[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Rules and Regulations]
[Pages 70885-71386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28005]



[[Page 70885]]

Vol. 80

Monday,

No. 220

November 16, 2015

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Part 405, 410, 411, et al.





Medicare Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2016; Final Rule

Federal Register / Vol. 80 , No. 220 / Monday, November 16, 2015 / 
Rules and Regulations

[[Page 70886]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 411, 414, 425, and 495

[CMS-1631-FC]
RIN 0938-AS40


Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2016

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

ACTION: Final rule with comment period.

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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.

DATES: Effective date: The provisions of this final rule with comment 
period are effective on January 1, 2016, except the definition of 
``ownership or investment interest'' in Sec.  411.362(a), which has an 
effective date of January 1, 2017.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on December 29, 2015. (See the SUPPLEMENTARY INFORMATION section of 
this final rule with comment period for a list of provisions open for 
comment.)

ADDRESSES: In commenting, please refer to file code CMS-1631-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-1631-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-1631-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.

FOR FURTHER INFORMATION CONTACT: 
    Donta Henson, (410) 786-1947 for issues related to pathology and 
ophthalmology services or any physician payment issues not identified 
below.
    Abdihakin Abdi, (410) 786-4735, for issues related to portable X-
ray transportation fees.
    Gail Addis, (410) 786-4522, for issues related to the refinement 
panel.
    Lindsey Baldwin, (410) 786-1694, for issues related to valuation of 
moderate sedation and colonoscopy services.
    Jessica Bruton, (410) 786-5991, for issues related to potentially 
misvalued code lists.
    Roberta Epps, (410) 786-4503, for issues related to PAMA section 
218(a) policy.
    Ken Marsalek, (410) 786-4502, for issues related to telehealth 
services.
    Ann Marshall, (410) 786-3059, for issues related to advance care 
planning, and for primary care and care management services.
    Geri Mondowney, (410) 786-4584, for issues related to geographic 
practice cost indices, malpractice RVUs, target, and phase-in 
provisions.
    Chava Sheffield, (410) 786-2298, for issues related to the practice 
expense methodology, impacts, and conversion factor.
    Michael Soracoe, (410) 786-6312, for issues related to the practice 
expense methodology and the valuation and coding of the global surgical 
packages.
    Regina Walker-Wren, (410) 786-9160, for issues related to the 
``incident to'' proposals.
    Pamela West, (410) 786-2302, for issues related to therapy caps.
    Emily Yoder, (410) 786-1804, for issues related to valuation of 
radiation treatment services.
    Amy Gruber, (410) 786-1542, for issues related to ambulance payment 
policy.
    Corinne Axelrod, (410) 786-5620, for issues related to rural health 
clinics or federally qualified health centers and payment to 
grandfathered tribal FQHCs.
    Simone Dennis, (410) 786-8409, for issues related to rural health 
clinics HCPCS reporting.
    Edmund Kasaitis (410) 786-0477, for issues related to Part B drugs, 
biologicals, and biosimilars.
    Alesia Hovatter, (410) 786-6861, for issues related to Physician 
Compare.
    Deborah Krauss, (410) 786-5264 and Alexandra Mugge, (410) 786-4457, 
for issues related to the physician quality reporting system and the 
merit-based incentive payment system.
    Alexandra Mugge, (410) 786-4457, for issues related to EHR 
Incentive Program.
    Sarah Arceo, (410) 786-2356 or Patrice Holtz, (410786-5663 for 
issues related to EHR Incentive Program-Comprehensive Primary Care 
(CPC) initiative and Medicare EHR Incentive Program aligned reporting.
    Rabia Khan or Terri Postma, (410) 786-8084 or [email protected], for 
issues related to Medicare Shared Savings Program.
    Kimberly Spalding Bush, (410) 786-3232, or Sabrina Ahmed (410) 786-
7499, for issues related to value-based Payment Modifier and Physician 
Feedback Program.
    Frederick Grabau, (410) 786-0206, for issues related to changes to 
opt-out regulations.
    Lisa Ohrin Wilson (410) 786-8852, or Matthew Edgar (410) 786-0698, 
for issues related to physician self-referral updates.
    Christiane LaBonte, (410) 786-7234, for issues related to 
Comprehensive Primary Care (CPC) initiative.
    JoAnna Baldwin (410) 786-7205, or Sarah Fulton (410) 786-2749, for 
issues

[[Page 70887]]

related to appropriate use criteria for advanced diagnostic imaging 
services.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.
    Provisions open for comment: We will consider comments that are 
submitted as indicated above in the DATES and ADDRESSES sections on the 
following subject areas discussed in this final rule with comment 
period: Interim final work, practice expense (PE), and malpractice (MP) 
RVUs (including applicable work time, direct PE inputs, and MP 
crosswalks) for CY 2016; interim final new, revised, potentially 
misvalued HCPCS codes as indicated in the Preamble text and listed in 
Addendum C to this final rule with comment period; and the additions 
and deletions to the physician self-referral list of HCPCS/CPT codes 
found on tables 50 and 51.

Table of Contents

I. Executive Summary and Background
    A. Executive Summary
    B. Background
II. Provisions of the Final Rule With Comment Period for PFS
    A. Determination of Practice Expense (PE) Relative Value Units 
(RVUs)
    B. Determination of Malpractice Relative Value Units (RVUs)
    1. Overview
    2. Proposed Annual Update of MP RVUs
    3. MP RVU Update for Anesthesia Services
    4. MP RVU Methodology Refinements
    5. CY 2016 Identification of Potentially Misvalued Services for 
Review
    6. Valuing Services That Include Moderate Sedation as an 
Inherent Part of Furnishing the Procedure
    7. Improving the Valuation and Coding of the Global Package
    C. Elimination of the Refinement Panel
    D. Improving Payment Accuracy for Primary Care and Care 
Management Services
    E. Target for Relative Value Adjustments for Misvalued Services
    F. Phase-In of Significant RVU Reductions
    G. Changes for Computed Tomography (CT) Under the Protecting 
Access to Medicare Act of 2014 (PAMA)
    H. Valuation of Specific Codes
    1. Background
    2. Process for Valuing New, Revised, and Potentially Misvalued 
Codes
    3. Methodology for Establishing Work RVUs
    4. Methodology for Establishing the Direct PE Inputs Used To 
Develop PE RVUs
    5. Methodology for Establishing Malpractice RVUs
    6. CY 2016 Valuation of Specific Codes
    a. Lower GI Endoscopy Services
    b. Radiation Treatment and Related Image Guidance Services
    c. Advance Care Planning Services
    d. Valuation of Other Codes for CY 2016
    7. Direct PE Input-Only Recommendations
    8. CY 2015 Interim Final Codes
    9. CY 2016 Interim Final Codes
    I. Medicare Telehealth Services
    J. Incident to Proposals: Billing Physician as the Supervising 
Physician and Ancillary Personnel Requirements
    K. Portable X-Ray: Billing of the Transportation Fee
    L. Technical Correction: Waiver of Deductible for Anesthesia 
Services Furnished on the Same Date as a Planned Screening 
Colorectal Cancer Test
    M. Therapy Caps
III. Other Provisions of the Final Rule With Comment Period
    A. Provisions Associated With the Ambulance Fee Schedule
    B. Chronic Care Management (CCM) Services for Rural Health 
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
    C. Healthcare Common Procedure Coding System (HCPCS) Coding for 
Rural Health Clinics (RHCs)
    D. Payment to Grandfathered Tribal FQHCs That Were Provider-
Based Clinics on or Before April 7, 2000
    E. Part B Drugs--Biosimilars
    F. Productivity Adjustment for the Ambulance, Clinical 
Laboratory, and DMEPOS Fee Schedules
    G. Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services
    H. Physician Compare Web site
    I. Physician Payment, Efficiency, and Quality Improvements--
Physician Quality Reporting System
    J. Electronic Clinical Quality Measures (eCQM) and Certification 
Criteria and Electronic Health Record (EHR) Incentive Program-- 
Comprehensive Primary Care (CPC) Initiative and Medicare Meaningful 
Use Aligned Reporting
    K. Discussion and Acknowledgement of Public Comments Received on 
the Potential Expansion of the Comprehensive Primary Care (CPC) 
Initiative
    L. Medicare Shared Savings Program
    M. Value-Based Payment Modifier and Physician Feedback Program
    N. Physician Self-Referral Updates
    O. Private Contracting/Opt-Out
    P. Physician Self-Referral Prohibition: Annual Update to the 
List of CPT/HCPCS Codes
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

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)
AWV Annual wellness visit
BBA Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA [Medicare, Medicaid and State Child Health Insurance Program] 
Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
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

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GPCI Geographic practice cost index
GPO Group purchasing organization
GPRO Group practice reporting option
GTR Genetic Testing Registry
HCPCS Healthcare Common Procedure Coding System
HHS [Department of] Health and Human Services
HOPD Hospital outpatient department
HPSA Health professional shortage area
IDTF Independent diagnostic testing facility
IPPE Initial preventive physical exam
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
ISO Insurance service office
IT Information technology
IWPUT Intensity of work per unit of time
LCD Local coverage determination
MA Medicare Advantage
MAC Medicare Administrative Contractor
MAP Measure Applications Partnership
MAPCP Multi-payer Advanced Primary Care Practice
MAV Measure application validity [process]
MCP Monthly capitation payment
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MFP Multi-Factor Productivity
MIPPA Medicare Improvements for Patients and Providers Act (Pub. L. 
110-275)
MMA Medicare Prescription Drug, Improvement and Modernization Act of 
2003 (Pub. L. 108-173, enacted on December 8, 2003)
MP Malpractice
MPPR Multiple procedure payment reduction
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan Statistical Areas
MSPB Medicare Spending per Beneficiary
MU Meaningful use
NCD National coverage determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQS National Quality Strategy
OACT CMS's Office of the Actuary
OBRA '89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)
OBRA '90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508)
OES Occupational Employment Statistics
OMB Office of Management and Budget
OPPS Outpatient prospective payment system
OT Occupational therapy
PA Physician assistant
PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)
PC Professional component
PCIP Primary Care Incentive Payment
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment, Chain, and Ownership System
PFS Physician Fee Schedule
PLI Professional Liability Insurance
PMA Premarket approval
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 
2016 PFS Final Rule with Comment Period, refer to item CMS-1631-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 Henson at (410) 786-1947.

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 2015 American Medical Association. 
All Rights Reserved. CPT is a registered trademark of the American 
Medical Association (AMA). Applicable Federal Acquisition Regulations 
(FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary and Background

A. Executive Summary

1. Purpose
    This major final rule 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 2016.
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 paid under the PFS, incorporating geographic 
adjustments to reflect the variations in the costs of furnishing 
services in different geographic areas. In this major final rule with 
comment period, we establish RVUs for CY 2016 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:
     Potentially Misvalued PFS Codes.
     Telehealth Services.
     Advance Care Planning.
     Establishing Values for New, Revised, and Misvalued Codes.
     Target for Relative Value Adjustments for Misvalued 
Services.
     Phase-in of Significant RVU Reductions.
     ``Incident to'' policy.
     Portable X-ray Transportation Fee.
     Updating the Ambulance Fee Schedule regulations.
     Changes in Geographic Area Delineations for Ambulance 
Payment.
     Chronic Care Management Services for RHCs and FQHCs.
     HCPCS Coding for RHCs.
     Payment to Grandfathered Tribal FQHCs that were Provider-
Based Clinics on or before April 7, 2000.
     Payment for Biosimilars under Medicare Part B.
     Physician Compare Web site.
     Physician Quality Reporting System.
     Medicare Shared Savings Program.
     Electronic Health Record (EHR) Incentive Program.

[[Page 70889]]

     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 changes in this final rule with 
comment period will 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 is larger for a few specialties.
    We have determined that this major 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 major 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 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in determining 
the original physician work RVUs, Harvard worked with panels of 
experts, both inside and outside the federal government, and obtained 
input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion 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

[[Page 70890]]

period during which we would accept these supplemental data through 
March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA amended section 1848(c) of the Act to 
require that we implement resource-based MP RVUs for services furnished 
on or after CY 2000. The resource-based MP RVUs were implemented in the 
PFS final rule with comment period published November 2, 1999 (64 FR 
59380). The MP RVUs are based on commercial and physician-owned 
insurers' malpractice insurance premium data from all the states, the 
District of Columbia, and Puerto Rico. For more information on MP RVUs, 
see section II.B.2. of this final rule 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.
    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 cause expenditures for the year to change by more 
than $20 million, we make adjustments to ensure that expenditures did 
not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services. The GPCIs reflect the relative costs of work, 
PE, and MP in an area compared to the national average costs for each 
component.
    We received several comments regarding GPCIs that are not within 
the scope of proposals in the CY 2016 PFS proposed rule. Many of these 
commenters requested adjustments to GPCI values for the Puerto Rico 
payment locality. These commenters contend that the data used to 
calculate GPCIs do not accurately reflect the cost of medical practice 
in Puerto Rico. We have addressed some of these issues in response to 
specific comments in prior rulemaking, such as the CY 2014 PFS final 
rule with comment period (78 FR 74380 through 74391), and will further 
take comments into account when we next propose to update GPCIs. 
However, we also note that we anticipate proposing updated GPCIs during 
CY 2017 rulemaking, and in the context of that update, we will consider 
the concerns expressed by commenters and others regarding the GPCIs for 
the Puerto Rico locality.
    RVUs are converted to dollar amounts through the application of a 
CF, which is calculated based on a statutory formula by CMS's Office of 
the Actuary (OACT). The formula for calculating the Medicare fee 
schedule payment amount for a given service and fee schedule area can 
be expressed as:

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

[[Page 70891]]

    Subsequently, section 202 of the Achieving a Better Life Experience 
Act of 2014 (ABLE) (Division B of Pub. L. 113-295, enacted December 19, 
2014) accelerated the application of the target, amending section 
1848(c)(2)(O) of the Act to specify that target provisions apply for 
CYs 2016, 2017, and 2018; and setting a 1 percent target for reduced 
expenditures for CY 2016 and a 0.5 percent target for CYs 2017 and 
2018. The implementation of the target legislation is discussed in 
section II.E. of this final rule with comment period.
    Section 1848(c)(7) of the Act, as added by section 220(e) of the 
PAMA, specified that for services that are not new or revised codes, if 
the total RVUs for a service for a year would otherwise be decreased by 
an estimated 20 percent or more as compared to the total RVUs for the 
previous year, the applicable adjustments in work, PE, and MP RVUs 
shall be phased in over a 2-year period. Section 220(e) of the PAMA 
required the phase-in of RVU reductions of 20 percent or more to begin 
for 2017. Section 1848(c)(7) of the Act was later amended by section 
202 of the ABLE Act to require instead that the phase-in must begin in 
CY 2016. The implementation of the phase-in legislation is discussed in 
section II.F. of this final rule with comment period.
    Section 218(a) of the PAMA added a new section 1834(p) of the Act. 
Section 1834(p) of the Act requires for certain computed tomography 
(CT) services reductions in payment for the technical component (TC) 
(and the TC of the global fee) of the PFS service and in the hospital 
OPPS payment (5 percent in 2016, and 15 percent in 2017 and subsequent 
years). The CT services that are subject to the payment reduction are 
services identified as of January 1, 2014 by HCPCS codes 70450-70498, 
71250-71275, 72125-72133, 72191-72194, 73200-73206, 73700-73706, 74150-
74178, 74261-74263, and 75571-75574, and succeeding codes, that are 
furnished using equipment that does not meet each of the attributes of 
the National Electrical Manufacturers Association (NEMA) Standard XR-
29-2013, entitled ``Standard Attributes on CT Equipment Related to Dose 
Optimization and Management.'' The implementation of the amendments 
made by section 218(a) of the PAMA is discussed in section II.G. of 
this final rule with comment period.
    The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) 
(Pub. L. 114-10, enacted on April 16, 2015) makes several changes to 
the statute, including but not limited to:
    (1) Repealing the sustainable growth rate (SGR) update methodology 
for physicians' services.
    (2) Revising the PFS update for 2015 and subsequent years.
    (3) Requiring that we establish a Merit-based Incentive Payment 
System (MIPS) under which MIPS eligible professionals (initially 
including physicians, physician assistants, nurse practitioners, 
clinical nurse specialists, and certified registered nurse 
anesthetists) receive annual payment adjustments (increases or 
decreases) based on their performance in a prior period. These and 
other MACRA provisions are discussions in various sections of this 
final rule with comment period. Please refer to the table of contents 
for the location of the various MACRA provision discussions.

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

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

1. Overview
    Practice expense (PE) is the portion of the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding malpractice expenses, as specified in section 1848(c)(1)(B) 
of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use 
a resource-based system for determining PE RVUs for each physicians' 
service. We develop PE RVUs by considering the direct and indirect 
practice resources involved in furnishing each service. Direct expense 
categories include clinical labor, medical supplies, and medical 
equipment. Indirect expenses include administrative labor, office 
expense, and all other expenses. The sections that follow provide more 
detailed information about the methodology for translating the 
resources involved in furnishing each service into service-specific PE 
RVUs. We refer readers to the CY 2010 PFS final rule with comment 
period (74 FR 61743 through 61748) for a more detailed explanation of 
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
    We determine the direct PE for a specific service by adding the 
costs of the direct resources (that is, the clinical staff, medical 
supplies, and medical equipment) typically involved with furnishing 
that service. The costs of the resources are calculated using the 
refined direct PE inputs assigned to each CPT code in our PE database, 
which are generally based on our review of recommendations received 
from the RUC and those provided in response to public comment periods. 
For a detailed explanation of the direct PE methodology, including 
examples, we refer readers to the Five-Year Review of Work Relative 
Value Units under the PFS and Proposed Changes to the Practice Expense 
Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final 
rule with comment period (71 FR 69629).
    Comment: Several commenters requested that CMS include pharmacists 
as active qualified health care providers for purposes of calculating 
physician PE direct costs. The commenters stated that there are a 
number of ongoing Center for Medicare and Medicaid Innovation (CMMI) 
initiatives in which pharmacists are making substantial contributions 
to redesigning healthcare delivery and financing. The commenters 
insisted that pharmacists need to be included in the calculation of 
direct PE expenses as an element of the clinical labor variable 
relating to physician services, to ensure optimal medication therapy 
outcomes for beneficiaries, and the absence of these pharmacists 
negatively impacts the health care system.
    Response: The direct PE input database contains the service-level 
costs in clinical labor based on the typical service furnished to 
Medicare beneficiaries. Commenters did not suggest that the labor costs 
of pharmacists are a typical resource cost in furnishing any particular 
physicians' service. When such costs are typically incurred in 
furnishing such services, we do not have any standing policies that 
would prohibit the inclusion of the costs in the direct PE input 
database used to develop PE RVUs for individual services, to the extent 
that inclusion of such costs would not lead to duplicative payments. 
Therefore, we welcome more detailed information regarding the typical 
clinical labor costs involving pharmacists for particular PFS services. 
We note, however, that in many of the CMMI initiatives, payment is 
provided for care management and care coordination services, including 
services provided by pharmacists. As such, we encourage commenters to 
provide information about the inclusion of additional clinical labor 
costs for specific services described by HCPCS codes for which payment 
is made under the PFS, as opposed to clinical labor costs that may be 
typical only under certain initiatives.

[[Page 70892]]

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).
    For CY 2016, we have incorporated the available utilization data 
for interventional cardiology, which became a recognized Medicare 
specialty during 2014. We proposed to use a proxy PE/HR value for 
interventional cardiology, as there are no PPIS data for this 
specialty, by crosswalking the PE/HR from Cardiology, since the 
specialties furnish similar services in the Medicare claims data. The 
change is reflected in the ``PE/HR'' file available on the CMS Web site 
under the supporting data files for the CY 2016 PFS proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    Comment: One commenter expressed support for the new proposal to 
use a proxy PE per hour for interventional cardiology by crosswalking 
to the PE/HR for cardiology.
    Response: We appreciate the commenter's support and are finalizing 
the crosswalk as proposed.
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 work RVUs. We 
also incorporated the survey data described earlier in the PE/HR 
discussion. The general approach to developing the indirect portion of 
the PE RVUs is as follows:
     For a given service, we used the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is 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

[[Page 70893]]

initial indirect allocator would equal 6.00, resulting in a 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 added the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had 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 incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey 
data, the average indirect cost of the specialties furnishing the first 
service with an allocator of 10.00 was half of the average indirect 
cost of the specialties furnishing the second service with an indirect 
allocator of 5.00, the indirect portion of the PE RVUs of the first 
service would be equal to that of the second service.
(4) 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.
(5) 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.)
(6) 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).
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service. Apply 
a scaling adjustment to the direct inputs.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. Under our current methodology, we first multiply the 
current year's conversion factor by the product of the current year's 
PE RVUs and utilization for each service to arrive at the aggregate 
pool of total PE costs (Step 2a). We then calculate the average direct 
percentage of the current pool of PE RVUs (using a weighted average of 
the survey data for the specialties that furnish each service (Step 
2b).) We then multiply the result of 2a by the result of 2b to arrive 
at the aggregate pool of direct PE costs for the current year. For CY 
2016, we proposed a technical improvement to step 2a of this 
calculation. In place of the step 2a calculation described above, we 
proposed to set the aggregate pool of PE costs equal to the product of 
the ratio of the current aggregate PE RVUs to current aggregate work 
RVUs and the proposed aggregate work RVUs. Historically, in allowing 
the current PE RVUs to determine the size of the base PE pool in the PE 
methodology, we have assumed that the relationship of PE RVUs to work 
RVUs is constant from year to year. Since this is not ordinarily the 
case, by not considering the proposed aggregate work RVUs in 
determining the size of the base PE pool, we have introduced some minor 
instability from year to year in the relative shares of work, PE, and 
MP RVUs. Although this modification would result in greater stability 
in the relationship among the work and PE RVU components in the 
aggregate, we do not anticipate it will affect the distribution of PE 
RVUs across specialties. The PE RVUs in addendum B of this final rule 
with comment period reflect this refinement to the PE methodology.
    We did not receive any comments on this proposed refinement of the 
methodology. Therefore, we are finalizing this refinement as proposed.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, 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.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    Historically, we have used the specialties that furnish the service 
in the most recent full year of Medicare claims data (crosswalked to 
the current year set of codes) to determine which specialties furnish 
individual procedures. For example, for CY 2015 ratesetting, we used 
the mix of specialties that

[[Page 70894]]

furnished the services in the CY 2013 claims data to determine the 
specialty mix assigned to each code. Although we believe that there are 
clear advantages to using the most recent available data in making 
these determinations, we have also found that using a single year of 
data contributes to greater year-to-year instability in PE RVUs for 
individual codes and often creates extreme, annual fluctuations for 
low-volume services, as well as delayed fluctuations for some services 
described by new codes once claims data for those codes becomes 
available. We believe that using an average of the three most recent 
years of available data may increase stability of PE RVUs and mitigate 
code-level fluctuations for both the full range of PFS codes, and for 
new and low-volume codes in particular. Therefore, we proposed to 
refine this step of the PE methodology to use an average of the 3 most 
recent years of available Medicare claims data to determine the 
specialty mix assigned to each code. The PE RVUs in Addendum B of the 
CMS Web site reflect this refinement to the PE methodology.
    Comment: We received several comments supporting this proposed 
refinement of the methodology. Several commenters also urged us to 
override the utilization data for low-volume codes using a recommended 
list of expected specialty or dominant specialty, consistent with our 
previous approach.
    Response: We appreciate the support for the use of the 3-year 
average of claims utilization for purposes of determining the specialty 
mix for individual service. As we stated in our proposal, we believe 
that the 3-year average will mitigate the need to use dominant or 
expected specialty instead of the claims data. However, we also 
understand that the hypothesis will be tested as soon as a new year of 
claims data is incorporated into the PFS ratesetting methodology. 
Because we anticipate incorporating CY 2015 claims data for use in CY 
2017 ratesetting, we believe that the proposed PE RVUs associated with 
the CY 2017 PFS proposed rule will provide the best opportunity to 
determine whether service-level overrides of claims data are necessary. 
Therefore, we are finalizing the policy as proposed for CY 2016 but 
will seek comment on the proposed CY 2017 PFS rates and whether or not 
the incorporation a new year of utilization data mitigates the need for 
service-level overrides. At that time, we would reconsider whether or 
not to use a claims-based approach (dominant specialty) or stakeholder-
recommended approach (expected specialty) in the development of PE RVUs 
for low-volume codes.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: the direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs will be allocated 
using the work RVUs, and for the TC service, indirect PEs will be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.) For presentation purposes in the examples in 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 the result of step 2a (as calculated with the proposed 
change) by the average indirect PE percentage from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 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 proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs, consistent with the proposed 
changes in Steps 2 and 9. 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

[[Page 70895]]

ratesetting calculation'' later in this section.)
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE RVUs, we exclude certain specialties, 
such as certain 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 code                    Specialty description
------------------------------------------------------------------------
49....................  Ambulatory surgical center.
50....................  Nurse practitioner.
51....................  Medical supply company with certified orthotist.
52....................  Medical supply company with certified
                         prosthetist.
53....................  Medical supply company with certified
                         prosthetist[dash]orthotist.
54....................  Medical supply company not included in 51, 52,
                         or 53.
55....................  Individual certified orthotist.
56....................  Individual certified prosthetist.
57....................  Individual certified prosthetist[dash]orthotist.
58....................  Medical supply company with registered
                         pharmacist.
59....................  Ambulance service supplier, e.g., private
                         ambulance companies, funeral homes, etc.
60....................  Public health or welfare agencies.
61....................  Voluntary health or charitable agencies.
73....................  Mass immunization roster biller.
74....................  Radiation therapy centers.
87....................  All other suppliers (e.g., drug and department
                         stores).
88....................  Unknown supplier/provider specialty.
89....................  Certified clinical nurse specialist.
96....................  Optician.
97....................  Physician assistant.
A0....................  Hospital.
A1....................  SNF.
A2....................  Intermediate care nursing facility.
A3....................  Nursing facility, other.
A4....................  HHA.
A5....................  Pharmacy.
A6....................  Medical supply company with respiratory
                         therapist.
A7....................  Department store.
B2....................  Pedorthic personnel.
B3....................  Medical supply company with pedorthic personnel.
------------------------------------------------------------------------

     Crosswalk certain low volume physician specialties: 
Crosswalk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
     Physical therapy utilization: Crosswalk the utilization 
associated with all physical therapy services to the specialty of 
physical therapy.
     Identify professional and technical services not 
identified under the usual TC and 26 modifiers: Flag the services that 
are PC and TC services but do not use TC and 26 modifiers (for example, 
electrocardiograms). This flag associates the PC and TC with the 
associated global code for use in creating the indirect PE RVUs. For 
example, the professional service, CPT code 93010 (Electrocardiogram, 
routine ECG with at least 12 leads; interpretation and report only), is 
associated with the global service, CPT code 93000 (Electrocardiogram, 
routine ECG with at least 12 leads; with interpretation and report).
     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time accordingly. Table 2 details the manner in which the 
modifiers are applied.

                         Table 2--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
           Modifier                    Description              Volume adjustment            Time adjustment
----------------------------------------------------------------------------------------------------------------
80,81,82......................  Assistant at Surgery....  16%..........................  Intraoperative portion.
AS............................  Assistant at Surgery--    14% (85% * 16%)..............  Intraoperative portion.
                                 Physician Assistant.
50 or LT and RT...............  Bilateral Surgery.......  150%.........................  150% of work time.
51............................  Multiple Procedure......  50%..........................  Intraoperative portion.
52............................  Reduced Services........  50%..........................  50%.

[[Page 70896]]

 
53............................  Discontinued Procedure..  50%..........................  50%.
54............................  Intraoperative Care only  Preoperative + Intraoperative  Preoperative +
                                                           Percentages on the payment     Intraoperative
                                                           files used by Medicare         portion.
                                                           contractors to process
                                                           Medicare claims.
55............................  Postoperative Care only.  Postoperative Percentage on    Postoperative portion.
                                                           the payment files used by
                                                           Medicare contractors to
                                                           process Medicare claims.
62............................  Co-surgeons.............  62.5%........................  50%.
66............................  Team Surgeons...........  33%..........................  33%.
----------------------------------------------------------------------------------------------------------------

    We also make adjustments to volume and time that correspond to 
other payment rules, including special multiple procedure endoscopy 
rules and multiple procedure payment reductions (MPPRs). We note that 
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments 
for multiple imaging procedures and multiple therapy services from the 
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These 
MPPRs are not included in the development of the RVUs.
    For anesthesia services, we do not apply adjustments to volume 
since we use the average allowed charge when simulating RVUs; 
therefore, the RVUs as calculated already reflect the payments as 
adjusted by modifiers, and no volume adjustments are necessary. 
However, a time adjustment of 33 percent is made only for medical 
direction of two to four cases since that is the only situation where a 
single practitioner is involved with multiple beneficiaries 
concurrently, so that counting each service without regard to the 
overlap with other services would overstate the amount of time spent by 
the practitioner furnishing these services.
     Work RVUs: The setup file contains the work RVUs from this 
final rule with comment period.
    The following is a summary of the comments we received regarding PE 
RVU methodology.
    Comment: We received several comments in response to our proposal 
to use the 3 most recent years of Medicare claims data to determine the 
specialty mix assigned to each code. All commenters broadly supported 
the proposal to use a 3-year average to increase stability of PE RVUs 
and mitigate code-level fluctuations. Some commenters, including the 
RUC, also stated that for codes which are very low volume in the 
Medicare population, the dominant specialty(ies) should be assigned. 
These commenters stressed that CMS should continue to utilize the 
expertise of the RUC when making these assignments.
    Response: For services that are newly created or very low volume, 
we will continue to explore different methods to ensure the utilization 
of the most accurate specialty mix.
(7) 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. We also direct the 
reader to section II.H.6.b of this final rule with comment period for a 
discussion of our change in the utilization rate assumption for the 
linear accelerator used in furnishing radiation treatment services.
    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, similar to other assumptions in the equipment cost per minute 
calculation. In CY 2015 rulemaking, we solicited comments regarding the 
availability of reliable data on maintenance costs that vary for 
particular equipment items. We received several comments about variable 
maintenance costs, and in reviewing the information offered in those 
comments, it is clear that the relationship between maintenance costs 
and the price of equipment is not necessarily uniform across equipment. 
After reviewing the comments received, we have been unable to identify 
a systematic way of varying the maintenance cost assumption relative to 
the price or useful life of equipment. Therefore, to accommodate a 
variable, as opposed to a standard, maintenance rate within the 
equipment cost per minute calculation, we believe we would have to 
gather and maintain valid data on the maintenance costs for each 
equipment item in the direct PE input database, much like we do for 
price and useful life.
    Given our longstanding difficulties in acquiring accurate pricing 
information for equipment items, we solicited comments on whether 
adding another item-specific financial variable for equipment costs 
will be likely to increase the accuracy of PE RVUs across the PFS. We 
noted that most of the information for maintenance costs we have 
received is for capital equipment, and for the most part, this 
information has been limited to single invoices. Like the invoices for 
the equipment items themselves, we do not believe that very small 
numbers of voluntarily submitted invoices are likely to reflect typical 
costs for all of the same reasons we have discussed in previous 
rulemaking. We noted that some commenters submitted high-level summary 
data from informal surveys but we currently have no means to validate 
that data. Therefore, we continue to seek a source of publicly 
available data on actual maintenance costs for medical equipment to 
improve the accuracy of the equipment costs used in developing PE RVUs.
    Comment: Many commenters stated that the current 5 percent 
equipment maintenance factor does not account for expensive maintenance 
contracts on pieces of highly technical equipment. Most commenters were 
supportive of the idea of adding an item-specific maintenance variable 
for equipment costs, which they stated would likely increase the 
accuracy of the PE RVUs across the PFS. These commenters stated that 
specialty societies and other stakeholders should be allowed to provide 
documentation to CMS, as they

[[Page 70897]]

currently do for pricing new supplies and equipment, to apply for an 
increase in maintenance costs. Other commenters requested that if a 
fixed maintenance factor remains in place, it should be increased from 
5 percent to 10 percent. One commenter expressed concern that CMS would 
entertain making a change in this aspect of the equipment cost per 
minute formula based on a few invoices when a change would impact every 
service in the fee schedule. The commenter expressed concerns with the 
possibility that CMS might adopt a variable maintenance factor based on 
the submission of individual invoices. Another commenter stated that 
without a systematic data collection methodology for determining 
maintenance factors, they had concerns that any invoices CMS received 
might not accurately capture the true costs of equipment maintenance.
    Although most commenters were supportive of adopting a variable 
maintenance factor for equipment items, commenters also stated that 
they were unaware of any publicly available data source containing this 
information. One commenter agreed that there is no comprehensive data 
source for the maintenance information and therefore it would be 
difficult to implement a variable maintenance formula. Multiple other 
commenters concurred that they were unaware of any such public dataset. 
Several commenters encouraged CMS to work with stakeholders to define 
service contracts/maintenance contracts, collect data on their 
associated costs and update the equipment maintenance adjustment factor 
as necessary.
    Response: We appreciate the submission of extensive comments 
regarding the subject of equipment maintenance factor. We agree with 
commenters that we do not believe the annual maintenance factor for all 
equipment is exactly 5 percent, and we concur that the current rate 
likely understates the true cost of maintaining some equipment. We also 
believe it likely overstates the maintenance costs for other equipment. 
However, in the absence of publicly available datasets regarding 
equipment maintenance costs or another systematic data collection 
methodology for determining maintenance factor, we do not believe that 
we have sufficient information at present to adopt a variable 
maintenance factor for equipment cost per minute pricing. While we 
believe that these costs ideally should be incorporated into the PE 
methodology, we also have serious concerns about the problems that 
result from incorporating anecdotal data based solely on voluntarily 
submitted pricing information. In establishing prices for equipment and 
supplies, in many cases we have found that the submitted invoices often 
overstate the costs for individual items relative to publically 
available prices. We believe that the incentives related to voluntarily 
submitted limited invoices for maintenance costs would likely produce 
information subject to similar limitations. However, in contrast to 
prices, where we have identified no feasible alternative, our 
alternative for determining maintenance rates is a long-established 
default maintenance rate. We also note that the amount of costs for 
maintenance under the current methodology is directly proportional to 
the equipment prices, largely determined by the voluntarily submitted 
invoices for particular equipment items. Therefore, we believe that 
absent an auditable, robust data source, using anecdotal data for 
maintenance costs is likely to compound the current problems of pricing 
equipment costs accurately, not increase accuracy.
    We will continue to investigate potential avenues for determining 
equipment maintenance costs across a broad range of equipment items.
    Interest Rate: In the CY 2013 final rule with comment period (77 FR 
68902), we updated the interest rates used in developing an equipment 
cost per minute calculation. The interest rate was based on the Small 
Business Administration (SBA) maximum interest rates for different 
categories of loan size (equipment cost) and maturity (useful life). 
The interest rates are listed in Table 3. (See 77 FR 68902 for a 
thorough discussion of this issue.) We did not propose any changes to 
these interest rates for CY 2016.

                  Table 3A--SBA Maximum Interest Rates
------------------------------------------------------------------------
                                                                Interest
                Price                        Useful life        rate (%)
------------------------------------------------------------------------
<$25K................................  <7 Years                     7.50
$25K to $50K.........................  <7 Years                     6.50
>$50K................................  <7 Years                     5.50
<$25K................................  7+ Years                     8.00
$25K to $50K.........................  7+ Years                     7.00
>$50K................................  7+ Years                     6.00
------------------------------------------------------------------------


[[Page 70898]]


                                                              Table 4--Calculation of PE RVUs Under Methodology for Selected Codes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                           33533
                                                                                               99213       CABG,    71020 Chest    71020-TC     71020-26    93000 ECG,   93005 ECG,   93010 ECG,
                                        Step               Source             Formula          Office    arterial,     x-ray       Chest x-     Chest x-    complete,     tracing       report
                                                                                             visit, est    single   nonfacility      ray,         ray,     nonfacility  nonfacility  nonfacility
                                                                                            nonfacility   facility               nonfacility  nonfacility
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Labor cost (Lab)...........  Step 1............  AMA...............  .................       13.32       77.52        5.74         5.74            0          5.1          5.1            0
(2) Supply cost (Sup)..........  Step 1............  AMA...............  .................        2.98        7.34        0.53         0.53            0         1.19         1.19            0
(3) Equipment cost (Eqp).......  Step 1............  AMA...............  .................        0.17        0.58        7.08         7.08            0         0.09         0.09            0
(4) Direct cost (Dir)..........  Step 1............  ..................       =(1)+(2)+(3)       16.48       85.45       13.36        13.36            0         6.38         6.38            0
(5) Direct adjustment (Dir.      Steps 2-4.........  See Footnote*.....  .................      0.5957      0.5957      0.5957       0.5957       0.5957       0.5957       0.5957       0.5957
 Adj.).
(6) Adjusted Labor.............  Steps 2-4.........  ..................           =(1)*(5)        7.93       46.18        3.42         3.42            0         3.04         3.04            0
(7) Adjusted Supplies..........  Steps 2-4.........  =Eqp * Dir Adj....           =(2)*(5)        1.78        4.37        0.32         0.32            0         0.71         0.71            0
(8) Adjusted Equipment.........  Steps 2-4.........  =Sup * Dir Adj....           =(3)*(5)         0.1        0.35        4.22         4.22            0         0.05         0.05            0
(9) Adjusted Direct............  Steps 2-4.........  ..................       =(6)+(7)+(8)        9.82        50.9        7.96         7.96            0          3.8          3.8            0
(10) Conversion Factor (CF)....  Step 5............  PFS...............  .................     35.9335     35.9335     35.9335      35.9335      35.9335      35.9335      35.9335      35.9335
(11) Adj. labor cost converted.  Step 5............  =(Lab * Dir Adj)/           =(6)/(10)        0.22        1.29         0.1          0.1            0         0.08         0.08            0
                                                      CF.
(12) Adj. supply cost converted  Step 5............  =(Sup * Dir Adj)/           =(7)/(10)        0.05        0.12        0.01         0.01            0         0.02         0.02            0
                                                      CF.
(13) Adj. equipment cost         Step 5............  =(Eqp * Dir Adj)/           =(8)/(10)           0        0.01        0.12         0.12            0            0            0            0
 converted.                                           CF.
(14) Adj. direct cost converted  Step 5............  ..................    =(11)+(12)+(13)        0.27        1.42        0.22         0.22            0         0.11         0.11            0
(15) Work RVU..................  Setup File........  PFS...............  .................        0.97       33.75        0.22            0         0.22         0.17            0         0.17
(16) Dir_pct...................  Steps 6,7.........  Surveys...........  .................        0.25        0.17        0.29         0.29         0.29         0.29         0.29         0.29
(17) Ind_pct...................  Steps 6,7.........  Surveys...........  .................        0.75        0.83        0.71         0.71         0.71         0.71         0.71         0.71
(18) Ind. Alloc. Formula (1st    Step 8............  See Step 8........  .................         14/         14/         14/          14/          14/          14/          14/          14/
 part).                                                                                      (16)*(17)   (16)*(17)   (16)*(17)    (16)*(17)    (16)*(17)    (16)*(17)    (16)*(17)    (16)*(17)
(19) Ind. Alloc.(1st part).....  Step 8............  ..................             See 18        0.83         6.7        0.54         0.54            0         0.26         0.26            0
(20) Ind. Alloc. Formula (2nd    Step 8............  See Step 8........  .................        (15)        (15)     (15+11)         (11)         (15)      (15+11)         (11)         (15)
 pt).
(21) Ind. Alloc.(2nd part).....  Step 8............  ..................             See 20        0.97       33.75        0.32          0.1         0.22         0.25         0.08         0.17
(22) Indirect Allocator (1st +   Step 8............  ..................         =(19)+(21)         1.8       40.45        0.85         0.63         0.22         0.52         0.35         0.17
 2nd).
(23) Indirect Adjustment (Ind    Steps 9-11........  See Footnote**....  .................      0.3816      0.3816      0.3816       0.3816       0.3816       0.3816       0.3816       0.3816
 Adj).
(24) Adjusted Indirect           Steps 9-11........  =Ind Alloc * Ind    .................        0.69       15.44        0.33         0.24         0.08          0.2         0.13         0.06
 Allocator.                                           Adj.
(25) Ind. Practice Cost Index    Steps 12-16.......  ..................  .................        1.07        0.76        0.98         0.98         0.98          0.9          0.9          0.9
 (IPCI).
(26) Adjusted Indirect.........  Step 17...........  = Adj.Ind Alloc *          =(24)*(25)        0.73       11.71        0.32         0.24         0.08         0.18         0.12         0.06
                                                      PCI.
(27) Final PE RVU..............  Step 18...........  =(Adj Dir + Adj          =((14)+(26))        1.01       13.16        0.54         0.46         0.08         0.28         0.23         0.06
                                                      Ind) * Other Adj.       * Other Adj)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CPT codes and descriptions are copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.
Notes: PE RVUs above (row 27), may not match Addendum B due to rounding.
The use of any particular conversion factor (CF) in the table to illustrate the PE Calculation has no effect on the resulting RVUs.
*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].


[[Page 70899]]

c. Changes to Direct PE Inputs for Specific Services
    This section focusses on specific PE inputs that we addressed in 
the proposed rule. The direct PE inputs are included in the CY 2016 
direct PE input database, which is available on the CMS Web site under 
downloads for the CY 2016 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(1) PE Inputs for Digital Imaging Services
    Prior to CY 2015 rulemaking, the RUC provided a recommendation 
regarding the PE inputs for digital imaging services. Specifically, the 
RUC recommended that we remove supply and equipment items associated 
with film technology from a list of codes since these items are no 
longer typical resource inputs. The RUC also recommended that the 
Picture Archiving and Communication System (PACS) equipment be included 
for these imaging services since these items are now typically used in 
furnishing imaging services. However, since we did not receive any 
invoices for the PACS system, we were unable to determine the 
appropriate pricing to use for the inputs. For CY 2015, we proposed, 
and finalized our proposal, to remove the film supply and equipment 
items, and to create a new equipment item as a proxy for the PACS 
workstation as a direct expense. We used the current price associated 
with ED021 (computer, desktop, w-monitor) to price the new item, ED050 
(PACS Workstation Proxy), pending receipt of invoices to facilitate 
pricing specific to the PACS workstation.
    Subsequent to establishing payment rates for CY 2015, we received 
information from several stakeholders regarding pricing for items 
related to the digital acquisition and storage of images. Some of these 
stakeholders submitted information that included prices for items 
clearly categorized as indirect costs within the established PE 
methodology and equivalent to the storage mechanisms for film. 
Additionally, some of the invoices we received included other products 
(like training and maintenance costs) in addition to the equipment 
items, and there was no distinction on these invoices between the 
prices for the equipment items themselves and the related services. 
However, we did receive invoices from one stakeholder that facilitated 
a proposed price update for the PACS workstation. Therefore, we 
proposed to update the price for the PACS workstation to $5,557 from 
the current price of $2,501 since the latter price was based on the 
proxy item and the former based on submitted invoices. The PE RVUs in 
Addendum B on the CMS Web site reflect the updated price.
    In addition to the workstation used by the clinical staff acquiring 
the images and furnishing the TC of the services, a stakeholder also 
submitted more detailed information regarding a workstation used by the 
practitioner interpreting the image in furnishing the PC of many of 
these services.
    As we stated in the CY 2015 final rule with comment period (79 FR 
67563), we generally believe that workstations used by these 
practitioners are more accurately considered indirect costs associated 
with the PC of the service. However, we understand that the 
professional workstations for interpretation of digital images are 
similar in principle to some of the previous film inputs incorporated 
into the global and technical components of the codes. Given that many 
of these services are reported globally in the nonfacility setting, we 
believe it may be appropriate to include these costs as direct inputs 
for the associated HCPCS codes. Based on our established methodology, 
these costs would be incorporated into the PE RVUs of the global and 
technical component of the HCPCS code.
    We solicited comments on whether including the professional 
workstation as a direct PE input for these codes would be appropriate, 
given that the resulting PE RVUs would be assigned to the global and 
technical components of the codes.
    Comment: Many commenters supported the equipment price increase to 
$5,557 for the PACS workstation. Commenters stated that this is a more 
accurate amount than the current price of $2,501. However, many 
commenters, including the RUC, stated that this price did not capture 
the appropriate pricing for the PC of the PACS workstation. One 
commenter expressed concerns with the method that CMS employed to 
establish the proposed price for the PACS workstation, disregarded the 
invoices and accompanying explanations submitted by several 
stakeholders and instead relying on the information submitted by a 
single group.
    Response: We acknowledge and appreciate that several stakeholders 
provided information intended to facilitate our pricing of the 
equipment related to PACS. However, much of that submitted information 
included costs that are considered indirect PE under the established 
methodology. We considered all of the submitted information and used 
the submitted prices that were consistent with the principles 
established under the PE methodology.
    Comment: Many commenters, including the RUC, stated that the 
proposed price did not capture the appropriate pricing for the PC of 
the PACS workstation. Several commenters indicated that the 
professional workstation was a direct PE item due to the fact that it 
is used for individual studies (one at a time) in the non-facility 
setting, and its use involves a bi-directional exchange between a 
technologist and a radiologist while the TC is being provided. These 
commenters also suggested that the professional PACS workstation was a 
direct proxy for the film alternators, film processors, and view-boxes 
previously considered direct PE inputs for many of these services prior 
to the film to digital conversion. Several commenters suggested that 
the true cost of the PACS workstation was significantly higher than the 
proposed $5,557 due to these professional expenses.
    Response: We appreciate the extensive feedback regarding the 
potential addition of a PC to the PACS workstation. We agree that the 
costs of the professional workstation may be analogous to costs 
previously incorporated as direct PE inputs for these services. 
Therefore, we are seeking comments and recommendations from 
stakeholders, including the RUC, regarding which codes would require 
the professional PACS workstation and for how many minutes the 
professional equipment workstation would be used relative to the work 
time or clinical labor tasks associated with individual codes. We would 
address any such recommendations in future rulemaking.
    Comment: One commenter stated that the CMS' attempt to analogize 
elements of a PACS workstation to the historic inputs associated with 
film technology was inherently flawed. This commenter stated that CMS 
should not characterize critical elements of the PACS workstation as 
indirect costs because film technology is fundamentally distinct from 
digital technology. The commenter indicated that the PACS workstation 
requires specific software to function, and the costs associated with 
training, maintenance, and warranties for the PACS workstation have not 
been factored into the cost of the equipment. The commenter suggested 
that not including these as direct costs reflects a mistaken assumption 
that a PACS workstation has functionality for non-imaging services, 
such as patient

[[Page 70900]]

scheduling, billing, or electronic medical records capability.
    Response: We believe that maintaining consistent treatment of PE 
costs is of central importance in the resource-based relative value 
system. Since the PE RVUs for individual services are relative to all 
other PFS services, we believe that we must categorize typical costs 
for individual services into the direct and indirect categories using 
the same definitions that apply to all PFS services. We believe it 
would be inconsistent with cost-based relative value principles to 
change the definition of those categories for particular procedures or 
tests, even when technology changes. Centralized record keeping 
systems, containing clinical or billing information are considered 
indirect expenses across the PFS. Due to technological changes, some of 
these systems are well-integrated into equipment items with clinical 
functionality, while others remain completely distinct. In pricing and 
categorizing these costs, we have aimed to separate these costs where 
possible and believe we have maintained relativity among PFS services 
to the greatest extent possible. We remind commenters that indirect PE 
RVUs are included for every nationally priced PFS service and that 
these RVUs contribute to payment for each and every service. We also 
note that over time, indirect costs change as direct costs change. For 
example, changes in technology might result in particular items using 
more or less office space, or using more or less electricity. We do not 
believe it would be appropriate to redefine indirect costs as direct 
costs whenever we have reason to believe that indirect costs have 
changed due to changes in technology. Instead, we acknowledge that 
indirect costs change over time for all those who are paid through the 
Medicare PFS, making it even more important to follow the established 
principles of relativity in establishing direct PE inputs.
    After consideration of comments received, we are finalizing our 
proposal to update the price for the PACS workstation to $5,557 from 
the current price of $2,501.
    As we noted in the proposed rule, one commenter expressed concern 
about the changes in direct PE inputs for CPT code 76377, (3D 
radiographic procedure with computerized image post-processing), that 
were proposed and finalized in CY 2015 rulemaking as part of the film 
to digital change. Based on a recommendation from the RUC, we removed 
the input called ``computer workstation, 3D reconstruction CT-MR'' from 
the direct PE input database and assigned the associated minutes to the 
proxy for the PACS workstation. Therefore, we sought comment from 
stakeholders, including the RUC, about whether or not the PACS 
workstation used in imaging codes is the same workstation that is used 
in the post-processing described by CPT code 76377, or if a more 
specific workstation should be incorporated in the direct PE input 
database.
    Comment: Multiple commenters indicated that CPT code 76377 requires 
image post-processing on an independent workstation. Commenters stated 
that the ``computer workstation, 3D reconstruction CT-MR'' equipment 
(ED014), which was removed by the RUC from the equipment list for this 
procedure, is separate from the PACS workstation and performs a 
different function. The commenters requested that ED014 be restored to 
the equipment inputs for CPT code 76377 and assigned 38 minutes of 
equipment time. The commenters also suggested that the PACS workstation 
should remain as a separate direct PE expense as well, since there are 
additional PACS related activities specific to the 3-D images after 
they have been created on the computer workstation.
    Response: We appreciate the additional information regarding the 
use of the 3D reconstruction computer workstation for CPT code 76377. 
After consideration of comments received, we agree that the ``computer 
workstation, 3D reconstruction CT-MR'' equipment (ED014) should be 
restored to the equipment list and assigned to CPT code 76377 with an 
equipment time of 38 minutes. However, we do not believe that the 
typical service for CPT code 76377 would also use the PACS workstation. 
Therefore, we substituted ED014 in place of the PACS workstation.
(2) Standardization of Clinical Labor Tasks
    As we noted in PFS rulemaking for CY 2015, we continue to work on 
revisions to the direct PE input database to provide the number of 
clinical labor minutes assigned for each task for every code in the 
database instead of only including the number of clinical labor minutes 
for the pre-service, service, and post-service periods for each code. 
In addition to increasing the transparency of the information used to 
set PE RVUs, this improvement would allow us to compare clinical labor 
times for activities associated with services across the PFS, which we 
believe is important to maintaining the relativity of the direct PE 
inputs. This information will facilitate the identification of the 
usual numbers of minutes for clinical labor tasks and the 
identification of exceptions to the usual values. It will also allow 
for greater transparency and consistency in the assignment of equipment 
minutes based on clinical labor times. Finally, we believe that the 
information can be useful in maintaining standard times for particular 
clinical labor tasks that can be applied consistently to many codes as 
they are valued over several years, similar in principle to the use of 
physician pre-service time packages. We believe such standards will 
provide greater consistency among codes that share the same clinical 
labor tasks and could improve relativity of values among codes. For 
example, as medical practice and technologies change over time, changes 
in the standards could be updated at once for all codes with the 
applicable clinical labor tasks, instead of waiting for individual 
codes to be reviewed.
    Although this work is not yet complete, we anticipate completing it 
in the near future. In the following paragraphs, we address a series of 
issues related to clinical labor tasks, particularly relevant to 
services currently being reviewed under the misvalued code initiative.
(a) Clinical Labor Tasks Associated With Digital Imaging
    In PFS rulemaking for CY 2015, we noted that the RUC recommendation 
regarding inputs for digital imaging services indicated that, as each 
code is reviewed under the misvalued code initiative, the clinical 
labor tasks associated with digital technology (instead of film) would 
need to be addressed. When we reviewed that recommendation, we did not 
have the capability of assigning standard clinical labor times for the 
hundreds of individual codes since the direct PE input database did not 
previously allow for comprehensive adjustments for clinical labor times 
based on particular clinical labor tasks. Therefore, consistent with 
the recommendation, we proposed to remove film-based supply and 
equipment items but maintain clinical labor minutes that were assigned 
based on film technology.
    As noted in the paragraphs above, we continue to improve the direct 
PE input database by specifying the minutes for each code associated 
with each clinical labor task. Once completed, this work would allow 
adjustments to be made to minutes assigned to particular clinical labor 
tasks related to digital technology, consistent with the changes that 
were made to individual supply and equipment items. In the meantime, we

[[Page 70901]]

believe it would be appropriate to establish standard times for 
clinical labor tasks associated with all digital imaging for purposes 
of reviewing individual services at present, and for possible broad-
based standardization once the changes to the database facilitate our 
ability to adjust time for existing services. Therefore, we solicited 
comments on the appropriate standard minutes for the clinical labor 
tasks associated with services that use digital technology, which are 
listed in Table 5. We note that the application of any standardized 
times we adopt for clinical labor tasks to codes that are not being 
reviewed in this final rule would be considered for possible inclusion 
in future notice and comment rulemaking.

    Table 5--Clinical Labor Tasks Associated With Digital Technology
------------------------------------------------------------------------
                                                              Typical
                   Clinical labor task                        minutes
------------------------------------------------------------------------
Availability of prior images confirmed..................               2
Patient clinical information and questionnaire reviewed                2
 by technologist, order from physician confirmed and
 exam protocoled by radiologist.........................
Technologist QC's* images in PACS, checking for all                    2
 images, reformats, and dose page.......................
Review examination with interpreting MD.................               2
Exam documents scanned into PACS. Exam completed in RIS                1
 system to generate billing process and to populate
 images into Radiologist work queue.....................
------------------------------------------------------------------------
* This clinical labor task is listed as it appears on the ``PE
  worksheets.'' QC refers to quality control, which we understand to
  mean the verification of the image using the PACS workstation.

    The following is a summary of the comments we received regarding 
whether these standard times accurately reflect the typical time it 
takes to perform these clinical labor tasks associated with digital 
imaging.
    Comment: Many commenters supported CMS' efforts to recognize the 
advances in digital technology and take them into account through 
updated RVUs. Several commenters agreed that the clinical labor tasks 
outlined in Table 5 reflected the PE Subcommittee's film to digital 
workgroup recommendations. The commenters suggested that the staff 
types in the tasks should be made more generalized and less specific 
(such as technologist to clinical staff or radiologist to physician), 
and stated that specialty societies should be afforded the opportunity 
to request deviations (that is, increases) from the standard times.
    Response: We believe that providing specific guidelines for the 
staff types associated with these tasks will aid in determining the 
most accurate value for each service. We also agree that specialties 
should be afforded the opportunity to request deviations from the 
standard times for unusual situations, when supported with the 
presentation of additional justification for the added time.
    Comment: The RUC commented that it had not supported standard times 
for clinical staff activities related to digital imaging in the past, 
as the RUC had recommended that the specialties should have an 
opportunity to determine the appropriate inputs at the individual 
distinct service level and there was too much variability across 
imaging modalities to propose standards. While the RUC continued to 
hold to its previous position on this subject, it also agreed that four 
of the five clinical labor activities proposed by CMS in Table 5 are 
representative across imaging and could appropriately be used as 
standard times. The one exception was the clinical labor task 
``Technologist QC's images in PACS, checking for all images, reformats, 
and dose page'', in which the RUC stated the number of minutes would 
vary significantly depending on the procedure in question. For example, 
a cardiac MR with hundreds of images would require more quality control 
time than a single view X-ray of the chest. The RUC recommended that 
this line item remain nonstandard, and that specialties should continue 
to have the opportunity to make a recommendation on the appropriate 
number of minutes based on clinical judgment.
    Another commenter also supported standard clinical labor times for 
four out of the five tasks associated with digital technology, again 
excepting the activity ``Technologist QC's images in PACS, checking for 
all images, reformats, and dose page.'' This commenter stated that a 
survey of imaging providers had been conducted which suggested that the 
median time required to perform this clinical labor task was 10 
minutes. The commenter stated that CMS did not have any data to support 
its belief in the standard time of 2 minutes, and recommended 
considering the commenter's data and information from other 
stakeholders regarding the appropriate standard minutes for the 
clinical labor tasks associated digital imaging.
    Response: With regard to the activity ``Technologist QC's images in 
PACS, checking for all images, reformats, and dose page'', we agree 
that this task may require a variable length of time depending on the 
number of images to be reviewed. We believe that it may be appropriate 
to establish several different standard times for this clinical labor 
task for a low/medium/high quantity of images to be reviewed, in the 
same fashion that the clinical labor assigned to clean a surgical 
instrument package has two different standard times depending on the 
use of a basic pack (10 minutes) or a medium pack (30 minutes). We are 
interested in soliciting public comment and feedback on this subject, 
with the anticipation of including a proposal in next year's proposed 
rule.
    After consideration of comments received, we are finalizing 
standard times for clinical labor tasks associated with digital imaging 
at 2 minutes for ``Availability of prior images confirmed'', 2 minutes 
for ``Patient clinical information and questionnaire reviewed by 
technologist, order from physician confirmed and exam protocoled by 
radiologist'', 2 minutes for ``Review examination with interpreting 
MD'', and 1 minute for ``Exam documents scanned into PACS. Exam 
completed in RIS system to generate billing process and to populate 
images into Radiologist work queue.'' We are not finalizing a standard 
time for clinical labor task ``Technologist QC's images in PACS, 
checking for all images, reformats, and dose page'' at this time, 
pending consideration of any additional public comment and future 
rulemaking, as described above.
(b) Pathology Clinical Labor Tasks
    As with the clinical labor tasks associated with digital imaging, 
many of the specialized clinical labor tasks associated with pathology 
services do not have consistent times across those

[[Page 70902]]

codes. In reviewing the recommendations for pathology services, we have 
not identified information that supports the judgment that the same 
tasks take significantly more or less time depending on the individual 
service for which they are performed, especially given the specificity 
with which they are described.
    Therefore, we developed standard times that we have used in 
finalizing direct PE inputs. These times are based on our review and 
assessment of the current times included for these clinical labor tasks 
in the direct PE input database. We have listed these standard times in 
Table 6. For services reviewed for CY 2016, in cases where the RUC-
recommended times differed from these standards, we have refined the 
time for those tasks to align with the values in Table 6. We solicited 
comments on whether these standard times accurately reflect the typical 
time it takes to perform these clinical labor tasks when furnishing 
pathology services.

    Table 6--Standard Times for Clinical Labor Tasks Associated With
                           Pathology Services
------------------------------------------------------------------------
                                                             Standard
                   Clinical labor task                    clinical labor
                                                          time (minutes)
------------------------------------------------------------------------
Accession specimen/prepare for examination..............               4
Assemble and deliver slides with paperwork to                        0.5
 pathologists...........................................
Assemble other light microscopy slides, open nerve                   0.5
 biopsy slides, and clinical history, and present to
 pathologist to prepare clinical pathologic
 interpretation.........................................
Assist pathologist with gross specimen examination......               3
Clean room/equipment following procedure (including any                1
 equipment maintenance that must be done after the
 procedure).............................................
Dispose of remaining specimens, spent chemicals/other                  1
 consumables, and hazardous waste.......................
Enter patient data, computational prep for antibody                    1
 testing, generate and apply bar codes to slides, and
 enter data for automated slide stainer.................
Instrument start-up, quality control functions,                       13
 calibration, centrifugation, maintaining specimen
 tracking, logs and labeling............................
Load specimen into flow cytometer, run specimen, monitor               7
 data acquisition and data modeling, and unload flow
 cytometer..............................................
Preparation: Labeling of blocks and containers and                   0.5
 document location and processor used...................
Prepare automated stainer with solutions and load                      4
 microscopic slides.....................................
Prepare specimen containers/preload fixative/label                   0.5
 containers/distribute requisition form(s) to physician.
Prepare, pack and transport specimens and records for in-              1
 house storage and external storage (where applicable)..
Print out histograms, assemble materials with paperwork                2
 to pathologists. Review histograms and gating with
 pathologist............................................
Receive phone call from referring laboratory/facility                  5
 with scheduled procedure to arrange special delivery of
 specimen procurement kit, including muscle biopsy clamp
 as needed. Review with sender instructions for
 preservation of specimen integrity and return
 arrangements. Contact courier and arrange delivery to
 referring laboratory/facility..........................
Register the patient in the information system,                        4
 including all demographic and billing information......
Stain air dried slides with modified Wright stain.                     3
 Review slides for malignancy/high cellularity (cross
 contamination).........................................
------------------------------------------------------------------------

    Comment: Many commenters stated that they did not support the 
standardization of clinical labor activities across pathology services. 
Commenters stated that a single standard time for each clinical labor 
task was infeasible due to the differences in batch size or number of 
blocks across different pathology procedures. Several commenters 
indicated that it may be possible to standardize across codes with the 
same batch sizes, and urged CMS to consider pathology-specific details, 
such as batch size and block number, in the creation of any future 
standard times for clinical labor tasks. One commenter stated that the 
CMS clinical labor times were uniformly too low, and that CMS did not 
provide enough information about how it arrived at these revised 
standard times. The commenter provided five examples of inadequate 
labor times, and stated that CMS should provide stakeholders with 
information about the source of its data and why it rejected the RUC 
recommendations for these clinical labor tasks.
    Response: We appreciate the extensive feedback provided by 
commenters on the standard times for clinical labor tasks associated 
with pathology services. As we stated in the CY 2016 PFS proposed rule, 
we developed the proposed standard times based on our review and 
assessment of the current times included for these clinical labor tasks 
in the direct PE input database. We believe that clinical labor tasks 
with the same work description are comparable across different 
pathology procedures. We concur with commenters that accurate clinical 
labor times for pathology codes may be dependent on the number of 
blocks or batch size typically used for each individual service. 
However, we believe that it is possible to establish ``per block'' 
standards or standards varied by batch size assumptions for many 
clinical labor activities that will be comparable across a wide range 
of individual services. We have received detailed information regarding 
batch size and number of blocks during review of individual pathology 
services on an intermittent basis in the past. We request regular 
submission of these details on the PE worksheets as part of the review 
process for pathology procedures, as a means to assist in the 
determination of the most accurate direct PE inputs. Were we to receive 
this information as part of standard recommendations, we would include 
these assumptions as part of the information open for comment in 
proposed revaluations. We are also seeking comment regarding how to 
best establish clinical labor standards for pathology services on a 
``per block'' or ``per batch size'' basis.
    We also believe that many of the clinical labor activities that we 
discussed in Table 6 are tasks that do not depend on number of blocks 
or batch size. Clinical labor activities such as ``Clean room/equipment 
following procedure'' and ``Dispose of remaining specimens'' would 
typically remain standard across different services without varying by 
block number or batch size, with the understanding of occasional 
allowance for additional time for clinical labor tasks of unusual 
difficulty.
    After consideration of comments received, we are finalizing 
standard times for clinical labor tasks associated with pathology 
services at 4 minutes for

[[Page 70903]]

``Accession specimen/prepare for examination'', 0.5 minutes for 
``Assemble and deliver slides with paperwork to pathologists'', 0.5 
minutes for ``Assemble other light microscopy slides, open nerve biopsy 
slides, and clinical history, and present to pathologist to prepare 
clinical pathologic interpretation'', 1 minute for ``Clean room/
equipment following procedure'', 1 minute for ``Dispose of remaining 
specimens, spent chemicals/other consumables, and hazardous waste'', 
and 1 minute for ``Prepare, pack and transport specimens and records 
for in-house storage and external storage (where applicable).'' We do 
not believe these activities would be dependent on number of blocks or 
batch size, and we believe that these values accurately reflect the 
typical time it takes to perform these clinical labor tasks. For the 
rest of the clinical labor tasks associated with pathology services, we 
are interested in soliciting further public comment and feedback on 
this subject as part of this final rule with comment period, with the 
anticipation of including a proposal in next year's proposed rule.
(c) Clinical Labor Task: ``Complete Botox Log''
    In the process of improving the level of detail in the direct PE 
input database by including the minutes assigned for each clinical 
labor task, we noticed that there are several codes with minutes 
assigned for the clinical labor task called ``complete botox log.'' We 
do not believe the completion of such a log is a direct resource cost 
of furnishing a medically reasonable and necessary physician's service 
for a Medicare beneficiary. Therefore, we proposed to eliminate the 
minutes assigned for the task ``complete botox log'' from the direct PE 
input database. The PE RVUs displayed in Addendum B on the CMS Web site 
were calculated with the modified inputs displayed in the CY 2016 
direct PE input database.
    The following is a summary of the comments we received regarding 
the clinical labor task ``complete botox log.''
    Comment: Several commenters, including the RUC, did not agree with 
the proposal to eliminate the minutes associated with this clinical 
labor task. Commenters maintained that the clinical labor task of 
completing the botox log was a medically reasonable direct resource 
cost. One commenter stated that it was critical for clinical staff to 
maintain accurate bookkeeping of split botox vials, and that 
documentation must reflect the exact dosage of the drug given to 
patients and a statement that the unused portion of the drug was 
discarded.
    Response: We continue to believe that the clinical labor assigned 
for the task ``complete botox log'' is a form of indirect PE that is 
not allocated to individual services. We believe that this is a quality 
control issue for clinical staff. Maintaining accurate administrative 
records, even for public safety, is not a task we generally allocate to 
individual services, instead we consider these costs as attributable 
across a range of services, and therefore, as an indirect PE. After 
consideration of comments received, we are finalizing the proposal to 
eliminate the minutes assigned for the task ``complete botox log'' from 
the direct PE input database.
(3) Clinical Labor Input Inconsistencies
    Subsequent to the publication of the CY 2015 PFS final rule with 
comment period, stakeholders alerted us to several clerical 
inconsistencies in the clinical labor nonfacility intraservice time for 
several vertebroplasty codes with interim final values for CY 2015, 
based on our understanding of RUC recommended values. We proposed to 
correct these inconsistencies in the CY 2016 proposed direct PE input 
database to reflect the RUC recommended values, without refinement, as 
stated in the CY 2015 PFS final rule with comment period. The CY 2015 
interim final direct PE inputs for these codes are displayed 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.
    For CY 2016, we proposed the following adjustments:
     For CPT codes 22510 (percutaneous vertebroplasty (bone 
biopsy included when performed), 1 vertebral body, unilateral or 
bilateral injection, inclusive of all imaging guidance; 
cervicothoracic) and 22511 (percutaneous vertebroplasty (bone biopsy 
included when performed), 1 vertebral body, unilateral or bilateral 
injection, inclusive of all imaging guidance; lumbosacral), a value of 
45 minutes for labor code L041B (``Radiologic Technologist'') we 
proposed to assign for the ``assist physician'' task and a value of 5 
minutes for labor code L037D (``RN/LPN/MTA'') for the ``Check dressings 
& wound/home care instructions/coordinate office visits/prescriptions'' 
task.
     For CPT code 22514 (percutaneous vertebral augmentation, 
including cavity creation (fracture reduction and bone biopsy included 
when performed) using mechanical device (e.g., kyphoplasty), 1 
vertebral body, unilateral or bilateral cannulation, inclusive of all 
imaging guidance; lumbar), we proposed to adjust the nonfacility 
intraservice time to 50 minutes for L041B, 50 minutes for L051A 
(``RN''), 38 minutes for a second L041B, and 12 minutes for L037D.
    The PE RVUs displayed in Addendum B on the CMS Web site were 
calculated with the inputs displayed in the CY 2016 direct PE input 
database.
    The following is a summary of the comments we received regarding 
clinical labor input inconsistencies.
    Comment: Two commenters indicated that although they appreciated 
CMS' efforts to clean up errors in the direct PE database, they had 
specific concerns regarding the proposed changes. The commenters stated 
that for CPT code 22510, it appeared that the direct PE clinical time 
file had the second technologist listed at 90 minutes for the ``Assist 
physician'' task, not 45 minutes as recommended. The commenters 
indicated that CMS stated an intention to include 5 minutes for ``Check 
dressings & wound'' but this time did not appear to be included in the 
direct PE input labor file. The commenters also noted that the 
postoperative E/M visit for CPT code 22510 was also not listed in the 
CMS file.
    The commenters stated that for CPT code 22511, the CMS direct PE 
labor file correctly included the 45 minutes of ``Assist physician'' 
time for the second technologist, however, the 5 minutes for the RN/
LPN/MTA blend (L037D) to ``Check dressings & wound'' was still not 
included in the CMS file. The commenter indicated that the 
postoperative E/M visit was also not included for this code. The 
commenters also stated that for CPT code 22514, CMS was proposing to 
include the 5 minutes for ``Check dressings & wound'' in the 
intraservice time for this service. The commenters indicated that this 
did not appear to be consistent with how CMS was proposing to handle 
the same clinical labor task in the prior two codes discussed. The 
commenters requested that CMS outline specifically which line items 
(from the PE spreadsheet) it proposed to change and the effects these 
changes would have on the direct inputs for these three codes.
    Response: We appreciate the detailed feedback from the commenters 
on the clinical labor inconsistencies in these three codes. We agree 
with the commenters that there were remaining clinical labor errors in 
these procedures beyond those detailed in the CY 2016 PFS proposed 
rule, and appreciate the opportunity to clarify the discrepancies

[[Page 70904]]

in clinical labor for these three procedures.
    For CPT code 22510, we agree with the commenters that the clinical 
labor assigned to the RadTech (L041B) for ``Assist Physician'' was 
incorrectly listed twice in our direct PE input database. The clinical 
labor staff type was also incorrectly entered as L041C, which is priced 
at the same rate but refers to a second Radiologic Technologist for 
Vertebroplasty. We will remove the duplicative clinical labor and 
assign type L041B to the ``Assist Physician'' activity. We do not agree 
with the commenters that the time for clinical labor task ``Check 
dressings & wound'' was missing, as it is present in the database. We 
agree with the commenters that the clinical labor time for the office 
visit was missing from CPT code 22510, and we will add it to the direct 
PE database.
    For CPT code 22511, the commenters are correct that the time for 
clinical labor task ``Assist physician'' was entered at the correct 
value of 45 minutes, and the 5 minutes of clinical labor for ``Check 
dressings & wound'' does not appear in the non-facility setting. This 
clinical labor time appears to have been incorrectly entered for the 
facility setting instead; we will remove this time and add it to its 
proper non-facility setting. We agree with the commenters that the 
clinical labor time for the office visit was again missing from CPT 
code 22511, and we will add it to the direct PE input database.
    For CPT code 22514, the time for clinical labor task ``Assist 
physician'' has been refined to 50 minutes as detailed in the CY 2016 
PFS proposed rule. We agree with the commenters that the 5 minutes of 
clinical labor time for ``Check dressings & wound'' is missing from the 
direct PE input database. We agree that the clinical labor for this 
activity should not be treated differently from the rest of the codes 
in the family, and therefore these 5 minutes are included in the direct 
PE input database. The postoperative office visit is included in the 
direct PE input database for CPT code 22514.
    After consideration of comments received, we are finalizing our 
proposed changes to clinical labor along with the additional 
corrections described above.
(4) Freezer
    We identified several pathology codes for which equipment minutes 
are assigned to the item EP110 ``Freezer.'' Minutes are only allocated 
to particular equipment items when those items cannot be used in 
conjunction with furnishing services to another patient at the same 
time. We do not believe that minutes should be allocated to items such 
as freezers since the storage of any particular specimen or item in a 
freezer for any given period of time would be unlikely to make the 
freezer unavailable for storing other specimens or items. Instead, we 
proposed to classify the freezer as an indirect cost because we believe 
that would be most consistent with the principles underlying the PE 
methodology since freezers can be used for many specimens at once. The 
PE RVUs displayed in Addendum B on the CMS Web site were calculated 
with the modified inputs displayed in the CY 2016 direct PE input 
database.
    We did not receive comments on this proposal, and therefore, we are 
finalizing as proposed.
(5) 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 2014, we received 
a request to update the price of supply item ``antigen, mite'' (SH006) 
from $4.10 per test to $59. In reviewing the request, it is evident 
that the requested price update does not apply to the SH006 item but 
instead represents a different item than the one currently included as 
an input in CPT code 86490 (skin test, coccidioidomycosis). Therefore, 
rather than changing the price for SH006 that is included in several 
codes, we proposed to create a new supply code for Spherusol, valued at 
$590 per 1 ml vial and $59 per test, and to include this new item as a 
supply for 86490 instead of the current input, SH006.
    Comment: Several commenters strongly supported the CMS proposal to 
create a new supply code for Spherusol that reflects the current price 
for the antigen and to update the direct inputs for CPT code 86490 to 
include this item. However, commenters noted that the public use files 
included in the CY 2016 PFS proposed rule continue to reflect the prior 
supply code SH006 with a price of $4.10. Commenters asked whether this 
was a technical error and urged CMS to correct the input files to be 
consistent with the proposal described in the regulation preamble.
    Response: We appreciate support for our proposal and acknowledge 
our inadvertent omission of this change in the proposed direct PE input 
database. After consideration of comments received, we are finalizing 
our proposal to create a supply item for Spherusol and it is included 
as a direct PE input for CPT code 86490.
    We also received a request to update the price for EQ340 (Patient 
Worn Telemetry System) used only in CPT code 93229 (External mobile 
cardiovascular telemetry with electrocardiographic recording, 
concurrent computerized real time data analysis and greater than 24 
hours of accessible ECG data storage (retrievable with query) with ECG 
triggered and patient selected events transmitted to a remote attended 
surveillance center for up to 30 days; technical support for connection 
and patient instructions for use, attended surveillance, analysis and 
transmission of daily and emergent data reports as prescribed by a 
physician or other qualified health care.) The requestor noted that we 
had previously proposed and finalized a policy to remove wireless 
communication and delivery costs related to the equipment item that had 
previously been included in the direct PE input database as supply 
items. The requestor asked that we alter the price of the equipment 
from $21,575 to $23,537 to account for the equipment costs specific to 
the patient-worn telemetry system.
    In the proposed rule, we stated that we considered this request in 
the context of the unique nature of this particular equipment item. 
This equipment item is unique in several ways, including that it is 
used continuously 24 hours per day and 7 days per week for an 
individual patient over several weeks. It is also unique in that the 
equipment is primarily used outside of a healthcare setting. Within our 
current methodology, we currently account for these unique properties 
by calculating the per minute costs with different assumptions than 
those used for most other equipment by increasing the number of hours 
the equipment is available for use. Therefore, we also believe it would 
be appropriate to incorporate other unique aspects of the operating 
costs of this item in our calculation of the equipment cost per minute. 
We believe the requestor's suggestion to do so by increasing the price 
of the equipment is practicable and appropriate. Therefore, we proposed 
to change the price for EQ340 (Patient Worn Telemetry System) to 
$23,537. The PE RVUs displayed in Addendum B on the CMS Web site were 
calculated with the modified inputs displayed in the CY 2016 direct PE 
input database.
    Comment: One commenter supported the CMS proposal regarding the 
Patient Worn Telemetry System (EQ340). The commenter agreed with the 
proposed increase in the price of the equipment

[[Page 70905]]

from $21,757 to $23,537, and the reason for this increase. We did not 
receive any comments opposing the proposal.
    Response: After consideration of comments received, we are 
finalizing our proposal regarding the Patient Worn Telemetry System 
equipment.
    For CY 2015, we received a request to update the price for supply 
item ``kit, HER-2/neu DNA Probe'' (SL196) from $105 to $144.50. 
Accordingly, in the CY 2015 proposed rule, we proposed to update the 
price to $144.50. In the CY 2015 final rule with comment period, we 
indicated that we obtained new information suggesting that further 
study of the price of this item was necessary before proceeding to 
update the input price. We obtained pricing information readily 
available on the Internet that indicated a price of $94 for this item 
for a particular hospital. Subsequent to the CY 2015 final rule with 
comment period, stakeholders requested that we use the updated price of 
$144.50. One stakeholder suggested that the price of $94 likely 
reflected discounts for volume purchases not received by the typical 
laboratory. We solicited comments on how to consider the higher-priced 
invoice, which is 53 percent higher than the price listed, relative to 
the price currently in the direct PE database. Specifically, we 
solicited information on the price of the disposable supply in the 
typical case of the service furnished to a Medicare beneficiary, 
including, based on data, whether the typical Medicare case is 
furnished by an entity likely to receive a volume discount.
    Comment: Several commenters disagreed with the CMS proposal 
regarding the updated price for the supply item ``kit, HER-2/neu DNA 
Probe'' (SL196). One commenter stated that the price of $94 reflected a 
volume discount that could not be obtained by the typical provider. The 
lowered price referenced in the CY 2016 PFS proposed rule indicated 
that the purchaser may be receiving a competitive contractually 
arranged price. The commenter stated that the lowered price referenced 
is what might be expected to be acquired by the largest hospitals, 
which would be expected to buy supplies in greater volume than a small 
community hospital or mid-sized laboratory, and the price indicated 
does not reflect the prices for a laboratory of typical size.
    Other commenters stated that they were unable to find this pricing 
information through publicly available sources, suggesting that it may 
not reflect typical transactions. The commenters also stated that it 
was unclear as to whether the proposed price referred to FDA-approved 
kits, which are more expensive than non-approved kits. The commenters 
further indicated that a number of new morphometric analysis, multiplex 
quantitative/semi-quantitative ISH tests are in use today with probe 
kit costs that are higher than those of HER-2/neu probe kits. The 
commenters suggested that CMS should adopt a weighted-average of the 
probe kit prices for the probe kits currently used to perform these 
procedures.
    Response: Without robust, auditable information regarding the 
actual prices paid by a range of practitioners that would allow us to 
reasonably determine a recommended price to be typical, we believe that 
we should assume that the best publicly available price is typical. 
Generally speaking, we do not believe vendors are likely to allow 
public display of pricing that is not broadly available to potential 
customers since that would present significant competitive 
disadvantages in the market. Therefore, given the options between the 
best publicly available price or prices on invoices selected for the 
distinct purpose of pricing individual services, we believe the best 
publicly available price is more likely to be typical. Therefore, we 
are not making any changes to the price of this supply item at this 
time.
    Comment: The RUC commented that in the CMS direct PE database the 
unit of measure for SL196 is listed as ``kit'', while on the submitted 
PE spreadsheet the unit is listed as ``kit assay.'' The RUC recommended 
that the unit of measure be changed to ``kit assay'' to correlate 
correctly with the cost shown in the database.
    Response: We appreciate this additional information, and will 
change the unit of measure of SL196 to ``kit assay'' in the direct PE 
database.
    Comment: Several commenters stated CMS's estimated per-minute labor 
cost inputs are too low for laboratory technicians (L033A), 
cytotechnologists (L045A) and histotechnologists (L037B). The 
commenters stated that the complexity of many laboratory services 
demands highly-skilled, highly-trained, certified, and experienced 
personnel who typically must be paid higher wages than the current 
rates provided by CMS. Commenters stated that CMS has underestimated 
the actual labor costs associated with the work that these more 
specialized laboratory personnel perform by 20 to 30 percent, after 
accounting for costs related to benefits, taxes, and training.
    Response: The clinical labor costs per minute are based on data 
from the Bureau of Labor Statistics. We believe that it is important to 
update that information uniformly among clinical labor types and will 
consider updating the clinical labor costs per minute in the direct PE 
database in future rulemaking.
(6) Typical Supply and Equipment Inputs for Pathology Services
    In reviewing public comments in response to the CY 2015 PFS final 
rule with comment period, we re-examined issues around the typical 
number of pathology tests furnished at once. In the CY 2013 final rule 
with comment period (77 FR 69074), we noted that the number of blocks 
assumed for a particular code significantly impacts the assumed 
clinical labor, supplies, and equipment for that service. We indicated 
that we had concerns that the assumed number of blocks was inaccurate, 
and that we sought corroborating, independent evidence that the number 
of blocks assumed in the current direct PE input recommendations is 
typical. We note that, given the high volume of many pathology 
services, these assumptions have a significant impact on the PE RVUs 
for all other PFS services. We refer readers to section II.H. where we 
detail our concerns about the lack of information regarding typical 
batch size and typical block size for many pathology services and 
solicit stakeholder input on approaches to obtaining accurate 
information that can facilitate our establishing payment rates that 
best reflect the relative resources involved in furnishing the typical 
service, for both pathology services in particular and more broadly for 
services across the PFS.
    Comment: Several commenters addressed the number of blocks and 
batch size for prostate biopsies in particular. We direct readers to 
section II.H. of this final rule with comment period for a more 
detailed discussion of the resource costs for these services. We 
continue to seek stakeholder input regarding the best sources of 
information for typical number of blocks and batch sizes for pathology 
services.
d. Developing Nonfacility Rates
    We noted that not all PFS services are priced in the nonfacility 
setting, but as medical practice changes, we routinely develop 
nonfacility prices for particular services when they can be furnished 
outside of a facility setting. We noted that the valuation of a service 
under the PFS in particular settings does not address whether those 
services are medically reasonable and necessary in the case of 
individual patients, including being furnished in a setting appropriate 
to the patient's medical needs and condition.

[[Page 70906]]

(1) Request for Information on Nonfacility Cataract Surgery
    Cataract surgery generally has been performed in an ambulatory 
surgery center (ASC) or a hospital outpatient department (HOPD). We 
have not assigned nonfacility PE RVUs under the PFS for cataract 
surgery. According to Medicare claims data, there are a relatively 
small number of these services furnished in nonfacility settings. 
Except in unusual circumstances, anesthesia for cataract surgery is 
either local or topical/intracameral. Advancements in technology have 
significantly reduced operating time and improved both the safety of 
the procedure and patient outcomes. As discussed in the proposed rule, 
we believe that it now may be possible for cataract surgery to be 
furnished in an in-office surgical suite, especially for routine cases. 
Cataract surgery patients require a sterile surgical suite with certain 
equipment and supplies that we believe could be a part of a 
nonfacility-based setting that is properly constructed and maintained 
for appropriate infection prevention and control.
    We also noted in the proposed rule that we believe there are 
potential advantages for all parties to furnishing appropriate cataract 
surgery cases in the nonfacility setting. Cataract surgery has been for 
many years the highest volume surgical procedure performed on Medicare 
beneficiaries. For beneficiaries, cataract surgery in the office 
setting might provide the additional convenience of receiving the 
preoperative, operative, and post-operative care in one location. It 
might also reduce delays associated with registration, processing, and 
discharge protocols associated with some facilities. Similarly, it 
might provide surgeons with greater flexibility in scheduling patients 
at an appropriate site of service depending on the individual patient's 
needs. For example, routine cases in patients with no comorbidities 
could be performed in the nonfacility surgical suite, while more 
complicated cases (for example, pseudoexfoliation) could be scheduled 
in the ASC or HOPD. In addition, furnishing cataract surgery in the 
nonfacility setting could result in lower Medicare expenditures for 
cataract surgery if the nonfacility payment rate were lower than the 
sum of the PFS facility payment rate and the payment to either the ASC 
or HOPD.
    We solicited comments from ophthalmologists and other stakeholders 
on office-based surgical suite cataract surgery. In addition, we 
solicited comments from the RUC and other stakeholders on the direct PE 
inputs involved in furnishing cataract surgery in the nonfacility 
setting in conjunction with our consideration of information regarding 
the possibility of development of nonfacility cataract surgery PE RVUs.
    We received 138 comments from stakeholders including professional 
medical societies, the RUC, ambulatory surgical centers (ASCs), 
practitioners, and the general public. The RUC deferred to the 
specialty societies regarding the appropriateness of performing these 
services in the nonfacility setting.
    Comment: A few commenters suggested that development of PE RVUs 
would allow for greater flexibility regarding scheduling and location 
where services are performed. Commenters provided information about 
clinical considerations related to furnishing these services in a 
nonfacility setting, with many commenters citing safety concerns 
involved in furnishing cataract surgery in the office setting.
    Response: We will use this information as we consider whether to 
proceed with development of nonfacility PE RVUs for cataract surgery.
(2) Direct PE Inputs for Functional Endoscopic Sinus Surgery Services
    A stakeholder indicated that due to changes in technology and 
technique, several codes that describe endoscopic sinus surgeries can 
now be furnished in the nonfacility setting. According to Medicare 
claims data, there are a relatively small number of these services 
furnished in nonfacility settings. These CPT codes are 31254 (Nasal/
sinus endoscopy, surgical; with ethmoidectomy, partial (anterior)), 
31255 (Nasal/sinus endoscopy, surgical; with ethmoidectomy, total 
(anterior and posterior)), 31256 (Nasal/sinus endoscopy, surgical, with 
maxillary antrostomy), 31267 (Nasal/sinus endoscopy, surgical, with 
maxillary antrostomy; with removal of tissue from maxillary sinus), 
31276 (Nasal/sinus endoscopy, surgical with frontal sinus exploration, 
with or without removal of tissue from frontal sinus), 31287 (Nasal/
sinus endoscopy, surgical, with sphenoidotomy), and 31288 (Nasal/sinus 
endoscopy, surgical, with sphenoidotomy; with removal of tissue from 
the sphenoid sinus). We solicited input from stakeholders, including 
the RUC, about the appropriate direct PE inputs for these services.
    We received 53 comments from stakeholders including specialty 
societies, device manufacturers, medical centers, and physician 
practices (otolaryngology, allergy, facial, and plastics specialists).
    Comment: The RUC indicated an intention to review direct PE inputs 
at the January 2016 RUC meeting. One specialty society representing 
otolaryngology head and neck surgeons indicated that endoscopic sinus 
surgery services have been identified by the CPT/RUC workgroup for 
development of bundled codes for this code family and inputs will 
likely be reviewed as part of this process. Some commenters submitted 
information about their respective PEs related to CPT codes 31254, 
31255, 31267, 31276, 31287, and 31288. Other commenters limited their 
comments to CPT codes 31254 and 31255, noting clinical concerns about 
performance of other sinus surgery procedures in the nonfacility 
setting. A few commenters did not support development of nonfacility 
direct PE RVUs for endoscopic sinus surgery due to clinical 
considerations such as patient safety, possible complications, use of 
anesthesia, and need for establishment of standards and oversight of 
in-office surgical suites.
    Response: We appreciate the feedback we received from all 
commenters. We will use this information as we consider whether to 
proceed with development of nonfacility PE RVUs or functional 
endoscopic sinus surgery services.

B. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that each service paid under 
the PFS be composed of three components: Work, PE, and malpractice (MP) 
expense. As required by section 1848(c)(2)(C)(iii) of the Act, 
beginning in CY 2000, MP RVUs are resource based. Malpractice RVUs for 
new codes after 1991 were extrapolated from similar existing codes or 
as a percentage of the corresponding work RVU. Section 1848(c)(2)(B)(i) 
of the Act also requires that we review, and if necessary adjust, RVUs 
no less often than every 5 years. In the CY 2015 PFS final rule with 
comment period, we implemented the third review and update of MP RVUs. 
For a discussion of the third review and update of MP RVUs see the CY 
2015 proposed rule (79 FR 40349 through 40355) and final rule with 
comment period (79 FR 67591 through 67596).
    As explained in the CY 2011 PFS final rule with comment period (75 
FR 73208), MP RVUs for new and revised codes effective before the next 
five-year review of MP RVUs were determined either by a direct 
crosswalk from a similar source code or by a modified

[[Page 70907]]

crosswalk to account for differences in work RVUs between the new/
revised code and the source code. For the modified crosswalk approach, 
we adjust (or ``scale'') the MP RVU for the new/revised code to reflect 
the difference in work RVU between the source code and the new/revised 
work RVU (or, if greater, the clinical labor portion of the fully 
implemented PE RVU) for the new code. For example, if the proposed work 
RVU for a revised code is 10 percent higher than the work RVU for its 
source code, the MP RVU for the revised code would be increased by 10 
percent over the source code MP RVU. Under this approach the same risk 
factor is applied for the new/revised code and source code, but the 
work RVU for the new/revised code is used to adjust the MP RVUs for 
risk.
    For CY 2016, we proposed to continue our current approach for 
determining MP RVUs for new/revised codes. For the new and revised 
codes for which we proposed work RVUs and PE inputs, we also published 
the proposed MP crosswalks used to determine their MP RVUs. The MP 
crosswalks for those new and revised codes were subject to public 
comment and we are responding to comments and finalizing them in 
section II.H. of this CY 2016 PFS final rule with comment period. The 
MP crosswalks for new and revised codes with interim final values 
established in this CY 2016 final rule with comment period will be 
implemented for CY 2016 and subject to public comment. We will then 
respond to comments and finalize them in the CY 2017 PFS final rule 
with comment period.
2. Proposed Annual Update of MP RVUs
    In the CY 2012 PFS final rule with comment period (76 FR 73057), we 
finalized a process to consolidate the five-year reviews of work and PE 
RVUs with our annual review of potentially misvalued codes. We 
discussed the exclusion of MP RVUs from this process at the time, and 
we stated that, since it is not feasible to obtain updated specialty 
level MP insurance premium data on an annual basis, we believe the 
comprehensive review of MP RVUs should continue to occur at 5-year 
intervals. In the CY 2015 PFS proposed rule (79 FR 40349 through 
40355), we stated that there are two main aspects to the update of MP 
RVUs: (1) Recalculation of specialty risk factors based upon updated 
premium data; and (2) recalculation of service level RVUs based upon 
the mix of practitioners providing the service. In the CY 2015 PFS 
final rule with comment period (79 FR 67596), in response to several 
stakeholders' comments, we stated that we would address potential 
changes regarding the frequency of MP RVU updates in a future proposed 
rule. For CY 2016, we proposed to begin conducting annual MP RVU 
updates to reflect changes in the mix of practitioners providing 
services, and to adjust MP RVUs for risk. Under this approach, the 
specialty-specific risk factors would continue to be updated every 5 
years using updated premium data, but would remain unchanged between 
the 5-year reviews. However, in an effort to ensure that MP RVUs are as 
current as possible, our proposal would involve recalibrating all MP 
RVUs on an annual basis to reflect the specialty mix based on updated 
Medicare claims data. Since under this proposal, we would be 
recalculating the MP RVUs annually, we also proposed to maintain the 
relative pool of MP RVUs from year to year; this will preserve the 
relative weight of MP RVUs to work and PE RVUs. We proposed to 
calculate the current pool of MP RVUs by using a process parallel to 
the one we use in calculating the pool of PE RVUs. (We direct the 
reader to section II.2.b.(6) for detailed description of that process, 
including a proposed technical revision that we are finalizing for 
2016.) To determine the specialty mix assigned to each code, we also 
proposed to use the same process used in the PE methodology, described 
in section II.2.b.(6) of this final rule with comment period. We note 
that for CY 2016, we proposed and are finalizing a policy to modify the 
specialty mix assignment methodology to use an average of the 3 most 
recent years of available data instead of a single year of data. We 
anticipate that this change will increase the stability of PE and MP 
RVUs and mitigate code-level fluctuations for all services paid under 
the PFS, and for new and low-volume codes in particular. We also 
proposed to no longer apply the dominant specialty for low volume 
services, because the primary rationale for the policy has been 
mitigated by this proposed change in methodology. However, we did not 
propose to adjust the code-specific overrides established in prior 
rulemaking for codes where the claims data are inconsistent with a 
specialty that could be reasonably expected to furnish the service. We 
believe that these proposed changes serve to balance the advantages of 
using annually updated information with the need for year-to-year 
stability in values. We solicited comments on both aspects of the 
proposal: Updating the specialty mix for MP RVUs annually (while 
continuing to update specialty-specific risk factors every 5 years 
using updated premium data); and using the same process to determine 
the specialty mix assigned to each code as is used in the PE 
methodology, including the proposed modification to use the most recent 
3 years of claims data. We also solicited comments on whether this 
approach will be helpful in addressing some of the concerns regarding 
the calculation of MP RVUs for services with low volume in the Medicare 
population, including the possibility of limiting our use of code-
specific overrides of the claims data.
    The following is a summary of the comments we received regarding 
our current approach for determining malpractice RVUs for new/revised 
codes.
    Comment: Several commenters, including the RUC, generally supported 
CMS' proposal to update the MP RVUs on an annual basis. Commenters, 
including the RUC, stated a preference for the annual collection of 
professional liability insurance (PLI) premium data to insure the MP 
RVUs for every service is accurate, as opposed to only collecting these 
data every five years.
    Response: We appreciate commenters' support of our proposal to 
update the MP RVUs on an annual basis. We also appreciate the comments 
from stakeholders regarding the frequency that we currently collect 
premium data. We will continue to consider the appropriate frequency 
for doing so, and we would address any potential changes in future 
rulemaking.
    Comment: Commenters, including the RUC, support CMS's proposal to 
use the 3 most recent years of available data for the specialty mix 
assignment.
    Response: We appreciate the commenters' support.
    Comment: Commenters supported CMS' proposal to maintain the code-
specific overrides established in previous rulemaking for codes where 
the claims data are inconsistent with a specialty that could be 
reasonably expected to furnish the service. Commenters also requested 
that CMS publish the list of overrides annually to receive stakeholder 
feedback related to necessary modification to the list, and in an 
effort to be as transparent as possible.
    Response: We appreciate the comments and agree that we should 
increase the transparency regarding the list of services with MP RVU 
overrides. Publication of this list will also allow commenters to alert 
us to any discrepancies between MP RVUs developed annually under the 
new methodology and previously established overrides. Therefore, we 
have posted a public use file containing the overrides.

[[Page 70908]]

The file is available on the CMS Web site under the supporting data 
files for the CY 2016 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    Comment: One commenter stated that CMS should be particularly 
mindful of using the specialty mix in the Medicare claims data for 
services with low Medicare volume but high volume in the United States 
health care system more generally, such as pediatric procedures; and 
that CMS' MP RVU methodology needs to differentiate between services 
that are truly low volume and those that occur frequently, but not 
among Medicare beneficiaries.
    Response: We believe that the list of overrides we are making 
available as a public use file on the CMS Web site will help address 
the commenter's concern since the purpose of the code-specific 
overrides is to address circumstances where the claims data are 
inconsistent with the specialty that could be reasonably expected to 
furnish the service. We have previously accepted comment on services 
like those identified by the commenter and will continue to consider 
comments regarding the need to use overrides for particular services, 
especially for high volume services outside the Medicare population.
    Comment: One commenter requested that CMS continue to use the 
dominant specialty for low volume codes.
    Response: We acknowledge the concern about using the dominant 
specialty for low volume codes, and will continue to monitor the 
resulting RVUs to determine if adjustments become necessary. In 
general, we believe the 3-year average mitigates the need to apply the 
dominant specialty for low volume services. However, we have a long 
history of applying the dominant specialty for low volume services in 
instances where the specialty indicated by the claims data is 
inconsistent with the specialty that could be reasonably expected to 
furnish the service, and we are maintaining that practice.
    Comment: Some commenters requested more information on how 
specialty impacts were determined. Two commenters expressed concerns 
about the estimated impact of the several proposed changes in the MP 
methodology on some specialties--particularly gastroenterology, colon 
and rectal surgery, and neurosurgery. Those commenters state that they 
appreciate the assertion that it may be difficult to obtain premium 
data for some specialties, such as neurosurgery, and state that CMS 
must thoroughly vet the methodology used by its contractor to determine 
MP premiums for such specialties. The commenters urge CMS to review the 
data, continue to try to obtain premium data in as many states as 
possible, and to share the data with the public for the agency and 
specialties to determine its accuracy.
    Response: Specialty impacts are determined by comparing the 
estimated overall payment for each specialty that would result from the 
proposed RVUs and policies to the estimated overall payment for each 
specialty under the current year RVUs and policies, using the most 
recent year of available claims data as a constant. We note that for MP 
RVUs, there were several refinements that resulted in minor impacts to 
particular specialties, especially those at the higher end of specialty 
risk factors. We believe that these impacts are consistent with the 
general tendency of greater change in MP RVUs for specialties with risk 
factors of greater magnitude. We agree with the commenters regarding of 
the importance of making certain that the collection of premium data 
and the methodology of calculating MP RVUs are as accurate as possible. 
This is the reason we continue to examine the methodology and develop 
technical improvements such as the ones described in this section of 
the final rule. Additionally, we believe that annual calibration of MP 
RVUs will be likely to reduce the risk of irregularities, since we will 
regularly compare MP RVUs for individual codes and for specialties 
between consecutive years instead of only comparing MP RVUs update 
years.
    After consideration of the public comments received, we are 
finalizing the policies as proposed. That is, we are finalizing the 
proposal to conduct annual MP RVU updates to reflect changes in the mix 
of practitioners providing services and to adjust MP RVUs for risk, and 
to modify the specialty mix assignment methodology to use an average of 
the 3 most recent years of available data instead of a single year. We 
note that we will continue to maintain the code-specific overrides 
where the claims data are inconsistent with a specialty that would 
reasonable be expected to furnish the services.
    We also proposed an additional refinement in our process for 
assigning MP RVUs to individual codes. Historically, we have used a 
floor of 0.01 MP RVUs for all nationally-priced PFS codes. This means 
that even when the code-level calculation for the MP RVU falls below 
0.005, we have rounded to 0.01. In general, we believe this approach 
accounts for the minimum MP costs associated with each service 
furnished to a Medicare beneficiary. However, in examining the 
calculation of MP RVUs, we do not believe that this floor should apply 
to add-on codes. Since add-on codes must be reported with another code, 
there is already an MP floor of 0.01 that applies to the base code, and 
therefore, to each individual service. By applying the floor to add-on 
codes, the current methodology practically creates a 0.02 floor for any 
service reported with one add-on code, and 0.03 for those with 2 add-on 
codes, etc. Therefore, we proposed to maintain the 0.01 MP RVU floor 
for all nationally-priced PFS services that are described by base 
codes, but not for add-on codes. We will continue to calculate, 
display, and make payments that include MP RVUs for add-on codes that 
are calculated to 0.01 or greater, including those that round to 0.01. 
We only proposed to allow the MP RVUs for add-on codes to round to 0.00 
where the calculated MP RVU is less than 0.005.
    Comment: Several commenters, including the RUC, opposed CMS' 
proposal to remove the MP RVU floor of 0.01 for add-on services. These 
commenters suggested that the incremental risk associated with 
performing an additional procedure is not mitigated by the risk 
inherent in the base procedure. Another commenter stated that each 
service should be considered separately for the purposes of calculating 
MP RVUs, and therefore, each service should be given the 0.01 floor 
regardless of base or add-on status.
    Response: We appreciate commenters' feedback, but note that we do 
not believe the comments respond to the rationale for the proposed 
refinement. We agree that the incremental risk in procedures described 
by add-on codes is not mitigated by the risk inherent in the base 
procedure. That is why we did not propose to eliminate MP RVUs for add-
on codes generally. Instead, we believe that when the incremental risk 
is calculated to be a number closer to 0.00 than 0.01, we do not 
believe that rounding such a number to 0.01 accurately reflects the 
risk of the service that is described by two codes (base code and add-
on) relative to the risks associated with other PFS services. We 
continue to believe that this refinement is the most appropriate 
approach, since we would continue to account for the incremental risk 
associated with add-on codes without overestimating the risk in 
circumstances where the MP RVU falls below 0.005. Therefore, we are 
finalizing the policy as proposed.

[[Page 70909]]

3. MP RVU Update for Anesthesia Services
    In the CY 2015 PFS 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 intended to 
propose an anesthesia adjustment for MP in the CY 2016 PFS proposed 
rule. We also solicited comments regarding how to best reflect updated 
MP premium amounts under the anesthesiology fee schedule.
    As we previously explained, anesthesia services under the PFS are 
paid based upon a separate fee schedule, so routine updates must be 
calculated in a different way than those for services for which payment 
is calculated based upon work, PE, and MP RVUs. To apply budget 
neutrality and relativity updates to the anesthesiology fee schedule, 
we typically develop proxy RVUs for individual anesthesia services that 
are derived from the total portion of PFS payments made through the 
anesthesia fee schedule. We then update the proxy RVUs as we would the 
RVUs for other PFS services and adjust the anesthesia fee schedule 
conversion factor based on the differences between the original proxy 
RVUs and those adjusted for relativity and budget neutrality.
    We believe that taking the same approach to update the anesthesia 
fee schedule based on new MP premium data is appropriate. However, 
because work RVUs are integral to the MP RVU methodology and anesthesia 
services do not have work RVUs, we decided to seek potential 
alternatives prior to implementing our approach in conjunction with the 
proposed CY 2015 MP RVUs based on updated premium data. One commenter 
supported the delay in proposing to update the MP for anesthesia at the 
same time as updating the rest of the PFS, and 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; no commenters offered alternatives to 
calculating updated MP for anesthesia services. The latter suggestion 
might apply more broadly to the MP methodology for the PFS and does not 
address the methodology as much as the data source.
    We continue to believe that payment rates for anesthesia should 
reflect MP resource costs relative to the rest of the PFS, including 
updates to reflect changes over time. Therefore, for CY 2016, to 
appropriately update the MP resource costs for anesthesia, we proposed 
to make adjustments to the anesthesia conversion factor to reflect the 
updated premium information collected for the 5 year review. To 
determine the appropriate adjustment, we calculated imputed work RVUs 
and MP RVUs for the anesthesiology fee schedule services using the 
work, PE, and MP shares of the anesthesia fee schedule. Again, this is 
consistent with our longstanding approach to making annual adjustments 
to the PE and work RVU portions of the anesthesiology fee schedule. To 
reflect differences in the complexity and risk among the anesthesia fee 
schedule services, we multiplied the service-specific risk factor for 
each anesthesia fee schedule service by the CY 2016 imputed proxy work 
RVUs and used the product as the updated raw proxy MP RVUs for each 
anesthesia service for CY 2016. We then applied the same scaling 
adjustments to these raw proxy MP RVUs that we apply to the remainder 
of the PFS MP RVUs. Finally, we calculated the aggregate difference 
between the 2015 proxy MP RVUs and the proxy MP RVUs calculated for CY 
2016. We then adjusted the portion of the anesthesia conversion factor 
attributable to MP proportionately; we refer the reader to section 
VI.C. of this final rule with comment period for the Anesthesia Fee 
Schedule Conversion Factors for CY 2016. We invited public comments 
regarding this proposal.
    The following is a summary of the comments we received regarding 
this proposal.
    Comment: We received few comments with regard to our proposal; 
commenters expressed appreciation that CMS recognized the unique 
aspects involved in updating the MP component associated with 
anesthesia services, and therefore, delayed the anesthesia MP update 
until the CY 2016 PFS.
    Response: We appreciate the commenters' feedback, and we are 
finalizing the policy as proposed.
4. MP RVU Methodology Refinements
    In the CY 2015 PFS final rule with comment period (79 FR 67591 
through 67596), we finalized updated MP RVUs that were calculated based 
on updated MP premium data obtained from state insurance rate filings. 
The methodology used in calculating the finalized CY 2015 review and 
update of resource-based MP RVUs largely paralleled the process used in 
the CY 2010 update. We posted our contractor's report, ``Final Report 
on the CY 2015 Update of Malpractice RVUs'' 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/. A more detailed explanation of the 2015 MP RVU 
update can be found in the CY 2015 PFS proposed rule (79 FR 40349 
through 40355).
    In the CY 2015 PFS proposed rule, we outlined the steps for 
calculating MP RVUs. In the process of calculating MP RVUs for purposes 
of the CY 2016 PFS proposed rule, we identified a necessary refinement 
to way we calculated Step 1, which involves computing a preliminary 
national average premium for each specialty, to align the calculations 
within the methodology to the calculations described within the 
aforementioned contractor's report. Specifically, in the calculation of 
the national premium for each specialty (refer to equations 2.3, 2.4, 
2.5 in the aforementioned contractor's report), we calculate a weighted 
sum of premiums across areas and divide it by a weighted sum of MP 
GPCIs across areas. The calculation currently takes the ratio of sums, 
rather than the weighted average of the local premiums to the MP GPCI 
in that area. Instead, we proposed to update the calculation to use a 
price-adjusted premium (that is, the premium divided by the GPCI) in 
each area, and then taking a weighted average of those adjusted 
premiums. The CY 2016 PFS proposed rule MP RVUs were calculated in this 
manner.
    Additionally, in the calculation of the national average premium 
for each specialty as discussed above, our current methodology used the 
total RVUs in each area as the weight in the numerator (that is, for 
premiums), and total MP RVUs as the weights in the denominator (that 
is, for the MP GPCIs). After further consideration, we believe that the 
use of these RVU weights is problematic. Use of weights that are 
central to the process at hand presents potential circularity since 
both weights incorporate MP RVUs as part of the computation to 
calculate MP RVUs. The use of different weights for the numerator and 
denominator introduces potential inconsistency. Instead, we believe 
that it would be better to use a different measure that is independent 
of MP RVUs and better represents the reason for weighting. 
Specifically, we proposed to use area population as a share of total 
U.S. population as the weight. The premium data are for all MP premium 
costs, not just those associated with Medicare patients, so we believe 
that the distribution of the population does a better job of capturing 
the role of each area's premium in the ``national'' premium for each 
specialty than our previous Medicare-specific measure.

[[Page 70910]]

Use of population weights also avoids the potential problems of 
circularity and inconsistency.
    The CY 2016 PFS final MP RVUs, as displayed in Addendum B of this 
final rule with comment period, reflect MP RVUs calculated following 
our established methodology, with the inclusion of the proposals and 
refinements described above.
    Comment: Commenters generally supported the technical changes to 
the MP RVU methodology and found them reasonable. One commenter stated 
that such refinements will increase stability of MP RVUs and does a 
better role of capturing the role of each local area's premium in the 
``national'' premium for each specialty.
    Response: We appreciate the commenters' support, and we are 
finalizing the policy as proposed.
    Comment: One commenter stated that the MP RVU for cataract and 
other ophthalmic surgeries is deflated significantly because CMS 
assumes that optometry is providing the actual surgical portion of the 
procedure, when there is no state that allows optometrists to perform 
cataract surgery or any other major ophthalmic procedure. The commenter 
states that the clinical reality is that optometry is involved only 
during the pre- or post- procedure time period, and CMS should not 
allow optometric utilization of those codes with co-management 
modifiers to be included in the calculations for any major ophthalmic 
surgical procedures. The commenter suggested that if CMS does not agree 
to remove optometry from the calculation of MP RVUs for ophthalmic 
surgery, that CMS should use a much lower percentage of utilization to 
accurately reflect the true risk that optometrists encounter during 
this limited portion of the service. The commenter also disagreed that 
all providers who pay for malpractice insurance should have their 
premiums taken into consideration, and stated that when CMS looks at 
the dominant specialty for a given service, it must ensure that the 
claims reported--particularly by non-physician providers such as 
optometrists, are for the surgical portion of the procedure for which 
the MP RVU is being considered.
    Response: We would clarify for the commenter that we apply the risk 
factor(s) of all specialties involved with furnishing services to 
calculate the service level risk factors for all PFS codes. Our 
methodology already accounts for codes with longer global periods or 
codes where two different practitioners report different parts of the 
service, weighing the volume differentially among the kinds of 
practitioners that report the service depending on which portion of the 
service each reports. We also remind commenters that, to determine the 
raw MP RVU for a given service, we consider the greater of the work RVU 
or clinical labor RVU for the service. Since the time and intensity of 
the pre-service and post-service period are incorporated into the work 
RVUs for these services and the work RVUs are used in the development 
of MP RVUs, we believe it is methodologically consistent to incorporate 
the portion of the overall services that is furnished by practitioners 
other than those that furnish the procedure itself in the calculation 
of MP RVUs. 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. 
Likewise, we also disagree with the suggestion that the 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 relative MP costs.
    Comment: One commenter identified three low volume codes typically 
performed by cardiac surgery or thoracic surgery that have anomalous MP 
RVU values: CPT code 31766 (carinal reconstruction), the commenter 
requested that the MP risk factor associated with Thoracic surgery be 
assigned; CPT Code 33420 (valvotomy, mitral valve; closed heart), the 
commenter requests that the MP risk factor associated with Cardiac 
Surgery be assigned; and for 32654 (thorascoscopy, surgical; with 
control of traumatic hemorrhage), the commenter requests that the MP 
risk factor associated with Thoracic surgery be assigned.
    Response: We agree with the commenters and have added these 
services to the list of those with specialty overrides for CY 2016. We 
hope to identify such anomalies more regularly in the future now that 
the public use file listing the overrides is available on the CMS Web 
site as indicated above.
5. CY 2016 Identification of Potentially Misvalued Services for Review
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). Members of the public including direct 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, but is not limited to, the 
following:
     Documentation in the peer reviewed medical literature or 
other reliable data that there have been changes in 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 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, Department of Veteran Affairs (VA) 
National Surgical Quality Improvement Program (NSQIP), the Society for 
Thoracic Surgeons (STS) National Database, and the Physician Quality 
Reporting System (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

[[Page 70911]]

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 periods for the CY 2015 proposed rule and final 
rule with comment period, we received nominations and supporting 
documentation for three codes to be considered as potentially misvalued 
codes. We evaluated the supporting documentation for each nominated 
code to ascertain whether the submitted information demonstrated that 
the code should be proposed as potentially misvalued.
    CPT code 36516 (Therapeutic apheresis; with extracorporeal 
selective adsorption or selective filtration and plasma reinfusion) was 
nominated for review as potentially misvalued. The nominator stated 
that CPT code 36516 is misvalued because of incorrect direct and 
indirect PE inputs and an incorrect work RVU. Specifically, the 
nominator stated that the direct supply costs failed to include an $18 
disposable bag and the $37 cost for biohazard waste disposal of the 
post-treatment bag, and that the labor costs for nursing staff were 
inaccurate. The nominator also stated that the overhead expenses 
associated with this service were unrealistic and that the current work 
RVU undervalues a physician's time and expertise. Based on the 
requestor's comment, we proposed this code as a potentially misvalued 
code. We also noted that we established a policy in CY 2011 to consider 
biohazard bags as an indirect expense, and not as a direct PE input (75 
FR 73192).
    Comment: Several commenters stated that they do not believe CPT 
code 36516 is potentially misvalued because they found no indication 
that the clinical staff time, indirect expenses, or work was misvalued. 
All commenters requested that this code be removed from the potentially 
misvalued list.
    Response: We appreciate the comments, but we believe that the 
nominator presented some concerns that may have merit, and review of 
the code is the best way to determine the validity of the concerns 
articulated by the original requestor. Therefore, we are adding CPT 
code 36516 to the list of potentially misvalued codes and anticipate 
reviewing recommendations from the RUC and other stakeholders.
    CPT Codes 52441 (Cystourethroscopy with insertion of permanent 
adjustable transprostatic implant; single implant) and 52442 
(Cystourethroscopy with insertion of permanent adjustable 
transprostatic implant; each additional permanent adjustable 
transprostatic implant) were nominated for review as potentially 
misvalued. The nominator stated that the costs of the direct PE inputs 
were inaccurate, including the cost of the implant. We proposed these 
services as potentially misvalued codes.
    Comment: Some commenters disagreed that the commenter intended to 
nominate CPT codes 52441 and 52442 as potentially misvalued.
    Response: After reviewing the original comment, we agree with these 
commenters' perspective that the intention was not to nominate the 
codes as potentially misvalued. Therefore, we are not finalizing our 
proposal to review these codes under the potentially misvalued code 
initiative.
b. Electronic Analysis of Implanted Neurostimulator (CPT Codes 95970-
95982)
    In the CY 2015 final rule with comment period (79 FR 67670), we 
reviewed and valued all of the inputs for the following CPT codes: 
95971 (Electronic analysis of implanted neurostimulator pulse generator 
system (e.g., rate, pulse amplitude, pulse duration, configuration of 
wave form, battery status, electrode selectability, output modulation, 
cycling, impedance and patient compliance measurements); simple spinal 
cord, or peripheral (i.e., peripheral nerve, sacral nerve, 
neuromuscular) neurostimulator pulse generator/transmitter, with 
intraoperative or subsequent programming); 95972 (Electronic analysis 
of implanted neurostimulator pulse generator system (e.g., rate, pulse 
amplitude, pulse duration, configuration of wave form, battery status, 
electrode selectability, output modulation, cycling, impedance and 
patient compliance measurements); complex spinal cord, or peripheral 
(i.e., peripheral nerve, sacral nerve, neuromuscular) (except cranial 
nerve) neurostimulator pulse generator/transmitter, with intraoperative 
or subsequent programming, up to one hour); and 95973 (Electronic 
analysis of implanted neurostimulator pulse generator system (e.g., 
rate, pulse amplitude, pulse duration, configuration of wave form, 
battery status, electrode selectability, output modulation, cycling, 
impedance and patient compliance measurements); complex spinal cord, or 
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) 
(except cranial nerve) neurostimulator pulse generator/transmitter, 
with intraoperative or subsequent programming, each additional 30 
minutes after first hour (List separately in addition to code for 
primary procedure)). Due to significant time changes in the base codes, 
we believe the entire family detailed in Table 7 is potentially 
misvalued and should be reviewed in a manner consistent with our review 
of CPT codes 95971, 95972 and 95973.

    Table 7--Potentially Misvalued Codes Identified in the Electronic
              Analysis of Implanted Neurostimulator Family
------------------------------------------------------------------------
               HCPCS                           Short descriptor
------------------------------------------------------------------------
95970..............................  Analyze neurostim no prog.
95974..............................  Cranial neurostim complex.
95975..............................  Cranial neurostim complex.
95978..............................  Analyze neurostim brain/1h.
95979..............................  Analyz neurostim brain addon.
95980..............................  Io anal gast n-stim init.
95981..............................  Io anal gast n-stim subsq.
95982..............................  Io ga n-stim subsq w/reprog.
------------------------------------------------------------------------

    Comment: One commenter agreed with the review of CPT codes 95970-
95982 as potentially misvalued services.
    Response: We are adding CPT codes 95970-95982 to the list of 
potentially misvalued codes and anticipate reviewing recommendations 
from the AMA RUC and other stakeholders.

[[Page 70912]]

c. Review of High Expenditure Services Across Specialties With Medicare 
Allowed Charges of $10,000,000 or More
    In the CY 2015 PFS rule, we proposed and finalized the high 
expenditure screen as a tool to identify potentially misvalued codes in 
the statutory category of ``codes that account for the majority of 
spending under the PFS.'' We also identified codes through this screen 
and proposed them as potentially misvalued in the CY 2015 PFS proposed 
rule (79 FR 40337-40338). However, given the resources required for the 
revaluation of codes with 10- and 90-day global periods, we did not 
finalize those codes as potentially misvalued codes in the CY 2015 PFS 
final rule with comment period. We stated that we would re-run the high 
expenditure screen at a future date, and subsequently propose the 
specific set of codes that meet the high expenditure criteria as 
potentially misvalued codes (79 FR 67578).
    As detailed in the CY 2016 PFS proposed rule (80 FR 41706), we 
believed that our current resources will not necessitate further delay 
in proceeding with the high expenditure screen for CY 2016. Therefore, 
we re-ran the screen with the same criteria finalized in last year's 
final rule. However, in developing this CY 2016 proposed list, we also 
excluded all codes with 10- and 90-day global periods since we believe 
these codes should be reviewed as part of the global surgery 
revaluation described in section II.B.6. of this final rule with 
comment period.
    We proposed 118 codes as potentially misvalued codes, identified 
using the high expenditure screen under the statutory category, ``codes 
that account for the majority of spending under the PFS.'' To develop 
the list, we followed the same approach taken last year except we 
excluded codes with 10- and 90-day global periods. Specifically, we 
identified the top 20 codes by specialty (using the specialties used in 
Table 64 in terms of allowed charges. As we did last year, we excluded 
codes that we have reviewed since CY 2010, those with fewer than $10 
million in allowed charges, and those that described anesthesia or E/M 
services. We excluded E/M services from the list of proposed 
potentially misvalued codes for the same reasons that we excluded them 
in a similar review in CY 2012. These reasons were explained in the CY 
2012 final rule with comment period (76 FR 73062 through 73065).
    Comment: Some commenters did not believe that high expenditure/high 
volume was an appropriate criterion for us to use to identify the codes 
for the potentially misvalued codes initiative. These commenters stated 
that high expenditure is not an objective gauge of potential 
misvaluation. Additionally, commenters believed that selecting codes 
that have not been reviewed in the past 5 years insinuates that the 
delivery of these services and procedures has changed radically over 
that time span, which many doubted. Other commenters believed CMS 
should provide justification for the revaluation by providing evidence 
and/or data to show how the delivery of a service or procedure has 
changed within 5 years. While many disagreed with our use of the high 
expenditure screen, some commenters specifically suggested use of 
different types of screens; some of which would screen for services for 
which volume has increased a certain percentage over a set period or 
screen for changes in the predominate site of service.
    Response: We appreciate commenters' perspective on the proposed 
list of potentially misvalued codes based on the high expenditure 
screen. It is clear that over time the resources involved in furnishing 
particular services can often change and, therefore, many services that 
have not recently been evaluated may become potentially misvalued. 
Under section 1848(c)(2)(B) of the Act, we are mandated to review 
relative values for codes for all physicians' services at least every 5 
years. The purpose of specifically identifying potentially misvalued 
codes through particular screens established through rulemaking is to 
prioritize the review of individual codes since comprehensive, annual 
review of all codes for physicians' services is not practical and, due 
to the need to maintain relativity, changes in values for individual 
services can have an impact across the PFS. We identify potentially 
misvalued codes in order to prioritize review of subsets of PFS 
services. We prioritize review of individual services based on 
indications that a particular code is likely to be misvalued and on the 
impact that the potential misvaluation of the code would have on the 
valuation of PFS services broadly. Our high expenditure screen is 
largely intended to address the latter situation where improved 
valuation would have the most significant impact on the valuation of 
PFS services more broadly. This approach is also consistent with 
another category of codes identified for screening by statute: Codes 
with high PE relative value units. In proposing to prioritize this list 
of high expenditure codes, we stated that the reason we identified 
these codes is because they have significant impact on PFS payment on a 
specialty level and have not been recently reviewed.
    Comment: A few commenters suggested that E/M services should not be 
exempt from review as potentially misvalued codes.
    Response: In the CY 2012 final rule (76 FR 73063), we explained the 
concerns expressed by commenters that informed our decision to refrain 
from finalizing our proposal to review 91 E/M codes as potentially 
misvalued. We believe that those concerns remain valid. We also believe 
that it is best to exempt E/M codes from our review of potentially 
misvalued codes since we are continuously exploring valuations of E/M 
services, potential refinements to the PFS, and other options for 
policies that may contribute to improved valuation of E/M services.
    Comment: Many commenters also stated that the review of codes over 
such a short time span puts significant burden on the specialty 
societies. Many commenters agreed that high expenditure codes should be 
reviewed on a periodic basis over multiple years. Some commenters 
specifically suggested that the periodic basis should be 10 years while 
others suggested delaying any review of the codes until after the 
misvalued code target has been met.
    Response: Because of the concerns expressed by commenters about the 
burden associated with code reviews, we continue to believe that it is 
appropriate to prioritize review of codes to a manageable subset that 
also have a high impact on the PFS and work with the specialty society 
to spread review of the remaining codes identified as potentially 
misvalued over a reasonable timeframe. Therefore, we do not believe it 
would be appropriate to remove codes from the high expenditure list 
unless we find that we have reviewed both the work RVUs and direct PE 
inputs for the code during the specified time period.
    Also, we believe that the resources involved in furnishing a 
service can evolve over time, including the time and technology used to 
furnish the service, and such efficiencies could easily develop in a 
time span as short as 5 years. As a result, we continue to believe that 
the review of these high expenditure codes is necessary to ensure that 
the services are appropriately valued. Additionally, not only do we 
believe that regular monitoring of codes with high impact on the PFS 
will produce a more accurate and equitable payment system, but we have 
a statutory obligation under

[[Page 70913]]

section 1848(c)(2)(B) of the Act to review code values at least every 5 
years (although we do not always conduct a review that involves the AMA 
RUC). Therefore, we do not agree with the commenter that suggested that 
changes in technology and practice can be effectively accounted for 
through review of code values every 10 years.
    Comment: Commenters stated that the following codes were reviewed 
since CY 2010 and, as a result, do not fit the criteria for the high 
expenditure screen and should be removed: CPT codes 51728 (Insertion of 
electronic device into bladder with voiding pressure studies), 51729 
(Insertion of electronic device into bladder with voiding and bladder 
canal (urethra) pressure studies), 76536 (Ultrasound of head and neck), 
78452 (Nuclear medicine study of vessels of heart using drugs or 
exercise multiple studies), 92557 (Air and bone conduction assessment 
of hearing loss and speech recognition), 92567 (Eardrum testing using 
ear probe), 93350 (Ultrasound examination of the heart performed during 
rest, exercise, and/or drug-induced stress with interpretation and 
report) and 94010 (Measurement and graphic recording of total and timed 
exhaled air capacity).
    Response: We agree with commenters that the codes identified do not 
fit the criteria for review based on the high expenditure screen. 
Therefore, we are not proposing to review CPT codes 51728, 51729, 
76536, 78452, 92557, 92567, 93350, and 94010 under the potentially 
misvalued code initiative.
    Comment: Commenters believed that services that are add-ons to the 
excluded 10- and 90-day global services should be removed from the list 
of codes identified through the high expenditure screen in order to 
maintain relativity. The specific codes suggested for removal were: CPT 
codes 22614 (Fusion of spine bones, posterior or posterolateral 
approach); 22840 (Insertion of posterior spinal instrumentation at base 
of neck for stabilization, 1 interspace); 22842 (Insertion of posterior 
spinal instrumentation for spinal stabilization, 3 to 6 vertebral 
segments); 22845 (Insertion of anterior spinal instrumentation for 
spinal stabilization, 2 to 3 vertebral segments); and 33518 (Combined 
multiple vein and artery heart artery bypasses).
    Response: We agree with the commenters that the codes identified 
should be removed from the list of codes identified for review through 
the high expenditure screen due to their relationship to the 10- and 
90-day global services that were excluded from our screen. Although we 
agree that these codes should be removed from this screen, we think it 
is worthwhile to note that for similar reasons, we believe we should 
consider these and similar add-on codes in conjunction with efforts to 
improve the valuation and the global surgery packages as described in 
section II.B.6. of this final rule with comment period. Therefore, we 
are not including CPT codes 22614, 22840, 22842, 22845 on the list of 
codes identified for review through the high expenditure screen.
    Comment: Commenters believed that CPT code 92002 (Eye and medical 
examination for diagnosis and treatment, new patient) is considered an 
ophthalmological evaluation and management (E/M) service and as a 
result, should be excluded for all the same reasons we excluded other 
E/M codes.
    Response: We agree with commenters that CPT code 92002 is 
considered an E/M and, as a result, should be excluded from the screen 
as were other E/Ms. Therefore, we are not including CPT code 92002 on 
the list of codes identified for review through the high expenditure 
screen.
    Comment: A few commenters requested that codes with a work RVU 
equal to 0.00 (CPT codes 51798 (Ultrasound measurement of bladder 
capacity after voiding), 88185 (Flow cytometry technique for DNA or 
cell analysis), 93296 (Remote evaluations of single, dual, or multiple 
lead pacemaker or cardioverter-defibrillator transmissions, technician 
review, support, and distribution of results up to 90 days), 96567 
(Application of light to aid destruction of premalignant and/or 
malignant skin growths, each session), and 96910 (Skin application of 
tar and ultraviolet B or petrolatum and ultraviolet B)) or equal to 
0.01 (CPT codes 95004 (Injection of allergenic extracts into skin, 
accessed through the skin)) be removed from the list of codes 
identified for review through the high expenditure screen. Commenters 
stated that historically, services with 0.00 work RVUs were excluded 
from screens and that re-reviewing a service with a 0.01 work RVU would 
most likely not lower the work component unless work was completely 
removed from the code.
    Response: We continue to believe that codes with 0.00 work RVUs or 
very low work RVUs of 0.01, should still be reviewed and can still be 
considered potentially misvalued. As stated earlier, we do not believe 
it would be appropriate to remove codes from the high expenditure list 
unless we find that we have reviewed both the work RVUs and direct PE 
inputs. Therefore, we are maintaining CPT codes 51798, 88185, 93296, 
96567, 96910 and 95004 as potentially misvalued codes and anticipate 
reviewing recommendations from the AMA RUC and other stakeholders.
    Comment: Various commenters objected to the presence of individual 
codes that met the high expenditure screen criteria based on absence of 
clinical evidence that the individual services are misvalued.
    Response: We reviewed each of these comments, and believe that 
these kinds of assessments are best addressed through the misvalued 
code review process. As we describe in this section, the criteria for 
many misvalued code screens, including this one, are designed to 
prioritize codes that may be misvalued not to identify codes that are 
misvalued. Therefore, we believe that supporting evidence for the 
accuracy of current values for particular codes is best considered as 
part of the review of individual codes through the misvalued code 
process.
    Comment: Several commenters believed that codes that are currently 
scheduled to be considered by either the CPT Editorial Panel for new 
coding or the RUC for revised valuations (for work RVUs and/or PE 
inputs) at an upcoming meeting should be removed from the screen. 
Commenters also believed that it was best to allow these codes to go 
through the RUC code review process rather than identifying the codes 
as potentially misvalued through this screen.
    Response: Although a number of codes have been or will be 
considered through the RUC review process, until we receive 
recommendations and review the codes for both work and direct PE 
inputs, we will continue to include these codes on the high expenditure 
list. We reiterate that we do not believe that the presence of a code 
on a misvalued code list signals that a particular code necessarily is 
misvalued. Instead, the lists are intended to prioritize codes to be 
reviewed under the misvalued code initiative. If any code on the list 
finalized here is already being reviewed by the RUC through its 
process, we will receive a recommendation regarding valuation for the 
code, and the presence or absence of the code in this particular list 
is immaterial. However, if subsequent to the removal of a code from the 
high expenditure code list, the RUC decides not to review the code, we 
would still want to consider the code as potentially misvalued based on 
its meeting the criteria established for the screen. Therefore, we do 
not agree that we should remove individual codes from a potentially 
misvalued code list because the RUC already anticipates

[[Page 70914]]

reviewing the code. However, we want to be clear that when we receive 
RUC recommendations regarding a code, we generally remove that code 
from misvalued code lists, regardless of whether or not the RUC 
reviewed the code on the basis of that particular screen.
    Accordingly, we are finalizing the 103 codes in Table 8 as 
potentially misvalued services under the high expenditure screen and 
seek recommended values for these codes from the RUC and other 
interested stakeholders.

  Table 8--List of Potentially Misvalued Codes Identified Through High
                     Expenditure by Specialty Screen
------------------------------------------------------------------------
                   HCPCS                          Short descriptor
------------------------------------------------------------------------
10022.....................................  Fna w/image.
11100.....................................  Biopsy skin lesion.
11101.....................................  Biopsy skin add-on.
11730.....................................  Removal of nail plate.
20550.....................................  Inj tendon sheath/ligament.
20552.....................................  Inj trigger point 1/2 muscl.
20553.....................................  Inject trigger points 3/>.
27370.....................................  Injection for knee x-ray.
29580.....................................  Application of paste boot.
31500.....................................  Insert emergency airway.
31575.....................................  Diagnostic laryngoscopy.
31579.....................................  Diagnostic laryngoscopy.
31600.....................................  Incision of windpipe.
36215.....................................  Place catheter in artery.
36556.....................................  Insert non-tunnel cv cath.
36569.....................................  Insert picc cath.
36620.....................................  Insertion catheter artery.
38221.....................................  Bone marrow biopsy.
51700.....................................  Irrigation of bladder.
51702.....................................  Insert temp bladder cath.
51720.....................................  Treatment of bladder lesion.
51784.....................................  Anal/urinary muscle study.
51798.....................................  Us urine capacity measure.
52000.....................................  Cystoscopy.
55700.....................................  Biopsy of prostate.
58558.....................................  Hysteroscopy biopsy.
67820.....................................  Revise eyelashes.
70491.....................................  Ct soft tissue neck w/dye.
70543.....................................  Mri orbt/fac/nck w/o & w/
                                             dye.
70544.....................................  Mr angiography head w/o dye.
70549.....................................  Mr angiograph neck w/o & w/
                                             dye.
71010.....................................  Chest x-ray 1 view frontal.
71020.....................................  Chest x-ray 2vw
                                             frontal&latl.
71260.....................................  Ct thorax w/dye.
71270.....................................  Ct thorax w/o & w/dye.
72195.....................................  Mri pelvis w/o dye.
72197.....................................  Mri pelvis w/o & w/dye.
73110.....................................  X-ray exam of wrist.
73130.....................................  X-ray exam of hand.
73718.....................................  Mri lower extremity w/o dye.
73720.....................................  Mri lwr extremity w/o & w/
                                             dye.
74000.....................................  X-ray exam of abdomen.
74022.....................................  X-ray exam series abdomen.
74181.....................................  Mri abdomen w/o dye.
74183.....................................  Mri abdomen w/o & w/dye.
75635.....................................  Ct angio abdominal arteries.
75710.....................................  Artery x-rays arm/leg.
75978.....................................  Repair venous blockage.
76512.....................................  Ophth us b w/non-quant a.
76519.....................................  Echo exam of eye.
77059.....................................  Mri both breasts.
77263.....................................  Radiation therapy planning.
77334.....................................  Radiation treatment aid(s).
77470.....................................  Special radiation treatment.
78306.....................................  Bone imaging whole body.
88185.....................................  Flowcytometry/tc add-on.
88189.....................................  Flowcytometry/read 16 & >.
88321.....................................  Microslide consultation.
88360.....................................  Tumor immunohistochem/
                                             manual.
88361.....................................  Tumor immunohistochem/
                                             comput.
91110.....................................  Gi tract capsule endoscopy.
92136.....................................  Ophthalmic biometry.
92240.....................................  Icg angiography.
92250.....................................  Eye exam with photos.
92275.....................................  Electroretinography.
93280.....................................  Pm device progr eval dual.
93288.....................................  Pm device eval in person.
93293.....................................  Pm phone r-strip device
                                             eval.
93294.....................................  Pm device interrogate
                                             remote.
93295.....................................  Dev interrog remote 1/2/mlt.
93296.....................................  Pm/icd remote tech serv.
93306.....................................  Tte w/doppler complete.
93351.....................................  Stress tte complete.
93503.....................................  Insert/place heart catheter.
93613.....................................  Electrophys map 3d add-on.
93965.....................................  Extremity study.
94620.....................................  Pulmonary stress test/
                                             simple.
95004.....................................  Percut allergy skin tests.
95165.....................................  Antigen therapy services.
95957.....................................  Eeg digital analysis.
96101.....................................  Psycho testing by psych/
                                             phys.
96116.....................................  Neurobehavioral status exam.
96118.....................................  Neuropsych tst by psych/
                                             phys.
96360.....................................  Hydration iv infusion init.
96372.....................................  Ther/proph/diag inj sc/im.
96374.....................................  Ther/proph/diag inj iv push.
96375.....................................  Tx/pro/dx inj new drug
                                             addon.
96401.....................................  Chemo anti-neopl sq/im.
96402.....................................  Chemo hormon antineopl sq/
                                             im.
96409.....................................  Chemo iv push sngl drug.
96411.....................................  Chemo iv push addl drug.
96567.....................................  Photodynamic tx skin.
96910.....................................  Photochemotherapy with uv-b.
97032.....................................  Electrical stimulation.
97035.....................................  Ultrasound therapy.
97110.....................................  Therapeutic exercises.
97112.....................................  Neuromuscular reeducation.
97113.....................................  Aquatic therapy/exercises.
97116.....................................  Gait training therapy.
97140.....................................  Manual therapy 1/regions.
97530.....................................  Therapeutic activities.
97535.....................................  Self care mngment training.
G0283.....................................  Elec stim other than wound.
------------------------------------------------------------------------

6. Valuing Services That Include Moderate Sedation as an Inherent Part 
of Furnishing the Procedure
    The CPT manual includes more than 400 diagnostic and therapeutic 
procedures, listed in Appendix G, for which the CPT Editorial Committee 
has determined that moderate sedation is an inherent part of furnishing 
the procedure. For these diagnostic and therapeutic procedures, only 
the procedure code is reported by the practitioner who conducts the 
procedure, without separate billing by the same practitioner for 
anesthesia services, and, in developing RVUs for these services, we 
include the resource costs associated with moderate sedation in the 
valuation. To the extent that moderate sedation is inherent in the 
diagnostic or therapeutic service, we believe that the inclusion of 
moderate sedation in the valuation of the procedure is appropriate. In 
the CY 2015 PFS proposed rule (79 FR 40349), we noted that it appeared 
practice patterns for endoscopic procedures were changing, with 
anesthesia increasingly being separately reported for these procedures. 
Due to the changing nature of medical practice, we noted that we were 
considering establishing a uniform approach to valuation for all 
Appendix G services. We continue to seek an approach that is based on 
using the best available objective, broad-based information about the 
provision of moderate sedation, rather than merely addressing this 
issue on a code-by-code basis using RUC survey data when individual 
procedures are revalued. We sought public comment on approaches to 
address the appropriate valuation of these services given that moderate 
sedation is no longer inherent for many of these services. To the 
extent that Appendix G procedure code 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.
    To establish an approach to valuation for all Appendix G services 
based on the best data about the provision of moderate sedation, we 
need to determine the extent to which each code may be misvalued. We 
know that there are standard packages for the direct PE inputs 
associated with moderate sedation, and we began to develop approaches 
to estimate how much of the work involved in these services is 
attributable to moderate sedation. However, we believe that we should 
seek input from the medical community prior to proposing changes in 
values for these services, given the different methodologies used to 
develop work RVUs for the hundreds of services in Appendix G. 
Therefore, in the CY 2016 PFS proposed rule, we solicited 
recommendations from the RUC and other interested stakeholders on the 
appropriate valuation of the work associated with moderate sedation 
before formally proposing an approach that allows Medicare to adjust 
payments based on the resource costs associated with the moderate 
sedation or anesthesia services that are being furnished.
    The anesthesia procedure codes 00740 (Anesthesia for procedure on 
gastrointestinal tract using an endoscope) and 00810 (Anesthesia for 
procedure on lower intestine using an endoscope) are used for 
anesthesia furnished in conjunction with lower GI

[[Page 70915]]

procedures. In reviewing Medicare claims data, we noted that a separate 
anesthesia service is now reported more than 50 percent of the time 
that several types of colonoscopy procedures are reported. Given the 
significant change in the relative frequency with which anesthesia 
codes are reported with colonoscopy services, we believe the relative 
values of the anesthesia services should be re-examined. Therefore, in 
the CY 2016 PFS proposed rule, we proposed to identify CPT codes 00740 
and 00810 as potentially misvalued. We welcomed comments on both of 
these issues.
    Comment: Several commenters noted that they support CMS' decision 
to seek input from the medical community prior to proposing a method 
for reporting and valuing moderate sedation as well as adjusting 
existing valuations to remove these services. One commenter also 
encouraged CMS to seek and consider recommendations from societies that 
represent members who provide dialysis vascular access interventional 
care, such as the American Society of Diagnostic and Interventional 
Nephrology.
    Response: We thank the commenters for their support. Through notice 
and comment rulemaking, we will review and consider any recommendations 
from the public, including those from any interested specialty 
societies.
    Comment: In response to CMS' proposal to identify anesthesia 
procedure codes 00740 and 00810 as potentially misvalued, the RUC 
stated that the committee anticipated reviewing CPT codes 00740 and 
00810 as potentially misvalued codes.
    Response: We appreciate the RUC's responsiveness to the proposal.
    Comment: One commenter disagreed that the increase in utilization 
of anesthesia is indicative of potential misvaluation of the codes in 
Appendix G. This commenter noted that the policy adopted by CMS in the 
CY 2015 final rule to eliminate cost-sharing for anesthesia furnished 
in conjunction with screening colonoscopies encourages patients to 
undergo these screenings. The commenter also noted that use of 
anesthesia with upper endoscopy procedures not only decreases patient 
discomfort, but also decreases complications and creates more optimal 
conditions for efficiency during the procedure as well as reduced 
recovery time as compared to the use of narcotics and sedative hypnotic 
agents. The commenter believes that this results in savings that offset 
the costs of anesthesia services. The commenter also expressed the view 
that the work involved in these services has not changed.
    Response: We thank the commenters for their input. Since the pool 
of beneficiaries that receive anesthesia in conjunction with these 
Appendix G services has grown, we believe it is possible that the 
typical circumstances under which patients receive these services have 
changed since the services were last reviewed. Therefore, we continue 
to seek recommendations regarding appropriate approaches to valuation 
for these services.
    Comment: A few commenters noted that there are a variety of 
services in Appendix G and stated their view that practitioners who 
furnish services for which there are claims data supporting the 
inherent nature of moderate sedation should not have to report moderate 
sedation separately, as they believe they would be faced with 
administrative burden and costs. They recommended that CMS conduct 
ongoing analysis of claims data to determine which codes may require 
unbundling of moderate sedation and to refer only those codes as 
potentially misvalued. One commenter noted that they opposed the use of 
any ``blanket approach'' to valuing moderate sedation such as removing 
the standard packages for the direct PE inputs associated with moderate 
sedation. The commenter recommended instead that we look at codes by 
family or specialty in order to ensure that reimbursements are fair and 
accurate. One commenter also noted the difference in the work involved 
with moderate sedation when it is furnished by the same physician who 
is furnishing the procedure compared with when it is furnished by 
another clinician, and requested that this be considered when valuing 
the moderate sedation services. Another commenter suggested that CMS 
create a modifier to be used by surgeons providing moderate sedation. 
They also suggested that CMS consider the expenses involved with using 
a registered nurse or CRNA, the medications and delivery systems, 
patient monitoring equipment, and lengthened postoperative recovery 
period when valuing moderate sedation services.
    Response: We thank the commenters for their input. We will consider 
input from the medical community on this issue through evaluation of 
CPT coding changes and associated RUC recommendations, as well as 
feedback received through public comments, as we value these services 
through future notice and comment rulemaking.
7. Improving the Valuation and Coding of the Global Package
a. Proposed Transition of 10-Day and 90-Day Global Packages Into 0-Day 
Global Packages
    In the CY 2015 PFS final rule (79 FR 67582 through 67591) we 
finalized a policy to transition all 10-day and 90-day global codes to 
0-day global periods in order to improve the accuracy of valuation and 
payment for the various components of global surgical packages, 
including pre- and postoperative visits and the surgical procedure 
itself. Although in previous rulemaking we have marginally addressed 
some of the concerns we identified with global packages, we believe 
there is still a need to address other fundamental issues with the 10- 
and 90-day postoperative global packages. We believe it is critical 
that the RVUs we use to develop PFS payment rates reflect the most 
accurate resource costs associated with PFS services. We believe that 
valuing global codes that package services together without objective, 
auditable data on the resource costs associated with the components of 
the services contained in the packages may significantly 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. 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.
    In the rulemaking for CY 2015, we stated our belief 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 postoperative care from a different practitioner 
during the global period;
     Eliminate disparities between the payment for E/M services 
in global periods and those furnished individually;
     Maintain the same-day packaging of pre- and postoperative 
physicians' services in the 0-day global code; and
     Facilitate availability of more accurate data for new 
payment models and quality research.

[[Page 70916]]

b. Impact of the Medicare Access and CHIP Reauthorization Act of 2015
    The MACRA was enacted into law on April 16, 2015. Section 523 of 
the MACRA addresses payment for global surgical packages. Section 
523(a) adds a new paragraph at section 1848(c)(8) of the Act. Section 
1848(c)(8)(A)(i) of the Act prohibits the Secretary from implementing 
the policy established in the CY 2015 PFS final rule with comment 
period that would have transitioned all 10-day and 90-day global 
surgery packages to 0-day global periods. Section 1848(c)(8)(A)(ii) of 
the Act provides that nothing in the previous clause shall be construed 
to prevent the Secretary from revaluing misvalued codes for specific 
surgical services or assigning values to new or revised codes for 
surgical services.
    Section 1848(c)(8)(B)(i) of the Act requires CMS to develop, 
through rulemaking, a process to gather information needed to value 
surgical services from a representative sample of physicians, and 
requires that the data collection shall begin no later than January 1, 
2017. The collected information must include the number and level of 
medical visits furnished during the global period and other items and 
services related to the surgery, as appropriate. This information must 
be reported on claims at the end of the global period or in another 
manner specified by the Secretary. Section 1848(c)(8)(B)(ii) of the Act 
requires that, every 4 years, we must reassess the value of this 
collected information; and allows us to discontinue the collection if 
the Secretary determines that we have adequate information from other 
sources in order to accurately value global surgical services. Section 
1848(c)(8)(B)(iii) of the Act specifies that the Inspector General will 
audit a sample of the collected information to verify its accuracy. 
Section 1848(c)(8)(C) of the Act requires that, beginning in CY 2019, 
we must use the information collected as appropriate, along with other 
available data, to improve the accuracy of valuation of surgical 
services under the PFS. Section 523(b) of the MACRA adds a new 
paragraph at section 1848(c)(9) of the Act that authorizes the 
Secretary, through rulemaking, to delay up to 5 percent of the PFS 
payment for services for which a physician is required to report 
information under section 1848(c)(8)(B)(i) of the Act until the 
required information is reported.
    Since section 1848(c)(8)(B)(i) of the Act, as added by section 
523(a) of the MACRA, requires us to use rulemaking to develop and 
implement the process to gather information needed to value surgical 
services no later than January 1, 2017, we sought input from 
stakeholders on various aspects of this task. We solicited comments 
from the public regarding the kinds of auditable, objective data 
(including the number and type of visits and other services furnished 
by the practitioner reporting the procedure code during the current 
postoperative periods) needed to increase the accuracy of the values 
for surgical services. We also solicited comment on the most efficient 
means of acquiring these data as accurately and efficiently as 
possible. For example, we sought information on the extent to which 
individual practitioners or practices may currently maintain their own 
data on services, including those furnished during the postoperative 
period, and how we might collect and objectively evaluate those data 
for use in increasing the accuracy of the values beginning in CY 2019.
    We received many comments regarding the kinds of auditable, 
objective data needed to increase the accuracy of the values for 
surgical services and the most efficient means of acquiring these data. 
Commenters had several suggestions for the approach that CMS should 
take, including the following:
     Collect and examine large group practice data for CPT code 
99024 (postoperative follow-up visit).
     Review Medicare Part A claims data to determine the length 
of stay of surgical services performed in the hospital facility 
setting.
     Prioritize services that the Agency has identified as high 
concern subjects.
     Review postoperative visit and length of stay data for 
outliers.
    In general, commenters were supportive of the need to identify 
auditable, objective, representative data, but many were not able to 
identify a specific source for such data. We appreciate the comments we 
received and we will consider these suggestions for purposes of future 
rulemaking.
    As noted above, section 1848(c)(8)(C) of the Act mandates that we 
use the collected data to improve the accuracy of valuation of surgery 
services beginning in 2019. We described in previous rulemaking (79 FR 
67582 through 67591) the limitations and difficulties involved in the 
appropriate valuation of the global packages, especially when the 
values of the component services are not clear. We sought public 
comment on potential methods of valuing the individual components of 
the global surgical package, including the procedure itself, and the 
pre- and postoperative care, including the follow-up care during 
postoperative days. We were also interested in stakeholder input on 
what other items and services related to the surgery, aside from 
postoperative visits, are furnished to beneficiaries during 
postoperative care.
    We received many comments regarding potential methods of valuing 
the individual components of the global surgical package, including the 
following:
     Use a measured approach to valuing the individual 
components of the global surgical package rather than implementing a 
blanket data collection policy.
     Examine and consider the level of the postoperative E/M 
visits, including differences between specialties.
     Consider the interaction between the valuing the global 
surgery package and the multiple procedure payment reduction (MPPR) 
policy.
    We will consider these comments regarding the best means to develop 
and implement the process to gather information needed to value 
surgical services and will provide further opportunity for public 
comment through future rulemaking.
    Comment: We received many comments expressing strong support for 
the CMS proposal to hold an open door forum or town hall meetings with 
the public.
    Response: We appreciate the extensive comments we received from the 
public regarding the global surgical package. We have noted the 
positive feedback from commenters about holding potential open forums 
or town hall meetings to discuss this process. We will consider these 
comments regarding the best means to develop and implement the process 
to gather information needed to value surgical services as we develop 
proposals for inclusion in next year's PFS proposed rule.

C. Elimination of the Refinement Panel

1. Background
    As discussed in the CY 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 RVUs for the subsequent year. 
We decided the panel would be composed 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

[[Page 70917]]

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 identify and 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.
    For CY 2015, in light of the changes we made to the process for 
valuing new, revised, and potentially misvalued codes (79 FR 67606), 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 the review of interim final values. It provides an 
opportunity for stakeholders to provide new 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. 
For CY 2015 interim final rates, we stated in the CY 2015 PFS final 
rule with comment period that we will use the refinement panel process 
as usual for these codes (79 FR 67609).
2. CY 2016 Refinement Panel Proposal
    We proposed to permanently eliminate the refinement panel beginning 
in CY 2016, and instead, publish the proposed rates for all interim 
final codes in the PFS proposed rule for the subsequent year. For 
example, we would publish the proposed rates for all CY 2016 interim 
final codes in the CY 2017 PFS proposed rule. With the change in the 
process for valuing codes adopted in the CY 2015 final rule with 
comment period (79 FR 67606), proposed values for most codes that are 
being valued for CY 2016 were published in the CY 2016 PFS proposed 
rule. As explained in the CY 2015 final rule with comment period, a 
smaller number of codes being valued for CY 2016 will be published as 
interim final in the 2016 PFS final rule with comment period and be 
subject to comment. Under our proposal, we will evaluate the comments 
we receive on these code values, and both respond to these comments and 
propose values for these codes for CY 2017 in the CY 2017 PFS proposed 
rule. Therefore, stakeholders will have two opportunities to comment 
and to provide any new clinical information that was not available at 
the time of the RUC valuation that might affect work RVU values that 
are adopted on an interim final basis. We believe that this proposed 
process, which includes two opportunities for public notice and 
comment, offers stakeholders a better mechanism and ample opportunity 
for providing any additional data for our consideration, and discussing 
any concerns with our interim final values, than the current refinement 
process. It also provides greater transparency because comments on our 
rules are made available to the public at http://www.regulations.gov. 
We welcomed comments on this proposed change to eliminate the use of 
refinement panels in our process for establishing final values for 
interim final codes.
    The following is a summary of the comments we received on this 
proposed change to eliminate the use of refinement panels in our 
process for establishing final values for interim final codes.
    Comment: The majority of commenters, including the American Medical 
Association/Specialty Society Relative (Value) Update Committee, 
opposed the proposal to eliminate the refinement panel. Commenters 
expressed concern that the complete elimination of the refinement 
process decreases CMS's accountability to its stakeholders who do not 
agree with the Agency's decisions. They urged CMS to provide detailed 
guidance on how to seek a change in previously finalized RVUs including 
the process to initiate a meeting with CMS staff to share and discuss 
new information or clarify previously shared information, as well as 
any key timelines or dates that may impact CMS's ability to initiate a 
change in previously finalized RVUs. Commenters also urged CMS to 
maintain a transparent appeal process. Another stated that, as CY 2017 
will be the first full year using the new process for establishing 
final values for interim final codes, it is possible that unforeseen 
needs for the continuation of the refinement panel could arise.
    Several commenters agreed with the proposal to eliminate the 
refinement panel. One commenter supported the permanent elimination of 
the refinement panel since CMS's display of interim final values in the 
subsequent year's proposed rule will provide another opportunity for 
public input. Another believed the new process will provide more timely 
input on the codes and stated that publishing interim final values for 
these in the proposed rule versus the final rule should allow adequate 
time for public comment and for physicians to prepare for changes that 
would have an impact on their practices and patients. Another commenter 
welcomed the increased opportunity to review and comment on interim 
values, especially given that CMS has not been obligated to accept 
recommendations of the refinement panels and has frequently rejected 
those recommendations.
    Response: We appreciate all of the comments on the proposal. We 
understand that commenters have an interest in a transparent process to 
review CMS's assignment of RVUs to individual PFS services. We also 
understand that some commenters believe that the purpose of the 
refinement panel process is to provide for reconsideration of the 
agency's previous decisions. However, the refinement panel was 
established to assist us in reviewing the public comments on CPT codes 
with interim final work RVUs and in balancing 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. Therefore, we 
do not believe that the refinement panel has generally served as the 
kind of ``appeals'' or reconsideration process that some stakeholders 
envision in their comments. We also have come to believe that the 
refinement panel is not achieving its intended purpose. Rather than 
providing us with additional information, balanced across specialty 
interests, to assist us in establishing work RVUs, the refinement panel 
process generally serves to rehash the issues raised and information 
already discussed at the RUC meetings and considered by CMS.
    We also appreciate commenters' interest in CMS maintaining a 
transparent process with public accountability in establishing values 
for physicians' services. In contrast to the prior process of 
establishing interim final values and using a refinement panel process 
that generally is not observed by members of the public, we believe 
that the new process of proposing the majority of code values in the 
proposed rule and making sure that those proposed values are open for 
comment prior to their taking effect for payment inherently represents 
greater transparency and accountability. We will also continue to work 
towards greater transparency in describing in rulemaking how we develop 
our proposed values for individual codes. We believe that focusing our 
resources on notice and comment rulemaking would facilitate greater 
transparency.

[[Page 70918]]

    Given that the timing for valuation of PFS services under the new 
process will in large part mitigate the need to establish values on an 
interim final basis and will provide two opportunities for notice and 
public comment, we do not believe that the refinement panel would 
necessarily provide value as an avenue for input, for either CMS or 
stakeholders, beyond that intrinsic in the notice and comment 
rulemaking process. However, we appreciate commenters' concerns that 
the new process has not been fully implemented and there may be 
unanticipated needs for additional input like the kind made available 
through the refinement panels. We agree that it may be advisable to 
preserve existing avenues for public input beyond the rulemaking 
process, like the refinement panel.
    Therefore, after consideration of all of the comments and the 
issues described in this section, we are not finalizing our proposal to 
eliminate the refinement panel process at this time. Instead, we will 
retain the ability to convene refinement panels for codes with interim 
final values under circumstances where additional input provided by the 
panel is likely to add value as a supplement to notice and comment 
rulemaking. We will make the determination on whether to convene 
refinement panels on an annual basis, based on review of comments 
received on interim final values. We remind stakeholders that CY 2016 
is the final year for which we anticipate establishing interim final 
values for existing services.
    We also want to remind stakeholders that we have established an 
annual process for the public nomination of potentially misvalued 
codes. This process, described in the CY 2012 PFS final rule (76 FR 
73058), provides an annual means for those who believe that values for 
individual services are inaccurate and should be readdressed through 
notice and comment rulemaking to bring those codes to our attention.

D. Improving Payment Accuracy for Primary Care and Care Management 
Services

    In the CY 2016 PFS proposed rule, we sought public comment on a 
number of issues regarding payment for primary care and care 
coordination under the PFS. We are committed to supporting primary 
care, and we have increasingly recognized care management as one of the 
critical components of primary care that contributes to better health 
for individuals and reduced expenditure growth (77 FR 68978). 
Accordingly, we have prioritized the development and implementation of 
a series of initiatives designed to improve the accuracy of payment 
for, and encourage long-term investment in, care management services.
    In addition to the Medicare Shared Savings Program, various 
demonstration initiatives including the Pioneer Accountable Care 
Organization (ACO) model, the patient-centered medical home model in 
the Multi-payer Advanced Primary Care Practice (MAPCP), the Federally 
Qualified Health Center (FQHC) Advanced Primary Care Practice 
demonstration and the Comprehensive Primary Care (CPC) initiative, 
among others (see the CY 2015 PFS final rule (79 FR 67715) for a 
discussion of these), we also have continued to explore potential 
refinements to the PFS that would appropriately value care management 
within Medicare's statutory structure for fee-for-service physician 
payment and quality reporting. The payment for some non-face-to-face 
care management services is bundled into the payment for face-to-face 
evaluation and management (E/M) visits. However, because the current E/
M office/outpatient visit CPT codes were designed with an overall 
orientation toward episodic treatment, we have recognized that these E/
M codes may not reflect all the services and resources involved with 
furnishing certain kinds of care, particularly comprehensive, 
coordinated care management for certain categories of beneficiaries.
    Over several years, we have developed proposals and sought 
stakeholder input regarding potential PFS refinements to improve the 
accuracy of payment for care management services. For example, in the 
CY 2013 PFS final rule with comment period, we adopted a policy to pay 
separately for transitional care management (TCM) involving the 
transition of a beneficiary from care furnished by a treating physician 
during an inpatient stay to care furnished by the beneficiary's primary 
physician in the community (77 FR 68978 through 68993). In the CY 2014 
PFS final rule with comment period, we finalized a policy, beginning in 
CY 2015 (78 FR 74414), to pay separately for chronic care management 
(CCM) services furnished to Medicare beneficiaries with two or more 
qualifying chronic conditions. We believe that these new separately 
billable codes more accurately describe, recognize, and make payment 
for non-face-to-face care management services furnished by 
practitioners and clinical staff to particular patient populations.
    We view ongoing refinements to payment for care management services 
as part of a broader strategy to incorporate input and information 
gathered from research, initiatives, and demonstrations conducted by 
CMS and other public and private stakeholders, the work of all parties 
involved in the potentially misvalued code initiative, and, more 
generally, from the public at large. Based on input and information 
gathered from these sources, we are considering several potential 
refinements that would continue our efforts to improve the accuracy of 
PFS payments. In this section, we discuss our comment solicitation and 
the public comments we received regarding these potential refinements.
1. Improved Payment for the Professional Work of Care Management 
Services
    Although both the TCM and CCM services describe certain aspects of 
professional work, some stakeholders have suggested that neither of 
these new sets of codes nor the inputs used in their valuations 
explicitly account for all of the services and resources associated 
with the more extensive cognitive work that primary care physicians and 
other practitioners perform in planning and thinking critically about 
the individual chronic care needs of particular subsets of Medicare 
beneficiaries. Commenters stated that the time and intensity of the 
cognitive efforts associated with such planning are in addition to the 
work typically required to supervise and manage the clinical staff 
associated with the current TCM and CCM codes. Similarly, we continue 
to receive requests from a few stakeholders for CMS to lead efforts to 
revise the current CPT E/M codes or construct a new set of E/M codes. 
The goal of such efforts would be to better describe and value the work 
(time and intensity) specific to primary care and other cognitive 
specialties in the context of complex care of patients relative to the 
time and intensity of the procedure-oriented care physicians and 
practitioners, who use the same codes to report E/M services. Some of 
these stakeholders have suggested that in current medical practice, 
many physicians, in addition to the time spent treating acute 
illnesses, spend substantial time working toward optimal outcomes for 
patients with chronic conditions and patients they treat episodically, 
which can involve additional work not reflected in the codes that 
describe E/M services since that work is not typical across the wide 
range of practitioners that report the same codes. According to these 
groups, this work involves

[[Page 70919]]

medication reconciliation, the assessment and integration of numerous 
data points, effective coordination of care among multiple other 
clinicians, collaboration with team members, continuous development and 
modification of care plans, patient or caregiver education, and the 
communication of test results.
    We agree with stakeholders that it is important for Medicare to use 
codes that accurately describe the services furnished to Medicare 
beneficiaries and to accurately reflect the relative resources involved 
with furnishing those services. Therefore, in the CY 2016 PFS proposed 
rule we solicited public comments on ways to recognize the different 
resources (particularly in cognitive work) involved in delivering 
broad-based, ongoing treatment, beyond those resources already 
incorporated in the codes that describe the broader range of E/M 
services. The resource costs of this work may include the time and 
intensity related to the management of both long-term and, in some 
cases, episodic conditions. To appropriately recognize the different 
resource costs for this additional cognitive work within the structure 
of PFS resource-based payments, we were particularly interested in 
codes that could be used in addition to, not instead of, the current E/
M codes.
    In our comment solicitation, we stated that, in principle, these 
codes could be similar to the hundreds of existing add-on codes that 
describe additional resource costs, such as additional blocks or slides 
in pathology services, additional units of repair in dermatologic 
procedures, or additional complexity in psychotherapy services. For 
example, these codes might allow for the reporting of the additional 
time and intensity of the cognitive work often undertaken by primary 
care and other cognitive specialties in conjunction with an E/M 
service, much like add-on codes for certain procedures or diagnostic 
test describe the additional resources sometimes involved in furnishing 
those services. Similar to the CCM code, the codes might describe the 
increased resources used over a longer period of time than during one 
patient visit. For example, the add-on codes could describe the 
professional time in excess of 30 minutes and/or a certain set of 
furnished services, per one calendar month, for a single patient to 
coordinate care, provide patient or caregiver education, reconcile and 
manage medications, assess and integrate data, or develop and modify 
care plans. Such activity may be particularly relevant for the care of 
patients with multiple or complicated chronic or acute conditions, and 
should contribute to optimal patient outcomes including more 
coordinated, safer care.
    Like CCM, we would require that the patient have an established 
relationship with the billing professional; and additionally, the use 
of an add-on code would require the extended professional resources to 
be reported with another separately payable service. However, in 
contrast to the CCM code, the new codes might be reported based on the 
resources involved in professional work, instead of the resource costs 
in terms of clinical staff time. The codes might also apply broadly to 
patients in a number of different circumstances, and would not 
necessarily make reporting the code(s) contingent on particular 
business models or technologies for medical practices. We stated that 
we were interested in stakeholder comments on the kinds of services 
that involve the type of cognitive work described above and whether or 
not the creation of particular codes might improve the accuracy of the 
relative values used for such services on the PFS. Finally, we were 
interested in receiving information from stakeholders on the overlap 
between the kinds of cognitive resource costs discussed above and those 
already accounted for through the currently payable codes that describe 
CCM and other care management services.
    We strongly encouraged stakeholders to comment on this topic to 
assist us in developing potential proposals to address these issues 
through rulemaking in CY 2016 for implementation in CY 2017. We 
anticipated using an approach similar to our multi-year approach for 
implementing CCM and TCM services, to facilitate broader input from 
stakeholders regarding details of implementing such codes, including 
their structure and description, valuation, and any requirements for 
reporting.
    Comment: We received many comments on these potential policy and 
coding refinements that will be useful in the development of potential 
future policy proposals. We note that the American Medical Association 
and others urged us to make separate Medicare payment for existing CPT 
codes that are not separately paid under the PFS, but that describe 
similar services and for which we have RUC-recommended values. These 
codes describe a broad range of services, some of which involve non 
face-to-face care management over a period of time.
    Response: We will take the comments into consideration in 
developing any potential policy proposals in future PFS rulemaking.
2. Establishing Separate Payment for Collaborative Care
    We believe that the care and management for Medicare beneficiaries 
with multiple chronic conditions, a particularly complicated disease or 
acute condition, or common behavioral health conditions often requires 
extensive discussion, information-sharing and planning between a 
primary care physician and a specialist (for example, with a 
neurologist for a patient with Alzheimer's disease plus other chronic 
diseases). We note that for CY 2014, CPT created four codes that 
describe interprofessional telephone/internet consultative services 
(CPT codes 99446-99449). Because Medicare includes payment for 
telephone consultations with or about a beneficiary as a part of other 
services furnished to the beneficiary, we currently do not make 
separate payment for these services. We note that such 
interprofessional consultative services are distinct from the face-to-
face visits previously reported to Medicare using the consultation 
codes, and we refer the reader to the CY 2010 PFS final rule for 
information regarding Medicare payment policies for those services (74 
FR 61767).
    However, in considering how to improve the accuracy of our payments 
for care coordination, particularly for patients requiring more 
extensive care, in the CY 2016 PFS proposed rule we also sought comment 
on how Medicare might accurately account for the resource costs of a 
more robust interprofessional consultation within the current structure 
of PFS payment. For example, we were interested in stakeholders' 
perspectives regarding whether there are conditions under which it 
might be appropriate to make separate payment for services like those 
described by these CPT codes. We expressed interest in stakeholder 
input regarding the parameters of, and resources involved in, these 
collaborations between a specialist and primary care practitioner, 
especially in the context of the structure and valuation of current E/M 
services. In particular, we were interested in comments about how these 
collaborations could be distinguished from the kind of services 
included in other E/M services, how these services could be described 
if stakeholders believe the current CPT codes are not adequate, and how 
these services should be valued under the PFS. We also expressed 
interest in comments on whether we should tie those interprofessional 
consultations to a beneficiary encounter, and on

[[Page 70920]]

developing appropriate beneficiary protections to ensure that 
beneficiaries are fully aware of the involvement of the specialist in 
the beneficiary's care and the associated benefits of the collaboration 
between the primary care physician and the specialist physician prior 
to being billed for such services.
    Additionally, we solicited comments on whether this kind of care 
might benefit from inclusion in a CMMI model that would allow Medicare 
to test its effectiveness with a waiver of beneficiary financial 
liability and/or variation of payment amounts for the consulting and 
the primary care practitioners. Without such protections, beneficiaries 
could be responsible for coinsurance for services of physicians whose 
role in the beneficiary's care is not necessarily understood by the 
beneficiary. Finally, we also solicited comments on key technology 
supports needed to support collaboration between specialist and primary 
care practitioners in support of high quality care management services, 
on whether we should consider including technology requirements as part 
of any proposed services, and on how such requirements could be 
implemented in a way that minimizes burden on providers. We encouraged 
stakeholders to comment on this topic to assist us in developing 
potential proposals to address these issues through rulemaking in CY 
2016 for implementation in CY 2017. We anticipated using an approach 
similar to our multi-year approach for implementing CCM and TCM 
services, to facilitate broader input from stakeholders regarding 
details of implementing such codes, including their structure and 
description, valuation, and any requirements for reporting.
    Comment: We received many comments on these potential policy and 
coding refinements that will be useful in the development of potential 
future policy proposals.
    Response: We will take the comments into consideration in 
developing any potential policy proposals in future PFS rulemaking.
a. Collaborative Care Models for Beneficiaries With Common Behavioral 
Health Conditions
    In recent years, many randomized controlled trials have established 
an evidence base for an approach to caring for patients with common 
behavioral health conditions called ``Collaborative Care.'' 
Collaborative care typically is provided by a primary care team, 
consisting of a primary care provider and a care manager, who works in 
collaboration with a psychiatric consultant, such as a psychiatrist. 
Care is directed by the primary care team and includes structured care 
management with regular assessments of clinical status using validated 
tools and modification of treatment as appropriate. The psychiatric 
consultant provides regular consultations to the primary care team to 
review the clinical status and care of patients and to make 
recommendations. Several resources have been published that describe 
collaborative care models in greater detail and assess their impact, 
including pieces from the University of Washington (http://aims.uw.edu/
), the Institute for Clinical and Economic Review (http://ctaf.org/reports/integration-behavioral-health-primary-care), and the Cochrane 
Collaboration (http://www.cochrane.org/CD006525/DEPRESSN_collaborative-care-for-people-with-depression-and-anxiety).
    Because this particular kind of collaborative care model has been 
tested and documented in medical literature, in the proposed rule, we 
were particularly interested in comments on how coding under the PFS 
might facilitate appropriate valuation of the services furnished under 
such a collaborative care model. As these kinds of collaborative models 
of care become more prevalent, we would evaluate potential refinements 
to the PFS to account for the provision of services through such a 
model. We solicited information to assist us in considering refinements 
to coding and payment to address this model in particular. We also 
sought comments on the potential application of the collaborative care 
model for other diagnoses and treatment modalities. For example, we 
solicited comments on how a code similar to the CCM code applicable to 
multiple diagnoses and treatment plans could be used to describe 
collaborative care services, as well as other interprofessional 
services, and could be appropriately valued and reported within the 
resource-based relative value PFS system, and how the resources 
involved in furnishing such services could be incorporated into the 
current set of PFS codes without overlap. We also requested input on 
whether requirements similar to those used for CCM services should 
apply to a new collaborative care code, and whether such a code could 
be reported in conjunction with CCM or other E/M services. For example, 
we might consider whether the code should describe a minimum amount of 
time spent by the psychiatric consultant for a particular patient per 
one calendar month and be complemented by either the CCM or other care 
management code to support the care management and primary care 
elements of the collaborative care model. As with our comment 
solicitation on interprofessional consultation, since the patient may 
not have direct contact with the psychiatric consultant we solicited 
comments on whether and, if so, how written consent for the non-face-
to-face services should be required prior to practitioners reporting 
any new interprofessional consultation code or the care management 
code.
    We also solicited comments on appropriate care delivery 
requirements for billing, the appropriateness of CCM technology 
requirements or other technology requirements for these services, 
necessary qualifications for psychiatric consultants, and whether or 
not there are particular conditions for which payment would be more 
appropriate than others; as well as how these services may interact 
with quality reporting, the resource inputs we might use to value the 
services under the PFS (specifically, work RVUs, time, and direct PE 
inputs), and whether or not separate codes should be developed for the 
psychiatric consultant and the care management components of the 
service.
    In addition, we solicited comments on whether this kind of care 
model should be implemented through a CMMI model that would allow 
Medicare to test its effectiveness with a waiver of beneficiary 
financial liability and/or variation of payment methodology and amounts 
for the psychiatric consultant and the primary care physician. Again, 
we encouraged stakeholders to comment on this topic to assist us in 
developing potential proposals to address these issues through 
rulemaking in CY 2016 for implementation in CY 2017.
    Comment: We received many positive comments regarding the 
possibility of implementing new payment codes that would allow more 
accurate reporting and payment when these services are furnished to 
Medicare beneficiaries.
    Response: We appreciate commenters' interest in appropriate coding 
and payment for these services. We will take all comments into 
consideration as we consider the development of proposals in future 
rulemaking.
    We took particular note that several commenters identified resource 
inputs CMS might use to value these services under the PFS, including 
defined time elements. As we consider those comments, we encourage 
stakeholders to consider whether there are alternatives to time 
elements that would account for the range in intensity of services 
delivered in accordance with beneficiary need. In addition, since the

[[Page 70921]]

collaborative care models described in the proposed rule include 
primary care-based care management, as well as psychiatric consulting, 
we encourage further input including comments on this final rule with 
comment period, from a broad group of stakeholders, including the 
community of primary care providers, who are critical in the successful 
provision of these Services.
3. CCM and TCM Services
a. Reducing Administrative Burden for CCM and TCM Services
    In CY 2013, we implemented separate payment for TCM services under 
CPT codes 99495 and 99496, and in CY 2015, we implemented separate 
payment for CCM services under CPT code 99490. We established many 
service elements and billing requirements that the physician or 
nonphysician practitioner must satisfy to fully furnish these services 
and to report these codes (77 FR 68989, 79 FR 67728). Particularly 
because of the significant amount of non face-to-face work involved in 
CCM and TCM services, these elements and requirements were relatively 
extensive and generally exceeded those for other E/M and similar 
services. Since the implementation of these services, some 
practitioners have stated that the service elements and billing 
requirements are too burdensome, and suggested that they interfere with 
their ability to provide these care management services to their 
patients who could benefit from them. In light of this feedback from 
the physician and practitioner community, we solicited comments on 
steps that we could take to further improve beneficiary access to TCM 
and CCM services. Our aims in implementing separate payment for these 
services are that Medicare practitioners are paid appropriately for the 
services they furnish, and that beneficiaries receive comprehensive 
care management that benefits their long term health outcomes. However, 
we understand that excessive requirements on practitioners could 
possibly undermine the overall goals of the payment policies. In the CY 
2016 PFS proposed rule, we solicited stakeholder input on how we could 
best balance access to these services and practitioner burdens such 
that Medicare beneficiaries may obtain the full benefit of these 
services.
b. Payment for CPT Codes Related to CCM Services
    As we stated in the CY 2015 PFS final rule (79 FR 67719), we 
believe that Medicare beneficiaries with two or more chronic conditions 
as defined under the CCM code can benefit from the care management 
services described by that code, and we want to make this service 
available to all such beneficiaries. As with most services paid under 
the PFS, we recognized that furnishing CCM services to some 
beneficiaries will require more resources and some less; but we value 
and make payment based upon the typical service. Because CY 2015 is the 
first year for which we are making separate payment for CCM services, 
we sought information regarding the circumstances under which CCM 
services are furnished. This information would include the clinical 
status of the beneficiaries receiving the service and the resources 
involved in furnishing the service, such as the number of documented 
non-face-to-face minutes furnished by clinical staff in the months the 
code is reported. We were interested in examining such information to 
identify the range of minutes furnished over those months as well as 
the distribution of the number of minutes within the total volume of 
services. We also solicited objective data regarding the resource costs 
associated with furnishing the services described by this code. We 
stated that as we review that information, in addition to our own 
claims data, we would consider any changes in payment and coding that 
may be warranted in the coming years, including the possibility of 
establishing separate payment amounts and making Medicare payment for 
the related CPT codes, such as the complex care coordination codes, CPT 
codes 99487 and 99489.
    Comment: We received several comments recommending various changes 
in the billing requirements for CCM and TCM services. Some commenters 
sought significant changes to the CCM scope of service elements, such 
as eliminating the requirement to use certified electronic health 
record technology (CEHRT); suspending the electronic care plan sharing 
requirement until such time that electronic health records (EHRs) have 
the ability to support such capabilities; or having CMS provide a model 
patient consent form. Other commenters recommended more minor changes 
such as clarifying the application of CCM rules regarding fax 
transmission from certified EHRs, and changing the reporting rules for 
TCM services (required date of service and when the claim can be 
submitted). Many commenters stated the current payment amounts are not 
adequate to cover the resources required to furnish CCM or TCM services 
and urged CMS to increase payments, for example by creating an add-on 
code to CPT code 99490, increasing the clinical labor PE input for CPT 
code 99490 to the RUC recommended 60 minutes, and/or paying separately 
for the complex CCM codes (CPT codes 99487 and 99489). Commenters also 
noted that since CY 2015 is the first year of separate payment for CCM, 
there is little utilization data available to assess average time spent 
in furnishing CCM services and similar issues. One commenter planned to 
share data with CMS next spring upon completion of a study on the cost 
and value associated with care management.
    Response: We will take these comments into consideration in the 
development of potential proposals for future PFS rulemaking. We will 
develop subregulatory guidance clarifying the intersection of fax 
transmission and CEHRT for purposes of CCM billing. Regarding TCM 
services, we are adopting the commenters' suggestions that the required 
date of service reported on the claim be the date of the face-to-face 
visit, and to allow (but not require) submission of the claim when the 
face-to-face visit is completed, consistent with current policy 
governing the reporting of global surgery and other bundles of services 
under the PFS. We will revise the existing subregulatory guidance for 
TCM services accordingly.

E. Target for Relative Value Adjustments for Misvalued Services

    Section 220(d) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added a new 
subparagraph at section 1848(c)(2)(O) of the Act to establish an annual 
target for reductions in PFS expenditures resulting from adjustments to 
relative values of misvalued codes. Under section 1848(c)(2)(O)(ii) of 
the Act, if the estimated net reduction in expenditures for a year as a 
result of adjustments to the relative values for misvalued codes is 
equal to or greater than the target for that year, reduced expenditures 
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS in accordance with the existing budget 
neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act. 
The provision also specifies that the amount by which such reduced 
expenditures exceeds the target for a given year shall be treated as a 
net reduction in expenditures for the succeeding year, for purposes of 
determining whether the target has been met for that subsequent year. 
Section 1848(c)(2)(O)(iv) of the Act defines a target recapture amount 
as the difference between the target for the year and the estimated net 
reduction in expenditures under the PFS resulting

[[Page 70922]]

from adjustments to RVUs for misvalued codes. Section 
1848(c)(2)(O)(iii) of the Act specifies that, if the estimated net 
reduction in PFS expenditures for the year is less than the target for 
the year, an amount equal to the target recapture amount shall not be 
taken into account when applying the budget neutrality requirements 
specified in section 1848(c)(2)(B)(ii)(II) of the Act. Section 220(d) 
of the PAMA applies to calendar years (CYs) 2017 through 2020 and sets 
the target under section 1848(c)(2)(O)(v) of the Act at 0.5 percent of 
the estimated amount of expenditures under the PFS for each of those 4 
years.
    Section 202 of the Achieving a Better Life Experience Act of 2014 
(ABLE) (Division B of Pub. L. 113-295, enacted December 19, 2014) 
amended section 1848(c)(2)(O) of the Act to accelerate the application 
of the PFS expenditure reduction target to CYs 2016, 2017, and 2018, 
and to set a 1 percent target for CY 2016 and 0.5 percent for CYs 2017 
and 2018. As a result of these provisions, if the estimated net 
reduction for a given year is less than the target for that year, 
payments under the fee schedule will be reduced.
    In the CY 2016 PFS proposed rule, we proposed a methodology to 
implement this statutory provision in a manner consistent with the 
broader statutory construct of the PFS. In developing this proposed 
methodology, we identified several aspects of our approach for which we 
specifically solicited comments. We organized this discussion by 
identifying and explaining these aspects in particular but we solicited 
comments on all aspects of our proposal.
1. Distinguishing ``Misvalued Code'' Adjustments From Other RVU 
Adjustments
    The potentially misvalued code initiative has resulted in changes 
in PFS payments in several ways. First, potentially misvalued codes 
have been identified, reviewed, and revalued through notice and comment 
rulemaking. However, in many cases, the identification of particular 
codes as potentially misvalued has led to the review and revaluation of 
related codes, and frequently, to revisions to the underlying coding 
for large sets of related services. Similarly, the review of individual 
codes has initiated reviews and proposals to make broader adjustments 
to values for codes across the PFS, such as when the review of a series 
of imaging codes prompted a RUC recommendation and CMS updated the 
direct PE inputs for imaging services to assume digital instead of film 
costs. This change, originating through the misvalued code initiative, 
resulted in a significant reduction in RVUs for a large set of PFS 
services, even though the majority of affected codes were not initially 
identified through potentially misvalued code screens. Finally, due to 
both the relativity inherent in the PFS ratesetting process and the 
budget neutrality requirements specified in section 
1848(c)(2)(B)(ii)(II) of the Act, adjustments to the RVUs for 
individual services necessarily result in the shifting of RVUs to broad 
sets of other services across the PFS.
    To implement the PFS expenditure reduction target provisions under 
section 1848(c)(2)(O) of the Act, we must identify a subset of the 
adjustments in RVUs for a year to reflect an estimated ``net 
reduction'' in expenditures. Therefore, we dismissed the possibility of 
including all changes in RVUs for a year in calculating the estimated 
net reduction in PFS expenditures, even though we believe that the 
redistributions in RVUs to other services are an important aspect of 
the potentially misvalued code initiative. Conversely, we considered 
the possibility of limiting the calculation of the estimated net 
reduction in expenditures to reflect RVU adjustments made to the codes 
formally identified as ``potentially misvalued.'' We do not believe 
that calculation would reflect the significant changes in payments that 
have directly resulted from the review and revaluation of misvalued 
codes under section 1848(c)(2) of the Act. We further considered 
whether to include only those codes that underwent a comprehensive 
review (work and PE). As we previously have stated (76 FR 73057), we 
believe that a comprehensive review of the work and PE for each code 
leads to the more accurate assignment of RVUs and appropriate payments 
under the PFS than do fragmentary adjustments for only one component. 
However, if we calculated the net reduction in expenditures using 
revisions to RVUs only from comprehensive reviews, the calculation 
would not include changes in PE RVUs that result from proposals like 
the film-to-digital change for imaging services, which not only 
originated from the review of potentially misvalued codes, but 
substantially improved the accuracy of PFS payments faster and more 
efficiently than could have been done through the multiple-year process 
required to complete a comprehensive review of all imaging codes.
    After considering these options, we believe that the best approach 
is to define the reduction in expenditures as a result of adjustments 
to RVUs for misvalued codes to include the estimated pool of all 
services with revised input values. This would limit the pool of RVU 
adjustments used to calculate the net reduction in expenditures to 
those for the services for which individual, comprehensive review or 
broader proposed adjustments have resulted in changes to service-level 
inputs of work RVUs, direct PE inputs, or MP RVUs, as well as services 
directly affected by changes to coding for related services. For 
example, coding changes in certain codes can sometimes necessitate 
revaluations for related codes that have not been reviewed as misvalued 
codes, because the coding changes have also affected the scope of the 
related services. This definition would incorporate all reduced 
expenditures from revaluations for services that are deliberately 
addressed as potentially misvalued codes, as well as those for services 
with broad-based adjustments like film-to-digital and services that are 
redefined through coding changes as a result of the review of misvalued 
codes.
    Because the annual target is calculated by measuring changes from 
one year to the next, we also considered how to account for changes in 
values that are best measured over 3 years, instead of 2 years. Under 
our current process, the overall change in valuation for many misvalued 
codes is measured across values for 3 years: the original value in the 
first year, the interim final value in the second year, and the 
finalized value in the third year. As we describe in section II.H.2. of 
this final rule with comment period, our misvalued code process has 
been to establish interim final RVUs for the potentially misvalued, 
new, and revised codes in the final rule with comment period for a 
year. Then, during the 60-day period following the publication of the 
final rule with comment period, we accept public comment about those 
valuations. For 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. However, the calculation of the target would 
only compare changes between 2 years and not among 3 years, so the 
contribution of a particular change towards the target for any single 
year would be measured against only the preceding year without regard 
to the overall change that takes place over 3 years.
    For recent years, interim final values for misvalued codes (year 2) 
have generally reflected reductions relative to original values (year 
1), and for most codes, the interim final values (year 2)

[[Page 70923]]

are maintained and finalized (year 3). However, when values for 
particular codes have changed between the interim final (year 2) and 
final values (year 3) based on public comment, the general tendency has 
been that codes increase in the final value (year 3) relative to the 
interim final value (year 2), even in cases where the final value (year 
3) represents a decrease from the original value (year 1). Therefore, 
for these codes, the year 2 changes compared to year 1 would risk over-
representing the overall reduction, while the year 3 to year 2 changes 
would represent an increase in value. If there were similar targets in 
every PFS year, and a similar number of misvalued code changes made on 
an interim final basis, the incongruence in measuring what is really a 
3-year change in 2-year increments might not be particularly 
problematic since each year's calculation would presumably include a 
similar number of codes measured between years 1 and 2 and years 2 and 
3.
    However, including changes that take place over 3 years generates 
challenges in calculating the target for CY 2016 for two reasons. 
First, CY 2015 was the final full year of establishing interim final 
values for all new, revised, and potentially misvalued codes. Starting 
with this final rule with comment period, we are finalizing values for 
a significant portion of misvalued codes during one calendar year. 
Therefore, CY 2015 will include a significant number of services that 
would be measured between years 2 and 3 relative to the services 
measured between 1 and 2 years. Second, because there was no target for 
CY 2015, any reductions that occurred on an interim final basis for CY 
2015 were not counted toward achievement of a target. If we were to 
include any upward adjustments made to these codes based on public 
comment as ``misvalued code'' changes for CY 2016, we would effectively 
be counting the service-level increases for 2016 (year 3) relative to 
2015 (year 2) against achievement of the target without any 
consideration to the service-level changes relative to 2014 (year 1), 
even in cases where the overall change in valuation was negative.
    Therefore, we proposed to exclude code-level input changes for CY 
2015 interim final values from the calculation of the CY 2016 misvalued 
code target since the misvalued change occurred over multiple years, 
including years not applicable to the misvalued code target provision.
    We note that the impact of interim final values in the calculation 
of targets for future years will be diminished as we transition to 
proposing values for almost all new, revised, and potentially misvalued 
codes in the proposed rule. We anticipate a smaller number of interim 
final values for CY 2016 relative to CY 2015. For calculation of the CY 
2018 target, we anticipate almost no impact based on misvalued code 
adjustments that occur over multiple years.
    The list of codes with changes for CY 2016 included under this 
definition of ``adjustments to RVUs for misvalued codes'' is available 
on the CMS Web site under downloads for the CY 2016 PFS final rule with 
comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The following is a summary of the comments we received regarding 
this aspect of the proposal to implement the statutory provision:
    Comment: Several commenters, including the RUC, supported CMS' 
proposal to include all services that receive revised input values even 
if the specific codes were not identified on a misvalued services list 
for review; the commenters' stated that this is a reasonable and fair 
approach.
    Response: We appreciate the commenters' feedback and support.
    Comment: A few commenters stated that the selection of codes to be 
included for review beyond the codes identified by the screens should 
be determined by the pertinent specialty societies as they are the best 
determiners of which codes make up a family of codes. Another commenter 
stated that CMS should include the E/M services in the list of codes 
that are potentially misvalued.
    Response: We note that the process for selection of codes to be 
reviewed as potentially misvalued is addressed in section II.H. of this 
final rule with comment period and has also been addressed in prior 
rulemaking. Our proposal to implement section 1848(c)(2)(O) of the Act 
does not address how codes are identified to be reviewed under the 
misvalued code initiative. Instead, it addresses how to identify the 
changes in expenditures that result from such reviews in the 
calculation of the target amount.
    Comment: Several commenters, including the RUC, also supported CMS' 
proposal to exclude code level input changes for CY 2015 interim final 
values from the calculation of the target. The commenters concur that 
the year 2 and year 3 changes in values represent an incomplete picture 
of the redistributive effects for a particular year resulting from the 
review of the misvalued services, and the vast majority of 
redistribution happens between year 1 and year 2.
    Response: We appreciate the commenters' support and feedback.
    Comment: One commenter disagreed with CMS' proposal to exclude 
code-level input changes for 2015 interim final values stating that it 
means organized medicine does not get credit for any net decreases 
associated with such codes and is therefore being penalized. The 
commenter requested that CMS consider including 2015 interim final 
values in the calculation of the 2016 misvalued code target even though 
the misvalued change occurred over multiple years. Another commenter 
stated that the proposed net reduction in expenditures of 0.25 percent, 
as opposed to 1.00, means that the 0.75 percent difference will come 
from the conversion factor, and doing so would more than negate the 0.5 
percent increase physicians were promised under MACRA, and therefore 
the commenter requested that CMS help mitigate this result by including 
2015 interim final values in the calculation of the target.
    Response: With regard to the commenters who disagreed with the 
exclusion of code-level input changes for 2015 interim final values, we 
cannot determine if the commenters intended to suggest that CMS was not 
including decreases that would help towards the achievement of the 
misvalued code target by excluding changes for 2015 interim final 
values, or that CMS should include the changes between years 1 and 3. 
As stated in the CY 2016 proposed rule (80 FR 41712 through 41713), 
when values for particular codes have changed between the interim final 
(year 2) and final values (year 3) based on public comment, the general 
tendency has been that code values increase in the final value (year 3) 
relative to the interim final value (year 2), even in cases where the 
final value (year 3) represents a decrease from the original value 
(year 1). Additionally, the statute requires comparison between 2 
years, and therefore, we do not believe we have the authority to 
include changes between year 1 and year 3. Since our remaining options 
were to include changes between year 2 and year 3 which, as indicated 
above, generally results in an increase, or to exclude code-level input 
changes for CY 2015 interim final values, and the commenters express 
interest in moving closer to achievement of the target, we do not 
believe it would be in the commenters' interest to include the changes 
between years 2 and 3.

[[Page 70924]]

    With regard to the commenter who stated that the net reduction in 
expenditures under the PFS if CMS does not achieve the target reduction 
would negate the 0.5 percent increase physicians were promised under 
MACRA, we note that both of these provisions continue to apply under 
current law.
    Comment: Some commenters, including the RUC, suggested that CMS 
should be sure to include existing codes that are either being deleted 
or will have utilization changes as a result of the misvalued code 
project and/or the CPT Editorial Panel process. Another commenter 
stated that CMS was excluding existing codes with large volume changes, 
and recommended that such codes be included in the calculation of the 
target. Some commenters recommended that CMS conduct a procedure-to-
procedure comparison and then calculate the net reduction in RVUs, 
including the values of new and deleted CPT codes prompted by the 
misvalued code initiative. The commenters stated that this is an area 
where the specialty societies and CMS need to work together to 
determine the comparisons for calculating the net reduction.
    Response: We agree that changes in coding often contribute to 
improved valuation of PFS services. We note that we included these 
changes in our methodology in the proposed rule and explained that we 
would include services directly affected by changes to coding for 
related services. We did not propose to exclude existing codes with 
large volume changes; changes for such codes have been included. To 
clarify, we are including changes in values for any codes for which 
changes in coding or policies may result in differences in how a given 
service is reported from one year to the next. Under our current 
ratesetting methodologies, we already consider how coding revisions 
change the way services are reported from one year to the next. The 
crosswalk we use to incorporate such changes in our methodology is 
based on RUC and specialty society recommendations that explicitly 
address the kinds of procedure-to-procedure comparisons suggested by 
the commenter. This file is available in the ``downloads'' section of 
the PFS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html 
under ``Analytic Crosswalk from CY 2015 to CY 2016.'' Since it reflects 
the best information available, we used the same crosswalk to account 
for coding changes in the calculation of the target. We also refer 
readers to the list of HCPCS defined as misvalued for purposes of the 
target which is available on the CMS Web site under downloads for the 
CY 2016 PFS final rule with comment period.
    Comment: One commenter recommended that CMS include the review of 
all individual codes and broader adjustments across the PFS, as this 
would more accurately represent the total revaluations.
    Response: As we explained in the proposed rule, our goal is to 
include the review of all individual codes and changes to inputs for 
additional codes where changes can be measured between two years. 
Because PFS payments are developed under the statutory requirements of 
relativity and budget neutrality, including all adjustments to all 
codes would necessarily result in a net of zero.
    Comment: A few commenters raised objections to the statutory 
provision. For example, one commenter stated that the legislation is 
penalizing physicians and other healthcare professionals for already 
having taken on the task of identifying and revaluating potentially 
misvalued codes over the past 10 years. Other commenters stated that 
since the RUC and specialty societies have been addressing potentially 
misvalued codes since 2006, there should be a way to include 
revaluations made back to 2006 in the calculation of the target. 
Another commenter stated that CMS should hold primary care and E/M 
services harmless in this process, since these services are not over-
valued but rather under-valued. One commenter requested more time to 
evaluate the proposed process to identify yearly targets, and 
encouraged CMS to work with the AMA to discuss this issue at future RUC 
Panel meetings prior to implementing the provision. One commenter 
requested that CMS review its approach to determine if there are other 
methods that will come closer to reaching the target. One commenter 
stated that this new requirement creates a potential incentive to 
target codes that offer the greatest likelihood of savings, not those 
that are actually misvalued.
    Response: We appreciate the commenters' feedback and have 
considered these concerns to the extent possible in light of the 
requirements of section 1848(c)(2)(O) of the Act.
    After consideration of the public comments received, we are 
finalizing the approach of defining the reduction in expenditures as a 
result of adjustments to RVUs for misvalued codes to include the 
estimated pool of all services with revised input values, including any 
codes for which changes in coding or policies might result in 
differences in how a given service is reported from one year to the 
next. We are also finalizing our proposal to exclude code-level input 
changes for CY 2015 interim final values from the calculation of the CY 
2016 misvalued code target. After considering all comments, we continue 
to believe this approach is appropriate and compliant with statutory 
directives.
2. Calculating ``Net Reduction''
    Once the RVU adjustments attributable to misvalued codes are 
identified, estimated net reductions in PFS expenditures resulting from 
those adjustments would be calculated by determining the sum of all 
decreases and offsetting them against any applicable increases in 
valuation within the changes that we defined as misvalued, as described 
above. Because section 1848(c)(2)(O)(i) of the Act only explicitly 
addresses reductions in expenditures, and we recognize that many 
stakeholders will want to maximize the overall magnitude of the 
measured reductions in order to prevent an overall reduction to the PFS 
conversion factor, we considered the possibility of ignoring the 
applicable increases in valuation in the calculation of net reduction. 
However, we believe that the requirement to calculate ``net'' 
reductions implies that we are to take into consideration both 
decreases and increases. Additionally, we believe this approach may be 
the only practical one due to the presence of new and deleted codes on 
an annual basis.
    For example, a service that is described by a single code in a 
given year, like intensity-modulated radiation therapy (IMRT) treatment 
delivery, could be addressed as a misvalued service in a subsequent 
year through a coding revision that splits the service into two codes, 
``simple'' and ``complex.'' If we counted only the reductions in RVUs, 
we would count only the change in value between the single code and the 
new code that describes the ``simple'' treatment delivery code. In this 
scenario, the change in value from the single code to the new 
``complex'' treatment delivery code would be ignored, so that even if 
there were an increase in the payment for IMRT treatment delivery 
service(s) overall, the mere change in coding would contribute 
inappropriately to a ``net reduction in expenditures.'' Therefore, we 
proposed to net the increases and decreases in values for services, 
including those for which there are coding revisions, in calculating 
the estimated net reduction in expenditures as a result of adjustments 
to RVUs for misvalued codes.

[[Page 70925]]

    The following is a summary of the comments we received regarding 
our proposal.
    Comment: One commenter stated that the proposal for calculating net 
reduction is consistent with the plain reading of the statute.
    Response: We appreciate the commenter's feedback and support.
    Comment: Several commenters, including the RUC, requested that CMS 
use a more transparent process for calculation of the target, 
suggesting that the discussion in the CY 2016 PFS proposed rule was not 
sufficiently detailed to allow for replication by external 
stakeholders. Commenters requested that CMS provide a comprehensive 
methodological description of how CMS will calculate the target, 
including publication of dollar figure estimates, and information about 
individual service level estimated impacts on the net reduction. 
Commenters further requested that we provide the impact on the net 
reduction either per CPT code, or that we identify a family of services 
and publish a combined impact for that family. Another commenter 
expressed concern with how CMS will operationalize this policy, noting 
that the language in the CY 2016 PFS proposed rule did not outline 
where the adjustments would be made. The commenter further questioned 
how CMS planned to track the ``savings'' from the revaluation of 
services, and requested that CMS clarify how new technology will be 
handled, as well as new codes that are a restructuring of existing 
codes.
    Response: We appreciate the commenters' feedback. In response to 
the request for greater transparency, we have posted a public use file 
that provides a comprehensive description of how the target is 
calculated as well as the estimated impact by code family on the CMS 
Web site under the supporting data files for the CY 2016 PFS final rule 
at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    In response to the commenter who asked for clarification on how new 
technology will be handled, we assume the commenter intends to ask 
about how new codes for new services would be addressed under our 
proposed methodology. Under our proposal, we would include adjustments 
to values for all deleted, new, and revised codes under our 
calculations of changes from one year to the next. We would also weight 
the changes in the values for those codes by the utilization for those 
services in order to calculate the net reduction in expenditures. If a 
new code describes a new service (new technology as opposed to recoding 
of an existing service), then there would be no utilization for that 
code in the calculation. Without utilization, the value for a new 
service would have no impact on the calculation of the target. In 
response to the commenter who expressed concern about how CMS would 
operationalize this policy, and stated that CMS did not explain where 
the adjustments would be, we note that if the estimated net reduction 
in expenditures is less than the target for the year, then there would 
be an overall reduction to the PFS conversion factor as described in 
section VI. of this final rule with comment period.
    Comment: One commenter disagreed that all increases should be 
incorporated into the net reduction calculation and requested that CMS 
consider an approach that would maximize the overall magnitude of the 
measured reductions in order to prevent an overall reduction to the PFS 
conversion factor as a result of failure to achieve the target for 
reductions. Specifically, the commenter stated that codes identified as 
potentially misvalued for which there is compelling evidence based on 
the RUC recommendations to support an increase in RVUs based on a 
change in work should not be defined as misvalued for the purposes of 
calculating the target.
    Response: We believe the requirement that we calculate the net 
reduction in expenditures indicates that we must account for 
adjustments in values including both increases and decreases and 
therefore, believe our proposal comports with the plain reading of the 
statute. We recognize that the RUC internal deliberations include rules 
that govern under what circumstances individual specialties can request 
that the RUC recommend CMS increase values for particular services. As 
observers to the RUC process, we appreciate having an understanding of 
these rules in the context of our review of RUC-recommended values. 
However, we do not believe that the internal RUC standards for 
developing recommendations are relevant in determining whether the 
statutory provision applies to adjustments to values for individual 
codes.
    Comment: Some commenters requested that CMS review its 
administrative authority to achieve a target recapture amount in a 
selective manner, rather than by an across-the-board adjustment to the 
conversion factor. A commenter stated that codes already sustaining 
reductions in 2016, and consequently contributing to the target, should 
not be subjected to additional across-the-board cuts to achieve the 
statutory target.
    Response: We do not believe that section 1848(c)(2)(O)(iii) of the 
Act provides us authority to insulate particular services from the 
effects of the budget neutrality adjustment for the target recapture 
amount that is required if the estimated net reduction in expenditures 
is less than the target for the year. The statute specifies that an 
amount equal to the target recapture amount is not to be taken into 
account in applying the PFS budget neutrality requirement under section 
1848(c)(2)(B)(ii)(II) of the Act. This PFS budget neutrality adjustment 
has been in place since the outset of the PFS, and we have consistently 
interpreted and implemented it as an adjustment that is made across the 
entire PFS. Therefore, we do not believe we can apply the budget 
neutrality adjustments in a selective manner.
    Comment: Several commenters, including the RUC, stated that when 
considering the net impact of service-level input changes in a given 
year, it is important for CMS to understand specific scenarios in which 
codes under review should not be included in the net reduction target 
calculation. The commenters requested that CMS not include particular 
payment initiatives, such as Advance Care Planning (ACP), in the target 
definition. Instead, since the payment rates for these services require 
budget neutrality and relativity adjustments to all other PFS services 
and these reductions are not otherwise accounted for in the target 
calculation, CMS should count the payments for ACP services as 
``redistribution'' (or, in other words, reductions) from other services 
for CY 2016. Commenters urged CMS to use the same approach for care 
management services valued under the PFS in the future. Generally, the 
commenters stated that these and similar new codes could not possibly 
be misvalued and therefore, should not only be excluded from the 
target, but the reductions to other services due to separate payment 
for these services should be counted as net reductions toward 
achievement of the misvalued code target.
    Response: Because we believe that all of our intended revaluations 
of services under the PFS are intended to improve the accuracy of the 
relative value units for PFS services, we do not believe we should 
exclude increases and decreases to particular services in the target 
calculation. Therefore, we do not agree with commenters' suggestions 
that codes describing one kind of service (e.g. care management) as 
opposed to another (for example, procedures or

[[Page 70926]]

diagnostic tests) should be excluded from the target under the 
statutory provision. Similarly, we do not agree that counting the 
relativity and budget neutrality redistributions that result from care 
management services as part of the net ``reduction'' would be 
consistent with a reasonable understanding of ``net reduction'' in 
allowed expenditures as a result of changes to misvalued codes.
    However, in considering the points raised by commenters, we do 
agree that the increases in value for new codes like ACP or Chronic 
Care Management (CCM) are not the same as increases to other services. 
In general, new codes describe new services that would not have been 
reported with particular codes in the previous years or new codes 
describe existing services that were reported using other codes in the 
prior year. In other cases, however, new codes describe services that 
were previously included in the payment for other codes. When those 
services become separately payable through new codes, we generally make 
adjustments to other relevant codes to adjust for the value of the 
services that will be separately reported. In general, new codes 
describing care management services fall into this latter category, 
since the associated resource costs for these services were previously 
bundled into payment for other services. However, unlike many other PFS 
services, the resource costs for these kinds of services were bundled 
into a set of broadly reported E/M codes and services that include E/M 
visits. Since these codes are so broadly reported across nearly all PFS 
specialties, to the extent that it would be impracticable to make 
adjustments to individual codes, we have not made corresponding 
adjustments to E/M visits to account for the status of the new codes as 
separately billable. Instead, when unbundling new separately reported 
services such as these, we have allowed our general budget neutrality 
adjustment to account for these types of changes, since budget 
neutrality adjustments apply broadly to the full range of PFS services, 
including both codes that specifically describe E/M visits and those 
with E/M services as components of the service, such as all codes with 
global periods. In terms of calculating the net reduction in 
expenditures for purposes of section 1848(c)(2)(O)(i) of the Act, this 
means that the shift in payment to these new separately reportable 
services, unlike the adjustments to values for other new services, is 
not offset by adjustments to any other individual codes. Therefore, 
under the methodology we proposed, the increase in payment for these 
new separately reportable services would be counted in the net 
reduction calculations since the adjustments to values for these 
services are reflected in values for individual codes, but the 
corresponding decreases would not be counted, since the corresponding 
decreases are not attributable to any particular codes. Under the 
methodology we proposed, the change to make these types of codes 
separately reported would be counted against achievement of the target 
even though the increases in value for these codes are fully offset by 
budget-neutrality adjustments to all other PFS services.
    As we have reflected on the comments and on this particular 
circumstance, we do not believe that the change to separate payment for 
these kinds of services should be counted as increases that are 
included in calculating the ``net reductions'' in expenditures 
attributable to adjustments for misvalued codes. Instead, we think that 
the adjustments to value these services should be considered in the 
context of the budget neutrality adjustments that are applied broadly 
to PFS services. This would be consistent with our treatment of the 
increase in values for other new codes since the reductions or deletion 
of predecessor codes are counted as offsets in our calculation. Since, 
under the established ratesetting methodology, the increases in new 
separately reportable services and the corresponding budget neutrality 
decreases fully offset one another and net to zero, we believe that the 
easiest way to account for the adjustments associated with valuing 
these services is to exclude altogether the changes for these types of 
codes from the list of codes included in the target. This will 
effectively make the creation and valuation of such codes neutral in 
the calculation of the misvalued code target.
    After considering public comments, we are finalizing our policy as 
proposed with a modification to exclude from the calculation of the 
``net reduction'' in expenditures changes in coding and valuation for 
services, such as ACP for CY 2016, that are newly reportable, but for 
which no corresponding reduction is made to existing codes and instead 
reductions are taken exclusively through a budget neutrality 
adjustment.
3. Measuring the Adjustments
    The most straightforward method to estimating the net reduction in 
expenditures due to adjustments to RVUs for misvalued codes is to 
compare the total RVUs of the relevant set of codes (by volume) in the 
current year to the update year, and divide that by the total RVUs for 
all codes (by volume) for the current year. This approach had the 
advantage of being intuitive and readily replicable.
    However, there are several issues related to the potential 
imprecision of this method. First, and most significantly, the code-
level PE RVUs in the update year include either increases due to the 
redistribution of RVUs from other services or reductions due to 
increases in PE for other services. Second, because relativity for work 
RVUs is maintained through annual adjustments to the CF, the precise 
value of a work RVU in any given year is adjusted based on the total 
number of work RVUs in that year. Finally, relativity for the MP RVUs 
is maintained by both redistribution of MP RVUs and adjustments to the 
CF, when necessary (under our proposed methodology this is true 
annually; based on our established methodology the redistribution of 
the MP RVUs only takes place once every 5 years and the CF is adjusted 
otherwise). Therefore, to make a more precise assessment of the net 
reduction in expenditures that are the result of adjustments to the 
RVUs for misvalued codes, we would need to compare, for the included 
codes, the update year's total work RVUs (by volume), direct PE RVUs 
(by volume), indirect PE RVUs (by volume), and MP RVUs (by volume) to 
the same RVUs in the current year, prior to the application of any 
scaling factors or adjustments. This would make for a direct comparison 
between years.
    However, this approach would mean that the calculation of the net 
reduction in expenditures would occur within various steps of the PFS 
ratesetting methodology. Although we believe that this approach would 
be transparent and external stakeholders could replicate this method, 
it might be difficult and time-consuming for stakeholders to do so. We 
also noted that when we modeled the interaction of the statutory phase-
in requirement under section 220(e) of the PAMA and the calculation of 
the target using this approach during the development of this proposal, 
there were methodological challenges in making these calculations. When 
we simulated the two approaches using information from prior years, we 
found that both approaches generally resulted in similar estimated net 
reductions. After considering these options, we proposed to use the 
simpler approach of comparing the total RVUs (by volume) for the 
relevant set of codes in the current year to the update year, and 
divide that result by the total RVUs (by volume) for the current year. 
We solicited comments on whether

[[Page 70927]]

comparing the update year's work RVUs, direct PE RVUs, indirect PE 
RVUs, and MP RVUs for the relevant set of codes (by volume) prior to 
the application of any scaling factors or adjustments to those of the 
current year would be a preferable methodology for determining the 
estimated net reduction.
    The following is a summary of the comments we received regarding 
our proposal.
    Comment: A few commenters supported CMS' selection of the simpler 
formula to calculate the target over the more precise but more complex 
formula since it is simpler and easier to understand. One commenter 
stated that CMS did not indicate exactly how similar the two proposals 
are or which method estimated the larger reduction, and stated that CMS 
should make this information available in the final rule and consider 
revising the approach in CY 2017 rulemaking and use the method that 
results in the larger reduction.
    Response: We do not agree that CMS should do both calculations and 
determine which to use based solely on which results in the higher 
amount. We note that the target for net reductions in expenditures from 
adjustments to values for misvalued codes is a multi-year provision and 
we believe neither of the two methodologies is assured to produce a 
consistently higher result from year to year. Since the majority of 
commenters agree that the more intuitive approach to estimating the net 
reduction in expenditures is preferable to the more precisely accurate 
approach, we are finalizing our approach as proposed.
    Comment: One commenter requested that CMS count the full reduction 
in payment for codes subject to the phase-in required under section 
1848(c)(7) of the Act as discussed in section II.F. of this final rule 
with comment period, toward the target in the first year. Another 
commenter stated that CMS used the fully reduced RVUs in calculating 
the target, not the first year phase-in RVUs, and therefore, CMS should 
include the full impact of the change in the equipment utilization rate 
for linear accelerators toward the target calculation. Similarly, the 
commenter requested that any future multi-year phase-in proposals 
should similarly be counted toward the target in the first year.
    Response: The target provision requires the calculation of an 
estimated net reduction measure between 2 years of PFS expenditures. As 
we have detailed in the above paragraphs, we believe that under certain 
specific circumstances, changes should be excluded from that estimate; 
but we do not believe we can include changes that would occur in future 
years based solely on the rulemaking cycle during which policies are 
established. Therefore we will not count the full reduction in payment 
for codes that are subject to the phase-in toward the calculation of 
the net reduction in expenditures for the first year. With regard to 
the commenter that stated that CMS used the fully reduced RVUs in 
calculating the target, we note that we only used the first year phase-
in RVUs and, for the reasons stated above, believe that we are limited 
to including only the changes in the immediate year in the calculation 
of the target.
    After consideration of the public comments received, we are 
finalizing the policy to calculate the net reduction using the simpler 
method as proposed.
4. Target Achievement for CY 2016
    We refer readers to the regulatory impact analysis section of this 
final rule with comment period for our final estimate of the net 
reduction in expenditures relative to the 1 percent target for CY 2016, 
and the resulting adjustment required to be made to the conversion 
factor. Additionally, we refer readers to the public use file that 
provides a comprehensive description of how the target is calculated as 
well as the estimated impact by code family on the CMS Web site under 
the supporting data files for the CY 2016 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

F. Phase-In of Significant RVU Reductions

    Section 1848(c)(7) of the Act, as added by section 220(e) of the 
PAMA, also specifies that for services that are not new or revised 
codes, if the total RVUs for a service for a year would otherwise be 
decreased by an estimated 20 percent or more as compared to the total 
RVUs for the previous year, the applicable adjustments in work, PE, and 
MP RVUs shall be phased-in over a 2-year period. Although section 
220(e) of the PAMA required the phase-in to begin for 2017, section 202 
of the ABLE Act amended section 1848(c)(7) of the Act to require that 
the phase-in begin for CY 2016.
    In the CY 2016 PFS proposed rule, we proposed a methodology to 
implement this statutory provision. In developing this methodology, we 
identified several aspects of our approach for which we specifically 
solicited comments, given the challenges inherent in implementing this 
provision in a manner consistent with the broader statutory construct 
of the PFS. We organized this discussion by identifying and explaining 
these aspects in particular but we solicited comments on all aspects of 
our proposal.
1. Identifying Services That Are Not New or Revised Codes
    As described in this final rule with comment period, the statute 
specifies that services described by new or revised codes are not 
subject to the phase-in of RVUs. We believe this exclusion recognizes 
the reality that there is no practical way to phase-in changes to RVUs 
that occur as a result of a coding change for a particular service over 
2 years because there is no relevant reference code or value on which 
to base the transition. To determine which services are described by 
new or revised codes for purposes of the phase-in provision, we 
proposed to apply the phase-in to all services that are described by 
the same, unrevised code in both the current and update year, and to 
exclude codes that describe different services in the current and 
update year. This approach excludes services described by new codes or 
existing codes for which the descriptors were altered substantially for 
the update year to change the services that are reported using the 
code. We also are excluding as new and revised codes those codes that 
describe a different set of services in the update year when compared 
to the current year by virtue of changes in other, related codes, or 
codes that are part of a family with significant coding revisions. For 
example, significant coding revisions within a family of codes can 
change the relationships among codes to the extent that it changes the 
way that all services in the group are reported, even if some 
individual codes retain the same number or, in some cases, the same 
descriptor. Excluding codes from the phase-in when there are 
significant revisions to the code family would also help to maintain 
the appropriate rank order among codes in the family, avoiding years 
for which RVU changes for some codes in a family are in transition 
while others were fully implemented. This application of the phase-in 
is also consistent with previous RVU transitions, especially for PE 
RVUs, for which we only applied transition values to those codes that 
described the same service in both the current and the update years. We 
also excluded from the phase-in as new and revised codes those codes 
with changes to the global period, since the code in the current year 
would not describe the

[[Page 70928]]

same units of service as the code in the update year.
    We received few comments regarding this aspect of our proposal, and 
some of the comments suggested changes that would require changes to 
the statutory provision that requires the phase-in of significant 
changes in RVUs. The following is a summary of the comments that we 
received.
    Comment: One commenter agreed with CMS' broad definition of new or 
revised.
    Response: We appreciate the commenter's feedback and support.
    Comment: One commenter did not agree that new and revised services 
should be excluded from the phase-in, and suggested that the phase-in 
be applied more broadly.
    Response: Section 1848(c)(7) of the Act specifies that services 
described by new or revised codes are not subject to the phase-in of 
significant reductions in RVUs. Additionally, because RVUs are assigned 
to individual codes, we do not believe there would be a straightforward 
or transparent way to phase in reductions for services that are 
described by new or revised codes between the years for which a phase-
in would apply.
    Comment: One commenter urged CMS to include in the phase-in codes 
that had interim Final values for CY 2015 and have substantial 
reductions of 20 percent or greater as compared to the 2014 values.
    Response: We do not believe it would be consistent with the 
statutory provision to phase in changes in values between 2015 and 2016 
based on 2014 values. Section 1848(c)(7) of the Act, as amended, 
specifies that the phase-in of significant reductions in values begins 
for fee schedules established beginning with 2016.
    Comment: One commenter stated that any code that has a decrease in 
value of over 20 percent due to repricing of expensive supplies (for 
example, over $500) should be excluded from the phase-in provision.
    Response: We appreciate the commenter's feedback and understand the 
rationale for the request; however, we do not believe that we have the 
discretion to exempt codes from the phase-in, regardless of the reason 
for the reduction.
    After consideration of the public comments received on this aspect 
of our proposal to implement the phase-in of significant changes in 
RVUs, we are finalizing the implementation of the phase-in for 
significant (20 percent or greater) reductions in RVUs as proposed.
2. Estimating the 20 Percent Threshold
    Because the phase-in of significant reductions in RVUs falls within 
the budget neutrality requirements specified in section 
1848(c)(2)(B)(ii)(II) of the Act, we proposed to estimate total RVUs 
for a service prior to the budget-neutrality redistributions that 
result from implementing phase-in values. We recognize that the result 
of this approach could mean that some codes may not qualify for the 
phase-in despite a reduction in RVUs that is ultimately slightly 
greater than 20 percent due to budget neutrality adjustments that are 
made after identifying the codes that meet the threshold in order to 
reflect the phase-in values for other codes. We believe the only 
alternative to this approach is not practicable, since it would be 
circular, resulting in cyclical iteration.
    The following is a summary of the comments we received regarding 
this proposal.
    Comment: One commenter supported CMS' proposal for estimating the 
20 percent threshold.
    Response: We appreciate the commenter's support.
    Comment: Another commenter did not agree with the proposal to 
estimate total RVUs for a service prior to the budget-neutrality 
redistributions that result from implementing phase-in values. The 
commenter stated that the methodology should not give inequitable 
treatment to any particular specialty, and instead it should apply to 
all codes that are cut greater than 20 percent in the final analysis.
    Response: We appreciate that our proposed methodology could, in the 
end, result in no phase-in for some codes that ultimately do have a 20 
percent or greater reduction in value after application of required 
budget neutrality adjustment. However, we have no reason to believe 
that this situation, resulting from using initial unadjusted RVUs to 
identify significant RVU reductions, would disadvantage one specialty 
more than the next. Therefore, we also do not believe that our proposed 
approach is likely to result in unequitable treatment to any one 
specialty over another.
    After consideration of the public comments received on this aspect 
of our proposal, we are finalizing without modification our proposal to 
identify significant reductions in RVUs based on a comparison of RVUs 
before application of budget neutrality adjustment.
3. RVUs in the First Year of the Phase-In
    Section 1848(c)(7) of the Act states that the applicable 
adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year 
period when the RVU reduction for a code is estimated to be equal to or 
greater than 20 percent. We believe that there are two reasonable ways 
to determine the portion of the reduction to be phase-in for the first 
year. Most recent RVU transitions have distributed the values evenly 
across several years. For example, for a 2-year transition we would 
estimate the fully implemented value and set a rate approximately 50 
percent between the value for the current year and the value for the 
update year. We believe that this is the most intuitive approach to the 
phase-in and is likely the expectation for many stakeholders. However, 
we believe that the 50 percent phase-in in the first year has a 
significant drawback. For instance, since the statute establishes a 20 
percent threshold as the trigger for phasing in the change in RVUs, 
under the 50 percent phase-in approach, a service that is estimated to 
be reduced by a total of 19 percent for an update year would be reduced 
by a full 19 percent in that update year, while a service that is 
estimated to be reduced by 20 percent in an update year would only be 
reduced 10 percent in that update year.
    The logical alternative approach is to consider a 19 percent 
reduction as the maximum 1-year reduction for any service not described 
by a new or revised code. This approach would be to reduce the service 
by the maximum allowed amount (that is, 19 percent) in the first year, 
and then phase in the remainder of the reduction in the second year. 
Under this approach, the code that is reduced by 19 percent in a year 
and the code that would otherwise have been reduced by 20 percent would 
both be reduced by 19 percent in the first year, and the latter code 
would see an additional 1 percent reduction in the second year of the 
phase-in. For most services, this would likely mean that the majority 
of the reduction would take place in the first year of the phase-in. 
However, for services with the most drastic reductions (greater than 40 
percent), the majority of the reduction would not take place in the 
first year of the phase-in.
    After considering both of these options, we proposed to consider 
the 19 percent reduction as the maximum 1-year reduction and to phase-
in any remaining reduction greater than 19 percent in the second year 
of the phase-in. We believe that this approach is

[[Page 70929]]

more equitable for codes with significant reductions but that are less 
than 20 percent. We solicited comments on this proposal.
    The following is a summary of the comments we received regarding 
this proposal.
    Comment: Several commenters supported CMS' proposal to consider the 
19 percent reduction as the maximum 1-year reduction and to phase in 
any remaining reduction greater than 19 percent in the second year of 
the phase-in.
    Response: We appreciate the commenters' feedback and support.
    Comment: Several commenters did not support CMS' proposal, and 
instead stated that CMS should spread the transition evenly over both 
years--meaning a 50 percent phase-in for year one and year two. One 
commenter stated that this would lead to a more equitable payment 
system and allow physicians more time to make changes in their 
practices to accommodate for reductions. Another commenter acknowledged 
that codes with reductions that are less than 20 percent and not 
phased-in may experience greater reductions in the first year, however 
the commenter stated that a more gradual phase-in for practices facing 
steeper cuts should be the paramount principle for any policy to 
transition cuts at or greater than 20 percent.
    Response: We have considered the comments and understand the 
commenters' concerns. We acknowledge some commenters' views that the 
gradual phase-in of reductions for services that would experience 
reductions above the threshold (20 percent) is an important principle 
in determining the best way to implement the phase-in provision. 
However, we note that the 19 percent reduction maximum also has the 
advantage of applying the most gradual reduction to services with the 
greatest reductions (greater than 40 percent). Furthermore, we remain 
concerned about several practical problems that could arise from 
utilizing the 50 percent approach. The first of these problems would 
occur whenever some codes within the same family of services would meet 
threshold reductions while others do not. For example if two codes in a 
four code family would be reduced by an estimated 20 percent while the 
other two were estimated to be reduced by 19 percent, then the first 
two would be reduced by 10 percent while the remaining two would be 
reduced by 19 percent. Such a scenario could easily create rank order 
anomalies within families of codes. The risks of such anomalies is 
associated with the financial incentives toward inaccurate downward 
coding that could not only jeopardize Medicare claims data as an 
accurate source of information, but more directly could have serious 
consequences within our ratesetting methodologies for both purposes of 
budget neutrality and for allocation of PE and MP RVUs. The second 
practical issue with the 50 percent approach would be that the impact 
of using the estimated reduction instead of the final reduction to 
determine whether or not particular codes qualify for the phase-in 
would be significant. Under the 19 percent approach, values for codes 
with reductions estimated to be very close to 19 percent would be 
similar regardless of whether or not we engage in various iterations of 
budget neutrality adjustments to determine whether or not the phase-in 
applies. Under the 50 percent approach, determinations that result from 
repeated iterations of ratesetting calculations and budget neutrality 
adjustments could decide significant changes in the rates for 
individual codes (up to 10 percent of the total payment.)
    In order to avoid these circumstances and apply the most gradual 
phase-in possible to codes with the most significant reductions, we 
continue to believe that a 19 percent reduction as the maximum 1-year 
reduction is the better approach to determining the phase-in amount.
    Comment: One commenter requested that the phase-in period be 
extended to a greater number of years when entire code groupings are 
impacted, and when multiple codes are identified within a code grouping 
and they significantly impact revenue to a specialist or specific 
provider.
    Response: The statute specifies a 2-year phase-in period and does 
not provide authority to extend the phase-in period as described by the 
commenter.
    After consideration of the comments, we are finalizing the policy 
to phase in 19 percent of the reduction in value in the first year, and 
the remainder of the reduction in the second year, as proposed.
4. Applicable Adjustments to RVUs
    Section 1848(c)(7) of the Act provides that the applicable 
adjustments in work, PE, and MP RVUs be phased-in over 2 years for any 
service for which total RVUs would otherwise be decreased by an 
estimated amount equal to or greater than 20 percent as compared to the 
total RVUs for the previous year. However, for several thousand 
services, we develop separate RVUs for facility and nonfacility sites 
of service. For nearly one thousand other services, we develop separate 
RVUs for the professional and technical components of the service, and 
sum those RVUs for global billing. Therefore, for individual 
practitioners furnishing particular services to Medicare beneficiaries, 
the relevant changes in RVUs for a particular code are based on the 
total RVUs for a code for a particular setting (facility/nonfacility) 
or for a particular professional/technical (PC/TC) component. We 
believe the most straightforward and fair approach to addressing both 
the site of service differential and the codes with professional and 
technical components is to consider the RVUs for the different sites of 
service and components independently for purposes of identifying when 
and how the phase-in applies. We proposed, therefore, to estimate 
whether a particular code met the 20 percent threshold for change in 
total RVUs by taking into account the total RVUs that apply to a 
particular setting, or to a particular professional or technical 
component. This would mean that if the change in total facility RVUs 
for a code met the threshold, then that change would be phased in over 
2 years, even if the change for the total nonfacility RVUs for the same 
code would not be phased in over 2 years. Similarly, if the change in 
the total RVUs for the technical component of a service meets the 20 
percent threshold, then that change would be phased in over 2 years, 
even if the change for the professional component did not meet the 
threshold. (Because the global is the sum of the professional and 
technical components, the portion of the global attributable to the 
technical component would then be phased-in, while the portion 
attributable to the professional component would not be.)
    However, we note that we create the site of service differential 
exclusively by developing independent PE RVUs for each service in the 
nonfacility and facility settings. That is, for these codes, we use the 
same work RVUs and MP RVUs in both settings and vary only the PE RVUs 
to implement the difference in resources depending on the setting. 
Similarly, we use the work RVUs assigned to the professional component 
codes as the work RVUs for the service when billed globally. Like the 
codes with the site of service differential, the PE RVUs for each 
component are developed independently. The resulting PE RVUs are then 
summed for use as the PE RVUs for the code, billed globally. Since 
variation of PE RVUs is the only constant across all individual codes,

[[Page 70930]]

codes with site of service differentials, and codes with professional 
and technical components, we are proposing to apply all adjustments for 
the phase-in to the PE RVUs.
    We considered alternatives to this approach. For example, for codes 
with a site of service differential, we considered applying a phase-in 
for codes in both settings (and all components) whenever the total RVUs 
in either setting reached the 20 percent threshold. However, there are 
cases where the total RVUs for a code in one setting (or one component) 
may reach the 20 percent reduction threshold, while the total RVUs for 
the other setting (or other component) are increasing. In those cases, 
applying phase-in values for work or MP RVUs would mean applying an 
additional increase in total RVUs for particular services. We also 
considered implementing the phase-in of the RVUs for the component 
codes billed globally by comparing the global value in the prior year 
versus the global value in the current year and applying the phase-in 
to the global value for the current year and letting the results flow 
through to the PC and TC for each code, irrespective of their 
respective changes in value. Similarly, for the codes with site of 
service differentials, we considered developing an overall, blended set 
of overall PE RVUs using a weighted average of site of service volume 
in the Medicare claims data and then comparing that blended value in 
the prior year versus the blended value in the current year and 
applying the phase-in to the value for the current year before re-
allocating the blended value to the respective PE RVUs in each setting, 
regardless of the changes in value for nonfacility or facility values. 
We did not pursue this approach for several reasons. First, the 
resulting phase-in amounts would not relate logically to the values 
paid to any individual practitioner, except those who bill the PC/TC 
codes globally. Second, the approach would be so administratively 
complicated that it would likely be difficult to replicate or predict.
    Therefore, we have concluded that applying the adjustments to the 
PE RVUs for all individual codes in order to effect the appropriate 
phase-in amount is the most straightforward and fair approach to 
implementing the 2-year phase-in of significant reductions of total 
RVUs.
    The following is a summary of the comments we received regarding 
this proposal.
    Comment: One commenter requested that CMS confirm that it would 
apply all adjustments for the phase-in to the PE RVUs only in 
situations in which just one site of service, or just one component is 
subject to the phase-in. That is, if both sites of service or both 
components of a code were subject to the phase-in, then any adjustments 
would be applied to work and malpractice RVUs as well.
    Response: As discussed in the proposal, all adjustments for the 
phase-in, including for codes with facility and nonfacility RVUs and 
PC/TC splits, will be applied to the PE RVUs only. We acknowledge that 
for some codes it would be hypothetically possible to phase in the 
reductions proportionally across all three RVU components. As we 
explained in the proposed rule, it would not be practical to do so for 
services with site of service differentials since each of the three RVU 
components represent a different proportion of overall nonfacility or 
facility RVUs. Therefore, we believe this alternative approach could 
only work for codes without site of service differentials and those 
without PC/TC splits, which represents a minority of PFS services. We 
believe that applying the phase-in for these large categories of codes 
differently than for the rest of PFS codes would be confusing to the 
public and make adjustments unpredictable since they would be based on 
whether or not the service priced in the opposite setting met the 
phase-in threshold. Furthermore, we remind commenters that because the 
work RVU is an important allocator of indirect PE in the established 
methodology, the overall payment impact of any changes in work RVUs is 
also automatically reflected in corresponding changes to the PE RVUs, 
whereas changes to direct PE inputs do not have a parallel impact on 
work RVUs. Therefore, even for individual codes for which it might be 
possible to establish phase-in values for work RVUs, the necessary 
adjustments would necessarily be weighted more heavily in PE RVUs.
    Comment: With regard to CMS' proposal to consider the RVUs for 
different sites of service and components independently for the 
purposes of identifying when and how the phase-in applies, one 
commenter expressed concerns that the proposed approach ignores the 
spirit of section 220(e) of the PAMA to benefit physician practices by 
dampening the year to year impact of large payment reductions. The 
commenter stated that if CMS adjusts only the PE RVUs, then a large 
number of codes with greater than 20 percent work RVU reductions could 
be excluded. The commenter urged CMS to clarify its intent to dampen 
the effects of year to year reductions to both work RVUs and PE RVUs 
independently, even for codes with separate facility and non-facility 
PE RVUs.
    Response: We appreciate the commenter's feedback and we acknowledge 
that our proposed approach would not dampen the year to year reductions 
in work RVUs. However, our approach would dampen the effect of any 
payment reductions for all codes, including those reductions that would 
result from reductions to work RVUs when such reductions contributed to 
an overall reduction of 20 percent or greater, consistent with the 
statutory provision. As a practical matter, we believe that 
practitioners reporting services furnished to Medicare beneficiaries 
and paid through the PFS would be paid very similar amounts regardless 
of which approach we implemented. We also note that the commenter did 
not provide any information that would help us to understand how the 
suggested phase-in could be applied to services with site of service 
differentials.
    After consideration of the comments received, we are finalizing 
this aspect of the phase-in methodology as proposed.
    The list of codes subject to the phase-in and the associated RVUs 
that result from this methodology are available on the CMS Web site 
under downloads for the CY 2016 PFS final rule with comment period at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

G. Changes for Computed Tomography (CT) Under the Protecting Access to 
Medicare Act of 2014 (PAMA)

    Section 218(a)(1) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93) amended section 1834 of the Act by establishing 
a new subsection 1834(p). Effective for services furnished on or after 
January 1, 2016, new section 1834(p) of the Act reduces payment for the 
technical component (TC) of applicable CT services paid under the 
Medicare PFS and applicable CT services paid under the OPPS (a 5-
percent reduction in 2016 and a 15-percent reduction in 2017 and 
subsequent years). The applicable CT services are identified by HCPCS 
codes 70450 through 70498; 71250 through 71275; 72125 through 72133; 
72191 through 72194; 73200 through 73206; 73700 through 73706; 74150 
through 74178; 74261 through 74263; and 75571 through 75574 (and any 
succeeding codes). As specified in section 1834(p)(4) of the Act, the 
reduction applies for applicable services furnished using equipment 
that does not meet

[[Page 70931]]

each of the attributes of the National Electrical Manufacturers 
Association (NEMA) Standard XR-29-2013, entitled ``Standard Attributes 
on CT Equipment Related to Dose Optimization and Management.'' Section 
1834(p)(4) of the Act also specifies that the Secretary may apply 
successor standards through rulemaking.
    Section 1834(p)(6)(A) of the Act requires that information be 
provided and attested to by a supplier and a hospital outpatient 
department that indicates whether an applicable CT service was 
furnished that was not consistent with the standard set forth in 
section 1834(p)(4) of the Act (currently the NEMA CT equipment 
standard) and that such information may be included on a claim and may 
be a modifier. Section 1834(p)(6)(A) of the Act also provides that such 
information must be verified, as appropriate, as part of the periodic 
accreditation of suppliers under section 1834(e) of the Act and 
hospitals under section 1865(a) of the Act. Section 218(a)(2) of the 
PAMA made a conforming amendment to section 1848 (c)(2)(B)(v) of the 
Act by adding a new subclause (VIII), which provides that, effective 
for fee schedules established beginning with 2016, reduced expenditures 
attributable to the application of the quality incentives for computed 
tomography under section 1834(p) of the Act shall not be taken into 
account for purposes of the budget neutrality calculation under the 
PFS.
    To implement this provision, in the CY 2016 PFS proposed rule (80 
FR 41716), we proposed to establish a new modifier to be used on claims 
that describes CT services furnished using equipment that does not meet 
each of the attributes of the NEMA Standard XR-29-2013. We proposed 
that, beginning January 1, 2016, hospitals and suppliers would be 
required to use this modifier on claims for CT scans described by any 
of the CPT codes identified in this section (and any successor codes) 
that are furnished on non-NEMA Standard XR-29-2013-compliant CT scans. 
We stated that the use of this proposed modifier would result in the 
applicable payment reduction for the CT service, as specified under 
section 1834(p) of the Act. We received the following comments on our 
proposal to require the modifier to be used on claims:
    Many commenters endorsed the use of quality incentives to improve 
patient safety and optimize the use of radiation when providing CT 
diagnostic imaging services. Several commenters were supportive of the 
proposal to establish the modifier to identify CT services furnished 
using equipment that does not meet each of the attributes of the NEMA 
Standard XR-29-2013.
    Comment: Several commenters requested that we delay implementation 
of section 1834(p) of the Act so that they have additional time to 
comply before the payment reduction becomes effective.
    Response: The statute requires that we apply the payment adjustment 
for computed tomography services furnished on or after January 1, 2016. 
Given this language, we believe that we must implement this provision 
beginning January 1, 2016. Therefore, we are not delaying 
implementation of this provision. We note that the payment reduction 
for 2016 is 5 percent, and it then increases to 15 percent in 
subsequent years. Hospitals and suppliers that furnish services that do 
not meet the equipment standard as of January 1, 2016, will receive 
this 5 percent payment reduction during 2016, but will have an 
opportunity to upgrade their CT scanners before the larger payment 
adjustment that takes effect beginning in CY 2017.
    Comment: One commenter cited section 1834 (p)(4) of the Act, which 
specifies that through rulemaking, the Secretary may apply successor 
standards for CT equipment. The commenter indicated that CMS should 
develop successor standards that exempt CT scans performed on cone beam 
CT (CBCT) scanners that are FDA cleared only for imaging of the head 
from the requirement for Automatic Exposure Control (AEC) capability. 
This request was based on the AEC capability being unavailable on CBCT 
scanners.
    Response: Although we agree with the commenter that the Secretary 
has authority to apply successor standards for CT equipment through 
notice and comment rulemaking, we would like to gain some experience 
with the NEMA Standard XR-29-2013 before adopting a successor standard. 
Therefore, we are not adopting a successor standard to the NEMA 
Standard XR-29-2013 in this final rule with comment period, but may 
consider doing so in future rulemaking.
    After consideration of the public comments we received, we are 
finalizing the establishment of new modifier, ``CT.'' This 2-digit 
modifier will be added to the HCPCS annual file as of January 1, 2016, 
with the label ``CT,'' and the long descriptor ``Computed tomography 
services furnished using equipment that does not meet each of the 
attributes of the National Electrical Manufacturers Association (NEMA) 
XR-29-2013 standard''.
    Beginning January 1, 2016, hospitals and suppliers will be required 
to report the modifier ``CT'' on claims for CT scans described by any 
of the CPT codes identified in this section (and any successor codes) 
that are furnished on non-NEMA Standard XR-29-2013-compliant CT 
scanners. The use of this modifier will result in the applicable 
payment reduction for the CT service, as specified under section 
1834(p) of the Act.

H. Valuation of Specific Codes

1. Background
    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 work RVUs for CY 1997, CY 2002, CY 
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 
2011. 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, as discussed in section II.B.5. of this 
final rule with comment period. Each year, when we received RUC 
recommendations, our process has been to establish interim final RVUs 
for the potentially misvalued codes, new codes, and any other codes for 
which there were coding changes in the final rule with comment period 
for a year. Then, during the 60-day period following the publication of 
the final rule with comment period, we accept public comment about 
those valuations.
    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 with comment period. 
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.

[[Page 70932]]

2. Process for Valuing New, Revised, and Potentially Misvalued Codes
    In the CY 2015 PFS final rule with comment period, we finalized a 
new process for establishing values for new, revised and potentially 
misvalued codes. Under the new process, we include proposed values for 
these services in the proposed rule, rather than establishing them as 
interim final in the final rule with comment period. CY 2016 represents 
a transition year for this new process. For CY 2016, we proposed new 
values in the CY 2016 proposed rule for the codes for which we received 
complete RUC recommendations by February 10, 2015. For recommendations 
regarding any new or revised codes received after the February 10, 2015 
deadline, including updated recommendations for codes included in the 
CY 2016 proposed rule, we are establishing interim final values in this 
final rule with comment period, consistent with previous practice. In 
this final rule with comment period, we considered all comments 
received in response to proposed values for codes in our proposed rule, 
including alternative recommendations to those used in developing the 
proposed rule.
    Beginning with valuations for CY 2017, the new process will be 
applicable to all codes. That is, 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 to 
facilitate continued payment for certain services for which we do not 
receive 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 
recommendations in time to propose values.
    For CY 2016, we received RUC recommendations prior to February 10, 
2015 for many new, revised and potentially misvalued codes and are 
establishing final values for those codes in this final rule with 
comment period. However, the RUC recommendations included CPT tracking 
codes instead of the actual 2016 CPT codes, which were first made 
available to the public subsequent to the publication of the CY 2016 
proposed rule with comment period. Because CPT procedure codes are 5 
alpha-numeric characters but CPT tracking codes typically have 6 or 7 
alpha-numeric characters and CMS systems only utilize 5-character HCPCS 
codes, we developed and used alternative 5-character placeholder codes 
for use in the proposed rule. The final CPT codes are included and used 
for purposes of discussion in this final rule with comment period. 
Table 9 lists the CPT tracking codes, the CMS placeholder codes, and 
the final CPT codes for all new CPT codes included in the CY 2016 PFS 
proposed rule.

                         Table 9--2016 Final Rule HCPCS Placeholder to CPT Code Numbers
----------------------------------------------------------------------------------------------------------------
                                                      CMS
               CPT Tracking code                  Placeholder      CPT 2016             Short descriptor
                                                     code
----------------------------------------------------------------------------------------------------------------
3160X1........................................           3160A           31652  Bronch ebus samplng 1/2 node.
3160X2........................................           3160B           31653  Bronch ebus samplng 3/> node.
3160X3........................................           3160C           31654  Bronch ebus ivntj perph les.
3347X1........................................           3347A           33477  Implant tcat pulm vlv perq.
3725X1........................................           3725A           37252  Intrvasc us noncoronary 1st.
3725X2........................................           3725B           37253  Intrvasc us noncoronary addl.
3940X1........................................           3940A           39401  Mediastinoscpy w/medstnl bx.
3940X2........................................           3940B           39402  Mediastinoscpy w/lmph nod bx.
5039X1........................................           5039A           50430  Njx px nfrosgrm &/urtrgrm.
5039X2........................................           5039B           50431  Njx px nfrosgrm &/urtrgrm.
5039X3........................................           5039C           50432  Plmt nephrostomy catheter.
5039X4........................................           5039D           50433  Plmt nephroureteral catheter.
5039X13.......................................           5039M           50434  Convert nephrostomy catheter.
5039X5........................................           5039E           50435  Exchange nephrostomy cath.
5069X7........................................           5069G           50693  Plmt ureteral stent prq.
5069X8........................................           5069H           50694  Plmt ureteral stent prq.
5069X9........................................           5069I           50695  Plmt ureteral stent prq.
5443X1........................................           5443A           54437  Repair corporeal tear.
5443X2........................................           5443B           54438  Replantation of penis.
657XX7........................................           657XG           65785  Impltj ntrstrml crnl rng seg.
692XXX........................................           692XX           69209  Remove impacted ear wax uni.
7208X1........................................           7208A           72081  X-ray exam entire spi 1 vw.
7208X2........................................           7208B           72082  X-ray exam entire spi 2/3 vw.
7208X3........................................           7208C           72083  X-ray exam entire spi 4/5 vw.
7208X4........................................           7208D           72084  X-ray exam entire spi 6/> vw.
7778X1........................................           7778A           77767  Hdr rdncl skn surf brachytx.
7778X2........................................           7778B           77768  Hdr rdncl skn surf brachytx.
7778X3........................................           7778C           77770  Hdr rdncl ntrstl/icav brchtx.
7778X4........................................           7778D           77771  Hdr rdncl ntrstl/icav brchtx.
7778X5........................................           7778E           77772  Hdr rdncl ntrstl/icav brchtx.
8835X0........................................           8835X           88350  Immunofluor antb addl stain.
9254X1........................................           9254A           92537  Caloric vstblr test w/rec.
9254X2........................................           9254B           92538  Caloric vstblr test w/rec.
99176X........................................           9917X           99177  Ocular instrumnt screen bil.
9935XX1.......................................           9935A           99415  Prolong clincl staff svc.
9935XX2.......................................           9935B           99416  Prolong clincl staff svc add.
GXXX1.........................................           GXXX1           G0296  Visit to determ ldct elig.
GXXX2.........................................           GXXX2           G0297  Ldct for lung ca screen.
----------------------------------------------------------------------------------------------------------------


[[Page 70933]]

3. Methodology for Establishing Work RVUs
    We conducted a review of each code identified in this section and 
reviewed the current work RVU (if any), RUC-recommended work RVU, 
intensity, time to furnish the preservice, intraservice, and 
postservice activities, as well as other components of the service that 
contribute to the value. Our review of recommended work RVUs and time 
generally includes, but is not limited to, a review of information 
provided by the RUC, 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, as 
well as Medicare claims data. 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 building block 
components could be the CPT codes that make up the bundled code and the 
inputs associated with those codes. Magnitude estimation refers to a 
methodology for valuing work that determines the appropriate work RVU 
for a service by gauging the total amount of work for that service 
relative to the work for a similar service across the PFS without 
explicitly valuing the components of that work. In addition to these 
methodologies, CMS has frequently utilized an incremental methodology 
in which we value a code based upon its incremental difference between 
another code or another family of codes. Since the statute specifically 
defines the work component as the resources in time and intensity 
required in furnishing the service and the published literature on 
valuing work has recognized the key role of time in overall work, we 
have also refined the work RVUs for particular codes in direct 
proportion to the changes in the best information regarding the time 
resources involved in furnishing particular services, either 
considering the total time or the intra-service time.
    Comment: Several commenters objected to CMS' use of these 
methodologies as unprecedented and invalid in the context of the 
development of PFS RVUs.
    Response: We appreciate that many commenters, including the RUC, 
have maintained that magnitude estimation, informed by survey results, 
is the only appropriate method for valuation of PFS services. However, 
we have observed that the approaches used by the RUC in developing 
recommended work RVUs have resulted in recommended values that do not 
adequately address significant changes in assumptions regarding the 
amount of time required to furnish particular PFS services. Since 
section 1848(c)(1)(A) of the Act explicitly identifies time as one of 
the two kinds of resources that comprise the work component of PFS 
payment, we do not believe that our use of the above methodologies is 
inconsistent with the statutory requirements related to the maintenance 
of work RVUs, and we have regularly used these and other methodologies 
in developing values for PFS services. 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. In our review of RUC-recommended values, we have noted that 
the RUC also uses a variety of methodologies to develop work RVUs for 
individual services, and subsequently validates the results of these 
approaches through magnitude estimation. We believe that our discrete 
use of methodologies that compare the time resources among PFS codes is 
fundamentally similar to that approach, but better facilitates our 
ability to identify the most accurate work RVU for individual services 
by explicitly considering the significance of time in the estimate of 
total work.
    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 
value services appropriately when they have common billing patterns. In 
cases where a service is typically furnished to a beneficiary on the 
same day as an 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 work 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 multiplied by 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 x 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, now addresses the 
overlap in time and work when a service is typically provided on the 
same day as an E/M service.
    Table 13 contains a list of codes for which we proposed work RVUs; 
this includes all RUC recommendations received by February 10, 2015. 
When the proposed work RVUs varied from those recommended by the RUC or 
for which we do not have RUC

[[Page 70934]]

recommendations, we address those codes in the portions of this section 
that are dedicated to particular codes. The work RVUs and other payment 
information for all CY 2016 payable codes are available in Addendum B. 
Addendum B is available on the CMS Web site under downloads for the CY 
2016 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/. The time values for all CY 2016 codes are 
listed in a file called ``CY 2016 PFS Work Time,'' available on the CMS 
Web site under downloads for the CY 2016 PFS final rule with comment 
period at http://www.cms.gov/physicianfeesched/downloads/.
4. Methodology for Establishing the Direct PE Inputs Used To Develop PE 
RVUs
a. Background
    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. 
Like our review of recommended work RVUs, our review of recommended 
direct PE inputs generally includes, but is not limited to, a review of 
information provided by the RUC, 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, as well as Medicare claims data. 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 the 
recommendations. 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, 
consistent with the principles of relativity, and reflect our payment 
policies, we use those direct PE inputs to value a service. If not, we 
refine the recommended 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.
    Our review and refinement of RUC-recommended direct PE inputs 
includes many refinements that are common across codes as well as 
refinements that are specific to particular services. Table 16 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In this final rule with comment period, we address 
several refinements that are common across codes, and refinements to 
particular codes are addressed in the portions of this section that are 
dedicated to particular codes. We note that for each refinement, we 
indicate the impact on direct costs for that service. We note that, on 
average, in any case where the impact on the direct cost for a 
particular refinement is $0.32 or less, the refinement has no impact on 
the interim final PE RVUs. This calculation considers both the impact 
on the direct portion of the PE RVU, as well as the impact on the 
indirect allocator for the average service. We also note that nearly 
half of the refinements listed in Table 14 result in changes under the 
$0.32 threshold and are unlikely to result in a change to the final 
RVUs.
    We also note that the final direct PE inputs for CY 2016 are 
displayed in the final CY 2016 direct PE input database, available on 
the CMS Web site under the downloads for the CY 2016 final rule at 
www.cms.gov/PhysicianFeeSched/. The inputs displayed there have also 
been used in developing the CY 2016 PE RVUs as displayed in Addendum B 
of this final rule.
b. Common Refinements
(1) Changes in Work Time
    Some direct PE inputs are directly affected by revisions in work 
time. Specifically, changes in the intraservice portions of the work 
time and changes in the number or level of postoperative visits 
associated with the global periods result in corresponding changes to 
direct PE inputs. Although the direct PE input recommendations 
generally correspond to the work time values associated with services, 
we believe that in some cases inadvertent discrepancies between work 
time values and direct PE inputs should be refined in the establishment 
of interim final direct PE inputs. In other cases, CMS refinement of 
RUC-recommended work times prompts necessary adjustments in the direct 
PE inputs.
    We proposed to remove the 6 minutes of clinical labor time allotted 
to ``discharge management, same day (0.5 x 99238)'' in the facility 
setting from a number of procedures under review. We proposed to align 
the clinical labor for discharge day management to align the work time 
assigned in the work time file. We made these proposed refinements 
under the belief that we should not allocate clinical labor staff time 
for discharge day management if there is no discharge visit included in 
the procedure's global period.
    Comment: Several commenters, including the RUC, disagreed with CMS 
and suggested that the clinical staff time in the facility setting may 
not conform with work time for discharge day management in a given 
code. Commenters stated that the work discharge time reflects the work 
involved in discharging from a facility setting. Therefore, if the 
service is typically performed in the nonfacility setting, the post-
service time for a CPT code 99238 discharge visit would not be 
included. However, since the inputs for PE are differentiated by site 
of service, the time for discharge day might be included in the 
facility inputs, even if the service is infrequently provided in the 
facility setting overall. Although the commenters agreed that there 
should not be clinical staff time for discharge management assigned to 
0-day global procedures, the commenters requested that this clinical 
staff time be restored for the nine 10-day global procedures under 
review. Commenters stressed that clinical staff must instruct the 
patient regarding home care prior to the post-operative visit and call 
in any necessary prescriptions. Commenters also requested that this 
clinical labor time be included as two, 3-minute phone calls under the 
task ``Conduct phone calls/call in prescriptions.''
    Response: We understand and agree that when cases typically 
performed in the non-facility setting are performed in the facility 
setting, discharge day management may not be typical for the code 
overall even if discharge day management activities may be typical when 
the service is furnished in the facility setting. However, we also 
believe that if a patient's conditions are serious enough to warrant 
treatment in the facility setting, then it is likely that the patient 
will also be receiving additional services that already include the 
resource costs involved with clinical labor tasks associated with 
discharge day management. Therefore, we do not believe that it is 
appropriate to include the additional time for staff phone calls for 
these services generally furnished in the office setting.
    We have thus far been addressing the subject of discharge day 
management on a code-by-code basis. Based on the comments received, we 
believe there is a need for a broader policy concerning the proper 
treatment of this issue. We will consider this subject for future 
rulemaking.
    After consideration of the comments received, we are finalizing our 
current

[[Page 70935]]

refinements to discharge day management clinical labor time.
(2) 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 time 
within the intraservice 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 those services for which we allocate cleaning 
time to portable equipment items, because the portable equipment does 
not need to be cleaned in the room where the service is furnished, we 
do not include that cleaning time for the remaining equipment items as 
those items and the room are both available for use for other patients 
during that time. In addition, when a piece of equipment is typically 
used during follow-up post-operative 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 (the clinical labor service period) and are 
typically available for other patients even when one member of the 
clinical staff may be occupied with a pre- service or post-service task 
related to the procedure. We also note that we believe these same 
assumptions would apply to inexpensive equipment items that are used in 
conjunction with and located in a room with non-portable highly 
technical equipment items. Some stakeholders have objected to this 
rationale for our refinement of equipment minutes on this basis and 
have reiterated these objections in comments regarding the proposed 
direct PE inputs. We are responding to these comments by referring the 
commenters to our extensive discussion in response to the same 
objections in the CY 2012 PFS final rule with comment period (76 FR 
73182) and the CY 2015 PFS final rule with comment period (79 FR 
67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
    In general, the preservice, intraservice period, and postservice 
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 RUC-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 and any rationale 
provided for the deviations. When we do not accept the RUC-recommended 
exceptions, we refine the proposed direct PE inputs to conform to the 
standard times for those tasks. In addition, in cases when a service is 
typically billed with an E/M service, 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.'' 
We believe that continual addition of new and distinct clinical labor 
tasks each time a code is reviewed under the misvalued code initiative 
is likely to degrade relativity between newly reviewed services and 
those with already existing inputs. To mitigate the potential negative 
impact of these additions, we review these tasks to determine whether 
they are fully distinct from existing clinical labor tasks, typically 
included for other clinically similar services under the PFS, and 
thoroughly explained in the recommendation. For those tasks that do not 
meet these criteria, we do not accept these newly recommended clinical 
labor tasks; two examples of such tasks encountered during our review 
of the recommendations include ``Enter data into laboratory information 
system, multiparameter analyses and field data entry, complete quality 
assurance documentation'' and ``Consult with pathologist regarding 
representation needed, block selection and appropriate technique.''
    In conducting our review of the RUC recommendations for CY 2016, we 
noted that several of the recommended times for clinical labor tasks 
associated with pathology services differed across codes, both within 
the CY 2016 recommendations and in comparison to codes currently in the 
direct PE database. We refer readers to Table 16 in section II.A.3. of 
this final rule with comment period for a discussion of these 
standards.
    Comment: Several commenters stated that our standard clinical labor 
inputs for digital imaging inputs for many different codes do not 
reflect the accurate number of minutes associated with clinical labor 
tasks for individual services.
    Response: In the CY 2015 PFS final rule with comment period (79 FR 
67561), we finalized the transition from film-based to digital direct 
PE inputs for imaging services. In the CY 2016 PFS proposed rule, we 
sought comment on the appropriate values for the clinical labor tasks 
associated with digital imaging. Please see section II.B. of this rule 
for a discussion of those policies. We believe that adherence to these 
standards produces the most accurate estimate of the resource costs for 
these kinds of tasks and supports relativity within the development of 
PE RVUs. For these reasons, absent extenuating factors for specific 
codes, we are finalizing interim final direct PE inputs that adhere to 
these standards.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment that cannot be allocated to individual 
services or patients. Two examples of such items are ``emergency 
service container/safety kit'' and ``service contract.'' We have 
addressed these kinds of recommendations in previous rulemaking (78 FR 
74242), and we do not use these recommended items as direct PE inputs 
in the calculation of PE RVUs.
(5) Moderate Sedation Inputs
    Over several rulemaking cycles, we have proposed and finalized a 
standard package of direct PE inputs for services where moderate 
sedation is considered inherent in the procedure (76 FR 73043 through 
73049). Our CY 2016 proposed direct PE inputs conform to these 
policies. This includes not

[[Page 70936]]

incorporating the recommended power table (EF031) where it was included 
during the intraservice period, since a stretcher is the standard item 
in the moderate sedation package. These refinements are reflected in 
the final CY 2016 PFS direct PE input database and detailed in Table 
16.
    Comment: One commenter agreed with CMS' proposal to include the use 
of a stretcher in the standard moderate sedation package, and that the 
time allocated for the stretcher should be the entire post procedure 
recovery period. The commenter recommended that CMS work with the RUC 
and specialty groups before removing the power table input from the 
service period of any codes.
    Response: We appreciate the commenter's support for the standard 
moderate sedation package, but we do not believe we should consult with 
the RUC prior to implementing the standards in developing or finalizing 
direct PE inputs. However, will consider the appropriate direct PE 
inputs for each code under review.
(6) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
and potentially misvalued codes. Some recommendations include supply or 
equipment items that are not currently in the direct PE input database. 
In these cases, the RUC has historically recommended that a new item be 
created and has facilitated our pricing of that item by working with 
the specialty societies to provide us copies of sales invoices. For CY 
2016, we received invoices for several new supply and equipment items. 
We have accepted the majority of these items and added them to the 
direct PE input database. Tables 18 and 19 detail the invoices received 
for new and existing items in the direct PE database. As discussed in 
section II.A. of this final rule with comment period, we encourage 
stakeholders to review the prices associated with these new and 
existing items to determine whether these prices appear to be accurate. 
Where prices appear inaccurate, we encourage stakeholders to provide 
invoices or other information to improve the accuracy of pricing for 
these items in the direct PE database. We remind stakeholders that due 
to the relativity inherent in the development of RVUs, reductions in 
existing prices for any items in the direct PE database increase the 
pool of direct PE RVUs available to all other PFS services. Tables 18 
and 19 also include the number of invoices received as well as the 
number of nonfacility allowed services for procedures that use these 
equipment items. We provide the nonfacility allowed services so that 
stakeholders will note the impact the particular price might have on PE 
relativity, as well as to identify items that are used frequently, 
since we believe that stakeholders are more likely to have better 
pricing information for items used more frequently. We are concerned 
that a single invoice may not be reflective of typical costs and 
encourage stakeholders to provide additional invoices so that we might 
identify and use accurate prices in the development of PE RVUs.
    In some cases, we do not use the price listed on the invoice that 
accompanies the recommendation because we identify publicly available 
alternative prices or information that suggests a different price is 
more accurate. In these cases, we include this in the discussion of 
these codes. In other cases, we cannot adequately price a newly 
recommended item due to inadequate information. Sometimes, no 
supporting information regarding the price of the item has been 
included in the recommendation. In other cases, the supporting 
information does not demonstrate that the item has been purchased at 
the listed price (for example, vendor price quotes instead of paid 
invoices). In cases where the information provided on the item allows 
us to identify clinically appropriate proxy items, we might use 
existing items as proxies for the newly recommended items. In other 
cases, we have included the item in the direct PE input database 
without any associated price. Although including the item without an 
associated price means that the item does not contribute to the 
calculation of the proposed PE RVU for particular services, it 
facilitates our ability to incorporate a price once we obtain 
information and are able to do so.
    The following is a summary of the comments we received regarding 
new supply and equipment items.
    Comment: Several commenters stated that they had concerns regarding 
the process of pricing new supply and equipment items for the PFS. The 
current process requires the submission of recently paid invoices for 
CMS to consider pricing a new direct PE item. The commenters asked CMS 
to develop a new pathway to submit pricing information that will 
protect physicians and vendors, since publishing copies of paid 
invoices, even when redacted, does not sufficiently protect private 
identities.
    Response: We share commenters' concerns about protecting the 
privacy of practitioners and vendors during invoice submission. We 
welcome and will consider additional feedback and suggestions submitted 
by stakeholders regarding alternate avenues to provide updated pricing 
information for individual supplies and equipment.
    Comment: A commenter stated that although the commenter understands 
that CMS cannot accurately value the typical cost of a supply or 
equipment if the agency is not provided with sufficient pricing 
information, they disagreed with CMS' decision to list the item in 
question in the direct PE database without assigning any value to it, 
as this can significantly affect the overall PE value for that service. 
The commenter requested that CMS highlight those cases where the price 
of a supply or equipment item is not being finalized due to inadequate 
documentation, so that there is an opportunity to provide additional 
resources that might assist in assigning an accurate value.
    Response: We agree with the commenter that a lack of sufficient 
pricing information can often be problematic in assigning an accurate 
value to new supplies and equipment. Although we do not specifically 
identify all such items in the preamble to PFS rules, we note that 
stakeholders can easily identify items without prices in the direct PE 
input database files that are included as downloads with each PFS rule. 
We urge the public to submit a comment alerting us to items without a 
price that appear to be errors in the database. As detailed above, we 
also encourage the submission of invoices to help provide up-to-date, 
accurate pricing information for medical supplies and equipment.
    Comment: A commenter wrote to express concern with the pricing of 
three supplies: Probe, radiofrequency, three array (StarBurstSDE) 
(SD109) from $1995 to $353.44; gas, helium (SD079) from 25 cents per 
cubic foot to one cent per cubic foot; and gas, argon (SD227) from 25 
cents per cubic foot to less than one cent per cubic foot. The 
commenter added that there was no evidence that supported lower prices 
for these supplies, and urged CMS to retain the existing pricing for 
these supply items. The commenter stated that CMS' concerns regarding 
the price of these supplies were not addressed in the proposed rule, 
which did not allow opportunity for public comment.
    Response: The prices of these three supplies were updated in 
response to invoices received during the previous calendar year. We 
appreciate the commenters' feedback and we recognize that it would have 
been easier for stakeholders to identify the prices had they been 
included on the Invoices

[[Page 70937]]

Received for Existing Direct PE Inputs table in the proposed rule. We 
believe that the commenter may have been mistaken about the pricing of 
supplies SD079 and SD227. Both of these supplies have increased in 
price, from 25 cents per cubic foot to 57 cents and 32 cents per cubic 
foot, respectively. Neither supply has been lowered in price to one 
cent per cubic foot. Absent better data sources, we continue to believe 
that the supply prices listed in the public use files for the CY 2016 
PFS proposed rule are the most accurate values for these items.
    Comment: Many commenters wrote to express their concern over the 
pricing of the radiofrequency generator (NEURO) (EQ214) equipment 
affecting CPT codes 41530, 43228, 43229, 43270, 64633, 64634, 64635 and 
64636. Commenters indicated that the invoice for this new equipment 
item was submitted in relation to CPT code 41530, and the equipment is 
not the same radiofrequency generator used to perform the services 
described by CPT codes 64633, 64634, 64635 and 64636. Commenters 
requested that the equipment input represented in the invoice be 
assigned an equipment code separate from existing code EQ214 and that 
CMS maintain the current price of $32,900 for EQ214.
    Response: We appreciate the additional information provided by 
commenters regarding the pricing of the radiofrequency generator 
equipment. After consideration of comments received, we will create a 
new equipment code for the radiofrequency generator described in the 
submitted invoice, and assign this equipment to CPT codes 41530, 43228, 
43229, and 43270. For CPT codes 64633, 64634, 64635, and 64636, we will 
maintain the current price of $32,900 for EQ214 and maintain this 
equipment.
    Comment: One commenter submitted additional invoices regarding the 
pricing of the PrePen (SH103) supply. The commenter requested that CMS 
update the price of the PrePen to $92 based on an average of the four 
invoices submitted.
    Response: We appreciate the commenter's submission of additional 
pricing information regarding the PrePen supply. We note that three of 
the four submitted invoices reported a price of $86 for supply item 
``PrePen'' (SH103); we believe that this represents the typical price 
of this supply.
    Therefore, after consideration of the comments received, we are 
increasing the price of supply SH103 from $83 to $86.
(7) Service Period Clinical Labor Time in the Facility Setting
    Several of the PE worksheets included in RUC recommendations 
contained clinical labor minutes assigned to the service period in the 
facility setting. Our proposed inputs did not include these minutes 
because the cost of clinical labor during the service period for a 
procedure in the facility setting is not considered a resource cost to 
the practitioner since Medicare makes separate payment to the facility 
for these costs. We received no general comments that addressed this 
issue; we will address code-specific refinements to clinical labor in 
the individual code sections.
(8) Duplicative Inputs
    Several of the PE worksheets included in the RUC recommendations 
contained time for the equipment item ``xenon light source'' (EQ167). 
Because there appear to be two special light sources already present 
(the fiberoptic headlight and the endoscope itself) in the services for 
which this equipment item was recommended by the RUC, we did not 
propose to include the time for this equipment item from these 
services. In the proposed rule, we solicited comments on whether there 
is a rationale for including this additional light source as a direct 
PE input for these procedures.
    The following is a summary of the comments we received.
    Comment: One commenter stated that if CMS believes two light 
sources are duplicative for these procedures, the commenter recommended 
retaining input EQ167 and removing input EQ170 (the fiberoptic 
headlight), as the xenon light source is compatible with various items 
and can serve as the light source throughout the procedures.
    Response: We appreciate the additional information from the 
commenter regarding the appropriate use of these two light sources.
    After consideration of comments received, we are restoring input 
EQ167 and removing input EQ170 with the same number of equipment 
minutes for CPT codes 30300, 31295, 31296, 31297, and 92511.
(9) Identification of Database Errors
    Several commenters identified possible errors in the direct PE 
database that did not apply to CPT codes under review. The following is 
a summary of the comments we received regarding potential database 
entry errors.
    Comment: A commenter located a potential error for CPT code 33262 
(Removal of implantable defibrillator pulse generator with replacement 
of implantable defibrillator pulse generator; single lead system) where 
the PE RVU dropped from 3.68 in 2015 to 2.35 in the CY 2016 PFS 
proposed rule. The commenter pointed out that no changes were made to 
the direct PE inputs for the code, and similar codes within the same 
family retained the same PE value. The commenter recommended that CMS 
review this PE RVU and make a correction in the final rule.
    Response: For CPT code 33262, the pre-existing direct PE inputs for 
this code were inadvertently not included in the development of the CY 
2016 PFS proposed direct PE input database . We believe this was the 
result of a data error, and therefore, we are restoring the direct PE 
inputs to this service.
    Comment: One commenter indicated that the underlying line item 
direct inputs for a series of CPT codes were missing from the 
individual labor, equipment, and supply public use files. The commenter 
provided a list of the ten codes affected by this issue, and asked 
whether this was the result of a technical error.
    Response: The ten codes in question were all procedures that the 
CPT Editorial Panel has assigned for deletion in CY 2016. These codes 
appeared in error in our public use files for the CY 2016 PFS proposed 
rule. We have identified the technical issue that was causing this 
error and corrected it in the CY 2016 final direct PE input database.
    Comment: One commenter identified a group of codes where the 
calculated clinical labor costs (based on the underlying direct input 
labor file) differed from the CMS summary labor findings. The commenter 
asked if there were instances where CMS was applying different labor 
inputs from those published in the files released with the rule.
    Response: We appreciate the commenter bringing this issue regarding 
conflicting information in the CY 2016 PFS proposed rule public use 
files to our attention. This discrepancy was caused by an error in the 
creation of the public use files that undercounted the number of 
clinical labor minutes assigned to the postoperative E/M visits 
assigned to codes with 10-day and 90-day global periods. This error did 
not affect the proposed rates in the proposed rule, only the displayed 
values in the ``labor task detail'' public use file. We have corrected 
this issue in the public use files for the CY 2016 final direct PE 
input database.
    Comment: A commenter indicated that for several codes, the CMS file 
for work times did not appear to be updated

[[Page 70938]]

with the RUC-approved times. In particular, the pre-evaluation time and 
immediate post-service time appeared to be missing from the CMS file.
    Response: These incorrect work times have been corrected in the CY 
2016 final direct PE input database.
(10) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We note that services subject to the MPPR lists on diagnostic 
cardiovascular services, diagnostic imaging services, diagnostic 
ophthalmology services and therapy services, and the list of procedures 
that meet the definition of imaging under section 5102(b) of the DRA 
and are therefore subject to the OPPS cap for the upcoming calendar 
year are displayed in the public use files for the PFS proposed and 
final rules for each year. The public use files for CY 2016 are 
available on the CMS Web site under downloads for the CY 2016 PFS final 
rule with comment period at http://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
5. Methodology for Establishing Malpractice RVUs
    As discussed in section II.B. of this final rule with comment 
period, our malpractice methodology uses a crosswalk to establish risk 
factors for new services until utilization data becomes available. 
Table 10 lists the CY 2016 HCPCS codes and their respective source 
codes used to set the CY 2016 MP RVUs. The MP RVUs for these services 
are reflected in Addendum B on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/ PhysicianFeeSched/.

                                     TABLE 10--CY 2016 Malpractice Crosswalk
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
CY 2016 new, revised or misvalued coMalpractice risk factor crosswalk code
----------------------------------------------------------------------------------------------------------------
10035....................  Perq Dev Soft Tiss 1St Imag..  19285...................  Perq dev breast 1st us imag
10036....................  Perq Dev Soft Tiss Add Imag..  19286...................  Perq dev breast add us imag
26356....................  Repair finger/hand tendon....  26356...................  Repair finger/hand tendon
26357....................  Repair finger/hand tendon....  26357...................  Repair finger/hand tendon
26358....................  Repair/graft hand tendon.....  26358...................  Repair/graft hand tendon
41530....................  Tongue base vol reduction....  41530...................  Tongue base vol reduction
43210....................  Egd esophagogastrc fndoplsty.  43276...................  Ercp stent exchange w/dilate
47531....................  Injection For Cholangiogram..  49450...................  Replace g/c tube perc
47540....................  Perq Plmt Bile Duct Stent....  47556...................  Biliary endoscopy thru skin
47541....................  Plmt Access Bil Tree Sm Bwl..  47500...................  Injection for liver x-rays
47542....................  Dilate Biliary Duct/Ampulla..  47550...................  Bile duct endoscopy add-on
47543....................  Endoluminal Bx Biliary Tree..  47550...................  Bile duct endoscopy add-on
47544....................  Removal Duct Glbldr Calculi..  47630...................  Remove bile duct stone
47532....................  Injection For Cholangiogram..  49407...................  Image cath fluid trns/vgnl
47533....................  Plmt Biliary Drainage Cath...  47510...................  Insert catheter bile duct
47534....................  Plmt Biliary Drainage Cath...  47511...................  Insert bile duct drain
47535....................  Conversion Ext Bil Drg Cath..  47505...................  Injection for liver x-rays
47536....................  Exchange Biliary Drg Cath....  49452...................  Replace g-j tube perc
47537....................  Removal Biliary Drg Cath.....  47505...................  Injection for liver x-rays
47538....................  Perq Plmt Bile Duct Stent....  47556...................  Biliary endoscopy thru skin
47539....................  Perq Plmt Bile Duct Stent....  47556...................  Biliary endoscopy thru skin
49185....................  Sclerotx Fluid Collection....  49407...................  Image cath fluid trns/vgnl
50606....................  Endoluminal Bx Urtr Rnl Plvs.  50955...................  Ureter endoscopy & biopsy
50705....................  Ureteral Embolization/Occl...  50393...................  Insert ureteral tube
50706....................  Balloon Dilate Urtrl Strix...  50395...................  Create passage to kidney
55866....................  Laparo radical prostatectomy.  55866...................  Laparo radical prostatectomy
61645....................  Perq Art M-Thrombect &/Nfs...  37218...................  Stent placemt ante carotid
61650....................  Evasc Prlng Admn Rx Agnt 1St.  37202...................  Transcatheter therapy infuse
61651....................  Evasc Prlng Admn Rx Agnt Add.  37202...................  Transcatheter therapy infuse
64461....................  Pvb Thoracic Single Inj Site.  64490...................  Inj paravert f jnt c/t 1 lev
64462....................  Pvb Thoracic 2Nd+ Inj Site...  64480...................  Inj foramen epidural add-on
64463....................  Pvb Thoracic Cont Infusion...  64446...................  N blk inj sciatic cont inf
64553....................  Implant neuroelectrodes......  64553...................  Implant neuroelectrodes
64555....................  Implant neuroelectrodes......  64555...................  Implant neuroelectrodes
64566....................  Neuroeltrd stim post tibial..  64566...................  Neuroeltrd stim post tibial
65778....................  Cover eye w/membrane.........  65778...................  Cover eye w/membrane
65779....................  Cover eye w/membrane suture..  65779...................  Cover eye w/membrane suture
65780....................  Ocular reconst transplant....  65780...................  Ocular reconst transplant
65855....................  Trabeculoplasty Laser Surg...  65855...................  Laser surgery of eye
66170....................  Glaucoma surgery.............  66170...................  Glaucoma surgery
66172....................  Incision of eye..............  66172...................  Incision of eye
67107....................  Repair Detached Retina.......  67107...................  Repair detached retina
67108....................  Repair Detached Retina.......  67108...................  Repair detached retina
67110....................  Repair detached retina.......  67110...................  Repair detached retina
67113....................  Repair Retinal Detach Cplx...  67113...................  Repair retinal detach cplx
67227....................  Dstrj Extensive Retinopathy..  67227...................  Treatment of retinal lesion
67228....................  Treatment X10Sv Retinopathy..  67228...................  Treatment of retinal lesion
72170....................  X-ray exam of pelvis.........  72170...................  X-ray exam of pelvis
73501....................  X-Ray Exam Hip Uni 1 View....  72170...................  X-ray exam of pelvis
73502....................  X-Ray Exam Hip Uni 2-3 Views.  72170...................  X-ray exam of pelvis
73503....................  X-Ray Exam Hip Uni 4/> Views.  72170...................  X-ray exam of pelvis
73521....................  X-Ray Exam Hips Bi 2 Views...  72170...................  X-ray exam of pelvis
73522....................  X-Ray Exam Hips Bi 3-4 Views.  72170...................  X-ray exam of pelvis
73523....................  X-Ray Exam Hips Bi 5/> Views.  72170...................  X-ray exam of pelvis
73551....................  X-Ray Exam Of Femur 1........  72170...................  X-ray exam of pelvis
73552....................  X-Ray Exam Of Femur 2/>......  72170...................  X-ray exam of pelvis
74712....................  Mri Fetal Sngl/1St Gestation.  72195...................  Mri pelvis w/o dye
----------------------------------------------------------------------------------------------------------------

[[Page 70939]]

 
CY 2016 new, revised or misvalued coMalpractice risk factor crosswalk code
----------------------------------------------------------------------------------------------------------------
74713....................  Mri Fetal Ea Addl Gestation..  72195...................  Mri pelvis w/o dye
77778....................  Apply Interstit Radiat Compl.  77778...................  Apply interstit radiat compl
77790....................  Radiation handling...........  77790...................  Radiation handling
78264....................  Gastric Emptying Imag Study..  78264...................  Gastric emptying study
78265....................  Gastric Emptying Imag Study..  78264...................  Gastric emptying study
78266....................  Gastric Emptying Imag Study..  78264...................  Gastric emptying study
91200....................  Liver elastography...........  91133...................  Electrogastrography w/test
93050....................  Art pressure waveform analys.  93784...................  Ambulatory bp monitoring
95971....................  Analyze neurostim simple.....  95971...................  Analyze neurostim simple
95972....................  Analyze Neurostim Complex....  95972...................  Analyze neurostim complex
----------------------------------------------------------------------------------------------------------------

6. CY 2016 Valuation of Specific Codes

Table 11--CY 2016 Work RVUs for New, Revised and Potentially Misvalued Codes With Proposed Values in the CY 2016
                                                PFS Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                                                                    Proposed CY    Final CY 2016
          HCPCS Code                    Long descriptor            CY 2015 WRVU    2016 work RVU     work RVU
----------------------------------------------------------------------------------------------------------------
11750........................  Excision of nail and nail matrix,            2.50            1.58            1.58
                                partial or complete (eg, ingrown
                                or deformed nail), for permanent
                                removal;.
20240........................  Biopsy, bone, open; superficial              3.28            2.61            2.61
                                (eg, ilium, sternum, spinous
                                process, ribs, trochanter of
                                femur).
27280........................  Arthrodesis, open, sacroiliac               14.64           20.00           20.00
                                joint, including obtaining bone
                                graft, including
                                instrumentation, when performed.
31652........................  Bronchoscopy, rigid or flexible,              NEW            4.71            4.71
                                including fluoroscopic guidance,
                                when performed; with
                                endobronchial ultrasound (EBUS)
                                guided transtracheal and/or
                                transbronchial sampling (eg,
                                aspiration[s]/biopsy[ies]), one
                                or two mediastinal and/or hilar
                                lymph node stat.
31653........................  Bronchoscopy, rigid or flexible,              NEW            5.21            5.21
                                including fluoroscopic guidance,
                                when performed; with
                                endobronchial ultrasound (EBUS)
                                guided transtracheal and/or
                                transbronchial sampling (eg,
                                aspiration[s]/biopsy[ies]), 3 or
                                more mediastinal and/or hilar
                                lymph node stati.
31654........................  Bronchoscopy, rigid or flexible,              NEW            1.40            1.40
                                including fluoroscopic guidance,
                                when performed; with
                                transendoscopic endobronchial
                                ultrasound (EBUS) during
                                bronchoscopic diagnostic or
                                therapeutic intervention(s) for
                                peripheral lesion(s) (List
                                separately in addition to.
31622........................  Bronchoscopy, rigid or flexible,             2.78            2.78            2.78
                                including fluoroscopic guidance,
                                when performed; diagnostic, with
                                cell washing, when performed
                                (separate procedure).
31625........................  Bronchoscopy, rigid or flexible,             3.36            3.36            3.36
                                including fluoroscopic guidance,
                                when performed; with bronchial
                                or endobronchial biopsy(s),
                                single or multiple sites.
31626........................  Bronchoscopy, rigid or flexible,             4.16            4.16            4.16
                                including fluoroscopic guidance,
                                when performed; with placement
                                of fiducial markers, single or
                                multiple.
31628........................  Bronchoscopy, rigid or flexible,             3.80            3.80            3.80
                                including fluoroscopic guidance,
                                when performed; with
                                transbronchial lung biopsy(s),
                                single lobe.
31629........................  Bronchoscopy, rigid or flexible,             4.09            4.00            4.00
                                including fluoroscopic guidance,
                                when performed; with
                                transbronchial needle aspiration
                                biopsy(s), trachea, main stem
                                and/or lobar bronchus(i).
31632........................  Bronchoscopy, rigid or flexible,             1.03            1.03            1.03
                                including fluoroscopic guidance,
                                when performed; with
                                transbronchial lung biopsy(s),
                                each additional lobe (List
                                separately in addition to code
                                for primary procedure).
31633........................  Bronchoscopy, rigid or flexible,             1.32            1.32            1.32
                                including fluoroscopic guidance,
                                when performed; with
                                transbronchial needle aspiration
                                biopsy(s), each additional lobe
                                (List separately in addition to
                                code for primary procedure).
33477........................  Transcatheter pulmonary valve                 NEW           25.00           25.00
                                implantation, percutaneous
                                approach, including pre-stenting
                                of the valve delivery site, when
                                performed.
37215........................  Transcatheter placement of                  19.68           18.00           18.00
                                intravascular stent(s), cervical
                                carotid artery, open or
                                percutaneous, including
                                angioplasty, when performed, and
                                radiological supervision and
                                interpretation; with distal
                                embolic protection.
37252........................  Intravascular ultrasound                      NEW            1.80            1.80
                                (noncoronary vessel) during
                                diagnostic evaluation and/or
                                therapeutic intervention,
                                including radiological
                                supervision and interpretation;
                                initial non-coronary vessel
                                (List separately in addition to
                                code for primary procedure).
37253........................  Intravascular ultrasound                      NEW            1.44            1.44
                                (noncoronary vessel) during
                                diagnostic evaluation and/or
                                therapeutic intervention,
                                including radiological
                                supervision and interpretation;
                                each additional noncoronary
                                vessel (List separately in
                                addition to code for primary
                                procedure.
38570........................  Laparoscopy, surgical; with                  9.34            8.49            8.49
                                retroperitoneal lymph node
                                sampling (biopsy), single or
                                multiple.

[[Page 70940]]

 
38571........................  Laparoscopy, surgical; with                 14.76           12.00           12.00
                                bilateral total pelvic
                                lymphadenectomy.
38572........................  Laparoscopy, surgical; with                 16.94           15.60           15.60
                                bilateral total pelvic
                                lymphadenectomy and peri-aortic
                                lymph node sampling (biopsy),
                                single or multiple.
39401........................  Mediastinoscopy; includes                     NEW            5.44            5.44
                                biopsy(ies) of mediastinal mass
                                (eg, lymphoma), when performed.
39402........................  Mediastinoscopy; with lymph node              NEW            7.25            7.25
                                biopsy(ies) (eg, lung cancer
                                staging).
43775........................  Laparoscopy, surgical, gastric                  C           20.38           20.38
                                restrictive procedure;
                                longitudinal gastrectomy (ie,
                                sleeve gastrectomy).
44380........................  Ileoscopy, through stoma;                    1.05            0.90            0.97
                                diagnostic, including collection
                                of specimen(s) by brushing or
                                washing, when performed
                                (separate procedure).
44381........................  Ileoscopy, through stoma; with                  I            1.48            1.48
                                transendoscopic balloon dilation.
44382........................  Ileoscopy, through stoma; with               1.27            1.20            1.27
                                biopsy, single or multiple.
44384........................  Ileoscopy, through stoma; with                  I            2.88            2.95
                                placement of endoscopic stent
                                (includes pre- and post-dilation
                                and guide wire passage, when
                                performed).
44385........................  Endoscopic evaluation of small               1.82            1.23            1.30
                                intestinal pouch (e.g., Kock
                                pouch, ileal reservoir [S or
                                J]); diagnostic, including
                                collection of specimen(s) by
                                brushing or washing, when
                                performed (separate procedure).
44386........................  Endoscopic evaluation of small               2.12            1.53            1.60
                                intestinal pouch (eg, Kock
                                pouch, ileal reservoir [S or
                                J]); with biopsy, single or
                                multiple.
44388........................  Colonoscopy through stoma;                   2.82            2.75            2.82
                                diagnostic, including collection
                                of specimen(s) by brushing or
                                washing, when performed
                                (separate procedure).
44389........................  Colonoscopy through stoma; with              3.13            3.05            3.12
                                biopsy, single or multiple.
44390........................  Colonoscopy through stoma; with              3.82            3.77            3.84
                                removal of foreign body(s).
44391........................  Colonoscopy through stoma; with              4.31            4.22            4.22
                                control of bleeding, any method.
44392........................  Colonoscopy through stoma; with              3.81            3.63            3.63
                                removal of tumor(s), polyp(s),
                                or other lesion(s) by hot biopsy
                                forceps.
44394........................  Colonoscopy through stoma; with              4.42            4.13            4.13
                                removal of tumor(s), polyp(s),
                                or other lesion(s) by snare
                                technique.
44401........................  Colonoscopy through stoma; with                 I            4.44            4.44
                                ablation of tumor(s), polyp(s),
                                or other lesion(s) (includes pre-
                                and post-dilation and guide wire
                                passage, when performed).
44402........................  Colonoscopy through stoma; with                 I            4.73            4.80
                                endoscopic stent placement
                                (including pre- and post-
                                dilation and guide wire passage,
                                when performed).
44403........................  Colonoscopy through stoma; with                 I            5.53            5.60
                                endoscopic mucosal resection.
44404........................  Colonoscopy through stoma; with                 I            3.05            3.12
                                directed submucosal
                                injection(s), any substance.
44405........................  Colonoscopy through stoma; with                 I            3.33            3.33
                                transendoscopic balloon dilation.
44406........................  Colonoscopy through stoma; with                 I            4.13            4.20
                                endoscopic ultrasound
                                examination, limited to the
                                sigmoid, descending, transverse,
                                or ascending colon and cecum and
                                adjacent structures.
44407........................  Colonoscopy through stoma; with                 I            5.06            5.06
                                transendoscopic ultrasound
                                guided intramural or transmural
                                fine needle aspiration/
                                biopsy(s), includes endoscopic
                                ultrasound examination limited
                                to the sigmoid, descending,
                                transverse, or ascending colon
                                and cecum and adjacent
                                structures.
44408........................  Colonoscopy through stoma; with                 I            4.24            4.24
                                decompression (for pathologic
                                distention) (eg, volvulus,
                                megacolon), including placement
                                of decompression tube, when
                                performed.
45330........................  Sigmoidoscopy, flexible;                     0.96            0.77            0.84
                                diagnostic, including collection
                                of specimen(s) by brushing or
                                washing, when performed
                                (separate procedure).
45331........................  Sigmoidoscopy, flexible; with                1.15            1.07            1.14
                                biopsy, single or multiple.
45332........................  Sigmoidoscopy, flexible; with                1.79            1.79            1.86
                                removal of foreign body(s).
45333........................  Sigmoidoscopy, flexible; with                1.79            1.65            1.65
                                removal of tumor(s), polyp(s),
                                or other lesion(s) by hot biopsy
                                forceps.
45334........................  Sigmoidoscopy, flexible; with                2.73            2.10            2.10
                                control of bleeding, any method.
45335........................  Sigmoidoscopy, flexible; with                1.46            1.07            1.14
                                directed submucosal
                                injection(s), any substance.
45337........................  Sigmoidoscopy, flexible; with                2.36            2.20            2.20
                                decompression (for pathologic
                                distention) (e.g., volvulus,
                                megacolon), including placement
                                of decompression tube, when
                                performed.
45338........................  Sigmoidoscopy, flexible; with                2.34            2.15            2.15
                                removal of tumor(s), polyp(s),
                                or other lesion(s) by snare
                                technique.
45340........................  Sigmoidoscopy, flexible; with                1.89            1.35            1.35
                                transendoscopic balloon dilation.
45341........................  Sigmoidoscopy, flexible; with                2.60            2.15            2.22
                                endoscopic ultrasound
                                examination.
45342........................  Sigmoidoscopy, flexible; with                4.05            3.08            3.08
                                transendoscopic ultrasound
                                guided intramural or transmural
                                fine needle aspiration/biopsy(s).
45346........................  Sigmoidoscopy, flexible; with                   I            2.84            2.91
                                ablation of tumor(s), polyp(s),
                                or other lesion(s) (includes pre-
                                 and post-dilation and guide
                                wire passage, when performed).
45347........................  Sigmoidoscopy, flexible; with                   I            2.75            2.82
                                placement of endoscopic stent
                                (includes pre- and post-dilation
                                and guide wire passage, when
                                performed).

[[Page 70941]]

 
45349........................  Sigmoidoscopy, flexible; with                   I            3.55            3.62
                                endoscopic mucosal resection.
45350........................  Sigmoidoscopy, flexible; with                   I            1.78            1.78
                                band ligation(s) (e.g.,
                                hemorrhoids).
45378........................  Colonoscopy, flexible;                       3.69            3.29            3.36
                                diagnostic, including collection
                                of specimen(s) by brushing or
                                washing, when performed
                                (separate procedure).
45379........................  Colonoscopy, flexible; with                  4.68            4.31            4.38
                                removal of foreign body(s).
45380........................  Colonoscopy, flexible; with                  4.43            3.59            3.66
                                biopsy, single or multiple.
45381........................  Colonoscopy, flexible; with                  4.19            3.59            3.66
                                directed submucosal
                                injection(s), any substance.
45382........................  Colonoscopy, flexible; with                  5.68            4.76            4.76
                                control of bleeding, any method.
45384........................  Colonoscopy, flexible; with                  4.69            4.17            4.17
                                removal of tumor(s), polyp(s),
                                or other lesion(s) by hot biopsy
                                forceps.
45385........................  Colonoscopy, flexible; with                  5.30            4.67            4.67
                                removal of tumor(s), polyp(s),
                                or other lesion(s) by snare
                                technique.
45386........................  Colonoscopy, flexible; with                  4.57            3.87            3.87
                                transendoscopic balloon dilation.
45388........................  Colonoscopy, flexible; with                     I            4.98            4.98
                                ablation of tumor(s), polyp(s),
                                or other lesion(s) (includes pre-
                                 and post-dilation and guide
                                wire passage, when performed).
45389........................  Colonoscopy, flexible; with                     I            5.27            5.34
                                endoscopic stent placement
                                (includes pre- and post-dilation
                                and guide wire passage, when
                                performed).
45390........................  Colonoscopy, flexible; with                     I            6.07            6.14
                                endoscopic mucosal resection.
45391........................  Colonoscopy, flexible; with                  5.09            4.67            4.74
                                endoscopic ultrasound
                                examination limited to the
                                rectum, sigmoid, descending,
                                transverse, or ascending colon
                                and cecum, and adjacent
                                structures.
45392........................  Colonoscopy, flexible; with                  6.54            5.60            5.60
                                transendoscopic ultrasound
                                guided intramural or transmural
                                fine needle aspiration/
                                biopsy(s), includes endoscopic
                                ultrasound examination limited
                                to the rectum, sigmoid,
                                descending, transverse, or
                                ascending colon and cecum, and
                                adjacent structures.
45393........................  Colonoscopy, flexible; with                     I            4.78            4.78
                                decompression (for pathologic
                                distention) (e.g., volvulus,
                                megacolon), including placement
                                of decompression tube, when
                                performed.
45398........................  Colonoscopy, flexible; with band                I            4.30            4.30
                                ligation(s) (e.g., hemorrhoids).
46500........................  Injection of sclerosing solution,            1.69            1.42            1.42
                                hemorrhoids.
46601........................  Anoscopy; diagnostic, with high-                I            1.60            1.60
                                resolution magnification (HRA)
                                (e.g., colposcope, operating
                                microscope) and chemical agent
                                enhancement, including
                                collection of specimen(s) by
                                brushing or washing, when
                                performed.
46607........................  Anoscopy; with high-resolution                  I            2.20            2.20
                                magnification (HRA) (e.g.,
                                colposcope, operating
                                microscope) and chemical agent
                                enhancement, with biopsy, single
                                or multiple.
47135........................  Liver allotransplantation;                  83.64           90.00           90.00
                                orthotopic, partial or whole,
                                from cadaver or living donor,
                                any age.
50430........................  Injection procedure for antegrade             NEW            3.15            3.15
                                nephrostogram and/or
                                ureterogram, complete diagnostic
                                procedure including imaging
                                guidance (e.g., ultrasound and
                                fluoroscopy) and all associated
                                radiological supervision and
                                interpretation; new access.
50431........................  Injection procedure for antegrade             NEW            1.10            1.10
                                nephrostogram and/or
                                ureterogram, complete diagnostic
                                procedure including imaging
                                guidance (e.g., ultrasound and
                                fluoroscopy) and all associated
                                radiological supervision and
                                interpretation; existing access.
50432........................  Placement of nephrostomy                      NEW            4.25            4.25
                                catheter, percutaneous,
                                including diagnostic
                                nephrostogram and/or ureterogram
                                when performed, imaging guidance
                                (e.g., ultrasound and/or
                                fluoroscopy) and all associated
                                radiological supervision and
                                interpretation.
50433........................  Placement of nephroureteral                   NEW            5.30            5.30
                                catheter, percutaneous,
                                including diagnostic
                                nephrostogram and/or ureterogram
                                when performed, imaging guidance
                                (e.g., ultrasound and/or
                                fluoroscopy) and all associated
                                radiological supervision and
                                interpretation, new access.
50435........................  Exchange nephrostomy catheter,                NEW            1.82            1.82
                                percutaneous, including
                                diagnostic nephrostogram and/or
                                ureterogram when performed,
                                imaging guidance (e.g.,
                                ultrasound and/or fluoroscopy)
                                and all associated radiological
                                supervision and interpretation.
50434........................  Convert nephrostomy catheter to               NEW            4.00            4.00
                                nephroureteral catheter,
                                percutaneous, including
                                diagnostic nephrostogram and/or
                                ureterogram when performed,
                                imaging guidance (e.g.,
                                ultrasound and/or fluoroscopy)
                                and all associated radiological
                                supervision and interpretation.
50693........................  Placement of ureteral stent,                  NEW            4.21            4.21
                                percutaneous, including
                                diagnostic nephrostogram and/or
                                ureterogram when performed,
                                imaging guidance (e.g.,
                                ultrasound and/or fluoroscopy)
                                and all associated radiological
                                supervision and interpretation;
                                pre-existing nephrostomy.

[[Page 70942]]

 
50694........................  Placement of ureteral stent,                  NEW            5.50            5.50
                                percutaneous, including
                                diagnostic nephrostogram and/or
                                ureterogram when performed,
                                imaging guidance (e.g.,
                                ultrasound and/or fluoroscopy)
                                and all associated radiological
                                supervision and interpretation;
                                new access, without separ.
50695........................  Placement of ureteral stent,                  NEW            7.05            7.05
                                percutaneous, including
                                diagnostic nephrostogram and/or
                                ureterogram when performed,
                                imaging guidance (e.g.,
                                ultrasound and/or fluoroscopy)
                                and all associated radiological
                                supervision and interpretation;
                                new access, with separate.
54437........................  Repair of traumatic corporeal                 NEW           11.50           11.50
                                tear(s).
54438........................  Replantation, penis, complete                 NEW           22.10           24.50
                                amputation including urethral
                                repair.
63045........................  Laminectomy, facetectomy and                17.95           17.95           17.95
                                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.
63046........................  Laminectomy, facetectomy and                17.25           17.25           17.25
                                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.
65785........................  Implantation of intrastromal                  NEW            5.39            5.39
                                corneal ring segments.
68801........................  Dilation of lacrimal punctum,                1.00            0.82            0.82
                                with or without irrigation.
68810........................  Probing of nasolacrimal duct,                2.15            1.54            1.54
                                with or without irrigation.
68811........................  Probing of nasolacrimal duct,                2.45            1.74            1.74
                                with or without irrigation;
                                requiring general anesthesia.
68815........................  Probing of nasolacrimal duct,                3.30            2.70            2.70
                                with or without irrigation; with
                                insertion of tube or stent.
68816........................  Probing of nasolacrimal duct,                3.06            2.10            2.10
                                with or without irrigation; with
                                transluminal balloon catheter
                                dilation.
71100........................  Radiologic examination, ribs,                0.22            0.22            0.22
                                unilateral; 2 views.
72070........................  Radiologic examination, spine;               0.22            0.22            0.22
                                thoracic, 2 views.
72081........................  Entire spine x ray, one view.....             NEW            0.26            0.26
72082........................  Entire spine x-ray; 2 or 3 views.             NEW            0.31            0.31
72083........................  Entire spine x-ray; 4 or 5 views.             NEW            0.35            0.35
72084........................  Entire spine x-ray; min 6 views..             NEW            0.41            0.41
73060........................  Radiologic examination; humerus,             0.17            0.16            0.16
                                minimum of 2 views.
73560........................  Radiologic examination, knee; 1              0.17            0.16            0.16
                                or 2 views.
73562........................  Radiologic examination, knee; 3              0.18            0.18            0.18
                                views.
73564........................  Radiologic examination, knee;                0.22            0.22            0.22
                                complete, 4 or more views.
73565........................  Radiologic examination, knee;                0.17            0.16            0.16
                                both knees, standing,
                                anteroposterior.
73590........................  Radiologic examination; tibia and            0.17            0.16            0.16
                                fibula, 2 views.
73600........................  Radiologic examination, ankle; 2             0.16            0.16            0.16
                                views.
76999........................  Unlisted ultrasound procedure                   C               C               C
                                (e.g., diagnostic,
                                interventional).
77385........................  Intensity modulated radiation                   I            0.00               I
                                treatment delivery (IMRT),
                                includes guidance and tracking,
                                when performed; simple.
77386........................  Intensity modulated radiation                   I            0.00               I
                                treatment delivery (IMRT),
                                includes guidance and tracking,
                                when performed; complex.
77387........................  Guidance for localization of                    I            0.58               I
                                target volume for delivery of
                                radiation treatment delivery,
                                includes intrafraction tracking,
                                when performed.
77402........................  Radiation treatment delivery, >=                I            0.00               I
                                1 MeV; simple.
77407........................  Radiation treatment delivery, >=                I            0.00               I
                                1 MeV; intermediate.
77412........................  Radiation treatment delivery, >=                I            0.00               I
                                1 MeV; complex.
77767........................  Remote afterloading high dose                 NEW            1.05            1.05
                                rate radionuclide skin surface
                                brachytherapy, includes basic
                                dosimetry, when performed;
                                lesion diameter up to 2.0 cm or
                                1 channel.
77768........................  Remote afterloading high dose                 NEW            1.40            1.40
                                rate radionuclide skin surface
                                brachytherapy, includes basic
                                dosimetry, when performed;
                                lesion diameter over 2.0 cm and
                                2 or more channels, or multiple
                                lesions.
77770........................  Remote afterloading high dose                 NEW            1.95            1.95
                                rate radionuclide interstitial
                                or intracavitary brachytherapy,
                                includes basic dosimetry, when
                                performed; 1 channel.
77771........................  Remote afterloading high dose                 NEW            3.80            3.80
                                rate radionuclide interstitial
                                or intracavitary brachytherapy,
                                includes basic dosimetry, when
                                performed; 2-12 channels.
77772........................  Remote afterloading high dose                 NEW            5.40            5.40
                                rate radionuclide interstitial
                                or intracavitary brachytherapy,
                                includes basic dosimetry, when
                                performed; over 12 channels.
88346........................  Immunofluorescent study, each                0.86            0.74            0.74
                                antibody; direct method.
88350........................  Immunofluorescence, per specimen;             NEW            0.56            0.56
                                each additional single antibody
                                stain procedure (List separately
                                in addition to code for primary
                                procedure).
88367........................  Morphometric analysis, in situ               0.73            0.73            0.73
                                hybridization (quantitative or
                                semi-quantitative), using
                                computer-assisted technology,
                                per specimen; initial single
                                probe stain procedure.
88368........................  Morphometric analysis, in situ               0.88            0.88            0.88
                                hybridization (quantitative or
                                semi-quantitative), manual, per
                                specimen; initial single probe
                                stain procedure.

[[Page 70943]]

 
91299........................  Unlisted diagnostic                             C               C               C
                                gastroenterology procedure.
92537........................  Caloric vestibular test with                  NEW            0.60            0.60
                                recording, bilateral; bithermal
                                (ie, one warm and one cool
                                irrigation in each ear for a
                                total of four irrigations).
92538........................  Caloric vestibular test with                  NEW            0.30            0.30
                                recording, bilateral;
                                monothermal (ie, one irrigation
                                in each ear for a total of two
                                irrigations).
99174........................  Instrument-based ocular screening               N               N               N
                                (e.g., photoscreening, automated-
                                refraction), bilateral.
99177........................  Instrument-based ocular screening             NEW               N               N
                                (e.g., photoscreening, automated-
                                refraction), bilateral; with on-
                                site analysis.
99497........................  Advance care planning including                 I            1.50            1.50
                                the explanation and discussion
                                of advance directives such as
                                standard forms (with completion
                                of such forms, when performed),
                                by the physician or other
                                qualified health care
                                professional; first 30 minutes,
                                face-to-face with the patient,
                                family member(s), and/or
                                surrogate.
99498........................  Advance care planning including                 I            1.40            1.40
                                the explanation and discussion
                                of advance directives such as
                                standard forms (with completion
                                of such forms, when performed),
                                by the physician or other
                                qualified health care
                                professional; each additional 30
                                minutes (List separately in
                                addition to code for primary
                                procedure).
G0104........................  Colorectal cancer screening;                 0.96            0.77            0.84
                                flexible sigmoidoscopy.
G0105........................  Colorectal cancer screening;                 3.69            3.29            3.36
                                colonoscopy on individual at
                                high risk.
G0121........................  Colorectal cancer screening;                 3.69            3.29            3.36
                                colonoscopy on individual not
                                meeting criteria for high risk.
----------------------------------------------------------------------------------------------------------------

a. Lower GI Endoscopy Services
    CPT revised the lower gastrointestinal endoscopy code set for CY 
2015 following identification of some of the codes as potentially 
misvalued and the affected specialty society's contention that this 
code set did not allow for accurate reporting of services based upon 
current medical practice. The RUC subsequently provided recommendations 
to us for valuing these services. In the CY 2015 PFS final rule with 
comment period, we delayed valuing the lower GI codes and indicated 
that we would propose values for these codes in the CY 2016 proposed 
rule, citing the new process for including proposed values for new, 
revised and potentially misvalued codes in the proposed rule as one of 
the reasons for the delay.
(1) Gastrointestinal (GI) Endoscopy (CPT Codes 43775, 44380-46607 and 
HCPCS Codes G0104, G0105, and G0121)
    In the CY 2014 PFS final rule with comment period, we indicated 
that we used what we called an ``incremental difference methodology'' 
in valuing the upper GI codes for that year. We explained that the RUC 
made extensive use of a methodology that uses the incremental 
difference in codes to determine values for many of these services. 
This methodology uses a base code or other comparable code and 
considers what the difference should be between that code and another 
code by comparing the differentials to those for other sets of similar 
codes. As with the esophagoscopy subfamily, many of the procedures 
described within the colonoscopy subfamily have identical counterparts 
in the esophagogastroduodenoscopy (EGD) subfamily. For instance, the 
base colonoscopy CPT code 45378 is described as ``Colonoscopy, 
flexible; diagnostic, including collection of specimen(s) by brushing 
or washing when performed, (separate procedure).'' The base EGD CPT 
code 43235 is described as ``Esophagogastroduodenoscopy, flexible, 
transoral; diagnostic, with collection of specimen(s) by brushing or 
washing, when performed.'' In valuing other codes within both 
subfamilies, the RUC frequently used the difference between these two 
base codes as an increment for measuring the difference in work 
involved in doing a similar procedure utilizing colonoscopy versus 
utilizing EGD. For example, the EGD CPT code 43239 includes a biopsy in 
addition to the base diagnostic EGD CPT code 43235. The RUC valued this 
by adding the incremental difference in the base colonoscopy code over 
the base EGD CPT code to the value it recommended for the esophagoscopy 
biopsy, CPT code 43202. With some variations, the RUC used this 
incremental difference methodology extensively in valuing subfamilies 
of codes. In the CY 2016 PFS proposed rule, we made use of similar 
methodologies in establishing the proposed work RVUs for codes in this 
family.
    We agreed with several of the RUC recommendations for codes in this 
family. Where we did not agree, we consistently applied the incremental 
difference methodology. Table 12 reflects how we applied this 
methodology and the values we proposed. To calculate the base RVU for 
the colonoscopy subfamily, we looked at the current intraservice time 
for CPT code 45378, which is 30 minutes, and the current work RVU, 
which is 3.69. The RUC recommended an intraservice time of 25 minutes 
and 3.36 RVUs. We then compared that service to the base EGD CPT code 
43235 for which the RUC recommended a work RVU of 2.26, giving an 
increment between EGD and colonoscopy of 1.10 RVUs. We added that 
increment to our proposed work RVU for CPT code 43235 of 2.19 to arrive 
at our proposed work RVU for the base colonoscopy CPT code 45378 of 
3.29. We used this value as the base code in the incremental 
methodology for establishing the proposed work RVU for the other base 
codes in the colonoscopy subfamilies which were then used to value the 
other codes in that subfamily.
    Comment: Many commenters expressed concerns that the proposed 
values for the lower GI code set will hinder efforts to reduce the 
incidence of colorectal cancer through detection and treatment by 
limiting access to screenings. Comments stated,

[[Page 70944]]

``According to a poll of more than 550 gastroenterologists, more than 
half of the respondents plan to limit new Medicare patients if the 
proposed cuts are implemented; 55 percent plan to limit procedures to 
Medicare patients; and 15 percent are considering opting out of 
Medicare entirely. These findings suggest that GI physicians may not be 
able to maintain the current mix of Medicare patients and protect the 
financial viability of their practices.'' Some commenters specifically 
disagreed with CMS' methodology of applying an incremental difference 
between the base procedure for upper GI and lower GI, stating they 
believe that is a misapplication of the incremental approach and some 
noted that they believe that the upper and lower GI services are 
clinically distinct. Additionally, many commenters expressed 
disappointment that CMS did not consider the survey results, which they 
believe are the most reliable indicator of the work involved in 
colonoscopy. These commenters suggested that CMS adopt the RUC-
recommended values for the lower GI code set. Additionally, the 
affected specialty societies suggested that we accept their original 
recommendations (a work RVU of 3.51 for the base colonoscopy code, CPT 
code 45378). Some commenters stated that new colorectal cancer 
screening protocols have resulted in increased work due to the 
attention required to identify and remove precancerous lesions.
    Response: In developing the proposed work RVUs, we did consider the 
survey data. However, we considered the survey data in the context of 
the work RVUs for services within the broader endoscopy family. While 
we continue to believe that relativity among families of codes is 
important and view the upper and lower endoscopy codes as one code 
family, in the context of receiving many comments urging us to accept 
the RUC-recommended value for diagnostic colonoscopy (and thus the 
screening colonoscopy), we reconsidered the differences between the 
RUC-recommended value and our proposed RVUs. We do not believe the 
relatively small difference between these two values is itself likely 
to present significant issues in PFS relativity. Therefore, we agree 
with commenters that the RUC-recommended values generally reflect the 
work resources involved in furnishing the service and we are finalizing 
the RUC-recommended value of 3.36 RVUs for the base colonoscopy code, 
CPT code 45378, and are adjusting the valuation of all the other codes 
in the lower GI code set using that base with the incremental 
difference methodology. We also note that while we appreciate and share 
commenters' interest in maintaining beneficiaries' access to screening 
colonoscopies where appropriate under the current benefit, we believe 
that establishing RVUs that most accurately reflect the relative 
resource costs involved in furnishing services paid under the PFS is 
not only required by the statute, but also important to preserve and 
promote beneficiary access to all PFS services.
    Comment: A few commenters requested that CMS delay finalizing 
values for the lower GI codes until codes that are used to report 
moderate sedation are separately valued, since implementation of those 
codes will require a methodology for removing the work RVUs for 
moderate sedation from the endoscopy codes.
    Response: We will review and consider recommendations from the 
medical community about the work RVUs associated with moderate sedation 
and will address the valuation of moderation sedation separately. Since 
moderate sedation is a broad, cross-cutting issue that affects many 
specialties and code families, we do not believe that it is appropriate 
to delay finalizing values for all codes with moderate sedation, and 
therefore, will not do so for the GI codes.
    Comment: A few commenters stated disagreement with CMS' proposed PE 
refinement to remove the mobile instrument table (EF027) from codes 
45330 and 45331on the basis that the procedures do not include moderate 
sedation. The commenter noted that, ``while the mobile instrument table 
is part of the moderate sedation standard package and moderate sedation 
is not inherent in the procedure, it is still a necessary part of 
flexible sigmoidoscopy codes 45330 and 45331.''
    Response: We agree with the commenter that the mobile instrument 
table is typically involved in furnishing these services, even though 
moderate sedation may not be inherent in the procedure. Therefore, we 
have included the mobile instrument table (EF027) in the direct PE 
input database for codes 45330 and 45331.
    Comment: We received a comment on the proposed PE refinements made 
to CPT code 45330, stating that the RUC approved sterile water for CPT 
code 43450 instead of distilled water due to the risk of infections and 
potential for contamination. The commenter stated an expectation that 
all GI endoscopy codes that currently contain distilled water should be 
revised to include sterile water instead.
    Response: We have considered the comment; however, we re-examined 
the RUC-recommended direct PE inputs, and we did not identify the 
sterile water as part of that recommendation. Additionally, the 
commenter did not provide a detailed rationale for the use of sterile 
water over distilled water. Therefore, for CY 2016, we are finalizing 
the inputs for code 45330 as proposed. However, we are seeking 
additional information regarding these inputs (including rationale and 
explanation for the use of the commenter's recommended inputs) and we 
will consider this issue for future rulemaking.

                                                                 Table 12--Application of the Incremental Difference Methodology
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                                      Finalized
                                                                                                                                                                                     WRVU (using
                HCPCS                        Descriptor          Current      RUC WRVU        Base procedure         Base RVU            Increment          Increment     Proposed    3.36 RVUs
                                                                   WRVU                                                                                       value         WRVU       for the
                                                                                                                                                                                        base)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
44380...............................  Ileoscopy, through              1.05         0.97  Colonoscopy............            3.29  Colonoscopy to                 -2.39          0.9         0.97
                                       stoma; diagnostic,                                                                          Ileoscopy.
                                       including collection
                                       of specimen(s) by
                                       brushing or washing,
                                       when performed.
44382...............................  Ileoscopy, through              1.27         1.27  Ileoscopy..............             0.9  Biopsy.................          0.3          1.2         1.27
                                       stoma; with biopsy,
                                       single or multiple.

[[Page 70945]]

 
44384...............................  Ileoscopy, through                NA         3.11  Ileoscopy..............             0.9  Stent..................         1.98         2.88         2.95
                                       stoma; with placement
                                       of endoscopic stent
                                       (includes pre- and
                                       post-dilation and
                                       guide wire passage,
                                       when performed).
44385...............................  Endoscopic evaluation           1.82          1.3  Colonoscopy............            3.29  Colonoscopy to endo.           -2.06         1.23          1.3
                                       of small intestinal                                                                         eval..
                                       pouch (e.g., Kock
                                       pouch, ileal reservoir
                                       [S or J]); diagnostic,
                                       including collection
                                       of specimen(s) by
                                       brushing or washing,
                                       when performed.
44386...............................  Endoscopic evaluation           2.12          1.6  Endo. Eval.............            1.23  Biopsy.................          0.3         1.53          1.6
                                       of small intestinal
                                       pouch (eg, Kock pouch,
                                       ileal reservoir [S or
                                       J]); with biopsy,
                                       single or multiple.
44388...............................  Colonoscopy through             2.82         2.82  Colonoscopy............            3.29  Colonoscopy to                 -0.54         2.75         2.82
                                       stoma; diagnostic,                                                                          Colonoscopy through
                                       including collection                                                                        stoma.
                                       of specimen(s) by
                                       brushing or washing,
                                       when performed
                                       (separate procedure).
44389...............................  Colonoscopy through             3.13         3.12  Colonoscopy through                2.75  Biopsy.................          0.3         3.05         3.12
                                       stoma; with biopsy,                                stoma.
                                       single or multiple.
44390...............................  Colonoscopy through             3.82         3.82  Colonoscopy through                2.75  Foreign body...........         1.02         3.77         3.84
                                       stoma; with removal of                             stoma.
                                       foreign body.
44402...............................  Colonoscopy through              4.7         4.96  Colonoscopy through                2.75  Stent..................         1.98         4.73          4.8
                                       stoma; with endoscopic                             stoma.
                                       stent placement
                                       (including pre- and
                                       post-dilation and
                                       guidewire passage,
                                       when performed).
44403...............................  Colonoscopy through               NA         5.81  Colonoscopy through                2.75  Endoscopic mucosal              2.78         5.53          5.6
                                       stoma; with endoscopic                             stoma.                                   resection.
                                       mucosal resection.
44404...............................  Colonoscopy through               NA         3.13  Colonoscopy through                2.75  Submucosal injection...          0.3         3.05         3.12
                                       stoma; with directed                               stoma.
                                       submucosal
                                       injection(s), any
                                       substance.
44406...............................  Colonoscopy through               NA         4.41  Colonoscopy through                2.75  Endoscopic ultrasound..         1.38         4.13          4.2
                                       stoma; with endoscopic                             stoma.
                                       ultrasound
                                       examination, limited
                                       to the sigmoid,
                                       descending,
                                       transverse, or
                                       ascending colon and
                                       cecum and adjacent
                                       structures.
45330...............................  Sigmoidoscopy,                  0.96         0.84  Colonoscopy............            3.29  Colonoscopy to                 -2.52         0.77         0.84
                                       flexible; diagnostic,                                                                       Sigmoidoscopy.
                                       including collection
                                       of specimen(s) by
                                       brushing or washing
                                       when performed.
45331...............................  Sigmoidoscopy,                  1.15         1.14  Sigmoidoscopy..........            0.77  Biopsy.................          0.3         1.07         1.14
                                       flexible; with biopsy,
                                       single or multiple.
45332...............................  Sigmoidoscopy,                  1.79         1.85  Sigmoidoscopy..........            0.77  Foreign body...........         1.02         1.79         1.86
                                       flexible; with removal
                                       of foreign body.

[[Page 70946]]

 
45335...............................  Sigmoidoscopy,                  1.46         1.15  Sigmoidoscopy..........            0.77  Submucosal injection...          0.3         1.07         1.14
                                       flexible; with
                                       directed submucosal
                                       injection(s), any
                                       substance.
45341...............................  Sigmoidoscopy,                   2.6         2.43  Sigmoidoscopy..........            0.77  Endoscopic ultrasound..         1.38         2.15         2.22
                                       flexible; with
                                       endoscopic ultrasound
                                       examination.
45346...............................  Sigmoidoscopy,                    NA         2.97  Sigmoidoscopy..........            0.77  Ablation...............         2.07         2.84         2.91
                                       flexible; with
                                       ablation of tumor(s),
                                       polyp(s), or other
                                       lesion(s) (includes
                                       pre- and post-dilation
                                       and guide wire
                                       passage, when
                                       performed).
45347...............................  Sigmoidoscopy,                    NA         2.98  Sigmoidoscopy..........            0.77  Stent..................         1.98         2.75         2.82
                                       flexible; with
                                       placement of
                                       endoscopic stent
                                       (includes pre- and
                                       post-dilation and
                                       guide wire passage,
                                       when performed).
45349...............................  Sigmoidoscopy,                    NA         3.83  Sigmoidoscopy..........            0.77  Endoscopic mucosal              2.78         3.55         3.62
                                       flexible; with                                                                              resection.
                                       endoscopic mucosal
                                       resection.
45378...............................  Colonoscopy, flexible;          3.69         3.36  Colonoscopy............            3.29                                                            3.36
                                       diagnostic, including
                                       collection of
                                       specimen(s) by
                                       brushing or washing,
                                       when performed,
                                       (separate procedure).
45379...............................  Colonoscopy, flexible;          4.68         4.37  Colonoscopy............            3.29  Foreign body...........         1.02         4.31         4.38
                                       with removal of
                                       foreign body.
45380...............................  Colonoscopy, flexible,          4.43         3.66  Colonoscopy............            3.29  Biopsy.................          0.3         3.59         3.66
                                       proximal to splenic
                                       flexure; with biopsy,
                                       single or multiple.
45381...............................  Colonoscopy, flexible;          4.19         3.67  Colonoscopy............            3.29  Submucosal injection...          0.3         3.59         3.66
                                       with directed
                                       submucosal
                                       injection(s), any
                                       substance.
45389...............................  Colonoscopy, flexible;            NA          5.5  Colonoscopy............            3.29  Stent..................         1.98         5.27         5.34
                                       with endoscopic stent
                                       placement (includes
                                       pre- and post-dilation
                                       and guide wire
                                       passage, when
                                       performed).
45390...............................  Colonoscopy, flexible;            NA         6.35  Colonoscopy............            3.29  Endoscopic mucosal              2.78         6.07         6.14
                                       with endoscopic                                                                             resection.
                                       mucosal resection.
45391...............................  Colonoscopy, flexible;          5.09         4.95  Colonoscopy............            3.29  Endoscopic ultrasound..         1.38         4.67         4.74
                                       with endoscopic
                                       ultrasound examination
                                       limited to the rectum,
                                       sigmoid, descending,
                                       transverse, or
                                       ascending colon and
                                       cecum, and adjacent
                                       structures.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(2) Laparoscopic Sleeve Gastrectomy (CPT Code 43775)
    Prior to CY 2013, CPT code 43775 described a non-covered service. 
For CY 2013, this service was covered as part of the bariatric surgery 
National Coverage Determination (NCD) and has been contractor-priced 
since 2013. In the CY 2016 PFS proposed rule, we proposed to establish 
national pricing for CPT code 43775. To establish a work RVU, we 
crosswalked the work RVUs for this code from CPT code 37217 
(Transcatheter placement of an intravascular stent(s), intrathoracic 
common carotid artery or innominate artery by retrograde treatment, via 
open ipsilateral cervical carotid artery

[[Page 70947]]

exposure, including angioplasty, when performed, and radiological 
supervision and interpretation), due to their identical intraservice 
times, similar total times, and similar levels of intensity. Therefore, 
we proposed a work RVU of 20.38 for CPT code 43775.
    Comment: Some commenters noted that CPT code 43775 was reviewed at 
the April 2009 RUC meeting and that the RUC submitted recommendations 
to CMS for CY 2010, including a recommendation of 21.40 work RVUs for 
CPT code 43775. The commenters stated that those recommendations are 
still valid and requested that CMS accept the RUC recommended work RVU 
of 21.40 for CPT code 43775.
    Response: We thank the commenters for pointing out the previous RUC 
recommendations from April 2009. We continue to believe that the 
proposed work RVU is appropriate based on the reasons stated in the 
proposed rule, and therefore, for CY 2016, we are finalizing a work RVU 
of 20.38 for CPT code 43775.
    Comment: A few commenters noted that they believe the crosswalk 
code used by CMS (CPT code 37217) does encourage relativity, but 
because it is an endovascular procedural code, does not accurately 
capture all aspects of a bariatric surgical patient in the pre-service, 
intra-service, or post-service periods. Commenters stated that they 
believed a comparison within the code family would provide an 
assessment that is more accurate. The commenters urged CMS to accept 
the previous valuation of 21.56.
    Response: After consideration of the comments, we continue to 
believe that the proposed work RVU is appropriate based on the reasons 
stated in the proposed rule, and that it maintains relativity within 
its family of codes. Therefore, for CY 2016, we are finalizing a work 
RVU of 20.38 for CPT code 43775.
(3) Incomplete Colonoscopy (CPT codes 44388, 45378, G0105, and G0121)
    Prior to CY 2015, according to CPT instruction, an incomplete 
colonoscopy was defined as a colonoscopy that did not evaluate the 
colon past the splenic flexure (the distal third of the colon). In 
accordance with that definition, the Medicare Claims Processing Manual 
(pub. 100-04, chapter 12, section 30.1.B., available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items) states that physicians should report an incomplete 
colonoscopy with 45378 and append modifier -53, which is paid at the 
same rate as a sigmoidoscopy.
    In CY 2015, the CPT instruction changed the definition of an 
incomplete colonoscopy to a colonoscopy that does not evaluate the 
entire colon. The 2015 CPT Manual states when performing a diagnostic 
or screening endoscopic procedure on a patient who is scheduled and 
prepared for a total colonoscopy, if the physician is unable to advance 
the colonoscope to the cecum or colon-small intestine anastomosis due 
to unforeseen circumstances, report 45378 (colonoscopy) or 44388 
(colonoscopy through stoma) with modifier -53 and provide appropriate 
documentation.
    Given that the new definition of an incomplete colonoscopy also 
includes colonoscopies where the colonoscope is advanced past the 
splenic flexure but not to the cecum, we proposed to establish new 
values for the incomplete colonoscopies, reported with the -53 
modifier. At present, we crosswalk the RVUs for the incomplete 
colonoscopies from the values of the corresponding sigmoidoscopy. Given 
that the new CPT instructions will reduce the number of reported 
complete colonoscopies and increase the number of colonoscopies that 
proceeded further toward completion reported with the -53 modifier, we 
believe CPT code 45378 reported with the -53 modifier will now describe 
a more resource-intensive group of services than were previously 
reported. Therefore, we proposed to develop RVUs for these codes 
reported with the -53 modifier by using one-half the value of the 
inputs for the corresponding codes reported without the -53 modifier.
    In addition to this change in input values, we also solicited 
comments on how to address the disparity of resource costs among the 
broader range of services now described by the colonoscopy codes billed 
with the -53 modifier. We believe that it may be appropriate for 
practitioners to report the sigmoidoscopy CPT code 45330 under 
circumstances when a beneficiary is scheduled and prepared for a total 
colonoscopy (diagnostic colonoscopy, screening colonoscopy or 
colonoscopy through stoma), but the practitioner is unable to advance 
the colonoscope beyond the splenic flexure. We solicited comments and 
recommendations on that possibility, as well as more generally, the 
typical resource costs of these incomplete colonoscopy services under 
CPT's new definition. Finally, we solicited information regarding the 
number of colonoscopies that will be considered incomplete under CPT's 
new definition relative to the old definition, as well as the number of 
incomplete colonoscopies where the practitioner is unable to advance 
the colonoscope beyond the splenic flexure. This information will help 
us determine whether or not differential payment is required, and if it 
is, how to make the appropriate utilization assumptions within our 
ratesetting process.
    Comment: Some commenters agreed with the proposed policy of using 
the-53 modifier to identify the reduced work involved with an 
incomplete colonoscopy and a reimbursement that is 50 percent of the 
full procedure. However, some noted that instances where the cecum is 
not reached immediately would be associated with greater PE than 
sigmoidoscopy, noting that the endoscopist will have utilized a 
colonoscope for the procedure requiring greater work for staff to clean 
and also noted that the endoscopist will commonly obtain a pediatric 
endoscope to navigate the narrowed sigmoid. Commenters also stated that 
sigmoidoscopy is a procedure commonly performed without moderate 
sedation. One commenter recommended that CMS establish a new modifier 
for instances in which the colonoscope has passed beyond the splenic 
flexure but has not reached the cecum or small bowel--large bowel 
anastomosis due to inadequate preparation precluding high-quality 
examination of the lumen of the bowel or technical limitations that 
preclude the ability of the physician to safely complete the 
examination of the colon. The commenter also recommended that payment 
for the professional services for colonoscopy in these circumstances be 
adjusted to 75 percent of the payment for the colonoscopy procedure, 
noting that appending this new modifier to the professional services 
for the procedure would allow the same or other physician to bring the 
patient back for another colonoscopy examination within 2 months 
without triggering the frequency limitation under the Act, and that 
facility payment for the procedure would not be adjusted when this 
modifier is reported with codes 45378, G0105 or G0121.
    Response: We appreciate the commenters' support for the proposed 
policy of using the-53 modifier. We also appreciate the additional 
feedback regarding the resource costs of incomplete colonoscopies and 
will consider whether further changes to valuation or the coding 
structure are necessary in future rulemaking.
(4) Malpractice (MP) Crosswalk
    We examined the RUC-recommended MP crosswalk for this family of 
codes. The MP crosswalks are used to identify the presumed mix of 
specialties that

[[Page 70948]]

furnish particular services until there is Medicare claims data for the 
new codes. We direct the reader to section II.B.1. of this final rule 
with comment period for further explanation regarding these crosswalks. 
In reviewing the recommended MP crosswalks for CPT codes 43775, 44407, 
44408, 46601, and 46607, we noted that the RUC-recommended MP crosswalk 
codes are inconsistent with our analysis of the specialties likely to 
furnish the service based on the description of the services and our 
review of the RUC-recommended utilization crosswalk. The inconsistency 
between the RUC-recommended MP and utilization crosswalks is not 
altogether unusual. However when there are discrepancies between the MP 
and utilization crosswalk recommendations, they generally reflect the 
RUC's expectation that due to changes in coding, there will be a 
different mix of specialties reporting a new code than might be 
reflected in the claims data for the code previously used to report 
that service. This often occurs when the new coding structure for a 
particular family of services is either more or less specific than the 
old set of codes. In most of these cases, we could identify a rationale 
for why the RUC-recommended MP crosswalks for these codes were likely 
to be more accurate than the RUC-recommended utilization crosswalk. But 
in the case of these codes, the reason for the discrepancies were 
neither apparent nor explained as part of the recommendation. Since the 
specialty mix in the claims data is used to determine the specialty mix 
for each HCPCS code for the purposes of calculating MP RVUs, and those 
data will be used to set the MP RVUs once it is available, we believe 
using a specialty mix derived from the claims data of the predecessor 
codes is more likely to be accurate than the RUC-recommended MP 
crosswalk as well as more likely to result in stable MP RVUs for these 
services over several years. Therefore, until claims data under the new 
set of codes are available, we proposed to use the specialty mix of the 
source code(s) in the RUC-recommended utilization crosswalk to 
calculate the malpractice risk factor for these services instead of the 
RUC-recommended MP crosswalk. Once claims data are available, those 
data will be incorporated into the calculation of MP RVUs for these 
services under the MP RVU methodology.
    Comment: The RUC commented that they support CMS' decision to use 
the utilization crosswalk in determining the malpractice crosswalk for 
CPT code 43775 given that there are newer data since the RUC last 
reviewed this code in 2009. However, the RUC commented that it did not 
agree with this proposed decision for the other four services, CPT 
codes 44407, 44408, 46601, and 46607, stating that its MP crosswalks 
for these codes were based on the intended specialty mix.
    Response: We continue to believe that the RUC-recommended MP 
crosswalk codes are inconsistent with our analysis of the specialties 
likely to furnish the service based on the description of the services 
and our review of the RUC recommended utilization crosswalk. Therefore, 
for CY 2016, we are finalizing these malpractice crosswalk codes as 
proposed.
b. Radiation Treatment and Related Image Guidance Services
    For CY 2015, the CPT Editorial Panel revised the set of codes that 
describe radiation treatment delivery services based in part on the CMS 
identification of these services as potentially misvalued in CY 2012. 
We identified these codes as potentially misvalued under a screen 
called ``Services with Stand-Alone PE Procedure Time.'' We proposed 
this screen following our discovery of significant discrepancies 
between the RUC-recommended 60 minute procedure time assumptions for 
intensity modulated radiation therapy (IMRT) and information available 
to the public suggesting that the procedure typically took between 5 
and 30 minutes per treatment.
    The CPT Editorial Panel's revisions included the addition and 
deletion of several codes and the development of new guidelines and 
coding instructions. Four treatment delivery codes (77402, 77403, 
77404, and 77406) were condensed into 77402 (Radiation Treatment 
Delivery, Simple), three treatment delivery codes (77407, 77408, 77409) 
were condensed into 77407 (Radiation treatment delivery, intermediate), 
and four treatment codes (77412, 77413, 77414, 77416) were condensed 
into 77412 (Radiation treatment delivery, complex). Intensity Modulated 
Radiation Therapy (IMRT) treatment delivery, previously reported under 
a single code, was split into two codes, 77385 (IMRT treatment 
delivery, simple) and 77386 (IMRT treatment delivery, complex). The CPT 
Editorial Panel also created a new image guidance code, 77387 (Guidance 
for localization of target volume for delivery of treatment, includes 
intrafraction tracking when performed) to replace 77014 (computed 
tomography guidance for placement of radiation therapy fields), 77421 
(stereoscopic X-ray guidance for localization of target volume for the 
delivery of radiation therapy,) and 76950 (ultrasonic guidance for 
placement of radiation therapy fields) when any of these services were 
furnished in conjunction with radiation treatment delivery.
    In response to stakeholder concerns regarding the magnitude of the 
coding changes and in light of the process changes we adopted for 
valuing new and revised codes, we did not implement interim final 
values for the new codes and delayed implementing the new code set 
until 2016. To address the valuation of the new code set through 
proposed rulemaking, and continue making payment based on the previous 
valuations even though CPT deleted the prior radiation treatment 
delivery codes for CY 2015, we created G-codes that mimic the 
predecessor CPT codes (79 FR 67667).
    We proposed to establish values for the new codes based on RUC 
recommendations, subject to standard CMS refinements. We also note that 
because the invoices used to price the capital equipment included ``on-
board imaging,'' and based on our review of the information used to 
price the equipment, we considered the costs of that equipment already 
to be reflected in the price per minute associated with the capital 
equipment. Therefore, we did not propose to include it as a separate 
item in the direct PE inputs for these codes, even though it appeared 
as a separate item on the PE worksheet included with the RUC 
recommendations for these codes. The proposed direct PE inputs for 
those codes were displayed the proposed direct PE input database 
available on the CMS Web site under the supporting data files for the 
CY 2016 PFS proposed rule with comment period at http://www.cms.gov/PhysicianFeeSched/. The RVUs that result from the use of these direct 
PE inputs (and work RVUs and work time, as applicable) were displayed 
in proposed rule Addendum B on the CMS Web site.
    We received many comments regarding various aspects of our proposal 
to implement the new CPT codes for radiation treatment services based 
on our refinement of RUC-recommended input values. Some commenters 
addressed issues for which we explicitly sought comment, while several 
commenters brought other issues to our attention. We address these 
comments in the following paragraphs.
(1) Image Guidance Services
    Under the previous CPT coding structure, image guidance was 
separately billable when furnished in

[[Page 70949]]

conjunction with the radiation treatment delivery services. The image 
guidance was reported using different CPT codes, depending on which 
image guidance modality was used. These codes were split into 
professional and/or technical components that allowed practitioners to 
report a single component or the global service. The professional 
component of each of these codes included the work of the physician 
furnishing the image guidance. CPT code 77014, used to report CT 
guidance, had a work RVU of 0.85; CPT code 77421, used to report 
stereotactic guidance, had a work RVU of 0.39, and CPT code 76950, used 
to report ultrasonic guidance, had a work RVU of 0.58. The technical 
component of these codes incorporated the resource costs of the image 
guidance capital equipment (such as CT, ultrasound, or stereotactic) 
and the clinical staff involved in furnishing the image guidance 
associated with the radiation treatment. When billed globally, the RVUs 
reflected the sum of the professional and technical components. In the 
revised coding structure, one new image guidance code is to be reported 
regardless of the modality used, and in developing its recommended 
values, the RUC assumed that CT guidance would be typical.
    However, the 2013 Medicare claims data for separately reported 
image guidance indicated that stereotactic guidance for radiation 
treatment services was furnished more frequently than CT guidance. The 
RUC recommended a work RVU of 0.58 and associated work times of three 
pre-service minutes, 10 intraservice minutes, and three post-service 
minutes for image guidance CPT code 77387. We reviewed this 
recommendation considering the discrepancy between the modality the RUC 
assumed to be typical in the vignette and the modality typically 
reported in the Medicare claims data. Given that the recommended work 
RVU for the new single code is similar to the work RVUs of the 
predecessor codes, roughly prorated based on their distribution in 
Medicare claims data, we agree with the RUC-recommended work RVU for 
the service. However, the RUC also recommended an increase in overall 
work time associated with image guidance consistent with the survey 
data used to value the new services. If accurate, this increase in time 
and maintenance of total work would suggest a decrease in the overall 
intensity for image guidance relative to the current codes. We 
solicited comments as to the appropriate work time associated with CPT 
code 77387.
    Comment: Commenters provided feedback that work time of 16 minutes 
is accurate for 77387, consistent with the RUC recommendation without 
explaining why the work time associated with image guidance has changed 
significantly.
    Response: We appreciate that commenters responded to our 
solicitation but the commenters did not provide a rationale for why the 
recommended work time for the new code would be significantly different 
than the current work time for the most frequently reported predecessor 
code. Absent an explanation, we remain concerned that the aspects of 
the recommended values for the new single modality code were developed 
based on erroneous assumptions regarding what imaging modality is most 
frequently used to provide guidance for radiation treatment services.
    Although CPT codes 77421 (stereotactic guidance) and 76950 
(ultrasonic guidance) have been deleted, we note that CPT maintained 
CPT code 77014 (Computed tomography guidance for placement of radiation 
therapy fields). The RUC recommendation stated that the CPT editorial 
panel maintained CPT code 77014 based on concerns that without this 
option, some practitioners might have no valid CPT alternative than to 
use higher valued diagnostic CT codes when they used this CT guidance. 
The RUC recommendation also included a statement that utilization of 
this code was expected to drop to negligible levels in 2015, assuming 
that practitioners would use the new codes that are not differentiated 
based on imaging modality. Once all the new codes are implemented for 
Medicare, we anticipate that CPT and/or the RUC will address the 
continued use of 77014 and, if it continues to be part of the code set, 
provide recommendations as to the appropriate values given changes in 
utilization.
    Comment: Several commenters stated that, while they believe that 
the volume for 77014 will fall to negligible levels, they support CMS' 
adoption of the decision to continue to monitor and review this code.
    Response: We appreciate commenters support and the stakeholder 
interest in making certain that the codes accurately describe the 
services furnished to Medicare beneficiaries.
    Regarding the reporting of the new image guidance codes, CPT 
guidance instructs that the technical portion of image guidance is now 
bundled into the IMRT and stereotactic radiation treatment delivery 
codes, but it is not bundled into the simple, intermediate, and complex 
radiation treatment delivery codes. CPT guidance states that the 
technical component of the image guidance code can be reported with CPT 
codes 77402, 77407, and 77412 (simple, intermediate, and complex 
radiation treatment) when furnished, which means that the technical 
component of the image guidance code should not be reported with the 
IMRT, stereotactic radiosurgery (SRS) or stereotactic body radiation 
therapy (SBRT) treatment delivery codes. The RUC recommendation, 
however, incorporated the same capital cost of image guidance equipment 
(a linear accelerator, or linac), for the conventional radiation 
treatment delivery codes and the the codes that describe IMRT treatment 
delivery services. The RUC explained that the older lower-dose external 
beam radiation machines are no longer manufactured and the image 
guidance technology is integrated into the single kind of linear 
accelerator used for all the radiation treatment services.
    In reviewing the new code structure and the RUC recommendations for 
the proposed rule, we assumed that the CPT editorial panel did not 
foresee that the RUC would recommend that we develop PE RVUs for all 
the radiation treatment delivery codes based on the assumption that the 
same capital equipment is typically used in furnishing this range of 
external beam radiation treatments. Because the RUC recommendations 
incorporate the more extensive capital equipment in the lower dose 
treatment codes as well, a portion of the resource costs of the 
technical portion of imaging guidance are already allocated into the PE 
RVUs for all of the treatment delivery codes, not just the IMRT, SRS, 
and SBRT treatment delivery codes as CPT guidance would suggest.
    In order to avoid incorporating the cost of this equipment into 
both the treatment delivery codes (CPT codes 77402, 77407, and 77412) 
and the technical component of the new imaging guidance code (CPT code 
77387-TC), we considered valuing CPT code 77387 as a professional 
service only and not creating the professional/technical component 
splits envisioned by CPT. In the proposed rule we stated that in the 
context of the budget neutral PFS, incorporating a duplicative direct 
input with a cost of more than six dollars per minute would have 
significant impacts on the PE RVUs for all other services. However, we 
also noted that the RUC did not address this issue in its 
recommendation and proposed that not all of the recommended direct PE 
inputs for the

[[Page 70950]]

technical component of CPT code 77387 are capital equipment costs. 
Therefore, we proposed to allow for professional and technical 
component billing for these services, as reflected in CPT guidance, and 
to use the RUC-recommended direct PE inputs for these services (refined 
as described in Table 13 of the proposed rule (80 FR 41725-41764). We 
solicited comments on the technical component billing for image 
guidance in the context of the inclusion of a single linac and the RUC-
recommended integration of imaging guidance technology for all external 
beam treatment codes.
    Comment: Many commenters stated that it was necessary for CPT code 
77387 to include both a technical and professional component because 
the current price of the linear accelerator used in radiation treatment 
delivery services does not include the additional costs of an 
integrated image guidance system. These commenters urged CMS to retain 
the technical and professional components for CPT code 77387 on the 
basis that there are equipment and labor costs associated with image 
guidance that are not reflected in a professional-only code.
    Some other commenters were concerned that the new coding structure 
for image guidance did not accurately reflect the way that image 
guidance is typically furnished. These commenters stated that multiple 
modalities of image guidance can be used in a single procedure, and 
that this heterogeneity is not reflected through a single image 
guidance code.
    Response: We appreciate that many commenters addressed the bundling 
in the new CPT codes of the technical component of image guidance for 
IMRT, SRS, and SBRT, but not for conventional radiation treatment 
delivery codes. However, in reviewing the comments, we did not identify 
any that address the fundamental issues we identified in the proposed 
rule. We understand that commenters generally agreed that image 
guidance was not necessarily typically used for conventional radiation 
treatment delivery services, so the related costs should not be 
embedded in the RVUs for the treatment delivery codes. We also 
understand that commenters recommended that we assume that image 
guidance costs, while integrated into the functionality of the linear 
accelerator, represent additional capital costs and should be used in 
the development of PE RVUs for these services. Despite these comments, 
we were unable to reconcile the inconsistencies and potential rank 
order anomalies associated with including the image guidance costs in 
the IMRT treatment delivery codes but not including the image guidance 
costs in the conventional radiation treatment delivery codes even 
though both use the same capital equipment. Based on the RUC 
recommendations and the information from the commenters, we understand 
that the same linear accelerator is typically used for all of these 
services, and that the image guidance is integrated into the only 
linear accelerator that is currently being manufactured and that, 
therefore, the image guidance costs should always be included in the 
RVUs for the IMRT treatment delivery codes. Based on these comments and 
the RUC-recommended values, it appears that when the same machine (with 
integrated image guidance) is used for intermediate and complex 
conventional treatment, the combination of the treatment costs and 
image guidance costs is significantly higher than the technical costs 
associated with IMRT treatment delivery furnished with image guidance. 
As a result, the PE RVUs for these services include higher overall 
payment for intermediate and complex conventional radiation treatment 
with imaging guidance than for simple IMRT treatment delivery with 
imaging guidance. After review of the comments, we continue to believe 
that this creates problematic rank order anomalies, both relative to 
the accuracy of the assumed costs and the financial incentives 
associated with Medicare paying more overall for conventional radiation 
treatment than for IMRT services.
    Comment: Many commenters, including equipment manufacturers, 
suggested that linacs that include integrated image guidance are 
significantly more expensive than the $2.6 million CMS proposed in the 
direct practice expense input database. One commenter, a manufacturer 
of linear accelerators, submitted several invoices intended to indicate 
that the price of a new linear accelerator is significantly higher than 
the current price in the direct PE input database. This commenter 
suggested that this higher price was due in part to the integrated 
image guidance, inherent in all new linear accelerators. The commenter 
also submitted invoices intended to illustrate the price of upgrading 
an older linear accelerator with image guidance capability.
    Response: We appreciate the submission of invoices that indicate 
prices for linear accelerators with image guidance and the price 
associated with updating existing linacs with image guidance. In our 
analysis of these documents, however, we identified several aspects 
that make us hesitant to use the documents to change the price of the 
equipment in the direct PE input database. First, many of the invoices 
listed a total contract value that was distinct from the sum of total 
prices listed on the invoice. The documents themselves did not include 
any explanation regarding the significant differences in value between 
these two prices and whether or not the differences in value represent 
costs related to other direct PE input equipment items, factors already 
incorporated into the equipment cost per minute calculation, or items 
included in the allocation of indirect PE. For example, some line items 
included the description of items such as ``travel and lodging,'' 
``education,'' and treatment planning software or software upgrades 
that are already accounted for in the allocation of indirect PE. In 
many cases line-item prices were not included, making it difficult to 
identify the portion of the total invoice price attributable to direct 
equipment costs, which is necessary under the established PE 
methodology. Therefore, we will maintain the current equipment price 
for CY 2016 while we seek accurate information regarding the price of 
this capital equipment.
(2) Equipment Utilization Rate for Linear Accelerators
    The cost of the capital equipment is the primary determining factor 
in the payment rates for these services. For each CPT code, the 
equipment costs are estimated based on multiplying the assumed number 
of minutes the equipment is used for that procedure by the per minute 
cost of the particular equipment item. Under our PE methodology, we 
currently use two default equipment usage assumptions in allocating 
capital equipment costs to calculate PE RVUs. The first is that each 
equipment item is only available to be used during what are assumed to 
be regular business hours for a physician's office: 10 hours per day, 5 
days per week (50 hours per week) and 50 weeks per year. The second 
assumption is that the equipment is in use only 50 percent of the time 
that it is available for use. The current default 50 percent 
utilization rate assumption translates into 25 hours per week out of a 
50-hour work week.
    We have previously addressed the accuracy of these default 
assumptions as they apply to particular equipment resources and 
particular services. In the CY 2008 PFS proposed rule (72 FR 38132), we 
discussed the 50 percent utilization assumption and acknowledged that 
the default 50

[[Page 70951]]

percent usage assumption is unlikely to capture the actual usage rates 
for all equipment. However, we stated that we did not believe that we 
had strong empirical evidence to justify any alternative approaches. We 
indicated that we would continue to monitor the appropriateness of the 
equipment utilization assumption, and evaluate whether changes should 
be proposed in light of the data available.
    Subsequently, a 2009 report on equipment utilization by MedPAC 
included studies that suggested a higher utilization rate for 
diagnostic imaging equipment costing more than $1 million. These 
studies cited by MedPAC suggested that for Magnetic Resonance Imaging 
equipment, a utilization rate of 92 percent on a 50-hour week would be 
most accurate. Similarly, another MedPAC-cited study suggested that for 
computed tomography scanners, 45 hours was more accurate, and would be 
equivalent to a 90 percent utilization rate on a 50-hour work week. For 
the CY 2010 PFS proposed rule, we proposed to increase the equipment 
usage rate to 90 percent for all services containing equipment that 
cost in excess of $1 million dollars. We stated that the studies cited 
by MedPAC suggested that physicians and suppliers would not typically 
make huge capital investments in equipment that would only be utilized 
50 percent of the time (74 FR 33532).
    In response to comments to that proposal, we finalized a 90 percent 
utilization rate assumption for MRI and CT to be transitioned over a 4-
year period. Regarding the utilization assumptions for other equipment 
priced over $1 million, we stated that we would continue to explore 
data sources regarding use of the most accurate utilization rates 
possible (74 FR 61755). Congress subsequently specified the utilization 
rate to be assumed for MRI and CT by successive amendments to section 
1848(b)(4)(C) of the Act. Section 3135(a) of the Affordable Care Act 
(Pub. L. 111-148) set the assumed utilization rate for expensive 
diagnostic imaging equipment to 75 percent, effective for 2011 and 
subsequent years. Section 635 of the American Taxpayer Relief Act 
(ATRA) (Pub. L. 112-240) set the assumed equipment utilization rate to 
90 percent, effective for 2014 and subsequent years. Both of these 
changes were exempted from the budget neutrality requirements described 
in section 1848(c)(2)(B)(ii)(II) of the Act.
    We have also made other adjustments to the default assumptions 
regarding the number of hours for which the equipment is available to 
be used. For example, some equipment used in furnishing services to 
Medicare beneficiaries is available to be used on a 24-hour/day, 7 
days/per week basis. For these items, we develop the rate per minute by 
amortizing the cost over the extended period of time the equipment is 
in use.
    Based on the RUC recommendations for the new codes that describe 
radiation treatment services, we do not believe our default assumptions 
regarding equipment usage are accurate for the capital equipment used 
in radiation treatment services. As we noted above, the RUC 
recommendations assume that the same type of linear accelerator is now 
typically used to furnish all levels and types of external beam 
radiation treatment services because the machines previously used to 
furnish these services are no longer manufactured. In valuing the 
previous code set and making procedure time assumptions, different 
equipment items were assumed to be used to furnish the different levels 
and types of radiation treatment. With the current RUC-recommended 
inputs, we can then assume that the same equipment item is used to 
furnish more services. If we assume the RUC recommendation to include 
the same kind of capital equipment for all of these codes is accurate, 
we believe that it is illogical to continue to assume that the 
equipment is only used for 25 out of a possible 50 hours per week. In 
order to estimate the difference between the previous number of minutes 
the linear accelerator was assumed to be in use under the previous 
valuation and the number of minutes now being recommended by the RUC, 
we applied the change in assumptions to the services reported in the 
most recent year of Medicare claims data. Under the assumptions 
reflected in the previous direct PE inputs, the kind of linear 
accelerator used for IMRT made up a total of 44.8 million out of 65 
million minutes of external beam treatments furnished to Medicare 
beneficiaries. Under the new code set, however, we suggested in the 
proposed rule that a single kind of linear accelerator would be used 
for all of the 65 million minutes furnished to Medicare beneficiaries. 
This represents a 45 percent increase in the aggregate amount of time 
that this kind of linac is in use. As we noted in the proposed rule, 
the utilization rate that corresponds with that increase in minutes is 
not necessarily precise since the current utilization rate only 
reflects the default assumption and is not itself rooted in empirical 
data. Additionally, in some cases, individual practices that already 
use linear accelerators for IMRT may have replaced the now-obsolete 
capital equipment with new, additional linear accelerators instead of 
increasing the use of capital equipment already owned. However, we do 
not believe that the latter scenario is likely to be common in cases 
where the linear accelerators had previously been used only 25 hours 
per week.
    Therefore, we proposed to adjust the equipment utilization rate 
assumption for the linear accelerator to account for the significant 
increase in usage. Instead of applying our default 50 percent 
assumption, we proposed to use a 70 percent assumption based on the 
recognition that the item is now being typically used in a 
significantly broader range of services, and that would increase how 
often the equipment is used in comparison to the previous assumption. 
In the proposed rule, we noted that we developed the 70 percent rate 
based on a rough reconciliation between the number of minutes the 
equipment is being used according to the new recommendations versus the 
current number of minutes based on an analysis of claims data.
    Comment: Several commenters objected to our analysis specifically 
because we described it as a ``rough reconciliation.''
    Response: We appreciate commenters' interest in our use of the best 
data available in determining what values to assign to necessary 
assumptions. We regret the use of the term ``rough reconciliation'' and 
clarify that our analysis relied on two somewhat imprecise data points: 
The RUC procedure time assumptions for individual services and the 
current 50 percent utilization assumption. Because both of these 
assumptions directly determine how capital equipment costs are 
translated into PE RVUs, they were essential to our analysis. However, 
we recognize that these assumptions are round figures, reflecting 
assumptions about what is typical. Therefore, when we combined these 
numbers with precise Medicare claims data in order to develop a more 
accurate assumption, we arrived at a very specific number that might 
have appeared to be very precise. Recognizing that the calculation was 
based on assumptions as noted above, we subsequently proposed to round 
the number to 70 percent instead of using the fractional result of the 
calculation. We continue to believe rounding to 70 percent is 
appropriate for the reasons stated above.
    Given the best available information, we believe that the 70 
percent utilization assumption based on the changes in direct PE input 
recommendations and Medicare claims

[[Page 70952]]

data is more accurate than the default utilization assumption of 50 
percent. However, we have reviewed other information that suggests this 
utilization rate may be higher than 70 percent and that the number of 
available hours per week is greater than 50.
    For example, as part of the 2014 RUC recommendations for the 
Radiation Treatment Delivery codes, the RUC submitted a 2011 staffing 
survey conducted by the American Society for Radiology Technicians 
(ASRT). Using the 2014 version of the same study, we noted that there 
are an average of 2.3 linacs per radiation treatment facility and 52.7 
patients per day treated per radiation treatment facility. These data 
suggest that an average of 22.9 patients are treated on each linac per 
day. Using an average of the RUC-recommended procedure times for CPT 
codes 77385, 77386, 77402, 77407, and 77412 weighted by the annual 
volume of procedures derived from Medicare claims data yielded a total 
of 670.39 minutes or 11.2 hours that a single linac is in use per day. 
This is in contrast to both the number of hours of use reflected in our 
default assumptions (5 of the 10 available business hours per day) and 
in our proposed revision to the equipment utilization rate assumptions 
(7 hours out of 10 available business hours per day).
    For advanced diagnostic imaging services, we finalized a policy for 
CY 2010 to change the equipment utilization assumption only by 10 
percent per year, in response to suggestions from commenters. Because 
capital equipment costs are amortized over several years, we believe it 
is reasonable to transition changes to the default assumptions for 
particular items over several years. We noted in the proposed rule that 
the change from one kind of capital equipment to another is likely to 
occur over a number of years, roughly equivalent to the useful life of 
particular items as they become obsolete. In the case of most of these 
items, we have assumed a 7-year useful life, and therefore, we assumed 
that the transition to use of a single kind of capital equipment would 
likely take place over seven years as individual pieces of equipment 
age into obsolescence. However, in the case of this transition in 
capital equipment, we have reason to believe that the transition to the 
new capital equipment has already occurred. First, we note that the 
specialty societies concluded that the single linear accelerator was 
typical for these services at the time that the current recommendations 
were developed in 2013. Therefore, we believe it is logical to assume 
that, at a minimum, the first several years of the transition to new 
capital equipment had already taken place by 2013. This would not be 
surprising, given that prior to the 2013 review by the RUC, the codes 
describing the non-IMRT external beam radiation treatments had last 
been reviewed in 2002. Second, because we proposed to use the 2013 
recommendations for the CY 2016 PFS payment rates, we believed it would 
be reasonable to assume that in the years between 2013 and 2016, the 
majority of the rest of the obsolete machines would have been replaced 
with the single linear accelerator.
    Nonetheless, we recognized that there would be value in following 
precedent to transition changes in utilization assumptions over several 
years.
    Given the fact that it is likely that the transition to the linear 
accelerator began prior to the 2013 revaluation of the radiation 
treatment delivery codes by the RUC and that the useful life of the 
newest generation of linear accelerator is seven years, we believe a 2-
year transition to the 70 percent utilization rate assumption would 
account for any remaining time to transition to the new equipment. 
Therefore, in developing PE RVUs for these services, we proposed to use 
a 60 percent utilization rate assumption for CY 2016 and a 70 percent 
utilization rate assumption for CY 2017. The proposed PE RVUs displayed 
in Addendum B on the CMS Web site were calculated using the proposed 60 
percent equipment utilization rate for the linac as displayed in the 
proposed direct PE input database.
    Additionally, we continue to seek empirical data on the capital 
equipment costs, including equipment utilization rates, for the linac 
and other capital-intensive machines, and seek comment on how to most 
accurately address issues surrounding those costs within the PE 
methodology.
    Comment: Most commenters were opposed to changing the default 
utilization assumption for linear accelerators. Many of these 
commenters stated that the rationale CMS used to support the change in 
default utilization assumption was inadequate and anecdotal. Several 
commenters performed and submitted their own data analyses.
    Response: We continue to believe a reconciliation of Medicare 
claims data with the RUC-recommended procedure times results in the 
most accurate equipment utilization rate assumption. We also believe 
that whenever possible we should use the Medicare claims data to test 
the validity and internal consistency of our ratesetting assumptions. 
We do not agree with the commenters that such an approach is anecdotal. 
While CMS appreciates the analyses performed by some commenters, no 
additional data were submitted to substantiate these analyses.
    Comment: One commenter conducted an analysis somewhat similar to 
ours, but used three data sets: Medicare claims data, the ASRT staffing 
survey CMS referenced in the proposed rule, and data from the CMS 
physician billing public use database. Based on this analysis, the 
commenter suggested that 50 percent is a more accurate utilization 
assumption.
    Response: We appreciate the commenter's analysis, and found it to 
be very useful in considering whether or not to finalize our proposal. 
However, the commenter's conclusion of a 50 percent utilization rate is 
entirely dependent on what we believe is an overestimate of the number 
of linacs used to deliver radiation treatment. In order to determine 
the number of linacs overall, the commenter multiplied the 2.3 linacs 
per center statistic cited in the ASRT staffing survey by the number of 
individual billing entities reporting treatment services in the 
Medicare claims data as a proxy for the number of freestanding centers. 
That approach would count two radiation oncologists reporting services 
in the same center as if they were practicing in two centers, not one, 
and therefore overestimate the number of machines. Were the same 
analysis conducted using the number of centers included in the same 
ASRT staffing survey, the result of the analysis would be an 
approximately 70 percent equipment utilization rate. Therefore, we did 
not find the commenter's analysis persuasive.
    Comment: Many commenters stated that a 70 percent utilization rate 
assumption did not take into account events beyond the control of the 
facility that could impact how long any given linear accelerator might 
be used over the course of time. These commenters suggested that issues 
such as time necessary to warm up the treatment machine, maintenance, 
patient preferences, missed appointments, and multiple treatment 
devices contributed to a lower utilization rate that CMS proposed to 
assume.
    Response: We understand that the day-to-day operation and 
utilization of capital equipment will vary, and that is precisely why 
the equipment cost per minute calculation does not assume that the 
equipment is used for the full amount of time possible (100 percent 
rate). Instead, the utilization rate assumption is used to allocate the 
total cost of the equipment relative to other

[[Page 70953]]

direct PE costs on a per-minute basis. Therefore, the assumptions are 
intended to reflect the percentage of total time (assuming a 50-hour 
work week) payment is made for services on the machine. In assigning 
minutes to individual codes, we generally assign minutes for preparing 
and cleaning the equipment; therefore, these minutes would contribute 
to the 70 percent portion, or 35 hours per week. In contrast, minutes 
for a missed appointment would count toward the 30 percent of the 50 
hours, or 15 hours per week, that the equipment is not being used.
    Comment: Many commenters were concerned that a higher utilization 
rate assumption would have a negative effect on rural treatment centers 
and treatment centers in medically disadvantaged areas.
    Response: We believe it is important to preserve access to care for 
all Medicare beneficiaries. However, we believe we are obligated under 
the statute to use accurate assumptions in developing RVUs for 
individual services under the PFS. Under the statutory construct of the 
PFS, we believe that accurate valuation for all PFS services is 
important in maintaining access to care for all Medicare beneficiaries.
    Comment: A few commenters suggested that CMS should phase in the 
utilization rate change over four years or delay implementing the 
change until 2017.
    Response: We appreciate the commenters' suggestions. We did 
consider these suggested alternatives as part of our rulemaking 
process. Although both a longer phase-in and a delay would temporarily 
mitigate the payment reductions for these services, especially in the 
context of other proposed payment reductions, we did not identify any 
persuasive rationale for delaying implementation or phasing in 
implementation over more than 2 years.
    Comment: Many commenters were concerned that the change in 
utilization rate assumption was affecting all equipment items in the 
radiation treatment delivery codes, and argued that it should only 
apply to the linac. Commenters urged CMS to use a 50 percent 
utilization rate assumption for the other equipment items. Some 
commenters argued that this was contradictory to the utilization 
assumption for advanced diagnostic imaging.
    Response: We applied the increased utilization rate assumption 
across all equipment items under the assumption that items generally 
located in the same room as the linear accelerator could not be used to 
furnish other services while the linear accelerator was in use, and 
therefore, would be subject to the same utilization assumptions. This 
approach is consistent with the application of the equipment 
utilization assumption for advanced diagnostic imaging.
    Comment: MedPAC expressed support for CMS' proposal to change the 
equipment utilization rate assumption for linear accelerators. MedPAC 
agreed that CMS should develop a normative standard based on the 
assumption that those who purchase an expensive piece of capital 
equipment would use it at a higher utilization rate.
    Response: We appreciate MedPAC's support for the proposal.
(3) Other Equipment Cost Variables
    Comment: A few commenters suggested that CMS update the price for 
the radiation treatment vault to approximately $800,000 and reduce the 
useful life assumption from 15 to 7 years. Several other commenters 
suggested that CMS update the variable maintenance rate from the 
default five percent assumption to between 10 and 15 percent.
    Response: We appreciate the commenter's feedback, and acknowledge 
our longstanding concerns regarding obtaining accurate, objective 
information regarding the pricing of direct PE inputs, particularly the 
prices for expensive equipment. In the case of the radiation treatment 
vault, we believe that at least some portions of the costs associated 
with the vault construction are indirect PE under the established 
methodology. We will continue to consider this issue, including these 
commenters' suggestion to use increased pricing for the item.
    Comment: Many commenters disagreed with the classification of 
``intercom'' as an indirect PE. These commenters stated that the 
intercom is specifically for the practitioner to communicate directly 
with the patient and, as such, it constitutes a direct PE.
    Response: We remind the commenter that under the established 
methodology, direct PE inputs are defined as clinical labor, disposable 
supplies, and medical equipment. Other items are incorporated as 
indirect costs, regardless of how the items are used.
    Comment: Several commenters, including the AMA RUC, stated that CMS 
should include 2 minutes for the clinical labor task ``dose output and 
verification'' as it is performed on the equipment items associated 
with these codes.
    Response: ``Dose output and verification'' occurs during the ``pre-
service'' period and pre-service minutes are generally not allocated to 
the equipment items, under our established methodology.
(4) Specialty Impacts
    Comment: One commenter stated that CMS should no longer display 
specialty level impacts for ``radiation therapy centers'' in the 
proposed and final rule. The commenter argued that since the PFS 
allowed charges associated with ``Radiation Therapy Centers'' represent 
only a small portion of radiation oncology services overall, displaying 
the impacts separately is misleading to the interested public.
    Response: We appreciate the commenter's concerns and agree with 
commenters that the PFS allowed charges associated with ``radiation 
therapy centers'' is only a small portion of overall payments for 
radiation oncology services, including the total amount of those 
furnished outside of the hospital setting. Because we think it is 
important to maintain a consistent display of specialty-level impacts 
between a proposed and final rule, we are not making a change for this 
year's final rule. However, we are seeking additional comment regarding 
how the impacts for these services should be displayed in future 
rulemaking.
(5) Implementation of New Coding
    Comment: Several commenters expressed concerns about the two new 
treatment delivery codes describing simple and complex IMRT treatment 
delivery in contrast to the current single code. Specifically, these 
commenters were concerned that that the CPT instruction that requires 
treatment for prostate and breast cancer to be reported using the 
simple IMRT treatment delivery code would have a negative impact on 
overall treatment for patients with prostate and breast cancer. These 
commenters suggested that that the new coding structure did not allow 
radiation therapy providers to accurately report prostate and breast 
cancer treatment services that are more resource intensive than those 
described in the simple IMRT code. These commenters also stated that 
the coding change including CMS' proposed valuations would have a 
widespread negative impact on access to care, including reduction in 
the number of freestanding centers offering radiation treatment for 
breast and prostate cancer, and therefore limit patients' access to 
care outside of the higher cost hospital setting.
    Response: We believe that increased specificity in coding for such 
a resource-intensive, high-volume group of services is a significant 
improvement compared to the use of a single code to describe all IMRT 
treatment services, regardless

[[Page 70954]]

of their relative resource costs. However, we understand the 
commenters' concerns about the potential negative impact of 
implementing the new code set for payment of treatment for breast and 
prostate cancers. The primary resource cost for these services is 
represented by the capital equipment, so we believe that for purposes 
of most accurate payment, the optimal coding for these services would 
group them based on how long the capital equipment is being used per 
service, so that payment is linked to the resource costs of furnishing 
particular services. Under the current set of codes, payment would be 
made based on the assumptions regarding the typical resource costs for 
the treatment of particular diseases, instead of the resource costs 
based on the length of treatment time.
    Comment: Several commenters pointed out a rank order anomaly in the 
PE RVUs among codes CPT codes 77402, 77407, and 77412 that describe 
simple, intermediate, and complex radiation treatment codes, 
respectively. The commenters stated that it was illogical for the 
intermediate radiation treatment delivery code to have higher PE RVUs 
and overall payment compared to the complex radiation treatment 
delivery. Commenters suggested that this anomaly may be the result of 
the allocation of indirect PE because the specialty reporting the 
utilization for the intermediate code is more frequently dermatology 
than radiation oncology and dermatology is allocated more indirect PE 
within the PE methodology.
    Response: We agree with commenters that this rank order anomaly is 
due to the difference in the mix of specialties in the utilization for 
these services. We also agree with the commenters that such rank order 
anomalies within families should be avoided when possible. We believe 
these kinds of rank order anomalies generally suggest inaccurate 
valuations and present risks to accurate billing and overall 
ratesetting. The risks are associated with incentives toward inaccurate 
downward coding. For example, in this case, individual practitioners 
would have the financial incentive to report radiation treatment 
delivery services using the intermediate code, even when the complex 
code would be more accurate. If practitioners acted on such an 
incentive, there would be serious consequences within our ratesetting 
methodologies for both purposes of budget neutrality and for allocation 
of PE RVUs. The increased utilization of the higher paying intermediate 
code would result in inappropriately low budge neutrality adjustment 
across the PFS. The rank order anomaly might also result in cyclical 
fluctuations in the year-to-year allocation of PE. This would happen if 
the inappropriate reporting of the intermediate code itself resulted in 
a concentration of most of the overall volume (including radiation 
oncology at a greater volume than dermatology) in the intermediate 
code. Then, once the claims data reflecting this concentration were 
incorporated into PFS ratesetting, the rank order anomaly would recur 
and the cycle would begin again. In considering these comments in the 
context of our proposal to implement these codes, we considered how we 
might eliminate this anomaly. We concluded that the best approach would 
be to maintain the total number of PE RVUs for these services overall, 
but to redistribute them among the three codes in order to eliminate 
the rank order anomaly. In order to do this, we would calculate the PE 
RVUs for these services under the established methodology and multiply 
these RVUs by the volume associated with each code. We would then 
reallocate the total number of PE RVUs among the three codes based on 
the weights of their direct costs included in the direct PE input 
database, since the total direct costs for these codes reflect 
appropriate valuation. We are seeking comment on this approach or other 
possible ways to mitigate the impact of the rank order anomaly among 
these codes.
    Comment: One commenter stated that, in light of the significant 
negative impact of the coding changes and the proposed change in the 
default utilization rate assumption, CMS should delay implementation of 
the new codes for another year and work with stakeholders to gather 
information on the appropriate pricing of equipment items, utilization 
of equipment, and coding structure. A few commenters also stated that 
CMS should consider pricing radiation treatment delivery through the 
OPPS. And finally, several commenters noted that the proliferation of 
TC-only codes had a negative impact on the overall allocation of PE 
RVUs for radiation oncology services.
    Response: We agree with commenters regarding the magnitude of 
changes that would result from the new code set. In general, we believe 
that significant changes in coding can improve the valuation and 
payment for PFS services. In the case of this set of new codes, we 
believe increased granularity in IMRT treatment delivery codes would 
benefit payment accuracy. We also believe that it is generally 
preferable for CMS to use CPT codes to describe physicians' services 
paid under the PFS and that, when possible, we should use consistent 
coding between the PFS and OPPS.
    In consideration of comments from stakeholders and our concerns as 
described above, however, we do not believe that, on balance, we should 
finalize the new code set for CY 2016. Therefore, for CY 2016, we are 
not finalizing our proposal to implement the new set of codes. We will 
continue the use of the current G-codes and values for CY 2016 while we 
seek more information, including public comments and recommendations 
regarding new codes to be developed either through the CPT process or 
through future PFS rulemaking. We believe that significant changes to 
the codes need to be made before we can develop accurate payment rates 
under the PFS for these services. These changes would include: 
developing a code set that recognizes the difference in costs between 
kinds of imaging guidance modalities; making sure that this code set 
facilitates valuation that incorporates the cost of imaging based on 
how frequently it is actually provided; and developing treatment 
delivery codes that are structured to differentiate payment based on 
the equipment resources used.
    While we are not finalizing the new code set for these services, we 
are finalizing our proposals to include the single linear accelerator 
for radiation treatment delivery services as recommended by the RUC, 
and to update the default utilization rate assumption for linear 
accelerators used in radiation treatment services from 50 to 70 
percent, phased in over 2 years. Under either set of codes, it is clear 
that the 50 percent utilization assumption is incompatible with the 
times used to develop payment rates for individual procedures, given 
that the same linear accelerator is used for the services.
    Finally, because the costs of capital equipment are the primary 
drivers of RVUs and payment amounts for these services, and we 
acknowledge significant difficult in obtaining quality information 
regarding the actual costs of such equipment across the wide range of 
practitioners and suppliers that furnish these services, we will be 
engaging in market research to develop independent estimates of 
utilization and pricing for linear accelerators and image guidance used 
in furnishing radiation treatment services. We will also consider ways 
in which data collected from hospitals under the OPPS may be helpful in 
establishing rates for these and other technical component services. We 
will consider this information, including public comment, as we develop 
proposals for inclusion in future notice and comment rulemaking.

[[Page 70955]]

(6) Superficial Radiation Treatment Delivery
    In the CY 2015 PFS final rule with comment period, we noted that 
changes to the CPT prefatory language modified the services that are 
appropriately billed using CPT code 77401 (radiation treatment 
delivery, superficial and/or ortho voltage, per day). The changes 
effectively meant that many other procedures supporting superficial 
radiation therapy were bundled with CPT code 77401. The RUC, however, 
did not review the inputs for superficial radiation therapy procedures, 
and therefore, did not assess whether changes in its valuation were 
appropriate in light of this bundling. Some stakeholders suggested that 
the change in the prefatory language precluded them from billing for 
codes that were previously frequently billed in addition to this code 
and expressed concern that as a result there would be significant 
reduction in their overall payments. In the CY 2015 PFS final rule with 
comment period, we requested information on whether the new radiation 
therapy code set, combined with modifications in prefatory text, 
allowed for appropriate reporting of the services associated with 
superficial radiation and whether the payment continued to reflect the 
relative resources required to furnish superficial radiation therapy 
services.
    In response to our request, we received a recommendation from a 
stakeholder to make adjustments to both the work and PE components for 
CPT code 77401. The stakeholder suggested that since crucial aspects of 
the service, such as treatment planning and device design and 
construction, were not currently reflected in CPT code 77401, and 
practitioners were precluded from reporting these activities 
separately, additional work should be included for CPT code 77401. 
Additionally, the stakeholders suggested that the current inputs used 
to value the code are not accurate because the inputs include zero work 
and minutes for a radiation therapist to provide the service directly 
to the patient. The stakeholders suggested, alternatively, that 
physicians, not radiation therapists, typically provide superficial 
radiation services directly. Finally, stakeholders also suggested that 
we amend the direct PE inputs by including nurse time and updating the 
price of the capital equipment used in furnishing the service.
    In response, we solicited recommendations from stakeholders, 
including the RUC, regarding whether or not it would be appropriate to 
add physician work for this service and remove minutes for the 
radiation therapists, even though physician work is not included in 
other radiation treatment services. We believe it would be appropriate 
to address the clinical labor assigned to the code in the context of 
the information regarding the work that might be associated with the 
service. We also solicited information on the possible inclusion of 
nurse time for this service as part of the comments and/or 
recommendations regarding work for the service. Lastly, we reviewed the 
invoices submitted in response to our request to update the capital 
equipment for the service.
    We proposed to update the equipment item ER045 ``orthovoltage 
radiotherapy system'' by renaming it ``SRT-100 superficial radiation 
therapy system'' and update the price from $140,000 to $216,000, on the 
basis of the submitted invoices. The proposed PE RVUs displayed in 
Addendum B on the CMS Web site were calculated with this proposed 
modification that was displayed in the CY 2016 direct PE input 
database.
    Comment: Multiple commenters from various specialty societies 
responded to our request for comment. Several stated that there was 
work in 77401, while other commenters stated that there was not. One 
commenter suggested that CMS create a G-code to account for work, while 
another commenter stated that 77401 should be resurveyed by the RUC.
    Response: Given the disagreement among commenters on the work 
involved in furnishing CPT code 77401, we are considering the 
possibility of creating a code to describe total work associated with 
the course of treatment for these services and are seeking additional 
information on alternatives descriptions and valuations for a code 
describing this work for consideration in future rulemaking.
    Comment: A few commenters pointed out that the description of 
equipment item ER045 as proposed, ``SRT-100 superficial radiation 
therapy system,'' is a particular item that might better be identified 
generically as ``superficial radiation therapy system.''
    Response: We agree with the commenter's suggestion and have updated 
the direct PE input database accordingly.
    Comment: A few commenters thanked CMS for updating the price of the 
superficial radiation therapy system.
    Response: We appreciate the support for our proposal.
    After considering the comments, we are finalizing the update to 
ER045 as proposed.
c. Advance Care Planning Services
    For CY 2015, the CPT Editorial Panel created two new codes 
describing advance care planning (ACP) services: CPT code 99497 
(Advance care planning including the explanation and discussion of 
advance directives such as standard forms (with completion of such 
forms, when performed), by the physician or other qualified health 
professional; first 30 minutes, face-to-face with the patient, family 
member(s) and/or surrogate); and an add-on CPT code 99498 (Advance care 
planning including the explanation and discussion of advance directives 
such as standard forms (with completion of such forms, when performed), 
by the physician or other qualified health professional; each 
additional 30 minutes (List separately in addition to code for primary 
procedure)). In the CY 2015 PFS final rule with comment period (79 FR 
67670-71), we assigned a PFS interim final status indicator of ``I'' 
(Not valid for Medicare purposes. Medicare uses another code for the 
reporting and payment of these services) to CPT codes 99497 and 99498 
for CY 2015. We said that we would consider whether to pay for CPT 
codes 99497 and 99498 after we had the opportunity to go through notice 
and comment rulemaking.
    In the CY 2016 PFS proposed rule, for CY 2016 we proposed to assign 
CPT codes 99497 and 99498 PFS status indicator ``A,'' which is defined 
as: ``Active code. These codes are separately payable under the PFS. 
There will be RVUs for codes with this status. The presence of an ``A'' 
indicator does not mean that Medicare has made a national coverage 
determination regarding the service. Contractors remain responsible for 
local coverage decisions in the absence of a national Medicare 
policy.'' We proposed to adopt the RUC-recommended values (work RVUs, 
time, and direct PE inputs) for CPT codes 99497 and 99498 beginning in 
CY 2016. The services could be paid on the same day or a different day 
as other E/M services. Physicians' services are covered and paid by 
Medicare in accordance with section 1862(a)(1)(A) of the Act. 
Therefore, under our proposal CPT code 99497 (and CPT code 99498 when 
applicable) would be reported when the described service is reasonable 
and necessary for the diagnosis or treatment of illness or injury. For 
example, this could occur in conjunction with the management or 
treatment of a patient's current condition, such as a 68 year old male 
with heart failure and diabetes on multiple medications seen by his 
physician for the E/M of these two

[[Page 70956]]

diseases, including adjusting medications as appropriate. In addition 
to discussing the patient's short-term treatment options, the patient 
may express interest in discussing long-term treatment options and 
planning, such as the possibility of a heart transplant if his 
congestive heart failure worsens and advance care planning including 
the patient's desire for care and treatment if he suffers a health 
event that adversely affects his decision-making capacity. In this case 
the physician would report a standard E/M code for the E/M service and 
one or both of the ACP codes depending upon the duration of the ACP 
service. However the ACP service as described in this example would not 
necessarily have to occur on the same day as the E/M service.
    We solicited comment on this proposal, including whether payment is 
needed and what type of incentives the proposal might create. In 
addition, we solicited comment on whether payment for advance care 
planning is appropriate in other circumstances such as an optional 
element, at the beneficiary's discretion, of the annual wellness visit 
(AWV) under section 1861(hhh)(2)(G) of the Act.
    We received approximately 725 public comments to the proposed rule 
regarding payment for ACP services. We received comments from 
individual citizens; several coalitions; professional associations; 
professional and community-based organizations focusing on end-of-life 
health care; healthcare systems; major employers; and many individual 
healthcare professionals working in primary care, geriatrics, hospice/
palliative medicine, critical care, emergency medicine and other 
settings. We also received comments from chaplains, ethicists, advanced 
illness counseling companies and other interested parties. The majority 
of commenters expressed support for the proposal, providing 
recommendations on valuation, the types of professionals who should 
able to furnish or bill for the services and the appropriate setting of 
care, intersection with existing codes, the establishment of standards 
or specialized training, and beneficiary cost sharing and education. 
Some commenters opposed or expressed provisional support for the 
proposal because they believed it might create perverse financial 
incentives relating to termination of patient care. We summarize all of 
the comments below.

Valuation

    Comment: Many commenters supported the separate identification and 
payment for ACP, either by adopting CPT codes 99497 and 99498 or other 
unique code(s). Many commenters supported the proposal broadly, 
advocating for improved Medicare coverage and payment of ACP. Several 
commenters supported our proposal to adopt the RUC-recommended payment 
inputs. Several other commenters stated the proposed payment amount was 
insufficient, and one of these commenters recommended a payment rate 
equal to the payment for CPT code 99215 (Office or other outpatient 
visit for the E/M of an established patient) in order to appropriately 
account for the physician's time.
    Response: We appreciate the commenters' support for separate 
identification and payment for voluntary ACP services. We believe the 
RUC-recommended inputs accurately reflect the resource costs involved 
in furnishing the services described by CPT codes 99497 and 99498, and 
therefore, are finalizing our proposal to adopt the RUC-recommended 
values for both codes.
    Comment: Regarding the time required to furnish ACP services, the 
commenters cited times ranging from 10 minutes to several hours over 
multiple encounters, depending on the setting and the patient's 
condition. Several commenters requested payment for increments of time 
of less than 30 minutes (for example, 10-15 minutes). One said the 
services typically require 30-45 minutes of face-to-face time with the 
patient and family. Several commenters recommended payment for services 
lasting less than 30 minutes, for example, by pro-rating the add-on 
code.
    Response: We believe the CPT codes describe time increments that 
are appropriate for furnishing ACP services in various settings. 
Therefore we are finalizing our proposal to adopt the CPT codes and CPT 
provisions regarding the reporting of timed services.
    Comment: Many commenters recommended that CMS issue a national 
coverage decision to avoid any local variation in coverage.
    Response: We believe it may be advantageous to allow time for 
implementation and experience with ACP services, including 
identification of any variation in utilization, prior to considering a 
controlling national coverage policy through the National Coverage 
Determination process (see 78 FR 48164, August 7, 2013). By including 
ACP services as an optional element of the AWV (for both the first 
visit and subsequent visits), as discussed below, this rule creates an 
annual opportunity for beneficiaries to access ACP services should they 
elect to do so.
    Comment: Many commenters recommended limits on utilization to 
prevent abuse, while others recommended no utilization limits in order 
to increase access and ensure periodic updates to advance care plans. 
Several commenters were concerned that the lack of utilization limits 
would lead to practitioners harassing patients.
    Response: In general, we do not agree with the commenters who 
suggested that this service is more likely to be subject to 
overutilization or abuse than other PFS services without our adoption 
of explicit frequency limitations. We believe the CPT codes describe 
time increments that are appropriate for furnishing ACP services in 
various settings. Therefore, we are finalizing our proposal to adopt 
the CPT codes and CPT provisions regarding the reporting of timed 
services. Since the services are by definition voluntary, Medicare 
beneficiaries may decline to receive them. When a beneficiary elects to 
receive ACP services, we encourage practitioners to notify the 
beneficiary that Part B cost sharing will apply as it does for other 
physicians' services (except when ACP is furnished as part of the AWV, 
see the discussion below). We plan to monitor utilization of the new 
CPT codes over time to ensure that they are used appropriately.

Intersection With Other Services

    Comment: Many commenters supported our proposal to pay for ACP 
services when furnished either on the same day or a different day than 
other E/M services. Several commenters asked CMS to specify whether and 
how the ACP codes could be billed in conjunction with E/M visits or 
services that span a given time period, such as 10- or 90-day global 
codes or Transitional Care Management (TCM) and Chronic Care Management 
(CCM) services. One commenter recommended that CMS unbundle ACP 
services from critical care services and pay at a higher rate, but did 
not suggest an alternative payment amount.
    Response: We believe that CPT guidance for these codes is 
consistent with the description and recommended valuation of the 
described services. When adopting CPT codes for payment, we generally 
also adopt CPT coding guidance. In this case, CPT instructs that CPT 
codes 99497 and 99498 may be billed on the same day or a different day 
as other E/M services, and during the same service period as TCM or CCM 
services and within global surgical periods. We are also are adopting 
the CPT guidance prohibiting the reporting of CPT codes 99497 and 99498 
on the same date of service as certain critical care services including 
neonatal and pediatric critical care.

[[Page 70957]]

Who Can Furnish/Setting of Care

    Comment: Many commenters who supported the proposal provided 
recommendations regarding which practitioners and support staff should 
be able to provide or be paid for ACP services. Many commenters sought 
clarification regarding who would qualify as the ``other health care 
professionals'' described by or able to bill the CPT codes. Many 
commenters described ACP services as being routinely provided by a 
multidisciplinary team under physician supervision. For example, they 
stated that ACP is routinely provided by physicians, non-physician 
practitioners and other staff under the order and medical management of 
the beneficiary's treating provider. They stated that often a team 
approach is used, involving coordination between the beneficiary's 
physicians, non-physician practitioners (such as licensed clinical 
social workers or clinical nurse specialists) and other licensed and 
credentialed hospital staff such as registered nurses.
    Similarly, other commenters described social workers, clinical 
psychologists, registered nurses, chaplains and other individuals as 
appropriate providers of ACP services, either alone or together with a 
physician, and recommended payment for the services of these 
individuals. For example, one commenter stated that a significant 
portion of ACP discussions occur between patients and registered nurses 
or allied health professionals functioning as care coordinators, care 
navigators or similar roles; that a growing proportion are performed at 
home; and that CMS should enable care coordinators and navigators to 
bill the ACP codes either by defining them as ``other qualified health 
professionals'' or under ``incident to'' provisions.
    Some commenters specifically recommended allowing social workers 
and chaplains qualified under the hospice benefit to bill the ACP 
codes. One community oncologist association stated that best practices 
have evolved to include a multi-disciplinary approach utilizing trained 
physician, advanced practice provider and social worker skill sets, and 
that nearly half of their oncology network's ACP is performed by 
licensed clinical social workers. This commenter stated that while it 
is typical for a physician to initiate the ACP discussion with 
patients, ACP usually occurs with a mid-level provider or social worker 
and therefore the association requested that CMS allow clinical social 
workers to bill for these services. Another national association stated 
that it was working towards the development of new CPT codes for 
practitioners such as social workers who the commenter believed would 
not be able to directly bill the proposed codes.
    Some commenters argued that such non-medically trained individuals 
are qualified and have special training and expertise (whether 
psychosocial, spiritual or legal) that are needed on ACP care teams. 
Some believed that ACP is sometimes appropriate for physicians to 
perform, but that physicians do not have enough time to supply all of 
the demand for ACP services. Some commenters similarly argued that 
inclusion of social workers and other non-medically trained individuals 
including Spiritual Directors, Chaplains, Clinical Pastoral Counselors 
and others would alleviate concerns about undue influence over patient 
decisions. These commenters stated that part of the ACP conversation is 
emotional and spiritual and not merely clinical, so it is important to 
include individuals who can address the non-clinical aspect of ACP. 
Some commenters argued that widening the field of professionals who can 
initiate these conversations within their scope of practice will 
further encourage appropriate and frequent ACP. Several commenters 
stated that physicians should not be paid for ACP services due to an 
ethical or financial conflict of interest, and that communities should 
take more responsibility for these services.
    In contrast, several commenters were concerned that allowing ACP to 
be paid to certain trained facilitators would undermine physician 
authority in treating patients. These commenters described the use of 
trained facilitators in certain community models that offer group 
discussions by trained lay and health professionals. These commenters 
were concerned that such facilitators would qualify as ``other 
qualified professionals'' under the CPT code descriptor and be given 
control over ACP, shaping physician behavior. One commenter stated that 
to prevent coercion of patients, it would be better if payment was 
limited to non-employees of hospitals.
    Response: We appreciate the many comments we received on existing 
or recommended practice patterns for the provision of ACP services. We 
acknowledge the broad range of commenters that stated that the services 
described by CPT codes 99497 and 99498 are appropriately provided by 
physicians or using a team-based approach provided by physicians, non-
physician practitioners and other staff under the order and medical 
management of the beneficiary's treating physician. We note that the 
CPT code descriptors describe the services as furnished by physicians 
or other qualified health professionals, which for Medicare purposes is 
consistent with allowing these codes to be billed by the physicians and 
NPPs whose scope of practice and Medicare benefit category include the 
services described by the CPT codes and who are authorized to 
independently bill Medicare for those services. Therefore only these 
practitioners may report CPT codes 99497 or 99498. We note that as a 
physicians' service, ``incident to'' rules apply when these services 
are furnished incident to the services of the billing practitioner, 
including a minimum of direct supervision. We agree with commenters 
that advance care planning as described by the proposed CPT codes is 
primarily the provenance of patients and physicians. Accordingly we 
expect the billing physician or NPP to manage, participate and 
meaningfully contribute to the provision of the services, in addition 
to providing a minimum of direct supervision. We also note that the 
usual PFS payment rules regarding ``incident to'' services apply, so 
that all applicable state law and scope of practice requirements must 
be met in order to bill ACP services.
    Comment: Several commenters recommended that CMS not require direct 
supervision for ACP services or allow it to be furnished ``incident 
to'' under general supervision.
    Response: As discussed above, we understand that the services 
described by CPT codes 99497 and 99498 can be provided by physicians or 
using a team-based approach where, in addition to providing a minimum 
of direct supervision, the billing physician or NPP manages, 
participates and meaningfully contributes to the provision of the 
services. We note that the ``incident to'' rules apply when these 
services are provided incident to the billing practitioner, including 
direct supervision. We do not believe it would be appropriate to create 
an exception to allow these services to be furnished incident to a 
physician or NPP's professional services under less than direct 
supervision because the billing practitioner must participate and 
meaningfully contribute to the provision of these face-to-face 
services.
    Comment: Many commenters made recommendations regarding the 
settings of care that would be appropriate for payment of ACP services. 
Some of these commenters specified that payment should be made in both 
ambulatory and inpatient settings. Many commenters stated that ACP is 
ideally performed in

[[Page 70958]]

a primary care setting, where the patient has a longstanding 
relationship with a physician and can engage in planning prior to 
illness, at which time they may be most receptive and most likely to 
have full decision making capacity. However many commenters believed 
payment was also appropriate in inpatient and other acute care 
settings. A few commenters recommended payment for an outpatient code 
or a code that would not be payable in the intensive care setting. Some 
commenters recommended that ACP should only be payable in clinical 
settings and that CMS should explicitly exclude group information 
sessions and similar offerings. Commenters stated that patients should 
be able to choose any location for ACP services including at home; in 
community-based settings; or via telehealth, telephone or other remote 
technologies. A few commenters were concerned that CMS might limit 
payment to certain specialists and recommended against such a policy.
    Response: We agree with commenters that ACP services are 
appropriately furnished in a variety of settings, depending on the 
condition of the patient. These codes will be separately payable to the 
billing physician or practitioner in both facility and non-facility 
settings and are not limited to particular physician specialties. We 
refer commenters to the CY 2016 hospital outpatient prospective payment 
system final rule with comment period for a discussion of how payment 
will be made to hospitals for ACP services furnished in hospital 
outpatient departments.
    Comment: Many commenters supported payment for ACP along the entire 
health continuum, in advance of acute illness, and revisiting the 
advance care plan with changes in the patient's condition. These 
commenters stated ACP is a routine service that should be regularly 
performed like preventive services. These commenters responded 
affirmatively to our solicitation as to whether or not ACP services 
should be included as an optional element, at the beneficiary's 
discretion, of the annual wellness visit (AWV) under section 
1861(hhh)(2)(G) of the Act. Several of these commenters specified that 
ACP should remain separately paid even if included as an optional 
element of the AWV.
    Response: We appreciate the response of commenters regarding our 
request for comment on whether or not we should include ACP as an 
optional element, at the beneficiary's discretion, of the annual 
wellness visit (AWV) under section 1861(hhh)(2)(G) of the Act. Based on 
the commenters' positive response to this solicitation, we are adding 
ACP as a voluntary, separately payable element of the AWV. We are 
instructing that when ACP is furnished as an optional element of AWV as 
part of the same visit with the same date of service, CPT codes 99497 
and 99498 should be reported and will be payable in full in addition to 
payment that is made for the AWV under HCPCS code G0438 or G0439, when 
the parameters for billing those CPT codes are separately met, 
including requirements for the duration of the ACP services. Under 
these circumstances, ACP should be reported with modifier -33 and there 
will be no Part B coinsurance or deductible, consistent with the AWV.
    Regarding who can furnish ACP when it is furnished as an optional 
element of the AWV, we note that AWV cannot be furnished as an 
``incident to'' service since the AWV has a separate, distinct benefit 
category from ``incident to'' services. However, the current 
regulations for the AWV allow the AWV to be furnished under a team 
approach by physicians or other health professionals under direct 
supervision. Therefore, the rules that apply to the AWV will also apply 
to ACP services when furnished as an optional element of the AWV, 
including the requirement for direct supervision.
    Comment: We received several comments requesting that ACP be added 
as a billable visit for FQHCs, and several comments requesting that we 
ensure that Medicare Administrative Contractors (MACs) are aware that a 
standalone ACP counseling session with an FQHC billable provider 
qualifies as a ``billable visit'' under Medicare's Prospective Payment 
System (PPS) for FQHCs.
    Response: RHCs and FQHCs furnish Medicare Part B services and are 
paid in accordance with the RHC all-inclusive rate system or the FQHC 
PPS. Beginning on January 1, 2016, ACP will be a stand-alone billable 
visit in a RHC or FQHC, when furnished by a RHC or FQHC practitioner 
and all other program requirements are met. If furnished on the same 
day as another billable visit, only one visit will be paid. Coinsurance 
will be applied for ACP when furnished in an FQHC, and coinsurance and 
deductibles will be applied for ACP when furnished in an RHC. 
Coinsurance and deductibles will be waived when ACP is furnished as 
part of an AWV. Additional information on RHC and FQHC billing of ACP 
will be available in sub-regulatory guidance.

Standards/Training

    Comment: Many commenters recommended that CMS establish standards 
or require specialized training as a condition of payment for ACP 
services. Many commenters recommended standards or special training in 
relevant state law and advance planning documents; content and time; 
communication, representation, counseling, shared decision making and 
skills outside the scope of physician training. Several commenters 
recommended standards regarding the use of certified electronic health 
record technology; contractual or employment relationships with nurses, 
social workers and other clinical staff working as part of an ACP team; 
use of written protocols and workflows to make ACP part of routine 
care; and working with professional societies and other organizations 
including the National Quality Forum and the Agency for Healthcare 
Research & Quality to establish quality standards for clinician-patient 
communication and ACP that would be tied to payment. Many commenters 
recommended policies to ensure documentation and transmission of the 
results of ACP among health care providers. Some of these commenters 
encouraged CMS to use technology to enhance the use and portability of 
advance directives across care settings and state lines, or recommended 
a universal registry.
    Several commenters were concerned about the nature of the services 
that would be payable under the proposed codes, noting that ACP should 
extend beyond education about advance directives and completing forms. 
Several recommended the development of content criteria or quality 
measures to ensure that ACP services are meaningful and of value to 
patients. Some commenters expressed concern about ensuring appropriate 
services were furnished as part of ACP. For example, they expressed 
concern that payable services would include mere group information 
sessions, filling out forms or similar offerings. One commenter 
recommended that CMS require some minimal element like one personal 
real-time encounter, whether face-to-face or by phone or telemedicine.
    Response: Since CPT codes 99497 and 99498 describe face-to-face 
services, we do not believe it would be appropriate at this time to 
apply additional payment standards as we have for certain non-face-to-
face services such as CCM services. We will continue to consider 
whether additional standards, special training or quality measures may 
be appropriate in the future as a condition of Medicare payment for ACP 
services. We note that we did not propose to add ACP services to the 
list of Medicare telehealth services, so the face-to-face

[[Page 70959]]

services described by the codes need to be furnished in-person in order 
to be reported to Medicare.
    Comment: Several commenters supported advance care planning between 
patients and clinicians, but expressed concern about the potential for 
bias against choosing treatment options involving living with 
disability, requiring physicians to discuss questionable treatment 
options (such as physician assisted suicide or other patient choices 
that might violate individual physician ethics) and similar issues. 
Some commenters were concerned that patients might change their 
decisions once care was actually needed and be unable to override 
previous advance directives; or that the government would be making 
healthcare decisions instead of patients, physicians, and families.
    Response: As discussed above, based on public comments we received, 
we believe the services described by CPT codes 99497 and 99498 are 
appropriately provided by physicians or using a team-based approach 
where ACP is provided by physicians, non-physician practitioners and 
other staff under the order and medical management of the beneficiary's 
treating physician. We also note that the CPT code descriptors describe 
the services as furnished by physicians or other qualified health 
professionals, which for Medicare purposes, is consistent with allowing 
these codes to be billed by the physicians and NPPs whose scope of 
practice and Medicare benefit category include the services described 
by the CPT codes and who are authorized to independently bill Medicare 
for those services. Therefore only these practitioners may report CPT 
codes 99497 or 99498, and ``incident to'' rules apply when these 
services are provided incident to the services of the billing 
practitioner under a minimum of direct supervision. We agree with 
commenters that advance care planning as described by the new CPT codes 
is primarily the provenance of patients and physicians. Accordingly we 
expect the billing physician or NPP, in addition to providing a minimum 
of direct supervision, to manage, participate and meaningfully 
contribute to the provision of the services. Also, we note that PFS 
payment rules apply when ACP is furnished incident to other physicians' 
services, including where applicable, that state law and scope of 
practice must be met. Since the ACP services are by definition 
voluntary, we believe Medicare beneficiaries should be given a clear 
opportunity to decline to receive them. We note that beneficiaries may 
receive assistance for completing legal documents from other non-
clinical assisters outside the scope of the Medicare program. Nothing 
in this final rule with comment period prohibits beneficiaries from 
seeking independent counseling from other individuals outside the 
Medicare program--either in addition to, or separately from, their 
physician or NPP.

Beneficiary Considerations

    Comment: Several commenters suggested that CMS pursue waivers of 
cost sharing for ACP services or that cost sharing should vary by the 
condition of the patient.
    Response: We lack statutory authority to waive beneficiary cost 
sharing for ACP services generally because they are not preventive 
services assigned a grade of A or B by the United States Preventive 
Services Task Force (USPSTF); nor may CMS vary cost sharing according 
to the patient's diagnosis. Under current law, the Part B cost sharing 
(deductible and coinsurance) will be waived when ACP is provided as 
part of the AWV, but we lack authority to waive cost sharing in other 
circumstances. We would recommend that practitioners inform 
beneficiaries that the ACP service will be subject to separate cost 
sharing.
    Comment: One commenter recommended beneficiary education through 
Medicare & You, partnerships with senior advocacy groups and other 
means.
    Response: We agree that beneficiary education about ACP services, 
especially the voluntary nature of the services, is important. We 
welcome such efforts by beneficiary advocacy and community-based 
organizations and will consider whether additional material should be 
added to the Medicare & You handbook to highlight new payment 
provisions for these voluntary services.
    In summary, we are finalizing our proposal to assign CPT codes 
99497 and 99498 PFS status indicator ``A'' with RVUs developed based on 
the RUC-recommended values. We are also adding ACP as an optional 
element, at the beneficiary's discretion, of the AWV. We are also 
making the conforming changes to our regulations at Sec.  410.15 that 
describe the conditions for and limitations on coverage for the AWV.
    We note that while some public commenters were opposed to Medicare 
paying for ACP services, the vast majority of comments indicate that 
most patients desire access to ACP services as they prepare for 
important medical decisions.
d. Valuation of Other Codes for CY 2016
(1) Excision of Nail Bed (CPT Code 11750)
    CPT code 11750 appeared on the RUC's misvalued code screen of 10-
day global services with greater than 1.5 office visits and utilization 
over 1,000. The Health Care Professional Advisory Committee (HCPAC) 
reviewed the survey results for valuing this code and determined that 
1.99 work RVUs, corresponding to the 25th percentile survey result, was 
the appropriate value for this service. As discussed in the proposed 
rule, we indicated that we believed the recommendation for this service 
overstated the work involved in performing this procedure, 
specifically, given the decrease in post-operative visits. Due to 
similarity in service and time, we indicated that we believed a direct 
crosswalk from the work RVU for CPT code 10140 (Drainage of blood or 
fluid accumulation), which is also a 10-day global service with one 
post-operative visit, more accurately reflects the time and intensity 
of furnishing the service. Therefore, for CY 2016 we proposed a work 
RVU of 1.58 for CPT code 11750.
    The following is a summary of the comments we received on our 
proposal.
    Comment: One commenter disagreed with CMS' direct crosswalk of the 
work RVU from CPT code 10140 to CPT code 11750. The commenters 
suggested that CMS establish the RVU for this procedure consistent with 
the recommendation. Additionally, the commenter stated that the HCPAC 
recommendation accounted for the removal of one post-operative visit 
from the global period. The commenter also stated that CMS' proposed 
work RVU would have an intraservice work intensity similar to a level 
one E/M visit (99211), which suggests that the value is too low.
    Response: In developing our proposed RVUs for this service, we 
reviewed codes with similar intra-service and total times, and 
identified CPT code 11760 (Repair of nail bed) and CPT code 11765 
(Excision of nail fold toe). Since we believe that the crosswalk for 
CPT code 11750 has similar intensity, and our proposed RVU is 
consistent with these similar services, we do not agree with the 
commenter who states that the proposed work RVU is inaccurate.
    After consideration of comments received, we are finalizing a work 
RVU of 1.58 for CPT code 11750, as proposed.

[[Page 70960]]

(2) Bone Biopsy Excisional (CPT Code 20240)
    In its review of 10-day global services, the RUC identified CPT 
code 20240 as potentially misvalued. Subsequent to this identification, 
the RUC requested that CMS change this code from a 10-day global period 
to a 0-day global period for this procedure. Based on survey data, the 
RUC recommended a decrease in the intraservice time from 39 to 30 
minutes, removal of two postoperative visits (one 99238 and one 99212), 
and an increase in the work RVUs for CPT code 20240 from 3.28 to 3.73. 
In the proposed rule, we stated that we did not believe the RUC 
recommendation accurately reflected the work involved in this 
procedure, especially given the decrease in intraservice time and post-
operative visits relative to the previous assumptions used in valuing 
the service. Therefore, for CY 2016, we proposed a work RVU of 2.61 for 
CPT code 20240 based on the reductions in time for the service.
    The following is a summary of the comments we received on our 
proposal.
    Comment: Several commenters, including the RUC, recommended that 
CMS reconsider its decision not to accept the RUC's recommendation for 
CPT code 20240. The commenters noted that the service was last valued 
by the Harvard study over 20 years ago and the assumptions made at the 
time no longer reflect current practice as the survey respondents 
included fewer than 10 non-orthopedic surgeons. Commenters stated that 
podiatry is currently the dominant provider of the service. Commenters 
also stated that deriving a new proposed work RVU based on existing 
work RVUs would be misguided in this case.
    The commenters also suggested that using a reverse building block 
methodology to convert a 10-day global code to 0-day global code by 
removing the bundled E/M services is inappropriate since magnitude 
estimation was used initially when establishing the work RVUs for 
surgical codes. Several commenters indicated that CMS' proposed work 
RVU has inappropriately low work intensity and expressed concern about 
CMS' approach to global code conversion.
    Additionally, the RUC expressed disagreement with CMS' decision to 
remove 6 minutes of clinical labor minutes for discharge management 
time from 0-day global services stating there is clinical staff time 
that needs to be accounted for; the commenter requested we include the 
6 minutes of clinical labor time based on the standard clinical labor 
task ``conduct phone calls/call in prescriptions.''
    Response: In proposing what we believed to be a more accurate value 
for CPT code 20240, we considered applying the intra-service ratio, 
which yielded a value of 2.52 RVUs; however we believed that value 
would have inadequately reflected the work involved in furnishing the 
service. Instead, we opted to use the reverse building block 
methodology to remove the post-operative visits, acknowledging the 
transition from a 10-day to a 0-day global period. We removed the RVUs 
associated with the visits (1.12 RVUs) from the RUC-recommended value 
of 3.73 RVUs and arrived at an RVU of 2.61, which we continue to 
believe accurately accounts for work involved in furnishing the 
service. While we generally understand that the work RVUs may not have 
been developed using a building-block methodology, and that the reverse 
building block methodology may not always be the best approach to 
valuing services, we do not agree that significant changes in the post-
operative period should be ignored, especially since we note that the 
RUC uses magnitude estimation to develop recommended work RVUs in the 
context of survey data regarding the number and level of visits in the 
post-operative periods.
    In terms of the clinical labor minutes associated with the 
discharge day management, we do not agree that the typical discharge 
work associated for this service or for others without work time for 
discharge day management would typically involve clinical staff 
conducting phone calls regarding prescriptions. We are aware that some 
codes include the clinical labor minutes for discharge management even 
though the work time for these codes do not include time for discharge 
management. We are seeking comment on how we might address this 
discrepancy in future rulemaking.
    After consideration of comments received, we are finalizing the 
proposed work RVU of 2.61 for CPT code 20240.
(3) Endobronchial Ultrasound (CPT Codes 31622, 31652, 31653, 31625, 
31626, 31628, 31629, 31654, 31632 and 31633)
    For CY 2016, the CPT Editorial Panel deleted one code, CPT code 
31620 (Ultrasound of lung airways using an endoscope), and created 
three new codes, CPT codes 31652-31654, to describe bronchoscopic 
procedures that are inherently performed with endobronchial ultrasound 
(EBUS).
    In their review of the newly revised EBUS family, the RUC 
recommended a change in the work RVUs for CPT code 31629 from 4.09 to 
4.00. The RUC also recommended maintaining the current work RVUs for 
CPT codes 31622, 31625, 31626, 31628, 31632 and 31633. We proposed to 
use those work RVUs for CY 2016.
    For the newly created codes, the RUC recommended work RVUs of 5.00 
for CPT code 31652, 5.50 for CPT code 31653 and 1.70 for CPT code 
31654. In the proposed rule, we stated that we believe the RUC-
recommended work RVUs for these services overstate the work involved in 
furnishing the procedures. In order to develop proposed work RVUs for 
CPT code 31652, we compared the service described by the code 
descriptor to deleted CPT codes 31620 and 31629, because this new code 
describes a service that combines services described by CPT code 31620 
and 31629. Specifically, we took the sum of the current work RVU of CPT 
code 31629 (WRVU = 4.09) and the CY 2015 work RVU of CPT code 31620 
(WRVU = 1.40) and multiplied it by the quotient of CPT code 31652's 
RUC-recommended intraservice time (INTRA = 60 minutes) and the sum of 
CPT codes 31620 and 31629's current and CY 2015 intraservice times 
(INTRA = 70 minutes), respectively. This resulted in a proposed work 
RVU of 4.71. To value CPT code 31653, we used the RUC-recommended 
increment of 0.5 work RVUs between this service and CPT code 31652 to 
calculate for CPT code 31653 our proposed work RVUs of 5.21. Lastly, 
because the service described by new CPT code 31654 is very similar to 
deleted CPT code 31620, we stated that we believed a direct crosswalk 
of the previous values for CPT code 31620 accurately reflected the time 
and intensity of furnishing the service described by CPT code 31654. 
Therefore, we proposed a work RVU of 1.40 for CPT code 31654.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters, including the RUC, stated they did not 
agree with CMS' calculations or methodology utilized in valuing these 
services. The commenters suggested that CMS' calculations were based on 
inconsistent data. One commenter stated the methodology outlined in the 
proposed rule had several flaws in the understanding of the new and 
deleted bronchoscopy codes and questioned what purpose the creation of 
the new bundled codes were designed to address.
    Response: As we have addressed more broadly, when we do not believe 
that

[[Page 70961]]

the RUC-recommended values adequately address changes in the time 
resources required to furnish particular services, we have used several 
methodologies to identify potential work RVUs. We examine the results 
of such approaches and consider whether or not these results 
appropriately account for the total work of the service. We continue to 
believe that the methodology used to calculate the proposed work RVU is 
the most appropriate methodology to use for these procedures.
    Specifically, in considering CPT code 31652 in the context of 
similar codes, including 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)) and CPT code 
31661(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, 
when performed; with bronchial thermoplasty, 2 or more lobes) both of 
which have 60 minutes of intraservice time and RVUs of 4.88 and 4.50, 
we continue to believe that a work RVU of 4.71 is the most accurate 
valuation. For CPT code 31653, we continue to believe that maintaining 
the RUC-recommended 0.5 work RVU increment between 31652 and 31653 
yields the most accurate value for CPT code 31653. For CPT code 31654, 
we note the direct crosswalk preserves the work RVU of 1.40 from the 
previous CPT code 31620, which was also an add-on code, and had more 
intraservice time. Therefore, after consideration of comments received, 
we are finalizing the work RVUs for CPT codes 31622, 31652, 31653, 
31625, 31626, 31628, 31629, 31654, 31632 and 31633 for CY 2016 as 
proposed.
    Comment: One commenter also expressed appreciation of CMS' 
acceptance of the RUC's PE recommendation for several codes in this 
family.
    Response: We appreciate the support of the commenter.
    Comment: In its comment, the RUC indicated that equipment items 
ES045 and ES016 were incorrectly included for 31652, 31653, and 31654 
and that these items were replaced with new equipment codes. In the CY 
2015 Technical Correction Notice (CMS-1612-F2), equipment item ES015 
was included in 31654, and the clinical labor direct PE inputs for 
31654 were omitted from the direct PE input database. Similarly, for 
CPT code 31629, the RUC indicated that CMS proposed 30 minutes for 
clinical labor tasks ``assist physician in performing procedure'' and 
``assist physician for moderate sedation'', as included in the CY 2016 
proposed direct PE input database, while the RUC had recommended 35 
minutes. The RUC opined that since the 30 minutes displayed for CPT 
code 31629 was incorrect, all of the corresponding equipment times 
included discrepancies of 5 minutes. The RUC suggested that all 
equipment times should increase by 5 minutes, excluding the stretcher, 
which should remain 89 minutes as that equipment is not needed during 
the intraservice portion of the procedure. In addition, the RUC 
suggested that the calculation of supply item ``gas, oxygen'' (SD084) 
would also be affected by the ``assist physician'' time and should be 
105 liters, rather than 90 liters as currently indicated in the supply 
direct PE input CMS file.
    Response: We agree with the RUC's comments regarding the proposed 
direct PE inputs for these procedures; the resulting changes appear in 
the final direct PE input database for CY 2016.
(4) Intravascular Ultrasound (CPT Codes 37252 and 37253)
    In the CY 2015 PFS proposed rule, a stakeholder requested that CMS 
establish non-facility PE RVUs for CPT codes 37250 and 37251. CMS 
sought comment regarding the setting and valuation of these services. 
In September 2014, these codes were referred to the CPT Editorial 
Panel. The CPT Editorial Panel deleted CPT codes 37250 and 37251 and 
created new bundled codes 37252 and 37253 to describe intravascular 
ultrasound (IVUS). The RUC recommended 1.80 RVUs for CPT code 37252 and 
1.44 RVUs for CPT code 37253. The RUC also recommended new direct PE 
inputs for an IVUS catheter and IVUS system. CMS proposed to accept the 
RUC-recommended work RVUs for intravascular ultrasound.
    Comment: Commenters expressed support for CMS' proposed work and 
time values, as well as for updating the direct PE inputs.
    Response: We appreciate commenters' support, and we are finalizing 
these values as proposed.
(5) Laparoscopic Lymphadenectomy (CPT Codes 38570, 38571 and 38572).
    The RUC identified three laparoscopic lymphadenectomy codes as 
potentially misvalued: CPT code 38570 (Laparoscopy, surgical; with 
retroperitoneal lymph node sampling (biopsy), single or multiple); CPT 
code 38571 (Laparoscopy, surgical; with retroperitoneal lymph node 
sampling (biopsy), single or multiple with bilateral total pelvic 
lymphadenectomy); and CPT code 38572 (Laparoscopy, surgical; with 
retroperitoneal lymph node sampling (biopsy), single or multiple with 
bilateral total pelvic lymphadenectomy and periaortic lymph node 
sampling (biopsy), single or multiple). Accordingly, the specialty 
society surveyed these 10-day global codes, and the survey results 
indicated decreases in intraservice and total work times. After 
reviewing the survey responses, the RUC recommended that CMS maintain 
the current work RVU for CPT code 38570 of 9.34; reduce the work RVU 
for CPT code 38571 from 14.76 to 12.00; and reduce the work RVU for CPT 
code 38572 from 16.94 to 15.60. We used the RUC recommendations to 
propose values for CPT codes 38571 and 38572, since the RUC recommended 
reductions in the work RVUs that correspond with marked decreases in 
intraservice time and decreases in total time. As discussed in the 
proposed rule, we did not agree with the RUC's recommendation to 
maintain the current work RVU for CPT code 38570 in spite of similar 
changes in intraservice and total times as were shown in the RUC 
recommendations for CPT codes 38571 and 38572. Therefore, we proposed a 
work RVU for CPT code 38570 of 8.49, which reflects the proportional 
reduction in total time for this code and maintains the rank order 
among the three codes.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters, including the RUC, indicated that CMS 
should use the recommended work RVU of 9.34 for CPT code 38570. 
Commenters stated that CMS used an erroneous calculation to derive the 
proposed work RVU of 8.49, with the use of time ratios being 
methodologically flawed due to an assumption that the existing time is 
correct, that physician intensity would remain constant for a service 
over a period of many years, and that different components of total 
time consisting of differing levels of physician intensity cannot be 
measured together. Commenters stated that using this rationale as the 
basis for not accepting the RUC recommendation was unprecedented and 
misguided.
    Commenters also stated that the recommended work RVU of 9.34 was 
based on work time and a comparison to CPT codes 31239 (Nasal/sinus 
endoscopy, surgical; with dacryocystorhinostomy) and 50590 
(Lithotripsy, extracorporeal shock wave). Commenters indicated that the 
comparison to these codes confirmed

[[Page 70962]]

that maintaining the current value for CPT code 38570 would be 
appropriate. A different commenter stated that the survey time for this 
procedure had increased to 280 minutes and included a hospital 
inpatient visit. This commenter also urged CMS to maintain the current 
work RVUs of 9.34 for CPT code 38570.
    Response: We refer the reader to our earlier discussion about time 
ratios. We continue to believe that the use of time ratios is one of 
several reasonable methods for identifying potential work RVUs for 
particular PFS services, particularly when the alternative values do 
not account for information that suggests the amount of time involved 
in furnishing the procedure has changed significantly. In the case of 
CPT code 38570, we noted that the intraservice time was reduced by 50 
percent, from 120 minutes to 60 minutes, and the total time was also 
reduced from 242 minutes to 220 minutes. We also noted that the other 
codes in the same family, CPT codes 38571 and 38572, reflected similar 
time reductions and consequently had reduced recommended work RVUs. We 
believe that in order to maintain relativity, it is appropriate to 
apply a similar reduction to the work RVUs of CPT code 38570.
    We were unable to find mention of CPT code 31239 in the RUC 
recommendations for 38570. Therefore, we considered the values for the 
code as a potential rationale for using the RUC-recommended value for 
CPT code 38570. We concluded that CPT code 31239 has limited utility as 
a comparison, since its values appear to be an outlier among codes with 
similar characteristics. For example, all 25 of the other 10-day global 
codes with 60 minutes of intraservice time have a lower work RVU than 
CPT code 38570, most of them substantially lower, with CPT code 49429 
(Removal of peritoneal-venous shunt) having the next highest work RVU 
of 7.44. We also do not agree with the comparison to CPT code 50590, 
since that code describes all of the work within a 90-day global 
period, and we do not believe that relativity between services would be 
preserved if we were to make direct work RVU comparisons between 10-day 
and 90-day global codes.
    After consideration of comments received, we are finalizing our 
proposed work RVUs of 8.49 for CPT code 38570, 12.00 for CPT code 
38571, and 15.60 for CPT code 38572.
(6) Mediastinoscopy With Biopsy (CPT Codes 39401 and 39402)
    The RUC identified CPT code 39400 (Mediastinoscopy, including 
biopsy(ies) when performed) as a potentially misvalued code due to an 
unusually high preservice time and Medicare utilization over 10,000. In 
reviewing the code's history, = the CPT Editorial Panel concluded that 
the code had been used to report two distinct procedural variations 
although the code was valued using a vignette for only one of them. As 
a result, CPT code 39400 is being deleted and replaced with CPT codes 
39401 and 39402 to describe each of the two mediastinoscopy procedures.
    We proposed to accept the RUC-recommended work RVU of 5.44 for code 
39401 and to use the RUC-recommended crosswalk from CPT code 52235 
(Cystourethroscopy, with fulguration), which accurately estimates the 
overall work for CPT code 39401. In the proposed rule, we disagreed 
with the RUC-recommended work RVU of 7.50 for CPT code 39402. We stated 
that the work RVU for CPT code 39401 establishes an accurate baseline 
for this family of codes, so we proposed to scale the work RVU of CPT 
code 39402 in accordance with the change in the intraservice times 
between CPT codes 39401 and 39402. We indicated that applying this 
ratio in the intraservice time to the work RVU of CPT code 39401 
yielded a total work RVU of 7.25 for CPT code 39402. We also noted that 
the RUC recommendation for CPT code 39401 represented a decrease in 
value by 0.64 work RVUs, which is roughly proportionate to the 
reduction from a full hospital discharge visit (99238) to a half 
discharge visit assumed to be typical in the post-operative period. The 
RUC recommendation for CPT code 39402 had the same reduction in the 
post-operative work without a corresponding decrease in its recommended 
work RVU. In order to reflect the reduction in post-operative work and 
to maintain relativity between the two codes in the family, we proposed 
a work RVU of 7.25 for CPT code 39402.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters stated that the use of intraservice 
time ratios was inappropriate for valuation of CPT codes. They 
indicated that CMS should instead use the RUC's recommended work RVU of 
7.50, due to the difference in technical skill, physical/mental effort, 
and additional stress involved in the performance of CPT code 39402 
relative to CPT code 39401. Commenters expressed the importance of 
using physician survey data and magnitude estimation to arrive at work 
RVUs.
    Response: We refer the reader to our earlier discussions about the 
utility of time ratios in identifying potential work RVUs for PFS 
services. We note that when comparing the work RVUs for CPT codes 39401 
and 39402, the work RVU for CPT code 39402 was higher than would be 
expected based on the difference in time between these two procedures, 
even considering the more difficult clinical nature of CPT code 39402. 
We continue to believe that the use of intraservice time ratios is one 
of several different methods that can be effectively employed for 
valuation of CPT codes. For this particular mediastinoscopy family, CPT 
codes 39401 and 39402 share identical preservice time, postservice 
time, and office visits. Based on this information, we continue to 
believe that the intraservice time ratio between the two codes is the 
most accurate method for determining the work RVU for this procedure.
    Comment: Several commenters suggested that CMS should use the RUC-
recommended work RVU of 7.50 for CPT code 39402 based on the use of a 
building block methodology. Commenters stated that the RUC arrived at 
this value by adding the work RVU of CPT code 39401 (5.44 RVUs) to one 
half of the work RVU of CPT code 32674 (4.12 RVUs). The resulting 
calculation of 5.44 plus 2.06 equaled 7.50 RVUs, exactly the same value 
recommended by the RUC and a proof of the accuracy of magnitude 
estimation.
    Response: We believe that the use of the reverse building block 
methodology would result in a significantly lower valuation for CPT 
code 39402. The current CPT code used for a mediastinoscopy with lymph 
node biopsy is 39400, which has a work RVU of 8.05, and includes three 
postoperative visits in its global period (a 99231 hospital inpatient 
visit, a 99238 hospital discharge visit, and a 99213 office visit). CPT 
code 39402 does not include the hospital inpatient visit (0.76 RVUs) or 
the office visit (0.97 RVUs), and includes only half of the discharge 
visit (0.64 RVUs). If the work of these visits were removed from CPT 
code 39400, the result would be a work RVU of 8.05 - 2.37 = 5.68. We 
believe that this work RVU understates the work of CPT code 39402, 
which is why we believe that a building block methodology would be less 
accurate than the use of the intraservice time ratio for this code 
family.
    After consideration of comments received, we are finalizing our 
proposed work RVU of 5.44 for CPT code 39401 and 7.25 for 39402.

[[Page 70963]]

(7) Hemorrhoid(s) Injection (CPT Code 46500)
    The RUC identified CPT code 46500 (Injection of sclerosing 
solution, hemorrhoids) as potentially misvalued, and the specialty 
society resurveyed this 10-day global code. The survey showed a 
significant decrease in the reported intraservice and total work times. 
After reviewing the survey responses, the RUC recommended that CMS 
maintain the current work RVU of 1.69 in spite of the reductions in 
intraservice and total times. We proposed to reduce the work RVU to 
1.42, which reduces the work RVU by the same ratio as the reduction in 
total time.
    We also proposed to refine the RUC-recommended direct PE inputs by 
removing the inputs associated with cleaning the scope.
    The following is a summary of the comments we received on our 
proposals.
    Comment: The RUC disagreed with the methodology CMS used to develop 
the proposed work RVUs stating that CMS' proposed methodology did not 
account for differences in pre-service or post-service time. The RUC 
also stated that different components of total time (preservice time, 
intra-service time, post-service time, and post-operative visits) 
consist of differing levels of physician intensity and CMS' 
calculations did not appear to have been based on any clinical 
information or any measure of physician intensity.
    Another commenter supported our efforts to identify and address 
such incongruities between work times and work RVUs, stating that when 
work time decreases, work RVUs should decrease comparatively, absent a 
compelling argument that the intensity of the service has increased 
sufficiently to offset the decrease in work time.
    One commenter disagreed with CMS' proposed PE refinements for CPT 
code 46500 regarding the pre-service clinical labor time for the 
facility setting, clinical labor time related to setting up endoscopy 
equipment, clinical labor time and supplies related to cleaning 
endoscopy equipment, equipment time for item ES002, and clinical labor 
time associated with clinical labor task ``follow-up phone calls and 
prescriptions''. The commenter also disagreed with CMS' refinement of 
not including setup and clean-up time for the scope at the post-
operative visit.
    Response: We believe the total time ratio produces an RVU that is 
comparable with other 10-day global services. We note that CPT code 
41825 (Excision of lesion or tumor (except listed above), dentoalveolar 
structures; without repair) and CPT code 10160 (Puncture aspiration of 
abscess, hematoma, bulla, or cyst) are similar 10-day global services 
that have comparable work RVUs. For CY 2016, we are finalizing our 
proposed value of 1.42 RVUs for CPT code 46500.
    After reviewing the public comments that were submitted regarding 
direct PE inputs, we recognize that we mistakenly believed that a 
disposable scope was included as a direct PE input, when a reusable 
equipment item was actually included. As a result, we removed the 
clinical labor time associated with setting up and cleaning the scope. 
Since we made this refinement in error, we will restore the clinical 
labor time associated with setting up and cleaning the scope. We also 
agree with commenters regarding the time for clinical labor task 
``follow-up phone calls and prescriptions''. Therefore, we are 
restoring the RUC-recommended clinical labor times for ``follow-up 
phone calls & prescriptions'', ``setup scope (non-facility setting 
only)'', and ``clean scope''. As a result of including the previously 
removed clinical labor time associated with the equipment input ES002 
(anoscope with light source), we are increasing the equipment time for 
this code from 60 minutes to 70 minutes. We did not add the set-up and 
clean scope time to the post-operative visits, however, since the 
clinical labor time for post-operative visits across PFS services match 
the clinical labor for the associated E/M visits. We are seeking 
comment regarding whether or not we should reconsider that practice 
broadly before making an exception in this particular case.
(8) Liver Allotransplantation (CPT Code 47135)
    The RUC identified CPT code 47135 (Liver allotransplantation; 
orthotopic, partial or whole, from cadaver or living donor, any age) as 
potentially misvalued, and the specialty society resurveyed this 90-day 
global code. The survey results showed a significant decrease in 
reported intraservice work time, but a significant increase in total 
work time (the number of post-operative visits significantly declined 
while the level of visits increased). After reviewing the survey 
responses, the RUC recommended an increase in the work RVU from 83.64 
to 91.78, which corresponds to the survey median result, as well as the 
exact work RVU for CPT code 33935 (Heart-lung transplant with recipient 
cardiectomy-pneumonectomy). In the proposed rule, we stated that we did 
not believe the RUC-recommended crosswalk was the most accurate from 
among the group of transplant codes. We noted that CPT code 32854 (Lung 
transplant, double (bilateral sequential or en bloc); with 
cardiopulmonary bypass) has intraservice and total times that are 
closer to those the RUC recommended for CPT code 47135, and CPT code 
32854 has a work RVU of 90.00 which corresponds to the 25th percentile 
survey result for CPT code 47135. Therefore, we proposed to increase 
the work RVU of CPT code 47135 to 90.00.
    The following is a summary of the comments we received on our 
proposal.
    Comment: The RUC stated that its original reference code is the 
most appropriate comparator for this service and revising the work RVU 
for CPT code 47135 to 1.9 percent below the RUC's recommendation would 
be arbitrary and punitive. Another commenter stated that while they 
believed the RUC proposed valuation more accurately reflected the work 
involved, they appreciated the proposal to increase the work RVUs 
associated with liver transplants, and suggested that CMS accept the 
RUC-recommended direct PE valuations.
    Response: As we stated in the proposed rule, CPT code 32854(Lung 
transplant, double (bilateral sequential or en bloc); with 
cardiopulmonary bypass) has very similar intra-service and total times, 
in addition to an identical work RVU (90.00) to the 25th percentile 
survey result. We continue to believe the proposed direct crosswalk 
from CPT code 32854 (Lung transplant, double (bilateral sequential or 
en bloc); with cardiopulmonary bypass) to CPT code 47135 results in the 
most accurate valuation. Therefore, for CY 2016 we are finalizing 
without modification our proposed work RVU of 90.00 for CPT code 47135.
(9) Genitourinary Catheter Procedures (CPT Codes 50430, 50431, 50432, 
50433, 50434, 50435, 50693, 50694, and 50695)
    For CY 2016, the CPT Editorial Panel deleted six CPT codes (50392, 
50393, 50394, 50398, 74475, and 74480) that were commonly reported 
together, and created 12 new CPT codes, both to describe these 
genitourinary catheter procedures more accurately and to bundle 
inherent imaging guidance. Three of these CPT codes (506XF, 507XK, and 
507XL) were referred back to CPT to be resurveyed as add-on codes. The 
other nine codes were reviewed at the January 2015 RUC meeting and 
assigned recommended work RVUs and direct PE inputs.
    We proposed to use the RUC-recommended work RVU of 3.15 for CPT 
code 50430. We agreed that this is

[[Page 70964]]

an appropriate value and that the code should be used as a basis for 
establishing relativity with the rest of the family. We began by making 
comparisons between the service times of CPT code 50430 and the other 
codes in the family in order to determine the appropriate proposed work 
RVU of each procedure.
    In our proposal for CPT code 50431, we stated that we disagreed 
with the RUC-recommended work RVU of 1.42; we instead proposed a work 
RVU of 1.10, based on three separate data points. First, the RUC 
recommendation stated that CPT code 50431 describes work previously 
described by a combination of CPT codes 50394 and 74425. These two 
codes have work RVUs of 0.76 and 0.36, respectively, which sum together 
to 1.12. Second, we noted that the work of CPT code 49460 (Mechanical 
removal of obstructive material from gastrostomy) is similar, with the 
same intraservice time of 15 minutes and same total time of 55 minutes 
but a work RVU of 0.96. Finally, we observed that the minimum survey 
result had a work RVU of 1.10, and we suggested that this value 
reflected the total work for the service. Accordingly, we proposed 1.10 
as the work RVU for CPT code 50431.
    We employed a similar methodology to develop a proposed work RVU of 
4.25 for CPT code 50432. The three previously established codes were 
combined in CPT code 50432; these had respective work RVUs of 3.37 (CPT 
code 50392), 0.54 (CPT code 74475), and 0.36 (CPT code 74425); together 
these sum to 4.27 work RVUs. We also examined the valuation of this 
service relative to other codes in the family. The ratio of the 
intraservice time of 35 minutes for CPT code 50430 and the intraservice 
time of 48 minutes for CPT code 50432, applied to the work RVU of base 
code 50430 (3.15), results in a potential work RVU of 4.32. The total 
time for CPT code 50432 is higher than CPT code 50430 (107 minutes 
relative to 91 minutes); applying this ratio to the base work RVU 
results in a work RVU of 3.70. We utilized these data to inform our 
proposed crosswalk. In valuing CPT code 50432, we considered CPT code 
31660 (Bronchoscopy, rigid or flexible, including fluoroscopic 
guidance), which has an intraservice time of 50 minutes, total time of 
105 minutes, and a work RVU of 4.25. Therefore, we proposed to 
establish the work RVU for CPT code 50432 at the crosswalked value of 
4.25 work RVUs.
    In the proposed rule, we stated that according to the RUC 
recommendations, CPT codes 50432 and 50433 are very similar procedures, 
with CPT code 50433 making use of a nephroureteral catheter instead of 
a nephrostomy catheter. The RUC valued the added difficulty of CPT code 
50433 at 1.05 work RVUs compared to CPT code 50432. We proposed to 
maintain the relative difference in work between these two codes by 
proposing a work RVU of 5.30 for CPT code 50433 (4.25 + 1.05). 
Additionally, we considered CPT code 57155 (Insertion of uterine tandem 
and/or vaginal ovoids for clinical brachytherapy), which has a work RVU 
of 5.40 and an identical intraservice time of 60 minutes, but 14 
additional minutes of total time (133 minutes compared to 119 minutes 
for CPT code 50433), which supported the difference of 0.10 RVUs. For 
these reasons, we proposed a work RVU of 5.30 for CPT code 50433.
    As with the other genitourinary codes, we developed the proposed 
work RVU of CPT code 50434 in order to preserve relativity within the 
family. In the proposed rule, we stated that CPT code 50434 has 15 
fewer minutes of intraservice time compared to CPT code 50433 (45 
minutes compared to 60 minutes). We proposed to apply this ratio of 
0.75 to the base work RVU of CPT code 50433 (5.30), which resulted in a 
potential work RVU of 3.98. We also considered CPT code 50432 as 
another similar service within this family of services, with three more 
minutes of intraservice time compared to CPT code 50434 (48 minutes of 
intraservice time instead of 45 minutes). We noted that applying this 
ratio (0.94) to the base work RVU of CPT code 50432 (4.25) resulted in 
a potential work RVU of 3.98. Based on this information, we identified 
CPT code 31634 (Bronchoscopy, rigid or flexible, with balloon 
occlusion) as an appropriate direct crosswalk, and proposed a work RVU 
of 4.00 for CPT code 50434. The two codes share an identical 
intraservice time of 45 minutes, though the latter possesses a lower 
total time of 90 minutes.
    For CPT code 50435, we considered how the code and work RVU would 
fit within the family in comparison to our proposed values for CPT 
codes 50430 and 50432. CPT code 50430 serves as the base code for this 
group; it has 35 minutes of intraservice time in comparison to 20 
minutes for CPT code 50435. This intraservice time ratio of 0.57 (20/
35) resulted in a potential work RVU of 1.80 for CPT code 50435 when 
applied to the work RVU of CPT code 50430 (3.15). Similarly, CPT code 
50432 is the most clinically similar procedure to CPT code 50435. CPT 
code 50432 has 48 minutes of intraservice time compared to 20 minutes 
of intraservice time for CPT code 50435. This ratio of 0.42 (20/48) 
applied to the base work RVU of CPT code 50432 (4.25) results in a 
potential work RVU of 1.77. We also considered two additional 
procedures to determine a proposed value for CPT code 50435. CPT code 
64416 (Injection, anesthetic agent; brachial plexus) also includes 20 
minutes of intraservice time and has a work RVU of 1.81. CPT code 36569 
(Insertion of peripherally inserted central venous catheter) has the 
same intraservice and total time as CPT code 50435, with a work RVU of 
1.82. Accordingly, we proposed a work RVU of 1.82, a direct crosswalk 
from CPT code 36569.
    The remaining three codes all utilize ureteral stents and form 
their own small subfamily within the larger group of genitourinary 
catheter procedures. For CPT code 50693, we proposed a work RVU of 
4.21, which corresponds to the 25th percentile survey result. We stated 
in the proposed rule that we believed that the work RVU corresponding 
to the 25th percentile survey result provided a more accurate value for 
CPT code 50693 based on the work involved in the procedure and within 
the context of other codes in the family. We also indicated that CPT 
code 31648 (Bronchoscopy, rigid or flexible, with removal of bronchial 
valve), which shares 45 minutes of intraservice time and has a work RVU 
of 4.20, was an accurate crosswalk for CPT code 50693.
    For CPT code 50694, we compared its intraservice time to the code 
within the family that had the most similar duration, CPT code 50433. 
This code has 60 minutes of intraservice time compared to 62 minutes 
for CPT code 50694. This is a ratio of 1.03; when applied to the base 
work RVU of CPT code 50433 (5.30), we arrived at a potential work RVU 
of 5.48. We also looked to procedures with similar times, in particular 
CPT code 50382 (Removal and replacement of internally dwelling ureteral 
stent), which has 60 minutes of intraservice time, 125 minutes of total 
time, and a work RVU of 5.50. We proposed a work RVU of 5.50, a direct 
crosswalk from CPT code 50382.
    Finally, we developed the proposed work RVU for CPT code 50695 
using three related methods. In the proposed rule, we stated that CPT 
codes 50694 and 50695 describe very similar procedures, with 50695 
adding the use of a nephrostomy tube. The RUC addressed the additional 
difficulty of this procedure by recommending 1.55 more work RVUs for 
CPT code 50695 than for CPT code 50694. Maintaining the 1.55 work RVUs 
increment, we noted that adding 1.55 to our proposed work RVU for CPT 
code 50694 (5.50)

[[Page 70965]]

would produce a work RVU of 7.05 for CPT code 50695. We also examined 
the ratio of intraservice times for CPT code 50695 (75 minutes) and the 
base code in the subfamily, CPT code 50693 (45 minutes). The 
intraservice time ratio between these two codes is 1.67; when applied 
to the base work RVU of CPT code 50693 (4.21), we calculated a 
potential work RVU of 7.02. We also noted that CPT code 36481 
(Percutaneous portal vein catheterization by any method) shares the 
same intraservice time as CPT code 50695 and has a work RVU of 6.98. 
Accordingly, to maintain relativity among this subfamily of codes, we 
proposed a work RVU of 7.05 for CPT code 50695 based on an incremental 
increase of 1.55 RVUs from CPT code 50694.
    In reviewing the direct PE inputs for this family of codes, we 
refined a series of the RUC- recommended direct PE inputs in order to 
maintain relativity with other codes in the direct PE database. All of 
the following refinements refer to the non-facility setting for this 
family of codes. Under the clinical labor inputs, we proposed to remove 
the RN/LPN/MTA (L037D) (intraservice time for assisting physician in 
performing procedure) for CPT codes 50431 and 50435. This amounts to 15 
minutes for CPT code 50431 and 20 minutes for CPT code 50435. Moderate 
sedation is not inherent in these procedures and, therefore, we 
indicated that we did not believe that this clinical labor task would 
typically be completed in the course of this procedure. We also reduced 
the RadTech (L041B) intraservice time for acquiring images from 47 
minutes to 46 minutes for CPT code 50694. This procedure contains 62 
minutes of intraservice time, with clinical labor assigned for 
acquiring images (75 percent) and a circulator (25 percent). The time 
for these clinical labor tasks is 46.5 minutes and 15.5 minutes, 
respectively. The RUC recommendation for CPT code 50694 rounded both of 
these values upwards, assigning 47 minutes for acquiring images and 16 
minutes for the circulator, which together sum to 63 minutes. We 
reduced the time for clinical labor tasks ``acquire images'' to 46 
minutes to preserve the 62 minutes of total intraservice time for CPT 
code 50694.
    With respect to the post-service portion of the clinical labor 
service period, we proposed to change the labor type for the task 
``patient monitoring following service/check tubes, monitors, drains 
(not related to moderate sedation)''. There are 45 minutes of clinical 
labor time assigned under this category to CPT codes 50430, 50432, 
50433, 50434, 50693, 50694, and 50695. Although we agreed that the 45 
minutes are accurate for these procedures as part of moderate sedation, 
we proposed to change the clinical labor type from the RUC-recommended 
RN (L051A) to RN/LPN/MTA (L037D) to reflect the staff that would 
typically be doing the monitoring for these procedures. Even though the 
CPT Editorial Committee's description of post-service work for CPT code 
50435 included a recovery period for sedation, we recognized in our 
proposal that according to the RUC recommendation, CPT codes 50431 and 
50435 did not use moderate sedation; therefore, we did not propose to 
include moderate sedation inputs for these codes.
    The RUC recommendation for CPT code 50433 included a nephroureteral 
catheter as a new supply input with an included invoice. However, the 
RUC recommendation did not discuss the use of a nephroureteral catheter 
in the intraservice work description. CPT code 50433 did mention the 
use of a nephroureteral stent in this description, but there is no 
request for a nephroureteral stent supply item on the PE worksheet for 
this code. We asked for feedback from stakeholders regarding the use of 
the nephroureteral catheter for CPT code 50433, but did not propose to 
add the nephroureteral catheter as a supply item for CPT code 50433 
pending this information. We also requested stakeholder feedback 
regarding the intraservice work description in for this code to explain 
the use, if any, of the nephroureteral catheter in this procedure.
    The RUC recommended the inclusion of ``room, angiography'' (EL011) 
for this family of codes. In our proposal we stated that we did not 
agree with the RUC that an angiography room would be used in the 
typical case for these procedures, as there are other rooms available 
which can provide fluoroscopic guidance. Most of the codes that make 
use of an angiography room are cardiovascular codes, and much of the 
equipment listed for this room would not be used for non-cardiovascular 
procedures. We therefore proposed to replace equipment item ``room, 
angiography'' (EL011) with equipment item ``room, radiographic-
fluoroscopic'' (EL014) for the same number of minutes. We requested 
public comment regarding the typical room type used to furnish the 
services described by these CPT codes, as well as the more general 
question of the typical room type used for GU and GI procedures. In the 
past, the RUC has developed broad recommendations regarding the typical 
uses of rooms for particular procedures, including the radiographic-
fluoroscopy room. In the proposed rule, we stated that we believed that 
such a recommendation from the RUC concerning all of these codes could 
be useful in ensuring relativity across the PFS.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters, including the RUC, stated that the CMS 
proposed work RVUs were based on a flawed methodology. Commenters 
stated that CMS ignored intensity measures, differences in patient 
population, and risk profile considerations between the genitourinary 
codes. These commenters indicated that they did not agree with the use 
of intraservice time ratios as a methodology for establishing work 
RVUs.
    Response: We refer the reader to our earlier discussion about the 
utility of time ratios in identifying potential work RVUs. For this 
particular group of codes, we believe that establishing CPT code 50430 
as the baseline value and then using intraservice time ratios to 
maintain relativity of work RVUs results in accurate work RVUs for 
these services. We note that these refined work RVUs were supported in 
all cases by the use of crosswalks to existing CPT codes which we 
believe reflect similar intensity, which further supported the refined 
work RVUs
    Comment: Several commenters indicated that the compelling evidence 
standard applied by the RUC for requiring an increase in valuation had 
been met for this code family, and therefore increased work RVUs were 
acceptable when compared to the previous group of genitourinary 
catheter procedures.
    Response: We recognize that the RUC internal deliberations include 
rules that govern under what circumstances individual specialties can 
request that the RUC recommend CMS increase values for particular 
services. As observers to the RUC process, we appreciate having an 
understanding of these rules in the context of our review of RUC-
recommended values. However, we remind the commenters that we are aware 
of such rules when we initially consider RUC recommendations. We are 
committed to preserving relativity between services across the entirety 
of the PFS, and believe that our proposed values best achieve that aim.
    Comment: Several commenters disagreed with the use of crosswalks to 
other CPT codes provided by CMS. Commenters stated that the work

[[Page 70966]]

between the codes was not comparable due to clinical differences 
between the genitourinary catheter codes and the procedures described 
in the crosswalk codes. Commenters specifically referenced the 
crosswalk that CMS selected for CPT code 50431 and stated that the CMS 
chosen crosswalk code does not have the same infectious considerations 
(bacteremia) or the magnitude of diagnostic considerations as CPT code 
50431.
    Response: In the resource-based relative value system, services do 
not have to be clinically similar in order to be comparable. Relative 
value units (RVUs) are comparable across services furnished by 
different medical specialties. We note as well that the crosswalk codes 
referenced by the RUC in its recommendations are frequently not 
clinically similar to the CPT code under review. In the case of 50431, 
we note that our crosswalk to CPT code 49460 has identical intraservice 
time and total time with CPT code 50431, along with similar clinical 
intensity, suggesting that it has value as a point of comparison for 
this code. Furthermore, we did not establish a direct crosswalk between 
the work of these two codes, only using CPT code 49460 (which has a 
work RVU of 0.96 RVUs) as one of three separate data points. For our 
second data point, we wrote that the recommendation for CPT code 50431 
stated that the new code described work previously performed by a 
combination of CPT codes 50394 and 74425. These two codes have work 
RVUs of 0.76 and 0.36, respectively, which sum together to 1.12. For 
our third data point, we observed that the minimum survey result had a 
work RVU of 1.10, which we believe accurately reflects the total work 
for this service. The survey minimum value of 1.10 RVUs was the method 
used to establish our proposed work RVU for this code. We refer readers 
to the discussion above in the Methodology for Establishing Work RVUs 
section for more information regarding the crosswalks used in 
developing values for this procedure.
    After consideration of comments received, we are finalizing our 
proposed work RVU of 1.10 for CPT code 50431.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 4.25 for CPT code 50432 and suggested that CMS accept the RUC-
recommended RVU of 4.70. They indicated that CMS used a clinically 
dissimilar crosswalk, CPT code 31660, which consists of very different 
work, patient populations, and potential complications. Commenters also 
stated that CMS used a different combination of existing CPT codes in 
its building block valuation of the new code 50432, leaving out CPT 
code 50390. Commenters indicated that this was a mistake and the use of 
CPT code 50390 would be typical.
    Response: As we mentioned previously, in the resource-based 
relative value system, services do not have to be clinically similar to 
be comparable. CPT code 31660 shares intraservice time and total time 
values that are nearly identical to CPT code 50432, along with similar 
clinical intensity, so we continue to believe that it is an accurate 
crosswalk. We also do not believe that the use of CPT code 50390 would 
be typical in constructing a building block methodology for CPT code 
50432. The new code is assembled through a combination of genitourinary 
catheter CPT code 50392 with injection CPT codes 74425 and 74475. We do 
not believe that CPT code 50390 would typically be included in this 
group as well, since the code descriptors for both 50390 and 50392 also 
include drainage and this service would not be performed twice. We 
believe that the new CPT code 50432 would be used for either the 
previously reported CPT codes 50390 or 50392 service, but not for both 
of them at once. In addition, the RUC has recommended that we assume 
that most of the procedures previously reported using CPT code 50392 
would be reported using new CPT code 50432.
    We note as well that our proposed work RVU for CPT code 50432 was 
supported by the use of two time ratios with CPT code 50430. Both the 
intraservice time ratio and the total time ratio suggested that a value 
below the RUC recommendation of 4.70 RVUs would be more accurate. After 
consideration of comments received, we are finalizing our proposed work 
RVU of 4.25 for CPT code 50432.
    Comment: Several commenters stated that CMS should accept the RUC-
recommended work RVU of 5.75 for CPT code 50433. While they agreed with 
CMS' use of the RUC-recommended increment of 1.05 RVUs relative to CPT 
code 50432, they did not agree with the CMS refined work RVU of CPT 
code 50432 itself. Some commenters also did not support the CMS 
crosswalk to CPT code 57155, which they stated had very different work, 
patient population, and potential complications.
    Response: We agree that CPT code 50433 is accurately valued at 1.05 
RVUs greater than CPT code 50432, which describes the additional work 
performed by placing a nephroureteral catheter relative to the work of 
placing a nephrostomy catheter. However, we continue to believe that 
our proposed work RVU for CPT code 50432 is an accurate value for the 
reasons detailed above. With regard to our crosswalk, we maintain that 
relative value units are comparable across different medical 
specialties. CPT code 57155 (Insertion of uterine tandem and/or vaginal 
ovoids for clinical brachytherapy) has an identical intraservice time 
of 60 minutes and 14 additional minutes of total time, along with 
similar clinical intensity, which support the difference of 0.10 RVUs 
when compared to CPT code 50433. After consideration of the comments 
received, we are finalizing a work RVU of 5.30 for CPT code 50433.
    Comment: Several commenters requested that CMS adopt the RUC-
recommended work RVU of 4.20 for CPT code 50434. Commenters disagreed 
with the methodology that CMS used to arrive at the proposed value of 
4.00 RVUs, in particular the use of intraservice time ratios, and 
stated that the CMS crosswalk to CPT code 31634 (Bronchoscopy, rigid or 
flexible, with balloon occlusion) was inappropriate due to clinical 
dissimilarity.
    Response: We refer the reader to our earlier discussion about 
intraservice time ratios. We found the identical result of 3.98 work 
RVUs for CPT code 50434 when we applied the intraservice time ratio to 
CPT codes 50432 and 50433. This lent further support to our proposed 
work RVU. With regard to our crosswalk, we note that in the resource-
based relative value system, CPT codes do not have to be clinically 
similar to be comparable. CPT code 31634 shares the identical 
intraservice time with CPT code 50434 and serves as a direct crosswalk. 
After consideration of comments received, we are finalizing our 
proposed work RVU of 4.00 for CPT code 50434.
    Comment: Several commenters made similar statements regarding the 
proposed work RVU for CPT code 50435, criticizing the use of 
intraservice time ratios with other codes in the genitourinary catheter 
family and disagreeing with the crosswalked CPT codes for being 
medically dissimilar.
    Response: We refer the reader to our earlier discussion about 
intraservice time ratios and continue to believe that their use results 
in accurate work RVUs for this family of codes. We made use of an 
intraservice time ratio with both CPT code 50430 (the base code for the 
family) and CPT code 50432 (the most clinically similar code), which 
produced results of 1.80 and 1.77 RVUs, respectively. We also found two 
different crosswalks with identical intraservice time and very similar 
work RVUs, including CPT code 36569, with identical intraservice time, 
identical

[[Page 70967]]

total time, and a work RVU of 1.82 RVUs. Although we maintain that 
relative value units are comparable across different medical 
specialties, CPT code 36569 does in fact describe a medically related 
procedure, with the insertion of a central venous catheter. After 
consideration of comments received, we are finalizing our proposed work 
RVU of 1.82 for CPT code 50435.
    Comment: Commenters urged CMS to adopt the RUC-recommended work 
RVU, corresponding to the median survey work RVU of 4.60 RVUs for CPT 
code 50693. They stated that the placement of a ureteral stent requires 
more work than the placement of a nephroureteral catheter, and the 0.21 
RVU differential proposed by CMS is insufficient to reflect the 
additional work difficulty of CPT code 50693.
    Response: We are uncertain about which codes are being compared by 
the commenters, since the 0.21 RVU differential referenced by the 
commenters does not exist in the codes that appear to be discussed in 
the comment (50433). Since the commenters did not include the five 
digit CPT designation in their comparison, we are uncertain which code 
the commenters intended to discuss.
    We continue to believe that a work RVU of 4.21, corresponding to 
the 25th percentile survey result, is the most accurate value for CPT 
code 50693. We believe that the ureteral stent procedures are 
clinically similar to the rest of the genitourinary catheter family, 
and the use of intraservice time ratios with these procedures provides 
an accurate method for determining relative values. We continue to 
believe that the work RVU of 4.21, corresponding to the 25th percentile 
survey result, is further supported through our crosswalk to CPT code 
31648 (Bronchoscopy, rigid or flexible, with removal of bronchial 
valve) which has similar times and a work RVU of 4.20. After 
consideration of comments received, we are finalizing our proposed work 
RVU of 4.21 for CPT code 50693.
    Comment: Several commenters made statements similar to those 
mentioned previously regarding the work RVU for CPT code 50694, 
criticizing the use of intraservice time ratios with other codes in the 
genitourinary catheter family and disagreeing with the crosswalked CPT 
codes for being medically dissimilar.
    Response: We refer the reader to our earlier discussion about 
intraservice time ratios and continue to believe that their use results 
in accurate work RVUs for this family of codes. We compared CPT code 
50694 with 50433, the code within the family with the most similar 
intraservice time, which resulted in a potential work RVU of 5.48. We 
also found that CPT code 50382 had nearly identical intraservice time 
and total time, and a work RVU of 5.50. While we maintain that relative 
value units are comparable across different medical specialties, we do 
not agree with the commenters that CPT code 50382 is medically 
dissimilar from CPT code 50694. The former refers to the removal and 
replacement of a ureteral stent, while the latter refers to the 
placement of a ureteral stent. We believe that these codes describe 
very similar procedures, share the same patient population, and can 
serve as a direct crosswalk for the work RVU of each other. After 
consideration of comments received, we are finalizing our proposed work 
RVU of 5.50 for CPT code 50694.
    Comment: A few commenters stated that their comments on CPT code 
50695 are similar to those they had made previously about CPT code 
50433. While they agreed that CMS was correct to maintain the RUC-
recommended increment of 1.55 RVUs greater than the value of CPT code 
50694, they did not agree with the CMS refined work RVU of 50694 
itself. Commenters also did not support the CMS crosswalk to CPT code 
36481, which they stated had very different work, patient population, 
and potential complications.
    Response: We agree that CPT code 50695 is accurately valued at 1.55 
RVUs greater than CPT code 50694, which describes the additional work 
performed by the use of a nephrostomy tube. However, we continue to 
believe that the proposed work RVU for CPT code 50694 is an accurate 
value for the reasons detailed above. With regard to our crosswalk, we 
continue to believe that relative value units are comparable across 
services furnished by different medical specialties. CPT code 36481 
(Percutaneous portal vein catheterization by any method) has an 
identical intraservice time of 75 minutes and 18 additional minutes of 
total time, but a lower work RVU (6.98 RVUs) than the one suggested by 
our incremental method. Commenters also did not discuss our use of an 
intraservice time ratio with the base code in this subfamily, CPT code 
50693, which suggested a work RVU of 7.02. After consideration of 
comments received, we are finalizing our proposed work RVU of 7.05 for 
CPT code 50695.
    Comment: Several commenters disagreed with the CMS proposal to 
eliminate the RN/LPN/MTA blend (L037D) of clinical labor for assisting 
the physician during procedures 50431 and 50435. The CMS rationale was 
based on the lack of moderate sedation taking place in these two 
procedures. However, commenters argued that these procedures do require 
monitoring for patient stability that the attending physician cannot 
provide. They urged that the RN/LPN/MTA blend would be most appropriate 
for these procedures.
    Response: We are not aware of any other procedures in which there 
is a third assistant in the procedure room when moderate sedation is 
not being provided. We believe that the standard use of clinical labor 
staff would be typical when performing these procedures.
    Comment: Commenters also disagreed with the CMS proposal to change 
the labor type for patient monitoring following service (not related to 
moderate sedation) from the RUC-recommended RN (L051A) to the RN/LPN/
MTA blend (L037D). Commenters stated that although use of the RN/LPN/
MTA blend is standard for this clinical labor task, the RUC allows 
specialty groups to use an RN with justification, and that was the case 
here for these procedures since they involve invasive percutaneous 
solid organ interventions.
    Response: After consideration of comments, we agree that the use of 
the RN (L051A) clinical labor is typical for patient monitoring 
following service (not related to moderate sedation) for these 
particular specialty groups. We will restore the recommended L051A 
labor type for this clinical labor task for CPT codes 50430, 50432, 
50433, 50434, 50693, 50694, and 50695. We will also consider making a 
formal proposal regarding the most suitable type of clinical labor 
staff for this monitoring in future rulemaking.
    Comment: CMS sought clarification regarding the use of the 
nephroureteral catheter (SD306) for CPT code 50433. CMS removed this 
supply from CPT code 50433 since it was not mentioned in the 
information about the survey included in the RUC recommendation. 
Commenters wrote to explain that the phrase ``An 8 Fr nephroureteral 
stent is inserted with the distal pigtail in the bladder'' is included 
in the description of work for CPT code 50433, and in the context of 
genitourinary and biliary procedures, the historic term ``stent'' has 
been used interchangeably with the term ``catheter''. Commenters 
suggested that the nephroureteral catheter should be maintained as a 
supply item for this code and for CPT code 50434.
    Response: We agree that the nephroureteral catheter should be 
maintained as a supply item for CPT codes 50433 and 50434, based on the 
presentation of this additional information. However, based on our 
analysis of the comments, we believe

[[Page 70968]]

that our review of the RUC recommendations would be facilitated by 
consistent use of terminology throughout the information included in 
the recommendations.
    Comment: Several commenters, including the RUC, disagreed with the 
CMS decision to replace the angiography room (EL011) with a 
fluoroscopic room (EL014) for the genitourinary catheter family of 
codes. Commenters stressed that the fluoroscopic room was incapable of 
3-axis rotational imaging, that it would require dangerous movement of 
the patient, and that it presented sterility concerns. Commenters 
further disagreed that use of the angiography room was typically 
limited to cardiovascular procedures. They suggested that looking at 
service utilization, rather than number of CPT codes, indicates that 
non-vascular interventional procedures together comprise more than 50 
percent of utilization of a typical angiography room. Commenters also 
provided a list of the equipment found in an angiography room, and 
stated that everything other than the ``Injector, Provis'' would be 
typically utilized for the genitourinary catheter procedures. As a 
result, the commenters urged CMS to reverse the proposed refinement and 
restore the use of the angiography room for these codes.
    Response: We continue to believe that the use of an angiography 
room would not be typical for these genitourinary catheter procedures. 
The new genitourinary catheter codes in this family are being 
constructed through the bundling of imaging guidance with previously 
existing genitourinary catheter procedures. With the exception of CPT 
code 50398, the direct PE inputs for the predecessor codes do not 
include the use of an angiography room. We do not have reason to 
believe the coding changes related to these procedures would 
necessitate the use of different technology in furnishing the services. 
While it is true that the angiography room was included as a direct PE 
input for some of the predecessor imaging services, such as CPT codes 
77475, 77480, and 77485, the equipment times for these services were 
significantly shorter than the time included for the base procedures, 
where use of the room was not considered to be typical. Given the six 
fold increase in recommended time and the significantly higher expenses 
of the newly recommended equipment versus the equipment costs 
associated with the predecessor codes, we are seeking not only a 
rationale for the use of the angiography room, but also evidence that 
this room is typically used when these services are reported in the 
nonfacility setting.
    Comment: One commenter disagreed with the CMS decision to refine 
the time for clinical labor task ``Clean room/equipment by physician 
staff'' (L041B) from 6 minutes to 3 minutes. The commenter stated that 
there had been a robust discussion of this topic at the RUC meeting, 
and the additional minutes are needed to clean fluids/equipment/etc.
    Response: We continue to believe that the standard time of 3 
minutes for this clinical labor task is more accurate for the 
genitourinary catheter family of codes. We do not believe that these 
procedures typically produce enough external fluids to justify 6 
minutes for room cleaning.
    Comment: Several commenters disagreed with the CMS refinement of 
supplies to remove those that were duplicative of the same supplies 
found in visit packs (SA048) and sedation packs (SA044). Commenters 
stated that the IV starter kit (SA019), endoscope cleaning and 
disinfecting pack (SA042), non-sterile gloves (SB022), sterile gloves 
(SB024), sterile surgical gown (SB028), and three-way stop cock (SC049) 
were not duplicative supplies, as they were used in addition to the 
supplies included in the packs. Commenters requested that these 
supplies be restored to the direct PE inputs for the genitourinary 
catheter codes.
    Response: We agree with the commenters that three sets of sterile 
garments would typically be used for the three medical professionals 
performing the procedure. We are therefore restoring one pair of 
sterile gloves, one sterile surgical gown, one IV starter kit, and one 
three-way stop cock to these codes, consistent with the RUC 
recommendation. We do not believe that the use of two more pairs of 
non-sterile gloves (beyond the two pairs already included in the visit 
pack) would be typical for these procedures. With regards to the 
``endoscope cleaning and disinfecting pack'', our rationale was not 
that this supply was duplicative, but rather that its use would not be 
typical because the genitourinary catheter codes do not make use of an 
endoscope. We did not receive comments that suggested that supply item 
``endoscope cleaning and disinfecting pack'' would typically be used.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed, with the addition of the nephroureteral 
catheter for CPT code 50433, the change in clinical labor type from 
L037D to L051A for patient monitoring following service (not related to 
moderate sedation), and the additional four supplies detailed in the 
previous paragraph for CPT codes 50430, 50432, 50433, 50434, 50693, 
50694, and 50695.
(10) Penile Trauma Repair (CPT Codes 54437 and 54438)
    The CPT Editorial Panel created these two new codes because there 
are no existing codes to capture penile traumatic injury that includes 
penile fracture, also known as traumatic corporal tear, and complete 
penile amputation. CPT code 54437 describes a repair of traumatic 
corporeal tear(s), while CPT code 54438 describes a replantation, 
penis, complete amputation.
    In the proposed rule, we stated that we disagreed with the RUC 
recommendation of 24.50 work RVUs for CPT code 54438. We indicated that 
a work RVU of 22.10, corresponding to the 25th percentile survey 
result, was a more accurate value based on the work involved in the 
procedure and within the context of other codes in the same family, 
since CPT code 54437 was also valued using the 25th percentile. We 
found further support for this valuation through a crosswalk to CPT 
code 43334 (Repair, paraesophageal hiatal hernia via thoracotomy, 
except neonatal), which has an identical intraservice time and a work 
RVU of 22.12. Therefore, we proposed a work RVU of 22.10 for CPT code 
54438.
    Because CPT codes 54437 and 54438 are typically performed on an 
emergency basis, in the proposed rule, we questioned the accuracy of 
the standard 60 minutes of preservice clinical labor in the facility 
setting, as we suggested that the typical procedure would not make use 
of office-based clinical labor. We suggested, for example, the typical 
case would require 8 minutes to schedule space in the facility for an 
emergency procedure, or 20 minutes to obtain consent. We solicited 
further public comment on this issue from the RUC and other 
stakeholders.
    The following is a summary of the comments we received on our 
proposals.
    Comment: One commenter urged CMS to accept the RUC-recommended 
value for CPT code 54438 at 24.50 RVUs. This commenter argued that the 
RUC regularly accepts the median survey work RVU for one service and 
the 25th percentile survey result work RVU for another when both are in 
the same code family, particularly when they diverge in length of time. 
The commenter also suggested that reducing the intensity of CPT code 
54438 below its RUC-recommended value of 0.071

[[Page 70969]]

was inappropriate for such a complex and difficult procedure, with an 
unusual patient population that is often schizophrenic and prone to 
self-injury. This commenter emphasized using the RUC-supplied reference 
of CPT code 53448 as justification for the RUC-recommended work RVU.
    Response: We appreciate the presentation of this additional 
information concerning the complexity and intensity of CPT code 54438. 
We agree that the unusual patient population for this procedure 
justifies a higher work RVU than the proposed value. After 
consideration of comments received, we are finalizing our proposed work 
RVU of 11.50 for CPT code 54437, and assigning the RUC-recommended work 
RVU of 24.50 for CPT code 54438.
(11) Intrastromal Corneal Ring Implantation (CPT Code 65785)
    CPT code 65785 is a new code describing insertion of prosthetic 
ring segments into the corneal stroma for treatment of keratoconus in 
patients whose disease has progressed to a degree that they no longer 
tolerate contact lens wear for visual rehabilitation.
    In the proposed rule, we stated that we disagreed with the RUC 
recommendation of a work RVU of 5.93 for CPT code 65785. Although we 
appreciated the extensive list of other codes the RUC provided as 
references, we expressed concern that the recommended value for CPT 
code 65785 overestimated the work involved in furnishing this service 
relative to other PFS services. We did not find any codes with 
comparable intraservice and total time that had a higher work RVU. The 
recommended crosswalk, CPT code 67917 (Repair of ectropion; extensive), 
appears to have the highest work RVU of any 90-day global surgery 
service in this range of work time values. It also has longer 
intraservice time and total time than the code in question, making a 
direct crosswalk unlikely to be accurate.
    As a result, we proposed a work RVU for CPT code 65785 based on the 
intraservice time ratio in relation to the recommended crosswalk. We 
compared the 33 minutes of intraservice time in CPT code 67917 to the 
30 minutes of intraservice time in CPT code 65785. The intraservice 
time ratio between these two codes is 0.91, and when multiplied by the 
work RVU of CPT code 67917 (5.93) resulted in a potential work RVU of 
5.39. We also considered CPT code 58605 (Ligation or transection of 
fallopian tube(s)), which has the same intraservice time, 7 additional 
minutes of total time, and a work RVU of 5.28. In the proposed rule, we 
stated that we believed that CPT code 58605 was a more accurate direct 
crosswalk because it shares the same intraservice time of 30 minutes 
with CPT code 65785. Accordingly, we proposed a work RVU of 5.39 for 
CPT code 65785.
    The RUC recommendation for CPT code 65785 included a series of 
invoices for several new supplies and equipment items. One of these was 
the 10-0 nylon suture with two submitted invoice prices of $245.62 per 
box of 12, or $20.47 per suture, and another was priced at $350.62 per 
box of 12, or $29.22 per suture. Given the range of prices between 
these two invoices, we sought publicly available information and 
identified numerous sutures that appear to be consistent with those 
recommended by the specialty society, at lower prices, which we 
believed were more likely to be typical since we assumed that the 
typical practitioner would seek the best price. One example is 
``Surgical Suture, Black Monofilament, Nylon, Size: 10-0, 12''/30cm, 
Needle: DSL6, 12/bx'' for $146. Therefore, we proposed to establish a 
new supply code for ``suture, nylon 10-0'' and price that item at 
$12.17 each. We welcomed comments from stakeholders regarding this 
supply item.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters indicated that CMS should reconsider 
its decision and accept the RUC-recommended work RVU of 5.93. These 
commenters stated that the intraservice time ratio used by CMS did not 
account for differences in preservice time, postservice time, or levels 
of physician intensity. Commenters also disagreed with CMS' statement 
that there were no services with a comparable intraservice and total 
time that had a higher work RVU than the RUC-recommended value of 5.93 
for CPT code 65785. The commenters supplied a list of seven CPT codes 
that have a work RVU higher than 5.93 RVUs.
    Response: We continue to believe that the use of intraservice time 
ratios is one of several different methods that can be used to identify 
potential work RVUs. For this particular code, the RUC used a direct 
crosswalk to CPT code 67917 (Repair of ectropion; extensive) to set 
their recommended work RVU at 5.93 RVUs. We do not believe that that 
direct crosswalk was the most accurate way to value CPT code 65785, 
since code 67917 has an intraservice time that is 10 percent longer 
than the intraservice time of CPT code 65785 (33 minutes to 30 
minutes). CPT code 67917 is a clinically similar code which the RUC 
used for its own valuation of CPT code 65785, making it an especially 
good choice for comparative purposes after applying a ratio to 
normalize the intraservice times. We continue to believe that the use 
of an intraservice time ratio resulted in the most accurate value, 
given the difference in time between the two codes.
    As discussed in the proposed rule, all CPT codes with comparable 
time values and the same global period had lower work RVUs than the 
RUC-recommended work RVU of 5.93. While it is true that the seven codes 
provided by the commenters have work RVUs higher than 5.93 RVUs, we do 
not agree that these CPT codes are appropriate for comparative purposes 
with code 65785. CPT code 33768 is an add-on code (global ZZZ) that 
cannot be compared to a code with a 90-day global period such as 65785. 
CPT code 59830 is a Harvard-valued code that has not been subject to 
RUC review, has low utilization (2013 = 7 reported services), and 20 
minutes fewer total time than CPT code 65785. CPT codes 66770 and 67145 
are also Harvard codes which have not been RUC reviewed, and both have 
different intraservice times than 65785, 5 minutes and 10 minutes, 
respectively. CPT codes 67210 and 67220 are the only codes supplied by 
the commenters to be recently reviewed by the RUC, but both of them 
have only 15 minutes intraservice time, limiting their utility for 
comparative purposes with the 30 minutes intraservice time assumed for 
CPT code 65785. Although we accept the commenters' point that other 
codes with work RVUs above 5.93 RVUs do exist, we do not agree that 
codes referenced by commenters have ``comparable intraservice and total 
time'' with CPT code 65785. We continue to believe that scaling the 
RUC's key reference code of 67917 by the intraservice time ratio 
between the two codes provides the most accurate value for CPT code 
65785.
    After consideration of comments received, we are finalizing the 
work RVU and the direct PE inputs for CPT code 65785 as proposed.
(12) Dilation and Probing of Lacrimal and Nasolacrimal Duct (CPT Codes 
66801, 68810, 68811, 68815 and 68816)
    The RUC reviewed 10-day global services and identified 18 services 
with greater than 1.5 office visits and 2012 Medicare utilization data 
over 1,000, including CPT codes 66801, 68810, 68811, 68815, and 68816. 
The RUC requested surveys and reviews of these services for CY 2016.
    As discussed in the proposed rule, the RUC recommended a work RVU 
of 1.00

[[Page 70970]]

for CPT code 68801 and a work RVU of 1.54 for CPT code 68810. Although 
we proposed to use the RUC-recommended work RVU for CPT code 68810, we 
stated that the recommendation for CPT code 68801 did not best reflect 
the work involved in the procedure because of a discrepancy between the 
post-operative work time and work RVU. Specifically, the RUC 
recommendation for the procedure included the removal of a 99211 visit, 
but the RUC-recommended work RVU did not reflect any corresponding 
adjustment. We proposed to accept the RUC's recommendation to remove 
the 99211 visit from the service but proposed to further reduce the 
work RVU for CPT code 68801 by removing the RVUs associated with CPT 
code 99211. Therefore, for CY 2016, we proposed a work RVUs of 0.82 to 
CPT code 68801 and 1.54 to CPT code 68810.
    The RUC recommended a work RVU of 2.03, 3.00, and 2.35 for CPT 
codes 68811, 68815 and 68816, respectively. In the proposed rule, we 
stated that the RUC recommendations for these services do not appear to 
best reflect the work involved in performing these procedures. To value 
these services for the proposed rule, we calculated a total time ratio 
by dividing the code's current total time by the RUC-recommended total 
time, and then applying that ratio to the current work RVU. This 
produced the proposed work RVUs of 1.74, 2.70, and 2.10 for CPT codes 
68811, 68815, and 68816, respectively.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters, including the RUC, suggested that CMS 
reconsider its decision to not accept the RUC recommendations. The 
commenters believe that using a reverse building block methodology to 
reduce a work RVU for this service is inappropriate since magnitude 
estimation was used to establish the recommended work RVUs for this 
series of codes. Commenters also believe that CMS did not provide 
detailed rationale for the rejection of the RUC-recommended work RVUs 
for CPT codes 68811, 68815 and 68816. Finally, commenters noted that 
the existing IWPUT for each of these three surgical services is below 
0.03, which the commenters believe calls into question the accuracy of 
the existing work time and its usage in deriving a new work RVU.
    Response: We appreciate the commenters' perspectives, but reiterate 
that our proposed values accounted for the changes in the time 
resources assumed to be involved in furnishing these services since 
they were previously valued. We note that the validity of the IWPUT 
alone as a measure of intensity is reliant on the accuracy of the 
assumption regarding the number and level of visits for services in the 
global period for individual services. Therefore, we do not generally 
agree that a low IWPUT itself indicates misvaluation, particularly for 
services with global periods. After considering the comments received, 
we continue to believe that the work RVUs proposed for these codes 
accurately reflect the work involved in furnishing these services.
    Therefore, for CY 2016 we are finalizing work RVUs for CPT codes 
68801, 68810, 68811, 68815, and 68816, as proposed.
(13) Spinal Instability (CPT Codes 72081, 72082, 72083, and 72084)
    For CY 2015, the CPT Editorial Panel deleted codes 72010 
(radiologic examination, spine, entire, survey study, anteroposterior 
and lateral), 72069 (radiologic examination, spine, thoracolumbar, 
standing (scoliosis)), and 72090 (radiological examination, spine; 
scoliosis study, including supine and erect studies), revised one code, 
72080 (Radiologic examination, spine; thoracolumbar junction, minimum 
of 2 views) and created four new codes which cover radiologic 
examination of the entire thoracic and lumbar spine, including the 
skull, cervical and sacral spine if performed. The new codes were 
organized by number of views, ranging from one view in 72081, two to 
three views in 72082, four to five views in 72083, and minimum of six 
views in 72084.
    In the proposed rule, we stated that we did not agree with the 
RUC's recommended work RVUs for the four new codes. For 72081, we noted 
that the one minute increase in time resulted in a larger work RVU than 
would be expected when taking the ratio between time and RVUs in the 
source code and comparing that to the time and work RVU ratio in the 
new code. Using the relationship between time and RVUs from deleted CPT 
code 72069, we proposed a work RVU of 0.26 for CPT code 72081, which 
differs from the RUC-recommended value of 0.30. Using an incremental 
methodology based on the relationship between work and time in the 
first code we proposed to adjust the RUC-recommended work RVUs for CPT 
codes 72082, 72083 and 72084 to 0.31, 0.35, and 0.41, respectively.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Many commenters, including the RUC, disagreed with CMS' 
proposed crosswalk for 72081 and urged CMS to use the RUC 
recommendation. The commenters stated that since CPT code 72069 is 
being deleted due to changes in technology and patient population, it 
is a poor comparison. Other commenters pointed out that CPT code 72081 
typically includes an X-ray of skull, cervical spine, and pelvis and 
therefore is by definition more work than CPT code 72069. CPT code 
72069 is also noted as ``CMS/other'' code in the RUC's time file and 
the times in that file are not divided into time periods as CPT code 
72081 is. One commenter suggested that a more accurate crosswalk was 
CPT code 74020 (Radiologic examination, abdomen; complete, including 
decubitus and/or erect views,) which has a work RVU of 0.30. Using the 
same increments, the commenter suggested that the CMS proposed change 
for CPT code 72081 to 0.26 RVUs would result in an accurate increase in 
work across the family.
    Response: We continue to believe that CPT code 72069 is an accurate 
crosswalk. While CPT code 72069 may not be divided into time periods, 
the ratio between the total time and the RVU adequately reflects the 
relationship between time and intensity in CPT code 72081. Although we 
used CPT code 72069 as a comparison to CPT code 72081, we note that CPT 
code 72081 has a higher work RVU, which accounts for the extra work 
associated with imaging the skull, cervical spine, and pelvis. We do 
not believe that CPT code 74020 would be an accurate crosswalk because 
it describes a radiological examination of the abdomen whereas CPT code 
72069 refers to the same anatomical region as CPT code 72081.
    Therefore, after considering the comments received, we are 
finalizing these work RVUs for 72081, 72082, 72083, and 72084 as 
proposed.
(14) Echo Guidance for Ova Aspiration (CPT Code 76948)
    In the CY 2014 PFS final rule with comment period, we requested 
additional information to assist us in the valuation of ultrasound 
guidance codes. We nominated these codes as potentially misvalued based 
on the extent to which standalone ultrasound guidance codes were billed 
separately from services where ultrasound guidance was an integral part 
of the procedure. CPT code 76948 was among the codes considered 
potentially misvalued. CPT code 76948 was surveyed by the specialty 
societies and the RUC issued a recommendation for CY 2016. In the 
proposed rule, we stated that we had concerns about valuation of this 
code since it is a guidance code

[[Page 70971]]

used only for a single procedure, CPT code 58970 (aspiration of ova), 
and that these two codes are typically billed concurrently. We believe 
CPT codes 76948 and 58970 should be bundled to accurately reflect how 
the service is furnished.
    We proposed to use work times based on refinements of the RUC-
recommended values by removing the 3 minutes of pre and post service 
time since these times are reflected in CPT code 58970. We proposed 
work and time values for 76948 based on a crosswalk from 76945 
(Ultrasonic guidance for chorionic villus sampling, imaging supervision 
and interpretation) which has a work time of 30 minutes and an RVU of 
0.56. Therefore we proposed to maintain 25 minutes of intraservice time 
for CPT code 76948 and proposed a work RVU of 0.56.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Commenters stated that CMS should not have removed the 
work from the pre and post service portions of the service period and 
should restore the RUC-recommended work RVU of 0.85. The commenters 
stated that in the pre service period the physician reviews clinical 
history as well as prior imaging studies, and in the post service 
period the physician reviews and signs final report. The RUC commented 
that CPT codes 58970 and 76945 were billed less than 10 times each in 
2014, and were not billed together in any of those instances. The RUC 
acknowledged that these codes may be billed together under private 
payers and stated they would continue to review codes billed together 
75 percent of the time and bundle them when appropriate.
    Response: We appreciate the commenters' feedback. However, given 
the definition of the codes, we continue to believe that CPT code 76945 
is the image guidance code for CPT code 58970, and that these codes 
would not typically be billed separately. We acknowledge the anomalies 
in the low volume of Medicare claims data but do not believe that data 
likely reflects the way the services are intended to be reported. 
Therefore, any pre- or post-service work would be accounted for in CPT 
code 58970. After considering the comments received, we are finalizing 
a work RVU of 0.56 for CPT code 76945 as proposed.
(15) Surface Radionuclide High Dose Radiation Brachytherapy (CPT Codes 
77767, 77768, 77770, 77771, and 77772)
    In October 2014 the CPT Editorial Panel created five new codes to 
describe high dose radiation (HDR) brachytherapy. We proposed the RUC-
recommended work RVUs of 1.05, 1.40, 1.95, 3.80, and 5.40 respectively, 
for CPT codes 77767, 77768, 77770, 77771, and 77772. The RUC also 
recommended a new PE input, a brachytherapy treatment vault, which we 
proposed to include without modification.
    Comment: Commenters expressed support for CMS' proposed work and 
time values for this family of codes, and for CMS' proposal to add the 
brachytherapy vault as a PE input. Many commenters expressed concern 
for the overall downward trend in reimbursement for brachytherapy 
services, citing a sustained decrease in office-based brachytherapy 
procedures since 2009. The commenters encouraged CMS to enact measures 
to improve this.
    Response: We appreciate commenters' concerns regarding accurate 
payment for brachytherapy services. The revaluation of services under 
the Potentially Misvalued Code Initiative is aimed at achieving the 
most appropriate relative values under the PFS. There is not an 
intentional ``downward trend'' for any particular family of services. 
We remind commenters and stakeholders that disagree with CMS values, 
including those based on RUC recommendations, that in addition to 
submitting comments on our proposed rules, they may also nominate codes 
as potentially misvalued through the public nomination process. We are 
finalizing the values for HDR brachytherapy as proposed.
(16) Immunohistochemistry (CPT Codes 88341, 88342, and 88344)
    As discussed in the proposed rule, in establishing CY 2015 interim 
final direct PE inputs for CPT codes 88341, 88342, and 88344, we 
replaced the RUC-recommended supply item ``UltraView Universal DAB 
Detection Kit'' (SL488) with ``Universal Detection Kit'' (SA117), since 
the RUC recommendation did not provide an explanation for the required 
use of a more expensive kit. We also adjusted the equipment time for 
equipment item ``microscope, compound'' (EP024). We reexamined these 
codes when valuing the immunofluorescence family of codes for CY 2016, 
and reviewed information received by commenters that explained the need 
for these supply items. Specifically, commenters explained that the 
universal detection kit that CMS included in place of the RUC-
recommended kit was not typically used in these services as it was not 
clinically appropriate. We proposed to include the RUC-recommended 
supply item SL488 for CPT codes 88341, 88342, and 88344, as well as the 
RUC-recommended equipment time for ``microscope, compound'' for CY 
2016.
    In establishing interim final work RVUs for this family of codes, 
we refined the RUC recommendation for CPT code 88341 to 0.42, such that 
the work RVU for this add-on code was 60 percent of that of the base 
code 88342 (0.70 work RVUs). We noted that for similar procedures in 
this family, the RUC had recommended work RVUs for add-on codes that 
were 60 percent of the base codes, and that we believed this 
methodology would appropriately value this add-on code. In the proposed 
rule, we reexamined the work RVU for this service in the context of 
reviewing the immunoflurescent studies procedures. In doing so, we 
increased the work RVU of this add-on code to 0.53, which reflected 76 
percent of 0.70, the base code for this service. We discuss our 
rationale for this adjustment in the immunofluorescent studies section 
below. However, we inadvertently omitted the rationale for this 
revision to the work RVU in the proposed rule.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters, including the RUC, stated their 
appreciation of CMS' reconsideration when reexamining the RUC-
recommended direct PE inputs, ``UltraView Universal DAB Detection Kit'' 
(SL488) and equipment time for the supply item ``microscope, compound'' 
(EP024) for CPT codes 88341, 88342, and 88344 following feedback from 
the public.
    A few commenters also noted that the work RVU for CPT code 88341 
(Immunohistochemistry or immunocytochemistry, per specimen; each 
additional single antibody stain procedure (List separately in addition 
to code for primary procedure) as displayed in Addendum B of the 
proposed rule was inconsistent with the CY 2015 work RVU but was not 
discussed elsewhere in the proposed rule.
    Response: The discussion about the rationale for the increased work 
RVU for CPT code 88341 was inadvertently omitted from the proposed 
rule. Since the proposed rule did not include this discussion, we will 
maintain the interim final status of the CY 2015 work RVU of 0.53 for 
CY 2016 and we are seeking comment on this work RVU during the comment 
period for this final rule with comment period.
(17) Immunofluorescent Studies (CPT Codes 88346 and 88350)
    For CY 2016, the CPT Editorial Panel deleted one code, CPT code 
88347

[[Page 70972]]

(Antibody evaluation), created a new add-on service, CPT code 88350, 
and revised CPT code 88346 to describe immunofluorescent studies. The 
RUC recommended a work RVU of 0.74 for CPT code 88346 and 0.70 for CPT 
code 88350. In the proposed rule, we stated that although we proposed 
to use the RUC recommendation for CPT code 88346, we did not believe 
the recommendation for CPT code 88350 best reflects the work involved 
in the procedure due to our concerns with the relationship between the 
RUC-recommended intraservice times for the base code and the newly 
created add-on code. We examined intraservice time relationships 
between other base codes and add-on codes and found that two codes in 
the Intravascular ultrasound family, CPT code 37250 (Ultrasound 
evaluation of blood vessel during diagnosis or treatment) and CPT code 
37251 (Ultrasound evaluation of blood vessel during diagnosis or 
treatment), share a similar base code/add-on code intraservice time 
relationship, and are also diagnostic in nature, as are CPT codes 88346 
and 88350. Due to these similarities, we believed it was appropriate to 
apply the relationship, which is a 24 percent difference, between CPT 
codes 37250 and 37251 in calculating work RVUs for CPT codes 88346 and 
88350. In the proposed rule, we explained that we multiplied the RVU of 
CPT code 88346, 0.74, by 24 percent, and then subtracted the product 
from 0.74, resulting in a work RVU of 0.56 for CPT code 88350. 
Therefore, for CY 2016, we proposed a work RVU of 0.74 for CPT code 
88346 and 0.56 for CPT code 88350.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters stated their disagreement with the 
comparison of immunofluorescent studies (CPT codes 88346 and 88350) to 
ultrasound evaluation of blood vessels (CPT Codes 37250 and 37251). 
Commenters specifically stated the ultrasound services are add-on 
services involving initial and additional vessels, whereas CPT codes 
88346 and 88350 involve work related to initial and additional single 
antibody stain procedures. Commenters maintain that the level of work 
required to evaluate the initial stain is nearly identical to the 
second and that no efficiency is gained from the initial to the next 
and, therefore, a reduction in work RVUs for the additional slide would 
be inappropriate.
    Response: We continue to believe that the RVUs should reflect a 
reduction of overall work in each additional antibody stain slide. We 
also note that for CY 2015, we established as interim final a 40 
percent reduction for add-on codes, which we subsequently refined to a 
24 percent reduction in the CY 2016 proposed rule. We have not received 
any alternative recommendations as to the appropriate value for CPT 
code 88350. Therefore, we are finalizing our proposed valuation for CPT 
codes 88346 and 88350.
(18) Morphometric Analysis (CPT Codes 88364, 88365, 88366, 88367, 
88373, 88374, 88377, 88368, and 88369)
    The RUC reviewed and developed recommendations regarding CPT codes 
88367 and 88368. We reviewed and proposed values based on those 
recommended values as discussed in the proposed rule. Subsequently, the 
RUC re-reviewed these services for CY 2016 due to the specialty 
society's initially low survey response rate. In our review of these 
codes, we noticed that the latest RUC recommendation was identical to 
the RUC recommendation provided for CY 2015. Therefore, we proposed to 
retain the CY 2015 work RVUs and work time for CPT codes 88367 and 
88368 for CY 2016.
    For CPT codes 88364 and 88369, we refined the RUC recommendations 
to 0.67 for both procedures, such that the work RVUs for these add-on 
codes was 60 percent of the base codes. We noted that for similar 
procedures in this family, the RUC had previously recommended work RVUs 
for add-on codes that were 60 percent of the base codes, and that we 
believed this methodology would appropriately value these add-on codes. 
In the proposed rule, we reexamined the work RVUs for these services in 
the context of reviewing the immunofluorescent studies procedures. In 
doing so, we increased the work RVUs of these add-on codes to 0.67, 
which reflected 76 percent of 0.88, the work RVUs of the base codes for 
these services. We discuss our rationale for this adjustment in the 
immunofluorescent studies section above. However, we inadvertently 
omitted the rationale for this revision to the work RVU in the proposed 
rule.
    As discussed in the proposed rule, in establishing interim final 
direct PE inputs for CY 2015 for CPT codes 88364, 88365, 88366, 88367, 
88373, 88374, 88377, 88368, and 88369, we refined the RUC-recommended 
direct PE inputs as follows. We refined the units of several supply 
items, including ``ethanol, 100%'' (SL189), ``ethanol, 70%'' (SL190), 
``ethanol, 85%'' (SL191), ``ethanol, 95%'' (SL248), ``kit, FISH 
paraffin pretreatment'' (SL195), ``kit, HER-2/neu DNA Probe'' (SL196), 
positive and negative control slides (SL112, SL118, SL119, SL184, 
SL185, SL508, SL509, SL510, SL511), ``(EBER) DNA Probe Cocktail'' 
(SL497),''Kappa probe cocktails'' (SL498) and ``Lambda probe 
cocktails'' (SL499), to maintain consistency within the codes in the 
family, and adjusted the quantities included in these codes to align 
with the code descriptors and better reflect the typical resources used 
in furnishing these services. We also adjusted the equipment time for 
equipment items ``water bath, FISH procedures (lab)'' (EP054), 
``chamber, Hybridization'' (EP045), ``microscope, compound'' (EP024), 
``instrument, microdissection (Veritas)'' (EP087), and ``ThermoBrite'' 
(EP088), to reflect the typical time the equipment is used, among other 
common refinements.
    For CY 2016, we reexamined these codes when valuing the 
immunofluorescence family of codes, and reviewed information received 
from commenters during the CY 2015 final rule's comment period that 
described the typical batch size for each of these services, which 
identified apparent inconsistencies and discrepancies in the quantity 
of units among the codes in the family. For CY 2016, we proposed to 
include the RUC-recommended quantities for each of these supply items 
for the CPT codes 88364, 88365, 88366, 88367, 88373, 88374, 88377, 
88368, and 88369. With regard to the equipment items, we received 
information explaining that the recommended equipment times already 
accounted for the typical batch size, and thus, the recommended times 
were already reflective of the typical case. Therefore, we proposed to 
adjust the equipment time for equipment items EP054, EP045, and EP087 
to align with the RUC-recommended times. We also received comments 
explaining the need for equipment item EP088. Therefore, we proposed to 
include this equipment item consistent with the RUC recommendations for 
CPT code 88366.
    In the proposed rule, we noted that the information we received 
regarding the typical batch size was critical in determining the 
appropriate direct PE inputs for these pathology services. We also 
noted that we usually do not have information regarding the typical 
batch size or block size when we are reviewing the direct PE inputs for 
pathology services. The supply quantity and equipment minutes are often 
a direct function of the number of tests processed at once. Given the 
importance of the typical number of tests being processed by a 
laboratory in determining the direct PE inputs, which often include 
expensive supplies, we

[[Page 70973]]

expressed concern that the direct PE inputs included in many pathology 
services may not reflect the typical resource costs involved in 
furnishing the typical service.
    In particular, we noted in the proposed rule that since 
laboratories of various sizes furnish pathology tests and that, 
depending on the test, a large laboratory may be at least as likely to 
have furnished a test to a Medicare beneficiary compared to a small 
laboratory, we noted that an equipment item involved in furnishing a 
service that is commercially available to a small laboratory may not be 
the same equipment item that is used in the typical case. If the 
majority of services billed under the PFS for a particular CPT code are 
furnished by laboratories that run many of these tests each day, then 
assumptions informed by commercially available products may 
significantly underestimate the typical number of tests processed 
together, and thus the assumptions underlying current valuations for 
per-test cost of supplies and equipment may be much higher than the 
typical resources used in furnishing the service. We invited 
stakeholders to provide us with information about the equipment and 
supply inputs used in the typical case for particular pathology 
services.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several commenters, including the RUC, stated their 
disagreement with the methodology utilized in valuing CPT code 88367 
and urged CMS to use survey data and magnitude estimation when 
proposing a work RVU. Commenters also suggested that there should be no 
comparison of intravascular ultrasound services to morphometric 
analysis, immunohistochemistry, immunofluorescence or any pathology 
service. One commenter noted that for CPT code 88374 (Morphometric 
analysis, in situ hybridization (quantitative or semi-quantitative), 
using computer-assisted technology, per specimen; each multiplex probe 
stain procedure), using computer-assisted technology does not replace 
the pathologist's work; it merely refers to computer-aided selection of 
images for the pathologist to review and that the computer does not 
establish the distinction between cancer and non-cancer cells.
    Response: As discussed in the CY 2015 final rule with comment 
period (79 FR 67669), we do not believe the RUC-recommended work RVU of 
0.86 for 88367 (intraservice time = 25 minute) adequately reflects the 
difference in time relative to 88368 (RVU = .88, intraservice time = 30 
minutes). Commenters did not address our concerns about this change in 
time not being reflected in the work RVU for 88367. Therefore, we 
continue to believe 0.73 RVUs accurately reflects the work for CPT code 
88367. With regard to CPT code 88374, while we acknowledge using 
computer-assisted technology does not replace the pathologist's work, 
we continue to believe there are some efficiencies gained with the 
computer assistance. After considering the comments received, for CY 
2016, we are finalizing the values for CPT codes 88367 and 88374 as 
proposed.
    Comment: A commenter noted that the work RVUs for CPT codes 88364 
and 88369 as displayed in Addendum B of the proposed rule were 
inconsistent with the CY 2015 work RVUs, but were not discussed 
elsewhere in the proposed rule.
    Response: As noted above, the discussion about the rationale for 
the increased work RVU was inadvertently omitted from the proposed 
rule. Since the proposed rule did not include this discussion, we will 
maintain the interim final status of the work RVU of 0.76 for CPT codes 
88464 and 88369 for CY 2016 and we are seeking comment on these work 
RVUs during the comment period for this final rule with comment period.
(19) Vestibular Caloric Irrigation (CPT Codes 92537 and 92538)
    For CY 2016, the CPT Editorial Panel deleted CPT code 92543 
(Assessment and recording of balance system during irrigation of both 
ears) and created two new CPT codes, 92537 and 92538, to report caloric 
vestibular testing for bithermal and monothermal testing procedures, 
respectively. The RUC recommended a work RVU of 0.80 for CPT code 92537 
and a work RVU of 0.55 for CPT code 92538. In the proposed rule, we 
stated that we believed that the recommendations for these services 
overstate the work involved in performing these procedures. Due to 
similarity in service and time, we proposed that a direct crosswalk of 
CPT code 97606 (Negative pressure wound therapy, surface area greater 
than 50 square centimeters, per session) to CPT code 92537 accurately 
reflects the total work involved in furnishing the service. To 
establish a proposed value for CPT code 92538, we divided the proposed 
work RVU for 92537 in half since the code descriptor for this procedure 
describes the service as having two irrigations as opposed to the four 
involved in CPT code 92537. Therefore, for CY 2016, we proposed work 
RVUs of 0.60 to CPT code 92537 and 0.30 to CPT code 92538.
    The following is a summary of the comments we received on our 
proposals.
    Comment: Several specialty societies stated their disappointment 
that CMS did not accept the RUC-recommended work RVUs for CPT codes 
92537 and 92538. Commenters stated their objection to the rationale CMS 
used, stating that the rationale ignored the cogent, methodical, and 
thorough approach utilized by the RUC.
    Response: We appreciate the commenters' feedback. However, we 
reiterate that CPT code 67606 has nearly identical intra-service and 
total times as CPT code 92537 and given the similarity in services we 
continue to believe the direct crosswalk from CPT code 97606 to CPT 
code 92537 to be the most accurate. Also, CPT code 92538 describes two 
irrigations which is half the work involved in furnishing the service 
of CPT code 92537. For that reason, we continue to believe it is 
appropriate to establish 92538 with half of the work RVUs of 92537. 
Therefore, for CY 2016 we are finalizing a work RVU of 0.60 for 92537 
and 0.30 for 92538.
(20) Instrument-Based Ocular Screening (CPT Codes 99174 and 99177)
    For CY 2015, the CPT Editorial Panel created a new code, CPT code 
99177, to describe instrument-based ocular screening with on-site 
analysis and also revised existing CPT code 99174, which describes 
instrument-based ocular screening with remote analysis and report. In 
the proposed rule, we stated that CPT code 99174 was currently assigned 
a status indicator of N (non-covered service) which we proposed should 
remain unchanged since this is a screening service. After review of CPT 
code 99177, we proposed that this service was also a screening service 
and should be assigned a status indicator of N (non-covered service). 
Therefore, for CY 2016, we proposed to assign a PFS status indicator of 
N (non-covered service) for CPT codes 99174 and 99177.
    The following is a summary of the comments we received on our 
proposals.
    Comment: A few commenters, including the RUC, stated their 
disagreement with CMS' proposal to assign a status indicator of ``N'' 
(non-covered service). Commenters stated there is a long-standing 
precedent that status indicator ``N,'' codes have had their RUC-
recommended values published in the PFS.
    Response: We continue to believe CPT codes 99174 and 99177 are 
screening

[[Page 70974]]

services and are therefore non-covered services under the Medicare 
program. Therefore, for CY 2016, we are finalizing our proposed 
assignment of a PFS status indicator of N (non-covered service) for CPT 
codes 99174 and 99177. Because we have not reviewed the recommended 
values for these services, we do not believe that we should develop or 
display RVUs for these services. In some cases in the past, we have 
developed and displayed RVUs for codes not separately payable by 
Medicare. However, we note that this practice has not been consistently 
applied and we have concerns about this practice since it is not 
apparent in the display itself that the resulting RVUs do not reflect 
our review or assessment of the recommendations nor do they reflect the 
influence of updated Medicare claims data. However, we understand that, 
for PFS nonpayable services, displaying RVUs that are based solely on 
recommendations may serve an interest for the public. Therefore, we 
will consider for the future how we might reconcile that interest with 
our interest in maintaining a clear distinction between the RVUs that 
result from our established methodology and RVUs that result solely 
from recommended input values.
(21) Lung Cancer Screening Counseling and Shared Decision Making Visit 
and Lung Cancer Screening With Low Dose Computed Tomography (CPT Codes 
G0296 and G0297)
    We issued national coverage determination (NCD) for Medicare 
coverage of a lung cancer screening counseling and shared decision 
making visit, and for appropriate beneficiaries, annual screening with 
low dose computed tomography (LDCT), as an additional preventive 
benefit, effective February 5, 2015. The American College of Radiology 
(ACR) submitted recommendations for work and direct PE inputs.
    We proposed to value CPT code G0296 (Counseling visit to discuss 
need for lung cancer screening (LDCT) using low dose CT scan (service 
is for eligibility determination and shared decision making)) using a 
crosswalk from the work RVU for G0443 (Brief face-to-face counseling 
for alcohol misuse, 15 minutes) which has a work RVU of 0.45. We added 
2 minutes of pre-service time, and one minute post-service time which 
we valued at 0.0224 RVU per minute yielding a total of 0.062 additional 
RVUs which we then added to 0.45, bringing the total proposed work RVUs 
for G0296 to 0.52. The direct PE input recommendations from the ACR 
were refined according to CMS standard refinements and appear in the CY 
2016 proposed direct PE input database.
    For CPT code G0297 (Low dose CT scan (LDCT) for lung cancer 
screening), the ACR recommended that CMS crosswalk CPT code G0297 to 
CPT code 71250 (computed tomography, thorax; without contrast material) 
with additional work added to account for the added intensity of the 
service. After reviewing this recommendation, we stated in our proposal 
that the work (time and intensity) was identical for both CPT code 
G0297 and CPT code 71250. Therefore, we proposed a work RVU of 1.02 for 
CPT code G0297. The following is a summary of the comments we received 
on our proposals.
    Comment: Several commenters stated that the CMS-proposed crosswalk 
for G0296 (Counseling visit to discuss need for lung cancer screening 
(LDCT) using low dose CT scan (service is for eligibility determination 
and shared decision making)) did not accurately reflect the time and 
intensity of furnishing this service. Some commenters suggested that 15 
minutes is not enough time for the practitioner to engage in a 
meaningful conversation with the patient and that the work and time for 
the shared decision making visit should reflect this.
    Response: Because we continue to believe that the cognitive work 
for G0296 is comparable to G0443 and that there is no additional work 
associated with fulfilling the requirements of the NCD, we believe that 
the work and time for the counseling and shared decision making visit 
is included in the values associated with the crosswalk code.
    Comment: For CPT code G0297 (Low dose CT scan (LDCT) for lung 
cancer screening), a few commenters expressed support for our proposed 
work RVUs of 1.02. Several commenters were concerned that the proposed 
crosswalks and work valuations did not adequately reflect the time and 
intensity involved in furnishing these services. The American College 
of Radiology suggested that a lung cancer screening low dose CT 
required greater technical skill and mental effort to make the correct 
diagnosis, and that the baseline increase of malignancy caused greater 
psychological stress for the provider and the additional requirements 
of the NCD add to the intensity of performing these services.
    Response: Reading radiologists that meet the eligibility 
requirements of the NCD have extensive experience interpreting chest 
CTs. For example, the NCD states that among other things, an eligible 
reading radiologist must have been involved in the supervision and 
interpretation of at least 300 chest CT acquisitions in the past 3 
years. Therefore, we do not believe that extra work is involved in 
furnishing the low-dose CT, as compared to CPT code 71250.
    Comment: Several commenters requested CMS clarify that a medically 
necessary E/M visit can be billed on the same day as the lung cancer 
screening counseling and shared decision making visit. Some commenters 
also requested that the shared decision making visit be considered part 
of, or complementary to, the annual wellness visit. Several commenters 
also asked CMS to clarify that the lung cancer LDCT screening and the 
counseling and shared decision making visit are not subject to cost 
sharing since they are preventive services.
    Response: As long as the NCD requirements for the counseling and 
shared decision making visit are met, the counseling visit may be 
billed on the same day as a medically necessary E/M visit or an annual 
wellness visit with the -25 modifier. Practitioners should refer to the 
NCD for information regarding the Medicare coverage requirements for 
the counseling and shared decision making visit. Lung cancer screening 
with LDCT, including a lung cancer screening counseling and shared 
decision making visit, is covered as an additional preventive benefit, 
identified for Medicare coverage through the NCD process. Therefore, 
this benefit meets the criteria in sections 1833(a)(1) and (b)(1) of 
the Act for nonapplication of the deductibles and coinsurance.
    Comment: Many commenters were concerned with the fact that, 
although the NCD was issued in February of 2015, there are no 
instructions for billing services performed prior to 2016.
    Response: CMS is in the process of developing claims processing, 
coding and billing instructions. This information is forthcoming.
    Comment: One commenter asked if the imaging facility would be 
subject to recoupment for a CT if a hospital performed a CT believing 
that the required counseling had occurred, and later it was determined 
that it had not.
    Response: We appreciate this comment. While we acknowledge the 
commenter's concern, we believe that this comment is outside the scope 
of this rulemaking.
    Comment: One commenter requested that the shared decision making 
visit be added to the list of telehealth services.
    Response: We refer readers to section II.I. of this final rule with 
comment period, where we discuss the process for adding services to the 
list of Medicare

[[Page 70975]]

telehealth services. In addition, we note that information about how to 
submit a request to add a service to the telehealth list is available 
on the CMS Web site at www.cms.gov/telehealth.
    Comment: Commenters were concerned that there was a discrepancy in 
reimbursement between the PFS and the OPPS.
    Response: Payments made under the PFS and the OPPS are established 
under different statutory provisions using different bases and 
methodologies, and therefore often result in differential payment 
amounts for similar services.
    Comment: Several commenters pointed out that there were no 
malpractice or PE inputs for G0296 and G0297 in the downloads available 
with the proposed rule.
    Response: We appreciate commenters' attention to detail and we have 
corrected these values in this final rule with comment period.
    After consideration of the comments received, we are finalizing the 
work RVUs for G0296 and G0297 as proposed.
7. Direct PE Input-Only Recommendations
    In CY 2014, 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 given our several longstanding concerns 
regarding the accuracy of certain aspects of the direct PE inputs, 
including both items and procedure time assumptions, and prices of 
individual supplies and equipment (78 FR 74248 through 74250). After 
considering the many comments we received regarding our proposal, the 
majority of which urged us to withdraw the proposal for a variety of 
reasons, we decided not to finalize the policy. However, we continue to 
believe that using PE data that are auditable, comprehensive, and 
regularly updated would contribute to the accuracy of PE calculations.
    Subsequent to our decision not to finalize the proposal, the RUC 
forwarded direct PE input recommendations for a subset of codes with 
nonfacility PE RVUs that would have been limited by the policy. Some of 
these codes also include work RVUs, but the RUC recommendations did not 
address the accuracy of those values.
    We generally believe that combined reviews of work and PE for each 
code under the potentially misvalued codes initiative leads to more 
accurate and appropriate assignment of RVUs. We also believe, and have 
previously stated, that our standard process for evaluating potentially 
misvalued codes is unlikely to be the most effective means of 
addressing our concerns regarding the accuracy of some aspects of the 
direct PE inputs (79 FR 74248).
    However, we also believe it is important to use the most accurate 
and up-to-date information available to us when developing PFS RVUs for 
individual services. Therefore, we reviewed the RUC-recommended direct 
PE inputs for these services and proposed to use them, with the 
refinements addressed in this section. However, we also identified 
these codes as potentially misvalued because their direct PE inputs 
were not reviewed alongside review of their work RVUs and time. We 
considered not addressing these recommendations until such time as 
comprehensive reviews could occur, but we recognized the public 
interest in using the updated recommendations regarding the PE inputs 
until such time as the work RVUs and time can be addressed. Therefore, 
we noted that while we proposed adjusted PE inputs for these services 
based on these recommendations, we would anticipate addressing any 
corresponding change to direct PE inputs once the work RVUs and time 
are addressed.
a. Repair of Nail Bed (CPT Code 11760)
    The RUC recommendation for CPT code 11760 included 22 minutes 
assigned to clinical labor task ``Assist physician in performing 
procedure.'' Because CPT code 11760 has 33 minutes of work intraservice 
time, we believe that this clinical labor input was intended to be 
calculated at 67 percent of work time. However, the equipment times 
were also calculated based on the 22 minutes of intraservice time. We 
proposed to use the RUC-recommended equipment times while we solicited 
comments on whether or not it would be appropriate to include the full 
33 minutes of work intraservice time for the equipment.
    Comment: A commenter clarified that the 22 minutes of time for 
clinical labor task ``Assist physician in performing procedure'' was 
indeed intended to represent 67 percent of the physician intraservice 
time of 33 minutes. The commenter agreed that it is appropriate to 
include the full 33 minutes of intraservice time in the equipment time 
calculation.
    Response: We appreciate the clarification of this issue from the 
commenter. After consideration of comments received, we will refine the 
equipment times for CPT code 11760 by adding 11 minutes to each item, 
to reflect the entire intraservice period of 33 minutes.
    Comment: One commenter disagreed with the CMS decision to remove 
pre-service clinical labor time in the non-facility setting. The 
commenter stated that the service is performed more than 33 percent of 
the time in a facility setting, and suggested that CMS should adopt the 
RUC recommendation.
    Response: We continue to believe that this clinical labor task 
would not be performed on a typical basis, as the procedure is most 
frequently done on an emergent basis. We also do not believe that time 
should be allotted for clinical labor task ``Provide pre-service 
education/obtain consent'' in the preservice period, since CPT code 
11760 also includes time for the same clinical labor task in the 
service period. We note that information about the percentage of time a 
service is performed in one setting versus another is not factored into 
our assessment of PE inputs for each setting. After consideration of 
comments received, we are finalizing the direct PE inputs as proposed 
for CPT code 11760, with the additional refinements to equipment time 
discussed above.
b. Simple Repair of Superficial Wounds (CPT Codes 12005, 12006, 12007, 
12013, 12014, 12015, and 12016)
    We refined the time for clinical labor task ``Check dressings & 
wound/home care instructions'' to 3 minutes for each code in this 
family to reflect the standard time for this clinical labor task.
    Comment: One commenter stated that the commenter was unaware that 
there was a standard time for this clinical labor task. The commenter 
stated that a reduction to 3 minutes was not warranted absent an 
identified standard in this regard.
    Response: Three minutes is the generally applied number of minutes 
assigned to the clinical labor task ``Check dressings & wound/home care 
instructions''. In general, we continue to believe that this is the 
most accurate time for this clinical labor task.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT codes 12005, 12006, 12007, 12013, 
12014, 12015, and 12016.
c. Intermediate Repair of Wounds (CPT Codes 12041, 12054, 12055, and 
12057)
    We refined the preservice clinical labor time in the non-facility 
setting to zero minutes, and the information in the proposed rule 
indicated that this refinement was because these codes are emergent 
procedures where certain

[[Page 70976]]

clinical labor tasks would not typically be performed. We also removed 
one of the two suture packs (SA054) from the recommended list of 
supplies, and adjusted the equipment time formulas to reflect the 
established standards.
    Comment: A commenter disagreed with the CMS decision to remove the 
preservice clinical labor time in the non-facility setting. The 
commenter stated that neither the site of service nor the diagnosis 
codes for these services indicate that these are emergency procedures, 
and they are most commonly performed in a non-emergent setting. The 
commenter urged CMS to accept the RUC-recommended times for these 
clinical labor tasks.
    Response: We appreciate the commenter bringing this issue to our 
attention. After reviewing these clinical labor activities again, we 
continue to believe that time for these preservice activities should 
not be included in the non-facility setting. However, our stated 
rationale for this refinement, that this is due to the emergent nature 
of these procedures, was incorrectly stated due to a clerical error. We 
intended to explain that we refined these preservice activities to zero 
minutes because the standard preservice clinical labor for 10-day 
global codes in the non-facility setting is zero minutes for all five 
preservice activities, and there was no additional justification to 
increase the value for this group of codes. We are maintaining this 
refinement to zero minutes.
    Comment: One commenter indicated that CMS incorrectly reduced the 
quantity of suture packs (SA054) from two to one for CPT codes 12055 
and 12057 in the facility setting. CMS stated that there was no 
rationale for the increase in the quantity of this supply and that 
sutures would only be removed one time, but the commenter stated that 
suture removal takes place twice for these procedures, with some of the 
sutures being removed at each of the two office visits. The commenter 
requested that CMS accept the RUC-recommended supply inputs.
    Response: We appreciate the additional information regarding the 
use of suture packs for this procedure. After consideration of comments 
received and based on this presentation of new information, we agree 
that the second suture pack would typically be used in these 
procedures, and we are restoring the quantity of SA054 to two for CPT 
codes 12055 and 12057 in the facility setting.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT codes 12041, 12054, 12055, and 
12057, with the additional refinement to SA054 discussed above.
d. Nasal or Sinus Surgical Endoscopy (CPT Codes 31295, 31296, and 
31297)
    We refined some of the preservice clinical labor times to align 
with standard values, as well as the fact that the decision for surgery 
would have been made on the previous day. We also refined the time for 
clinical labor task ``Sedate/apply anesthesia'' to reflect the 
established standard, refined the quantity of the Afrin nasal spray 
(SJ037) to the amount typical for the procedures, and refined the 
equipment times to conform to our standard policies.
    Comment: A commenter disagreed with the decision by CMS to refine 
the time for clinical labor task ``Sedate/apply anesthesia'' from 5 
minutes to 2 minutes. The commenter stated that 5 minutes would be 
typical for these procedures, since a topical anesthesia requires 
additional time to be applied, the staff typically applies a local 
anesthetic after the initial topical form, and a second application is 
necessary in the majority of patients.
    Response: We continue to believe that the established standard of 2 
minutes for clinical labor task ``Sedate/apply anesthesia'' is the most 
accurate value for these procedures. The RUC recommendations for these 
codes did not provide a rationale for anesthesia times in excess of the 
standard value.
    After consideration of comments received, we are finalizing the 
direct PE inputs for CPT codes 31295, 31296, and 31297 as proposed.
e. Removal of Embedded Foreign Body From Mouth and Pharynx (CPT Codes 
40804 and 42809)
    In the proposed rule, we stated that the ENT suction and pressure 
cabinet (EQ234) would not typically be used during an office visit, and 
we refined the equipment times to remove the minutes associated with 
the office visit. We also refined the quantity of supply item ``suction 
canister'' (SD009) from two to one to reflect the amount typically used 
during these procedures.
    Comment: One commenter indicated that the suction and pressure 
cabinet would be standard in ENT rooms, and would be used to store 
items and equipment to keep them clean. The commenter urged CMS to 
accept the RUC-recommended equipment time for the suction and pressure 
cabinet.
    Response: We include direct PE inputs for items and services that 
are typically involved in furnishing a particular service. The presence 
of the suction and pressure cabinet in the same room where the 
procedure is being performed does not provide sufficient rationale for 
its inclusion in this service since it is not typically used in 
furnishing the service. We continue to believe that the suction and 
pressure cabinet would only be utilized during the intraservice portion 
of CPT codes 40804 and 42809, and not during the follow-up office 
visits.
    Comment: The same commenter stated that these procedures required 
the use of two suction canisters. The commenter explained that one 
suction canister would be used during the intraservice portion of the 
procedure, and the other suction canister would be used during a 
follow-up office visit.
    Response: We continue to believe that the use of a suction and 
pressure cabinet would not be typical for an office visit, and 
therefore there is only a need for one suction canister for these 
procedures. Furthermore, the RUC considered this issue in making its 
recommendations, and found that no suction canister is needed in the 
follow-up visit for the service when furnished in the facility setting. 
We therefore do not believe that the suction and pressure cabinet, with 
a corresponding suction canister, would be typically used during a 
follow-up visit when the procedure is furnished in the non-facility 
setting.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT Codes 40804 and 42809.
f. Cytopathology Fluids, Washings or Brushings and Cytopathology 
Smears, Screening, and Interpretation (CPT Codes 88104, 88106, 88108, 
88112, 88160, 88161, and 88162)
    We proposed to update the price for supply item ``Millipore 
filter'' (SL502) based on stakeholder submission of new information 
following the RUC's original recommendation. As requested, we proposed 
to crosswalk the price of SL502 from the cytology specimen filter 
(Transcyst) supply (SL041) and assign a price of $4.15. The proposed 
direct PE inputs are included in the proposed CY 2016 direct PE input 
database, which is available on the CMS Web site under downloads for 
the CY 2016 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. We also refined the time for clinical 
labor task ``Order, restock, and distribute specimen containers with 
requisition forms'' to zero minutes due to our belief that this task 
was not allocable to individual services and therefore an

[[Page 70977]]

indirect PE under our established methodology.
    As discussed in the proposed rule, we are concerned that there is a 
lack of clarity and the possibility for confusion contained in the CPT 
descriptors of CPT codes 88160 and 88161. The CPT descriptor for the 
first code refers to the ``screening and interpretation'' of 
cytopathology smears, while the descriptor for the second code refers 
to the ``preparation, screening and interpretation'' of cytopathology 
smears. We believe that there is currently the potential for 
duplicative counting of direct PE inputs due to the overlapping nature 
of these two codes. We are concerned that the same procedure may be 
billed multiple times under both CPT code 88160 and 88161. We believe 
that these codes are potentially misvalued, and we are seeking a full 
review of this family of codes for both work and PE, given the 
potential for overlap. We recognize that the ideal solution may involve 
revisions by the CPT Editorial Panel.
    With regard to the current direct PE input recommendations, we 
proposed to remove the clinical labor minutes recommended for ``Stain 
air dried slides with modified Wright stain'' for CPT code 88160 since 
staining slides would not be a typical clinical labor task if no slide 
preparation is taking place, as the descriptor for this code suggests.
    We proposed to update supply item ``protease solution'' (SL506) 
based on stakeholder submission of new information following the RUC's 
original recommendation. As requested, we proposed to change the name 
of the supply to ``Protease'', alter the unit of measurement from 
milliliters to milligrams, change the quantity assigned to CPT code 
88182 from 1 to 1.12, and update the price from $0.47 to $0.4267. These 
changes are reflected in the direct PE input database, which is 
available on the CMS Web site under downloads for the CY 2016 final 
rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Subsequent to receiving these recommendations, we received 
additional recommendations from the RUC for this family of procedures 
following the publication of the CY 2016 PFS proposed rule. We will 
address both recommendations here.
    Comment: A commenter provided an invoice for supply item 
``Millipore filter'' (SL502) to replace the current supply crosswalk to 
the cytology specimen filter (SL041).
    Response: We appreciate the submission of this supply invoice. 
After consideration of comments received, we will update the price of 
supply item ``Millipore filter'' (SL502) in our direct PE inputs 
database from the current value of $4.15 to the submitted invoice price 
of $0.75.
    Comment: A commenter stated that the clinical labor task ``Order, 
restock, and distribute specimen containers with requisition forms'' is 
a direct PE as it is a variable clinical labor task. The commenter 
stated that this task depends on the typical laboratory volume mix for 
each service, and any blanket categorization cannot be justified.
    Response: We continue to believe that the clinical labor task 
``Order, restock, and distribute specimen containers with requisition 
forms'' is an indirect PE, as it is not allocated to any individual 
service. We have defined direct PE inputs as clinical labor, medical 
supplies, or medical equipment that are individually allocable to a 
particular patient for a particular service. For a detailed explanation 
of the direct PE methodology, including examples, we refer readers to 
the CY 2007 PFS final rule with comment period (71 FR 69629). 
Therefore, whether a particular cost is fixed or variable does not 
determine whether it is a direct PE input under the methodology. We 
have removed the recommended 0.5 minutes of time for clinical labor 
task ``Order, restock, and distribute specimen containers with 
requisition forms'' from all seven of these procedures. However, we 
have maintained 0.5 minutes of time for clinical labor task ``Prepare 
specimen containers/preload fixative/label containers/distribute 
requisition form(s) to physician'' from the previous recommendations 
for CPT codes 88160, 88161, and 88162, and added this 0.5 minutes to 
the other four codes in the family to conform with the other codes in 
the family.
    Comment: Several commenters disagreed that there is a lack of 
clarity and possibility for confusion within the cytopathology smears, 
screening and interpretation family. These commenters stated that in 
CPT code 88160, the slide is received in the laboratory typically as a 
spray-fixed and air-dried slide that has not been stained. The slide is 
then stained in the laboratory with the appropriate stain per fixation 
prior to review and interpretation. For CPT code 88161, the laboratory 
must first put the patient material on the slide (that is, prepare the 
slide) then stain it in the laboratory with the appropriate stain per 
fixation prior to review and interpretation. Both codes therefore 
include staining, review and interpretation in the laboratory. 
Commenters did not agree that there was any provider confusion 
concerning these specialized, low volume codes, and stressed that these 
codes did not need to be added to the potentially misvalued code list.
    Response: We appreciate the additional information clarifying the 
nature of the work that takes place during these two procedures.
    Comment: The same commenters did not agree with the refinement to 
the time for clinical labor task ``Stain air dried slides with modified 
Wright stain'' from 5 minutes to 0 minutes for CPT code 88160 and from 
5 minutes to 3 minutes for CPT code 88161. Commenters explained that 
for CPT code 88160, the slides are received in the laboratory typically 
as spray-fixed and air-dried slides that have not been stained. They 
must be stained prior to review and interpretation. For CPT code 88161, 
the laboratory must put the patient material on the slide, followed by 
staining for review and interpretation. Both codes therefore include 
staining, review and interpretation in the laboratory.
    Response: We appreciate the submission of this additional 
information regarding the staining of slides in these procedures. After 
consideration of comments received and based on the submission of this 
additional information, we agree that there should be time for 
allocated for clinical labor task ``Stain air dried slides with 
modified Wright stain'' in CPT code 88160. We later received additional 
recommendations from the RUC that suggested a time of 2 minutes for the 
clinical labor task. We are therefore accepting the time for clinical 
labor task ``Stain air dried slides with modified Wright stain'' at the 
value of 2 minutes in the most recent set of RUC recommendations for 
all seven procedures; we believe that 2 minutes is an accurate standard 
for this clinical labor task.
    Comment: One commenter disagreed with the CMS refinement to the 
clinical labor task ``Prepare automated stainer with solutions and load 
microscopic slides.'' The commenter stated that 4 minutes were 
recommended for this task, which applied specifically to these 
particular CPT codes based on the typical laboratory and efficiency 
assumptions.
    Response: We agree with the commenter that 4 minutes is an accurate 
value for this clinical labor task, but note that we refined the value 
to 4 minutes during our initial review.
    Comment: A commenter recommended that CMS refine the

[[Page 70978]]

equipment time of the solvent recycling system to 2 minutes. The 
commenter expressed the opinion that the use of this equipment is not 
dependent on clinical labor time.
    Response: We continue to believe that the solvent recycling system 
is an indirect PE cost used across numerous services and not 
individually allocated to particular procedures. We have removed the 
clinical labor time associated with the solvent recycling system from 
all seven codes.
    In addition, we have removed the time associated with clinical 
labor task ``Recycle xylene from stainer'' from all of the codes for 
similar reasons. We also noticed what appeared to be an error in the 
amount of non-sterile gloves (SB022), impermeable staff gowns (SB027), 
and eye shields (SM016) assigned to CPT codes 88108 and 88112. The 
recommended value of these supplies was a quantity of 0.2, which we 
believe was intended to be a quantity of 2. We are therefore refining 
the value of these supplies to 2 for CPT codes 88108 and 88112. After 
consideration of comments received, we are finalizing the direct PE 
inputs as proposed for CPT Codes 88104, 88106, 88108, 88160, 88161, and 
88162 with the exception of the refinements to the clinical labor, 
supplies, and equipment described above.
g. Flow Cytometry, Cell Cycle or DNA Analysis (CPT Code 88182)
    We refined many of the clinical labor activities in this procedure 
to align with the typical times included for other recently reviewed 
pathology codes. We requested additional information regarding the use 
of the desktop computer with monitor (ED021) since the RUC 
recommendation did not specify how it is used.
    Comment: One commenter disagreed with the eight refinements that 
CMS made to the clinical labor time for CPT code 88182, and with the 
rationale of using clinical labor standards for pathology activities in 
general. The commenter stated that the time for these clinical labor 
tasks varies for each CPT code, and the RUC-recommended times only 
reflect the time associated with each particular CPT code. The times 
associated with pathology clinical labor activities vary by typical 
laboratory-specific efficiencies, such as batch size. The commenter 
stated that it was inappropriate for CMS to establish standard clinical 
labor times for these clinical labor activities, and urged CMS to 
accept the RUC recommendation for these inputs.
    Response: We refer the reader to section II.A. of this final rule 
for our discussion about clinical labor standards for pathology codes. 
We continue to believe that clinical labor tasks with the same 
description are comparable across different pathology CPT codes. We 
continue to believe that our refinements to clinical labor time ensure 
the most accurate values for these activities, based on a comparison 
with other pathology codes that share these same clinical labor 
activities.
    Comment: Several commenters provided additional information 
concerning the use of the desktop computer with monitor. These 
commenters explained that CPT code 88182 is performed using ploidy 
analysis, by comparing the tumor curve to normal cells. These analyses 
are performed using a dedicated desktop computer with a monitor, which 
is located in the same room and is dedicated to the patient for each 
use.
    Response: We appreciate the submission of additional information 
regarding the use of the desktop computer with monitor. After 
consideration of comments received, we believe that the use of this 
equipment item is typical during this service and will retain this 
equipment item for CPT code 88182. After consideration of comments 
received, we are finalizing the direct PE inputs as proposed for CPT 
Code 88182.
h.. Flow Cytometry, Cytoplasmic Cell Surface (CPT Codes 88184 and 
88185)
    We refined many of the clinical labor activities in these 
procedures to align with the times typically included in other recently 
reviewed pathology codes. We also requested additional information 
regarding the specific use of the desktop computer with monitor (ED021) 
for CPT codes 88184 and 88185 since the recommendation does not specify 
how it is used.
    Comment: Many commenters disagreed with the decrease in direct PE 
inputs for these codes. Commenters emphasized that the CMS proposal for 
these codes reflected reductions in the PE RVUs of 38 percent to CPT 
code 88184 and 69 percent to CPT code 88185. Commenters stated that 
these reductions are unreasonable and could jeopardize patient access 
to care. Several commenters requested that these codes be re-reviewed 
by the RUC process because certain inputs were not considered in the 
original RUC deliberations.
    Response: We agree with the commenters that there were major 
changes to the direct PE inputs for these two procedures. We note that 
almost all of the change in direct PE inputs resulted from RUC 
recommendations. With the exception of the equipment time for the dye 
sublimation color photo printer and the clinical labor activities that 
we refined to bring into accordance with pathology standards, we used 
the RUC-recommended values to develop proposed PE inputs for these 
codes and we believe that they provide the most accurate valuation for 
these services.
    Comment: Several commenters indicated that the pathology 
specialties inadvertently left an equipment item out of their 
recommendation, Flow Cytometry Analytics Software. The commenters 
stated that this software is typically used for both CPT codes 88184 
and 88185, and recommended adding 10 minutes of equipment time to CPT 
code 88184 along with 2 minutes of equipment time for CPT code 88185.
    Response: Equipment time for flow cytometry analytics software is 
not currently included in CPT codes 88184 and 88185, and equipment time 
for this software was not included in the RUC recommendation for these 
procedures. We believe that if there are new direct PE inputs for these 
procedures, the commenter should publicly nominate CPT codes 88184 and 
88185 for further review through the potentially misvalued code 
initiative.
    Comment: Multiple commenters disagreed with the CMS decision to 
refine the time for clinical labor task ``Other Clinical Activity: Load 
specimen into flow cytometer, run specimen, monitor data acquisition, 
and data modeling, and unload flow cytometer.'' The commenters 
requested adding 10 minutes to this clinical labor task for CPT code 
88184 and 2 minutes for CPT code 88185. This additional time would 
reflect the Cytotechnician's time spent using the Cytometry Analytics 
Software to analyze the data generated from the service on a designated 
desktop computer, w-monitor (ED021). The commenters also requested 
adding these additional minutes to the equipment time for the desktop 
computer.
    Response: We continue to believe that 7 minutes is the most 
accurate time for this clinical labor task for CPT code 88184 based on 
a comparison with CPT code 88182, which is another flow cytometry code 
in the same family where we included the recommended 7 minutes of time 
for the same clinical labor task. Since we do not believe that this 
clinical labor time would be typical, we also do not believe that an 
additional 10 minutes would be typical for use of the desktop computer 
with monitor. We continue to believe that the recommended 20 minutes of 
equipment time for the desktop computer with monitor, which is shared 
by CPT code

[[Page 70979]]

88182, is the most accurate value for CPT code 88184.
    Comment: Several commenters stated that the pathology specialties 
inadvertently miscalculated the amount of supply item ``antibody, flow 
cytometry'' (SL186) that are necessary for CPT codes 88184 and 88185. 
The commenters recommended a revised supply quantity of 1.6 for both 
codes instead of the quantity of 1 included in the RUC recommendation.
    Response: CPT codes 88184 and 88185 currently use 1 unit of supply 
SL186, and the recommendation for these procedures also indicated that 
1 unit of supply SL186 is typical. We continue to agree with the RUC 
recommendation that 1 unit of supply SL186 is the most accurate amount 
for these procedures. If the commenter believes that these codes are 
potentially misvalued, then we suggest the submission of a public 
comment following the publication of the CY2016 final rule with comment 
period to nominate CPT codes 88184 and 88185 as a potentially misvalued 
code that could facilitate development of new recommended values.
    Comment: A commenter explained that the equipment time for the dye 
sublimation color photo printer (ED031) is independent of clinical 
labor time. The commenter suggested that CMS should therefore accept 
the RUC recommendation of 5 minutes of equipment time for CPT code 
88184 and 2 minutes for CPT code 88185, instead of the CMS refinement 
of 1 minute chosen to reflect the clinical labor time assigned to 
printing in each procedure.
    Response: We appreciate the commenter bringing this issue to our 
attention. Although we agree with the general principle that equipment 
time for printers may not align with clinical labor time assigned to 
printing, we do not agree that 5 minutes of equipment time would be the 
most accurate value for the dye sublimation color photo printer 
assigned to CPT code 88184. However, we did notice that we 
inadvertently set the equipment time of this printer to 1 minute, when 
it should have been 2 minutes to align with the time for clinical labor 
task ``Print out histograms.'' After consideration of comments 
received, we are refining the equipment time of the dye sublimation 
color photo printer to 2 minutes for CPT code 88184, and maintaining an 
equipment time of 1 minute for the dye sublimation color photo printer 
for CPT code 88185.
    Comment: Several commenters disagreed with the CMS refinement to 
the time for clinical labor task ``Enter data into laboratory 
information system, multiparameter analyses and field data entry, 
complete quality assurance documentation.'' The commenters stated that 
entering this information takes additional time, that these are 
extremely important tasks that require technical skill, and assigning 
zero minutes to this clinical labor task is illogical for a service 
like flow cytometry.
    Response: We have not recognized the laboratory information system 
as an equipment item that can be allocated to an individual service. We 
continue to believe that this is a form of indirect PE, and therefore 
we do not recognize the laboratory information system as a direct PE 
input, as we do not believe this task is typically performed by 
clinical labor for each service.
    Comment: One commenter stated that CMS should accept the RUC 
recommendation of 5 minutes of clinical labor for ``Print out 
histograms, assemble materials with paperwork to pathologists, review 
histograms and gating with pathologists.'' The commenter stated that it 
is not reasonable to expect a cytotechnologist to print out histograms, 
assemble the documents and deliver them to a pathologist, and review 
the histograms with a pathologist, all in the span of 2 minutes. The 
commenter stated that a technologist would not be able to produce a 
high quality product and ensure its accuracy in the clinical labor time 
assigned to this task by CMS.
    Response: We believe that in order to maintain relativity, it is 
important to apply standards to ensure consistency in the time for the 
same clinical labor task among similar procedures. In refining the time 
for this clinical labor task, we examined procedures that included the 
same task, such CPT code 88182, which include 2 minutes for this task. 
Therefore, we continue to believe that 2 minutes is the appropriate 
value for this clinical labor task.
    Comment: A commenter requested that CMS maintain the current 
quantity of supply item ``lysing reagent'' (SL089). The commenter 
indicated that there are increased supply costs associated with the 
newer, more automated flow cytometers, such as additional costs for 
tandem conjugates and other fluorochromes. Although the commenter 
agreed that the new technology may require less lysing reagent 
supplies, they urged CMS to maintain the current supply quantity of 
SL089.
    Response: We believe that the increasing use of new technology 
reduces the need for the same quantity of lysing reagent used in the 
past for these procedures. Since the commenter did not provide a 
rationale for us to maintain the current quantity for supply item SL089 
relative to the actual use of that quantity in furnishing the service, 
we continue to agree that the RUC-recommended quantities of 5 ml for 
CPT code 88184 and 2 ml for CPT code 88185 are the most accurate 
amounts of lysing reagent typically required for these procedures.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT codes 88184 and 88185, with the 
additional refinements to equipment time discussed above.
i. Consultation on Referred Slides and Materials (CPT Codes 88321, 
88323, and 88325)
    We proposed to remove the time for clinical labor task ``Accession 
specimen/prepare for examination'' for CPT codes 88321 and 88325. These 
codes do not involve the preparation of slides, so this clinical labor 
task is duplicative with the labor carried out under ``Open shipping 
package, remove and sort slides based on outside number.'' We proposed 
to maintain the recommended 4 minutes for this clinical labor task for 
CPT code 88323, since it does require slide preparation.
    We proposed to refine the time for clinical labor task ``Register 
the patient in the information system, including all demographic and 
billing information'' from 13 minutes to 5 minutes for all three codes. 
As indicated in Table 6, our standard time for clinical labor task 
``entering patient data'' is 4 minutes for pathology codes, and we 
believe that the extra tasks involving label preparation described in 
this clinical labor task would typically require an additional 1 minute 
to complete. We also believe that the additional recommended time 
likely reflects administrative tasks that are appropriately accounted 
for in the allocation of indirect PE under our established methodology.
    We proposed to refine the time for clinical labor task ``Receive 
phone call from referring laboratory/facility with scheduled procedure 
to arrange special delivery of specimen procurement kit, including 
muscle biopsy clamp as needed. Review with sender instructions for 
preservation of specimen integrity and return arrangements. Contact 
courier and arrange delivery to referring laboratory/facility'' from 7 
minutes to 5 minutes. Based on the description of this task, we 
indicated that we believe that this task would typically take 5 minutes 
to be performed by the Lab Technician.
    We proposed to remove supply item ``eosin solution'' (SL063) from 
CPT code

[[Page 70980]]

88323. We do not agree that this supply would typically be used in this 
procedure, since the eosin solution is redundant when used together 
with supply item ``hematoxylin stain supply'' (SL135). We also refined 
the quantity of SL135 from 32 to 8 for CPT code 88323, to be consistent 
with its use in related procedures.
    We proposed to remove many of the inputs for clinical labor, 
supplies, and equipment for CPT code 88325. The descriptor for this 
code indicates that it does not involve slide preparation, and 
therefore we proposed to refine the labor, supplies, and equipment 
inputs to align with the inputs recommended for CPT code 88321, which 
also does not include the preparation of slides.
    Comment: One commenter disagreed with the CMS refinements and urged 
CMS to accept the RUC recommendations. The commenter stated that the 
clinical labor task ``Accession specimen/prepare for examination'' is 
actually far more time consuming for outside cases than accessioning 
inside cases, due to the need to individually identify and enter each 
slide and block. The commenter disagreed with the CMS proposal to 
remove this clinical labor time for CPT codes 88321 and 88325.
    Response: According to the code descriptors, there is no slide 
preparation taking place in CPT codes 88321 and 88325. These services 
consist of the consultation and review of specimens prepared by another 
practitioner. We continue to believe that accession of specimens would 
not be typical for these procedures, and we therefore maintain that 
time should not be allocated for this clinical labor task. In addition, 
any clinical labor required for preparation of the referred slides is 
already included in the descriptions for other clinical labor tasks 
included for these codes, such as:
     Register the patient in the information system, including 
all demographic and billing information. In addition to standard 
accessioning, enter contributing physician name and address, number of 
slides and the outside case number, etc., into the laboratory 
information system. Print labels for slides, and affix labels to 
slides.
     Print label for outside block and affix to block.
     List and label all accompanying material (imaging on a 
disk, portion of chart, etc.)
    Comment: The commenter also disagreed with the CMS refinement to 
the time for clinical labor task ``Register the patient in the 
information system, including all demographic and billing 
information.'' The commenter stated that these tasks are performed in 
addition to accessioning the specimen and preparing for examination.
    Response: We continue to believe that the typical time for the 
clinical labor task ``accession of specimen'' is 4 minutes, based on 
comparison to other pathology services. We refined the time for this 
clinical labor task to 5 minutes based on our belief that the 
additional tasks involving label preparation would typically take 1 
minute. We also continue to believe that the additional recommended 
time for CPT codes 88321, 88323, and 88325 likely reflects 
administrative tasks that are appropriately accounted for in the 
indirect PE methodology.
    Comment: A commenter disagreed with the proposal to remove the time 
for clinical labor tasks ``Assemble and deliver slides with paperwork 
to pathologists'' and ``Clean equipment while performing service'' for 
CPT code 88323. The commenter stated that the assembling of slides in 
this task was a separate task from the clinical labor associated with 
preparation of materials associated with the non-frozen section 
processing of the specimen. The commenter also stated that for the 
typical laboratory setting, specific equipment must be cleaned and 
maintained immediately after use.
    Response: We continue to believe that these are duplicative 
clinical labor activities. CPT code 88323 already includes time for 
clinical labor task ``Complete workload recording logs. Collate slides 
and paperwork. Deliver to pathologist'' and ``Clean room/equipment 
following procedure.'' We do not believe that there it would be typical 
to assemble slides or clean the room twice.
    Comment: The commenter disagreed with the removal of the eosin 
solution (SL063) from CPT code 88323. The commenter stated that the 
eosin solution would be used for the hematoxylin stain (SL135), and 
elimination of this supply item would likely compromise patient care. 
The commenter also indicated that 32 ml of the hematoxylin stain is 
typical for these services in the typical laboratory setting.
    Response: We appreciate the additional information regarding this 
supply and its importance for staining in this procedure. After 
consideration of comments received, we believe that this is the most 
accurate type of eosin supply for use in this type of slide staining 
because it is most similar to the eosin supply previously used in CPT 
code 88323. Therefore, we are replacing supply SL063 with supply SL201 
(stain, eosin) and restoring a quantity of 8 ml for CPT code 88323. We 
are also refining our proposed quantity of 8 ml of the hematoxylin 
stain to 16 ml for CPT code 88323. The current supply inputs for CPT 
code 88323 have twice the amount of hematoxylin stain compared to 
eosin, 4.8 compared to 2.4, and we are maintaining the same 2:1 ratio.
    Comment: The commenter disagreed with the removal of time for many 
clinical labor tasks in CPT code 88325, such as ``Dispose of remaining 
specimens'', ``Prepare, pack and transport specimens and records for 
in-house storage and external storage'', and several other activities 
related to slide preparation. The commenter objected to the 
standardization of clinical labor tasks across differing pathology 
codes, and stated that these are necessary and integral tasks for this 
service that cannot be eliminated without compromising standards of 
care.
    Response: As the code descriptor indicates for CPT code 88325, we 
continue to believe that there is no slide preparation taking place in 
this procedure. Therefore, we do not believe that clinical labor tasks 
related to the preparation of slides or the disposal of hazardous waste 
materials would typically be performed.
    Comment: The commenter also disagreed with the CMS decision to 
remove supplies and equipment unassociated with slide preparation from 
CPT code 88325. The commenter wrote to indicate that when hematoxylin 
and eosin (H&E) slides are prepared from referred blocks, all technical 
services are performed. The commenter urged that the recommended 
supplies and equipment be restored to CPT code 88325.
    Response: We do not agree that referred materials require the same 
clinical labor, supplies, and equipment as materials prepared locally. 
The vignette for CPT code 88325 states that the pathologist performing 
the service is receiving prepared slides from another laboratory; 
therefore, we do not believe that the use of these supplies and 
equipment associated with slide preparation would be typical for the 
second pathologist performing this consultation.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT Codes 88321, 88323, and 88325, 
with the additional refinement to the eosin stain and hematoxylin stain 
supplies discussed above in CPT code 88323.

[[Page 70981]]

j. Pathology Consultation During Surgery (CPT Codes 88329, 88331, 
88332, 88333, and 88334)
    We refined many of the clinical labor activities in these 
procedures to align with the typical times included in recently 
reviewed pathology codes, in particular the clinical labor times for 
CPT code 88305. We also removed supply item ``H&E stain kit supply'' 
(SL231) and replaced it with supply item ``H&E frozen section stain 
supply'' (SL134) and refined the quantity of the microscope slides 
(SL122) for CPT codes 88333 and 88334.
    Comment: A commenter disagreed with the CMS refinement of these 
clinical labor activities. The commenter stated that clinical labor 
times should not be standardized for pathology services, and that 
although standards may be used as a starting point, the work for 
pathology codes varies depending on the pathology task that is being 
done.
    Response: We refer the reader to our earlier discussion about 
clinical labor standards for pathology codes. We continue to believe 
that clinical labor tasks with the same description are comparable 
across different pathology CPT codes. For these pathology consultation 
codes, we have refined the clinical labor times to bring them into 
accordance with other similar codes, in particular CPT code 88305. For 
example, we do not believe that the time for clinical labor task 
``Assist pathologist with gross specimen examination'' for a 
consultation procedure (as in CPT code 88331) should require more 
clinical labor time than the identical clinical labor task in a tissue 
biopsy procedure (as in CPT code 88305).
    Comment: The same commenter stated that 3 minutes of time for 
clinical labor task ``Clean room/equipment following procedure'' is the 
standard for surgical procedures, and the same clinical labor time 
should be applied to pathology procedures.
    Response: We do not believe that clinical labor times for surgical 
procedures are typically applicable to pathology procedures. We believe 
that it is more accurate to compare clinical labor times for pathology 
procedures to other pathology procedures that utilize the same clinical 
labor tasks. In the case of the clinical labor for ``Clean room/
equipment following procedure'', we continue to believe that 1 minute 
is the standard time for these services, based on a comparison to other 
recently reviewed pathology codes.
    Comment: The commenter stated that the H&E stain supply kit removed 
by CMS is needed to perform the procedure for CPT codes 88331 and 
88332, as the kit is needed to prepare the slides (that is, xylene, 
alcohol, bluing agent, etc). The commenter also stated that the 
preamble text in the CY 2016 PFS proposed rule did not state anything 
specific about this substitution, and that CMS must supply a better 
rational for this proposed change.
    Response: We appreciate the opportunity to clarify our position 
regarding the replacement of the H&E stain supply kit with an H&E 
frozen section stain. We noticed that these procedures had previously 
been performed using 1 H&E frozen section stain, which was removed by 
the RUC in favor of a quantity of 0.1 of supply item ``H&E stain supply 
kit''. Because the RUC recommendation did not explain why the use of an 
H&E stain supply kit would be typical, we believed that it would be 
more accurate to maintain the quantity of 1 for supply item ``H&E 
frozen section stain'' as is currently included in these codes. We 
believe that this maintains relativity with other codes in the family, 
and maintains consistency with other related pathology procedures.
    Comment: A different commenter disagreed with the CMS decision to 
remove the time for clinical labor task ``Prepare room. Filter and 
replenish stains and supplies.'' The commenter stated that this 
dedicated room must be prepared for the next immediate consultation 
after each service; stains must be filtered and changed, while 
cryostats and chucks must be cleaned. The commenter requested the 
restoration of the RUC recommended clinical labor time.
    Response: We continue to believe that the preparation in this 
clinical labor task is duplicative with the clinical labor assigned for 
``Clean room/equipment following procedure.'' We also continue to 
believe that the labor involved in replenishing stains and supplies is 
not allocated to an individual service, and therefore comprises an 
indirect PE.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT Codes 88329, 88331, 88332, 88333, 
and 88334.
k. Morphometric Analysis (CPT Code 88355)
    We refined many of the clinical labor activities in these 
procedures to align with the standard times used by other recently 
reviewed pathology codes, in particular the clinical labor times for 
CPT code 88305. We also removed the equipment time for the ultradeep 
freezer (EP046), as we believe that items used for storage such as 
freezers are more accurately classified as indirect PE.
    Comment: One commenter disagreed with the CMS removal of the 
equipment time for the ultradeep freezer. The commenter stated that the 
use of the ultradeep freezer is specific to CPT code 88355. While other 
specimens may be stored in the same freezer, freezer space is 
unavailable for other specimens or items during storage. Freezer space 
is therefore a variable direct expense dependent upon patient specimen 
caseloads, and should be considered a direct expense for pathology 
services.
    Response: As we stated in the CY 2016 PFS proposed rule (80FR 
41699), we do not believe that minutes should be allocated to items 
such as freezers since the storage of any particular specimen in a 
freezer for any given length of time would be unlikely to make the 
freezer unavailable for storing other specimens. We continue to believe 
that the ultradeep freezer is most accurately classified as an indirect 
PE since freezers can be used for many specimens at once. We refer 
readers to our discussion of direct PE inputs earlier in this section.
    Comment: The same commenter objected to the CMS refinements to 
standard pathology times for clinical labor tasks ``Assemble and 
deliver slides with paperwork to pathologist'', ``Clean room/equipment 
following procedure,'' and ``Receive phone call from referring 
laboratory/facility with scheduled procedure to arrange special 
delivery of specimen procurement kit.'' The commenter indicated their 
disagreement with these refinements and the standardization of 
pathology clinical labor tasks more generally, as the time for these 
tasks varies for each unique service.
    Response: We refer the reader to our earlier discussion about 
clinical labor standards for pathology codes. We continue to believe 
that clinical labor tasks with the same description are comparable 
across different pathology CPT codes. For this morphometric analysis of 
the skeletal muscle procedure, we have refined the clinical labor times 
to bring them into accordance with other similar procedures.
    Comment: The commenter disagreed with the CMS refinement to the 
time for clinical labor task ``Prepare specimen containers/preload 
fixative/label containers/distribute requisition form(s) to 
physician.'' The commenter explained that nerves and muscle typically 
arrive in the laboratory on saline soaked gauze held in a clamp, and 
the tissue requires specialized knowledge to further prepare and

[[Page 70982]]

process it. The commenter stressed that the specimen preparation for 
these services is vastly different than for routine surgical pathology 
specimens where large numbers of specimen containers are prepared at 
one time, and therefore the typical batch size for this type of 
specimen would be one, necessitating the increased time.
    Response: We appreciate the additional description of the clinical 
labor tasks taking place in CPT code 88355 provided by the commenter. 
Based on this presentation of further clinical information and after 
consideration of comments, we believe that additional time for clinical 
labor task ``Prepare specimen containers/preload fixative/label 
containers/distribute requisition form(s) to physician.'' is 
appropriate. We note that the original RUC recommendation included 9 
minutes for this clinical labor task. However, this clinical labor task 
is related to clinical labor task ``Accession specimen/prepare for 
examination''. To avoid duplicative preparation labor, we have assigned 
an additional 4.5 minutes relative to our proposal, for a total of 5 
minutes, of time for clinical labor task ``Prepare specimen containers/
preload fixative/label containers/distribute requisition form(s) to 
physician'' for CPT code 88355.
    Comment: The commenter requested that CMS adopt the RUC-recommended 
time of 4 minutes for clinical labor task for ``Prepare, pack and 
transport specimens and records for storage.'' The commenter explained 
that these specimens are quite unique and require special care and 
handling and the time allocated to this task is typically longer than 
other pathology specimens.
    Response: We appreciate the commenter submission of additional 
information regarding this clinical labor task. After consideration of 
comments received, we believe that it would be more accurate to 
increase the time for this clinical labor task to 3 minutes for CPT 
code 88355, to reflect the additional preparation taking place over the 
typical storage of specimens in other pathology procedures.
    Comment: The commenter disagreed with the CMS decision to remove 
the recommended time for clinical labor task ``Prepare specimen for -70 
degree storage.'' The commenter stated that this task was not on the 
table of standard times for clinical labor tasks associated with 
pathology services included in the CY 2016 PFS proposed rule, and this 
specimen preparation task is unique to CPT code 88355.
    Response: We believe that the resource costs associated with 
storage preparation are accurately accounted for under the minutes 
assigned to the clinical labor tasks ``Prepare, pack and transport 
specimens and records for storage'' for CPT code 88355. We believe that 
the clinical labor associated with preparation for -70 degree storage 
would be duplicative of this clinical labor task. We have also added 
additional time for clinical labor task ``slide storage preparation'' 
under the clinical labor task ``Prepare, pack and transport specimens 
and records for storage'' to reflect the extra storage requirements of 
this procedure.
    Comment: The commenter also disagreed with the CMS decision to 
refine the time for clinical labor task ``Assist pathologist with gross 
examination.'' The commenter wrote that specialty knowledge is required 
to further process the tissue. The tag of nerve or muscle outside the 
clamp must be carefully trimmed by hand with the trimmings going to 
formalin containers. Clinical labor staff is needed to collaborate with 
the pathologist often to prepare the specimen and process the specimen. 
Tissue must be examined and, if too thick, must be further trimmed to 
allow penetration by glutaraldehyde. The properly trimmed, clamped 
tissue can then be transferred to a glutaraldehyde container, which is 
then transferred to a refrigerator for at least 24 hours when it can 
then be processed with further consultation with the pathologist.
    Response: We appreciate the submission of additional clinical 
information regarding the clinical labor utilized in the performance of 
CPT code 88355. However, we do not agree that all of this labor would 
take place during the ``Assist pathologist with gross examination'' 
task. We believe that the information provided by the commenter 
describes several other steps in the procedure, such as ``Measure 
specimen and fix on muscle/nerve clamp'' and ``Process specimen for 
slide preparation'', each task having its own respective clinical labor 
time. In order to avoid the potential for duplicative clinical labor, 
we are maintaining the CMS refinement to 3 minutes for clinical labor 
task for ``Assist pathologist with gross examination'' for CPT code 
88355.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT code 88355, with the additional 
clinical labor refinements discussed above.
l. Morphometric Analysis, Tumor Immunohistochemistry (CPT Codes 88360 
and 88361)
    We refined many of the clinical labor activities in these 
procedures to align with the typical times included in recently 
reviewed pathology codes. We also proposed to update the pricing for 
the Benchmark ULTRA automated slide preparation system (EP112) and the 
E-Bar II Barcode Slide Label System (EP113). Based on stakeholder 
submission of information subsequent to the original RUC 
recommendation, we proposed to reclassify these two pieces of equipment 
as a single item with a price of $150,000, which will use equipment 
code EP112. CPT codes 88360 and 88361 have been valued using this new 
price. The equipment minutes remain unchanged.
    The RUC recommendation for CPT codes 88360 and 88361 included an 
invoice for supply item ``Antibody Estrogen Receptor monoclonal'' 
(SL493). The submitted invoice had a price of $694.70 per box of 50, or 
$13.89 per test. We sought publicly available information regarding 
this supply and identified numerous monoclonal antibody estrogen 
receptors that appear to be consistent with those recommended by the 
specialty society, at publicly available lower prices, which we believe 
are more likely to be typical since we assume that the practitioner 
would seek the best price available to the public. One example is 
Estrogen Receptor Antibody (h-151) [DyLight 405], priced at 100 tests 
per box for $319. Therefore, we proposed to establish a new supply code 
for ``Antibody Estrogen Receptor monoclonal'' and price that item at 
$3.19 each. We welcomed comments from stakeholders regarding this 
supply item.
    Comment: Several commenters disagreed with the CMS refinements to 
the time for clinical labor task ``Enter patient data, computational 
prep for antibody testing, generate and apply bar codes to slides, and 
enter data for automated slide stainer'', ``Verify results and complete 
work load recording logs'', and ``Recycle xylene from tissue processor 
and stainer.'' The commenters stated that entering patient data 
requires far longer than the 1 minute proposed by CMS, and that 
removing the time for clinical labor tasks related to verifying results 
and recycling xylene could result in laboratory disaccreditation or 
errors that are harmful to patients.
    Response: We refer the reader to our earlier discussion about 
clinical labor standards for pathology codes. We continue to believe 
that clinical labor

[[Page 70983]]

tasks with the same description are comparable across different 
pathology CPT codes. We continue to believe it is most accurate to 
allocate zero minutes of time for the task ``Verify results and 
complete work load recording logs'', and ``Recycle xylene from tissue 
processor and stainer'', as we believe that these are indirect PE tasks 
not allocated to any individual service.
    Comment: One commenter provided a list of eight additional clinical 
labor activities for CPT code 88360 and one additional clinical labor 
task for CPT code 88361. The commenter suggested that CMS should 
consider adding these tasks, which were not included in the RUC 
recommendations, into its labor estimates for the two procedures.
    Response: We appreciate the suggestion from the commenter of 
additional tasks that can aid in the performance of IHC special stains. 
We believe that the tasks associated with furnishing particular PFS 
services could be described and categorized in various ways. We believe 
that particular tasks should be considered in the context of 
comprehensive review that allows for an assessment of overall number of 
minutes involved in furnishing the service. If the commenter examines 
the list of clinical labor tasks used by the RUC to develop 
recommendations for these services and finds that many tasks are 
missing, then we believe that the commenter may want to consider 
submitting the codes through the public nomination process of the 
misvalued code initiative to improve the accuracy of the valuations.
    Comment: Another commenter disagreed with CMS' refinement to the 
equipment time of the compound microscope (EP024). The commenter stated 
that this refinement was not discussed in the preamble text, and that 
the time involves 35 minutes of work time plus 1 minute of clinical 
labor time, as described in the RUC recommendation. The commenter asked 
for CMS to accept the RUC recommended equipment time of 36 minutes.
    Response: We note that we did not fully explain our rationale for 
the refinement of equipment time for the compound microscope equipment 
time. We observed that the description of the intraservice work for the 
physician includes many tasks that do not use the microscope. As a 
result, we do not believe that use of the compound microscope would be 
typical for the entire intraservice period. We continue to believe that 
the most accurate equipment time for the compound microscope is 25 
minutes: 24 Minutes for the work time (66 percent of 35 minutes) plus 1 
minute for the technician.
    Comment: Many commenters disagreed with the CMS proposal to price 
supply item ``monoclonal antibody estrogen receptor'' (SL493) at $3.19. 
Commenters stated that this was substantially lower than the submitted 
invoice of $13.89; CMS instead referenced the Estrogen Receptor 
Antibody (h-151) [DyLight 405] for its price of $3.19. Commenters 
stated that this supply is for research use only, and that it is not 
approved for use in humans or in clinical diagnosis. According to the 
commenters, this item is not an alternate reagent for CPT codes 88360 
and 88361, and would not be used for these services.
    Response: We appreciate all of the additional information provided 
by the commenter. The only pricing information that we received for 
SL493 was an invoice that included a hand-written price over redacted 
information. We were unable to verify the accuracy of this invoice. In 
order to price SL493 appropriately, we believe that we need additional 
information. We will use the publicly available price of $3.19 as a 
proxy value pending the submission of additional pricing information. 
We welcome the submission of updated pricing information regarding 
SL493 through valid invoices from commenters and other stakeholders.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT Codes 88360 and 88361.
m. Nerve Teasing Preparations (CPT Code 88362)
    We proposed to refine the recommended time for clinical labor task 
``Assist pathologist with gross specimen examination including the 
following; Selection of fresh unfixed tissue sample; selection of 
tissue for formulant fixation for paraffin blocking and epon blocking. 
Reserve some specimen for additional analysis'' from 10 minutes to 5 
minutes. We noted that the 5 minutes includes 3 minutes for assisting 
the pathologist with the gross specimen examination (as listed in Table 
6 of the proposed rule (80 FR 41698) and an additional 2 minutes for 
the additional tasks due to the work taking place on a fresh specimen.
    Comment: Several commenters disagreed with the CMS decision to 
refine the time for clinical labor task ``Assist pathologist with gross 
specimen examination'' from 10 minutes to 5 minutes. The commenters 
stated that the pathologist must work together with clinical labor 
staff during the gross specimen work, and the clinical labor could not 
be performed in 5 minutes due to the number of specimens involved.
    Response: We continue to believe that the 5 minutes for this 
clinical labor task included 3 minutes for assisting the pathologist 
with the gross specimen examination and an additional 2 minutes for the 
additional tasks due to the work taking place on a fresh specimen. We 
also continue to believe that this is the most accurate value for this 
clinical labor task in the absence of additional data supporting an 
increase in the time for this clinical labor task.
    Comment: These commenters also expressed their disagreement with 
the CMS removal of the recommended time for clinical labor task 
``Consult with pathologist regarding representation needed, block 
selection and appropriate technique.'' Commenters stated that clinical 
labor staff must collaborate with the pathologist in the preservice 
time, and the unique technical protocols required for nerve teasing 
pathology services requires the clinical labor staff to have a complete 
understanding of what is necessary for each individual specimen case. 
Commenters emphasized that nerve teasing pathology services cannot be 
batched as they are complex, low volume unusual studies requiring 
special handling, preparation, and storage.
    Response: We continue to believe that the clinical labor described 
in this clinical labor task constitutes basic knowledge for a 
practicing Histotechnologist. We noted that this clinical labor task 
appears to be unique to CPT code 88362, and does not appear in other 
pathology services. We do not believe it maintains relativity to 
include increasingly specialized clinical labor tasks that are not 
included in similar procedures. We also do not believe that it would be 
typical for the Histotechnologist to require this kind of extensive 
consultation with the pathologist before performing each individual 
procedure, since the technician would have prior knowledge of what he 
or she will be doing.
    Comment: One commenter disagreed with the CMS refinements to 
clinical labor tasks associated with slide preparation. For the 
clinical labor tasks ``Assemble and deliver cedar mounted slides with 
paperwork to pathologists'', ``Assemble other light microscopy slides, 
epon nerve biopsy slides, and clinical history, and present to 
pathologist to prepare clinical pathologic interpretation'', and 
``Dispose of remaining specimens, spent chemicals/other consumables, 
and hazardous waste'', the commenter indicated that there are less 
batch size

[[Page 70984]]

efficiencies with these specimens compared to other typical surgical 
pathology services, and the recommendation for extra clinical labor 
time reflected the need for careful handling of materials.
    Response: We refer the reader to our earlier discussion about 
clinical labor standards for pathology codes. We continue to believe 
that clinical labor tasks with the same description are comparable 
across different pathology CPT codes. The proposed refinement to 0.5 
minutes for these clinical labor tasks reflects the time typically 
included for slide preparation established across many different 
pathology procedures.
    Comment: The same commenter disagreed with the CMS refinement to 
the time for clinical labor tasks ``Preparation: labeling of blocks and 
containers and document location and processor used'' and ``Accession 
specimen and prepare for examination.'' The commenter stated that 
although they agreed with the reduction in time, they disagreed with 
the refinement rationale and the standardization of pathology clinical 
labor tasks, as the time for each task varies for each CPT code.
    Response: We appreciate that the commenter's support for our 
proposal to reduce the clinical labor for these activities. We continue 
to believe that clinical labor tasks with the same description are 
comparable across different pathology CPT codes assuming similar batch 
sizes, and we appreciate further comments as we work to establish 
clinical labor standards across pathology services.
    Comment: The commenter did not agree with the CMS refinement to the 
time for clinical labor task ``Prepare specimen containers preload 
fixative label containers distribute requisition form(s) to 
physician.'' The commenter explained that nerves and muscle typically 
arrive in the laboratory on saline soaked gauze for this procedure. 
Specialty knowledge is required to further prepare and process the 
tissue, and as a result the specimen preparation for CPT code 88362 is 
different from routine surgical pathology specimens where large numbers 
of specimen containers are prepared at one time. The commenter stated 
that the typical batch size for this type of specimen would be one, 
which necessitates the increased time.
    Response: We appreciate the additional description of the clinical 
labor taking place in CPT code 88362 provided by the commenter. Based 
on this presentation of further clinical information, and in order to 
maintain consistency with our refinements to CPT code 88355, we believe 
that additional clinical labor time is appropriate. Since this is the 
same clinical labor task taking place in CPT code 88355, we will also 
assign 5 minutes for ``Prepare specimen containers/preload fixative/
label containers/distribute requisition form(s) to physician'' for CPT 
code 88362 using the same rationale as described for 88355.
    Comment: The commenter also disagreed with the CMS refinements to 
the time for clinical labor task ``Prepare, pack and transport 
specimens and records for in-house storage and external storage'' and 
``Prepare, pack and transport cedar oiled glass slides and records for 
in-house special storage.'' The commenter stressed that the specimens 
used in these labor tasks were unique to CPT code 88362, and therefore 
they cannot be standardized as part of a wider set of clinical labor 
activities for the field of pathology. However, the commenter did agree 
that the clinical labor task ``Prepare, pack and transport specimens 
and records for in-house storage and external storage'' would typically 
take 1 minute, although the typical time in the commenter's specialized 
laboratory would be higher.
    Response: We appreciate the commenter's support for our proposal to 
refine the time for clinical labor task ``Prepare, pack and transport 
specimens and records for in-house storage and external storage''. We 
continue to believe that this and other pathology clinical labor tasks 
more generally, can be standardized across different services. We do 
not believe that there should be time allocated for clinical labor task 
``Prepare, pack and transport cedar oiled glass slides and records for 
in-house special storage'' for this procedure, since there is already 
time for clinical labor tasks related to preparing, packing, and 
transportation of materials.
    Comment: The commenter also did not agree with the CMS removal of 
the recommended time for clinical labor task ``Storage remaining 
specimen. (Osmicated nerve strands, potential for additional teased 
specimens).'' The commenter stated that this clinical labor task was 
not listed anywhere in the proposed rule to explain why CMS believes 
this is a standard clinical labor task. This storage clinical labor 
task is unique to CPT code 88362 and its removal could potentially 
compromise patient care.
    Response: We appreciate this opportunity to clarify our rationale 
regarding the refinement to this clinical labor task. We believe that 
the clinical labor described in this clinical labor task is duplicative 
of the clinical labor described in the task ``Prepare, pack and 
transport specimens and records for in-house storage and external 
storage.'' We do not believe that the use of three different clinical 
labor activities for storage of specimens would be typical for CPT code 
88362.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT code 88362, with the additional 
clinical labor refinements discussed above.
n. Nasopharyngoscopy With Endoscope (CPT Code 92511)
    We proposed to remove the endosheath (SD070) from this procedure, 
because we indicated that we do not believe it would be typically used 
and it was not included in the recommendations for any of the other 
related codes in the same tab. If the endosheath were included as a 
supply with the presentation of additional clinical information, then 
we stated we believed it would be appropriate to remove all of the 
clinical labor and equipment time currently assigned to cleaning the 
scope. We sought public comment regarding the proper use of the 
endosheath supply and the clinical labor associated with scope 
cleaning.
    Comment: Several commenters agreed that the endosheath is not 
typically used for CPT code 92511 and was inadvertently included from 
past direct PE inputs for the service. The commenters stated that after 
removing the endosheath, it was appropriate to retain all the clinical 
labor and equipment time assigned to cleaning the scope. In addition, 
in order to clean the equipment and to be consistent with other codes 
in the family, commenters requested adding four supplies to the code 
associated with scope cleaning, which were excluded previously because 
the endosheath was retained.
    Response: We appreciate the additional clarification from the 
commenters regarding the use of supply item ``endosheath'' for this 
procedure. After consideration of comments received, we agree that it 
is appropriate to retain the clinical labor and equipment time assigned 
to cleaning the scope, as well as include the additional requested 
cleaning supplies. Based on this additional information, we are 
refining the direct PE inputs to include the following supply items: 2 
Endoscope cleaning brushes (SM010), 4 oz. of enzymatic detergent 
(SM015), 4 oz. of glutaraldehyde 3.4% (SM018), and 1 glutaraldehyde 
test strip (SM019).
    Comment: One commenter disagreed with the CMS decision to remove 
the recommended surgical masks,

[[Page 70985]]

impervious staff gowns, and non-sterile drape sheet from the procedure. 
The commenter stated that these supplies were necessary, with one mask 
and gown needed for the physician and one mask and gown needed for the 
staff, since the procedure produces a lot of secretion transmission. 
Therefore, these were not duplicative supplies.
    Response: We appreciate the additional clarification regarding the 
use of these supplies. After consideration of comments received, we are 
restoring these supplies and adding 2 surgical masks (SB033), 2 
impervious staff gowns (SB027), and 1 non-sterile sheet drape (SB006) 
to CPT code 92511 in the non-facility setting.
    After consideration of comments received, we are finalizing the 
direct PE inputs for CPT code 92511, with the additional supply 
refinements described above.
o. EEG Extended Monitoring (CPT Codes 95812 and 95813)
    We refined several of the clinical labor times for CPT codes 95812 
and 95813 to align them with our proposed standards, including refining 
the time for clinical labor task ``Assist physician in performing 
procedure'' to align with the intraservice time of each procedure. We 
also removed the service period time for clinical labor task ``Provide 
pre-service education/obtain consent'' to avoid duplicative clinical 
labor with the same task in the preservice period, and refined several 
of the equipment times to align with the standard equipment times for 
non-highly technical equipment.
    Comment: Some commenters did not agree with the CMS refinement of 
the time for clinical labor task ``Assist physician in performing 
procedure.'' The commenters stated that the practitioner reads the 
patient record subsequently without the technologist present, and that 
the intraservice work time is not temporally equivalent with the tech's 
assist physician clinical labor time. The line ``Assist physician in 
performing procedure'' was used as a surrogate data entry line for 
where to place the technologist's service in performing the testing, 
and it was not meant to be taken literally. The commenter therefore 
requested that CMS adopt the RUC-recommended time for both procedures.
    Response: The RUC recommendation for these procedures explicitly 
stated that CPT code 95812 requires 50 minutes of time for clinical 
labor task ``EEG recording'', and CPT code 95813 requires 80 minutes of 
clinical labor time for the same clinical labor task. We do not believe 
that existing clinical labor tasks should be used as data entry 
surrogates for other tasks, and we do not believe that clinical labor 
time should be allocated to tasks that are not described in the 
submitted recommendations. We continue to believe that this represents 
the clinical labor time which would be spent assisting the physician in 
performing the procedure.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT codes 95812 and 95813.
p. Testing of Autonomic Nervous System Function (CPT Code 95923)
    We proposed to reduce the quantity of supply item ``iontophoresis 
electrode kit'' (SA014) from 4 to 3. According to the description of 
this code, the procedure typically uses 2-4 electrodes, and we 
indicated that we therefore believe that a supply quantity of 3 would 
better reflect the typical case. We requested further information 
regarding the typical number of electrodes used in this procedure; if 
the maximum of 4 electrodes is in fact typical for the procedure, then 
we recommended that the code descriptor be referred to CPT for further 
clarification.
    Comment: Several commenters pointed out that CMS incorrectly 
labeled this section of the CY 2016 PFS proposed rule under the heading 
of ``Needle Electromyography'' with associated CPT codes 95863, 95864, 
95869, and 95870. Commenters inferred that CMS intended to reference 
CPT code 95923 instead of the needle electromyography procedures.
    Response: The commenters are correct, and we agree that we included 
the wrong heading for this part of the CY 2016 PFS proposed rule (80 FR 
41781). We apologize for any confusion caused by this error.
    Comment: The commenters also explained that the use of 4 
iontophoresis electrode kits would be typical for CPT code 95923. 
According to the commenters, several experts in the field of autonomic 
testing confirmed that when providing this service they always, without 
exception, used at least 4 sites of iontophoresis: forearm, proximal 
leg, distal leg, and foot. The commenters therefore maintained that 4 
units of the iontophoresis electrode kit would be the appropriate 
quantity.
    Response: We appreciate the submission of this additional clinical 
information regarding the use of the iontophoresis electrodes. After 
consideration of comments received, we are increasing the quantity of 
the iontophoresis electrode kit (SA014) to 4 for CPT code 95923 in line 
with the recommended value.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT Code 95923, with the additional 
refinement to SA014 discussed above.
q. Central Motor Evoked Study (CPT Codes 95928 and 95929)
    We refined portions of the clinical labor time for CPT codes 95928 
and 95929 as duplicative with other tasks, and refined the time for 
clinical labor task ``Assist physician in performing procedure'' to 
align with the intraservice work duration. We also removed a minimum 
multi-specialty visit pack (SA048) from CPT code 95928 due to the fact 
that it is typically billed with a same-day E/M service, and we refined 
some of the equipment times for both procedures to conform to the 
standard equipment formulas.
    Comment: One commenter disagreed with the CMS decision to refine 
the time for clinical labor task ``Assist physician in performing 
procedure'' to align with the intraservice work time. This commenter 
stated that the technologist sets up the service without the physician 
present, after which the physician enters the room for the main portion 
of the testing. Afterwards, the physician leaves the room and the 
technologist completes the last portion of the procedure without the 
physician present. The commenter indicated that the time for clinical 
labor task ``Assist physician in performing procedure'' and the 
physician intraservice work time were not temporally equivalent, and 
that this clinical labor task was only used as a surrogate data entry 
line for where to place the technologist's service in performing the 
testing, not meant to be taken literally.
    Response: The RUC recommendation for CPT codes 95928 and 95929 
states that the technologist will ``Assist physician in conducting the 
test.'' As a result, we do not believe that the clinical labor assigned 
to ``Assist physician in performing procedure'' was merely a surrogate 
data entry line that was not meant to be taken literally. We do not 
agree that existing clinical labor tasks should be used as data entry 
surrogates for other tasks, and we do not believe that clinical labor 
time should be allocated to tasks that are not described in the 
submitted recommendations. We continue to believe that this clinical 
labor task should align with the intraservice work time, and we are 
maintaining durations of 40 minutes for CPT code 95928 and 95929.

[[Page 70986]]

    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT codes 95928 and 95929.
r. Blink Reflex Test (CPT Code 95933)
    We added 2 minutes of time for clinical labor task ``Prepare room, 
equipment, supplies'' to CPT code 95933 and refined the time for 
clinical labor task ``Clean room/equipment by physician staff'' to 3 
minutes, in both cases conforming to the established standards for 
these clinical labor tasks.
    Comment: One commenter indicated that the CY 2016 PFS proposed rule 
summary showed a net reduction in PE relative value units for CPT code 
95933, from a 2015 PE RVU of 1.75 to a proposed 2016 PE RVU of 1.50. 
The commenter disagreed with this reduction and stated that they were 
unable identify the source for the proposed reductions.
    Response: To clarify the proposed change in PE for CPT code 95933, 
we note that we believe this reduction is due to two changes in the 
recommended values. We accepted the RUC recommendation to reduce the 
time for clinical labor task ``Assist physician in cleaning area, 
relaxing patient. Take notes from physician'' from 30 minutes to 25 
minutes. We also accepted the RUC recommendation to reduce the quantity 
of supply item ``electrode skin prep gel (NuPrep)'' (SJ022) from 100 ml 
to 10 ml. These two reductions likely account for the reduction in PE 
RVUs.
    After consideration of comments received, we are finalizing the 
direct PE inputs as proposed for CPT code 95933.
8. CY 2015 Interim Final Codes
    In this section, we discuss each code for which we received a 
comment on the CY 2015 interim final work RVU or work time during the 
comment period for the CY 2015 final rule or for which we are modifying 
the CY 2015 interim final work RVU, work time or procedure status 
indicator for CY 2016. If a code in Table 15 is not discussed in this 
section, we did not receive any comments on that code or received only 
comment(s) in support of the CY 2015 interim final status; for those, 
we are finalizing the interim final work RVU and time without 
modification for CY 2016.
    A comprehensive list of all interim final values for which public 
comments were sought in the comment period for the CY 2015 PFS final 
rule is contained in Addendum C to the CY 2015 PFS final rule with 
comment period. We note that the values for some codes with interim 
final values were addressed in the CY 2016 PFS proposed rule (see: 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html), and therefore, are addressed in section 
II.H. of this final rule with comment period. A comprehensive list of 
all CY 2016 RVUs is in Addendum B. All Addenda to the PFS final rule 
with comment period are available on the CMS Web site under downloads 
at http://www.cms.gov/physicianfeesched/PFSFederalRegulationNotices.html/. The time values and direct PE inputs 
for all codes are listed files called ``CY 2016 PFS Work Time,'' and 
``CY 2016 Direct PE Inputs,'' available on the CMS Web site under 
downloads for the CY 2016 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.

                       Table 13--CY 2016 Actions on Codes With CY 2015 Interim Final RVUs
----------------------------------------------------------------------------------------------------------------
                                                           CY 2015 interim    CY 2016 work
          HCPCS code                 Long descriptor        final work RVU        RVU           CY 2016 action
----------------------------------------------------------------------------------------------------------------
11980........................  Subcutaneous hormone                  1.10             1.10   Finalize.
                                pellet implantation
                                (implantation of
                                estradiol and/or
                                testosterone pellets
                                beneath the skin).
20604........................  Arthrocentesis, aspiration            0.89             0.89   Finalize.
                                and/or injection, small
                                joint or bursa (e.g.,
                                fingers, toes); with
                                ultrasound guidance, with
                                permanent recording and
                                reporting.
20606........................  Arthrocentesis, aspiration            1.00             1.00   Finalize.
                                and/or injection,
                                intermediate joint or
                                bursa (e.g.,
                                temporomandibular,
                                acromioclavicular, wrist,
                                elbow or ankle, olecranon
                                bursa); with ultrasound
                                guidance, with permanent
                                recording and reporting.
20611........................  Arthrocentesis, aspiration            1.10             1.10   Finalize.
                                and/or injection, major
                                joint or bursa (e.g.,
                                shoulder, hip, knee,
                                subacromial bursa); with
                                ultrasound guidance, with
                                permanent recording and
                                reporting.
20983........................  Ablation therapy for                  7.13             7.13   Finalize.
                                reduction or eradication
                                of 1 or more bone tumors
                                (e.g., metastasis)
                                including adjacent soft
                                tissue when involved by
                                tumor extension,
                                percutaneous, including
                                imaging guidance when
                                performed; cryoablation.
21811........................  Open treatment of rib                10.79            10.79   Finalize.
                                fracture(s) with internal
                                fixation, includes
                                thoracoscopic
                                visualization when
                                performed, unilateral; 1-
                                3 ribs.
21812........................  Open treatment of rib                13.00            13.00   Finalize.
                                fracture(s) with internal
                                fixation, includes
                                thoracoscopic
                                visualization when
                                performed, unilateral; 4-
                                6 ribs.
21813........................  Open treatment of rib                17.61            17.61   Finalize.
                                fracture(s) with internal
                                fixation, includes
                                thoracoscopic
                                visualization when
                                performed, unilateral; 7
                                or more ribs.
22510........................  Percutaneous                          8.15             8.15   Finalize.
                                vertebroplasty (bone
                                biopsy included when
                                performed), 1 vertebral
                                body, unilateral or
                                bilateral injection,
                                inclusive of all imaging
                                guidance; cervicothoracic.
22511........................  Percutaneous                          7.58             7.58   Finalize.
                                vertebroplasty (bone
                                biopsy included when
                                performed), 1 vertebral
                                body, unilateral or
                                bilateral injection,
                                inclusive of all imaging
                                guidance; lumbosacral.
22512........................  Percutaneous                          4.00             4.00   Finalize.
                                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).
22513........................  Percutaneous vertebral                8.90             8.90   Finalize.
                                augmentation, including
                                cavity creation (fracture
                                reduction and bone biopsy
                                included when performed)
                                using mechanical device
                                (e.g., kyphoplasty), 1
                                vertebral body,
                                unilateral or bilateral
                                cannulation, inclusive of
                                all imaging guidance;
                                thoracic.

[[Page 70987]]

 
22514........................  Percutaneous vertebral                8.24             8.24   Finalize.
                                augmentation, including
                                cavity creation (fracture
                                reduction and bone biopsy
                                included when performed)
                                using mechanical device
                                (e.g., kyphoplasty), 1
                                vertebral body,
                                unilateral or bilateral
                                cannulation, inclusive of
                                all imaging guidance;
                                lumbar.
22515........................  Percutaneous vertebral                4.00             4.00   Finalize.
                                augmentation, including
                                cavity creation (fracture
                                reduction and bone biopsy
                                included when performed)
                                using mechanical device
                                (e.g., 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).
22856........................  Total disc arthroplasty              24.05            24.05   Finalize.
                                (artificial disc),
                                anterior approach,
                                including discectomy with
                                end plate preparation
                                (includes osteophytectomy
                                for nerve root or spinal
                                cord decompression and
                                microdissection); single
                                interspace, cervical.
22858........................  Total disc arthroplasty               8.40             8.40   Finalize.
                                (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).
27279........................  Arthrodesis, sacroiliac               9.03             9.03   See II.J.5.a.
                                joint, percutaneous or
                                minimally invasive
                                (indirect visualization),
                                with image guidance,
                                includes obtaining bone
                                graft when performed, and
                                placement of transfixing
                                device.
29200........................  Strapping; thorax.........            0.39             0.39   Finalize.
29240........................  Strapping; shoulder (e.g.,            0.39             0.39   Finalize.
                                Velpeau).
29260........................  Strapping; elbow or wrist.            0.39             0.39   Finalize.
29280........................  Strapping; hand or finger.            0.39             0.39   Finalize.
29520........................  Strapping; hip............            0.39             0.39   Finalize.
29530........................  Strapping; knee...........            0.39             0.39   Finalize.
31620........................  Endobronchial ultrasound              1.40   ...............  Deleted.
                                (EBUS) during
                                bronchoscopic diagnostic
                                or therapeutic
                                intervention(s) (List
                                separately in addition to
                                code for primary
                                procedure[s]).
33215........................  Repositioning of                      4.92             4.92   Finalize.
                                previously implanted
                                transvenous pacemaker or
                                implantable defibrillator
                                (right atrial or right
                                ventricular) electrode.
33216........................  Insertion of a single                 5.87             5.87   Finalize.
                                transvenous electrode,
                                permanent pacemaker or
                                implantable defibrillator.
33217........................  Insertion of 2 transvenous            5.84             5.84   Finalize.
                                electrodes, permanent
                                pacemaker or implantable
                                defibrillator.
33218........................  Repair of single                      6.07             6.07   Finalize.
                                transvenous electrode,
                                permanent pacemaker or
                                implantable defibrillator.
33220........................  Repair of 2 transvenous               6.15             6.15   Finalize.
                                electrodes for permanent
                                pacemaker or implantable
                                defibrillator.
33223........................  Relocation of skin pocket             6.55             6.55   Finalize.
                                for implantable
                                defibrillator.
33224........................  Insertion of pacing                   9.04             9.04   Finalize.
                                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).
33225........................  Insertion of pacing                   8.33             8.33   Finalize.
                                electrode, cardiac venous
                                system, for left
                                ventricular pacing, at
                                time of insertion of
                                implantable defibrillator
                                or pacemaker pulse
                                generator (e.g., for
                                upgrade to dual chamber
                                system) (List separately
                                in addition to code for
                                primary procedure).
33240........................  Insertion of implantable              6.05             6.05   Finalize.
                                defibrillator pulse
                                generator only; with
                                existing single lead.
33241........................  Removal of implantable                3.29             3.29   Finalize.
                                defibrillator pulse
                                generator only.
33243........................  Removal of single or dual            23.57            23.57   Finalize.
                                chamber implantable
                                defibrillator
                                electrode(s); by
                                thoracotomy.
33244........................  Removal of single or dual            13.99            13.99   Finalize.
                                chamber implantable
                                defibrillator
                                electrode(s); by
                                transvenous extraction.
33249........................  Insertion or replacement             15.17            15.17   Finalize.
                                of permanent implantable
                                defibrillator system,
                                with transvenous lead(s),
                                single or dual chamber.
33262........................  Removal of implantable                6.06             6.06   Finalize.
                                defibrillator pulse
                                generator with
                                replacement of
                                implantable defibrillator
                                pulse generator; single
                                lead system.
33263........................  Removal of implantable                6.33             6.33   Finalize.
                                defibrillator pulse
                                generator with
                                replacement of
                                implantable defibrillator
                                pulse generator; dual
                                lead system.
33270........................  Insertion or replacement              9.10             9.10   Finalize.
                                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.
33271........................  Insertion of subcutaneous             7.50             7.50   Finalize.
                                implantable defibrillator
                                electrode.
33272........................  Removal of subcutaneous               5.42             5.42   Finalize.
                                implantable defibrillator
                                electrode.

[[Page 70988]]

 
33273........................  Repositioning of                      6.50             6.50   Finalize.
                                previously implanted
                                subcutaneous implantable
                                defibrillator electrode.
33418........................  Transcatheter mitral valve           32.25            32.25   Finalize.
                                repair, percutaneous
                                approach, including
                                transseptal puncture when
                                performed; initial
                                prosthesis.
33419........................  Transcatheter mitral valve            7.93             7.93   Finalize.
                                repair, percutaneous
                                approach, including
                                transseptal puncture when
                                performed; additional
                                prosthesis(es) during
                                same session (List
                                separately in addition to
                                code for primary
                                procedure).
33946........................  Extracorporeal membrane               6.00             6.00   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; initiation,
                                veno-venous.
33947........................  Extracorporeal membrane               6.63             6.63   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; initiation,
                                veno-arterial.
33949........................  Extracorporeal membrane               4.60             4.60   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; daily
                                management, each day,
                                veno-arterial.
33951........................  Extracorporeal membrane               8.15             8.15   Finalize.
                                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).
33952........................  Extracorporeal membrane               8.15             8.15   Finalize.
                                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).
33953........................  Extracorporeal membrane               9.11             9.11   Finalize.
                                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.
33954........................  Extracorporeal membrane               9.11             9.11   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; insertion
                                of peripheral (arterial
                                and/or venous)
                                cannula(e), open, 6 years
                                and older.
33955........................  Extracorporeal membrane              16.00            16.00   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; insertion
                                of central cannula(e) by
                                sternotomy or
                                thoracotomy, birth
                                through 5 years of age.
33956........................  Extracorporeal membrane              16.00            16.00   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; insertion
                                of central cannula(e) by
                                sternotomy or
                                thoracotomy, 6 years and
                                older.
33957........................  Extracorporeal membrane               3.51             3.51   Finalize.
                                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).
33958........................  Extracorporeal membrane               3.51             3.51   Finalize.
                                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).
33959........................  Extracorporeal membrane               4.47             4.47   Finalize.
                                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).
33962........................  Extracorporeal membrane               4.47             4.47   Finalize.
                                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).
33963........................  Extracorporeal membrane               9.00             9.00   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; reposition
                                of central cannula(e) by
                                sternotomy or
                                thoracotomy, birth
                                through 5 years of age
                                (includes fluoroscopic
                                guidance, when performed).
33964........................  Extracorporeal membrane               9.50             9.50   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; reposition
                                central cannula(e) by
                                sternotomy or
                                thoracotomy, 6 years and
                                older (includes
                                fluoroscopic guidance,
                                when performed).
33965........................  Extracorporeal membrane               3.51             3.51   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; removal of
                                peripheral (arterial and/
                                or venous) cannula(e),
                                percutaneous, birth
                                through 5 years of age.
33966........................  Extracorporeal membrane               4.50             4.50   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; removal of
                                peripheral (arterial and/
                                or venous) cannula(e),
                                percutaneous, 6 years and
                                older.
33969........................  Extracorporeal membrane               5.22             5.22   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; removal of
                                peripheral (arterial and/
                                or venous) cannula(e),
                                open, birth through 5
                                years of age.

[[Page 70989]]

 
33984........................  Extracorporeal membrane               5.46             5.46   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; removal of
                                peripheral (arterial and/
                                or venous) cannula(e),
                                open, 6 years and older.
33985........................  Extracorporeal membrane               9.89             9.89   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; removal of
                                central cannula(e) by
                                sternotomy or
                                thoracotomy, birth
                                through 5 years of age.
33986........................  Extracorporeal membrane              10.00            10.00   Finalize.
                                oxygenation (ECMO)/
                                extracorporeal life
                                support (ECLS) provided
                                by physician; removal of
                                central cannula(e) by
                                sternotomy or
                                thoracotomy, 6 years and
                                older.
33987........................  Arterial exposure with                4.04             4.04   Finalize.
                                creation of graft conduit
                                (e.g., chimney graft) to
                                facilitate arterial
                                perfusion for ECMO/ECLS
                                (List separately in
                                addition to code for
                                primary procedure).
33988........................  Insertion of left heart              15.00            15.00   Finalize.
                                vent by thoracic incision
                                (e.g., sternotomy,
                                thoracotomy) for ECMO/
                                ECLS.
33989........................  Removal of left heart vent            9.50             9.50   Finalize.
                                by thoracic incision
                                (e.g., sternotomy,
                                thoracotomy) for ECMO/
                                ECLS.
34839........................  Physician planning of a                  B                B   Finalize.
                                patient-specific
                                fenestrated visceral
                                aortic endograft
                                requiring a minimum of 90
                                minutes of physician time.
34841........................  Endovascular repair of                    C                C  Finalize.
                                visceral aorta (e.g.,
                                aneurysm, pseudoaneurysm,
                                dissection, penetrating
                                ulcer, intramural
                                hematoma, or traumatic
                                disruption) by deployment
                                of a fenestrated visceral
                                aortic endograft and all
                                associated radiological
                                supervision and
                                interpretation, including
                                target zone angioplasty,
                                when performed; including
                                one visceral artery
                                endoprosthesis (superior
                                mesenteric, celiac or
                                renal artery).
34842........................  Endovascular repair of                    C                C  Finalize.
                                visceral aorta (e.g.,
                                aneurysm, pseudoaneurysm,
                                dissection, penetrating
                                ulcer, intramural
                                hematoma, or traumatic
                                disruption) by deployment
                                of a fenestrated visceral
                                aortic endograft and all
                                associated radiological
                                supervision and
                                interpretation, including
                                target zone angioplasty,
                                when performed; including
                                two visceral artery
                                endoprostheses (superior
                                mesenteric, celiac and/or
                                renal artery[s]).
34843........................  Endovascular repair of                    C                C  Finalize.
                                visceral aorta (e.g.,
                                aneurysm, pseudoaneurysm,
                                dissection, penetrating
                                ulcer, intramural
                                hematoma, or traumatic
                                disruption) by deployment
                                of a fenestrated visceral
                                aortic endograft and all
                                associated radiological
                                supervision and
                                interpretation, including
                                target zone angioplasty,
                                when performed; including
                                three visceral artery
                                endoprostheses (superior
                                mesenteric, celiac and/or
                                renal artery[s]).
34844........................  Endovascular repair of                    C                C  Finalize.
                                visceral aorta (e.g.,
                                aneurysm, pseudoaneurysm,
                                dissection, penetrating
                                ulcer, intramural
                                hematoma, or traumatic
                                disruption) by deployment
                                of a fenestrated visceral
                                aortic endograft and all
                                associated radiological
                                supervision and
                                interpretation, including
                                target zone angioplasty,
                                when performed; including
                                four or more visceral
                                artery endoprostheses
                                (superior mesenteric,
                                celiac and/or renal
                                artery[s]).
34845........................  Endovascular repair of                    C                C  Finalize.
                                visceral aorta and
                                infrarenal abdominal
                                aorta (e.g., aneurysm,
                                pseudoaneurysm,
                                dissection, penetrating
                                ulcer, intramural
                                hematoma, or traumatic
                                disruption) with a
                                fenestrated visceral
                                aortic endograft and
                                concomitant unibody or
                                modular infrarenal aortic
                                endograft and all
                                associated radiological
                                supervision and
                                interpretation, including
                                target zone angioplasty,
                                when performed; including
                                one visceral artery
                                endoprosthesis (superior
                                mesenteric, celiac or
                                renal artery).
34846........................  Endovascular repair of                    C                C  Finalize.
                                visceral aorta and
                                infrarenal abdominal
                                aorta (e.g., aneurysm,
                                pseudoaneurysm,
                                dissection, penetrating
                                ulcer, intramural
                                hematoma, or traumatic
                                disruption) with a
                                fenestrated visceral
                                aortic endograft and
                                concomitant unibody or
                                modular infrarenal aortic
                                endograft and all
                                associated radiological
                                supervision and
                                interpretation, including
                                target zone angioplasty,
                                when performed; including
                                two visceral artery
                                endoprostheses (superior
                                mesenteric, celiac and/or
                                renal artery[s]).
34847........................  Endovascular repair of                    C                C  Finalize.
                                visceral aorta and
                                infrarenal abdominal
                                aorta (e.g., aneurysm,
                                pseudoaneurysm,
                                dissection, penetrating
                                ulcer, intramural
                                hematoma, or traumatic
                                disruption) with a
                                fenestrated visceral
                                aortic endograft and
                                concomitant unibody or
                                modular infrarenal aortic
                                endograft and all
                                associated radiological
                                supervision and
                                interpretation, including
                                target zone angioplasty,
                                when performed; including
                                three visceral artery
                                endoprostheses (superior
                                mesenteric, celiac and/or
                                renal artery[s]).

[[Page 70990]]

 
34848........................  Endovascular repair of                    C                C  Finalize.
                                visceral aorta and
                                infrarenal abdominal
                                aorta (e.g., aneurysm,
                                pseudoaneurysm,
                                dissection, penetrating
                                ulcer, intramural
                                hematoma, or traumatic
                                disruption) with a
                                fenestrated visceral
                                aortic endograft and
                                concomitant unibody or
                                modular infrarenal aortic
                                endograft and all
                                associated radiological
                                supervision and
                                interpretation, including
                                target zone angioplasty,
                                when performed; including
                                four or more visceral
                                artery endoprostheses
                                (superior mesenteric,
                                celiac and/or renal
                                artery[s]).
36475........................  Endovenous ablation                   5.30             5.30   See II.J.5.a
                                therapy of incompetent
                                vein, extremity,
                                inclusive of all imaging
                                guidance and monitoring,
                                percutaneous,
                                radiofrequency; first
                                vein treated.
36476........................  Endovenous ablation                   2.65             2.65   See II.J.5.a
                                therapy of incompetent
                                vein, extremity,
                                inclusive of all imaging
                                guidance and monitoring,
                                percutaneous,
                                radiofrequency; second
                                and subsequent veins
                                treated in a single
                                extremity, each through
                                separate access sites
                                (List separately in
                                addition to code for
                                primary procedure).
36478........................  Endovenous ablation                   5.30             5.30   See II.J.5.a.
                                therapy of incompetent
                                vein, extremity,
                                inclusive of all imaging
                                guidance and monitoring,
                                percutaneous, laser;
                                first vein treated.
36479........................  Endovenous ablation                   2.65             2.65   See II.J.5.a.
                                therapy of incompetent
                                vein, extremity,
                                inclusive of all imaging
                                guidance and monitoring,
                                percutaneous, laser;
                                second and subsequent
                                veins treated in a single
                                extremity, each through
                                separate access sites
                                (List separately in
                                addition to code for
                                primary procedure).
36818........................  Arteriovenous anastomosis,           12.39            12.39   Finalize.
                                open; by upper arm
                                cephalic vein
                                transposition.
36819........................  Arteriovenous anastomosis,           13.29            13.29   Finalize.
                                open; by upper arm
                                basilic vein
                                transposition.
36820........................  Arteriovenous anastomosis,           13.07            13.07   Finalize.
                                open; by forearm vein
                                transposition.
36821........................  Arteriovenous anastomosis,           11.90            11.90   Finalize.
                                open; direct, any site
                                (e.g., Cimino type)
                                (separate procedure).
36825........................  Creation of arteriovenous            14.17            14.17   Finalize.
                                fistula by other than
                                direct arteriovenous
                                anastomosis (separate
                                procedure); autogenous
                                graft.
36830........................  Creation of arteriovenous            12.03            12.03   Finalize.
                                fistula by other than
                                direct arteriovenous
                                anastomosis (separate
                                procedure); nonautogenous
                                graft (e.g., biological
                                collagen, thermoplastic
                                graft).
36831........................  Thrombectomy, open,                  11.00            11.00   Finalize.
                                arteriovenous fistula
                                without revision,
                                autogenous or
                                nonautogenous dialysis
                                graft (separate
                                procedure).
36832........................  Revision, open,                      13.50            13.50   Finalize.
                                arteriovenous fistula;
                                without thrombectomy,
                                autogenous or
                                nonautogenous dialysis
                                graft (separate
                                procedure).
36833........................  Revision, open,                      14.50            14.50   Finalize.
                                arteriovenous fistula;
                                with thrombectomy,
                                autogenous or
                                nonautogenous dialysis
                                graft (separate
                                procedure).
37218........................  Transcatheter placement of           15.00            15.00   Finalize.
                                intravascular stent(s),
                                intrathoracic common
                                carotid artery or
                                innominate artery, open
                                or percutaneous antegrade
                                approach, including
                                angioplasty, when
                                performed, and
                                radiological supervision
                                and interpretation.
43180........................  Esophagoscopy, rigid,                 9.03             9.03   Finalize.
                                transoral with
                                diverticulectomy of
                                hypopharynx or cervical
                                esophagus (e.g., Zenker's
                                diverticulum), with
                                cricopharyngeal myotomy,
                                includes use of telescope
                                or operating microscope
                                and repair, when
                                performed.
45399........................  Unlisted procedure, colon.               I                 C  Finalize.
47383........................  Ablation, 1 or more liver             9.13             9.13   Finalize.
                                tumor(s), percutaneous,
                                cryoablation.
52441........................  Cystourethroscopy, with               4.50             4.50   Finalize.
                                insertion of permanent
                                adjustable transprostatic
                                implant; single implant.
52442........................  Cystourethroscopy, with               1.20             1.20   Finalize.
                                insertion of permanent
                                adjustable transprostatic
                                implant; each additional
                                permanent adjustable
                                transprostatic implant
                                (List separately in
                                addition to code for
                                primary procedure).
55840........................  Prostatectomy, retropubic            21.36            21.36   Finalize.
                                radical, with or without
                                nerve sparing.
55842........................  Prostatectomy, retropubic            21.36            21.36   Finalize.
                                radical, with or without
                                nerve sparing; with lymph
                                node biopsy(s) (limited
                                pelvic lymphadenectomy).
55845........................  Prostatectomy, retropubic            25.18            25.18   Finalize.
                                radical, with or without
                                nerve sparing; with
                                bilateral pelvic
                                lymphadenectomy,
                                including external iliac,
                                hypogastric, and
                                obturator nodes.
58541........................  Laparoscopy, surgical,               12.29            12.29   Finalize.
                                supracervical
                                hysterectomy, for uterus
                                250 g or less.
58542........................  Laparoscopy, surgical,               14.16            14.16   Finalize.
                                supracervical
                                hysterectomy, for uterus
                                250 g or less; with
                                removal of tube(s) and/or
                                ovary(s).
58543........................  Laparoscopy, surgical,               14.39            14.39   Finalize.
                                supracervical
                                hysterectomy, for uterus
                                greater than 250 g.
58544........................  Laparoscopy, surgical,               15.60            15.60   Finalize.
                                supracervical
                                hysterectomy, for uterus
                                greater than 250 g; with
                                removal of tube(s) and/or
                                ovary(s).
58570........................  Laparoscopy, surgical,               13.36            13.36   Finalize.
                                with total hysterectomy,
                                for uterus 250 g or less.

[[Page 70991]]

 
58571........................  Laparoscopy, surgical,               15.00            15.00   Finalize.
                                with total hysterectomy,
                                for uterus 250 g or less;
                                with removal of tube(s)
                                and/or ovary(s).
58572........................  Laparoscopy, surgical,               17.71            17.71   Finalize.
                                with total hysterectomy,
                                for uterus greater than
                                250 g.
58573........................  Laparoscopy, surgical,               20.79            20.79   Finalize.
                                with total hysterectomy,
                                for uterus greater than
                                250 g; with removal of
                                tube(s) and/or ovary(s).
62284........................  Injection procedure for               1.54             1.54   Finalize.
                                myelography and/or
                                computed tomography,
                                lumbar (other than C1-C2
                                and posterior fossa).
62302........................  Myelography via lumbar                2.29             2.29   Finalize.
                                injection, including
                                radiological supervision
                                and interpretation;
                                cervical.
62303........................  Myelography via lumbar                2.29             2.29   Finalize.
                                injection, including
                                radiological supervision
                                and interpretation;
                                thoracic.
62304........................  Myelography via lumbar                2.25             2.25   Finalize.
                                injection, including
                                radiological supervision
                                and interpretation;
                                lumbosacral.
62305........................  Myelography via lumbar                2.35             2.35   Finalize.
                                injection, including
                                radiological supervision
                                and interpretation; 2 or
                                more regions (e.g.,
                                lumbar/thoracic, cervical/
                                thoracic, lumbar/
                                cervical, lumbar/thoracic/
                                cervical).
62310........................  Injection(s), of                      1.91             1.91   Finalize.
                                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                      1.54             1.54   Finalize.
                                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               2.04             2.04   Finalize.
                                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.
62319........................  Injection(s), including               1.87             1.87   Finalize.
                                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).
64486........................  Transversus abdominis                 1.27             1.27   Finalize.
                                plane (TAP) block
                                (abdominal plane block,
                                rectus sheath block)
                                unilateral; by
                                injection(s) (includes
                                imaging guidance, when
                                performed).
64487........................  Transversus abdominis                 1.48             1.48   Finalize.
                                plane (TAP) block
                                (abdominal plane block,
                                rectus sheath block)
                                unilateral; by continuous
                                infusion(s) (includes
                                imaging guidance, when
                                performed).
64488........................  Transversus abdominis                 1.60             1.60   Finalize.
                                plane (TAP) block
                                (abdominal plane block,
                                rectus sheath block)
                                bilateral; by injections
                                (includes imaging
                                guidance, when performed).
64489........................  Transversus abdominis                 1.80             1.80   Finalize.
                                plane (TAP) block
                                (abdominal plane block,
                                rectus sheath block)
                                bilateral; by continuous
                                infusions (includes
                                imaging guidance, when
                                performed).
64561........................  Percutaneous implantation             5.44             5.44   Finalize.
                                of neurostimulator
                                electrode array; sacral
                                nerve (transforaminal
                                placement) including
                                image guidance, if
                                performed.
66179........................  Aqueous shunt to                     14.00            14.00   Finalize.
                                extraocular equatorial
                                plate reservoir, external
                                approach; without graft.
66180........................  Aqueous shunt to                     15.00            15.00   Finalize.
                                extraocular equatorial
                                plate reservoir, external
                                approach; with graft.
66184........................  Revision of aqueous shunt             9.58             9.58   Finalize.
                                to extraocular equatorial
                                plate reservoir; without
                                graft.
66185........................  Revision of aqueous shunt            10.58            10.58   Finalize.
                                to extraocular equatorial
                                plate reservoir; with
                                graft.
67036........................  Vitrectomy, mechanical,              12.13            12.13   Finalize.
                                pars plana approach;.
67039........................  Vitrectomy, mechanical,              13.20            13.20   Finalize.
                                pars plana approach; with
                                focal endolaser
                                photocoagulation.
67040........................  Vitrectomy, mechanical,              14.50            14.50   Finalize.
                                pars plana approach; with
                                endolaser panretinal
                                photocoagulation.
67041........................  Vitrectomy, mechanical,              16.33            16.33   Finalize.
                                pars plana approach; with
                                removal of preretinal
                                cellular membrane (e.g.,
                                macular pucker).

[[Page 70992]]

 
67042........................  Vitrectomy, mechanical,              16.33            16.33   Finalize.
                                pars plana approach; with
                                removal of internal
                                limiting membrane of
                                retina (e.g., for repair
                                of macular hole, diabetic
                                macular edema), includes,
                                if performed, intraocular
                                tamponade (i.e., air, gas
                                or silicone oil).
67043........................  Vitrectomy, mechanical,              17.40            17.40   Finalize.
                                pars plana approach; with
                                removal of subretinal
                                membrane (e.g., choroidal
                                neovascularization),
                                includes, if performed,
                                intraocular tamponade
                                (i.e., air, gas or
                                silicone oil) and laser
                                photocoagulation.
67255........................  Scleral reinforcement                 8.38             8.38   Finalize.
                                (separate procedure);
                                with graft.
70486........................  Computed tomography,                  0.85             0.85   See II.J.5.a.
                                maxillofacial area;
                                without contrast material.
70487........................  Computed tomography,                  1.13             1.13   See II.J.5.a.
                                maxillofacial area; with
                                contrast material(s).
70488........................  Computed tomography,                  1.27             1.27   See II.J.5.a.
                                maxillofacial area;
                                without contrast
                                material, followed by
                                contrast material(s) and
                                further sections.
70496........................  Computed tomographic                  1.75             1.75   Finalize.
                                angiography, head, with
                                contrast material(s),
                                including noncontrast
                                images, if performed, and
                                image postprocessing.
70498........................  Computed tomographic                  1.75             1.75   Finalize.
                                angiography, neck, with
                                contrast material(s),
                                including noncontrast
                                images, if performed, and
                                image postprocessing.
71275........................  Computed tomographic                  1.82             1.82   Finalize.
                                angiography, chest
                                (noncoronary), with
                                contrast material(s),
                                including noncontrast
                                images, if performed, and
                                image postprocessing.
72191........................  Computed tomographic                  1.81             1.81   Finalize.
                                angiography, pelvis, with
                                contrast material(s),
                                including noncontrast
                                images, if performed, and
                                image postprocessing.
72240........................  Myelography, cervical,                0.91             0.91   Finalize.
                                radiological supervision
                                and interpretation.
72255........................  Myelography, thoracic,                0.91             0.91   Finalize.
                                radiological supervision
                                and interpretation.
72265........................  Myelography, lumbosacral,             0.83             0.83   Finalize.
                                radiological supervision
                                and interpretation.
72270........................  Myelography, 2 or more                1.33             1.33   Finalize.
                                regions (e.g., lumbar/
                                thoracic, cervical/
                                thoracic, lumbar/
                                cervical, lumbar/thoracic/
                                cervical), radiological
                                supervision and
                                interpretation.
74174........................  Computed tomographic                  2.20             2.20   Finalize.
                                angiography, abdomen and
                                pelvis, with contrast
                                material(s), including
                                noncontrast images, if
                                performed, and image
                                postprocessing.
74175........................  Computed tomographic                  1.82             1.82   Finalize.
                                angiography, abdomen,
                                with contrast
                                material(s), including
                                noncontrast images, if
                                performed, and image
                                postprocessing.
74230........................  Swallowing function, with             0.53             0.53   Finalize.
                                cineradiography/
                                videoradiography.
76641........................  Ultrasound, breast,                   0.73             0.73   Finalize.
                                unilateral, real time
                                with image documentation,
                                including axilla when
                                performed; complete.
76642........................  Ultrasound, breast,                   0.68             0.68   Finalize.
                                unilateral, real time
                                with image documentation,
                                including axilla when
                                performed; limited.
76700........................  Ultrasound, abdominal,                0.81             0.81   Finalize.
                                real time with image
                                documentation; complete.
76705........................  Ultrasound, abdominal,                0.59             0.59   Finalize.
                                real time with image
                                documentation; limited
                                (e.g., single organ,
                                quadrant, follow-up).
76770........................  Ultrasound,                           0.74             0.74   Finalize.
                                retroperitoneal (e.g.,
                                renal, aorta, nodes),
                                real time with image
                                documentation; complete.
76775........................  Ultrasound,                           0.58             0.58   Finalize.
                                retroperitoneal (e.g.,
                                renal, aorta, nodes),
                                real time with image
                                documentation; limited.
76856........................  Ultrasound, pelvic                    0.69             0.69   Finalize.
                                (nonobstetric), real time
                                with image documentation;
                                complete.
76857........................  Ultrasound, pelvic                    0.50             0.50   Finalize.
                                (nonobstetric), real time
                                with image documentation;
                                limited or follow-up
                                (e.g., for follicles).
76930........................  Ultrasonic guidance for               0.67             0.67   Finalize.
                                pericardiocentesis,
                                imaging supervision and
                                interpretation.
76932........................  Ultrasonic guidance for               0.85             0.67   Finalize.
                                endomyocardial biopsy,
                                imaging supervision and
                                interpretation.
76942........................  Ultrasonic guidance for               0.67             0.67   Finalize.
                                needle placement (e.g.,
                                biopsy, aspiration,
                                injection, localization
                                device), imaging
                                supervision and
                                interpretation.
76948........................  Ultrasonic guidance for               0.38             0.38   Finalize.
                                aspiration of ova,
                                imaging supervision and
                                interpretation.
77055........................  Mammography; unilateral...             0.7             0.70   Finalize.
77056........................  Mammography; bilateral....            0.87             0.87   Finalize.
77057........................  Screening mammography,                 0.7             0.70   Finalize.
                                bilateral (2-view film
                                study of each breast).
77061........................  Digital breast                           I                I   Finalize.
                                tomosynthesis; unilateral.
77062........................  Digital breast                           I                I   Finalize.
                                tomosynthesis; bilateral.
77063........................  Screening digital breast              0.60             0.60   Finalize.
                                tomosynthesis, bilateral
                                (List separately in
                                addition to code for
                                primary procedure).
77080........................  Dual-energy X-ray                     0.20             0.20   Finalize.
                                absorptiometry (DXA),
                                bone density study, 1 or
                                more sites; axial
                                skeleton (e.g., hips,
                                pelvis, spine).
77085........................  Dual-energy X-ray                     0.30             0.30   Finalize.
                                absorptiometry (DXA),
                                bone density study, 1 or
                                more sites; axial
                                skeleton (e.g., hips,
                                pelvis, spine), including
                                vertebral fracture
                                assessment.

[[Page 70993]]

 
77086........................  Vertebral fracture                    0.17             0.17   Finalize.
                                assessment via dual-
                                energy X-ray
                                absorptiometry (DXA).
77300........................  Basic radiation dosimetry             0.62             0.62   See II.J.5.a.
                                calculation, central axis
                                depth dose calculation,
                                TDF, NSD, gap
                                calculation, off axis
                                factor, tissue
                                inhomogeneity factors,
                                calculation of non-
                                ionizing radiation
                                surface and depth dose,
                                as required during course
                                of treatment, only when
                                prescribed by the
                                treating physician.
77306........................  Teletherapy isodose plan;             1.40             1.40   See II.J.5.a.
                                simple (1 or 2 unmodified
                                ports directed to a
                                single area of interest),
                                includes basic dosimetry
                                calculation(s).
77307........................  Teletherapy isodose plan;             2.90             2.90   See II.J.5.a.
                                complex (multiple
                                treatment areas,
                                tangential ports, the use
                                of wedges, blocking,
                                rotational beam, or
                                special beam
                                considerations), includes
                                basic dosimetry
                                calculation(s).
77316........................  Brachytherapy isodose                 1.40             1.40   Finalize.
                                plan; simple
                                (calculation[s] made from
                                1 to 4 sources, or remote
                                afterloading
                                brachytherapy, 1
                                channel), includes basic
                                dosimetry calculation(s).
77317........................  Brachytherapy isodose                 1.83             1.83   Finalize.
                                plan; intermediate
                                (calculation[s] made from
                                5 to 10 sources, or
                                remote afterloading
                                brachytherapy, 2-12
                                channels), includes basic
                                dosimetry calculation(s).
77318........................  Brachytherapy isodose                 2.90             2.90   Finalize.
                                plan; complex
                                (calculation[s] made from
                                over 10 sources, or
                                remote afterloading
                                brachytherapy, over 12
                                channels), includes basic
                                dosimetry calculation(s).
88341........................  Immunohistochemistry or               0.53             0.53   See II.I.5.d.
                                immunocytochemistry, per
                                specimen; each additional
                                single antibody stain
                                procedure (List
                                separately in addition to
                                code for primary
                                procedure).
88342........................  Immunohistochemistry or               0.70             0.70   Finalize.
                                immunocytochemistry, per
                                specimen; initial single
                                antibody stain procedure.
88344........................  Immunohistochemistry or               0.77             0.77   Finalize.
                                immunocytochemistry, per
                                specimen; each multiplex
                                antibody stain procedure.
88348........................  Electron microscopy,                  1.51             1.51   Finalize.
                                diagnostic.
88356........................  Morphometric analysis;                2.80             2.80   Finalize.
                                nerve.
88364........................  In situ hybridization                 0.67             0.67   See II.I.5.d
                                (e.g., FISH), per
                                specimen; each additional
                                single probe stain
                                procedure (List
                                separately in addition to
                                code for primary
                                procedure).
88365........................  In situ hybridization                 0.88             0.88   Finalize.
                                (e.g., FISH), per
                                specimen; initial single
                                probe stain procedure.
88366........................  In situ hybridization                 1.24             1.24   Finalize.
                                (e.g., FISH), per
                                specimen; each multiplex
                                probe stain procedure.
88369........................  Morphometric analysis, in             0.67             0.67   See II.I.5.d.
                                situ hybridization
                                (quantitative or semi-
                                quantitative), manual,
                                per specimen; each
                                additional single probe
                                stain procedure (List
                                separately in addition to
                                code for primary
                                procedure).
88373........................  Morphometric analysis, in             0.43             0.43   Finalize.
                                situ hybridization
                                (quantitative or semi-
                                quantitative), using
                                computer-assisted
                                technology, per specimen;
                                each additional single
                                probe stain procedure
                                (List separately in
                                addition to code for
                                primary procedure).
88374........................  Morphometric analysis, in             0.93             0.93   See II.I.5.d.
                                situ hybridization
                                (quantitative or semi-
                                quantitative), using
                                computer-assisted
                                technology, per specimen;
                                each multiplex probe
                                stain procedure.
88377........................  Morphometric analysis, in             1.40             1.40   Finalize.
                                situ hybridization
                                (quantitative or semi-
                                quantitative), manual,
                                per specimen; each
                                multiplex probe stain
                                procedure.
88380........................  Microdissection (i.e.,                1.14             1.14   See II.J.5.a.
                                sample preparation of
                                microscopically
                                identified target); laser
                                capture.
88381........................  Microdissection (i.e.,                0.53             0.53   See II.J.5.a.
                                sample preparation of
                                microscopically
                                identified target);
                                manual.
91200........................  Liver elastography,                   0.30             0.27   See II.J.5.a.
                                mechanically induced
                                shear wave (e.g.,
                                vibration), without
                                imaging, with
                                interpretation and report.
92145........................  Corneal hysteresis                    0.17             0.17   Finalize.
                                determination, by air
                                impulse stimulation,
                                unilateral or bilateral,
                                with interpretation and
                                report.
92540........................  Basic vestibular                      1.50             1.50   Finalize.
                                evaluation, includes
                                spontaneous nystagmus
                                test with eccentric gaze
                                fixation nystagmus, with
                                recording, positional
                                nystagmus test, minimum
                                of 4 positions, with
                                recording, optokinetic
                                nystagmus test,
                                bidirectional foveal and
                                peripheral stimulation,
                                with recording, and
                                oscillating tracking
                                test, with recording.
92541........................  Spontaneous nystagmus                 0.40             0.40   Finalize.
                                test, including gaze and
                                fixation nystagmus, with
                                recording.
92542........................  Positional nystagmus test,            0.48             0.48   Finalize.
                                minimum of 4 positions,
                                with recording.
92543........................  Caloric vestibular test,              0.10   ...............  Deleted.
                                each irrigation
                                (binaural, bithermal
                                stimulation constitutes 4
                                tests), with recording.
92544........................  Optokinetic nystagmus                 0.27             0.27   Finalize.
                                test, bidirectional,
                                foveal or peripheral
                                stimulation, with
                                recording.
92545........................  Oscillating tracking test,            0.25             0.25   Finalize.
                                with recording.

[[Page 70994]]

 
93260........................  Programming device                    0.85             0.85   Finalize.
                                evaluation (in person)
                                with iterative adjustment
                                of the implantable device
                                to test the function of
                                the device and select
                                optimal permanent
                                programmed values with
                                analysis, review and
                                report by a physician or
                                other qualified health
                                care professional;
                                implantable subcutaneous
                                lead defibrillator system.
93261........................  Interrogation device                  0.74             0.74   Finalize.
                                evaluation (in person)
                                with analysis, review and
                                report by a physician or
                                other qualified health
                                care professional,
                                includes connection,
                                recording and
                                disconnection per patient
                                encounter; implantable
                                subcutaneous lead
                                defibrillator system.
93282........................  Programming device                    0.85             0.85   Finalize.
                                evaluation (in person)
                                with iterative adjustment
                                of the implantable device
                                to test the function of
                                the device and select
                                optimal permanent
                                programmed values with
                                analysis, review and
                                report by a physician or
                                other qualified health
                                care professional; single
                                lead transvenous
                                implantable defibrillator
                                system.
93283........................  Programming device                    1.15             1.15   Finalize.
                                evaluation (in person)
                                with iterative adjustment
                                of the implantable device
                                to test the function of
                                the device and select
                                optimal permanent
                                programmed values with
                                analysis, review and
                                report by a physician or
                                other qualified health
                                care professional; dual
                                lead transvenous
                                implantable defibrillator
                                system.
93284........................  Programming device                    1.25             1.25   Finalize.
                                evaluation (in person)
                                with iterative adjustment
                                of the implantable device
                                to test the function of
                                the device and select
                                optimal permanent
                                programmed values with
                                analysis, review and
                                report by a physician or
                                other qualified health
                                care professional;
                                multiple lead transvenous
                                implantable defibrillator
                                system.
93287........................  Peri-procedural device                0.45             0.45   Finalize.
                                evaluation (in person)
                                and programming of device
                                system parameters before
                                or after a surgery,
                                procedure, or test with
                                analysis, review and
                                report by a physician or
                                other qualified health
                                care professional;
                                single, dual, or multiple
                                lead implantable
                                defibrillator system.
93289........................  Interrogation device                  0.92             0.92   Finalize.
                                evaluation (in person)
                                with analysis, review and
                                report by a physician or
                                other qualified health
                                care professional,
                                includes connection,
                                recording and
                                disconnection per patient
                                encounter; single, dual,
                                or multiple lead
                                transvenous implantable
                                defibrillator system,
                                including analysis of
                                heart rhythm derived data
                                elements.
93312........................  Echocardiography,                     2.55             2.55   Finalize.
                                transesophageal, real-
                                time with image
                                documentation (2D) (with
                                or without M-mode
                                recording); including
                                probe placement, image
                                acquisition,
                                interpretation and report.
93313........................  Echocardiography,                     0.51             0.51   Finalize.
                                transesophageal, real-
                                time with image
                                documentation (2D) (with
                                or without M-mode
                                recording); placement of
                                transesophageal probe
                                only.
93314........................  Echocardiography,                     2.10             2.10   Finalize.
                                transesophageal, real-
                                time with image
                                documentation (2D) (with
                                or without M-mode
                                recording); image
                                acquisition,
                                interpretation and report
                                only.
93315........................  Transesophageal                       2.94             2.94   Finalize.
                                echocardiography for
                                congenital cardiac
                                anomalies; including
                                probe placement, image
                                acquisition,
                                interpretation and report.
93316........................  Transesophageal                       0.85             0.85   Finalize.
                                echocardiography for
                                congenital cardiac
                                anomalies; placement of
                                transesophageal probe
                                only.
93317........................  Transesophageal                       2.09             2.09   Finalize.
                                echocardiography for
                                congenital cardiac
                                anomalies; image
                                acquisition,
                                interpretation and report
                                only.
93318........................  Echocardiography,                     2.40             2.40   Finalize.
                                transesophageal (TEE) for
                                monitoring purposes,
                                including probe
                                placement, real time 2-
                                dimensional image
                                acquisition and
                                interpretation leading to
                                ongoing (continuous)
                                assessment of
                                (dynamically changing)
                                cardiac pumping function
                                and to therapeutic
                                measures on an immediate
                                time basis.
93320........................  Doppler echocardiography,             0.38             0.38   Finalize.
                                pulsed wave and/or
                                continuous wave with
                                spectral display (List
                                separately in addition to
                                codes for
                                echocardiographic
                                imaging); complete.
93321........................  Doppler echocardiography,             0.15             0.15   Finalize.
                                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).
93325........................  Doppler echocardiography              0.07             0.07   Finalize.
                                color flow velocity
                                mapping (List separately
                                in addition to codes for
                                echocardiography).

[[Page 70995]]

 
93355........................  Echocardiography,                     4.66             4.66   Finalize.
                                transesophageal (TEE) for
                                guidance of a
                                transcatheter
                                intracardiac or great
                                vessel(s) structural
                                intervention(s) (e.g.,
                                TAVR, transcatheter
                                pulmonary valve
                                replacement, mitral valve
                                repair, paravalvular
                                regurgitation repair,
                                left atrial appendage
                                occlusion/closure,
                                ventricular septal defect
                                closure) (peri-and intra-
                                procedural), real-time
                                image acquisition and
                                documentation, guidance
                                with quantitative
                                measurements, probe
                                manipulation,
                                interpretation, and
                                report, including
                                diagnostic
                                transesophageal
                                echocardiography and,
                                when performed,
                                administration of
                                ultrasound contrast,
                                Doppler, color flow, and
                                3D.
93644........................  Electrophysiologic                    3.29             3.29   Finalize.
                                evaluation of
                                subcutaneous implantable
                                defibrillator (includes
                                defibrillation threshold
                                evaluation, induction of
                                arrhythmia, evaluation of
                                sensing for arrhythmia
                                termination, and
                                programming or
                                reprogramming of sensing
                                or therapeutic
                                parameters).
93880........................  Duplex scan of                        0.80             0.80   Finalize.
                                extracranial arteries;
                                complete bilateral study.
93882........................  Duplex scan of                        0.50             0.50   Finalize.
                                extracranial arteries;
                                unilateral or limited
                                study.
93886........................  Transcranial Doppler study            0.91             0.91   Finalize.
                                of the intracranial
                                arteries; complete study.
93888........................  Transcranial Doppler study            0.50             0.50   Finalize.
                                of the intracranial
                                arteries; limited study.
93895........................  Quantitative carotid                     N                N   Finalize.
                                intima media thickness
                                and carotid atheroma
                                evaluation, bilateral.
93925........................  Duplex scan of lower                  0.80             0.80   Finalize.
                                extremity arteries or
                                arterial bypass grafts;
                                complete bilateral study.
93926........................  Duplex scan of lower                  0.50             0.50   Finalize.
                                extremity arteries or
                                arterial bypass grafts;
                                unilateral or limited
                                study.
93930........................  Duplex scan of upper                  0.80             0.80   Finalize.
                                extremity arteries or
                                arterial bypass grafts;
                                complete bilateral study.
93931........................  Duplex scan of upper                  0.50             0.50   Finalize.
                                extremity arteries or
                                arterial bypass grafts;
                                unilateral or limited
                                study.
93970........................  Duplex scan of extremity              0.70             0.70   Finalize.
                                veins including responses
                                to compression and other
                                maneuvers; complete
                                bilateral study.
93971........................  Duplex scan of extremity              0.45             0.45   Finalize.
                                veins including responses
                                to compression and other
                                maneuvers; unilateral or
                                limited study.
93975........................  Duplex scan of arterial               1.16             1.16   Finalize.
                                inflow and venous outflow
                                of abdominal, pelvic,
                                scrotal contents and/or
                                retroperitoneal organs;
                                complete study.
93976........................  Duplex scan of arterial               0.80             0.80   Finalize.
                                inflow and venous outflow
                                of abdominal, pelvic,
                                scrotal contents and/or
                                retroperitoneal organs;
                                limited study.
93978........................  Duplex scan of aorta,                 0.80             0.80   Finalize.
                                inferior vena cava, iliac
                                vasculature, or bypass
                                grafts; complete study.
93979........................  Duplex scan of aorta,                 0.50             0.50   Finalize.
                                inferior vena cava, iliac
                                vasculature, or bypass
                                grafts; unilateral or
                                limited study.
93990........................  Duplex scan of                        0.50             0.50   Finalize.
                                hemodialysis access
                                (including arterial
                                inflow, body of access
                                and venous outflow).
95971........................  Electronic analysis of                0.78             0.78   Finalize.
                                implanted neurostimulator
                                pulse generator system
                                (e.g., rate, pulse
                                amplitude, pulse
                                duration, configuration
                                of wave form, battery
                                status, electrode
                                selectability, output
                                modulation, cycling,
                                impedance and patient
                                compliance measurements);
                                simple spinal cord, or
                                peripheral (i.e.,
                                peripheral nerve, sacral
                                nerve, neuromuscular)
                                neurostimulator pulse
                                generator/transmitter,
                                with intraoperative or
                                subsequent programming.
95972........................  Electronic analysis of                0.80             0.80   Finalize.
                                implanted neurostimulator
                                pulse generator system
                                (e.g., rate, pulse
                                amplitude, pulse
                                duration, configuration
                                of wave form, battery
                                status, electrode
                                selectability, output
                                modulation, cycling,
                                impedance and patient
                                compliance measurements);
                                complex spinal cord, or
                                peripheral (i.e.,
                                peripheral nerve, sacral
                                nerve, neuromuscular)
                                (except cranial nerve)
                                neurostimulator pulse
                                generator/transmitter,
                                with intraoperative or
                                subsequent programming,
                                up to 1 hour.
95973........................  Electronic analysis of                0.49   ...............  Deleted.
                                implanted neurostimulator
                                pulse generator system
                                (e.g., rate, pulse
                                amplitude, pulse
                                duration, configuration
                                of wave form, battery
                                status, electrode
                                selectability, output
                                modulation, cycling,
                                impedance and patient
                                compliance measurements);
                                complex spinal cord, or
                                peripheral (i.e.,
                                peripheral nerve, sacral
                                nerve, neuromuscular)
                                (except cranial nerve)
                                neurostimulator pulse
                                generator/transmitter,
                                with intraoperative or
                                subsequent programming,
                                each additional 30
                                minutes after first hour
                                (List separately in
                                addition to code for
                                primary procedure).
97605........................  Negative pressure wound               0.55             0.55   Finalize.
                                therapy (e.g., vacuum
                                assisted drainage
                                collection), utilizing
                                durable medical equipment
                                (DME), including topical
                                application(s), wound
                                assessment, and
                                instruction(s) for
                                ongoing care, per
                                session; total wound(s)
                                surface area less than or
                                equal to 50 square
                                centimeters.

[[Page 70996]]

 
97606........................  Negative pressure wound               0.60             0.60   Finalize.
                                therapy (e.g., vacuum
                                assisted drainage
                                collection), utilizing
                                durable medical equipment
                                (DME), including topical
                                application(s), wound
                                assessment, and
                                instruction(s) for
                                ongoing care, per
                                session; total wound(s)
                                surface area greater than
                                50 square centimeters.
97607........................  Negative pressure wound                   C                C  Finalize.
                                therapy, (e.g., vacuum
                                assisted drainage
                                collection), utilizing
                                disposable, non-durable
                                medical equipment
                                including provision of
                                exudate management
                                collection system,
                                topical application(s),
                                wound assessment, and
                                instructions for ongoing
                                care, per session; total
                                wound(s) surface area
                                less than or equal to 50
                                square centimeters.
97608........................  Negative pressure wound                   C                C  Finalize.
                                therapy, (e.g., vacuum
                                assisted drainage
                                collection), utilizing
                                disposable, non-durable
                                medical equipment
                                including provision of
                                exudate management
                                collection system,
                                topical application(s),
                                wound assessment, and
                                instructions for ongoing
                                care, per session; total
                                wound(s) surface area
                                greater than 50 square
                                centimeters.
97610........................  Low frequency, non-                   0.35             0.35   Finalize.
                                contact, non-thermal
                                ultrasound, including
                                topical application(s),
                                when performed, wound
                                assessment, and
                                instruction(s) for
                                ongoing care, per day.
99183........................  Physician or other                    2.11             2.11   Finalize.
                                qualified health care
                                professional attendance
                                and supervision of
                                hyperbaric oxygen
                                therapy, per session.
99184........................  Initiation of selective               4.50             4.50   Finalize.
                                head or total body
                                hypothermia in the
                                critically ill neonate,
                                includes appropriate
                                patient selection by
                                review of clinical,
                                imaging and laboratory
                                data, confirmation of
                                esophageal temperature
                                probe location,
                                evaluation of amplitude
                                EEG, supervision of
                                controlled hypothermia,
                                and assessment of patient
                                tolerance of cooling.
99188........................  Application of topical                   N                N   Finalize.
                                fluoride varnish by a
                                physician or other
                                qualified health care
                                professional.
99487........................  Complex chronic care                     B                B   Finalize.
                                management services, with
                                the following required
                                elements: Multiple (two
                                or more) chronic
                                conditions expected to
                                last at least 12 months,
                                or until the death of the
                                patient; chronic
                                conditions place the
                                patient at significant
                                risk of death, acute
                                exacerbation/
                                decompensation, or
                                functional decline;
                                establishment or
                                substantial revision of a
                                comprehensive care plan;
                                moderate or high
                                complexity medical
                                decision making; 60
                                minutes of clinical staff
                                time directed by a
                                physician or other
                                qualified health care
                                professional, per
                                calendar month.
99490........................  Chronic care management               0.61             0.61   Finalize.
                                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 monitored.
G0277........................  Hyperbaric oxygen under               0.00             0.00   Finalize.
                                pressure, full body
                                chamber, per 30 minute
                                interval.
G0279........................  Diagnostic digital breast             0.60             0.60   Finalize.
                                tomosynthesis, unilateral
                                or bilateral (list
                                separately in addition to
                                G0204 or G0206).
G0389........................  Ultrasound b-scan and/or              0.58             0.58   Finalize.
                                real time with image
                                documentation; for
                                abdominal aortic aneurysm
                                (AAA) screening.
G0473........................  Face-to-face behavioral               0.23             0.23   Finalize.
                                counseling for obesity,
                                group (2-10), 30 minutes.
----------------------------------------------------------------------------------------------------------------

a. Specific Issues for Codes With CY 2015 Interim Final Values
(1) Ablation Therapy (CPT Code 20983)
    In CY 2015 we established the RUC-recommended work RVU for CPT code 
20983 and made minor refinements to the RUC-recommended direct PE 
inputs.
    Comment: A commenter stated that the total clinical labor times in 
the direct PE input database are inconsistent with the RUC-recommended 
values. The commenter mentioned that some of the service period 
activity time was assigned to the total post-service clinical labor 
time.
    Response: We reviewed the direct PE input database and confirmed 
the time for clinical labor task ``Assist Physician'' was missing for 
labor type L046A. We will restore the missing labor time as we intended 
to establish as interim final the RUC recommendation for the clinical 
labor times without refinement.
(2) Automatic Fixation of Rib Fracture (CPT Codes 21811, 21812, and 
21813)
    For CY 2015, the CPT Editorial Panel deleted CPT code 21810 
(Treatment of rib fracture requiring external fixation) and replaced it 
with CPT codes 21811, 21812, and 21813 to address internal fixation of 
rib fracture. As described in the CY 2015 PFS final rule with comment 
period, the RUC recommended that we value these procedures with 90-day 
global periods. We indicated that we believed it would be more 
appropriate to value these

[[Page 70997]]

procedures with 0-day global periods. We valued each of these services 
by subtracting the work RVU related to postoperative care from the 
total work RVU. We also refined the RUC-recommended time by subtracting 
the time associated with the postoperative visits, and removed direct 
PE inputs associated with the postoperative visits.
    In the CY 2015 PFS final rule with comment period, we considered 
whether certain pre-service clinical labor tasks would typically be 
performed given that these procedures are frequently furnished on an 
emergency basis. We reviewed other emergency procedures valued under 
the PFS to determine whether pre-service clinical labor activities were 
typically included in the PE worksheets and found that the 
recommendations for these procedures were inconsistent. Therefore, in 
the CY 2015 PFS final rule with comment period, we did not remove the 
time allocated for certain clinical labor activities, but sought public 
comment on this issue.
    Comment: One commenter expressed concerns with the methodology 
employed by CMS. The commenter stated that CMS staff had attended the 
RUC meeting where these codes were reviewed and were aware that a 
building block methodology (BBM) was not used to build the work RVUs 
for these codes. Therefore, the commenter suggested it was incorrect 
for CMS to use a reverse BBM to calculate a new value.
    Response: We are committed to establishing the most accurate 
valuation possible for each procedure. In this case, we examined the 
results of the reverse BBM and determined that it was the most 
appropriate approach to value these services. Due to the emergency 
nature of these procedures, we believe that they are more accurately 
valued using a 0-day global period.
    Comment: Another commenter reminded CMS that the specialty 
societies surveyed these three codes based on a 90-day global period 
and that CMS had ample opportunity to inform the RUC and the 
specialties of an impending change in the global assignment prior to 
the development of recommended RVUs.
    Response: We understand that the specialties surveyed the codes 
under the assumption that they would be valued with a 90-day global 
period, prior to our determination that these services would be more 
accurately valued as 0-day globals due to their emergency nature. We 
believe that in the case of these emergent services, it may not be 
typical for the individual performing the initial procedure to be 
responsible for providing the follow-up care. Therefore, we believe 
that the 0-day global period to more accurately reflect the care 
furnished. This is precisely why it was necessary for us to account for 
the change in global period when establishing interim final work RVUs 
for the codes. To do so, we employed a reverse BBM to establish 
separate work RVUs for the individual procedure in each case. As we 
have previously stated, we believe that the best way to improve the 
valuation of codes that describe multiple services over long periods of 
time (for example, 90 days) is to develop discrete values for the 
component services. We agree that survey results are likely to be most 
useful when there is consistency between the global period as surveyed 
and the global period in the final valuation of the code. However, 
because we did not have such survey data in this case, we used another 
established methodology to develop a potential work RVUs. In this case, 
we believe that the reverse building block methodology establishes the 
most accurate value for this group of codes. Although the RUC 
recommends global periods for individual services and often consults 
with CMS staff regarding the typical global periods for such services, 
we believe that it is appropriate to establish global period for 
particular codes through rulemaking. If stakeholders are concerned 
about the final values for services surveyed based on a presumed global 
period that is not ultimately applied to the individual code, then we 
encourage stakeholders to consider nominating such codes as potentially 
misvalued through the public nomination process.
    Comment: One commenter suggested that CMS did not provide reference 
codes with 0-day global periods to support the new interim final work 
RVUs. The commenter disagreed with the work RVUs established by CMS and 
suggested that all three of the codes in question were undervalued. The 
commenter provided information about other codes with 0-day global 
periods that had similar work time. The commenter urged CMS to 
reinstate the 90-day global period and accept the RUC recommendations 
for work RVUs, similar to other trauma codes.
    Response: After reviewing the codes provided by the commenter, we 
believe that the values of other existing codes support our valuation 
of these procedures. For CPT code 21811, we note that CPT code 93650 
(Intracardiac catheter ablation of atrioventricular node function) 
shares the same intraservice time of 120 minutes and has a higher total 
time (240 minutes compared to 220 minutes for CPT code 21811), but a 
lower work RVU of 10.49. We believe that the work RVU assigned to CPT 
code 21811 fits well within the work RVUs for the group of codes that 
have 0-day global periods and 120 intraservice minutes. For CPT code 
21812, we note that 92997 (Percutaneous transluminal pulmonary artery 
balloon angioplasty), which has 5 additional minutes of intraservice 
time (155 minutes compared to 150 minutes for 21812) and a higher total 
time (275 minutes compared to 250 minutes for 21812), has a lower work 
RVU of 11.98. We believe that our valuation of CPT code 21812 maintains 
relativity within this group of 0-day global codes with times of 
approximately 150 intraservice minutes.
    For CPT code 21813, we agree with the commenter that there is a 
lack of 0-day global codes with comparable intraservice times. We also 
agree with the commenter's suggestion that CPT codes 93654 and 93656 
provide the best references available. These codes share an 
intraservice time of 240 minutes compared to the 210 minutes of 
intraservice time for CPT code 21813. However, we disagree with the 
commenter that CPT code 21813 is undervalued based on a comparison of 
these intraservice times. Applying the ratio between the 210 minutes 
for CPT code 21813 and the 240 minutes for the reference CPT code 93654 
(0.875) to the work RVU of 20.00 for CPT code 93654, results in a work 
RVU of 17.50. This is similar to our valuation for CPT code 21813 of 
17.61. We believe that this intraservice time ratio further supports 
our valuation of CPT code 21813, which maintains relativity with 
similar 0-day global codes. After consideration of comments received, 
we are finalizing the interim final work RVUs for CPT codes 21811, 
21812, and 21813 for CY 2016.
(3) Percutaneous Vertebroplasty and Augmentation (CPT Codes 22510, 
22511, 22512, 22513, 22514, and 22515)
    In CY 2015, we established the RUC-recommended work RVUs as interim 
final for all of the codes in this family except CPT code 22511 because 
we did not agree with its RUC-recommended crosswalk. To value this 
code, we took the difference between the work RVUs for the predecessor 
codes for CPT codes 22510 and 22511, CPT codes 22520 (Percutaneous 
vertebroplasty (bone biopsy included when performed), one vertebral 
body, unilateral or bilateral injection; thoracic)) and 22521 
(Percutaneous vertebroplasty (bone biopsy included when performed), one 
vertebral body, unilateral or bilateral injection; thoracic; lumbar)) 
and applied

[[Page 70998]]

that to the work RVU we established for CPT code 22510. We believed 
that increment established the appropriate rank order in the family, 
and thus, assigned an interim final work RVU of 7.58 for CPT code 
22511.
    Comment: A commenter disagreed with the methodology CMS used for 
valuing CPT code 22511 because they believed CMS' approach was 
arbitrary and invalidated the RUC process of using new survey data. The 
commenter urged CMS to accept the RUC-recommended work RVU of 8.05 for 
this code.
    Another commenter requested that CMS reconsider the RVUs for these 
codes. The commenter believed that, due to the bundling of these 
imaging codes for CY 2015, additional PE costs were added to the 
service. The commenter expressed concerns that practitioners might find 
it infeasible to furnish these services in the non-facility setting if 
payment continues to be based on the interim final values we adopted 
for CY 2015.
    Additionally, several commenters alerted CMS to missing clinical 
labor times for ``assist physician'' for all of the codes in this 
family. Some commenters also stated that clinical labor time was 
missing for the post-operative visit in CPT codes 22510, 22511, 22513, 
and 22514.
    Response: Unlike other codes in this family for which the RUC-
recommended work RVU was based on the 25th percentile in the survey, 
the RUC established its recommended work RVU for CPT code 22511 by 
crosswalking the service to CPT code 39400 (Mediastinoscopy, includes 
biopsy(ies), when performed), which has a work RVU of 8.05. Because the 
level of work performed by a practitioner in the two services differs, 
we continue to believe that this crosswalk is inaccurate. We maintain 
that a more accurate comparison is found in the difference between the 
work RVUs for the predecessor codes for CPT codes 22510 and 22511 and 
that applying this differential leads to appropriate valuation.
    We agree with the commenters that there were inconsistencies in the 
clinical labor times for these codes as entered in our direct PE 
database. We direct the reader to section II.B. of this final rule with 
comment period for a discussion of these clinical labor input 
inconsistencies.
    Therefore, we are finalizing our CY 2015 work valuation for CPT 
codes 22510, 22511, 22512, 22513, 22514, and 22515.
(4) Total Disc Arthroplasty (CPT code 22856)
    In the CY 2015 PFS final rule with comment period, we maintained 
the CY 2014 work RVU for CPT code 22856, consistent with the RUC 
recommendation.
    Comment: One commenter suggested that CPT code 22856 has been 
undervalued since 2009. The commenter believed CMS should value this 
service relative to several other codes that together comprise standard 
anterior cervical discectomy and fusion which the commenter believes is 
appropriately valued. The commenter stated that a higher valuation 
would be consistent with higher procedure operating room time included 
for CPT code 22856 in six clinical trials.
    Response: We appreciate the submission of this additional 
information about the current practice of cervical disc replacement 
from the commenter. However, for the purpose of valuation, we typically 
compare a procedure against a broad range of other procedures across 
the PFS to help maintain relativity, rather than a single related 
procedure. In addition to intraservice operating time, other resource 
costs are included in the work RVU, such as the clinical intensity of 
the procedure and the time and intensity of the pre- and post-work, 
including post-operative visits.
    After consideration of comments received, we are finalizing the CY 
2015 interim final work RVU for CY 2016 without modification, 
consistent with the RUC recommendation.
(5) Sacroiliac Joint Fusion (CPT code 27279)
    In the CY 2015 PFS final rule with comment period, we maintained 
the CY 2014 work RVU for CPT code 27279, consistent with the RUC 
recommendation.
    Comment: Several commenters stated that the RUC survey data were 
not reliable because the reference service (CPT code 62287, 
Percutaneous discectomy) with a work RVU of 9.03 is not comparable. One 
of the commenters, a professional association, recommended a work RVU 
of 14.36 based upon its own survey or a work RVU of 13.18 based on a 
comparison with CPT code 63030 (Low back disk surgery). This commenter 
requested that CMS refer CPT code 27279 to the multispecialty 
refinement panel.
    Response: CPT code 27279 was referred to the CY 2015 Multi-
Specialty Refinement Panel per the commenter's request. The outcome of 
the refinement panel was a median of 9.03 work RVUs. After 
consideration of the comments and the results of the refinement panel, 
we are finalizing our interim final work RVU of 9.03 for CPT code 
27279.
(6) Subcutaneous Implantable Defibrillator Procedures (CPT Codes 33270, 
33271, 33272, 33273, 93260, 93261 and 93644)
    For CY 2015, the CPT Editorial Panel added the word ``implantable'' 
to the descriptors for several codes in this family and created several 
new codes (CPT codes 33270, 33271, 33272, 33273, 93260, 93261, and 
93644). We established as interim final the RUC-recommended work RVUs 
for all of the codes in this family except CPT code 93644. The RUC-
recommended times for CPT code 93644 included an intraservice time of 
20 minutes and a total time of 84 minutes. We disagreed with the RUC-
recommended direct crosswalk for CPT code 93644 because the code that 
serves as the source for the crosswalk had greater intraservice time 
(29 minutes) and total time (115 minutes). We believed that a crosswalk 
to CPT code 32551 was more accurate since the intraservice time for CPT 
code 32551 was 20 minutes, total time was 83 minutes, and intensity was 
comparable. Therefore, we established a CY 2015 interim final work RVU 
of 3.29 for CPT code 93644.
    Comment: Two commenters expressed disappointment that CMS did not 
accept the RUC recommendation for CPT code 93644. The commenters 
disagreed with the decision to crosswalk the work RVU for CPT code 
93644 from CPT code 32551 because they believed that the services were 
not similar in nature. Commenters suggested that CMS accept the RUC 
recommendation with a crosswalk from CPT code 15002, due to a similar 
intraservice time. The commenters also requested that CPT code 93644 be 
referred to the multispecialty refinement panel.
    Response: We continue to believe that crosswalking the value for 
CPT code 93644 from CPT code 32551 is the best way to value this 
service due to the codes' similar intraservice and total times and 
similar intensity. We believe that the difference in time values for 
the RUC-recommended crosswalk is too great to serve as a direct 
crosswalk for overall work. We did not receive any new clinical 
information needed for referral of this code to the multispecialty 
refinement panel. Therefore, we are finalizing our CY 2015 valuation.

[[Page 70999]]

(7) Fenestrated Endovascular Repair (FEVAR) Endograft Planning (CPT 
Codes 34839-34848)
    For CY 2015, we examined several FEVAR codes. CPT code 34839 was 
created to report the planning that occurs prior to the work included 
in the global period for a FEVAR. We accepted the RUC recommendation 
for all of the codes in this family except CPT code 34839. We believed 
the planning that occurs prior to the work was included in the global 
period for FEVAR and should be bundled with the underlying service. We 
did not believe bundling was inappropriate in this case. Accordingly, 
we assigned a PFS procedure status indicator of B (Bundled Code) to CPT 
code 34839.
    Comment: One commenter requested that CMS issue coding guidance 
regarding with which codes the FEVAR co-surgeon modifier can be used.
    Response: We appreciate the commenter's feedback. We will take this 
comment into consideration in developing guidance for use of the co-
surgeon modifier.
(8) Endovenous Ablation Therapy (CPT Codes 36475-36479)
    For CY 2015, we examined several endovenous ablation therapy codes 
and used the RUC-recommended work RVUs to establish interim final work 
RVUs. We made minor refinements to the RUC recommended direct PE inputs 
to establish interim final direct PE inputs for this family of codes.
    Comment: A commenter requested that CMS review the difference in PE 
inputs between CPT codes 36475 and 36478. The commenter stated that 
they believed CPT code 36478 was missing supplies which are commonly 
used in the procedure, and that this difference in reimbursement could 
only be explained by errors in the supply and staff inputs. The 
commenter also provided clinical information suggesting that the laser 
technique of endovenous ablation therapy described in CPT code 36478 is 
more effective than the radiofrequency treatment described in CPT code 
36475.
    Response: We thank the commenter for bringing this issue to our 
attention. We agree that there are errors in the direct PE database 
regarding these two codes. After consideration of comments received, we 
are making the following refinements. For CPT code 36475, we are adding 
one unit of supply item ``needle, spinal 18-26g'' (SC028) and one unit 
of supply item ``syringe 20 ml'' (SC053). For CPT code 36478, we are 
adding 5 minutes of clinical labor time of staff type L037D for ``Apply 
multi-layer comprehensive dressing'' and adding 3 minutes of clinical 
labor time of the same type for ``Check dressings & wounds.'' We are 
also removing 2 minutes of clinical labor time of staff type L054A for 
``Patient clinical information and questionnaire reviewed by 
technologist'', as this time was inadvertently included in the direct 
PE database. This results in identical clinical labor inputs for the 
two procedures, as the commenter correctly pointed out should be the 
case.
    With regards to the commenter's feedback regarding the supplies 
allocated to CPT codes 36475 and 36478, we reviewed the direct PE 
inputs as recommended by the RUC and agree that they represent the 
typical inputs used in furnishing these procedures.
    Comment: One commenter disagreed with all of the PE refinements 
made in this family. The commenter stated that 30 minutes was typical 
recovery time for input code EF019 (stretcher chair) and that 32 
minutes is the time the room is unavailable to other patients for input 
codes EL015 (room, ultrasound, general), EQ215 (radiofrequency 
generator (vascular)), and EQ160 (laser, endovascular ablation (ELVS)). 
The commenter also stated that additional images are inherent to the 
add-on codes which justify the extra minute in input code L054A 
(vascular technologist). Another commenter expressed support for CMS' 
acceptance of the RUC-recommended RVUs and times for these services.
    Response: In establishing interim final times for the direct 
equipment inputs, we followed our standard methodologies that resulted 
in the allocated equipment times for EL015, EL215, and EQ160 for these 
codes in the direct PE input database. We believe that adherence to 
these standard methodologies maintains relativity within the 
development of PE RVUs and is likely to reflect the typical case. We 
disagree with commenters regarding the equipment times for EL015, 
El215, and EQ160. However, we agree additional images are inherent in 
the add-on codes, which supports the additional minute of clinical 
labor time. Therefore, we are finalizing the interim final values for 
these services, with the exception of the refinements to the clinical 
labor, supplies, and equipment described above.
(9) Cryoablation of Liver Tumor (CPT Code 47383)
    For CY 2015, we proposed the RUC-recommended work RVU of 9.13 for 
CPT code 47383 and made several refinements to the recommended clinical 
labor and equipment times.
    Comment: A commenter stated that the clinical labor time associated 
with the 99212 postoperative visit did not appear in the CMS direct PE 
public use files.
    Response: We appreciate the assistance from the commenter in 
bringing this issue to our attention. We have corrected this error in 
the CMS direct PE public use files; we note that this issue was limited 
to the public use files and had no impact on the calculation of PE 
RVUs. For further information, please see the Identification of 
Database Errors in section II.H. of this final rule with comment 
period.
    After consideration of comments received, we are finalizing the CY 
2015 interim final work RVU and direct PE inputs as proposed for CPT 
code 47383.
(10) Transprostatic Implant Procedures (TIP) (CPT Codes 52441 and 
52442)
    In CY 2015, we established the RUC-recommended work RVUs and direct 
PE inputs as interim final for CPT codes 52441 and 52442.
    Comment: One commenter agreed with the list and total cost of 
direct PE supplies established by CMS.
    Response: We appreciate the commenter's supportive comments. We are 
finalizing our CY 2015 valuation for CPT codes 52441 and 52442.
(11) Laparoscopic Hysterectomy (CPT codes 58541, 58542, 58543, 58544, 
58570, 58571, 58572, and 58573)
    In the CY 2015 final rule with comment period, we established as 
interim final the RUC-recommended work RVUs and direct PE inputs for 
these codes.
    Comment: Two commenters requested that these codes be sent to the 
multispecialty refinement panel prior to finalizing their work RVUs for 
CY 2016. Commenters stated that gynecologic oncologists were not 
offered the chance to participate in the RUC surveys for these 
procedures. As a result, the survey results did not reflect the typical 
patients that receive these procedures from practitioners of that 
specialty, who have complex medical needs with co-morbid conditions and 
complications. Commenters also indicated that the Food and Drug 
Administration (FDA) recently discouraged the use of morcellation 
during these procedures, which increases the amount of time it takes to 
perform the procedure and remove the fibroids prior to removing the 
uterus. The commenters stated that these changes need to be taken into 
account with new data prior to finalizing these work RVUs.

[[Page 71000]]

    Response: We received and granted a request for multispecialty 
refinement panel review based on the presentation of new clinical 
information. However, the specialty groups making the original request 
later chose not to present these procedures at the 2015 Multi-Specialty 
Refinement Panel. After consideration of comments received and the lack 
of review by the multispecialty refinement panel, we are finalizing the 
CY 2015 interim final work RVUs for CPT codes 58541, 58542, 58543, 
58544, 58570, 58571, 58572, and 58573 for CY 2016.
(12) Myelography (CPT Codes 62284, 62302, 62303, 62304, 62305, 72240, 
72255, 72265, and 72270)
    In the CY 2015 PFS final rule with comment period, we accepted the 
RUC-recommended work RVU for these nine codes on an interim final 
basis. We made refinements to the clinical labor and equipment time for 
the non-radiological codes in the family.
    Comment: A commenter stated that the RUC recommended only a single 
staff type for the myelography codes, with clinical labor L041B for the 
radiological codes and L037D for the non-radiological ones. The 
commenter stated that they did not believe it would be typical to have 
two staff types involved in the procedure, and suggest allocating all 
minutes for the non-radiological codes to L037D.
    Response: We agree with the commenter that assigning all of the 
clinical labor to a single staff type for each of the two types of 
procedure in the myelography family would be more typical for these 
services. Therefore we are changing the clinical labor type from L041B 
to L037D for the clinical labor activities ``Availability of prior 
images confirmed'', ``Patient clinical information and questionnaire 
reviewed by technologist, order from physician confirmed and exam 
protocoled by radiologist'' and ``Assist physician in performing 
procedure'' for CPT codes 62302, 62303, 62304, and 62305. This ensures 
a single staff type for each of the nine codes in this family.
    After consideration of comments received, we are finalizing these 
codes as proposed, with the change in clinical staff type detailed 
above.
(13) Maxillofacial Computed Tomography (CT) (CPT Codes 70486, 70487 and 
70488)
    In the CY 2015 PFS final rule with comment period, we used the RUC-
recommended work RVU to establish an interim final work RVU of 0.85 for 
CPT code 70486 (Computed tomography, maxillofacial area; without 
contrast material). The RUC arrived at this value by crosswalking CPT 
code 70486 to CPT code 70460 (Computed tomography, head or brain; with 
contrast material(s)), which is the equivalent code in the head and 
brain CT family. To maintain rank order within and across CT families, 
we crosswalked the work RVU for CPT code 70487 (Computed tomography, 
maxillofacial area; with contrast material(s)) from CPT code 70460 
(Computed tomography, head or brain; with contrast material(s)). We 
also crosswalked the work RVU for CPT code 70488 (Computed tomography, 
maxillofacial area; without contrast material, followed by contrast 
material(s) and further sections) from CPT code 70470 (Computed 
tomography, head or brain; without contrast material, followed by 
contrast material(s) and further sections). Therefore, we established 
interim final work RVUs of 1.13 for CPT code 70487 and 1.27 for CPT 
code 70488.
    Comment: For CPT codes 70487 and 70488, commenters suggested that 
the CMS crosswalks did not accurately reflect the intensity of 
maxillofacial CT. Commenters suggested that CPT codes 70487 and 70488 
require a thinner CT slice technique than the CMS crosswalks of CPT 
codes 70460 and 70470, and that the volume of images to be interpreted 
is greater. Commenters suggested that maxillofacial CTs were 
instrumental in imaging potentially dangerous conduits, which could be 
damaged due to maxillofacial disease.
    Response: We continue to believe that since the lowest of the brain 
CT code family was an accurate crosswalk for CPT code 70486, the other 
two codes in the brain CT family are also accurate crosswalks for CPT 
codes 70487 and 70488. The procedures are similar in terms of both 
intraservice time and complexity of the anatomical region. While 
commenters requested that these codes be addressed by the 
multispecialty refinement panel, the request did not include 
information reflecting new clinical evidence, and therefore, did not 
meet the established criteria for review by the multispecialty 
refinement panel.
    Comment: For CPT codes 70487 and 70488, commenters requested 3 
minutes for the clinical labor task ``Provide pre-service education and 
obtain consent.''
    Response: Upon review of the task ``provide pre-service education 
and obtain consent,'' we agree with commenters that 3 minutes is an 
accurate estimate for the amount of time required to discuss the risks 
involved in these procedures. Three minutes also maintains consistency 
within the code family. Therefore, we are including 3 minutes for 
``provide pre-service education and obtain consent in the direct PE 
input database.
(14) Abdominal Ultrasound (CPT Codes 76700, 76705, 76770, 76775, 76856, 
and 76857)
    For CY 2015, we used the RUC-recommended work RVUs and PE inputs to 
establish interim final values for six codes in the abdominal 
ultrasound family.
    Comment: Commenters noted that CPT codes 76700 and 76705 were 
missing from the direct PE input database.
    Response: We appreciate the commenters' attention to detail and we 
have included these codes in the updated direct PE input database.
(15) Breast Ultrasound (CPT Codes 76641 and 76642)
    For CY 2015, the CPT Editorial Panel replaced CPT code 76645 
(Ultrasound, breast(s) (unilateral or bilateral), real time with image 
documentation) with two codes: CPT codes 76641 (Ultrasound, breast, 
unilateral, real time with image documentation, including axilla when 
performed; complete) and 76642 (Ultrasound, breast, unilateral, real 
time with image documentation, including axilla when performed; 
limited). We used the RUC-recommended work RVUs of 0.73 and 0.68 to 
establish interim final work RVUs for CPT codes 76641 and 76642, 
respectively.
    Comment: A few commenters encouraged CMS to refine the input for 
ultrasound room from 27 minutes to 29 minutes for CPT code 76641 and 
from 20 to 22 minutes for CPT code 76642 because ultrasound uses 
distinctive imaging equipment. All clinical labor tasks require usage 
of the machine, making the room unavailable during that time.
    Response: The number of minutes assigned to the ultrasound room for 
both codes conforms to established times for highly technical 
equipment. We believe that adherence to these standard methodologies 
maintains relativity within the development of PE RVUs. Therefore, we 
are finalizing the interim final direct PE inputs for these services.
(16) CT Angiography (CTA) Head (CPT Codes 70496 and 70498)
    In the CY 2015 PFS final rule with comment period, we used the RUC-
recommended work and direct PE input recommendations without refinement 
to establish interim final values for these codes.
    Comment: Some stakeholders stated that clinical staff time for 
confirming prior images and reviewing patient

[[Page 71001]]

clinical information was erroneously allocated to Rad Tech (L041B) 
instead of CT tech (L046A) and that CMS removed 2 minutes from clinical 
labor task ``technologist QC''. Commenters suggested that both actions 
were inconsistent with other codes in the CTA family.
    Response: We reviewed the interim final direct PE inputs as well as 
the ``PE worksheet'' that accompanied the RUC recommendation. We noted 
that the values in ``CMS code'' and ``staff type'' columns were 
discrepant for the two clinical labor tasks noted by the commenters. 
While the CMS code indicated L041B, the Staff Type indicated CT Tech. 
We have therefore corrected the CMS code from L041B to L046A to 
correspond to the clinical staff type. We reviewed the direct PE 
database and confirmed that clinical labor task ``Technologist QC's 
images in PACS, checking for all images, reformats, and dose page'' is 
included for these codes. We are finalizing the interim final values 
for these services, with the additional correction of the staff type 
discrepancy.
(17) Breast Tomosynthesis (CPT Codes 77061, 77062, and 77063)
    In the CY 2015 PFS final rule with comment period, we assigned a 
PFS indicator of ``I'' to CPT codes 77061 and 77062 on an interim basis 
while awaiting recommendations from the RUC for all mammography 
services. Since CPT code 77063 is an add-on code and did not have an 
equivalent CY 2014 code, we believed it was appropriate to value it on 
an interim final basis in advance of receiving the RUC recommendations 
for other mammography services. We assigned it a CY 2015 interim final 
work RVU of 0.60 as recommended by the RUC. We also removed the 
equipment time for the PACS Workstation proxy from all three codes, and 
removed the time for task ``Federally Mandated MQSA Activities 
Allocated To Each Mammogram'' from CPT code 77063.
    Comment: A commenter indicated that the direct PE input files 
included a PACS Workstation proxy for CPT code 77063, but did not 
allocate clinical staff time to this proxy.
    Response: We removed the 4 minutes of clinical labor associated 
with ``Federally Mandated MQSA Activities Allocated To Each Mammogram'' 
due to the fact that CPT code 77063 is an add-on code, and this task 
would already have been performed previously with another mammography 
service. We did not assign equipment time for the PACS Workstation as 
we do not believe that its use would be typical for this procedure.
    After consideration of comments received, we are finalizing the PFS 
indicator ``I'' for CPT codes 77061 and 77062, the interim final work 
RVU of 0.60 for CPT code 77063, and the interim final direct PE inputs 
for all three codes.
(18) Dosimetry (CPT Codes 77300, 77306, and 77307)
    To establish interim final RVUs for these codes, we used the RUC-
recommend work and direct PE inputs for these codes with PE 
refinements, with the refinement of consideration of the ``record and 
verify system'' as an indirect PE.
    Comment: A few commenters expressed support for CMS' adoption of 
the RUC-recommended work RVUs for CPT codes 77306 and 77307. Other 
commenters requested that CMS consider equipment item ED011 (record and 
verify) as a direct PE input because it is typically used during the 
procedures.
    Response: We appreciate the commenters' feedback related to these 
services. We reviewed the ``record and verify'' equipment item and 
agree with commenters that ``record and verify'' should be included as 
a direct PE to maintain consistency with other services in the direct 
PE database, and have updated the direct PE input database accordingly.
(19) Brachytherapy Isodose Plan (CPT Codes 77316, 77317, and 77318)
    For CY 2015, the CPT Editorial Panel replaced six CPT codes (77305, 
77310, 77315, 77326, 77327, and 77328) with five new CPT codes to 
bundle basic dosimetry calculation(s) with teletherapy and 
brachytherapy isodose planning. We established interim final work RVUs 
based on the RUC-recommended work RVUs for CY 2015 for all of the codes 
in this family except CPT code 77316. Instead of using the RUC-
recommended work RVU for CPT code 77316, a simple isodose planning 
code, we developed an interim final work RVU based on a direct 
crosswalk from the corresponding simple isodose planning code in the 
same family, CPT code 77306. Therefore, for CY 2015 we established an 
interim final work RVU of 1.40 for CPT code 77316. This approach is 
similar to the crosswalk the RUC used to develop the recommended work 
RVUs for CPT code 77318.
    Comment: Commenters disagreed with CMS' refinements to CPT code 
77316 and stated that although CPT code 77316 is the simple isodose 
planning code in the family, the CMS-recommended crosswalk to CPT code 
77306 does not accurately capture the intensity of the procedure. 
Commenters suggested that CPT code 77316 is typically used for HDR 
brachytherapy with a single channel and more than four dwell positions. 
This requires more work than CPT code 77306, which is for external beam 
radiation planning. Commenters requested that CPT code 77316 be 
referred to the multispecialty refinement panel.
    Response: Commenters did not provide new clinical information and, 
therefore we did not refer the codes to the multispecialty refinement 
panel. The RUC recommended a crosswalk for CPT code 77318 to CPT code 
77307. We believe that if the work resources for the complex isodose 
planning codes are comparable between the two families, then the work 
resources between the simple isodose planning codes are also 
comparable. Therefore, we believe that the most accurate work RVU for 
CPT code 77316 is 1.40, based on a crosswalk to CPT code 77306.
    Comment: Several commenters thanked CMS for adopting the RUC-
recommended work RVUs for CPT codes 77317 and 77318.
    Response: We appreciate the commenters' support. We are finalizing 
the CY 2015 interim final work RVUs as established.
(20) Electron Microscopy (CPT Code 88348)
    We received PE-only recommendations for CPT code 88348 following 
the October 2013 RUC meeting. After reviewing these recommendations, we 
used the RUC recommendations without refinement to establish interim 
final values for CY 2015.
    Comment: One commenter wrote to express their disagreement with the 
79 percent reduction in the technical component of the procedure 
following the publication of the CY 2015 final rule. The commenter 
suggested that there was an error in evaluating the value and cost of 
this service, and provided additional information regarding the direct 
costs associated with providing electron microscopy to patients. The 
commenter stated that continued reduction in the value for CPT code 
88348 will result in a reduction in the availability of tests which 
will provide impaired service to many patients with treatable 
conditions and salvageable kidney function.
    Response: We concur with the commenter on the importance of 
providing patient access to quality testing. However, we do not believe 
that there was an error in evaluating the value and cost of this 
service. We agreed with the RUC recommendations for

[[Page 71002]]

direct PE inputs for CPT code 88348, and we continue to believe that 
these represent the most accurate values for this procedure.
(21) Microdissection (CPT Codes 88380 and 88381)
    In reviewing the RUC recommendations for CPT code 88380, the work 
vignette indicated that the microdissection is performed by the 
pathologist. However, the PE worksheet also included several subtasks 
of ``Microdissect each stained slide sequentially while reviewing H and 
E stained slide'' that are performed by the cytotechnologist. Since we 
did not believe that both the pathologist and the cytotechnologist were 
completing these tasks, we did not allocate clinical labor time for the 
specific tasks we believe are completed by the pathologist. Table 31 of 
the CY 2015 final rule (FR 79 67697-67698) detailed our refinements to 
these clinical labor tasks. We accepted the RUC-recommended work RVU of 
1.14 for CPT code 88380 and 0.53 for CPT code 88381 on an interim final 
basis for CY 2015.
    Comment: A commenter urged CMS to accept and implement the practice 
expense inputs recommended by the RUC for CPT code 88380. For the 
clinical labor task ``Dispose of razor blade, Cap tube and vortex 
specimens'', the commenter stated that the recommended 3 minutes for 
blade disposal tube capping is part of the processing of the individual 
specimen. The commenter suggested that the word ``blade disposal'' may 
have been confusing since it is not a cleaning function. The commenter 
requested that CMS restore the RUC-recommended 3 minutes for this task.
    Response: We do not believe that clinical labor time should be 
assigned for this task, as CPT code 88380 uses a laser to perform the 
same activity. We do not believe that the use of a razor blade, and 
associated clinical labor, would be typical for this procedure.
    Comment: One commenter stated that the RUC recommended 18 minutes 
for the clinical labor task ``Turn on dissecting microscope, place 
slide on scope, remove razor blade from box. Microdissect tissue within 
etched area, while viewing slide under dissecting scope, place tissue 
into cap of collection tube with blade. Repeat this step for seven 
other slides.'' The commenter indicated that the cytotechnologist and 
pathologist are working together during this task, and the assistance 
of the cytotechnologist is necessary during these ancillary tasks for 
the efficiency of the dissection process. The work survey results 
indicated that some of the work time has shifted to the clinical labor 
time for this particular task.
    Response: We continue to believe that the pathologist is the 
individual performing this clinical labor task, not the 
cytotechnologist.
    Comment: One commenter disagreed with the CMS refinement to the 
equipment time for the Veritas microdissection instrument (EP087). The 
commenter stated that the equipment time associated with EP087 is the 
sum of time to prepare the instrument for use, plus the time the 
pathologist and cytotechnologist are using it, plus the time the room 
and equipment are cleaned. The commenter suggested that while 
microdissection is taking place, the equipment cannot be used for any 
other purpose. The commenter indicated that the sum of these time 
increments equals 34 minutes, not the 32 minutes as refined by CMS.
    Response: We appreciate the commenter's assistance in providing 
clarification regarding the appropriate equipment time for EP087. After 
consideration of comments received, we agree that the Veritas 
microdissection instrument would typically be in use for 33 minutes of 
intraservice time, plus 3 minutes for laser preparation, plus one 
minute for room cleaning following equipment use. Therefore, we are 
refining the equipment time for EP087 to 37 minutes for CPT code 88380, 
to match the standard equipment time formula, and finalizing all other 
direct PE inputs as established as interim final.
(22) Electro-Oculography (EOG VNG) (CPT Code 92543)
    We established a work RVU of 0.10 for CPT code 92543 as interim 
final for CY 2015. Several commenters disagreed with our interim final 
values. However, the CPT Editorial Panel deleted CPT code 92543 for CY 
2016; we refer readers to section II.H. of this final rule with comment 
period, where we discuss CPT codes 9254A and 9254B, used to report 
related services.
(23) Doppler Echocardiography (CPT Codes 93320, 93321 and 93325)
    As detailed in the CY 2015 PFS final rule with comment period, we 
maintained the CY 2014 work RVUs for CPT codes 93320, 93321 and 93325, 
based upon the RUC-recommended work RVUs. In establishing interim final 
direct PE inputs for CY 2015, we refined the RUC's recommendations for 
CPT codes 93320, 93321 and 93325 by removing the minutes associated 
with equipment item ED021 (computer, desktop, w/monitor) since a 
computer is included in the other equipment inputs associated with 
codes.
    Comment: One commenter supported CMS' adopting the work RVUs and 
times recommended by the RUC for these services (CPT codes 93320, 
93321, and 93325).
    Response: We appreciate the commenters support. We are finalizing 
the CY 2015 interim final work RVUs as established.
    Comment: One commenter stated that ED021 is not included in the 
room.
    Response: We disagree that ``computer, desktop w/monitor'' (ED021) 
is not included in the equipment room ``room, vascular ultrasound.'' 
The PE reference materials submitted by the RUC indicate that 
``ultrasound room, vascular'' includes a computer (Vascoguard II, main 
station with cart, keyboard, LCD monitor, deskjet printer, Doppler, and 
probe holder). Therefore, we are finalizing the direct PE inputs for 
CPT codes 93320, 93321, and 93225 as established as interim final.
(24) Interventional Transesophageal Echocardiography (TEE) (CPT Codes 
93312, 93313, 93314, 93315, 93316, 93317, 93318 and 93355)
    For CY 2015, we used the RUC-recommended work RVU of 2.40 to 
establish an interim final value for CPT code 93318 and 4.66 for CPT 
code 93355. Based on a crosswalk from CPT code 75573, we assigned CPT 
code 93312 a CY 2015 interim final work RVU of 2.55. We noted that 
based on the CPT descriptor for CPT code 93315, we believed that the 
appropriate work for this service was reflected in the combined work of 
CPT codes 93316 and 93317, resulting in a CY 2015 interim final work 
RVU of 2.94. For CPT codes 93313, 93314, 93316 and 93317, we assigned 
CY 2015 interim final work RVUs that corresponded to the 25th 
percentile survey result. Each of these codes had a significant 
reduction in intraservice time since the last valuation. We noted that 
we believe the 25th percentile survey values better describe the work 
and time involved in these procedures than the RUC recommendations, and 
that it helps maintain appropriate relativity in the family. 
Additionally, we refined the preservice and intraservice times for CPT 
codes 93314 and 93317 to 10 and 20 minutes, respectively, to maintain 
relativity among the interim final work RVUs and times.
    Comment: Some commenters disagreed with CMS' decision to value the 
work RVU for CPT code 93312 by crosswalking it from CPT code 75573, 
rather than the RUC-recommended work

[[Page 71003]]

RVU based on a crosswalk from CPT code 43247 
(Esophagogastroduodenoscopy).
    Response: The RUC-recommended crosswalk code, CPT code 43247, is a 
0-day global service, whereas CPT code 75573 has no global period. 
Since CPT code 75573 and CPT code 93312 do not have global periods, 
while 43247 has a global period, we do not believe that the latter code 
can serve as an appropriate crosswalk. Therefore, we are finalizing the 
CY 2015 work RVUs as established for CPT code 93312.
    Comment: A few commenters disagreed with CMS' refinement of the 
work RVUs for CPT codes 93313 and 93314. The commenters stated that the 
work RVU that corresponds to the 25th percentile survey result fails to 
account for changes in technique, technology, and knowledge.
    Response: After review of the comments, we continue to believe that 
the RUC-recommended work RVUs do not adequately reflect the significant 
reduction in intraservice time, and that our corresponding refinements 
to the work RVUs are appropriate. We do not believe that the work RVUs 
corresponding to the survey 25th percentile result fail to account for 
typical changes in technique, technology, and knowledge. Therefore, we 
are finalizing the CY 2015 work RVUs as established for CPT codes 93313 
and 93314.
    Comment: A few commenters disagreed with the time refinement made 
to CPT codes 93314 and 93317.
    Response: To maintain consistency with the work RVUs, we continue 
to believe that these time refinements are appropriate. Therefore, we 
are finalizing the times for CPT codes 93314 and 93317 as established 
for CY 2015.
    Comment: Some commenters disagreed with CMS' use of the BBM to 
determine a work RVU for CPT code 93315, suggesting that it did not 
incorporate updated service times and changes in technique, technology, 
and knowledge.
    Response: After consideration of the comments received, we continue 
to believe that the appropriate work RVU for CPT code 93315 is 
reflected in the combined work of CPT codes 93316 and 93317, resulting 
in a CY 2015 interim final work RVU of 2.94. We are finalizing the 
interim final work RVUs for these codes as established.
    Comment: A commenter requested that this family of codes be 
referred to the multispecialty refinement panel.
    Response: The request for referral to the multispecialty refinement 
panel did not include new clinical information; therefore, the request 
did not meet the criteria for review by the multispecialty refinement 
panel.
    Commen One commenter questioned why the TC codes within the 
congenital TEE family are contractor-priced.
    Response: We did not receive recommendations for the direct PE 
inputs for CPT codes 93315, 93317, and 93318. Without such 
recommendations, we did not have sufficient information about the 
resource costs necessary to establish national pricing and we therefore 
assigned a contractor-priced status to the technical component of these 
codes. We are finalizing the contractor-priced status for the technical 
component of CPT codes 93315, 93317, and 93318.
    Comment: One commenter supported CMS' proposal to adopt the RUC-
recommended work RVU and times for CPT code 93355.
    Response: We appreciate the commenter's feedback, and we are 
finalizing the CY 2015 work RVUs and direct PE inputs as established as 
interim final.
(25) Duplex Scans (CPT Codes 93880, 93882, 93886, 93888, 93926, 93975, 
93976, 93977, 93978, and 93979)
    For CY 2014, we maintained the CY 2013 RVUs for CPT codes 93880 and 
93882. As we stated in the CY 2014 PFS final rule with comment period 
(78 FR 74342), we were concerned that the RUC-recommended work RVUs for 
CPT codes 93880 and 93882, as well as our final work RVUs 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. 
We referred the entire family to the RUC to assess relativity among the 
codes and to 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 intracranial arteries; limited study) in conjunction with 
the duplex scan codes to assess the relativity between and among the 
codes. In the CY 2015 PFS final rule with comment period, we used the 
RUC-recommended work RVUs for CPT codes 93880, 93882, 93925, and 93926 
while making several standard PE refinements consistent with standard 
inputs for digital imaging and our policies for not allocating quality 
assurance documentation to individual services as a direct expense.
    Comment: Some commenters stated that quality assurance (QA) 
documentation is an integral part of the procedure, so it should be 
included as a direct PE input clinical labor task.
    Response: We consider QA documentation to be an indirect PE since 
it is not generally allocated to a single patient during an individual 
procedure. Instead, we believe QA activities are undertaken through 
different means across a wide range of practices.
    Comment: One commenter disagreed with the minutes assigned to the 
vascular ultrasound room (EL016) for CPT code 93880. The commenter 
disagreed with the CMS refinement from 68 minutes of equipment time to 
51 minutes, and objected to the removal of equipment time for 
preservice tasks not typically associated with highly technical 
equipment. The commenter stated that there was no data to support the 
CMS rationale, and presented survey data suggesting that preservice 
activities are routinely carried out in the vascular ultrasound room.
    Response: We continue to 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 and are typically 
available for other patients even when one member of the clinical staff 
may be occupied with a pre-service or post-service task related to the 
procedure. We refer readers to our extensive discussion in response to 
those objections in the CY 2012 PFS final rule with comment period (76 
FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 
67639).
    Comment: A few commenters stated that a desktop computer is a 
necessary PE input for these codes.
    Response: We believe that computer processing functionality is 
inherent in the ultrasound system included in the general ultrasound 
room. We refer readers to Table 14 for the items and associated prices 
that constitute the ultrasound rooms.

          Table 14--Items That Constitute the Ultrasound Rooms
------------------------------------------------------------------------
 
------------------------------------------------------------------------
$369,945...........................  General Ultrasound Room, General.

[[Page 71004]]

 
    $220,000.......................     GE Logic 9 ultrasound system
                                         (H4902SG).
    $18,000........................     transducer, 3-8MHz matrix array
                                         convex (H40412LC).
    $650...........................     probe starter kit for H40412LD:
                                         bracket, needle guides, probe
                                         covers (E8385RF).
    $18,000........................     transducer, 5-13MHz linear
                                         matrix array (H40412LD).
    $650...........................     probe starter kit for H40412LD:
                                         bracket, needle guides, probe
                                         covers (E8385RF).
    $12,000........................     transducer, 4-10MH micro convex
                                         probe (H40412LE).
    $11,000........................     transducer, 4-10MHz probe
                                         (H40412LG).
    $10,000........................     transducer, 2-5MHz probe
                                         (H4901PE).
    $12,500........................     software, B-flow (H4901BF).
    $5,500.........................     software, DICOM (H4901DM).
    $8,000.........................     software, LOGIQ View (h4901LW).
    $4,900.........................     VHS video recorder (Sony SVO-
                                         9500MD/2).
    $6,500.........................     digital printer (Sony UPD21).
    $1,995.........................     monochrome thermal printer (Sony
                                         UPD895).
    $5,250.........................     ultrasound table (E8375F).
    $35,000........................     compound imaging.
    $466,492.......................     Ultrasound Room, Vascular.
                                        General Ultrasound Room,
                                         General.
                                        Nicojet VasoGuard P84 (PPG &
                                         lower extremity):
                                           Nicolet Pioneer TC 8080
                                            (transcranial).
                                           Atrium Medical Vaslab--
                                            software add-on for data
                                            collection, database
                                            maintenance, and
                                            accreditation processing.
------------------------------------------------------------------------

    In the CY 2014 PFS final rule with comment period (78 FR 74342), we 
requested that the RUC assess the relativity among the entire family of 
duplex scans codes and 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 intracranial arteries; limited 
study) in conjunction with the duplex scan codes to assess the 
relativity between and among those codes. For CY 2015, we established 
the RUC-recommended work RVUs as interim final for all of the codes in 
the family except CPT codes 93886, 93888, 93926, 93975, 93976, 93977, 
93978, and 93979. For several codes in this family with 10 minutes of 
intraservice time, the RUC recommended 0.50 work RVUs. CPT code 93926 
(Duplex scan of lower extremity arteries or arterial bypass grafts; 
unilateral or limited study), CPT code 93979 (Duplex scan of aorta, 
inferior vena cava, iliac vasculature, or bypass grafts; unilateral or 
limited study,) and CPT code 93888 all have 10 minutes intraservice 
time and we assigned them an interim final work RVU of 0.50. For 
several codes in this family with 15 minutes of intraservice time, the 
RUC recommended work RVUs that corresponded to the 25th percentile 
survey result. We found this to appropriately reflect the work involved 
and applied the same logic to other codes with 15 minutes of 
intraservice time. We established the work RVUs for CPT codes 93975, 
93976, and 93978 that corresponded to the 25th percentile survey 
result, which all have 15 minutes of intraservice time. Therefore, for 
CY 2015 we established the following interim final work RVUs: 1.16 for 
CPT code 93975; 0.80 for CPT code 93976; 0.80 for CPT code 93978; and 
0.50 for CPT code 93979.
    Comment: Several commenters disagreed with the allocation of 0.50 
RVUs to codes with 10 minutes of intraservice time across the Doppler/
duplex code family. The commenters suggested that 0.50 RVUs does not 
reflect the relationship between the codes based on their time, 
intensity, rank order, and complexity. Commenters stated that 
transcranial Doppler studies are more intense than Doppler studies of 
other body parts and thus should be valued with higher RVUs. Commenters 
requested that CPT codes 93886 and 93888 be referred to the 
multispecialty refinement panel.
    Response: When valuing these codes, we used the RUC recommendation 
of 0.80 RVUs for CPT code 93880, which has an intraservice time of 15 
minutes. Applying the work RVU-to-time ratio of CPT code 93880 to CPT 
code 93886, which has an intraservice time of 17 minutes, results in 
our interim final work RVU of 0.91 for CPT code 93886. For CPT code 
93888, we noted that it had an identical time and similar intensity to 
code 93882; therefore, we found an RVU of 0.50 to be appropriate. The 
commenters did not include any new clinical information in their 
requests for referral of CPT codes 93886 and 93888. Therefore, the 
requests did not meet the criteria for referral to the multispecialty 
refinement panel.
    Comment: Several commenters encouraged CMS to adopt the RUC 
recommendation for CPT code 93926, stating that, although CPT code 
93926 has 10 minutes of intraservice time, the intensity is greater 
than 0.50 RVUs.
    Response: We appreciate the commenters' feedback. However, we 
believe that 0.50 is the accurate work RVU for CPT code 93926 based on 
a crosswalk from CPT code 93880. We believe that because the intensity 
is similar and the overall time is the same, the overall work is 
comparable.
    Comment: Several commenters pointed out that CPT code 93975 has 20 
minutes of intraservice time, and should not have the same RVU as a 
code with 15 minutes of intraservice time. A few commenters suggested 
that CPT code 93976 involves arterial and venous blood flow and is 
therefore more intense than other procedures in the code family. 
Commenters requested that CPT codes 93975 and 93976 be referred to the 
multispecialty refinement panel.
    Response: When valuing code 93965, we noted that we did not think 
the RVU that resulted in application of the intraservice ratio to 93880 
accurately reflected the work involved in furnishing the procedure. 
Therefore, we used the work RVU that corresponded to the 25th 
percentile survey result to establish the RVU. For code 93976, we noted 
that the intraservice time is identical to CPT code 93880, which has a 
work RVU of 0.50. This value also corresponds to the 25th percentile 
survey result.
    Comment: A commenter commended CMS for accepting the RUC-
recommended work RVU for CPT code 93931.
    Response: We appreciate the commenter's feedback and support.
    After considering these comments, we are finalizing the CY 2015 
interim final values as established.
(26) Carotid Intima-Media Thickness Ultrasound (CPT Code 93895)
    For CY 2015, the CPT Editorial Panel created new CPT code 93895 to 
describe the work of using carotid ultrasound to measure 
atherosclerosis and quantify the intima-media thickness. After review 
of this code, we determined that

[[Page 71005]]

it was used only for screening, and therefore, we assigned a PFS 
procedure status indicator of N (Noncovered service) to CPT code 93895.
    Comment: Two commenters were dissatisfied with our designation of 
this service as a noncovered screening tool. One commenter stated that 
``other methods for atherosclerosis imaging are already approved for 
coverage under Medicare local coverage determination policies and are 
directly comparable to carotid atherosclerosis imaging in terms of 
their purpose and clinical application.'' Another commenter suggested 
that the test was ``designed to be used in patients with cardiovascular 
risk to enhance care and assist physicians in selection and intensity 
of risk reducing therapies.'' All commenters encouraged CMS to 
reconsider its decision to classify CPT code 93895 as a noncovered 
screening service.
    Response: While we appreciate the commenter's feedback, we are 
unaware of other carotid atherosclerosis imaging services for which we 
provide payment when used for patients without signs or symptoms of 
disease. Information that we received from the RUC and specialty 
societies indicated that the typical patient would be one without signs 
or symptoms of carotid disease. Therefore, this test does not meet the 
statutory definition of a diagnostic test and as such, is not covered 
under Medicare.
(27) Negative Pressure Wound Therapy (CPT Codes 97605, 97606, 97607 and 
97608)
    Prior to CY 2013, CPT codes 97605 and 97606 were both used to 
report negative pressure wound therapy, which were typically reported 
in conjunction with durable medical equipment that was separately 
payable. In the CY 2013 final rule with comment period, we created two 
HCPCS codes to provide a payment mechanism for negative pressure wound 
therapy services furnished to beneficiaries using equipment that is not 
paid for as durable medical equipment: G0456 (Negative pressure wound 
therapy, (for example, vacuum assisted drainage collection) using a 
mechanically powered device, not durable medical equipment, including 
provision of cartridge and dressing(s), topical application(s), wound 
assessment, and instructions for ongoing care, per session; total 
wound(s) surface area less than or equal to 50 square centimeters) and 
G0457 (Negative pressure wound therapy, (for example, vacuum assisted 
drainage collection) using a mechanically-powered device, not durable 
medical equipment, including provision of cartridge and dressing(s), 
topical application(s), wound assessment, and instructions for ongoing 
care, per session; total wound(s) surface area greater than 50 sq. cm).
    For CY 2015, the CPT Editorial Panel created CPT codes 97607 and 
97608 to describe negative pressure wound therapy with the use of a 
disposable system. In addition, CPT codes 97605 and 97606 were revised 
to specify the use of durable medical equipment. Based upon the revised 
coding scheme for negative pressure wound therapy, we deleted the G-
codes. We contractor-priced CPT codes 97607 and 97608 for CY 2015 and 
the CPT codes were designated ``Sometimes Therapy'' on our Therapy Code 
List, consistent with the G-codes.
    Comment: One commenter was disappointed with CMS' decision to 
contractor price CPT Codes 97607 and 97608, since CMS originally 
created G-codes to provide a payment mechanism for negative pressure 
wound therapy services furnished to beneficiaries through means 
unrelated to the durable medical equipment benefit. They expressed 
concern that practitioners who utilize the new disposable device will 
be paid amounts derived from crosswalks from the DME-related codes (CPT 
codes 97605 and 97606), which include more work time and work.
    Response: We agree that the codes are intended to provide a payment 
mechanism for negative pressure wound therapy services furnished to a 
beneficiary using equipment that is not paid for as durable medical 
equipment. However, we do not agree that contractor pricing the codes 
is unlikely to result in accurate payment amounts for the services. 
There are several obstacles to developing accurate payment rates for 
these services within the PE RVU methodology, including the indirect PE 
allocation for the typical practitioners who furnish these services and 
the diversity of the products used in furnishing these services. Since 
our methodology values services based on the typical case, and the cost 
structure differs among a variety of products, we believe that 
contractor pricing allows for more accurate payment than national 
prices that would be based on the cost structure of a single product. 
Thus, contractor pricing these codes allows for flexibility in the 
products used, pending additional information about what product is 
typically involved in furnishing these services.
    Comment: One commenter expressed disappointment that CMS had 
adjusted the equipment and staff time downward for CPT codes 97605 and 
97606. The commenter expressed that the timing of the publication of 
this rule does not allow adequate time to evaluate the impact these 
changes will have on operating expenses and noted that the complicated 
nature of the formula used to calculate PE RVUs limits their ability to 
predict the impact of these changes.
    Response: The intraservice clinical labor time already included 
time for wound checking. As a result, the 5 minutes in the post-service 
period were refined to 2 minutes. Accordingly, equipment times were 
refined to conform to the changes in clinical labor time. After 
consideration of the comment, we are finalizing the direct PE inputs 
for CPT codes 97605 and 97606 as established. In response to the 
commenter's concerns regarding the timing of changes in values for 
particular PFS services, we note that beginning in rulemaking for CY 
2017, we anticipate that most changes in payment based on review of 
individual codes will be proposed in the annual PFS proposed rule 
instead of established as interim final in the annual final rule. We 
also note that we display the resulting PE RVUs for each code in 
Addendum B for each proposed and final rule. This allows stakeholders 
to see the PE RVUs that result from any changes in input assumptions 
for particular codes.
(28) Hyperbaric Oxygen Therapy (HBOT) (CPT Code 99183 and HCPCS Code 
G0277)
    For CY 2015, we received RUC recommendations for CPT code 99183 
that included significant increases to the direct PE inputs, which 
assumed a treatment time of 120 minutes. Prior to CY 2015, CPT code 
99183 was used to report both the professional attendance and 
supervision, and the costs associated with treatment delivery were 
included in nonfacility direct PE inputs for the code. We created HCPCS 
code G0277 to be used to report the treatment delivery separately, 
consistent with the OPPS coding mechanism, to allow the use of the same 
coding structure across settings. In establishing interim final direct 
PE inputs for HCPCS code G0277, we used the RUC-recommended direct PE 
inputs for CPT code 99183 and adjusted them to align with the 30-minute 
treatment interval. We observed that the quantity of oxygen increased 
significantly relative to the previous value. To better understand this 
change, we reviewed the instruction manual for the most commonly used 
HBOT chamber, which provided guidance regarding the quantity of oxygen 
used. Based on our review, we determined that 12,000, rather than 
47,000, was the typical number of units. Therefore, in

[[Page 71006]]

aligning the direct PE inputs as described above, we first adjusted the 
units of oxygen to 12,000 for the recommended 120-minute time, and 
subsequently adjusted it to align with the 30 minute G-code.
    Comment: Several commenters disagreed with the volume of oxygen 
consumed for a 120 minute treatment time cited in the final rule and 
some recommended adopting 42,000-47,000 liters or units for a typical 
120-minute HBO2 profile. We also received a few additional comments on 
these services during the comment period for the proposed rule. The 
commenters reiterated that they support the change from C1300 to G0277 
as the 30 minute interval for hyperbaric oxygen therapy; however, they 
suggested that the methodology used by the RUC more accurately reflects 
the amount of oxygen that is used in a hyperbaric oxygen treatment. 
They stated, ``the provision of a hyperbaric oxygen treatment requires 
a pressure of greater than 1.4 ATA and a therapeutic dose of as close 
to 100 percent oxygen as can be achieved in the monoplace environment. 
This level of oxygen delivery must be reached and maintained for the 
duration of the designated treatment time. Therefore, a treatment of 
2.4 ATA for 120 minutes will require that the target chamber oxygen 
concentration must be achieved at the same time as the designated 
pressure.'' The commenter additionally requested that CMS not finalize 
the proposed CY 2016 reduction in PE RVUs.
    Response: We thank the commenters for their feedback and have 
considered the materials submitted. We agree that a high purge flow 
rate is needed in order to reach maximum pressure/O2; however, we still 
have not seen data that demonstrates the need to continue a maximum 
flow rate throughout the entire session. The RUC forwarded an invoice 
for the Sechrist Model 3600E Hyperbaric Chamber for use in pricing the 
capital equipment for this service. According to the manufacturer's 
manual for this model, ``once the nitrogen has been purged from the 
chamber and the internal oxygen concentration has exceeded 95 percent, 
high flows are no longer needed to maintain the patient's saturation 
level.'' The manual also states that ``the plateau purge flow can be 
set to 80 lpm.'' We calculated that 13 minutes at 400 lpm plus 120 
minutes at 80 lpm equals 14,800 liters of oxygen. Based on the current 
publicly available information in the manufacturer's manual, we believe 
that this represents the typical usage for a 120 minute treatment. This 
amount represents an increase from the interim final amount of 12,000. 
As we described in the CY 2015 final rule, we aligned this total oxygen 
requirement to the 30 minute G-code. Following that principle here, we 
are updating the direct PE inputs to 3,700 liters of oxygen for HCPCS 
code G0277. In response to the commenter's request regarding a 
reduction in the PE RVUs in the CY 2016 PFS proposed rule, any changes 
from the CY 2015 PE RVUs for HCPCS code G0277 to values displayed in 
association with the CY 2016 proposed rule resulted from overall 
changes in PE relativity and PFS budget neutrality and did not result 
from a change in the direct PE inputs.
9. CY 2016 Interim Final Codes
    For recommendations regarding any new or revised codes received 
after the February 10, 2015 deadline, including updated recommendations 
for codes included in the CY 2016 proposed rule, we are establishing 
interim final values in this final rule with comment period, consistent 
with previous practice.
    We note that in the CY 2016 PFS proposed rule, we inadvertently 
published work RVUs for several CPT codes in Addendum B that were not 
explicitly discussed in the text. Those CPT codes include 88341, 88364, 
and 88369; these codes had previously been proposed on an interim basis 
in the CY 2015 PFS final rule with comment period. While these codes 
were not discussed in the proposed rule because our files displayed 
incorrect work RVUs for these codes due to the data error, some 
commenters raised questions about these codes' displayed work RVUs. To 
allow public comment on the correct valuations, we are therefore 
establishing interim final work RVUs for these codes for CY 2016 and 
requesting comment on those interim final values in this final rule. We 
will respond to comments on these values in CY 2017 rulemaking.

            Table 15--CY 2016 Interim Final Work RVUs for New/Revised or Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
                                                                      RUC/HCPAC
           HCPCS Code               Long descriptor     CY 2015      recommended     CMS 2016       CMS time
                                                          WRVU        work RVU       work RVU      refinement
----------------------------------------------------------------------------------------------------------------
10035...........................  Placement of soft           NEW            1.70         1.70  No.
                                   tissue
                                   localization
                                   device(s) (e.g.,
                                   clip, metallic
                                   pellet, wire/
                                   needle,
                                   radioactive
                                   seeds),
                                   percutaneous,
                                   including imaging
                                   guidance; first
                                   lesion.
10036...........................  Placement of soft           NEW            0.85         0.85  No.
                                   tissue
                                   localization
                                   device(s) (e.g.,
                                   clip, metallic
                                   pellet, wire/
                                   needle,
                                   radioactive
                                   seeds),
                                   percutaneous,
                                   including imaging
                                   guidance; each
                                   additional lesion.
26356...........................  Repair or                 10.62           10.03         9.56  No.
                                   advancement,
                                   flexor tendon, in
                                   zone 2 digital
                                   flexor tendon
                                   sheath (e.g., no
                                   man's land);
                                   primary, without
                                   free graft, each
                                   tendon.
26357...........................  Repair or                  8.77           11.50        10.53  No.
                                   advancement,
                                   flexor tendon, in
                                   zone 2 digital
                                   flexor tendon
                                   sheath (e.g., no
                                   man's land);
                                   secondary,
                                   without free
                                   graft, each
                                   tendon.
26358...........................  Repair or                  9.36           13.10        12.13  No.
                                   advancement,
                                   flexor tendon, in
                                   zone 2 digital
                                   flexor tendon
                                   sheath (e.g., no
                                   man's land);
                                   secondary, with
                                   free graft
                                   (includes
                                   obtaining graft),
                                   each tendon.
41530...........................  Submucosal                 4.51            3.50         3.50  No.
                                   ablation of the
                                   tongue base,
                                   radiofrequency, 1
                                   or more sites,
                                   per session.
43210...........................  Esophagogastroduod          NEW            9.00         7.75  Yes.
                                   enoscopy,
                                   flexible,
                                   transoral; with
                                   esophagogastric
                                   fundoplasty,
                                   partial or
                                   complete,
                                   includes
                                   duodenoscopy when
                                   performed.
47531...........................  Injection                   NEW            1.80         1.80  No.
                                   procedure for
                                   cholangiography,
                                   percutaneous,
                                   complete
                                   diagnostic
                                   procedure
                                   including imaging
                                   guidance (e.g.,
                                   ultrasound and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation;
                                   existing access.

[[Page 71007]]

 
47532...........................  Injection                   NEW            4.25         4.25  No.
                                   procedure for
                                   cholangiography,
                                   percutaneous,
                                   complete
                                   diagnostic
                                   procedure
                                   including imaging
                                   guidance (e.g.,
                                   ultrasound and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation;
                                   new access (e.g.,
                                   percutaneous
                                   transhepatic
                                   cholangiogram).
47533...........................  Placement of                NEW            6.00         6.00  No.
                                   biliary drainage
                                   catheter,
                                   percutaneous,
                                   including
                                   diagnostic
                                   cholangiography
                                   when performed,
                                   imaging guidance
                                   (e.g., ultrasound
                                   and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation;
                                   external.
47534...........................  Placement of                NEW            8.03         8.03  No.
                                   biliary drainage
                                   catheter,
                                   percutaneous,
                                   including
                                   diagnostic
                                   cholangiography
                                   when performed,
                                   imaging guidance
                                   (e.g., ultrasound
                                   and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation;
                                   internal-external.
47535...........................  Placement of                NEW            4.50         4.50  No.
                                   biliary drainage
                                   catheter,
                                   percutaneous,
                                   including
                                   diagnostic
                                   cholangiography
                                   when performed,
                                   imaging guidance
                                   (e.g., ultrasound
                                   and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation;
                                   internal-external.
47536...........................  Exchange of                 NEW            2.88         2.88  No.
                                   biliary drainage
                                   catheter (e.g.,
                                   external,
                                   internal-
                                   external, or
                                   conversion of
                                   internal-external
                                   to external
                                   only),
                                   percutaneous,
                                   including
                                   diagnostic
                                   cholangiography
                                   when performed,
                                   imaging guidance
                                   (e.g.,
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation.
47537...........................  Removal of biliary          NEW            1.83         1.83  No.
                                   drainage
                                   catheter,
                                   percutaneous,
                                   requiring
                                   fluoroscopic
                                   guidance (e.g.,
                                   with concurrent
                                   indwelling
                                   biliary stents),
                                   including
                                   diagnostic
                                   cholangiography
                                   when performed,
                                   imaging guidance
                                   (e.g.,
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation.
47538...........................  Placement of                NEW            6.60         6.60  No.
                                   stent(s) into a
                                   bile duct,
                                   percutaneous,
                                   including
                                   diagnostic
                                   cholangiography,
                                   imaging guidance
                                   (e.g.,
                                   fluoroscopy and/
                                   or ultrasound),
                                   balloon dilation,
                                   catheter exchange
                                   or removal when
                                   performed, and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation,
                                   each stent;
                                   existing access.
47539...........................  Placement of                NEW            9.00         9.00  No.
                                   stent(s) into a
                                   bile duct,
                                   percutaneous,
                                   including
                                   diagnostic
                                   cholangiography,
                                   imaging guidance
                                   (e.g.,
                                   fluoroscopy and/
                                   or ultrasound),
                                   balloon dilation,
                                   catheter exchange
                                   or removal when
                                   performed, and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation,
                                   each stent; new
                                   access, without
                                   placement of
                                   separate biliary
                                   drainage catheter.
47540...........................  Placement of                NEW           12.00        10.75  No.
                                   stent(s) into a
                                   bile duct,
                                   percutaneous,
                                   including
                                   diagnostic
                                   cholangiography,
                                   imaging guidance
                                   (e.g.,
                                   fluoroscopy and/
                                   or ultrasound),
                                   balloon dilation,
                                   catheter exchange
                                   or removal when
                                   performed, and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation,
                                   each stent; new
                                   access, with
                                   placement of
                                   separate biliary
                                   drainage catheter
                                   (e.g., external
                                   or internal-
                                   external ).
47541...........................  Placement of                NEW            5.61         5.61  No.
                                   access through
                                   the biliary tree
                                   and into small
                                   bowel to assist
                                   with an
                                   endoscopic
                                   biliary procedure
                                   (e.g., rendezvous
                                   procedure),
                                   percutaneous,
                                   including
                                   diagnostic
                                   cholangiography
                                   when performed,
                                   imaging guidance
                                   (e.g., ultrasound
                                   and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation;
                                   new access.
47542...........................  Balloon dilation            NEW            3.28         2.50  No.
                                   of biliary
                                   duct(s) or of
                                   ampulla
                                   (sphincteroplasty
                                   ), percutaneous,
                                   including imaging
                                   guidance (e.g.,
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation,
                                   each duct.
47543...........................  Endoluminal                 NEW            3.51         3.07  No.
                                   biopsy(ies) of
                                   biliary tree,
                                   percutaneous, any
                                   method(s) (e.g.,
                                   brush, forceps
                                   and/or needle),
                                   including imaging
                                   guidance (e.g.,
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation,
                                   single or
                                   multiple.
47544...........................  Removal of calculi/         NEW            4.74         4.29  No.
                                   debris from
                                   biliary duct(s)
                                   and/or
                                   gallbladder,
                                   percutaneous,
                                   including
                                   destruction of
                                   calculi by any
                                   method (e.g.,
                                   mechanical,
                                   electrohydraulic,
                                   lithotripsy) when
                                   performed,
                                   imaging guidance
                                   (e.g.,
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation
                                   (List separately
                                   in addition to
                                   code for primary
                                   procedure).
49185...........................  Sclerotherapy of a          NEW            2.78         2.35  No.
                                   fluid collection
                                   (e.g.,
                                   lymphocele, cyst,
                                   or seroma),
                                   percutaneous,
                                   including
                                   contrast
                                   injection(s),
                                   sclerosant
                                   injection(s),
                                   diagnostic study,
                                   imaging guidance
                                   (e.g.,
                                   ultrasound,
                                   fluoroscopy) and
                                   radiological
                                   supervision and
                                   interpretation
                                   when performed.

[[Page 71008]]

 
50606...........................  Endoluminal biopsy          NEW            3.16         3.16  No.
                                   of ureter and/or
                                   renal pelvis, non-
                                   endoscopic,
                                   including imaging
                                   guidance (e.g.,
                                   ultrasound and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation.
50705...........................  Ureteral                    NEW            4.03         4.03  No.
                                   embolization or
                                   occlusion,
                                   including imaging
                                   guidance (e.g.,
                                   ultrasound and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation.
50706...........................  Balloon dilation,           NEW            3.80         3.80  No.
                                   ureteral
                                   stricture,
                                   including imaging
                                   guidance (e.g.,
                                   ultrasound and/or
                                   fluoroscopy) and
                                   all associated
                                   radiological
                                   supervision and
                                   interpretation.
55866...........................  Laparoscopy,              32.06           26.80        21.36  No.
                                   surgical
                                   prostatectomy,
                                   retropubic
                                   radical,
                                   including nerve
                                   sparing, includes
                                   robotic
                                   assistance, when
                                   performed.
61645...........................  Percutaneous                NEW           17.00        15.00  Yes.
                                   arterial
                                   transluminal
                                   mechanical
                                   thrombectomy and/
                                   or infusion for
                                   thrombolysis,
                                   intracranial, any
                                   method, including
                                   diagnostic
                                   angiography,
                                   fluoroscopic
                                   guidance,
                                   catheter
                                   placement, and
                                   intraprocedural
                                   pharmacological
                                   thrombolytic
                                   injection(s).
61650...........................  Endovascular                NEW           12.00        10.00  Yes.
                                   intracranial
                                   prolonged
                                   administration of
                                   pharmacologic
                                   agent(s) other
                                   than for
                                   thrombolysis,
                                   arterial,
                                   including
                                   catheter
                                   placement,
                                   diagnostic
                                   angiography, and
                                   imaging guidance;
                                   initial vascular
                                   territory.
61651...........................  Endovascular                NEW            5.50         4.25  No.
                                   intracranial
                                   prolonged
                                   administration of
                                   pharmacologic
                                   agent(s) other
                                   than for
                                   thrombolysis,
                                   arterial,
                                   including
                                   catheter
                                   placement,
                                   diagnostic
                                   angiography, and
                                   imaging guidance;
                                   each additional
                                   vascular
                                   territory (List
                                   separately in
                                   addition to the
                                   primary code).
64461...........................  Paravertebral               NEW            1.75         1.75  No.
                                   block (PVB)
                                   (paraspinous
                                   block), thoracic;
                                   single injection
                                   site (includes
                                   imaging guidance,
                                   when performed).
64462...........................  Paravertebral               NEW            1.10         1.10  No.
                                   block (PVB)
                                   (paraspinous
                                   block), thoracic;
                                   second and any
                                   additional
                                   injection
                                   site(s),
                                   (includes imaging
                                   guidance, when
                                   performed).
64463...........................  Paravertebral               NEW            1.90         1.81  No.
                                   block (PVB)
                                   (paraspinous
                                   block), thoracic;
                                   continuous
                                   infusion by
                                   catheter
                                   (includes imaging
                                   guidance, when
                                   performed).
64553...........................  Percutaneous               2.36            2.36         2.36  No.
                                   implantation of
                                   neurostimulator
                                   electrode array;
                                   cranial nerve.
64555...........................  Percutaneous               2.32            2.32         2.32  No.
                                   implantation of
                                   neurostimulator
                                   electrode array;
                                   peripheral nerve
                                   (excludes sacral
                                   nerve).
64566...........................  Posterior tibial           0.60            0.60         0.60  No.
                                   neurostimulation,
                                   percutaneous
                                   needle electrode,
                                   single treatment,
                                   includes
                                   programming.
65778...........................  Placement of               1.19            1.00         1.00  No.
                                   amniotic membrane
                                   on the ocular
                                   surface; without
                                   sutures.
65779...........................  Placement of               3.92            2.50         2.50  Yes.
                                   amniotic membrane
                                   on the ocular
                                   surface; single
                                   layer, sutured.
65780...........................  Ocular surface            10.73            8.80         7.81  No.
                                   reconstruction;
                                   amniotic membrane
                                   transplantation,
                                   multiple layers.
65855...........................  Trabeculoplasty by         3.99            3.00         2.66  No.
                                   laser surgery.
66170...........................  Fistulization of          15.02           13.94        11.27  No.
                                   sclera for
                                   glaucoma;
                                   trabeculectomy ab
                                   externo in
                                   absence of
                                   previous surgery.
66172...........................  Fistulization of          18.86           14.81        12.57  No.
                                   sclera for
                                   glaucoma;
                                   trabeculectomy ab
                                   externo with
                                   scarring from
                                   previous ocular
                                   surgery or trauma
                                   (includes
                                   injection of
                                   antifibrotic
                                   agents).
67107...........................  Repair of retinal         16.71           16.00        14.06  No.
                                   detachment;
                                   scleral buckling
                                   (such as lamellar
                                   scleral
                                   dissection,
                                   imbrication or
                                   encircling
                                   procedure),
                                   including, when
                                   performed,
                                   implant,
                                   cryotherapy,
                                   photocoagulation,
                                   and drainage of
                                   subretinal fluid.
67108...........................  Repair of retinal         22.89           17.13        15.19  No.
                                   detachment; with
                                   vitrectomy, any
                                   method,
                                   including, when
                                   performed, air or
                                   gas tamponade,
                                   focal endolaser
                                   photocoagulation,
                                   cryotherapy,
                                   drainage of
                                   subretinal fluid,
                                   scleral buckling,
                                   and/or removal of
                                   lens by same
                                   technique.
67110...........................  Repair of retinal         10.25           10.25         8.31  No.
                                   detachment; by
                                   injection of air
                                   or other gas
                                   (e.g., pneumatic
                                   retinopexy).
67113...........................  Repair of complex         25.35           19.00        19.00  No.
                                   retinal
                                   detachment (e.g.,
                                   proliferative
                                   vitreoretinopathy
                                   , stage C-1 or
                                   greater, diabetic
                                   traction retinal
                                   detachment,
                                   retinopathy of
                                   prematurity,
                                   retinal tear of
                                   greater than 90
                                   degrees), with
                                   vitrectomy and
                                   membrane peeling,
                                   including, when
                                   performed, air,
                                   gas, or silicone
                                   oil tamponade,
                                   cryotherapy,
                                   endolaser
                                   photocoagulation,
                                   drainage of
                                   subretinal fluid,
                                   scleral buckling,
                                   and/or removal of
                                   lens.

[[Page 71009]]

 
67227...........................  Destruction of             7.53            3.50         3.50  No.
                                   extensive or
                                   progressive
                                   retinopathy
                                   (e.g., diabetic
                                   retinopathy),
                                   cryotherapy,
                                   diathermy.
67228...........................  Treatment of              13.82            4.39         4.39  No.
                                   extensive or
                                   progressive
                                   retinopathy
                                   (e.g., diabetic
                                   retinopathy),
                                   photocoagulation.
72170...........................  Radiologic                 0.17            0.17         0.17  No.
                                   examination,
                                   pelvis; 1 or 2
                                   views.
73501...........................  Radiologic                  NEW            0.18         0.18  No.
                                   examination, hip,
                                   unilateral, with
                                   pelvis when
                                   performed; 1 view.
73502...........................  Radiologic                  NEW            0.22         0.22  No.
                                   examination, hip,
                                   unilateral, with
                                   pelvis when
                                   performed; 2-3
                                   views.
73503...........................  Radiologic                  NEW            0.27         0.27  No.
                                   examination, hip,
                                   unilateral, with
                                   pelvis when
                                   performed;
                                   minimum of 4
                                   views.
73521...........................  Radiologic                  NEW            0.22         0.22  No.
                                   examination,
                                   hips, bilateral,
                                   with pelvis when
                                   performed; 2
                                   views.
73522...........................  Radiologic                  NEW            0.29         0.29  No.
                                   examination,
                                   hips, bilateral,
                                   with pelvis when
                                   performed; 3-4
                                   views.
73523...........................  Radiologic                  NEW            0.31         0.31  No.
                                   examination,
                                   hips, bilateral,
                                   with pelvis when
                                   performed;
                                   minimum of 5
                                   views.
73551...........................  Radiologic                  NEW            0.16         0.16  No.
                                   examination,
                                   femur; 1 view.
73552...........................  Radiologic                  NEW            0.18         0.18  No.
                                   examination,
                                   femur; minimum 2
                                   views.
74712...........................  Magnetic resonance          NEW            3.00         3.00  No.
                                   (e.g., proton)
                                   imaging, fetal,
                                   including
                                   placental and
                                   maternal pelvic
                                   imaging when
                                   performed; single
                                   or first
                                   gestation.
74713...........................  Magnetic resonance          NEW            1.85         1.78  No.
                                   (e.g., proton)
                                   imaging, fetal,
                                   including
                                   placental and
                                   maternal pelvic
                                   imaging when
                                   performed; each
                                   additional
                                   gestation.
77778...........................  Interstitial              11.32            8.78         8.00  No.
                                   radiation source
                                   application,
                                   complex, includes
                                   supervision,
                                   handling, loading
                                   of radiation
                                   source, when
                                   performed.
77790...........................  Supervision,               1.05            0.00         0.00  No.
                                   handling, loading
                                   of radiation.
78264...........................  Gastric emptying           0.80            0.80         0.74  No.
                                   imaging study
                                   (e.g., solid,
                                   liquid, or both).
78265...........................  Gastric emptying            NEW            0.98         0.98  No.
                                   imaging study
                                   (e.g., solid,
                                   liquid, or both);
                                   with small bowel
                                   transit, up to 24
                                   hours.
78266...........................  Gastric emptying            NEW            1.08         1.08  No.
                                   imaging study
                                   (e.g., solid,
                                   liquid, or both);
                                   with small bowel
                                   and colon
                                   transit, multiple
                                   days.
88104...........................  Cytopathology,             0.56            0.56         0.56  No.
                                   fluids, washings
                                   or brushings,
                                   except cervical
                                   or vaginal;
                                   smears with
                                   interpretation.
88106...........................  Cytopathology,             0.37            0.37         0.37  No.
                                   fluids, washings
                                   or brushings,
                                   except cervical
                                   or vaginal;
                                   simple filter
                                   method with
                                   interpretation.
88108...........................  Cytopathology,             0.44            0.44         0.44  No.
                                   concentration
                                   technique, smears
                                   and
                                   interpretation
                                   (e.g., Saccomanno
                                   technique).
88112...........................  Cytopathology,             0.56            0.56         0.56  No.
                                   selective
                                   cellular
                                   enhancement
                                   technique with
                                   interpretation
                                   (e.g., liquid
                                   based slide
                                   preparation
                                   method), except
                                   cervical or
                                   vaginal.
88160...........................  Cytopathology,             0.50            0.50         0.50  No.
                                   smears, any other
                                   source; screening
                                   and
                                   interpretation.
88161...........................  Cytopathology,             0.50            0.50         0.50  No.
                                   smears, any other
                                   source;
                                   preparation,
                                   screening and
                                   interpretation.
88162...........................  Cytopathology,             0.76            0.76         0.76  No.
                                   smears, any other
                                   source; extended
                                   study involving
                                   over 5 slides and/
                                   or multiple
                                   stains.
91200...........................  Liver                      0.30            0.27         0.27  No.
                                   elastography,
                                   mechanically
                                   induced shear
                                   wave (e.g.,
                                   vibration),
                                   without imaging,
                                   with
                                   interpretation
                                   and report.
93050...........................  Arterial pressure           NEW            0.17         0.17  No.
                                   waveform analysis
                                   for assessment of
                                   central arterial
                                   pressures,
                                   includes
                                   obtaining
                                   waveform(s),
                                   digitization and
                                   application of
                                   nonlinear
                                   mathematical
                                   transformations
                                   to determine
                                   central arterial
                                   pressures and
                                   augmentation
                                   index, with
                                   interpretation
                                   and report, upper
                                   extremity artery,
                                   non-invasive.
95971...........................  Electronic                 0.78            0.78         0.78  No.
                                   analysis of
                                   implanted
                                   neurostimulator
                                   pulse generator
                                   system (e.g.,
                                   rate, pulse
                                   amplitude, pulse
                                   duration,
                                   configuration of
                                   wave form,
                                   battery status,
                                   electrode
                                   selectability,
                                   output
                                   modulation,
                                   cycling,
                                   impedance and
                                   patient
                                   compliance
                                   measurements);
                                   simple spinal
                                   cord, or
                                   peripheral (i.e.,
                                   peripheral nerve,
                                   sacral nerve,
                                   neuromuscular)
                                   neurostimulator
                                   pulse generator/
                                   transmitter, with
                                   intraoperative or
                                   subsequent
                                   programming.

[[Page 71010]]

 
95972...........................  Electronic                 0.80            0.80         0.80  No.
                                   analysis of
                                   implanted
                                   neurostimulator
                                   pulse generator
                                   system (e.g.,
                                   rate, pulse
                                   amplitude, pulse
                                   duration,
                                   configuration of
                                   wave form,
                                   battery status,
                                   electrode
                                   selectability,
                                   output
                                   modulation,
                                   cycling,
                                   impedance and
                                   patient
                                   compliance
                                   measurements);
                                   complex spinal
                                   cord, or
                                   peripheral (i.e.,
                                   peripheral nerve,
                                   sacral nerve,
                                   neuromuscular)
                                   (except cranial
                                   nerve)
                                   neurostimulator
                                   pulse generator/
                                   transmitter, with
                                   intraoperative or
                                   subsequent
                                   programming.
G0416...........................  Surgical                   3.09            3.09         3.09  No.
                                   pathology, gross
                                   and microscopic
                                   examinations, for
                                   prostate needle
                                   biopsy, any
                                   method.
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       Table 17--CY 2016 Interim Final Codes With Direct PE Input
              Recommendations Accepted Without Refinements
------------------------------------------------------------------------
           HCPCS code                           Description
------------------------------------------------------------------------
26356...........................  Repair finger/hand tendon.
26357...........................  Repair finger/hand tendon.
26358...........................  Repair/graft hand tendon.
43210...........................  Egd esophagogastrc fndoplsty.
47543...........................  Endoluminal bx biliary tree.
55866...........................  Laparo radical prostatectomy.
64461...........................  Pvb thoracic single inj site.
64462...........................  Pvb thoracic 2nd+ inj site.
64463...........................  Pvb thoracic cont infusion.
64566...........................  Neuroeltrd stim post tibial.
65778...........................  Cover eye w/membrane.
65780...........................  Ocular reconst transplant.
65855...........................  Trabeculoplasty laser surg.
66172...........................  Incision of eye.
67107...........................  Repair detached retina.
67108...........................  Repair detached retina.
67227...........................  Dstrj extensive retinopathy.
72170...........................  X-ray exam of pelvis.
73501...........................  X-ray exam hip uni 1 view.
73502...........................  X-ray exam hip uni 2-3 views.
73503...........................  X-ray exam hip uni 4/> views.
73521...........................  X-ray exam hips bi 2 views.
73522...........................  X-ray exam hips bi 3-4 views.
73551...........................  X-ray exam of femur 1.
73552...........................  X-ray exam of femur 2.
74712...........................  Mri fetal sngl/1st gestation.
74713...........................  Mri fetal ea addl gestation.
77778...........................  Apply interstit radiat compl.
77790...........................  Radiation handling.
88104...........................  Cytopath fl nongyn smears.
91200...........................  Liver elastography.
93050...........................  Art pressure waveform analys.
95971...........................  Analyze neurostim simple.
95972...........................  Analyze neurostim complex.
G0416...........................  Prostate biopsy, any mthd.
------------------------------------------------------------------------


                                  Table 18--Invoices Received for New Direct PE Inputs for CY 2016 Interim Final Codes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Estimated non-
                                                                                                                                             facility
                                                                                                                                              allowed
             CPT/HCPCS codes                           Item name                       CMS code            Average price     Number of     services for
                                                                                                                             invoices       HCPCS codes
                                                                                                                                            using this
                                                                                                                                               item
--------------------------------------------------------------------------------------------------------------------------------------------------------
41530, 43229, 43270......................  radiofrequency generator (Gyrus    EQ374.....................      $10,000.00               1           2,932
                                            ENT G3 workstation).
47534, 47535, 47536, 47538, 47539, 47540.  internal/external biliary          SD312.....................          162.80               1             220
                                            catheter.
47538, 47539, 47540......................  Viabil covered biliary stent.....  SD313.....................        2,721.00               2              26
47543....................................  Radial Jaw.......................  SD314.....................           94.20               1               0
47543....................................  stone basket.....................  SD315.....................          417.00               1               0
64463....................................  Catheter securement device.......  SD316.....................  ..............               0             514
76377....................................  computer workstation, 3D           ED014.....................       45,926.00               1          67,296
                                            reconstruction CT-MR.
77778....................................  Applicator (TPV-200)/Kit.........  EQ373.....................        9,770.00               1             517
77778....................................  reentrant well ionization chamber  EP117.....................        5,180.00               2             517
77778, 77790.............................  L-block (needle loading shield)..  EP118.....................        1,195.00               1           1,848
78264, 78265, 78266......................  Bread............................  SK121.....................            0.16               1           9,735
78264, 78265, 78266......................  Egg Whites.......................  SK122.....................            0.16               1           9,735
78264, 78265, 78266......................  Jelly............................  SK123.....................            0.06               1           9,735
78264, 78265, 78266......................  paper plate......................  SK124.....................            0.17               1           9,735
93050....................................  Central Blood Pressure Monitoring  EP119.....................       14,700.00               2          25,000
                                            Equipment (XCEL PWA & PWV
                                            System).
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                Table 19--Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Estimated non-
                                                                                                                                             facility
                                                                                                                                              allowed
              CPT/HCPCS codes                         Item name              CMS code      Current price   Updated price     % Change      services for
                                                                                                                                            HCPCS codes
                                                                                                                                            using this
                                                                                                                                               item
--------------------------------------------------------------------------------------------------------------------------------------------------------
10035, 10036, 19081, 19082, 19083, 19084,   clip, tissue marker.........           SD037          $75.00          $98.20              31          58,640
 19085, 19086, 19285, 19286, 19287, 19288.
20982, 32998, 50592, 64600, 64605, 64610,   radiofrequency generator               EQ214     $ 10,000.00      $32,900.00             229         262,846
 64633, 64634, 64635, 64636.                 (NEURO).
65778.....................................  human amniotic membrane                SD248         $895.00         $949.00               6           8,807
                                             allograft mounted on a non-
                                             absorbable self-retaining
                                             ring.
65779.....................................  human amniotic membrane                SD247         $595.00         $670.00              13             104
                                             allograft.
88106.....................................  Millipore filter............           SL502           $4.15           $0.75             -82           1,204

[[Page 71052]]

 
95018.....................................  benzylpenicilloyl polylysine           SH103          $83.00          $86.00               4          60,683
                                             (e.g., PrePen) 0.25ml uou.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(1) Repair Flexor Tendon (CPT Codes 26356, 26357, and 26358)
    The RUC recommended a work RVU of 10.03 for CPT code 26356. 
Although the RUC-recommended work RVU represents a reduction from the 
current work RVU of 10.62, we believe that the decrease in resource 
costs as reflected in the survey data (specifically in the intraservice 
time, the total time, and the change in the office visits) are not 
adequately reflected in the recommended work RVU. The intraservice time 
decreased from 90 minutes to 60 minutes (33 percent) while the RUC-
recommended work RVU decreased from 10.62 to 10.03, a reduction of less 
than 6 percent. The total time and the number of office visits were 
also reduced by about 25 percent in each case, which is significantly 
greater than the 6 percent decrease in the recommended work RVU. We 
examined CPT code 25607 (Open treatment of distal radial extra-
articular fracture), which has an intraservice time of 60 minutes and a 
total time of 275 minutes, which closely approximates the 60 minutes 
and 277 minutes reflected in the survey results for CPT code 26356. We 
also believe that these procedures have similar intensity based on 
their clinical profiles. We are therefore establishing an interim final 
work RVU of 9.56 for CPT code 26356 after considering both its 
similarity in time to CPT code 25607 and the reduction in time relative 
to the current times included for this procedure.
    The RUC recommended a work RVU of 11.50 for CPT code 26357. We 
refined the RUC-recommended work RVU, employing a similar methodology 
to the one we used in valuing CPT code 26356. While we agree that the 
value of this code should increase from its current work RVU of 8.77, 
we believe that the RUC-recommended work RVU of 11.50 does not 
accurately reflect the change in time for this code. The RUC-
recommended work RVU is an increase of 31 percent from the current work 
RVU of the code, while the total time increases from 256 minutes to 302 
minutes, an increase of only 18 percent. The intraservice time for CPT 
code 26357 decreases from 89 minutes to 85 minutes, which does not 
suggest that a significant increase to the work RVU is accurate. 
Therefore, we considered CPT code 27654, (Repair, secondary, Achilles 
tendon, with or without graft) which has a similar intraservice time of 
90 minutes, a total time of 283 minutes, a similar intensity, and a 
work RVU of 10.53. We are establishing an interim final work RVU of 
10.53 for CPT code 26357 based on this direct crosswalk from CPT code 
27654, as we believe this work RVU better reflects the changes in time 
for this procedure.
    The RUC recommended a work RVU of 13.10 for CPT code 26358. We do 
not believe that this value accurately reflects the change in the 
intraservice time and the total time for this code. The RUC-recommended 
work RVU is an increase of 40 percent over the current work RVU of 
9.36, while the total time only increases from 286 minutes to 327 
minutes, an increase of 14 percent, and the intraservice time only 
increases from 108 minutes to 110 minutes, an increase of 2 percent. We 
do not believe that the RUC-recommended work RVU of 13.10, which 
corresponds to the survey median result, accurately reflects the 
increase in time. In the interest of preserving relativity among the 
codes in this family, we are maintaining the RUC-recommended increment 
of 1.6 work RVUs between CPT codes 26257 and 26358. Therefore, we are 
establishing an interim final work RVU of 12.13 for CPT code 26358, 
based on an increase of 1.6 work RVUs relative to CPT code 26357.
(2) Submucosal Ablation of Tongue Base (CPT Code 41530)
    In the proposed rule, we proposed CPT code 41530 as potentially 
misvalued based on a public nomination. The nominator stated that CPT 
code 41530 is misvalued because there have been changes in the direct 
PE inputs used in furnishing the service. In the CY 2015 PFS Final Rule 
(79 FR 67575), we noted that the RUC submitted PE recommendations and 
stated that, under our usual process, we value work and PE at the same 
time and would expect to receive RUC recommendations for both before we 
revalued this service. Subsequently, the RUC submitted recommendations 
for both. The RUC recommended a work RVU of 3.50 for CPT code 41530, 
which we are establishing as the interim final work RVU for the code. 
To address the concerns raised by CMS in the CY 2015 PFS Final Rule, 
the PE Subcommittee reviewed minor revisions submitted by the specialty 
society. The RUC determined that this service should not be performed 
in the office setting and recommended removing the nonfacility direct 
PE inputs from the direct PE input database. However, 2014 Medicare 
claims data indicate that this service is furnished in the office 
setting 95 percent of the time, and that this service is frequently 
furnished multiple times to a beneficiary. Due to this discrepancy, we 
are seeking comment about the typical site of service and whether 
changes to the coding are needed to clarify this issue. For CY 2016, we 
have established interim final nonfacility direct PE inputs based on 
the current direct PE inputs for the code.
(3) Esophagogastric Fundoplasty Trans-Oral Approach (CPT Code 43210)
    The CPT Editorial Panel established CPT code 43210 to describe 
trans-oral esophagogastric fundoplasty. The RUC recommended a work RVU 
of 9.00 for CPT code 43210. We were unable to identify CPT codes with 
an intraservice time of 60 minutes that have an RVU of 9.00 or greater. 
We were also unable to identify esophago gastro duoden os copy (EGD) 
codes with an RVU of 9.00 or greater. We compared this code to CPT code 
43240 (Drainage of cyst of the esophagus, stomach, and/or upper small 
bowel using an endoscope), which has similar total work time and a work 
RVU of 7.25. We believe a work RVU of 7.75, which corresponds to the 
25th percentile survey result, more accurately reflects the resources 
used in furnishing the service. Therefore, for CY 2016 we are 
establishing an interim final work RVU of 7.75 for CPT code

[[Page 71053]]

43210. Additionally, in accordance with our established policy, as 
described in the CY 2012 PFS Final Rule (76 FR 73119), we removed the 
subsequent observation visit (99224) included in the RUC recommended 
value for this code and adjusted the total work time accordingly, by 
including the intraservice time of the inpatient hospital visit in the 
immediate post-service time of the code.
(4) Percutaneous Biliary Procedures (CPT Codes 47531, 47532, 47533, 
47534, 47535, 47536, 47537, 47538, 47539, 47540, 47541, 47542, 47543, 
and 47544)
    Several percutaneous biliary catheter and related image guidance 
procedures were identified through a misvalued code screen of codes 
reported together more than 75 percent of the time. For CY 2016, the 
CPT Editorial Panel deleted six existing biliary catheter codes (47500, 
47505, 47510, 47511, 47525, and 47530) and five related image-guidance 
codes (74305, 74320, 74327, 75980, and 75982) and created 14 new codes, 
CPT codes 47531 through 47544, to describe percutaneous biliary 
procedures and to bundle inherent imaging services. We are establishing 
the RUC recommended work RVUs as interim final for CY 2016 for all of 
the percutaneous biliary procedures with the exception of CPT codes 
47540, 47542, 47543, and 47544.
    The RUC recommended a work RVU of 12.00 for CPT code 47540 
(Placement of stent(s) into a bile duct, percutaneous, including 
diagnostic cholangiography, imaging guidance (e.g., fluoroscopy and/or 
ultrasound), balloon dilation, catheter exchange or removal when 
performed, and all associated radiological supervision and 
interpretation, each stent; new access, with placement of separate 
biliary drainage catheter (e.g., external or internal-external)) 
corresponding to the survey median result. We believe that a work RVU 
of 10.75, which corresponds to the 25th percentile survey result, more 
accurately reflects the work associated with this service. The RUC used 
magnitude estimation to value CPT code 47540, considering reference 
codes CPT code 37226 (Revascularization, endovascular, open or 
percutaneous, femoral, popliteal artery(s), unilateral; with 
transluminal stent placement(s), includes angioplasty within the same 
vessel, when performed) and CPT code 37228 (Revascularization, 
endovascular, open or percutaneous, tibial, peroneal artery, 
unilateral, initial vessel; with transluminal angioplasty). These codes 
have work RVUs of 10.49 and 11.00 RVUs respectively; both less than the 
RUC-recommended work RVU of 12.00 for CPT code 47540. In reviewing CPT 
codes with 90 minutes of intraservice times and a 0-day global period, 
we found that the majority of codes had a work RVU of less than 12.00. 
As such, we believe that a work RVU of 10.75 better aligns this service 
with other 0 day global codes with similar intraservice times and 
maintains appropriate relativity among the codes in this family. We are 
establishing a CY 2016 interim final work RVU of 10.75 for CPT code 
47540.
    The RUC recommended a work RVU of 3.28 for 47542. We believe that a 
work RVU of 2.50 more accurately reflects the work associated with this 
service. In valuing CPT code 47542, the RUC used a direct crosswalk 
from CPT code 37185 (Primary percutaneous transluminal mechanical 
thrombectomy, noncoronary, arterial or arterial bypass graft, including 
fluoroscopic guidance and intraprocedural pharmacological thrombolytic 
injection(s); second and all subsequent vessel(s) within the same 
vascular family), which has an intraservice time of 40 minutes. We 
believe that a more appropriate direct crosswalk is CPT code 15116 
(Epidermal autograft, face, scalp, eyelids, mouth, neck, ears, orbits, 
genitalia, hands, feet, or multiple digits) because it shares an 
intraservice time of 35 minutes. Therefore, we are establishing an 
interim final work RVU of 2.50 for CPT code 47542 for CY 2016.
    The RUC recommended work RVUs of 3.51 and 4.74 for CPT codes 47543 
and 47544, respectively. We do not believe the RUC-recommended work 
RVUs accurately reflect the work involved in furnishing these 
procedures. To value the work described in these procedures, we used 
the intraservice time ratio to identify values. We used CPT code 47542 
as the base code, and calculated an intraservice time ratio by dividing 
the intraservice time of CPT code 47543 (43 minutes) by the 
intraservice time of CPT code 47542 (35 minutes); we then applied that 
ratio (1.228) to the interim final work RVU of 2.50 for CPT code 47542. 
This resulted in a work RVU of 3.07 for CPT code 47543. We used the 
same intraservice time ratio approach to calculate the interim final 
work RVU for CPT code 47544. We divided the intraservice time for CPT 
code 47544 (60 minutes) by the intraservice time for CPT code 47542 (35 
minutes), and then applied that ratio (1.714) to the interim final work 
RVU of 2.50 for CPT code 47542, which results in a work RVU of 4.29. We 
are establishing an interim final work RVU of 3.07 for CPT code 47543 
and 4.29 for CPT code 47544 for CY 2016.
    We also refined a series of RUC-recommended direct PE inputs. We 
are replacing supply item ``catheter, balloon, PTA'' (SD152) with 
supply item ``catheter, balloon ureteral (Dowd)'' (SD150) on an interim 
final basis. We believe that the use of this balloon catheter, which is 
specifically designed for catheter and image guidance procedures, would 
be more typical than the use of a PTA balloon catheter.
    We are also refining the RUC-recommended malpractice crosswalks for 
most of the codes in this family to align with the specialty mix that 
furnishes these procedures; we believe that these better reflect the 
malpractice risk associated with these procedures. We are establishing 
as interim final the malpractice crosswalks listed in Table 20.

       Table 20--MP Crosswalks for Biliary and Catheter Procedures
------------------------------------------------------------------------
                                                           CMS interim
             HCPCS code                RUC recommended      final MP
                                        MP crosswalk        crosswalk
------------------------------------------------------------------------
47531...............................             49450             49450
47532...............................             49407             49407
47533...............................             37191             47510
47534...............................             36247             47511
47535...............................             36247             47505
47536...............................             49452             49452
47537...............................             49451             47505
47538...............................             37191             47556
47539...............................             37226             47556
47540...............................             37226             47556

[[Page 71054]]

 
47541...............................             36247             47500
47542...............................             37222             47550
47543...............................             22515             47550
47544...............................             37235             47630
------------------------------------------------------------------------

(5) Percutaneous Image Guided Sclerotherapy (CPT Code 49185)
    The CPT Editorial Panel created CPT code 49185 (Sclerotherapy of a 
fluid collection (eg, lymphocele, cyst, or seroma), percutaneous, 
including contrast injection(s), sclerosant injection(s)) to describe 
percutaneous image-guided sclerotherapy of fluid collections. These 
services were previously reported using CPT code 20500 (Injection of 
sinus tract; therapeutic (separate procedure)). To develop recommended 
work RVUs for CPT code 49185, the RUC used a direct crosswalk from 
reference code 31622 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed; diagnostic, with cell washing, 
when performed), which has an intraservice time of 30 minutes and work 
RVU of 2.78. Although CPT code 31622 is clinically similar to CPT code 
49185, we do not believe CPT code 31622 has a similar intensity to CPT 
code 49185. To establish the CY 2016 interim final work RVU for CPT 
code 49185, we instead used a direct crosswalk from CPT code 62305 
(injection, radiologic supervision and interpretation), which shares an 
intraservice time of 30 minutes and is clinically similar, as it also 
includes an injection, radiologic supervision, and interpretation. We 
are establishing an interim final work RVU of 2.35 for CPT code 49185.
    The RUC recommended including 300 ml of supply item ``sclerosing 
solution injection'' (SHO62) for CPT code 49185, which is priced at 
$2.29 per millimeter. The predecessor code included supply item 
``obupivacaine (0.25% inj (Marcaine)'' (SH021)), which is priced at 
25.4 cents per millimeter. We are concerned that supply item SH062 may 
not be used in the typical case for this procedure. We note that other 
CPT codes that include supply item SH062 include between 1 and 10 ml. 
We request that stakeholders review this supply item and provide 
invoices to improve the accuracy of pricing. We are also requesting 
information regarding the price of supply item SH062 given the 
significant increase in volume used in this procedure relative to other 
procedures.
(6) Genitourinary Catheter Procedures (CPT Codes 50606, 50705, and 
50706)
    We are establishing as interim final the RUC-recommended work RVUs 
for all three codes.
    For CPT code 50706, we are replacing the RUC-recommended supply 
item ``catheter, balloon, PTA'' (SD152) with a ``catheter, balloon, 
ureteral-GI (strictures)'' (SD019) in the nonfacility setting. We 
believe that the latter balloon catheter, which is specifically 
designed for ureteral procedures, would be more typically used for 
these procedures than a PTA balloon catheter. We welcome further 
comment regarding the appropriate catheter supply for CPT code 50706, 
including any objective data regarding which supply item is more 
typically used for these procedures.
    The RUC recommended the inclusion of ``room, angiography'' (EL011) 
for this family of codes. As discussed in section II.H.d.8. of this 
final rule with comment period, we do not believe that an angiography 
room would be used in the typical case for these procedures, and are 
therefore replacing the recommended equipment item ``room, 
angiography'' with equipment item ``room, radiographic-fluoroscopic'' 
(EL014) for all three codes on an interim final basis. Since the 
predecessor procedure codes generally did not include an angiography 
room and we do not have a reason to believe that the procedure would 
have shifted to an angiography room in the course of this coding 
change, we do not believe that the use of an angiography room would be 
typical for these procedures.
    We are refining the RUC-recommended MP crosswalks for the codes in 
this family, as we do not believe that the source codes, which are 
cardiovascular services, are representative of the specialty mix that 
would typically furnish the genitourinary catheter procedures. Instead, 
we are establishing interim final MP crosswalks from codes with a 
specialty mix similar to the expected mix of those furnishing the 
services described by the new codes. We are therefore establishing the 
following MP crosswalks as interim final for 2016: CPT code 50606 from 
50955, CPT code 50705 from 50393, and CPT code 50706 from 50395.
(7) Laparoscopic Radical Prostatectomy (CPT Code 55866)
    For CPT code 55866, the RUC recommended a work RVU of 26.80. This 
is significantly higher than the work RVU for CPT code 55840 
(Prostatectomy, retropubic radical, with or without nerve sparing), the 
key reference code selected by the specialty society's survey 
participants. This reference code shares an intraservice time of 180 
minutes as well as similar total time (442 minutes for CPT code 55866, 
relative to 448 minutes for CPT code 55840). We believe that these 
codes are medically similar and would require similar work resources, 
and CPT code 55840 was recently reviewed in CY 2014. However, CPT code 
55840 has a work RVU of 21.36 while the RUC-recommended work RVU for 
CPT code 55866 is 26.80. We do not believe that difference in intensity 
between CPT code 55840 and CPT code 55866 is significant enough to 
warrant the difference of 5.50 work RVUs.
    In addition to CPT code 55840, we also examined CPT code 55845 as 
another medically similar and recently RUC-reviewed procedure. CPT code 
55845 is an open procedure that involves a lymphadenectomy, while CPT 
code 55866 is a laparoscopic procedure without a lymphadenectomy. In 
the CY 2014 PFS Final Rule with Comment Period, CMS requested review of 
CPT codes 55845 and 55866 as potentially misvalued because the work RVU 
for the laparoscopic procedure (55866) was higher than for the open 
procedure (55845). In general, we do not believe that a laparoscopic 
procedure would require greater resources than the open procedure. 
However, the RUC-recommended work RVU for CPT code 55866 is 26.80, 
which is still higher than the work RVU of 25.18 for CPT code 55845. We 
do not believe that the rank order of these work RVUs accurately 
reflects the relative resources

[[Page 71055]]

typically required to furnish these procedures, and believe that the 
work RVU for CPT code 55866 should be lower than that of CPT code 
55845. Therefore, we are establishing an interim final work RVU of 
21.36 for CPT code 55866 based on a crosswalk from CPT code 55840.We 
believe that this is an appropriate valuation based on the procedure 
time and the resources typically used to furnish the procedure.
(8) Intracranial Endovascular Intervention (CPT Codes 61645, 61650 and 
61651)
    The CPT Editorial Panel created three new codes to describe 
percutaneous intracranial endovascular intervention procedures and to 
bundle inherent imaging services. These services were previously 
reported using CPT codes 61640-61642 (Balloon dilatation of 
intracranial vasospasm). In establishing interim final values for these 
services, we are refining the RUC-recommended work RVUs for all of the 
codes in this family. The RUC recommended a work RVU of 17.00 for CPT 
code 61645 (Percutaneous arterial transluminal mechanical thrombectomy 
and/or infusion for thrombolysis, intracranial), referencing CPT code 
37231 (Revascularization, endovascular, open or percutaneous, tibial, 
peroneal artery, unilateral, initial vessel; with transluminal stent 
placement(s) and atherectomy, includes angioplasty within the same 
vessel, when performed) and CPT code 37182 (Insertion of transvenous 
intrahepatic portosystemic shunt(s) (TIPS)). We believe that CPT code 
37231 is an appropriate direct crosswalk because the overall work is 
similar to that of CPT code 61645. Therefore, we are establishing an 
interim final work RVU of 15.00 for CPT code 61645. Additionally, in 
reviewing the work time for CPT code 61645, we noted that it includes 
postservice work time associated with postoperative visit CPT code 
99233 (level 3 subsequent hospital care, per day). As we stated in the 
CY 2010 PFS proposed rule (74 FR 33557) and affirmed in the CY 2011 PFS 
proposed rule (75 FR 40072), we believe that for the typical patient, 
these services would be considered hospital outpatient services, not 
inpatient services. We believe that we should treat the valuation of 
the work time in the same manner as discussed previously, that is, by 
valuing the intraservice time of the hospital observation care service 
in the immediate post service time of the 23-hour stay code being 
valued. Therefore, we refined the work time for CPT code 61645 by 
removing the 55 minutes of work time associated with CPT code 99233 
(subsequent hospital care) and instead included the 30 minutes of 
intraservice time from CPT code 99233 in the immediate postservice time 
of the procedure. This reduces the total work time from 266 minutes to 
241 minutes and increases the immediate post service time from 53 
minutes to 83 minutes.
    The RUC recommended a work RVU of 12.00 for CPT code 61650 
(Endovascular intracranial prolonged administration of pharmacologic 
agent(s) other than for thrombolysis, arterial, including catheter 
placement, diagnostic angiography, and imaging guidance; initial 
vascular territory). We believe the RUC-recommended work RVU 
overestimates the work involved in furnishing this procedure. To 
establish an interim final work RVU for CPT code 61650, we are using a 
direct crosswalk from CPT code 37221 (Revascularization, endovascular, 
open or percutaneous, iliac artery, unilateral, initial vessel; with 
transluminal stent placement(s), includes angioplasty within the same 
vessel, when performed), which shares an intraservice time of 90 
minutes with similar intensity. Therefore, we are establishing an 
interim final work RVU of 10.00 for CPT code 61650.
    For CY 2016, we are also establishing interim final work time by 
removing the 55 minutes total time associated with CPT code 99233 
(subsequent hospital care) as recommended by the RUC and instead 
allocating the intraservice time of 30 minutes to the immediate 
postservice time of the procedure. This reduces the total time from 231 
minutes to 206 minutes and the immediate post service time from 45 
minutes to 75 minutes.
    The RUC recommended a work RVU of 5.50 for CPT code 61651 
(Endovascular intracranial prolonged administration of pharmacologic 
agent(s) other than for thrombolysis, arterial, including catheter 
placement, diagnostic angiography, and imaging guidance; each 
additional vascular territory (List separately in addition to the 
primary code)). We believe that a direct crosswalk from CPT code 37223 
(Revascularization, endovascular, open or percutaneous, iliac artery, 
each additional ipsilateral iliac vessel; with transluminal stent 
placement(s), includes angioplasty within the same vessel, when 
performed (List separately in addition to code for primary procedure)), 
more accurately reflects the work described by CPT code 61651. We 
believe that CPT code 37223 is an appropriate crosswalk because it 
shares intraservice time, has similar intensity, and is clinically 
similar to CPT code 61651. Therefore, we are establishing an interim 
final work RVU of 4.25 for CPT code 61651.
    We have also refined the RUC-recommended malpractice crosswalks for 
this family of codes to align with the specialty mix that furnish the 
services in this family. We are establishing the following interim 
final malpractice crosswalks in place of the RUC-recommended 
malpractice crosswalks: CPT code 37218 to CPT code 61645; and CPT code 
37202 to CPT codes 61650 and 61651.
(9) Paravertebral Block Injection (CPT Codes 64461, 64462, and 64463)
    In CY 2015, the CPT Editorial Panel created three new codes to 
describe paravertebral block injections at single or multiple levels, 
as well as for continuous infusion for the administration of local 
anesthetic for post-operative pain control and thoracic and abdominal 
wall analgesia. We are establishing as interim final the RUC-
recommended work RVUs for CPT codes 64461 and 64462. For CPT code 64463 
(Paravertebral block (PVB) (paraspinous block), thoracic continuous 
infusion by catheter (includes imaging guidance, when performed) the 
RUC recommended a work RVU of 1.90, which corresponds to the 25th 
percentile survey result. After considering similar injection codes 
with identical intra-service time and longer total times, we believe 
the RUC recommendation for CPT code 64463 overestimates the work 
involved in furnishing the service. We believe a direct crosswalk from 
three other injection codes which all have a work RVU of 1.81 (CPT 
codes 64461, 64446, and 64449) more accurately reflects the work 
involved in furnishing this service. Therefore, for CY 2016, we are 
establishing an interim final work RVU of 1.81 for CPT code 64463.
(10) Ocular Surface Membrane Placement (CPT Codes 65778 and 65779)
    These services were identified through the New Technology/New 
Services List in February 2010. For CY 2015, the RUC's Relativity 
Assessment Workgroup noted there may have been diffusion in technology 
for these services and requested that the specialty society survey 
these codes for work and direct PE inputs. While we are establishing 
the RUC-recommended work RVUs for CPT code 65778 and 65779 as interim 
final, we removed the work time associated with the half-day discharge 
management from CPT code 65779.

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(11) Ocular Reconstruction Transplant (CPT Code 65780)
    The RUC identified 65780 as potentially misvalued through a 
misvalued code screen of 90-day global services (based on 2012 Medicare 
utilization data) reported at least 1,000 times per year that included 
more than 6 office visits. The RUC recommended a direct work RVU 
crosswalk from CPT code 27829 (Open treatment of distal tibiofibular 
joint (syndesmosis) disruption, includes internal fixation, when 
performed). After examining comparable codes, we believe the RUC-
recommended work RVU of 8.80 for CPT code 65780 overstates the work 
involved in the procedures given the reduction in intraservice and 
total times. We believe that the ratio of the total times (230/316) 
applied to the work RVU (10.73) more accurately reflects the work 
involved in this procedure. Therefore, we are establishing an interim 
final work RVU of 7.81 to CPT code 65780.
(12) Trabeculoplasty by Laser Surgery (CPT Code 65855)
    The RUC identified CPT code 65855 (Trabeculoplasty by laser 
surgery, 1 or more sessions (defined treatment series)) as potentially 
misvalued through the review of 10-day global services with more than 
1.5 postoperative visits. The RUC noted that the code was changed from 
a 90-day to a 10-day global period when it was last valued in 2000. 
However, the descriptor was not updated to reflect that change. CPT 
code 65855 describes multiple laser applications to the trabecular 
meshwork through a contact lens to reduce intraocular pressure. The 
current practice is to perform only one treatment session of the laser 
for glaucoma during a 10-day period and then wait for the effect on the 
intraocular pressure. The descriptor for CPT code 65855 has been 
revised and removes the language ``1 or more sessions'' to clarify this 
change in practice.
    The RUC recommended a work RVU of 3.00. While the RUC-recommended 
value represents a reduction from the CY 2015 work RVU of 3.99, we 
believe that significant reductions in the intraservice time, the total 
time, and the change in the office visits represent a more significant 
change in the work resources involved in furnishing the typical 
service. The intraservice and total times were decreased by 
approximately 33 percent while the elimination of two post-operative 
visits (CPT code 99212) alone would reduce the overall work RVU by at 
least 24 percent under the reverse BBM. However, the recommended work 
RVU only represents a 25 percent reduction relative to the previous 
value. To develop an interim final work RVU for this service, we 
calculated an intraservice time ratio between the CY 2015 intraservice 
time, 15 minutes, and the RUC-recommended intraservice time, 10 
minutes, and applied this ratio to the current work RVU of 3.99 to 
arrive at a work RVU of 2.66 for CPT code 65855. Therefore, for CY 
2016, we are establishing an interim final work RVU of 2.66 for CPT 
code 65855.
(13) Glaucoma Surgery (CPT Codes 66170 and 66172)
    The RUC identified CPT codes 66170 and 66172 as potentially 
misvalued through a 90-day global post-operative visits screen 
(services reported at least 1,000 times per year that included more 
than 6 office visits). We believe the RUC-recommended work RVU of 13.94 
for CPT code 66170 (fistulization of sclera for glaucoma; 
trabeculectomy ab externo in absence of previous surgery) does not 
accurately account for the reductions in time. Specifically, the survey 
results indicated reductions of 25 percent in intraservice time and 28 
percent in total time. These reductions suggest that the RUC-
recommended work RVU for CPT code 66170 overstates the work involved in 
furnishing the service, since the recommended value only represents a 
reduction of approximately seven percent. We believe that applying the 
intraservice time ratio, as described above, to the current work RVU 
results in a more appropriate work RVU. Therefore, for CY 2016, we are 
establishing an interim final work RVU of 11.27 for CPT code 66170.
    For CPT code 66172 (fistulization of sclera for glaucoma; 
trabeculectomy ab externo with scarring from previous ocular surgery or 
trauma (includes injection of antifibrotic agents)), the RUC 
recommended a work RVU of 14.81. After comparing the RUC-recommended 
work RVUs for this code to the work RVUs of similar codes (for example, 
CPT code 44900 (Incision and drainage of appendiceal abscess, open) and 
CPT code 59100 (Hysterotomy, abdominal (eg, for hydatidiform mole, 
abortion)), we believe the RUC-recommended work RVU of 14.81 overstates 
the work involved in this procedure. For the same reasons and following 
the same valuation methodology utilized above, we applied the 
intraservice time ratio between the CY 2015 intraservice time and the 
survey intraservice time, 60/90, to the CY 2015 work RVU of 18.86. This 
results in a work RVU of 12.57 for CPT code 66172. Therefore, for CY 
2016, we are establishing an interim final work RVU of 12.57 for CPT 
code 66172.
(14) Retinal Detachment Repair (CPT Codes 67107, 67108, 67110, and 
67113)
    CPT codes 67107, 67108, 67110 and 67113 were identified as 
potentially misvalued through the 90-day global post-operative visit 
screen (either directly or indirectly as being part of the same 
family). The RUC recommended a work RVU of 16.00 for CPT code 67107, 
which corresponds to the 25th percentile survey result. While the RUC 
recommendation represents a 5 percent reduction from the current work 
RVU of 16.71, we believe the RUC recommendation still overvalues the 
service given the 15 percent reduction in intraservice time and 25 
percent reduction in total time. Using the methodology previously 
described, we used the intraservice time ratio to arrive at an interim 
final work RVU of 14.06. We believe this value more accurately reflects 
the work involved in this service and is comparable to other codes that 
have the same global period and similar intraservice time and total 
time. For CY 2016, we are establishing an interim final work RVU of 
14.06 for CPT code 67107.
    For CPT code 67108, the RUC recommended a work RVU of 17.13 based 
on the 25th percentile survey result, which reflects a 25 percent 
reduction from the current work RVU. The survey results reflect a 53 
percent reduction in intraservice time and a 42 percent reduction in 
total time. We believe the RUC-recommended work RVU overstates the 
work, given the significant reductions in intraservice time and total 
time and does not maintain relativity among the codes in this family. 
To determine the appropriate value for this code and maintain 
relativity within the family, we preserved the 1.13 increment 
recommended by the RUC, between this code and CPT code 67107, and 
applied that increment to the interim final work RVU of 14.06 for CPT 
code 67107. Therefore, we are establishing an interim final work RVU of 
15.19 for CPT code 67108.
    For CPT code 67110, the RUC recommended maintaining the current 
work RVU of 10.25. To maintain appropriate relativity with the work 
RVUs established for the other services within this family, we are 
using the RUC-recommended -5.75 RVU differential between CPT code 67107 
and CPT code 67110 to establish the CY 2016 interim final work RVU of 
8.31 for CPT code 67110.

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    (15) Fetal MRI (CPT Codes 74712 and 74713)
    For CY 2016, the CPT Editorial Panel established two new codes to 
describe fetal MRI services, which were previously billed using CPT 
codes 72195 (Magnetic resonance (eg, proton) imaging, pelvis; without 
contrast material(s)), 72196 (with contrast material(s)