedation when it is furnished while avoiding potential duplicative payments when separate anesthesia is furnished and billed. To the extent that Appendix G procedure values are adjusted to no longer include moderate sedation, we requested suggestions as to how moderate sedation should be reported and valued, and how to remove from existing valuations the RVUs and inputs related to moderate sedation.

We noted that in the CY 2014 PFS final rule with comment period, we established values for many upper gastrointestinal procedures, 58 of which were included in Appendix G. For those interim final values, we included the inputs related to moderate sedation. We stated that we did not expect to change existing policies for valuing moderate sedation as inherent in these procedures until we have the opportunity to assess and respond to the comments on the proposed rule on the overall valuation of Appendix G codes.

We received many helpful suggestions in response to our comment solicitation. At this time, we are not making any changes to how we value Appendix G codes for which moderate sedation is an inherent part of the procedure. We intend to address this topic in future notice and comment rulemaking, taking into account the comments we received. In section II.G. of this CY 2015 PFS final rule with comment period, we address interim final values and establish CY 2015 inputs for the lower gastrointestinal procedures, many of which are also listed in Appendix G.

C. Malpractice Relative Value Units (RVUs)

1. Overview

Section 1848(c) of the Act requires that each service paid under the PFS be comprised of three components: Work; PE; and malpractice (MP) expense. As required by section 1848(c) 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. For CY 2015, we are proposing to implement the third comprehensive review and update of MP RVUs. For details about prior updates, see the CY 2010 final rule with comment period (74 FR 33537).

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

The proposed MP RVUs were calculated by a CMS contractor based on updated MP premium data obtained from state insurance rate filings. The methodology used in calculating the proposed CY 2015 review and update of resource-based MP RVUs largely paralleled the process used in the CY 2010 update. The calculation required using information on specialty-specific MP premiums linked to a specific service based upon the relative risk factors of the various specialties that furnish a particular service. Because MP premiums vary by state and specialty, Start Printed Page 67592the MP premium information were weighted geographically and by specialty. Accordingly, the proposed MP RVUs were based upon three data sources: CY 2011 and CY 2012 MP premium data; CY 2013 Medicare payment and utilization data; and CY 2015 proposed work RVUs and geographic practice cost indices (GPCIs).

Similar to the previous update, we calculated the proposed MP RVUs using specialty-specific MP premium data because they represent the actual expense incurred by practitioners to obtain MP insurance. We obtained and used MP premium data from state departments of insurance rate filings, primarily for physicians and surgeons. When the state insurance departments did not provide data, we used state rate filing data from the Perr and Knight database, which derives its data from state insurance departments. We used information obtained from MP insurance rate filings with effective dates in 2011 and 2012. These were the most current data available during our data collection process.

We collected MP insurance premium data from all 50 States, the District of Columbia, and Puerto Rico. Rate filings were not available in American Samoa, Guam, or the Virgin Islands. Premiums were for $1 million/$3 million, mature, claims-made policies (policies covering claims made, rather than those covering services furnished, during the policy term). A $1 million/$3 million liability limit policy means that the most that would be paid on any claim is $1 million and the most that the policy would pay for claims over the timeframe of the policy is $3 million. We made adjustments to the premium data to reflect mandatory surcharges for patient compensation funds (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) in states where participation in such funds is mandatory. We attempted to collect premium data representing at least 50 percent of the medical MP premiums paid.

We included premium information for all physician and NPP specialties, and all risk classifications available in the collected rate filings. Most insurance companies provided crosswalks from insurance service office (ISO) codes to named specialties. We matched these crosswalks to Medicare primary specialty designations (specialty codes). We also used information we obtained regarding surgical and nonsurgical classes. Some companies provided additional surgical subclasses; for example, distinguishing family practice physicians who furnish obstetric services from those who do not.

Although we collected premium data from all states and the District of Columbia, not all specialties had premium data in the rate filings from all states. Additionally, for some specialties, MP premiums were not available from the rate filings in any state. Therefore, for specialties for which there was not premium data for at least 35 states, and specialties for which there was not distinct premium data in the rate filings, we crosswalked the specialty to a similar specialty, conceptually or by available premium data, for which we did have sufficient and reliable data. Additionally, we crosswalked three specialties—physician assistant, registered dietitian and optometry—for which we had data from at least 35 states to a similar specialty type because the available data contained such extreme variations in premium amounts that we found it to be unreliable. The range in premium amounts for registered dietitians is $85 to $20,813 (24,259 percent), for physician assistants is $614 to $35,404 (5,665 percent), and for optometry is $189 to $10,798 (5,614 percent). We crosswalked these specialties to allergy and immunology, the specialty with the lowest premiums for which we had sufficient and reliable data.

Our proposed methodology for updating the MP RVUs conceptually followed the specialty-weighted approach, used in the CY 2010 update. The specialty-weighted approach bases the MP RVUs for a given service upon a weighted average of the risk factors of all specialties furnishing the service. This approach ensures that all specialties furnishing a given service are accounted for in the calculation of the MP RVUs. We also continued to use the risk factor of the dominant specialty for rarely billed services (that is, when CY 2013 claims data reflected allowed services of less than 100).

We proposed minor refinements for updating the CY 2015 MP RVUs as compared to the previous update. These refinements included calculating a combined national average surgical premium and risk factor for neurosurgery and neurology and updating the list of invasive cardiology service HCPCS codes (for example, cardiac catheterization and angioplasty) to be classified as surgery for purposes of assigning service level risk factors. Additionally, we proposed to classify injection procedures used in conjunction with cardiac catheterization as surgery (for purposes of assigning a service specific risk factor). To calculate the risk factor for TC services we proposed to use the mean umbrella non-physician MP premiums obtained from Radiology Business Management Association (RBMA) survey data, used for the previous MP RVU update in 2010, and adjusted the premium data to reflect the change in non-surgical premiums for all specialties since the previous MP RVU update.

As discussed in the CY 2015 proposed rule (79 FR 40354 through 40355), we did not include an adjustment under the anesthesia fee schedule to reflect updated MP premium information and stated that we intend to propose an anesthesia adjustment for MP in the CY 2016 PFS proposed rule. We also requested comments on how to reflect updated MP premium amounts under the anesthesiology fee schedule.

We posted our contractors report, “Report on the CY 2105 Update of Malpractice RVUs” on the CMS Web site. The report on MP RVUs for the CY 2015 proposed rule and the proposed MP premium amounts and specialty risk factors are accessible from the CMS Web site under the supporting documents section of the CY 2015 PFS proposed rule at http://www.cms.gov/​PhysicianFeeSched/​. A more detailed explanation of our proposed MP RVU update can be found in the CY 2015 PFS proposed rule (79 FR 40349 through 40355).

3. Response to Public Comments

We received over 70 industry comments on the CY 2015 proposed MP RVU update. A summary of the comments we received on the proposed MP RVU update and our responses are discussed below.

Comment: Two commenters supported our proposal to combine the surgical premium data for neurosurgery and neurology for establishing the surgical risk factor for neurosurgery.

Response: We agree with the commenters and will finalize our approach for determining the surgical premium for neurosurgery as proposed. We will combine surgical premiums for neurology and neurosurgery to calculate a national average surgical premium and risk factor for neurosurgery.

Comment: Three commenters requested that we phase in the reduction for ophthalmology and optometry services over 2 years. The commenters stated that the reduction is due in part to an error we made in calculating the MP RVUs for ophthalmology and optometry codes under the previous MP RVU update in CY 2010. The commenters stated that an immediate implementation of the correction would result in significant Start Printed Page 67593payment reductions for ophthalmologists.

Response: We note that for the CY 2015 MP RVU update we did not correct the mistake that was made in CY 2010. For the CY 2015 MP update we recalculated the MP RVUs based upon the most recently available data for all services, including ophthalmic services. Accordingly, the proposed MP RVU update reflects the use of updated MP premium data and risk factors by specialty and is not affected in any way by the CY 2010 MP RVUs. In doing so, even though the proposed CY 2015 ophthalmology non-surgical risk factor was 14 percent greater than the CY 2010 non-surgical risk factor and the proposed surgical risk factor was 17 percent greater, the proposed MP RVUs for most services with significant ophthalmology volume decreased because the CY 2010 error resulted in MP RVUs that were higher than they should have been. That is, the reduction in MP RVUs for ophthalmology and optometry are solely due to overpayments made due to a mistake during the previous MP RVU update rather than a proposed change in methodology or the use of updated premium data. We do not believe that a previous error is sufficient justification for not fully implementing updated MP RVUs based on more recent premium data. Therefore, we will implement the updated MP RVUs for ophthalmology and optometry services as proposed.

Comment: We received comments regarding the application of our specialty weighted approach for calculating service level risk factors for surgical services. For instance, the same commenters that requested a 2-year phase in of the reduction to ophthalmology services also requested that we exclude optometry from calculating the risk factor for ophthalmic surgery. One commenter stated that “MP RVUs for cataract and other ophthalmic surgeries are deflated because CMS assumes that optometry is providing the surgical portion of the procedure.” The commenter also stated that optometrists are involved only during the pre- or post-procedure periods of ophthalmic surgery. Another specialty society stated that it appears that CMS's methodology for calculating service level risk factors for surgical services “may include the allowed services for surgical assistance possibly discounted to reflect the assistant role under payment policy.” The commenter also stated that “specialties that assist at the procedure do not perform it, and the assistant's associated MP risk factor has no bearing on the MP cost for the surgeon.”

Response: The commenter is correct to say that we calculated service level risk factors based on the mix of all practitioners billing for a given service and that the specialty weighted approach is applied to both surgical and non-surgical services . That is, we apply the risk factor(s) of all specialties involved with furnishing the surgical procedure to calculate service level risk factors and MP RVUs. For assistants at surgery, we discount the utilization to reflect his or her role in furnishing the surgical procedure. Although we agree that MP cost for the surgeon may not be affected by the surgical assistant's MP cost, we do not agree with the suggestion that assistants at surgery should be excluded from our specialty weighted approach for determining service level MP risk factors and MP RVUs for surgical services. We believe it is appropriate to apply the specialty risk factor(s) of all practitioners participating in and receiving a payment for the surgical procedure for purposes of determining a service level risk factor and thus the payment for that service. If we were to exclude the risk factors of some specialties that bill a specific code from the calculation of the service level risk factor, the resulting MP RVU would not reflect all utilization. Similarly, we also disagree with the suggestion that pre- and post- utilization should be removed from determining MP RVUs for ophthalmic surgical services. The resources associated with pre- and post-operative periods for ophthalmic surgery are included in the total RVUs for the global surgical package. Accordingly, if we did not include the portion of utilization attributed to pre- and post-operative visits in the calculation of service level risk factors, the MP RVUs for global surgery would overstate the MP costs.

We note that in both of these cases by using the discounted utilization file the weighted average that we use reflects only the proportion of the utilization by these practitioners and only at the payment rate made. Including specialty utilization for all practitioners involved in furnishing the global service reflects the MP risk for the entire global service.

Comment: We received two comments regarding how risk factors are assigned to existing services without Medicare utilization. The commenters stated that we crosswalk to the risk factor of an analogous source code with Medicare utilization for new codes but assign the average risk factor for all physicians to existing services without Medicare utilization. The commenters contend that “it is inappropriate for a service to have fluctuating MP risk factors simply due to whether it is reported in Medicare claims data for a given year.” The commenters requested that we crosswalk existing services without Medicare utilization to a recommended source code.

Response: We used the most recently available Medicare claims data (that is, from CY 2013) to determine the service level risk factors, either based on the risk factors of the actual mix of practitioners furnishing the service, or in the case of low volume services, the risk factor of the dominant specialty. We disagree with the commenters' suggestion to assign the risk factor of a recommended specialty to an existing service without Medicare utilization as indicated by our most recently available claims data. In the absence of Medicare utilization we continue to believe that the most appropriate risk factor is the weighted average risk factor for all service codes. The proposed weighted average risk factor for all service codes was 2.11. Using the weighted average risk factor for all services effectively neutralizes the impact of updated MP premiums and risk factors for any specific specialty (or mix of specialties).

Comment: The AMA and the RUC and other commenters agreed with the majority of our proposed claims based dominant specialty designations for codes with less than 100 allowed services; however, the commenters disagreed with our proposed dominant specialty for some services. The commenters believe that some claims have been miscoded, resulting in erroneous specialty designations. One commenter stated that using the dominant specialty from the claims data resulted in unjustifiably low MP RVUs for congenital heart surgery. The commenter stated that congenital heart surgery can only be done by a heart surgeon and requested that we override the dominant specialty in our claims data and use the RUCs recommended specialty.

Response: As discussed in the previous response, we proposed to use CY 2013 claims data to determine the service level MP risk factors, either based on the mix of practitioners furnishing the service, or in the case of low volume services, assigning the risk factor of the dominant specialty. We continue to believe that use of actual claims data to determine the dominant specialty is preferable to using a “recommended” specialty. However, we recognize that anomalies in the claims data can occur that would affect the dominant specialty for low volume services, and therefore resulting in the need for a subjective review of some services in place of a complete reliance on claims data. To that end, we Start Printed Page 67594reviewed the commenter's recommendations for overriding the dominant specialty from our claims data with a recommended specialty. After careful consideration of the comments, we will override the dominant specialty from Medicare claims data when the dominant specialty from our claims data is inconsistent with a specialty that could be reasonably expected to furnish the service. For example, our claims data indicates that pulmonary disease is the dominant specialty for HCPCS code 33622 (Reconstruction of complex cardiac anomaly), however as the commenter mentioned, this service is furnished by heart surgeons. A complete listing of low volume services for which we will override the claims based dominant specialty with the recommended specialty to assign a service level risk factor is illustrated in Table 12.

Table 12—Low Volume Service Codes Where Assigned Specialty Used Rather Than Claims Based Dominant Specialty

HCPCS CodeShort descriptorClaims based dominant specialtyAssigned specialty
25490Reinforce radiusOtolaryngologyOrthopedic Surgery.
26556Toe joint transferPulmonary DiseaseOrthopedic Surgery.
31320Diagnostic incision larynxCardiologyOtolaryngology.
33620Apply r&l pulm art bandsAnesthesiologyCardiac Surgery.
33621Transthor cath for stentCardiologyCardiac Surgery.
33622Redo compl cardiac anomalyPulmonary DiseaseCardiac Surgery.
33697Repair of heart defectsCardiologyCardiac Surgery.
33766Major vessel shuntGeneral SurgeryCardiac Surgery.
36261Revision of infusion pumpGeneral PracticeGeneral Surgery.
43341Fuse esophagus & intestineGastroenterologyThoracic Surgery.
43350Surgical opening esophagusGeneral PracticeGeneral Surgery.
49491Rpr hern preemie reducGeneral PracticeGeneral Surgery.
50686Measure ureter pressureInternal MedicineUrology.
54352Reconstruct urethra/penisPediatric MedicineUrology.
54380Repair penisGastroenterologyUrology.
61000Remove cranial cavity fluidFamily PracticeNeurosurgery.
61558Excision of skull/suturesFamily PracticeNeurosurgery.
61567Incision of brain tissueCardiologyNeurosurgery.
74710X-ray measurement of pelvisThoracic SurgeryDiagnostic Radiology.
96003Dynamic fine wire emgCardiologyPhysical Therapist/Independent Practice.
96420Chemo ia push techniqueUrologyHematology Oncology.
99170Anogenital exam child w imagOphthalmologyPediatric Medicine.
99461Init nb em per day non-facCardiac ElectrophysiologyPediatric Medicine.

Comment: Some commenters requested that we crosswalk gynecological oncology to general surgery, instead of crosswalking to obstetrics/gynecology because gynecological oncology is more akin to general surgery procedures than obstetrics/gynecology. One specialty society stated that gynecological oncologists are predominantly cancer surgeons with MP risk similar to general surgery.

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

Comment: One commenter requested that we crosswalk clinical laboratory to pathology instead of the risk factor used for TC services because clinical laboratories and pathologists render essentially identical medical procedures that are paid on the Medicare PFS.

Response: We believe that the MP risk for clinical laboratories is more akin to the MP risk of radiation therapy centers, mammography screening centers and IDTFs, for which we assigned the TC risk factor, than to the MP risks for pathologists. The commenters did not provide sufficient rationale to support that MP risk for clinical laboratories is similar to the MP risk of pathologists. Therefore, we will crosswalk clinical laboratory to the TC risk factor as proposed.

Comment: One commenter encouraged us to crosswalk the interventional pain management specialty to a specialty that more closely reflects the risks and services associated with interventional pain management, such as interventional radiology or a comparable surgical subspecialty.

Response: We believe that the MP risk associated with interventional pain management is conceptually similar to the MP risk for anesthesiology more so than to the MP risk for interventional radiology. Given that the commenters did not provide sufficient rationale to support that MP risk for interventional pain management is similar to interventional radiology or to a comparable surgical specialty, we will crosswalk interventional pain management to anesthesiology as proposed.

Comment: We received contrasting comments on our proposal to crosswalk NPPs to the premium and risk factor calculated for allergy/immunology. For instance, one commenter acknowledged the difficulty in identifying comprehensive, accurate premium data across the majority of states, especially for NPPs. To that end, the commenter supported our decision to crosswalk the MP premiums of NPPs to the lowest physician risk factor, allergy/immunology. Another commenter, specifically supported crosswalking registered dieticians to the risk factor calculated for allergy/immunology.

In contrast, the AMA and other commenters did not support crosswalking NPPs with insufficient or unreliable premium data to the premium amounts and risk factor used for allergy/immunology. The commenters stated that allergy/immunology premiums overstate NPP premiums and requested that we use the generally lower MP survey data from the Physician Practice Information Survey (PPIS) for NPPs instead of crosswalking NPPs to the lowest physician specialty (allergy/immunology) or use some other measure of central tendency within the existing collected premium data to determine accurate MP premium risk factors for NPPs. Another commenter suggested that we work with the AMA Start Printed Page 67595to obtain the necessary data to ensure the process for reviewing and updating MP rates is accurate for all providers.

Response: As discussed previously in this section, the resource-based MP RVUs are based on verifiable MP premium data. We do not believe it would be appropriate to base the MP RVUs for nonphysician specialties on survey data and use premium data for all other specialties. Therefore, we do not agree with the commenters that suggested using survey data for NPPs and will finalize the specialty crosswalks for NPPs as proposed. However, in light of the commenter's suggestions, we will explore ways to enhance our MP premium data collection efforts to obtain better premium data for NPPs for future updates. We will also explore other potential measures of central tendency for determining the “indexed” specialty as an alternative to using the premium values of the lowest specialty.

Comment: We received two comments regarding the data and or methodology used to calculate the TC and PC of diagnostic services. One specialty group noted that the proposed MP RVUs for the TC of some diagnostic services increased while the MP RVUs for the PC decreased. Specifically, the commenter questioned why the MP RVUs for the PC of diagnostic cardiac catheterization as described by HCPCS codes 93451 through 93461 decreased by 6 to 12 percent while the TC portion for these codes increased by 20 to 33 percent. The commenter encouraged us to review the reasons for this shift to TC MP RVUs. Additionally, the RBMA submitted updated MP premium information collected from IDTFs in 2014. The RBMA requested that we use the recently obtained data reflecting the median “50th percentile” premium data for “umbrella non-physician MP liability” for calculating CY 2015 MP RVUs for TC services.

Response: To calculate the risk factor for TC services we used the mean umbrella non-physician MP premiums obtained from the RBMA survey data (used for the previous MP RVU update in 2010) and adjusted the data to reflect the change in non-surgical premiums for all specialties since the previous MP RVU update, for example, $9,374 deflated by −20.41 percent = $7,455. However, given that the premiums of the lowest physician specialty (allergy/immunology) decreased by more than 20 percent, the proposed CY 2015 risk factor for TC services increased from the previous update in CY 2010 from 0.86 to 0.91, resulting in minor increases in MP RVUs for TC services. However, given that the MP RVUs for TC services are generally low, any increase to the MP RVUs could result in a significant percentage increase. For example, the proposed CY 2015 MP RVU for HCPCS code 93455 increased from 0.04 to 0.05 yielding a 25 percent increase. Therefore, a minor increase in MP RVUs for a TC service could result in a significant percentage change.

We believe that using the updated RBMA premium data without further study is problematic because the updated data reflects only the median umbrella non-physician MP premium, rather than the mean as was used for the 2010 MP RVU update and the proposed 2015 MP RVU update.

We believe further study is necessary to reconcile comments on the use of updated RBMA premium data for TC services (which would result in an increase MP RVU for TC services) and our current methodology for calculating the risk factor for PC services relative to the global service and TC service. Therefore, we will finalize the TC premium data as proposed and maintain our current methodology for calculating the PC risk factor. We will consider the request to use the updated premium information from RBMA and alternatives to our current methodology for calculating the PC risk factor as part of our further study and would propose any changes through future rulemaking.

Comment: Several commenters supported our proposal to classify cardiac catheterization and angioplasty services as surgical procedures for the purpose of establishing service level risk factors. The commenters also agreed with our proposal to apply the surgical risk factor to injection procedures used in conjunction with cardiac catheterization. The same commenters identified additional cardiac catheterization and angioplasty services that were not included on the proposed list of invasive cardiology services. Specifically, the commenters requested that we consider adding HCPCS codes 92961, 92986, 92987, 92990, 92992, 92993, 92997, and 92998 to the list of invasive cardiology procedures classified as surgery for purposes of assigning service level risk factors because the MP risk for these services is similar to surgery.

Response: We agree that the MP risk associated with the cardiac catheterization and angioplasty services mentioned by the commenters are more akin to surgical procedures than most non-surgical services. Therefore, we will add cardiac catheterization and angioplasty services as described by HCPCS codes 92961, 92986, 92987, 92990, 92997, and 92998 to the list of services outside of the surgical HCPCS code range to be considered surgery for purposes of assigning service level MP risk factors. We note that HCPCS codes 92992 and 92993 are contractor-priced codes, wherein the Medicare claims processing contractors establish RVUs and payment amounts for these services. Therefore, we are not adding HCPCS codes 92992 and 92993.

Comment: One commenter stated that several injection codes were not included in the list of services outside of the surgical HCPCS code range considered surgery. The commenter requested that we add injection services as described by HCPCS codes 93565, 93566, 93567, and 93568 to the services considered as surgery.

Response: The commenter is mistaken. As discussed in the CY 2015 proposed rule (79 FR 40353 through 40354), we included the injection procedure codes mentioned by the commenter on the list of services outside of the surgical HCPCS code range to be considered surgery for purposes of assigning service level MP risk factors.

Comment: One commenter questioned why the MP RVUs decrease for cardiac catheterization services as described by HCPCS codes 93530, 93531 and 93580. The commenter stated that our proposal to assign the surgical risk factor to invasive cardiology services outside of the surgical HCPCS code range should result in an increase in MP RVUs.

Response: Cardiac catheterizations as described by HCPCS codes 93530, 93531 and 93580 are currently on the list of invasive cardiology services classified as surgery for purposes of assigning service level risk factors. Therefore, the MP RVUs for HCPCS codes 93530, 93531, 93580 were calculated in the last update using the surgical risk factor applicable to the specialty(s) furnishing these services. As discussed previously in this section, the service level risk factors reflect the average risk factor (weighted by allowed services) of the specialties furnishing a given service. Changes in the specialty mix since the previous MP RVU update in 2010 resulted in a decrease in MP RVUs for HCPCS codes 93530, 93531, and 93580. That is, the percentage of allowed services attributed to cardiology decreased for these service codes while the percentage of allowed services furnished by other specialties with risk factors lower than cardiology, such as internal medicine and pediatric medicine, increased.

Comment: Many commenters requested an explanation as to why the MP RVUs decreased for 4 out of the 6 newly bundled image guided breast biopsy procedures. The commenters Start Printed Page 67596stated that given that the MP RVUs assigned to breast biopsy codes are being reduced, CMS is not appropriately capturing the risk a physician assumes when performing a procedure to diagnose cancer. Several commenters also explained that the misdiagnosis of breast cancer is a leading source of MP litigation and that reduction in payment for breast biopsies will have an impact on patient care.

Response: For the image guided breast biopsy procedures as described by HCPCS codes 19081 through 19086, we used the risk factors from source codes as recommended by the RUC. The source codes for breast biopsy codes 19081, 19082, 19083, 19084, 19085 and 19086 are HCPCS codes 32553, 64480, 32551, 64480, 36565, and 76812, respectively. Given that the proposed risk factors for HCPCS codes 32553, 64480, and 32551 decreased from 2014 to 2015, the corresponding “destination” service codes, that is HCPCS codes 19081, 19082, 19083, and 19084 also decreased.

Comment: Several commenters recommended that we implement an annual collection and review of MP premium data and rescale the MP RVUs each year, as we do with the PE RVUs. The commenters also stated that an annual update would provide additional transparency and allow stakeholders to identify potential problems and or improvements to MP RVUs more frequently.

Response: We appreciate the comments from stakeholders regarding the frequency that we currently review changes in MP premium data. As discussed in the CY 2015 PFS proposed rule (79 FR 40349 through 40355), there are two main aspects to the update of MP RVUs, recalculation of specialty risk factors based upon updated premium data and recalculation of service level RVUs based upon the mix of practitioners providing the service. We will consider the recommendation from stakeholders to conduct annual MP RVU updates to reflect corrections and changes in the mix of practitioners providing services. We will also consider the appropriate frequency for collecting new MP premium data. After reviewing these issues, we would address potential changes regarding the frequency of MP RVU updates in a future proposed rule.

Comment: One commenter urged us to calculate risk factors for all specialties approved by the American Board Medical Specialties (ABMS) since 2010. The commenter stated that by using the approved ABMS specialties, all specialties and subspecialties will be represented, including the recently approved sub-specialty of Female Pelvic Medicine and Reconstructive Surgery.

Response: We calculate service level risk factors based on the mix of specialties that furnish a given service as indicated by our claims data. Medicare claims data reflects the service volume by Medicare primary specialty designations. Therefore, we can only use MP risk factors by Medicare primary specialty codes.

Comment: We received two comments regarding our discussion of how to reflect updated MP premium data under the anesthesiology fee schedule. One commenter supported our decision to delay the anesthesia MP update and requested to work with us on developing an appropriate method for updating the MP component associated with anesthesia fee schedule services. Another commenter suggested using mean anesthesia MP premiums per provider over a 4- or 5-year period prorated by Medicare utilization to yield the MP expense for anesthesia services. The commenter stated that the calculation of premiums over a longer period of time renders the average more accurate and less volatile than a calculation over a 1-year period.

Response: We appreciate the comments on our potential approach for updating the MP resource costs for anesthesia fee schedule services. We will consider the commenter's suggestions to use multi-year average premiums as we develop a method for updating MP payments for services paid on the anesthesia fee schedule.

4. Result of Evaluation of Comments

After consideration of the public comments received on the CY 2015 MP RVU update, we are finalizing the CY 2015 MP RVU update as proposed with minor modifications. We are crosswalking gynecological oncology to the risk factor for general surgery (instead of the risk factor for obstetrics gynecology). We are also adding HCPCS codes 92961, 92986, 92987, 92990, 92997, and 92998 to the list of services outside of the surgical HCPCS code range considered as surgery for purposes of assigning service level risk factors. Additionally, for determining the risk factor for low volume services, we are overriding the dominant specialty from our claims data with the recommended specialty for the low volume service codes listed in Table 12. For all other low volume services, we are finalizing our proposal to use the risk factor of the dominant specialty from our Medicare claims data. The MP premium amounts, specialty risk factors, and a complete list of service codes outside the surgical HCPCS code range considered surgery for the purpose of assigning service level risk factors, may be found on the CMS Web site under the supporting documents section of the CY 2015 PFS final rule with comment period.

Additional information on the CY 2015 update may be found in our contractor's report, “Final Report on the CY 2105 Update of Malpractice RVUs,” which is available on the CMS Web site. It is also located under the supporting documents section of the CY 2015 PFS final rule with comment period located at http://www.cms.gov/​PhysicianFeeSched/​.

D. Geographic Practice Cost Indices (GPCIs)

1. Background

Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure relative cost differences among localities compared to the national average for each of the three fee schedule components (that is, work, PE, and MP). Although the statute requires that the PE and MP GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in frontier states (as defined in section 1848(e)(1)(I) of the Act) beginning January 1, 2011. Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor for the work GPCIs, which was set to expire on March 31, 2014. However, section 102 of the PAMA extended application of the 1.0 floor to the work GPCI through March 31, 2015.

Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. Section 1848(e)(1)(C) of the Act requires that “if more than 1 year has elapsed since the date of the last previous adjustment, the adjustment to be applied in the first year of the next adjustment shall be 1/2 of the adjustment that otherwise would be made.” We completed a review and finalized updated GPCIs in the CY 2014 PFS final rule with comment period (78 FR 74390). Since the last GPCI update had been implemented over 2 years prior, CY 2011 and CY 2012, we phased in 1/2 of the latest GPCI adjustment in CY 2014. We also revised the cost share Start Printed Page 67597weights that correspond to all three GPCIs in the CY 2014 PFS final rule with comment period. We calculated a corresponding geographic adjustment factor (GAF) for each PFS locality. The GAFs are a weighted composite of each area's work, PE and MP GPCIs using the national GPCI cost share weights. Although the GAFs are not used in computing the fee schedule payment for a specific service, we provide them because they are useful in comparing overall areas costs and payments. The actual effect on payment for any actual service will deviate from the GAF to the extent that the proportions of work, PE and MP RVUs for the service differ from those of the GAF.

As previously noted, section 102 of the PAMA extended the 1.0 work GPCI floor through March 31, 2015. Therefore, the CY 2015 work GPCIs and summarized GAFs were revised to reflect the 1.0 work floor. Additionally, as required by sections 1848(e)(1)(G) and 1848(e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier states are permanent, and therefore, applicable in CY 2015.

Comment: A few commenters requested that we extend the 1.0 work GPCI floor beyond March 31, 2015.

Response: As discussed in section II.D.1, the 1.0 work GPCI floor is established by statute and expires on March 31, 2015. We do not have authority to extend the 1.0 work GPCI floor beyond March 31, 2015.

As discussed in the CY 2014 PFS final rule with comment period (78 FR 74380) the updated GPCIs were calculated by a contractor to CMS. We used updated Bureau of Labor and Statistics Occupational Employment Statistics (BLS OES) data (2009 through 2011) as a replacement for 2006 through 2008 data for purposes of calculating the work GPCI and the employee compensation component and purchased services component of the PE GPCI. We also used updated U.S. Census Bureau American Community Survey (ACS) data (2008 through 2010) as a replacement for 2006 through 2008 data for calculating the office rent component of the PE GPCI. To calculate the MP GPCI we used updated malpractice premium data (2011 and 2012) from state departments of insurance as a replacement for 2006 through 2007 premium data. We also noted that we do not adjust the medical equipment, supplies and other miscellaneous expenses component of the PE GPCI because we continue to believe there is a national market for these items such that there is not a significant geographic variation in relative costs. Additionally, we updated the GPCI cost share weights consistent with the modifications made to the 2006-based MEI cost share weights in the CY 2014 final rule with comment period. As discussed in the CY 2014 final rule with comment period, use of the revised GPCI cost share weights changed the weighting of the subcomponents within the PE GPCI (employee wages, office rent, purchased services, and medical equipment and supplies). For a detailed explanation of how the GPCI update was developed, see the CY 2014 final rule with comment period (78 FR 74380 through 74391).

2. Proposed Changes to the GPCI Values for the Virgin Islands Payment Locality

As discussed in the CY 2015 proposed rule (79 FR 40355 through 40356) the current methodology for calculating locality level GPCIs relies on the acquisition of county level data (when available). Where data for a specific county are not available, we assign the data from a similar county within the same payment locality. The Virgin Islands have county level equivalents identified as districts. Specifically, the Virgin Islands are divided into 3 districts: Saint Croix; Saint Thomas; and Saint John. These districts are, in turn, subdivided into 20 sub-districts. Although the Virgin Islands are divided into these county equivalents, county level data for the Virgin Islands are not represented in the BLS OES wage data. Additionally, the ACS, which is used to calculate the rent component of the PE GPCI, is not conducted in the Virgin Islands, and we have not been able to obtain malpractice insurance premium data for the Virgin Islands payment locality. Given the absence of county level wage and rent data and the insufficient malpractice premium data by specialty type, we have historically set the three GPCI values for the Virgin Islands payment locality at 1.0.

For CY 2015, we explored using the available data from the Virgin Islands to more accurately reflect the geographic cost differences for the Virgin Islands payment locality as compared to other PFS localities. Although county level data for the Virgin Islands are not represented in the BLS OES wage data, aggregate territory level BLS OES wage data are available. We believe that using aggregate territory level data is a better reflection of the relative cost differences of operating a medical practice in the Virgin Islands payment locality as compared to other PFS localities than the current approach of assigning a value of 1.0. At our request, our contractor calculated the work GPCI, and the employee wage component and purchased services component of the PE GPCI, for the Virgin Islands payment locality using aggregated 2009 through 2011 BLS OES data.

As discussed in this section, the ACS is not conducted in the Virgin Islands and we have not been able to obtain malpractice premium data for the Virgin Islands payment locality. Therefore, we assigned a value of 1.0 for the rent index of the PE GPCI and to the MP GPCI.

Using aggregate territory-level BLS OES wage data resulted in a −2.3 percent decrease in the work GPCI, a −4.48 percent decrease in the PE GPCI and a −3.2 percent decrease to the GAF for the Virgin Islands payment locality. However, with the application of the 1.0 work GPCI floor, there is no change to the work GPCI and the overall impact of using actual BLS OES wage data on the Virgin Islands payment locality is only reflected by the change in PE GPCI (−4.48 percent) resulting in a −2.00 percent decrease to the GAF. As mentioned previously in this section, since we have not been able to obtain malpractice premium data for the Virgin Islands payment locality we maintained the MP GPCI at 1.0. As such, we did not propose any changes to the MP GPCI.

We requested comments on our proposal to use aggregate territory-level BLS OES wage data to calculate the work GPCI and the employee wage component and purchased services component of the PE GPCI for the Virgin Islands payment locality beginning for CY 2015, and for future GPCI updates. However, we did not receive any specific comments on this proposal. As discussed above, we believe that using aggregate territory level BLS OES wage data is a better reflection of the relative cost differences of operating a medical practice in the Virgin Islands payment locality as compared to other PFS localities than the current approach of assigning a value of 1.0. Therefore, we will finalize the changes to the GPCI values for the Virgin Islands payment locality as proposed. See Addenda D and E for the CY 2015 GPCIs and summarized GAFs. Additional information on the changes to GPCI values for the Virgin Islands payment locality may be found in our contractor's report, “Revised Final Report on the CY 2014 Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule,” which is available on the CMS Web site. It is located under the supporting documents section of the CY 2015 PFS final rule with comment period located at http://www.cms.gov/​PhysicianFeeSched/​.Start Printed Page 67598

3. Additional Comments

We received several comments on topics that are not within the scope of proposals in the CY 2015 PFS proposed rule. These comments are briefly discussed below.

Comment: Many commenters continued to request an increase in the GPCI values for the Puerto Rico payment locality. The commenters stated that the cost of practicing medicine in Puerto Rico continues to rise. The commenters believe that commercial rent and utility costs, and the cost of obtaining medical equipment and supplies are higher in Puerto Rico than many states and territories. Commenters contend that the data used to calculate GPCIs do not accurately reflect the cost of operating a medical practice in Puerto Rico.

Response: Aside from proposing to use territory-wide wage data for the Virgin Islands payment locality, we finalized the methodology and values for the 7th GPCI update in the CY 2014 PFS final rule with comment period. We did not propose any changes to the GPCIs for the Puerto Rico payment locality, and the commenters on the CY 2015 PFS proposed rule raised the same issues they raised in response to the proposed GPCI update that we finalized in CY 2014. In the CY 2014 PFS final rule with comment period (78 FR 74380 through 74391), we summarized these comments and responded to these issues.

Comment: A few commenters stated that GPCIs for rural areas are too low which leads to reduced numbers of rural practitioners and reduced access to care. Two commenters stated that the PE GPCI does not account for differences in practice costs for x-rays and imaging studies. The same commenters and another commenter also requested that we replace the current method for calculating the work GPCIs with one that reflects the labor market for physicians and other health professionals as recommended by MedPAC. Another commenter raised questions about state patient compensation fund surcharges for malpractice insurance and the implications of those for the MP GPCI values. Additionally, we received a comment about the physician fee schedule payment localities.

Response: As noted in this section, we finalized the 7th GPCI update in the CY 2014 PFS final rule with comment period and, other than the proposal relating to the use of territory-wide wage data for the Virgin Islands payment locality, we did not propose any further changes in the CY 2015 PFS proposed rule. We will consider these points raised by commenters when we develop a proposal for the 8th GPCI update.

E. Medicare Telehealth Services

1. Billing and Payment for Telehealth Services

Several conditions must be met in order for Medicare payments to be made for telehealth services under the PFS. Specifically, the service must be on the list of Medicare telehealth services and meet all of the following additional requirements for coverage:

  • The service must be furnished via an interactive telecommunications system.
  • The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.
  • The service must be furnished to an eligible telehealth individual.
  • The individual receiving the services must be in an eligible originating site.

When all of these conditions are met, Medicare pays an originating site fee to the originating site and provides 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 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 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 regulations at § 410.78(a)(1), store-and-forward means the asynchronous transmission of medical information from an originating site to be reviewed at a later time by the practitioner at the distant site.

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 means an individual enrolled under Part B who receives a telehealth service furnished at an 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 Medicare Administrative Contractors 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 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 areas (MSAs).

Historically, we have defined rural HPSAs to be those located outside of MSAs. Effective January 1, 2014, we modified the regulations regarding Start Printed Page 67599originating sites to define rural HPSAs as those located in rural census tracts as determined by the Office of Rural Health Policy (ORHP) 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 www.cms.gov/​telehealth/​.

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 eligibility for an originating site would be established and maintained on an annual basis, consistent with other telehealth payment policies (78 FR 74400). Geographic eligibility 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 December 31, 2002 Federal Register (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services. This process provides the public with an ongoing opportunity to submit requests for adding services. 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 November 28, 2011 Federal Register (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 with the beneficiary in the originating site. We also look for similarities in the telecommunications system used to deliver the proposed service; for example, the use of interactive audio and video equipment.
  • Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests includes an assessment of whether the service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benefit to the patient. In reviewing these requests, we look for evidence indicating that the use of a telecommunications system in furnishing the candidate telehealth service produces 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 improves 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 covered telehealth services, see the CMS Web site at www.cms.gov/​teleheath/​. 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 2014 will be considered for the CY 2016 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, requestors 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 www.cms.gov/​telehealth/​.

3. Submitted Requests to the List of Telehealth Services for CY 2015

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 with respect to 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, the criteria also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.

a. Submitted Requests

We received several requests in CY 2013 to add various services as Medicare telehealth services effective for CY 2015. The following presents a discussion of these requests, and our proposals for additions to the CY 2015 telehealth list. Of the requests received, we find that the following services are sufficiently similar to psychiatric diagnostic procedures or office/outpatient visits currently on the telehealth list to qualify on a category one basis. Therefore, we propose to add the following services to the telehealth list on a category 1 basis for CY 2015:

  • CPT codes 90845 (Psychoanalysis); 90846 (family psychotherapy (without the patient present); and 90847 (family psychotherapy (conjoint psychotherapy) (with patient present);
  • CPT codes 99354 (prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (list separately in addition to code for office or other outpatient evaluation and management service); and, 99355 (prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (list Start Printed Page 67600separately in addition to code for prolonged service); and,
  • HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service (pps), initial visit; and, G0439 (annual wellness visit, includes a personalized prevention plan of service (pps), subsequent visit).

We also received requests to add services to the telehealth list that do not meet our criteria for being on the Medicare telehealth list. We did not propose to add the following procedures for the reasons noted:

  • CPT codes 92250 (fundus photography with interpretation and report); 93010 (electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), 93307 (echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, complete, without spectral or color Doppler echocardiography; 93308 (echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, follow-up or limited study); 93320 (Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); complete); 93321 (Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); follow-up or limited study (list separately in addition to codes for echocardiographic imaging); and 93325 (Doppler echocardiography color flow velocity mapping (list separately in addition to codes for echocardiography). These services include a technical component (TC) and a professional component (PC). By definition, the TC portion of these services needs to be furnished in the same location as the patient and thus cannot be furnished via telehealth. The PC portion of these services could be (and typically would be) furnished without the patient being present in the same location. (Note: For services that have a TC and a PC, there is sometimes an entirely different code that is used when only the PC portion of the service is being furnished, and other times the same CPT code is used with a -26 modifier to indicate that only the PC is being billed.) For example, the interpretation by a physician of an actual electrocardiogram or electroencephalogram tracing that has been transmitted electronically, can be furnished without the patient being present in the same location as the physician. Given the nature of these services, it is not necessary to consider including the PC of these services for addition to the telehealth list. When these PC services are furnished remotely, they do not meet the definition of Medicare telehealth services under section 1834(m) of the Act. Rather, these remote services are considered physicians' services in the same way as services that are furnished in-person without the use of telecommunications technology; they are paid under the same conditions as in-person physicians' services (with no requirements regarding permissible originating sites), and should be reported in the same way as other physicians' services (that is, without the -GT or -GQ modifiers).
  • CPT codes 96103 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, eg, MMPI), administered by a computer, with qualified health care professional interpretation and report); and, 96120 (neuropsychological testing (eg, Wisconsin Card Sorting Test), administered by a computer, with qualified health care professional interpretation and report). These services involve testing by computer, can be furnished remotely without the patient being present, and are payable in the same way as other physicians' services. These remote services are not Medicare telehealth services as defined under the Act; therefore, we need not consider them for addition to the telehealth list, and the restrictions that apply to telehealth services do not apply to these services.
  • CPT codes 90887 (interpretation or explanation of results of psychiatric, other medical examinations and procedures, or other accumulated data to family or other responsible persons, or advising them how to assist patient); 99090 (analysis of clinical data stored in computers (eg, ECGs, blood pressures, hematologic data); 99091 (collection and interpretation of physiologic data (eg, ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time); 99358 (prolonged evaluation and management service before and/or after direct patient care; first hour); and 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). These services are not separately payable by Medicare. It would be inappropriate to include services as telehealth services when Medicare does not otherwise make a separate payment for them.
  • CPT codes 96101 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, eg, 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, eg, 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 (eg, 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 (eg, 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). These services are not similar to other services on the telehealth list, as they require close observation of how a patient responds. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we did not propose to add these services to the list of telehealth services.
  • CPT codes 57452 (colposcopy of the cervix including upper/adjacent vagina; 57454 colposcopy of the cervix including upper/adjacent vagina; with biopsy(s) of the cervix and endocervical curettage); and, 57460 (colposcopy of the cervix including upper/adjacent vagina; with loop electrode biopsy(s) of the cervix). These services are not similar to other services on the telehealth service list. Therefore, it would not be appropriate to add them on a category 1 basis. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we did not propose to add these services to the list of telehealth services.
  • HCPCS code M0064 (brief office visit for the sole purpose of monitoring or changing drug prescriptions used in the treatment of mental psychoneurotic Start Printed Page 67601and personality disorders) is being deleted for CY 2015. This code was created specifically to describe a service that is not subject to the statutory outpatient mental health limitation, which limited payment amounts for certain mental health services. Section 102 of the Medicare Improvements for Patients and Providers Act (Pub. L. 110- 275, enacted on July 15, 2008) (MIPPA) required that the limitation on payment for outpatient mental health treatment to 62.5 percent of incurred expenses, in effect since the inception of the Medicare program, be reduced over four years. This limitation on payment for mental health treatment created a higher share of beneficiary coinsurance for these services than for most other Medicare services paid under the PFS. Effective January 1, 2014, 100 percent of expenses incurred for mental health treatment services are considered as incurred for purposes of Medicare, resulting in the same beneficiary cost sharing for these services as for other PFS services. Since the statute was amended to phase out the limitation, and the phase-out was complete effective January 1, 2014, Medicare no longer has a need to distinguish services subject to the mental health limitation from those that are not. Accordingly, the appropriate CPT code can now be used to bill Medicare for the services that would have otherwise been reported using M0064 and M0064 will be eliminated as a telehealth service, effective January 1, 2015.
  • Urgent Dermatologic Problems and Wound Care—The American Telemedicine Association (ATA) cited several studies to support adding dermatology services to the telehealth list. However, the request did not include specific codes. Since we did not have specific codes to consider for this request, we cannot evaluate whether the services are appropriate for addition to the Medicare telehealth services list. We note that some of the services that the requester had in mind may be billed under the telehealth office visit codes or the telehealth consultation G-codes.

In summary, we proposed to add the following codes to the telehealth list on a category 1 basis:

  • Psychotherapy services CPT codes 90845, 90846 and 90847.
  • Prolonged service office CPT codes 99354 and 99355.
  • Annual wellness visit HCPCS codes G0438 and G0439.

3. Modifying § 410.78 Regarding List of Telehealth Services

As discussed in section II.E.2. of this final rule with comment period, under the statute, we created an annual process for considering the addition of services to the Medicare telehealth list. Under this process, we propose services to be added to the list in the proposed rule in response to public nominations or our own initiative and seek public comments on our proposals. After consideration of public comments, we finalize additions to the list in the final rule. We have also revised § 410.78(b) each year to include the description of the added services. Because the list of Medicare telehealth services has grown quite lengthy, and given the other mechanisms by which we can make the public aware of the list of Medicare telehealth services for each year, we proposed to revise § 410.78(b) by deleting the description of the individual services for which Medicare payment can be made when furnished via telehealth. Under this proposal, we would continue our current policy to address requests to add to the list of telehealth services through the PFS rulemaking process so that the public would have the opportunity to comment on additions to the list. We also proposed to revise § 410.78(f) to indicate that a list of Medicare telehealth codes and descriptors is available on the CMS Web site.

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

Comment: All commenters supported one or more of our proposals to add psychotherapy services (CPT codes 90845, 90846 and 90847); prolonged service office (CPT codes 99354 and 99355); and annual wellness visit (HCPCS codes G0438 and G0439) to the list of Medicare telehealth services for CY 2015.

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 CY 2015 proposal to add these services to the list of telehealth services for CY 2015 on a category 1 basis.

Comment: Commenters also agreed with our rationale for rejecting other requested additions to the telehealth list. However, one commenter disagreed with our decision not to propose adding dermatology services, including those furnished using store-and-forward technology, to the list of telehealth services. Another commenter objected to our proposal not to add psychological testing services to the telehealth services list.

Response: As we noted in the proposed rule, the request to add dermatology services did not include specific codes. Without specific codes to consider, we cannot evaluate whether the services are appropriate for addition to the Medicare telehealth services list. We note that some of the services that the requester had in mind may be billed under the telehealth office visit codes or the telehealth consultation G-codes.

Concerning payment for services furnished using store-and-forward technology, we note that the statute at section 1861(m) of the Act includes store-and-forward technology as a telecommunication system for telehealth services only in the case of federal telemedicine demonstration programs in Alaska and Hawaii (see § 410.78(d)).

Concerning psychological testing services, we noted that remote services (CPT codes 96103 and 96120) are not Medicare telehealth services as defined under the Act and thus can be furnished when beneficiary is not in the same place as the practitioner. It would also be counter-productive to add these codes to the telehealth list because, if we did, the telehealth originating site, geographic, and other restrictions would apply to these services.

CPT codes 90887, 90991, 93358 and 99359 are not separately payable by Medicare. It would be inappropriate to include services as telehealth services when Medicare does not otherwise make a separate payment for them.

Finally, CPT codes 96101, 96102, 96118 and 96119 are not similar to other services on the telehealth list, as they require close observation of how a patient responds. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we did not propose to add these services to the list of telehealth services.

We received other public comments on matters related to Medicare telehealth services that were not the subject of proposals in the CY 2015 PFS proposed rule. Because we did not make any proposals regarding these matters, we generally do not summarize or respond to such comments in the final rule. However, we are summarizing and responding to the following comments to acknowledge the interests and concerns of the commenters, and a mechanism to address some of those concerns.

Many commenters supported the overall expansion of telehealth by:

  • Removing geographic restrictions to include both rural and urban areas.
  • Revising permissible originating sites to include a patient's home, domiciliary care and first responder vehicles.Start Printed Page 67602
  • Adopting a broader definition of telehealth technologies to include services provide via mobile technology, including emails, phone calls, and store-and-forward technologies.
  • Adding physical and occupational therapists as practitioners who can remotely furnish telehealth services.
  • Adding more services to the telehealth list, including services under category 2.
  • Prioritizing coverage of services that include care coordination with the patient's medical home and/or existing treating physicians.
  • Considering the use of telehealth technology for the purpose of furnishing direct supervision of services furnished by on-site practitioners.
  • Using demonstration projects under CMS's Center for Medicare and Medicaid Innovation (CMMI) to collect clinical evidence on the effect of expanding telehealth and to address how telemedicine can be integrated into new payment and delivery models.

Response: We appreciate the commenters' suggestions. As some commenters noted, we do not have authority to implement many of these revisions under the current statute. The CMS Innovation Center is responsible for developing and testing new payment and service delivery models to lower costs and improve quality for Medicare, Medicaid, and CHIP beneficiaries. As part of that authority, the CMS Innovation Center can consider potential new payment and service delivery models to test changes to Medicare's telehealth payment policies.

In summary, after consideration of the comments we received, we are finalizing our proposal to add psychotherapy services CPT codes 90845, 90846 and 90847; prolonged service office CPT codes 99354 and 99355; and annual wellness visit HCPCS codes G0438 and G0439 to the list of Medicare telehealth services.

In addition, we are finalizing our proposal to change our regulation at § 410.78(b) by deleting the description of the individual services for which Medicare payment can be made when furnished via telehealth. We will continue our current policy to address requests to add services to the list of Medicare telehealth services through the PFS rulemaking process so that the public has the opportunity to comment on additions to the list. We are also finalizing our proposal to revise § 410.78(f) to indicate that a list of Medicare telehealth codes and descriptors is available on the CMS Web site.

We remind all interested stakeholders that we are currently soliciting public requests to add services to the list of Medicare telehealth services. To be considered during PFS rulemaking for CY 2016, these requests must be submitted and received by December 31, 2014. 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 www.cms.gov/​telehealth/​.

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 MEI increase for 2015 is 0.8 percent. Therefore, for CY 2015, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $24.83. The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 13.

Table 13—The Medicare Telehealth Originating Site Facility Fee and MEI Increase by the Applicable Time Period

Facility feeMEI increasePeriod
$20.00N/A10/01/2001-12/31/2002
20.603.001/01/2003-12/31/2003
21.202.901/01/2004-12/31/2004
21.863.101/01/2005-12/31/2005
22.472.801/01/2006-12/31/2006
22.942.101/01/2007-12/31/2007
23.351.801/01/2008-12/31/2008
23.721.601/01/2009-12/31/2009
24.001.201/01/2010-12/31/2010
24.100.401/01/2011-12/31/2011
24.240.601/01/2012-12/31/2012
24.430.801/01/2013-12/31/2013
24.630.801/01/2014-12/31/2014
24.830.801/01/2015-12/31/2015

F. Valuing New, Revised and Potentially Misvalued Codes

Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since inception of the PFS, it has also been a priority to revalue services regularly to assure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the five-year review process, which resulted in revised RVUs for CY 1997, CY 2002, CY 2007, and CY 2012. Under the five-year review process, revisions in RVUs were proposed in a proposed rule and finalized in a final rule. In addition to the five-year reviews, in each year beginning with CY 2009, CMS and the RUC have identified a number of potentially misvalued codes using various identification screens, such as codes with high growth rates, codes that are frequently billed together, and high expenditure codes. Section 3134 of the Affordable Care Act codified the misvalued code initiative in section 1848(c)(2)(K) of the Act.

In the CY 2012 rulemaking process, we proposed and finalized consolidation of the five-year review and the potentially misvalued code activities into an annual review of potentially misvalued codes to avoid redundancies in these efforts and better accomplish our goal of assuring regular assessment of code values. Under the consolidated process, we issue interim final RVUs for all revaluations and new codes in the PFS final rule with comment period, and make payment based upon those values during the calendar year covered by the final rule. (Changes in the PFS methodology that may affect valuations of a variety of codes are issued as proposals in the proposed rule.) We consider and respond to any public comments on the interim final values in the final rule with comment period for the subsequent year. When consolidating these processes, we indicated that it was Start Printed Page 67603appropriate to establish interim values for new, revised, and potentially misvalued codes because of the incongruity between the PFS rulemaking cycle and the release of codes by the AMA CPT Editorial Panel and the RUC review process. We stated that if we did not establish interim final values for revalued codes in the final rule with comment period, “a delay in implementing revised values for codes that have been identified as misvalued would perpetuate payment for the services at a rate that does not appropriately reflect the relative resources involved in furnishing the service and would continue unwarranted distortion in the payment for other services across the PFS.” We also reiterated that if we did not establish interim final values for new and revised codes, we would either have to delay the use of new and revised codes for one year, or permit each Medicare contractor to establish its own payment rate for these codes. We stated, “We believe it would be contrary to the public interest to delay adopting values for new and revised codes for the initial year, especially since we have an opportunity to receive significant input from the medical community [through the RUC] before adopting the values, and the alternatives could produce undesirable levels of uncertainty and inconsistency in payment for a year.”

1. Current Process for Valuing New, Revised, and Potentially Misvalued Codes

Under the process finalized in the CY 2012 PFS final rule with comment period, in each year's proposed rule, we propose specific codes and/or groups of codes that we believe may be appropriate to consider under our potentially misvalued code initiative. As part of our process for developing the list of proposed potentially misvalued codes, we consider public nominations for potentially misvalued codes under a process also established in the CY 2012 PFS final rule with comment period. If appropriate, we include such codes in our proposed potentially misvalued code list. In the proposed rule, we solicit comments on the proposed potentially misvalued codes. We then respond to comments and establish a final list of potentially misvalued codes in the final rule for that year. These potentially misvalued codes are reviewed and revalued, if appropriate, in subsequent years. In addition, the RUC regularly identifies potentially misvalued codes using screens that have previously been identified by CMS, such as codes performed together more than 75 percent of the time.

Generally, the first step in revaluing codes that have been identified as potentially misvalued is for the RUC to review these codes through its standard process, which includes active involvement of national specialty societies for the specialties that ordinarily use the codes. Frequently, the RUC's discussion of potentially misvalued codes will lead the CPT Editorial Panel to make adjustments to the codes involved, such as bundling of codes, creation of new codes or revisions of code descriptors. The AMA has estimated that 75 percent of all annual CPT coding changes result from the potentially misvalued code initiative.

The RUC provides CMS with recommendations for the work values and direct PE inputs for the codes we have identified as potentially misvalued codes or, in the case of a coding revision, for the new or revised codes that will replace these potentially misvalued codes. (This process is also applied to codes that the RUC identifies using code screens that we have identified, and to new or revised codes that are issued for reasons unrelated to the potentially misvalued code process.) Generally, we receive the RUC recommendations concurrently for all codes in the same family as the potentially misvalued code(s). We believe it is important to evaluate and establish appropriate work and MP RVUs and direct PE inputs for an entire code family at the same time to avoid rank order anomalies and to maintain appropriate relativity among codes. We generally receive the RUC recommendations for the code or replacement code(s) within a year or two following the identification of the code as potentially misvalued.

We consider the RUC recommendations along with other information that we have, including information submitted by other stakeholders, and establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there are coding changes in the final rule with comment period for a year. There is a 60-day period for the public to comment on those interim final values after we issue the final rule. For services furnished during the calendar year following the publication of interim final rates, we pay for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we consider and respond to public comments received on the interim final values, and make any appropriate adjustments to values based on those comments. We then typically finalize the values for the codes.

As we discussed in the CY 2012 PFS final rule with comment period, we adopted this consolidated review process to combine all coding revaluations into one annual process allowing for appropriate consideration of relativity in and across code families. In addition, this process assures that we have the benefit of the RUC recommendations for all codes being valued.

2. Concerns With Current Process

Some stakeholders who have experienced reductions in payments as the result of interim final valuations have objected to the process by which we revise or establish values for new, revised, and potentially misvalued codes. Some have stated that they did not receive notice of the possible reductions before they occurred. Generally, stakeholders are aware that we are considering changes in the payment rates for particular services either because CPT has made changes to codes or because we have identified the codes as potentially misvalued. As the RUC considers the appropriate value for a service, representatives of the specialties that use the codes are involved in the process. The RUC usually surveys physicians or other practitioners who furnish the services described by the codes regarding the time it takes to furnish the services, and representatives of the specialty(ies) also participate in the RUC meetings where recommendations for work RVUs and direct PE inputs are considered. Through this process, representatives of the affected specialties are generally aware of the RUC recommendations.

Some stakeholders have stated that even when they are aware that the RUC has made recommendations, they have no opportunity to respond to the RUC recommendations before we consider them in adopting interim final values because the RUC actions and recommendations are not public. Some stakeholders have also said that the individuals who participate in the RUC review process are not able to share the recommendations because they have signed a confidentiality agreement. We note, however, that at least one specialty society has raised funds via its Web site to fight a “pending cut” based upon its knowledge of RUC recommendations for specific codes prior to CMS action on the recommendation. Additionally, some stakeholders have pointed out that some types of suppliers that are paid Start Printed Page 67604under the PFS are not permitted to participate in the RUC process at all.

We recognize that some stakeholders, including those practitioners represented by societies that are not participants in the RUC process, may not be aware of the specifics of the RUC recommendations before we consider them in establishing interim final values for new, revised, and potentially misvalued codes. We note that, as described above, before we review a service as a potentially misvalued code, we go through notice and comment rulemaking to identify it as a potentially misvalued code. Thus, the public has notice and an opportunity to comment on whether we should review the values for a code before we finalize the code as potentially misvalued and begin the valuation process. As a result, all stakeholders should be aware that a particular code is being considered as potentially misvalued and that we may establish revised interim final values in a subsequent final rule with comment period. As noted above, there may be some codes for which we receive RUC recommendations based upon their identification by the RUC through code screens that we establish. These codes are not specifically identified by CMS through notice and comment rulemaking as potentially misvalued codes. We recognize that if stakeholders are not monitoring RUC activities or evaluating Medicare claims data, they may be unaware that these codes are being reviewed and could be revalued on an interim final basis in a final rule with comment period for a year.

In recent years, we have increased our scrutiny of the RUC recommendations and have increasingly found cause to modify the values recommended by the RUC in establishing interim final values under the PFS. Sometimes we also find it appropriate, on an interim final basis, to refine how the CPT codes are to be used for Medicare services or to create G-codes for reporting certain services to Medicare. Some stakeholders have objected to such interim final decisions because they do not learn of the CMS action until the final rule with comment period is issued. Stakeholders said that they do not have an opportunity to meaningfully comment and for CMS to address their comments before the coding or valuation decision takes effect.

We received comments on the CY 2014 PFS final rule with comment period suggesting that the existing process for review and adoption of interim final values for new, revised, and misvalued codes violates section 1871(a)(2) of the Act, which prescribes the rulemaking requirements for the agency in establishing payment rates. In response to those commenters, we note that the process we use to establish interim final rates is in full accordance with the statute and we do not find this a persuasive reason to consider modifying the process that we use to establish PFS rates.

Our recent revaluation of the four epidural injection codes provides an example of the concerns that have been expressed with the existing process. In the CY 2014 PFS final rule with comment period, we established interim final values for four epidural injection codes, which resulted in payment reductions for the services when furnished in the office setting of between 35 percent and 56 percent. (In the facility setting, the reductions ranged from 17 percent to 33 percent.) One of these codes had been identified as a potentially misvalued code 2 years earlier. The affected specialties had been involved in the RUC process and were generally aware that the family of codes would be revalued on an interim basis in an upcoming rule. They were also aware that the RUC had made significant changes to the direct PE inputs, including removal of the radiographic-fluoroscopy room, which explains, in large part, the reduction to values in the office setting. The societies representing the affected specialty were also aware of significant reductions in the RUC-recommended “time” to furnish the procedures based on the most recent survey of practitioners who furnish the services, which resulted in reductions in both the work and PE portion of the values. Although the specialties were aware of the changes that the RUC was recommending to direct PE inputs, they were not specifically aware of how those changes would affect the values and payment rate. In addition, we decreased the work RVUs for these procedures because we found the RUC-recommended work RVUs did not adequately reflect the RUC-recommended decreases in time. This decision is consistent with our general practice when the best available information shows that the time involved in furnishing the service has decreased, and in the absence of information suggesting an increase in work intensity. Since the interim final values for these codes were issued in the CY 2014 PFS final rule with comment period, we have received numerous comments that will be useful to us as we consider finalizing values for these codes. If we had followed a process that involved proposing values for these codes in a proposed rule, we would have been able to consider the additional information contained in these comments prior to making payments for the services based upon revised values. (See section II.B.3.b.(2) of this final rule with comment period for a discussion of proposed valuation of these epidural injection codes for CY 2015.)

3. Alternatives to the Current Process

In the proposed rule, we noted that given our heightened review of the RUC recommendations and the increased concerns expressed by some stakeholders, we believed that an assessment of our process for valuing these codes was warranted. To that end, we considered potential alternatives to address the timing and rulemaking issues associated with establishing values for new, revised and potentially misvalued codes (as well as for codes within the same families as these codes). Specifically, we explored three alternatives to our current approach:

  • Propose work and MP RVUs and direct PE inputs for all new, revised and potentially misvalued codes in a proposed rule.
  • Propose changes in work and MP RVUs and direct PE inputs in the proposed rule for new, revised, and potentially misvalued codes for which we receive RUC recommendations in time; continue to establish interim final values in the final rule for other new, revised, and potentially misvalued codes.
  • Increase our efforts to make available more information about the specific issues being considered in the course of developing values for new, revised and potentially misvalued codes to increase transparency, but without making changes to the existing process for establishing values.

In the proposed rule we discussed each of these alternatives as follows.

(a) Propose work and MP RVUs and direct PE inputs for new, revised, and potentially misvalued codes in the proposed rule:

Under this approach, we stated that we would evaluate the RUC recommendations for all new, revised, and potentially misvalued codes, and include proposed work and MP RVUs and direct PE inputs for the codes in the first available PFS proposed rule. We would receive and consider public comments on those proposals and establish final values in the final rule. The primary obstacle to this approach relates to the current timing of the CPT coding changes and RUC activities. Under the current calendar, all CPT coding changes and most RUC recommendations are not available to us in time to include proposed values for Start Printed Page 67605all codes in the proposed rule for that year.

Therefore, we stated that if we were to adopt this proposal, which would require us to propose changes in inputs before we revalue codes based upon those values, we would need a mechanism to pay for services for which the existing codes would no longer be available, or for which there would be changes for a given year.

As we noted in the CY 2012 PFS final rule with comment period, the RUC recommendations are an essential element that we consider when valuing codes. Likewise, we recognize the significant contribution that the CPT Editorial Panel makes to the success of the potentially misvalued code initiative through its consideration and adoption of coding changes. Although we have increased our scrutiny of the RUC recommendations in recent years and accepted fewer of the recommendations without making our own refinements, the CPT codes and the RUC recommendations continue to play a major role in our valuations. For many codes, the surveys conducted by specialty societies as part of the RUC process are the best data that we have regarding the time and intensity of work. The RUC determines the criteria and the methodology for those surveys. It also reviews the survey results. This process allows for development of survey data that are more reliable and comparable across specialties and services than would be possible without having the RUC at the center of the survey vetting process. In addition, the debate and discussion of the services at the RUC meetings in which CMS staff participate provides a good understanding of what the service entails and how it compares to other services in the family, and to services furnished by other specialties. The debate among the specialties is also an important part of this process. Although we increasingly consider data and information from many other sources, and we intend to expand the scope of those data and sources, the RUC recommendations remain a vital part of our valuation process.

Thus, if we were to adopt this approach, we would need to address how to make payment for the services for which new or revised codes take effect for the following year but for which we did not receive RUC recommendations in time to include proposed work values and PE inputs in the proposed rule. Because the annual coding changes are effective on January 1st of each year, we would need a mechanism for practitioners to report services and be paid appropriately during the interval between the date the code takes effect and the time that we receive RUC recommendations and complete rulemaking to establish values for the new and revised codes. One option would be to establish G-codes with identical descriptors to the predecessors of the new and revised codes and, to the fullest extent possible, carry over the existing values for those codes. This would effectively preserve the status quo for one year.

The primary advantage of this approach would be that the RVUs for all services under the PFS would be established using a full notice and comment procedure, including consideration of the RUC recommendations, before they take effect. In addition to having the benefit of the RUC recommendations, this would provide the public the opportunity to comment on a specific proposal prior to it being implemented. This would be a far more transparent process, and would assure that we have the full benefit of stakeholder comments before establishing values.

One drawback to such a process is that the use of G-codes for a significant number of codes may create an administrative burden for CMS and for practitioners. Presumably, practitioners would need to use the G-codes to report certain services for purposes of Medicare, but would use the new or revised CPT codes to report the same services to private insurers. The number of G-codes needed each year would depend on the number of CPT code changes for which we do not receive the RUC recommendations in time to formulate a proposal to be included in the proposed rule for the year. To the extent that we receive the RUC recommendations for all new and revised codes in time to develop proposed values for inclusion in the proposed rule, there would be no need to use G-codes for this purpose.

Another drawback is that we would need to delay for at least one year the revision of values for any misvalued codes for which we do not receive RUC recommendations in time to include a proposal in the proposed rule. For a select set of codes, we would be continuing to use the RVUs for the codes for an additional year even though we know they do not reflect the most accurate resources. Since the PFS is a budget neutral system, misvalued services affect payments for all services across the fee schedule. On the other hand, if we were to take this approach, we would have the full benefit of public comments received on the proposed values for potentially misvalued services before implementing any revisions.

(b) Propose changes in work and MP RVUs and PE inputs in the proposed rule for new, revised, and potentially misvalued codes for which we receive RUC recommendations in time; continue to establish interim final values in the final rule for other new, revised, and potentially misvalued codes:

This alternative approach would allow for notice and comment rulemaking before we adopt values for some new, revised and potentially misvalued codes (those for which we receive RUC recommendations in time to include a proposal in the proposed rule), while others would be valued on an interim final basis (those for which we do not receive the RUC recommendations in time). Under this approach, we would establish values in a year for all new, revised, and potentially misvalued codes, and there would be no need to provide for a mechanism to continue payment for outdated codes pending receipt of the RUC recommendations and completion of a rulemaking cycle. For codes for which we do not receive the RUC recommendations in time to include a proposal in the proposed rule for a year, there would be no change from the existing valuation process.

This would be a balanced approach that recognizes the benefits of a full opportunity for notice and comment rulemaking before establishing rates when timing allows, and the importance of establishing appropriate values for the current version of CPT codes and for potentially misvalued codes when the timing of the RUC recommendations does not allow for a full notice and comment procedure.

However, this alternative would go only part of the way toward addressing concerns expressed by some stakeholders. For those codes for which the RUC recommendations are not received in time for us to include a proposal in the proposed rule, Medicare payment for one year would still be based on inputs established without the benefit of full public notice and comment. Another concern with this approach is that it could lead to the valuation of codes within the same family at different times depending on when we receive RUC recommendations for each code within a family. As discussed previously, we believe it is important to value an entire code family together to make adjustments to account appropriately for relativity within the family and between the family and other families. If we receive RUC recommendations in time to propose Start Printed Page 67606values for some, but not for all, codes within a family, we would respond to comments in the final rule to establish final values for some of the codes while adopting interim final values for other codes within the same family. The differences in the treatment of codes within the same family could limit our ability to value codes within the same family with appropriate relativity. Moreover, under this alternative, the main determinant of how a code would be handled would be the timing of our receipt of the RUC recommendation for the code. Although this approach would offer stakeholders the opportunity to comment on specific proposals in the proposed rule, the adoption of changes for a separate group of codes in the final rule could significantly change the proposed values simply due to the budget neutrality adjustments due to additional codes being valued in the final rule.

(c) Increase our efforts to make available more information about the specific issues being considered in the course of developing values for new, revised and potentially misvalued codes in order to increase transparency, but without a change to the existing process for establishing values:

The main concern with continuing our current approach is that stakeholders have expressed the desire to have adequate and timely information to permit the provision of relevant feedback to CMS for our consideration prior to establishing a payment rate for new, revised, and potentially misvalued codes. We could address some aspects of this issue by increasing the transparency of the current process. Specifically, we could make more information available on the CMS Web site before interim final values are established for codes. Examples of such information include an up-to-date list of all codes that have been identified as potentially misvalued, a list of all codes for which RUC recommendations have been received, and the RUC recommendations for all codes for which we have received them.

Although the posting of this information would significantly increase transparency for all stakeholders, it still would not allow for full notice and comment rulemaking procedures before values are established for payment purposes. Nor would it provide the public with advance information about whether or how we will make refinements to the RUC recommendations or coding decisions in the final rule with comment period. Thus, stakeholders would not have an opportunity to provide input on our potential modifications before interim final values are adopted.

4. Proposal To Modify the Process for Establishing Values for New, Revised, and Potentially Misvalued Codes

After considering the current process, including its strengths and weaknesses, and the alternatives to the current process described previously, we proposed to modify our process to make all changes in the work and MP RVUs and the direct PE inputs for new, revised and potentially misvalued services under the PFS by proposing the changes in the proposed rule, beginning with the PFS proposed rule for CY 2016. We proposed to include proposed values for all new, revised and potentially misvalued codes for which we have complete RUC recommendations by January 15th of the preceding year. We also proposed to delay revaluing the code for one year (or until we receive RUC recommendations for the code before January 15th of a year) and include proposed values in the following year's rule if the RUC recommendation was not received in time for inclusion in the proposed rule. Thus, we would include proposed values prior to using the new code (in the case of new or revised codes) or revising the value (in the case of potentially misvalued codes). Due to the complexities involved in code changes and rate setting, there could be some circumstances where, even when we receive the RUC recommendations by January 15th of a year, we are not able to propose values in that year's proposed rule. For example, we might not have recommendations for the whole family or we might need additional information to appropriately value these codes. In situations where it would not be appropriate or possible to propose values for certain new, revised, or potentially misvalued codes, we would treat them in the same way as those for which we did not receive recommendations before January 15th.

For new, revised, and potentially misvalued codes for which we do not receive RUC recommendations before January 15th of a year, we proposed to adopt coding policies and payment rates that conform, to the extent possible, to the policies and rates in place for the previous year. We would adopt these conforming policies on an interim basis pending our consideration of the RUC recommendations and the completion of notice and comment rulemaking to establish values for the codes. For codes for which there is no change in the CPT code, it is a simple matter to continue the current valuation. For services for which there are CPT coding changes, it is more complicated to maintain the current payment rates until the codes can be valued through the notice and comment rulemaking process. Since the changes in CPT codes are effective on January 1st of a year, and we would not have established values for the new or revised codes (or other codes within the code family), it would not be practical for Medicare to use those CPT codes. For codes that were revised or deleted as part of the annual CPT coding changes, when the changes could affect the value of a code and we have not had an opportunity to consider the relevant RUC recommendations prior to the proposed rule, we propose to create G-codes to describe the predecessor codes to these codes. If CPT codes are revised in a manner that would not affect the resource inputs used to value the service (for example, a grammatical changes to CPT code descriptors), we could use these revised codes and continue to pay at the rate developed through the use of the same resource inputs. For example, if a single CPT code was separated into two codes and we did not receive RUC recommendations for the two codes before January 15th of the year, we would assign each of those new codes an “I” status indicator (which denotes that the codes are “not valid for Medicare purposes”), and those codes could not be used for Medicare payment during the year. Instead, we would create a G-code with the same description as the single predecessor CPT code and continue to use the same inputs as the predecessor CPT code for that G-code during the year.

For new codes that describe wholly new services, as opposed to new or revised codes that are created as part of a coding revision of a family or that describe services are already on the PFS, we would make every effort to work with the RUC to ensure that we receive recommendations in time to include proposed values in the proposed rule. However, if we do not receive timely recommendations from the RUC for such a code and we determine that it is in the public interest for Medicare to use a new code during the code's initial year, we would establish values for the code's initial year. As we do under our current policy, if we receive the RUC recommendations in time to consider them for the final rule, we propose to establish values for the initial year on an interim final basis subject to comment in the final rule. In the event we do not receive RUC recommendations in time to consider them for the final rule, or in other situations where it would not be appropriate to establish interim final Start Printed Page 67607values (for example, because of a lack of necessary information about the work or the price of the PE inputs involved), we would contractor price the code for the initial year.

We specifically sought comments on the following topics:

  • Is this proposal preferable to the present process? Is another one of the alternatives better?
  • If we were to implement this proposal, is it better to move forward with the changes, or is more time needed to make the transition such that implementation should be delayed beyond CY 2016? What factors should we consider in selecting an implementation date?
  • Are there alternatives other than the use of G-codes that would allow us to address the annual CPT changes through notice and comment rather than interim final rulemaking?

Comment: The vast majority of commenters support a process, such as the one we proposed, that would result in having an opportunity for public comment on specific CMS proposals to change rates prior to payments being made based upon those rates. Commenters supporting a more transparent process include most medical organizations. MedPAC supported including proposals for rate changes in the proposed rule, but disagreed with preserving existing rates when RUC recommendations were not received in time to value in the proposed rule stating that this perpetuates paying at rates that we know are misvalued. As an alternative, MedPAC suggested that for codes for which we received RUC recommendations after the deadline for the proposed rule, we establish interim final values using the existing process. MedPAC also encouraged us to work with the CPT Editorial Panel and the RUC to better disseminate information about coding and payment recommendations that might be used for interim values as far in advance as possible. Several commenters who do not currently participate in the development of RUC recommendations suggested that we require the RUC to make its operations more transparent. Most of the commenters that supported the proposal also suggested making at least some modifications to the proposal. Some commenters indicated there was no need for a change from the current process. Another commenter stated “CMS's proposal is overly complex, potentially burdensome, and goes well beyond the principal request of the medical specialty societies and Congress—that is, for CMS to publish reimbursement changes for misvalued codes in the proposed rule, as opposed to waiting until the final rule.”

Response: We appreciate the many comments in support of our proposal to be more transparent in our ratesetting process by including proposed changes in inputs for new, revised, and potentially misvalued codes in the PFS proposed rules each year. We received only minimal comments on the other alternatives we presented, and only one comment suggesting that the current process was ideal and should be maintained. Thus, we are finalizing the proposal, with the modifications discussed below, to change our process for establishing values for new, revised, and potentially misvalued codes each year by proposing values for them in the proposed rule. We note that the CPT Editorial Panel and the RUC have made significant efforts in recent years to make their processes more transparent, such as making minutes of meetings publicly available. We encourage them to continue these efforts and also to consider ways that all physicians, practitioners and other suppliers paid under the PFS are aware of issues that are being considered by the RUC, and have an opportunity to provide input. With regard to comments suggesting that we propose values for some codes in the proposed rule and establish values for others as interim final in the final rule with comment period, as we discussed in making the proposal, we believe this type of system has several flaws. Most significantly, since the PFS is a budget neutral system, proposals are more meaningful when they can be considered in relation to all codes being revalued in a year in order to allow public comment on the entire fee schedule at one time. Additionally, we believe it is difficult to justify the presence or absence of an opportunity for public comment in advance of our adopting and using new values and inputs for services when the outcome essentially depends upon when we receive RUC recommendations.

Comment: Commenters expressed mixed opinions on when the new process should begin. The AMA, the RUC, and most medical specialties opposed the proposed CY 2016 implementation and asked that it be delayed until CY 2017. Commenters supporting a delay suggested that much work had already been done for the CY 2016 coding cycle in anticipation that these codes could be used for CY 2016, and stated it seems unfair to now delay valuing these codes because the process is being changed. These commenters also suggested that by delaying until CY 2017, the CPT Editorial Panel and the RUC would have time to adjust their agendas and workload so as to provide more recommendations in time for the proposed rule. By contrast, several commenters, including those with major code revisions for CY 2015, such as codes for radiation therapy and upper gastrointestinal procedures, suggested that we should implement the new process immediately, and thus, delay implementation of the new code sets and values so that they could be issued as proposals in the CY 2016 proposed rule. Although each of the commenters took some unique positions in supporting a delay, they emphasized the importance of the opportunity to comment on our specific proposals for valuation as a major consideration for the delay. A few other commenters also suggested that the benefit of the opportunity for public comment prior to changing values warrants immediate implementation. Some commenters supported a CY 2016 implementation date as we proposed. A small group of commenters suggested an interim approach under which, for CY 2016, we would publish “some, but not all, values” in the proposed rule and use the interim final approach for others.

Response: After reviewing the comments, we understand that the implementation of a new process such as this one will affect stakeholders in differing ways. As we consider the most appropriate time frame for implementation, we believe that flexibility in implementation offers the optimal solution. Accordingly, we are delaying the adoption of two new codes sets (radiation therapy and lower gastrointestinal endoscopies) until CY 2016 as requested by affected stakeholders so that those most affected by these significant changes have the opportunity to comment on our proposals for valuing these codes sets before they are implemented. (See section II.G.3 of this final rule.)

Similarly, as requested by the AMA and most other medical specialty societies, we are delaying the complete implementation of this process so that those who have requested new codes and modifications in existing codes with the expectation that they would be valued under the PFS for CY 2016 will not be negatively affected by timing of this change. We note that the AMA has been working to develop timeframes that would allow a much higher percentage of codes to be addressed in the proposed rule, and has shared with us some plans to achieve this goal. We appreciate AMA's efforts and are confident that with the finalization of this process, the CPT Editorial Panel and the RUC will be able to adjust their timelines and processes so that most, if Start Printed Page 67608not all, of the annual coding changes and valuation recommendations can be addressed in the proposed rule prior to the effective date of the coding changes. This delay in implementation will provide additional time for these bodies to adjust their agendas and the timing of their recommendations to CMS to more appropriately align with the new process. As suggested by some commenters, we will use CY 2016 as a transition year. In the PFS proposed rule for CY 2016, we will propose values for the new, revised and potentially misvalued codes for which we receive the RUC recommendations in time for inclusion in the CY 2016 proposed rule. We will also include proposals for the two code sets delayed from CY 2015 in the CY 2016 proposed rule, as discussed above. For those new, revised, and potentially misvalued codes for which we do not receive RUC recommendations in time for inclusion in the proposed rule, we anticipate establishing interim final values for them for CY 2016, consistent with the current process. Beginning with valuations for CY 2017, the new process will be applicable to all codes. In other words, beginning with rulemaking for CY 2017, we will propose values for the vast majority of new, revised, and potentially misvalued codes and consider public comments before establishing final values for the codes; use G-codes as necessary in order to facilitate continued payment for certain services for which we do not receive RUC recommendations in time to propose values; and adopt interim final values in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive RUC recommendations in time to propose values. Consistent with this policy, we are finalizing our proposed regulatory change to § 414.24 with the addition of the phrase “For valuations for calendar year 2017 and beyond,” to paragraph (b) to reflect the implementation for all CY 2017 valuations.”

Comment: Commenters also addressed the January 15th deadline for valuations to be considered for the proposed rule. The AMA recommended a deadline of 30 days after the RUC's January meeting to allow time to submit complete recommendations for the proposed rule. Many others supported this, with some commenters suggesting a variety of dates between January 31st and April. Commenters suggested using an April deadline so that we could include the recommendations from the April RUC meeting in the proposed rule.

Response: In proposing a deadline for inclusion in the proposed rule, we attempted to strike a balance that allows CMS adequate time for CMS to do a thorough job in vetting recommendations and formulating proposals, and allows the RUC as much time as possible to complete its activities. Review of RUC recommendations and application of the PFS methodology to particular codes requires significant time to complete. With new statutory requirements being implemented in CY 2017, such as those requiring multi-year transitions of certain changes in values and modification to PFS payments if specified targets are not met, we believe we will need more time to complete the process of formulating proposals. We believe that we need to establish a consistent deadline for receipt of RUC recommendations in order to allow all stakeholders and CMS to plan appropriately. To balance competing priorities, we are finalizing a deadline of February 10th. Our ability to complete our work in this more limited time will depend in large part on the volume of recommendations handled at the last RUC meeting and when we receive those recommendations. We are seeking the RUC's assistance in minimizing the recommendations that we receive after the beginning of the year.

Comment: The majority of commenters opposed the use of G-codes, primarily citing the administrative burden of having to use a separate set of codes for Medicare claims. One commenter called the G-code proposal “unworkable.” In addition, MedPAC objected to the principal of attempting to maintain rates that are known to be misvalued. Those supporting the use of G-codes generally recognized the administrative burden, but believed the importance of the opportunity for public comment on proposed values before they take effect outweighed the administrative inconvenience. Commenters urged us to minimize the use of G-codes.

Response: We recognize the commenters' concerns with the use of G-codes. We agree that it is preferable to use CPT codes whenever possible. Under our finalized process, the use of G-codes for the purpose of holding over current coding and payment policies should not be necessary, generally, as long as we receive RUC recommendations for all new, revised and potentially misvalued codes before February 10th of the prior year. However, we need to preserve our ability to establish a proxy for current coding and values in situations where we receive the RUC recommendations too late or, for some other reason, encounter serious difficulty developing proposed values for revised code sets. In the proposed rule, we sought input as to ways to achieve this without using G-codes. The only suggestion offered by commenters was to value such codes on an interim final basis. As we discuss above, we believe the program and its stakeholders are better served by delaying revaluations for one year while we used the notice and comment process to obtain public comments in advance. The comments on this proposal were overall overwhelming supportive of this point of view. Accordingly, we are not foreclosing the possibility of using G-codes for this purpose when warranted by the circumstances. However, we are cognizant of the difficulties created by the use of G-codes and will seek to minimize their use. We also note that the RUC and stakeholders can assist us in minimizing the use of G-codes by taking steps to insure that we receive RUC recommendations as early as possible.

5. Refinement Panel

As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on CPT codes with interim final work RVUs for a year and in developing final work values for the subsequent year. We decided the panel would be comprised of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed establishing the panel with a multispecialty group would balance the interests of the specialty societies who commented on the work RVUs with the budgetary and redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services.

Following enactment of section 1848(c)(2)(K) of the Act, which required the Secretary periodically to review potentially misvalued codes and make appropriate adjustments to the RVUs, we reassessed the refinement panel process. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306), we continued using the established refinement panel process with some modifications.

As we considered making changes to the process for valuing codes, we reassessed the role that the refinement panel process plays in the code valuation process. We noted that the current refinement panel process is tied to interim final values. It provides an opportunity for stakeholders to provide Start Printed Page 67609new clinical information that was not available at the time of the RUC valuation that might affect work RVU values that are adopted in the interim final value process. We noted that if our proposal to modify the valuation process for new, revised, and potentially misvalued codes is adopted, there would no longer be interim final values except for very few codes that describe totally new services. Thus, we proposed eliminating the refinement panel process.

We also noted that by using the proposed process for new, revised, and potentially misvalued codes, we believed the consideration of additional clinical information and any other issues associated with the CMS proposed values could be addressed through the notice and comment process. Similarly, prior to CY 2012 when we consolidated the five-year valuation, changes made as part of the five-year review process were addressed in the proposed rule and those codes were generally not subject to the refinement process. The notice and comment process would provide stakeholders with complete information on the basis and rationale for our proposed inputs and any relating coding policies. We also noted that an increasing number of requests for refinement do not include new clinical information that would justify a change in the work RVUs and that was not available at the time of the RUC meeting, in accordance with the current criteria for refinement. Thus, we did not believe the elimination of the refinement panel process would negatively affect the code valuation process. We believe the proposed process, which includes a full notice and comment procedure before values are used for purposes of payment, offers stakeholders a better mechanism for providing any additional data for our consideration and discussing any concerns with our proposed values than the current refinement process

Comment: We received many comments on our proposal to eliminate the refinement panel, but most addressed problems with the existing refinement process and suggested improvements and alternatives rather than reasons not to eliminate the refinement panel. Concerns with the refinement panel process included that CMS imposed too high a standard for referring codes to refinement and that CMS decreasingly changed values based upon the refinement panel results. Some noted that organizations with limited resources are disadvantaged compared to those with significant resources to overturn any CMS interim final values without a refinement process. In addition, some commenters stated that elimination of the refinement panel runs contrary to the transparency that CMS is trying to achieve. Many discussed their previous understanding that the refinement panel was essentially an appeals process for interim final values.

Commenters supported “a fair, objective, and consistently applied appeals process that would be open to any commenting organization.” Commenters expressed concern that the elimination of the refinement panel without a replacement mechanism “indicates that CMS will no longer seek the independent advice of contractor medical officers and practicing physicians and will solely rely on Agency staff to determine if the comment is persuasive in modifying a proposed value. The lack of any perceived organized appeal process will likely lead to a fragmented lobbying effort, rather than an objective review process.”

MedPAC suggested that we use a panel with membership limited to those without a financial stake in the process, such as contractor medical directors, experts in medical economics and technology diffusion, private payer representatives, and a mix of physicians and other health professionals not directly affected by the RVUs in question. It also suggested user fees to provide the resources needed or such a refinement panel.

Response: We acknowledge the commenters' concerns and believe that some of the dissatisfaction with the current refinement panel mechanism stems from the expectation that it constitutes an appeals process. We do not agree. We believe the purpose of the refinement panel is to give us additional information to consider in exercising our responsibility to establish appropriate RVUs for Medicare services. Like many of the commenters, we believe the refinement panel is not achieving its purpose. Rather than providing us with additional information to assist us in establishing work RVUs, most often the refinement panel discussion reiterates the issues raised and information discussed at the RUC. Since we had access to this information at the time interim final values were established, it seems unlikely that a repeat discussion of the same issues would lead us to change valuations based upon information that already had been carefully considered. We remain concerned about the amount of resources devoted to refinement panel activities as compared to the benefit received. However, in light of the significant concerns raised by commenters, we are not finalizing our proposal to eliminate the refinement panel. We will use the refinement panel for consideration of interim final rates for CY 2015 under the existing rules. We will also explore ways to address the many concerns that we and stakeholders have about the refinement panel process and whether the change in process eliminates the need for a refinement panel.

We are also finalizing our proposed change to the regulation at § 414.24 with the addition of the phrase “For valuations for calendar year 2017 and beyond,” to paragraph (b) to reflect implementation of the revised process for all valuations beginning with those for CY 2017.

G. Establishing RVUs for CY 2015

1. Methodology

We conducted a review of each code identified in this section and reviewed the current work RVU, if one exists, the RUC-recommended work RVUs, intensity, and time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our review generally includes, but is not limited to, a review of information provided by the RUC, Health Care Professionals Advisory Committee (HCPAC), and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the Medicare PFS, consultation with other physicians and health care professionals within CMS and the federal government. We also assessed the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the 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. When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process. The building block methodology is used to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Components used in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the components could be the CPT Start Printed Page 67610codes that make up the bundled code. Magnitude estimation refers to a methodology for valuing physician work that determines the appropriate work RVU for a service by gauging the total amount of physician work for that service relative to the physician work for similar service across the PFS without explicitly valuing the components of that work.

The PFS incorporates cross-specialty and cross-organ system relativity. Valuing services requires an assessment of relative value and takes into account the clinical intensity and time required to furnish a service. In selecting which methodological approach will best determine the appropriate value for a service, we consider the current and recommended work and time values, as well as the intensity of the service, all relative to other services.

Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently there are six preservice time packages for services typically furnished in the facility setting, reflecting the different combinations of straightforward or difficult procedure, straightforward or difficult patient, and without or with sedation/anesthesia. Currently, there are three preservice time packages for services typically furnished in the nonfacility setting, reflecting procedures without and with sedation/anesthesia care. We have developed several standard building block methodologies to appropriately value services when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. We believe that at least one-third of the physician time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit. Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service times the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU. Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we do not believe the overlap in time has already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, addresses the overlap in time and work when a service is typically provided on the same day as an E/M service. The RVUs and other payment information for all CY 2015 payable codes are available in Addendum B. The RVUs and other payment information for all codes subject to public comment are available in Addendum C. Both addenda are available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/​physicianfeesched/​downloads/​. The time values for all CY 2015 codes are listed in a file called “CY 2015 PFS Physician Time,” available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/​physicianfeesched/​downloads/​.

2. Addressing CY 2014 Interim Final RVUs

In this section, we are responding to the public comments received on specific interim final values established in the CY 2014 PFS final rule with comment period and discussing the final values that we are establishing for CY 2015. The final CY 2015 work, PE, and MP RVUs are in Addendum B of a file called “CY 2015 PFS Addenda,” available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/​physicianfeesched/​PFS-Federal-Regulation-Notices.html/​. The direct PE inputs are listed in a file called “CY 2015 PFS Direct PE Inputs,” available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/​physicianfeesched/​PFS-Federal-Regulation-Notices.html/​.

a. Finalizing CY 2014 Interim Final Work RVUs for CY 2015

(i) Refinement Panel

(1) Refinement Panel Process

As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process soon after implementing the fee schedule to assist us in reviewing the public comments on CPT codes with interim final work RVUs and in developing final work values for the subsequent year. We decided the panel would be comprised of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed a multispecialty group would balance the interests of the specialty societies who commented on the work RVUs with the budgetary and redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services. Depending on the number and range of codes that are subject to refinement in a given year, we establish refinement panels with representatives from four groups: Clinicians representing the specialty identified with the procedures in question; physicians with practices in related specialties; primary care physicians; and contractor medical directors (CMDs). Typical panels have included 8 to 10 physicians across the four groups.

Following the addition of section 1848(c)(2)(K) to the Act, which requires the Secretary periodically to review potentially misvalued codes and make appropriate adjustments to the RVUs, we reassessed the refinement panel process. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306), we believed that the refinement panel process might provide an opportunity to review and discuss the proposed and interim final work RVUs with a clinically diverse group of experts, who could provide informed recommendations following the discussion. Therefore, we indicated that we would continue the refinement process, but with administrative modification and clarification. We also noted that we would continue using the established panel composition that includes representatives from the four groups—clinicians representing the specialty identified with the procedures in question, physicians with practices in related specialties, primary care physicians, and CMDs.

At that time, we made a change in how we calculated refinement panel results. The basis of the refinement panel process is that, following discussion of the information but without an attempt to reach a consensus, each member of the panel submits an independent rating to CMS. Historically, the refinement panel's recommendation to change a work value or to retain the interim final value had Start Printed Page 67611hinged solely on the outcome of a statistical test on the ratings (an F-test of panel ratings among the groups of participants). Over time, we found the statistical test used to evaluate the RVU ratings of individual panel members became less reliable as the physicians in each group tended to select a previously discussed value, rather than developing a unique value, thereby reducing the observed variability needed to conduct a robust statistical test. In addition, reliance on values developed using the F-test also occasionally resulted in rank order anomalies among services (that is, a more complex procedure is assigned lower RVUs than a less complex procedure). As a result, we eliminated the use of the statistical F-test and replaced it with the median work value of the individual panel members' ratings. We stated that this approach would simplify the refinement process administratively, while providing a result that reflects the summary opinion of the panel members based on a commonly used measure of central tendency that is not significantly affected by outlier values. We also clarified that we have the final authority to set the work RVUs, including making adjustments to the work RVUs resulting from the refinement process, and that we will make such adjustments if warranted by policy concerns (75 FR 73307).

We remind readers that the refinement panels are not intended to review the work RVUs for every code for which we did not accept the RUC-recommended work RVUs. Rather, refinement panels are designed for situations where there is new clinical information available that might provide a reason for a change in work values and where a multispecialty panel of physicians might provide input that would assist us in establishing work RVUs. To facilitate the selection of services for the refinement panels, commenters seeking consideration by a refinement panel should specifically state in their public comments that they are requesting refinement panel review. Furthermore, we have asked commenters requesting refinement panel review to submit any new clinical information concerning the work required to furnish a service so that we can consider whether the new information warrants referral to the refinement panel (57 FR 55917).

We note that most of the information presented during the last several refinement panel discussions has been duplicative of the information provided to the RUC during its development of recommendations and considered by CMS in establishing values. As detailed above, we consider information and recommendations from the RUC when assigning proposed and interim final RVUs to services. Thus, if the only information that a commenter has to present is information already considered by the RUC, referral to a refinement panel is not appropriate. We request that commenters seeking refinement panel review of work RVUs submit supporting information that has not already been considered by the RUC in developing recommendations or by CMS in assigning proposed and interim final work RVUs. We can make best use of our resources, as well as those of the specialties and physician volunteers involved, by avoiding duplicative consideration of information by the RUC, CMS, and a refinement panel. To achieve this goal, CMS will continue to critically evaluate the need to refer codes to refinement panels in future years, specifically considering any new information provided by commenters.

(2) CY 2014 Interim Final Work RVUs Considered by the Refinement Panel

We referred to the CY 2014 refinement panel 19 CPT codes with CY 2014 interim final work values for which we received a request for refinement that met the requirements described above. For these 19 CPT codes, all commenters requested increased work RVUs. For ease of discussion, we will be referring to these services as “refinement codes.” Consistent with the process described above, we convened a multi-specialty panel of physicians to assist us in the review of the information submitted to support increased work RVUs. The panel was moderated by our physician advisors, and consisted of the following voting members:

  • One to two clinicians representing the commenting organization.
  • One to two primary care clinicians nominated by the American Academy of Family Physicians and the American College of Physicians.
  • Four Contractor Medical Directors (CMDs).
  • One to two clinicians with practices in related specialties, who were expected to have knowledge of the services under review.

The panel process was designed to capture each participant's independent judgment and his or her clinical experience which informed and drove the discussion of the refinement code during the refinement panel proceedings. Following the discussion, each voting participant rated the work of the refinement code(s) and submitted those ratings to CMS directly and confidentially. We note that not all voting participants voted for every CPT code. There was no attempt to achieve consensus among the panel members. As finalized in the CY 2011 PFS final rule with comment period (75 FR 73307), we calculated the median value for each service based upon the individual ratings that were submitted to CMS by panel participants.

Table 14 presents information on the work RVUs for the refinement codes, including the refinement panel ratings and the final CY 2015 work RVUs. In section II.G.2.a.ii., we discuss the CY 2015 work RVUs assigned each of the individual refinement codes.

Table 14—Codes Reviewed by the 2014 Multi-Specialty Refinement Panel

HCPCS CodeDescriptorCY 2014 interim final work RVURUC recommended work RVURefinement panel median ratingCY 2015 work RVU
19081Biopsy of breast accessed through the skin with stereotactic guidance3.293.293.403.29
19082Biopsy of breast accessed through the skin with stereotactic guidance1.651.651.781.65
19083Biopsy of breast accessed through the skin with ultrasound guidance3.103.103.103.10
19084Biopsy of breast accessed through the skin with ultrasound guidance1.551.551.551.55
19085Biopsy of breast accessed through the skin with MRI guidance3.643.643.643.64
19086Biopsy of breast accessed through the skin with MRI guidance1.821.821.821.82
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19281Placement of breast localization devices accessed through the skin with mammographic guidance2.002.002.002.00
19282Placement of breast localization devices accessed through the skin with mammographic guidance1.001.001.001.00
19283Placement of breast localization devices accessed through the skin with stereotactic guidance2.002.002.002.00
19284Placement of breast localization devices accessed through the skin with stereotactic guidance1.001.001.001.00
19285Placement of breast localization devices accessed through the skin with ultrasound guidance1.701.701.701.70
19286Placement of breast localization devices accessed through the skin with ultrasound guidance0.850.850.850.85
19287Placement of breast localization devices accessed through the skin with MRI guidance2.553.023.022.55
19288Placement of breast localization devices accessed through the skin with MRI guidance1.281.511.511.28
43204Injection of dilated esophageal veins using an endoscope2.402.892.772.40
43205Tying of esophageal veins using an endoscope2.513.002.882.51
43213Dilation of esophagus using an endoscope4.735.005.004.73
43233Balloon dilation of esophagus, stomach, and/or upper small bowel using an endoscope4.054.454.264.26
43255Control of bleeding of esophagus, stomach, and/or upper small bowel using an endoscope3.664.204.203.66

(ii) Code-Specific Issues

For each code with an interim final work value, Table 15 lists the CY 2014 interim final work RVU and the CY 2015 work RVU and indicates whether we are finalizing the CY 2015 work RVU. For codes without a work RVU, the table includes a PFS procedure status indicator. A list of the PFS procedure status indicators can be found in Addendum A. If the CY 2015 Action column indicates that the CY 2015 values are interim final, we will accept public comments on these values during the public comment period for this final rule with comment period. A comprehensive list of all values for which public comments are being solicited is contained in Addendum C to the CY 2015 PFS final rule with comment period. A comprehensive list of all CY 2015 RVUs is in Addendum B to this final rule with comment period. All Addenda to PFS final rule are available on the CMS Web site under downloads at http://www.cms.gov/​physicianfeesched/​PFSFederalRegulationNotices.html/​. The time values for all codes are listed in a file called “CY 2015 PFS Work Time,” available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at ­http://www.cms.gov/​physicianfeesched/​downloads/​.

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In the following section, we discuss each code for which we received a comment on the CY 2014 interim final work value or work time during the comment period for the CY 2014 final rule with comment period or for which we are modifying the CY 2014 interim final work RVU, work time or procedure status indicator for CY 2015. If a code in Table 15 is not discussed in this section, we did not receive any comments on that code and are finalizing the interim final work RVU and time without modification for CY 2015.

(1) Mohs Surgery (CPT Codes 17311 and 17313)

As detailed in the CY 2014 PFS final rule with comment period, we maintained the CY 2013 work RVUs for CPT codes 17311 and 17313 codes, based upon the RUC-recommended work RVUs.

Comment: We received a comment that was supportive of the interim final work RVU.

Response: We thank the commenter for their support and are finalizing the CY 2014 interim final values for CY 2015.

(2) Breast Biopsy (CPT Codes 19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288)

For CY 2014, the CPT Editorial Panel created 14 new codes, CPT codes 19081 through 19288, to describe breast biopsy and placement of breast localization devices, and the RUC recommended work RVUs for each of these codes. In the 2014 final rule with comment period, we established interim final values for all of these codes as recommended by the RUC except for CPT code 19287 and its add-on CPT code, 19288, which are used for magnetic resonance (MR) guidance. We expressed concern that for CPT code 19287 the RUC-recommended work RVUs were too high in relation to those of other marker placement codes, and refined it to a lower value. Since we had adopted the RUC recommendation that all the add-on codes in this family have work RVUs equal to 50 percent of the base code's work RVU, our refinement of CPT code 19287 resulted in a refinement of CPT code 19288 also. We also changed the intraservice time of CPT code 19286, an add-on code, from 19 minutes to 15 minutes since we believed the intraservice time of an add-on code should not be higher than its base code and the base code for CPT code 19286, has an intraservice time of 15 minutes.

Comment: Several commenters disagreed with the new CPT coding structure for breast biopsy and placement of breast localization devices because, unlike the predecessor structure, it fails to distinguish between the two types of biopsy devices—standard core needle and vacuum assisted. One commenter suggested that the payment should be higher when services are vacuum assisted, and suggested that CMS create a modifier to report when these services are furnished using a vacuum assisted biopsy or create a series of G-codes that distinguish between standard core needle biopsy and vacuum assisted biopsy.

Response: We prefer to use the CPT coding structure unless a programmatic need suggests that an alternative coding structure is preferable. In this case, we believe that we can pay appropriately for these services using the new CPT coding structure. To the extent that the commenters think the CPT coding system is not ideal for these services, we believe the CPT Editorial Panel is the appropriate forum for this concern. The commenters are mistaken regarding how the inputs for these codes were determined as they are based upon the typical service being vacuum assisted.

Comment: Several commenters disagreed with the interim final work RVUs we established for CPT codes 19287 and 19288, stating that the higher RUC-recommended RVUs were more appropriate and would maintain relativity within the family. The commenters stated that these services have longer intraservice time than other codes in the marker placement family, are of high intensity, produce high patient and family anxiety, and have higher malpractice costs. One commenter requested that the entire breast biopsy code family be referred to refinement. Other commenters requested refinement panel review of selected codes within this family.

Response: Based upon this request, we referred this family of codes to the CY 2014 multi-specialty refinement panel for further review. Prior to CY Start Printed Page 676322014, breast biopsies and marker placements were billed using a single code. In addition, the appropriate image guidance code was separately billed. Prior to CY 2014, there were individual guidance codes for the different types of guidance including MR and stereotactic guidance.

For CY 2013, the MR guidance code, CPT code 77032, had a lower work RVU than the stereotactic guidance code, CPT code 77031. Combining the values for the marker placement or biopsy codes with the guidance codes should not, in our view, result in a change in the rank order of the guidance. Accordingly, we do not believe the bundled code that includes MR guidance should now be valued significantly higher than one that includes the stereotactic guidance. Also, the refinement panel discussions did not provide new clinical information. Therefore, we continue to believe the CY 2014 interim final values are appropriate for CPT codes 19287 and 19288, and are finalizing them for CY 2015.

Comment: Commenters stated that the RUC-recommended intraservice time of 19 minutes for CPT code 19286, which is an add-on code, was incorrect and that the code should have the same intraservice time as its base code (15 minutes) rather than the 14 minutes assigned by CMS. The commenter said that this was consistent with the other base code/add-on relationships across the family.

Response: We agree and are finalizing the intraservice time for CPT code 19286 at 15 minutes.

Comment: In response to our request for confirmation that a post procedure mammogram is typically furnished with a breast marker placement procedure, commenters agreed that it was. However, they disagreed with our assertion that if it was typical it should be bundled with the appropriate breast marker procedures. Commenters said that it should be a separately reportable service because it requires additional work not captured by the codes in this family.

Response: We thank commenters for their feedback. We are not bundling post procedure mammograms with the appropriate breast marker codes at this time, but will consider whether as a services that typically occur together they should be bundled.

(3) Hip and Knee Replacement (CPT Codes 27130, 27446 and 27447)

In the CY 2014 final rule with comment period we established interim final values for three CPT codes for hip and knee replacements that had previously been identified as potentially misvalued codes under the CMS high expenditure procedural code screen. For CY 2014, we established the RUC-recommended work value of 17.48 as interim final work RVUs for CPT code 27446. As we explained in the CY 2014 final rule with comment period, we established interim final work RVUs for CPT codes 27130 and 27447 that varied from those recommended by the RUC based upon information that we received from the relevant specialty societies. We noted that the information presented by the specialty societies and the RUC raised concerns regarding the appropriate valuation of these services, especially related to the use of the best data source for determining the intraservice time involved in furnishing PFS services. Specifically, there was significant variation between the time values estimated through a survey versus those collected through specialty databases. We characterized our concerns saying, “The divergent recommendations from the specialty societies and the RUC regarding the accuracy of the estimates of time for these services, including both the source of time estimates for the procedure itself as well as the inpatient and outpatient visits included in the global periods for these codes, lead us to take a cautious approach in valuing these services.”

With regard to the specific valuations, we agreed with the RUC's recommendation to value CPT codes 27130 and 27447 equally. We explained that we modified the RUC-recommended work RVUs for these two codes to reflect the visits in the global period as recommended by the specialty societies, resulting in a 1.12 work RVU increase from the RUC-recommended value for each code. Accordingly, we assigned CPT codes 27130 and 27447 an interim final work RVU of 20.72. We sought public comment regarding, not only the appropriate work RVUs for these services, but also the most appropriate reconciliation for the conflicting information regarding time values for these services as presented to us by the physician community. We also sought public comment on the use of specialty databases as compared to surveys for determining time values, potential sources of objective data regarding procedure times, and levels of visits furnished during the global periods for the services described by these codes.

Comment: The RUC submitted comments explaining how it reached its recommendations for these codes and that it followed its process consistently in developing its recommendations on these codes. All those who commented specifically on the interim final work RVUs for these codes objected to the interim final work RVUs—some citing potential access problems. Commenters suggested that we use more reliable time data. Commenters suggested that valuation should be based on actual time data, which demonstrates that the time for this code has not changed since the last valuation; and thus the work RVUs should not decrease from the CY 2013 values. Among the commenters' suggestions were using data from the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), which includes data on more than 15,000 total lower extremity joint arthroplasty procedures, including time in/time out data for at least half of the procedures, and working with the specialty societies to explore the best data collection methods. A commenter suggested restoring the CY 2013 work RVUs until additional time data are available. Another commenter suggested valuing these services utilizing a reverse building block methodology resulting in work RVU of 21.18 for CPT codes 27130 and 22.11 for CPT code 27447. A commenter stated that the hip and knee replacement codes should be valued differently since they are clinically different procedures. Two commenters expressed concern regarding the use of a final rule to establish interim values for established hip and knee procedures due to the lack of opportunity it provides stakeholders to analyze and comment on reductions prior to implementation.

Response: In the CY 2014 final rule with comment period, we noted concerns about the time data used in valuing these services and requested additional input from stakeholders regarding using other sources of data beyond the surveys typically used by the RUC. We do not believe that we received the kind of information and the level of detail about the other types of data suggested by commenters that we would need to be able to use routinely in valuing procedures. We will continue to explore the use of other data on time. As we discuss in section II.B. we have engaged contractors to assist us in exploring alternative data sources to use in determining the times associated with particular services. At this time, we are not convinced that data from another source would result in an improved value for these services. Nor did we find the reasons given for modifying the interim final work values established in CY 2014. The interim final values are based upon the best data we have available and preserve appropriate relativity with other codes. Start Printed Page 67633Accordingly, we are finalizing the interim final values for these procedures.

(4) Transcatheter Placement Intravascular Stent (CPT Code 37236, 37237, 37238, and 37239)

For CY 2014, we established the RUC-recommended work RVUs for newly created CPT codes 37236, 37237, and 37238 as the interim final values. We disagreed with the RUC-recommended work RVU for CPT code 37239, which is the add-on code to CPT code 37238, for the placement of an intravascular stent in each additional vein. As we described in the CY 2014 final rule with comment period we believe that the work for placement of an additional stent in a vein should bear the same relationship to the work of placing an initial stent in the vein as the placement of an additional stent in an artery to the placement of the initial stent in an artery.

Comment: Many commenters indicated that our valuation of CPT code 37239 was inappropriate. They indicated that instead we should use the RUC's recommended work RVU of 3.34 for this code since the procedure is more intense and requires more physician work than would result from the comparison made by CMS. One commenter requested that CPT code 37239 be referred to the refinement panel.

Response: After re-review, we continue to believe that the ratio of the work of the placement of the initial stent to the placement of additional stents is the same whether the stents are placed in an artery or a vein, and accordingly the appropriate ratio is found in the RUC-recommended work RVUs of CPT codes 37236 and 37237, the comparable codes for the arteries. For that reason, we are finalizing our CY 2014 interim final values. Additionally, we did not refer these codes for refinement panel review because the criteria for refinement panel review were not met.

(5) Embolization and Occlusion Procedures (CPT Codes 37242 and 37243)

For CY 2014, we established interim final work RVUs for these two codes based upon the survey's 25th percentile. As we discussed in the CY 2014 interim final rule with comment period, we believed that the RUC-recommended work RVU for CPT code 37242 did not adequately take into account the substantial decrease in intraservice time. We indicated that we believed that the survey's 25th percentile work RVU of 10.05 was more consistent with the decreases in intraservice time since its last valuation and more appropriately reflected the work of the procedure. Similarly, we did not believe that the RUC-recommended work RVU for CPT code 37243 adequately considered the substantial decrease in intraservice time for the procedure; and we also use the survey's 25th percentile for CPT code 37243.

Comment: Many commenters disagreed with our interim final valuation of 37242, including one who recommended a work RVU of 11.98. One commenter also believed the work RVU assigned to CPT code 37243 was inappropriate and recommended instead a work RVU of 14.00. Commenters requested that the family of codes be referred for refinement.

Response: After consideration of the comments, we continue to believe that work RVUs should reflect the decreases in intraservice time that have occurred since the last valuation. As a result, we continue to believe that our CY 2014 interim final values are most appropriate and are finalizing them for CY 2015. Additionally, we did not refer these codes for refinement panel review because the criteria for refinement panel review were not met.

(6) Rigid Transoral Esophagoscopy (CPT Codes 43191, 43192, 43193, 43194, 43195 and 43196)

We established CY 2014 interim final work RVUs for the rigid transoral esophagoscopy codes using a ratio of 1 RVU per 10 minutes of intraservice time, resulting in a RVU of 2.00 for CPT code 43191, 3.00 for CPT code 43193, 3.00 for CPT code 43194, 3.00 for CPT code 43195, and 3.30 for CPT code 43196. As we detailed in the CY 2014 final rule with comment period, the surveys showed that this ratio was reflected for about half of the rigid transoral esophagoscopy codes. Additionally, we noted that this ratio was further supported by the relationship between the CY 2013 work value of 1.59 RVUs for CPT code 43200 (Esophagoscopy, rigid or flexible; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure)) and its intraservice time of 15 minutes. For CPT code 43192, the 1 work RVU per 10 minutes ratio resulted in a value that was less than the survey low, and thus did not appear to be appropriate for this procedure. Therefore, we established a CY 2014 interim final work RVU for CPT code 43192 of 2.45 based upon the survey low.

Comment: Multiple commenters objected to the interim final work RVUs assigned to CPT codes 43191-43196, and expressed dissatisfaction with CMS's explanation for the valuations. The commenters specifically noted that CMS did not account for the difference in intensity between flexible and rigid scopes now that there are separate codes for these procedures. The commenters also suggested that the reduction in time in the RUC recommendations for codes 43191, 43193, 43195, and 43196 was also based on data from procedures with flexible scopes. The commenters also stated that our valuation of services based upon 1 work RVU per 10 minutes of intraservice time was inappropriate and was based on the survey low, which is an anomalous outlier. The commenters suggested the following work RVUs based upon the RUC recommended values: 2.78 For CPT code 43191, 3.21 for CPT code 43192, 3.36 for CPT code 43193, 3.99 for CPT code 43194, 3.21 for CPT code 43195 and 3.36 or CPT code 43196. Finally, the commenters asked that all these codes be referred to a refinement panel for reconsideration.

Response: After consideration of the comments, we agree that modification of the CY 2014 interim final values is appropriate. Based upon the information provided in comments and further investigation, we believe that greater intensity is involved in furnishing rigid than flexible transoral esophagoscopy. Accordingly, rather than assigning 1 work RVU per 10 minutes of intraservice time as we did for the CY 2014 interim final, we are assigning a final work RVU to the base code, CPT code 41391, of 2.49. This work RVU is based on increasing the work RVU of the previous comparable code (1.59) to reflect the percentage increase in time for the CY 2014 code. For the remaining rigid esophagoscopy codes, we developed RVUs by starting with the RVUs for the corresponding flexible esophagoscopy codes, and increasing those values by adding the difference between the base flexible esophagoscopy and the base rigid esophagoscopy codes to arrive at final RVUs. We are establishing a final work RVU of 2.79 to CPT code 43192, 2.79 to CPT code 43193, 3.51 to CPT code 43194, 3.07 to CPT code 43195, and 3.31 to CPT code 43196. These codes were not referred to refinement because the request did not meet the criteria for referral.

(7) Flexible Transnasal Esophagoscopy (CPT Codes 43197 and 43198)

We established CY 2014 interim final work RVUs of 1.48 for CPT code 43197 and 1.78 for CPT code 43198. As detailed in the CY 2014 final rule with comment period, we removed 2 minutes Start Printed Page 67634of the pre-scrub, dress and wait preservice time from the calculation of the work RVUs that we established for CY 2014 for CPT codes 43200 and 43202 because we believed that unlike the transoral codes, which they correspond to, the transnasal services are not typically furnished with moderate sedation.

Comment: Multiple commenters objected to the work RVUs for these codes and in particular to CMS basing its valuation on the fact that these codes typically do not involve moderate sedation. Although the commenters agreed that these codes typically do not involve moderate sedation, they said that procedures involving local/topical anesthesia often take more work than those involving general sedation due to the difficulties of furnishing services to a conscious and often anxious patient. Some also noted that it ignores the time necessary to apply local/topical anesthesia and wait for it to take effect. A commenter urged CMS to establish values based upon the RUC recommendations. Commenters requested that these codes be referred for refinement.

Response: After consideration of the comments, we agree that the work RVUs for these codes should not be reduced because moderate sedation is not typically used. Accordingly, we agree with the RUC recommendation to assign the same work RVUs to these codes as to CPT code 43200 (Esophagoscopy, flexible, transoral; diagnostic, including collection of specimen(s) by brushing or washing when performed) and 43202 (Esophagoscopy, flexible, transoral; with biopsy, single or multiple) the comparable transoral codes. We are finalizing work RVUs of 1.52 and 1.82 for CPT codes 43197 and 43198, respectively. We did not refer these codes to refinement because the request did not meet the criteria for refinement panel review.

(8) Flexible Transoral Esophagoscopy, (CPT Codes 43200, 43202, 43204, 43205, 43211, 43212, 43213, 43214, 43215, 43227, 43229, 43231, and 43232)

We established CY 2014 interim final work RVUs for the flexible transoral esophagoscopy family, which are detailed in Table 15. As we described in the CY 2014 final rule with comment period, to establish work values for these codes we used a variety of methodologies as did the RUC. The methodologies used by CMS And the RUC include basing values on the surveys (either medians or 25th percentiles), crosswalking values to other codes, using the building block methodology, and valuing a family of codes based on the incremental differences in the work RVUs between the codes being valued and another family of codes. As we did for the rigid transoral esophagoscopy codes, in addition to the methodologies used by the RUC, we also reduced the work RVUs for particular codes in direct proportion to the reduction in times that were recommended by the RUC. Using these methodologies, we assigned the RUC-recommended work RVUs for five codes in this family; for the other eight codes we used these same methodologies but because of different values for a base code or variation in the crosswalk selected we obtained different values.

Comment: Commenters objected to the interim final RVUs we assigned for CPT code 43200, the base code for flexible transoral esophagoscopy, because they did not believe the work RVU for the code should be less than they were as of CY 2013 when there was a single code to report both flexible and rigid esophagoscopy services. Commenters also disagreed with t he way we used standard methodologies to value many of these codes, including using the ratio of 1 work RVU per 10 minutes of intraservice time to CPT code 43200. Commenters requested that we accept the RUC values for all the flexible transoral esophagoscopy codes and asked that we refer all these codes to the refinement panel.

Response: Although refinement was requested for all of the flexible transoral esophagoscopy codes, we found that the codes (CPT codes 43204, 43205 and 43233) met the refinement criteria, and those were referred to the refinement panel. After consideration of the comments and the refinement panel results, we are revising the work RVUs for many of the codes in this family.

For CPT code 43200, which is the base code for flexible transoral esophagoscopy, we agree with commenters that another methodology is preferable to applying the work RVU ratio of 1 RVU per 10 minutes of intraservice time. In revaluing this service, we subtracted 0.07 to account for the 3 minute decrease in postservice time since the last valuation from the CY 2013 work RVU for the predecessor base code, which resulted in a work RVU of 1.52. We are finalizing this work RVU.

The CY 2014 interim final work RVUs for CPT codes 43201, 43202, 43204, 43205 and 43215 were all based upon methodologies using the work RVU of the base code, 43200. As we are establishing a final value for CPT code 43200 that is higher than the CY 2014 interim final value, we are also adjusting the work RVUs for the other codes based upon the new work RVU for CPT code 43200. We are finalizing a work RVU of 1.82 for 43201, 1.82 for 43202, 2.43 for 43204, 2.54 for 43205, and 2.54 for 43215.

CPT codes 43204 and 43205 were considered by the refinement panel. The refinement panel median for each of these codes was 2.77 and 2.88, respectively. The refinement panel discussion reiterated the information presented to the RUC and in the comments in response to the CY 2014 final rule with comment period, such as that the typical patient for these codes are sicker and thus the work is more intense. Because we do not agree with commenters' contention that higher work RVUs are warranted since these codes involve the sicker patients or that our methodology for calculating the interim final RVUs was inappropriate, we are establishing final values determined using these methodologies. However, due to the change in the base code, CPT code 43200, as discussed in the previous paragraph the final values for these codes are higher than the interim final values.

In the CY 2014 final rule with comment period, we assigned an interim final work RVU of 4.21 to CPT code 43211 by using a comparable esophagogastroduodenoscopy (EGD) code and subtracting the difference in work between the base esophagoscopy and base EGD codes. After consideration of the comments that indicated the interim final work RVU of 4.21 was too low, we believe this code should instead be crosswalked to CPT code 31636 (Bronchoscopy bronch stents), which we believe is a comparable service with comparable intensity. It has the same intraservice time and slightly higher total time. As a result we are finalizing a work RVU of 4.30.

As we noted in the CY 2014 final rule with comment period, we crosswalked the interim final work RVU for CPT 43212 to that of CPT code 43214. Since we are increasing the work RVU for CPT code 43214, we are also increasing the work RVU for CPT code 43212, which is consistent with comments that we had undervalued this procedure.

As we detailed in the CY 2014 final rule with comment period, we based the work RVU of 4.73 for CPT code 43213 on the value of CPT code 43220, increased proportionately to reflect the longer intraservice time of CPT code 43213. The refinement panel median was 5.00 for this code. No new information was presented at the refinement panel. We continue to believe that 4.73 is the appropriate work RVU and are finalizing it.Start Printed Page 67635

Based upon the information presented by commenters about the typical patient and the advanced skills required for the procedure, we are changing our method of valuing CPT code 43214. We believe it should be crosswalked to CPT 52214 (cystoscopy), which we believe is similar in intensity. This results in a final work RVU of 3.50 as compared to an interim final of 3.38. This refinement also supports the belief made by commenters that the work of CPT code 43214 is greater than the interim final work RVU. Therefore, we are finalizing a work RVU of 3.50 for CPT code 43214.

For CPT code 43227, we modified the CY 2013 work RVU to reflect the percentage decrease in intraservice time of 36 minutes to 30 minutes in the RUC recommendation to establish a CY 2014 interim final value of 2.99. The commenters stated that the survey validates the RUC recommendation of 3.26 and that the drop in intraservice time that upon which we based our change in the work RVU was inappropriate since the intraservice time had not really changed. They contend that the change was from moving the time for moderate sedation from intraservice to preservice. We disagree. We have no information from the RUC that leads us to believe that when the pre-service packages were developed several years ago and moderate sedation was explicitly recognized as a pre-service item that the RUC also intended CMS to assume that the intraservice times were no longer correct. We believe that our proposed valuation methodology is correct and thus are finalizing a work RUV of 2.99.

Commenters, disagreeing with our crosswalk of CPT code 43229 to CPT code 43232, stated that the two codes were not comparable. We disagree. We continue to believe this crosswalk is appropriate as the times and intensities are quite similar. We note that the RUC also bases crosswalks on the comparability of time and intensity of codes and not on the clinical similarity of work. Thus, we will continue this crosswalk. However, as discussed below, we are refining the interim final value of CPT code 43232 to 3.59 and thus are finalizing the work RVU of 3.59 for CPT code 43229.

For CPT code 43231, we added the work of an endobronchial ultrasound (EBUS) to the work of the base esophagoscopy code to arrive at our interim final value. The commenters disagreed with our approach, stating that the EBUS code is an add-on code and as such does not have pre- and postservice work. We agree that pre- and postservice work is not included in the EBUS code nor should it be for the ultrasound portion of the examination of esophagus. Therefore, we are finalizing a work RVU of 2.90.

For CPT code 43232, the commenters stated our interim final value is too low and that the work involved in this code is appropriately reflected in the RUC recommendation. They objected to our basing the work RVU for 43232 on the difference between the RUC-recommended values for this code and CPT code 43231. We learned from the comments that the typical patient for this service has advanced cancer and agree that our interim final value may not represent the full extent of the work involved in this procedure. Therefore, we are crosswalking this code to CPT code 36595 (Mechanical removal of pericatheter obstructive material (eg, fibrin sheath) from central venous device via separate venous access), which has identical intraservice time, slightly less total time, and a slightly higher intensity and are finalizing a work RVU of 3.59.

(10) Esophagogastroduodenoscopy (EGD) (CPT Codes 43233, 43235, 43236, 43237, 43238, 43239, 43242, 43244, 43246, 43247, 43249, 43253, 43254, 43255, 43257, 43259, 43266, and 43270.

We established interim final work RVUs for various EGD codes in the CY 2014 final rule with comment period. In this section, we discuss the 18 EGD codes on which we received comments disagreeing with or making recommendations for changes in our interim final values. As we detailed in the CY 2014 final rule with comment period, we valued many of these codes by adding the additional work of an EGD to the comparable esophagoscopy (ESO) code. We determined the additional work of an EGD by subtracting the work RVU of CPT code 43200, the base ESO code, from the work of CPT code 43235, the base EGD code. For example, CPT code 43233 is an identical procedure to CPT code 43214 except that it uses EGD rather than ESO. We valued it by adding the additional work of EGD to the work RVU of CPT code 43214, resulting in an interim final work RVU of 4.05. We valued the additional work the same way the RUC did in its recommendations. The following EGD codes were valued in the same way using the code in parentheses as the corresponding ESO code: 43233 (43214), 43236 (43201), 43237 (43231), 43238 (43232), 43247 (43215), 43254 (43211), 43255 (43227), 43266 (43212), and 43270 (43229). In valuing CPT codes 43235, we agreed with the RUC recommended work RVU difference between this EGD base code and the esophagoscopy base code, CPT 43200 but applied the difference to our CY 2014 RVU values. In a similar fashion, in valuing CPT code 43242 we agreed with the RUC recommended methodology of which took the increment between CPT code 43238 and CPT code 43237 but we applied the difference to our CY 2014 values. In order to value other EGD codes, we crosswalked the services to similar procedures; specifically for CY 2014 we crosswalked CPT codes 43239 to 43236, 43246 to 43255, 43253 to 43242 and 43257 to 43238. We valued CPT codes 43244 and 43249 through acceptance of the RUC work RVU recommendation. Lastly, we valued CPT code 43259 by adjusting the CY 2013 work RVU to account for the CY 2014 RUC recommended reduction in total time.

Comment: For all codes, commenters objected to our work RVUs and said that our reductions from the RUC recommendations were based on a decrease in intraservice time that did not reflect a change in the time required to furnish the procedures but rather only a change in which part of the procedure the RUC includes the moderate sedation time. Commenters disagree with our valuing CPT code 43233 based on the value of CPT code 43214, saying that CPT code 43233 is more intense due to the risk of perforation, and that the achalasia patients are at high risk and poor candidates for surgery. Commenters disagreed with our methodology for valuing CPT code 43235, and suggested that we use the RUC crosswalk to CPT code 31579, contending that the slight reductions in pre- and post-service times are consistent with the slight drop in the RUC-recommended RVU. For CPT code 43237, commenters also noted a rank order anomaly because the interim final work RVU for this code is the same as for CPT code 43251. Commenters said that the robust survey data on CPT code 43238 should override CMS decisions. With regard to CPT code 43239, commenters suggest that the survey is wrong and further point to the fact that our valuation results in the same value for CPT code 43239 as the base EGD code, which they state is not appropriate due to the additional work in CPT code 43239. Commenters disagreed with our value for CPT code 43242 stating that we inappropriately valued CPT code 43259, which we used in calculating the work RVUs for CPT code 43242. Commenters objected to our value of CPT code 43246 because they disagree with the work RVU for the code that it is crosswalked to, CPT code 43255. Commenters urged us to modify Start Printed Page 67636our work RVU for CPT code 43247 to equal the RUC recommendation. For CPT code 43253, commenters did not disagree with the valuation approach, but disagreed with the valuation we had assigned to the base code, CPT code 43259, which affected the valuation of CPT code 43253. Comments indicated that they did not understand how the value of CPT code 43254 was derived. Commenters indicated that they disagreed with the reduction in the work in CPT code 43255 due to a decrease in time. They also cited that this was an emergency procedure in unstable patients and that it was more difficult to control bleeding in the stomach than in the esophagus. For CPT code 43257, commenters disagreed with our crosswalk to CPT code 43238 indicating that CPT code 43257 was more intense than CPT code 43238. Commenters acknowledged that reduced times should result in reduced work, but disagreed with our proportional reduction approach. Commenters agreed with our approach to valuing CPT code 43266, but disagreed with the valuation of the CPT code 43212, that we used as the base. With regard to CPT code 43270, commenters disagreed with using CPT code 43229 as the base.

Response: For each of these codes, commenters were concerned that we did not accept the RUC-recommended values. Their common reasoning for urging us to accept the RUC-recommended values was that moderate sedation time had been removed from intraservice time and that these intraservice time changes should not result in a change in the RUC-recommended RVU. However, for CPT codes 43233, 43236, 43237, 43238, 43247, 43254, 43255, 43266, and 43270, we used the standard methodology described above for valuing EGD codes and did not base our values on the time change. Thus, any refinements to the RUC recommendations for the EGD codes are solely due to refinements in the ESO codes. We discussed our valuations of these codes in the previous section. Since we have finalized most of the ESO codes at higher levels than the CY 2014 interim final values, we are making corresponding increases in the EGD codes. Therefore, we are finalizing these codes at the following work RVUs: 43233 at 4.17, 43235 at 2.19, 43236 at 2.49, 43237 at 3.57, 43238 at 4.26, 43247 at 3.21, 43254 at 4.97, 43255 at 3.66, 43266 at 4.17, and 43270 at 4.26.

CPT code 43233 was referred to the refinement panel and received a median work RVU of 4.26. As outlined above, we are finalizing a work RVU of 4.17 for CPT code 43233 at 4.17, which is higher than our interim value of 4.05, but consistent with our valuation of the other EGD codes. We do not believe that the comments provided at the refinement panel justify adoption of the higher median value.

The interim final work value of CPT code 43239 was crosswalked to the work RVU of CPT code 43236. Since we increased the final work RVU from the interim final for this code, the final work RUV of CPT code 43239 increases to 2.49.

(11) Endoscopic Retrograde Cholangiopancreatography (ERCP) (CPT Codes 43263, 43274, 43276, 43277 and 43278)

In the CY 2014 final rule with comment period we established interim final work RVUs for several ERCP codes due to coding revisions. For all those codes not discussed in this section, we are finalizing the interim final work RVUs. For CPT code 43263, we established an interim final work RVU based upon a crosswalk to CPT code 43262. As we detailed in the CY 2014 final rule with comment period, we valued CPT codes 43274, 43276, and 43278 using the same formula that the RUC used in determining its recommendations, but substituting our interim final work RVUs for codes used in the formula for the RUC-recommended values. CPT code 43277 was valued using the survey 25th percentile.

Comment: Commenters objected to our valuation of CPT 43263 based upon a crosswalk to CPT code 43262, saying that CPT 43263 is more intense and has greater risks than CPT code 43262. Commenters also indicated that we underestimated the intensity of CPT code 43276 indicating that CPT code 43276 typically involves replacing stents that are overgrown with cancerous tissues. They also said that we underestimated the intensity of CPT coded 43274 and 43277. Commenters further took issue with our valuing CPT code 43277 based upon the survey when most codes in this family were valued based upon the incremental formula. Commenters stated that CPT code 43278 is valued incorrectly because we did not correctly value CPT code 43229, which is used in the formula we used to value CPT code 43278.

Response: After consideration of the comments, we continue to believe that CPT code 43263 is the appropriate crosswalk for CPT code 43262 and we are finalizing a work RVU of 6.60 for that code. With regard to CPT code 43274, we continue to believe the formula described in the CY 2014 final rule with comment period is the appropriate methodology. We are finalizing a work RVU of 8.58 for CPT code 43274 using the final values for the codes used in the formula and thus increasing the work RVU from the interim final value of 8.48. Similarly, we are finalizing a work RVU of 8.94 for CPT code 43276 based upon the formula described in the CY 2014 final rule with comment period adjusted for changes in the final work RVUs for values used in the formula. For CPT code 43277, we continue to believe the survey 25th percentile is appropriate. This valuation is supported by a drop in the intraservice time from the code it replaces. Thus, we are finalizing the interim final work RVU of 7.00. For CPT code 43278, we continue to believe use of the RUC formula for this code is most appropriate, and we are adjusting the work RVU to reflect final work RVUs for values used in the formula. The final work RVU for CPT code 43278 is 8.

(12) Spinal Injections (CPT Codes 62310, 62311, 62318 and 62319)

We proposed new work RVUs for these codes in the PFS proposed rule. (79 FR 40338-40339). See section II.B.3 for a discussion of the valuation of these codes, and a summary of public comments and our responses.

(13) Laminectomy (CPT Codes 63045, 63046, 63047 and 63048)

We established interim final work RVUs for CPT codes 63047 and 63048 for CY 2014. As we indicated in the CY 2014 final rule with comment period, we had identified CPT code 63047 as potentially misvalued through the high expenditure procedure code screen and the RUC included a recommendation for CPT code 63048. We noted that, to appropriately value these codes, we need to consider the other two codes in this family: CPT codes 63045 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; cervical) and 63046 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; thoracic). Although we did not receive recommendations for CPT codes 63045 and 63046, we established CY 2014 interim final work RVUs for CPT codes 63047 and 63048 of 15.37 and 3.47, respectively, based upon the RUC recommendations. We noted that we expected to review these values in concert with the RUC Start Printed Page 67637recommendations for CPT codes 63045 and 63046 when we received them.

Comment: Commenters questioned our determination that CPT codes 63047, 63048, 63045 and 63046 constituted a family, noting that CPT codes 63045 and 63046 require different work. Commenters questioned the value of resurveying this set of codes as a family since CPT codes 63045 and 63046 constitute a small percentage of the total volume of these codes. The survey of CPT codes 63047 and 63048 did not reveal significant change in the values of the codes, and the work involved in resurveying would be burdensome for those involved. One commenter urged us to withdraw our request to survey these codes.

Response: We continue to believe that it is appropriate to value a family of codes together in order to maintain relativity. We also continue to believe that CPT codes 63045 and 63046 are indeed in the same family as CPT codes 63047 and 63048 due to similarity of service. We have received new RUC recommendations for CPT code 63045 and 63046, but did not receive them in time to include in this rule. As a result, we will finalize the interim work values for CPT codes 63047 and 63048 for CY 2015.

(14) Chemodenervation of Muscles (CPT Codes 64616, 64617, 64642, 64643, 64644, and 64645)

We assigned refined interim final work RVU values of 1.53 to CPT code 64616 and 1.90 to CPT code 64617. As detailed in the CY 2014 final rule with comment period, we refined the RUC-recommended work RVUs of 1.79 for CPT code 64616 and 2.06 for CPT code 64617 to reflect the deletion of an outpatient visit that was included in the predecessor code, CPT code 64613 (chemodenervation of muscle(s); neck muscle(s) (eg, for spasmodic torticollis, spasmodic dysphonia)). We also explained that since CPT code 64617, chemodenervation of the larynx, includes EMG guidance when furnished we determined the interim final work RVU by adding the work RVU for CPT code 95874 (Needle electromyography for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure)) to the CY 2013 work RVU for CPT 64616.

For CY 2014, we assigned interim final work RVUs for CPT code 64643 and CPT code 64645 of 1.22 and 1.39, respectively. As we explained in the CY 2014 final rule with comment period, we refined the RUC-recommended work RVUs for these add-on codes by subtracting the RVUs to account for 19 minutes of pre-service time and the decrease in time for furnishing the add-on service. Additionally, we based the global period for these codes on the predecessor code, CPT code 64614 (chemodenervation of muscle(s); extremity and/or trunk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis)), which was deleted for CY 2014. Therefore, we assigned 10-day global periods to the services.

Comment: Most commenters disagreed with the CY 2014 interim final work RVU valuations for CPT codes 64616, 64643, and 64645. One commenter stated that the work RVU for the predecessor code, CPT code 64614, did not take into account the full level of intensity, time, and work that it takes to perform the service. This commenter also disagreed with the times for this service. Several commenters disagreed with the valuation of CPT code 64616 saying that we ignored the RUC recommendation which was based on survey data and RUC deliberations and asked that we value the code based upon the RUC recommendation. Several commenters disagreed with the valuations for CPT codes 64643 and 64645 saying that CMS did not explain our valuation, ignored the fact that the RUC discounted the add-on codes based on the pre- and post-service time and did not articulate any basis for our valuation decision. Several commenters requested refinement of the codes in the chemodenervation family.

Response: After consideration of the comments we are finalizing the interim final work RVUs and time for these codes. We continue to believe that our valuations for this family take into account the full level of intensity, time, and work that are required to furnish these services. Additionally, we disagree with commenters that we did not explain our valuation of CPT codes 64643 and 64645. In the CY 2014 final rule with comment period, we detail and thoroughly explain the methodology utilized to value CPT codes 64643 and 64645. Additionally, the request for refinement panel review was not granted as the criteria for refinement were not met.

(15) Impacted Cerumen (CPT Code 69210)

After it was identified as a potentially misvalued code pursuant to the CMS high expenditure screen, CPT code 69210, which describes removal of impacted cerumen, was revised from being applicable to “1 or both ears” to a unilateral code effective January 1, 2014. For Medicare purposes we limited the code to billing once whether it was furnished unilaterally or bilaterally because we believed the procedure would typically be furnished in both ears as the physiologic processes that create cerumen impaction likely would affect both ears. Similarly, we continued the CY 2013 value as our interim final CY 2014 value since for Medicare purposes the service was unchanged.

Comment: Commenters requested that we allow CPT code 69210 to be billed twice when it is furnished bilaterally, consistent with code descriptor. Commenters stated that our assumption regarding the physiologic processes that create cerumen was flawed and requested we provide a clinical rationale and/or literature to support our claim. Lastly, the commenters requested guidance from the agency as to how best deal with this CPT code; specifically, if it should be sent to CPT for clarification or if not, that we provide further guidance as to how this procedure should be billed using the new code.

Response: We continue to believe that the procedure will be furnished in both ears as the physiologic processes that create cerumen impaction likely would affect both ears. As a result, we will continue to allow only one unit of CPT 69210 to be billed when furnished bilaterally and are finalizing our CY 2014 interim final work RVU for this service.

(16) Magnetic Resonance Imaging (MRI) Brain (CPT Codes 77001, 77002, and 77003)

As detailed in the CY 2014 final rule with comment period, we agreed with the RUC-recommended values for CPT codes 77001, 77002 and 77003 but were concerned that the recommended intraservice times for all three codes was generally higher than the procedure codes with which they were typically billed. We sought additional public comment and input from the RUC and other stakeholders regarding the appropriate relationship between the intraservice time associated with fluoroscopic guidance and the intraservice time of the procedure codes with which they are typically billed.

Comment: Some commenters disagreed with the concern expressed by CMS that the intraservice time for codes 77001, 77002 and 77003 is higher than the codes alongside which they are typically billed, as the commenters believed that the combinations being used to support this concern were not appropriate, and they requested additional examples to support its concern. The commenters believed that the concerns CMS expressed are unfounded and that we should assign work RVUs of 0.38, 0.54, and 0.60 for Start Printed Page 67638CPT code 77001, 77002, and 77003, respectively.

Response: We continue to have concerns regarding the appropriate relationship between the intraservice time associated with fluoroscopic guidance and the intraservice time of the procedure codes with which they are typically billed and will continue to study this issue. We are finalizing the CY 2014 interim final values for CY 2015.

(17) Immunohistochemistry (CPT Codes 88342 and 88343 and HCPCS Codes G0461 and G0462)

These codes were revised for CY 2015. For discussion of valuation for CY 2015, see section II.G.3.b.

(18) Optical Endomicroscopy (Code 88375)

As detailed in the CY 2014 final rule with comment period, we believed that the typical optical endomicroscopy case would involve only the endoscopist, and CPT codes 43206 and 43253 were valued to reflect this. Accordingly, we believed a separate payment for CPT code 88375 would result in double payment for a portion of the overall optical endomicroscopy service. Therefore, we assigned a PFS procedure status of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) to CPT code 88375.

Comment: Multiple commenters objected to CMS's decision to assign a PFS status indicator of “I” to code 88375, stating that the code already includes distinctions that would prevent a physician from billing the code when it would double count work. The commenters urge CMS to assign CPT code 88375 a Medicare status of A (Active Code), and to immediately publish RVUs associated with the service.

Response: In our re-review of this procedure and consideration of the information provided by commenters, we believe the coding is adequate to avoid double payment for a portion of the service. Accordingly, we assigned a Medicare status indicator of A (Active). To value this service, we based the RVUs on those assigned to CPT code 88329, adjusted for the difference in intraservice time between the two codes. We are assigning a final work RVU of 0.91 for CPT code 88375 for CY 2015.

(19) Speech Language (CPT Codes 92521, 92522, 92523 and 92524)

In CY 2014, we assigned CY 2014 interim final work RVUs of 1.75 and 1.50 for CPT codes 92521 and 92522, respectively, as the HCPAC recommended. For CPT code 92523, we disagreed with the HCPAC-recommended work RVU of 3.36. We believed that the appropriate value for 60 minutes of work for the speech evaluation codes was reflected in CPT code 92522, for which the HCPAC recommended 1.50 RVUs. Because the intraservice time for CPT code 92523 was twice that for CPT code 92522, we assigned a work RVU of 3.0 to CPT code 92523. Similarly, since CPT codes 92524 and 92522 had identical intraservice time recommendations and similar descriptions of work we believed that the work RVU for CPT code 92524 should be the same as the work RVU for CPT code 95922. Therefore, we assigned a work RVU of 1.50 to CPT code 92524.

Comment: Commenters disagreed with the interim final work RVUs assigned to CPT codes 92523 and 92524, saying they based on inaccurate assumptions. Commenters stated that survey respondents appropriately took time and effort into account when valuing CPT code 92523 but had difficulty using a time-based reference code to value the RVU of an untimed code like CPT code 92523. Commenters noted that the HCPAC acknowledged that the work of the second hour involved in CPT code 92523 is indeed more intense than the first hour. Additionally, commenters stated that the work RVU reduction of CPT code 92524 was arbitrary because it was based solely on intraservice time and failed to recognize the more difficult aspects of performing the service compared to that of CPT code 92522. Commenters requested reconsideration of CPT codes 92523 and 92524 through refinement panel review.

Response: We believe that our interim final work RVU is most appropriate for these services. In the HCPAC recommendation for CPT code 92523 the affected specialty society stated that its survey results were faulty for this CPT code because those surveyed did not consider all the work necessary to perform the service. The commenters did not provide any information that demonstrates that our valuations fail to fully account for the intensity, work, and time required to perform these services. Therefore, we are finalizing our CY 2014 interim final values for CY 2015. We did not refer these codes to refinement because the request did not meet the criteria for refinement.

(20) Percutaneous Transcatheter Closure (CPT Code 93582)

As detailed in the CY 2014 final rule with comment period, we reviewed new CPT code 93582. Although the RUC compared this code to CPT code 92941 (percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary), which has a work RVU of 12.56 and 70 minutes of intraservice time, it recommended a work RVU of 14.00, the survey's 25th percentile. We agreed with the RUC that CPT code 92941 is an appropriate comparison code and believed that due to the similarity in intensity and time that the codes should be valued with the same work RVU. Therefore, we assigned an interim final work RVU of 12.56 to CPT code 93582.

Comment: One commenter disagreed with the work RVU valuation of CPT code 93582 because they believed it did not accurately reflect the intensity of the procedure, particularly in treating infants. The commenter stated that the RUC concluded that a 55 percent work differential exists between performing this service on a child versus an adult—a fact that they stated supports the higher work RVU recommended by the RUC. As a result, the commenter suggests we assign the RUC-recommended work RVU to CPT code 93582. A commenter requested referral to the refinement panel.

Response: We continue to believe that CPT code 92941 is an appropriate comparison code to CPT code 93582 due to similarity in intensity and time and, as a result, the codes should be valued with the same work RVU. Therefore, we are finalizing our CY 2014 interim final work RVU of 12.56 to CPT code 93582 for CY 2015. We did not refer this code to refinement because the request did not meet the criteria for refinement.

(21) Duplex Scans (CPT Codes 93925, 93926, 93880 and 93882)

For CY 2014 we maintained the CY 2013 RVUs for CPT codes 93880 and 93882. We were concerned that the RUC-recommended values for CPT codes 93880 and 93882, as well as our final values for CPT codes 93925 (Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study) and 93926 (Duplex scan of lower extremity arteries or arterial bypass grafts; unilateral or limited study), did not maintain the appropriate relativity within the family and referred the entire family to the RUC to assess relativity among the codes and then recommend appropriate work RVUs. We also requested that the RUC consider CPT codes 93886 (Transcranial Doppler study of the intracranial arteries; complete study) and 93888 (Transcranial Doppler study of the Start Printed Page 67639intracranial arteries; limited study) in conjunction with the duplex scan codes to assess the relativity between and among the codes.

Comment: One commenter questioned why we did not include all duplex scan codes we determined to be part of the family in our original request to the RUC. Another commenter opposed our valuation approach and stated that we should not redefine the codes in this family and that we should reject the RUC recommendations.

Response: The valuations for CPT codes 93880, 93882, 93925, 93926, 93886 and 93888 are included in this year's valuations in section II.G.3.b

(22) Interprofessional Telephone/Internet Consultative Services (CPT Codes 99446, 99447, 99448 and 99449)

In CY 2014 we assigned CPT codes 99446, 99447, 99448, and 99449 a PFS procedure status indicator of B (Bundled code. Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs are shown, they are not used for Medicare payment). If these services are covered, payment for them is subsumed by the payment for the services to which they are bundled (for example, a telephone call from a hospital nurse regarding care of a patient) because Medicare pays for telephone consultations regarding beneficiary services as a part of other services furnished to the beneficiary.

Comment: A commenter expressed concern that the services covered by codes 99446-99449 were bundled together, and that no RVUs were published for these codes. The commenter observed that CMS compares the services to contact between nurses and patients in justifying its decision to bundle the services in with other work, and stated that this comparison is inappropriate to use regarding consultation between physicians. The commenter also stated that these services are vital in providing specific specialty expertise in areas where timely face-to-face service is not a viable option. The commenter urged that the status of these services be changed to “Active,” or at least “Non-covered,” and that the RUC-recommended values for these services be published.

Response: Medicare pays for telephone consultations regarding beneficiary services as part of other services furnished to a beneficiary. As a result, we continue to believe that CPT codes 99446- 99449 are bundled; and we are finalizing the PFS procedure status indicator of B for these codes for CY 2015.

b. Finalizing CY 2014 Interim Direct PE Inputs

i. Background and Methodology

In this section, we address interim final direct PE inputs as presented in the CY 2014 PFS final rule with comment period and displayed in the final CY 2014 direct PE database available on the CMS Web site under the downloads at http://www.cms.gov/​PhysicianFeeSched/​PFSFRN/​list.asp#TopOfPage.

On an annual basis, the RUC provides CMS with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code-by-code basis. When we determine that the RUC recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.

In the CY 2014 PFS final rule with comment period (78 FR 74242), we addressed the general nature of some of our common refinements to the RUC-recommended direct PE inputs, as well as the reasons for refinements to particular inputs. In the following sections, we respond to the comments we received regarding common refinements we made based on established principles or policies. Following those discussions, we summarize and respond to comments received regarding other refinements to particular codes.

We note that the interim final direct PE inputs for CY 2014 that are being finalized for CY 2015 are displayed in the final CY 2015 direct PE input database, available on the CMS Web site under the downloads for the CY 2015 PFS final rule at www.cms.gov/​PhysicianFeeSched/​. The inputs displayed there have also been used in developing the CY 2015 PE RVUs as displayed in Addendum B of this final rule with comment period.

Comment: Commenters indicated that it would be helpful to have additional information about the specific rationale used in developing refinements, and specifically requested that CMS provide more information regarding how CMS makes the determination of whether an item is typical.

Response: We continually seek ways to increase opportunity for public comment. In response to comments received, we have provided more detailed explanations about refinements made for the CY 2015 interim final direct PE inputs. We recognize that we make assumptions about what is typical, and note that we welcome objective data that provides information about the typical case. We prefer that this information be submitted through the notice and comment rulemaking process. We also refer interested stakeholders to section II.F. of this final rule with comment period, in which we provide extensive discussion of the changes to the process that we are finalizing for valuing new, revised, and potentially misvalued codes.

ii. Common Refinements

(1) Equipment Time

Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We continue to appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.

In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We have clarified this principle, indicating that we consider equipment time as the times within the intra-service period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For services in which we allocate cleaning time to portable equipment items, because the equipment does not need to be cleaned in the room that contains the remaining equipment items, we do not include that time for the remaining equipment items as they are available for use for other patients during that time. In addition, when a piece of equipment is typically used during any additional visits included in the global period for a service, the equipment time would also reflect that use.

We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the pre-service or post-service tasks performed by clinical labor staff on the day of the procedure Start Printed Page 67640(the clinical labor service period) and are typically available for other patients even when one member of clinical staff may be occupied with a pre-service or post-service task related to the procedure.

Some commenters have repeatedly objected to our rationale for refinement of equipment minutes on this basis. We acknowledge the comments we received reiterating those objections to this rationale and refer readers to our extensive discussion in response to those objections in the CY 2012 PFS final rule with comment period (76 FR 73182). In the following paragraphs, we address new comments on this policy.

Comment: A commenter indicated that CMS removed minutes assigned to vascular ultrasound rooms for activities that CMS does not believe take place in the room, but CMS did not provide factual support for this assumption. The commenter further stated that CMS did not articulate the connection between the relevant data that the Administrative Procedures Act (APA) requires CMS to consider and the conclusion that CMS reached. The commenter indicated that they conducted a survey of a significant number of providers, in which most providers indicated that they performed these pre-service tasks in the room.

Response: We note that we would welcome comments that include vetted survey results, especially where the data are included. Statements regarding the existence of data to support commenters' assertions do not provide us with information to support conclusions based on the data. We acknowledge that we make assumptions about we believe to be typical. If there are data that support or refute these assumptions, we would be interested in reviewing that information. We would be most interested in reviewing survey data that address multiple points of our assumptions regarding high-cost equipment, including how many procedures are furnished in a day, how often the equipment is being used, and other such information.

Comment: A commenter stated that CMS should publish, on a quarterly basis, refinements to the equipment times, rather than waiting until the final rule to publish these changes.

Response: We appreciate the commenter's concern about our making available timely information about refinements to practice expense inputs. We note that since we do not review and make refinements to practice expense inputs on a quarterly basis, we do not have information to publish on a quarterly basis. Rather, we have reviewed and refined practice expense recommendations from the RUC on an annual basis for the subset of codes for which recommendations have been provided to us. Because we have received many requests from stakeholders to publish our refinements as proposals in the proposed rule rather than in the final rule, we are finalizing a change in the process in which changes to RVUs and direct PE inputs will be included in the proposed rule rather than first appearing in the final rule with comment period. We refer readers to section II.F. of this final rule with comment period for further information about this change. We believe that this process will address commenters' concerns about having an opportunity to review these changes prior to the publishing of the final rule.

Comment: Several commenters asked that CMS identify what constitutes a highly technical piece of equipment.

Response: As we have previously indicated, during our review of all recommended direct PE inputs, we consider such items as the degree of specificity of a piece of equipment, which may influence whether the equipment item is likely to be stored in the same room in which the clinical staff greets and gowns, obtains vitals, or provides education to a patient prior to the procedure itself. We would expect that items that are highly specific to particular procedures would be moved between rooms for those procedures. We also consider the level of portability (including the level of difficulty involved in cleaning the equipment item) to determine whether an item could be easily transferred between rooms before or after a given procedure. Items that are portable would also be expected to be moved between rooms. We also examine the prices for the particular equipment items to determine whether the equipment is likely to be located in the same room used for all the tasks undertaken by clinical staff prior to and following the procedure. We believe that highly expensive equipment would not be kept in a location that does not allow for its maximum utilization. For each service, on a case-by-case basis, we look at the description provided in the RUC recommendation and consider the overlap of the equipment item's level of specificity, portability, and cost; and, consistent with the review of other recommended direct PE inputs, we make the determination of whether the recommended equipment items are highly technical. We note that it is not practical to ensure that all of the existing equipment time in the database is allocated accordingly, but as we review any recommendations received from the RUC, we make this determination. To provide stakeholders with examples of the types of equipment items that are and are not considered highly technical, we have listed several items below and indicated whether they are highly technical.

Table 16—Classification of Highly Technical Equipment

Highly technicalNot highly technical
ItemCMS codePriceItemCMS codePrice
room, CTEL007$1,284,000.00Light, examEQ168$1,630.12
accelerator, 6-18 MVER0101,832,941.00Table, examEF0231,338.17
gamma camera system, single-dual head SPECT CTER097600,272.00Chair, medical reclinerEF009829.03

(2) Standard Tasks and Minutes for Clinical Labor Tasks

In general, the pre-service, service period, and post-service clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there are a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, CMS staff reviews the deviations from the standards to determine their appropriateness. When we do not accept Start Printed Page 67641the RUC-recommended exceptions, we refine the interim final direct PE inputs to match the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M, we remove the pre-service clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.

In general, clinical labor tasks fall into one of the categories on the PE worksheets. In cases where tasks cannot be attributed to an existing category, the tasks are labeled “other clinical activity.” In these instances, CMS staff reviews these tasks to determine whether they are similar to tasks delineated for other services under the PFS. For those tasks that do not meet this criterion, we do not accept those clinical labor tasks as direct inputs.

(3) Equipment Minutes for Film Equipment Inputs

In section II.A. of this final rule with comment period, we finalize our proposal to accept the RUC recommendation to remove inputs associated with film technology that are associated with imaging services. We acknowledge comments received regarding the minutes allocated to equipment items associated with film technology; we will not address those comments below, because subsequent to the publication of the CY 2014 final rule with comment period, as discussed in section II.A. of this final rule with comment period, we finalized our proposal to remove these inputs from the Direct PE database, and thus the comments are no longer relevant.

(4) Standard Inputs for Moderate Sedation

In establishing interim final direct PE inputs for services that contain the standard moderate sedation input package, we refined the RUC's recommendation by removing the stretcher (EF018) and adjusting the standard moderate sedation equipment inputs to conform to the standard moderate sedation equipment times. These procedures are listed in Table 17.

Comment: Commenters objected to our refinement of the standard moderate sedation equipment input times to conform to the moderate sedation equipment standard times, since it decreased the time allocated to these equipment items.

Response: We note that for moderate sedation procedures, the equipment time is tied to the RN time rather than to the entire service period. Specifically, this time includes 2 minutes for sedate/apply anesthesia, 100 percent of physician intraservice time, and 60 minutes of post-procedure time for every 15 minutes of RN monitoring time. The times included in Table 17 reflect this standard. We note that for all procedures in Table 17 the times allocated to the equipment items that were interim final for 2014 were already consistent with the moderate sedation standard equipment times, with the exception of CPT code 37238, which was mistakenly allocated 257 minutes, when the correct time is actually 242 minutes.

Comment: Commenters indicated that for office endoscopic procedures, the stretcher is typically used throughout the entire procedure, as well as during post-procedure monitoring. Other commenters indicated that the stretcher is required during the moderate sedation recovery time. The commenters requested that we include the stretcher for those procedures, and that we reduce the increased time allocated to the power table.

Response: In section II.A. of this final rule with comment period, we finalized our proposal to modify the standard moderate sedation input package to include a stretcher for the same length of time as the other equipment items in the moderate sedation package. We indicated that the revised package would be applied to relevant codes as we review them through future notice and comment rulemaking. We have therefore refined those inputs to incorporate the stretcher for these codes listed in Table 17. Since we are incorporating the stretcher, we have removed the power table for procedures in which a power table was previously included. We will hold these procedures as interim final for CY 2015 due to the insertion of the stretcher and removal of the power table.

We are therefore finalizing the PE inputs for the procedures containing the standard moderate sedation inputs, with the additional refinements of including the stretcher for all of these procedures, removing the power table for the codes noted in Table 17 as containing a power table, and adjusting the equipment time for CPT code 37238. We note that these changes are displayed in the final CY 2015 direct PE input database, available on the CMS Web site under the downloads for the CY 2015 PFS final rule at www.cms.gov/​PhysicianFeeSched/​.

Table 17—CPT Codes With Stretcher Added

CPT CodeShort descriptorModerate sedationContained power table?
10030Guide cathet fluid drainage152
36245Ins cath abd/l-ext art 1st167
37236Open/perq place stent 1st332
37238Open/perq place stent same242
37241Vasc embolize/occlude venous272
37242Vasc embolize/occlude artery342
37243Vasc embolize/occlude organ362
37244Vasc embolize/occlude bleed332
43200Esophagoscopy flexible brush77Yes.
43201Esoph scope w/submucous inj80Yes.
43202Esophagoscopy flex biopsy82Yes.
43206Esoph optical endomicroscopy92Yes.
43213Esophagoscopy retro balloon107Yes.
43215Esophagoscopy flex remove fb82Yes.
43216Esophagoscopy lesion removal84Yes.
43217Esophagoscopy snare les remv92Yes.
43220Esophagoscopy balloon <30mm82Yes.
43226Esoph endoscopy dilation87Yes.
43227Esophagoscopy control bleed92Yes.
43229Esophagoscopy lesion ablate107Yes.
43231Esophagoscop ultrasound exam107Yes.
Start Printed Page 67642
43232Esophagoscopy w/us needle bx122Yes.
43235Egd diagnostic brush wash77Yes.
43236Uppr gi scope w/submuc inj82Yes.
43239Egd biopsy single/multiple77Yes.
43245Egd dilate stricture85Yes.
43247Egd remove foreign body92Yes.
43248Egd guide wire insertion82Yes.
43249Esoph egd dilation <30 mm82Yes.
43250Egd cautery tumor polyp82Yes.
43251Egd remove lesion snare82Yes.
43252Egd optical endomicroscopy92Yes.
43255Egd control bleeding any92Yes.
43270Egd lesion ablation107Yes.
43450Dilate esophagus 1/mult pass77Yes.
43453Dilate esophagus87Yes.
49405Image cath fluid colxn visc162
49406Image cath fluid peri/retro162
49407Image cath fluid trns/vgnl167

(5) Recommended PE Inputs Not Used in the Calculation of Practice Expense Relative Value Units

In preparing the Direct Practice Expense Input database for CY 2014, we noted that in some cases, there were recommended inputs in the database that were not used in the calculation of the PE RVUs. In cases where inputs are included for a particular service in a particular setting, but that service is not priced in that setting, the inputs are not used. In the documentation files for the CY 2014 final rule, we stated, “In previous years, we have displayed recommended inputs even when these inputs are not used in the calculation of the practice expense relative value units. We note that we are no longer displaying such inputs in these public use files since they are not used in the calculation of the practice expense relative value units that appear in the final rule.”

Comment: Some commenters objected to our removing practice expense inputs for services that were not reviewed for CY 2014.

Response: As indicated in the documentation files, the inputs removed were not used in the calculation of the PE RVUs. Therefore, their removal has no impact on the PE RVUs for these services or the payment for services. We remind readers that, from our perspective, the sole purpose of the Direct PE database is to establish PE RVUs. We believe it is more transparent for these inputs to not appear in the Direct Practice Expense Input database when they do not contribute to the PE RVU calculation for the relevant services.

iii. Code-Specific Direct PE Inputs

We note that we received many comments objecting to refinements made based on “CMS clinical review” (including our determination that certain recommended PE inputs were duplicative of others already included with the service), statutory requirements, or established principles and policies under the PFS. We note that for many of our refinements, the specialty societies that represent the practitioners who furnish the service objected to most of these refinements for the general reasons described above or for the reasons we respond to in the “background and methodology” portion of this section, or stated that they supported the RUC recommended PE inputs. Below, we respond to comments in which commenters address specific CPT/HCPCS codes and explain their objections to our refinements by providing us with new information supporting the inclusion of the items and/or times requested. When discussing these refinements, rather than listing all refinements made for each service, we discuss only the specific refinements for which commenters provided supporting information. We indicate the presence of other refinements by noting “among other refinements” after delineating the specific refinements for a particular service or group of services. For those comments that stated that an item was “necessary for the service” and provided no additional rationale or information, we conducted further review to determine whether the inputs as refined were appropriate and concluded that the inputs as refined were indeed appropriate. We also note that in many cases, commenters objected to our indication that items were duplicative, stating that they did not know where the duplication existed. In future rulemaking, we do not intend to respond to comments where the commenters dispute the duplicative nature of inputs unless commenters specifically explain why the relevant items are not duplicative with the identical items included in a room, kit, pack, or tray. We expect that commenters will review the components of the room, kit, pack, or tray included for that procedure prior to commenting that the item is not duplicative. Finally, we note that in some cases we made proposals related to comments received in response to the CY 2014 final rule with comment period. In cases where we have addressed the concerns of commenters in the proposed rule, we do not respond to comments here as well.

(1) Cross-Family Comments

Comment: We received comments regarding refinements to equipment times for many procedures for which commenters indicated that the equipment time for the procedure should include the time that the equipment is unavailable for other patients, including while preparing equipment, positioning the patient, assisting the physician, and cleaning the room. Commenters also requested that we indicate which clinical labor tasks should be included in calculating the equipment time for highly technical equipment.

Response: As stated above, we agree with commenters that the equipment time should include the times within the intra-service period when a clinician is using the piece of equipment plus any Start Printed Page 67643additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. We believe that some of these commenters are suggesting that we should allocate the full number of clinical labor minutes included in the service period to the equipment items. However, as we have explained, the clinical labor service period includes minutes based on some clinical labor tasks associated with pre- and post-service activities that we do not believe typically preclude equipment items from being used in furnishing services to other patients because these activities typically occur in other rooms. The equipment times allocated to the CPT codes in Table 18 already include the full intraservice time the equipment is typically used in furnishing the service, plus additional minutes to reflect time that the equipment is unavailable for use in furnishing services to other patients. In response to commenters request for clarification, Table 19 lists the standard clinical labor tasks to be included in the calculation of time allocated to highly technical equipment. We note that in some cases, some specialized intraservice clinical labor tasks are also included in the equipment time calculations; we have not detailed every possible case in this table.

Table 18—Equipment Inputs That Include Appropriate Clinical Labor Tasks About Which Comments Were Received

CPT CodeEquipment Items
70551EL008
70552EL008
70553EL008
93880EL016
93882EL016

Table 19—Clinical Labor Tasks Included in Calculation of Equipment Time for Highly Technical Equipment

Clinical Labor Task
Prepare room, equipment, supplies
Prepare and position patient
Assist physician in performing procedure and/or Acquire images
Clean room/equipment by physician staff
Technologist QC's images in PACS, checking for all images, reformats, and dose page

Comment: We received comments regarding refinements to clinical labor times for several procedures, in which commenters indicated that CMS reduced the clinical labor minutes inappropriately for tasks related to film inputs, since the recommended minutes were based on the PEAC surveyed times. Tasks included “Process images, complete data sheet, present images and data to the interpreting physician” and “Retrieve prior appropriate imaging exams.”

Response: The surveyed times referenced by the commenters refer to the clinical labor tasks associated with film technology. In reviewing the times associated with these clinical labor tasks, we noted that it would be consistent with our policy finalized in this rule to adjust the times associated with clinical labor tasks for all interim final codes to be consistent with the RUC recommendations regarding clinical labor tasks for digital technology. We are making the associated changes and holding these direct PE inputs interim final for 2015. These clinical labor tasks associated with film and digital inputs are presented side-by-side, along with the range of typical times, in Table 20. The specific interim final codes and their time changes are listed in Table 21.

Table 20—Clinical Labor Tasks Associated with Digital Technology

Service periodClinical labor task: film inputsTypical minutesClinical labor task: digital inputsTypical minutes
Pre-ServiceRetrieve prior appropriate imaging exams and hang for MD review, verify orders, review the chart to incorporate relevant clinical information and confirm contrast protocol with interpreting MD/Retrieve Prior Image for Comparison4 to 7Availability of prior images confirmed Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist2 2
Service Period: Post-ServiceProcess Images, complete data sheet, present images and data to the interpreting physician/Process films, hang films and review study with interpreting MD prior to patient discharge4 to 20Technologist QC's images in PACS, checking for all images, reformats, and dose page Review examination with interpreting MD Exam documents scanned into PACS. Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue2 2 1

Table 21—Interim Final Codes with Adjusted Clinical Labor Times Due to Film-to-Digital Migration

CPT codeCMS codeTotal film task time (2014)Total digital task timeTime change
19081L043A891
19082L043A550
19083L051B891
19084L051B5* 50
19085L047A891
19086L047A5* 50
19281L043A891
19282L043A5* 50
19283L043A891
19284L043A5* 50
19285L051B891
19286L051B5* 50
19287L047A891
Start Printed Page 67644
19288L047A5* 50
19281L043A550
19282L043A550
70450L046A109−1
70460L046A119−2
70470L046A139−4
70551L047A692
70552L047A890
70553L047A890
72141L047A149−5
72142L047A169−7
72156L047A189−9
72146L047A149−5
72147L047A169−7
72157L047A189−9
72148L047A149−5
72149L047A169−7
72158L047A189−9
74174L046A279−22
* Add-on codes are allocated fewer minutes for these activities.

(2) Code-Specific Comments

(a) Destruction of Premalignant Lesions (CPT Codes 17000, 17003, 17004)

In establishing interim final direct PE inputs for CY 2014, CMS accepted the RUC's recommendations for supply item LMX 4% anesthetic cream (SH092).

Comment: Commenters indicated that the quantity of cream units in CPT code 17003 created a rank order anomaly with CPT codes 17000 and 17004, and that the inclusion of 3 grams was incorrect. Instead, 1 gram should have been included in CPT code 17003.

Response: We agree with the commenters that the quantity of SH092 in 17003 should be 1 gram. However, we also note that CPT code 17000 should also contain a quantity of 1 gram in order to avoid the rank order anomaly. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 17000, 17003, and 17004, with the additional refinement of changing the quantity of SH092 to 1 for CPT codes 17000 and 17003.

(b) Breast Biopsy (CPT Codes 19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 19085, 19086, 19287, and 19288 by removing several new PE inputs, including items called “20MM handpiece—MR,” “vacuum line assembly,” “introducer localization set (trocar),” and “tissue filter,” since we concluded that these items served redundant clinical purposes with other biopsy supplies already included in the PE inputs for these codes. We also removed three new equipment items, described as “breast biopsy software,” “breast biopsy device (coil),” and “lateral grid,” because we determined that these items served clinical functions to items already included in the MR room.

Comment: Commenters indicated that the vacuum assisted breast biopsy requires an assisted biopsy needle system, and tubing must be run from the biopsy device to the biopsy control unit. Commenters also discussed supply items “introducer localization set (trocar)” and “tissue filter,” stating that the trocar is used to target the biopsy on the correct lesion, and the tissue filter is necessary to remove the collected core samples from the collection chamber. Commenters described the importance of the “breast biopsy device (coil), ” which is used to move one breast out of the way and the “breast biopsy software,” which is required to make the necessary calculations to target and biopsy the lesions. Finally, commenters stated that the lateral grid is necessary to place the trocar correctly.

Response: The equipment item “breast biopsy device w-system (Mammotome)” (EQ074) is described as “an all-in-one platform designed for use under ultrasound, MRI, stereotactic and 3D image guidance” and is used with supply item “Mammotome probe” (SD094). Therefore, the supply items “20 MM handpiece,” “vacuum line assembly,” “tissue filter,” and “trocar,” are duplicative of items already included in this procedure. We do note that we have used the invoice to create a price for equipment item “Breast biopsy device (coil)” (EQ371) at a price of $12,238. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 19085, 19086, 19287, and 19288 as established with the additional refinement of incorporating the equipment item “Breast biopsy device (coil)” (EQ371).

Comment: A commenter noted that the new breast biopsy codes do not distinguish between the type of biopsy device used for the procedure, and that the cost of using the vacuum-assisted biopsy device (including a Mammotome probe, a Mammotome probe guide, and tubing and vacuum for the Mammotome device) is nearly eight times the cost of the equipment and supplies required to perform a standard (mechanical) core needle biopsy. The commenter noted that vacuum-assisted biopsy devices are predominantly used in stereotactic and MRI-guided breast biopsy procedures and 50 percent of the time in ultrasound-guided breast biopsy procedures.

Response: For a discussion about the change in coding, we refer readers to section II.F. of this final rule with comment period, where we finalize the work RVUs for interim final 2014 codes. With regard to the direct PE inputs for these services, we note that we include direct PE inputs based on the typical case, and since, as the commenter Start Printed Page 67645points out, the vacuum-assisted biopsy devices are typically used, we include these items as direct PE inputs.

In reviewing the breast biopsy codes, we noted that we inadvertently included supply and equipment items related to breast biopsies in CPT codes 19283, 19284, 19285, 19286, 19087, and 19088, which are procedures that describe the placement of a localization device, not a biopsy. We will therefore remove the items listed in Table 22, which are currently included as direct PE inputs for these procedures. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288 as established, with the additional refinements noted above.

Table 22—Supply and Equipment Items Inadvertently Included in Localization Device Placement Breast Biopsy Codes

CPTSD034SC022EQ074
19283XX
19284XX
19285X
19286X
19087XXX
19088XXX

(c) Nasal/Sinus Endoscopy (CPT Codes 31237, 31238)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 31237 and 31238 by refining the nurse blend (L037D) clinical labor time associated with task “Monitor pt. following service/check tubes, monitors, drains” from 15 minutes to 5 minutes.

Comment: Commenters stated that CMS should maintain consistency in the direct PE inputs across services by allocating the standard 15 minutes for every hour of post-procedure monitoring time. Commenters indicated that monitoring after these procedures is critical, since the risk of recurrent bleeding is high and patients may become lightheaded.

Response: There are two types of post-procedure monitoring time; a standard 15 minutes per hour of post-procedure monitoring time for moderate sedation, and a standard 15 minutes per hour of post-procedure monitoring time unrelated to moderate sedation. We understand the commenter's position to mean that there is 60 minutes of post-procedure monitoring required for these services (in accordance with the 15 minutes of RN time per 60 minutes of monitoring). Because these procedures previously included 5 minutes of post-procedure monitoring time, we do not have a reason to believe that the monitoring time would have increased by 55 minutes. Should commenters believe this is the case, we invite commenters to provide information to justify this change. In cases where the specialty society is recommending post-procedure monitoring unrelated to moderate sedation, it is important that the recommendation clearly indicates the reason for the monitoring and the relationship between the clinical staff time and the monitoring time. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 31237 and 31238 as established.

(d) Implantation and Removal of Patient Activated Cardiac Event Recorder (CPT Codes 33282 and 33284)

In the CY 2013 final rule with comment period, in response to nomination of CPT codes 33282 and 33284 as potentially misvalued codes, we indicated that we did not consider the absence of pricing in a particular setting as an indicator of potentially misvalued codes. However, we requested that the RUC review these codes, including the work RVUs, for appropriate nonfacility and facility inputs.

Comment: A commenter expressed disappointment that CMS did not price these services in the nonfacility setting but did not provide further information about this decision.

Response: We received recommendations from the RUC for CPT codes 33282 and 33284 that did not include nonfacility inputs. Stakeholders who are interested in providing information about the direct PE inputs used in furnishing these services are welcome to submit this information to us; information about the level of information we seek is available to stakeholders in the sample PE worksheet available on the CMS Web site under downloads at http://www.cms.gov/​PhysicianFeeSched/​PFSFRN/​list.asp#TopOfPage. We encourage commenters to submit the best data available on the appropriate inputs for these services.

(e) Transcatheter Placement of Intravascular Stent (CPT Codes 37236, 37237)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 37236 and 37237 by including supply item “catheter, balloon, PTA” (SD152) as a proxy for “balloon expandable” because we believed that was an appropriate proxy. The invoices provided with the recommendation did not indicate the items on the PE worksheet with which they were associated.

Comment: The specialty society representing practitioners who furnish these services indicated that the item “balloon expandable” actually referred to a “balloon implantable stent,” and that the invoices provided were associated with that item.

Response: We acknowledge the specialty society's clarification of the RUC recommendation. We will add item “balloon implantable stent” at a price of $1,500, and remove the proxy item SD152. We note that when line items on the invoices provided are not clearly labeled, it is often difficult for us to determine how to relate the items on the PE spreadsheet with the items on the invoices. For specialty societies to ensure that the requested items are considered for inclusion in the relevant procedure codes, it is important that invoices accompany the RUC recommendations and the line items associated with items on the PE spreadsheet are clearly labeled.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 37236 and 37237 as established with the additional refinement of including “balloon implantable stent” and removing “catheter, balloon, PTA” (SD152).

(f) Esophagoscopy (CPT Codes 43197 and 43198)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 43197 and 43198 to remove the Medical/Technical Assistant (L026A) time associated with clinical labor task “Clean Surgical Instrument Package,” since no surgical instrument package is included in the service, and to remove the endoscopic biopsy forceps (SD066) from CPT code 43198, among other refinements.

Comment: Commenters acknowledged that the procedure did not contain a surgical instrument package, but stated that the time was still necessary for cleaning equipment, such as the nasal speculum, bayonette forceps, and biopsy forceps.

Response: In general, as a matter of relativity throughout the PFS, the time allocated for the standard clinical labor task “Clean room/equipment following procedure” encompasses time for cleaning all equipment items. The only exceptions to this rule are for equipment items that are tied to specific clinical Start Printed Page 67646labor tasks, such as cleaning the surgical instrument pack or cleaning a scope. We do not believe it would serve relativity to separately break out time to clean various different types of equipment.

For the biopsy forceps, we indicated in the final rule with comment period that the information included with the RUC recommendation suggested that the biopsy forceps was reusable (as suggested by the cleaning time mentioned in this comment). As such, we have created a new equipment item based on the invoice provided with the recommendation and assigned 46 minutes to this equipment item. However, since we did not receive a paid invoice with this item, we will price it at $0 until we receive a paid invoice.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 43197 and 43198 as established, with the additional refinement of including 46 minutes for the reusable biopsy forceps.

(g) Esophagoscopy/Esophagoscopy Gastroscopy Duodenoscopy (EGD) (CPT Codes 43200, 43201. 43202, 43206, 43215, 43216, 43217, 43220, 43226, 43227, 43231, 43232, 43235, 43236, 43239, 43245, 43247, 43248, 43248, 43250, 43251, 43252, 43255, 43270)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 43200, 43201. 43202, 43206, 43215, 43216, 43217, 43220, 43226, 43227, 43231, 43232, 43235, 43236, 43239, 43245, 43247, 43248, 43248, 43250, 43251, 43252, 43255, and 43270 by refining the quantity of item “canister, suction” (SD009) from 2 to 1.

Comment: Commenters indicated that, for patient safety reasons, one suction canister is needed for the mouth, and another for the scope for patient safety reasons. Other stakeholders, specifically, several specialty societies with whom we met during the comment period, informed us that one suction canister is sufficient and typical for these services.

Response: We are persuaded by the information provided by the medical specialty societies during the comment period who indicated that one suction canister is typical.

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 43201 by removing needle, micropigmentation (tattoo) (SC079), as the needle required for this procedure needs to go through an endoscope, and no invoice was provided for this item.

Comment: Commenters indicated that the tattoo needle was required to mark the site for injection.

Response: We did not receive an invoice for the tattoo needle and have no information about this item. We are also unable to include this item in the PE calculations without a method to price it. We do not believe that we have a reasonable proxy at this time. If we receive invoices for this item, we will be able to include it in the direct PE input database.

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 43201, 43220, 43226, and 43231 by removing supply item “cup, biopsy-specimen non-sterile 4oz” (SL035).

Comment: Commenters indicated that the endoscopy base code, 43200, is included in all of these procedures. Since the biopsy cup is included in the endoscopy base code, it should be included for these codes as well.

Response: We agree with commenters that it is appropriate to include this supply item for these procedures. We will include the supply item “cup, biopsy-specimen non-sterile 4oz” in the direct PE inputs for these procedures.

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT code 43220 by substituting supply item “SD019” as a proxy for “SD025.”

Comment: Commenters requested that we include “endoscopic balloon, dilation” (SD287) rather than a proxy, as this supply item is now included in the database.

Response: After receiving clarification regarding this request, we agree with commenters that SD287 is an appropriate supply input for this procedure. Therefore, we will include SD287 for CPT code 43220.

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 43220, 43249, and 43270 by removing supply item “guidewire, STIFF” (SD090), among other refinements.

Comment: Commenters indicated that the guidewire is required to safely straddle tumors for which there is impaired visibility and an inability to pass the scope through.

Response: We agree with commenters that it would be appropriate to include supply item “guidewire—STIFF” in these procedures. We will include the supply item “guidewire—STIFF” in the direct PE inputs for these procedures.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for codes 43200, 43201. 43202, 43206, 43215, 43216, 43217, 43220, 43226, 43227, 43231, 43232, 43235, 43236, 43239, 43245, 43247, 43248, 43248, 43250, 43251, 43252, 43255, and 43270 as established, with the additional refinements of including the supply items noted above.

(h) Dilation of Esophagus (CPT Codes 43450, 43453)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 43450 and 43453 by removing equipment item “endoscope disinfector, rigid or fiberoptic, w-cart” (ES005), and not creating a new item “mobile stand, vital signs monitor,” and other refinements.

Comment: Commenters stated that the endoscope disinfector is a necessary part of all endoscopic procedures for sanitary and safety reasons, and that it should be restored for all gastrointestinal endoscopy codes. Commenters also noted that the mobile stand is the standard method of monitoring that must be moved along with the patient.

Response: Since these are non-endoscopic dilation codes, there is no scope to clean, and thus the endoscope disinfector is unnecessary. The standard inputs for moderate sedation as recommended by the RUC were included in this procedure; the mobile stand overlaps with the standard moderate sedation input items. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for codes CPT codes 43450 and 43453 as established.

(i) Spinal Injections (CPT Codes 62310, 62311, 62318, 62319)

In establishing interim final direct PE inputs for CY 2014, CMS accepted the RUC recommendations for CPT codes 62310, 62311, 62318, and 62319. Based on comments received, we made a proposal to maintain the CY 2014 direct PE inputs for CY 2015 while the codes are reexamined for bundling. We are finalizing this proposal, so while we acknowledge comments received on these codes, we will not respond to these comments as the interim final inputs to which the comments relate will not be used for 2015.

(j) Percutaneous Implantation of Neurostimulator (CPT Code 63650)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT code time by removing the time associated with clinical labor task “Clean Surgical Instrument Package” and removing supply item “pack, cleaning, surgical instruments” (SA043) since no surgical Start Printed Page 67647instrument package is included in the service.

Comment: Commenters indicated that clinical staff time is critical for the safety and efficiency of the procedure, and that the surgical instrument cleaning package is necessary to ensure proper adherence of the electrodes.

Response: In general, as a matter of relativity throughout the PFS, the time allocated for the standard clinical labor task “Clean room/equipment following procedure” encompasses time for cleaning all equipment items. The only exceptions to this rule are for equipment items which are tied to specific clinical labor tasks, such as cleaning the surgical instrument pack or cleaning a scope. We do not believe it would serve relativity to separately break out time to clean various different types of equipment. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code 63650 as established.

(k) Chemodenervation (CPT Codes 64616, 64642, 64644, 64646, 64647)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 64616, 64642, 64644, 64646, and 64647 by reducing the minutes allocated to “table, exam” (EF023) and removing the time associated with clinical labor task “Complete botox log,” as well as reducing the L037D time for clinical labor “assist physician performing procedure” for CPT code 64616, among other refinements.

Comment: One commenter opposed our adjusting the minutes allocated to the exam table. Commenters stated that the reference code, 64615, included three minutes of clinical labor time for “complete botox log,” and requested that they be included since they are in the reference code. One commenter asked whether CMS planned to remove the minutes from the reference code as well. Other commenters indicated that as with most injections, it is necessary to document various elements of information for safety purposes.

Response: Upon reviewing the time allocated to the exam table, we noted that our standard equipment policy is to allocate the entire service period for equipment that is not highly technical. Therefore, we will allocate minutes for the entire service period for the exam table, as follows: 28 minutes for 64616, 44 minutes for 64642, 49 minutes for 64644, 44 minutes for 64646, and 49 minutes for 64647. We appreciate commenters pointing out the three minutes of time inadvertently allocated for “complete botox log” in the reference code, 64615, and will consider this issue in future rulemaking. We note that one of the benefits of having information stored in the direct PE database at the clinical labor task level is that it allows us to make comparisons of codes under review to existing codes in the PE database. This will help us ensure greater consistency in our refinements. As commenters point out, various injections are documented in logs, rather than medical records. The use of a different location for documentation is not a reason to allocate additional clinical labor time for a particular service.

Comment: One commenter supported our adjustment of “assist physician” time from 7 minutes to 5 minutes. Another commenter disagreed with the refinement and requested that CMS explain how physician time was calculated, while a different commenter stated that the “assist physician” time should be 28 minutes.

Response: Upon reviewing the work time and the time allocated for assist physician, we determined that 7 minutes is actually appropriate for the assist physician task.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 64616, 64642, 64644, 64646, and 64647 as established, with the additional refinement of adjusting the minutes for the exam table as indicated above and adding 2 minutes of clinical labor for the “assist physician” task for 64616.

(l) MRI Brain (CPT Codes 70551, 70552, 70553)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 70551, 70552, and 70553 by adjusting the time for clinical labor task “assist physician in performing procedure/acquire images,” removing 2 minutes of clinical labor time for clinical labor task “escort patient from exam room due to magnetic sensitivity,” removing supply items “gauze,sterile 2in x 2in” (SG053), “tape, phix strips (for nasal catheter)” (SG089), “povidone swabsticks (3 pack uou” (SJ043), and “swab-pad, alcohol” (SJ 053) from CPT codes 70552 and 70553, among other refinements.

Comment: Commenters indicated that the times associated with clinical labor task “assist physician in performing procedure/acquire images” reflected the PEAC surveyed times, and they had no reason to believe that the time had decreased since the PEAC review.

Response: As indicated in the PFS CY 2014 final rule with comment period (78 FR 74345), the procedure time for these services was last reviewed in 2002. We noted that we believe there should be no significant difference between the time to acquire images for an MRI of the brain and an MRI of the spine, and that, rather than rely on very old survey data, it would be appropriate to crosswalk the time associated with the MRI of the spine to the MRI of the brain. We continue to believe that this time is more accurate than that of the survey data.

Comment: Commenters noted that the clinical labor task “escort patient from exam room due to magnetic sensitivity” is a necessary activity for patient safety.

Response: Upon review of this clinical labor task, we noted that this task was included in the PE worksheets from when these codes were previously reviewed in 2002. Therefore, since this activity does not reflect a newly added clinical labor task, we agree with commenters that it would be appropriate to include 2 minutes for this clinical labor task.

Comment: Commenters stated that the supplies removed from CPT codes 70552 and 70553 were necessary supplies for the service, and that the specialty society incorrectly included supply item “tape, phix strips (for nasal catheter)” (SG089), when the correct supply item was “tape, surgical paper 1in (Micropore)” (SG079).

Response: We note that these supplies were removed because they were already contained in the supply item “kit, IV starter” (SA019). Table 23 shows the items contained in the IV starter kit and the corresponding supply items removed due to redundancy.

Table 23—Items Removed for Redundancy and Parallel Items Included in IV Starter Kit

Items in IV starter kitCorresponding items removed for redundancy
1 tourniquet
1 PVP ointmentpovidone swabsticks (3 pack uou)
1 PVP prep padswab-pad, alcohol
Start Printed Page 67648
2 gauze spongesgauze, sterile 2in x 2in
1 bandage (1″x3″)
1 sm roll surgical tapetape, surgical paper 1in
1 pr gloves
1 underpad 2ft x 3ft (Chux)

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 70551, 70552, and 70553, with the additional refinement of including 2 minutes of clinical labor time as noted above.

(m) MRI Spine (CPT Codes 72141, 72142, 72146, 72147, 72149, 72156, 72157, 72158)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 72141, 72142, 72146, 72147, 72149, 72156, 72157, and 72158 by removing 2 minutes of clinical labor time for clinical labor task “escort patient from exam room due to magnetic sensitivity,” and other refinements.

Comment: Commenters noted that the clinical labor task “escort patient from exam room due to magnetic sensitivity” is a necessary activity for patient safety.

Response: Upon review of this clinical labor task, we noted that this task was included in the PE worksheets from when these codes were previously reviewed in 2002. Therefore, since this activity does not reflect a newly added clinical labor task, we agree with commenters that it would be appropriate to include 2 minutes for this clinical labor task.

Comment: A commenter noted that CMS did not include a contrast imaging pack, which includes supplies necessary for contrast enhanced studies.

Response: In section II.B. of this final rule with comment period, we finalized our policy to add a contrast imaging pack to be used for imaging services with contrast. Therefore, we will include the contrast supply pack (CMS code SA114) for CPT codes 72142, 74147, 72149, 72156, 72157, and 72158.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 72141, 72142, 72146, 72147, 72149, 72156, 72157, and 72158, with the additional refinement of including 2 minutes of clinical labor time and including the supply pack for the services noted above.

(n) Selective Catheter Placement (CPT Code 75726)

In establishing interim final direct PE inputs for CY 2014, when reviewing CPT code 36245, which was identified through a misvalued code screen of codes reported together more than 75 percent of the time, we noted that it was frequently billed with 75726. We then noted that these two services had identical time for “assist physician in performing procedure,” and since the time for 36245 was reduced from 73 to 45 minutes, refined the clinical labor time for 75726 to correspond to this change.

Comment: Commenters indicated that the 73 minutes reflected the PEAC surveyed times, and that these activities are imaging-related, and in addition to the time and activities inherent in the accompanying surgical base code.

Response: As indicated elsewhere in this section, we note that the PEAC survey data are very old, and that refinements based on more updated information are appropriate. We continue to believe that it is appropriate for the intraservice times for 36245 and 75726 to continue to correspond to one another, as they are frequently furnished together. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code 75726 as established.

(o) Radiation Treatment Delivery (CPT Codes 77373, 77422, 77423)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT code 77373 by refining the equipment time for “pulse oximeter w-printer” (EQ211) and “SRS system, SBRT, six systems, average” (ER083) to conform to established equipment policies.

Comment: Commenters stated that the times should be maintained at 104 minutes, rather than being reduced to 86 minutes, and indicated the clinical labor task lines that should be included in the calculations.

Response: Upon reviewing the equipment times associated with this procedure, we agree with commenters that the time allocated for the equipment should include the time associated with the indicated clinical labor tasks for these equipment items. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code 77373 as established, with the additional refinement of adjusting the equipment times to 104 minutes as noted above.

For CY 2014, we also eliminated several anomalous supply inputs included in the direct PE database, which affected 77422 and 77423, among other services.

Comment: Commenters indicated that upon reviewing the inputs for these services, they noted that the Record and Verify System and the laser targeting system were missing in both of these services, despite being in the original 2005 recommendation.

Response: We appreciate the commenters' attention to detail. However, as indicated elsewhere, we do not believe that the record and verify system is medical equipment used in furnishing the technical component of the service. We refer readers to our discussion of this issue in the PFS 2014 Final rule with Comment period (78 FR 74317). Further, since these codes have not been reviewed in many years, we do not know if the laser targeting system continues to be an appropriate input for these services. Therefore, we request that the RUC examine the inputs for these services to ensure their accuracy.

(p) Hyperthermia (CPT Code 77600)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT code 77600 by refining the time allocated to equipment item “hyperthermia system, ultrasound, external” (ER035) and removing the time associated with clinical labor task “clean scope,” among other refinements.

Comment: Commenters indicated that the appropriate lines were not used to calculate the recommended equipment times, including cleaning the scope and check dressing.

Response: Upon reviewing the comments, we re-examined the equipment time calculation and Start Printed Page 67649continue to believe that the time allocated to this equipment item is appropriate. We note that there is no scope used in this procedure, so time to clean the scope is unnecessary. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code 77600 as established.

(q) High Dose Rate Brachytherapy (CPT Codes 77785, 77586, 77787)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 77785, 77786, and 77787 to remove “Emergency service container—safety kit,” as we consider it an indirect PE.

Comment: Commenters noted that the emergency container is a safety device used when a source must be retrieved manually. Commenters indicated that it is a mobile item and that the service cannot be provided unless it is in the room, and thus it is a direct PE, since it is directly assumed by a physician in the course of providing the service. Commenters asked that we reclassify this item as a direct input.

Response: In our clinical review, we reviewed the work vignettes for these procedures, which did not include the use of the “emergency service container—safety kit” as a part of the procedure. Although we acknowledge that the emergency service container safety kit needs to be readily available during the procedure, we note that “standby” equipment, or items that are not used in the typical case, are considered indirect costs. For further discussion of this issue, we refer readers to our discussion of “standby” equipment in the CY 2001 PFS proposed rule (65 FR 44187).

When reviewing the interim final direct PE inputs for these services, we noted that the specialty societies conducted a survey of the technicians, which revealed higher procedure times than the current procedure times. However, since the RUC indicated that they did not have “compelling evidence,” the specialty society did not request the higher procedure times. We believe that if the specialty society believes that the code is undervalued relative to the expert panel value, and there is no indication that the survey was flawed, the specialty society should recommend the use of the surveyed procedure times. In doing so, the specialty society would give CMS the opportunity to consider the information provided alongside the RUC recommended times. We believe that surveys of technicians have the potential to be more accurate, rather than less accurate, than those of physicians, as the technicians do not have incentives to increase the surveyed time. We suggest that rather than attempting to insert items that are not standard in the PE methodology, that specialty societies make a strong, data-driven case, for why the survey times are correct.

Comment: A commenter noted that there have been significant reductions to these CPT codes over the last several years, and urged CMS to phase in the reductions over time should the reductions be deemed appropriate after review of the methodology and data.

Response: We note that reductions to CPT codes are made on the basis that they are potentially misvalued. We do not typically transition such reductions. However, the Protecting Access to Medicare Act (PAMA) requires that beginning in 2017, CMS transition code-level reductions of greater than or equal to 20 percent in a given year; therefore, beginning in 2017, such reductions will be transitioned.

After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 77785, 77786, and 77787 as established.

(r) Cytopathology (CPT Code 88112)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT code 88112 by removing the clinical labor time associated with several clinical labor tasks, including “Order, restock, and distribute specimen containers with requisition forms,” “Perform screening function (where applicable),” “Confirm patient ID, organize work, verify and review history,” and “Enter screening diagnosis in laboratory information system, complete workload recording logs, manage any relevant utilization review/quality assurance activities and regulatory compliance documentation and assemble and deliver slides with paperwork to pathologist.”

Comment: Commenters pointed out that CPT code 88112 was inadvertently listed in Table 28 in the CY 2014 final rule with comment period as being unrefined by CMS. Commenters also opposed the reductions in clinical labor time, and noted that the PE subcommittee thoroughly reviewed these inputs.

Response: We apologize for the inadvertent inclusion of CPT code 88112 in Table 28 of the CY 2014 final rule with comment period. We re-examined the clinical labor tasks in light of the comments received and noted that the clinical labor task “Order, restock, and distribute specimen containers with requisition forms” is not a clinical labor task associated with furnishing a service to a particular patient, and is therefore allocated in the indirect practice expense. Clinical labor task “Perform screening function (where applicable)” is not a task completed in the typical service, and is therefore not included. Further, clinical labor task “Confirm patient ID, organize work, verify and review history” is subsumed within clinical labor task “Remove slide from coverslipper; confirm patient ID, organize work, send slides to cytotech for screening”; including both would therefore be duplicative. Clinical labor task “Enter screening diagnosis in laboratory information system, complete workload recording logs, manage any relevant utilization review/quality assurance activities and regulatory compliance documentation and assemble and deliver slides with paperwork to pathologist” involves quality assurance activities. We refer readers to the CY 2014 PFS final rule with comment period (78 FR 74308) for a discussion regarding quality assurance activities. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code 88112.

Comment: One commenter noted that the refinements to the PE inputs for CPT code 88112 resulted in a rank-order anomaly, as CPT code 88108 has higher PE RVUs than CPT code 88112, while CPT code 88108 is a less complex service than CPT code 88112. Specifically, commenters stated that it is illogical for a cytology specimen processing technique that involves an additional step that requires materially more resources to have an RVU that is less than an associated technique that requires fewer resources, and expressed concerns about the potential for misreporting.

Response: We appreciate this commenter bringing this rank order anomaly to our attention. As indicated in section II.B. of this final rule with comment period, we are referring this code to the RUC as potentially misvalued based on the information received from the commenter.

(s) Duplex Scans (CPT Codes 93880 and 93882)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 93880 and 93882 by removing the equipment time allocated for equipment items “video SVHS VCR (medical grade)” (ED034) and “video printer, color (Sony medical grade)” (ED036), and refining the equipment time for “computer desktop, w-monitor” Start Printed Page 67650(ED021) from 68 to 51 minutes, among other refinements.

Comment: Commenters indicated that these items are not redundant and asked that CMS explain which items encompass ED034 and ED036. Commenters also stated that the desktop computer is used for the entire intraservice period. Commenters also stated that the refinements were expressed as a final decision effective January 1, 2014.

Response: The equipment item “room, vascular ultrasound” (EL016) contains “room, ultrasound general” (EL015), which contains both “video SVHS VCR (medical grade)” and “digital printer (Sony UPD21).” We also note that the RUC has reviewed these codes again for 2015; we refer readers to section II.F. of this rule for further discussion, including the new interim final inputs established for 2015. We further note that contrary to the commenters' assertion, the refinements made were indeed effective January 1, 2014, but were not final decisions; rather, they were interim final for 2014 and subject to public comment.

(t) Electroencephalogram (CPT Codes 95816, 95819, 95822)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 95816, 95819, and 95822 by refining the equipment time allocated to equipment item “EEG, digital, testing system (computer hardware, software & camera)” (EQ330), among other refinements.

Comment: Commenters indicated that various staff activities are performed on the computer and requested that we restore the time previously removed.

Response: Upon reviewing comments regarding the equipment time, we agree with commenters that we should allocate the entire service period for EQ330, since it is not highly technical equipment. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT codes 95816, 95819, and 95822 as established, with the additional refinement of assigning the intraservice time to EQ330.

(u) Anogenital Examination With Colposcopic Magnification in Childhood for Suspected Trauma (CPT Code 99170)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes, we accepted the RUC's recommendation to include a new clinical labor type called “child life specialist.”

Comment: One commenter supported the inclusion of clinical labor staff time for the child life specialist.

Response: We appreciate the commenter's support for this decision. After consideration of the comments received, we are finalizing the CY 2014 interim final direct PE inputs for CPT code 99170 as established.

(v) Immunohistochemistry (HCPCS Codes G0461 and G0462)

In establishing interim final direct PE inputs for CY 2014, CMS refined the RUC's recommendations for CPT codes 88342 and 88343 by creating G-codes G0461 and G0462 and refining the inputs for these services. We acknowledge comments regarding the refinements CMS made to these inputs, as well as comments indicating that the direct practice expense inputs for these procedures implied that the reporting would be different than the reporting implied by the code descriptors. We note that the RUC has subsequently reviewed CPT codes 88342 and 88343 again and we present the interim final values for 2015 in this final rule with comment period. Therefore, we will not address specific comments regarding G0461 and G0462 except, as discussed below, as they pertain to errors identified with regard to the pricing of supplies.

Comment: Commenters alerted us to an error in the calculation of the supply price for SL483 and SL486. Commenters pointed out that the price for SL483 is $22.56/ml, rather than the .00256/ml that was listed in the database, and based on the unit of measure established in the direct PE inputs database for SL486, which costs $65.63 for 250 tests, the per test quantity should be 1, rather than 0.004.

Response: We agree with commenters that these prices were calculated incorrectly and have made the adjustments to the direct PE database.

c. Finalizing CY 2014 Interim Malpractice Crosswalks for CY 2015

In accordance with our malpractice methodology, we adjusted the malpractice RVUs for the CY 2014 new/revised/potentially misvalued codes for the difference in work RVUs (or, if greater, the clinical labor portion of the PE RVUs) between the source codes and the new/revised codes to reflect the specific risk-of-service for the new/revised codes. The interim final malpractice crosswalks were listed in Table 30 of the CY 2014 PFS final rule with comment period.

We received only one comment on our CY 2014 interim final cross walks. As detailed in the CY 2014 final rule with comment period, we assigned malpractice crosswalk of CPT code 31575 (Laryngoscopy, flexible fiberoptic; diagnostic) to CPT codes 43191-43195 and CPT code 31638 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with revision of tracheal or bronchial stent inserted at previous session (includes tracheal/bronchial dilation as required)) to CPT code 43196.

Comment: A commenter said that the established PLI crosswalk, CPT code 31575, for CPT code 43191-43196 is not appropriate because the latter services have a life-threatening risk to patients and the same is not true for CPT code 31575. The commenter recommends instead that we utilize the RUC recommended crosswalk of bronchoscopy, rigid or flexible codes (CPT codes 31622 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; diagnostic, with cell washing, when performed (separate procedure)) for CPT code 43191, 31625 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial or endobronchial biopsy(s), single or multiple sites) for CPT code 43192, 43193, and 43195, and 31638 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with revision of tracheal or bronchial stent inserted at previous session (includes tracheal/bronchial dilation as required)) for CPT codes 43194 and 43196.

Response: We continue to believe that our assigned CY 2014 malpractice crosswalks best define the malpractice risk associated with CPT codes 43191-43196. Therefore, we are finalizing our CY 2014 interim final crosswalks.

We received no comments on the CY 2014 interim final malpractice crosswalks and are finalizing them without modification for CY 2015.

The malpractice RVUs for these services are reflected in Addendum B of this CY 2014 PFS final rule with comment period. Since we are finalizing a five-year review of MP RVUs in this final rule with comment period, the MP RVUs assigned to this codes will also be affected by the updates due to this review. For details on the review, see section II.C.

d. Other New, Revised or Potentially Misvalued Codes with CY 2014 Interim Final RVUs Not Specifically Discussed in the CY 2015 Final Rule With Comment Period

For all other new, revised, or potentially misvalued codes with CY 2014 interim final RVUs that are not Start Printed Page 67651specifically discussed in this CY 2015 PFS final rule with comment period, we are finalizing for CY 2015, without modification, the CY 2014 interim final or CY 2014 proposed work RVUs, malpractice crosswalks, and direct PE inputs. Unless otherwise indicated, we agreed with the time values recommended by the RUC or HCPAC for all codes addressed in this section. The time values for all codes are listed in a file called “CY 2014 PFS Work Time,” available on the CMS Web site under downloads 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.html.

3. Establishing CY 2015 RVUs

a. Finalizing CY 2015 Proposed RVUs

In the CY 2015 proposed rule, we proposed CY 2015 work values for several codes. Table 24 contains a list of these codes and the final CY 2015 work RVUs. For more information on these codes and the establishment of the values, see section II.Bof this final rule with comment period.

Table 24—CY 2015 Final Work RVUS for Codes With Proposed Work RVUs

HCPCS codeLong descriptorCY 2014 WRVUProposed CY 2015 work RVUCY 2015 work RVU
G0389Ultrasound, B-scan and/or real time with image documentation; for abdominal aortic aneurysm (AAA) screening0.580.580.58
G0416Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method;3.093.093.09
G0473Face-to-face behavioral counseling for obesity, group (2-10), 30 minutes(1)N/A0.25
62310Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic1.181.911.91
62311Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)1.171.541.54
62318Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic)1.542.042.04
62319Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)1.501.871.87
77055mammography; unilateral,.70.70.70
77056mammography; bilateral.87.87.87
77057screening mammography, bilateral (2-view film study of each breast).70.70.70
99490Chronic care management services, 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: 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 monitoredNew.61.61
1 New.

b. Establishing CY 2015 Interim Final Work RVUs

Table 25 contains the CY 2015 interim final work RVUs for all codes for which we received RUC recommendations for CY 2015 and G-codes with interim final values for CY 2015. These values are subject to public comment. The column labeled “CMS Time Refinement” indicates whether CMS refined the time values recommended by the RUC or HCPAC.

This section discusses codes for which the interim final work RVU or time values assigned for CY 2015 vary from those recommended by the RUC or for which we do not have RUC recommendations.

Table 25—CY 2015 Interim Final Work RVUS for New/Revised or Potentially Misvalued Codes

HCPCS CodeLong descriptorCY 2014 WRVURUC/HCPAC recommended work RVUCY 2015 work RVUCMS time refinement
11980Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin)1.481.101.10No
20604Arthrocentesis, aspiration and/or injection, small joint or bursa (eg, fingers, toes); with ultrasound guidance, with permanent recording and reporting(1)0.890.89No
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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(1)1.001.00No
20611Arthrocentesis, aspiration and/or injection, major joint or bursa (eg, shoulder, hip, knee, subacromial bursa); with ultrasound guidance, with permanent recording and reporting(1)1.101.10No
20983Ablation therapy for reduction or eradication of 1 or more bone tumors (eg, metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; cryoablation(1)7.137.13No
21811Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 1-3 ribs(1)19.5510.79Yes
21812Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 4-6 ribs(1)25.0013.00Yes
21813Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 7 or more ribs(1)35.0017.61Yes
22510Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic(1)8.158.15No
22511Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral(1)8.057.58No
22512Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; each additional cervicothoracic or lumbosacral vertebral body (list separately in addition to code for primary procedure)(1)4.004.00No
22513Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic(1)8.908.90No
22514Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar(1)8.248.24No
22515Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body (list separately in addition to code for primary procedure)(1)4.004.00No
22856Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); single interspace, cervical24.0524.0524.05No
22858Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); second level, cervical (list separately in addition to code for primary procedure)(1)8.408.40No
27279Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device(1)9.039.03No
29200Strapping; thorax0.650.390.39No
29240Strapping; shoulder (eg, velpeau)0.710.390.39No
29260Strapping; elbow or wrist0.550.390.39No
29280Strapping; hand or finger0.510.390.39No
29520Strapping; hip0.540.390.39No
29530Strapping; knee0.570.390.39No
31620Endobronchial ultrasound (ebus) during bronchoscopic diagnostic or therapeutic intervention(s) (list separately in addition to code for primary procedure[s])1.401.501.40No
33215Repositioning of previously implanted transvenous pacemaker or implantable defibrillator (right atrial or right ventricular) electrode4.924.924.92No
33216Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator5.875.875.87No
33217Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator5.845.845.84No
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33218Repair of single transvenous electrode, permanent pacemaker or implantable defibrillator6.076.076.07No
33220Repair of 2 transvenous electrodes for permanent pacemaker or implantable defibrillator6.156.156.15No
33223Relocation of skin pocket for implantable defibrillator6.556.556.55No
33224Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator)9.049.049.04No
33225Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system) (list separately in addition to code for primary procedure)8.338.338.33No
33240Insertion of implantable defibrillator pulse generator only; with existing single lead6.056.056.05No
33241Removal of implantable defibrillator pulse generator only3.293.293.29No
33243Removal of single or dual chamber implantable defibrillator electrode(s); by thoracotomy23.5723.5723.57No
33244Removal of single or dual chamber implantable defibrillator electrode(s); by transvenous extraction13.9913.9913.99No
33249Insertion or replacement of permanent implantable defibrillator system, with transvenous lead(s), single or dual chamber15.1715.1715.17No
33262Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; single lead system6.066.066.06No
33263Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; dual lead system6.336.336.33No
33270Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed(1)9.109.10No
33271Insertion of subcutaneous implantable defibrillator electrode(1)7.507.50No
33272Removal of subcutaneous implantable defibrillator electrode(1)5.425.42No
33273Repositioning of previously implanted subcutaneous implantable defibrillator electrode(1)6.506.50No
33418Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis(1)32.2532.25No
33419Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session (list separately in addition to code for primary procedure)(1)7.937.93No
33946Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; initiation, veno-venous(1)6.006.00No
33947Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; initiation, veno-arterial(1)6.636.63No
33949Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; daily management, each day, veno-arterial(1)4.604.60No
33951Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, birth through 5 years of age (includes fluoroscopic guidance, when performed)(1)8.158.15No
33952Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed)(1)8.438.15No
33953Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), open, birth through 5 years of age(1)9.839.11No
33954Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), open, 6 years and older(1)9.439.11No
33955Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of central cannula(e) by sternotomy or thoracotomy, birth through 5 years of age(1)16.0016.00No
33956Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of central cannula(e) by sternotomy or thoracotomy, 6 years and older(1)16.0016.00No
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33957Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), percutaneous, birth through 5 years of age (includes fluoroscopic guidance, when performed)(1)4.003.51No
33958Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed)(1)4.053.51No
33959Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), open, birth through 5 years of age (includes fluoroscopic guidance, when performed)(1)4.694.47No
33962Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), open, 6 years and older (includes fluoroscopic guidance, when performed)(1)4.734.47No
33963Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition of cent