[Federal Register Volume 82, Number 219 (Wednesday, November 15, 2017)]
[Rules and Regulations]
[Pages 52976-53371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23953]



[[Page 52975]]

Vol. 82

Wednesday,

No. 219

November 15, 2017

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 405, 410, 414, et al.





Medicare Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention Program; 
Final Rule

  Federal Register / Vol. 82 , No. 219 / Wednesday, November 15, 2017 / 
Rules and Regulations  

[[Page 52976]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 414, 424, and 425

[CMS-1676-F]
RIN 0938-AT02


Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2018; 
Medicare Shared Savings Program Requirements; and Medicare Diabetes 
Prevention Program

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

ACTION: Final rule.

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SUMMARY: This major final rule addresses changes to the Medicare 
physician fee schedule (PFS) and other Medicare Part B payment policies 
such as changes to the Medicare Shared Savings Program, to ensure that 
our payment systems are updated to reflect changes in medical practice 
and the relative value of services, as well as changes in the statute. 
In addition, this final rule includes policies necessary to begin 
offering the expanded Medicare Diabetes Prevention Program model.

DATES: These regulations are effective on January 1, 2018.

FOR FURTHER INFORMATION CONTACT: Jessica Bruton, (410) 786-5991, for 
any physician payment issues not identified below.
    Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804, 
for issues related to telehealth services and primary care.
    Roberta Epps, (410) 786-4503, for issues related to PAMA section 
218(a) policy and transition from traditional X-ray imaging to digital 
radiography.
    Isadora Gil, (410) 786-4532, for issues related to the valuation of 
cardiovascular services, bone marrow services, surgical respiratory 
services, dermatological procedures, and payment rates for nonexcepted 
items and services furnished by nonexcepted off-campus provider-based 
departments of a hospital.
    Donta Henson, (410) 786-1947, for issues related to ophthalmology 
services.
    Jamie Hermansen, (410) 786-2064, for issues related to the 
valuation of anesthesia services.
    Tourette Jackson, (410) 786-4735, for issues related to the 
valuation of musculoskeletal services, allergy and clinical immunology 
services, endocrinology services, genital surgical services, nervous 
system services, INR monitoring services, injections and infusions, and 
chemotherapy services.
    Ann Marshall, (410) 786-3059, for issues related to primary care, 
chronic care management (CCM), and evaluation and management (E/M) 
services.
    Geri Mondowney, (410) 786-1172, for issues related to malpractice 
RVUs.
    Patrick Sartini, (410) 786-9252, for issues related to the 
valuation of imaging services and malpractice RVUs.
    Michael Soracoe, (410) 786-6312, for issues related to the practice 
expense methodology, impacts, conversion factor, and valuation of 
pathology and surgical procedures.
    Pamela West, (410) 786-2302, for issues related to therapy 
services.
    Corinne Axelrod, (410) 786-5620, for issues related to rural health 
clinics or federally qualified health centers.
    Felicia Eggleston, (410) 786-9287, for issues related to DME 
infusion drugs.
    Rasheeda Johnson, (410) 786-3434, for issues related to initial 
data collection and reporting periods for the clinical laboratory fee 
schedule.
    Edmund Kasaitis, (410) 786-0477, for issues related to biosimilars.
    JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, 
for issues related to appropriate use criteria for advanced diagnostic 
imaging services.
    Crystal Kellam, (410) 786-7970, for issues related to physician 
quality reporting system.
    Alesia Hovatter, (410) 786-6861, for issues related to Physician 
Compare.
    Alexandra Mugge, (410) 786-4457, for issues related to the EHR 
incentive program.
    Kari Vandegrift, (410) 786-4008, or [email protected], for issues 
related to the Medicare Shared Savings Program.
    Kimberly Spalding Bush, (410) 786-3232, or Fiona Larbi, (410) 786-
7224, for issues related to Value-based Payment Modifier and Physician 
Feedback Program.
    Wilfred Agbenyikey, (410) 786-4399, for issues related to MACRA 
patient relationship categories and codes.
    Carlye Burd, (410) 786-1972, or Albert Wesley, (410) 786-4204, for 
issues related to the Medicare Diabetes Prevention Program expanded 
model.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
II. Provisions of the Proposed Rule and Analysis of and Responses to 
Public Comments
    A. Background
    B. Determination of Practice Expense (PE) Relative Value Units 
(RVUs)
    C. Determination of Malpractice Relative Value Units (RVUs)
    D. Medicare Telehealth Services
    E. Potentially Misvalued Services Under the PFS
    F. Payment Incentive for the Transition from Traditional X-Ray 
Imaging to Digital Radiography and Other Imaging Services
    G. Establishment of Payment Rates Under the Medicare PFS for 
Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus 
Provider-Based Departments of a Hospital
    H. Valuation of Specific Codes
    I. Evaluation & Management (E/M) Guidelines and Care Management 
Services
    J. Therapy Caps
III. Other Provisions of the Proposed Rule
    A. New Care Coordination Services and Payment for Rural Health 
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
    B. Part B Drug Payment: Infusion Drugs Furnished Through an Item 
of Durable Medical Equipment (DME)
    C. Solicitation of Public Comments on Initial Data Collection 
and Reporting Periods for Clinical Laboratory Fee Schedule
    D. Payment for Biosimilar Biological Products Under Section 
1847A of the Act
    E. Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services
    F. Physician Quality Reporting System Criteria for Satisfactory 
Reporting for Individual EPs and Group Practices for the 2018 PQRS 
Payment Adjustment
    G. Clinical Quality Measurement for Eligible Professionals 
Participating in the Electronic Health Record (EHR) Incentive 
Program for 2016
    H. Medicare Shared Savings Program
    I. Value-Based Payment Modifier and Physician Feedback Program
    J. MACRA Patient Relationship Categories and Codes
    K. Changes to the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model
    L. Physician Self-Referral Law: Annual Update to the List of 
CPT/HCPCS Codes
IV. Collection of Information Requirements
V. Regulatory Impact Analysis
Regulations Text

Acronyms

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

A1c Hemoglobin A1c
AAA Abdominal aortic aneurysms
ABLE Achieving a Better Life Experience Act of 2014 (Pub. L. 113-
295)
ACI Advancing Care Information
ACO Accountable care organization
AMA American Medical Association
APM Alternative Payment Model
ASC Ambulatory surgical center
ATA American Telehealth Association
ATRA American Taxpayer Relief Act (Pub. L. 112-240)
AUC Appropriate Use Criteria

[[Page 52977]]

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)
BHI Behavioral health integration
BLS Bureau of Labor Statistics
CAD Coronary artery disease
CAH Critical access hospital
CBSA Core-Based Statistical Area
CCM Chronic care management
CDSM Clinical Decision Support Mechanism
CEHRT Certified EHR technology
CF Conversion factor
CG-CAHPS Clinician and Group Consumer Assessment of Healthcare 
Providers and Systems
CLFS Clinical Laboratory Fee Schedule
CoA Certificate of Accreditation
CoC Certificate of Compliance
CoCM Collaborative care model
CoR Certificate of Registration
CNM Certified nurse-midwife
CP Clinical psychologist
CPC Comprehensive Primary Care
CPEP Clinical Practice Expert Panel
CPT [Physicians] Current Procedural Terminology (CPT codes, 
descriptions and other data only are copyright 2015 American Medical 
Association. All rights reserved.)
CQM Clinical quality measure
CSW Clinical social worker
CT Computed tomography
CW Certificate of Waiver
CY Calendar year
DFAR Defense Federal Acquisition Regulations
DHS Designated health services
DM Diabetes mellitus
DSMT Diabetes self-management training
eCQM Electronic clinical quality measures
ED Emergency Department
EHR Electronic health record
E/M Evaluation and management
EMT Emergency Medical Technician
EP Eligible professional
eRx Electronic prescribing
ESRD End-stage renal disease
FAR Federal Acquisition Regulations
FDA Food and Drug Administration
FFS Fee-for-service
FQHC Federally qualified health center
FR Federal Register
FSHCAA Federally Supported Health Centers Assistance Act
GAF Geographic adjustment factor
GAO Government Accountability Office
GPCI Geographic practice cost index
GPO Group purchasing organization
GPRO Group practice reporting option
GTR Genetic Testing Registry
HCPCS Healthcare Common Procedure Coding System
HHS [Department of] Health and Human Services
HOPD Hospital outpatient department
HPSA Health professional shortage area
IDTF Independent diagnostic testing facility
IPPE Initial preventive physical exam
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
ISO Insurance service office
IT Information technology
IWPUT Intensity of work per unit of time
LCD Local coverage determination
MA Medicare Advantage
MAC Medicare Administrative Contractor
MACRA Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 
114-10)
MAP Measure Applications Partnership
MAPCP Multi-payer Advanced Primary Care Practice
MAV Measure application validity [process]
MCP Monthly capitation payment
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MFP Multi-Factor Productivity
MIPPA Medicare Improvements for Patients and Providers Act (Pub. L. 
110-275)
MIPS Merit-based Incentive Payment System
MMA Medicare Prescription Drug, Improvement and Modernization Act of 
2003 (Pub. L. 108-173, enacted on December 8, 2003)
MP Malpractice
MPPR Multiple procedure payment reduction
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan Statistical Areas
MSPB Medicare Spending per Beneficiary
MU Meaningful use
NCD National coverage determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQS National Quality Strategy
OACT CMS's Office of the Actuary
OBRA '89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)
OBRA '90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508)
OES Occupational Employment Statistics
OMB Office of Management and Budget
OPPS Outpatient prospective payment system
OT Occupational therapy
PA Physician assistant
PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)
PAMPA Patient Access and Medicare Protection Act (Pub. L. 114-115)
PC Professional component
PCIP Primary Care Incentive Payment
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment, Chain, and Ownership System
PFS Physician Fee Schedule
PLE Provider-led Entity
PLI Professional Liability Insurance
PMA Premarket approval
PMH-NP Psychiatric mental health nurse practitioner
PPM Provider-Performed Microscopy
PQRS Physician Quality Reporting System
PPIS Physician Practice Expense Information Survey
PPS Prospective Payment System
PT Physical therapy
PT Proficiency Testing
PT/INR Prothrombin Time/International Normalized Ratio
PY Performance year
QA Quality Assessment
QC Quality Control
QCDR Qualified clinical data registry
QRUR Quality and Resources Use Report
RBRVS Resource-based relative value scale
RFA Regulatory Flexibility Act
RHC Rural health clinic
RIA Regulatory impact analysis
RUC American Medical Association/Specialty Society Relative Value 
Scale Update Committee
RUCA Rural Urban Commuting Area
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SIM State Innovation Model
SLP Speech-language pathology
SMS Socioeconomic Monitoring System
SNF Skilled nursing facility
TAP Technical Advisory Panel
TC Technical component
TIN Tax identification number
TCM Transitional Care Management
UAF Update adjustment factor
UPIN Unique Physician Identification Number
USPSTF United States Preventive Services Task Force
VBP Value-based purchasing
VM Value-Based Payment Modifier

Addenda Available Only Through the Internet on the CMS Web Site

    The PFS Addenda along with other supporting documents and tables 
referenced in this final rule are available 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 2018 PFS Final Rule, refer to item CMS-
1676-F. Readers with questions related to accessing any of the Addenda 
or other supporting documents referenced in this final rule and posted 
on the CMS Web site identified above should contact Jessica Bruton at 
(410) 786-5991.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this final rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2016 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.

[[Page 52978]]

I. Executive Summary

A. Purpose

    This final rule makes payment and policy changes under the Medicare 
Physician Fee Schedule (PFS) and implements required statutory changes 
under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) 
(Pub. L. 114-10), Achieving a Better Life Experience Act of 2014 (ABLE) 
(Pub. L. 113-295), Protecting Access to Medicare Act of 2014 (PAMA) 
(Pub. L. 113-93), and the Consolidated Appropriations Act of 2016 (Pub. 
L. 114-113). This final rule also makes changes to payment policy and 
other related policies for Medicare Part B, Part D, and Medicare 
Advantage.
1. Summary of the Major Provisions
    Section 1848 of 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 statute requires that RVUs be established for 
three categories of resources: Work, practice expense (PE); and 
malpractice (MP) expense; and, that we establish by regulation each 
year's payment amounts for all physicians' services paid under the PFS, 
incorporating geographic adjustments to reflect the variations in the 
costs of furnishing services in different geographic areas. In this 
major final rule, we establish RVUs for CY 2018 for the PFS, and other 
Medicare Part B payment policies, to ensure that our payment systems 
are updated to reflect changes in medical practice and the relative 
value of services, as well as changes in the statute. In addition, this 
final rule includes discussions and finalized policies regarding:
     Potentially Misvalued Codes.
     Telehealth Services.
     Establishing Values for New, Revised, and Misvalued Codes.
     Establishing Payment Rates under the PFS for Nonexcepted 
Items and Services Furnished by Nonexcepted Off-Campus Provider-Based 
Departments of a Hospital.
     Evaluation & Management (E/M) Guidelines and Care 
Management Services.
     Care Coordination Services and Payment for Rural Health 
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
     Part B Drug Payment: Infusion Drugs Furnished Through an 
Item of Durable Medical Equipment (DME).
     Solicitation of Public Comments on Initial Data Collection 
and Reporting Periods for Clinical Laboratory Fee Schedule.
     Payment for Biosimilar Biological Products under Section 
1847A of the Act.
     Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services.
     PQRS Criteria for Satisfactory Reporting for Individual 
EPs and Group Practices for the 2018 PQRS Payment Adjustment.
     Clinical Quality Measurement for Eligible Professionals 
Participating in the Electronic Health Record (EHR) Incentive Program 
for 2016.
     Medicare Shared Savings Program.
     Value-Based Payment Modifier and the Physician Feedback 
Program.
     MACRA Patient Relationship Categories and Codes.
     Changes to the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model.
     Physician Self Referral Law: Annual Update to the List of 
CPT/HCPCS Codes.
     Therapy Caps.
2. Summary of Costs and Benefits
    The statute requires that annual adjustments to PFS RVUs may not 
cause annual estimated expenditures to differ by more than $20 million 
from what they would have been had the adjustments not been made. If 
adjustments to RVUs would cause expenditures to change by more than $20 
million, we must make adjustments to preserve budget neutrality. These 
adjustments can affect the distribution of Medicare expenditures across 
specialties. We have determined that this major final rule is 
economically significant. For a detailed discussion of the economic 
impacts, see section V. of this final rule.

II. Provisions of the Final Rule, and Analysis of and Responses to 
Public Comments for PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Act, ``Payment for Physicians' Services.'' 
The PFS relies on national relative values that are established for 
work, PE, and MP, which are adjusted for geographic cost variations. 
These values are multiplied by a conversion factor (CF) to convert the 
RVUs into payment rates. The concepts and methodology underlying the 
PFS were enacted as part of the Omnibus Budget Reconciliation Act of 
1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and 
the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted 
on November 5, 1990) (OBRA '90). The final rule published on November 
25, 1991 (56 FR 59502) set forth the first fee schedule used for 
payment for physicians' services.
    We note that throughout this major final rule, unless otherwise 
noted, the term ``practitioner'' is used to describe both physicians 
and nonphysician practitioners (NPPs) who are permitted to bill 
Medicare under the PFS for services furnished to Medicare 
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
    The work RVUs established for the initial fee schedule, which was 
implemented on January 1, 1992, were developed with extensive input 
from the physician community. A research team at the Harvard School of 
Public Health developed the original work RVUs for most codes under a 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in determining 
the original physician work RVUs, Harvard worked with panels of 
experts, both inside and outside the federal government, and obtained 
input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion 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 Scale 
Update Committee (RUC), the Health Care Professionals Advisory 
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), 
and other public commenters; medical literature and comparative 
databases; as well as a comparison of the work for other codes within 
the Medicare PFS, and consultation with other physicians and health 
care professionals within CMS and the federal government. We also 
assess the methodology and data used to develop the recommendations 
submitted to us by the RUC and other public commenters, and the 
rationale for their recommendations. In the CY 2011 PFS final rule with 
comment period (75 FR 73328 through 73329), we discussed a variety of 
methodologies and approaches used to develop work RVUs, including 
survey data, building blocks, crosswalk to key reference or

[[Page 52979]]

similar codes, and magnitude estimation. More information on these 
issues is available in that rule.
b. Practice Expense RVUs
    Initially, only the work RVUs were resource-based, and the PE and 
MP RVUs were based on average allowable charges. Section 121 of the 
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on 
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and 
required us to develop resource-based PE RVUs for each physicians' 
service beginning in 1998. We were required to consider general 
categories of expenses (such as office rent and wages of personnel, but 
excluding malpractice expenses) comprising PEs. The PE RVUs continue to 
represent the portion of these resources involved in furnishing PFS 
services.
    Originally, the resource-based method was to be used beginning in 
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the 
resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA provided for a 4-year transition period from 
the charge-based PE RVUs to the resource-based PE RVUs.
    We established the resource-based PE RVUs for each physicians' 
service in a final rule, published on November 2, 1998 (63 FR 58814), 
effective for services furnished in CY 1999. Based on the requirement 
to transition to a resource-based system for PE over a 4-year period, 
payment rates were not fully based upon resource-based PE RVUs until CY 
2002. This resource-based system was based on two significant sources 
of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and 
the AMA's Socioeconomic Monitoring System (SMS) data. These data 
sources are described in greater detail in the CY 2012 final rule with 
comment period (76 FR 73033).
    Separate PE RVUs are established for services furnished in facility 
settings, such as a hospital outpatient department (HOPD) or an 
ambulatory surgical center (ASC), and in nonfacility settings, such as 
a physician's office. The nonfacility RVUs reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some costs are borne by the facility. 
Medicare's payment to the facility (such as the outpatient prospective 
payment system (OPPS) payment to the HOPD) would reflect costs 
typically incurred by the facility. Thus, payment associated with those 
facility resources is not made under the PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of 
Health and Human Services (the Secretary) to establish a process under 
which we accept and use, to the maximum extent practicable and 
consistent with sound data practices, data collected or developed by 
entities and organizations to supplement the data we normally collect 
in determining the PE component. On May 3, 2000, we published the 
interim final rule (65 FR 25664) that set forth the criteria for the 
submission of these supplemental PE survey data. The criteria were 
modified in response to comments received, and published in the Federal 
Register (65 FR 65376) as part of a November 1, 2000 final rule. The 
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 
and 68 FR 63196) extended the period during which we would accept these 
supplemental data through March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA amended section 1848(c) of the Act to 
require that we implement resource-based MP RVUs for services furnished 
on or after CY 2000. The resource-based MP RVUs were implemented in the 
PFS final rule with comment period published November 2, 1999 (64 FR 
59380). The MP RVUs are based on commercial and physician-owned 
insurers' malpractice insurance premium data from all the states, the 
District of Columbia, and Puerto Rico. For more information on MP RVUs, 
see section II.C. of this final rule.
d. Refinements to the RVUs
    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no 
less often than every 5 years. Prior to CY 2013, we conducted periodic 
reviews of work RVUs and PE RVUs independently. We completed 5-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 5-year reviews, beginning for CY 2009, CMS and 
the RUC have identified and reviewed a number of potentially misvalued 
codes on an annual basis based on various identification screens. This 
annual review of work and PE RVUs for potentially misvalued codes was 
supplemented by the amendments to section 1848 of the Act, as enacted 
by section 3134 of the Affordable Care Act, that require the agency to 
periodically identify, review and adjust values for potentially 
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
    As described in section V.C. of this final rule, in accordance with 
section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs 
cause expenditures for the year to change by more than $20 million, we 
make adjustments to ensure that expenditures do not increase or 
decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services. The GPCIs reflect the relative costs of work, 
PE, and MP in an area compared to the national average costs for each 
component.
    RVUs are converted to dollar amounts through the application of a 
CF, which

[[Page 52980]]

is calculated based on a statutory formula by CMS's Office of the 
Actuary (OACT). The formula for calculating the Medicare PFS 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 CF, in a 
manner to ensure that fee schedule amounts for anesthesia services are 
consistent with those for other services of comparable value. 
Therefore, there is a separate fee schedule methodology for anesthesia 
services. Specifically, we establish a separate CF 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.

B. 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 5 Year Review of Work Relative Value 
Units under the PFS and Proposed Changes to the Practice Expense 
Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final 
rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
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 NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data. 
Consistent with our past practice, the previous indirect PE/HR values 
from the supplemental surveys for these specialties were updated to CY 
2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare-recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS-based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and comment rulemaking and are 
available in the file called ``CY 2018 PFS Final Rule PE/HR'' on the 
CMS Web site under downloads for the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Comment: Several commenters recommended that it was time to 
consider a new nationwide all specialty

[[Page 52981]]

PE/HR survey, given the amount of time that has passed since the last 
survey was conducted. The commenters stated that the practice of 
medicine has significantly and substantially evolved in the past decade 
and that many specialties have had extensive changes in physician 
employment models during that time. The commenters stated that 
continued use of the outdated PPIS survey leads to an inappropriate and 
inaccurate distortion of the PE RVUs for current practice.
    Response: We have previously identified several concerns regarding 
the underlying data used in determining PE RVUs in the CY 2014 PFS 
final rule (78 FR 74246 through 74247). Even when we first incorporated 
the survey data into the PE methodology beginning in CY 1999 (63 FR 
58814), many commenters expressed serious concerns over the accuracy of 
this or other PE surveys as a way of gathering data on PE inputs from 
the diversity of providers paid under the PFS. However, we currently 
lack another source of comprehensive data regarding PE costs, and as a 
result, we continue to believe that the PPIS survey data is the best 
data currently available. We continue to seek the best broad-based, 
auditable, routinely-updated source of information regarding PE costs.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs to the code level on the basis of 
the direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion (see section 
II.B.2.b of this final rule). The general approach to developing the 
indirect portion of the PE RVUs is as follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. 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, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 
percent of 8.00).
     Next, we add the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had a work RVU of 
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we 
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey data, the relative relationship between the indirect cost 
portions of the PE RVUs for any two services would be determined by the 
relative relationship between these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00, the indirect 
portion of the PE RVUs of the first service would be twice as great as 
the indirect portion of the PE RVUs for the second service.
     Next, we incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey 
data, the average indirect cost of the specialties furnishing the first 
service with an allocator of 10.00 was half of the average indirect 
cost of the specialties furnishing the second service with an indirect 
allocator of 5.00, the indirect portion of the PE RVUs of the first 
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
    For procedures that can be furnished in a physician's office, as 
well as in a facility setting, where Medicare makes a separate payment 
to the facility for its costs in furnishing a service, we establish two 
PE RVUs: Facility and nonfacility. The methodology for calculating PE 
RVUs is the same for both the facility and nonfacility RVUs, but is 
applied independently to yield two separate PE RVUs. In calculating the 
PE RVUs for services furnished in a facility, we do not include 
resources that would generally not be provided by physicians when 
furnishing the service. For this reason, the facility PE RVUs are 
generally lower than the nonfacility PE RVUs.
    Comment: One commenter requested that CMS develop nonfacility PE 
RVUs for CPT code 31255 (Nasal/sinus endoscopy, surgical; with 
ethmoidectomy, total (anterior and posterior)), stating that this would 
be consistent with the migration of many sinus surgery procedures to 
the office setting. The commenter indicated that the availability of 
new technology has transformed these services to become minimally 
invasive, and as a result, they can be safely and effectively performed 
in the office setting for many patients.
    Response: We appreciate the information provided by the commenter. 
However, we note that CPT code 31255 was reviewed by the RUC for the 
current CY 2018 rule cycle, and the RUC did not recommend any direct PE 
inputs for this code in the nonfacility setting. We welcome an ongoing 
dialogue with stakeholders regarding the direct PE inputs for this 
code, which we will take under consideration for future rulemaking. We 
also note that pricing in a particular setting does not constitute a 
coverage determination.
(4) Services With Technical Components and Professional Components
    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.)

[[Page 52982]]

(5) PE RVU Methodology
    For a more detailed description of the PE RVU methodology, we refer 
readers to the CY 2010 PFS final rule with comment period (74 FR 61745 
through 61746). We also direct interested readers to the file called 
``Calculation of PE RVUs under Methodology for Selected Codes'' which 
is available on our Web site under downloads for the CY 2018 PFS final 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this final rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the proposed aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
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 adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to a RVU scale for each 
service. To do this, divide the results of Step 4 by the CF. Note that 
the actual value of the CF used in this calculation does not influence 
the final direct cost PE RVUs as long as the same CF is used in Step 4 
and Step 5. Different CFs would result in different direct PE scaling 
adjustments, but this has no effect on the final direct cost PE RVUs 
since changes in the CFs and changes in the associated direct scaling 
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    We generally use an average of the 3 most recent years of available 
Medicare claims data to determine the specialty mix assigned to each 
code. Prior to implementing that policy, we used the most recent year 
of available claims data to determine the specialty mix assigned to 
each code.
    Under either of these approaches, codes with low Medicare service 
volume require special attention since billing or enrollment 
irregularities for a given year can result in significant changes in 
specialty mix assignment. Prior to adopting the 3-year average of data, 
for low-volume services (fewer than 100 Medicare allowed services), we 
assigned the values associated with the specialty that most frequently 
reported the service in the most recent claims data (dominant 
specialty). For some time, stakeholders, including the RUC, have 
requested that we use a recommended ``expected'' specialty for all low 
volume services instead of the information contained in the claims 
data. Currently, in the development of PE RVUs we use ``expected 
specialty'' overrides for only several dozen services based on several 
code-specific policies we established in prior rulemaking. As we stated 
in the CY 2016 final rule with comment period (80 FR 70894), we hoped 
that the 3-year average would mitigate the need to use dominant or 
expected specialty instead of the specialty identified using claims 
data. Because we incorporated CY 2015 claims data for use in the CY 
2017 proposed rates, we believe that the finalized PE RVUs associated 
with the CY 2017 PFS final rule provided a first opportunity to 
determine whether service-level overrides of claims data are necessary.
    Although we believe that the use of the 3-year average of claims 
data to determine specialty mix has led to an improvement in the 
stability of PE and MP RVUs from year to year, after reviewing the RVUs 
for low volume services, we continue to see possible distortions and 
wide variability from year to year in PE and MP RVUs for low volume 
services. Several stakeholders have suggested that CMS implement 
service-level overrides based on the expected specialty in order to 
determine the specialty mix for these low volume procedures. The RUC 
previously supplied us with a list of nearly 2,000 lower volume codes 
and their suggested specialty overrides. After reviewing the finalized 
PE RVUs for the CY 2017 PFS final rule, we agree that the use of 
service-level overrides for low volume services would help mitigate 
annual fluctuations and provide greater stability in the valuation of 
these services. While the use of the 3-year average of claims data to 
determine specialty mix has helped to mitigate some of the year to year 
variability for low volume services, it has not fully mitigated what 
appear to be anomalies for many of these lower volume codes.
    Therefore, we proposed to use the most recent year of claims data 
to determine which codes are low volume for the coming year (those that 
have fewer than 100 allowed services in the Medicare claims data). For 
codes that fall into this category, instead of assigning specialty mix 
based on the specialties of the practitioners reporting the services in 
the claims data, we proposed to instead use the expected specialty that 
we identify on a list. For CY 2018, we proposed to use a list that was 
developed based on our medical review of the list most recently 
recommended by the RUC, in addition to our own proposed expected 
specialty for certain other low-volume codes for which we have 
historically used expected specialty assignments. We would display this 
list as part of the annual set of data files we make available as part 
of notice and comment rulemaking. We proposed to consider 
recommendations from the RUC and other stakeholders on changes to this 
list on an annual basis.
    We also proposed to apply these service-level overrides for both PE 
and MP, rather than one or the other category. We believe that this 
would simplify the implementation of service-level overrides for PE and 
MP, and would also address stakeholder concerns about the year-to-year 
variability for low volume services. We solicited public comment on the 
proposal to use service-level overrides to determine the specialty mix 
for low volume procedures, as well as on the proposed list of expected 
specialty overrides itself, which is largely based on the 
recommendations submitted by the RUC last year. The proposed list of 
expected specialty assignments for individual low volume services is 
available on our Web site under downloads for the CY 2018 PFS proposed 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-

[[Page 52983]]

Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Services 
for which the specialty is automatically assigned based on previously 
finalized policies under our established methodology (for example, 
``always therapy'' services) would be unaffected by this proposal.
    The following is a summary of the public comments received on our 
proposal to use service-level overrides to determine the specialty mix 
for low volume procedures and our responses:
    Comment: Many commenters supported the use of the expected 
specialty assignments and urged CMS to finalize the proposal. 
Commenters stated that the proposal was consistent with a longstanding 
RUC recommendation and the use of the expected specialty assignments 
would help mitigate some of the year to year variability for low volume 
services. Commenters supported the creation of a list of these service-
level overrides and its maintenance on an annual basis, with several 
commenters stating that the RUC should review updated claims data each 
year to determine if any new codes fall below 100 claims and submit an 
expected specialty recommendation for these additional codes.
    Response: We appreciate the comments in support of the proposal. As 
we stated in the proposed rule, we will consider recommendations from 
the RUC and other stakeholders on changes to the list of expected 
specialty assignments on an annual basis.
    Comment: Several commenters made specific recommendations about the 
proposed list of expected specialty assignments for individual low 
volume services. One commenter recommended that the following CPT codes 
should be added to the list of expected specialty assignments: 
Cardiology: 33477; Cardiac surgery: 33238, 33514, 33548, 33951, 33953, 
33955, 33957, 33958, 33959, 33962, 33963, 33964, 33965, 33969, 33973, 
33985, 33987, 33988, 33989, 33991, 35271; General Surgery: 35251, 
43325; Thoracic Surgery: 32672, 33025, 33215, 43135. The same commenter 
recommended the following changes to the indicated codes on the low 
volume override list:
     CPT codes 33363 and 33364: The commenter recommended 
changing the override specialty from cardiology to cardiac surgery.
     CPT codes 33516, 33976 and 35812: The commenter 
recommended changing the override specialty from thoracic surgery to 
cardiac surgery.
     CPT codes 35311 and 35526: The commenter recommended 
changing the override specialty from vascular surgery to cardiac 
surgery.
     CPT codes 38382, 43108, 43118, 43123, 43360, 43405 and 
43425: The commenter recommended changing the override specialty from 
general surgery to thoracic surgery.
    In addition, a different commenter recommended changing the 
proposed expected specialty for CPT code 43754 from gastroenterology to 
emergency medicine.
    Response: We appreciate the submission of specific recommendations 
to the proposed list of expected specialty assignments. These 
recommendations from the commenter included newer information about the 
typical practice of these CPT codes than what we possessed when 
initially proposing the low volume services list, which was based, in 
part, upon a review that took place in CY 2016. After reviewing the 
recommendations provided by the commenters, and in light of the 
additional information supplied by the commenter about these codes, we 
are finalizing the addition of these updated recommendations to the 
list.
    Comment: Several commenters expressed concern regarding the 
treatment of existing codes with no Medicare volume (as distinct from 
low volume) reported for any given year. Under the methodology used in 
the proposed rule, these codes with no utilization data received the 
average risk factor for all physician specialties rather than the 
expected specialty assignments on the list of service-level overrides. 
The commenters recommended that the proposed list of expected specialty 
overrides be utilized for both low volume and no volume codes.
    Response: We agree with the commenters that the RVUs for services 
with no Medicare volume should be calculated in a manner that is 
consistent with services with low Medicare volume because our proposal 
was for fewer than 100 allowed services, and no-volume services would 
fit within that standard. Therefore, we are finalizing the 
recommendation from the commenters to use the proposed list of expected 
specialty overrides for both low volume and no volume codes.
    Comment: A commenter agreed with the CMS proposal that there would 
no longer be a need to apply service-level MP RVU crosswalks for new or 
revised codes in order to assign a specialty-mix risk factor. The 
commenter stated that CMS would be able to derive the specialty mix 
assumption in the first year for a new or revised code from the 
specialty mix used for purposes of ratesetting. The commenter indicated 
their support for this change to calculating MP RVUs for new or revised 
codes.
    Response: We are finalizing our proposal to remove service-level MP 
RVU crosswalks for new or revised codes, and we will instead derive the 
specialty mix assumption for the first year for a new or revised code 
from the specialty mix used for purposes of ratesetting.
    Comment: One commenter supported the CMS proposal and requested the 
use of the phrase ``Family Medicine'' for the list of expected 
specialty assignments rather than the phrase ``Family Practice'', which 
the commenter stated was a more outdated term.
    Response: Regarding the requested update to the name assigned to a 
specialty, we would direct the commenter to the standard process for 
updating specialty designations. This change would have to be made to 
the Medicare enrollment specialty and lies outside the scope of the 
proposal.
    After consideration of comments received, we are finalizing our 
proposal to use service-level overrides to determine the specialty mix 
for low volume procedures, with the modifications as discussed in this 
section. Based on comments, we are also finalizing the use of service-
level overrides to determine the specialty mix for no volume 
procedures. In addition, we are finalizing the proposed list of 
expected specialty overrides with modifications. We are finalizing the 
addition of certain CPT codes to the list and updated specialty 
assignments for certain CPT 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

[[Page 52984]]

RVUs and the clinical labor PE RVUs. We do this to recognize that, for 
the PC service, indirect PEs would be allocated using the work RVUs, 
and for the TC service, indirect PEs would be allocated using the 
direct PE RVUs and the clinical labor PE RVUs. This also allows the 
global component RVUs to equal the sum of the PC and TC RVUs.)
    For presentation purposes, in the examples in the download file 
called ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act 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. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
    Comment: One commenter stated that CMS should take a phased in 
approach to avoid any beneficiary access issues presented by the 
significant payment decreases caused by PE decreases for imaging 
services. These decreases could affect the viability of many practices 
providing these critical services as the new payment rates might create 
economic hardships for continuation of these services. The commenter 
stated that CMS should implement the RUC-recommended practice expenses 
over a phased in period to reduce the financial impact of the PE 
changes, particularly for codes with a proposed decrease of more than 
10 percent.
    Response: We agree with the commenter that there is a need to 
ensure access to patient care and mitigate the potential for economic 
hardship on the part of providers facing decreases in the valuation of 
services. We note in response to the commenter that section 1848(c)(7) 
of the Act already stipulates 19 percent as the maximum 1-year 
reduction for any service not described by a new or revised code. This 
phase-in methodology has been in use for PFS ratesetting since CY 2016.
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE RVUs, we exclude certain specialties, 
such as certain NPPs paid at a percentage of the PFS and low-volume 
specialties, from the calculation. These specialties are included for 
the purposes of calculating the BN adjustment. They are displayed in 
Table 1.

       Table 1--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
        Specialty code                   Specialty description
------------------------------------------------------------------------
49...........................  Ambulatory surgical center.
50...........................  Nurse practitioner.

[[Page 52985]]

 
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
                                     Physician Assistant.                                  portion.
50 or LT and RT...................  Bilateral Surgery......  150%.......................  150% of work time.
51................................  Multiple Procedure.....  50%........................  Intraoperative
                                                                                           portion.
52................................  Reduced Services.......  50%........................  50%.
53................................  Discontinued Procedure.  50%........................  50%.
54................................  Intraoperative Care      Preoperative +               Preoperative +
                                     only.                    Intraoperative Percentages   Intraoperative
                                                              on the payment files used    portion.
                                                              by Medicare 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%.
----------------------------------------------------------------------------------------------------------------


[[Page 52986]]

    We also make adjustments to volume and time that correspond to 
other payment rules, including special multiple procedure endoscopy 
rules and multiple procedure payment reductions (MPPRs). We note that 
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments 
for multiple imaging procedures and multiple therapy services from the 
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These 
MPPRs are not included in the development of the RVUs.
    For anesthesia services, we do not apply adjustments to volume 
since we use the average allowed charge when simulating RVUs; 
therefore, the RVUs as calculated already reflect the payments as 
adjusted by modifiers, and no volume adjustments are necessary. 
However, a time adjustment of 33 percent is made only for medical 
direction of two to four cases since that is the only situation where a 
single practitioner is involved with multiple beneficiaries 
concurrently, so that counting each service without regard to the 
overlap with other services would overstate the amount of time spent by 
the practitioner furnishing these services.
     Work RVUs: The setup file contains the work RVUs from this 
final rule.
(6) Equipment Cost per Minute
    The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + 
interest rate) [caret] 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 in this final rule.
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 in this final rule.

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Stakeholders have often suggested that particular equipment items 
are used less frequently than 50 percent of the time in the typical 
setting and that CMS should reduce the equipment utilization rate based 
on these recommendations. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items. However, we believe 
that absent robust, objective, auditable data regarding the use of 
particular items, the 50 percent assumption is the most appropriate 
within the relative value system. We welcome the submission of data 
that illustrates an alternative rate.
    Comment: One commenter stated that most ophthalmology diagnostic 
equipment is in use far less than 50 percent of the time. The commenter 
indicated that they had developed a survey instrument that asked 
ophthalmic technicians to provide time usage estimates for the 16 most-
utilized pieces of diagnostic testing equipment. The commenter stated 
that their preliminary survey results produced a utilization rate of 22 
percent, much lower than the 50 percent assumption currently used by 
CMS. The commenter suggested that CMS should work with the RUC to do a 
robust survey to help determine a more valid utilization rate, 
including the possibility of specialty-specific equipment utilization 
rates.
    Response: We are always looking for more accurate information to 
improve our PE methodology. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items, and we will review any 
information that the RUC's PE Subcommittee or other stakeholders are 
willing to submit through the public comment process. We concur with 
the commenter that a wide-ranging survey or similar study designed to 
address the subject of equipment utilization rates would be an 
appropriate tool to investigate this subject in further detail. At the 
moment, we believe that absent robust, objective, auditable data 
regarding the use of particular items, the 50 percent assumption is the 
most appropriate within the relative value system. We welcome the 
further submission of data that illustrates an alternative rate.
    Maintenance: This factor for maintenance was finalized in the CY 
1998 PFS final rule with comment period (62 FR 33164).
    Comment: Several commenters addressed the issue of equipment 
maintenance costs. One commenter stated that the current maintenance 
percentage of 5 percent across all types of medical equipment does not 
adequately address the maintenance costs of imaging equipment in 
general and particularly not for advanced imaging modalities like CT 
and MRI. This commenter stated that a CT scanner would have an 
estimated annual maintenance cost of 7.2 percent. Another commenter 
supported our willingness to investigate potential avenues for 
determining variable equipment maintenance costs across a broad range 
of equipment items. The commenter stated that the standard equipment 
rate assumption fails to appreciate the significant costs associated 
with the maintenance of highly technical and particularly complex 
equipment items, and indicated that that CMS should not persist in an 
inaccurate approach while it collects additional data.
    Response: We appreciate the additional information regarding 
equipment maintenance rates from the commenters. As we previously 
stated in the CY 2016 final rule with comment period (80 FR 70897), we 
agree with the commenters that we do not believe the annual maintenance 
factor for all equipment is precisely 5 percent, and we concur that the 
current rate likely understates the true cost of maintaining some 
equipment. We also believe it likely overstates the maintenance costs 
for other equipment. When we solicited comments regarding sources of 
data containing equipment maintenance rates, commenters were unable to 
identify an auditable, robust data source that could be used by CMS on 
a wide scale. We do not believe that voluntary submissions regarding 
the maintenance costs of individual equipment items would be an 
appropriate methodology for determining costs. As a result, in the 
absence of publicly available datasets regarding equipment maintenance 
costs or another systematic data collection methodology for determining 
maintenance factor, we do not believe that we have sufficient 
information at present to adopt a variable maintenance factor for 
equipment cost per minute pricing. We continue to investigate potential 
avenues for determining equipment maintenance costs across a broad 
range of equipment items.
    Interest Rate: In the CY 2013 PFS final rule with comment period 
(77 FR 68902), we updated the interest rates used in developing an 
equipment cost per minute calculation (see 77 FR 68902 for a thorough 
discussion of this issue). 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). We 
did not propose any changes to these interest rates for CY 2018. The 
interest rates are listed in Table 3.

[[Page 52987]]



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

3. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2018 direct PE input database, which is 
available on the CMS Web site under downloads for the CY 2018 PFS final 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(a) PE Inputs for Digital Imaging Services
    In the CY 2017 PFS final rule (81 FR 80179 through 80184), we 
finalized our proposal to add a professional PACS workstation (ED053) 
used for interpretation of digital images to a series of CPT codes and 
to address costs related to the use of film that had previously been 
incorporated as direct PE inputs for these services. We finalized the 
following criteria for the inclusion of a professional PACS 
workstation:
     We did not add the professional PACS workstation to any 
code that currently lacks a technical PACS workstation (ED050) or lacks 
a work RVU. We continue to believe that procedures that do not include 
a technical workstation, or do not have physician work, would not 
require a professional workstation.
     We did not add the professional PACS workstation to add-on 
codes. Because the base codes include equipment minutes for the 
professional PACS workstation, we continue to believe it would be 
duplicative to add additional equipment time for the professional PACS 
workstation in the add-on code.
     We also did not add the professional PACS workstation to 
image guidance codes where the dominant provider is not a radiologist 
according to the most recent year of claims data, because we believe a 
single technical PACS workstation would be more typical in those cases.
     We agreed with commenters that because the clinical 
utility of the PACS workstation is not necessarily limited to 
diagnostic services, there may be therapeutic codes where it would be 
reasonable to assume its use to be typical. Based on information 
provided by commenters and our own medical review, we stated that we 
believe that the use of the professional PACS workstation is typical 
for many of the specific codes that were identified. We added the 
workstation to many of the therapeutic codes requested by commenters, 
specifically CPT codes listed outside the 70000 series, where we agreed 
that use of the professional PACS workstation was typical.
     For CPT codes in the 80000 and 90000 series, we expressed 
our concerns about whether it is appropriate to include the technical 
PACS workstation in many of these services. PACS workstations were 
created for imaging purposes, but many of these services that include a 
technical PACS workstation do not appear to make use of imaging. 
Although we did not remove the technical PACS workstation from these 
codes at that time, we did not believe that a professional PACS 
workstation should be added to these procedures.
    Prior to the publication of this CY 2018 PFS proposed rule, a 
stakeholder expressed concern about our decision not to include the 
professional PACS workstation in a series of vascular ultrasound codes 
that use technical PACS workstations. The stakeholder indicated that 
the vascular ultrasound codes in question do make use of a professional 
PACS workstation, and that the dominant specialty provider requirement 
(that is, that the code's dominant specialty provider be diagnostic 
radiology) would exclude codes for which the professional PACS 
workstation is typical based on a mistaken assumption. The stakeholder 
stated that to furnish vascular ultrasound services following the 
transition from film to digital imaging, both a technical and a 
professional PACS workstation are required, regardless of whether the 
practitioner furnishing the service is a radiologist, cardiologist, 
neurologist, or vascular surgeon.
    We appreciate the submission of this additional information 
regarding the use of the professional PACS workstation in vascular 
ultrasound codes. Therefore, we solicited comments regarding whether or 
not the use of the professional PACS workstation would be typical in 
the following list of CPT and HCPCS codes. The codes brought to our 
attention by the stakeholder are CPT codes 93880, 93882, 93886, 93888, 
93890, 93892, 93893, 93922, 93923, 93924, 93925, 93926, 93930, 93931, 
93965, 93970, 93971, 93975, 93976, 93978, 93979, 93980, 93981, 93990, 
and 76706, and HCPCS code G0365. We considered information submitted in 
comments to determine whether the professional PACS workstation should 
be included as a direct PE input for these codes.
    The following is a summary of the public comments received 
regarding whether or not the use of the professional PACS workstation 
would be typical in the previous list of CPT and HCPCS codes and our 
responses:
    Comment: Several commenters stated that the finalized policy in CY 
2017 that did not add the professional PACS workstation to image 
guidance codes where the dominant practitioner is not a radiologist was 
an arbitrary decision. The commenters stated that CMS did not provide 
any rationale for this policy, and that for many services, both a 
technical and a professional PACS workstation would be typically used 
regardless of whether the practitioner performing the service is a 
radiologist or in another specialty. These commenters urged CMS to add 
a professional PACS workstation in services where its use would be 
typical without concern for whether diagnostic radiology is the 
dominant provider.
    Response: We agree with the commenters that equipment allocated to 
each code should be determined based on the resources typically 
required to furnish the service. In general, we believe that examining 
Medicare claims data for dominant specialty is a useful and data-driven 
approach to making educated assumptions regarding typical resources 
involved in furnishing particular procedures. However, in this case, we 
are persuaded by commenters who stated that other specialties, outside 
of diagnostic radiology, utilize the professional PACS workstation. 
After reviewing the information supplied by the commenters, we agree 
the use of both a technical and a professional PACS workstation may be 
typical in some services where diagnostic radiology is not the dominant 
provider. We welcome feedback from stakeholders in identifying 
additional services where the use of a professional PACS workstation 
would be typical.
    Comment: One commenter disagreed with the exclusion of add-on codes 
from the list of codes that included a professional PACS workstation. 
The commenter stated that the add-on codes require additional time to 
perform and therefore more time with the technical PACS workstation for 
the technician, as well as additional time for the review and 
interpretation performed by the

[[Page 52988]]

physician using the professional PACS workstation.
    Response: We disagree with the commenter. We continue to believe it 
would be duplicative to add additional equipment time for the 
professional PACS workstation in the add-on code, as the base codes 
already include equipment time for the practitioner's use following the 
service.
    Comment: Many commenters stated that the use of a professional PACS 
workstation would be typical in the 26 CPT codes detailed previously. 
Commenters stated that in the wake of the transition from film to 
digital imaging, use of both a technical and a professional PACS 
workstations has become typical for many diagnostic imaging services, 
including vascular ultrasound and digital pathology services. One 
commenter indicated that the use of the professional PACS workstation 
served a vital part in coordination of care for their treatment of 
vascular access issues related to ESRD patients. Another commenter 
stated that HCPCS code G0365 may have been mistakenly included on this 
list, as it already includes a professional PACS workstation added in 
CY 2017, while CPT code 93965 should not be considered for the 
professional PACS workstation as the code was previously deleted.
    Response: We agree with the commenters that the use of the 
professional PACS workstation would be typical in 21 of the 26 codes 
listed in the proposed rule. As mentioned by one commenter, CPT code 
93965 has been deleted while code G0365 already includes a professional 
PACS workstation. We disagree with adding a professional PACS 
workstation to CPT codes 93922, 93923, and 93924 because these codes do 
not include a technical PACS workstation and we continue to believe 
that procedures that do not include a technical workstation would not 
require a professional workstation. We will assign equipment time for 
the professional PACS workstation in the nonfacility setting according 
to the equipment time formula finalized in CY 2017. For diagnostic 
codes, we are assigning equipment minutes equal to half the preservice 
physician work time plus the full intraservice physician work time, 
consistent with the previously finalized policy. For the relatively 
smaller group of diagnostic codes with no service period time 
breakdown, we are assigning equipment time equal to half of the total 
physician work time, consistent with the previously finalized policy. 
The equipment time to be added is shown in Table 4.

      Table 4--Additional Codes With Professional PACS Workstation
------------------------------------------------------------------------
                                                                ED053
             HCPCS                     Procedure type          minutes
------------------------------------------------------------------------
93880.........................  Diagnostic.................           18
93882.........................  Diagnostic.................           13
93886.........................  Diagnostic.................           20
93888.........................  Diagnostic.................           13
93890.........................  Diagnostic.................           20
93892.........................  Diagnostic.................           25
93893.........................  Diagnostic.................           25
93925.........................  Diagnostic.................           18
93926.........................  Diagnostic.................           13
93930.........................  Diagnostic.................           18
93931.........................  Diagnostic.................           13
93970.........................  Diagnostic.................           17
93971.........................  Diagnostic.................           12
93975.........................  Diagnostic.................           23
93976.........................  Diagnostic.................           18
93978.........................  Diagnostic.................           18
93979.........................  Diagnostic.................           13
93980.........................  Diagnostic.................           21
93981.........................  Diagnostic.................           10
93990.........................  Diagnostic.................           14
76706.........................  Diagnostic.................           13
------------------------------------------------------------------------

    Comment: One commenter stated that the costs associated with 
storing digital images should be included as a direct PE. The commenter 
noted that CMS treated film as a supply item for purposes of direct 
cost determination and cited an MRI study in the 2010 direct PE 
database with 12 pieces of 14 x 17 film at a price of $1.17 each or 
$14.04. The commenter stated that this film was not replaced and that 
digital imaging studies need to be recorded and then archived. The 
commenter suggested that storage costs for digital images should be 
added as a maintenance percentage for digital imaging services.
    Response: We disagree with the commenter that the costs associated 
with storing digital images are excluded from digital imaging services, 
as these costs are incorporated into the indirect PE methodology that 
cover administrative costs and office rent. We do not pay separately 
for the storage of digital images as these expenses are not allocable 
to individual services, just as we do not explicitly incorporate the 
storage costs of electronic health records (EHRs) as direct PE inputs 
for the range of practitioners that use EHRs. We understand and agree 
that we previously treated film itself as direct PE input. However, the 
film was allocable to an individual patient. We believe that the better 
analog for the storage of images under the previous assumptions would 
be the office cabinets and office space in which the film was stored. 
These items were clearly considered to be indirect PE expenses and, 
therefore, such costs are included in the specialty-specific data that 
is used to allocate indirect PE RVUs. We previously replaced the direct 
PE components of imaging services during the film-to-digital transition 
that took place in CY 2015 (79 FR 67561).
    Comment: One commenter recommended that CMS revisit its definition 
of room time for imaging procedures. Under the current policy, room 
time for imaging studies is defined as the time it takes to acquire the 
images 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. The commenter stated that this definition was 
inconsistent with how imaging centers actually function, as most 
patient-related activities take place in the imaging room with the 
involvement of multiple technologists. The commenter suggested that CMS 
should return to the previous definition, in which equipment time for 
highly technical equipment was based on total technologist time.
    Response: We disagree with the commenter regarding the current 
standard equipment time formula for highly technical equipment. As we 
wrote in the CY 2011 final rule with comment period (75 FR 73350), 
certain highly technical pieces of equipment and equipment rooms are 
less likely to be used by a clinician over the full course of a 
procedure and are typically available for other patients during time 
that may still be in the intraservice portion of the service. When we 
identify these services, we adjust those equipment times accordingly. 
For example, CPT code 74178 (Computed tomography, abdomen and pelvis; 
without contrast material in more than one body region) includes 3 
minutes of intra-service clinical labor time associated with obtaining 
the patient's consent for the procedure. Since we believe that it would 
be atypical for this activity to occur within the CT room, we believe 
these 3 minutes should not be attributed to the CT room. We agree with 
the commenter that the standard formula used to determine equipment 
time for highly technical equipment may not be typical for all 
services, which is why we evaluate equipment time on a case-by-case 
basis as services are reviewed. We appreciate the information submitted 
by the commenter, and we will take these comments under consideration 
as we evaluate codes on an individual basis.
    After consideration of comments received, we are finalizing the 
addition of a professional PACS workstation to the codes listed in 
Table 4 with the equipment time detailed.

[[Page 52989]]

(2) Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640-67641), we continue to make improvements to the direct PE 
input database to provide the number of clinical labor minutes assigned 
for each task for every code in the database instead of only including 
the number of clinical labor minutes for the preservice, service, and 
postservice periods for each code. In addition to increasing the 
transparency of the information used to set PE RVUs, this improvement 
would allow us to compare clinical labor times for activities 
associated with services across the PFS, which we believe is important 
to maintaining the relativity of the direct PE inputs. This information 
would facilitate the identification of the usual numbers of minutes for 
clinical labor tasks and the identification of exceptions to the usual 
values. It would also allow for greater transparency and consistency in 
the assignment of equipment minutes based on clinical labor times. 
Finally, we believe that the information can be useful in maintaining 
standard times for particular clinical labor tasks that can be applied 
consistently to many codes as they are valued over several years, 
similar in principle to the use of physician preservice time packages. 
We believe such standards would provide greater consistency among codes 
that share the same clinical labor tasks and could improve relativity 
of values among codes. For example, as medical practice and 
technologies change over time, changes in the standards could be 
updated simultaneously for all codes with the applicable clinical labor 
tasks, instead of waiting for individual codes to be reviewed.
    The following is a summary of the public comments received 
regarding the standardization of clinical labor tasks and our 
responses:
    Comment: One commenter supported the efforts of the AMA RUC to 
standardize clinical labor activities in the new PE worksheet and urged 
CMS to accept these standards.
    Response: We appreciate the efforts to establish greater 
organizational consistency through the RUC's use of the new PE 
worksheet and new clinical labor activity codes in developing and 
making recommendations to CMS.
    Comment: Several commenters stated that, while they supported the 
revisions to the direct PE database providing the number of clinical 
labor minutes assigned for each clinical labor activity for each code, 
they had concerns regarding the over-standardization of clinical labor 
activities. These commenters indicated that each service requires 
different clinical labor resources and creating standard times is not 
possible for all clinical labor activities. Commenters stated that the 
RUC's PE Subcommittee is the entity best suited to make service-level 
determinations for clinical labor, and that blanket changes to 
standardize clinical labor activities outside of RUC review would lead 
to misvaluation of codes.
    Response: We agree with the commenters that there are often 
important differences between services and that no two services are 
necessarily identical. We also acknowledge that there is a balance 
between establishing standards for clinical labor activities and the 
need for individual review of each code. We concur with the commenters 
that some services require greater or less time than the clinical labor 
standards, and we have frequently finalized clinical labor times 
outside the standard values. The standard times for clinical labor 
activities are a starting point for our clinical review of individual 
services, not necessarily an ending point. As we have written in past 
rulemaking, we believe that the establishment of standard times helps 
to facilitate greater transparency of information and maintain 
consistency in review patterns over time. Our goal is to maintain 
relativity among services, and we believe that the creation of clinical 
labor standards helps to facilitate that goal.
    Comment: One commenter stated that the proposed standardized 
clinical labor times for CT and MRI codes required additional time due 
to a need to assess patients for any special needs, review screening 
sheets with patients, and obtain a clinical history from the patient.
    Response: When reviewing clinical labor times for individual codes, 
we typically work closely with the recommendations provided by the RUC, 
which did not include additional clinical labor time for these specific 
activities in these services. While we appreciate the additional 
information from the commenter, we do not agree that it would serve 
overall PFS relativity to include additional clinical labor time for 
these services based on this rationale.
    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. Preservice Clinical Labor for 0-Day and 10-Day Global Services
    Several years ago, the RUC's PE Subcommittee reviewed the 
preservice clinical labor times for CPT codes with 0-day and 10-day 
global periods. The RUC concluded that these codes are assumed to have 
no preservice clinical staff time (standard time of 0 minutes) unless 
the specialty can provide evidence that the preservice time is 
appropriate. In other words, for minor procedures, it is assumed that 
there is no clinical staff time typically spent preparing for the 
specific procedure prior to the patient's arrival. However, we note 
that for CY 2018, 41 of the 53 reviewed codes with 0-day or 10-day 
global periods include preservice clinical labor of some kind, 
suggesting that it is typical for clinical staff to prepare for the 
procedure prior to the patient's arrival. As we review misvalued codes, 
we believe that the general adherence to values that we have 
established as standards supports relativity within the PFS. Because 77 
percent of the reviewed codes for the current calendar year deviate 
from the ``standard,'' we sought comment on the value and appropriate 
application of the standard in our review of RUC recommendations in 
future rulemaking. In reviewing the inputs included in the direct PE 
inputs database, we found that for the 1,142 total 0-day global codes, 
741 of them had preservice clinical labor of some kind (65 percent). We 
also noticed a general correlation between preservice clinical labor 
time and the recent review. We sought comment specifically on whether 
the standard preservice clinical labor time of 0 minutes should be 
consistently applied for 0-day and 10-day global codes in future 
rulemaking.
    The following is a summary of the public comments received 
regarding whether the standard preservice clinical labor time of 0 
minutes should be consistently applied for 0-day and 10-day global 
codes in future rulemaking and our responses:
    Comment: Many commenters opposed eliminating clinical staff 
preservice time from all 0-day and 10-day global procedures in future 
rulemaking. Several commenters stated that although it is accurate to 
assume that no clinical staff time is necessary for minor procedures, 
it is no longer true that all 0-day and 10-day globals can be 
classified as minor procedures, as increasingly complex services are 
now performed using this global period. For example, there are several 
cardiothoracic surgery procedures that in the past would have been 
valued as

[[Page 52990]]

90-day global services but instead were implemented as 0-day global 
procedures to allow additional flexibility in the delivery of patient 
care. One commenter stated that the ``trend'' identified in the 
proposed rule occurred only because of the significant number of 0-day 
endoscopy and interventional codes that have recently been reviewed. 
Other commenters stated that the standard preservice clinical labor 
time of 0 minutes is only applicable if specialties cannot provide 
evidence of the need for preservice clinical labor, and that the rise 
in preservice clinical labor time indicated the growing recognition 
that the use of clinical staff is typical for these services. Many 
commenters stated that the RUC's PE Subcommittee should review the 
evidence on a case-by-case basis to determine if individual services 
justify preservice clinical labor time. Commenters urged CMS to work 
with the RUC to identify circumstances where deviations from the 
standard clinical labor times would be appropriate and develop clear 
definitions and criteria that support compelling reasons for clinical 
staff time that deviates from the standard for 0-day and 10-day global 
procedures. A few commenters, including the RUC, acknowledged that the 
high number of preservice clinical labor exceptions raised the question 
of the utility of the standard given this high number of exemptions.
    Response: We appreciate the responses from the commenters. We note 
that several commenters also acknowledged the problematic nature of 
having so many exceptions to the established standard for preservice 
clinical labor. We appreciate in particular the additional information 
regarding the increasing use of the 0-day and 10-day global periods for 
procedures that are not minor in nature. In light of this information, 
we agree with the commenters who suggested that there is a need to 
identify circumstances where deviations from the standard clinical 
labor times would be appropriate and develop clear definitions and 
criteria for these situations. If an increasingly large number of major 
procedures are performed using the 0-day and 10-day global periods, we 
believe that there will be a need for the establishment of new 
guidelines for the typical allotment of preservice clinical labor. We 
agree with the commenters that preservice clinical labor must be 
determined on an individual basis based on the resources typically 
required to furnish the service. However, the need for individual 
review of services does not preclude the development of standards 
which, as we stated above, helps to facilitate greater transparency of 
information and maintain consistency in review patterns over time.
    After consideration of comments received, we do not believe that 
the standard preservice clinical labor time of 0 minutes should be 
consistently applied for 0-day and 10-day global codes in future 
rulemaking. We look forward to working with stakeholders and seeing 
their recommendations for preservice clinical labor that maintain 
relativity among the different kind of procedures classified as 0-day 
and 10-day globals.
b. Obtain Vital Signs Clinical Labor
    The direct PE inputs for each CPT code paid under the PFS include 
minutes assigned to a series of standard clinical labor tasks assumed 
to be typical for the service in question. The minutes assigned to each 
of these tasks for each CPT code have been developed over several 
decades, and what was previously considered to be a standard value in 
the review of the codes has changed over time. Because each year we 
perform a detailed review of all of the inputs for only several hundred 
of the over 7,000 CPT codes paid under the PFS, valuation for 
individual services can be influenced by shifts in review standards 
over time rather than purely based on changes in practice.
    For example, we traditionally assigned a clinical labor time of 3 
minutes for the ``Obtain vital signs'' clinical labor activity, based 
on the amount of time typically required to check a patient's vitals. 
Over time, that number of minutes has increased as codes are reviewed. 
For example, many of the reviewed codes for the current CY 2018 
rulemaking cycle have a recommended clinical labor time of 5 minutes 
for ``Obtain vital signs,'' based on the understanding that these 
services are measuring two additional vital signs: the patient's height 
and weight. We do not have any reason to believe that measuring a 
patient's height and weight is only typical for services described by 
recently reviewed codes. Instead, we believe that the review standards 
have changed, perhaps in conjunction with changes in medical practice, 
and that the change in the minutes assigned for the ``Obtain vital 
signs'' task for newer-reviewed services is detrimental to relativity 
among PFS services.
    Therefore, to preserve relativity among the PFS codes, we proposed 
to assign 5 minutes of clinical labor time for all codes that include 
the ``Obtain vital signs'' task, regardless of the date of last review. 
We proposed to assign this 5 minutes of clinical labor time for all 
codes that include at least 1 minute previously assigned to this task. 
We also proposed to update the equipment times of the codes with this 
clinical labor task accordingly to match the changes in clinical labor 
time. For codes that were not recently reviewed and for which we lacked 
a breakdown of how the equipment time was derived from the clinical 
labor tasks, we could not determine if the equipment time included time 
assigned for the ``Obtain vital signs'' task. In these cases, we 
proposed to adjust the equipment time of any equipment item that 
matched the clinical labor time of the full service period to match the 
change in the ``Obtain vital signs'' clinical labor time. The list of 
all codes affected by these proposed vital signs changes to direct PE 
inputs is available on the CMS Web site under downloads for the CY 2018 
PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The following is a summary of the public comments received on the 
list of all codes affected by these proposed vital signs changes to 
direct PE inputs proposals and our responses:
    Comment: Many commenters supported the CMS proposal. Commenters 
agreed that these differences in the minutes assigned to the ``Obtain 
vital signs'' clinical labor task appeared to be attributed to 
variances in review standards over time rather than reflecting actual 
variations in practice. One commenter stated that medical practice 
typically requires measurement of height and weight when vital signs 
are measured, while another commenter stated that the new standard time 
would be an administrative simplification for stakeholders and help 
streamline reviews. These commenters urged CMS to finalize the proposal 
to help preserve relativity between PFS codes.
    Response: We appreciate the support from the commenters for the 
proposal.
    Comment: Other commenters disagreed with the proposal to establish 
5 minutes as the new clinical labor standard for the ``Obtain vital 
signs'' task. These commenters stated that the RUC PE Subcommittee's 
standard for vital signs clinical labor, based on the number of vital 
signs being taken, remained accurate and was the best way to make sure 
that individual codes are allocated the correct amount of time. These 
commenters were opposed to changing the clinical labor time of a large 
number of codes at once, and stressed the need for individual review

[[Page 52991]]

of each service. Commenters urged CMS not to finalize this proposal and 
suggested the issue should be referred to the RUC and its Practice 
Expense Advisory Committee for further review and input.
    Response: We generally agree with commenters that the 
determinations for individual clinical labor activities are typically 
made at the code level, such as those recommended by the RUC's PE 
subcommittee. Therefore, we are not finalizing our proposal to use 5 
minutes as the universal input for this clinical labor task. However, 
since even the comments opposing the proposal did not suggest that the 
clinical labor associated with taking vital signs has changed over 
time, only the review standards associated with them, we will assign 5 
minutes as the input for all codes that include the ``Obtain vital 
signs'' task for CY 2018, as proposed. For future rulemaking we will 
consider code-level recommendations that will help distinguish services 
that may require fewer or greater than 5 minutes for this activity. We 
believe that finalizing 5 minutes for the codes as proposed will serve 
to mitigate the detrimental impact of review standards shifting over 
time while preserving the principle that the number of minutes involved 
in obtaining vital signs may vary for different services.
    Comment: One commenter asked if CMS would accept vital sign data 
from fitness wearable devices such as an Apple watch, Garmin, or 
Fitbit.
    Response: Our proposal concerns the number of minutes assumed to be 
involved in obtaining vital signs for purposes of PFS ratesetting and 
is not intended to establish requirements regarding how vital signs are 
obtained.
    After consideration of comments received, we are not finalizing our 
proposal to establish 5 minutes as the new standard for the ``Obtain 
vital signs'' clinical labor task. However, since we continue to 
believe that the review standards associated with the clinical labor 
time for obtaining vital signs have changed over time, we will assign 5 
minutes as the input for all codes that include the ``Obtain vital 
signs'' task for CY 2018, as proposed.
c. Establishment of Clinical Labor Activity Codes
    Historically, the RUC has submitted a ``PE worksheet'' that details 
the recommended direct PE inputs for our use in developing PE RVUs. The 
format of the PE worksheet has varied over time and among the medical 
specialties developing the recommendations. These variations have made 
it difficult for both the RUC's development and our review of code 
values for individual codes. Beginning for the CY 2019 PFS rulemaking 
cycle, we understand that the RUC intends to mandate the use of a new 
PE worksheet for purposes of their recommendation development process 
that standardizes the clinical labor tasks and assigns them a clinical 
labor activity code. We believe the RUC's use of the new PE worksheet 
in developing and submitting recommendations to us would, in turn, help 
us to simplify and standardize the hundreds of different clinical labor 
tasks currently listed in our direct PE database.
    To help facilitate this transition to the new clinical labor 
activity codes, we developed a crosswalk to link the old clinical labor 
tasks to the new clinical labor activity codes. Our crosswalk is for 
informational purposes only, and would not change either the direct PE 
input values or the PE RVUs for codes. Instead, we hope that the 
crosswalk would help us to translate the sprawling, existing data set 
into a condensed version that would significantly improve the 
standardization of clinical labor recommendations and improve the 
ability of commenters to identify concerns with our proposed valuation. 
For CY 2018 rulemaking, we are displaying two versions of the Labor 
Task Detail public use file: One version with the old listing of 
clinical labor tasks, and one with the same tasks as described by the 
new listing of clinical labor activity codes. These lists are available 
on the CMS Web site under downloads for the CY 2018 PFS final rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(3) Equipment Recommendations for Scope Systems
    During our routine reviews of direct PE input recommendations, we 
have regularly found unexplained inconsistencies involving the use of 
scopes and the video systems associated with them. Some of the scopes 
include video systems bundled into the equipment item, some of them 
include scope accessories as part of their price, and some of them are 
standalone scopes with no other equipment included. It is not always 
clear which equipment items related to scopes fall into which of these 
categories. We have also frequently found anomalies in the equipment 
recommendations, with equipment items that consist of a scope and video 
system bundle recommended, along with a separate scope video system. 
Based on our review, the variations do not appear to be consistent with 
the different code descriptions.
    To promote appropriate relativity among the services and facilitate 
the transparency of our review process, during review of recommended 
direct PE inputs for the CY 2017 PFS proposed rule, we developed a 
structure that separates the scope and the associated video system as 
distinct equipment items for each code. Under this approach, we 
proposed standalone prices for each scope, and separate prices for the 
video systems that are used with scopes. We proposed to define the 
scope video system as including: (1) A monitor; (2) a processor; (3) a 
form of digital capture; (4) a cart; and (5) a printer. We believe that 
these equipment components represent the typical case for a scope video 
system. Our model for this system was the ``video system, endoscopy 
(processor, digital capture, monitor, printer, cart)'' equipment item 
(ES031), which we proposed to re-price as part of this separate pricing 
approach. We obtained current pricing invoices for the endoscopy video 
system as part of our investigation of these issues involving scopes, 
which we proposed to use for this re-pricing. We understand that there 
may be other accessories associated with the use of scopes; we proposed 
to separately price any scope accessories, and individually evaluate 
their inclusion or exclusion as direct PE inputs for particular codes 
as usual under our current policy based on whether they are typically 
used in furnishing the services described by the particular codes.
    We also proposed standardizing refinements to the way scopes have 
been defined in the direct PE input database. We believe that there are 
four general types of scopes: Non-video scopes; flexible scopes; semi-
rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and 
rigid scopes would typically be paired with one of the scope video 
systems, while the non-video scopes would not. The flexible scopes can 
be further divided into diagnostic (or non-channeled) and therapeutic 
(or channeled) scopes. We proposed to identify for each anatomical 
application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video 
flexible scope; (4) a non-channeled flexible video scope; and (5) a 
channeled flexible video scope. We proposed to classify the existing 
scopes in our direct PE database under this classification system, to 
improve the transparency of our review process and improve appropriate 
relativity among the services. We planned to propose

[[Page 52992]]

input prices for these equipment items through future rulemaking.
    We proposed these changes only for the reviewed codes for CY 2017 
that made use of scopes, along with updated prices for the equipment 
items related to scopes utilized by these services. But, we did not 
propose to apply these policies to codes with inputs reviewed prior to 
CY 2017. We also solicited comment on this separate pricing structure 
for scopes, scope video systems, and scope accessories, which we could 
consider proposing to apply to other codes in future rulemaking. In 
response to comments, we finalized the addition of a digital capture 
device to the endoscopy video system (ES031) in the CY 2017 PFS final 
rule. We finalized our proposal to price the system at $33,391, based 
on component prices of $9,000 for the processor, $18,346 for the 
digital capture device, $2,000 for the monitor, $2,295 for the printer, 
and $1,750 for the cart. We also finalized a price of $16,843.87 for 
the stroboscopy system scope accessory (ES065). We did not finalize 
price increases for a series of other scopes and scope accessories, as 
the invoices submitted for these components indicated that they are 
different forms of equipment with different product IDs and different 
prices. We did not receive any data to indicate that the equipment on 
the newly submitted invoices was more typical in its use than the 
equipment that we were currently using for pricing.
    We did not make further changes to existing scope equipment in CY 
2017 in order to allow the RUC's PE Subcommittee the opportunity to 
provide feedback. However, we believed there was some miscommunication 
on this point, as the RUC's PE Subcommittee workgroup that was created 
to address scope systems stated that no further action was required 
following the finalization of our proposal. Therefore, we made further 
proposals to continue clarifying scope equipment inputs, and sought 
comments regarding the new set of scope proposals. We welcomed feedback 
from all stakeholders, including practitioners with direct experience 
in the use of scope equipment.
    We sought comment on several potential categories of scope system 
PE inputs. We are considering creating a single scope equipment code 
for each of the five categories detailed in this rule: (1) A rigid 
scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a 
non-channeled flexible video scope; and (5) a channeled flexible video 
scope. Under the current classification system, there are many 
different scopes in each category depending on the medical specialty 
furnishing the service and the part of the body affected. We believe 
that the variation between these scopes is not significant enough to 
warrant maintaining these distinctions, and we believe that creating 
and pricing a single scope equipment code for each category would help 
provide additional clarity. We sought public comment on the merits of 
this potential scope organization, as well as any pricing information 
regarding these five new scope categories.
    For CY 2018, we proposed two minor changes to PE inputs related to 
scopes. We proposed to add an LED light source into the cost of the 
scope video system (ES031), which would remove the need for a separate 
light source in these procedures. If this proposal were to be 
finalized, we would remove the equipment time for the separate light 
source from CPT codes that include the scope video system. We also 
proposed an increase to the price of the scope video system of 
$1,000.00 to cover the expense of miscellaneous small equipment 
associated with the system that falls below the threshold of individual 
equipment pricing as scope accessories (such as cables, microphones, 
foot pedals, etc.) We sought comments on the inclusion of the LED light 
in the scope video system, and the appropriate pricing of the system 
with the inclusion of these additional equipment items.
    We anticipate adopting detailed changes to scope systems at the 
code level through rulemaking for CY 2019, because we believe that 
additional feedback from expert stakeholders will improve the details 
of the proposed changes. We did not propose any additional pricing 
changes to scope equipment for CY 2018 due to the proposed 
reorganization into a single type of scope equipment for each of the 
five scope categories. However, we would consider updating prices for 
these equipment items through the public request process for price 
updates, or based on information submitted as part of RUC 
recommendations.
    The following is a summary of the public comments received on the 
continued organization of scope equipment and our responses:
    Comment: Many commenters disagreed with the CMS proposal to create 
and price a single scope equipment code for each category. Commenters 
stated that there were significant differences in the scopes used by 
different specialties, and the proposal to establish a single scope for 
each category would not sufficiently capture variations across 
specialties in terms of typical scopes and typical costs. As an 
example, one commenter stated that the price difference between scopes 
could be as large as $10,000. Many commenters suggested that CMS should 
create packages on a per-specialty basis for these five categories of 
scopes, as applicable.
    Response: In light of the information supplied by commenters 
regarding the significant differences in price and usage across 
specialties, we will not finalize our proposal to create and price a 
single scope equipment code for each of the five categories previously 
identified.
    Comment: Commenters supported the CMS proposal to add an LED light 
source and miscellaneous costs into the price of the scope video system 
(ES031). Commenters indicated that the addition of the light and 
$1,000.00 for small various small items like foot pedals and 
microphones would more accurately describe the resource costs of the 
scope video system.
    Response: We appreciate the comments supporting the proposal. 
However, we are not finalizing the proposal to add an LED light source 
and an increase of $1,000 for miscellaneous small equipment to the 
price of scope video systems for CY 2018. We intend to update the price 
of the scope video system with these changes for CY 2019 as part of the 
scope reorganization project.
    Comment: Many commenters agreed with the proposal to delay 
implementation of these proposed changes until CY 2019 and encouraged 
CMS to request that the RUC review this issue and provide guidance on 
the correct pricing.
    Response: We agree that the anticipated delay on implementation 
until CY 2019 will allow additional time for stakeholders to provide 
recommendations on the proper organization and pricing of scope 
equipment.
    Comment: One commenter disagreed with the five categories of scope 
equipment that CMS identified and finalized in CY 2017. This commenter 
stated that these five categories did not represent all scope equipment 
categories and recommended adding a sixth category, a multi-channeled 
flexible video scope.
    Response: We will take the recommendation from the commenter into 
consideration. We look forward to receiving additional feedback from 
stakeholders regarding whether adding a sixth category for multi-
channeled flexible video scopes would be appropriate as part of the 
project to organize scope equipment.

[[Page 52993]]

    Comment: Several commenters stated that some of the scope equipment 
currently in use was inaccurately priced, and appeared to reflect older 
technology that has become outdated. One commenter submitted an 
extensive list of invoices related to the pricing of scope equipment.
    Response: We appreciate the submission of additional information 
related to scope pricing from the commenters. We stated in the proposed 
rule that we anticipated adopting detailed changes to scope systems at 
the code level for CY 2019 in order to incorporate additional feedback 
from expert stakeholders. Since we did not propose any additional 
pricing changes to scope equipment for CY 2018 due to this proposed 
reorganization, we believe that it would be more appropriate to delay 
any price updates until the following year rather than make changes for 
CY 2018 and, again, shortly thereafter. The general reorganization of 
scopes taking place in CY 2019 will include updates to scope pricing.
    After consideration of comments received, we will not finalize our 
proposal to create and price a single scope equipment code for each of 
the five categories previously identified. Instead, we are supportive 
of the recommendation from the commenters to create scope equipment 
codes on a per-specialty basis for these five, or potentially six, 
categories of scopes as applicable. Our goal is to create an 
administratively simple scheme that will be easier to maintain and 
helps to reduce administrative burden. We look forward to receiving 
detailed recommendations from expert stakeholders regarding the number 
of these scope equipment items that would be typically required for 
each scope category as well as the proper pricing for each scope.
    We are not finalizing our proposal to add an LED light source and 
an increase to the price of the scope video system of $1,000.00 to 
cover the expense of miscellaneous small equipment associated. We 
intend to address these changes for CY 2019 in order to incorporate the 
aforementioned feedback from expert stakeholders.
(4) Clarivein Kit for Mechanochemical Vein Ablation
    In the CY 2017 PFS final rule, we finalized work RVUs and direct PE 
inputs for two new codes related to mechanochemical vein ablation, CPT 
codes 36473 (Endovenous ablation therapy of incompetent vein, 
extremity, inclusive of all imaging guidance and monitoring, 
percutaneous, mechanochemical; first vein treated) and 36474 
(Endovenous ablation therapy of incompetent vein, extremity, inclusive 
of all imaging guidance and monitoring, percutaneous, mechanochemical; 
subsequent vein(s) treated in a single extremity, each through separate 
access sites). Following the publication of the final rule, 
stakeholders contacted CMS and requested that a Clarivein kit supply 
item (SA122) be added to the direct PE inputs for CPT code 36474, the 
add-on code for ablation of subsequent veins. They stated that the 
Clarivein kit was accidentally omitted from the RUC recommendations, 
and that an additional kit is necessary to perform the service 
described by the add-on procedure. We solicited comment regarding the 
use of multiple kits during procedures described by the base and add-on 
codes to determine whether or not this supply should be included as a 
direct PE input for CPT code 36474 for CY 2018.
    The following is a summary of the public comments received 
regarding the use of the Clarivein kit supply in CPT code 36474 for CY 
2018 and our responses:
    Comment: A device manufacturer wrote to explain the proper assembly 
and use of the Clarivein kit in great detail. The commenter stated that 
the kit is used to treat a single vein and a separate Clarivein kit is 
necessary for each vein treated to ensure functionality and safety. The 
commenter cited an informal survey of their customers which suggested 
that more than 50 percent of mechanochemical vein ablation procedures 
require treatment of a subsequent vein. The commenter urged that CMS 
include the Clarivein kit as a supply input for CPT code 36474.
    Response: We appreciate the additional information from the 
commenter regarding the use of the Clarivein kit supply.
    Comment: Several commenters disagreed with the proposed inclusion 
of the Clarivein kit as a supply input for CPT code 36474. A commenter 
indicated that a second Clarivein kit might be needed for CPT code 
36474 in some cases, but noted that the mechanochemical vein ablation 
codes have been flagged as new technology and will be reviewed by the 
RUC during the next two years. This commenter recommended that the 
number of Clarivein kits necessary for CPT code 36474 should be 
reviewed at that time.
    Response: We agree with the commenter that the decision on whether 
to include a Clarivein kit in CPT code 36474 should be made as part of 
a broader review of the direct PE inputs that are typically required to 
furnish the procedure. We also note that if physicians do not typically 
use the kit when furnishing services described by the add-on codes, 
then including the kit as part of the direct PE inputs for the add-on 
code would represent a significant misvaluation. After consideration of 
comments received, we are not finalizing the addition of the Clarivein 
kit to CPT code 36474 at this time, though we will review any 
recommendations received for consideration in future rulemaking.
(5) Removal of Oxygen From Non-Moderate Sedation Post-Procedure 
Monitoring
    After finalizing the creation of separately billable codes for 
moderate sedation during the CY 2017 PFS final rule, we received 
additional recommendations to remove the oxygen gas supply item (SD084) 
from a series of CPT codes that were previously valued with moderate 
sedation as an inherent part of the procedure. Because oxygen gas is 
included in the moderate sedation pack contained within the separately 
billed moderate sedation codes, we believe that the continued inclusion 
of the oxygen gas in these codes is a duplicative supply. Therefore, we 
proposed to remove the oxygen gas from the codes in Table 5.

  Table 5--CY 2018 Proposed Removal of Oxygen (SD084) From Non-Moderate
                   Sedation Post-Procedure Monitoring
------------------------------------------------------------------------
                                              Current
             HCPCS                NF/F       (liters)          Cost
------------------------------------------------------------------------
31622.........................  NF                    90           -0.27
31625.........................  NF                   105           -0.32
31626.........................  NF                   135           -0.41
31627.........................  NF                   150           -0.45

[[Page 52994]]

 
31628.........................  NF                   120           -0.36
31629.........................  NF                   105           -0.32
31632.........................  NF                    54           -0.16
31633.........................  NF                    60           -0.18
31652.........................  NF                   180           -0.54
31653.........................  NF                   225           -0.68
31654.........................  NF                    90           -0.27
52647.........................  NF                    10           -0.03
52648.........................  NF                    10           -0.03
90870.........................  NF                   198           -0.59
------------------------------------------------------------------------

    Comment: Several commenters supported our proposal to remove the 
oxygen gas for this list of codes.
    Response: We appreciate the support for our proposal. After 
consideration of the comments, we are finalizing our proposal to remove 
the oxygen gas from the codes listed in Table 5.
(6) Technical Corrections to Direct PE Input Database and Supporting 
Files
    Subsequent to the publication of the CY 2017 PFS final rule, 
stakeholders alerted us to several clerical inconsistencies in the 
direct PE database. We proposed to correct these inconsistencies as 
described in the proposed rule and reflected in the CY 2018 proposed 
direct PE input database displayed on the CMS Web site under downloads 
for the CY 2018 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2018, we proposed to address the following inconsistencies:
     For CY 2018, we proposed to make direct PE changes for CPT 
code 96416 (Chemotherapy administration, intravenous infusion 
technique; initiation of prolonged chemotherapy infusion (more than 8 
hours), requiring use of a portable or implantable pump) to improve 
payment accuracy, in response to a stakeholder inquiry regarding the 
use of the ambulatory IV pump equipment for this service. We proposed 
to add 6 additional minutes of RN/OCN clinical labor (L056A), 4 minutes 
for the ``Review charts by chemo nurse regarding course of treatment & 
obtain chemotherapy-related medical hx'' task, and 2 minutes for the 
``Greet patient and provide gowning'' task. We proposed to add 1 
quantity of the IV infusion set supply (SC018) and proposed to lower 
the quantity from 2 to 1 of the 20 ml syringe supply (SC053). We 
proposed to add 1800 minutes for the new ambulatory IV pump equipment, 
and we proposed to increase the equipment time of the medical recliner 
chair (EF009) from 83 minutes to 89 minutes to match the increase in 
RN/OCN clinical labor. For CY 2018, these proposed direct PE changes 
would be used to calculate the PE RVU for CPT code 96416. We sought 
comments on these proposed direct PE refinements.
     We proposed to correct an anomaly in the postservice work 
time for CPT code 91200 (Liver elastography, mechanically induced shear 
wave (e.g., vibration), without imaging, with interpretation and 
report) by changing it from 5 minutes to 3 minutes, which also results 
in a refinement in the total work time for the code from 18 minutes to 
16 minutes.
     In the process of making updates to our direct PE 
database, we discovered a series of discrepancies between the finalized 
direct PE inputs and the values entered into the database from previous 
calendar years. To reconcile these discrepancies, we proposed the 
following direct PE refinements:

                       Table 6--Direct PE Database Data Discrepancies and Proposed Changes
----------------------------------------------------------------------------------------------------------------
                                         Input code
      HCPCS            Input code        description      NF/F          Old             New            Cost
----------------------------------------------------------------------------------------------------------------
11307............  SF033............  scalpel with      NF                     1               2            0.69
                                       blade, surgical
                                       (#10-20).
11311............  SG056............  gauze, sterile    NF                     1               2            0.80
                                       4in x 4in (10
                                       pack uou).
11311............  SH046............  lidocaine 1% w-   NF                    10               4           -0.38
                                       epi inj
                                       (Xylocaine w-
                                       epi).
11719............  L037D............  Greet patient,    NF                     1               3            0.74
                                       provide
                                       gowning, ensure
                                       appropriate
                                       medical records
                                       are available.
11719............  L037D............  Provide pre-      NF                     1               2            0.37
                                       service
                                       education/
                                       obtain consent.
11719............  L037D............  Prepare room,     NF                     1               2            0.37
                                       equipment,
                                       supplies.
11719............  L037D............  Clean room/       NF                     1               3            0.74
                                       equipment by
                                       physician staff.
17312............  SL097............  OCT Tissue-Tek..  NF                     8               6           -0.12
17313............  SF004............  blade, microtome  NF                     1               0           -1.72
17313............  SF044............  blade, surgical,  NF                     0               1            4.17
                                       super-sharp.
17313............  SG056............  gauze, sterile    NF                     3               0           -2.39
                                       4in x 4in (10
                                       pack uou).
17313............  SG088............  tape, foam,       NF                    10               8           -0.01
                                       elastic, 2in
                                       (Microfoam).
17314............  SG056............  gauze, sterile    NF                     2               0           -1.60
                                       4in x 4in (10
                                       pack uou).
17314............  SL097............  OCT Tissue-Tek..  NF                     8               6           -0.12
17315............  SL078............  histology         NF                     0             0.2            0.29
                                       freezing spray
                                       (Freeze-It).
19283............  L043A............  Service total     NF                    55              54           -0.43
                                       costs.
19286............  L051B............  Service total     NF                    30              31            0.51
                                       costs.
19286............  EL015............  room,             NF                    19              20            1.40
                                       ultrasound,
                                       general.
19286............  EQ168............  light, exam.....  NF                    19              20            0.00
23333............  L037D............  Post service      F                     63              90            9.99
                                       total costs.
28045............  SC029............  needle, 18-27g..  NF                     2               1           -0.09

[[Page 52995]]

 
32405............  L041B............  Service total     NF                    52              57            2.05
                                       costs.
37765............  L037D............  Service total     NF                    91              94            1.11
                                       costs.
37766............  L037D............  Service total     NF                   121             124            1.11
                                       costs.
45171............  SJ052............  swab, procto      F                      2               3            0.12
                                       16in.
45172............  L037D............  Service total     F                      6              12            2.22
                                       costs.
45172............  SJ052............  swab, procto      F                      2               3            0.12
                                       16in.
52214............  SH047............  lidocaine 1%-2%   NF                     1              50            1.72
                                       inj (Xylocaine).
72120............  EL012............  room, basic       NF                    16              17            0.48
                                       radiology.
72148............  L047A............  Service total     NF                    47              49            0.84
                                       costs.
74230............  L041B............  Technologist      NF                     0               2            0.82
                                       QC's images in
                                       PACS, checking
                                       for all images,
                                       reformats, and
                                       dose page.
91013............  EF023............  table, exam.....  NF                     0               9            0.03
91013............  EF015............  mayo stand......  NF                     0               9            0.01
91013............  EQ235............  suction machine   NF                     0               9            0.02
                                       (Gomco).
91013............  EQ181............  manometry system  NF                     0               9            1.15
                                       (computer,
                                       transducers,
                                       catheter).
91013............  EQ339............  manometry         NF                     0               9            0.05
                                       accessory cable.
91013............  ED050............  PACS Workstation  NF                     0               9            0.20
                                       Proxy.
91132............  EQ019............  EGG monitoring    NF                    22              30            0.83
                                       system.
92227............  EL006............  lane, screening   NF                    12               0           -1.07
                                       (oph).
92227............  EL005............  lane, exam (oph)  NF                     0              12            1.15
93017............  L051A............  Preservice total  NF                    15               5           -5.10
                                       costs.
95819............  SG079............  tape, surgical    NF                     6              42            0.07
                                       paper 1in
                                       (Micropore).
----------------------------------------------------------------------------------------------------------------

    The proposed PE RVUs displayed in Addendum B on our Web site were 
calculated with the inputs displayed in the CY 2018 proposed direct PE 
input database.
    The following is a summary of the public comments received on these 
proposed direct PE refinements and our responses:
    Comment: Several commenters indicated their support for the 
proposed direct PE changes for CPT code 96416. Commenters stated that 
the proposed changes accurately reflected provider time and intensity 
in providing this service and would help to ensure that cancer care and 
treatment are appropriately valued and reimbursed. There were no 
comments opposed to the proposed changes.
    Response: We appreciate the support for our proposal from the 
commenters. We are finalizing the direct PE changes to CPT code 96416 
as proposed.
    Comment: One commenter was uncertain how CMS arrived at the 
conclusion that there were discrepancies of the direct PE inputs for 
the identified codes in Table 5 of the proposed rule. The commenter 
disagreed with several of the proposed changes to the data 
discrepancies and requested that CMS clarify the method used to 
determine these discrepancies in the direct PE inputs.
    Response: Prior to the publication of the CY 2018 proposed rule, we 
identified a series of anomalies in our direct PE database where the 
entered data did not match the values that had been finalized through 
rulemaking. For example, in CY 2013 we finalized the RUC recommendation 
to include 1 surgical super-sharp blade (SF044) in CPT code 17313. 
However, the direct PE database for CPT code 17313 instead included 1 
microtome blade (SF004), which was not included in the finalized PE 
inputs at all. This discrepancy was due to a technical issue that 
occurred while inputting the values into the database during the CY 
2013 rule cycle. The same pattern applies to the other discrepancies in 
the data that we identified for the codes on the table above: the 
information in the database was discrepant with the direct PE inputs 
that had been finalized in previous calendar years. We proposed this 
series of changes in order to ensure that the PE inputs in our database 
matched the inputs that have been finalized through rulemaking. We did 
not propose to make changes in the direct PE inputs of these codes 
based on clinical judgment or new recommendations, only to correct the 
technical anomalies that had crept into the direct PE database via user 
error. As a result, after consideration of comments received, we are 
finalizing the proposed changes to the direct PE database detailed in 
the previous table.
    Comment: One commenter alerted CMS to a series of similar technical 
corrections in the Physician Work Time file. The commenter stated that 
there was an issue with 108 codes that had incorrect immediate 
postservice times and total times that had been identified in the CY 
2014 final rule as due to an inadvertent error. The commenter also 
stated that in the CY 2014 PFS final rule with comment period physician 
work time file, CMS implemented the correct number and level of 
postoperative visits and correct total times, though inadvertently kept 
erroneously inflated immediate postservice times for these codes. In 
addition, the commenter stated that for CY 2015 up to the present, this 
erroneous immediate postservice time was added back into the total 
time, resulting in the total times being again incorrect for these 100+ 
services. The commenter submitted additional data for these codes and 
requested that CMS implement a technical correction.
    Response: After reviewing the data supplied by the commenter, we 
agree that these 108 codes contained an erroneous amount of total time. 
As the commenter mentioned, we previously addressed these codes in the 
CY 2014 PFS final rule with comment period (78 FR 74259) with a 
technical correction. We believe this correction will populate the 
physician time file with data that, absent the inadvertent error, would 
have been present in the time file. We are finalizing a technical 
correction to the physician work time of these codes as noted in Table 
7.

       Table 7--Technical Correction to Physician Work Total Time
------------------------------------------------------------------------
                                                  CY 2017      CY 2018
                   CPT code                      total time   total time
------------------------------------------------------------------------
19368.........................................          830          770
19369.........................................          755          690
20100.........................................          296          266
20816.........................................          809          697
20822.........................................          685          590
20824.........................................          784          690
20827.........................................          728          625

[[Page 52996]]

 
20838.........................................         1085          986
20955.........................................         1095          957
20969.........................................         1216         1048
20970.........................................         1156          988
20973.........................................         1156          988
21139.........................................          458          466
21151.........................................          715          686
21154.........................................          857          853
21155.........................................          972          939
21188.........................................          570          572
22100.........................................          475          372
22101.........................................          490          387
22110.........................................          595          479
22112.........................................          675          530
22114.........................................          685          530
22210.........................................          763          609
22212.........................................          788          640
22214.........................................          763          624
22220.........................................          733          585
22222.........................................          818          651
22224.........................................          808          666
22315.........................................          315          252
22325.........................................          652          528
22326.........................................          600          480
22327.........................................          723          604
22548.........................................          800          673
22556.........................................          693          557
22590.........................................          630          501
22595.........................................          650          521
22600.........................................          595          490
22610.........................................          656          549
22630.........................................          599          487
22800.........................................          695          571
22802.........................................          670          538
22804.........................................          768          595
22808.........................................          691          530
22810.........................................          751          595
22812.........................................          854          700
32650.........................................          400          290
32656.........................................          517          377
32658.........................................          420          330
32659.........................................          492          357
32661.........................................          400          300
32664.........................................          420          330
32820.........................................         1054          854
33236.........................................          376          346
33237.........................................          516          456
33238.........................................          517          472
33243.........................................          642          537
33321.........................................          949          754
33417.........................................         1003          750
33502.........................................          973          688
33503.........................................         1213          838
33504.........................................         1043          789
33600.........................................          958          628
33602.........................................          928          628
33606.........................................         1058          728
33608.........................................          938          668
33690.........................................          883          636
33702.........................................          956          751
33722.........................................          908          608
33732.........................................          848          578
33735.........................................         1073          770
33736.........................................          848          548
33750.........................................          968          722
33764.........................................         1023          750
33767.........................................          938          608
33774.........................................         1348          998
33788.........................................         1033          736
33802.........................................          751          556
33803.........................................          811          586
33820.........................................          558          414
33824.........................................          811          615
33840.........................................          831          639
33845.........................................          978          726
33851.........................................          891          700
33852.........................................          951          719
33853.........................................          998          668
33917.........................................          878          608
33920.........................................          958          658
33922.........................................          756          546
33974.........................................          464          314
34502.........................................          951          741
35091.........................................          995          790
35694.........................................          546          456
35901.........................................          602          482
35903.........................................          506          416
49422.........................................          212          182
49429.........................................          407          317
50320.........................................          598          524
50845.........................................          823          613
56632.........................................         1013          683
60520.........................................          624          474
60521.........................................          595          445
60522.........................................          703          533
61557.........................................          627          510
63700.........................................          497          401
63702.........................................          567          463
63704.........................................          732          609
63706.........................................          800          679
64712.........................................          245          294
------------------------------------------------------------------------

    We note that the technical correction to the total work time of 
these codes will not have a direct effect on the calculation of their 
individual RVUs, as changes to work time affect code valuation at the 
specialty level, not the service level, in the ratesetting methodology. 
For additional information, please see section II.B.2.c. of this final 
rule regarding the allocation of PE to services.
    Comment: In addition to these 108 codes detailed above, the same 
commenter identified seven additional codes with a need for potential 
technical corrections in their physician work times. Listed in order, 
the commenter identified these issues:
     For CPT code 28122 (Partial excision (craterization, 
saucerization, sequestrectomy, or diaphysectomy) bone (e.g., 
osteomyelitis or bossing); tarsal or metatarsal bone, except talus or 
calcaneus), in the CY2012 Final Rule CMS finalized 0.5 99238 discharge 
visits. The commenter stated that the CY 2018 Physician Work Time file 
incorrectly still listed this service as having one 99238 visit.
     For CPT code 46900 (Destruction of lesion(s), anus (e.g., 
condyloma, papilloma, molluscum contagiosum, herpetic vesicle), simple; 
chemical), the commenter stated that the CY 2018 Physician Work Time 
file inadvertently omitted one 99213 post-operative visit for this 10-
day global service. When this service was last reviewed by the PEAC in 
March 2004, the PEAC recommended and CMS finalized 36 minutes of RN/
LPN/MTA post-service period time, which corresponds with one 99213 
office visit bundled into the 10-day global period. Therefore, the 
commenter stated that the CY 2018 direct PE inputs and the physician 
work time file for this service did not match.
     For CPT code 47562 (Laparoscopy, surgical; 
cholecystectomy), the CY 2013 final rule only detailed refining the 
preservice work time and made no mention of not accepting the RUC 
recommended postoperative visits. The commenter stated that the work 
time file should have two 99213 post-operative visits instead of one.
     For CPT code 76948 (Ultrasonic guidance for aspiration of 
ova, imaging supervision and interpretation), the commenter stated that 
the CY 2014 final rule did not mention any refinements to the RUC-
recommended times for the interim final valuation of this service. For 
the CY 2015 final rule, the preamble text discussed removing preservice 
and postservice work times for a different service in this family of 
codes, CPT code 76945. The commenter stated that it appeared that this 
refinement was inadvertently applied to both CPT codes 76948 and 76945 
in the work time file.
     For CPT code 77767 (Remote afterloading high dose rate 
radionuclide skin surface brachytherapy, includes basic dosimetry, when 
performed; lesion diameter up to 2.0 cm or 1 channel), the commenter 
stated that the CY 2016 NPRM work time file included the RUC-
recommended preservice, intraservice and postservice work times but 
incorrectly summed the total time (listed as CPT dummy code number 
7778A). The commenter stated that this error appeared to have been 
carried forward to the present, since there was no mention of any work 
time refinements for this code in the CY 2016 final rule.
     For CPT codes (93668 Peripheral arterial disease (PAD) 
rehabilitation, per session) and 96904 (Whole body integumentary 
photography, for monitoring of high risk patients with dysplastic nevus 
syndrome or a history of dysplastic nevi, or patients with a personal 
or familial history of melanoma), the RUC had recommended and CMS had 
agreed that these services do not include physician work. However, the 
commenter stated that the CY 2018 physician work time file

[[Page 52997]]

erroneously listed physician time for these services.
    The commenter requested for the work time for these services to be 
corrected in the CY 2018 Physician Work Time file for the CY 2018 final 
rule.
    Response: After reviewing the data supplied by the commenter, we 
agree that six of the seven codes identified by the commenter contained 
an erroneous amount of work time. We do not agree with the commenter 
regarding CPT code 76948, as the refinements to work time that took 
place were finalized as intended, and were not due to confusion with 
CPT code 76945 (80 FR 70970-70971). For the other six codes, we are 
finalizing technical corrections to the work time file as described by 
the commenter.
    After consideration of comments received, we are finalizing the 
direct PE changes to CPT code 96416 as proposed, the correction to an 
anomaly in the postservice work time for CPT code 91200 as proposed, 
and the proposed changes to the direct PE database detailed in Table 6. 
We are also finalizing technical corrections in physician work times as 
detailed above in the preceding paragraphs.
(7) Updates to Prices for Existing Direct PE Inputs
    In the CY 2011 PFS final rule with comment period (75 FR 73205), we 
finalized a process to act on public requests to update equipment and 
supply price and equipment useful life inputs through annual 
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2018, 
we proposed the following price updates for existing direct PE inputs.
    We proposed to update the price of thirteen supplies and one 
equipment item in response to the public submission of invoices. For 
the details of these proposed price updates, please refer to section 
II.H, of this final rule, Table 16: Invoices Received for Existing 
Direct PE Inputs.
    We did not propose to update the price of the blood warmer (EQ072), 
the cell separator system (EQ084), or the photopheresor system (EQ206) 
equipment items. The only pricing information that we received for 
these three equipment items was an invoice that included a hand-written 
price over redacted information. We were unable to verify the accuracy 
of this invoice. We are also not proposing to update the price of the 
DNA image analyzer (ACIS) (EP001) equipment item, due to the inclusion 
of many components on the submitted invoice that are not part of the 
price of the DNA image analyzer. We were unable to determine which of 
these components were included in the cost of the DNA image analyzer, 
and which of these components were unrelated types of equipment. To 
price these equipment items accurately, we believe that we need 
additional information. We continued to use the current price for these 
equipment items pending the submission of additional pricing 
information. We welcomed the submission of updated pricing information 
regarding these equipment items through valid invoices from commenters 
and other stakeholders.
    We also proposed to change the name of the ED050 equipment from the 
``PACS Workstation Proxy'' to the ``Technologist PACS workstation.'' In 
the CY 2017 final rule (81 FR 80180-80182), we finalized a policy to 
add a professional PACS workstation (ED053) to the list of approved 
equipment items, and we believe that renaming ED050 to the technologist 
PACS workstation would help to alleviate potential confusion between 
the two PACS workstations.
    We routinely accept public submission of invoices as part of our 
process for developing payment rates for new, revised, and potentially 
misvalued codes. Often these invoices are submitted in conjunction with 
the RUC-recommended values for the codes. For CY 2018, we note that 
some stakeholders have submitted invoices for new, revised, or 
potentially misvalued codes after the February 10th deadline 
established for code valuation recommendations. To be included in a 
given year's proposed rule, we generally need to receive invoices by 
the same February 10th deadline. However, we would consider invoices 
submitted as public comments during the comment period following the 
publication of the proposed rule, and would consider any invoices 
received after February or outside of the public comment process as 
part of our established annual process for requests to update supply 
and equipment prices.
    The following is a summary of the public comments received on 
updates to prices for new and existing direct PE inputs and our 
responses:
    Comment: Several commenters supported the price changes that CMS 
proposed in response to the submission of invoices.
    Response: We appreciate the response from the commenters, as well 
as the timely submission of these invoices prior to the February 10th 
deadline.
    Comment: One commenter, in response to the CMS request for 
additional updated pricing information for the blood warmer (EQ072), 
the cell separator system (EQ084), the photopheresor system (EQ206), 
and the DNA image analyzer (EP001) equipment items, submitted an 
attachment with current valid invoices. The commenter urged CMS to use 
these invoices to update the price of these equipment items.
    Response: We appreciate the additional invoices from the commenter 
in response to our request for more information in the proposed rule. 
We are finalizing updated prices for all four of these equipment items 
as detailed in Table 16: Invoices Received for Existing Direct PE 
Inputs. For the first three equipment items, we are finalizing the 
price indicated on their respective invoices. For the DNA image 
analyzer (EP001), we are finalizing a price of $248,946.30, based on 
the submitted price of $258,042.30 minus the price of the user training 
($6,800.00), the instructor-led online training ($646.00) and the 
shipping and handling costs ($1,650.00). These costs are allocated 
through the indirect allocation under the established PE methodology. 
We are also finalizing a change in the name of the EP001 equipment from 
``DNA image analyzer'' to ``DNA/digital image analyzer'' as requested 
by commenters.
    Comment: Several commenters disagreed with the proposed price of 
$4.10 for the UV goggles (SJ027) supply and the proposal to treat the 
patient and clinician goggles used for photodynamic therapy as the same 
SJ027 supply item rather than create a new supply code. One commenter 
stated they were concerned with the blended price methodology used by 
CMS to calculate the proposed price, and indicated that the current 
market price was higher than the proposed price for the SJ027 supply. 
Another commenter stated that the goggles used for photodynamic therapy 
are proprietary to the company that produces aminolevulinic acid and 
are not available through other sources, which made the use of the 
proposed blended price inappropriate. Commenters submitted several 
additional invoices for the price of both the UV goggles and the 
patient/clinician goggles used for photodynamic therapy.
    Response: We appreciate the additional information supplied by the 
commenters regarding these different types of goggles, especially the 
additional pricing information included in the invoices. After 
consideration of the comments, we agree that these are two separate 
supply items and that it would not be appropriate to blend their prices 
together. We are finalizing a price of $7.95 for the UV goggles (SJ027) 
and a price of $6.00 for the new patient/clinician goggles (SD326). 
Regarding the

[[Page 52998]]

new SD326 supply, since these very similar goggles were produced by the 
same company and sold for the same price, we did not agree that each of 
them should be described by a separate supply code and will instead 
group them together as ``patient/clinician goggles'' under a single 
supply code.
    Comment: Several commenters disagreed with the price update to the 
LMX 4% anesthetic cream (SH092) supply and the use of an online price 
quote found by CMS. A commenter stated that physicians' only purchased 
drugs from reputable medical suppliers in order to ensure the safety of 
their patients and that the current price of the SH092 supply was 
accurate. The commenters also submitted three additional invoices for 
the SH092 supply.
    Response: We disagree with the commenters that the use of prices 
obtained online carries an elevated risk of patient complications due 
to false or improperly prepared medication. We have no reason to 
believe that healthcare providers will typically purchase medical 
supplies and equipment at higher than rates generally available on the 
market, and LMX 4% anesthetic cream is a widely available non-
prescription supply item that can be commonly found both online and in 
pharmaceutical stores. We have no reason to believe the price quote 
that we obtained online is atypical of market rates or reflects an 
inferior product that represents a danger to patients. However, given 
commenters' suggestions that some physicians purchase the item at 
prices higher than the best market price, we will average together our 
online price quote together with the three invoices submitted by the 
commenters. We are therefore finalizing a price of $1.357 for the SH092 
supply based on the use of this methodology.
    Comment: One commenter addressed the proposed update to the price 
of the INR test strips (SJ055) supply. The commenter stated that the 
price change would lead to substantial reductions for HCPCS codes G0248 
and G0249, and while the commenter agreed that the market price for INR 
test strips had changed since the item was priced initially 15 years 
ago, the current direct PE inputs for these codes did not reflect the 
resources typically required to furnish the services.
    Response: We appreciate the additional information submitted by the 
commenter. Although we are finalizing the price of the INR test strip 
(SJ055) at the proposed rate of $5.66, we agree that the current direct 
PE inputs for these services may not reflect the typical resources that 
they require. For additional details regarding the INR Monitoring codes 
and refinements to their direct PE inputs, please refer to the code 
valuation section (II.H) of this final rule.
    Comment: One commenter requested that the cytology, preservative 
and vial, (cytospin) 88108--30ml (SL501) supply should be deleted from 
the CMS supply database. The commenter stated that this supply is 
redundant with the cytology, preservative and vial (Preserv-cyt) 
(SL040) supply and that the quantity of SL040 for CPT code 88108 should 
be 1 item. The commenter stated that this was an error made in 2014 and 
in 2015 when CPT code 88108 code was reviewed and urged CMS to correct 
this error.
    Response: After reviewing the supply inputs for CPT code 88108, we 
agree with the commenter. The SL501 supply appeared in no other CPT 
codes and did not have a price. We agree that the resources typically 
required to furnish CPT code 88108 are more accurately described by 
including 1 quantity of the SL040 supply. We are finalizing this 
addition to CPT code 88108 and the removal of the SL501 supply from our 
database.
    Comment: One commenter called attention to the fact that there are 
a number of supply and equipment items that currently do not have a 
price. The commenter stated that the lack of a price adversely affects 
the specialties when they use these supply and equipment items since 
the cost of the item is not being factored into the formula used to 
determine the PE RVU. The commenter stated that CMS should ensure that 
all supplies and equipment have a price included in the database in 
order to facilitate payment for all the resources associated with a 
service.
    Response: We appreciate the extra attention drawn by the commenter 
to the supply and equipment items currently present in our database 
that lack a price. We encourage commenters to submit invoices to update 
the pricing of these supplies and equipment items through the process 
detailed above.
    Comment: One commenter stated that CMS provides no additional 
payments for drug-coated balloons and bundles those payments within the 
payments of existing procedures for office-based procedures. The 
commenter indicated that CMS proposed to package the device costs of 
drug coated balloons into the costs of the procedures with which the 
device is utilized, which meant that angioplasty procedures with drug 
coated balloons and plain balloons will receive the same payment 
amount. The commenter detailed the clinical benefits of drug coated 
balloons in angioplasty and requested an alternate payment structure to 
avoid patient access barriers to this technology.
    Response: We appreciate the additional information supplied by the 
commenter regarding the use of drug coated balloons. We encourage 
stakeholders to submit comments with additional information when 
practice patterns for services may change over time, which may lead to 
the nomination of individual services as potentially misvalued. 
However, the commenter did not provide specific CPT codes in which 
these new treatments would be utilized, nor did the commenter supply 
evidence to indicate that the use of these drug coated balloons would 
be typical. We also did not receive recommendations from the RUC or 
other medical specialty groups requesting the addition of drug coated 
balloons as a new supply item. As a result, we will retain the current 
direct PE inputs for angioplasty services unless otherwise mentioned in 
this final rule.
    Comment: One commenter stated concerns regarding the need for more 
accurate pricing of expensive equipment and disposable supplies. The 
commenter noted that the current pricing of supplies and equipment, 
based on the voluntary submission of small numbers of invoices, creates 
the potential for highly biased, non-representative invoices, and makes 
these cost inputs relatively unreliable. This potential overestimation 
of resource costs augments the reimbursement disparities between 
proceduralists and primary care physicians, inappropriately rewards 
physicians who perform procedures, and provides an improper incentive 
for overuse of these services. The commenter suggested addressing this 
issue through subjecting expensive equipment and supplies to fixed 
discounting of their costs over time.
    Response: We agree with the commenter that the methodology used for 
price updates to new and existing supplies and equipment has the 
potential to create disparities in resource cost. As we have stated in 
past rulemaking, such as in the CY 2016 final rule with comment period 
(80 FR 70896), we do not believe that very small numbers of voluntarily 
submitted invoices are likely to reflect typical resource costs and 
create the potential for overestimation of supply and equipment costs. 
As part of our authority under section 1848(c)(2)(M) of the Act to 
collect and use information on physicians' services in the 
determination of relative values under the PFS, which was added to the 
statute by section 220(a)(1) of the PAMA, we

[[Page 52999]]

have initiated a contract to collect data that we hope will facilitate 
more accurate prices for supplies and equipment. Based on the data 
collected and additional stakeholder feedback, we may make proposals to 
update supply and equipment pricing in future rulemaking. We will also 
consider other suggestions to address the issues involving high cost 
supplies and equipment, such as the fixed discounting recommended by 
the commenter.
    After consideration of comments received, we are finalizing the 
updated supply and equipment prices as detailed in Table 16: Invoices 
Received for Existing Direct PE Inputs.
4. Adjustment to Allocation of Indirect PE for Some Office-Based 
Services
    As we explain in section II.B.2.c.(2) of this final rule, we 
allocate indirect costs for each code 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. Indirect expenses include 
administrative labor, office expense, and all other expenses. For PFS 
services priced in both the facility and non-facility settings, the 
difference in indirect PE RVUs between the settings is driven by 
differences in direct PE inputs for those settings since the other 
allocator of indirect PE, the work RVU, does not differ between 
settings. For most services, the direct PE input costs are higher in 
the nonfacility setting than in the facility setting. As a result, 
indirect PE RVUs allocated to these services are higher in the 
nonfacility setting than in the facility setting. When direct PE inputs 
for a service are very low, however, the allocation of indirect PE RVUs 
is almost exclusively based on work RVUs, which results in a very small 
(or no) site of service differential between the total PE RVUs in the 
facility and nonfacility setting.
    Some stakeholders have suggested that for codes in which direct PE 
inputs for a service are very low, this allocation methodology does not 
allow for a site of service differential that accurately reflects the 
relative indirect costs involved in furnishing services in nonfacility 
settings. Among the services most affected by this anomaly are the 
primary therapy and counseling services available to Medicare 
beneficiaries for treatment of behavioral health conditions, including 
substance use disorders. For example, for the most commonly reported 
psychotherapy service (CPT code 90834), the difference between the 
nonfacility and facility PE RVUs is only 0.02 RVUs, which seems 
unlikely to represent the difference in relative resource costs in 
terms of administrative labor, office expense, and all other expenses 
incurred by the billing practitioner for 45 minutes of psychotherapy 
services when furnished in the office setting versus the facility 
setting.
    We agree with these stakeholders that the site of service 
differential for these services that is produced by our PE methodology 
seems unlikely to reflect the relative resource costs for the 
practitioners furnishing these services in nonfacility settings. For 
example, we believe the 0.02 RVUs, which translates to approximately 
$0.72, would be unlikely to reflect the relative administrative labor, 
office rent, and other overhead involved in furnishing the 45 minute 
psychotherapy service in a nonfacility setting. Consequently, we 
believe it would be appropriate to modify the existing methodology for 
allocating indirect PE RVUs in order to better reflect the relative 
indirect PE resources involved in furnishing these kinds of services in 
the nonfacility setting.
    In examining the range of services furnished in the nonfacility 
setting that are most affected by this circumstance, we identified 
HCPCS codes that describe face-to-face services, have work RVUs greater 
than zero, and are priced in both the facility and nonfacility setting. 
From among these codes, we further selected those with the lowest ratio 
between nonfacility PE RVUs and work RVUs. We selected 0.4 as an 
appropriate threshold based on several factors, including the range of 
nonfacility PE RVU to work RVU ratios among the codes identified. Based 
on these criteria, there were fewer than 50 codes that we identified 
with a ratio of less than 0.4 nonfacility PE RVUs for each work RVU, 
most of which are primarily furnished by behavioral health 
professionals, for a potential modification to our indirect PE 
allocation methodology.
    In considering how to address the anomaly and ensure that an 
appropriate number of indirect PE RVUs are allocated to these services 
in the nonfacility setting, we looked at the indirect, nonfacility PE 
RVU for the most commonly billed physician office visit, CPT code 
99213, which is billed by a wide range of physicians and non-physician 
practitioners under the PFS. We believe that the indirect PE costs 
allocated to services reported with CPT code 99213, including 
administrative labor and office rent, would be common for a broad range 
of physicians and non-physician practitioners across the PFS. We 
recognize that the services we seek to address are primarily furnished 
by behavioral health professionals who may be unlikely to incur some of 
the costs incurred by other practitioners furnishing a broader range of 
medical services. For instance, a practitioner furnishing a broader 
range of primary care services likely requires separate office and 
examination room space, and storage for disposable medical supplies and 
equipment. Some costs, however, such as those for office staff and 
records maintenance, would be analogous.
    We looked at the relationship between indirect PE and work RVUs for 
CPT code 99213 as a marker because that is the most commonly and 
broadly reported PFS code that describes face-to-face office-based 
services. We compared the relationship between indirect PE and work 
RVUs for the set of HCPCS codes that we identified using the criteria 
discussed above and found that for the significant majority of codes, 
that ratio was at least 0.4 nonfacility PE RVUs for each work RVU. We 
believe the 0.4 nonfacility PE RVUs can serve as an appropriate marker 
that appropriately reflects the relative resources involved in 
furnishing these services.
    For the fewer than 50 outlier codes identified using the criteria 
above, we believe it would be appropriate to establish a minimum 
nonfacility indirect PE RVU that would be a better reflection the 
resources involved in furnishing these services. We propose to set the 
nonfacility indirect PE RVUs for these codes using the indirect PE RVU 
to work RVU ratio for the most commonly furnished office-based, face-
to-face service (CPT 99213) as a marker. Specifically, for each of 
these outlier codes, we propose to compare the ratio between indirect 
PE RVUs and work RVUs that result from the preliminary application of 
the standard methodology to the ratio for the marker code, CPT code 
99213. Our proposed change in the methodology would then increase the 
allocation of indirect PE RVUs to the outlier codes to at least one 
quarter of the difference between the two ratios. We believe this 
approach reflects a reasonable minimum allocation of indirect PE RVUs, 
but we do not currently have empirical data that would be useful in 
establishing a more precise number.
    In developing the proposed PE RVUs for CY 2018, we proposed to 
implement only one quarter of this proposed minimum value for 
nonfacility indirect PE for the outlier codes. We recognize that this 
change in the PE methodology could have a significant impact on the 
allocation of indirect PE RVUs across all PFS services. In making 
significant changes to the PE methodology in

[[Page 53000]]

previous years, we have implemented such changes using 4 year 
transitions, based largely on concerns that some specialties experience 
significant payment reductions with changes in PE relativity, and a 
transition period allows for a more gradual adjustment for affected 
practitioners. Under the approach we proposed, we estimate that 
approximately $40 million, or approximately 0.04 percent of total PFS 
allowed charges, would shift within the PE methodology for each year of 
the proposed 4-year transition, including for CY 2018. We also note 
that we proposed to exclude the codes directly subject to this proposed 
change from the misvalued code target calculation because the proposed 
change is a methodological change to address an anomaly produced by our 
indirect PE allocation process as opposed to a change to address 
misvalued codes. The PE RVUs displayed in Addendum B on our Web site 
were calculated with the one quarter of the indirect PE adjustment 
factor implemented.
    The following is a summary of the public comments received on our 
proposed change to the indirect PE methodology for some office-based 
services.
    Comment: Several commenters supported the CMS proposal. Commenters 
stated that the proposal would more accurately reflect the resource 
costs incurred by psychiatrists providing services for patients with 
mental health and substance use disorders in nonfacility settings. One 
commenter indicated their support for the commitment of greater 
resources toward behavioral and mental health services given the 
ongoing opioid crisis. Commenters were also supportive of the proposal 
to exclude the codes directly impacted by this change in methodology 
from the misvalued code target.
    Response: We appreciate the support from the commenters for our 
proposal.
    Comment: One commenter disagreed with the CMS proposal. The 
commenter stated that this change to PE methodology could have a 
significant impact on the allocation of indirect PE RVUs across all PFS 
services, with approximately 0.04 percent of the total PFS allowed 
charges shifting within the PE methodology. The commenter recommended 
that the proposal should not be finalized until it was discussed 
through the RUC process, and that the codes in question should be 
placed on the misvalued code list.
    Response: We appreciate the feedback from the commenter on our 
proposal. We note that the RUC has generally provided recommendations 
on a routine basis regarding work, work time, and direct PE inputs. We 
do not believe that placing these codes on the misvalued code list for 
additional RUC review would serve to address the issues identified in 
our proposal, as we do not have reason to believe that the work or 
direct PE inputs assigned to these services are inaccurate. However, we 
welcome recommendations from the RUC or other interested stakeholders 
on any aspects of the PFS ratesetting methodology, including elements 
that have not traditionally been provided such as indirect PE 
allocation. We believe that CMS receiving public input on potential 
changes to the methodology is critical and that notice and comment 
rulemaking is the best way to obtain such input. We do not agree that 
changes in the methodology need to be developed or discussed as part of 
the RUC process prior to being implemented through notice and comment 
rulemaking.
    After consideration of comments received, we are finalizing our 
proposed change to the indirect PE methodology for some office-based 
services.

C. 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. Section 
1848(c)(2)(B)(i) of the Act also requires that we review, and if 
necessary adjust, RVUs no less often than every 5 years. In the CY 2015 
PFS final rule with comment period, we implemented the third review and 
update of MP RVUs. For a comprehensive discussion of the third review 
and update of MP RVUs see the CY 2015 proposed rule (79 FR 40349 
through 40355) and final rule with comment period (79 FR 67591 through 
67596).
    To determine MP RVUs for individual PFS services, our MP 
methodology is composed of three factors: (1) Specialty-level risk 
factors derived from data on specialty-specific MP premiums incurred by 
practitioners, (2) service level risk factors derived from Medicare 
claims data of the weighted average risk factors of the specialties 
that furnish each service, and (3) an intensity/complexity of service 
adjustment to the service level risk factor based on either the higher 
of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were 
only updated once every 5 years, except in the case of new and revised 
codes.
    As explained in the CY 2011 PFS final rule with comment period (75 
FR 73208), MP RVUs for new and revised codes effective before the next 
5-year review of MP RVUs were determined either by a direct crosswalk 
from a similar source code or by a modified crosswalk to account for 
differences in work RVUs between the new/revised code and the source 
code. For the modified crosswalk approach, we adjusted (or scaled) the 
MP RVU for the new/revised code to reflect the difference in work RVU 
between the source code and the new/revised work RVU (or, if greater, 
the difference in the clinical labor portion of the fully implemented 
PE RVU) for the new code. For example, if the proposed work RVU for a 
revised code was 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 
was applied for the new/revised code and source code, but the work RVU 
for the new/revised code was used to adjust the MP RVUs for risk.
    In the CY 2016 PFS final rule with comment period (80 FR 70906 
through 70910), we finalized a policy to begin conducting annual MP RVU 
updates to reflect changes in the mix of practitioners providing 
services (using Medicare claims data), and to adjust MP RVUs for risk, 
intensity and complexity (using the work RVU or clinical labor RVU). We 
also finalized a policy to modify the specialty mix assignment 
methodology (for both MP and PE RVU calculations) to use an average of 
the 3 most recent years of data instead of a single year of data. Under 
this approach, for new and revised codes, we generally assign a 
specialty risk factor to individual codes based on the same utilization 
assumptions we make regarding the specialty mix we use for calculating 
PE RVUs and for PFS budget neutrality. We continue to use the work RVU 
or clinical labor RVU to adjust the MP RVU for each code for intensity 
and complexity. In finalizing this policy, we stated that the 
specialty-specific risk factors would continue to be updated through 
notice and comment rulemaking every 5 years using updated premium data, 
but would remain unchanged between the 5-year reviews.
    In CY 2017, we finalized the eighth GPCI update, which reflected 
updated MP premium data. We did not propose to use the updated MP 
premium data to propose updates for CY 2017 to the specialty risk 
factors used in the calculation of MP RVUs because it was inconsistent 
with the policy we previously finalized in the CY 2016 PFS

[[Page 53001]]

final rule with comment period, whereby we indicated that the 
specialty-specific risk factors would continue to be updated through 
notice and comment rulemaking every 5 years using updated premium data, 
but would remain unchanged between the 5-year reviews. However, we 
solicited comment on whether we should consider doing so, perhaps as 
early as for CY 2018, prior to the fourth review and update of MP RVUs 
that must occur no later than CY 2020. After consideration of the 
comments received, we stated that we would consider the possibility of 
using the updated MP data to update the specialty risk factors used in 
the calculation of the MP RVUs prior to the next 5-year update in 
future rulemaking (81 FR 80191 through 80192). Since MP premium data 
are used to update both the MP GPCIs and the MP RVUs, going forward we 
believe it would be logical to align the update of MP premium data used 
to determine the MP RVUs with the update of the MP GPCI. Section 
1848(e)(1)(C) of the Act requires us to review and, if necessary, 
adjust the GPCIs at least every 3 years. The next review of the GPCIs 
must occur by CY 2020.
    In the CY 2018 PFS proposed rule, we proposed to use the most 
recent data for the MP RVUs for CY 2018 and to align the update of MP 
premium data and MP GPCIs to once every 3 years. We sought comment on 
these proposals, and we also sought comment on methodologies and 
sources that we might use to improve the next update of MP premium 
data.
2. Methodology for the Revision of Resource Based Malpractice RVUs
a. General Discussion
    The proposed MP RVUs were calculated based on updated malpractice 
premium data obtained from state insurance rate filings by a CMS 
contractor. The methodology used in calculating the proposed CY 2018 
review and update of resource based MP RVUs largely paralleled the 
process used in the CY 2015 update. The calculation requires using 
information on specialty-specific malpractice premiums linked to 
specific services based upon the relative risk factors of the various 
specialties that furnish a particular service. Because malpractice 
premiums vary by state and specialty, the malpractice premium 
information must be weighted geographically and by specialty. 
Accordingly, the proposed MP RVUs were based upon four data sources: CY 
2014 and CY 2015 malpractice premium data; CY 2016 and 2017 Medicare 
payment and utilization data; CY 2017 GPCIs, and CY 2018 proposed work 
and clinical labor RVUs.
    Similar to the previous update, we calculated the proposed MP RVUs 
using specialty-specific malpractice premium data because they 
represent the actual expense incurred by practitioners to obtain 
malpractice insurance. We obtained malpractice premium data exclusively 
from the most recently available data published in the 2014 and 2015 
Market Share Reports accessed from the National Association of 
Insurance Commissioners (NAIC) Web site. We used information obtained 
from malpractice insurance rate filings with effective dates in 2014 
and 2015. These were the most current data available during our data 
collection process.
    We collected malpractice insurance premium data from all 50 States, 
the District of Columbia, and Puerto Rico. Rate filings were not 
available in American Samoa, Guam or the Virgin Islands. Premiums were 
for $1 million/$3 million, mature, claims-made policies (policies 
covering claims made, rather than those covering services furnished, 
during the policy term). A $1 million/$3 million liability limit policy 
means that the most that would be paid on any claim is $1 million and 
the most that the policy would pay for claims over the timeframe of the 
policy is $3 million. We made adjustments to the premium data to 
reflect mandatory surcharges for patient compensation funds (funds to 
pay for any claim beyond the statutory amount, thereby limiting an 
individual physician's liability in cases of a large suit) in states 
where participation in such funds is mandatory.
    We included premium information for all physician and NPP 
specialties, and all risk classifications available in the collected 
rate filings. Although we collected premium data from all states, the 
District of Columbia, and Puerto Rico, not all specialties had distinct 
premium data in the rate filings from all states. Additionally, for 
some specialties, MP premiums were not available from the rate filings 
in any state. Therefore, for specialties for which there were not 
premium data for at least 35 states, and specialties for which there 
were not distinct premium data in the rate filings, we crosswalked the 
specialty to a similar specialty, either conceptually or by available 
premium data, for which we did have sufficient and reliable data.
    For example, for radiation oncology, data were only available from 
23 states, and therefore this specialty does not meet our 35-state 
threshold, which determines whether or not a specialty is deemed to 
have premium data sufficient to construct a unique risk factor. 
However, based on the 23 states' worth of rate filings for radiation 
oncology, the resource costs for the premiums suggests a similar, 
though slightly lesser average than that of the premiums for diagnostic 
radiology. We developed the proposed MP RVUs for radiation oncology by 
crosswalking the risk factor for diagnostic radiology as a similar 
specialty with similar premium data. We sought comment as to the 
appropriateness of this and the other crosswalks used in developing MP 
RVUs.
    For the proposed CY 2018 MP RVU update, sufficient and reliable 
premium data were available for 43 specialty types, representing over 
76 percent of allowed Medicare PFS services, which we used to develop 
specialty specific malpractice risk factors.
b. Steps for Calculating Malpractice RVUs
    Calculation of the proposed MP RVUs conceptually follows the 
specialty-weighted approach used in the CY 2015 final rule with comment 
period (79 FR 67591). The specialty-weighted approach bases the MP RVUs 
for a given service upon a weighted average of the risk factors of all 
specialties furnishing the service. This approach ensures that all 
specialties furnishing a given service are accounted for in the 
calculation of the MP RVUs. The steps for calculating the proposed MP 
RVUs are described below.
    Step (1): Compute a preliminary national average premium for each 
specialty.
    Insurance rating area malpractice premiums for each specialty are 
mapped to the county level. The specialty premium for each county is 
then multiplied by its share of the total U.S. population (from the 
U.S. Census Bureau's 2014 American Community Survey (ACS) estimates). 
This is in contrast to the method used for creating national average 
premiums for each specialty in the 2015 update; in that update, 
specialty premiums were weighted by the total RVU per county, rather 
than by the county share of the total U.S. population. We refer readers 
to the CY 2016 PFS final rule with comment period (80 FR 70909) for a 
discussion of why we have adopted a weighting method based on a share 
of the total U.S. population. This calculation is then divided by the 
average MP GPCI across all counties for each specialty to yield a 
normalized national average premium for each specialty. The specialty 
premiums are normalized for geographic variation so that the locality 
cost differences (as

[[Page 53002]]

reflected by the GPCIs) would not be counted twice. Without the 
geographic variation adjustment, the cost differences among fee 
schedule areas would be reflected once under the methodology used to 
calculate the MP RVUs and again when computing the service specific 
payment amount for a given fee schedule area.
    Step (2): Determine which premium class(es) to use within each 
specialty.
    Some specialties had premium rates that differed for surgery, 
surgery with obstetrics, and non-surgery. These premium classes are 
designed to reflect differences in risk of professional liability and 
the cost of malpractice claims if they occur. To account for the 
presence of different classes in the malpractice premium data and the 
task of mapping these premiums to procedures, we calculated distinct 
risk factors for surgical, surgical with obstetrics, and nonsurgical 
procedures. However, the availability of data by surgery and non-
surgery varied across specialties. Consistent with the CY 2015 MP RVU 
update, because no single approach accurately addressed the variability 
in premium class among specialties, we employed several methods for 
calculating average premiums by specialty. These methods are discussed 
below.
    (a) Substantial Data for Each Class: For 10 out of 86 specialties, 
we determined that there were sufficient data for surgery and non-
surgery premiums, as well as sufficient differences in rates between 
classes. Therefore, we calculated a national average surgical premium 
and non-surgical premium. We noted that, unlike in the CY 2015 MP RVU 
update, for CY 2018, there were no specialties that fell under the 
``unspecified dominates'' specialty/surgery class scenario; therefore, 
we omitted that surgical class category.
    (b) Major Surgery Dominates: For 9 surgical specialties, rate 
filings that included non-surgical premiums were relatively rare. For 
most of these surgical specialties, the rate filing did not include an 
``unspecified'' premium. When it did, the unspecified premium was lower 
than the major surgery rate. For these surgical specialties, we 
calculated only a surgical premium and used the premium for major 
surgery for all procedures furnished by this specialty.
    (c) Blend All Available: For the remaining specialties, there was 
wide variation across the rate filings in terms of whether or not 
premium classes were reported and which categories were reported. 
Because there was no clear strategy for these remaining specialties, we 
blended the available rate information into one general premium rate. 
For these specialties, we developed a weighted average ``blended'' 
premium at the national level, according to the percentage of work RVUs 
correlated with the premium classes within each specialty. For example, 
the surgical premiums for a given specialty were weighted by that 
specialty's work RVUs for surgical services; the nonsurgical premiums 
were weighted by the work RVUs for non-surgical services and the 
unspecified premiums were weighted by all work RVUs for the specialty 
type.
    Step (3): Calculate a risk factor for each specialty.
    The relative differences in national average premiums between 
specialties are expressed in our methodology as a specialty risk 
factor. These risk factors are an index calculated by dividing the 
national average premium for each specialty by the national average 
premium for the specialty with the lowest premiums for which we had 
sufficient and reliable data, allergy and immunology. For specialties 
with sufficient surgical and non-surgical premium data, we calculated 
both a surgical and non-surgical risk factor. For specialties with rate 
filings that distinguished surgical premiums with obstetrics, we 
calculated a separate surgical with obstetrics risk factor. For all 
other specialties, we calculated a single risk factor and applied the 
specialty risk factor to both surgery and non-surgery services.
    We noted that for determining the risk factor for suppliers of TC-
only services in the CY 2015 update, we updated the premium data for 
independent diagnostic testing facilities (IDTFs) that we used in the 
CY 2010 update. These data were obtained from a survey conducted by the 
Radiology Business Management Association (RBMA) in 2009; we ultimately 
used these data to calculate an updated TC specialty risk factor. We 
applied the updated TC specialty risk factor to suppliers of TC-only 
services. In the CY 2015 final rule with comment period (79 FR 67595), 
RBMA voluntarily submitted updated MP premium information collected 
from independent diagnostic testing facilities (IDTFs) in 2014, and 
requested that we use the data for calculating the CY 2015 MP RVUs for 
TC services. We declined to utilize the data and stated that we believe 
further study is necessary and we would consider this matter and 
propose any changes through future rulemaking. We believed that data 
for a broader set of technical component services are needed, and 
sought comment on appropriate, comparable data sources for such 
information. We also sought comment on whether the data for IDTFs are 
comparable and appropriate as a proxy for the broader set of TC 
services. We endeavor to, in the next update of specialty risk factors, 
collect more data across a broader set of the technical component 
services, not just for radiology (as is currently reflected in the RBMA 
data), but data for services performed by other non-physician 
practitioners including cytotechnologists, and cardiovascular 
technologists. In the interim, for CY 2018, we proposed to assign a TC 
risk factor of 1.0, which corresponds to the lowest physician specialty 
risk factor.
    We assigned the risk factor of 1.0 to the TC services because we 
did not have comparable professional liability premium data for the 
full range of clinicians that furnish these services. In lieu of 
comprehensive, comparable data, we used 1.0 as the default minimum risk 
factor, though we sought information on the best available data sources 
for use in the next update, as well as empirical information that would 
support assignment of an alternative risk factor for these services.
    Step (4): Calculate malpractice RVUs for each HCPCS code.
    Resource-based MP RVUs were calculated for each HCPCS code that has 
work or PE RVUs. The first step was to identify the percentage of 
services furnished by each specialty for each respective HCPCS code. 
This percentage was then multiplied by each respective specialty's risk 
factor as calculated in Step 3. The products for all specialties for 
the HCPCS code were then added together, yielding a specialty-weighted 
service specific risk factor reflecting the weighted malpractice costs 
across all specialties furnishing that procedure. The service specific 
risk factor was multiplied by the greater of the work RVU or PE 
clinical labor index for that service to reflect differences in the 
complexity and risk-of-service between services.
    Low volume service codes: As we discussed in section II.B. of this 
final rule, we proposed to use a list of expected specialties instead 
of the claims-based specialty mix for low volume services in order to 
address stakeholder concerns about the year to year variability in PE 
and MP RVUs for low volume services. We solicited comments on the 
proposal to use these service-level overrides to determine the 
specialty for low volume procedures, as well as on the list of 
overrides itself.
    The proposed list of codes and expected specialties is available on 
our Web site under downloads for the CY 2018 PFS proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-

[[Page 53003]]

for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-
Notices.html. In previous MP RVU updates, as discussed in the CY 2015 
final rule with comment period (79 FR 40354), we assigned specialty for 
low volume services based on dominant specialty. As discussed in the CY 
2012 final rule with comment period (76 FR 73187 through 73189), we 
applied an additional list of service-level overrides for purposes of 
calculating MP RVUs for a number of cardiothoracic surgery codes. 
Therefore, we noted that there are certain codes for which we have 
previously applied expected specialty overrides for purposes of 
calculating MP RVUs based on assumptions regarding low Medicare volume. 
Because we are consolidating policies for low volume service expected 
specialty overrides into a single list for PE and MP, and because we 
did not believe that there is a reason to assume different specialties 
for purposes of calculating PE RVUs than for MP RVUs for any particular 
code, we also proposed to assign the specialty mix solely based on the 
claims data for any code that does not meet the low volume threshold of 
99 allowed services or fewer in the previous year, for the purposes of 
calculating MP RVUs.
    Given that we now annually recalibrate MP RVUs based on claims 
data, and in light of our proposed introduction of the service-level 
specialty override for low volume services, we believed that there 
would no longer be a need to apply service-level MP crosswalks in order 
to assign a specialty-mix risk factor. Contingent on finalizing this 
proposal, we also proposed to eliminate general use of an MP-specific 
specialty-mix crosswalk for new and revised codes. However, we would 
continue to consider, in conjunction with annual recommendations, 
specific recommendations from the public and the RUC regarding 
specialty mix assignments for new and revised codes, particularly in 
cases where coding changes are expected to result in differential 
reporting of services by specialty, or where the new or revised code is 
expected to be low-volume. Absent such information, we would derive the 
specialty mix assumption for the first year for a new or revised code 
from the specialty mix used for purposes of ratesetting. In subsequent 
years when claims data are available, we would assign the specialty 
based on claims data unless the service does not exceed the low volume 
threshold (99 or fewer allowed services). If the service is low volume, 
we would assign the expected specialty, establishing a new expected 
specialty through rulemaking as needed, which is consistent with our 
approach for developing PE RVUs.
    Step (5): Rescale for budget neutrality.
    The statute requires that changes to fee schedule RVUs must be 
budget neutral. Thus, the last step is to adjust for relativity by 
rescaling the proposed MP RVUs so that the total proposed resource 
based MP RVUs are equal to the total current resource based MP RVUs 
scaled by the ratio of current aggregate MP and work RVUs. This scaling 
is necessary in order to maintain the work RVUs for individual services 
from year to year while also maintaining the overall relationship among 
work, PE, and MP RVUs.
    Additional information on our proposed methodology for updating the 
MP RVUs may be found in our contractor's report, ``Interim Report on 
Malpractice RVUs for the CY 2018 PFS Proposed Rule,'' which is 
available on the CMS Web site under the downloads section of the CY 
2018 PFS proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    We sought comments on these proposals for calculating the MP RVUs 
for CY 2018. The following is a summary of the public comments received 
on our proposals and our responses:
    Comment: Several commenters, including the RUC, expressed concerns 
about the proposed valuation changes, which they believe were not 
indicative of what is occurring in the professional liability premium 
market. The RUC stated that, generally, the market has not reflected 
significant changes in the past several years. The commenters stated 
that the premium data collected for this update were insufficient, and 
many noted changes in specialty premiums and risk factors compared to 
the last update as particularly concerning. Some commenters expressed 
concern that CMS was unable to obtain sufficient data from all states 
for common specialties and questioned the validity of the data being 
used to propose new MP RVUs for CY 2018. The RUC stated that while the 
crosswalks proposed by CMS appear to be appropriate, they were 
concerned with the data collection process, and recommended that rather 
than crosswalking, CMS should acquire adequate premium data. Several 
commenters, including the RUC, specifically expressed concern about the 
proposed Cardiology surgical risk factor. The commenters disagreed with 
the risk factor for Cardiology being classified as a blend rather than 
split into distinct surgical and non-surgical risk factors as it had 
been in the past, and recommended that CMS use the Cardiac Surgery Risk 
Factor as a more appropriate crosswalk to establish a Cardiology 
surgical risk factor or otherwise maintain the existing risk factors 
while additional data are gathered. Several commenters, including the 
RUC, stated that CMS should consider delaying implementation of new 
premium data until CMS has the opportunity to seek additional data to 
avoid blending risk factors and crosswalking. While some commenters 
were generally supportive of more frequent updates of MP premium data 
and aligning updates of MP RVUs with the triennial MP GPCI updates, 
they stated that given concerns about accuracy and flaws in the 
methodology for calculating MP risk factors, that CMS should not 
accelerate the schedule for updating MP RVUs based on the MP GPCI data 
at this time. A few commenters recommended that CMS not modify the 
current 5-year cycle of updating the MP premium data used in the MP RVU 
calculations to every 3 years; one commenter stated that more frequent 
updates will cause greater variation in the MP RVU calculations.
    Response: We agree that some of the changes are substantial 
compared to the last update and merit further consideration. However, 
we believe it is important to delineate the precise cause of these 
changes, as the shifts were primarily driven by changes in how the rate 
filings were classified by specialty, rather than inherent deficiencies 
in the raw rate filing data. We collected malpractice premium data from 
the NAIC's System for Electronic Rate and Form Filing (SERFF) Access 
Interface, which is a standardized data source that includes many rate 
filings from the same insurers that were used in the CY 2015 MP RVU 
update, as well as additional data. Using SERFF enabled us to collect 
malpractice data for 32 states. For states that do not participate in 
the SERFF Access Interface, we contacted state departments of insurance 
and requested medical malpractice rate filings. Using these methods, we 
were able to collect a total of 7,212 raw rate filings from all 50 
states, the District of Columbia, and Puerto Rico. This is an 
improvement on the CY 2015 update, for which 3,473 raw rate filings 
were collected. We note that the number of specialties with sufficient 
data in this proposed update is very similar to prior years. In the CY 
2010 update, sufficient data were found for 44 specialties. In the CY 
2015 update, sufficient data were found for 41 specialties, and we 
found sufficient

[[Page 53004]]

data for 43 specialties in the proposed CY 2018 update. Overall, there 
is very little change in the total number of specialties with 
sufficient data.
    For the the comments that noted differences in which specialties 
had sufficient data this year, compared to the CY 2015 update, we have 
determined that this is due to differences in the codes that insurance 
issuers use to identify the physician speciality on the descriptions on 
the raw rate filings and/or how these raw data were categorized into 
CMS specialties. CMS specialty coding information is not available on 
the raw rate filings, and Insurance Services Office (ISO) codes are 
only sometimes present. Thus, it is always necessary to use a crosswalk 
to map malpractice premium data to the CMS specialty classifications. 
This means that changes in malpractice insurers' premium coding 
practices or the rate filing categorization process can easily lead to 
shifts in the number of rate filings across related specialties, which 
in turn may skew the weighting of the data, which is what we observed 
in the CY 2018 proposed update.
    The Cardiology specialty is illustrative of this issue. In the last 
update, Cardiology had a surgical risk factor of 6.98 and a non-
surgical risk factor of 1.93. In this update, Cardiology did not have 
sufficient data to compute separate surgical and non-surgical risk 
factors and was proposed to receive a blended risk factor of 1.90. This 
change was understandably concerning to several commenters. The reason 
that Cardiology did not have sufficient data to compute a surgical risk 
factor was directly due to how the raw rate filings were categorized 
rather than the data availability itself. In the past, some rate 
filings that referred to cardiac surgery and interventional cardiology 
in their specialty descriptions were categorized as Specialty 06: 
Cardiology, but comparable filings for this year's proposal were 
categorized as Specialty 78: Cardiac Surgery and C3: Interventional 
Cardiology. As several commenters suggested, it is possible to mitigate 
this problem by assigning Cardiology to receive the surgical risk 
factor of Cardiac Surgery. In the long-term, we understand commenters' 
concerns and in order to alleviate this issue, we intend to revisit how 
we categorize all rate filings by specialty. This is particularly 
important because some physicians may not have updated their specialty 
codes despite performing surgical and interventional cardiac 
procedures, and we want to ensure that their rates are properly 
adjusted if they are still registered as part of the general Cardiology 
specialty. We also understand that this issue may have occurred for 
other groups of related specialties and intend to do a comprehensive 
assessment in the future to avoid potential discrepancies such as those 
previously described. For these reasons, we are not finalizing our 
proposal to use the most recent data for the CY 2018 MP RVUs and to 
align the update of MP premium data and MP GPCIs to once every 3 years. 
We recognize that, going forward, we need to resolve differences 
regarding the variances in the descriptions on the raw rate filings as 
well as how these raw data were categorized to conform with the CMS 
specialties.
    Comment: One commenter expressed concern that the average premiums 
and risk factors for Interventional Cardiology were not proposed. The 
Interventional Cardiology specialty code went into effect in January 
2015, so the commenter urged CMS to establish risk factors for this 
specialty.
    Response: Because the malpractice rate filings collected for this 
update were from 2014 and 2015, very little data were available for 
Interventional Cardiology. Until more data are available, it will be 
necessary to crosswalk this specialty to receive average premiums and 
risk factors from cardiac specialties that carry similar levels of 
risk.
    Comment: A few commenters expressed concern about a lack of 
transparency in the proposed changes to the determination of MP RVUs, 
and some stated that stakeholders were at a disadvantage and unable to 
respond to the changes and assumptions used in the proposed update to 
MP RVUs.
    Response: We would like to note that the methodology as well as the 
steps for calculating MP RVUs were outlined in the preamble text to the 
proposed rule, and are also included in this final rule; we sought 
comments on these proposals in the proposed rule. The documentation 
included in the Downloads section on the CMS Web site support and 
provide additional technical details and information used in 
establishing the proposed policies. To the extent that the supporting 
documentation is material to the proposals we made in the proposed 
rule, we believe they are within the scope of the rule. Information 
that provides more context and understanding of the data, and how the 
data is collected, which can be found in the contractor's report, is 
material to the rulemaking process, so when stakeholders provide 
concerns about the supporting documentation we consider those concerns 
as comments in response to the proposals. We also note that this has 
been our longstanding process.
    Comment: Several commenters, including the RUC, stated that CMS 
should not crosswalk non-physician specialties to the lowest physician 
risk factor specialty for which it has premium rates, which is Allergy 
Immunology. The commenters stated that CMS should collect premium data 
for the non-physician specialties or otherwise use the data from the 
AMA's Physician Practice Expense Information Survey from 2006. The 
commenters expressed that this crosswalk would likely serve as an 
overestimate of professional liability for non-physician specialties.
    Response: We thank commenters for their feedback, and would like to 
clarify that we did collect whatever data was available for non-
physician specialties during our data collection process. This enabled 
us to find sufficient data for one major non-physician specialty--Nurse 
Practitioner, which received a blended risk factor of 1.95. 
Additionally, we note that not all non-physician specialties were 
mapped to Allergy/Immunology. For example, Certified Nurse Midwife was 
mapped to Obstetrics and Gynecology, and Certified Registered Nurse 
Anesthesiologist was mapped to Anesthesiology, which both reflect 
higher risk than Allergy/Immunology. We revisited the malpractice rate 
filings we collected for other non-physician specialties, and although 
they did not meet the 35-state threshold for sufficient data to compute 
specialty premiums and risk factors, some of the data we do have 
indicate premiums and risk factors that are close to that of Allergy/
Immunology. Therefore, we believe that the proposed crosswalks were 
reasonable. However, we are not finalizing our proposal.
    Comment: One commenter highlighted that the Sleep Medicine 
specialty did not have sufficient data in this proposed update and was 
crosswalked to General Practice, which the commenter did not believe 
was appropriate.
    Response: We appreciate the commenter's feedback, and note that 
this is the same crosswalk that was used in the last update. 
Additionally, while the surgical risk factor decreases for General 
Practice in the proposed update, the non-surgical factor increased. We 
revisited the malpractice rate filings we collected for Sleep Medicine 
and, although they did not meet the 35-state threshold for sufficient 
data to compute specialty premiums and risk factors, the data we do 
have indicate premiums and risk factors that are close to that of 
General Practice.

[[Page 53005]]

Therefore, we believe that the proposed crosswalk was reasonable. 
However, we are not finalizing our proposal.
    Comment: A few specialty societies expressed support for the 
proposed crosswalks as an appropriate course of action given the lack 
of available data for most non-physician specialties. One commenter 
expressed concern that insufficient data was found for Hospice and 
Palliative Care and it was mapped to Allergy/Immunology. Another 
commenter expressed support for crosswalking Certified Registered Nurse 
Anesthesiologist (CRNA) to Anesthesiology, though they question whether 
Anesthesiology Assistant should have been crosswalked the same way.
    Response: We appreciate the commenters' feedback and support. We 
reviewed the malpractice rate filings that were collected for Hospice 
and Palliative Care, and although they did not meet the 35-state 
threshold for sufficient data to compute specialty premiums and risk 
factors, the data we do have indicate premiums and risk factors that 
are close to Allergy/Immunology; we also note that insufficient data 
for this specialty were found in the last update and it was previously 
crosswalked to Allergy/Immunology. We also reviewed the malpractice 
rate filings that were collected for Anesthesiology Assistant and 
similarly, although they did not meet the threshold for sufficient 
data, the data we do have indicate premium and risk factors that are 
close to that of Anesthesiology. Therefore, we believe that the 
proposed crosswalks were reasonable. However, we are not finalizing our 
proposal.
    Comment: A few commenters, including the RUC, questioned whether 
the 35-state threshold for rate filing data was too high, and suggested 
that fewer specialties would need to be crosswalked to receive premiums 
and risk factors from other specialties if that requirement were 
lowered or removed.
    Response: While we agree that lowering the threshold would allow 
more specialties to receive dedicated premiums and risk factors, we 
believe that lowering the 35 state threshold would have a direct trade-
off with the accuracy and the reliability of the results. Removing or 
lowering the threshold would increase the likelihood that the resulting 
premiums and risk factors could fluctuate due to outliers. 
Additionally, the 35-state threshold is consistent with the past 
updates to MP RVUs.
    Comment: A few commenters urged CMS to use work RVUs instead of 
regional population counts to weight geographic differences to 
calculate national average premiums.
    Response: We thank the commenters for their feedback, and note this 
population weighting refinement to the MP RVU methodology was issued 
through notice and comment rulemaking in the CY 2016 PFS final rule 
with comment period (80 FR 70909 through 70910), and there were no 
additional proposals with regard to this matter for CY 2018.
    Comment: One commenter recommended that CMS use the phrase ``Family 
Medicine'' rather than ``Family Practice'' on the basis that the latter 
is considered outdated.
    Response: We appreciate the commenter's feedback. We did not 
propose changes to the specialty nomenclature; however, we will 
consider this in future updates.
    Comment: A commenter requested that we add HCPCS codes 92992 and 
92993 to the list of invasive cardiology procedures classified as 
surgery for purposes of assigning service level risk factors because 
cardiac catheterization and angioplasty procedures are similar to 
surgical procedures for the purpose of establishing MP premium rates 
and risk factors.
    Response: HCPCS codes 92992 and 92993 are contractor-priced codes, 
for which the Medicare Administrative Contractors (MACs) establish RVUs 
and payment amounts. Therefore, we are not adding HCPCS codes 92992 and 
92993 to the ``Invasive Cardiology Outside of Surgical Range'' list.
    Comment: Several commenters, including the RUC, were supportive of 
the proposal to override claims data for low volume services with an 
expected specialty for both the PE RVU, and MP RVU valuation process. 
The commenters also recommended that CMS use the expected specialty 
overrides lists for codes with no Medicare volume for a given year, as 
well as low volume codes.
    Response: We thank commenters for their support. We refer 
commenters to section II.B. of this final rule for further discussion 
of low volume service codes.
    After consideration of the comments received, we are not finalizing 
our proposal to use the most recent data for the CY 2018 MP RVUs and to 
align the update of MP premium data and MP GPCIs to once every 3 years. 
Similar to CY 2017, the CY 2018 MP RVUs will continue to be based on 
the premium data that was collected for the CY 2015 MP RVU update. For 
CY 2018, the MP RVUs will be calculated based on the existing specialty 
risk factors (the same risk factors that were used to calculate the CY 
2017 MP RVUs); these specialty risk factors are shown in the CY 2018 
Final Rule Malpractice Risk Factors and Premium Amounts by Specialty 
file located on the CMS Web site under the downloads section of the CY 
2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    For low volume service codes, we thank the commenters for their 
support, and we are finalizing the proposal to use a list of expected 
specialties, instead of a claims-based specialty mix, for low volume, 
which also includes no volume codes, and to apply these overrides for 
both PE and MP. We believe that this will simplify the implementation 
of service-level overrides for PE and MP, and will also address 
stakeholder concerns about year-to-year variability for low volume 
services. We refer readers to section II.B. of this final rule for 
further discussion regarding the low volume service codes.
    We note that the next MP update must occur by CY 2020. We continue 
to believe that updating the MP premium data on a more frequent basis 
would enable the resulting premiums and RVUs to better reflect market 
trends in malpractice insurance for different specialties. In 
principle, more frequent updates are optimal, and we will consider this 
in future rulemaking.
    Many of the commenters expressed concerns regarding the sufficiency 
of the data. As previously explained, this is not a matter of a lack of 
sufficient or robust data, but an issue regarding how the rate filings 
are being classified by specialty. We re-examined the data and after 
further review, we recognize that going forward we need to resolve 
differences regarding variances in the descriptions on the raw rate 
filings as well as how these raw data were categorized to conform with 
the CMS specialties. Understanding that this is a driver of the 
fluctuations that were reflected in the updated MP RVUs that we 
proposed, moving forward we will be able to prioritize reconciling the 
coding changes and categorizations in the raw rate filings in order to 
avoid data fluctuations between updates that are not representative of 
the actual data. We thank the commenters for their detailed feedback, 
and will continue to take it into consideration as we work to make the 
MP RVUs as accurate as possible for all specialties. We also note that 
a few commenters noted concerns regarding potential errors in the 
proposed MP RVUs for specific codes as a result of the proposed updated 
specialty risk factors; however, since we are not finalizing those MP 
RVUs based on the proposed updated specialty risk

[[Page 53006]]

factors, we are not responding to those comments in this final rule.
    The resource based MP RVUs for CY 2018 are shown in Addendum B, 
which is available on the CMS Web site under the downloads section of 
the CY 2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

C. Medicare Telehealth Services

1. Billing and Payment for Telehealth Services
    Several conditions must be met for Medicare to make payments for 
telehealth services under the PFS. The service must be on the list of 
Medicare telehealth services and meet all of the following additional 
requirements:
     The service must be furnished via an interactive 
telecommunications system.
     The service must be furnished by a physician or other 
authorized practitioner.
     The service must be furnished to an eligible telehealth 
individual.
     The individual receiving the service must be located in a 
telehealth originating site.
    When all of these conditions are met, Medicare pays a facility fee 
to the originating site and makes a separate payment to the distant 
site practitioner furnishing the service.
    Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth 
services to include professional consultations, office visits, office 
psychiatry services, and any additional service specified by the 
Secretary, when furnished via a telecommunications system. We first 
implemented this statutory provision, which was effective October 1, 
2001, in the CY 2002 PFS final rule with comment period (66 FR 55246). 
We established a process for annual updates to the list of Medicare 
telehealth services as required by section 1834(m)(4)(F)(ii) of the Act 
in the CY 2003 PFS final rule with comment period (67 FR 79988).
    As specified at Sec.  410.78(b), we generally require that a 
telehealth service be furnished via an interactive telecommunications 
system. Under Sec.  410.78(a)(3), an interactive telecommunications 
system is defined as multimedia communications equipment that includes, 
at a minimum, audio and video equipment permitting two-way, real-time 
interactive communication between the patient and distant site 
physician or practitioner.
    Telephones, facsimile machines, and stand-alone electronic mail 
systems do not meet the definition of an interactive telecommunications 
system. An interactive telecommunications system is generally required 
as a condition of payment; however, section 1834(m)(1) of the Act 
allows the use of asynchronous ``store-and-forward'' technology when 
the originating site is part of a federal telemedicine demonstration 
program in Alaska or Hawaii. As specified in Sec.  410.78(a)(1), 
asynchronous store-and-forward is the transmission of medical 
information from an originating site for review by the distant site 
physician or practitioner at a later time.
    Medicare telehealth services may be furnished to an eligible 
telehealth individual notwithstanding the fact that the practitioner 
furnishing the telehealth service is not at the same location as the 
beneficiary. An eligible telehealth individual is an individual 
enrolled under Part B who receives a telehealth service furnished at a 
telehealth originating site.
    Practitioners furnishing Medicare telehealth services are reminded 
that these services are subject to the same non-discrimination laws as 
other services, including the effective communication requirements for 
persons with disabilities of section 504 of the Rehabilitation Act of 
1973 and section 1557 of the Affordable Care Act, as well as and 
language access for persons with limited English proficiency, as 
required under Title VI of the Civil Rights Act of 1964 and section 
1557 of the Affordable Care Act. For more information, see http://www.hhs.gov/ocr/civilrights/resources/specialtopics/hospitalcommunication.
    Practitioners furnishing Medicare telehealth services submit claims 
for telehealth services to the Medicare Administrative Contractors 
(MACs) that process claims for the service area where their distant 
site is located. Section 1834(m)(2)(A) of the Act requires that a 
practitioner who furnishes a telehealth service to an eligible 
telehealth individual be paid an amount equal to the amount that the 
practitioner would have been paid if the service had been furnished 
without the use of a telecommunications system.
    Originating sites, which can be one of several types of sites 
specified in the statute where an eligible telehealth individual is 
located at the time the service is being furnished via a 
telecommunications system, are paid a facility fee under the PFS for 
each Medicare telehealth service. The statute specifies both the types 
of entities that can serve as originating sites and the geographic 
qualifications for originating sites. For geographic qualifications, 
our regulation at Sec.  410.78(b)(4) limits originating sites to those 
located in rural health professional shortage areas (HPSAs) or in a 
county that is not included in a metropolitan statistical area (MSA).
    Historically, we have defined rural HPSAs to be those located 
outside of MSAs. Effective January 1, 2014, we modified the regulations 
regarding originating sites to define rural HPSAs as those located in 
rural census tracts as determined by the Federal Office of Rural Health 
Policy of the Health Resources and Services Administration (HRSA) (78 
FR 74811). Defining ``rural'' to include geographic areas located in 
rural census tracts within MSAs allows for broader inclusion of sites 
within HPSAs as telehealth originating sites. Adopting the more precise 
definition of ``rural'' for this purpose expands access to health care 
services for Medicare beneficiaries located in rural areas. HRSA has 
developed a Web site tool to provide assistance to potential 
originating sites to determine their geographic status. To access this 
tool, see our Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    An entity participating in a federal telemedicine demonstration 
project that has been approved by, or received funding from, the 
Secretary as of December 31, 2000 is eligible to be an originating site 
regardless of its geographic location.
    Effective January 1, 2014, we also changed our policy so that 
geographic status for an originating site would be established and 
maintained on an annual basis, consistent with other telehealth payment 
policies (78 FR 74400). Geographic status for Medicare telehealth 
originating sites for each calendar year is now based upon the status 
of the area as of December 31 of the prior calendar year.
    For a detailed history of telehealth payment policy, see 78 FR 
74399.
2. Adding Services to the List of Medicare Telehealth Services
    As noted previously, in the CY 2003 PFS final rule with comment 
period (67 FR 79988), we established a process for adding services to 
or deleting services from the list of Medicare telehealth services. 
This process provides the public with an ongoing opportunity to submit 
requests for adding services, which are then reviewed by us. Under this 
process, we assign any submitted request to make additions to the list 
of telehealth services to one of two categories. Revisions to the 
criteria that we use to review requests in the second category were 
finalized in the CY 2012

[[Page 53007]]

PFS final rule with comment period (76 FR 73102). The two categories 
are:
     Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the list of telehealth services. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site 
and, if necessary, the telepresenter, a practitioner who is present 
with the beneficiary in the originating site. We also look for 
similarities in the telecommunications system used to deliver the 
service; for example, the use of interactive audio and video equipment.
     Category 2: Services that are not similar to the current 
list of telehealth services. Our review of these requests includes an 
assessment of whether the service is accurately described by the 
corresponding code when furnished via telehealth and whether the use of 
a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits.
    Some examples of clinical benefit include the following:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     Reduced recovery time.
    The list of telehealth services, including the proposed additions 
described below, is included in the Downloads section to this final 
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Requests to add services to the list of Medicare telehealth 
services must be submitted and received no later than December 31 of 
each calendar year to be considered for the next rulemaking cycle. To 
be considered during PFS rulemaking for CY 2019, qualifying requests 
must be submitted and received by December 31, 2017. Each request to 
add a service to the list of Medicare telehealth services must include 
any supporting documentation the requester wishes us to consider as we 
review the request. Because we use the annual PFS rulemaking process as 
a vehicle for making changes to the list of Medicare telehealth 
services, requesters should be advised that any information submitted 
is subject to public disclosure for this purpose. For more information 
on submitting a request for an addition to the list of Medicare 
telehealth services, including where to mail these requests, see our 
Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
3. Submitted Requests To Add Services to the List of Telehealth 
Services for CY 2018
    Under our existing policy, we add services to the telehealth list 
on a category 1 basis when we determine that they are similar to 
services on the existing telehealth list for the roles of, and 
interactions among, the beneficiary, physician (or other practitioner) 
at the distant site and, if necessary, the telepresenter. As we stated 
in the CY 2012 PFS final rule with comment period (76 FR 73098), we 
believe that the category 1 criteria not only streamline our review 
process for publicly requested services that fall into this category, 
but also expedite our ability to identify codes for the telehealth list 
that resemble those services already on this list.
    We received several requests in CY 2016 to add various services as 
Medicare telehealth services effective for CY 2018. The following 
presents a discussion of these requests, and our proposals for 
additions to the CY 2018 telehealth list. Of the requests received, we 
found that three services were sufficiently similar to services 
currently on the telehealth list to qualify on a category 1 basis. 
Therefore, we proposed to add the following services to the telehealth 
list on a category 1 basis for CY 2018:

 HCPCS code G0296 (Counseling visit to discuss need for lung 
cancer screening using low dose ct scan (ldct) (service is for 
eligibility determination and shared decision making))

    We found that the service described by HCPCS code G0296 is 
sufficiently similar to office visits currently on the telehealth list. 
We believed that all the components of this service, which include 
assessment of the patient's risk for lung cancer, shared decision 
making, and counseling on the risks and benefits of LDCT, can be 
furnished via interactive telecommunications technology.

 CPT codes 90839 and 90840 (Psychotherapy for crisis; first 60 
minutes) and (Psychotherapy for crisis; each additional 30 minutes 
(List separately in addition to code for primary service))

    We proposed to add CPT codes 90839 and 90840 on a Category 1 basis. 
We found that these services are sufficiently similar to the 
psychotherapy services currently on the telehealth list, even though 
these codes describe patients requiring more urgent care and 
psychotherapeutic interventions to minimize the potential for 
psychological trauma. However, we identified one specific element of 
the services as described in the CPT prefatory language that we 
concluded may or may not be able to be furnished via telehealth, 
depending on the circumstances of the particular service. The CPT 
prefatory language specifies that the treatment described by these 
codes requires, ``mobilization of resources to defuse the crisis and 
restore safety.'' In many cases, we believed that a distant site 
practitioner would have access (via telecommunication technology, 
presumably) to the resources at the originating site that would allow 
for the kind of mobilization required to restore safety. However, we 
also believed that it would be possible that a distant site 
practitioner would not have access to such resources. Therefore we 
proposed to add the codes to the telehealth list with the explicit 
condition of payment that the distant site practitioner be able to 
mobilize resources at the originating site to defuse the crisis and 
restore safety, when applicable, when the codes are furnished via 
telehealth. ``Mobilization of resources'' is a description used in the 
CPT prefatory language. We believed the critical element of 
``mobilizing resources'' is the ability to communicate with and inform 
staff at the originating site to the extent necessary to restore 
safety. We solicited comment on whether our assumption that the remote 
practitioner is able to mobilize resources at the originating site

[[Page 53008]]

to defuse the crisis and restore safety is valid.
    Although we did not receive specific requests, we also proposed to 
add four additional services to the telehealth list based on our review 
of services. All four of these codes are add-on codes that describe 
additional elements of services currently on the telehealth list and 
would only be considered telehealth services when billed as an add-on 
to codes already on the telehealth list. The four codes are:

 CPT code 90785 (Interactive complexity (List separately in 
addition to the code for primary procedure))
 CPT codes 96160 and 96161 (Administration of patient-focused 
health risk assessment instrument (e.g., health hazard appraisal) with 
scoring and documentation, per standardized instrument) and 
(Administration of caregiver-focused health risk assessment instrument 
(e.g., depression inventory) for the benefit of the patient, with 
scoring and documentation, per standardized instrument))
 HCPCS code G0506 (Comprehensive assessment of and care 
planning for patients requiring chronic care management services (list 
separately in addition to primary monthly care management service))

    In the case of CPT codes 96160 and 96161, and HCPCS code G0506, we 
recognized that these services may not necessarily be ordinarily 
furnished in-person with a physician or billing practitioner. 
Ordinarily, services that are typically not considered to be face-to-
face services do not need to be on the list of Medicare telehealth 
services; however, these services would only be considered Medicare 
telehealth services when billed with a base code that is also on the 
telehealth list and would not be considered Medicare telehealth 
services when billed with codes not on the Medicare telehealth list. We 
believed that by adding these services to the telehealth list it will 
be administratively easier for practitioners who report these services 
in association with a visit code that is furnished via telehealth as 
both the base code and the add-on code would be reported with the 
telehealth place of service.
    We also received requests to add services to the telehealth list 
that do not meet our criteria for Medicare telehealth services. We did 
not propose adding the following procedures for physical, occupational, 
and speech therapy, initial hospital care, and online E/M by physician/
qualified healthcare professional to the telehealth list, or changing 
the requirements for ESRD procedure codes furnished via telehealth, for 
the reasons noted in the paragraphs that follow.
    a. Physical and Occupational Therapy and Speech-Language Pathology 
Services: CPT Codes--

 CPT code 97001: Now deleted and reported with CPT codes 97161, 
97162, or 97163, as follows: CPT code 97161 (Physical therapy 
evaluation: Low complexity, requiring these components: A history with 
no personal factors and/or comorbidities that impact the plan of care; 
An examination of body system(s) using standardized tests and measures 
addressing 1-2 elements from any of the following: Body structures and 
functions, activity limitations, and/or participation restrictions; A 
clinical presentation with stable and/or uncomplicated characteristics; 
and Clinical decision making of low complexity using standardized 
patient assessment instrument and/or measurable assessment of 
functional outcome); CPT code 97162 (Physical therapy evaluation: 
Moderate complexity, requiring these components: A history of present 
problem with 1-2 personal factors and/or comorbidities that impact the 
plan of care; An examination of body systems using standardized tests 
and measures in addressing a total of 3 or more elements from any of 
the following: Body structures and functions, activity limitations, 
and/or participation restrictions; An evolving clinical presentation 
with changing characteristics; and Clinical decision making of moderate 
complexity using standardized patient assessment instrument and/or 
measurable assessment of functional outcome); or CPT code 97163 
(Physical therapy evaluation: High complexity, requiring these 
components: A history of present problem with 3 or more personal 
factors and/or comorbidities that impact the plan of care; An 
examination of body systems using standardized tests and measures 
addressing a total of 4 or more elements from any of the following: 
Body structures and functions, activity limitations, and/or 
participation restrictions; A clinical presentation with unstable and 
unpredictable characteristics; and Clinical decision making of high 
complexity using standardized patient assessment instrument and/or 
measurable assessment of functional outcome.)
 CPT code 97002: Now deleted and reported as CPT code 97164 
(Re-evaluation of physical therapy established plan of care, requiring 
these components: An examination including a review of history and use 
of standardized tests and measures is required; and Revised plan of 
care using a standardized patient assessment instrument and/or 
measurable assessment of functional outcome.)
 CPT code 97003: Now deleted and reported with CPT codes 97165, 
97166, or 97167, as follows: CPT code 97165 (Occupational therapy 
evaluation, low complexity, requiring these components: An occupational 
profile and medical and therapy history, which includes a brief history 
including review of medical and/or therapy records relating to the 
presenting problem; An assessment(s) that identifies 1-3 performance 
deficits (i.e., relating to physical, cognitive, or psychosocial 
skills) that result in activity limitations and/or participation 
restrictions; and Clinical decision making of low complexity, which 
includes an analysis of the occupational profile, analysis of data from 
problem-focused assessment(s), and consideration of a limited number of 
treatment options. Patient presents with no comorbidities that affect 
occupational performance. Modification of tasks or assistance (e.g., 
physical or verbal) with assessment(s) is not necessary to enable 
completion of evaluation component); CPT code 97166 (Occupational 
therapy evaluation, moderate complexity, requiring these components: An 
occupational profile and medical and therapy history, which includes an 
expanded review of medical and/or therapy records and additional review 
of physical, cognitive, or psychosocial history related to current 
functional performance; An assessment(s) that identifies 3-5 
performance deficits (i.e., relating to physical, cognitive, or 
psychosocial skills) that result in activity limitations and/or 
participation restrictions; and Clinical decision making of moderate 
analytic complexity, which includes an analysis of the occupational 
profile, analysis of data from detailed assessment(s), and 
consideration of several treatment options. Patient may present with 
comorbidities that affect occupational performance. Minimal to moderate 
modification of tasks or assistance (e.g., physical or verbal) with 
assessment(s) is necessary to enable patient to complete evaluation 
component)); or CPT code 97167 (Occupational therapy evaluation,

[[Page 53009]]

high complexity, requiring these components: An occupational profile 
and medical and therapy history, which includes review of medical and/
or therapy records and extensive additional review of physical, 
cognitive, or psychosocial history related to current functional 
performance; An assessment(s) that identifies 5 or more performance 
deficits (i.e., relating to physical, cognitive, or psychosocial 
skills) that result in activity limitations and/or participation 
restrictions; and Clinical decision making of high analytic complexity, 
which includes an analysis of the patient profile, analysis of data 
from comprehensive assessment(s), and consideration of multiple 
treatment options. Patient presents with comorbidities that affect 
occupational performance. Significant modification of tasks or 
assistance (e.g., physical or verbal) with assessment(s) is necessary 
to enable patient to complete evaluation component.)
 CPT code 97004: Now deleted and reported as CPT code 97168 
(Re-evaluation of occupational therapy established plan of care, 
requiring these components: An assessment of changes in patient 
functional or medical status with revised plan of care; An update to 
the initial occupational profile to reflect changes in condition or 
environment that affect future interventions and/or goals; and a 
revised plan of care. A formal reevaluation is performed when there is 
a documented change in functional status or a significant change to the 
plan of care is required.)
 CPT code 97110 (Therapeutic procedure, 1 or more areas, each 
15 minutes; therapeutic exercises to develop strength and endurance, 
range of motion and flexibility)
 CPT code 97112 (Therapeutic procedure, 1 or more areas, each 
15 minutes; neuromuscular reeducation of movement, balance, 
coordination, kinesthetic sense, posture, and/or proprioception for 
sitting and/or standing activities)
 CPT code 97116 (Therapeutic procedure, 1 or more areas, each 
15 minutes; gait training (includes stair climbing))
 CPT code 97535 (Self-care/home management training (e.g., 
activities of daily living (ADL) and compensatory training, meal 
preparation, safety procedures, and instructions in use of assistive 
technology devices/adaptive equipment) direct one-on-one contact, each 
15 minutes)
 CPT code 97750 (Physical performance test or measurement 
(e.g., musculoskeletal, functional capacity), with written report, each 
15 minutes)
 CPT code 97755 (Assistive technology assessment (e.g., to 
restore, augment or compensate for existing function, optimize 
functional tasks and/or maximize environmental accessibility), direct 
one-on-one contact, with written report, each 15 minutes)
 CPT code 97760 (Orthotic(s) management and training (including 
assessment and fitting when not otherwise reported), upper 
extremity(s), lower extremity(s) and/or trunk, each 15 minutes)
 CPT code 97761 (Prosthetic training, upper and/or lower 
extremity(s), each 15 minutes)
 CPT code 97762 (Checkout for orthotic/prosthetic use, 
established patient, each 15 minutes)

    Section 1834(m)(4)(E) of the Act specifies the types of 
practitioners who may furnish and bill for Medicare telehealth services 
as those practitioners under section 1842(b)(18)(C) of the Act. 
Physical therapists, occupational therapists and speech-language 
pathologists are not among the practitioners identified in section 
1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final rule (81 
FR 80198) that because these services are predominantly furnished by 
physical therapists, occupational therapists and speech-language 
pathologists, we did not believe it would be appropriate to add them to 
the list of telehealth services at this time. In a subsequent 
submission for 2018, the original requester suggested that we might 
propose these services to be added to the list so that they can be 
furnished via telehealth when furnished by eligible distant site 
practitioners. We considered that possibility; however, since the 
majority of the codes are furnished by therapy professionals over 90 
percent of the time, we believed that adding therapy services to the 
telehealth list that explicitly describe the services of the kinds of 
professionals not included on the statutory list of distant site 
practitioners could result in confusion about who is authorized to 
furnish and bill for these services when furnished via telehealth. We 
also noted that several of these services, such as CPT code 97761, 
require directly physically manipulating the beneficiary, which is not 
possible to do through telecommunications technology. Therefore, we did 
not propose adding these codes to the list of Medicare telehealth 
services.
    b. Initial Hospital Care Services: CPT Codes--

 CPT code 99221 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A detailed or comprehensive history; A detailed or 
comprehensive examination; and Medical decision making that is 
straightforward or of low complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the problem(s) 
requiring admission are of low severity.)
 CPT code 99222 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of moderate complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of moderate severity.)
 CPT code 99223 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of high complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of high severity.)

    We previously considered a request to add these codes to the 
telehealth list. As we stated in the CY 2011 PFS final rule with 
comment period (75 FR 73315), while initial inpatient consultation 
services are currently on the list of approved telehealth services, 
there are no services on the current list of telehealth services that 
resemble initial hospital care for an acutely ill patient by the 
admitting practitioner who has ongoing responsibility for the patient's 
treatment during the course of the hospital stay. Therefore, consistent 
with prior rulemaking, we did not propose that initial hospital care 
services be

[[Page 53010]]

added to the Medicare telehealth services list on a category 1 basis.
    The initial hospital care codes describe the first visit of the 
hospitalized patient by the admitting practitioner who may or may not 
have seen the patient in the decision-making phase regarding 
hospitalization. Based on the description of the services for these 
codes, we believed it is critical that the initial hospital visit by 
the admitting practitioner be conducted in person to ensure that the 
practitioner with ongoing treatment responsibility comprehensively 
assesses the patient's condition upon admission to the hospital through 
a thorough in-person examination. Additionally, the requester submitted 
no additional research or evidence that the use of a telecommunications 
system to furnish the service produces demonstrated clinical benefit to 
the patient; therefore, we also did not propose adding initial hospital 
care services to the Medicare telehealth services list on a category 2 
basis.
    We note that Medicare beneficiaries who are being treated in the 
hospital setting can receive reasonable and necessary E/M services 
using other HCPCS codes that are currently on the Medicare telehealth 
list including those for subsequent hospital care, initial and follow-
up telehealth inpatient and emergency department consultations, as well 
as initial and follow-up critical care telehealth consultations.
    Therefore, we did not propose to add the initial hospital care 
services to the list of Medicare telehealth services for CY 2018.
    c. Online E/M by physician/QHP: CPT Code--

 CPT code 99444 (Online evaluation and management service 
provided by a physician or other qualified health care professional who 
may report evaluation and management services provided to an 
established patient or guardian, not originating from a related E/M 
service provided within the previous 7 days, using the Internet or 
similar electronic communications network)

    As we indicated in the CY 2016 final rule with comment period (80 
FR 71061), CPT code 99444 is assigned a status indicator of ``N'' (Non-
covered service). Under section 1834(m)(2)(A) of the Act, Medicare pays 
the physician or practitioner furnishing a telehealth service an amount 
equal to the amount that would have been paid if the service was 
furnished without the use of a telecommunications system. Because CPT 
code 99444 is currently non-covered, there would be no Medicare payment 
if this service were furnished without the use of a telecommunications 
system. Because this code is a non-covered service for which no 
Medicare payment may be made under the PFS, we did not propose adding 
online E/M services to the list of Medicare telehealth services for CY 
2018.
    d. Monthly Capitation Payment (MCP) for ESRD-Related Services for 
Home Dialysis, by Age: CPT Codes--

 CPT codes 90963 (End-stage renal disease (ESRD) related 
services for home dialysis per full month, for patients younger than 2 
years of age to include monitoring for the adequacy of nutrition, 
assessment of growth and development, and counseling of parents); 90964 
(End-stage renal disease (ESRD) related services for home dialysis per 
full month, for patients 2-11 years of age to include monitoring for 
the adequacy of nutrition, assessment of growth and development, and 
counseling of parents); 90965 (End-stage renal disease (ESRD) related 
services for home dialysis per full month, for patients 12-19 years of 
age to include monitoring for the adequacy of nutrition, assessment of 
growth and development, and counseling of parents); and 90966 (End-
stage renal disease (ESRD) related services for home dialysis per full 
month, for patients 20 years of age and older)
 90967 (End-stage renal disease (ESRD) related services for 
dialysis less than a full month of service, per day; for patients 
younger than 2 years of age); 90968 (End-stage renal disease (ESRD) 
related services for dialysis less than a full month of service, per 
day; for patients 2-11 years of age); and 90969 (End-stage renal 
disease (ESRD) related services for dialysis less than a full month of 
service, per day; for patients 12-19 years of age); and 90970 (End-
stage renal disease (ESRD) related services for dialysis less than a 
full month of service, per day; for patients 20 years of age and 
older).

    In the CY 2004 PFS final rule with comment period (68 FR 63216), we 
established HCPCS G-codes for ESRD monthly capitation payments (MCPs), 
which were replaced by CPT codes in CY 2009 (73 FR 69898). The services 
described by CPT codes 90963 through 90966 were added to the Medicare 
telehealth list in CY 2005 (69 FR 66276) and CPT codes 90967 through 
90970 were added to the Medicare telehealth list in the CY 2017 PFS 
final rule (81 FR 80194); however, we specified that the required 
clinical examination of the vascular access site must be furnished 
face-to-face ``hands on'' (without the use of an interactive 
telecommunications system) by a physician, clinical nurse specialist 
(CNS), nurse practitioner (NP), or physician assistant (PA). The 
American Telemedicine Association (ATA) submitted a new request for CY 
2018 requesting that we allow telehealth coverage of ESRD procedure 
codes without in-person exam of the catheter access site monthly. Our 
current policy reflects our understanding that evaluation of the 
integrity and functionality of the access site is a critical element of 
the services described by the codes and that this element cannot be 
performed via telecommunications technology. The requester did not 
submit evidence to support the assertion that effective examination of 
the access site can be executed via telecommunications technology. 
Therefore, for CY 2018, we did not propose any changes to the policy 
requiring that the MCP practitioner must furnish at least one face-to-
face encounter with the home dialysis patient per month for clinical 
examination of the catheter access site. However, we are interested in 
more information about current clinically accepted care practices and 
to what extent telecommunications technology can be used to examine the 
access site. We are also interested in information about the clinical 
standards of care regarding the frequency of the evaluation of the 
access site.
    In summary, we proposed adding the following codes to the list of 
Medicare telehealth services beginning in CY 2018 on a category 1 
basis:

 HCPCS code G0296 (Counseling visit to discuss need for lung 
cancer screening using low dose CT scan (ldct) (service is for 
eligibility determination and shared decision making))
 HCPCS code G0506 (Comprehensive assessment of and care 
planning for patients requiring chronic care management services (list 
separately in addition to primary monthly care management service))
 CPT code 90785 (Interactive complexity (List separately in 
addition to the code for primary procedure))
 CPT codes 90839 and 90840 (Psychotherapy for crisis; first 60 
minutes) and (Psychotherapy for crisis; each additional 30 minutes 
(List separately in addition to code for primary procedure))
 CPT codes 96160 and 96161 (Administration of patient-focused 
health risk assessment instrument

[[Page 53011]]

(e.g., health hazard appraisal) with scoring and documentation, per 
standardized instrument) and (Administration of caregiver-focused 
health risk assessment instrument (e.g., depression inventory) for the 
benefit of the patient, with scoring and documentation, per 
standardized instrument)

    The following is a summary of the comments we received regarding 
the proposed addition of services to the list of Medicare telehealth 
services:
    Comment: Many commenters supported one or more of our proposals to 
add the counseling visit to discuss need for lung cancer screening 
using low dose CT scan (LDCT) (HCPCS code G0296) and psychotherapy for 
crisis (CPT codes 90839 and 90840) to the Medicare telehealth list for 
CY 2018. Commenters also supported one or more of our proposals to add 
comprehensive assessment of and care planning for patients requiring 
chronic care management services (HCPCS code G0506), interactive 
complexity (CPT code 90785) and administration of health risk 
assessment (CPT codes 96160 and 96161). Commenters noted that by adding 
these services to the Medicare telehealth list, CMS was enhancing 
access and quality of care for Medicare beneficiaries.
    Response: We thank commenters for their support of the proposed 
additions to the list of Medicare telehealth services. After 
consideration of the public comments received, we are finalizing our 
proposal to add these services to the list of Medicare telehealth 
services for CY 2018 on a Category 1 basis.
    Comment: Several commenters were supportive of CMS's proposed 
requirement that the distant site practitioner be able to mobilize 
resources at the originating site to defuse the crisis and restore 
safety, when applicable, when furnishing psychotherapy for crisis. One 
commenter stated that CMS' requirements for mobilization of resources 
are very important and the distant site practitioner should be aware of 
available services where the beneficiary is located in the event of a 
crisis. Another commenter pointed out that social workers who provide 
telehealth services are required by the National Association of Social 
Workers to be familiar with the resources in the state in which the 
patient resides. Several commenters requested that CMS clarify what was 
meant by ``mobilization of resources'' and provide applicable examples.
    Response: We appreciate commenters' responses to the explicit 
requirement regarding mobilization of resources for the psychotherapy 
for crisis codes (CPT codes 90839 and 90840). As noted above, 
``mobilization of resources'' is a description used in the CPT 
prefatory language. We would reiterate that, according to CPT, the 
critical element of ``mobilizing resources'' is the ability to 
communicate with and inform staff at the originating site to the extent 
necessary to restore safety.
    Comment: Several commenters disagreed with the proposal not to add 
CPT codes 99221-99223 (inpatient hospital care) to the Medicare 
telehealth list. One commenter stated that they believe these services 
could be furnished via Medicare telehealth. They pointed to the fact 
that for CY 2017, CMS valued the critical care consultation G-codes 
(HCPCS codes G0508 and G0509) with RVUs similar to those for the 
inpatient hospital care codes as evidence that CMS believes they are 
essentially the same service.
    Response: As we discussed in the 2018 PFS proposed rule, we do not 
believe that the full range of services described by CPT codes 99221-
99223 can be furnished via telecommunications technology as we believe 
it is critical that the initial hospital visit by the admitting 
practitioner be conducted in person to ensure that the practitioner 
with ongoing treatment responsibility comprehensively assesses the 
patient's condition upon admission to the hospital through a thorough 
in-person examination.
    We believe that the telehealth critical care consultation codes 
(HCPCS codes G0508 and G0509) more accurately describe the kind of 
services that can be furnished to patients via telehealth than the 
initial inpatient hospital visit E/M codes that describe services with 
elements that can only be furnished in-person. The valuation for HCPCS 
codes G0508 and G0509 was developed based on our assessment that the 
overall work (resources in time and intensity) involved in furnishing 
the services is similar to the in-person critical care service codes, 
not that all elements of the services are the same. Many services paid 
under the PFS share similar, if not exactly the same work RVUs, without 
necessarily describing the exact same elements of the service. For more 
on the critical care consultation codes in the context of telehealth, 
please see the CY 2017 PFS final rule (81 FR 80196 through 80197 and 81 
FR 80352).
    Comment: Several commenters disagreed with our decision not to add 
various physical and occupational therapy, and speech language 
pathology services to the Medicare telehealth list.
    Response: As noted above, the majority of the codes requested are 
furnished by therapy professionals over 90 percent of the time, and we 
believe that adding therapy services to the telehealth list that are 
furnished by professionals not included on the statutory list of 
distant site practitioners could result in confusion about who is 
authorized to bill for these services when furnished via telehealth. 
Additionally, some of the codes involve physical manipulation of the 
patient, which cannot be accomplished via an interactive 
telecommunications system.
    Comment: Several commenters responded to our decision not to remove 
the requirement for a monthly in-person visit to examine the catheter 
access site for ESRD services conducted via telehealth. Another 
commenter encouraged CMS to lessen the requirements by making the in-
person visit a quarterly, as opposed to monthly, requirement. Other 
commenters stated that the examination of the catheter access site 
could be conducted remotely via telecommunications technology.
    Response: We appreciate the feedback on our proposal and we will 
consider the comments on the frequency of the examination of the 
catheter access site and whether the examination could be conducted 
remotely for future rulemaking.
    Comment: One commenter disagreed with the decision not to propose 
to add CPT code 99444 (online E/M) to the Medicare telehealth list, 
stating that this service would increase access to care, especially for 
follow-up visits and medication management.
    Response: As we noted above, CPT code 99444 is currently non-
covered, so there is no Medicare payment for this service. As such, 
there would be no payment for this service even if we were to add it to 
the telehealth list. Additionally, because this service does not 
describe a service typically furnished in-person, it would not be 
considered a telehealth service under the applicable provisions of law. 
For both of these reasons, we continue to believe that it would not be 
appropriate to add CPT code 99444 to the Medicare telehealth list.
    Comment: Many commenters provided recommendations for additional 
services that could be added to the Medicare telehealth list, such as 
an add-on code for patients requiring care planning for cognitive 
impairment, follow-up care for liver transplant patients, emergency 
department visits, oncology and podiatric-specific services, eConsult 
services, Medical Nutrition Therapy (MNT), and Diabetes Self Management 
Training (DSMT).

[[Page 53012]]

    Response: We thank commenters for these suggestions and will 
consider these for future notice and comment rulemaking. We also wish 
to remind commenters that requests for specific services to be added to 
the Medicare telehealth list can be submitted until December 31st of 
each calendar year to be considered for the next rulemaking cycle. For 
more information on submitting a request for an addition to the list of 
Medicare telehealth services, including where to mail these requests, 
see our Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    Since several commenters requested that we add MNT and DSMT to the 
telehealth list, we also wish to remind commenters that codes for both 
MNT and DSMT are currently on the Medicare telehealth list. The current 
list of Medicare telehealth services can be viewed on our Web site, 
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.html.
4. Elimination of the Required Use of the GT Modifier on Professional 
Claims
    We have required distant site practitioners to report one of two 
longstanding HCPCS modifiers when reporting telehealth services. 
Current guidance instructs practitioners to submit claims for 
telehealth services using the appropriate CPT or HCPCS code for the 
professional service along with the telehealth modifier GT (via 
interactive audio and video telecommunications systems). For federal 
telemedicine demonstration programs in Alaska or Hawaii, practitioners 
are instructed to submit claims using the appropriate CPT or HCPCS code 
for the professional service along with the telehealth modifier GQ if 
telehealth services are performed ``via an asynchronous 
telecommunications system.'' By coding and billing these modifiers with 
a service code, practitioners are certifying that both the broad and 
code-specific telehealth requirements have been met.
    In the CY 2017 PFS final rule (81 FR 80201), we finalized payment 
policies regarding Medicare's use of a new Place of Service (POS) Code 
describing services furnished via telehealth. The new POS code became 
effective January 1, 2017, and we believe its use is redundant with the 
requirements to apply the GT modifier for telehealth services. We did 
not propose to implement a change to the modifier requirements during 
CY 2017 rulemaking because at the time of the CY 2017 PFS proposed 
rule, we did not know whether the telehealth POS code would be made 
effective for January 1, 2017. However, we noted in the CY 2017 PFS 
final rule that, like the modifiers, use of the telehealth POS code 
certifies that the service meets the telehealth requirements.
    Because a valid POS code is required on professional claims for all 
services, and the appropriate reporting of the telehealth POS code 
serves to indicate both the provision of the service via telehealth and 
certification that the requirements have been met, we believe that it 
is unnecessary to also require the distant site practitioner report the 
GT modifier on the claim. Therefore, we proposed to eliminate the 
required use of the GT modifier on professional claims. Because 
institutional claims do not use a POS code, we proposed for distant 
site practitioners billing under CAH Method II to continue to use the 
GT modifier on institutional claims. For purposes of the federal 
telemedicine demonstration programs in Alaska or Hawaii, we proposed to 
retain the GQ modifier to maintain the distinction between synchronous 
and asynchronous telehealth services, as reflected in statute.
    The following is a summary of the public comments received on our 
proposal to eliminate the required use of the GT modifier on 
professional claims:
    Comment: The majority of the commenters were supportive of 
eliminating the required use of the GT modifier on professional claims 
and agreed that this would reduce administrative burden.
    Response: We thank the commenters for their support of the 
proposal. After considering the public comments, we are finalizing the 
proposal to eliminate the required use of the GT modifier on 
professional claims.
    Comment: One commenter supported the proposal to no longer require 
the GT modifier on professional claims, but requested that we not 
delete the GT modifier because other payers who receive Medicare 
crossover claims might still require its use.
    Response: We appreciate the commenters' concerns and reiterate that 
the GT modifier will be retained for Medicare for use in CAH Method II 
billing. Our decision to no longer use the modifier for professional 
claims will not affect its use in other appropriate circumstances.
    Comment: One commenter stated that there is significant effort 
involved in updating computer systems to use the new POS code rather 
than a modifier, and encouraged CMS to consider that in future 
rulemaking.
    Response: We appreciate the comment. We note that the required use 
of the telehealth POS code was finalized for CY 2017; however, we have 
a continuing interest in reducing administrative burden and will 
consider this for future rulemaking.
    Comment: One commenter urged CMS to adopt a uniform method for 
identification of telehealth services and suggested that we use the 95 
modifier, the new CPT modifier for CY 2017.
    Response: We appreciate the comment, especially with the 
possibility that this could reduce administrative burdens associated 
with multiple modifiers. We will consider use of the 95 modifier for 
this purpose for future rulemaking.
    Comment: A few commenters noted that the policy on the telehealth 
place of service (POS) code that was finalized for CY 2017 and took 
effect on January 1, 2017 resulted in a decrease in payment for some 
distant site practitioners furnishing services via telehealth in the 
non-facility setting and one commenter requested that we reverse the 
policy to pay the facility rate for all services furnished via 
telehealth.
    Response: We understand the concerns raised about the current 
policy of using the facility rate for payment to distant site 
telehealth practitioners for telehealth services and will also further 
consider this policy for future rulemaking.
5. Comment Solicitation on Medicare Telehealth Services
    We have received numerous requests from stakeholders to expand 
access to telehealth services. As noted above, Medicare payment for 
telehealth services is restricted by statute, which establishes the 
services initially eligible for Medicare telehealth and limits the use 
of telehealth by defining both eligible originating sites (the location 
of the beneficiary) and the distant site practitioners who may furnish 
and bill for telehealth services. Originating sites are limited both by 
geography and provider setting. We have the authority to add to the 
list of telehealth services based on our annual process, but cannot 
change the limitations relating to geography, patient setting, or type 
of furnishing practitioner because these requirements are specified in 
statute. For CY 2018, we sought information regarding ways that we 
might further expand access to telehealth services within the current 
statutory authority and pay appropriately for services that take full 
advantage of communication technologies.
    Comment: We received many thoughtful comments in response to the

[[Page 53013]]

comment solicitation. Commenters were very supportive of CMS expanding 
access to telehealth services. Many commenters noted that Medicare 
payment for telehealth services is restricted by statute, but 
encouraged CMS to continue to explore alternate means to recognize and 
support technological developments in healthcare. Commenters provided 
many suggestions for how CMS could expand access to telehealth services 
within the current statutory authority and pay appropriately for 
services that take full advantage of communication technologies, such 
as waiving portions of the statutory restrictions using demonstration 
authority.
    Response: We thank the commenters for their input. We reiterate our 
commitment to expanding access to telehealth services consistent with 
statutory authority, and paying appropriately for services that 
maximize telecommunications technology. We will carefully review the 
comments and consider commenters' suggestions for future rulemaking and 
any appropriate sub-regulatory changes.
6. Comment Solicitation on Remote Patient Monitoring
    In addition to the broad comment solicitation regarding Medicare 
telehealth services, we also specifically solicited comment on whether 
to make separate payment for CPT codes that describe remote patient 
monitoring. We note that remote patient monitoring services would 
generally not be considered Medicare telehealth services as defined 
under section 1834(m) of the Act. Rather, like the interpretation by a 
physician of an actual electrocardiogram or electroencephalogram 
tracing that has been transmitted electronically, these services 
involve the interpretation of medical information without a direct 
interaction between the practitioner and beneficiary. As such, they are 
paid under the same conditions as in-person physicians' services with 
no additional requirements regarding permissible originating sites or 
use of the telehealth place of service code.
    We noted we were particularly interested in comments regarding CPT 
code 99091 (Collection and interpretation of physiologic data (e.g., 
ECG, blood pressure, glucose monitoring) digitally stored and/or 
transmitted by the patient and/or caregiver to the physician or other 
qualified health care professional, qualified by education, training, 
licensure/regulation (when applicable) requiring a minimum of 30 
minutes of time). This code is currently assigned a procedure status of 
B (bundled). As with many other bundled codes, we currently assign RVUs 
for this code based on existing RUC recommendations, even though we 
have considered the services described by the code to be bundled with 
other services. In addition to comments on the payment status and 
valuation for this code (the RUC-recommended value, specifically) we 
sought information about the circumstances under which this code might 
be reported for separate payment, including how to differentiate the 
time related to these services from other services, including care 
management services. For example, PFS payment for analysis of patient-
generated health data is considered included in chronic care management 
(CCM) services (CPT codes 99487, 99489, and 99490) to the extent that 
this activity is medically necessary and performed as part of CCM (see 
the CY 2015 PFS final rule (79 FR 67727), CY 2016 PFS final rule (81 FR 
80244), and the CMS FAQ available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Payment_for_CCM_Services_FAQ.pdf). We also sought comment from 
beneficiaries and beneficiary advocacy organizations on the value of 
such services and what protections might be necessary to assure that 
beneficiaries are properly informed that they are receiving a remote 
monitoring service, since beneficiaries would be required to pay 
standard cost sharing for such services. Finally, regarding CPT code 
99091, we sought available information regarding potential utilization 
assumptions we might make for the service for purposes of PFS 
ratesetting, were we to make it payable for CY 2018 or in the future; 
since making such assumptions would be necessary to implement separate 
payment. We noted that since the PFS is a budget neutral system, any 
increase in payment made for particular services would result in 
decreases in payment for other services, and the degree of that 
decrease would depend, in large part, on the utilization assumptions.
    We also sought comment on other existing codes that describe 
extensive use of communications technology for consideration for future 
rulemaking, including CPT code 99090 (Analysis of clinical data stored 
in computers (e.g., ECGs, blood pressures, hematologic data)). CPT code 
99090 is also assigned a procedure status of B (bundled). CPT code 
99090 also has a payment status of bundled; and we do not have RUC-
recommended values for this service, and therefore, currently do not 
assign RVUs.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Commenters were generally supportive of CMS recognizing 
the increasing importance of remote patient monitoring. Several 
commenters recommended that CMS make separate payment for CPT code 
99091. Other commenters acknowledged that the current code, which has 
not been separately payable for some time, may not optimally describe 
the services furnished using current technology. Some of these 
commenters encouraged CMS to make the services separately payable for 
CY 2018, but also noted that the CPT Editorial Panel is currently 
working on codes that more accurately describe remote monitoring.
    A few commenters expressed opposition to making CPT codes 99090 
and/or 99091 separately payable, noting that these are generic codes 
and are duplicative of other codes that are more specific, such as CPT 
codes 93297 ((Interrogation device evaluation(s), (remote) up to 30 
days; implantable cardiovascular monitor system, including analysis of 
1 or more recorded physiologic cardiovascular data elements from all 
internal and external sensors, analysis, review(s) and report(s) by a 
physician or other qualified health care professional)) and CPT code 
93228 (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; 
review and interpretation with report by a physician or other qualified 
health care professional)). Several commenters encouraged CMS to wait 
for the CPT Editorial Panel to complete its work of reviewing and 
revising the CPT codes and consider valuing the new codes in the 
future. Of the commenters who were supportive of unbundling and making 
separate payment for CPT code 99091, a few suggested that CPT code 
99091 could be billed in association with chronic care management (CCM) 
services.
    Response: We agree with commenters that monitoring services can be 
a significant part of ongoing medical care and that we should recognize 
these services for separate payment as soon as practicable. However, we 
also agree with commenters that the two codes in question may not 
optimally describe these services as currently furnished. In order to 
reconcile these concerns,

[[Page 53014]]

especially considering the expectation that CPT coding revisions are 
expected in the immediate future, we believe that activating CPT code 
99091 for separate payment under Medicare for 2018 will serve to 
facilitate appropriate payment for these services in the short term. 
Unlike CPT code 99090, CPT code 99091 specifies that the information is 
interpreted by a physician or other qualified health care professional, 
and it specifies that this activity requires a minimum of 30 minutes of 
time. After consideration of these differences between the two CPT 
codes, and after consideration of the public comments recommending that 
we make separate payment for CPT code 99091, we were persuaded to 
change the status of CPT code 99091 from bundled to active for CY 2018. 
In addition, as noted in the CY 2018 PFS proposed rule, the RUC had 
already provided CMS with RVUs for CPT code 99091, whereas it did not 
provide CMS with RVUs for CPT code 99090. Also, we did not receive 
specific comments to suggest reasons for changing CPT code 99090 to 
``active'' status, so we are retaining the ``bundled'' status for that 
code. We will consider whether to adopt and establish relative value 
units for CPT codes that may be developed by the CPT Editorial Panel 
under our standard process for future years through notice and comment 
rulemaking. However, the comments make it clear to us that separate 
payment for this code will not mitigate the need for coding revisions. 
In order to account for some of the concerns raised by commenters 
regarding the broad nature of the code that describes professional 
collection and interpretation of the stored patient data, we believe 
that we can apply some of the current requirements regarding chronic 
care management services (CCM) to identify circumstances appropriate 
for reporting the code. Specifically, given the non face-to-face nature 
of the services described by CPT code 99091, we are requiring that the 
practitioner obtain advance beneficiary consent for the service and 
document this in the patient's medical record. Additionally, for new 
patients or patients not seen by the billing practitioner within 1 year 
prior to billing CPT code 99091, we are requiring initiation of the 
service during a face-to-face visit with the billing practitioner, such 
as an Annual Wellness Visit or Initial Preventive Physical Exam, or 
other face-to-face visit with the billing practitioner. Levels 2 
through 5 E/M visits (CPT codes 99212 through 99215) would qualify as 
the face-to-face visit. However, services that do not involve a face-
to-face visit by the billing practitioner or are not separately payable 
under the PFS (such as CPT code 99211, anticoagulant management, online 
services, telephone and other E/M services) do not qualify as 
initiating visits. The face-to-face visit included in transitional care 
management (TCM) services (CPT codes 99495 and 99496) would also 
qualify. We are also adopting the prefatory language for CPT code 
99091, including the requirement that it ``should be reported no more 
than once in a 30-day period to include the physician or other 
qualified health care professional time involved with data accession, 
review and interpretation, modification of care plan as necessary 
(including communication to patient and/or caregiver), and associated 
documentation.''
    Finally, because we believe the kind of analysis involved in 
furnishing this service is complementary to CCM and other care 
management services, for the purposes of Medicare billing, we are 
allowing that CPT code 99091 can be billed once per patient during the 
same service period as CCM (CPT codes 99487, 99489, and 99490), TCM 
(CPT codes 99495 and 99496), and behavioral health integration (BHI) 
(CPT codes 99492, 99493, 99494, and 99484). We note that under current 
billing rules, time counted toward the CCM codes generally refers to 
time spent by clinical staff furnishing care management services; while 
CPT code 99091 refers to practitioner time. We note that time spent 
furnishing these services could not be counted towards the required 
time for both codes for a single month.
    We also note that the new separate payment for CPT code 99091 will 
be excluded from the calculation of the net reduction in expenditures 
due to changes in coding and valuation for purposes of the misvalued 
code target, consistent with policies finalized in the CY 2016 PFS 
final rule with comment period (80 FR 70926). CPT code 99091 describes 
a service that is newly separately reportable, but for which no 
corresponding reduction is being made to existing codes and instead 
reductions under the PFS are being taken exclusively through a budget 
neutrality adjustment.
    We look forward to forthcoming coding changes through the CPT 
process that we anticipate will better describe the role of remote 
patient monitoring in contemporary practice and potentially mitigate 
the need for the additional billing requirements associated with these 
services.
7. Telehealth Originating Site Facility Fee Payment Amount Update
    Section 1834(m)(2)(B) of the Act established the Medicare 
telehealth originating site facility fee for telehealth services 
furnished from October 1, 2001 through December 31, 2002, at $20.00. 
For telehealth services furnished on or after January 1 of each 
subsequent calendar year, the telehealth originating site facility fee 
is increased by the percentage increase in the Medicare Economic Index 
(MEI) as defined in section 1842(i)(3) of the Act. The originating site 
facility fee for telehealth services furnished in CY 2017 is $25.40. 
The MEI increase for 2018 is 1.4 percent and is based on the most 
recent historical update through 2017Q2 (1.8 percent), and the most 
recent historical MFP through calendar year 2016 (0.4 percent). 
Therefore, for CY 2018, the payment amount for HCPCS code Q3014 
(Telehealth originating site facility fee) is 80 percent of the lesser 
of the actual charge or $25.76. The Medicare telehealth originating 
site facility fee and the MEI increase by the applicable time period is 
shown in Table 8.

     Table 8--The Medicare Telehealth Originating Site Facility Fee
------------------------------------------------------------------------
               Time period                 MEI increase    Facility fee
------------------------------------------------------------------------
10/01/2001-12/31/2002...................             N/A          $20.00
01/01/2003-12/31/2003...................               3           20.60
01/01/2004-12/31/2004...................             2.9           21.20
01/01/2005-12/31/2005...................             3.1           21.86
01/01/2006-12/31/2006...................             2.8           22.47
01/01/2007-12/31/2007...................             2.1           22.94
01/01/2008-12/31/2008...................             1.8           23.35
01/01/2009-12/31/2009...................             1.6           23.72
01/01/2010-12/31/2010...................             1.2           24.00
01/01/2011-12/31/2011...................             0.4           24.10

[[Page 53015]]

 
01/01/2012-12/31/2012...................             0.6           24.24
01/01/2013-12/31/2013...................             0.8           24.43
01/01/2014-12/31/2014...................             0.8           24.63
01/01/2015-12/31/2015...................             0.8           24.83
01/01/2016-12/31/2016...................             1.1           25.10
01/01/2017-12/31/2017...................             1.2           25.40
01/01/2018-12/31/2018...................             1.4           25.76
------------------------------------------------------------------------

E. Potentially Misvalued Services Under the Physician Fee Schedule

1. Background
    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the RVUs 
established under the PFS. Section 1848(c)(2)(K) of the Act requires 
the Secretary to periodically identify potentially misvalued services 
using certain criteria and to review and make appropriate adjustments 
to the relative values for those services. Section 1848(c)(2)(L) to the 
Act also requires the Secretary to develop a process to validate the 
RVUs of certain potentially misvalued codes under the PFS, using the 
same criteria used to identify potentially misvalued codes, and to make 
appropriate adjustments.
    As discussed in section II.H. of this final rule, each year we 
develop appropriate adjustments to the RVUs taking into account 
recommendations provided by the American Medical Association/Specialty 
Society Relative Value Scale Update Committee (RUC), the Medicare 
Payment Advisory Commission (MedPAC), and others. For many years, the 
RUC has provided us with recommendations on the appropriate relative 
values for new, revised, and potentially misvalued PFS services. We 
review these recommendations on a code-by-code basis and consider these 
recommendations in conjunction with analyses of other data, such as 
claims data, to inform the decision-making process as authorized by 
law. We may also consider analyses of work time, work RVUs, or direct 
PE inputs using other data sources, such as Department of Veteran 
Affairs (VA), National Surgical Quality Improvement Program (NSQIP), 
the Society for Thoracic Surgeons (STS), and the Physician Quality 
Reporting System (PQRS) databases. In addition to considering the most 
recently available data, we assess the results of physician surveys and 
specialty recommendations submitted to us by the RUC for our review. We 
also consider information provided by other stakeholders. We conduct a 
review to assess the appropriate RVUs in the context of contemporary 
medical practice. We note that section 1848(c)(2)(A)(ii) of the Act 
authorizes the use of extrapolation and other techniques to determine 
the RVUs for physicians' services for which specific data are not 
available and requires us to take into account the results of 
consultations with organizations representing physicians who provide 
the services. In accordance with section 1848(c) of the Act, we 
determine and make appropriate adjustments to the RVUs.
    In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/congressional-testimony/testimony-report-to-the-congress-medicare-payment-policy-march-2006-.pdf?sfvrsn=0), MedPAC 
discussed the importance of appropriately valuing physicians' services, 
noting that misvalued services can distort the market for physicians' 
services, as well as for other health care services that physicians 
order, such as hospital services. In that same report, MedPAC 
postulated that physicians' services under the PFS can become misvalued 
over time. MedPAC stated, ``When a new service is added to the 
physician fee schedule, it may be assigned a relatively high value 
because of the time, technical skill, and psychological stress that are 
often required to furnish that service. Over time, the work required 
for certain services would be expected to decline as physicians become 
more familiar with the service and more efficient in furnishing it.'' 
We believe services can also become overvalued when PE declines. This 
can happen when the costs of equipment and supplies fall, or when 
equipment is used more frequently than is estimated in the PE 
methodology, reducing its cost per use. Likewise, services can become 
undervalued when physician work increases or PE rises.
    As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since 
MedPAC made the initial recommendations, CMS and the RUC have taken 
several steps to improve the review process. Also, section 
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the 
Secretary to specifically examine, as determined appropriate, 
potentially misvalued services in the following categories:
     Codes that have experienced the fastest growth.
     Codes that have experienced substantial changes in 
practice expenses.
     Codes that describe new technologies or services within an 
appropriate time period (such as 3 years) after the relative values are 
initially established for such codes.
     Codes which are multiple codes that are frequently billed 
in conjunction with furnishing a single service.
     Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment.
     Codes that have not been subject to review since 
implementation of the fee schedule.
     Codes that account for the majority of spending under the 
physician fee schedule.
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
     Codes for which there may be a change in the typical site 
of service since the code was last valued.
     Codes for which there is a significant difference in 
payment for the same service between different sites of service.
     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intra-service work per unit of time.
     Codes with high practice expense relative value units.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.

[[Page 53016]]

    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the physician fee schedule.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we plan to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well.
    Since CY 2009, as a part of the annual potentially misvalued code 
review and Five-Year Review process, we have reviewed approximately 
1,700 potentially misvalued codes to refine work RVUs and direct PE 
inputs. We have assigned appropriate work RVUs and direct PE inputs for 
these services as a result of these reviews. A more detailed discussion 
of the extensive prior reviews of potentially misvalued codes is 
included in the CY 2012 PFS final rule with comment period (76 FR 73052 
through 73055). In the CY 2012 PFS final rule with comment period (76 
FR 73055 through 73958), we finalized our policy to consolidate the 
review of physician work and PE at the same time, and established a 
process for the annual public nomination of potentially misvalued 
services.
    In the CY 2013 PFS final rule with comment period, we built upon 
the work we began in CY 2009 to review potentially misvalued codes that 
have not been reviewed since the implementation of the PFS (so-called 
``Harvard-valued codes''). In CY 2009 (73 FR 38589), we requested 
recommendations from the RUC to aid in our review of Harvard-valued 
codes that had not yet been reviewed, focusing first on high-volume, 
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we 
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services. 
In the CY 2013 PFS final rule with comment period, we identified 
specific Harvard-valued services with annual allowed charges that total 
at least $10,000,000 as potentially misvalued. In addition to the 
Harvard-valued codes, in the CY 2013 PFS final rule with comment period 
we finalized for review a list of potentially misvalued codes that have 
stand-alone PE (codes with physician work and no listed work time and 
codes with no physician work that have listed work time).
    In the CY 2016 PFS final rule with comment period, we finalized for 
review a list of potentially misvalued services, which included eight 
codes in the neurostimulators analysis-programming family (CPT 95970-
95982). We also finalized as potentially misvalued 103 codes identified 
through our screen of high expenditure services across specialties.
    In the CY 2017 PFS final rule, we finalized for review a list of 
potentially misvalued services, which included eight codes in the end-
stage renal disease home dialysis family (CPT codes 90963-90970). We 
also finalized as potentially misvalued 19 codes identified through our 
screen for 0-day global services that are typically billed with an 
evaluation and management (E/M) service with modifier 25.
3. CY 2018 Identification and Review of Potentially Misvalued Services
    In the CY 2012 PFS final rule with comment period (76 FR 73058), we 
finalized a process for the public to nominate potentially misvalued 
codes. The public and stakeholders may nominate potentially misvalued 
codes for review by submitting the code with supporting documentation 
by February 10 of each year. Supporting documentation for codes 
nominated for the annual review of potentially misvalued codes may 
include the following:
     Documentation in peer reviewed medical literature or other 
reliable data that there have been changes in physician work due to one 
or more of the following: Technique, knowledge and technology, patient 
population, site-of-service, length of hospital stay, and work time.
     An anomalous relationship between the code being proposed 
for review and other codes.
     Evidence that technology has changed physician work.
     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.
    We evaluate the supporting documentation submitted with the 
nominated codes and assess whether the nominated codes appear to be 
potentially misvalued codes appropriate for review under the annual 
process. In the following year's PFS proposed rule, we publish the list 
of nominated codes and indicate whether we proposed each nominated code 
as a potentially misvalued code. The public has the opportunity to 
comment on these and all other proposed potentially misvalued codes. In 
that year's final rule, we finalize our list of potentially misvalued 
codes.

[[Page 53017]]

a. Public Nomination of Arthrodesis of Sacroiliac Joint (CPT Code 
27279)
    After we issued the CY 2017 PFS final rule, we received a 
nomination and supporting documentation for one code to be considered 
as potentially misvalued. We evaluated the supporting documentation for 
this nominated code to ascertain whether the submitted information 
demonstrated that the code should be proposed as potentially misvalued.
    CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or 
minimally invasive (indirect visualization), with image guidance, 
includes obtaining bone graft when performed, and placement of 
transfixing device) was nominated for review as a potentially misvalued 
code because the current work RVU is potentially undervalued and 
stakeholders recommended that it should be increased to 14.23. We 
proposed this code as a potentially misvalued code in the CY 2018 PFS 
proposed rule.
    The following is a summary of the public comments received on 
whether CPT code 27279 should be reviewed under the misvalued code 
initiative and our responses:
    Comment: One commenter disagreed with CMS' proposal of CPT code 
27279 as potentially misvalued, while many other commenters supported 
the proposal because they believe the service is significantly 
undervalued relative to other PFS services. While some commenters 
suggested the work RVU should be increased relative to other joint 
replacement procedures, like CPT code 63030 (Laminotomy 
(hemilaminectomy), with decompression of nerve root(s), including 
partial facetectomy, foraminotomy and/or excision of herniated 
intervertebral disc; 1 interspace, lumbar) which has a work RVU of 
13.18, other commenters recommended increasing the work RVU to 14.23 
because they stated that value better reflects the technical difficulty 
and increased time required to perform the procedure. Other commenters 
suggested specific work RVUs that were higher than 14.23 for similar 
reasons.
    A few commenters noted that CPT code 27279 is scheduled for review 
by the RUC in October 2018 as part of its standard review process. As a 
result, some commenters suggested that CMS should wait until the RUC 
makes a recommendation regarding the appropriate valuation of the code. 
Some commenters noted that the RUC intends to review this service in 
October 2018 and suggested that the timeframe for that review would 
mean that the code could not be appropriately valued prior to CY 2020.
    Response: After reviewing the range of public comments, we agree 
with commenters that CPT code 27279 is a potentially misvalued, and 
believe that a comprehensive review of the code values is warranted.
    While we appreciate the comments that included suggestions 
regarding the specific work RVUs that might represent more appropriate 
valuation, we agree with those commenters that urged us to wait for the 
code to be reviewed by the RUC. We note that should the RUC and other 
relevant stakeholders expedite their review process, we would be able 
to consider making changes during next year's rulemaking. If the RUC 
review process is not completed in time, we may not be able to make 
changes in next year's rulemaking and would wait for the RUC to 
complete its process before making changes in subsequent rulemaking.
b. Comment Solicitation on Dialysis Vascular Access Codes (CPT Codes 
36901-36909)
    In the CY 2017 PFS final rule, we noted that the assertions by some 
commenters regarding appropriate values for the dialysis vascular 
access codes newly created in CY 2017 (CPT codes 36901 through 36909) 
did not include data that would warrant increases to the work RVUs we 
proposed and finalized in that rule (81 FR 80290-80297). However, we 
urged interested stakeholders to consider submitting robust data 
regarding costs for these and other services (81 FR 80290-80297). We 
have continued to receive feedback from stakeholders regarding the work 
valuation of these codes. Stakeholders have expressed concerns 
regarding the typical patient for these procedures as reflected in the 
information included in the RUC recommendations for CY 2017 and the 
importance of appropriate payment for ensuring access to care for 
Medicare beneficiaries. Therefore, we sought additional comment and 
requested robust data regarding the potentially misvalued work RVUs for 
CPT codes 36901 through 36909 and considered alternate work valuations 
for CY 2018, such as the RUC-recommended work RVUs from CY 2017, or 
other potential values based on submission of data through the public 
comment process. We noted that the RUC-recommended work RVUs for these 
services were displayed in the CY 2017 PFS final rule (81 FR 80290 
through 80296).
    The following is a summary of the public comments received on CPT 
codes 36901-36909 and our responses:
    Comment: Many commenters were concerned that the values currently 
assigned to the dialysis circuit family of codes have already and will 
continue to compromise patient access to vascular access services; with 
one commenter specifically requesting that CMS promptly reevaluate 
these codes. Several commenters supported increases to the work RVUs 
and explained that the greater complexity of the patient population for 
these services involved greater relative intensity than other services, 
especially since the codes involve obtaining new access as well as 
secondary access to the dialysis circuit, while the codes used as 
crosswalks for the current valuation involve colonoscopy through an 
existing access.
    The overwhelming majority of commenters suggested we finalize the 
CY 2017 RUC-recommended work RVUs for CPT codes 36901-36909.
    Response: We appreciate commenters' responses to our request for 
new information. After further reflection, we are persuaded by 
commenters' explanations regarding the complexities of care related to 
this patient population specifically and after reviewing these 
additional remarks, agree that these services are currently misvalued. 
Therefore for CY 2018, we are finalizing the CY 2017 RUC-recommended 
work RVUs for CPT codes 36901-36909, consistent with the requests of 
public commenters.
c. CMS Nomination of Flow Cytometry Codes (CPT Codes 88184 and 88185)
    We have received conflicting information about the direct PE inputs 
for CPT codes 88184 (Flow cytometry, cell surface, cytoplasmic, or 
nuclear marker, technical component only; first marker) and 88185 (Flow 
cytometry, cell surface, cytoplasmic, or nuclear marker, technical 
component only; each additional marker (List separately in addition to 
code for first marker)). In the CY 2018 PFS proposed rule, we proposed 
these codes as potentially misvalued so that they can be reviewed again 
because some stakeholders have suggested the clinical labor and 
supplies that were previously finalized are no longer accurate.
    Comment: We received several comments regarding various clinical 
labor and supply inputs for CPT codes 88184 and 88185 urging CMS to use 
the RUC recommendations for CY 2017 in developing final PE RVUs for 
these services instead of recommending additional review of these codes 
under the misvalued code initiative.
    Response: We appreciate these comments and, based on this

[[Page 53018]]

suggestion, we have re-examined the CY 2017 RUC-recommended direct PE 
inputs for these services in light of specific comments. We refer 
readers to section II.H of this final rule. This section describes the 
direct PE input changes between CY 2017 and CY 2018 for specific 
services.
d. Comment Solicitation on Emergency Department Payment Rates (CPT 
Codes 99281-99385)
    We received information suggesting that the work RVUs for emergency 
department visits did not appropriately reflect the full resources 
involved in furnishing these services. Specifically, stakeholders 
expressed concerns that the work RVUs for these services have been 
undervalued given the increased acuity of the patient population and 
the heterogeneity of the sites, such as freestanding and off-campus 
emergency departments, where emergency department visits are furnished. 
Therefore, we sought comment on whether CPT codes 99281-99385 
(Emergency department visits for the evaluation and management of a 
patient) should be reviewed under the misvalued code initiative.
    The following is a summary of the public comments received on 
whether CPT codes 99281-99385 should be reviewed under the misvalued 
code initiative and our responses:
    Comment: Most commenters had no objection to review of these codes. 
Several commenters stated that the work RVUs for the emergency 
department evaluation and management (E/M) services, like most other E/
M services, are undervalued given the increased acuity of the patient 
population and the heterogeneity of the sites where emergency 
department visits are furnished. One commenter suggested that CMS 
evaluate alternatives to the misvalued code initiative for review of 
these codes, but another commenter explicitly stated that review of 
these services should be undertaken by the RUC rather than CMS. In its 
comment, the RUC stated if CMS finalizes the codes as potentially 
misvalued, it will add these codes to its list of potentially misvalued 
services.
    In contrast, one commenter stated that the problem of under-
reimbursement for these services would be better addressed by 
streamlining the E/M process for documenting the higher level of care. 
Another commenter stated that given the significant changes to 
documentation guidelines for E/M services that may be forthcoming in 
this rule cycle, it is premature and somewhat difficult to advise on 
potential revaluation of any E/M codes, pending details on how the 
documentation guideline revisions are resolved.
    Response: We agree with the majority of commenters that these 
services may be potentially misvalued given the increased acuity of the 
patient population and the heterogeneity of the sites where emergency 
department visits are furnished. As a result, we look forward to 
reviewing the RUC's recommendations regarding the appropriate valuation 
of these services for our consideration in future notice and comment 
rulemaking. Additionally, regarding the commenters' concerns about 
documentation guidelines for E/M services, we refer readers to section 
II.I for details regarding our comment solicitation on documentation 
for E/M guidelines more generally.
e. Comment Solicitation on New Potentially Misvalued Code Screens
    For over a decade, CMS has collaborated with the RUC to regularly 
prioritize codes for review by using the categories specified in the 
statute or as determined appropriate. We generally have referred to 
these categories as ``misvalued code screens.'' To supplement ongoing 
RUC identification of potentially misvalued codes through established 
screens, CMS regularly uses PFS rulemaking to identify other screens 
for use in identifying potentially misvalued codes. For example, in 
recent years, CMS has prioritized the following screens:
     Codes with low work RVUs commonly billed in multiple units 
per single encounter.
     Codes with high volume and low work RVUs.
     Codes with site-of-service-anomalies.
     E/M codes.
     PFS high expenditure services.
     Services with standalone PE procedure time.
     Services with anomalous time.
     Contractor Medical Director identified potentially 
misvalued codes.
     Codes with higher total Medicare payments in office than 
in hospital or ASC.
     Publicly nominated potentially misvalued codes.
     0-day global services that are typically billed with an 
evaluation and management (E/M) service with modifier 25.
    Although we did not propose a new screen for CY 2018, we continue 
to believe that it is important to prioritize codes for review under 
the misvalued code initiative. As a result, we solicited public comment 
on the best approach for developing screens, as well as what particular 
new screens we might consider. We will consider these comments for 
future rulemaking.
    The following is a summary of the public comments received on the 
best approach for developing screens, as well as what particular new 
screens we might consider and our responses:
    Comment: One commenter suggested revisiting two recent efforts 
funded by CMS, reports by the Urban Institute and RAND, for 
prioritization of codes for review under the misvalued code initiative. 
Both reports include examination on the relationship between service 
times and work RVUs, in some cases for specific services. One commenter 
suggested that we no longer utilize potentially misvalued code screens 
due to the burden it causes the specialty societies. Other commenters 
suggest that CMS work in collaboration with the RUC to identify 
potentially misvalued codes and to not re-review codes that were 
recently reviewed by the RUC.
    Response: We thank commenters for their input and will consider all 
recommendations for future rulemaking.

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

    Section 502(a)(1) of Division O, Title V of the Consolidated 
Appropriations Act of 2016 (Pub. L. 114-113) amended section 1848(b) of 
the Act by establishing a new paragraph (9) of subsection (b). Section 
1848(b)(9)(B) of the Act provides for a 7 percent reduction in payments 
for the technical component (TC) for imaging services made under the 
PFS that are X-rays (including the technical component portion of a 
global service) taken using computed radiography technology furnished 
during CYs 2018 through 2022, and for a 10 percent reduction for the 
technical component of such imaging services furnished during CY 2023 
or a subsequent year. Computed radiography technology is defined for 
purposes of this paragraph as cassette-based imaging that utilizes an 
imaging plate to create the image involved. Section 1848(b)(9) of the 
Act also requires implementation of the reduction in payments through 
appropriate mechanisms, which can include the use of modifiers. In 
accordance with section 1848(c)(2)(B)(v)(X) of the Act, the adjustments 
under section 1848(b)(9)(A) of the Act are exempt from the budget 
neutrality requirement.
    We stated in the CY 2017 PFS proposed rule that because the 
required reductions in PFS payment for the TC

[[Page 53019]]

of imaging services (including the TC portion of a global service) that 
are X-rays taken using computed radiography technology did not apply 
for CY 2017, we would address implementation of section 1848(b)(9)(B) 
of the Act in future rulemaking. Therefore, to implement the provisions 
of section 1848(b)(9)(B) of the Act relating to the payment reduction 
for the TC (including the TC portion of a global service) of X-rays 
taken using computed radiography technology during CY 2018 or 
subsequent years, we proposed in the CY 2018 PFS proposed rule to 
establish a new modifier to be used on claims for these services.
    We proposed that beginning January 1, 2018, this modifier would be 
required to be used when reporting imaging services for which payment 
is made under the PFS that are X-rays (including the X-ray component of 
a packaged service) taken using computed radiography technology. The 
modifier would be required on claims for the technical component of the 
X-ray service, including when the service is billed globally because 
the PFS payment adjustment is made to the technical component 
regardless of whether it is billed globally, or billed separately using 
the TC modifier. The modifier must be used to report the specific 
services that are subject to the payment reduction and accurate use is 
subject to audit. The use of this proposed modifier to indicate an X-
ray taken using computed radiography would result in a 7 percent 
reduction for CYs 2018 through 2022 and a 10 percent reduction for CY 
2023 or a subsequent calendar year to the payments for the TC for such 
imaging services furnished as specified under section 1848(b)(9)(B) of 
the Act.
    The following is a summary of the public comments received and our 
responses:
    Comment: One commenter noted support for the computed radiography 
to digital X-ray payment differential but sought clarification 
regarding its implementation. The commenter stated that a new modifier 
will be designated to denote the CPT codes for computed radiography and 
HCPCS X-ray codes that are subject to the payment reduction; however, 
no listing of such codes was provided in the proposed rule. The 
commenter noted that similarly last year it requested a listing of the 
X-ray codes to which the modifier would apply. CMS declined to provide 
such a list on the basis that the payment differential would apply to 
any service performed using the film X-rays. The commenter stated that 
the listing of the film and computed radiography CPT and HCPCS codes 
would facilitate easy implementation, prevent ambiguity, be less 
burdensome, and prevent risk of audit.
    Response: We considered the commenter's concerns and recommendation 
that we maintain a list of CPT and HCPCS codes to which the policy 
applies. However, we do not agree that such a list would facilitate 
easy implementation, prevent ambiguity, be less burdensome, or prevent 
the risk of audit. We believe that the professionals who furnish and 
bill for these services are in the best position to determine whether a 
particular imaging service is appropriately described as X-rays taken 
using computed radiography.
    Comment: Some commenters expressed concern that rural and 
underserved areas are particularly penalized by this provision and that 
the use of a modifier places a burden on all providers and creates 
another opportunity for miscoding.
    Response: We appreciate the commenters' concerns, but under current 
law, we do not currently believe that we have authority to provide 
exemptions from the policy. We believe that the use of a modifier is 
the least burdensome method to identify the services to which the 
payment reduction applies, and to implement the required payment 
reduction for services that are X-rays taken using computed 
radiography.
    Comment: One commenter opined that the continued overall trend in 
imaging payment reductions is not sustainable for any quality imaging 
provider and that CMS should look for more creative solutions such as 
the AUC program, as well as reductions in mandated reporting.
    Response: We thank the commenter for the suggestions and will take 
these recommendations into consideration for future rulemaking.
    Comment: One commenter requested that CMS work with Congress to 
delay or eliminate the payment reductions, and ensure that clinicians 
are thoroughly educated and outreach is provided to ensure that 
stakeholders are thoroughly aware of the new requirements.
    Response: We will include information to educate clinicians 
regarding the new modifier requirement for services that are X-rays 
taken using computed radiography as part of ongoing provider education 
activities, though we acknowledge that we also appreciate assistance 
from private, national organizations, such as medical specialty 
societies in educating their membership. We appreciate the commenters' 
concerns regarding the overall merits of the statutory provision, but 
we do not believe that we have the authority to alter the application 
of the provision.
    Comment: Some commenters urged that physician practices be held 
harmless from financial and criminal penalties if the new modifiers are 
omitted or incorrectly applied at least for the first 3 years of the 
program (2017-2019). In addition, the commenter stated that audits by 
the Recovery Audit Contractors (RACs) related to the implementation of 
the transition from traditional X-ray imaging to digital radiology 
using the modifier should not be approved for the same time period.
    Response: We appreciate these suggestions and concerns but note 
that this final rule specifically addresses the payment policies 
related to the statutory provision. The kinds of enforcement activities 
addressed by these commenters are outside the scope of this final rule.
    Comment: Some commenters supported the use of the modifier to 
implement this requirement, but requested that the modifier be released 
as soon as possible in order to allow radiology practices to work out 
the logistics associated with compliance with the new requirement.
    Response: To implement this provision, we created modifier ``FY'' 
(X-ray taken using computed radiography technology/cassette-based 
imaging). Beginning in 2018, claims for X-rays taken using computed 
radiography/cassette-based imaging must include modifier ``FY'' that 
will result in the applicable payment reduction.
    Comment: One commenter supported the use of the modifier as the 
best indicator for the use of traditional X-rays or digital radiology. 
Another commenter supported the transition to digital imaging services 
because, according to the commenter, it is essential to reach 
widespread interoperability.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
proposal without modification.

G. Payment Rates Under the Medicare Physician Fee Schedule for 
Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus 
Provider-Based Departments of a Hospital

1. Background
    Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that 
certain items and

[[Page 53020]]

services furnished by certain off-campus provider-based departments 
(PBDs) (collectively referenced here as nonexcepted items and services 
furnished by nonexcepted off-campus PBDs) shall not be considered 
covered OPD services for purposes of payment under the OPPS, and 
payment for those nonexcepted items and services furnished on or after 
January 1, 2017 shall be made under the applicable payment system. In 
the CY 2017 OPPS/ASC final rule with comment period (81 FR 79713), we 
finalized the PFS as the ``applicable payment system'' for most 
nonexcepted items and services furnished by off-campus PBDs.
    As part of that discussion, we indicated that, in response to 
public comments received on the proposed payment policies for 
nonexcepted items and services, we would issue an interim final rule 
with comment period (the CY 2017 interim final rule, 81 FR 79720 
through 79729) to establish payment policies under the PFS for 
nonexcepted items and services furnished on or after January 1, 2017. 
In the following paragraphs, we summarize what we proposed for the 
payment policies under the PFS for nonexcepted items and services 
furnished during CY 2018. The CY 2017 interim final rule can be found 
on the Internet at https://www.gpo.gov/fdsys/pkg/FR-2016-11-14/pdf/2016-26515.pdf.
2. Payment Mechanism
    Coding and payment policies under the PFS have long recognized the 
differences between the portions of services for which direct costs 
generally are incurred by practitioners and the portions of services 
for which direct costs generally are incurred by facilities. At 
present, the coding and RVUs established for particular groups of 
services under the PFS generally reflect such direct cost differences. 
As described in section II.B of this final rule, we establish separate 
nonfacility and facility RVUs for many HCPCS codes describing 
particular services paid under the PFS. For many other services, we 
establish separate RVUs for the professional component and the 
technical component of the service described by the same HCPCS code. 
For other services, we establish RVUs for the different HCPCS codes 
that segregate and describe the discrete professional and technical 
aspects of particular services.
    Because hospitals with nonexcepted off-campus PBDs that furnish 
nonexcepted items and services are likely to furnish a broader range of 
services than other provider or supplier types for which there is a 
separately valued technical component under the PFS, for CY 2017, we 
established a new set of payment rates under the PFS that reflected the 
relative resource costs of furnishing the technical component of a 
broad range of services to be paid under the PFS specific to the 
nonexcepted off-campus PBD of a hospital with packaging (bundling) 
rules that are unique to the hospital outpatient setting under the 
OPPS.
    In principle, the coding and billing mechanisms required to make 
appropriate payment to hospitals for nonexcepted items and services 
furnished by nonexcepted off-campus PBDs are parallel to those used to 
make payment for the technical component services for a range of 
supplier types paid under the PFS. That is, payments to hospitals are 
made for the technical aspect of services, while physicians and other 
practitioners report the professional aspect of these same services. In 
some cases, the entities reporting the technical aspect of services use 
the same coding that is used by the individuals reporting the 
professional services. In other cases, different coding applies. We 
proposed to maintain this coding and billing mechanism for CY 2018.
    Comment: A number of commenters supported our proposal to continue 
to allow hospitals to bill using an institutional claim with the 
modifier ``PN'' to indicate that the nonexcepted items and services are 
furnished by nonexcepted PBDs.
    Response: We appreciate the comments in support of our proposal to 
allow hospitals to continue to bill for nonexcepted items and services 
furnished by nonexcepted off-campus PBDs using an institutional claim 
for CY 2018.
3. Establishment of Payment Rates
    Using the relativity among OPPS payments to establish rates for the 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
and billed by hospitals under the PFS was only one aspect of 
establishing the necessary relativity of these services under the PFS 
more broadly. It was necessary to estimate the relativity of these 
services compared to PFS services furnished in other settings paid 
under the PFS. For CY 2017, we used our best estimate of the more 
general relativity between the technical component of PFS services 
furnished in nonexcepted off-campus PBDs and all other PFS services 
furnished in other settings using the limited information available to 
us at that time. As described in the CY 2017 interim final rule (81 FR 
79722 through 79726), we estimated that for CY 2017, scaling the OPPS 
payment rates downward by 50 percent would strike an appropriate 
balance that avoided potentially underestimating the relative resources 
involved in furnishing services in nonexcepted off-campus PBDs as 
compared to the services furnished in other settings for which payment 
was made under the PFS. Specifically, we established site-specific 
rates under the PFS for the technical component of the broad range of 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
to be paid under the PFS that was based on the OPPS payment amount for 
the same items and services, scaled downward by 50 percent. We called 
this adjustment the ``PFS Relativity Adjuster.'' The PFS Relativity 
Adjuster refers to the percentage of the OPPS payment amount paid under 
the PFS for a nonexcepted item or service to the nonexcepted off-campus 
PBD under this policy.
a. Methodology for Establishing CY 2017 PFS Relativity Adjuster
    In developing the CY 2017 interim final rule, we began by analyzing 
hospital outpatient claims data from January 1 through August 26, 2016, 
that contained the ``PO'' modifier signifying that they were billed by 
an off-campus department of a hospital paid under the OPPS other than a 
remote location, a satellite facility, or a dedicated emergency 
department (ED). We noted that the use of the ``PO'' modifier was a new 
mandatory reporting requirement for CY 2016. We limited our analysis to 
those claims billed on the 13X Type of Bill because those claims were 
used for Medicare Part B billing under the OPPS. We then identified the 
top (most frequently billed) 25 major codes that were billed by claim 
line; that is, items and services that were separately payable or 
conditionally packaged. Specifically, we restricted our analysis to 
codes with OPPS status indicators ``J1'', ``J2'', ``Q1'', ``Q2'', 
``Q3'', ``S'', ``T'', or ``V''. We did not include separately payable 
drugs or biologicals in this analysis because those drugs or 
biologicals were not paid under the PFS under the CY 2017 interim final 
rule. As such, under the CY 2017 interim final rule, the PFS Relativity 
Adjuster did not apply to separately payable drugs and biologicals 
furnished by a nonexcepted off-campus PBD. Similarly, we excluded codes 
assigned an OPPS status indicator ``A'' because the services described 
by those codes were already paid at a rate under a fee schedule other 
than the OPPS and payment for those nonexcepted items and services was 
not changed by the rates established under

[[Page 53021]]

the CY 2017 interim final rule. Next, for the same major codes (or 
analogous codes in the rare instance that different coding applies 
under the OPPS than the PFS), we compared the CY 2016 payment rate 
under the OPPS to a CY 2016 payment rate under the PFS attributable to 
the nonprofessional relative resource costs involved in furnishing the 
services.
    The most frequently billed service with the ``PO'' modifier was 
described by HCPCS code G0463 (Hospital outpatient clinic visit for 
assessment and management of a patient), which is paid under APC 5012; 
the total number of CY 2016 claim lines for that service was 
approximately 6.7 million as of August 2016. In CY 2016, the OPPS 
payment rate for APC 5012 was $102.12. Because there were multiple CPT 
codes (CPT codes 99201 through 99215) used under the PFS for billing 
that service, an exact comparison between the $102.12 OPPS payment rate 
for APC 5012 and the payment rate for a single CPT code billed under 
the PFS was not possible. Therefore, for purposes of the analysis, we 
examined the difference between the nonfacility payment rates and the 
facility payment rates under the PFS for CPT codes 99213 and 99214, 
which were the billing codes for a Level III and a Level IV office 
visit. Although we did not have data to precisely determine the 
equivalent set of PFS visit codes to use for the comparison, we 
believed that, based on the distribution of services billed for the 
visit codes under the PFS and the distribution of the visit codes under 
the OPPS from the last time period the CPT codes were used under the 
OPPS in CY 2014, those two codes provided reliable points of 
comparison. For CPT code 99213, the difference between the nonfacility 
payment rate and the facility payment rate under the PFS in CY 2016 was 
$21.86, which was 21 percent of the OPPS payment rate for APC 5012 of 
$102.12. For CPT code 99214, the difference between the nonfacility 
payment rate and the facility payment rate under the PFS in CY 2016 was 
$29.02, which was 28 percent of the OPPS payment rate for APC 5012. 
However, we recognized that, due to the more extensive packaging that 
occurred under the OPPS for services provided along with clinic visits 
relative to the more limited packaging that occurred under the PFS for 
office visits, those payment rates were not entirely comparable.
    We then assessed the next 24 major codes most frequently billed on 
the 13X claim form by hospitals. We removed HCPCS code 36591 
(Collection of blood specimen from a completely implantable venous 
access device) because, under current PFS policies, the code is used 
only to pay separately under the PFS when no other service was on the 
claim. We also removed HCPCS code G0009 (Administration of Pneumococcal 
Vaccine) because there was no payment for the code under the PFS. For 
the remaining 22 major codes most frequently billed, we estimated the 
amount that would have been paid to the physician in the office setting 
under the PFS for practice expenses not associated with the 
professional component of the service. As indicated in Table 9, this 
amount reflected (1) the difference between the PFS nonfacility payment 
rate and the PFS facility rate, (2) the technical component, or (3) in 
instances where payment would have been made only to the facility or 
only to the physician, the full nonfacility rate. This estimate ranged 
from zero percent to 137.8 percent of the OPPS payment rate for a code. 
Overall, the average (weighted by claim line volume times rate) of the 
nonfacility payment rate estimate for the PFS compared to the estimate 
for the OPPS for the 22 remaining major codes was 45 percent.

Table 9--Comparison of CY 2016 OPPS Payment Rate to CY 2016 PFS Payment Rate for Top Hospital Codes Billed Using
                                               the ``PO'' Modifier
----------------------------------------------------------------------------------------------------------------
                                                                     CY 2016
                                                                    applicable
                                                        CY 2016        PFS       Col (5) as
    HCPCS code        Code description   Total claim      OPPS      technical    a percent       PFS estimate
                                            lines       payment      payment      of OPPS
                                                          rate        amount
                                                                     estimate
(1)                 (2)................          (3)          (4)          (5)               (6)
----------------------------------------------------------------------------------------------------------------
96372.............  Injection beneath        338,444       $42.31       $25.42         60.1  Single rate paid
                     the skin or into                                                         exclusively to
                     muscle for                                                               either
                     therapy,                                                                 practitioner or
                     diagnosis, or                                                            facility: Full
                     prevention.                                                              nonfacility rate.
71020.............  X-ray of chest, 2        333,203        60.80        16.83         27.7  Technical
                     views, front and                                                         component: Full
                     side.                                                                    nonfacility rate.
93005.............  Routine                  318,099        55.94         8.59         15.4  Technical
                     electrocardiogram                                                        component: Full
                     (EKG) with tracing                                                       nonfacility rate.
                     using at least 12
                     leads.
96413.............  Infusion of              254,704       280.27       136.41         48.7  Single rate paid
                     chemotherapy into                                                        exclusively to
                     a vein up to 1                                                           either
                     hour.                                                                    practitioner or
                                                                                              facility: Full
                                                                                              nonfacility rate.
93798.............  Physician services       203,926       103.92        11.10         10.7  Nonfacility rate--
                     for outpatient                                                           Facility rate.
                     heart
                     rehabilitation
                     with continuous
                     EKG monitoring per
                     session.
96375.............  Injection of             189,140        42.31        22.56         53.3  Single rate paid
                     different drug or                                                        exclusively to
                     substance into a                                                         either
                     vein for therapy,                                                        practitioner or
                     diagnosis, or                                                            facility: Full
                     prevention.                                                              nonfacility rate.
93306.............  Ultrasound               179,840       416.80       165.77         39.8  Technical
                     examination of                                                           component: Full
                     heart including                                                          nonfacility rate.
                     color-depicted
                     blood flow rate,
                     direction, and
                     valve function.
77080.............  Bone density             155,513       100.69        31.15         30.9  Technical
                     measurement using                                                        component: Full
                     dedicated X-ray                                                          nonfacility rate.
                     machine.
77412.............  Radiation treatment      137,241       194.35       267.86        137.8  Technical component
                     delivery.                                                                (Full nonfacility
                                                                                              rate) based on
                                                                                              weighted averages
                                                                                              for the following
                                                                                              PFS codes: G6011;
                                                                                              G6012; G6013; and
                                                                                              G6014.
90853.............  Group psychotherapy      123,282        69.65         0.36          0.5  Nonfacility rate--
                                                                                              Facility rate.
96365.............  Infusion into a          122,641       173.18        69.82         40.3  Nonfacility rate--
                     vein for therapy,                                                        Facility rate.
                     prevention, or
                     diagnosis up to 1
                     hour.
20610.............  Aspiration and/or        106,769       223.76        13.96          6.2  Nonfacility rate--
                     injection of large                                                       Facility rate.
                     joint or joint
                     capsule.
11042.............  Removal of skin and       99,134       225.55        54.78         24.3  Nonfacility rate--
                     tissue first 20 sq                                                       Facility rate.
                     cm or less.

[[Page 53022]]

 
96367.............  Infusion into a           98,930        42.31        30.79         72.8  Single rate paid
                     vein for therapy                                                         exclusively to
                     prevention or                                                            either
                     diagnosis                                                                practitioner or
                     additional                                                               facility: Full
                     sequential                                                               nonfacility rate.
                     infusion up to 1
                     hour.
93017.............  Exercise or drug-         96,312       220.35        39.74         18.0  Technical
                     induced heart and                                                        component: Full
                     blood vessel                                                             nonfacility rate.
                     stress test with
                     EKG tracing and
                     monitoring.
77386.............  Radiation therapy         81,925       505.51       347.30         68.7  Technical
                     delivery.                                                                component:
                                                                                              Nonfacility rate
                                                                                              for CPT code G6015
                                                                                              (analogous code
                                                                                              used under the
                                                                                              PFS).
78452.............  Nuclear medicine          79,242     1,108.46       412.82         37.2  Technical
                     study of vessels                                                         component: Full
                     of heart using                                                           nonfacility rate.
                     drugs or exercise--
                     multiple studies.
74177.............  CT scan of abdomen        76,393       347.72       220.20         63.3  Technical
                     and pelvis with                                                          component: Full
                     contrast.                                                                nonfacility rate.
71260.............  CT scan chest with        75,052       236.86       167.21         70.6  Technical
                     contrast.                                                                component: Full
                                                                                              nonfacility rate.
71250.............  CT scan chest......       74,570       112.49       129.61        115.2  Technical
                                                                                              component: Full
                                                                                              nonfacility rate.
73030.............  X-ray of shoulder,        71,330        60.80        19.33         31.8  Technical
                     minimum of 2 views.                                                      component: Full
                                                                                              nonfacility rate.
90834.............  Psychotherapy, 45         70,524       125.04         0.36          0.3  Nonfacility rate--
                     minutes with                                                             Facility rate.
                     patient and/or
                     family member.
----------------------------------------------------------------------------------------------------------------
Weighted Average (claim line volume * rate) of the PFS payment compared to OPPS payment for  45%
 the 22 major codes:
----------------------------------------------------------------------------------------------------------------

    As noted with the clinic visits, we recognized that there were 
limitations to our data analysis, including that OPPS payment rates 
include the costs of packaged items or services billed with the 
separately payable code, and therefore the comparison to rates under 
the PFS was not a one-to-one comparison. Also, we included only a 
limited number of services, and noted that additional services may have 
different patterns than the services described. After considering the 
payment differentials for major codes billed by off-campus departments 
of hospitals with the ``PO'' modifier and based on the data limitations 
of our analysis, we adopted, with some exceptions noted below, a set of 
PFS payment rates that were based on a 50 percent PFS Relativity 
Adjuster to the OPPS payment rates (inclusive of packaging) for 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
in the CY 2017 interim final rule. Generally speaking, we arrived at 
the 50 percent PFS Relativity Adjuster by examining the 45 percent 
comparison noted above, the ASC payment rate--which was roughly 55 
percent of the OPPS payment rate on average--and the payment rate 
differential for the large number of OPPS and PFS E/M services, as 
described above. We recognized that the equivalent PFS nonfacility 
rates may be higher or lower on a code-specific basis than the rates 
that result from applying the overall PFS Relativity Adjuster to the 
OPPS payment rates on a code-specific basis. However, we believed that, 
on the whole, the percentage reduction did not underestimate the 
overall relativity between the OPPS and the PFS based on the limited 
data that were available. We were concerned, however, that the 50 
percent PFS Relativity Adjuster might overestimate PFS nonfacility 
payments relative to OPPS payments. For example, if we were able at the 
time to sufficiently estimate the effect of the packaging differences 
between the OPPS and PFS, we suspected that the equivalent portion of 
PFS payments for evaluation and management codes, and for PFS services 
on average, would likely have been less than 50 percent for the same 
services. We considered the 50 percent PFS Relativity Adjuster for CY 
2017 to be a transitional policy until such time that we had more 
precise data to better identify and value nonexcepted items and 
services furnished by nonexcepted off-campus PBDs and billed by 
hospitals.
    We established several significant exceptions to the application of 
the 50 percent PFS Relativity Adjuster. For example, we did not apply 
the 50 percent PFS Relativity Adjuster to services that are currently 
paid under the OPPS based on payment rates from other Medicare fee 
schedules (including the PFS) on an institutional claim. The items and 
services that are assigned status indicator ``A'' in Addendum B to the 
CY 2017 OPPS/ASC final rule with comment period (available on the CMS 
Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1656-FC.html) continue to be reported on an 
institutional claim and paid under the required Medicare fee schedule 
such as the PFS, the CLFS, or the Ambulance Fee Schedule without a 
payment reduction. Similarly, drugs and biologicals that are separately 
payable under the OPPS (identified by status indicator ``G'' or ``K'' 
in Addendum B to the CY 2017 OPPS/ASC final rule with comment period) 
are paid in accordance with section 1847A of the Act (that is, 
typically ASP + 6 percent), consistent with payment rules in the 
physician office setting. Drugs and biologicals that are 
unconditionally packaged under the OPPS and are not separately payable 
(that is, those drugs and biologicals assigned status indicator of 
``N'' in Addendum B to the CY 2017 OPPS/ASC final rule with comment 
period) are bundled into the PFS payment and are not separately paid to 
hospitals billing for nonexcepted items and services furnished by 
nonexcepted off-campus PBDs. The full range of exceptions and 
adjustments to the otherwise applicable OPPS payment rate that were 
adopted in the new PFS site-of-service payment rates in the CY 2017 
interim final rule can be found on the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/
HospitalOutpatientPPS/Downloads/

[[Page 53023]]

CMS-1656-FC-2017-OPPS-Status-Indicator.zip.
    All nonexcepted items and services furnished by nonexcepted off-
campus PBDs and billed by a hospital on an institutional claim with 
modifier ``PN'' (Nonexcepted service provided at an off-campus, 
outpatient, provider-based department of a hospital) are currently paid 
under the PFS at the rate established in the CY 2017 interim final 
rule. Specifically, nonexcepted off campus PBDs must report modifier 
``PN'' on each UB-04 claim line to indicate a nonexcepted item or 
service, and otherwise continue to bill as they currently do. Further 
billing instructions on the PN modifier can be found in the January 
2017 OPPS Quarterly Update (transmittal 3685, Change Request 9930) 
released December 22, 2016, available on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3685CP.pdf.
b. PFS Relativity Adjuster
    As noted in the CY 2017 interim final rule, we considered the CY 
2017 PFS Relativity Adjuster of 50 percent to be a transitional policy 
until such time that we had more precise data to better identify and 
value nonexcepted items and services furnished by nonexcepted off-
campus PBDs and billed by hospitals. At present, we do not have more 
precise data than were available when we established the PFS Relativity 
Adjuster in the CY 2017 interim final rule, and we do not anticipate 
having such data until after the end of CY 2017, at the earliest. 
However, in developing a policy for CY 2018, we have continued to 
explore options for modifying the calculation of the CY 2018 PFS 
Relativity Adjuster.
    There is no consensus among stakeholders regarding the appropriate 
PFS Relativity Adjuster. Many stakeholders have suggested that making 
separate facility fee payments to hospitals under the PFS for all 
services that are separately paid under the OPPS itself undermines site 
neutral payment because practitioners are only paid a single combined 
fee for many services when furnished in an office setting, while there 
are two separate fees (professional and facility) paid when the service 
is furnished in the hospital setting. We acknowledge that there are 
many cases where single fees are paid to practitioners for services 
furnished in an office setting while fees for comparable services when 
furnished in the hospital setting are paid to both the professional and 
facility entities. However, we do not agree that this necessarily means 
that overall payment cannot be site neutral. We point out that the sum 
of the professional and the facility portions of payment for a service 
furnished in a nonexcepted off-campus PBD or in a different 
institutional setting could be equivalent to a single fee paid to the 
professional in the office setting. In the case of some services, in 
fact, the single payment made under the PFS at the nonfacility rate 
exceeds the sum of the separate payments Medicare makes to the 
professional at the facility rate under the PFS and to the facility 
under the OPPS. We also note that there are many separately reportable 
services under the PFS (for example, the vast majority of services 
described by add-on codes) for which separate payment is made to 
physician offices but no separate payment is made under either the OPPS 
or under the site-specific PFS payments made to hospitals billing for 
nonexcepted items and services furnished by nonexcepted off-campus 
PBDs. For these reasons, we believe that the overall total payment made 
for services is more relevant to the goal of site neutrality than the 
quantity of individual payments made. Nonetheless, we continue to 
recognize and share stakeholders' concerns regarding the importance of 
equivalent overall payment for services, regardless of setting.
    In considering the appropriate PFS Relativity Adjuster for CY 2018, 
we continue to believe that claims data from CY 2017, which are not yet 
available, are needed to guide potential changes to our general 
approach. In the absence of such data, however, we have continued to 
consider the appropriate PFS Relativity Adjuster based on the 
information that is available. In the analysis we used to establish the 
PFS Relativity Adjuster for CY 2017, we attempted to identify the 
appropriate value by comparing OPPS and PFS payment rates for services 
frequently reported in off-campus departments of a hospital and 
described by the same codes under the two payment systems. As we 
acknowledged in the CY 2017 interim final rule, that data analysis did 
not include the most frequently billed service furnished in off-campus 
departments of a hospital, outpatient clinic visits. Outpatient clinic 
visits are reported using a single G-code under the OPPS and by one of 
ten different codes under the PFS.
    Consistent with our previously stated concern that the PFS 
Relativity Adjuster for CY 2017 might be too small, generally resulting 
in greater overall payments to hospitals for services furnished by 
nonexcepted off-campus PBDs than would otherwise be paid under the PFS 
in the non-facility setting, we believed it was appropriate to propose 
changing the PFS Relativity Adjuster in order to ensure that payment 
made to these nonexcepted off-campus PBDs better aligns with these 
services that are the most frequently furnished in this setting.
    In the CY 2018 PFS proposed rule, we proposed to revise the PFS 
Relativity Adjuster for nonexcepted items and services furnished by 
nonexcepted off-campus PBDs to be 25 percent of the OPPS payment rate. 
We arrived at this PFS Relativity Adjuster by making a code-level 
comparison for the service most commonly billed in the off-campus PBD 
setting under the OPPS: A clinic visit reported using HCPCS code G0463. 
In order to determine the analogous payment for the technical aspects 
of this service under the PFS in nonfacility settings, we compared the 
CY 2017 OPPS national payment rate for HCPCS code G0463 ($102.12) to 
the difference between the nonfacility and facility PFS payment amounts 
under the PFS using CY 2016 rates for the weighted average of 
outpatient visits (CPT codes 99201-99205 and CPT codes 99211-99215) 
billed by physicians and other professionals in an outpatient hospital 
department as the place of service.
    The proposed PFS Relativity Adjuster of 25 percent was based solely 
on the comparison for the single service that reflects more than 50 
percent of services billed in off-campus PBDs. We continue to recognize 
that the comparison between the OPPS and PFS rates for other services 
varies greatly, and that there are other factors, including the 
specific mix of services furnished by nonexcepted off-campus PBDs, 
policies related to packaging of codes under OPPS, and payment 
adjustments like MPPRs and bundling under the PFS that rely on 
empirical information about whether or not codes are billed on the same 
day, that contribute to the differences in aggregate payment amounts 
for a broader range of services. However, for CY 2018, as for CY 2017, 
we are setting the PFS Relativity Adjuster using currently available 
data from CY 2016 because we have not had the opportunity to study the 
CY 2017 claims data that may allow us to consider and incorporate many 
more factors, including the ones stated above. When we established the 
PFS Relativity Adjuster for CY 2017 at 50 percent, we stated that we 
did so with the goal of ensuring adequate payment but remained 
concerned that the resulting reduction was too conservative. For CY 
2018, we were focused on ensuring that we did not overestimate the 
appropriate overall payment relativity for these nonexcepted items and 
services. Until

[[Page 53024]]

we are able to analyze the CY 2017 claims data, we believed that the 
comparison between PFS and OPPS payment for the most common services 
furnished in off-campus PBDs, an outpatient clinic visit, was a better 
proxy to base the adjuster than our previous approach.
    We welcomed stakeholder input with regard to this analysis and the 
resulting PFS Relativity Adjuster. We also requested comment on whether 
we should adopt a different PFS Relativity Adjuster, such as 40 
percent, that represents a relative middle ground between the CY 2017 
PFS Relativity Adjuster, selected to ensure adequate payment to 
hospitals and our proposed CY 2018 PFS Relativity Adjuster, selected to 
ensure that hospitals are not paid more than others would be paid 
through the PFS nonfacility rate. We intend to continue to study this 
issue and welcomed comments regarding potential future refinements to 
payment rates for nonexcepted items and services furnished by 
nonexcepted off-campus PBDs as we gain more experience with these new 
site-of-service PFS rates.
    Finally, we noted that for CY 2018, as in recent years, the annual 
update to OPPS payments exceeds the annual update to PFS payments. 
Because we proposed to make a single, across-the-board and, by 
necessity, imprecise adjustment to OPPS payment rates to establish PFS 
payment rates for nonexcepted items and services furnished by 
nonexcepted off-campus PBDs, we expected that the actual difference 
between OPPS and PFS payment rates for nonexcepted items and services 
furnished by nonexcepted off-campus PBDs falls in a range which 
includes our proposed PFS Relativity Adjuster (that is, the actual 
differential may differ from our proposed PFS Relativity Adjuster). As 
such, taking into account the differential between the OPPS and PFS 
annual updates by making an adjustment to the PFS Relativity Adjuster, 
our proposal for CY 2018 presumed a level of precision in our estimates 
that is simply not present in our analysis. Therefore, we did not 
adjust our proposal to reflect the relative updates to PFS and OPPS 
between CY 2017 and CY 2018, and instead noted that the differential 
between the OPPS and PFS payment update for CY 2018 is a factor that 
suggests that the PFS Relativity Adjuster may underestimate PFS 
nonfacility payment relative to OPPS payments; in future years, we 
intend to more precisely account for any differential between these two 
update factors.
c. Geographic Adjustments
    For CY 2017, we established class-specific geographic practice cost 
indices (GPCIs) under the PFS exclusively used to adjust these site-
specific, technical component rates for nonexcepted items and services 
furnished in nonexcepted off-campus PBDs. These class-specific GPCIs 
are parallel to the geographic adjustments made under the OPPS based on 
the hospital wage index. We believed it was appropriate to adopt the 
hospital wage index areas for purposes of geographic adjustment because 
nonexcepted off-campus PBDs are still considered to be part of a 
hospital, and the PFS payments to these entities will be limited to the 
subset of PFS services furnished by hospitals. We also believed it was 
appropriate, as an initial matter for CY 2017, to adopt the actual wage 
index values for these hospitals in addition to the wage index areas. 
The PFS GPCIs that would otherwise currently apply are not based on the 
hospital wage index areas. For CY 2018, we proposed to continue using 
the authority under section 1848(e)(1)(B) of the Act to maintain a 
class-specific set of GPCIs for these site-specific technical component 
rates that are based both on the hospital wage index areas and the 
hospital wage index value themselves. For purposes of payment to 
hospitals, this means that the geographic adjustments used under the 
OPPS continue to apply.
d. Coding Consistency
    For most services, the same HCPCS codes are used to describe 
services paid under both the PFS and the OPPS. There are two notable 
exceptions that describe high-volume services. The first is the set of 
codes that describe evaluation and management (E/M) services which are 
reported under the PFS using the 5 levels of CPT codes describing new 
or established patient visits (for a total of 10 codes). However, since 
CY 2014, these visits have been reported under the OPPS using the 
single HCPCS code G0463 (Hospital Outpatient Clinic Visit) (see 78 FR 
75042). We proposed to maintain the current coding and PFS payment rate 
for HCPCS code G0463 based on the OPPS payment rate modified by the PFS 
Relativity Adjuster.
    The second exception is a set of radiation treatment delivery and 
imaging guidance services that are reported using different codes under 
the PFS and the OPPS. CMS established HCPCS Level II G-codes to 
describe radiation treatment delivery services when furnished in the 
physician office setting (see 79 FR 67666 through 67667). However, 
these HCPCS G-codes are not recognized under the OPPS; rather, CPT 
codes are used to describe these services when furnished in the HOPD. 
Both sets of codes were implemented for CY 2015 and were maintained for 
CY 2016. Under the PFS, there is a statutory provision under section 
1848(c)(2)(K) of the Act that requires maintenance of the CY 2016 
coding and payment inputs for these services for CY 2017 and also for 
CY 2018. Accordingly, the CY 2018 PFS rates for these services are 
calculated based on the maintenance of the CY 2016 coding and payment 
inputs. Because nonexcepted items and services furnished by a 
nonexcepted off-campus PBD are paid under the PFS starting in CY 2017, 
and we are required to maintain the CY 2016 coding and payment inputs 
for these services under the CY 2018 PFS, we proposed to maintain 
coding and payment amounts for nonexcepted items and services furnished 
by a nonexcepted off-campus PBD consistent with the payments that would 
be made to other facilities under the PFS. That is, nonexcepted off-
campus PBDs submitting claims for these nonexcepted items and services 
will continue to bill the HCPCS G-codes established under the PFS to 
describe radiation treatment delivery services. Under this proposal, 
the nonexcepted off-campus PBD must append modifier ``PN'' to each 
applicable claim line for these nonexcepted items and services, even 
though the PFS Relativity Adjuster will not apply, on the institutional 
claim. The payment amount for these services would be set to reflect 
the technical component rate for the code under the PFS.
4. OPPS Payment Adjustments
    In the CY 2017 interim final rule, we adopted the packaging payment 
rates and MPPR percentage that applied under the OPPS to establish the 
PFS payment rates for nonexcepted items and services furnished by 
nonexcepted off-campus PBDs and billed by hospitals. That is, the 
claims processing logic that was used for payments under the OPPS for 
comprehensive APCs (C-APCs), conditionally and unconditionally packaged 
items and services, and major procedures, was incorporated into the 
newly established PFS rates. We continue to believe it is necessary to 
incorporate the OPPS payment policies for C-APCs, packaged items and 
services, and the MPPR in order to maintain the integrity of the PFS 
Relativity Adjuster because the adjuster is intended, in part, to 
account for the methodological differences between the OPPS and the PFS 
rates that would otherwise apply. We also

[[Page 53025]]

direct interested stakeholders to related policies under the OPPS, 
since prospective changes in the applicable adjustments and policies 
would generally apply to nonexcepted items and services furnished by 
nonexcepted off-campus PBDs for CY 2018. We were interested in comments 
regarding the applicability of particular prospective OPPS adjustments 
to nonexcepted items and services.
    In order to apply these OPPS payment policies and adjustments to 
nonexcepted items and services, we proposed that hospitals continue to 
bill on an institutional claim form that will pass through the 
Outpatient Code Editor and into the OPPS PRICER for calculation of 
payment. This approach will yield data based on claims for nonexcepted 
items and services furnished by nonexcepted off-campus PBDs, which can 
be used to refine PFS payment rates for these services in future years.
    There were several OPPS payment adjustments that we did not adopt 
in the CY 2017 interim final rule, including, but not limited to, 
outlier payments, the rural sole community hospital (SCH) adjustment, 
the cancer hospital adjustments, transitional outpatient payments, the 
hospital outpatient quality reporting payment adjustment, and the 
inpatient hospital deductible cap to the cost-sharing liability for a 
single hospital outpatient service. We believed these payment 
adjustments were expressly authorized for, and should be limited to, 
hospitals that are paid under the OPPS for covered OPD services in 
accordance with section 1833(t) of the Act. We believed that these 
policies should not apply to nonexcepted items and services furnished 
by nonexcepted off-campus PBDs, and did not propose that they apply for 
CY 2018.
5. Partial Hospitalization Services
    For partial hospitalization programs (PHP), which are intensive 
outpatient psychiatric day treatment programs furnished to patients as 
an alternative to inpatient psychiatric hospitalization or as a 
stepdown to shorten an inpatient stay and transition a patient to a 
less intensive level of care, section 1861(ff)(3)(A) of the Act 
specifies that a PHP is a program furnished by a hospital, to its 
outpatients, or by a Community Mental Health Center (CMHC). In the CY 
2017 OPPS/ASC proposed rule (81 FR 45690), in the discussion of the 
proposed implementation of section 603 of Bipartisan Budget Act of 
2015, we noted that because CMHCs also furnish PHP services and are 
ineligible to be provider-based to a hospital, a nonexcepted off-campus 
PBD would be eligible for PHP payment if the entity enrolls and bills 
as a CMHC for payment under the OPPS. We further noted that a hospital 
may choose to enroll a nonexcepted off-campus PBD as a CMHC, provided 
it meets all Medicare requirements and conditions of participation.
    Commenters expressed concern that without a clear payment mechanism 
for PHP services furnished by nonexcepted off-campus PBDs, access to 
partial hospitalization services would be limited, and pointed out the 
critical role PHPs play in the continuum of mental health care. Many 
commenters believed that Congress did not intend for partial 
hospitalization services to no longer be paid for by Medicare when such 
services are furnished by nonexcepted off-campus PBDs. Several 
commenters disagreed with the notion of enrolling as a CMHC in order to 
receive payment for PHP services. These commenters stated that 
hospital-based PHPs and CMHCs are inherently different in structure, 
operation, and payment, and noted that the conditions of participation 
for hospital departments and CMHCs are different. Several commenters 
requested that CMS find a mechanism to pay hospital-based PHPs in 
nonexcepted off-campus PBDs.
    Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC 
final rule with comment period and interim final rule with comment 
period (81 FR 79715, 79717, and 79727), we adopted payment for partial 
hospitalization items and services furnished by nonexcepted off-campus 
PBDs under the PFS. When billed in accordance with the CY 2017 interim 
final rule, these partial hospitalization services are paid at the CMHC 
per diem rate for APC 5853, for providing three or more partial 
hospitalization services per day (81 FR 79727).
    In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), the CY 2017 
OPPS/ASC final rule with comment period, and interim final rule with 
comment period (81 FR 79717 and 79727), we noted that when a 
beneficiary receives outpatient services in an off-campus department of 
a hospital, the total Medicare payment for those services is generally 
higher than when those same services are provided in a physician's 
office. Similarly, when partial hospitalization services are provided 
in a hospital-based PHP, Medicare pays more than when those same 
services are provided by a CMHC. Our rationale for adopting the CMHC 
per diem rate for APC 5853 as the PFS payment amount for nonexcepted 
off-campus PBDs providing PHP services is because CMHCs are 
freestanding entities that are not part of a hospital, but they provide 
the same PHP services as hospital-based PHPs (81 FR 79727). This is 
similar to the differences between freestanding entities paid under the 
PFS that furnish other services also provided by hospital-based 
entities. Similar to other entities currently paid for their technical 
component services under the PFS, we believe CMHCs would typically have 
lower cost structures than hospital-based PHPs, largely due to lower 
overhead costs and other indirect costs such as administration, 
personnel, and security. We believe that paying for nonexcepted 
hospital-based partial hospitalization services at the lower CMHC per 
diem rate aligns with section 603 of Bipartisan Budget Act of 2015, 
while also preserving access to PHP services. In addition, nonexcepted 
off-campus PBDs will not be required to enroll as CMHCs in order to 
bill and be paid for providing partial hospitalization services. 
However, a nonexcepted off-campus PBD that wishes to provide PHP 
services may still enroll as a CMHC if it chooses to do so and meets 
the relevant requirements. Finally, we recognize that because hospital-
based PHPs are providing partial hospitalization services in the 
hospital outpatient setting, they can offer benefits that CMHCs do not 
have, such as an easier patient transition to and from inpatient care, 
and easier sharing of health information between the PHP and the 
inpatient staff.
    In the CY 2018 PFS proposed rule, we did not propose to require 
these PHPs to enroll as CMHCs but instead we proposed to continue to 
pay nonexcepted off-campus PBDs providing PHP items and services under 
the PFS. Further, in that CY 2018 PFS proposed rule, we proposed to 
continue to adopt the CMHC per diem rate for APC 5853 as the PFS 
payment amount for nonexcepted off-campus PBDs providing three or more 
PHP services per day in CY 2018.
    The following is a summary of the public comments received on 
potential changes to our methodology and our responses:
    Comment: We received several comments in response to the CY 2018 
PFS proposals pertaining to nonexcepted off-campus PBDs providing PHP 
services. Many of the commenters believed that paying nonexcepted off-
campus PBDs providing PHP services at the CMHC per diem rate does not 
compensate enough for financial viability and would jeopardize access 
to critically needed mental health services. Other

[[Page 53026]]

commenters were concerned that the payment rate under section 603 of 
the Bipartisan Budget Act of 2015 or the lower CMHC payment rate would 
affect access by hindering needed expansion of PHPs or limiting the 
ability of PHPs to address the growing substance abuse/opioid crisis. 
One commenter stated that now is not the time to reduce resources and 
treatments for behavioral health, and expressed concern that payment 
reductions could push some behavioral health care providers beyond the 
point of financial viability. One commenter suggested that the proposed 
cuts could force outpatients requiring intensive services, like 
beneficiaries in PHPs, back into the inpatient setting.
    One commenter had concerns about the accuracy and stability of the 
CMHC claims data or CMHC rates, and asked for fair and equitable 
payments. A few commenters suggested alternatives, such as exempting 
PHP APC codes from section 603 of the Bipartisan Budget Act of 2015 
entirely, researching other payment methods, or paying at the hospital-
based PHP rate.
    Response: We believe that the CMHC per diem rate provides 
appropriate payment for partial hospitalization services. In the CY 
2017 OPPS/ASC proposed rule (81 FR 45681) and earlier in this section 
of this CY 2018 MPFS final rule, we noted that when a beneficiary 
receives services in an excepted off-campus PBD, the Medicare payment 
for those services is generally higher than when those same services 
are provided in a physician's office. Similarly, when partial 
hospitalization services are provided in a hospital-based PHP, Medicare 
pays more than when those same services are provided by a CMHC. CMHCs 
are freestanding providers that are not part of a hospital, and that 
have lower cost structures than hospital-based PHPs. This is similar to 
the differences between freestanding entities paid under the MPFS that 
furnish other services also provided by hospital-based entities. We 
believe that the cost structure for nonexcepted off-campus PBDs 
providing PHP items and services is similar to CMHCs. We continue to 
believe that paying for nonexcepted hospital-based partial 
hospitalization services at the lower CMHC per diem rate is in 
alignment with section 603 of Bipartisan Budget Act of 2015 and results 
in fair and equitable payments, while also preserving access to the PHP 
benefit. As such, we do not believe that the lower CMHC payments made 
to nonexcepted off-campus PBDs providing PHP services would result in 
these PHP patients being shifted into inpatient care.
    Regarding the comment about the accuracy of CMHC claims and rates, 
we refer readers to the CY 2016 OPPS/ASC final rule with comment period 
(80 FR 70462 through 70466) and the CY 2017 OPPS/ASC final rule with 
comment period (81 FR 79680 through 79686) for details on the 
ratesetting methodology, including policies that we believe result in 
stable and accurate PHP payment rates. Furthermore, we note that the 
final CY 2018 CMHC per diem rate is higher than that proposed in the CY 
2018 OPPS/ASC proposed rule (82 FR 33639). The final CY 2018 CMHC per 
diem rate is 68.8 percent of the final CY 2018 hospital-based PHP per 
diem rate under the OPPS (see the CY 2018 OPPS/ASC final rule with 
comment period for details). This is a significantly higher percentage 
of payment than was proposed for most other items or services provided 
in nonexcepted off-campus PBDs that derive their payment amount from CY 
2018 OPPS APC rates, and we believe it will help to address commenters' 
concerns about ensuring access to valuable PHP services.
    In response to the alternatives that commenters suggested, we are 
unable to pay nonexcepted off-campus PBDs that are PHPs at the same 
rate that hospital-based PHPs are paid under the OPPS or to exempt PHP 
APC codes from the requirements of section 603 of the Bipartisan Budget 
Act of 2015 because doing so would not meet the requirements of the 
amendments made by section 603 of the Bipartisan Budget Act of 2015. 
Regarding the comment about considering other payment methodologies for 
PHP services, we will take these comments under advisement in 
considering whether to propose a different methodology for PHP services 
in future rulemaking.
    In summary, after considering the public comments, we are 
finalizing our proposals as proposed. Therefore, in CY 2018, we are 
identifying the PFS as the applicable payment system for PHP services 
furnished by a nonexcepted off campus PBDs, and we are setting the PFS 
payment rate for these PHP services as the per diem rate that would be 
paid to a CMHC in CY 2018.
6. Supervision Rules
    The supervision rules that apply for hospitals continue to apply 
for nonexcepted off-campus PBDs that furnish nonexcepted items and 
services. The amendments made by section 603 of the Bipartisan Budget 
Act of 2015 did not change the status of these PBDs, only the status 
of, and payment mechanism for, the services they furnish. These 
supervision requirements are specified in Sec.  410.27.
7. Beneficiary Cost-Sharing
    Under the PFS, the beneficiary copayment is generally 20 percent of 
the fee schedule amount, unless there is an applicable exception in 
accordance with the statute. All cost-sharing rules that apply under 
the PFS in accordance with section 1848(g) of the Act and section 
1866(a)(2)(A) of the Act continue to apply for all nonexcepted items 
and services furnished by nonexcepted off-campus PBDs, regardless of 
the cost-sharing obligation under the OPPS.
8. CY 2019 and Future Years
    We continue to believe the amendments made to the statute by 
section 603 of the Bipartisan Budget Act of 2015 intended to eliminate 
the Medicare payment incentive for hospitals to purchase physician 
offices, convert them to off-campus PBDs, and bill under the OPPS for 
items and services they furnish there. Therefore, we continue to 
believe the payment policy under this provision should ultimately 
equalize payment rates between nonexcepted off-campus PBDs and 
physician offices to the greatest extent possible, while allowing 
nonexcepted off-campus PBDs to bill in a straight-forward way for 
services they furnish.
    We note that a full year of claims data regarding the mix of 
services reported using the ``PN'' modifier (from CY 2017) will first 
be available for use in PFS ratesetting for CY 2019. Under the current 
methodology, we would expect to use that data in order to ensure that 
Medicare payment to hospitals billing for nonexcepted items and 
services furnished by nonexcepted off-campus PBDs under the PFS would 
reflect the relative resources involved in furnishing the items and 
services relative to other PFS services. We recognize that under our 
current approach, payment rates would not be equal on a procedure-by-
procedure basis. However, the application of the PFS Relativity 
Adjuster would move toward equalizing payment rates in the aggregate 
between physician offices and nonexcepted off-campus PBDs to the extent 
appropriate. Therefore, for certain specialties, service lines, and 
nonexcepted off-campus PBD types, total Medicare payments for the same 
services might be either higher or lower when furnished by a 
nonexcepted off-campus PBD rather than in a physician office.
    Depending on the mix of services for particular off-campus PBDs, we 
remain concerned that such specialty-specific patterns in payment 
differentials could result in continued incentives for hospitals to buy 
certain types of

[[Page 53027]]

physician offices and convert them to excepted off-campus PBDs; these 
are the incentives we believe Congress intended to avoid. However, 
continuing a policy similar to the one we proposed in the proposed rule 
would allow hospitals to continue billing through a facility claim form 
and would allow for continuation of the packaging rules and cost 
report-based relative payment rate determinations under OPPS, which we 
believe are preferable to using the current valuation methodologies 
under the PFS that are not well-suited for nonexcepted items and 
services furnished by nonexcepted off-campus PBDs. Therefore, for CY 
2019 and for future years, we intend to examine the claims data in 
order to determine not only the appropriate PFS Relativity Adjuster(s), 
but also to determine whether additional adjustments to the methodology 
are appropriate--especially with the goal of attaining site neutral 
payments to promote a level playing field under Medicare between 
physician office settings and nonexcepted off-campus PBD settings, 
without regard to the kinds of services furnished by particular off-
campus PBDs. We solicited comments on potential changes to our 
methodology that would better account for these specialty-specific 
patterns.
    The following is a summary of the public comments received on the 
potential changes to our methodology and the PFS Relativity Adjuster.
    Comment: We received many comments from stakeholders opposing our 
proposal to reduce the PFS Relativity Adjuster to 25 percent. The 
majority of commenters questioned why CMS would propose a different PFS 
Relativity Adjuster for CY 2018 than is currently in place for CY 2017 
given the absence of any additional data to inform a more precise 
estimate. A number of commenters, including MedPAC, also mentioned the 
large variation in the rate differential between the PFS and the OPPS 
across the top 22 services, and stated that a PFS Relativity Adjuster 
calculated from a single outpatient clinic visit does not represent the 
mix of services provided by PBDs.
    In addition, several commenters stated their concern that CMS's 
approach in developing the PFS Relativity Adjuster fails to account for 
the extensive packaging that occurs for outpatient clinic visits 
(billed using HCPCS code G0463 under the OPPS) and other common 
services. They stated that additional services are often provided with 
a single code, and that the PFS Relativity Adjuster does not account 
for the resources required to furnish these additional services. They 
note that CMS does not account for packaging that occurs under the 
OPPS, despite recognizing the importance of such differences between 
the payment systems. Some commenters offered their own estimates of the 
value of packaging that occurs under the OPPS for the top 22 HCPCS 
codes and provided suggestions for incorporating those estimates into 
our analysis.
    Response: We agree with the commenters' concerns about the proposed 
change to the PFS Relativity Adjuster for CY 2018, specifically that 
the single code level comparison of the service most commonly billed in 
the off-campus setting under the OPPS doesn't adequately reflect the 
large variation in services furnished in off-campus PBDs. Furthermore, 
we recognize the possibility that our proposed PFS Relativity Adjuster 
of 25 percent may overcorrect for the possibility that the CY 2017 PFS 
Relativity Adjuster of 50 percent was an overestimate of the relativity 
between the OPPS and PFS. We also agree with commenters who stressed 
the need to account for packaging rules that apply under the OPPS. 
However, we have clearly outlined the challenges we face in calibrating 
the PFS Relativity Rate to account for the effect of packaging.
    After consideration of the public comments, we believe that an 
approach in which we integrate the code-level comparison for the 
service most commonly billed in the off-campus PBD setting under the 
OPPS (a clinic visit reported using HCPCS code G0463), which was the 
basis of our proposed PFS Relativity Adjuster for CY 2018 of 25 
percent, with the comparison of relative PFS to OPPS rates for the top 
25 (most frequently billed) major codes, which was the basis of our PFS 
Relativity Adjuster for CY 2017 of 50 percent, addresses many of the 
concerns and comments we received.
    For this approach, we updated the list of the 25 major codes billed 
by off-campus hospital departments using the ``PO'' modifier to reflect 
a full year of claims data for CY 2016 (see Table 10). We did not 
exclude HCPCS code G0463 from the analysis, but we retained all other 
parameters that we described in the CY 2017 interim final rule, 
including the exclusion of separately payable drugs and biologics, 
services assigned an OPPS status indicator ``A''. We removed HCPCS code 
36591 (Collection of blood specimen from a completely implantable 
venous access device) because, under PFS policies, the code is used 
only to pay separately under the PFS when no other service was on the 
claim. We also removed HCPCS code G0009 (Administration of Pneumococcal 
Vaccine) and HCPCS code G0008 (Administration of influenza vaccine) 
because there is no payment for these codes under the PFS. Two of these 
codes, CPT 36591 and HCPCS G0009, were also removed from our 
calculation of the top major codes when we calculated the PFS 
Relativity Adjuster in the CY 2017 interim final rule. HCPCS code G0008 
was not on the list of the top major codes when we initially analyzed 
claims data for CY 2016 available through August 26, 2016, but it 
appears on the list of the top codes that contained a ``PO'' modifier 
when we analyzed the same data through the end of CY 2016.
    We determined the analogous payment for each of the top major HCPCS 
codes, including HCPCS code G0463, using the same logic that we applied 
in our calculation of the top 22 codes for the CY 2017 interim final 
rule. Table 10 shows data for the OPPS rates, the analogous PFS rates, 
and the full year utilization for these codes. The resulting 
utilization-weighted average comparison between the PFS and the OPPS 
for the top 22 codes, following the approach described above, is 35 
percent. In other words, on average, the applicable payment amount 
under the PFS is 35 percent of the amount that would have been paid 
under the OPPS.
    In the CY 2018 PFS proposed rule, we sought comment on whether a 
different PFS Relativity Adjuster, such as 40 percent, would reflect a 
middle ground between the CY 2017 PFS Relativity Adjuster of 50 
percent, selected to ensure adequate payment to hospitals, and our 
proposed CY 2018 PFS Relativity Adjuster of 25 percent, selected to 
ensure that hospitals are not paid more than others would be paid 
through the PFS nonfacility rate. Since, as we acknowledged in response 
to public comments, we are unable at this time to fully calculate the 
effects of packaging under the OPPS, we believe that a 40 percent PFS 
Relativity Adjuster, which is an upward adjustment to the 35 percent 
calculation described above, is appropriate. We are, therefore, 
finalizing a PFS Relativity Adjuster of 40 percent for CY 2018.
    Comment: Several commenters requested clarification with regard to 
payment for drugs that are packaged under the OPPS. One commenter 
stated its belief that many drugs and biological therapies are not paid 
separately under the OPPS and therefore would be subject to the 
adjuster in the PBD setting. The commenter suggested that the new Level 
I and II drug administration codes conditionally packaged under the 
OPPS, as finalized in the OPPS CY 2018, would be subject

[[Page 53028]]

to the PFS Relativity Adjuster. Other commenters requested 
clarification regarding how CMS will handle 340B drug payment for 
nonexcepted off-campus PBDs under section 603 of the Bipartisan Budget 
Act of 2015. One commenter wrote that CMS did not specify whether it 
will reduce the payment for 340B drugs furnished in nonexcepted off-
campus PBDs, and that there could be a large payment differential for 
these drugs furnished in nonexcepted vs. excepted off-campus PBDs.
    Response: We appreciate the commenters' request for clarification. 
In prior rulemaking, we established the policy that drugs and 
biologicals that are separately payable under the OPPS (identified by 
status indicator ``G'' or ``K'' under the OPPS) are paid in accordance 
with section 1847A of the Act, consistent with payment rules in the 
physician office setting. Drugs and biologicals that are 
unconditionally packaged under the OPPS will continue to be packaged 
when furnished in a nonexcepted off-campus PBD. Drug administration 
services subject to conditional packaging (identified by status 
indicator ``Q1'' under the OPPS) will be packaged under the OPPS if the 
relevant criteria are met; otherwise they are separately paid. We refer 
commenters to the file ``Nonexcepted Items and Services Payment by OPPS 
Status Indicator'', available on the CMS Web site under downloads for 
the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html, for information about the services, by OPPS status 
indicator, which are subject to the PFS Relativity Adjuster. Drugs that 
are acquired under the 340B program and furnished by nonexcepted off-
campus PBDs are paid under the PFS and are not subject to the OPPS drug 
payment policies. We did not propose to adjust payment for 340B-
acquired drugs in nonexcepted off-campus PBDs in CY 2018 but will be 
monitor drug utilization in these PBDs. Please refer to section V.B.7 
of the CY 2018 OPPS/ASC final rule with comment for a detailed 
discussion of the 340B payment policy.
    Comment: Several commenters stated their belief that the 
appropriate comparison between the PFS and OPPS for purpose of 
determining the PFS Relativity Adjuster is the full PFS nonfacility 
rate rather than the difference between the facility and the 
nonfacility rate.
    Response: We disagree with commenters that the total PFS 
nonfacility rate should be used to assess relativity between the PFS 
and OPPS. As we have stated previously, the practice expense portion of 
the nonfacility rate reflects both direct and indirect costs that would 
be incurred by the physician in furnishing the service. The facility 
rate reflects the relative resources involved in furnishing the service 
in a facility setting, where the billing professional does not incur 
practice expense costs because they are incurred by the facility. We 
believe the most appropriate code-level comparison between the PFS and 
the OPPS would reflect the technical component (TC) of each HCPCS code 
under the PFS. However, we do not currently calculate a separate 
technical component rate for all HCPCS codes under the PFS--only for 
those for which the professional and technical components of the 
service are distinct and can be separately billed by two different 
practitioners or other suppliers under the PFS. We continue to believe 
that, for HCPCS codes for which there is a different payment for 
facility and nonfacility settings, it is appropriate to compare the 
difference under the PFS between the nonfacility and the facility rate 
with the OPPS rate.
    Comment: We received a few comments suggesting that the PFS rate 
for services should be established as a payment floor for nonexcepted 
items and services furnished by nonexcepted off-campus PBDs or, 
alternatively, that some items and services should be excluded from the 
PFS Relativity Adjuster. A few commenters noted that the reduced rate 
from applying the PFS Relativity Adjuster would be lower, for certain 
services, than what is paid for the technical component for these 
services under the PFS. A few commenters specifically cited CPT codes 
for PET imaging procedures (CPT codes 78459, 79491, 78492, 78608, and 
78811-78816), which are subject to payment policies under the Deficit 
Reduction Act (DRA) of 2005.
    Response: We appreciate the commenters' concerns. We recognize that 
the PFS payment for some services will be lower or higher, on a code by 
code basis, than the PFS payment for nonexcepted items and services 
furnished by nonexcepted PBDs calculated using the PFS Relativity 
Adjuster. We also recognize that there are certain CPT codes that are 
subject to payment rules limiting the payment amount for services. We 
will consider whether it would be appropriate to set a floor using the 
PFS, or otherwise address codes subject to statutory payment 
restrictions, in future rulemaking.
    Comment: We received support from several commenters about our 
proposal to reduce the PFS Relativity Adjuster to 25 percent. 
Generally, the commenters indicated that the proposed rate more 
accurately represents the intent of the statute, which is to reduce 
financial incentives for hospitals to purchase freestanding physician 
practices. Several commenters, including a major national health 
insurer, were supportive of efforts in general to establish more 
equitable payment across sites of service.
    Response: We thank commenters for their support. We are encouraged 
by the amount of interest generated in response to the implementation 
of section 603 of the Bipartisan Budget Act of 2015. As we stated 
above, we were persuaded by commenters that the establishment of the 
proposed PFS Relativity Adjuster of 25 percent derived from a single 
HCPCS code for outpatient clinic visits may overcorrect for the risk 
that the CY 2017 PFS adjuster overstated relativity between the OPPS 
and the PFS. We believe that our revised approach, which builds the 
relative payment for clinic visits between the PFS and the OPPS into 
our prior analysis of the top 22 HCPCS codes, is a more appropriate 
approach for payment in CY 2018, in response to these concerns. 
Therefore, using such an approach, we are finalizing a PFS Relativity 
Adjuster of 40 percent for CY 2018.
    Comment: Several commenters pointed out that nonexcepted off-campus 
PBDs face higher operational and regulatory costs than freestanding 
physician offices, and that intent of the statute could not have been 
to equalize payments between nonexcepted off-campus PBDs and 
freestanding physician offices.
    Response: We do not disagree that there may be additional 
regulatory and operational costs faced by off-campus PBDs. However, we 
continue to believe that the amendments made to the statute by section 
603 of the Bipartisan Budget Act of 2015 are intended to eliminate the 
Medicare payment incentive for hospitals to purchase physician offices 
and bill under the OPPS for items and services furnished there. We 
believe that, by removing the financial incentive for hospitals to 
purchase freestanding facilities, we allow market forces to determine 
the appropriate number and distribution of hospital PBDs and physician 
offices based on regional costs, practice patterns, patient needs.
    Comment: We received comments expressing general frustration with 
the longstanding differences in payment policies between the PFS and 
the OPPS. The commenters stated their belief that the PFS underpays for 
the value of services furnished in nonfacility

[[Page 53029]]

settings, thereby driving physicians into hospital employment 
agreements. They stated that this general pattern detracts from 
developing and implementing more cost efficient models of care. 
Moreover, disparate payments between OPPS and PFS drive the creation of 
health system monopolies, which generally increase the overall cost of 
care for the population and reduce the feasibility of operating 
independent physician practices.
    Response: We appreciate the perspectives of the commenters. We note 
that payments made under the PFS and the OPPS are established under 
different statutory authorities using wholly different bases and 
methodologies, and therefore often result in differential payment 
amounts for similar services. We do not have the legal authority, with 
limited exceptions such as section 603 of the Bipartisan Budget Act of 
2015, to develop or implement modified payment rates that would broadly 
reduce the differences in payment between physician offices and 
hospital outpatient departments.
    Comment: Many commenters described the importance of hospital off-
campus PBDs in meeting the needs of rural and high risk patients. They 
maintained that payments made using the PFS Relativity Adjuster, 
particularly at the proposed rate of 25 percent, would be so low as to 
prohibit hospitals from providing needed services to high risk 
populations and may even require some hospital locations to close. A 
commenter specifically requested that CMS conduct an impact assessment 
before continuing with implementation of the statute.
    Response: We appreciate the comment and understand the 
stakeholders' concerns about access to care for rural populations. As 
you know, section 603 amended the statute at section 1833(t) of the Act 
to carve out certain items and services furnished by certain off-campus 
outpatient departments of a provider from the definition of covered 
outpatient services, and from payment under the OPPS beginning on 
January 1, 2017. We do not believe that section 603 of the Bipartisan 
Budget Act of 2015 restricts options for patients in rural and 
underserved areas, and moreover, we do not believe the statutory 
amendments have been implemented in a manner that restricts access to 
care for rural populations.
    We have previously stated that we consider the PFS Relativity 
Adjuster to be an interim policy until a complete year of claims data 
from CY 2017 are available for analysis. Once such data are available, 
we expect to calculate and propose a more precise payment rate. 
Additionally, we continue to consider options for nonexcepted off-
campus PBDs to bill for nonexcepted items and services using a PFS 
claim, effectively allowing us to develop and pay a code-specific 
amount representing the technical component of furnishing a service.
    Comment: A couple of commenters indicated their belief that CMS is 
making drastic changes to payment policies for nonexcepted items and 
services furnished by nonexcepted off-campus PBDs and that this 
adversely impacts the ability of hospitals and physician offices to 
conduct long term planning. One commenter stated that our proposal to 
change the PFS Relativity Adjuster for CY 2018 contradicts CMS's 
statement in the CY 2017 interim final rule (81 FR 79720 through 79729) 
in which we articulated that, unless there are significant changes to 
the policies set forth in the interim final rule, we anticipate 
continuing to use the same method to determine PFS payment amounts for 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
in the near term. Several commenters indicated that they had 
interpreted CMS's statements as a promise that the PFS Relativity 
Adjuster would remain at 50 percent until such time that we had 
required data available to more precise calculation. The commenters, 
representing hospital stakeholders, suggested that they may not have 
moved forward with planned expansions of new off-campus PBDs if they 
had known we would change the PFS Relativity Adjuster.
    Response: We thank commenters for their concerns. We do not agree 
that our statements in the CY 2017 interim final rule reflected a 
promise not to change the PFS Relativity Adjuster over the next two to 
three years. Rather, we stated that the general approach, in which we 
calculate an overall reduction--the PFS Relativity Adjuster--to 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
when billed with a ``PN'' modifier, would remain in place until we were 
able to establish code-specific reductions that represent the technical 
component of services furnished under the PFS or until we were able to 
implement system changes needed to enable nonexcepted off-campus PBDs 
to bill for the technical component of nonexcepted items and services 
using a professional claim. We are required by law to implement payment 
changes for nonexcepted PBDs. Through notice and comment rulemaking in 
the CY 2017 interim final rule and the CY 2018 PFS proposed rule, we 
have been as transparent as possible in our methodology for determining 
the PFS Relativity Adjuster, including limitations related to data 
availability. We believe we have given sufficient information about our 
underlying concerns and objectives, including the transitory nature of 
this payment policy until we have the opportunity to analyze CY 2017 
claims data. In addition, while we currently lack both the data and the 
infrastructure to require hospitals to bill for nonexcepted items and 
services furnished by nonexcepted off-campus PBDs using a professional 
claim, we are continuing to explore the changes that would be needed to 
do so for future years. This change would allow nonexcepted off-campus 
PBDs to report services using the same coding as would be used by 
practitioners and suppliers under the PFS and to bill specifically for 
nonexcepted items and services at rates that represent the technical 
component of services furnished under the PFS.
    Comment: Several stakeholders commented on topics related to 
policies we addressed in prior rulemaking or policies that are outside 
the scope of this final rule. Commenters urged CMS to expand excepted 
status of an off-campus PBD that is changing location or ownership. 
Other commenters, however, suggested that we remove the excepted status 
for off-campus PBDs entirely, even for those billing as a PBD prior to 
November 2, 2015.
    Response: We appreciate commenters' concerns regarding these 
topics. However, we note that the implementation of section 603 of the 
Bipartisan Budget Act of 2015 was finalized in the CY 2017 CY OPPS/ASC 
final rule with comment period (81 FR 79699 through 79719), and we did 
not make any proposals in the CY 2018 PFS proposed rule related to 
defining the applicable items and services furnished by certain off-
campus outpatient departments of a provider, which will not be 
considered covered OPD services on or after January 1, 2017 (that is, 
how we defined nonexcepted items and services furnished by nonexcepted 
off-campus PBDs). Thus, comments addressing such issues are outside the 
scope of this rulemaking. Comments submitted with technical billing 
questions are addressed through applicable program instructions. For 
policies related to patient cost sharing under the OPPS and for 
guidance related to cost reporting for nonexcepted items and services 
furnished by nonexcepted PBDs, we direct commenters to the OPPS CY 2018 
final rule.

[[Page 53030]]

    Comment: We received several comments questioning why we have not 
responded to comments on the CY 2017 OPPS interim final rule in which 
we implemented the CY 2017 PFS Relativity Adjuster of 50 percent. The 
same commenters also questioned whether our proposal to reduce the PFS 
Relativity Adjuster to 25 percent might be a violation of our 
rulemaking obligations under the Administrative Procedure Act (APA) (5 
U.S.C. 553) insofar as we indicated our intention to develop a revised 
PFS relativity adjuster based on claims data when they became 
available, and there are not yet claims data available to develop a 
more appropriate payment adjustment. Some commenters further suggested 
that our policies regarding the PFS relativity adjuster, made in the 
absence of specific data to support them as explained in the CY 2017 
interim final rule, are arbitrary and capricious.
    Response: We appreciate the commenters' concerns about adhering to 
the rulemaking requirements of the APA. To meet our rulemaking 
obligations, we generally respond to comments on an interim final rule 
at the time that we adopt final policies relating to that interim final 
rule. On the whole, commenterson the CY 2017 interim final rule who 
disagreed with setting the CY 2017 PFS Relativity Adjuster at 50 
percent articulated concerns about the approach we used to arrive at 
that rate. In particular, commenters highlighted the differences in 
packaging rules under the PFS and the OPPS, and suggested that CMS 
should use the total nonfacility rate (rather than the nonfacility 
minus facility rate) to compare relative payments between PFS and OPPS. 
We are currently addressing, through notice and rulemaking for CY 2018, 
the concerns raised by commenters and stakeholders related to the 
policies that we proposed and are finalizing for CY 2018. However, we 
note that the public comments on the CY 2017 interim final rule and on 
the CY 2018 PFS proposed rule express many of the same views and 
concerns about how we should set the PFS relativity adjuster.
    We presented the analysis and reasons that led us to the proposed 
PFS Relativity Adjuster of 25 percent for CY 2018; and we responded to 
public comments on that proposal with a revised analysis and the final 
PFS Relativity Adjuster of 40 percent for CY 2018. We have provided the 
data required to replicate our analysis, consistently based upon CY 
2016 payment rates under the PFS and OPPS, for the CY 2017 interim 
final, and for the proposed and final CY 2018 PFS relativity adjusters. 
Furthermore, we have been as transparent as possible in our approach, 
including the limitations related to data availability, and our 
inability to develop a precise adjustment to the relative payment rates 
that would account for differences between the two payment systems, 
including packaging. We believe we are moving as judiciously as 
possible, given these limitations, to meet the requirements of the 
statute, providing public transparency into our policy considerations, 
and in full accordance with our notice and comment rulemaking 
obligations. We are finalizing a PFS Relativity Adjuster of 40 percent 
for CY 2018 as discussed earlier in this section.
    Comment: Several commenters requested that CMS move all of the 
rulemaking, including requests for comments, comment summaries and our 
responses, for policies relating to the implementation of section 603 
of the Bipartisan Budget Act of 2015 from the PFS rule to the OPPS 
rule. They cited the additional burden of responding to such 
interrelated policies in different rules.
    Response: We appreciate the commenters' concern about the 
challenges presented by addressing policies that implicate two payment 
systems that are issued in two separate rulemaking processes. However, 
because the policies included in this final rule relate to payments 
that are made under the PFS to nonexcepted off-campus PBDs furnishing 
nonexcepted items and services, we believe it is appropriate that these 
issues be addressed in rulemaking for the PFS. We note that policies 
related to interpretation of the OPPS statute will continue to be 
addressed in OPPS rulemaking.

   Table 10--Comparison of CY 2016 OPPS Payment Rate to CY 2016 PFS Payment Rate for Top Hospital Codes Billed
                                            Using the ``PO'' Modifier
----------------------------------------------------------------------------------------------------------------
                                                                     CY 2016
                                                                    applicable
                                           CY 2016      CY 2016        PFS       Col (5) as
    HCPCS code        Code description   total claim      OPPS      technical        a           PFS estimate
                                             lines      payment      payment     percentage
                                                          rate        amount      of OPPS
                                                                     estimate
(1)                 (2)................          (3)          (4)          (5)               (6)
----------------------------------------------------------------------------------------------------------------
G0463.............  Hospital outpt        13,835,921      $102.12       $26.71        26.16  Nonfacility rate--
                     clinic visit.                                                            Facility rate
                                                                                              based on the
                                                                                              average of ten PFS
                                                                                              CPT codes: 99201--
                                                                                              99205 and 99211 0
                                                                                              99215.
96372.............  Ther/proph/diag inj      725,665        42.31        25.42         60.1  Single rate paid
                     sc/im.                                                                   exclusively to
                                                                                              either
                                                                                              practitioner or
                                                                                              facility; full
                                                                                              nonfacility rate.
71020.............  Chest x-ray 2vw          719,451        60.80        16.83         27.7  Technical
                     frontal&latl.                                                            component: Full
                                                                                              nonfacility rate.
93005.............  Electrocardiogram        662,763        55.94         8.59         15.4  Single rate paid
                     tracing.                                                                 exclusively to
                                                                                              either
                                                                                              practitioner or
                                                                                              facility; full
                                                                                              nonfacility rate.
96413.............  Chemo iv infusion 1      563,245       280.27       136.41         48.7  Single rate paid
                     hr.                                                                      exclusively to
                                                                                              either
                                                                                              practitioner or
                                                                                              facility: Full
                                                                                              nonfacility rate.
93798.............  Cardiac rehab/           448,130       103.92        11.10         10.7  Nonfacility rate--
                     monitor.                                                                 Facility rate.
96375.............  Tx/pro/dx inj new        408,751        42.31        22.56         53.3  Single rate paid
                     drug addon.                                                              exclusively to
                                                                                              either
                                                                                              practitioner or
                                                                                              facility; full
                                                                                              nonfacility rate.
93306.............  Tte w/doppler            369,856       416.80       165.77         39.8  Technical
                     complete.                                                                component: full
                                                                                              nonfacility rate.
77080.............  Dxa bone density         344,118       100.69        31.15         30.9  Technical
                     axial.                                                                   component: full
                                                                                              nonfacility rate.
90853.............  Group psychotherapy      299,446        69.65         0.36          0.5  Nonfacility rate--
                                                                                              Facility rate.
77412.............  Radiation treatment      296,601       194.35       266.86        137.3  Technical component
                     delivery.                                                                (Full nonfacility
                                                                                              rate) based on
                                                                                              weighted averages
                                                                                              for the following
                                                                                              PFS codes: G6011;
                                                                                              G6012; G6013; and
                                                                                              G6014.
96365.............  Ther/proph/diag iv       269,899       173.18        69.82         40.3  Single rate paid
                     inf init.                                                                exclusively to
                                                                                              either
                                                                                              practitioner or
                                                                                              facility: Full
                                                                                              nonfacility rate.
20610.............  Drain/inj joint/         221,922       223.76        13.96          6.2  Nonfacility rate--
                     bursa w/o us.                                                            Facility rate.

[[Page 53031]]

 
96367.............  Tx/proph/dg addl         217,098        42.31        30.79         72.8  Single rate paid
                     seq iv inf.                                                              exclusively to
                                                                                              either pracitioner
                                                                                              or facility: Full
                                                                                              nonfacility rate.
11042.............  Deb subq tissue 20       215,734       225.55        54.78         24.3  Nonfacility rate--
                     sq cm/<.                                                                 Facility rate.
93017.............  Cardiovascular           196,183       220.35        39.74         18.0  Single rate paid
                     stress test.                                                             exclusively to
                                                                                              either
                                                                                              practitioner or
                                                                                              facility; full
                                                                                              nonfacility rate.
77386.............  Ntsty modul rad tx       182,989       505.51       347.30         68.7  Technical
                     dlvr cplx.                                                               component:
                                                                                              Nonfacility rate
                                                                                              for CPT code G6015
                                                                                              (analogous code
                                                                                              used under the
                                                                                              PFS).
74177.............  Ct abd & pelv w/         167,549       347.72       220.20         63.3  Technical
                     contrast.                                                                component: Full
                                                                                              nonfacility rate.
71260.............  Ct thorax w/dye....      163,756       236.86       167.21         70.6  Technical
                                                                                              component: Full
                                                                                              nonfacility rate.
71250.............  Ct thorax w/o dye..      160,956       112.49       129.61        115.2  Technical
                                                                                              component: Full
                                                                                              nonfacility rate.
78452.............  Ht muscle image          159,219     1,108.46       412.82         37.2  Technical
                     spect mult.                                                              component: Full
                                                                                              nonfacility rate.
96415.............  Chemo iv infusion        151,700        42.31        28.64         67.7  Single rate paid
                     addl hr.                                                                 exclusively to
                                                                                              either
                                                                                              practitioner or
                                                                                              facility; full
                                                                                              nonfacility rate.
----------------------------------------------------------------------------------------------------------------
Weighted Average (claim line volume * rate) of the PFS payment compared to OPPS payment for  35%
 the 22 major codes:
----------------------------------------------------------------------------------------------------------------

H. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially 
Misvalued Codes
    Establishing valuations for newly created and revised CPT codes is 
a routine part of maintaining the PFS. Since the inception of the PFS, 
it has also been a priority to revalue services regularly to make sure 
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 5-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 5-year review process, revisions in RVUs were proposed 
and finalized via rulemaking. In addition to the 5-year reviews, 
beginning with CY 2009, CMS and the RUC have identified a number of 
potentially misvalued codes each year using various identification 
screens, as discussed in section II.E.4 of this final rule. 
Historically, when we received RUC recommendations, our process had 
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 for a year. Then, during the 60-day period 
following the publication of the final rule, we accepted public comment 
about those valuations. For services furnished during the calendar year 
following the publication of interim final rates, we paid for services 
based upon the interim final values established in the final rule. In 
the final rule with comment period for the subsequent year, we 
considered and responded to public comments received on the interim 
final values, and typically made any appropriate adjustments and 
finalized those values.
    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. Beginning with the 
CY 2017 PFS proposed rule, the new process was applicable to all codes, 
except for new codes that describe truly new services. For CY 2017, we 
proposed new values in the CY 2017 PFS proposed rule for the vast 
majority of new, revised, and potentially misvalued codes for which we 
received complete RUC recommendations by February 10, 2016. To complete 
the transition to this new process, for codes for which we established 
interim final values in the CY 2016 PFS final rule with comment period, 
we reviewed the comments received during the 60-day public comment 
period following release of the CY 2016 PFS final rule with comment 
period, and re-proposed values for those codes in the CY 2017 PFS 
proposed rule.
    We considered public comments received during the 60-day public 
comment period for the proposed rule before establishing final values 
in the CY 2017 PFS final rule. As part of our established process, we 
will adopt interim final values only 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 2017, we 
did not identify any new codes that described such wholly new services. 
Therefore, we did not establish any code values on an interim final 
basis.
2. Methodology for Establishing Work RVUs
    For each code identified in this section, we conducted a review 
that included 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 reviews of recommended work RVUs and time 
inputs have generally included, but have not been limited to, a review 
of information provided by the RUC, the Health Care Professionals 
Advisory Committee (HCPAC), and other public commenters, medical 
literature, and comparative databases, as well as a comparison with 
other codes within the PFS, consultation with other physicians and 
health care professionals within CMS and the federal government, as 
well as Medicare claims data. We have 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,

[[Page 53032]]

including survey data, building blocks, crosswalks to key reference or 
similar codes, and magnitude estimation (see the CY 2011 PFS final rule 
with comment period (75 FR 73328 through 73329) for more information). 
When referring to a survey, unless otherwise noted, we mean the surveys 
conducted by specialty societies as part of the formal RUC process. We 
have used the building block methodology to construct, or deconstruct, 
the work RVU for a CPT code based on component pieces of the code.
    Components that we have used in the building block approach may 
have included preservice, intraservice, or postservice time and post-
procedure visits. When referring to a bundled CPT code, the building 
block components could include 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, we have frequently utilized an incremental 
methodology in which we value a code based upon its incremental 
difference between another code and another family of codes. The 
statute specifically defines the work component as the resources in 
time and intensity required in furnishing the service. Also, the 
published literature on valuing work has recognized the key role of 
time in overall work. For particular codes, we have refined the work 
RVUs 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 intraservice time.
    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 preservice time packages for 
services typically furnished in the facility setting (for example: 
Preservice time packages reflecting the different combinations of 
straightforward or difficult procedure, and straightforward or 
difficult patient). Currently, there are three preservice time packages 
for services typically furnished in the nonfacility setting.
    We 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 evaluation and management (E/M) service, we believe that there is 
overlap between the two services in some of the activities furnished 
during the preservice evaluation and postservice time. Our longstanding 
adjustments have reflected a broad assumption 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 have believed that the RUC has not 
adequately accounted for the overlapping activities in the recommended 
work RVU and/or times, we have adjusted 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 have removed 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 have also 
removed a work RVU of 0.09 (4 minutes x 0.0224 IWPUT) if we have not 
believed the overlap in time had 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 
furnished on the same day as an E/M service.
    We note that many commenters and stakeholders have expressed 
concerns over time with our ongoing adjustment of work RVUs based on 
changes in the best information we have had regarding the time 
resources involved in furnishing individual services. We have been 
particularly concerned with the RUC's and various specialty societies' 
objections to our approach given the significance of their 
recommendations to our process for valuing services and since much of 
the information we have used to make the adjustments is derived from 
their survey process. We are statutorily obligated to consider both 
time and intensity in establishing work RVUs for PFS services. As 
explained in the CY 2016 PFS final rule with comment period (80 FR 
70933), we recognize that adjusting work RVUs for changes in time is 
not always a straightforward process, so we have applied various 
methodologies to identify several potential work values for individual 
codes.
    We have observed that for many codes reviewed by the RUC, 
recommended work RVUs have appeared to be incongruous with recommended 
assumptions regarding the resource costs in time. This has been the 
case for a significant portion of codes for which we have recently 
established or proposed work RVUs that are based on refinements to the 
RUC-recommended values. When we have adjusted work RVUs to account for 
significant changes in time, we have begun by looking at the change in 
the time in the context of the RUC-recommended work RVU. When the 
recommended work RVUs have not appeared to account for significant 
changes in time, we have employed the different approaches to identify 
potential values that reconcile the recommended work RVUs with the 
recommended time values. Many of these methodologies, such as survey 
data, building block, crosswalks to key reference or similar codes, and 
magnitude estimation have long been used in developing work RVUs under 
the PFS. In addition to these, we have sometimes used the relationship 
between the old time values and the new time values for particular 
services to identify alternative work RVUs based on changes in time 
components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe had not otherwise been reflected in 
the RUC-recommended value. When we have believed that such changes in 
time have already been accounted for in the RUC recommendation, then we 
have not made such adjustments. Likewise, we have not arbitrarily 
applied time ratios to current work RVUs to calculate proposed work 
RVUs. We have used the ratios to identify potential work RVUs and 
considered these work RVUs as potential options relative to the values 
developed through other options.
    We do not imply that the decrease in time as reflected in survey 
values must equate to a one-to-one or linear decrease in newly valued 
work RVUs. Instead, we have believed that, since the two components of 
work are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
increased, significant decreases in time should be reflected in 
decreases to work RVUs. If the RUC recommendation had appeared to 
disregard or dismiss the

[[Page 53033]]

changes in time, without a persuasive explanation of why such a change 
should not be accounted for in the overall work of the service, then we 
have generally used one of the aforementioned methodologies to identify 
potential work RVUs, including the methodologies intended to account 
for the changes in the resources involved in furnishing the procedure.
    Several stakeholders, including the RUC, in general have objected 
to our use of these methodologies and deemed our actions in adjusting 
the recommended work RVUs as inappropriate; other stakeholders have 
also expressed concerns with CMS refinements to RUC recommended values 
in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277) 
we responded in detail to several comments that we received regarding 
this issue. In the CY 2017 PFS proposed rule, we requested comments 
regarding potential alternatives to making adjustments that would 
recognize overall estimates of work in the context of changes in the 
resource of time for particular services; however, we did not receive 
any specific potential alternatives as requested.
    In developing proposed values for new, revised, and potentially 
misvalued codes for CY 2018, we considered the lack of alternative 
approaches to making the adjustments, especially since many 
stakeholders have routinely urged us to propose and finalize the RUC-
recommended values. We also considered the RUC's consistent reassurance 
that these kinds of concerns (regarding changes in time, for example) 
had already been considered, and either incorporated or dismissed, as 
part of the development of their recommended values. These have led us 
to shift our approach to reviewing RUC recommendations, especially as 
we believe that the majority of practitioners paid under the PFS, 
though not necessarily those in any particular specialty, would prefer 
CMS rely more heavily on RUC recommended values in establishing payment 
rates under the PFS.
    For CY 2018, we generally proposed the RUC-recommended work RVUs 
for new, revised, and potentially misvalued codes. We proposed these 
values based on our understanding that the RUC generally considers the 
kinds of concerns we have historically raised regarding appropriate 
valuation of work RVUs. However, during our review of these recommended 
values, we identified some concerns similar to those we have recognized 
in prior years. Given the relative nature of the PFS and our obligation 
to ensure that the RVUs reflect relative resource use, we included 
descriptions of potential approaches we might have taken in developing 
work RVUs that differ from the RUC-recommended values. We sought 
comment on both the RUC-recommended values as well as the alternatives 
considered.
    The following is a summary of the public comments received on both 
the RUC-recommended values as well as the alternatives we considered in 
developing work RVUs and our responses:
    Comment: Several commenters generally support the proposed use of 
the RUC-recommended work RVUs, without refinement. One commenter 
encouraged further collaboration between the RUC and CMS to improve the 
relativity within the payment system.
    Response: We thank the commenters for their input and support of 
the proposals. We also agree that collaboration is a critical element 
in our establishment of work RVUs. In our review of work RVUs and time 
inputs, we have and will continue to consider information from various 
public commenters, medical literature, the HCPAC, information provided 
by the RUC, Medicare claims data, and other relevant sources.
    Comment: One commenter stated that the RUC thoroughly vets the 
times and values of the procedures it reviews, applies the right 
valuation methodology to appropriately value the procedures that are 
being reviewed, and usually adjusts the times identified by the survey 
if the times seem unreasonable. Another commenter stated that 
recommendations by the RUC remain the most robust mechanism for 
collecting data and establishing relative values. A few commenters 
stated that CMS should depend on RUC-recommended values instead of 
trying to create an arbitrary, new methodology that lacks reliability 
or reflects significantly flawed rationales. A few commenters stated 
that CMS work value reductions are done with complete disregard for the 
rigorous process conducted by the RUC with input from medical specialty 
societies to develop data driven recommendations for physician work 
values and without presenting data to support these reductions.
    Response: We agree that the RUC provides critically important 
information for our review process. However, our review of recommended 
work RVUs and time inputs also generally includes review of various 
sources, in addition to the RUC, such as information provided by other 
public commenters, comparative databases, and medical literature which 
are also vital sources of information. We disagree with the commenters 
that CMS has created arbitrary, unreliable work value reductions that 
have disregarded the RUC process. We have historically used the RUC-
recommended values or existing values as a starting point in our 
review, and then applied adjustments as necessary, particularly when we 
find that the RUC recommendation does not appropriately account for 
recommended changes in time, and provides no explanation as to why this 
would be appropriate.
    Comment: One commenter expressed disappointment with situations 
where CMS rejects recommended work valuations and direct PE inputs that 
would have resulted in expenditure decreases, and was concerned that 
all professionals are impacted. The commenter stated that CMS should 
accept RUC-recommended values and inputs that would result in 
expenditure decreases or hold all other healthcare professionals 
harmless for the decision to reject them.
    Response: We appreciate the commenter's views, but note that we are 
required to establish appropriate valuations and ensure that RVUs are 
reflective of relative resources involved in furnishing a service. In 
reviewing specific codes, we make these decisions the same way 
regardless of whether the decisions would result in increases or 
decreases to overall expenditures under the PFS. Additionally, we do 
not have authority to exempt the rates for particular services from 
budget neutrality adjustments, relativity adjustments, or the effects 
of the misvalued code target recapture adjustments based on differences 
between what the RUC recommends and what CMS finalizes through notice 
and comment rulemaking.
    Comment: Some commenters expressed concern about the effect of the 
misvalued code reviews on particular specialties and settings. The 
commenters recommended insulating particular settings or specialties 
from the impact of the code reviews.
    Response: We are required to periodically review the accuracy of 
RVUs for all services furnished under the PFS. We do not believe it 
would be appropriate, nor do we have any specific authority, to 
insulate particular settings or specialties from the impact of this 
review. We also note that most misvalued code reviews and revaluations 
are triggered by the identification of codes under the potentially 
misvalued code categories that are enumerated in the statute.

[[Page 53034]]

    Comment: One commenter stated that it is open to supporting our 
alternative methods of valuation if the methods are disclosed and there 
is ample time to review, comment, and iterate on suggestions. The 
commenter stated that the RUC process currently allows for this. 
Another commenter stated that it appreciates CMS providing stakeholders 
with discussion of alternative approaches that the agency might have 
used to reach a different value, rather than proposing those values. 
The commenter stated that this gives specialties an opportunity to 
consider the alternative values, while also providing a pathway for us 
to finalize an alternative value based on information provided by 
stakeholders. The commenter also stated that it believes many of these 
alternative methods could be raised during deliberations at RUC 
meetings when specialties and their expert physician advisors are 
available to engage in a dialogue with CMS representatives. In 
addition, the commenter stated that CMS representatives who attend the 
RUC meetings should engage more actively in discussion with society 
representatives about the agency's issues and concerns with work and 
direct PE inputs, rather than first sharing concerns in the proposed 
rule when dialogue is restricted due to the rulemaking process.
    Response: While the comment period does not provide for an 
iterative process as suggested by one of the commenters, it does 
provide an opportunity for all interested parties to review and have an 
opportunity to comment on the proposals and alternative valuations 
considered. While we acknowledge that discussion and consideration of 
different valuations occurs during the RUC process, we also note that 
not all interested parties have the opportunity to participate in the 
RUC process, and not all relevant stakeholders are members of the RUC. 
Additionally, we would like to reiterate that, while we appreciate that 
some commenters believe that CMS staff could offer useful perspectives 
by regularly attending and participating more fully in the RUC 
meetings, we do not believe that would be appropriate for many reasons, 
not least of which is that CMS staff participation in the RUC process 
cannot supplant our obligation to establish through notice and comment 
rulemaking what we determine to be appropriate RVUs for each reviewed 
code. Accordingly, we disagree with the commenter's suggestion that CMS 
staff should preemptively address the concerns of work and PE values 
during the RUC meeting, instead of through notice and comment 
rulemaking. Formal notice and comment rulemaking allows all interested 
parties the opportunity to review our proposals and provide feedback, 
as well as to submit supplemental information about our proposals, and 
address any concerns or alternatives we have expressed in making our 
proposals.
    Comment: Several commenters expressed concern and disappointment 
with our proposed approach for valuing codes for CY 2018. MedPAC stated 
that it believes CMS is moving in the wrong direction by proposing to 
accept all of the RUC recommendations for work RVUs for CY 2018 without 
modification, and that this approach is inconsistent with MedPAC's 
longstanding view that CMS relies too heavily on input from the RUC, 
which is made up of practitioners who have a financial stake in the 
payment rates for services paid under the PFS. MedPAC stated that the 
Secretary is responsible for establishing RVUs for services, and this 
authority should not be delegated to a private entity; therefore, CMS 
should independently evaluate the RUC-recommended RVUs based on 
objective data and revise them when they are inaccurate. MedPAC also 
stated that CMS should collect data from a set of efficient practices 
to validate the time estimates and establish more accurate RVUs. Other 
commenters stated that from their perspective, CMS is abandoning its 
responsibility to set work RVUs under the PFS. One commenter stated 
that CMS should actively supervise and take responsibility for setting 
physician payments based on reliable, objective evidence. Another 
commenter stated that while it appreciates the work of the RUC, they 
had concerns that primary care is undervalued by the RUC, and stated 
that the RUC tends to favor more procedural and specialty-based 
services. The commenter stated that if CMS steps away from taking an 
active role in determining RVUs under its own PFS, the agency would be 
inflating the role of the RUC and thus underemphasizing primary care in 
the process. The commenter also stated that the RUC's final 
recommendations do not necessarily strike the balance across different 
provider types and services, and that it is the responsibility of CMS, 
not the RUC, to set RVUs under the PFS; and therefore, CMS should 
retain an active role in evaluating information and data and setting 
reimbursement rates for services across the PFS.
    Response: We would like to clarify that we are not relinquishing 
our obligation to independently establish appropriate RVUs for services 
paid under the PFS. We will continue to thoroughly review and consider 
information we receive from the RUC, the HCPAC, public commenters, 
medical literature, Medicare claims data, comparative databases, 
comparison with other codes within the PFS, as well as consultation 
with other physicians and healthcare professionals within CMS and the 
federal government as part of our process for establishing valuations. 
We also note that given the critical role of the resource of time in 
establishing work RVUs and the concerns that have been raised about 
time values used in rate-setting, we contracted with the Urban 
Institute to develop empirical time estimates based on data collected 
from several health systems with multispecialty group practices. We 
refer readers to the CY 2017 PFS final rule for discussion of the Urban 
Institute report (81 FR 80203). While generally proposing the RUC-
recommended work RVUs for new, revised, and potentially misvalued codes 
was our approach for CY 2018, we note that we also included alternative 
values where we believed there was a possible opportunity for increased 
precision.
    We also want to clarify that as part of our obligation to establish 
RVUs for the PFS, we annually make an independent assessment of the 
available recommendations, supporting documentation, and other 
available information from the RUC and other commenters to determine 
the appropriate valuations. Where we concur that the RUC 
recommendations, or recommendations from other commenters, are 
reasonable and appropriate and are consistent with the time and 
intensity paradigm of physician work, we propose those values as 
recommended. Additionally, we will continue to engage with 
stakeholders, including the RUC, with regard to our approach for 
accurately valuing codes.
    CMS appreciates the efforts of the RUC to deliberate on highly 
technical matters involving clinical care. The RUC is comprised of 31 
physicians, the majority of whom are appointed by major medical 
specialty societies. Commenters have noted concerns with the range of 
expertise represented in the RUC membership and have advocated for more 
balanced representation from across the medical community. Commenters 
have also suggested that the RUC should consider how to further engage 
the public in its deliberative processes. CMS encourages the RUC to 
consider acting on these comments and suggestions in its ongoing 
deliberations.

[[Page 53035]]

This action could involve improving the ability of stakeholders or the 
public to meaningfully participate in or learn about the deliberations, 
considering the balance of primary care and specialty expertise on the 
committee, and examining how payers are included in this process. 
Stakeholder input could include surveying retired physicians and nurses 
in addition to physicians, and receiving additional information about 
how payers view relative resource use for services. CMS may also 
consider updating its internal review of RUC recommendations in the 
future.
    Comment: One commenter stated that data obtained through the RUC 
survey process, based on subjective physician perceptions of work and 
time, may not always be the most accurate data available. The commenter 
stated that CMS should be open to reviewing additional sources of 
objective and validated work time data furnished by stakeholders. Such 
sources might include peer reviewed and published studies of 
comparative surgery times among different procedures in the same 
institution using standardized metrics.
    Response. We continue to be open to reviewing additional and 
supplemental sources of data furnished by stakeholders. We encourage 
stakeholders to continue to provide such information for CMS 
consideration in establishing work RVUs.
    Comment: One commenter stated that nurse practitioners have had 
little opportunity to participate in RUC activities, and since the fee 
schedule recommendations from the RUC impact all clinicians, it is 
important that all clinicians, including nurse practitioners, have 
input in that process. Another commenter stated that the process for 
setting the fee schedule should be accurate and robust, include input 
from multiple stakeholders, and be an open process that should have 
oversight from, and be transparent to, the many stakeholders who are 
affected by the PFS.
    Response: We concur that the process of valuing codes should be 
accurate and robust, and, as previously stated, we consider input from 
various sources when determining the appropriate valuation. Notice and 
comment rulemaking provides for an open process whereby we welcome 
input from all interested parties, and encourage the commenters to 
provide feedback regarding our annual proposed valuations.
    We look forward to continuing to engage with stakeholders and 
commenters, including the RUC, as we prioritize our obligation to value 
new, revised, and potentially misvalued codes, and will continue to 
welcome feedback from all interested parties regarding valuation of 
services for consideration through our rulemaking process. We refer 
readers to section II.H.4 of this final rule for detailed discussion of 
the proposed valuation, and alternative valuation considered for 
specific codes. Table 12 contains a list of codes for which we proposed 
work RVUs; this includes all codes for which we received RUC 
recommendations by February 10, 2017. The proposed work RVUs, work time 
and other payment information for all proposed CY 2018 payable codes 
are available on the CMS Web site under downloads for the CY 2018 PFS 
final rule. Table 12 also contains the CPT code descriptors for all 
proposed, new, revised, and potentially misvalued codes discussed in 
this section.
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
    On an annual basis, the RUC provides us 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 PFS, and consultation with 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's recommendations appropriately estimate the 
direct PE inputs (clinical labor, disposable supplies, and medical 
equipment) required for the typical service, are 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 13 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In this final rule, 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 $0.30 or less, the refinement has no impact on the 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 13 result in changes under the $0.30 threshold and are 
unlikely to result in a change to the RVUs.
    We also note that the direct PE inputs for CY 2018 are displayed in 
the CY 2018 direct PE input database, available on the CMS Web site 
under the downloads for the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs 
displayed there have also been used in developing the proposed CY 2018 
PE RVUs as displayed in Addendum B.
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. The direct PE input recommendations generally 
correspond to the work time values associated with services. We believe 
that inadvertent discrepancies between work time values and direct PE 
inputs should be refined or adjusted in the establishment of proposed 
direct PE inputs to resolve the discrepancies.
(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

[[Page 53036]]

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 over several years of rulemaking, 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 preservice 
or postservice 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 preservice or postservice 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 since any items in the room in question would be available if the 
room is not being occupied by a particular patient. For additional 
information, we refer readers to our discussion of these issues 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, 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, we review 
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 preservice clinical labor 
tasks to avoid duplicative inputs and to reflect the resource costs of 
furnishing the typical service.
    We refer readers to section II. B. of this final rule for more 
information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
(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 or that cannot be allocated to 
individual services or patients. We have addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) 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, however, 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 2018, we received invoices for several new supply and 
equipment items. Tables 13 and 14 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this final rule, 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 during the 60-day public comment period for this 
final rule. We expect that invoices received outside of the public 
comment period would be submitted by February 10th of the following 
year for consideration in future rulemaking, similar to our new process 
for consideration of RUC recommendations.
    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 13 and 14 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. A single invoice may not be reflective of 
typical costs and we 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.

[[Page 53037]]

(6) Service Period Clinical Labor Time in the Facility Setting
    Generally speaking, our proposed inputs did not include clinical 
labor minutes assigned to the service period 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 address proposed code-specific refinements to clinical labor in the 
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We note that the public use files for the PFS proposed and final 
rules for each year display both the 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 
1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap 
for the upcoming calendar year. The public use files for CY 2018 are 
available on the CMS Web site under downloads for the CY 2018 PFS final 
rule at For more information regarding the history of the MPPR policy, 
we refer readers to the CY 2014 PFS final rule (78 FR 74261-74263). For 
more information regarding the history of the OPPS cap, we refer 
readers to the CY 2007 PFS final rule (71 FR 69659-69662).
4. Proposed Valuation of Specific Codes for CY 2018
(1) Anesthesia Services for Gastrointestinal (GI) Procedures (CPT Codes 
00731, 00732, 00811, 00812, and 00813)
    In the CY 2016 PFS proposed rule (80 FR 41686), we discussed that 
in reviewing Medicare claims data, a separate anesthesia service is 
typically reported more than 50 percent of the time that various 
colonoscopy procedures are reported. We discussed that given the 
significant change in relative frequency with which anesthesia codes 
are reported with colonoscopy services, we believed the relative values 
of the anesthesia services should be reexamined and proposed to 
identify CPT codes 00740 (Anesthesia for upper gastrointestinal 
endoscopic procedures, endoscope introduced proximal to duodenum) and 
00810 (Anesthesia for lower intestinal endoscopic procedures, endoscopy 
introduced distal to duodenum) as potentially misvalued.
    For CY 2018, the CPT Editorial Panel is deleting CPT codes 00740 
and 00810 and creating new codes for anesthesia services furnished in 
conjunction with and in support of gastrointestinal endoscopic 
procedures: Two codes for upper GI procedures, CPT code 00731 
(Anesthesia for upper gastrointestinal endoscopic procedures, endoscope 
introduced proximal to duodenum; not otherwise specified) and CPT code 
00732 (Anesthesia for upper gastrointestinal endoscopic procedures, 
endoscopy introduced proximal to duodenum; endoscopic retrograde 
cholangiopancreatography (ERCP)); and two codes for lower GI 
procedures, CPT code 00811 (Anesthesia for lower intestinal endoscopic 
procedures, endoscope introduced distal to duodenum; not otherwise 
specified) and CPT code 00812 (Anesthesia for lower intestinal 
endoscopic procedures, endoscope introduced distal to duodenum; 
screening colonoscopy); and one code for upper and lower GI procedures, 
CPT code 00813 (Anesthesia for combined upper and lower 
gastrointestinal endoscopic procedures, endoscope introduced both 
proximal to and distal to the duodenum).
    In the CY 2018 PFS proposed rule, we proposed the RUC-recommended 
base units without refinement for CPT codes 00731 (5.00 base units), 
00732 (6.00 base units), 00811 (4.00 base units), 00812 (4.00 base 
units) and 00813 (5.00 base units). We considered 3.00 base units for 
CPT code 00812 based on our comparison of the surveyed post-induction 
anesthesia-intensity allocation for CPT code 00812 to codes with 
similar allocations, such as CPT code 01382 (Anesthesia for diagnostic 
arthroscopic procedures of knee joint). We found that CPT code 01382, 
which was also valued with 3 base units, had similar allocations 
compared to the survey results for CPT code 00812. We received comments 
from anesthesia providers and professional specialty societies, 
including the RUC that specifically addressed the codes in this family.
    Comment: Regarding CPT code 00812, the RUC stated that its 
recommendation of 4.00 base units was made on an interim basis since 
the initial survey response rate did not meet the RUC's required 
minimum threshold based on the high utilization of predecessor CPT code 
00810. Subsequently, the RUC included as part of its public comments a 
revised final recommendation of 3.00 base units for CPT code 00812 
based on its review of new survey data, with the majority of survey 
respondents choosing CPT code 00910 (3.00 base units) as the key 
reference code more closely related to the work of CPT code 00812. Some 
commenters suggested that CMS should finalize its proposed values for 
each code in this family, including the proposed 4.00 base units for 
CPT code 00812, and suggested that CPT codes 00812 and 00811 represent 
similar work. A few commenters indicated that CPT code 00410 (4.00 base 
units) was a better comparator and crosswalk than the alternative 
crosswalk to CPT code 01382 that CMS considered for CPT code 00812.
    Response: We reviewed additional information submitted by the RUC 
as part of its public comment, which included an analysis of new survey 
data. We find this additional data persuasive and believe that 3.00 
base units better reflects the work of CPT code 00812.
    Comment: Several commenters expressed concerns about the process 
used for identifying CPT codes 00740 and 00810 as potentially 
misvalued. Commenters requested that we maintain the CY 2017 payment 
levels for CY 2018, suggesting that if we were to finalize the proposed 
base units for each code in this family, it would discourage use of 
anesthesia during GI procedures.
    Response: We continue to believe that the physician performing the 
GI procedure is in the best position to consider the beneficiary's 
needs when determining whether to utilize moderate sedation or 
anesthesia services. Additionally, while we understand the commenters' 
concerns, section 1848(c)(2)(K) of the Act requires the Secretary to 
periodically identify potentially misvalued services and to review and 
make appropriate adjustments to the relative values for those services. 
Section 1848(c)(2)(K) of the Act identifies several categories of 
services as potentially misvalued, including codes that have 
experienced the fastest growth, along with codes as determined 
appropriate by the Secretary. Therefore, as discussed in the CY 2016 
PFS proposed rule (80 FR 41686), we indicated that given the 
significant change in relative frequency with which anesthesia codes 
are reported with colonoscopy services, we believed the relative values 
of the anesthesia services should be reexamined as potentially 
misvalued.
    Comment: Commenters raised concerns about how a change in valuation 
for anesthesia services would affect payments made by private insurers.
    Response: While we appreciate commenters' concerns, this final rule

[[Page 53038]]

addresses valuation of services for purposes of Medicare payments made 
under the PFS. Valuation and payment determinations made by private 
insurers are outside the scope of this final rule.
    After consideration of comments received that specifically 
addressed the codes in this family, for CY 2018, we are finalizing 5.00 
base units for CPT codes 00731, 6.00 base units for CPT code 00732, 
4.00 base units for CPT code 00811, 3.00 base units for CPT code 00812, 
and 5.00 base units for CPT code 00813.
(2) Acne Surgery (CPT Code 10040)
    CPT code 10040 (Acne surgery (e.g., marsupialization, opening or 
removal of multiple milia, comedones, cysts, pustules) was identified 
as potentially misvalued on a screen of Harvard-valued codes with 
utilization over 30,000 in CY 2014. In the CY 2018 PFS proposed rule, 
we proposed the RUC-recommended work RVU of 0.91 for CPT code 10040 and 
the RUC-recommended work time values. We considered using the current 
number of 0.5 post-procedure office visits of CPT code 99212 (Office/
outpatient visit est) rather than the RUC-recommended number of 1.0 
post-procedure office visits. For CPT code 10040, the RUC stated that 
it is a low intensity service that can be performed by a nurse under a 
physician's supervision, and that the average number of office visits 
in the follow-up period of acne surgery is 0.4. We sought public 
comments regarding the typical number of postoperative visits for this 
code, considering there have been no changes made to the code 
descriptor and we have not found evidence of changes to the typical 
patient population.
    We proposed the RUC-recommended direct PE inputs for CPT code 10040 
without refinement. We considered refinements to the clinical labor for 
``Assist physician in performing procedure'' from 10 minutes to 3 
minutes. CPT code 10040 previously used about one third of the 
intraservice work time for this clinical labor activity (5 minutes out 
of 14 minutes), and the RUC-recommended value of 10 minutes would have 
increased this to 100 percent of the intraservice work time without 
rationale for the change. We considered 3 minutes for this clinical 
labor activity, which is about one third of the intraservice work time 
(3 minutes out of 10 minutes) and would have maintained the current 
ratio between clinical labor time and work time. For CY 2018, we 
proposed the RUC-recommended work RVUs and direct PE inputs for CPT 
code 10040 and sought comment on our proposed and alternative values.
    Comment: Commenters supported the proposed values for CPT code 
10040 but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for CPT code 10040 as 
proposed.
(3) Muscle Flaps (CPT Codes 15734, 15736, 15738, 15730, and 15733)
    CPT codes 15732 and 15736 were identified via a screen of high 
level E/M visits included in their global periods. This screen 
identified that a CPT code 99214 office visit was included for CPT 
codes 15732 and 15736 but not included in the other codes in this 
family. During the CPT Editorial Panel's review process for this family 
of codes, CPT code 15732 was deleted and replaced with two new codes, 
CPT codes 15730 and 15733, to better differentiate and describe the 
work of large muscle flaps performed on patients with head and neck 
cancer depending on the site where the service was performed.
    For CY 2018, we proposed the RUC-recommended work RVUs of 23.00 for 
CPT code 15734, 17.04 for CPT code 15736, 19.04 for CPT code 15738, 
13.50 for CPT code 15730, and 15.68 for CPT code 15733. For CPT code 
15730, we considered a work RVU of 12.03, crosswalking to CPT code 
36830 (Creation of arteriovenous fistula by other than direct 
arteriovenous anastomosis (separate procedure); nonautogenous graft 
(e.g., biological collagen, thermoplastic graft)). We had concerns 
because the RUC-recommended work RVU of 13.50 would represent nearly 
double the intensity of CPT codes 15734 through 15738, as well as 
nearly double the intensity of deleted CPT code 15732. The RUC-
recommended work RVU for CPT code 15730 is also based on a direct 
crosswalk to CPT code 36832 (Revision, open, arteriovenous fistula; 
without thrombectomy, autogenous or nonautogenous dialysis graft 
(separate procedure)), which has the same intraservice time, but with 
20 additional minutes of total time. We considered a potential 
crosswalk to another code in the same family, CPT code 36830, which 
also shares the same intraservice time with CPT code 15730 but differs 
by only 8 minutes of total time. However, we sought comment on whether 
the RUC recommendation was appropriate given the significant variation 
in intensity among these services.
    We considered a work RVU of 14.63 for CPT code 15733 (survey 25th 
percentile), crosswalking to CPT code 36833 (Revision, open, 
arteriovenous fistula; with thrombectomy, autogenous or nonautogenous 
dialysis graft (separate procedure)), which has the same intraservice 
time, 1 minute of additional total time, and a work RVU of 14.50. We 
sought comment on the effect that an alternative work RVU of 14.50 
would have on relativity among the codes in this family.
    We considered refining the clinical labor time for ``Check 
dressings & wound/home care instructions'' for CPT code 15730 from 10 
minutes to 5 minutes. We sought comment on the typical time input for 
checking dressings, and whether removing and replacing dressings would 
typically take place during the intraservice or postservice period.
    We also sought comments regarding the use of the new ``plate, 
surgical, mini-compression, 4 hole'' (SD189) supply included in CPT 
code 15730, including whether use of this supply would be typical, and 
if so, whether it should be included in the work description. We noted 
that SD189 is mentioned in the direct PE recommendations, but the 
supply does not appear in the work description. In the work 
description, the fixation screws are applied to the orbital rim and 
lateral nasal wall, not the surgical plate.
    Comment: Several commenters supported the proposed values for all 
five of the codes but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    Comment: Several commenters stated that the use of the ``plate, 
surgical, mini-compression, 4 hole'' (SD189) supply was typical in CPT 
code 15730. Commenters mentioned that this supply had a number of 
clinical benefits, such as greater stability, less risk of infection, 
fewer screws, and a wide area of support. Commenters stated that the 
recommendation forms that accompany the work descriptor do not normally 
list all supplies or materials used before, during, or after the 
surgery in great detail.

[[Page 53039]]

    Response: We appreciate the additional information supplied by the 
commenters regarding the use of the SD189 supply. While we agree that 
the work descriptor for a procedure would not necessarily list all of 
the supplies used before, during, or after a surgery, we remain puzzled 
at the lack of any mention of the surgical plate in the description of 
work for this service. The surgical plate is an expensive ($226) supply 
that appears to be integral to the work being performed in this 
service. The deleted predecessor code for this service, CPT code 15732, 
did not include a surgical plate among its direct PE inputs, and if the 
use of the surgical plate is now typical for the new CPT code 15730, we 
believe that the description of work for this service would more 
accurately explain the work taking place by detailing the use of the 
supply. We agree with the commenters regarding the clinical benefits of 
the surgical plate, and believe that this should be reflected in the 
description of work for this service.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
muscle flaps family as proposed.
(4) Application of Rigid Leg Cast (CPT Code 29445)
    CPT code 29445 (Application of rigid total contact leg cast) 
appeared on a high growth screen of all services with total Medicare 
utilization of 10,000 or more services that increased by at least 100 
percent from 2008 through 2013. This screen also indicated that the 
code was last surveyed more than 10 years previously, and that the 
dominant specialty had changed during that time.
    For CY 2018, we proposed the RUC-recommended work RVU of 1.78 for 
CPT code 29445. For the direct PE inputs, we proposed to refine the 
clinical labor time for ``Check dressings & wound/home care 
instructions'' from 5 minutes to 3 minutes. We believed that the 
additional 2 minutes of clinical labor time that we proposed to remove 
would take place during the monitoring time following the procedure and 
be accounted for in that clinical labor time.
    We also considered refining the clinical labor time for ``Remove 
cast'' from 22 minutes to 11 minutes: 1 minute for room prep, 10 
minutes for assisting the physician, and 0 minutes for the additional 
activities described in the RUC recommendations, which would have only 
taken place during the initial casting. We had concerns that the RUC-
recommended clinical labor regarding the ``remove cast'' task is based 
only on an initial visit where a new cast would be applied and 22 
minutes may be an appropriate length of time. However, the RUC 
recommendations suggested that four to twelve cast changes are common 
for patients, and we sought comment on whether the initial application 
of a new cast would be typical for CPT code 29445. We reviewed the 
Medicare claims data for CPT code 29445 and found that three or more 
castings took place for 52 percent of beneficiaries, which suggests 
that three or more castings may be the typical case. A single casting 
only took place for 30 percent of services reported with CPT code 
29445.
    Comment: Several commenters supported the proposed values for CPT 
code 29445 but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    Comment: One commenter stated that they disagreed with our proposal 
to refine the clinical labor time for ``Check dressings & wound/home 
care instructions'' from 5 minutes to 3 minutes. The commenter did not 
supply any rationale for its disagreement.
    Response: We continue to believe that the additional 2 minutes of 
clinical labor time that we proposed to remove would take place during 
the monitoring time following the procedure and be accounted for in 
that clinical labor time, since we did not receive any information to 
suggest otherwise for CPT code 29445.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for CPT code 29445 as 
proposed.
(5) Strapping Multi-Layer Compression (CPT Codes 29580 and 29581)
    The RUC reviewed CPT code 29580 since it appeared on the screen for 
high expenditure services and reviewed CPT code 29581 as part of this 
family of codes. For CY 2018, the CPT Editorial Panel is deleting two 
additional codes in the family: CPT codes 29582 (Application of multi-
layer compression system; thigh and leg, including ankle and foot, when 
performed) and 29583 (Application of multi-layer compression system; 
upper arm and forearm).
    For CY 2018, we proposed the RUC-recommended work RVUs for CPT code 
29580 (a work RVU of 0.55) and CPT code 29581 (a work RVU of 0.60).
    However, we were concerned about the changes in preservice time 
reflected in the specialty surveys compared to the RUC-recommended work 
RVUs. For instance, for CPT code 29580, we considered a work RVU of 
0.46, crosswalking to CPT code 98925 (Osteopathic manipulative 
treatment (OMT); 1-2 body regions involved)), which has a work RVU of 
0.46 and shares a similar intraservice time. Compared to the specialty 
survey times, the RUC recommended a slight decrease (9 minutes) in 
preservice time for CPT code 29580, with the intraservice and immediate 
postservice times remaining unchanged.
    For CPT code 29581, we considered a work RVU of 0.51 [we note that 
in the CY 2018 PFS proposed rule (82 FR 33991), this was cited as 0.50] 
by using the RUC-recommended work RVU increment between CPT codes 29580 
and 29581 (+0.05), added to the work RVU we considered for CPT code 
29580 (0.46), and crosswalking to CPT code 97597 (Debridement (e.g., 
high pressure waterjet with/without suction, sharp selective 
debridement with scissors, scalpel and forceps), open wound, (e.g., 
fibrin, devitalized epidermis and/or dermis, exudate, debris, biofilm), 
including topical application(s), wound assessment, use of a whirlpool, 
when performed and instruction(s) for ongoing care, per session, total 
wound(s) surface area; first 20 sq cm or less)), which has similar 
intraservice and total times to the RUC-recommended services times for 
CPT code 29581. We sought comment on whether a work RVU of 0.51 would 
improve relativity among the codes in this family.
    For CY 2018, we proposed the RUC-recommended work RVUs for CPT 
codes 29580 and 29581 and sought comment on whether the alternative 
values we considered would be more appropriate.
    Comment: In general, commenters were supportive of our proposal of 
the RUC-recommended work RVUs. Some expressed opposition to the 
alternative work RVUs.
    Response: We will continue to consider alternative work RVUs as we 
propose the valuation of services for future notice and comment 
rulemaking.
    Comment: Several commenters were supportive of the RUC-recommended 
PE inputs for these services.
    Response: We disagree with the RUC-recommended PE inputs for these 
services. We proposed to refine the L037D clinical labor time for 
``Provide pre-service education/obtain consent'' from 3 minutes to 2 
minutes to conform to the standard for this clinical labor

[[Page 53040]]

activity. The RUC recommendation did not include a written 
justification for additional clinical labor time beyond the standard 2 
minutes for this activity. As a result, we also proposed to refine the 
recommended equipment times for the exam table (EF023) and exam light 
(EQ168) to conform to changes in clinical labor time. Thus, we proposed 
to refine the equipment times for EF023 and EQ168 to 34 minutes for CPT 
code 29580 and to 36 minutes for CPT code 29581, to reflect the service 
period time associated with these codes. We continue to believe that 
the use of clinical labor standards provides greater consistency among 
codes that share the same clinical labor tasks and can improve 
relativity of values among codes.
    After consideration of comments received, we are finalizing the 
work RVUs and direct PE inputs for these services as proposed.
(6) Resection Inferior Turbinate (CPT Code 30140)
    CPT code 30140 (Submucous resection inferior turbinate, partial or 
complete, any method) was identified as potentially misvalued on a 
screen of Harvard-valued codes with utilization over 30,000 in CY 2014. 
During the review process, the RUC re-surveyed the code as a 0-day 
global period, based on the presence of a negative intensity value in 
the initial survey and highly variable postoperative office visits.
    For CY 2018, we proposed the RUC-recommended work RVU of 3.00 for 
CPT code 30140 as a 0-day global code. We also considered a work RVU of 
2.68 for CPT code 30140 and sought comment on changes in practice 
patterns since the code was previously reviewed, service times of 
comparable services, and whether a work RVU of 2.68 would better 
maintain relativity among similar codes. We noted that the RUC-
recommended work RVU of 3.00 nearly doubles the derived intensity of 
the code as currently valued. We noted that the RUC recommendations 
referenced services that had similar service times to CPT code 30140 
(CPT code 31240 (Nasal/sinus endoscopy, surgical; with concha bullosa 
resection), with a work RVU of 2.61; and CPT code 31295 (Nasal/sinus 
endoscopy, surgical; with dilation of maxillary sinus ostium (e.g., 
balloon dilation), transnasal or via canine fossa), with a work RVU of 
2.70.
    We noted that the initial survey for CPT code 30140 as a 90-day 
global resulted in a RUC-recommended work RVU of 3.57, while the second 
survey for the code as a 0-day global resulted in a RUC-recommended 
work RVU of 3.00, despite the removal of two postoperative office 
visits of CPT code 99212 and a half discharge visit of CPT code 99238. 
These removed postoperative visits have a total work RVU of 2.58, which 
is notably higher than the difference in the RUC-recommended work RVUs 
between the two surveys.
    We also proposed to create equipment codes for three new equipment 
items based on invoices submitted with the RUC recommendations for CPT 
code 30140. We proposed to create three new equipment codes based on 
the invoices submitted for this code family: The 2mm reusable shaver 
blade (EQ383) at a price of $790, the microdebrider handpiece (EQ384) 
at a price of $4,760, and the microdebrider console (EQ385) at a price 
of $9,034.
    Comment: Several commenters supported the proposed values for CPT 
code 30140 but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    Comment: One commenter requested that CMS add a new supply named 
the ``turbinate reduction wand'' to the supply inputs associated with 
this procedure when performed in the physician office setting. The 
commenter stated that this device is designed to ablate, coagulate, and 
remove a core of tissue that provides the desired volumetric reduction 
of the anatomy, and supplied several invoices for use in pricing the 
new supply.
    Response: We note that the suggested turbinate reduction wand has a 
price of nearly $200, which would add substantially to the costs of CPT 
code 30140. Before including such significant resource costs in the 
code, we believe that we should see input from the physician community 
such as the RUC. At present, we do not have any information to suggest 
that the use of this new supply is typical for CPT code 30140, and the 
RUC did not recommend the inclusion of this supply on either of the two 
occasions when this code was reviewed in CY 2017. For these reasons, we 
do not believe that it would be appropriate to add the turbinate 
reduction wand to CPT code 30140 at this time. We welcome the 
submission of additional information regarding this use of this supply 
from stakeholders.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for CPT code 30140 as 
proposed.
(7) Control Nasal Hemorrhage (CPT Codes 30901, 30903, 30905, and 30906)
    In the CY 2018 PFS proposed rule, we proposed the RUC-recommended 
work RVU of 1.10 for CPT code 30901, 1.54 for CPT code 30903, 1.97 for 
CPT code 30905, and 2.45 for CPT code 30906. We also proposed the RUC-
recommended direct PE inputs for CPT codes 30901, 30903, 30905, and 
30906, with standard refinements to the equipment times to account for 
patient monitoring times. We noted that as part of its recommendation, 
the RUC informed us that the specialty societies presented evidence 
stating that the 1995 valuations for these services factored in 
excessive times, specifically to account for infection control 
procedures that were necessary at that time due to the prevalence of 
HIV/AIDS. The specialty societies also noted that increased 
availability and use of blood thinner medications compared to those 
available in 1995, has increased the difficulty and intensity of these 
procedures. We sought additional information regarding the presumption 
that the relative resource intensity of these services specifically 
would be affected by the commercial availability of additional blood 
thinner medications. We stated in the CY 2018 PFS proposed rule that we 
believe blood thinner medications were widely available before 1995 
when these codes were last valued. We also sought comments on the 
prevalence of HIV/AIDS and whether the work related to infection 
control procedures would be relative across many PFS services or 
specifically related to nasal hemorrhage control procedures.
    For CPT code 30901 (Control nasal hemorrhage, anterior, simple 
(limited cautery and/or packing) any method), we considered a work RVU 
of 1.00 (the 25th percentile survey result), crosswalking to CPT code 
20606 (Arthrocentesis, aspiration 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), which has similar service times. The median 
survey total time (24 minutes) dropped by 2 minutes (from preservice 
time), to 24 minutes compared to the existing total time. The 
difference in total time reflected a small decrease in preservice time, 
with no change in intraservice time (10 minutes). Among codes with 
similar service times, we found only three codes that had a higher work 
RVU than the RUC-recommended value.

[[Page 53041]]

    For CPT code 30903 (Control nasal hemorrhage, anterior, complex 
(extensive cautery and/or packing) any method), we considered a work 
RVU of 1.30 (the 25th percentile survey result), which would have been 
further supported by CPT codes 36584 and 51710, which have similar 
service times to the median survey results. The RUC recommended a 
decreased total time of 39 minutes compared to the existing total time 
(70 minutes), with intraservice time dropping from 30 to 15 minutes.
    For CPT code 30905 (Control nasal hemorrhage, posterior, with 
posterior nasal packs and/or cautery, any method; initial), we 
considered a work RVU of 1.73, using the RUC-recommended work RVU 
increment between CPT codes 30903 and 30905 (0.43), added to the work 
RVU we considered for CPT code 30903 (1.30), and crosswalking to CPT 
code 45321 (Proctosigmoidoscopy, rigid; with decompression of 
volvulus), which has similar service times. The surveyed intraservice 
time dropped from 48 minutes to 20 minutes. The RUC recommendations 
indicated that surveyed service times for CPT code 30905 are longer 
than for CPT code 30903 since the service is performed to control an 
arterial posterior bleed. According to the specialty society, arterial 
posterior bleeds are more difficult to treat and require a more 
extensive procedure in comparison to services reported with CPT code 
30903. We considered using the RUC-recommended work RVU increment 
between CPT codes 30903 and 30905 (0.43), added to the work RVU we 
considered for CPT code 30903 (1.30), resulting in a work RVU of 1.73. 
We sought comment on whether a work RVU of 1.73 would potentially 
affect relativity among the codes in this family.
    For CPT code 30906 (Control nasal hemorrhage, posterior, with 
posterior nasal packs and/or cautery, any method; subsequent), we 
considered a work RVU of 2.21, using the RUC-recommended work RVU 
increment between CPT codes 30905 and 30906 (0.48), added to the work 
RVU we considered for CPT code 30905 (1.73), and crosswalking to 
services with similar service times (CPT codes 19281 (Placement of 
breast localization device(s) (e.g., clip, metallic pellet, wire/
needle, radioactive seeds), percutaneous; first lesion, including 
mammographic guidance), 51727 (Simple Cystometrogram (CMG) (e.g., 
spinal manometer); with urethral pressure profile studies (i.e., 
urethral closure pressure profile), any technique), 49185 
(Sclerotherapy of a 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), and 62305 (Myelography via lumbar injection, including 
radiological supervision and interpretation; 2 or more regions (e.g., 
lumbar/thoracic, cervical/thoracic, lumbar/cervical, lumbar thoracic/
cervical)). The surveyed median intraservice time dropped from 60 
minutes to 30 minutes. We sought comment on whether a work RVU of 2.21 
would potentially improve relativity among the codes in this family.
    Given the RUC's consensus, for CY 2018, we proposed the RUC-
recommended work RVUs for each code in this family and sought comment 
on whether our alternative values would be more appropriate.
    Comment: We received a few comments that specifically addressed our 
proposed values for this code family from professional specialty 
societies, including the RUC. Commenters expressed support for CMS' 
proposed values including the proposed direct PE inputs with standard 
refinements to equipment times.
    Response: We appreciate the commenters' support and, after 
consideration of the comments received that specifically address the 
codes in this family, we are finalizing a work RVU of 1.10 for CPT code 
30901, a work RVU of 1.54 for CPT code 30903, a work RVU of 1.97 for 
CPT code 30905, and a work RVU of 2.45 for CPT code 30906. We are also 
finalizing the direct PE inputs as proposed, with standard refinements 
to equipment times to account for patient monitoring times.
(8) Nasal Sinus Endoscopy (CPT Codes 31254, 31255, 31256, 31267, 31276, 
31287, 31288, 31295, 31296, 31297, 31241, 31241, 31253, 31257, 31259, 
and 31298)
    In October 2016, the CPT Editorial Panel created five new codes 
(CPT codes 31241, 31241, 31253, 31257, 31259 and 31298) and revised CPT 
codes 31238, 31254, 31255, 31276, 31287, 31288, 31296, and 31297. CPT 
codes 31253--31298 are newly bundled services representing services 
that are frequently reported together. CPT code 31241 represents a new 
service. The RUC reviewed this family of codes at its January 2017 
meeting. For CY 2018, we proposed the RUC-recommended work RVUs for all 
15 CPT codes in this family as follows: 4.27 for CPT code 31254, 5.75 
for CPT code 31255, 3.11 for CPT code 31256, 4.68 for CPT code 31267, 
6.75 for CPT code 31276, 3.50 for CPT code 31287, 4.10 for CPT code 
31288, 2.70 for CPT code 31295, 3.10 for CPT code 31296, 2.44 for CPT 
code 31297, 8.00 for CPT code 31241, 9.00 for CPT code 31253, 8.00 for 
CPT code 31257, 8.48 for CPT code 31259, and 4.50 for CPT code 31298.
    For CPT code 31296, we considered a work RVU of 2.82, supported by 
a crosswalk to CPT code 36901 (Intro cath dialysis circuit) with an 
intraservice time of 25 minutes and total time of 66 minutes, similar 
to the service times for CPT code 31296. We were concerned about the 
decrease in service time compared to the work RVU and sought comment on 
whether or not a work RVU of 2.82 might improve relativity with other 
PFS services.
    For CPT code 31256, we considered a work RVU of 2.80, supported by 
a crosswalk to CPT code 43231 (Esophagoscopy, flexible, transoral; with 
endoscopic ultrasound examination), which has 30 minutes of 
intraservice time and 81 minutes of total time, similar to the RUC-
recommended service times. We were concerned about the difference in 
total time between CPT code 31256 and the RUC-recommended crosswalk to 
CPT code 43247. CPT code 43247 has 30 minutes intraservice time and 58 
minutes total time), and CPT code 31256 (30 minutes intraservice time 
and 83 minutes total time).
    For CPT code 31254, we noted the RUC's explanation that this 
service is more intense than the functional endoscopic sinus surgery on 
the maxillary or sphenoid sinuses due to the risk of major 
complications such as injury to the eye muscles, bleeding into the eye 
or brain fluid leak and, consequently, that the RUC concluded that it 
should be valued higher than either CPT code 31256 or CPT code 31287. 
Since CPT code 31256 has the same total time (30 minutes) and 
intraservice time (30 minutes) as CPT code 31254, we considered whether 
the incremental difference recommended by the RUC between these two 
codes (work RVU of 1.16) would reflect the intensity of the service. We 
considered a work RVU of 2.80 for CPT code 31256, and also considered 
an alternative work RVU of 3.97 for CPT code 31254.
    For CPT code 31287, we considered a work RVU of 3.19 based on the 
difference between the RUC-recommended work RVU for the maxillary sinus 
surgery (CPT code 31256) and the sphenoid sinus surgery (CPT code 
31287) (difference = 0.28) added to the work RVU that we considered for 
the base code (CPT code 31256, a work RVU of 2.80). We noted that the 
magnitude of decreases in

[[Page 53042]]

service times is greater than those for the work RVU, which potentially 
could affect relativity among PFS services.
    For CPT code 31255, we considered a work RVU of 5.30, based on a 
crosswalk to CPT codes 36475 (Endovenous rf 1st vein) and 36478 
(Endovenous laser 1st vein) since both of these services have the same 
intraservice times, total times, and work RVUs. We noted that there are 
several CPT codes with similar total and intraservice times as CPT code 
31255 that have lower work RVUs than the RUC's recommended work RVU of 
5.75, such as CPT code 36246 (Ins cath abd/l-ext art 2nd), which has 45 
minutes intraservice time, 96 minutes total time and a work RVU of 5.02
    For CPT code 31276 (Nasal/sinus endoscopy, surgical; with frontal 
sinus exploration, including removal of tissue from frontal sinus, when 
performed), we considered a work RVU of 6.30, which is similar to other 
functional endoscopic surgeries. We noted that the services reported 
with CPT code 31276 are the most intense and complex of the functional 
endoscopic surgeries due to the risks of working in the narrow confines 
in the frontal recess. However, we had concerns regarding the RUC-
recommended crosswalk to CPT code 52352 (Cystourethroscopy, with 
ureteroscopy and/or pyeloscopy; with removal or manipulation of 
calculus (ureteral catheterization is included)), and sought comment on 
whether the RUC-recommended decrease in service times was appropriate 
since CPT code 52352 has 20 minutes more total time than CPT code 
31276.
    For CPT code 31241 (nasal/sinus endoscopy, surgical; with ligation 
of Sphenopalatine artery), we had concerns and sought comment regarding 
the accuracy and applicability of the surveys as the RUC indicated that 
the specialty society did not use the survey instrument that contained 
questions about the number and types of visits and that this service 
requires including a half day discharge day management as the patients 
typically stay overnight to be monitored for further bleeding. We 
sought comment on whether inclusion of a half day discharge day visit 
was typical for this service since services assigned 0-day global 
periods do not typically include discharge visits. We considered 
reducing the total time from 142 minutes to 123 minutes by removing the 
half day discharge. Using the alternative total time of 123 minutes, we 
found services with similar total and intraservice time (60 minutes) 
and total time (123 minutes).
    We considered a work RVU of 7.30 for CPT code 31241, supported by a 
direct crosswalk to CPT code 36253 (Superselective catheter placement 
(one or more second order or higher renal artery branches) renal artery 
and any accessory renal artery(s) for renal angiography, including 
arterial puncture, catheterization, fluoroscopy, contrast injection(s), 
image postprocessing, permanent recording of images, and radiological 
supervision and interpretation, including pressure gradient 
measurements when performed, and flush aortogram when performed; 
unilateral), since CPT code 36253 has a similar total time compared to 
our alternative total time.
    For CPT code 31257, we considered a work RVU of 7.30, based on a 
crosswalk to CPT code 36253 (Superselective catheter placement (one or 
more second order or higher renal artery branches) renal artery and any 
accessory renal artery(s) for renal angiography, including arterial 
puncture, catheterization, fluoroscopy, contrast injection(s), image 
postprocessing, permanent recording of images, and radiological 
supervision and interpretation, including pressure gradient 
measurements when performed, and flush aortogram when performed; 
unilateral). We had similar concerns regarding the service times for 
this service, including the cited reference codes, compared to the RUC-
recommended work RVU. We sought comment on whether a work RVU of 7.30 
for CPT code 31257 would improve consistency among the combined CPT 
codes in this family.
    CPT code 31259 is a new code representing a combination of the 
services previously described by CPT codes 31255 and 31288. We noted 
the changes in overall service times compared to other codes in this 
family and other PFS services. We considered a work RVU of 7.85 for CPT 
code 31259, crosswalking to CPT code 93461 (R&l hrt art/ventricle 
angio), which has identical intraservice times. We sought comment on 
the effect that this alternative work RVU might have on consistency and 
rank order compared to the other bundled codes in this family.
    CPT code 31298 represents a combination of CPT codes 31296 and 
31297. We had concerns about the use of the RUC-recommended comparison 
codes, CPT codes 47532 and 58558, due to differences in both 
intraservice and total time compared to the service times for CPT code 
31298. We considered a work RVU of 4.10 for CPT code 31298, 
crosswalking to CPT code 44406 (Colonoscopy w/ultrasound), which has 
similar service times.
    In the CY 2018 PFS proposed rule, we proposed the RUC-recommended 
work RVUs for each code in this family and sought comment on our 
alternative values.
    Comment: In general, commenters supported the work RVUs for 
existing CPT codes in this family as proposed. One commenter expressed 
concern about the proposed work RVUs for the newly bundled CPT codes: 
CPT code 31253, 31257, 31259, and 31298. The commenter encouraged CMS 
to adopt a payment rate for the newly bundled codes that more closely 
aligns with the payment if the individual codes are reported separately 
on the same claim. Valuing the newly bundled codes as the sum of the 
component codes would yield a work RVU of 12.50 for CPT 31253 instead 
of the proposed 9.00; a work RVU of 9.25 for CPT 31257 instead of the 
proposed 8.00; a work RVU of 9.85 for 31259 instead of the proposed 
8.48; and a work RVU of 5.44 for CPT 31298 instead of the proposed 
4.50.
    Response: We believe that certain efficiencies occur when certain 
services are furnished together. From a payment perspective, those 
efficiencies are reflected in the multiple procedure payment reduction. 
Similarly, when services that used to be described by two separate 
codes are combined, those efficiencies are reflected in the work RVU 
for the combined code. Therefore, we are finalizing all work RVUs for 
the CPT codes in this family, including the newly combined services, as 
proposed.
    Comment: One commenter noted that a few of the CPT codes have work 
RVUs that are decreasing by more than 20 percent and requested that CMS 
phase-in these rate reductions.
    Response: Section 1848(c)(7) of the Act requires that, 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. We note that the phase-in 
requirement does not apply to codes that are new or revised. Therefore, 
the CPT codes in this code family with work RVU reductions of greater 
than 20 percent are not subject to the phase-in requirement. Please see 
section II.F of the CY 2016 PFS final rule with comment period (80 FR 
70930) for more information regarding the phase-in of significant RVU 
reductions. The document 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.
    Regarding the recommended direct PE inputs, we expressed concern 
about one of the supply items used in furnishing

[[Page 53043]]

services for several CPT codes in this family: ``sinus surgery balloon 
(maxillary, frontal, or sphenoid) kit'' (SA106). In the current 
recommendations, half of one kit (each kit has sufficient supply for 
two sinuses) is included in the PE inputs for CPT codes 31295, 31296, 
and 31297. The new CPT code 31298 has one full kit, reflecting a 
service consisting of two sinuses, according to the RUC's explanation. 
The price of the full kit (two sinuses) of this disposable supply is 
$2,599.06. Our analysis of 2016 Medicare claims data indicated that 48 
percent of the time one of the three CPT codes (31295, 31296, and 
31297) is billed, it is reported on a claim with either one or both of 
the other codes. Ten percent of the time one of the three CPT codes is 
billed, it is reported on a claim with both of the other two codes. 
Effectively, 10 percent of claims reporting these CPT codes are being 
paid for three sinuses. We sought comments on the number of units of 
this supply item that are used for each service. We welcomed 
suggestions about improved methodologies for identifying the quantity 
of this disposable supply used during these procedures and will 
continue to monitor utilization and reporting of these services.
    Comment: We received several comments in response to our request 
for input about the number of units of supply item ``sinus surgery 
balloon (maxillary, frontal, or sphenoid) kit'' (SA106) that are 
appropriate for CPT codes 31295, 31296, 31297, and 31298. Commenters, 
including the RUC, noted that each kit includes one balloon, and each 
sinus requires 0.5 of a balloon, and that the current PE input of 0.5 
of SA106 is appropriate for CPT 31295, 31296, and 31297. Commenters 
also noted that, since CPT code 31298 bundles CPT codes 31296 and 
31297, an entire balloon kit is appropriate. The RUC also reiterated 
support for CMS to develop a standalone HCPCS supply code for the 
balloon kit.
    Response: We are finalizing the PE input for supply item SA106 as 
proposed, which includes 0.5 kit for CPT codes 31295, 31296, and 31297, 
and one kit for CPT code 31298.
    Comment: One commenter suggested that several PE inputs for CPT 
code 31254 are either missing, insufficient, or have an incorrect 
price. The commenter also requested that CMS develop nonfacility PE 
inputs for CPT code 31255.
    Response: After reviewing the commenter's suggestions regarding 
supply items for CPT code 31254, we believe that the current supplies 
and prices, as developed by the RUC in concert with the specialty 
societies, account for the items that are typically involved in 
furnishing this service. We refer the commenter to the process by which 
additional information for consideration of prices for supply items can 
be provided to CMS through the annual rulemaking cycle, in particular 
through invoices. Regarding the request to establish nonfacility values 
for this code, we have historically proposed payment rates for specific 
settings that have been vetted through the RUC process. We also 
consider information on Medicare utilization that may indicate trends 
on where the service is being furnished to identify when it might be 
appropriate to value a code in the nonfacility setting. If stakeholders 
are interested in submitting information about PE inputs that reflect 
resource costs typical for a particular setting, we encourage 
collaboration with the RUC in addressing such inputs. We note 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. We 
are finalizing the PE inputs for CPT codes in this family as proposed.
    In reviewing the RUC recommendations for this family of CPT codes, 
we noted that the CPT codes in this family are subject to the standard 
payment adjustment for multiple surgeries. In our analysis of the 
claims data, we noted that the average number of HCPCS codes in this 
family reported together on a claim line is approximately 2.89. In 
addition, about 15 percent of claims have two of the newly bundled CPT 
codes reported together on a claim line. We expressed concern about the 
frequency with which the nasal sinus endoscopy CPT codes in this family 
are billed together. We sought comments on whether we should consider 
the endobase code adjustments as a better approach to adjusting payment 
for these services instead of the current multiple procedure payment 
reduction. For additional information about the payment adjustment 
under the special rule for multiple endoscopic services, we refer 
readers to the Medicare Claims Processing Manual, Chapter 23 (available 
on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS018912.html.
    Comment: There was no consensus among commenters about whether we 
should consider the endobase code adjustments as a better approach to 
adjusting payment for these services instead of the multiple procedure 
payment reduction. A few commenters stated their opposition, noting 
that in cases where multiple endoscopies are provided on the same date 
of service, this would result in the base procedure not being 
reimbursed, and that this would be grossly inappropriate because these 
are therapeutic procedures and each sinus represents very different 
work and risks. Other commenters supported the application of the 
payment reduction for multiple endoscopic procedures.
    Response: We will consider these comments. We welcome feedback from 
stakeholders regarding these and other services for which a change in 
the indicator status designating the applicable type of multiple 
procedure payment reduction might be appropriate. We are finalizing our 
proposal to maintain the standard multiple procedure payment reduction 
for this group of nasal sinus endoscopy services.
    To estimate utilization for new or newly bundled services in this 
group of complex codes, we used a different crosswalk to current 
services than was recommended by the RUC. We believe that the RUC did 
not sufficiently account for utilization changes that occur when 
several newly bundled CPT codes describe formerly separate services. We 
direct readers to the file called ``CY 2017 Analytic Crosswalk to CY 
2018'' on the CMS Web site under downloads for the CY 2018 PFS final 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(9) Tracheostomy (CPT Codes 31600, 31601, 31603, 31605, and 31610)
    CPT code 31600 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. CPT codes 31601, 31603, 
31605, and 31610 were added and reviewed as part of the code family.
    We proposed the RUC-recommended work RVUs for all five codes in 
this family. We proposed work RVUs of 5.56 for CPT code 31600, 8.00 for 
CPT code 31601, 6.00 for CPT code 31603, 6.45 for CPT code 31605, and 
12.00 for CPT code 31610.
    We considered a work RVU of 6.50 for CPT code 31601. We sought 
comment on the effect that this alternative value would have on 
relativity compared to other PFS services, especially since the survey 
data do not suggest an increase in the time required to perform the 
procedure.

[[Page 53044]]

    We considered a work RVU of 4.77 for CPT code 31605, based on the 
survey 25th percentile from the combined survey total. We also 
considered an intraservice work time of 15 minutes, based on the median 
intraservice work time from the combined survey total for CPT code 
31605. We sought comments on the methodology used to determine the RUC-
recommended work RVU and intraservice work time. We were concerned that 
the number of respondents (20) was below the threshold typically 
required for submission of a survey, and the effect of using survey 
results only from physicians who had personal experience performing the 
procedure. CPT code 31605 has a lower intraservice and total time, but 
a higher work RVU than comparable codes under the PFS. We noted that 
the next highest 0-day global code with 20 minutes of intraservice time 
is CPT code 16035 (Escharotomy; initial incision) at a work RVU of 
3.74. All other 0-day global codes with a work RVU of 6.45 or greater 
have at least 40 minutes of intraservice time.
    We sought comment on the effect that an alternative work RVU of 
4.77 would have on the relativity of this service compared to other 
services in this family of codes and compared to other PFS services, 
taking into account that CPT code 31605 describes a difficult and 
dangerous life-threatening emergency procedure.
    We considered a work RVU of 6.50 for CPT code 31610 based on a 
direct crosswalk to CPT code 31601 (Incision of windpipe). We 
understand that the RUC considered the possibility of recommending this 
code be assigned a 0-day global period based on concerns about negative 
derived intensity. We shared the RUC's concerns with the current 
construction of CPT code 31610, particularly with the 242 minutes of 
work time included in the postoperative visits, which is an unusually 
large amount for a procedure with only 45 minutes of intraservice time. 
We did not identify any other comparable codes under the PFS with 45 
minutes of intraservice time and more than 300 minutes of total time. 
We sought comment on whether the unusually high volume of physician 
work time included in the postoperative visits for CPT code 31610 
contributed to the negative derived intensity reported by the survey 
data. Considering that the other codes in this family have 0-day global 
periods, we considered and sought comment on whether a 0-day global 
period should be assigned to CPT code 31610. Removal of the 
postoperative E/M visits from CPT code 31610 would result in an 
intraservice time of 45 minutes and a total time of 125 minutes, 
similar to CPT code 31601 with 45 minutes of intraservice time and 135 
minutes of total time.
    We proposed the RUC-recommended direct PE inputs for all five CPT 
codes in this family without refinements. As discussed earlier, we 
considered a 0-day global period for CPT code 31610, which would also 
have resulted in removal of the clinical labor associated with the 
postoperative E/M visits, along with the supplies and equipment 
utilized during those visits. While we remained concerned about the 
global period assigned to CPT code 31610 and the changes in service 
times reflected in the specialty surveys compared to the RUC-
recommended work RVUs, for CY 2018, we proposed the RUC-recommended 
work RVUs and direct PE inputs for each code in this family and sought 
comment on our proposed and alternative values.
    Comment: The commenters supported the proposed values for all five 
of the codes but disagreed with the alternative values.
    Response: We appreciate the feedback from the commenters. We 
continue to welcome information from all interested parties regarding 
valuation of services for consideration through our rulemaking process.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs, direct PE inputs, and global periods for the 
codes in the tracheostomy family as proposed.
(10) Bronchial Aspiration of Tracheobronchial Tree (CPT Codes 31645 and 
31646)
    CPT code 31645 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed with therapeutic aspiration of 
tracheobronchial tree, initial) was identified as potentially misvalued 
on a screen of Harvard-valued codes with utilization over 30,000 in CY 
2014. CPT code 31646 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed with therapeutic aspiration of 
tracheobronchial tree, subsequent, same hospital stay) was added for 
review as part of the family of codes, and both were revised to reflect 
recent changes in how the services are typically performed. For CY 
2018, we proposed the RUC-recommended work RVUs of 2.88 for CPT code 
31645 and 2.78 for CPT code 31646.
    We considered a work RVU of 2.72 for CPT code 31645, crosswalking 
to CPT code 45347 (Sigmoidoscopy, flexible; with placement of 
endoscopic stent). We had concerns regarding the decrease in 
intraservice and total time compared to the current values; we also 
believe that it is important to note how these related codes have been 
affected by the creation of separately billable codes for moderate 
sedation (see the CY 2017 PFS final rule (81 FR 80339)). The RUC 
recommended a work RVU for CPT code 31645 that is higher than the work 
RVU for CPT code 31622 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed; diagnostic, with cell washing, 
when performed), which is the base procedure for this broader group of 
codes. We agreed that CPT code 31645 should be valued at a higher work 
RVU than CPT code 31622; however, we sought comment on whether the work 
of moderate sedation was inadvertently included in the development of 
the recommended work RVU. We noted that as part of the CY 2017 PFS 
final rule (81 FR 80339), we finalized separate payment for moderate 
sedation. Following the creation of separately billable codes for 
moderate sedation, CPT code 31622 is currently valued at a work RVU of 
2.53, not 2.78 as it was previously valued, and we did not believe it 
would be appropriate to continue to value CPT code 31645 as though 
moderate sedation was still an inherent part of the work of this 
service. As a result, we considered a direct crosswalk to CPT code 
45347, which has the same intraservice time and 8 additional minutes of 
total time, at a work RVU of 2.72.
    We considered a work RVU of 2.53 for CPT code 31646, crosswalking 
to CPT code 31622 (Dx bronchoscope/wash). The RUC recommendation for 
CPT code 31646 indicated that the code was comparable to CPT code 
31622, since they share the same intraservice time and similar total 
time, and that the recommended work RVU of 2.78 for CPT code 31646 was 
equal to the work RVU of CPT code 31622 before the CY 2017 changes to 
reporting of moderate sedation. We agreed with the survey participants 
that these two codes are comparable to one another, but had concerns 
about valuation of CPT code 31646 using a cross reference to a code 
that included moderate sedation. We considered crosswalking CPT code 
31646 using the current CY 2017 valuation for CPT code 31622 (a work 
RVU of 2.53).
    For the direct PE inputs, we proposed to remove the oxygen gas 
(SD084) from CPT code 31645. This supply is included in the separately 
billable moderate sedation codes, and we proposed to remove the oxygen 
gas as recommended by the RUC's PE Subcommittee as part of the removal 
of

[[Page 53045]]

oxygen from non-moderate sedation post-procedure monitoring codes. We 
also proposed to remove the equipment time for the IV infusion pump 
(EQ032) from CPT code 31645. We did not agree that there would 
typically be a need for a separate infusion pump in CPT code 31645, as 
the infusion pump is contained in the separately reportable moderate 
sedation codes. We also proposed to remove the equipment time for the 
CO2 respiratory profile monitor (EQ004) and the mobile instrument table 
(EF027) from CPT code 31645. These equipment items are not contained in 
the current composition of the code, and there was no rationale 
provided in the RUC recommendations for their inclusion. As a result, 
we did not believe that their use would be typical for CPT code 31645.
    We proposed to increase the equipment time for the flexible 
bronchoscopy fiberscope (ES017) for CPT code 31645 consistent with 
standard equipment times for scopes. We also proposed to increase the 
equipment time for the Gomco suction machine (EQ235) and the power 
table (EF031) consistent with standard equipment times for non-highly 
technical equipment. For CY 2018, we proposed the RUC-recommended work 
RVUs for both codes in this family and sought comment on whether we 
should finalize refined values consistent with the implementation of 
separately billable codes for moderate sedation.
    Comment: Several commenters supported the proposed values for both 
of the codes but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    Comment: One commenter disagreed with our proposal to remove the 
oxygen gas (SD084) and the equipment time for the CO2 respiratory 
profile monitor (EQ004) from CPT code 31645. The commenter stated that 
although the separately reported moderate sedation codes do include 
some oxygen, the new codes fail to include enough oxygen for the entire 
procedure, and there would be an unacceptable risk to the patient 
population if insufficient quantities of oxygen were allotted for this 
service. The commenter indicated that the use of these direct PE inputs 
was the standard of care for bronchoscopies.
    Response: After reviewing the information supplied by the 
commenter, we agree that the removal of these two direct PE inputs from 
CPT code 31645 could create a risk for the patient population. 
Therefore, we are finalizing the inclusion of 175 liters of oxygen gas 
and 58 minutes of equipment time for the CO2 respiratory profile 
monitor for CPT code 31645.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
bronchial aspiration of tracheobronchial tree family as proposed, with 
the exception of the proposed removal of the oxygen gas and CO2 
respiratory profile monitor as detailed above.
(11) Cryoablation of Pulmonary Tumor (CPT Codes 32998 and 32994)
    For CY 2018, the CPT Editorial Panel modified the descriptor for 
CPT code 32998 (Ablation therapy for reduction or eradication of 1 or 
more pulmonary tumor(s) including pleura or chest wall when involved by 
tumor extension, percutaneous, including imaging guidance when 
performed, unilateral; radiofrequency) to include imaging guidance. In 
addition, the panel deleted Category III CPT Code 0304T and replaced it 
with a new CPT code 32994, to describe ablation therapy for reduction 
of pulmonary tumor using cryoablation with imaging guidance. In the CY 
2018 PFS proposed rule, we proposed the RUC-recommended work RVUs for 
CPT codes 32998 (a work RVU of 9.03) and 32994 (a work RVU of 9.03).
    However, we expressed concerns about the descriptions of the codes 
and the recommended valuations assuming that imaging guidance is 
inherent to the procedure. Based on our analysis of claims data from 
2014, existing CPT code 32998 is currently reported with one of the 
three imaging guidance codes (CPT codes 76940, 77013, or 77022) less 
than 50 percent of the time. We sought comment on whether there is 
additional information that would help explain why the codes are being 
bundled despite what is reflected in the Medicare claims data. We 
considered a work RVU of 7.69 for CPT code 32998, that included 
approximately one half the value of the imaging guidance in the new 
codes that describe the work of both the procedure and the image 
guidance (that is, the sum of the current work RVU for CPT code 32998 
and one-half of the work RVU for CPT code 77013 (the imaging guidance 
code most frequently billed with CPT code 32998 according to 2014 
claims data)). We applied the same general rationale regarding the use 
of imaging guidance for new CPT code 32994. Since the RUC recommended 
identical work RVUs for these codes, we also considered a work RVU of 
7.69 for CPT code 32994.
    For CPT codes 32998 and 32994, we proposed to use the RUC-
recommended direct PE inputs with standard refinements and sought 
comment on our proposed values.
    Comment: Commenters generally supported the work RVUs for these 
codes, as proposed. Some commenters expressed concerns about our 
analysis of utilization data related to the bundling of imaging 
guidance services with ablation therapy. In addition, commenters 
disagreed with our refinement to times for several equipment items.
    Response: We continue to remain interested in ensuring that, when 
two services are combined into a single CPT code, that they are 
furnished together so frequently that the resulting resource valuation 
is not inadvertently overestimating resource costs.
    After consideration of the public comments, we are finalizing the 
work RVUs as proposed. With regard to the PE inputs, we note that we 
applied the standard formulas for equipment times, and we continue to 
believe that these refinements are reasonable for these codes. An 
explanation of the standards and formulas for equipment related to 
direct PE inputs is in the CY 2014 PFS final rule with comment period 
(79 FR 67557). We are also finalizing the direct PE inputs with 
standard refinements for these services, as proposed.
(12) Artificial Heart System Procedures (CPT Codes 33927, 33929, and 
33928)
    For CY 2018, the CPT Editorial Panel deleted Category III CPT Codes 
0051T through 0053T and created CPT codes 33927 (Implantation of a 
total replacement heart system (artificial heart) with recipient 
cardiectomy), 33929 (Removal of a total replacement heart system 
(artificial heart) for heart transplantation), and 33928 (Removal and 
replacement of total replacement heart system (artificial heart)) to 
report artificial heart system procedures. We proposed the RUC-
recommended work RVU of 49.00 for CPT code 33927, and proposed to 
assign contractor-priced status to CPT codes 33929 and 33928, as 
recommended by the RUC. We considered assigning contractor-priced 
status for CPT code 33927. We had concerns regarding the accuracy of 
the RUC-recommended work valuation for CPT code 33927, due to its low 
utilization and the resulting difficulties in finding enough 
practitioners with direct experience of the procedure for the specialty 
societies to survey. We sought comment on the sufficiency of the survey 
data, especially since new

[[Page 53046]]

technologies and those with lower utilization are typically contractor-
priced. For CY 2018, we proposed the RUC-recommended work RVUs for CPT 
code 33927. We sought comment on this alternative pricing for this CPT 
code 33927. We did not propose any direct PE inputs, as we did not 
receive RUC-recommended PE information for CPT codes 33927, 33929, and 
33928. These three codes will be placed on the RUC's new technology 
list and will be re-reviewed by the RUC in 3 years.
    Comment: Several commenters supported the proposed values for CPT 
code 33927 but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    After consideration of comments received for CY 2018, we are 
finalizing the work RVU of 49.00 for CPT code 33927 and finalizing 
contractor-priced status for CPT codes 33929 and 33928 as proposed.
(13) Endovascular Repair Procedures (CPT Codes 34701, 34702, 34703, 
34704, 34705, 34706, 34707, 34708, 34709, 34710, 34711, 34712, 34713, 
34812, 34714, 34820, 34833, 34834, 34715, and 34716)
    The CPT/RUC joint workgroup on codes recommended in October 2015 to 
bundle endovascular abdominal aortic aneurysm repair (EVAR) codes 
together with radiologic supervision and interpretation codes, since 
these codes were typically reported together at least 50 percent of the 
time. The CPT Editorial Panel bundled these services together in 
September 2016, creating 16 new codes, revising four existing codes, 
and deleting 14 other codes related to endovascular repair procedures.
    We proposed the RUC-recommended work RVUs for all 20 codes in this 
family. We proposed work RVUs of 23.71 for CPT code 34701, 36.00 for 
CPT code 34702, 26.52 for CPT code 34703, 45.00 for CPT code 34704, 
29.58 for CPT code 34705, 45.00 for CPT code 34706, 22.28 for CPT code 
34707, 36.50 for CPT code 34708, 6.50 for CPT code 34709, 15.00 for CPT 
code 34710, 6.00 for CPT code 34711, 12.00 for CPT code 34712, 2.50 for 
CPT code 34713, 4.13 for CPT code 34812, 5.25 for CPT code 34714, 7.00 
for CPT code 34820, 8.16 for CPT code 34833, 2.65 for CPT code 34834, 
6.00 for CPT code 34715, and 7.19 for CPT code 34716. We also proposed 
the RUC-recommended direct PE inputs without refinement for all 20 
codes in the family.
    We considered a work RVU of 32.00 for CPT code 34702 based on the 
survey 25th percentile, and further supported with a crosswalk to CPT 
code 48000 (Placement of drains, peripancreatic, for acute 
pancreatitis), which has the same intraservice time of 120 minutes and 
a work RVU of 31.95. When we compared the RUC-recommended work RVU to 
similar codes valued under the PFS, we were unable to find any 90-day 
global services with 120 minutes of intraservice time and approximately 
677 minutes of total time that had a work RVU greater than 36.00.
    We considered a work RVU of 40.00 for CPT code 34704 based on the 
survey 25th percentile, crosswalking to CPT code 33534 (Coronary artery 
bypass, using arterial graft(s); 2 coronary arterial grafts) which has 
a work RVU of 39.88. CPT code 33534 has 193 minutes of intraservice 
time, but a lower total time of 717 minutes. When we compared the RUC-
recommended work RVU for CPT code 34704 to similar codes paid under the 
PFS, we were unable to find any 90-day global services with 180 minutes 
of intraservice time and approximately 737 minutes of total time that 
had a work RVU greater than 45.00.
    We considered a work RVU of 40.00 for CPT code 34706 based on the 
survey 25th percentile. CPT code 34706 has nearly identical time values 
to CPT code 34704, with 2 fewer minutes of intraservice time and total 
time, and the RUC-recommended work RVU was the same for both of these 
codes. The survey respondents also believed that these two codes had a 
comparable amount of work, as the survey 25th percentile work RVU was 
40.00 for both codes.
    We considered a work RVU of 30.00 for CPT code 34708 based on the 
survey 25th percentile and sought comment on whether a work RVU of 
30.00 would improve relativity among the codes in this family. CPT code 
34708 has identical intraservice and total times as CPT code 34702. 
However, we noted that the RUC-recommended work RVU of 36.50 for CPT 
code 34708 is higher than the RUC-recommended work RVU of 36.00 for CPT 
code 34702. This is the inverse of the relationship between CPT codes 
34707 and 34701, which describe the same procedures in a non-emergent 
state when a rupture does not take place. CPT code 34707 has a RUC-
recommended work RVU of 22.28, while CPT code 34701 has a RUC-
recommended work RVU of 23.71. We sought comment on whether the RUC-
recommended work RVUs would create a rank order anomaly within the 
family by reversing the relationship between these paired codes when 
performed in an emergent state. We noted that if CPT codes 34708 and 
34702 were valued at the survey 25th percentile, this potential rank 
order anomaly disappears; in this scenario, we considered valuing CPT 
code 34708 at a work RVU of 30.00 and CPT code 34702 at a work RVU of 
32.00. We sought comment on whether these alternative work values would 
improve relativity with the RUC-recommended work RVUs for CPT code 
34707 (22.28) and CPT code 34701 (23.71), with an increment of 
approximately 1.50 to 2.00 RVUs between the two code pairs.
    For the eight remaining codes that describe endovascular access 
procedures, we considered assignment of a 0-day global period, instead 
of the RUC-recommended add-on (ZZZ) global period and subsequently 
adding back the preservice and immediate postservice work time, and 
increasing the work RVU of each code accordingly using a building block 
methodology. We noted that as add-on procedures, these eight codes 
would not be subject to the multiple procedure payment discount. We 
were concerned that the total payment for these services will be 
increasing in the aggregate based on changes in coding that alter MPPR 
adjustments, despite the information in the surveys that reflects a 
decrease in the intraservice time required to perform the procedures, 
and a decrease in their overall intensity as compared to the current 
values.
    We considered a work RVU of 3.95 for CPT code 34713, based on the 
RUC-recommended work RVU of 2.50 plus an additional 1.45 work RVUs. 
This additional work results from the addition of 38 total minutes of 
preservice work time and 30 minutes of postservice work time based on a 
crosswalk to CPT code 37224 (Revascularization, endovascular, open or 
percutaneous, femoral, popliteal artery(s), unilateral; with 
transluminal angioplasty) as valued by using the building block 
methodology. Using the same method, we considered a work RVU of:
     6.48 for CPT code 34812 based on maintaining the current 
75 minutes of preservice work time and the current 30 minutes of 
postservice work time, with a total work RVU of 2.35, added to the RUC-
recommended work RVU of 4.13;
     7.53 for CPT code 34714 with the addition of 75 minutes of 
preservice work time and 27 minutes of postservice work time to match 
CPT code 34833;
     9.46 for CPT code 34820 based on maintaining the current 
80 minutes of preservice work time and the current 30 minutes of 
postservice work time;

[[Page 53047]]

     10.44 for CPT code 34833 based on maintaining the current 
75 minutes of preservice work time and the current 27 minutes of 
postservice work time;
     5.00 for CPT code 34834 based on maintaining the current 
70 minutes of preservice work time and the current 35 minutes of 
postservice work time;
     8.35 for CPT code 34715 with the addition of 70 minutes of 
preservice work time and 35 minutes of postservice work time to match 
CPT code 34834; and
     9.47 for CPT code 34716 with the addition of 75 minutes of 
preservice work time and 27 minutes of postservice work time to match 
CPT code 34833.
    We proposed the RUC-recommended work RVUs and direct PE inputs for 
each code in this family and sought comment on whether our alternative 
values would be more appropriate.
    Comment: Several commenters supported the proposed values for all 
20 of the codes but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
endovascular repair procedures family as proposed.
(14) Selective Catheter Placement (CPT Codes 36215, 36216, 36217, and 
36218)
    CPT code 36215 was identified as potentially misvalued on a screen 
of Harvard-valued codes with utilization over 30,000 in CY 2014, as 
well as on a screen of high expenditure services across specialties 
with Medicare allowed charges of over $10 million. CPT codes 36216, 
36217, and 36218 were added to the family to be reviewed together with 
CPT code 36215.
    We proposed the RUC-recommended work RVUs for each code in this 
family. We proposed work RVUs of 4.17 for CPT code 36215, 5.27 for CPT 
code 36216, 6.29 for CPT code 36217, and 1.01 for CPT code 36218.
    We also considered refinements to the intraservice work time for 
CPT code 36217 from 60 minutes to 50 minutes, consistent with the RUC's 
usual use of the survey median intraservice work time. We had concerns 
that the use of the recommended survey 75th percentile intraservice 
work time will not be clinically appropriate for this code, as the 75th 
percentile time was identical for CPT codes 36216 and 36217, and 
therefore, the use of this value would not preserve the incremental, 
linear consistency between the work RVU and the intraservice time 
within the family.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Post-procedure doppler evaluation (extremity)'' activity 
from 3 minutes to 1 minute for CPT codes 36215, 36216, and 36217. We 
believed that 1 minute would be more typical for this task, as the 
practitioner would be able to quickly evaluate if there was an issue 
with the extremity because there would be visual signs of arterial 
insufficiency resulting from the procedure.
    We proposed to remove the equipment time for the mobile instrument 
table (EF027) from CPT codes 36215, 36216, and 36217. We believed that 
the mobile instrument table would be used for moderate sedation, which 
was removed from these procedures in CY 2017 (see the CY 2017 PFS final 
rule (81 FR 80339). While we recognized that 180 minutes of post-
procedure monitoring time remains in these codes during which the 
stretcher (EF018), IV infusion pump (EQ032), and 3-channel ECG (EQ011) 
would remain in use, we did not agree that the mobile instrument table 
would typically be in use during this period of monitoring. As a 
result, we proposed to remove this equipment time from these three 
codes.
    While we remained concerned about the use of the survey 75th 
percentile intraservice work time for CPT code 36217, for CY 2018, we 
proposed the RUC-recommended work RVUs for each code in this family and 
sought comment on whether our alternative values would be more 
appropriate.
    Comment: Commenters supported the proposed values for all four of 
the codes but disagreed with the alternative values. We did not receive 
any comments specifically requesting the use of the alternative values 
for this family of codes.
    Response: We appreciate the feedback from the commenters. We 
continue to welcome information from all interested parties regarding 
valuation of services for consideration through our rulemaking process. 
We will continue to consider alternative work RVUs as we propose the 
valuation of services for future notice and comment rulemaking.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the clinical labor time for the ``Post-procedure doppler 
evaluation (extremity)'' activity from 3 minutes to 1 minute for CPT 
codes 36215, 36216, and 36217. Commenters stated that CMS picked 
another time under the impression that clinical staff should be able to 
perform this task more quickly and that this was not a reason to change 
the recommended clinical labor time.
    Response: The response from the commenters did not provide any 
rationale as to why a clinical labor time of 3 minutes would be typical 
for this activity. We continue to believe that 1 minute would be more 
typical for this task, as the practitioner would be able to quickly 
evaluate if there was an issue with the extremity via visual signs of 
arterial insufficiency.
    Comment: Several commenters disagreed with the proposal to remove 
equipment time for the mobile instrument table (EF027) from CPT codes 
36215, 36216, and 36217. Commenters stated that the office still needed 
the instrument table during the postoperative period, outside of 
moderate sedation, to house all of the monitoring items.
    Response: While we appreciate the concerns raised by the 
commenters, we disagree. Storage equipment is a form of indirect PE 
that is not individually allocable to services and therefore is not 
separately payable. Our methodology incorporates the costs of non-
medical infrastructure, such as cabinets and counter space, as part of 
the office rent expenses contained as part of indirect PE. Because the 
mobile instrument table is analogous to storage equipment in this 
particular circumstance, we continue to believe that it would be 
classified as a form of indirect PE and would not typically be in use 
during this period of monitoring.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
selective catheter placement family as proposed.
(15) Treatment of Incompetent Veins (CPT Codes 36470, 36471, 36482, 
36483, 36465, and 36466)
    In September 2016, the CPT Editorial Panel created four new codes 
to describe the treatment of incompetent veins, and revised existing 
CPT codes 36470 and 36471. These six codes were reviewed together as 
part of the same family of procedures. For CY 2018, we proposed the 
RUC-recommended work RVU for all six codes. We proposed work RVUs of 
0.75 for CPT code 36470, 1.50 for CPT code 36471, 3.50 for CPT code 
36482, 1.75 for CPT code 36483, 2.35 for CPT code 36465, and 3.00 for 
CPT code 36466.
    We considered a work RVU of 4.38 for CPT code 36482, which would 
have been based on the RUC-recommended work RVU of 3.50 plus half of 
the RUC-recommended work RVU of CPT code

[[Page 53048]]

36483. We also considered assigning CPT code 36483 a status indicator 
of ``bundled.'' The services that would be reported using CPT codes 
36482 and 36483 in CY 2018 are currently reported with unlisted CPT 
code 37799 (Unlisted procedure, vascular surgery). We had concerns 
about how frequently the current services include treatment of an 
initial vein (CPT code 36482) as compared to the treatment of initial 
and subsequent veins (CPT codes 36482 and 36483 together). We believed 
it may be more accurate to describe these services through the use of a 
single code, as in the rest of this code family, instead of a base code 
and add-on code pair. Under this potential scenario, we looked at the 
RUC-recommended crosswalk and noted that the add-on CPT code 36483 was 
estimated to be billed 50 percent of the time together with CPT code 
36482. We therefore considered adding half of the RUC-recommended work 
RVU of CPT code 36483 (0.88) to the RUC-recommended work RVU of CPT 
code 36482 (3.50), which would result in a work RVU of 4.38.
    We proposed to remove the 2 minutes of clinical labor for the 
``Setup scope'' (CA015) activity and add the same 2 minutes of clinical 
labor for the ``Prepare room, equipment and supplies'' (CA013) activity 
for CPT codes 36482, 36465, and 36466. The RUC-recommended materials 
stated that these 2 minutes were a proxy for setting up the ultrasound 
machine, and we believe that this 2 minutes was more accurately 
described by the ``Prepare room, equipment and supplies'' (CA013) 
activity code, since there is no scope equipment utilized in these 
procedures. We proposed to maintain the Vascular Tech (L054A) clinical 
labor type for these 2 minutes. We also proposed to refine the clinical 
labor for the ``Check dressings, catheters, wounds'' (CA029) activity 
for CPT codes 36470, 36471, 36482, 36465, and 36466, consistent with 
the standard times for this clinical labor activity.
    We proposed to remove the six individual 4x4 sterile gauze (SG055) 
supplies and replace them with a 4x4 sterile gauze pack of 10 (SG056) 
for CPT codes 36470, 36471, 36482, 36465, and 36466. The pack of 10 
sterile gauze is cheaper than six individual pieces of sterile gauze, 
and we did not agree that it would be typical to pay a higher cost for 
fewer supplies. We also proposed to create three new supply codes in 
response to the invoices submitted for this family of codes. We 
proposed to establish a price of $1,495 for the Venaseal glue (SD323) 
supply, a price of $3,195 for the Varithena foam (SD324) supply, and a 
price of $40 for the Varithena admin pack (SA125) supply.
    We proposed to adjust the equipment times for the surgical light 
(EF014), the power table (EF031), and the portable ultrasound unit 
(EQ250) for CPT codes 36482, 36465, and 36466, consistent with the 
standards for non-highly technical equipment and to reflect the changes 
in the clinical labor described in this section of the final rule.
    While we remained concerned about the creation of a base code and 
add-on code pairing (CPT codes 36482 and 36483) out of services that 
are currently reported using an unlisted code, for CY 2018, we proposed 
the RUC-recommended work RVUs for each code in this family and sought 
comment on whether our alternative values would be more appropriate.
    Comment: Several commenters supported the proposed values for all 
six of the codes but disagreed with the alternative values.
    Response: We appreciate the feedback from the commenters.
    Comment: One commenter stated that they agreed with the direct PE 
refinements as proposed.
    Response: We appreciate the support from the commenter.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
treatment of incompetent veins family as proposed.
(16) Therapeutic Apheresis (CPT Codes 36511, 36512, 36513, 36514, 
36516, and 36522)
    CPT code 36516 was nominated as potentially misvalued in the CY 
2016 PFS proposed rule. The CPT Editorial Panel deleted CPT code 36515 
and made revisions to CPT code 36516 to include immunoabsorption. CPT 
codes 36511, 36512, 36513, 36514, and 36522 were added to CPT code 
36516 to be reviewed together as part of the therapeutic apheresis 
family.
    For CY 2018, we proposed the RUC-recommended work RVUs for all six 
codes in the family. We proposed work RVUs of 2.00 for CPT code 36511, 
2.00 for CPT 36512, 2.00 for CPT code 36513, 1.81 for CPT code 36514, 
1.56 for CPT code 36516, and 1.75 for CPT code 36522.
    We proposed to use the RUC-recommended direct PE inputs for these 
codes without refinement. We considered refining the clinical labor 
time for the ``Prepare room, equipment, supplies'' activity from 20 
minutes to 10 minutes for CPT codes 36514 and 36522, and from 30 
minutes to 10 minutes for CPT code 36516. We also considered refining 
the clinical labor for the ``Prepare and position patient/monitor 
patient/set up IV'' activity from 15 minutes to 10 minutes for these 
same three codes. In both cases, we considered maintaining the current 
clinical labor time for CPT codes 36514 and 36516, and adjusting the 
clinical labor time for CPT code 36522 to match the other two codes in 
the family. We had concerns about the lack of a rationale provided for 
these changes in clinical labor time, and whether these clinical labor 
tasks would typically require this additional time.
    We proposed the RUC-recommended work RVUs and to use the RUC-
recommended direct PE inputs for each code in this family and sought 
comment on whether our alternative values would be more appropriate. We 
also sought comment on whether these procedures were creating a new 
point of venous access or utilizing a previously placed access.
    Comment: Several commenters supported the proposed values for all 
six of the codes but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    Comment: Several commenters stated that a cell separator system 
(EQ084) was mistakenly left out of the RUC's recommendation for CPT 
code 36516. The commenters stated that this particular equipment item 
is critical for all of the therapeutic apheresis services and that CPT 
code 36516 uses a piece of equipment (the Liposorber system) that 
attaches to this missing equipment item. The commenters recommended 
adding this piece of equipment (EQ084) to CPT code 36516 with 324 
minutes of use.
    Response: We disagree with the commenters. Based on the information 
that we currently have available, we do not believe that the cell 
separator system (EQ084) was mistakenly left out of the RUC 
recommendation for CPT code 36516. We note that the RUC did not include 
the cell separator system in its recommendations for this procedure, 
and also made no mention of an error in the recommended direct PE 
inputs for CPT code 36516 in its comments on the CY 2018 PFS proposed 
rule. We are also confused by the statement from one commenter that the 
cell separator system is critical for all of the therapeutic apheresis 
services, since this equipment item is not included in the current 
direct PE inputs for CPT

[[Page 53049]]

code 36516, nor was it recommended for CPT code 36522 in the same 
family. We welcome additional feedback from stakeholders regarding 
whether the use of the cell separator system is typical in CPT code 
36516.
    Comment: Many commenters responded to the request for additional 
information regarding whether these procedures were creating a new 
point of venous access or utilizing a previously placed access point. 
Commenters agreed that both of the vignettes for these services, as 
well as the descriptions of work, stated that the typical patient has a 
previously placed venous access that is then utilized. While in some 
cases, a revision to the access site may need to be made, or initial 
access achieved, these cases were not representative of the typical 
patient scenario. There was widespread agreement from the commenters on 
the utilization of a previously placed access point in these services.
    Response: We appreciate the feedback from the commenters in 
clarifying the clinical details surrounding the point of venous access.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
therapeutic apheresis family as proposed.
(17) Insertion of Catheter (CPT Codes 36555, 36556, 36620, and 93503)
    CPT code 36556 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. CPT codes 36555, 36620, and 
93503 were added for review by the RUC as part of the code family. We 
proposed the RUC-recommended work RVUs for each code in this family. We 
proposed work RVUs of 1.93 for CPT code 36555, 1.75 for CPT code 36556, 
1.00 for CPT code 36620, and 2.00 for CPT code 93503.
    We proposed to remove the clinical labor time for the ``Monitor pt. 
following procedure'' activity and the equipment time for the 3-channel 
ECG (EQ011) for CPT code 36555. CPT code 36555 no longer includes 
moderate sedation as part of the procedure (see the CY 2017 PFS final 
rule (81 FR 80339). We proposed to remove the direct PE inputs related 
to moderate sedation from CPT code 36555 as they would now be included 
in the separately reported moderate sedation services. We also proposed 
to refine the equipment times for the exam table (EF023) and the exam 
light (EQ168) to reflect changes in the clinical labor time.
    Comment: Several commenters requested that CMS not finalize its 
proposal to accept the RUC's recommendations for CPT codes 36555, 
36556, 36620 and 93503 and instead finalize higher work RVUs that the 
specialty had provided to the RUC. The commenters stated that these 
work RVUs maintained relativity within the resource-based relative 
value scale (RBRVS) range of services and represented a more accurate 
valuation of these procedures. One commenter stated that the RUC-
recommended work RVUs create a rank order anomaly in the intensity of 
the services in this family of codes.
    Response: As we stated in the background of this code valuation 
section, we generally proposed RUC-recommended work RVUs for new, 
revised, and potentially misvalued codes for CY 2018. We believe that 
in the absence of other data regarding the appropriate valuation of 
these codes, the RUC-recommended work RVUs represent the most accurate 
valuation of the procedures. We continue to be open to reviewing 
additional and supplemental sources of data furnished by stakeholders. 
We encourage stakeholders to continue to provide such information for 
consideration in establishing work RVUs.
    Comment: Several commenters disagreed with the proposal to remove 
the direct PE inputs related to moderate sedation from CPT code 36555. 
The commenters stated that any PE refinement necessary to address 
separate reporting of moderate sedation would have already taken place, 
so no further refinement to PE as it relates to this change should be 
necessary. Another commenter indicated agreement with the proposed 
direct PE refinements.
    Response: We appreciate the support from the commenter for our 
proposed direct PE refinements. Regarding the other comments, we 
continue to believe that further refinements are needed to address the 
separate reporting of moderate sedation. CPT code 36555 does not 
currently contain any clinical labor for post procedure clinical labor 
monitoring related to moderate sedation; however, 7.5 minutes of 
monitoring time was added back into the procedure as part of the RUC-
recommended direct PE inputs for CY 2018. Since this clinical labor for 
the monitoring time would be included in the separately reported 
moderate sedation code, we believe that it would be duplicative to 
include the same monitoring clinical labor time, or the equipment time 
for the 3-channel ECG, in CPT code 36555.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
insertion of catheter family as proposed.
(18) Insertion of PICC Catheter (CPT Code 36569)
    CPT code 36569 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. For CY 2018, we proposed the 
RUC-recommended work RVU of 1.70 for CPT code 36569.
    We proposed to remove the equipment time for the exam table 
(EF023), as this equipment item is a component part of the 
radiographic-fluoroscopic room (EL014) included in CPT code 77001 
(Fluoroscopic guidance for central venous access device placement, 
replacement (catheter only or complete), or removal). Because CPT code 
36569 is typically billed together with CPT code 77001, we believed 
that including the additional equipment time for the exam table in CPT 
code 36569 would be duplicative.
    Comment: Several commenters disagreed with the proposal to remove 
the equipment time for the exam table (EF023). Commenters stated that 
CMS' rationale for removing the exam table, that it is a component part 
of the radiographic-fluoroscopic room (EL014), was incorrect. 
Commenters pointed out that the radiographic-fluoroscopic room only 
includes a radiographic machine and camera, and requested that the exam 
table should be reinstated consistent with the RUC's recommendation.
    Response: We appreciate the clarification regarding the contents of 
the radiographic-fluoroscopic room from the commenters. After reviewing 
the room's contents, we agree with the commenters that the 
radiographic-fluoroscopic room only includes a radiographic machine and 
camera. While we believe that the radiographic machine likely 
incorporates an exam table on which to place the patient, we concede 
that this is not specifically stated in the documentation for the 
radiographic-fluoroscopic room from the commenters. As a result, we are 
not finalizing our proposal to remove the equipment time for the exam 
table. We are restoring the exam table to CPT code 36569 at an 
equipment time of 32 minutes in accordance with our standard formula 
for non-highly technical equipment time.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes for CPT 
code 36569 as proposed, with the exception of the

[[Page 53050]]

change for the exam table as detailed above.
(19) Bone Marrow Aspiration (CPT Codes 38220, 38221, 38222, and 20939)
    CPT code 38221 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. The descriptors for CPT codes 
38220 and 38221 were revised to reflect changes in practice patterns, 
and two new CPT codes (38222 and 20939) were created to more accurately 
describe new services that are now available. For CY 2018, we proposed 
the RUC-recommended work RVUs for each code in this family. We proposed 
a work RVU of 1.20 for CPT code 38220, 1.28 for CPT code 38221, 1.44 
for CPT code 38222, and 1.16 for CPT code 20939.
    We also received a recommendation from the RUC to change the global 
periods for CPT codes 38220, 38221, and 38222 from XXX global periods 
to 0-day global periods, even though these codes were surveyed under 
the XXX global period. We agreed with the recommendation that for these 
three particular codes, their services were more accurately described 
when assigned 0-day global periods as opposed to the XXX global status. 
Therefore, we proposed to assign a 0-day global period to all three 
codes in this family. We noted, however, that we believed that global 
period changes must be addressed on an individual basis, especially 
when the routine survey methodologies rely on assumptions regarding 
global periods for particular codes. Subsequently, we proposed to 
refine the preservice work time from 15 minutes of evaluation time to 9 
minutes of evaluation time, 1 minute of positioning time, and 5 minutes 
of scrub, dress, and wait time. We proposed these refinements to the 
work times for these three codes to more closely align with the 
preservice times of other recently reviewed 0-day global procedures, 
such as CPT code 30903 (Control nasal hemorrhage, anterior, complex 
(extensive cautery and/or packing) any method). We also noted that 
given our proposal to value CPT code 38222, we proposed to eliminate 
payment using HCPCS code G0364 for CY 2018 since the changes to the set 
of CPT codes will now accurately describe the services currently 
reported by HCPCS code G0364. For CPT code 20939, we considered a work 
RVU of 1.00 based on a direct crosswalk to CPT codes 64494 
(Injection(s), diagnostic or therapeutic agent, paravertebral facet 
(zygapophyseal) joint (or nerves innervating that joint) with image 
guidance (fluoroscopy or CT), lumbar or sacral; second level) and 64495 
(Injection(s), diagnostic or therapeutic agent, paravertebral facet 
(zygapophyseal) joint (or nerves innervating that joint) with image 
guidance (fluoroscopy or CT), lumbar or sacral; third and any 
additional level(s)). CPT code 20939 is a global ZZZ add-on code for 
CPT code 38220, and we were concerned with maintaining relativity among 
PFS services, considering that an add-on code typically has 
significantly less intraservice time and total time compared to the 
base code. We considered an alternative crosswalk to CPT codes 64494 
and 64495, which share the same intraservice and total time with CPT 
code 20939 and have work RVUs of 1.00.
    We also proposed to refine the clinical labor for ``Lab Tech 
activities'' from 12 minutes to 9 minutes for CPT code 38220, from 7.5 
minutes to 7 minutes for CPT code 38221, and from 12.5 minutes to 10 
minutes for CPT code 38222. We maintained the current time value for 
the two existing codes, as we had no reason to believe that the typical 
duration has increased for these lab activities. We assigned 10 minutes 
for CPT code 38222 based on the statement in the RUC-recommended 
materials for the direct PE inputs that this activity takes 0.5 minutes 
longer than it does in the current version of CPT code 38220. We also 
proposed to remove the breakout lines for the lab activities. We 
believe that the breakout of activities into numerous subactivities 
generally tends to inflate the total time assigned to clinical labor 
activities and results in values that are not consistent with the 
analogous times for other PFS services.
    We considered refining the clinical labor time for ``Provide 
preservice education/obtain consent'' for CPT codes 38220, 38221, and 
38222 from 12 minutes to 6 minutes. We had concerns regarding whether 
12 minutes would be typical for education and consent prior to these 
procedures, as much of the patient education takes place following the 
procedure, in the clinical labor activity described under the ``Check 
dressings & wound/home care instructions'' heading. We proposed the 
RUC-recommended work RVUs for each code in this family and sought 
comment on whether our alternative values would be more appropriate.
    Comment: Several commenters agreed with the proposal to change the 
global period for CPT codes 38220, 38221, and 38222 from XXX global 
periods to 0-day global periods. These commenters also supported the 
proposed change to the preservice work times to more closely align with 
the preservice times of other recently reviewed 0-day global 
procedures.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Other commenters disagreed with the proposed change in 
global period. Commenters stated that maintaining these codes as XXX 
globals was consistent with the survey methodology used to generate the 
RUC-recommended work RVUs, as these codes were surveyed under the XXX 
global period. The commenters stated that these codes are billed less 
than 25 percent of the time with an E/M service, and that since an E/M 
service being performed on the same day is not typical, there was not a 
compelling reason to change the global period.
    Response: We appreciate the additional responses from commenters 
requesting that the XXX global period should be retained for these 
three CPT codes. As these codes were surveyed and valued under XXX 
global status and the RUC has maintained that there is a need to 
resurvey when the global period changes, we will not finalize our 
proposal to change CPT codes 38220, 38221, and 38222 from XXX global 
periods to 0-day global periods. In the absence of compelling evidence 
that the 0-day global status would be more typical for these services, 
we believe that the current XXX global period should be maintained. We 
will also not finalize our related proposal to refine the preservice 
work time from 15 minutes of evaluation time to 9 minutes of evaluation 
time, 1 minute of positioning time, and 5 minutes of scrub, dress, and 
wait time. We welcome additional feedback from stakeholders regarding 
the global period that should be assigned to these codes.
    Comment: Several commenters supported the proposed values for all 
four of the codes but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor for ``Lab Tech activities'' in CPT codes 38220, 
38221, and 38222. Commenters stated that each CPT code is unique and 
the recommended clinical labor reflects the typical time of those 
activities associated with each service. Commenters also disagreed with 
the proposal to remove the breakout lines for the lab activities, 
stating that the

[[Page 53051]]

methodology at the time of review was to provide as much detail as 
possible and that just because these subactivities were fully displayed 
did not mean that they had been double counted. Several of the 
commenters supplied clinical information describing the activities that 
took place in additional detail.
    Response: We appreciate the additional information supplied by the 
commenters. We agree with the commenters that each service is unique 
and must be valued on an individual basis. We also agree that the lab 
activities taking place in these services are important and that they 
must be performed. Our concern is that the individual accounting of 
clinical labor activities can lead to PE proliferation, and that this 
breakout of activities into numerous subactivities generally tends to 
inflate the total time assigned to clinical labor activities and 
results in values that are not consistent with the analogous times for 
other PFS services. In the case of these codes, we believe that 
maintaining the current clinical labor times as proposed will better 
serve the purposes of ensuring relativity. We will continue to look for 
additional information related to the clinical labor assigned to lab 
activities, and we welcome additional feedback from stakeholders.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the bone 
marrow aspiration family as proposed. We are not finalizing the 
proposal to change CPT codes 38220, 38221, and 38222 from XXX global 
periods to 0-day global periods, and we are not finalizing the related 
proposal to refine the preservice work time from 15 minutes of 
evaluation time to 9 minutes of evaluation time, 1 minute of 
positioning time, and 5 minutes of scrub, dress, and wait time for 
these three codes.
(20) Esophagectomy (CPT Codes 43107, 43112, 43117, 43286, 43287, and 
43288)
    CPT codes 43286, 43287, and 43288 were created by the CPT Editorial 
Panel to report esophagectomy via laparoscopic and thoracoscopic 
approaches. CPT codes 43107, 43112, and 43117 were also reviewed as 
part of the family with the three new codes. CPT code 43112 was revised 
to clarify the nature of the service being performed. We proposed the 
RUC-recommended work RVUs for all six codes in the family. We proposed 
work RVUs of 52.05 for CPT code 43107, 62.00 for CPT code 43112, 57.50 
for CPT code 43117, 55.00 for CPT code 43286, 63.00 for CPT code 43287, 
and 66.42 for CPT code 43288.
    We also proposed the RUC-recommended work times for all six codes 
in this family. We considered removing 20 minutes from the preservice 
evaluation work time from all six of the codes in this family. We had 
concerns as to whether this additional evaluation time should be 
included for surgical procedures, due to the lack of evidence 
indicating that it takes longer to review outside imaging and lab 
reports for surgical services than for non-surgical services. We also 
considered refining the preservice positioning work time and the 
immediate postservice work time for all six of the codes in this family 
consistent with standard preservice and postservice work times 
allocated to other PFS services.
    We had concerns about the presence of two separate surveys 
conducted for the three new CPT codes. We noted that CPT codes 43286, 
43287, and 43288 were surveyed initially in January 2016, and then were 
surveyed again in October 2016 together with CPT codes 43107, 43112, 
and 43117 due to concerns about the description of the typical patient 
in the original vignette and a change in the codes on the reference 
service list (RSL). We noted that CPT codes 43286 and 43287 had the 
same median intraservice time on both surveys, while CPT code 43288 had 
a median intraservice time that was an hour longer on its second survey 
(420 minutes) as compared to its first survey (360 minutes). We also 
noted that the total survey time for CPT code 43286 decreased from 
1,058 minutes in the first survey to 972 minutes in the second survey, 
while the median work RVU increased from 50.00 to 65.00. We did not 
understand how the survey median intraservice time could increase so 
significantly from the first survey to the second survey for CPT code 
43288, or how the surveyed times for CPT code 43286 could be decreasing 
while the work RVU was simultaneously increasing by 15.00 work RVUs.
    Based on our analysis, it appeared that the accompanying RSL was 
the main difference between the two surveys; the codes on the initial 
RSL had a median work RVU of 44.18, while the codes on the second RSL 
had a median work RVU of 59.64. This increase of 15.00 work RVUs 
between the two RSLs that accompanied the surveys appeared to account 
for the increase in the work RVUs for the three new codes. We were 
concerned that the second survey may have overestimated the work 
required to perform these procedures, as the 25th percentile work RVU 
of the second survey was higher than the median work RVU of the initial 
survey for all three codes, despite no change in the median 
intraservice work time for CPT codes 43286 and 43287.
    Given these concerns, we considered a work RVU of 50.00 for CPT 
code 43286, a work RVU of 60.00 for CPT code 43287, and a work RVU of 
61.00 for CPT code 43288, by using the survey median work RVU from the 
first survey for the three new codes. For CPT codes 43107 and 43117, we 
considered employing the intraservice time ratio between the 
laparoscopic version of the procedure represented by the new code and 
the open version of the same procedure represented by the existing 
code.
    We considered a work RVU of 45.00 for CPT code 43107 based on the 
intraservice time ratio with CPT code 43286 and a work RVU of 55.00 for 
CPT code 43117 based on the intraservice time ratio with CPT code 
43287. CPT code 43107 has 270 minutes of intraservice time as compared 
with 300 minutes of intraservice time for CPT code 43286, which 
produces a ratio of 0.9, and when multiplied by a work RVU of 50.00 
(CPT code 43286), results in the proposed work RVU of 45.00. We 
considered using the same methodology for CPT codes 43117 and 43287.
    Finally, we considered a work RVU of 58.94 for CPT code 43112 based 
on a direct crosswalk to CPT code 46744 (Repair of cloacal anomaly by 
anorectovaginoplasty and urethroplasty, sacroperineal approach). We 
noted that the intraservice time ratio when applied to CPT codes 43112 
and 43288, the paired McKeown esophagectomy procedures, would have 
produced a potential work RVU of 52.29, creating a rank order anomaly 
within the family by establishing a higher work RVU for CPT code 43117 
than CPT code 43112, and we were concerned with whether this was an 
appropriate valuation for the code.
    We sought comment on whether the alternative work RVUs that we 
considered might reflect the relative difference in work more 
accurately between the six codes in the family. We noted, for example, 
that these valuations corrected the rank order anomaly between CPT 
codes 43112 and 43121 as noted in the RUC recommendations.
    We proposed the RUC-recommended direct PE inputs for all six codes 
in the family without refinement. We considered changing the preservice 
clinical labor type for all six codes from an RN (L051) to an RN/LPN/
MTA blend (L037D). We had concerns about whether the use of RN clinical 
labor would be typical for filling out referral forms or for scheduling 
space and equipment in the facility. We also

[[Page 53052]]

considered removing the additional clinical labor time for the 
``Additional coordination between multiple specialties for complex 
procedures (e.g., tests, meds, scheduling)'' activity, consistent with 
preservice standards for codes with 90-day global periods. We were 
concerned that this time would not typically be included in non-
surgical procedures performed by other specialties even when additional 
coordination is required. We sought comment regarding the changes in 
the valuation between the two surveys, the preservice and immediate 
postservice work times, and the RN staffing type employed for routine 
preservice clinical labor.
    Comment: Several commenters supported the proposed values for all 
six of the codes but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
esophagectomy family as proposed.
(21) Transurethral Electrosurgical Resection of Prostate (CPT Code 
52601)
    CPT code 52601 appeared on a screen of potentially misvalued codes, 
which indicated that it was performed less than 50 percent of the time 
in the inpatient setting, yet included inpatient hospital E/M services 
within the global period. For CY 2018, we proposed the RUC-recommended 
work RVU of 13.16 for CPT code 52601 and proposed to use the RUC-
recommended direct PE inputs without refinements.
    We considered a work RVU of 12.29 for CPT code 52601 based on a 
direct crosswalk to CPT code 58541 (Laparoscopy, surgical, 
supracervical hysterectomy, for uterus 250 g or less), which is one of 
the reference codes. CPT code 58541 may potentially be a more accurate 
crosswalk for CPT code 52601 than the RUC-recommended direct crosswalk 
to CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis). 
Although all three of these codes share the same intraservice time of 
75 minutes, CPT code 58541 is a closer match in terms of the total time 
at only 10 minutes difference. CPT code 58541 also shares the same 
postoperative office visits as CPT code 52601, a pair of CPT code 99213 
office visits, while CPT code 29828 also contains two CPT code 99212 
office visits that are not present in the reviewed code.
    We noted that if we were to use a reverse building block 
methodology for CPT code 52601 and subtract out the value of the E/M 
visits being removed, the proposed work RVU would be 11.21. We did not 
propose this work RVU; however, because as we noted in the CY 2017 PFS 
final rule (81 FR 80274), we agree that the per-minute intensity of 
work is not necessarily static over time or even necessarily during the 
course of a procedure. Instead, we utilize time ratios and building 
block methodologies to identify potential values that account for 
changes in time and compare these values to other PFS services for 
estimates of overall work. When the values we develop reflect a similar 
derived intensity, we agree that our values are the result of our 
assessment that the relative intensity of a given service has remained 
similar. For CPT code 52601, we were concerned about how the RUC-
recommended derived intensity of the procedure could be increasing by 
30 percent over the current derived intensity, while at the same time 
the typical site of service was changing from inpatient to outpatient 
status. In other words, if it was now typical for CPT code 52601 to be 
performed on an outpatient basis, then we would generally expect the 
intensity of the procedure to be decreasing, not increasing. We 
considered a work RVU of 12.29 for CPT code 52601 based on a direct 
crosswalk to CPT code 58541 (Lsh uterus 250 g or less), and sought 
comment on whether this alternative value might better reflect 
relativity.
    Comment: Several commenters supported the proposed values for CPT 
code 52601 but disagreed with the alternative values.
    Response: We appreciate the feedback from the commenters. We 
continue to welcome information from all interested parties regarding 
valuation of services for consideration through our rulemaking process.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for CPT code 52601 as 
proposed.
(22) Peri-Prostatic Implantation of Biodegradable Material (CPT Code 
55874)
    In October 2016, the CPT Editorial Panel deleted CPT Category III 
code 0438T and created a new CPT code 55874 (Transperineal placement of 
biodegradable material, peri-prostatic, single or multiple 
injection(s), including image guidance, when performed). For CY 2018, 
we proposed the RUC-recommended work RVU of 3.03 for CPT code 55874.
    In reviewing the RUC recommendations, we noted a decrease in 
preservice time (30 minutes) compared to the current value. In order to 
account for this change in time, we considered calculating the 
intraservice time ratio between the key reference code (CPT code 
49411), which has an intraservice time of 40 minutes, and the RUC-
recommended intraservice time (30 minutes) and multiplying that by the 
work RVU for CPT code 49411 (3.57), which would have resulted in a work 
RVU of 2.68. A work RVU of 2.68 would have been further supported by a 
bracket of two crosswalk codes, CPT code 65779 (Placement of amniotic 
membrane on the ocular surface; single layer, sutured), which has a 
work RVU of 2.50 and CPT code 43252 (Esophagogastroduodenoscopy, 
flexible, transoral; with optical endomicroscopy), which has a work RVU 
of 2.96. Compared with CPT code 55874, these codes have identical 
intraservice and similar total times. We sought comment on whether 
these alternative values should be considered, especially given the 
changes in time reflected in the survey data.
    We received invoices with pricing information regarding two new 
supply items: ``endocavity balloon'' and ``biodegradeable material 
kit--periprostatic.'' The invoice for the endocavity balloon was 
$399.00 and the input price on the PE spreadsheet for this supply item 
was noted as such. We believed that the input price noted on the PE 
spreadsheet was an error, given that the invoice noted that the price 
of $399.00 was for a box of ten and the specialty society requested a 
single unit of this supply item. Therefore, we proposed to use this 
information to propose for supply item ``endocavity balloon'' a price 
of $39.90. The invoice for the ``biodegradeable material kit--
periprostatic'' totaled $2,850.00. We proposed to use this information 
to propose for the supply item ``biodegradeable material kit--
periprostatic'' a price of $2850.00. We also received an invoice with 
pricing information regarding the new equipment item ``endocavitary US 
probe'' which totaled $16,146.00. We proposed to use this information 
to propose for equipment item ``endocavitary US probe'', a per-minute 
price of $0.0639. We questioned, given an invoice price of $29,999.00 
for this existing equipment item EQ250 (portable ultrasound unit), 
whether this equipment item includes probes. We sought public comments 
related to

[[Page 53053]]

whether equipment item EQ250 (portable ultrasound) includes probes.
    Comment: In general, commenters were supportive of our proposal of 
the RUC-recommended work RVUs. Some commenters expressed opposition to 
the alternative work RVUs we considered.
    Response: We are appreciative of the commenters' feedback. We 
continue to welcome information from all interested parties regarding 
valuation of services for consideration through our rulemaking process. 
We will continue to consider alternative work RVUs as we propose the 
valuation of services for future notice and comment rulemaking.
    Comment: The RUC stated that CMS acknowledges that physician work 
intensity per minute is not typically linear and also that making 
reductions to RVUs in strict proportion to changes in time is 
inappropriate. The RUC further noted that for several comment periods 
they have laid out a compelling case to justify this position on work 
intensity per minute. They noted that they appreciate CMS's agreeing 
with the RUC's assertion that the usage of time ratios to reduce work 
RVUs is typically not appropriate, as often a change in the work time 
coincides with a change in the work intensity per minute.
    Response: We do not agree with the commenter's characterization of 
our statements. We stated in the CY 2017 PFS final rule (81 FR 80273) 
that we are not implying that the decrease in time as reflected in 
survey values must necessarily equate to a one-to-one or linear 
decrease in newly valued work RVUs, given that intensity for any given 
procedure may change over several years or within the intraservice 
period. Nevertheless, we believe that since the two components of work 
are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
specifically increased or that the reduction in time is 
disproportionally from less intensive portions of the procedure, 
significant decreases in time should generally be reflected in 
decreases to work RVUs.
    Comment: The RUC noted that they wanted to remind CMS of its and 
the RUC's longstanding position that treating all components of 
physician time as having identical intensity is incorrect, and 
inconsistently applying this treatment to only certain services under 
review creates inherent payment disparities in a payment system that is 
based on relative valuation. The commenter stated that when physician 
times are updated in the fee schedule, the ratio of intraservice time 
to total time, the number and level of bundled post-operative visits, 
the length of pre-service, and the length of immediate post-service 
time may all potentially change for the same service. These changing 
components of physician time result in the physician work intensity per 
minute often changing when physician time also changes, and the 
commenters recommended that CMS always account for these nuanced 
variables. The RUC highlighted that their recommendations now 
explicitly state when physician time has changed and address whether 
and to what magnitude these changes in time impact the work involved.
    Response: We stated in the CY 2017 PFS final rule (81 FR 80275) 
that we understand that not all components of physician time have 
identical intensity and are mindful of this point when determining what 
the appropriate work RVU values should be. We agree that the nuanced 
variables involved in the changing components of physician time must be 
accounted for, and it is our goal to do so when determining the 
appropriate valuation. We appreciate when the RUC recommendations 
provide as much detailed information regarding the recommended 
valuations as possible, including thorough discussions regarding 
physician time changes and how the RUC believes such changes should or 
should not impact the work involved, and we consider that information 
when conducting our review of each code.
    Comment: The RUC noted that its support of the proposed refinements 
for EF031, EQ250, EQ386, ER061, ER062, and L037D, was contingent on the 
assumption that the proposed PE refinements were because of the change 
in time for the clinical labor task, ``Obtain vital signs''.
    Response: The proposed PE refinements for EF031, EQ250, EQ386, 
ER061, ER062, L037D, are a result of our proposal to refine the L037D 
clinical labor time for ``Obtain vital signs'' from 3 minutes to 5 
minutes, to conform to the proposed standard for this clinical labor 
activity. As a result, we proposed to refine the equipment times for 
the power table (EF031) from 63 minute to 65 minutes and from 48 
minutes to 50 minutes for the following: Portable ultrasound unit 
(EQ250), endocavitary US probe (EQ386), stepper stabilizer, template 
(for brachytherapy treatment) (ER061), and stirrups (for brachytherapy 
table) (ER062) to reflect the service period time associated with this 
code.
    Comment: Several commenters, including the RUC, were supportive of 
our proposed price updates for the ``endocavity balloon'' (SD325), 
biodegradeable material kit--periprostatic'' (SA126), and 
``endocavitary US probe'' (EQ386) and urged CMS to finalize the 
proposal.
    Response: We appreciate the support from commenters.
    After consideration of comments received, we are finalizing the 
following supply and equipment prices: SD325, at a price of $39.90; 
SA126, at a price of $2850.00; and EQ386, at a price of $16,146.00 (a 
per-minute price of $0.0639).
    Comment: Several commenters, including the RUC, noted that 
``portable ultrasound unit'' (EQ250), which has a cost of $29,999.00, 
does not include an intracavitary probe. These commenters further noted 
that the probe is necessary to perform this procedure and recommended 
that both the portable unit and the intracavitary probe be recognized 
as direct PE inputs for this service. One commenter included pricing 
information in its comment letter, noting that the probe should be 
added as an additional direct PE input at a cost of $20,700.
    Response: While we appreciate the submission of this pricing 
information from the commenter, we are unable to consider this pricing 
information for the CY 2018 final rule without documentation of 
invoices. We request that commenters submit invoices for pricing 
updates and that the invoices contain clear documentation regarding the 
item in question: Its name, the CMS supply/equipment code that it 
references (if any), the unit quantity if the item is shipped in boxes 
or batches, and any other information relevant for pricing. To be 
considered for a given year's proposed rule, we generally need to 
receive invoices by February. In similar fashion, we generally need to 
receive invoices by the end of the comment period for the proposed rule 
in order to consider them for the supply and equipment pricing for the 
final rule for that calendar year. We note that both the ``endocavitary 
US probe'' (EQ386) and ``portable ultrasound unit'' (EQ250) are 
included in the PE inputs for this service, which are displayed in the 
CY 2018 PFS final rule direct PE input database, available on the CMS 
Web site under the downloads for the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    After consideration of comments received, we are finalizing the 
work RVUs and direct PE inputs for CPT code 55874 as proposed.

[[Page 53054]]

(23) Colporrhaphy With Cystourethroscopy (CPT Codes 57240, 57250, 57260 
and 57265)
    In October 2015, CPT code 57240 was identified by analysis of the 
Medicare data from 2011-2013 that indicated that services reported with 
CPT code 57240 were performed less than 50 percent of the time in the 
inpatient setting, yet include inpatient hospital E/M services within 
the global period. The RUC recommended that CPT codes 57240 (Anterior 
colporrhaphy, repair of cystocele with or without repair of 
urethrocele), 57250 (Posterior colporrhaphy, repair of rectocele with 
or without perineorrhaphy), 57260 (Combined anteroposterior 
colporrhaphy), and 57265 (Combined anteroposterior colporrhaphy; with 
enterocele repair) be referred to the CPT Editorial Panel. In September 
2016, the CPT Editorial Panel revised CPT codes 57240, 57260 and 57265 
to preclude separate reporting of follow up cystourethroscopy after 
colporrhaphy (CPT code 52000).
    For CY 2018, we proposed the RUC-recommended work RVUs for CPT code 
57240 (a work RVU of 10.08), CPT code 57250 (a work RVU of 10.08), CPT 
code 57260 (a work RVU of 13.25), and CPT code 57265 (a work RVU of 
15.00).
    We note that there were changes in service times reflected in the 
specialty surveys compared to the RUC-recommended work RVUs for CPT 
code 57240. Specifically, we note that the RUC recommended a 48 minute 
decrease in total time, compared to the specialty survey total time of 
259 minutes. The difference in total time reflected a decrease in 
preservice time (29 minutes) and inpatient visits (0.5 visits = 19 
minutes). We considered a work RVU of 9.77 for CPT code 57240, 
crosswalking to CPT code 50590 (Lithotripsy, extracorporeal shock 
wave), which has similar service times. We sought comment on whether 
CPT code 57250 would be a relevant comparator for CPT code 57240, based 
on the described elements of each service and existing or surveyed 
service times, compared to CPT code 57240. We considered a work RVU of 
11.47 for CPT code 57260 [we note that in the CY 2018 PFS proposed rule 
(82 FR 34000), this was cited as CPT code 57265], crosswalking to CPT 
code 47563 (Laparoscopy, surgical; cholecystectomy with 
cholangiography) with similar service times. We sought comment on how 
an alternative work RVU of 11.47 for CPT code 57260 [we note that in 
the CY 2018 PFS proposed rule (82 FR 34000), this was cited as CPT code 
57260] would affect relativity among PFS services, and on whether CPT 
code 57265 [we note that in the CY 2018 PFS proposed rule (82 FR 
34000), this was cited as CPT code 57260] is a relevant comparator for 
CPT code 57260 [we note that in the CY 2018 PFS proposed rule (82 FR 
34000), this was cited as CPT code 57265], considering differences in 
the described procedures and service times.
    We proposed the RUC-recommended direct PE inputs for CPT codes 
57240, 57250, 57260 and 57265 without refinements.
    Comment: In general, commenters were supportive of our proposal of 
the RUC-recommended work RVUs. We continue to welcome information from 
all interested parties regarding valuation of services for 
consideration through our rulemaking process. Some expressed opposition 
to the alternative work RVUs we considered.
    Response: We will continue to consider alternative work RVUs as we 
propose the valuation of services for future notice and comment 
rulemaking.
    After consideration of comments received, we are finalizing the 
work RVUs as proposed. We are finalizing the proposed direct PE inputs 
for CPT codes 57240, 57250, 57260 and 57265, without refinement.
(24) Injection of Anesthetic Agent (CPT Code 64418)
    CPT code 64418 (Injection, anesthetic agent; suprascapular nerve) 
was identified by the AMA through their screen of Harvard-valued codes 
with utilization over 30,000. We proposed the RUC-recommended work RVU 
of 1.10 and RUC-recommended direct PE inputs without refinement.
    Comment: We received one comment that expressed support for CMS' 
proposed value.
    Response: We appreciate the commenter's support.
    After consideration of the comment received that specifically 
addressed this code, for CY 2018, we are finalizing a work RVU of 1.10 
and the proposed direct PE inputs without refinement for CPT code 
64418.
(25) Nerve Repair With Nerve Allograft (CPT Codes 64910, 64911, 64912, 
and 64913)
    The CPT Editorial Panel created two new Category I CPT codes (64912 
and 64913) to report the repair of a nerve using a nerve allograft. CPT 
codes 64910 and 64911 were also reviewed as part of this code family. 
CPT codes 64912 and 64913 will be placed on the new technology list to 
be re-reviewed by the RUC in 3 years to ensure correct valuation and 
utilization assumptions.
    For CY 2018, we proposed the RUC-recommended work RVUs for the 
following codes: A work RVU of 10.52 for CPT code 64910, a work RVU of 
14.00 for CPT code 64911, a work RVU of 12.00 for CPT code 64912, and a 
work RVU of 3.00 for CPT code 64913.
    We noted a decrease in preservice time (7 minutes) for CPT code 
64910 and considered an alternate work RVU of 10.15, crosswalking to 
CPT code 15120 (Split-thickness autograft, face, scalp, eyelids, mouth, 
neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; 
first 100 sq cm or less, or 1 percent of body area of infants and 
children (except 15050)), which has similar service times. We sought 
comments on whether an alternative work RVU of 10.15 for CPT code 64910 
would better reflect relativity among PFS services with similar service 
times.
    For CPT code 64911 (Nerve repair; with autogenous vein graft 
(includes harvest of vein graft), each nerve)), we considered a work 
RVU of 13.50, by crosswalking to CPT code 31591 (Laryngoplasty, 
medicalization, unilateral), which has similar service times and a work 
RVU of 13.56. We sought comments on whether a work RVU of 13.50 for CPT 
code 64911 would better reflect relativity among other PFS services 
with similar service times.
    The new coding structure for these services increases granularity 
by including add-on codes that describe each strand of nerve repair. 
While we recognize that additional granularity may be important and 
useful for purposes of data collection, the advantages to Medicare for 
such granularity for purposes of payment are unclear, especially since 
we are unaware of a payment-related reason for such coding complexity. 
We considered proposing a bundled status to the new add-on codes and 
incorporating the relative resources in furnishing the add-on code (CPT 
code 64913) into the base code (CPT code 64912) based on the 
utilization assumptions that accompanied the RUC's recommendations. The 
RUC estimated that CPT code 64912 would have 750 Medicare allowed 
services in CY 2018, and that the corresponding add-on CPT code 64913 
would have 150 Medicare allowed services in CY 2018. Therefore, the RUC 
estimated that CPT code 64912 will be billed without add-on CPT code 
64913 for 80 percent (750/900) of the Medicare allowed services, and 
that CPT code 64912 will be billed with add-on CPT code time 64913 for 
20 percent (150/900) of the Medicare allowed services in CY 2018. To 
account for the additional work involved in 20 percent of the allowed 
services, we added a

[[Page 53055]]

work RVU of 0.60 (20 percent of the work RVU of 3.00 for CPT code 
64913) to the work RVU of 12.00 for CPT code 64912, to derive an 
alternative work RVU of 12.60 for CPT code 64912 and increased the 
intraservice time by 6 minutes to account for the bundling of services 
from CPT code 64913. The alternative work RVU of 12.60 would have been 
further supported by a crosswalk to CPT code 14301 (Adjacent tissue 
transfer or rearrangement, any area; defect 30.1 sq cm to 60.0 sq cm), 
which has similar intraservice and total times.
    We proposed the RUC-recommended direct PE inputs for CPT codes 
64910, 64911, 64912 and 64913 without refinements.
    Comment: In general commenters were supportive of our proposal of 
the RUC-recommended work RVUs. Some expressed opposition to the 
alternative work RVUs.
    Response: We will continue to consider alternative work RVUs as we 
propose the valuation of services for future notice and comment 
rulemaking.
    Comment: Some commenters disagreed with our proposal to bundle CPT 
codes 64912 and 64913. Several commenters, including the RUC, noted 
that bundling the service would place a financial burden on the 
patients who do not require multiple strands because they would be 
charged 120 percent of what they should be charged. One commenter cited 
this as the payment-related reason to not bundle the services, and 
further noted that bundling would undermine the premise of coding and 
relative reimbursement. The RUC noted that CPT code 64913 is an add-on 
code for the additional work related to insertion of an additional 
nerve allograft for the same nerve. They stated that the additional 
work is not typically performed with the base code and therefore would 
not be appropriate to bundle into the work of the base code.
    Response: We note that section 1848(c)(2)(K)(iii)(V) of the Act 
specifies that the Secretary may make appropriate coding revisions 
(including using existing processes for consideration of coding 
changes) that may include consolidation of individual services into 
bundled codes for payment under the physician fee schedule. We will 
continue to consider these options as we propose the valuation of 
services for future notice and comment rulemaking.
    Comment: The RUC stated that it is atypical for CMS to question the 
coding structure of newly proposed services via rulemaking. In the 
future, they requested that CMS voice concerns regarding coding 
structure as part of the agency's participation in the CPT Editorial 
Panel review process.
    Response: While we acknowledge that the discussion and 
consideration of different coding structures occurs during the CPT 
Editorial Panel review process, we also note that not all interested 
parties have the opportunity to participate in the CPT Editorial Panel 
review process, and not all relevant stakeholders are members of the 
CPT Editorial Panel. Additionally, we would like to reiterate that, 
while we appreciate that some commenters believe that CMS staff could 
offer useful perspectives by regularly attending and participating more 
fully in the CPT Editorial Panel review process, we do not believe that 
would be appropriate for many reasons, not least of which is that CMS 
staff participation in the CPT Editorial Panel review process cannot 
supplant our obligation to establish through notice and comment 
rulemaking what we determine to be appropriate coding structures for 
each reviewed code. Accordingly, we disagree with the commenter's 
suggestion that CMS staff should preemptively address the concerns of 
coding structures during the CPT Editorial Panel review process, 
instead of through notice and comment rulemaking. Formal notice and 
comment rulemaking allows all interested parties the opportunity to 
review our proposals and provide feedback, as well as to submit 
supplemental information about our proposals, and address any concerns 
or alternatives we have expressed in making our proposal.
    Comment: A commenter questioned why CMS would be concerned with a 
code pair that is not typically reported for Medicare-aged patients, 
but instead is a service for younger patients that have better nerve 
healing capacity.
    Response: As discussed in the CY 2017 PFS final rule (82 FR 80172), 
the statute requires us to establish, by regulation, each year's 
payment amounts for all physicians' services paid under the PFS. 
Although we prioritize high volume services when we routinely examine 
the valuation and coding for existing services under the misvalued code 
initiative, we also value low-volume services in accordance with the 
statute.
    After consideration of comments received, we are finalizing the 
work RVUs for CPT codes 64910, 64911, 64912, and 64913 as proposed. We 
are also finalizing the proposed direct PE inputs for these codes, 
without refinement.
(26) Correction of Trichiasis (CPT Code 67820)
    In CY 2016, CPT code 67820 was identified by the screen for high 
expenditure services across specialties with Medicare allowed charges 
of $10 million or more. The screen identified the top 20 codes by 
specialty in terms of allowed charges, excluding 10- and 90-day global 
services, anesthesia and E/M services and services reviewed since CY 
2010. During the review process, the RUC re-surveyed the code and 
recommended a work RVU of 0.32, which we proposed in the CY 2018 PFS 
proposed rule.
    The RUC also recommended 15 minutes of preservice time in the 
facility setting to complete preservice diagnostic and referral forms, 
coordinate pre-surgery services, schedule space and equipment in the 
facility, provide preservice education/obtain consent, and follow-up 
phone calls and prescriptions. We believed it to be atypical for a 
physician's staff to be performing these activities in a facility-
setting with a procedure that has a 0-day global period. Therefore, we 
proposed removing the time associated with these activities.
    We also note that in the course of refining the times associated 
with the clinical activities referenced above, we inadvertently reduced 
the time associated with the screening lane (EL006) from 11 minutes to 
5 minutes.
    Comment: Commenters stated that a default policy of allowing zero 
minutes of preservice time in the facility setting was inappropriate as 
ambulatory practices often expend staff time to coordinate with the 
facility in order to bring their patients in to perform procedures. 
Commenters also acknowledged that it may be atypical for epilation of 
eyelashes to require pre-surgery coordination, follow-up phone calls or 
prescriptions and that by removing these two activities, the total 
clinical staff preservice time would be more appropriate for the 
service.
    Response: We appreciate the information provided by commenters 
regarding the preservice clinical activities and agree that certain 
activities are typical for this service. Therefore, for CY 2018, we 
will finalize a total of 9 minutes of preservice time which corresponds 
with coordinating pre-surgery services, scheduling space and equipment 
in the facility, and providing preservice education/obtain consent.
    Comment: Commenters stated their disagreement with the reduction of 
time from 11 to 5 minutes for the screening lane (EL006), as the 
physician would be

[[Page 53056]]

treating the patient in the screening lane for all aspects of the 
procedure and therefore, it would be unavailable for any other use 
during the procedure.
    Response: As we stated above, we inadvertently reduced the time of 
the screening lane and did not intend to make a proposal regarding this 
equipment item. Therefore, for CY 2018, we will finalize the RUC-
recommended 11 minutes for the screening lane.
    Comment: Another commenter expressed their support for the RUC 
process, but opposed the RUC-recommended work RVU of 0.32 for CPT code 
67820. The commenter recommended CMS increase the work RVU to the 0.40 
to align with 25th percentile of the survey.
    Response: We believe the RUC's recommend valuation of 0.32 for CPT 
code 67820 is appropriate due to the overall reduction in total time 
and it having less intensity than its key reference code, CPT code 
11900, Injection, intralesional; up to and including 7 lesions (work 
RVU = 0.52, intra time = 8 minutes). Therefore, after consideration of 
the comments, we will finalize the RUC-recommended work RVU of 0.32 for 
CPT code 67820 for CY 2018.
(27) CT Soft Tissue Neck (CPT Codes 70490, 70491, and 70492)
    CPT codes 70490 and 70492 were identified through the high 
expenditure services across specialties with Medicare allowed charges 
of $10 million or more screen. CPT code 70491 was also included for 
review as part of this code family. For CY 2018, we proposed the RUC-
recommended work RVUs of 1.28 for CPT code 70490, 1.38 for CPT code 
70491, and 1.62 for CPT code 70492. For CPT code 70490, we considered a 
work RVU of 1.07 based on a crosswalk to CPT code 72125 (Computed 
tomography, cervical spine; without contrast material). CPT code 72125 
is a non-contrast CT service on a similar anatomical area and has 
identical intraservice and total times to those recommended by the RUC 
for CPT code 70490. We also considered work RVUs of 1.17 for CPT code 
70491 and 1.41 for CPT code 70492. We sought comment on how relativity 
among other CT services paid under the PFS would be affected by 
applying the alternative work RVUs described above for CPT codes in 
this family.
    Comment: Commenters disagreed with our alternative values and 
supported our proposal to implement the RUC-recommended values.
    Response: We appreciate the comments regarding our proposals.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs as proposed.
(28) Magnetic Resonance Angiography (MRA) Head (CPT Codes 70544, 70545, 
and 70546)
    CPT code 70544 was identified by a screen of services across 
specialties with Medicare allowed charges of $10 million or more. 
Subsequently, CPT codes 70545 and 70546 were also reviewed as part of 
this code family. We proposed the RUC-recommended work RVUs of 1.20 for 
CPT code 70544, 1.20 for CPT code 70545, and 1.48 for CPT code 70546. 
We also proposed the following refinements to the RUC-recommended 
direct PE inputs. For the service period clinical labor activity 
``Provide preservice education/obtain consent,'' we proposed 5 minutes 
for CPT code 70544, 7 minutes for CPT code 70545, and 7 minutes for CPT 
code 70546 so that the times for this activity are consistent with 
other magnetic resonance (MR) services performed without-contrast 
materials, with-contrast materials, and without-and-with contrast 
materials, respectively. For the clinical labor task ``Acquire 
images,'' we proposed using the RUC-recommended clinical time of 26 
minutes for CPT code 70544. We considered proposing 20 minutes of 
clinical time to maintain the relativity among the three codes in this 
family and for consistency with other MRA and magnetic resonance 
imaging (MRI) codes, which do not typically assign more clinical labor 
time to this task for services without contrast material than for 
services with contrast material. We sought comment as to the 
appropriate time value for this clinical labor task. For the clinical 
labor task ``Technologist QCs images in PACS, checking all images, 
reformats, and dose page,'' we proposed to refine the clinical labor 
time from the RUC recommended 4 minutes to 3 minutes to comply with the 
standards.
    Comment: A commenter disagreed with our proposed clinical labor 
time for the task ``Technologist QCs images in PACS, checking all 
images, reformats, and dose page,'' and stated that CMS had previously 
determined that the amount of clinical labor needed to check images in 
a PACS workstation may vary depending on the service, and that CMS 
would agree to times above the standard if a compelling rationale is 
presented.
    Response: We believe that MRA services are analogous to MRI 
services in that they are most accurately considered procedures of 
intermediate complexity.
    Comment: One commenter did not agree with our alternative value for 
the clinical labor task ``acquire images.''
    Response: We appreciate the comment, and we are finalizing as 
proposed the RUC-recommended clinical labor time value for this task.
    After consideration of the comments, we are finalizing these PE 
refinements as well as the RUC-recommended work RVUs, as proposed.
(29) Magnetic Resonance Angiography (MRA) Neck (CPT Codes 70547, 70548, 
and 70549)
    CPT code 70549 was identified through a high expenditure screen. 
CPT codes 70547 and 70748 were also reviewed as part of this family of 
codes. We proposed the RUC-recommended work RVUs of 1.20 for CPT code 
70547, 1.50 for CPT code 70548, and 1.80 for CPT code 70549. We also 
proposed several refinements to the RUC-recommended direct PE inputs 
for these services. For the service period clinical labor activity 
``Provide preservice education/obtain consent,'' we proposed 5 minutes 
for CPT code 70547, 7 minutes for CPT code 70548, and 7 minutes for CPT 
code 70549 so that the times for this activity are consistent with 
other MR services performed without contrast material, with contrast 
material, and without-and with contrast material, respectively. For the 
intraservice clinical labor task acquire images, for CPT code 70547, we 
proposed to use the RUC-recommended 26 minutes. We considered applying 
20 minutes to this clinical labor task, which would have maintained 
consistency with the 20 minutes recommended by the RUC for CPT code 
70548 (the service that includes with-contrast material). We stated 
concern about the lack of evidence that a non-contrast MRA would 
require more clinical labor time than the with-contrast MRA service. We 
sought comment as to the appropriate time value for this clinical labor 
task. For the clinical labor task ``Technologist QCs images in PACS, 
checking all images, reformats, and dose page,'' we proposed to refine 
the clinical labor time from the RUC recommended 4 minutes to 3 minutes 
to comply with the standards.
    Comment: A commenter did not agree with our alternative time value 
for the task ``acquire images.''
    Response: We appreciate the comment, and we are finalizing the RUC-
recommended time value for this clinical labor task as proposed.
    Comment: A commenter disagreed with our proposed clinical labor 
time for the task ``Technologist QCs images in PACS, checking all 
images, reformats,

[[Page 53057]]

and dose page,'' stating that CMS had previously determined that the 
amount of clinical labor needed to check images in a PACS workstation 
may vary depending on the service, and that we will agree to times 
above the standard if a compelling rationale is presented.
    Response: We believe that MRA services are analogous to MRI 
services in that they are most accurately considered procedures of 
intermediate complexity. Therefore, for CPT codes 70547, 70548, and 
70549, we are finalizing these PE refinements as well as the RUC-
recommended work RVUs, as proposed.
(30) CT Chest (CPT Codes 71250, 71260, and 71270)
    CMS identified this code family through the high expenditures 
screen. We proposed the RUC-recommended work RVUs of 1.16 for CPT code 
71250, 1.24 for CPT code 71260, and 1.38 for CPT code 71270. For CPT 
code 71250, we considered maintaining the CY 2017 work RVU of 1.02. We 
stated that we are concerned with the lack of evidence that the 
physician time or intensity of furnishing this service has changed 
since it was last valued. In addition, we noted that a comparison to 
other CT codes indicated that the RUC-recommended work values could be 
overvalued relative to other CT services and compared to similar, non-
contrast CT studies such as CPT codes 72131 (Computed tomography, 
lumbar spine; without contrast material) and 73700 (Computed 
tomography, lower extremity; without contrast material), both of which 
have work RVUs of 1.00. For CPT code 71260, we considered proposing a 
work RVU of 1.10 by applying the RUC-recommended increment between CPT 
code 71250 and 71260 (0.08) to CPT code 71260. For CPT code 71270, we 
considered a work RVU of 1.24 by applying the RUC-recommended increment 
between CPT codes 71260 and 71270 (0.22) to CPT code 71270. In addition 
to maintaining relatively among the codes in this family, we considered 
further supporting these alternative values based on a comparison to 
other CT studies, such as with-contrast material CT studies, and 
without-and-with contrast CT studies. While noting our concerns, we 
proposed the RUC recommended work RVUs for CPT code 71250, 71260, and 
71270 and sought comment on whether our alternative values would 
improve relativity.
    Comment: Commenters supported the proposed values for these codes 
but disagreed with the alternative values.
    Response: We appreciate the comments in support of our proposals.
    After consideration of the public comments, we are finalizing the 
RUC-recommended values as proposed.
(31) MRI of Abdomen and Pelvis (CPT Codes 72195, 72196, 72197, 74181, 
74182, and 74183)
    CPT codes 74182 and 72196 were identified as part of the screen of 
high expenditure services across specialties with Medicare allowed 
charges of $10 million or more. CPT codes 74181, 74183, 72195, and 
72197 were also reviewed as part of this code family. We proposed the 
RUC-recommended work RVUs of 1.46 for CPT code 72195, 1.73 for CPT code 
72196, 2.20 for CPT code 72197, 1.46 for CPT code 74181, 1.73 for CPT 
code 74182, and 2.20 for CPT code 74183. While we proposed the RUC-
recommended direct PE inputs, we considered 30 minutes for clinical 
labor task ``Acquire images'' for CPT codes 74181 and 74182, which we 
stated appeared to be more consistent with the codes in this family and 
more consistent with other MR codes. We also noted that for CPT codes 
74181 and 74182, the clinical labor time for acquired images appears to 
have been developed through a consensus panel from the specialty 
society over 15 years ago. Given that these times are estimates based 
on expert panel consensus rather than survey data, we sought comment on 
whether using a structure that matches other MR code families would be 
more appropriate to value these clinical labor times.
    Comment: A commenter stated that all clinical labor time inputs are 
based on an expert panel, and our expression of concern for this code 
family is thus inconsistent with our review of other services in 
current and past rulemaking.
    Response: We appreciate the comment and we are finalizing the RUC-
recommended work RVUs, as proposed.
(32) MRI Lower Extremity (CPT Codes 73718, 73719, and 73720)
    CPT codes 73718 and 73720 were identified as part of the screen of 
high expenditure services, and CPT code 73719 was included for review 
as part of the code family. We proposed the RUC-recommended work RVUs 
of 1.35 for CPT code 73718, 1.62 for CPT code 73719, and 2.15 for CPT 
code 73720. We are also proposing the following refinements to the RUC-
recommended direct PE inputs. For the service period clinical labor 
activity ``Provide preservice education/obtain consent,'' we proposed 5 
minutes for CPT code 73718, 7 minutes for CPT code 73719, and 7 minutes 
for CPT code 73720. Likewise, for the service period task ``Prepare 
room, equipment, supplies,'' we proposed 3 minutes for CPT code 73718, 
5 minutes for CPT code 73719, and 5 minutes for CPT code 73720. We 
proposed these changes to maintain consistency with other MR services 
without contrast materials, with contrast materials, and without-and-
with contrast materials, respectively.
    Comment: A commenter disagreed with our proposed PE refinements to 
the clinical labor activity ``Prepare room, equipment, supplies,'' 
stating that the RUC-recommended clinical labor time paralleled other 
recent MRI codes, including MRI brain and MRI face, and that MR 
involves strong magnetic fields and ensuring patient safety is 
important. More specifically, all objects in the room must be MRI 
compatible. MR exams involve the use of MR coils which vary based on 
the body part studied and are specifically selected to fit the patient. 
These coils must be prepared for the intended exam, positioned, and 
attached to the MR unit. In addition, the examinations involving the 
use of contrast require setup of the injector apparatus and preparation 
of the contrast material.
    Response: We agree that the RUC-recommended clinical labor times 
for this activity appear consistent with those for the code family 
mentioned by the commenter. Therefore, we are not finalizing our 
proposed time values for this activity, and are instead finalizing the 
RUC-recommended values of 5 minutes, 7 minutes, and 7 minutes for CPT 
codes 73718, 73719, and 73720, respectively, to maintain consistency 
among similar services.
(33) Abdominal X-Ray (CPT Codes 74022, 74018, 74019, and 74021)
    CPT codes 74000 (Radiologic examination, abdomen; single 
anteroposterior view) and 74022 (Radiologic examination, abdomen; 
complete acute abdomen series, including supine, erect, and/or 
decubitus views, single view chest) were identified via a high 
expenditure screen. The CPT Editorial Panel created CPT codes 
7401874018, 7401974019, and 7402174021to replace CPT codes 74000, 
74010, and 74020. The RUC suggested a utilization scenario that assumes 
that 25 percent of services currently reported with CPT code 74010 will 
be reported with CPT code 74019 and 75 percent will be reported with 
CPT code 74021; and 75 percent of services currently reported with CPT 
code 74020 will be reported with CPT code 74019 and 25 percent will be 
reported with CPT code 74021. In the CY 2018 PFS proposed rule, we 
stated that we did not identify evidence or a rationale for these 
assumptions. For

[[Page 53058]]

purposes of calculating the proposed RVUs, we used an even distribution 
of services previously reported as CPT codes 74010 and 74020 to CPT 
codes 740X2 and 740X3 instead of the RUC-recommended distribution 
because we thought that the services previously reported with codes 
74010 and 74020 will be reported in equal volume between the code 
representing two views and the code representing three views, and we 
sought comment on information that would help us improve on this 
distribution for purposes of developing final RVUs, including rationale 
for the distribution reflected in the RUC's utilization crosswalk.
    Comment: The RUC commented that its utilization assumptions are 
based on expert panel consensus, and said that its utilization 
assumptions will result in savings that would be reapplied to the 
Medicare conversion factor. The RUC also requested clarity regarding 
our utilization assumptions and their relationship to the work RVUs we 
proposed for this code family.
    Response: We appreciate the RUC's input regarding utilization 
assumptions. We note that we are finalizing the RUC-recommended work 
RVUs as proposed, and our utilization assumptions do not determine the 
valuation of work RVUs, which will be incorporated into overall budget 
neutrality calculations.
(34) Angiography of Extremities (CPT Codes 75710 and 75716)
    This code family was identified through the $10 million or more 
screen of high expenditure services. We proposed the RUC-recommended 
work RVUs of 1.75 for CPT code 75710 and 1.97 for CPT code 75716. We 
also proposed to use the RUC-recommended direct PE inputs for CPT codes 
75710 and 75716, with the following refinements. For the clinical labor 
task ``Technologist QC's images in PACS, checking for all images, 
reformats, and dose page,'' we proposed refinements consistent with the 
standard clinical labor times for tasks associated with the PACS 
Workstation. We also proposed to refine the clinical labor by removing 
the 2 minutes associated with the task ``prepare room, equipment, and 
supplies.'' CPT codes 75710 and 75716, which represent radiological 
supervision and interpretation, are billed with codes that include 
activities such as needle placement and imaging, and the ``prepare 
room, equipment, supplies,'' activity will be accounted for with the 
codes that are billed with these interpretation codes.
    Comment: A commenter disagreed with our proposed clinical labor 
time for the task ``Technologist QCs images in PACS, checking all 
images, reformats, and dose page,'' stating that CMS had previously 
determined that the amount of clinical labor needed to check images in 
a PACS workstation may vary depending on the service, and that we would 
agree to times above the standard if a compelling rationale is 
presented.
    Response: We believe that MRA services are analogous to MRI 
services in that they are most accurately considered procedures of 
intermediate complexity.
    After consideration of the comment we received, we are finalizing 
these PE refinements as well as the RUC-recommended work RVUs, as 
proposed.
(35) Ophthalmic Biometry (CPT Codes 76516, 76519, and 92136)
    In the CY 2016 PFS final rule with comment period, CMS identified 
CPT codes 76519 and 92136 as potentially misvalued on the high 
expenditure screen. For CY 2018, we proposed the RUC-recommended work 
RVUs for each code in this family as follows: 0.40 for CPT code 76516, 
0.54 for CPT code 76519, and 0.54 for CPT code 92136.
    For CPT codes 76519 and 92136, the RUC recommended adding an 
additional 8 minutes of immediate postservice time for dictating the 
report of the procedure for the medical record, review and sign report, 
communicate results to the patient, discussing lens implant options for 
desired postoperative refractive result, and entering an order for the 
intraocular lens implant. We considered time and work values that would 
not include the additional 8 minutes of immediate postservice time in 
either of these codes, due to the concern that the additional time may 
not reflect the typical case. Were we to not include those 8 minutes, 
each of these procedures would have a total time of 14 minutes. We 
considered applying the total time ratio (decrease from 17 minutes to 
14 minutes; ratio of 0.824) to the RUC-recommended work RVU of 0.54, 
which would have resulted in a work RVU of 0.44 for CPT codes 76519 and 
92136. We sought comment on whether these alternative values would 
improve relativity.
    Comment: Several commenters, including the RUC, stated the 
additional immediate postservice time for CPT codes 76519 and 92136 was 
appropriate due to the need for the provider to discuss the multiple 
lens options and refractive outcomes with the patient; as many of these 
medical options were not available when the code was last surveyed.
    Response: We appreciate the feedback from the commenters regarding 
the relativity of our alternative value. After considering these 
comments, we are finalizing the RUC-recommended values of 0.54 RVUs for 
CPT codes 76519 and 92136, for CY 2018.
(36) Ultrasound of Extremity (CPT Codes 76881 and 76882)
    The RUC identified CPT codes 76881 and 76882 for review only of PE 
inputs. For CPT code 76881, we proposed the RUC-recommended inputs with 
refinements. We proposed to remove 1 minute from the clinical labor 
task ``Exam documents scanned into PACS. Exam completed in RIS system 
to generate billing process and to populate images into Radiologist 
work queue,'' because this code does not include any equipment time for 
the PACS workstation proxy or professional PACS workstation. We noted 
that the RUC-recommended inputs shift the general ultrasound room from 
the PE inputs for CPT code 76881 to the PE inputs for CPT code 76882. 
We proposed to make this change, consistent with the RUC 
recommendations; however, we sought comment on whether a portable 
ultrasound unit would be a more accurate PE input for both codes, given 
that the dominant specialty for both of these services is podiatry, 
based on available 2016 Medicare claims data. As noted in the CY 2018 
PFS proposed rule, we proposed that these codes would not be subject to 
the phase-in of significant RVU reductions given the significance of 
this shift of resource costs between codes in the same family and 
sought comment on this proposed application of the phase-in policy.
    Comment: Many commenters disagreed with the RUC recommendations for 
the direct PE inputs, stating that the shift of PE from CPT code 76881 
to CPT code 76882 is based on inaccurate assumptions regarding the 
typical equipment used in furnishing these services. These commenters 
noted that the equipment used to furnish the two procedures is 
identical. These commenters stated that the RUC-recommended direct PE 
inputs for CPT code 76881, which were developed based on the assumption 
that the dominant specialty furnishing the service is podiatry, do not 
reflect the equipment inputs utilized by rheumatologists such as an 
ultrasound room and PACS workstation.
    Furthermore, these commenters stated that valuing CPT code 76882, 
which is the limited ultrasound procedure, at a higher price than CPT 
code 76881, which is the complete ultrasound procedure, represents a 
rank order anomaly. The RUC disagreed with our statement that podiatry 
is the dominant

[[Page 53059]]

specialty for both codes and re-affirmed its recommendation.
    Response: Examination of 2016 claims indicates that the dominant 
specialty for both codes, when considering the volume of global and TC 
services in aggregate, is podiatry. Therefore, we are finalizing the 
RUC-recommended direct PE inputs with refinements for CPT code 76881 as 
proposed. For CPT code 76882, we are not finalizing our proposal to 
include an ultrasound room, and we are instead finalizing the RUC-
recommended equipment, with the exception of the ultrasound room, which 
we are replacing with a portable ultrasound unit. This is based on the 
RUC's determination, as expressed through its recommendations for CY 
2018, that a portable unit is the equipment type that is typical for 
podiatry, which is the dominant specialty furnishing CPT code 76882. We 
are thus applying the PE inputs that the RUC has determined are typical 
for the dominant specialty for both codes in order to maintain 
consistency and rank order.
    Comment: A commenter requested that CMS reconsider our proposal not 
to subject these codes to the phase-in of significant RVU reductions.
    Response: The significant RVU reductions that will result from the 
PE inputs that we are finalizing comprise a change in resource costs 
overall for the code family. This is in contrast to our proposal, which 
would have shifted costs within codes of the same family. Therefore, we 
are not finalizing our proposal to exempt these codes from the phase-
in, and the reduction in the PE for CPT code 76881 will thus be limited 
to 19 percent for the first year. This transition period will allow us 
to obtain more stakeholder input on the appropriate PE inputs and 
specialty assumptions for these services, and we expect to consider 
this input for future rulemaking.
    Comment: A commenter disagreed with our decision to remove from CPT 
code 76881 the one minute of clinical labor assigned to the task ``Exam 
document scanned into PACS. Exam completed in RIS system to generate 
billing process and to populate images into Radiologist work queue,'' 
stating that regardless of whether the service includes a PACS 
workstation, there is still documentation to be entered.
    Response: The task of entering documentation, when not applied to a 
code that includes a PACS workstation as an equipment item, is most 
appropriately considered indirect PE; therefore, we are finalizing this 
refinement as proposed.
(37) Flow Cytometry Codes (CPT Codes 88184 and 88185)
    The flow cytometry interpretation family of codes is split into a 
pair of codes used to describe the technical component of flow 
cytometry (CPT codes 88184 and 88185) that do not have a work 
component, and a trio of codes (CPT codes 88187, 88188, and 88189) that 
do not have direct PE inputs, as they are professional component only 
services. CPT codes 88184 and 88185 were reviewed by the RUC in April 
2014, and their CMS-refined values were included in the CY 2016 PFS 
final rule with comment period. These codes were reviewed again at the 
January 2016 RUC meeting, and new recommendations were submitted to CMS 
as part of the CY 2017 PFS rulemaking cycle. In the CY 2017 PFS final 
rule (81 FR 80325), we finalized all of the direct PE inputs for CPT 
codes 88184 and 88185, as proposed, except for the proposed refinement 
to the dye sublimation printer.
    As discussed in the potentially misvalued services section of this 
final rule (section II.E), we have received conflicting information 
about the direct PE inputs for CPT codes 88184 (Flow cytometry, cell 
surface, cytoplasmic, or nuclear marker, technical component only; 
first marker) and 88185 (Flow cytometry, cell surface, cytoplasmic, or 
nuclear marker, technical component only; each additional marker). 
Therefore, in the CY 2018 PFS proposed rule, we proposed these codes as 
potentially misvalued so that they can be reviewed again because some 
stakeholders have suggested the clinical labor and supplies that were 
previously finalized are no longer accurate. In response to the CY 2018 
PFS proposed rule, several commenters urged CMS to use the RUC's 
recommendations for CY 2017 in developing final PE RVUs for these 
services instead of recommending additional review under the misvalued 
code initiative. Based on this suggestion from the commenters, which 
appears to reflect a broad consensus, we have re-examined the CY 2017 
RUC-recommended direct PE inputs for these services, in light of the 
specific comments. In the paragraphs below, we summarize the direct PE 
inputs that we are changing based on these comments.
    Comment: Several commenters urged CMS to use the RUC-recommended 15 
minutes for the clinical labor activity ``Instrument start-up, quality 
control functions, calibration, centrifugation, maintaining specimen 
tracking, logs and labeling.'' from CY 2017 for this clinical labor 
activity. Commenters stated that the CMS comparison to CPT code 88182 
was not appropriate, as that code uses older/simpler technology, and 
that the more robust testing described in these codes requires a higher 
level of skill, experience, and continuing education in the laboratory 
staff than in CPT code 88182.
    Response: After reviewing this additional information, we agree 
with the commenters that 15 minutes would be typical for this task. We 
are finalizing a clinical labor time of 15 minutes for the ``Instrument 
start-up, quality control functions . . .'' clinical labor activity for 
CPT code 88184.
    Comment: Several commenters stated that the RUC-recommended time of 
10 minutes for ``Load specimen into flow cytometer, run specimen, 
monitor data acquisition, and data modeling, and unload flow 
cytometer'' activity for CPT code 88184 reflects the typical case. 
Commenters stated that the time it takes for data capture, data 
modeling, data acquisition, and computational analysis is significantly 
longer for CPT code 88184 than for CPT code 88182, since additional 
colors result in more complicated profiles which are more difficult and 
time consuming to evaluate.
    Response: After reviewing this additional information, we agree 
with the commenters that 10 minutes would be typical for this task. We 
were persuaded by the additional information that the commenters 
supplied regarding the need for extra clinical labor time in CPT code 
88184 as compared to CPT code 88182 due to the additional colors used 
in flow cytometry. Therefore, we are finalizing a clinical labor time 
of 10 minutes for the ``Load specimen into flow cytometer . . .'' 
clinical labor activity for CPT code 88184.
    Comment: Several commenters objected to the finalized supply 
quantity of 1 for the flow cytometry antibody (SL186) in CPT codes 
88184 and 88185. Commenters stated that although it is standard 
practice to use a single antibody multiple times during the analysis, 
each antibody or marker can only be billed once per analysis. According 
to commenters, multiple uses of such antibodies are not reportable or 
billable, but are critical to the overall analysis and interpretation 
of results and are part of the total cost for each procedure performed. 
A commenter stated that for a typical immunophenotyping panel, it takes 
38 units of different antibody reagents to identify 24 distinct cell 
surface markers across 10-12 separately analyzed tubes, and therefore a 
ratio of 1.6 units of antibody reagent for each reportable and billable 
surface marker is required, not

[[Page 53060]]

the 1:1 ratio in the finalized CY 2017 values. All of the commenters 
requested using the CY 2017 RUC recommendation of 1.6 supply quantity 
for this input.
    Response: We appreciate the additional information supplied by the 
commenters regarding the flow cytometry antibody (SL186) in CPT codes 
88184 and 88185, and in particular the extensive data provided to 
explain why the supply quantity of 1.6 would be typical for these 
procedures. After reviewing this additional information, we agree with 
the commenters and we are finalizing a supply quantity of 1.6 for the 
flow cytometry antibody in these two CPT codes.
    Comment: Several commenters disagreed with the finalized equipment 
time for the dye sublimation printer (ED031). One commenter stated that 
printing is not performed all at one time, with 25-30 pages of 
information and data printed over a 5-minute time span. One commenter 
indicated that this time cannot be linked directly to one particular 
clinical labor task line, and the printer cannot be used for any other 
task during these 5 minutes even while it is not actively printing, and 
urged CMS to adopt the RUC-recommended 5 minutes of equipment time. 
Another commenter stated that this process takes usually 10 minutes for 
their most technically advanced personnel.
    Response: We note that in the CY 2017 PFS final rule, due to the 
presentation of new information detailing how the equipment time for 
the printer was disassociated from any clinical labor tasks, we 
increased the finalized equipment time to the RUC-recommended 5 minutes 
for CPT code 88184 and 2 minutes for CPT code 88185. Regarding the 
request to increase the equipment time for the dye sublimation printer 
to 10 minutes, we have no data to indicate that this amount of 
equipment time would be typical. The information that we received from 
commenters during the CY 2017 rule cycle, which was again echoed by 
additional commenters in this rule cycle, indicated that 5 minutes was 
the typical length of time required to print the 25-30 pages of 
materials used in this service. The commenter who disagreed and 
suggested 10 minutes of equipment time included time for the 
pathologist to review the printed materials, and we do not agree that 
the printer would typically need to remain in use while the pathologist 
conducted this review. We continue to believe that the RUC-recommended 
equipment times for the dye sublimation printer would be typical for 
these services.
    After consideration of the comments received as part of the CY 2018 
rule cycle, we are updating the direct PE inputs finalized in CY 2017 
for CPT codes 88184 and 88185 with the changes detailed above.
(38) Pathology Consultation During Surgery (CPT Codes 88333 and 88334)
    CPT codes 88333 and 88334 were surveyed for both work and PE for 
the CY 2018 rule cycle. We proposed the RUC-recommended work RVU of 
1.20 for CPT code 88333 and the RUC-recommended work RVU of 0.73 for 
CPT code 88334. For the direct PE inputs, we proposed to remove the 
clinical labor for the ``Prepare room. Filter and replenish stains and 
supplies (including setting up grossing station with colored stains)'' 
activity from CPT code 88333. This clinical labor is not currently 
included in the direct PE inputs for CPT code 88333, and we believed 
that this is a form of indirect PE that is not individually allocable 
to a particular patient for a particular service. While we agreed that 
replenishing stains and supplies is a necessary task, under the 
established methodology, we believed that it is more appropriately 
classified as indirect PE.
    We proposed to refine the clinical labor time for ``Clean room/
equipment following procedure'' activity for CPT code 88333, consistent 
with the standard clinical labor time assigned for room cleaning when 
used by laboratory services. We sought comments related to the 
equipment time assigned to the ``grossing station w-heavy duty 
disposal'' (EP015) for CPT codes 88333 and 88334. Although the 
recommended equipment time of 10 minutes maintains the current 
equipment time assigned to the grossing station, and we had no reason 
to believe that this time is incorrect, it was unclear to us how this 
equipment time was derived.
    Comment: Several commenters stated that the RUC recommended that 
CPT code 88334 should have a ZZZ global period rather than a XXX global 
period because it is an add-on code and does not include any preservice 
or postservice work time. These commenters requested the assignment of 
a ZZZ global period for CPT code 88334.
    Response: We appreciate the identification of this issue with the 
global period for CPT code 88334 from the commenters. Due to a 
technical error, a global period of XXX was incorrectly assigned to 
this code in the proposed rule. We are finalizing a global period of 
ZZZ for CPT code 88334 as the RUC recommended.
    Comment: Several commenters disagreed with the proposal to remove 
the clinical labor for the ``Prepare room. Filter and replenish stains 
and supplies (including setting up grossing station with colored 
stains)'' activity from CPT code 88333. One commenter stated that this 
was not a form of indirect PE as the clinical labor task was 
attributable to a specific patient and constituted a necessary function 
of directly providing patients with important lab services. Another 
commenter stated that this was not a form of indirect PE because it was 
akin to a number of recognized direct PE activity codes such as Prepare 
room, equipment and supplies (CA013) and Provide education/obtain 
consent (CA011). The commenter stated that to classify these PE 
activities as indirect expenses would be unintentionally biased against 
pathology and laboratory services, due to their unique status as a 
medical specialty in which many procedures can be performed in batches, 
serving multiple patients simultaneously.
    Response: We continue to believe that many of the activities 
described by the clinical labor task ``Prepare room. Filter and 
replenish stains and supplies (including setting up grossing station 
with colored stains)'' constitute forms of indirect PE. The fact that 
many clinical labor tasks associated with pathology and laboratory 
services cannot be allocated to individual patients is the reason why 
they are classified as indirect PE under our methodology. While some of 
these issues may be unique to pathology and laboratory services, in 
many other non-lab cases there are also supplies or clinical labor 
tasks that are not allocable to individual services that we have 
assigned to indirect PE. However, we agree with the commenters that 
some of the clinical labor described in this task is analogous to the 
clinical labor described in non-laboratory direct PE activity codes 
such as Prepare room, equipment and supplies (CA013). Since 2 minutes 
is the standard time allocated for the CA013 clinical labor activity 
code in non-laboratory services, we will assign 2 minutes for room 
preparation and equipment setup for CPT code 88333. We continue to 
believe that the replenishing of stains and supplies constitutes a form 
of indirect PE, and we do not agree that clinical labor time should be 
allocated for this task.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for ``Clean room/equipment following 
procedure'' activity for CPT code 88333 from 5

[[Page 53061]]

minutes to 1 minute, consistent with the standard clinical labor time 
assigned for room cleaning when used by laboratory services. Commenters 
stated that they were aware of the existence of this specific standard, 
but indicated that they looked to the typical patient scenario as well 
as similar services to arrive at a time estimate. The recommended time 
of 5 minutes included tasks performed when the add-on CPT code 88334 
was also provided.
    Response: We continue to believe that the standard clinical labor 
time of 1 minute for room and equipment cleaning in laboratory services 
should be applied to CPT code 88333, as the commenters did not supply a 
rationale as to why this time would not be typical. The RUC's 
recommendations for this clinical labor task stated that cleaning the 
grossing area was attributable to the first code only (CPT code 88333), 
and if there is additional clinical labor required when CPT code 88334 
is performed, we believe that it should be included in the direct PE 
inputs for that service.
    Comment: Several commenters responded to CMS' request for 
information regarding the derivation of the recommended equipment time 
for the ``grossing station w-heavy duty disposal'' (EP015). Commenters 
stated that the time assigned to the EP015 grossing station w-heavy 
duty disposal is derived from a combination of the total clinical labor 
time for the service and the physician time of reviewing the patient 
case at the same grossing station.
    Response: We appreciate the additional information from the 
commenters regarding the equipment time. As we stated in the proposed 
rule, we have no reason to believe that the recommended equipment time 
is incorrect, it was simply unclear to us how this equipment time was 
derived.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs and direct PE inputs for the codes in the 
pathology consultation during surgery family as proposed, with the 
exception of the refinement to the ``Prepare room. Filter and replenish 
stains and supplies (including setting up grossing station with colored 
stains)'' clinical labor time as detailed above. We are also finalizing 
an add-on global period (ZZZ) for CPT code 88334 as the RUC 
recommended.
(39) Radiation Therapy Planning (CPT Codes 77261, 77262, and 77263)
    CPT code 77263 was identified through a screen of high expenditure 
services across specialties. CPT codes 77261 and 77262 were included 
for review. For CY 2018, we proposed the RUC-recommended work RVUs of 
1.30 for CPT code 77261, 2.00 for CPT code 77262, and 3.14 for CPT code 
77263. However, we stated that we had concerns regarding the RUC-
recommended work RVUs given the decreases in service times as 
recommended by the RUC and reflected in the survey data compared to the 
current values. For CPT code 77263, we considered a work RVU of 2.60 
based on a crosswalk to CPT code 96111 (Developmental testing, 
(includes assessment of motor, language, social, adaptive, and/or 
cognitive functioning by standardized developmental instruments) with 
interpretation and report), which has an identical intraservice time, 
and similar total time to the RUC-recommended time values for CPT code 
77263. We expressed concern that despite a 15 minute decrease in 
intraservice time, the RUC did not recommend a work RVU decrease. We 
noted that the majority of the utilization among the codes in this 
family would be reported with CPT code 77263. Therefore, we considered 
using a work RVU of 2.60 for CPT code 77263 as a base for alternative 
valuations for CPT codes 77261 and 77262 by applying the ratio of the 
crosswalk work RVU of CPT code 96111 (Developmental test extend) to the 
RUC-recommended work RVU of CPT code 77263 (that is, 2.60/3.14 = 0.83) 
to the RUC-recommended work RVU for CPT code 77261 (that is, 0.83 x 
1.30 = 1.08) and CPT code 77262 (that is, 0.83 x 2.0 = 1.66), which 
would have resulted in work RVUs of 1.08 for CPT code 77261 and 1.66 
for CPT code 77262. We sought comments on whether the alternative 
valuation would be more appropriate for these codes.
    Comment: Some commenters disagreed with our considered alternative 
values, and urged us to adopt the RUC-recommendations as proposed.
    Response: We appreciate the feedback from commenters on our 
proposal and our alternative values.
    After consideration of the comments, we are finalizing the RUC-
recommended work RVUs as proposed.
(40) Tumor Immunohistochemistry (CPT Codes 88360 and 88361)
    CPT codes 88360 and 88361 appeared on a high expenditure services 
screen across specialties with Medicare allowed charges of over $10 
million. We proposed the RUC-recommended work RVU of 0.85 for CPT code 
88360 and the RUC-recommended work RVU of 0.95 for CPT code 88361.
    We proposed to refine the clinical labor time for the ``Enter 
patient data, computational prep for antibody testing, generate and 
apply bar codes to slides, and enter data for automated slide stainer'' 
activity for both codes, consistent with the standard time for this 
clinical labor activity across different pathology services. For CPT 
code 88361, we also proposed to remove the 1 minute of clinical labor 
time from the ``Performing instrument calibration, instrument qc and 
start up and shutdown'' and the ``Gate areas to be counted by the 
machine'' activities. These clinical labor activities do not appear in 
other recently reviewed computer-assisted pathology codes. We believe 
that these clinical labor activities would not be typical for CPT code 
88361 and are already included in the allocation of indirect PE, 
consistent with our established methodology.
    We proposed to remove the clinical labor time for ``Clean room/
equipment following procedure'' for CPT codes 88360 and 88361, as we 
believed that this clinical labor is duplicative of the 4 minutes of 
clinical labor assigned to ``Clean equipment and work station in 
histology lab''. We also proposed to remove the clinical labor time for 
the ``Verify results and complete work load recording logs'' and the 
``Recycle xylene from tissue processor and stainer'' activities for CPT 
codes 88360 and 88361. As we stated in previous rules, such as in the 
CY 2017 PFS final rule (81 FR 80319), we believed these clinical labor 
activities were already included in the allocation of indirect PE, 
consistent with our established methodology.
    We proposed to refine the equipment time for the ``Benchmark ULTRA 
auto slide prep & E-Bar Label system'' (EP112) from 18 minutes to 16 
minutes for both codes. The RUC-recommended equipment time of 18 
minutes was an increase of 3 minutes from the current EP112 equipment 
time to incorporate the equipment time of the ``E-Bar II Barcode Slide 
Label System'' (EP113), which the recommended materials have clarified 
is part of the EP112 equipment item. We proposed to add 1 minute over 
the current value of 15 minutes to the EP112 equipment time to reach 
the aforementioned 16 minutes, as we believed that this would be more 
typical for the slide labeling taking place.
    For CPT code 88361, we proposed to maintain the current price of 
$195,000.00 for the DNA image analyzer (EP001) equipment, as the 
submitted invoice contained a series of unrelated items that have been 
crossed out, making it difficult to determine the cost of the 
equipment. We considered refining the equipment time for the DNA image 
analyzer from 30 minutes to 5 minutes. The equipment literature for

[[Page 53062]]

the DNA image analyzer states that the machine can run 50 slides per 
hour, and CPT code 88361 only requires 3 slides per procedure. This 
works out to 3.6 minutes of equipment usage (3 slides divided by 50 
slides per hour multiplied by 60 minutes in an hour), to which we 
considered adding 1 minute for preparing the slides. The resulting 
figure of 4.6 minutes would then round up to 5 minutes, which we 
considered as the potential equipment time for EP001 assigned to CPT 
code 88361. We sought comments on additional pricing information for 
the EP001 DNA image analyzer equipment, specifically, invoices solely 
for this equipment containing a rationale for each component part, as 
well as the appropriate equipment time typically required for use in 
CPT code 88361.
    Comment: Several commenters disagreed with our proposal to refine 
the clinical labor time for the ``Enter patient data, computational 
prep for antibody testing, generate and apply bar codes to slides, and 
enter data for automated slide stainer'' activity for both codes from 5 
minutes to 1 minute. One commenter stated that this clinical labor task 
was unique to immunohistochemistry services and was significantly more 
complicated than performance of a hematoxylin and eosin stained section 
in the traditional histology laboratory. Another commenter stated that 
CMS did not finalize a standardized time for this particular clinical 
labor activity in the CY 2017 PFS final rule, and expressed concern 
with the reliance on standardized pathology clinical labor tasks and 
times. The commenter stated that it would be inappropriate to finalize 
this particular refinement since there had not been an opportunity for 
stakeholders to comment on the establishment of this standard.
    Response: As we stated in the CY 2017 PFS final rule (81 FR 80324), 
we agree with the commenters that entering patient data into 
information systems is an important task, and we agree that it would 
take more than zero minutes to perform. However, we continue to believe 
that this is correctly categorized as indirect PE, and therefore, we do 
not recognize the entry of patient data as a direct PE input, and we do 
not consider this task as typically performed by clinical labor on a 
per-service basis.
    We also agree with the commenter that we did not finalize a 
standard clinical labor time for this particular clinical labor task. 
However, we believe that the clinical labor described here under 
``generate and apply bar codes to slides'' is broadly analogous to the 
clinical labor task ``Complete workload recording logs. Collate slides 
and paperwork. Deliver to pathologist'' in CPT codes 88321, 88323, and 
88325, which were addressed in the CY 2017 PFS final rule (81 FR 80325-
80326) and were finalized with 1 minute of clinical labor time. 
Although we agree that the unique nature of pathology and laboratory 
services can make comparisons across codes more difficult than in other 
services, we believe the comparison of similar clinical labor 
activities across different services is important to maintaining the 
relativity of the direct PE inputs. Since we have typically allocated 1 
minute to the labeling of slides in other recently reviewed laboratory 
services, and we have no reason to believe that CPT codes 88360 and 
88361 would not be typical, we are finalizing a clinical labor time of 
1 minute for this activity.
    Comment: Several commenters disagreed with the proposal to remove 
the 1 minute of clinical labor time from the ``Performing instrument 
calibration, instrument qc and start up and shutdown'' and the ``Gate 
areas to be counted by the machine'' activities from CPT code 88361. 
Commenters stated that the fact that these activities do not appear in 
other recently reviewed pathology CPT codes should have no bearing on 
CPT code 88361, as not all pathology services are identical in terms of 
the individual components involved in their execution and many are 
unique. Commenters stated that accurate calibration and quality control 
are key to accurately measuring the cells and this clinical labor 
should be recognized.
    Response: We agree with the commenter that there are distinctions 
between individual services, and that no two services are identical. We 
also believe that comparisons across similar services have an important 
role in allowing for greater transparency and consistency, as well as 
maintaining the relativity of the direct PE inputs. We are concerned 
that too much individual accounting of clinical labor activities, such 
as with these two tasks, can lead to PE proliferation, and that this 
breakout of activities into numerous subactivities generally tends to 
inflate the total time assigned to clinical labor activities and 
results in values that are not consistent with the analogous times for 
other PFS services. The fact that these clinical labor activities do 
not appear in other recently reviewed computer-assisted pathology codes 
is noteworthy since it suggests that these tasks were previously 
subsumed under other clinical labor activities, rather than being 
broken out into individual clinical labor tasks. Instead of listing 
``Performing instrument calibration, instrument qc and start up and 
shutdown'' and ``Load slides on automatic image analyzer'' as separate 
clinical labor tasks, we believe that these activities have 
historically been grouped together under more general headings related 
to preparation. In other words, we believe that the additional 
recommended clinical labor time in this case derives from the separate 
listing of these activities as individual tasks rather than 
representing a change in practice patterns. We also continue to believe 
that these clinical labor activities would not be typical for CPT code 
88361 and are already included in the allocation of indirect PE, 
consistent with our established methodology.
    Comment: Several commenters disagreed with our proposal to remove 
the clinical labor time for ``Clean room/equipment following 
procedure'' for CPT codes 88360 and 88361. Commenters stated that the 
histology laboratory prepares the tissue for sectioning by embedding 
the tissue into blocks while the immunohistochemistry laboratory is 
typically in a separate and distinct work area. Since these procedures 
require both of these work areas to be cleaned, the commenters 
requested the restoration of this clinical labor time.
    Response: After reviewing this new information, we agree with the 
commenters that this clinical labor is not duplicative of the 4 minutes 
of clinical labor assigned to ``Clean equipment and work station in 
histology lab''. We are finalizing the restoration of this 1 minute of 
clinical labor time, as recommended.
    Comment: Several commenters disagreed with the proposal to remove 
the clinical labor time for the ``Verify results and complete work load 
recording logs'' and the ``Recycle xylene from tissue processor and 
stainer'' activities for CPT codes 88360 and 88361. Commenters stated 
that the time associated with these tasks was a direct expense, not an 
indirect cost input, and was allocable to a specific patient. One 
commenter indicated that 1 minute was necessary for these tasks in 
these services. Another commenter stated that while completion of the 
work load reporting logs might be an indirect expense, the quality 
control of results is performed for each and every case, and it should 
be reported separately as a direct expense.
    Response: We appreciate the support from the commenter who agreed 
that completion of work load recording logs was a form of indirect PE. 
We continue to believe that both of these clinical labor activities are 
already included in the allocation of indirect PE consistent

[[Page 53063]]

with our established methodology. Other non-laboratory services conduct 
similar administrative activities, such as filling out electronic 
health records and recycling supplies, without receiving clinical labor 
time for individual services.
    Comment: Several commenters disagreed with the proposal to refine 
the equipment time for the ``Benchmark ULTRA auto slide prep & E-Bar 
Label system'' (EP112) from 18 minutes to 16 minutes for both codes. 
Commenters stated that this appeared to be an arithmetic error made 
when equipment items EP112 and EP113 were combined, and that there was 
a need to add back minutes that had been removed when EP113 was 
deleted. The commenters urged CMS to adopt the RUC-recommended EP112 
for CPT codes 88360 and 88361, along with CPT codes 88341, 88342, and 
88344.
    Response: Our proposed value of 16 minutes was not based on an 
arithmetic error, as we proposed to add 1 minute over the current value 
of 15 minutes to the EP112 equipment time because we believed that 1 
minute would be more typical than 3 minutes for the slide labeling 
taking place in CPT codes 88360 and 88361. However, after consideration 
of the additional evidence supplied by the commenters, we agree that 
there should be 3 additional minutes of EP112 equipment time in these 
codes as recommended. We were persuaded by the commenters that slide 
labeling would indeed take the full 3 minutes of additional time 
previously assigned to EP113, rather than the 1 minute that we proposed 
to assign for this task. We are finalizing this change to the equipment 
time for CPT codes 88360 and 88361, along with a correction to the 
total equipment time reclassified as EP112 for the other three codes 
mentioned by commenters, as described in Table 11.

              Table 11--Benchmark ULTRA Auto Slide Prep & E-Bar Label System (EP112) Equipment Time
----------------------------------------------------------------------------------------------------------------
                                                                                                Total equipment
                        CPT code                           Current EP112      Current EP113    time reclassified
                                                              minutes            minutes            as EP112
----------------------------------------------------------------------------------------------------------------
88341..................................................                 15                  1                 16
88342..................................................                 15                  3                 18
88344..................................................                 30                  3                 33
88360..................................................                 15                  3                 18
88361..................................................                 15                  3                 18
----------------------------------------------------------------------------------------------------------------

    Comment: Several commenters disagreed with the alternative proposal 
to refine the equipment time for the DNA image analyzer (EP001) from 30 
minutes to 5 minutes. Commenters stated that although the product 
literature provides information for 20x and 40x (50 slides/hr.) 
however, this is just the initial step in the analytical process of 
obtaining an image of the tissue stained for the appropriate antigen. 
The commenters stated that it was the additional steps of analysis that 
resulted in the RUC recommending 30 minutes of equipment time, and 
listed a series of tasks performed by the histotechnologist involving 
the EP001 equipment. Commenters stated that 30 minutes of equipment 
time is appropriate for the DNA image analyzer. Commenters also 
supplied new invoices to address CMS' concerns with the pricing of the 
EP001 equipment, and requested a name change from ``DNA image 
analyzer'' to ``DNA/digital image analyzer.''
    Response: We appreciate the additional information supplied by the 
commenters regarding the use of the EP001 equipment.
    After consideration of the comments, we are finalizing our proposed 
equipment time of 30 minutes instead of the alternative equipment time. 
We are finalizing a price of $248,946.30 for this equipment, based on 
the submitted price of $258,042.30 minus the price of the user training 
($6,800.00), the instructor-led online training ($646.00) and the 
shipping and handling costs ($1,650.00). These costs are allocated 
through the indirect allocation under the established PE methodology. 
We are also finalizing the name change to the EP001 equipment, as 
requested by the commenters.
    Comment: One commenter recommended a series of clinical labor times 
that were higher than the RUC's recommendations. The commenter stated 
that these were the average times required to perform the clinical 
labor tasks based on their internal time studies.
    Response: We are supportive of the submission of additional data 
that can aid in the process of determining the resources that are 
typically used to furnish these services. However, because we did not 
receive data on these specific time studies from the commenter to 
support these increases above the RUC recommendations, we are not 
incorporating these changes to clinical labor into the tumor 
immunohistochemistry codes at this time. We urge interested 
stakeholders to consider submitting robust data for these and other 
services.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs for the codes in the tumor 
immunohistochemistry family as proposed. We are finalizing the direct 
PE inputs for these codes, as proposed, along with the refinements 
detailed above in response to the comments.
(41) Cardiac Electrophysiology Device Monitoring Services (CPT Codes 
93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287, 93288, 93289, 
93290, 93291, 93292, 93293, 93294, 93295, 93296, 93297, 93298, and 
93299)
    As part of the CY 2016 PFS final rule with comment period (80 FR 
70914), several services in this family (reported with CPT codes 93288, 
93293, 93294, 93295, and 93296) were identified as potentially 
misvalued through the high expenditure by specialty screen. Seven of 
the 21 services in this family involve remote monitoring of 
cardiovascular devices, and two of these services (reported with CPT 
codes 93296 and 93299) are valued for PE only. In the CY 2018 PFS 
proposed rule, we proposed the RUC-recommended work RVUs for the 19 CPT 
codes in this family that are valued with physician work as follows: 
0.65 for CPT code 93279, 0.77 for CPT code 93280, 0.85 for CPT code 
93281, 0.85 for CPT code 93282, 1.15 for CPT code 93283, 1.25 for CPT 
code 93284, 0.52 for CPT code 93285, 0.30 for CPT code 93286, 0.45 for 
CPT code 93287, 0.43 for CPT code 93288, 0.75 for CPT code 93289, 0.43 
for CPT code 93290, 0.37 for CPT code 93291, 0.43 for CPT code 93292, 
0.31 for CPT code 93293, 0.60 for CPT code 93294, 0.74 for CPT code 
93295, 0.52 for CPT code 93297, and 0.52 for CPT code 93298.
    For CPT code 93293, we considered a work RVU of 0.91 (25th 
percentile survey result) and sought comment on

[[Page 53064]]

whether this alternative work RVU would better maintain relativity 
between single and dual lead pacemaker systems and cardioverter 
defibrillator services. We considered reducing the work RVU for CPT 
code 93282 by 0.11 work RVUs and sought comments on whether this 
alternative value would better reflect relativity between the single 
and dual lead systems that exist within pacemaker services and within 
cardioverter defibrillator services. We also noted that there is a 
difference of 0.10 work RVUs between the RUC-recommended values for CPT 
codes 93289 and 93282. Therefore, we considered a proportionate 
reduction for CPT code 93289 to a work RVU of 0.69. For CPT code 93283, 
we considered a work RVU of 0.91, consistent with the 25th percentile 
from the survey results, and sought comment on whether this value would 
improve relativity.
    As noted in this section of the final rule, several of the CPT 
codes (99392, 99294, 99295, 99297, and 99298) reviewed by the RUC in 
January 2017 involve remote monitoring services for cardiac devices. We 
agreed with the RUC that these services are difficult to value 
considering that the monitoring duration (number of days between 30 and 
90) and the average number of transmissions vary. We also noted that 
these codes were surveyed twice, and in both cases the intraservice and 
total times were considered by the specialty societies to be 
inconsistent with existing times. The RUC explained that it 
extrapolated total and intraservice time data for these codes and 
warned against making comparisons. Without additional information about 
the methods and sources used for extrapolation, however, we had no 
basis for assuming the imputed values are of higher quality and/or 
accuracy than those from the survey. We did not agree, therefore, that 
survey results should not be used as a point of comparison in the 
context of other factors, particularly when they are used to support 
other considerations.
    Although we proposed the RUC-recommended work RVUs for each of 
these CPT codes, we considered alternative values. The RUC recommended 
a work RVU of 0.31 for CPT code 93293, which is 0.01 work RVUs lower 
than the existing work RVU for this code. We have concerns that the 
amount of the reduction in the work RVU recommended by the RUC may not 
be consistent with the decrease in total time of 7 minutes. We 
considered an alternative crosswalk for CPT code 93293 (Pm phone r-
strip device eval) (5 minutes intraservice time and 13 minutes total 
time) to CPT code 94726 (Pulm funct tst plethysmograp), which has 5 
minutes intraservice time and 15 minutes total time and a work RVU of 
0.26. We sought comments on our proposed and alternative valuations for 
this code.
    For CPT code 93294, we considered a work RVU of 0.55, crosswalking 
from CPT code 76706 (Us abdl aorta screen aaa), and sought comments on 
whether it would better align with the RUC-recommended service times. 
We were concerned that a work RVU of 0.60 may not account for the 
difference between existing service times and the RUC-recommended 
service times. Similarly, the RUC recommended a work RVU for CPT code 
93294 of 0.60, which is 0.05 work RVUs less than the existing work RVU. 
The total time for furnishing services reported with CPT code 93294 
decreased by 10 minutes, however, and we believe this reduction in time 
may not be appropriately reflected by a decrease of 0.05 work RVUs. 
Compared to services with similar total and intraservice times, we 
identified CPT code 76706 (Us abdl aorta screen aaa) as a potentially 
more appropriate crosswalk. CPT code 76706 has identical intraservice 
and total service times as CPT code 93294, with a work RVU of 0.55. We 
sought comments on whether our alternative value would better reflect 
the time and intensity involved in furnishing this service.
    For CPT code 93295, we considered a work RVU of 0.69, crosswalking 
to CPT code 76586, which has identical intraservice and total times 
compared to CPT code 93295. We considered using a work RVU of 0.69 to 
maintain the differential between CPT code 93295 and the work RVU we 
considered for the previous code in this family (a work RVU of 0.11 for 
CPT code 93295). We were concerned about the decrease in service time 
compared to the work RVU. We noted that the existing intraservice time 
is 22.5 minutes, compared to the RUC-recommended intraservice time of 
10 minutes. We sought comments on whether our alternative value would 
better reflect the time and intensity involved in furnishing this 
service.
    For CPT code 93298, the RUC recommended a work RVU of 0.52, which 
is unchanged from the current work RVU for this code. We were concerned 
about that recommendation given the reduction in both intraservice and 
total time for this service. The intraservice time decreased from 24 to 
7 minutes, while total time decreased from 44 to 17 minutes. We 
acknowledged that the current times for this CPT code and others in 
this family are extrapolations. However, without additional information 
about the extrapolation of data from survey results, we question 
whether the survey results should be excluded from consideration 
altogether. We considered a work RVU of 0.37 for CPT code 93297, 
crosswalking to CPT code 96446 (Chemotx admn prtl cavity). We also 
considered a work RVU of 0.37 for CPT code 93298 based on a crosswalk 
to CPT code 96446, since the RUC indicated that the work RVUs for CPT 
codes 93297 and 93298 should be the same. We sought comment on our 
proposed valuation and whether our alternative valuation would be more 
appropriate for this code.
    We proposed the RUC-recommended direct PE inputs with the following 
refinements. We proposed to remove 2 minutes for ``review charts'' from 
CPT codes 93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287, 
93288, 93289, 93290, 93291, and 93292 to maintain relativity since it 
is not typically incorporated for similar PFS codes. We also proposed 
removing 2 minutes for ``complete diagnostic forms, lab & X-ray 
requisitions'' for the labor category ``med tech/asst'' (L026A) for 
these services because we believe the same activity is being performed 
by labor category RN/LPN/MTA (L037D). We sought comments regarding 
whether this row was included in error. For the same group of CPT 
codes, we also proposed standard refinements for the time for equipment 
items EF023 and EQ198.
    We proposed to use the RUC-recommended direct PE inputs and times 
for all other CPT codes in this family (CPT codes 93293, 93294, 93295, 
93296, 93297, 93298, and 93299) without refinement.
    Comment: We received several comments requesting that CMS retain 
the contractor priced status of the PE-only CPT code 93299. In general, 
commenters opposed to the change were concerned that the amount of 
payment proposed for this code was too low to adequately reimburse 
practitioners.
    Response: After reviewing the range of current prices established 
by MACs, we agree with concerns that the proposed rate of 0.77 RVUs 
corresponds to a low reimbursement relative to the range of payments 
across localities and states. We concur that there is no need, at this 
time, to establish a national rate, and we defer to individual MACs to 
set a reimbursement rate for this CPT code that reflects local 
populations, supply costs, and practice patterns. For these reasons, we 
are not finalizing our proposal with respect to CPT code 93299, and 
this code will remain contractor-priced.

[[Page 53065]]

    Comment: We received a comment specifically regarding the proposed 
decrease in work RVUs for CPT code 93295 from 1.29 to 0.74. The 
commenter maintained that the decrease in work RVUs is inconsistent 
with the time requirements and focus on patient care required for 
ongoing review of monitoring reports over a 90-day period. The 
commenter further noted that the reduction in work RVUs for this code 
is inconsistent with a shift in paradigm from an office-based patient 
care model to comprehensive care.
    Response: We appreciate the commenters' concerns about the RUC-
recommended decrease in work RVUs for this code. However, we note that 
the survey conducted by the specialty societies as part of the RUC 
process describes a time period of up to 90 days for this code. For 
this code, as with many others, these surveys are the best data we have 
about the time and intensity of work for a particular CPT code, as well 
as the labor time, supplies, and equipment required in furnishing the 
service. After consideration of the public comments, we are finalizing 
a work RVU of 0.74 for CPT code 93295, as proposed. We are also 
finalizing work RVUs for the remainder of the CPT codes in this family 
as proposed.
(42) Transthoracic Echocardiography (TTE) (CPT Codes 93306, 93307, and 
93308)
    In the CY 2016 PFS final rule with comment period (80 FR 70914), 
CMS identified CPT code 93306 through the high expenditures screen. 
Subsequently, the RUC reviewed CPT codes 93307 and 93308, in addition 
to CPT code 93306, as part of this family of codes that describe 
transthoracic echocardiograms. In the CY 2018 PFS proposed rule, we 
proposed the RUC-recommended work RVUs for CPT codes 93306 (a work RVU 
of 1.50), 93307 (a work RVU of 0.92), and 93308 (a work RVU of 0.53), 
and proposed the RUC-recommended direct PE inputs for CPT codes 93306, 
93307, and 93308 without refinement.
    For CPT code 93306 (Echocardiography, transthoracic, real-time with 
image documentation (2D), includes M-mode recording, when performed, 
complete, with spectral Doppler echocardiography, and with color flow 
Doppler echocardiography), we considered maintaining the CY 2017 work 
RVU of 1.30. The surveyed total time for this code dropped slightly due 
to changes in the immediate postservice time. The median preservice and 
intraservice time remained unchanged.
    For CPT code 93307 (Echocardiography, transthoracic, real-time with 
image documentation (2D), includes M-mode recording, when performed, 
complete, without spectral or color Doppler echocardiography), we 
considered a work RVU of 0.80, crosswalking to services with similar 
service times (CPT codes 93880 (Duplex scan of Extracranial arteries; 
complete bilateral study), 93925 (Duplex scan of lower extremity 
arteries or arterial bypass grafts; complete bilateral study), 93930 
(Duplex scan of upper extremity arteries or arterial bypass grafts; 
complete bilateral study), 93976 (Duplex scan of arterial inflow and 
venous outflow of abdominal, pelvic, scrotal contents and/or 
retroperitoneal organs; limited study), and 93978 (Duplex scan of 
aorta, inferior vena cava, iliac vasculature or bypass grafts; complete 
study)). The surveyed total time dropped 3 minutes (from the 
intraservice time) compared to the existing service times for this 
code.
    For CPT code 93308 (Echocardiography, transthoracic, real-time with 
image documentation (2D), includes M-mode recording, when performed, 
follow-up or limited study), we considered a work RVU of 0.43, 
crosswalking to CPT code 93292 (Interrogation device 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; wearable defibrillator system) 
based on similar service times. The surveyed total time dropped by 5 
minutes (from the intraservice time) compared to the existing service 
times for this code.
    For CY 2018, we proposed the RUC-recommended work RVUs for CPT 
codes 93306, 93307, and 93308 and sought comments on whether our 
alternative values would have better reflected the time and intensity 
of these services.
    Comment: A few commenters addressed the codes in this family 
including the RUC. Commenters expressed support for CMS' proposed 
values.
    Response: We appreciate the commenter's support.
    After consideration of the comments received that specifically 
addressed this code family, for CY 2018, we are finalizing a work RVU 
of 1.50 for CPT code 93306, a work RVU of 0.92 for CPT code 93307, and 
a work RVU of 0.53 for CPT code 93308, as proposed. We are also 
finalizing the proposed direct PE inputs without refinement for all 
codes in this family.
(43) Stress Transthoracic Echocardiography (TTE) Complete (CPT Codes 
93350 and 93351)
    CPT code 93351 was identified as potentially misvalued and the RUC 
reviewed CPT code 93350 as part of the same code family. In the CY 2018 
PFS proposed rule, we proposed the RUC-recommended work RVUs for CPT 
codes 93350 (a work RVU of 1.46) and 93351 (a work RVU of 1.75).
    We proposed the following refinements to the RUC-recommended direct 
PE inputs for CPT codes 93350 and 93351. For both codes, we applied the 
standard formula in developing the minutes for equipment item ED053 
(professional PACS workstation), which results in 18 minutes for CPT 
code 93350 and 25 minutes for CPT code 93351. We also proposed standard 
clinical labor times for providing preservice education/obtaining 
consent. We did not propose to include clinical labor time for the task 
setup scope since there is no scope used in the procedure and we did 
not agree with the RUC's statement that this replicates 5 minutes in 
CPT code 93015 when the RN prepares patients for 10-lead ECG. We found 
that there was no corresponding time of 5 minutes for setup scope in 
the PE inputs for CPT code 93015. We proposed refinements to the 
equipment time for ED050 (PACS workstation proxy) for CPT code 93351, 
consistent with our standard equipment times for PACS Workstation 
Proxy.
    Comment: Commenters generally supported our proposed work RVUs for 
CPT codes 93350 and 93351, which are remaining unchanged from CY 2017.
    Response: We appreciate the feedback from stakeholders and we are 
finalizing work RVUs for these two codes, as proposed.
    Comment: Several commenters, including the RUC, disagreed with our 
proposed refinements to PE inputs, particularly with regard to changes 
in the equipment time to conform to established policies for non-highly 
technical equipment and PACS workstations.
    Response: We note that these refinements are in accordance with the 
standards and formulas for equipment related to direct PE inputs as 
described in the CY 2015 PFS final rule with comment period (79 FR 
67557). Therefore, we are finalizing the PE inputs and refinements for 
CPT 93350 and 93351 as proposed.
(44) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
    We have issued a national coverage determination (NCD) for Medicare

[[Page 53066]]

coverage of supervised exercise therapy (SET) for the treatment of 
peripheral artery disease (PAD). Information regarding the NCD can be 
found on the CMS Web site at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287. CPT code 93668, 
currently assigned PROCSTAT N (noncovered service by Medicare), will be 
payable before the end of CY 2017, retroactive to the effective date of 
the NCD to implement payment under the NCD.
    For CY 2018, we proposed to make payment for Medicare-covered SET 
for the treatment of PAD, consistent with the NCD, reported with CPT 
code 93668. For CPT code 93668, we proposed to use the most recent RUC-
recommended work and direct PE inputs. We are also sought comment on 
the coding structure and valuation assumptions. Since the RUC has not 
reviewed CPT code 93668 since 2001, we sought comments on the direct PE 
inputs assigned to the code, which appear in the direct PE input 
database. We also noted that CPT code 93668 is a PE-only code and does 
not include physician work.
    CPT prefatory language states that CPT code 93668 may be separately 
reported with appropriate E/M services, including office and/or 
outpatient services (CPT codes 99201 through 99215), initial hospital 
care (CPT codes 99221 through 99223), subsequent hospital care (CPT 
codes 99231 through 99233), and critical care services (CPT codes 99291 
through 99292). Our understanding of CPT's prefatory language is that 
these E/M codes may only be billed when review or exam of the patient 
is medically indicated and must conform to all existing E/M 
documentation requirements. E/M visit codes should not be billed to 
account for supervision of SET for the treatment of PAD by a physician 
or other qualified healthcare practitioner. We sought comments on 
whether to develop professional coding to reflect the supervision of 
clinical staff, and on the potential overlap with CPT code 99211 
(Office or other outpatient visit for the evaluation and management of 
an established patient, that may not require the presence of a 
physician or other qualified health care professional. Usually, the 
presenting problem(s) are minimal. Typically, 5 minutes are spent 
performing or supervising these services.) and any distinctions between 
time spent by clinical staff for CPT code 99211 and time spent by 
clinical staff for CPT code 93668.
    Comment: Commenters were supportive of CMS' proposal to make CPT 
code 93668 active for CY 2018 and payable before the end of CY 2017, 
retroactive to the effective date of the NCD, to facilitate separate 
payment for SET. The RUC responded to CMS' request for comment on the 
coding structure and the valuation assumptions by stating that it 
intends to work with the specialty societies through the CPT Editorial 
Panel and the RUC process to evaluate both. The RUC recommended 
maintaining current PE inputs until they provide recommendations for CY 
2019.
    Response: We will be maintaining the current PE inputs until we 
receive a new recommendation from the RUC.
    Comment: One commenter stated that advanced practice providers, 
such as nurse practitioners, clinical nurse specialists, or physician 
assistants, should be able to refer patients for SET. This commenter 
noted that these practitioners are often relied up to provide referrals 
and education for patients.
    Response: Under the conditions of the NCD, beneficiaries must have 
a face-to-face visit with the physician responsible for the overall PAD 
treatment to obtain a referral for SET.
    After consideration of these public comments, we are finalizing the 
RUC-recommended values for CPT code 93668, as proposed.
(45) INR Monitoring (CPT Codes 93792 and 93793)
    In October 2015, AMA staff assembled a list of all services with 
total Medicare utilization of 10,000 or more that have increased by at 
least 100 percent from 2008 through 2013, and these services were 
identified on that list. The RUC recommended that HCPCS codes G0248, 
G0249 and G0250, which describe related INR monitoring services, be 
referred to the CPT Editorial Panel to create Category I codes to 
describe these services.
    For CY 2018, the CPT Editorial Panel is deleting CPT codes 99363 
and 99364 and creating new CPT codes 93792 (Patient/caregiver training 
for initiation of home INR monitoring under the direction of a 
physician or other qualified health care professional, including face-
to-face, use and care of the INR monitor, obtaining blood sample, 
instructions for reporting home INR test results, and documentation of 
patient's/caregiver's ability to perform testing and report results) 
and 93793 (Anticoagulant management for a patient taking warfarin, must 
include review and interpretation of a new home, office, or lab 
International Normalized Ratio (INR) test result, patient instructions, 
dosage adjustment (as needed), and-scheduling of additional test(s) 
when performed). CPT code 93792 is a technical component-only code. 
With the creation of CPT codes 93792 and 93793, the RUC recommended 
that CMS delete HCPCS codes G0248, G0249 and G0250.
    For CPT code 93793, we proposed the RUC-recommended work RVU of 
0.18. Because HCPCS codes G0248, G0249 and G0250 are used to report 
related services under a Medicare National Coverage Determination, we 
did not propose to delete the G-codes.
    In reviewing the recommended PE inputs for these services, we 
obtained updated invoices for prices for particular items. We proposed 
to use the invoices to update the price of the supply ``INR test 
strip'' (SJ055). We obtained publically available pricing information 
from two vendors. The pricing from one vendor indicated the price for a 
box of 24 of supply item SJ055 item (INR test strip) is $150.00, which 
equated to a unit price of $6.25. Pricing from a second vendor 
indicated the price of a box of 48 of the supply item SJ055 to be 
$233.00, which equated to a unit price of $5.06. The average price of 
these two unit prices is $5.66.
    Therefore, we proposed to re-price SJ055 from $21.86 to $5.66 for 
CPT code 93792. We sought public comments on current pricing for the 
INR test strip supply.
    Comment: In general, commenters were supportive of our proposal of 
the RUC-recommended work RVUs.
    Response: We appreciate the commenters' feedback. We continue to 
welcome information from all interested parties regarding valuation of 
services for consideration through our rulemaking process.
    Comment: The RUC noted that it agreed with CMS' proposal to update 
the price of the thirteen supplies and one equipment item listed on 
Table 14: CY 2018 Proposed Rule Invoices Received for Existing Direct 
PE Inputs of the CY 2018 proposed rule (82 FR 34078).
    Response: We thank the RUC for its support and note that the re-
price of supply item SJ055 was included in Table 14: CY 2018 Proposed 
Invoices Received for Existing Direct PE Inputs of the CY 2018 proposed 
rule (82 FR 34078).
    Comment: A commenter disagreed with our proposed re-pricing of 
SJ055, noting that it would result in an RVU reduction of almost 50 
percent for HCPCS codes G0248 and G0249, which would adversely impact 
access to these services.
    This commenter discussed ``home-use'' vs ``professional-use only'' 
INR test strips, noting that the method CMS used to re-price SJ055 was 
incorrect because

[[Page 53067]]

the pricing information was based on two vendors who were selling 
``professional-use only'' strips in units of 24 and 48. The commenter 
provided publicly available pricing information and recommended that we 
re-price the INR test strip to $20.31 per unit, inclusive of $1.85 per 
unit for shipping.
    Response: In reviewing the publicly available pricing information 
provided by the commenter, the price for a box of 6 INR test strips was 
noted at $110.79, which equated to $18.46 per test strip. We note that 
the product did not make a distinction of ``home-use'' or 
``professional-use only''. Furthermore, this was the same product we 
used to propose to re-price the INR test strip, but in a smaller 
quantity. Because we believe it is reasonable to assume that an 
efficient practice would be more likely to purchase the same supply in 
a larger quantity in order to take advantage of a significantly lower 
unit price for that supply, we are not including this price in our 
valuation of the INR test strip.
    Furthermore, given that beneficiaries are generally responsible for 
paying cost-sharing, the re-price of $20.31 recommended by the 
commenter would increase beneficiary cost-sharing. Also, as discussed 
in the CY 2017 PFS final rule (81 FR 80525), after reviewing the public 
comments in response to the CY 1998 PFS proposed rule, we finalized in 
Phase I significant revisions with respect to the scope of the volume 
or value standard. We revised our interpretation of the ``volume or 
value'' standard for purposes of section 1877 of the Act to permit, 
among other things, payments based on a unit of service, provided that 
the unit-based payment is fair market value and does not vary over time 
(66 FR 876 through 879).
    Comment: Several commenters noted that the RVUs used to support the 
ongoing provision of INR Test Materials/Equipment (that is, G0249) are 
based on the patient producing 4 test results and not the IDTF simply 
providing 4 test strips. These commenters recommended the inclusion of 
6 to 7 or more test strips for this service. One commenter noted that 
in order to produce 4 test results, IDTFs must provide a sealed vial of 
6 test strips and that two additional strips are used to allow patients 
to re-confirm critical out of range (or aberrant) test results before 
their physician alters therapy.
    Response: The commenter did not provide, nor were we able to find, 
documentation to support the requirement for a sealed vial of 6 test 
strips.
    After consideration of the comments received, we will finalize the 
re-price of SJ055 as proposed, and increase the number of INR test 
strips by two as recommended by commenters.
    Comment: One commenter noted that the supply ``INR test strip'' 
(SJ055) is categorized as ``Pharmacy, Non-Rx'' but should be more 
accurately categorized as ``Pharmacy, Rx''.
    Response: Historically, this supply item has been categorized as 
``Pharmacy, Non-Rx''. We note that the internal use of this 
categorization does not have an impact on how this supply is priced 
under the PFS.
    After consideration of the comments received, we will finalize the 
re-price of SJ055 as proposed, but will increase the number of INR test 
strips by two, as recommended by commenters. We will also increase the 
number of lancets and alcohol swab-pads by two each, which we believe 
are typically used to furnish this service. For CPT code 93793, we are 
finalizing the RUC-recommended work RVU of 0.18 for CY 2018, as 
proposed.
(46) Pulmonary Diagnostic Tests (CPT Codes 94621, 94617, and 94618)
    CPT code 94620 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. CPT code 94621 was added to 
the family for review. The CPT Editorial Panel deleted CPT code 94620 
and split it into two new codes, CPT codes 94617 and 94618, to describe 
two different tests commonly performed for evaluation of dyspnea. We 
proposed the RUC-recommended work RVUs of 1.42 for CPT code 94621, 0.70 
for CPT code 94617, and 0.48 for CPT code 94618.
    We proposed to refine the clinical labor time for the ``Provide 
preservice education/obtain consent'' activity from 10 minutes to 5 
minutes for CPT code 94621, which is the current time assigned for this 
task. While we agree that CPT code 94621 requires additional time above 
the standard for this clinical labor activity, we do not believe that 
double the current time would be typical for this procedure. We also 
proposed to refine the clinical labor time for the ``Prepare and 
position patient/monitor patient/set up IV'' activity from 5 minutes to 
3 minutes for the same code. The standard time for this activity is 2 
minutes, and we proposed a value of 3 minutes to reflect 1 minute of 
additional preparation time above the standard. We believed that 
additional clinical labor time used for preparation would be included 
under the 10 minutes assigned to the ``Prepare room, equipment, 
supplies'' activity for this code.
    We proposed to refine the clinical labor time for the ``Complete 
diagnostic forms, lab & X-ray requisitions'' activity, consistent with 
the standard clinical labor time for this activity. We also proposed to 
refine the equipment times for CPT codes 94621 and 94617 to account for 
1:4 patient monitoring time, and to refine the equipment times for CPT 
code 94618 consistent with standards for non-highly technical 
equipment.
    We considered refining the clinical labor time for the ``pre 
exercise ECG, VC, Min Vent. Calculation'' activity from 27 minutes to 
15 minutes for CPT code 94621. We considered proposing this value of 15 
minutes based on assigning 5 minutes apiece for the ECG, the MVV, and 
the spirometry. We believed that each of these three components of this 
clinical labor activity would typically take no longer than 5 minutes 
based on a comparison to the use of these tasks in other CPT codes. We 
also considered refining the clinical labor time for the ``Clinical 
staff performs procedure'' activity from 55 minutes to 35 minutes for 
CPT code 94617 and from 14 minutes to 12 minutes for CPT code 94621. 
The RUC-recommended materials for the PE inputs state that this 
clinical labor task consists of performing 5 spirometries at 9 minutes 
each plus 10 minutes of exercise time for CPT code 94617; we believed 
that the spirometries typically take 5 minutes each, which would reduce 
this activity from 55 minutes to 35 minutes. For CPT code 94621, we 
considered maintaining the current value of 12 minutes due to a lack of 
justification for increasing the time to 14 minutes.
    While we remained concerned about the intraservice period clinical 
labor times, for CY 2018, we proposed the RUC-recommended work RVUs for 
each code in this family and sought comment on whether our alternative 
clinical labor times would better reflect the work and times for these 
services.
    Comment: The commenters supported the proposed values for all three 
of the codes but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process. We will continue to consider alternative work RVUs 
as we propose the valuation of services for future notice and comment 
rulemaking.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Provide preservice education/obtain 
consent'' activity from 10 minutes to 5 minutes

[[Page 53068]]

for CPT code 94621. Commenters stated that the explanation to the 
patient involves a back and forth discussion that is important for 
obtaining an accurate test for the patient, and this education cannot 
be rushed. The commenters indicated that sufficient time for informed 
consent is also important since exercising to maximal capacity does 
have risks, including death, and testing may include additional 
invasive procedures which require additional and adequate explanation 
to the patient.
    Response: We agree that there is an important need for preservice 
education and that this service requires additional clinical labor time 
beyond the standard. However, the standard time for this clinical labor 
activity is 3 minutes, and CPT code 94621 is currently receiving 
additional time beyond the standard with 5 minutes of allocated 
clinical labor time. We continue to believe that increasing the 
clinical labor time for preservice education above the current 
valuation would not be typical for this procedure.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Prepare and position patient/monitor 
patient/set up IV'' activity from 5 minutes to 3 minutes for the same 
code. Commenters stated that any breakdown in monitoring or IV access 
during the test itself adversely impacted the ability to interpret the 
test due to a lack of full and continuous data, and could also impact 
the validity of the test if the patient exercise were interrupted for 
any reason. Commenters explained that it takes more than the standard 
time to set up patient with 10 ECG leads and a blood pressure cuff, fit 
the patient with a face mask ensuring tight seal, and position on the 
bicycle ergometer.
    Response: After reviewing this additional information, we agree 
with the commenters that 5 minutes would be typical to conduct the 
positioning as described. We are finalizing a clinical labor time of 5 
minutes for the ``Prepare and position patient/monitor patient/set up 
IV'' clinical labor activity for CPT code 94621.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Complete diagnostic forms, lab & X-
ray requisitions'' activity to 3 minutes, consistent with the standard 
clinical labor time for this activity. Commenters stated that the 
technician had to summarize over 40 pages of data and compile reports 
for physician to interpret, including ECG and spirometries.
    Response: We continue to believe that 3 minutes would be typical 
for three codes, consistent with the standard clinical labor time for 
this activity. We did not receive any information from the commenters 
to suggest that the standard clinical labor time would not be typical 
for these services.
    Comment: Several commenters disagreed with the proposed refinements 
to the equipment time for these three codes. Commenters stated that CMS 
proposed the use of a 1:4 patient monitoring time rather than the RUC 
recommended 1:1 time. Commenters explained that patients recover in the 
testing room, not a separate room, while technologists are cleaning 
equipment, and therefore the equipment time could not be a 1:4 ratio 
because the typical procedure environment allowed only one patient in 
one room.
    Response: We believe that the specific refinement comment used for 
the equipment time in CPT codes 94621 and 94617 (Refined equipment time 
to conform to established policies for equipment with 4x monitoring 
time) may have been misinterpreted by the commenters. This specific 
comment was intended to convey only that the equipment times were 
adjusted in accordance with our standard equipment time formulas. In 
the specific context of CPT codes 94621 and 94617, this refinement 
comment indicated that we did not include the clinical labor time for 
``Complete diagnostic forms, lab & X-ray requisitions'' into the 
equipment times for these two codes, as this clinical labor activity is 
not part of our standard equipment formula and we do not believe that 
equipment such as the pulse oximeter would typically be in use while 
completing forms. Aside from the removal of this single clinical labor 
activity's time, the proposed equipment time formula for these two 
codes was the same as the RUC-recommended equipment time formula. We 
were not conveying a clinical judgment about the use of 1:4 patient 
monitoring time as opposed to 1:1 patient monitoring time for these 
services. However, we do note that the RUC's recommendations for CPT 
codes 94621 and 94617 include the clinical labor activity ``Monitor pt. 
following procedure/check tubes, monitors, drains, multitasking 1:4'', 
which led us to believe that 1:4 patient monitoring time was in use for 
these services. If we were to adopt 1:1 patient monitoring time for 
these services, we note that this would reduce the equipment times for 
CPT code 94621 by 22 minutes and for CPT code 94617 by 6 minutes. After 
consideration of the comments, we are finalizing the 1:4 patient 
monitoring time.
    After consideration of comments received, for CY 2018, we are 
finalizing the work RVUs for the codes in the pulmonary diagnostic 
tests family as proposed. We are finalizing the direct PE inputs for 
these codes as proposed along with the refinements detailed above in 
response to the comments.
(47) Percutaneous Allergy Skin Tests (CPT Code 95004)
    In the CY 2016 PFS proposed rule (80 FR 41706), CPT code 95004 was 
identified through the high expenditures screen as potentially 
misvalued. The RUC suggested in its comments on the CY 2016 PFS 
proposed rule (80 FR 41706), that CPT code 95004 should be removed from 
the list of potentially misvalued codes because it has a work RVU of 
0.01 and that it would serve little purpose to survey physician work 
for this code. The RUC and CMS previously determined that there is 
physician work involved in providing this service since the physician 
must interpret the test and prepare a report. In the CY 2016 PFS final 
rule with comment period (80 FR 70913), CMS reiterated an interest in 
the review of work and PE for this service.
    We note that our interest in stakeholder review of a particular 
code should not be considered a directive for survey under the RUC 
process. We intend to more clearly state our interests in the future, 
so that under similar circumstances, such effort need not be undertaken 
based on a mistaken impression. To reiterate, we believed that whether 
or not a code should be surveyed in response to our interest in 
receiving recommendations regarding the work RVUs should be at the 
discretion of the RUC and the specialty societies. In many cases, we 
have used recommendations developed through means other than surveys in 
developing RVUs. For example, for many PFS services, the direct PE 
inputs are the primary drivers of overall RVUs and Medicare payment. In 
most of these cases, the recommended inputs are not derived from survey 
data. In some cases, especially for resource-intensive and highly 
technical services, we have expressed some concern about the lack of 
survey or other broad-based data that we have relied on in developing 
rates across the PFS for many years.
    For CY 2018, we proposed the RUC-recommended work RVU of 0.01 for 
CPT code 95004.
    Regarding direct PE inputs, we proposed to refine the equipment 
times for the ``exam table'' (EF023) and the ``mayo stand'' (EF015) to 
79 minutes

[[Page 53069]]

each to account for clinical 1:4 patient monitoring time. We received 
invoices with new pricing information for two supplies: SH101 
``negative control, allergy test'' ($5.17) and SH102 ``positive 
control, allergy test'' ($26.12). Using this information, we proposed a 
price of $0.03 per test for supply item SH101 and a price of $0.13 per 
test for supply item SH102.
    Comment: In general, commenters were supportive of our proposal of 
the RUC-recommended work RVUs.
    Response: We will continue to consider alternative work RVUs as we 
propose the valuation of services for future notice and comment 
rulemaking. We appreciate the commenter's feedback.
    Comment: Several commenters noted that they would expect that CMS 
will phase in reductions for this service.
    Response: The payment reductions for CPT code 95004 are subject to 
the phase-in. We note that the CY 2018 PFS Final Rule List of Codes 
Subject to Phase-in is available on the CMS Web site under the 
downloads section of the CY 2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-;Service-Payment/PhysicianFeeSched/PFS-
Federal-Regulation-Notices.html. For a more detailed description of the 
methodology for the phase-in of significant RVU changes, we refer 
readers to the CY 2016 PFS final rule with comment period (80 FR 
70927).
    After consideration of the comments received, we are finalizing the 
work RVUs and PE inputs for CPT code 95004, as proposed.
(48) Continuous Glucose Monitoring (CPT Codes 95250, 95251, and 95249)
    CPT codes 95250 (Ambulatory continuous glucose monitoring of 
interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 
hours; sensor placement, hook-up, calibration of monitor, patient 
training, removal of sensor, and printout of recording) and 95251 
(Ambulatory continuous glucose monitoring of interstitial tissue fluid 
via a subcutaneous sensor for a minimum of 72 hours; interpretation and 
report) are used to report the technical and professional component for 
continuous glucose monitoring. In April 2013, CPT code 95251 was 
identified through the high volume growth services screen and 
subsequently this code family was reviewed at the RUC's October 2016 
meeting.
    For CY 2018, we proposed the RUC-recommended work RVU of 0.70 for 
CPT code 95251. However, we were concerned and sought comments on 
whether the 2 minutes of physician preservice time was necessary. Since 
CPT code 95251 is typically billed with an E/M service on the same day, 
we believed the 2 minutes of preservice time may be duplicative. 
Furthermore, we sought comment on whether it would be typical for the 
physician to spend 2 minutes to obtain the CGM reports for review since 
we believed the report would typically be obtained by clinical staff on 
behalf of the physician.
    For the direct PE inputs, the RUC submitted 19 invoices to update 
the price of the medical supply item ``glucose monitoring 
(interstitial) sensor'' (SD114) for CPT code 95250. We proposed to use 
these invoice prices for the glucose monitoring (interstitial) sensor 
(SD114), with an average cost of $53.08. Therefore, we proposed to use 
the average price of $53.08 for this supply item.
    As part of our review of this service, we obtained publicly 
available pricing information for the CGM system (EQ125). We reviewed 
the information provided in a study titled, ``The cost-effectiveness of 
continuous glucose monitoring in type 1 diabetes,'' (Huang, SE., 
O'Grady, M., Basu, A. et al., Diabetes Care. June 2010), which 
indicated the price of CGM technology (without sensors) from 3 
different vendors, reflective of full retail prices with no insurer 
discounts, to be $600.00, $1119.00, and $1250.00, which equated to an 
average cost of $1016.00 for the CGM system. In addition, we obtained 
publicly available pricing information for two vendors. This 
information indicated the price of a CGM system to be $1061.90 and 
$1279.17, which equated to an average cost of $1170.54. For CY 2018, we 
proposed to price supply items SD114 at $53.08 and EQ125 at $1170.54. 
We sought comments on current pricing for equipment item ``continuous 
glucose monitoring system'' (EQ125).
    Comment: In general, commenters were supportive of our proposal of 
the RUC-recommended work RVUs. Some expressed opposition to the 
alternative work RVUs.
    Response: We will continue to consider alternative work RVUs as we 
propose the valuation of services for future notice and comment 
rulemaking.
    Comment: The RUC noted that the CPT Editorial Panel indicated that 
the new PE-only CPT code 95249 (Ambulatory continuous glucose 
monitoring of interstitial tissue fluid via a subcutaneous sensor for a 
minimum of 72 hours; patient-provided equipment, sensor placement, 
hook-up, calibration of monitor, patient training, and printout of 
recording), along with CPT codes 95250 and 95251 (with editorial 
revisions), will appear in the 2018 CPT coding manual. The RUC 
requested an exemption to CMS's policy to propose values in the 
proposed rule for all RUC recommendations that we receive by the 
February 10th deadline each year, and asked that we include CPT code 
95249 in the CY 2018 PFS final rule. The RUC recommendations for CPT 
codes 95250 and 95251 were affirmed without change at the April 2017 
RUC meeting. At this same meeting, the RUC developed recommendations 
for the direct PE inputs for the newly approved CPT code 95249, a PE-
only code that is a part of the code family that includes CPT codes 
95250 and 95251. The RUC used the direct PE inputs from CPT code 95250 
to derive the PE inputs for CPT code 95249 by removing PE inputs that 
were not applicable to CPT code 95249. Several other commenters also 
recommended inclusion of CPT code 95249 in the CY 2018 final rule.
    Response: We recognize that the CPT Editorial Panel created CPT 
code 95249, which is part of the family of services described by CPT 
codes 95250 and 95251, in order to accommodate the different ways in 
which this service can be furnished and billed. While we continue to 
believe that the process we established through rulemaking where we 
propose values in the PFS proposed rule and finalize values in the PFS 
final rule is suitable for the vast majority of services that we price 
on the PFS, we believe there is merit to the RUC's request so that we 
can ensure relativity within this code family.
    Comment: The RUC noted that it agreed with CMS' proposal to update 
the price of the 13 supplies and one equipment item listed on Table 14: 
CY 2018 Proposed Rule Invoices Received for Existing Direct PE Inputs 
of the CY 2018 proposed rule (82 FR 34078).
    Response: We appreciate the commenter's feedback.
    After consideration of the comments received, we are finalizing the 
work RVUs and PE inputs for CPT codes 95250 and 95251, as proposed. We 
are also finalizing the PE inputs for CPT code 95249 and will include 
this code in the CY2018 Medicare Physician Fee Schedule.
(49) Parent, Caregiver-Focused Health Risk Assessment (CPT Codes 96160 
and 96161)
    In the CY 2017 PFS final rule (81 FR 80330), we discussed that in 
October 2015, the CPT Editorial Panel created two new PE-only codes, 
CPT code 96160 (Administration of patient focused health risk 
assessment instrument (e.g., health hazard

[[Page 53070]]

appraisal) with scoring and documentation, per standardized instrument) 
and CPT code 96161 (Administration of caregiver-focused health risk 
assessment instrument (e.g., depression inventory) for the benefit of 
the patient, with scoring and documentation, per standardized 
instrument). We assigned an active payment status to both codes for CY 
2017 and finalized use of the RUC recommended values for these codes. 
We also assigned an add-on code status to both of these services. As 
add-on codes, CPT codes 96160 and 96161 describe additional resource 
components of a broader service furnished to the patient that are not 
accounted for in the valuation of the base code. The RUC submitted 
updated recommendations for the direct PE inputs for CPT codes 96160 
and 96161 after reviewing new specialty society surveys. The RUC 
recommended 7 total minutes of clinical staff time, and we proposed to 
adopt this number of minutes in valuing the services. The PE worksheet 
included several distinct tasks with minutes for each; however, in 
keeping with the standardization of clinical labor tasks, we proposed 
to designate all 7 minutes under ``administration, scoring, and 
documenting results of completed standardized instrument'' rather than 
dividing the minutes into the four categories as shown in the RUC 
recommendations.
    Comment: One commenter noted that they appreciate CMS' review of 
these services and agreed with the refinement to aggregate the four 
clinical activities into one direct PE input.
    Response: We appreciate the comment.
    After consideration of the public comment, we are finalizing the 
direct PE inputs for CPT codes 96160 and 96161, as proposed.
(50) Chemotherapy Administration (CPT Codes 96401, 96402, 96409, and 
96411)
    In the CY 2016 PFS proposed rule, CPT codes 96401 (Chemotherapy 
administration, subcutaneous or intramuscular; non-hormonal anti-
neoplastic), 96402 (Chemotherapy administration, subcutaneous or 
intramuscular; hormonal anti-neoplastic), 96409 (Chemotherapy 
administration; intravenous, push technique, single or initial 
substance/drug), and 96411 (Chemotherapy administration; intravenous, 
push technique, each additional substance/drug (List separately in 
addition to code for primary procedure)) were identified through the 
high expenditure services screen across specialties with Medicare 
allowed charges of over $10 million.
    For CY 2018, we proposed the RUC-recommended work RVUs of 0.21 for 
CPT code 96401, 0.19 for CPT code 96402, 0.24 for CPT code 96409, and 
0.20 for CPT code 96411.
    For CPT code 96402, we proposed the RUC-recommended equipment times 
with refinements for the biohazard hood (EP016) and exam table (EF023) 
from 31 minutes to 34 minutes to reflect the service period time 
associated with this code. We proposed the RUC-recommended direct PE 
inputs for CPT codes 96401, 96409, and 96411 without refinements.
    Comment: In general, commenters were supportive of our proposal of 
the RUC-recommended work RVUs and RUC-recommended PE inputs for these 
services. One commenter noted that maintaining the recommended 
physician work RVUs will promote fair and adequate reimbursement and 
protect patient access.
    Response: We appreciate the commenter's feedback.
    Comment: One commenter noted that there are no acuity adjustments 
for chemotherapy or infusion services. The commenter further noted that 
CMS could enact site-of-service neutrality for payment of these codes 
in addition to adding acuity adjustment modifiers to reflect more 
intensive care given to some patients.
    Response: We refer readers to section II.G. of this final rule for 
more information on site neutrality regarding payment rates under the 
Medicare physician fee schedule for nonexcepted items and services 
furnished by nonexcepted off-campus provider-based departments of a 
hospital. With regard to acuity adjustments for chemotherapy or 
infusion services, we will consider whether to propose such adjustments 
in future notice and comment rulemaking.
    Comment: Several commenters supported our proposed equipment times 
for the biohazard hood and the exam table to reflect the service period 
time associated with CPT code 96402. One commenter noted support for 
our proposal of the RUC-recommended PE inputs for the other three 
services in this code family.
    Response: We appreciate the comments. We note that the PE inputs 
for these services are displayed in the CY 2018 PFS final rule direct 
PE input database, available on the CMS Web site under the downloads 
for the CY 2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Comment: Several commenters expressed concern with our proposed 
reductions in payment for many drug administration codes. Commenters 
stated that the payment for CPT code 96402 would be reduced by almost 
12 percent and that these reductions could harm access to care, 
especially in rural settings, and they urged CMS not to implement them. 
Furthermore, they noted that if CMS implemented the proposed payment 
reductions, that it would be essential to monitor patient access to 
care.
    Response: We share the concern of the commenters in maintaining 
access to care for Medicare beneficiaries. We continue to carefully 
consider the impact that our valuation of these services will have on 
beneficiary access to care. We note that we believe that improved 
payment accuracy under the PFS generally facilitates access to 
reasonable and necessary physicians' services. The statute requires us 
to establish payments under the PFS based on national uniform RVUs that 
account for the relative resources used in furnishing a service. We 
proposed the RUC-recommended PE inputs for this family of services, 
which were based on the expertise of the RUC. We believe that the RUC 
recommendations appropriately reflect the resource costs of furnishing 
the services and thus would result in appropriate valuation of these 
services.
    Comment: One commenter noted the importance of ensuring that 
chemotherapy treatments are funded and allowed to continue in order to 
sustain life.
    Response: We are appreciative of the commenter's perspective and 
share the commenter's concern in maintaining access to care for 
Medicare beneficiaries. We did not make any proposals and are not 
finalizing any policies to limit Medicare coverage of these services. 
These services will be payable under the PFS for CY 2018.
    Comment: One commenter noted that it was aware that CMS is 
researching how to minimize payment differentials between hospital-
based infusion centers and practice infusion centers. The commenter 
also noted that the coding nomenclature used for both chemotherapy and 
infusion services do not have acuity adjustments. Another commenter 
noted that the RVU supervision credit is only given for practice-based 
infusion centers and not when the service is provided in the facility, 
where many of these complicated infusions take place. They noted that 
RVU supervision of these chemotherapy and infusion services

[[Page 53071]]

should be usable by both providers and facility providers.
    Response: For more information on how CMS is researching how to 
minimize payment differentials between hospital-based infusion centers 
and practice infusion centers, we refer readers to section II.G of this 
final rule for more information on payment rates under the Medicare 
physician fee schedule for nonexcepted items and services furnished by 
nonexcepted off-campus provider-based departments of a hospital.
    After consideration of comments received, we are finalizing the 
work RVUs and PE inputs for CPT codes 96401, 96402, 96409, and 96411, 
as proposed.
(51) Photochemotherapy (CPT Code 96910)
    CPT code 96910 appeared on a high expenditure services screen 
across specialties with Medicare allowed charges of over $10 million. 
It is a PE-only code that does not have a work RVU.
    We proposed to refine the clinical labor time for the ``Provide 
preservice education/obtain consent'' activity from 3 minutes to 1 
minute for CPT code 96910. We believed that 1 minute would be typical 
for patient education, as CPT code 96910 is a repeat procedure where 
there would not be a need to obtain consent again. We also proposed to 
remove the 2 minutes of clinical labor for the ``Complete diagnostic 
forms, lab & X-ray requisitions'' activity, as this item is considered 
indirect PE under our established methodology. We proposed to create a 
new supply code (SB054) for the sauna suit, and proposed to price at 
$9.99 based on the submitted invoice. Finally, we also proposed to 
adjust the equipment times to reflect changes in the clinical labor for 
CPT code 96910.
    We proposed the RUC-recommended clinical labor time of 15 minutes 
for the ``Prepare and position patient/monitor patient/set up IV'' 
activity, the RUC-recommended clinical labor time of 16 minutes for the 
``Monitor patient during procedure'' activity, and the RUC-recommended 
clinical labor time of 15 minutes for the ``Clean room/equipment by 
physician staff'' activity, but we sought additional information 
regarding the rationale for these values. Given the lack of 
explanation, we considered using the current clinical labor time of 7 
minutes for the ``Prepare and position patient/monitor patient/set up 
IV'' activity, the current clinical labor time of 4 minutes for the 
``Monitor patient during procedure'' activity, and the current clinical 
labor time of 10 minutes for the ``Clean room/equipment by physician 
staff'' activity. We sought comment on whether maintaining the current 
values would improve relativity.
    We considered removing the ``Single Patient Discard Bag, 400 ml'' 
(SD236) supply and replacing it with the ``biohazard specimen transport 
bag'' (SM008). We were concerned about whether the single patient 
discard bag is the appropriate size for storing the sauna suit used in 
this procedure, and whether use of a biohazard specimen transport bag 
would be typical. We sought comments on our proposed and alternative 
values for these direct PE inputs.
    Comment: Several commenters supported the proposed values for CPT 
code 96910 but disagreed with the alternative values.
    Response: We continue to welcome information from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process.
    Comment: One commenter disagreed with the proposal to refine the 
clinical labor time for the ``Provide preservice education/obtain 
consent'' activity from 3 minutes to 1 minute. The commenter stated 
that the preservice education needed for this procedure takes longer 
due to the nature of the procedure, as the staff needs to provide very 
specific instructions to insure the safety and comfort of the patients 
while they are in the ultraviolet treatment unit receiving treatment.
    Response: After reviewing this additional information, we agree 
with the commenter that 3 minutes would be typical to conduct the 
preservice education as described. Therefore, we are finalizing a 
clinical labor time of 3 minutes for the ``Provide preservice 
education/obtain consent'' clinical labor activity for CPT code 96910.
    Comment: One commenter disagreed with the proposal to remove the 2 
minutes of clinical labor time for the ``Complete diagnostic forms, lab 
& X-ray requisitions'' activity. The commenter stated that the 
subjective, objective, assessment, and plan notes needs to be completed 
for each patient.
    Response: We agree with the commenter that these diagnostic forms 
need to be filled out for each patient. However, this activity is 
considered indirect PE under our established methodology and is 
included in the administrative costs of the service. Filling out forms 
or restocking shelves are necessary tasks, but they are not 
individually allocable to a service and therefore fall under the 
category of indirect PE.
    Comment: One commenter disagreed with the proposal to adjust the 
equipment times to reflect changes in the clinical labor. The commenter 
did not provide a rationale for this disagreement, other than restating 
its opposition to the removal of the clinical labor time and the other 
proposed refinements.
    Response: Over the past decade, the increasing standardization of 
clinical labor tasks has resulted in greater transparency and 
consistency in the assignment of equipment minutes based on clinical 
labor times. We currently utilize a series of standard formulas for 
equipment time, which are calculated based on the clinical labor 
activities in which the equipment would typically be in use. When the 
clinical labor for a procedure is altered in response to a proposal, we 
will typically alter the equipment time for that procedure as well to 
reflect the changes in clinical labor time, assuming of course that the 
equipment in question would typically be utilized during that clinical 
labor activity. We proposed to decrease the equipment time for CPT code 
96910 in accordance with the changes in the proposed clinical labor 
time, and we have no reason to believe that the standard equipment time 
formulas would be inapplicable for this service. We also note that as a 
result of the increase in the clinical labor time for the ``Obtain 
vital signs'' activity from 3 minutes to 5 minutes, the final equipment 
time for everything other than the phototherapy UVB measuring device 
(EQ203) is 67 minutes, the same equipment time contained in the RUC's 
recommendations.
    After consideration of comments received, we are finalizing the 
direct PE inputs for CPT code 96910 as proposed, with the exception of 
the change to the ``Provide preservice education/obtain consent'' 
clinical labor activity, as detailed above.
(52) Photodynamic Therapy (CPT Codes 96567, 96573, and 96574)
    CPT code 96567 was identified as potentially misvalued through a 
CMS screen for codes with high expenditures. This code describes a 
service furnished by clinical staff and does not include physician 
work. For CY 2018, the CPT Editorial Panel created two new codes, CPT 
codes 96573 and 96574, to describe photodynamic therapy by external 
application of light to destroy premalignant skin lesions, including 
the physician work involved in furnishing the service. CPT codes 96567, 
96573, and 96574 were reviewed during the RUC's January 2017 meeting.
    For CY 2018, we proposed the RUC-recommended work RVUs for CPT

[[Page 53072]]

codes 96573 (a work RVU of 0.48) and 96574 (a work RVU of 1.01).
    We proposed the RUC-recommended PE inputs with refinements due to 
inconsistencies between the stated description of clinical activities 
and the submitted spreadsheets. First, we proposed to add assist 
physician clinical staff time to CPT codes 96573 (10 minutes) and 96574 
(16 minutes), which is equivalent to the physician intraservice times 
for these services. For both CPT codes 96573 and 96574, we proposed a 
reduction from 35 minutes to 17 minutes for clinical activity in the 
postservice time, consistent with the description of clinical work in 
the summary of recommendations, which states that the patient receives 
activation of the affected area with the BLU-U Photodynamic Therapy 
Illuminator for approximately 17 minutes. For CPT codes 96573 and 
96574, we proposed to refine equipment formulas for two items: Power 
table (EF031) and LumaCare external light with probe set (EQ169), 
consistent with standards for nonhighly technical equipment. An 
explanation of the standards and formulas for equipment related to 
direct PE inputs is in the CY 2014 PFS final rule with comment period 
(79 FR 67557).
    Comment: Several commenters, including the RUC, disagreed with our 
proposal to change the RUC-recommended clinical labor times for CPT 
96573 and 96574 due to inconsistencies between the stated description 
of clinical activities and the submitted spreadsheets. Commenters also 
noted that Table 11 in the CY 2018 PFS proposed rule did not reflect 
these changes.
    Response: We appreciate commenters' attention to this discrepancy. 
In the proposed rule, we wrote that we proposed this change, but as 
commenters pointed out, the proposed refinements were reflected in the 
data presented in Table 11. We are finalizing the RUC recommended PE 
clinical labor times for these two CPT codes. We are finalizing our 
proposal to refine equipment formulas for EF031 and EQ169 for these two 
CPT codes, in accordance with formula standards.
    We identified several vendors with publically available prices for 
supply item LMX 4 percent cream (SH092) for significantly less than the 
existing $1.60 per gram. Based on our research of vendors, we proposed 
to set the price of supply item SH092 to $0.78 per gram. Other CPT 
codes affected by the proposed change in the price of supply item LMX 4 
percent cream (SH092) would be: CPT code 46607 (Anoscopy; with high-
resolution magnification (HRA) (e.g., colposcope, operating microscope) 
and chemical agent enhancement, with biopsy, single or multiple), CPT 
code 17000 (Destruction (e.g., laser surgery, electrosurgery, 
cryosurgery, chemosurgery, surgical curettement), premalignant lesions 
(e.g., actinic keratoses); first lesion), CPT code 17003 (Destruction 
(e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, 
surgical curettement), premalignant lesions (e.g., actinic keratoses); 
second through 14 lesions, each (List separately in addition to code 
for first lesion)), and CPT code 17004 (Destruction (e.g., laser 
surgery, electrosurgery, cryosurgery, chemosurgery, surgical 
curettement), premalignant lesions (e.g., actinic keratoses), 15 or 
more lesions)).
    In addition, the RUC forwarded an invoice for a new supply item, 
safety goggles, at $6.00 and requested three goggles each for CPT codes 
96573 and 96574. Because we did not have a basis for distinguishing the 
requested new goggles from the existing UV-blocking goggles, we 
considered this invoice to be an additional price point for SJ027 
rather than an entirely new item. We proposed a price of $4.10 for 
supply item SJ027 (the average of the two prices for this supply item 
($2.30 + $6.00)/2 = $4.10)). Other CPT codes affected by the proposed 
change in the price of supply item UV-blocking goggles (SJ027) are: CPT 
code 36522 (Photopheresis, extracorporeal), CPT code 96910 
(Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or 
petrolatum and ultraviolet B), CPT code 96912 (Photochemotherapy; 
psoralens and ultraviolet A (PUVA)), and CPT code 96913 
(Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive 
dermatoses requiring at least 4-8 hours of care under direct 
supervision of the physician (includes application of medication and 
dressings)), CPT code 96920 (Laser treatment for inflammatory skin 
disease (psoriasis); total area less than 250 sq cm), CPT code 96921 
(Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm 
to 500 sq cm), and CPT code 96922 (Laser treatment for inflammatory 
skin disease (psoriasis); over 500 sq cm). We sought comments on our 
proposed PE refinements, including our proposed supply item prices.
    Comment: Commenters generally supported our proposed work RVUs for 
CPT codes 96573 and 96574. Two commenters disagreed with our proposal 
to accept the RUC's recommended PE inputs for the existing CPT code 
96567. They stated that the staff and equipment times for CPT codes 
96567 should mirror the times in CPT code 96573, with the addition of 
10 minutes for staff to apply the photosensitizing agent. As currently 
proposed, the commenters noted that staff times for CPT code 96567 are 
inadequate to perform the service.
    Response: Based on support from commenters on our proposed work 
RVUs for CPT codes 96573 and 96574, we are finalizing those values as 
proposed. We thank commenters for their comments regarding clinical 
labor inputs for CPT code 96567. The RUC provides recommendations 
regarding clinical labor that are developed through a collaborative 
process with specialty societies. The RUC did not, in its comment 
letter, modify recommendations for this CPT code. The RUC has a process 
for identifying potentially missing clinical labor time, and we 
encourage commenters to work in concert with the RUC to resolve those 
concerns.
    Comment: One commenter questioned whether the CPT Editorial Panel 
should have used the same code number as an existing service, rather 
than a new one, to describe the revised service for CPT code 96567.
    Response: In certain circumstances, we may find it necessary to 
deviate from the CPT Editorial Panel's decisions. However, we note that 
CMS does not direct the CPT Editorial Panel and we encourage the 
commenter to follow the panel's established process for reviewing CPT 
codes and descriptors.
    Comment: A few commenters questioned our proposal to refine 
equipment times to confirm to standard formulas. In particular, they 
maintained that the equipment time for the power table should not be 
refined because the patient has to stay on the table during the 
illumination period and the room is not available for other patients' 
use.
    Response: We agree that the power table may be required throughout 
the illumination period, and we would consider the recommendation if 
there were additional information explaining why equipment time for the 
power table included the entire service time plus 3 additional hours. 
However, the total time for the power table formula of 230 minutes and 
232 minutes for CPT codes 96573 and 96574, respectively, was not 
consistent with the narrative accompanying the recommendation. In the 
narrative for both CPT codes, illumination of the affected area is 
approximately 17 minutes with no specific amount of time for incubation 
provided. In the absence of additional information explaining why the 
times are needed, we are finalizing our

[[Page 53073]]

proposed refinement for this and two other equipment items.
    Comment: We received several comments about our proposal to reduce 
the price for supply item LMX 4 percent cream (SH092) from $1.60 to 
$0.78. We also received comments about our proposal to blend the prices 
of two types of goggles, SJ027 and SD326.
    Response: We discuss these supply items and prices in detail in 
section II.B of this final rule.
(53) Physical Medicine and Rehabilitation (PM&R) (CPT Codes 97012, 
97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110, 97112, 97113, 
97116, 97140, 97530, 97533, 97535, 97537, 97542, and HCPCS Code G0283)
    In our CY 2015 PFS final rule with comment period (79 FR 67576) and 
CY 2016 PFS final rule with comment period (80 FR 70917), we identified 
a total of ten codes through the high expenditure by specialty screen 
for services primarily furnished by physical and occupational 
therapists: CPT codes 97032, 97035, 97110, 97112, 97113, 97116, 97140, 
97530, 97535, and HCPCS code G0283. An additional nine codes in this 
PM&R family were identified for review by the physical therapy (PT) and 
occupational therapy (OT) specialty societies: CPT codes 97012, 97016, 
97018, 97022, 97033, 97034, 97533, 97537, and 97542. Many of these code 
values had not been reviewed since they were established in 1994, 1995 
or 1998.
    After review during its January 2017 meeting, the HCPAC submitted 
recommendations to CMS for all 19 codes. While the HCPAC included 
recommendations for CPT code 97014, we note that this is a code we have 
not recognized for PFS payment since 2002 when we implemented our wound 
care electrical stimulation policies. For payment under the PFS, 
instead of CPT code 97014, we recognize HCPCS code G0281 for wound care 
electrical stimulation and HCPCS code G0283 for all other electrical 
stimulation scenarios, when covered. For CY 2018, we proposed the HCPAC 
recommendations for CPT code 97014, HCPCS code G0283, and HCPCS code 
G0281.
    CMS considers all 19 codes as ``always therapy'' which means they 
are always considered to be furnished under a physical therapy (PT), 
occupational therapy (OT), or speech-language pathology (SLP) plan of 
care regardless of who furnishes them and the payment amounts are 
counted towards the appropriate statutory therapy cap--either the 
therapy cap for PT and SLP services combined, or the single therapy cap 
for OT services. These ``always therapy'' codes are also subject to the 
therapy MPPR.
    For CY 2018, we proposed the HCPAC's recommended work RVUs for CPT 
codes 97012, 97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110, 
97112, 97113, 97116, 97140, 97530, 97533, 97535, 97537, 97542, and 
G0283 (97014).
    For supervised modality services reported with CPT codes 97012, 
97016, 97018, and 97022, and HCPCS code G0283 (97014), we considered 
maintaining the current values for these codes rather than the HCPAC 
recommendations. We note that the work times recommended by the HCPAC 
reflect use of the survey data even though the HCPAC explained in its 
recommendations that the survey results were not deemed credible 
because of a lack of evidence to support higher work RVUs of each 
survey's 25th percentile or median values. We note total time decreases 
among these codes ranging from 1 to 8 minutes.
    While we proposed the HCPAC-recommended work RVUs and work times 
for each code in this family, we sought comments on whether maintaining 
the current times, given the HCPAC's lack of confidence in the survey 
data, would better reflect the work times for these services.
    We proposed to maintain the existing CY 2017 PE inputs for all 19 
codes. We noted that section 1848(b)(7) of the Act requires a 50 
percent therapy MPPR instead of the 25 percent therapy MPPR established 
during CY 2011 PFS rulemaking. One of the primary rationales for the 
MPPR policy developed through the rulemaking process was that the 
direct PE inputs for these services did not fully recognize the 
redundant inputs when these services were furnished together, or in 
multiple units. After reviewing the recommended direct PE inputs, it 
was evident that they were developed based on an acknowledgement of the 
efficiencies of services typically furnished together as well as codes 
billed in multiple units. Given this assessment, we believed that were 
we to use the recommended inputs to develop the PE RVUs, the 50 percent 
MPPR on the PE for these services, as required by current law, would 
functionally duplicate the payment adjustments to account for 
efficiencies that had already been addressed through code-level 
valuation. Therefore, for CY 2018, we proposed to retain the existing 
CY 2017 PE inputs for these services and sought comments on whether 
there is an alternative approach that would avoid duplicative downward 
payment adjustments while still allowing for the direct PE inputs to be 
updated to better reflect current practice.
    We noted that we believed that the always therapy codes subject to 
the therapy MPPR on PE are unique from other therapeutic and diagnostic 
procedure codes paid under the PFS and subject to MPPRs. For example, 
unlike most surgical services, these ``always therapy'' codes are 
typically billed either with other therapy codes or in multiple units, 
or both. Generally, MPPRs are used when codes are often, but not 
typically, furnished with other particular codes. When full sets of 
related codes are almost all typically billed with other codes, or 
billed in multiple units, coding and valuation have changed to reflect 
these practices. For example, new codes have been introduced to 
describe combined services or some related services are described by 
add-on codes. In other cases, the MPPR is considered in the valuation 
for individual services.
    The following is a summary of public comments received on our 
proposal to accept the HCPAC-recommended work RVUs for all 19 PM&R 
codes and the request for comment for the supervised modality codes--
CPT codes 97012, 97016, 97018, and 97022, and HCPCS code G0283 
(97014)--to alternatively not accept the work times:
    Comment: We received many comments all of which were in support of 
our proposal to accept the HCPAC-recommended work RVUs for the 19 PM&R 
codes that includes an increase in work RVUs for six of the codes. The 
majority of commenters disagreed with the alternative we considered to 
retain the current work times associated with the five supervised 
modality services, while one commenter agreed. The HCPAC and other 
commenters disagreed and asked us to maintain the proposed 
recommendations in this final rule because they noted that the survey's 
25th percentile time for each of these codes more accurately reflects 
the time necessary to perform the service and takes into account 
efficiencies based on the typical number of services reported per 
session. One commenter asked us to keep the current time values for the 
supervised modality services reported with CPT codes 97012, 97016, 
97018, and 97022, and HCPCS code G0283 (97014) and not accept the 
HCPAC's proposed time values and offered several clinical scenarios for 
some of the supervised modality services they believe demonstrate the 
need for maintaining the current time values for these services.
    Response: We appreciate the many commenters who supported our

[[Page 53074]]

proposal to accept the work RVU recommendations we received from the 
HCPAC for the 19 PM&R codes. While we appreciate the various comments 
we received on our alternative consideration to retain the times 
associated with the work RVUs for the supervised modality codes, we are 
finalizing our proposal to accept the work RVUs, including the times, 
for all 19 PM&R codes.
    The following is a summary of the public comments received as to 
whether there is an alternative approach to our proposal to retain the 
CY 2017 direct PE inputs for always therapy codes that would avoid 
duplicative downward payment adjustments while still allowing for the 
direct PE inputs to be updated to better reflect current practice and 
our responses:
    Comment: Many commenters agreed with our proposal to maintain the 
existing 2017 PE inputs for all 19 PM&R codes. A number of these 
commenters noted the importance of the PE values that reflect the costs 
of maintaining a therapy practice (such as renting office space, buying 
supplies and equipment, and staff salary/benefits). Some of these 
commenters thanked CMS for recognizing that if the recommended inputs 
to develop the PE RVUs were adopted, the 50 percent MPPR on the PE for 
these services would duplicate the payment adjustments to account for 
efficiencies that had already been addressed through the code-level 
valuation process.
    Several other commenters, including the HCPAC, urged us to 
implement the recommended direct PE inputs. In its comment, the HCPAC 
assured CMS that the RUC PE Subcommittee understood the 50 percent MPPR 
and took it into account, in addition to the efficiencies of services 
billed together, when reviewing the direct PE inputs for these 
services. The HCPAC noted in its comment letter that the PE inputs were 
reviewed with the understanding that as a result of the MPPR, a 50 
percent reduction is in place for the second and subsequent reporting 
of a physical medicine and rehabilitation service on the same date of 
service. The HCPAC comment letter clarified that the PE Subcommittee's 
recommendations apply to the 22 codes that are subject to the therapy 
MPPR--the 19 codes in this PM&R section and the three codes for 
orthotic and prosthetic management services (discussed in the below 
section).
    Response: We are persuaded by the HCPAC's reassurance that the PE 
Subcommittee took the 50 percent MPPR into consideration during its 
deliberative process and that the forwarded recommendations reflect the 
therapy MPPR policy, in addition to the efficiencies of services billed 
together. Therefore, we will not finalize our proposal to maintain the 
existing direct PE inputs for therapy codes; instead, we will accept 
the HCPAC recommendations for the direct PE inputs for the 19 PM&R 
codes in this section and the three codes discussed in a subsequent 
section for services related to orthotics and prosthetics management 
and/or training.
    After consideration of comments received, we are finalizing the 
HCPAC-recommended work RVUs, including the times, for all 19 PM&R codes 
as proposed. We are also finalizing to accept the HCPAC recommendations 
for the direct PE inputs for all 19 codes.
(54) Cognitive Function Intervention (CPT Code 97127)
    We received HCPAC recommendations for new CPT code 97127 that 
describes services currently reported under CPT code 97532 (Development 
of cognitive skills to improve attention, memory, problem solving 
(includes compensatory training), direct (one-on-one) patient contact, 
each 15 minutes). CPT code 97532 is scheduled to be deleted for CY 2018 
and replaced by CPT code 97127.
    The existing code is reported per 15 minutes and the new code is 
reported once. Under current coding, Medicare utilization for these 
services is heterogeneous and indicates that practitioners of different 
disciplines incur significantly different resource costs (especially in 
time) when furnishing these services to Medicare beneficiaries. As 
described by both the existing and new code, the service might be 
appropriately furnished both by therapists under the outpatient therapy 
(OPT) services benefit (includes physical therapy (PT), occupational 
therapy (OT) or speech-language pathology (SLP)); and outside the 
therapy benefit by physicians, certain NPPs, and psychologists. As an 
OPT service, it can (1) be billed by physicians, certain NPPs, or 
private practice therapists including physical therapists (PT-PPs), 
occupational therapists (OT-PPs) and speech-language pathologists (SLP-
PPs) in private practice, or (2) be billed by institutional providers 
(for example, skilled nursing facilities, rehabilitation agencies, 
outpatient hospitals, etc.) when furnished by therapists working for 
the institutional providers.
    According to the HCPAC, professional claims data indicate that CPT 
code 97532 was most often billed in 4 units. The HCPAC recommended a 
work RVU of 1.50 for CPT code 97127, which is only 3.4 times greater 
than the work RVU for the predecessor code (0.44). Assuming 
professional billing patterns remain the same, the recommended coding 
and valuation could result in a significant reduction in overall 
Medicare payment under the PFS.
    However, our analysis of the claims data indicates that the number 
of units typically reported for the current code suggests a significant 
difference in the amount of time spent with the patient, depending on 
which discipline (and implicitly under which benefit) bills Medicare 
for services described by this single code.
    Based on our review of claims data by specialty, SLP-PPs, OT-PPs 
and PT-PPs furnishing the same services under the OPT benefit would 
receive overall payment increases due simply to the change in coding 
because they typically bill for fewer than 4 units, while overall 
payment for clinical psychologists furnishing therapeutic interventions 
for cognitive function would decrease because they typically bill in 
units of four or more.
    We sought additional information regarding the potential impact of 
this coding and payment change prior to proposing its use under the 
PFS. For CY 2018, we proposed to maintain the current coding and 
valuation for these cognitive function services. If the CPT Editorial 
Panel deletes the existing CPT code for CY 2018, we would effectuate 
this proposal through use of a new a HCPCS code G-code, G0515, which 
would maintain the descriptor and values from existing CPT code 97532. 
Under this proposal, new CPT code 97127 would be given a procedure 
status of ``I'' (Invalid for Medicare).
    We also noted that this change in coding and payment could have 
significant impact for payment to Medicare institutions for OPT 
services. Under section 1834(k) of the Act, when reported by Medicare 
institutional providers, OPT services are paid at PFS non-facility 
payment rates. Institutional claims data for CPT code 97532 when 
furnished by the three therapist disciplines show a much higher 
utilization overall than that for professional claims, but 
significantly fewer 15 minute units reported. This suggests that 
outpatient therapy professionals generally spend significantly less 
time with patients in the institutional setting. Use of the new CPT 
code could, therefore, result in significant additional expenditure to 
the Medicare program, as well as other payers, including Medicaid 
programs, based on the change in coding alone.

[[Page 53075]]

    The following is a summary of the public comments received on 
additional information regarding the potential impact of this coding 
and payment change prior to its use under the PFS and our responses:
    Comment: The HCPAC and other commenters--after considering CMS 
concerns and an independent review and analysis conducted by the 
speech-language pathology specialty of Medicare Part B facility-based 
claims (using the Medicare 5% Limited Data Set (LDS)) that confirmed 
the same variable billing patterns and higher utilization of CPT code 
97532--generally agreed with our proposal to create HCPCS code G0515 
instead of recognizing CPT code 97127 in the short term and encouraged 
us to work with stakeholders, including the AMA, on a more permanent 
coding solution. These same commenters had expressed concern that CMS 
did not use the data in the same way as the HCPAC and RUC to determine 
the typical units billed, and that moving forward, they would be 
interested to work with CMS to identify exceptional procedure codes 
such as this one where the more commonly used database may be 
misleading.
    Response: We agree that the untimed CPT code 97127 designed to 
replace the 15-minute timed CPT code 97532 represents an 
``exceptional'' procedure code, primarily because it would be covered 
and paid by Medicare under two separate benefits--one for medical 
services and the other for OPT services. It is this uniqueness that 
prompted us to examine the differing billing patterns of the various 
practitioners furnishing these cognitive therapy services as well as 
the overall utilization in all the settings it is reported. Because CPT 
code 97127 would have been reported by institutional providers of OPT 
services and typical units in a same-day billing file is not available, 
our review required us to look at the average units reported by each 
therapy discipline. We appreciate the work of the SLP and psychology 
specialties in completing the HCPAC survey process for CPT code 97127, 
and we thank the HCPAC and the specialty societies for recognizing our 
necessity to develop HCPCS code G0515 to report these cognitive therapy 
services.
    Comment: One commenter expressed concern that our proposal to 
create HCPCS code G0515 instead of adopting CPT code 97127 would result 
in confusion for providers that would have two different codes to 
report for cognitive therapy services: One for Medicare and another for 
private payers. The commenter requested that we use CPT code 97127, 
perhaps with modifiers to account for billing pattern differences, 
unless CMS commits to extensive outreach services to the provider 
community.
    Response: If we were to adopt the new coding and higher payment for 
CPT code 97127, instead of creating HCPCS code G0515 to maintain 
current coding and valuation for these services as we proposed, we 
acknowledge that the institutional providers of OPT services such as 
those represented by this commenter would benefit the most from the 
untimed nature of CPT code 97127, assuming current billing patterns and 
resource use, since therapists in these settings typically furnish 
these services in fewer units. We note that private payers have the 
option to adopt our G-codes for reporting purposes. In addition, the 
coding we proposed for HCPCS code G0515 is identical to that which 
Medicare providers have used in the past for these cognitive therapy 
services. As with all new therapy codes, we will address changes to the 
2018 therapy code list made in this CY 2018 PFS final rule in an 
upcoming Change Request (CR) for the 2018 Annual Update to the Therapy 
Code List, CR 10303, which will be available on the 2017 Transmittals 
Web page at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017-Transmittals.html.
    Comment: The HCPAC and other commenters pointed out that the 
description of HCPCS code GXXX1 listed in Table 10: Proposed CY 2018 
Work RVUs for New, Revised and Potentially Misvalued Codes of the 
proposed rule, (82 FR 34021) does not reflect CMS' intent to maintain 
the descriptor for CPT code 97532.
    Response: We thank the commenters for notifying us about the 
incorrect descriptor for GXXX1 that we inadvertently included in Table 
10 of the CY 2018 PFS proposed rule (82 FR 34021). The correct 
descriptor for GXXX1/G0515 in that table should have been the same as 
that for the prior CPT code 97532 that we defined and included in our 
discussion as: Development of cognitive skills to improve attention, 
memory, problem solving (includes compensatory training), direct (one-
on-one) patient contact, each 15 minutes.
    Comment: The HCPAC and other commenters expressed concern about 
CMS' refinement of PE inputs for CPT code 97127, contending that the 
agency lacked a rationale for the refinements shown in Table 11--CY 
2018 Proposed Codes with Direct PE Input Recommendations with 
Refinements. These commenters encouraged CMS to either use the existing 
PE inputs in CPT code 97532 for HCPCS code G0515 or more closely mirror 
the PE refinements that were forwarded by the HCPAC for CPT code 97127 
to those for CPT code 97532. The commenters noted that any changes that 
result in significant deviations from current PE inputs should not be 
implemented absent another review of cognitive therapy services through 
the HCPAC valuation process.
    Response: We thank the commenters for informing us that Table 11 
contained PE input refinements for CPT code 97127. Their inclusion in 
Table 11 was inadvertent given that we proposed to retain the same 
valuation of CPT code 97532 for HCPCS code G0515 and not to recognize 
CPT code 97127 for Medicare purposes.
    Comment: One commenter asked us to provide greater insight as to 
what we believe would comprise an effective permanent coding solution 
that permits sufficient coverage of and fair payment for these 
cognitive therapy services when furnished to outpatients in both the 
professional office and facility-based settings.
    Response: CMS' typical role is to review the codes forwarded to us 
from the RUC and HCPAC and to agree or disagree with those valuations. 
Through the review and analysis necessary for valuation purposes, we 
have at times found it necessary due to Medicare programmatic concerns 
to create our own G-code instead of recognizing the code sent to us, as 
we did in the case of the untimed code, CPT code 97127. This code, 
which represents services that are utilized and reported under two 
separate benefits--medical services and outpatient therapy services--
the latter of which can be billed by facility-based providers on 
institutional claims when furnished by qualified therapists, or on 
professional claims by therapists in private practice, physicians, or 
certain NPPs (NPs, PAs, CNSs)--presents an unusual coding challenge. 
Other than what has been already discussed in this rulemaking process, 
we do not believe we are in a position to provide additional insight to 
a permanent code that the HCPAC has not yet forwarded to us.
    After consideration of the public comments, we are finalizing our 
proposal to create HCPCS code G0515 to mirror the coding and valuation 
of existing CPT code 97532, instead of adopting CPT code 97127. We will 
assign CPT code 97127 a status indicator of ``I'' to indicate that it 
is ``Invalid'' for Medicare policy and payment purposes.
    We have designated HCPCS code G0515 a as ``sometimes therapy'' 
code,

[[Page 53076]]

which means that an appropriate therapy modifier--GN, GO or GP, to 
reflect that it is under an SLP, OT, or PT plan of care--is always 
required when this service is furnished by therapists; and, when it is 
furnished by or incident to physicians and NPP when the services are 
integral to an SLP, OT, or PT plan of care. Accordingly, HCPCS code 
G0515 is sometimes appropriately reported by physicians, NPPs, and 
psychologists without a therapy modifier when it is appropriately 
furnished outside an SLP, OT, or PT plan of care. When furnished by 
psychologists, the services of HCPCS code G0515 are never considered 
therapy services and may not be reported with a GN, GO, or GP therapy 
modifier.
(55) Management and/or Training: Orthotics and Prosthetics (CPT Codes 
97760, 97761, and 977X1)
    For CY 2018, the CPT Editorial Panel revised the set of codes that 
comprise the CPT manual's PM&R subsection for orthotic management and 
prosthetic management at its September 2016 meeting. According to the 
CPT Editorial Panel, these revisions were made at the request of the 
specialty societies representing physical and occupational therapists 
to differentiate between the initial and subsequent encounters and to 
describe the ongoing management and/or training that is involved in 
subsequent encounters. These changes include:
     Revising the code descriptors by adding the term ``initial 
encounter'' to CPT code 97760 (Orthotic(s) management and training 
(including assessment and fitting when not otherwise reported), upper 
extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s) 
encounter, each 15 minutes), and CPT code 97761 (Prosthetic(s) 
training, upper and/or lower extremity(ies), initial prosthetic(s) 
encounter, each 15 minutes);
     Creating a new CPT code 977X1 (Orthotic(s)/prosthetic(s) 
management and/or training, upper extremity(ies), lower extremity(ies), 
and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15 
minutes); and
     Deleting CPT code 97762 (checkout for orthotic/prosthetic 
use, established patient, each 15 minutes).
    Intended for the management and/or training of patients with 
orthotics and/or prosthetics, CPT codes 97760 and 97761 were previously 
used to report both the initial and subsequent encounters, that, when 
furnished under the Medicare outpatient therapy services benefit, 
included services occurring during the same PT or OT episode of care. 
CPT code 97762 was used to separately report the assessment and fitting 
(including any adjustments) of an orthotic or prosthetic for an 
established patient when these services were not bundled into another 
code or service. For CY 2018, CPT codes 97760 and 97761 are intended to 
be reported only for the initial encounter, and CPT code 977X1 is 
intended to be reported for all other orthotic and/or prosthetic 
services for an established patient that occur on a ``subsequent 
encounter'' or a different date of service from that of the initial 
encounter service.
    The HCPAC submitted work and PE recommendations for CPT codes 
97760, 97761, and 977X1 from their January 2017 meeting. For CY 2018, 
we proposed the HCPAC-recommended work RVU of 0.50 for CPT code 97760, 
a work RVU of 0.50 for CPT code 97761, and a work RVU of 0.48 for CPT 
code 977X1. We noted that for budget neutrality purposes, the HCPAC 
recommendations also included utilization crosswalks for each of the 
three codes that were each assigned a one-to-one crosswalk to the 
utilization of the prior codes: All the prior services of CPT codes 
97760 and 97761 were each crosswalked to the same newly revised codes; 
and, all the utilization from CPT code 97762 was crosswalked to the new 
CPT code 977X1.
    For CPT code 977X1, we considered a work RVU of 0.33, crosswalking 
to CPT code 92508 (Speech/hearing therapy), which has a similar total 
therapist time (22 minutes). We were concerned and sought comments on 
the HCPAC one-to-one utilization crosswalk recommendations for all 
three codes in this family since the utilization assumptions are 
potentially flawed when viewed in the context of the new CPT code 
descriptors. For instance, for CPT code 977X1, the new descriptor 
indicates that the services inherent to CPT code 97762 (over 14,000 in 
2015), as well as the new services for subsequent encounters previously 
reported via CPT codes 97760 and 97761 will also be encompassed, 
although it is difficult to estimate the number of additional services 
the latter represents. We were concerned that the HCPAC's valuation is 
inconsistent with the submitted information regarding how services will 
be reported under the new coding. We sought comments on our proposed 
and alternative values for CPT code 977X1. We were also interested in 
receiving comments from stakeholders and clinicians with expertise in 
furnishing these orthotic management and/or prosthetics training 
services about the utilization and types of services that would be 
furnished under the new CPT coding structure, particularly those of the 
newly created CPT code 977X1 and how these services differ from the 
services reported with the predecessor CPT code 97762.
    We proposed to maintain the current PE inputs for CPT codes 97760, 
97761, and 977X1, as we discussed in our proposals for the PM&R codes 
discussed above; the same therapy MPPR applies. We proposed the current 
direct PE inputs for CPT code 97762 and for new CPT code 977X1, though 
we sought comment as to whether or not a different crosswalk or other 
adjustment would be appropriate given the change in code descriptor.
    The following is a summary of the public comments received as to 
whether or not a different crosswalk or other adjustment would be 
appropriate for CPT code 97763 given the change in code descriptor and 
our responses:
    Comment: Many commenters supported of our proposal to adopt the 
HCPAC recommendations for revised work RVUs for CPT codes 97760 and 
97761, and the proposed work RVU of newly created CPT code 977X1/97763. 
A few commenters also expressed support for the revised CPT descriptors 
of codes 97760 and 97761 to include the term ``initial encounter'', 
which they believe will eliminate billing confusion; and, also that the 
addition of the term ``subsequent encounter'' to the descriptor of CPT 
code 97763, because, the commenters stated it clarifies when this code 
is used--that, for the same patient, the provider would only report CPT 
code 97763 on the second or other subsequent visit after previously 
reporting an initial encounter for orthotic and/or prosthetic training 
and management using either CPT code 97760 or 97761. Other commenters 
informed us that they support the revised descriptors because they 
better align with the descriptions used within the ICD-10 system. One 
commenter noted that the new descriptors designation of subsequent or 
initial services will contribute confusion to the coding process for 
these services.
    Response: We appreciate the support of the many commenters for our 
proposal to accept the work RVU values for these orthotic and/or 
prosthetic management and training services.
    Comment: In response to our alternative work valuation of 0.33 RVUs 
for CPT code 97763, several commenters disagreed, stating that the 
suggested crosswalk to CPT code 92508 is inappropriate, that the work 
involved in delivering the orthotic/prosthetic subsequent encounter 
service is very similar to that furnished in the initial encounter, as 
substantiated through the

[[Page 53077]]

HCPAC survey process. One commenter that does not support the 0.33 work 
RVU, told us they agree with our crosswalk of CPT code 92508 for 
purposes of therapist time (17 minutes), given that we were limited for 
comparable crosswalks since the 97000 series of codes was under review. 
Another commenter noted that our alternative value was too low and that 
we should adopt the higher value based on their belief that many 
``orthotics and prosthetics require increasingly complex and critical 
subsequent encounter adjustments based on changes in the status of a 
patient. These services often require a great deal of time and 
expertise on the part of the therapist.'' In addition, the commenter 
noted that some orthotic devices are dynamic in nature and need regular 
adjustments to ensure that the fit is correct and that orthotics and 
prosthetics management and training technology has evolved since the 
last valuation of these codes, meaning more specialized expertise is 
needed by a therapist.
    Response: We thank the commenters for their input. We continue to 
believe that the proposed value most accurately captures the work 
involved in this service. As a result, we are finalizing our proposed 
value for CY 2018.
    Comment. One commenter supported ``CMS' proposal to eliminate code 
97762'' but did not support the adoption of CPT code 97763 in its place 
because in their view it eliminates the evaluation component of CPT 
code 97760 that was previously used to report subsequent encounters for 
orthotic management services. This commenter believes that the new CPT 
codes descriptors complicate coding through the unnecessary designation 
of subsequent or initial services. This commenter also noted this to 
mean that all other encounters are subsequent encounters to this 
initial fabrication--which they believe is typically billed using a 
HCPCS L-code; that the new CPT code 97763 is redundant because it is 
used at a subsequent encounter from the one during which the orthosis 
was fabricated, and that CPT code 97760 is the only code needed to bill 
correctly for both the evaluation of fit and use, subsequent 
modifications and additional training or repairs revealed during 
reassessment of the orthosis. Regardless of the specific encounter 
during which these orthotic management services are billed, the 
commenter noted that the level of work is the same--supporting the 
increased work RVUs of code 97760.
    Response: We thank the commenter for the information provided on 
their coding concerns and their support for the work RVU of CPT code 
97760. We note that while CMS proposes and finalizes the valuation of 
these services, it is the CPT Editorial Panel that revises CPT 
descriptors as well as adds and deletes CPT codes.
    Comment. Several commenters expressed concern that the HCPAC one-
to-one utilization crosswalk recommendations for all three codes in 
this family are potentially flawed when viewed in the context of the 
new CPT code descriptors. One commenter stated that they anticipate 
there will be a redistribution in coding between CPT codes 97760 and 
97761 to 977X1/97763 based on the assumption that the majority of 
patients have more than 1 billing session for an orthosis or 
prosthesis; therefore, the commenter estimated some volume of services 
previously billed under CPT codes 97760 and 97761 will be billed under 
CPT code 977X1. Another commenter noted the code descriptor revisions, 
particularly the addition of ``initial encounter'' to CPT code 97760, 
could be interpreted to include that encounter in which the therapist 
billed for the fabrication of the orthotic using an HCPCS L-code, and 
could result in a shift to CPT code 97763.
    Response: We appreciate the feedback that these commenters provided 
on the utilization crosswalk recommendations from the HCPAC, and note 
that these concerns echo some of the concerns that we raised in the CY 
2018 PFS proposed rule. After consideration of the public comments, we 
are finalizing our proposal to accept the HCPAC recommended work RVUs 
for CPT codes 97760, 97761, and 97763. Because these codes are subject 
to the same MPPR policy as the 19 PM&R codes discussed in the above 
section, we are not finalizing our proposal to retain the existing PE 
inputs for these three codes. Instead, we are not finalizing our 
proposal to retain the existing PE inputs for these three codes 
because, as we discussed in an above section on PM&R codes, we were 
persuaded by the HCPAC that the PE Subcommittee took into account the 
50 percent MPPR policy when developing the PE inputs for these codes.
    We also note that these codes are designated as ``always therapy,'' 
meaning that they always represent therapy services regardless of who 
furnishes them; and that a GO or GP therapy modifier is always required 
to indicate that the services are furnished under an OT or PT plan of 
care, respectively. As ``always therapy,'' these codes are subject to 
the therapy MPPR and the statutory therapy caps.
(56) Assessment of and Care Planning for Patients With Cognitive 
Impairment (CPT Code 99483)
    For CY 2017, CMS began making separate payment for HCPCS code G0505 
(Assessment and care planning for patients with cognitive impairment) 
as an interim means of facilitating payment for a CPT code that was 
forthcoming for CY 2018, eventual CPT code 99483. As part of public 
comment on the CY 2017 PFS proposed rule, the RUC submitted recommended 
values for this code, which we adopted in the CY 2017 PFS final rule. 
For CY 2018, CMS is adopting CPT code 99483, and deleting the interim 
HCPCS code G0505. As is our longstanding practice, when we propose to 
accept the RUC-recommended values for a code and did not have any 
significant concerns, we did not write about this proposal in the 
preamble to the CY 2018 PFS proposed rule.
    Comment: Several commenters supported the adoption of CPT code 
99483. Commenters stated that by making separate payment for this code, 
we were helping patients with dementia gain access to valuable medical 
care. One commenter also included questions that it had gathered from 
practitioners about billing HCPCS code G0505. We did not receive any 
comments that opposed adoption of CPT code 99483.
    Response: We thank commenters for their support, and will consider 
the practitioners' questions for forthcoming guidance, as appropriate.
    Comment: A few commenters noted that there were slight variations 
in scope of service elements between the HCPCS code G0505 and CPT code 
99483.
    Response: We believe that despite the differences, the policies of 
CPT code 99483 conform to those of the HCPCS G-code and intend to 
monitor this service and seek input from stakeholders as to whether we 
should issue additional regulatory or sub-regulatory guidance.
    For CY 2018, CMS is deleting the interim HCPCS code G0505 and 
replacing it with CPT code 99483. After consideration of these 
comments, we are finalizing the new descriptor for CPT code 99483, as 
proposed. We note that we previously adopted the RUC-recommended values 
for this service in the CY 2017 PFS final rule and will continue to use 
the RUC-recommended values with our adoption of CPT code 99483.
(57) Psychiatric Collaborative Care Management Services (CPT Codes 
99492, 99493, 99494, and 99484).
    In the CY 2017 PFS final rule (81 FR 80230), we established 
separate

[[Page 53078]]

payment for three services (HCPCS codes G0502, G0503, and G0504) under 
the psychiatric collaborative care model that paralleled CPT codes that 
were being created to report these services as well as a G-code for 
general behavioral health integration (BHI) services (HCPCS code 
G0507).
    For CY 2018, the CPT Editorial Panel is creating CPT codes 99492, 
99493, 99494, and 99484 to describe these services. For CY 2018, we are 
adopting these CPT codes and deleting HCPCS codes G0502, G0503, G0504, 
and G0507. We proposed the RUC-recommended work RVUs for each of these 
CPT codes, which are identical to the current values for HCPCS codes 
G0502, G0503, G0504, and G0507.
    We proposed the RUC-recommended PE inputs, with one refinement. The 
RUC-recommended values included clinical labor inputs in the facility 
setting, but we did not propose to include these minutes in developing 
the facility PE RVUs.
    Were we to develop facility PE RVUs for these services that 
included clinical staff time, when a practitioner working in a 
provider-based department of a hospital was furnishing these services, 
both the professional and the hospital would be paid for the same 
clinical labor costs. We presumed that this aspect of the RUC's 
recommendation reflects the circumstance where the patient receiving 
the services spends a significant period of time in a facility setting, 
but the billing practitioner is nonetheless incurring the cost 
associated with the non-face-to-face clinical staff time over the 
course of a month. We recognized that the binary site of service 
differential may not recognize the different models of this kind of 
care and may not be appropriate in some cases. We sought comments on 
how to best address this valuation issue for these and other monthly 
care management services. We noted that we could consider a range of 
options for future rulemaking, including allowing separate billing for 
the professional, technical, and global components of these services to 
allow practitioners to bill the component of the service they furnish.
    We stated in the CY 2017 PFS final rule (81 FR 80236) that the 
general BHI code (CPT code 99484) may be used to report a range of 
models of BHI services and that we expected this code to be refined 
over time as we receive more information about other BHI models in use. 
We remain interested in how this code is being used and look forward to 
hearing from stakeholders regarding its use in reporting different 
models of BHI services. Additionally, we have received inquiries from 
stakeholders about whether or not professionals who cannot report E/M 
services to Medicare might nonetheless serve as a primary hub for BHI 
services. For example, stakeholders have suggested that a clinical 
psychologist might serve as the primary practitioner that integrates 
medical care and psychiatric expertise. For purposes of future 
rulemaking, we sought comment on the circumstances under which this 
model of care is happening and whether additional coding would be 
needed to accurately describe and value other models of care.
    Comment: A few commenters noted that the logic that would dictate a 
lower PE RVU in a facility does not fit with the care management model 
and one commenter also noted that patients in facility settings are 
more medically and behaviorally complex. Some commenters stated that 
they would be open to separate billing for the professional, technical, 
and global components of these services in order to allow practitioners 
to appropriately bill the component of the service they furnish and 
preferred that option over not including clinical staff time in the 
facility setting. One commenter suggested that CMS instruct 
practitioners billing for these services to report the place of service 
where they practice rather than the location of the patient.
    Response: We will consider the commenters' input on solutions to 
the site of service differential for care management services for 
future notice and comment rulemaking. We also note that because these 
codes describe services that take place over the course of a calendar 
month, we have issued additional guidance, which can be found on the 
CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Behavioral-Health-Integration-FAQs.pdf.
    Comment: A few commenters suggested that CMS create separate codes 
to describe behavioral health care management services that could be 
billed by psychologists and other non-physician practitioners who are 
not authorized to bill Medicare for E/M services. One commenter 
suggested that CMS include psychiatric diagnostic evaluation services 
that can be furnished and billed by psychologists as eligible 
initiating visits. Another commenter urged CMS to expand coverage to 
make separate reimbursement to the psychiatric consultant in the 
collaborative care model. Alternatively, another commenter noted that 
integration of medical and psychiatric care requires the ability to 
advise and make medical recommendations as needed for all relevant 
medical care, including treatment for physical health conditions, which 
may include psychiatric and other medical differential diagnosis, 
treatment strategies regarding appropriate therapies, medication 
management, and medical management of complications associated with 
treatment of psychiatric disorders. Commenters also described other 
models of care that are in use, including the STAR-VA model and a model 
used in outpatient health care settings where a clinical social worker 
not only provides psychiatric care but also assists with psychosocial 
aspects of medical care.
    Response: We thank commenters for their input and note that there 
were several issues for which there was not stakeholder consensus. We 
will consider all of the comments for future notice and comment 
rulemaking.
    For CY 2018, CMS is deleting the interim HCPCS codes G0502, G0503, 
G0504, and G0507 and replacing them with CPT codes 99492, 99493, 99494, 
and 99484, respectively. After consideration of these comments, for CY 
2018, we are finalizing the coding and valuation for CPT codes 99492, 
99493, 99494, and 99484, as proposed.
(58) Hyperbaric Oxygen Therapy (HCPCS Code G0277)
    In the CY 2016 PFS final rule with comment period (80 FR 71005), we 
discussed the CY 2015 valuation of hyperbaric oxygen therapy services 
(79 FR 67677). 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 the 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 
multiple settings. In establishing interim final direct PE inputs for 
HCPCS code G0277, we used the RUC-recommended direct PE inputs for CPT 
code 99183, which assumed a 120-minute treatment interval and adjusted 
them to align with the 30-minute treatment interval of HCPCS code 
G0277. We observed that the quantity of oxygen increased significantly 
relative to the previous inputs for CPT code 99183.
    To better understand why the oxygen supply increased, we reviewed 
the instruction manual for the Sechrist Model 3600E Hyperbaric Chamber, 
which was the model noted on the invoice that was included with the RUC

[[Page 53079]]

recommendations for use in pricing the capital equipment. The 
instruction manual for the Sechrist 3600E model provided guidance 
regarding the quantity of oxygen to be used in furnishing the service 
described by HCPCS code G0277. Based on our review at that time, we 
determined that 12,000 liters, rather than 47,000 liters, was the 
typical number of units for the oxygen gas. Therefore, in aligning the 
direct PE inputs as described in the CY 2016 final rule with comment 
period, we first adjusted the units of oxygen to 12,000 liters for the 
recommended 120 minute time, and subsequently adjusted it to align with 
the 30-minute G-code by dividing by 4. We stated that we agreed that an 
initial high purge flow rate is needed to reach maximum pressure/
O2; however, we still had not seen data that demonstrated 
the need to continue the high purge flow rate throughout the entire 
session. According to the manufacturer's instruction 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 stated that ``the plateau purge flow can be set to 80 
liters per minute (lpm).'' We calculated that 13 minutes at 400 lpm 
plus 120 minutes at 80 lpm equals 14,800 liters of oxygen. We stated 
that based on information in the manufacturer's manual that was 
publicly available at the time, we believed that this represented the 
typical usage for a 120-minute treatment. That amount represented an 
increase from the interim final amount of 12,000 liters. We aligned 
this total oxygen requirement to the 30-minute G-code by dividing 
14,800 liters of oxygen by 4 and stated we were updating the direct PE 
inputs to 3,700 liters of oxygen for HCPCS code G0277.
    For CY 2018, we received requests from stakeholders to update the 
direct PE inputs for HCPCS code G0277. In the CY 2016 PFS final rule 
with comment period (80 FR 71005), we explained that we had previously 
established values for this service based on information suggesting 
that the Sechrist Model 3600E Hyperbaric Chamber was typically used in 
furnishing the service in the non-facility setting. As we noted in that 
rule, we established the amount of oxygen used in furnishing the 
service based on use of the equipment item described as part of the RUC 
recommendation, instead of the RUC-recommended amount of oxygen, which 
appeared to be based on use of a different equipment product, the 
Sechrist Model 3200. Based on information received from stakeholders, 
we proposed in the CY 2018 PFS proposed rule to update both the 
equipment item and the amount of oxygen so that the amount of oxygen 
conforms to the RUC-recommended value of 47,600 liters of oxygen, which 
we divided by 4 to conform to the 30-minute service period for HCPCS 
code G0277, and that the equipment item is consistent with that 
recommendation. The proposed direct PE inputs for HCPCS code G0277 were 
displayed in the proposed CY 2018 direct PE input database, available 
on the CMS Web site under the downloads for the CY 2018 PFS proposed 
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We also proposed to exclude this change in direct PE inputs from 
the calculation of the misvalued code target, since we viewed this 
proposed change as a refinement of a single recommendation over several 
years. Since the initial recommendation (79 FR 67677) was undertaken in 
a year without the misvalued code target, we believed it would be 
consistent with our previously established policy (80 FR 70923) to 
exclude this change from the calculation. We noted that this change 
would represent an increase from the current PE RVUs for this service.
    Comment: Commenters were supportive of our proposal to update the 
equipment item and the quantity of oxygen in the supply items for this 
service.
    Response: We appreciate the commenters' feedback.
    After consideration of the comments received, we are finalizing the 
direct PE inputs for HCPCS code G0277 as proposed. The direct PE inputs 
for HCPCS code G0277 are displayed in the CY 2018 final rule direct PE 
Input database, available on the CMS Web site under the downloads for 
the CY 2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(59) Payment Accuracy for Prolonged Preventive Services (HCPCS Codes 
G0513 and G0514)
    Many services paid under the PFS are coded to reflect differential 
resource costs associated with different levels of care. However, this 
level of granularity is not applied evenly across the PFS. For example, 
there are far fewer E/M visit codes than there are codes that describe 
procedures. While not a comprehensive solution to address the 
differential resource costs of certain E/M visits, prolonged services 
codes can be used to report medically necessary E/M visits that require 
additional amounts of time. Like E/M visit codes, many of the Medicare-
covered preventive services codes describe a service that has an 
atypically broad range of potential resource costs, including 
differential amounts of time required to furnish services. However, 
unlike for most E/M visit codes, there are not prolonged services codes 
that apply to Medicare-covered preventive services.
    Some stakeholders expressed concerns to CMS regarding the lack of a 
coding mechanism for practitioners to report the additional time 
sometimes required to appropriately furnish care to a patient receiving 
a Medicare-covered preventive service. We noted that Medicare covers a 
broad range of preventive services, such as a ``Welcome to Medicare 
Preventive Visit'', yearly wellness visits, cancer screenings, and many 
types of counseling. Medicare beneficiary coinsurance and deductible 
payments are not applicable for certain Medicare-covered preventive 
services. Additional information about preventive services covered 
under Medicare, including whether beneficiary coinsurance or deductible 
apply, is available on the CMS Web site at https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/Downloads/MPS-QuickReferenceChart-1TextOnly.pdf. To more accurately reflect the differential resource 
costs when additional time is required to furnish a Medicare-covered 
preventive service, we proposed to make payment for prolonged 
preventive services using two new HCPCS G-codes that could be billed 
along with the Medicare-covered preventive service codes, when a 
clinician provides a prolonged Medicare-covered preventive service.
     G0513: Prolonged preventive service(s) (beyond the typical 
service time of the primary procedure) in the office or other 
outpatient setting requiring direct patient contact beyond the usual 
service; first 30 minutes (List separately in addition to code for 
preventive service)), and
     G0514: Prolonged preventive service(s) (beyond the typical 
service time of the primary procedure) in the office or other 
outpatient setting requiring direct patient contact beyond the usual 
service; each additional 30 minutes (List separately in addition to 
code for preventive service)).
    We proposed that HCPCS codes G0513 and G0514 could only be billed 
with Medicare-covered preventive services. Beneficiary coinsurance and

[[Page 53080]]

deductible would not be applicable for HCPCS codes G0513 and G0514 
because the codes can only be reported to describe prolonged portions 
of services where beneficiary coinsurance and deductible are not 
applicable.
    We proposed to create prolonged services codes in 30-minute 
increments instead of the 60-minute increments that apply for the 
parallel office/outpatient prolonged services codes, since some 
Medicare-covered preventive services have a shorter duration than E/M 
visits. For purposes of valuation for both initial and additional 30 
minute codes, we proposed to use one half of the current work RVUs and 
direct PE inputs for CPT code 99354 (Prolonged evaluation and 
management or psychotherapy service(s) beyond the typical service time 
of the primary procedure) in the office or other outpatient setting 
requiring direct patient contact beyond the usual service; first hour 
(List separately in addition to code for office or other outpatient 
Evaluation and Management or psychotherapy service)). CPT code 99354 
has a total time of 60 minutes and a work RVU of 2.33. Therefore, we 
proposed a work RVU of 1.17 and 30 minutes of total work time for HCPCS 
codes G0513 and G0514. We proposed to use one half of the direct PE 
inputs for CPT code 99354, which resulted in a proposal of 7 minutes of 
clinical labor type L037D (RN/LPN/MTA) and 15 minutes for equipment 
type EF031 (table, power) for HCPCS codes G0513 and G0514 as the best 
reflection of typical direct PE costs. We understood that these 
specific clinical labor and equipment types may be functioning as proxy 
inputs for some Medicare-covered preventive services.
    We proposed that HCPCS codes G0513 and G0514 be billed for 
prolonged preventive services beyond the typical service time of the 
primary procedure. For preventive services with both physician work and 
PE, we considered the typical service time of the primary procedure to 
be the intraservice work time used for the purposes of PFS ratesetting. 
For Medicare-covered preventive services with no face-to-face physician 
work, the typical time is the service period clinical staff time that 
best represents the face-to-face time with the patient. The counted 
time guidelines (derived from the typical times assumed for PFS 
ratesetting) for all eligible companion Medicare-covered preventive 
services are available in the file called ``CY 2018 Preventive Services 
Billed with Prolonged Preventives Code'' on the CMS Web site under 
downloads for the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Comment: Many commenters supported our proposal to pay separately 
for prolonged preventive services. Commenters stated that by paying 
separately for necessary additional time spent with patients during 
preventive visits, CMS was both improving payment accuracy and 
increasing accessibility to these services. Commenters also agreed with 
our decision to only allow HCPCS codes G0513 and G0514 to be billed 
with the preventive services where beneficiary coinsurance and 
deductible are not applicable.
    Response: We thank the commenters for their support of coding and 
valuation for prolonged preventive services.
    Comment: One commenter urged CMS to continue to work with the 
disability community on innovative solutions as part of a broader 
approach to ensuring equal health care access for people with 
disabilities and suggested additional activities.
    Response: We thank the commenter for the suggestions and look 
forward to collaborating on other steps to improve access for people 
with disabilities.
    Comment: One commenter suggested that CMS allow HCPCS codes G0513 
and G0514 to be billed with HCPCS code G0296 (Counseling visit to 
discuss need for lung cancer screening using low dose CT scan), while 
another commenter recommended that CMS expand use of these codes beyond 
preventive services. One commenter requested that CMS allow HCPCS codes 
G0513 and G0514 to be billed with HCPCS code G0447 (Face-to-face 
behavioral counseling for obesity, 15 minutes). This commenter 
expressed concern that there were very few cognitive services on the 
list of eligible codes, yet the nature of a cognitive service may 
require more time to furnish to a patient.
    Response: We appreciate the commenters' interest in adding to the 
types of services that can be billed with these codes. For many 
services on the PFS, there are already coding mechanisms in place to 
account for extra time spent with patients such as the CPT codes 
available to account for prolonged E/M services (CPT codes 99354 and 
99355). However, as we have previously noted, there continue to be 
areas where we believe that current PFS coding may not accurately 
reflect the differential resource costs associated with certain visits, 
and we remain committed to working with beneficiaries, advocates, and 
practitioners to continue to explore improvements in payment accuracy 
for these services. To continue address this issue and to better align 
coding and payment for prolonged E/M services with prolonged preventive 
services, we proposed the above codes. As Medicare preventive services, 
these codes may only be added on to other Medicare covered preventive 
services for which there is also no applicable cost sharing.
    With regard to HCPCS code G0447, we do not believe that HCPCS codes 
G0513 and G0514 are coded to be applicable to timed services. We 
welcome additional input from stakeholders regarding appropriate coding 
and billing for these services and will consider addressing these 
issues in future rulemaking. Finally, we note that HCPCS code G0296 is 
eligible to be billed with prolonged preventive services.
    Comment: Several commenters made specific suggestions as to the 
format of the file CMS released with the typical times for eligible 
preventive services. One commenter stated that releasing the file as a 
download on the CY 2018 PFS final rule Web page was insufficient, and 
that we should also include the typical times in the text of the CY 
2018 PFS final rule as well. Another commenter stated that they 
appreciated CMS releasing a file with the typical times, and encouraged 
us to incorporate this information into other sources, such as the 
Provider Payment Summary file.
    Response: We appreciate these suggestions. We will make the file 
with the typical times available via the downloads section of the CY 
2018 PFS final rule as this is sufficiently accessible for 
practitioners and stakeholders.
    Comment: One commenter requested that CMS clarify whether it would 
be able to bill the prolonged preventives codes if the additional time 
was distributed across multiple services performed on a single 
encounter.
    Response: We believe that it would be appropriate to bill the 
prolonged preventive services if all of the services performed are un-
timed preventive services with no beneficiary cost-sharing.
    Comment: Several commenters provided suggestions as to how CMS 
could further engage in outreach and guidance for practitioners. One 
commenter provided feedback on the kinds of monitoring and 
incentivizing activities CMS could undertake to advance beneficiary 
access to these services.

[[Page 53081]]

    Response: We thank commenters for their suggestions, and will 
consider them for the future.
    After consideration of comments received, we are finalizing our 
proposal for prolonged preventive services using HCPCS codes G0513 and 
G0514 with the work RVUs, work times, direct PE inputs, and 
requirements for these codes as proposed.
(60) Physician Coding for Insertion and Removal of Subdermal Drug 
Implants for the Treatment of Opioid Addiction (HCPCS Codes G0516, 
G0517, and G0518)
    We met with representatives from the American Society of Addiction 
Medicine (ASAM) in April 2016 to discuss the possibility of making 
separate payment for insertion and removal of buprenorphine 
hydrochloride, formulated as a 4-rod, 80 mg, long-acting subdermal drug 
implant for the treatment of opioid addiction. There are existing CPT 
codes that broadly describe the insertion and removal of non-
biodegradable drug delivery implants (CPT codes 11981 through 11983). 
However, ASAM contended that the resources associated with the 
administration of this particular drug are greater than that of other 
drug delivery implants, stating that the physician must insert four 
rods using a newly designed applicator and obturator and use a 
specially designed clamp to remove the four rods, which in some cases 
requires careful shaving of tissue that has attached to the rods during 
the 6-month period that the rods have been inserted. They noted that 
these procedures can have unique challenges associated with treating 
patients with opioid addiction, who often have complications and/or co-
morbidities. They also noted that the FDA has recognized the complexity 
of the technology and patient needs by establishing regulatory 
standards to adhere to the protocol and imposing special training 
requirements on physicians. ASAM indicated that they would pursue an 
application to the CPT Editorial Panel for new CPT codes.
    ASAM informed CMS that the CPT Editorial Panel did not approve its 
application; therefore, ASAM repeated its request that CMS establish 
separate payment for the insertion, removal, and removal with 
reinsertion of the buprenorphine subdermal implants.
    To improve payment accuracy, for CY 2018, we proposed to make 
separate payment for the insertion, removal, and removal with 
reinsertion of Buprenorphine subdermal implants using HCPCS G codes:
     HCPCS code G0516: Insertion, non-biodegradable drug 
delivery implants, 4 or more.
     HCPCS code G0517: Removal, non-biodegradable drug delivery 
implants, 4 or more.
     HCPCS code G0518: Removal with reinsertion, non-
biodegradable drug delivery implants, 4 or more.
    For HCPCS code G0516, ASAM stated that performing the procedure 
according to the FDA-required Risk Evaluation and Mitigation Strategies 
(REMS) program takes approximately 23-25 minutes for the a physician 
who is not a trainer/proctor for this procedure. They stated that in 
developing crosswalk recommendations for physician work values, they 
used a total time of 35-40 minutes, which is based on a preservice time 
of 10 minutes, an intraservice time of 20-25 minutes, and a postservice 
time of 5 minutes. Based on ASAM's recommendations, we proposed a work 
RVU of 1.82 for HCPCS code G0516, which is supported by a direct 
crosswalk to CPT code 64644 (Chemodenervation of one extremity; 5 or 
more muscles).
    For HCPCS code G0517, ASAM stated that data from physicians who 
perform this procedure indicated that it takes approximately 15-20 
additional minutes compared to the insertion procedure (HCPCS code 
G0516) based on the FDA-required REMS program for removal of the 
implant. ASAM noted that this procedure is of a higher intensity 
compared to CPT code 11982 as this service requires identification and 
removal of multiple subdermal implants. ASAM stated that in developing 
crosswalk recommendations for physician work values, they used a total 
time of 45-60 minutes, which is based on a preservice time of 10 
minutes, an intraservice time of 30-45 minutes, and a postservice time 
of 5 minutes. Based on ASAM's recommendations, we proposed a work RVU 
of 2.10 for HCPCS code G0517, which is supported by a direct crosswalk 
to CPT code 96922 (Laser treatment for inflammatory skin disease 
(psoriasis); over 500 sq cm).
    For HCPCS code G0518, ASAM indicated that there is minimal 
consolidation of effort since the removal of the implants from one arm 
is followed by insertion of a new set of implants in the contralateral 
arm. Physician data from those who have performed this procedure 
indicated that it takes approximately 70 minutes of total intra-service 
time. ASAM stated that in developing crosswalk recommendations for 
physician work values, they assumed a preservice evaluation time of 10 
minutes (7 minutes for removal and 3 minutes for insertion), 
positioning of 4 minutes (2 minutes for each arm), and wait time of 2 
minutes (1 minute for each arm). ASAM stated that using the multiple 
surgical procedure rule, they calculated an intraservice time of 40-58 
minutes based on 100 percent of the intraservice time for HCPCS code 
G0517 (30-45 minutes) and 50 percent of the intraservice time for HCPCS 
code G0516 (0.5 x (20 - 25) = 10 - 13). ASAM used a postservice time of 
8 minutes based on 100 percent of the postservice time for the removal 
arm and 50 percent of the postservice time for the insertion arm, 
equaling a total time of 58-76 minutes. Based on ASAM's 
recommendations, we proposed a work RVU of 3.55 for HCPCS code G0518, 
which is supported by a direct crosswalk to CPT code 31628 
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when 
performed; with transbronchial lung biopsy(s), single lobe).
    We proposed to use the direct PE inputs requested by ASAM for HCPCS 
codes G0516, G0517, and G0518, which are reflected in the Direct PE 
Inputs public use files for clinical labor, supplies, and equipment, 
available on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    In addition to seeking comment on the proposal to make separate 
payment for these services using HCPCS codes, we also sought comment on 
the appropriateness and accuracy of our proposed work RVUs and direct 
PE inputs.
    Comment: We received several comments on this proposal, which were 
unanimously supportive. Commenters commended CMS for its ongoing 
efforts to address the national opioid epidemic and ensure that 
patients with substance use disorders have access to medically 
necessary care.
    Response: We appreciate the commenters' support of the proposal. 
After consideration of the public comments, we are finalizing our 
proposal for separate payment for insertion, removal, and removal with 
reinsertion of Buprenorphine subdermal implants using HCPCS codes 
G0516, G0517, and G0518, and the valuation for HCPCS codes G0516, 
G0517, and G0518, as proposed.
(60) Superficial Radiation Treatment Planning and Management (HCPCS 
Code GRRR1)
    In the CY 2015 PFS final rule with comment period (79 FR 67666 
through 67667), we noted that changes to the CPT prefatory language 
limited the

[[Page 53082]]

codes that could be reported when describing services associated with 
superficial radiation treatment (SRT) delivery, described by CPT code 
77401 (radiation treatment delivery, superficial and/or ortho voltage, 
per day). The changes effectively meant that many other related 
services were bundled with CPT code 77401, instead of being separately 
reported. For example, CPT guidance clarified that certain codes used 
to describe clinical treatment planning, treatment devices, isodose 
planning, physics consultation, and radiation treatment management 
cannot be reported when furnished in association with superficial 
radiation treatment. Stakeholders stated that these changes to the CPT 
prefatory language prohibited them from billing Medicare for codes that 
were previously frequently billed in addition to CPT code 77401. We 
solicited comments as to whether the coding for SRT allowed for 
accurate reporting of the associated services.
    In the CY 2016 PFS final rule with comment period (80 FR 70955), we 
noted that the RUC did not review the inputs for SRT procedures, and 
therefore did not assess whether changes in valuation were appropriate 
in light of the bundling of associated services. In addition, we 
solicited recommendations from stakeholders regarding whether or not it 
would be appropriate to add physician work for this service, even 
though physician work is not included in other radiation treatment 
services. As commenters were not in agreement as to whether the service 
should be valued with physician work, we introduced the possibility of 
creating a HCPCS G-code to describe total work associated with the 
course of treatment for these services. The 2016 National Correct 
Coding Initiative (NCCI) Policy Manual for Medicare Services stated 
that radiation oncology services may not be separately reported with E/
M codes. While this edit is no longer active, stakeholders have stated 
that MACs have denied claims for E/M services associated with SRT based 
on the NCCI policy manual language. According to stakeholders, the 
bundling of services associated with SRT, as well as the confusion 
regarding the appropriate use of E/M coding to report associated 
physician work, meant that practitioners were not being accurately paid 
for planning and treatment management associated with furnishing SRT.
    Due to these concerns regarding reporting of services associated 
with SRT, in the CY 2018 PFS proposed rule, we proposed to make 
separate payment for the professional planning and management 
associated with SRT using HCPCS code GRRR1 (Superficial radiation 
treatment planning and management related services, including but not 
limited to, when performed, clinical treatment planning (for example, 
77261, 77262, 77263), therapeutic radiology simulation-aided field 
setting (for example, 77280, 77285, 77290, 77293), basic radiation 
dosimetry calculation (for example, 77300), treatment devices (for 
example, 77332, 77333, 77334), isodose planning (for example, 77306, 
77307, 77316, 77317, 77318), radiation treatment management (for 
example, 77427, 77431, 77432, 77435, 77469, 77470, 77499), and 
associated E/M per course of treatment). We proposed for this code to 
describe the range of professional services associated with a course of 
SRT, including services similar to those not otherwise separately 
reportable under CPT guidance and the NCCI manual. To value this code, 
we included the physician work and time associated with radiation 
management-related services that we think would be typical for a course 
of SRT treatment. These services include: CPT code 77261 (Therapeutic 
radiology treatment planning; simple), CPT code 77280 (Therapeutic 
radiology simulation-aided field setting; simple), CPT code 77300 
(Basic radiation dosimetry 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), CPT code 77306 (Teletherapy 
isodose plan; simple (1 or 2 unmodified ports directed to a single area 
of interest), includes basic dosimetry calculation(s)), CPT code 77332 
(Treatment devices, design and construction; simple (simple block, 
simple bolus)), and CPT code 77427 (Radiation treatment management, 5 
treatments). Therefore, for CY 2018, we proposed a work RVU of 7.93 for 
HCPCS code GRRR1. To develop the proposed direct PE inputs for this 
code, we proposed to use the RUC-recommended direct PE inputs from the 
aforementioned codes with several adjustments. We proposed to apply the 
staff type ``RN/LPN/MTA'' for all of the clinical labor inputs for this 
code because we believe that the typical office performing SRT would be 
staffed with this labor type, rather than with another clinical labor 
type such as radiation therapists, and we sought comment as to the 
appropriateness of the staff type ``RN/LPN/MTA'' for this SRT-related 
service. Some stakeholders have suggested that many services related to 
SRT are personally performed by the billing practitioner rather than by 
clinical staff. We proposed to remove the supply items ``gown, 
patient'' and ``pillow case'' that are associated with CPT code 77280, 
as these items are included in the minimum multispecialty visit pack 
that is associated with CPT code 77427. We did not propose to include 
the equipment items ``radiation virtual simulation system,'' ``room, 
CT'' and ``PACS Workstation Proxy'' that are associated with CPT code 
77280, as we do not believe that a typical office furnishing SRT uses 
this kind of equipment. Instead, we included additional time for the 
capital equipment used in delivering SRT in the proposed direct PE 
inputs.
    For ``radiation dose therapy plan,'' we proposed to apply the 
clinical labor time that is associated with CPT code 77300 to HCPCS 
code GRRR1 for purposes of developing a proposed value, but we sought 
comment as to whether the clinical staff would typically perform the 
radiation dose therapy planning for this service, or if the physician 
would perform this and/or other tasks, and, in the case of the latter, 
what the appropriate physician time would be. Likewise, we solicited 
comment as to whether the clinical labor associated with the 
teletherapy isodose plan would be performed by the physician. We 
proposed to assign 14 minutes each to the equipment items ``radiation 
therapy dosimetry software (Argus QC)'', ``computer workstation'', and 
``3D teletherapy treatment planning'' as these are the times assigned 
to these equipment items for CPT code 77300. We did not propose to 
include inputs related to radiation physics consultation, described by 
CPT code 77336, as we think that a typical course of SRT would not 
require this service, and the typical practitioner providing SRT would 
not be performing physics consultation, and we sought comment as to 
whether inputs associated with this code or other inputs used in 
furnishing analogous services should be included. We did not propose to 
include the post-operative office visits included in the valuation of 
CPT code 77427, as we did not believe that a typical course of SRT 
would require post-operative visits; however, we solicited comment 
regarding the amount of face-to-face time typically spent by the 
practitioner with the patient for radiation treatment management 
associated with SRT. As discussed in the CY 2016 PFS final rule with 
comment period (80 FR 70924 through

[[Page 53083]]

70927), in the case of new codes that describe services that were 
previously included in the payment for other codes, we finalized the 
policy that these new codes are excluded from the misvalued code target 
when they were previously bundled into a set of broadly reported E/M 
codes and services that include E/M visits. We noted that we did not 
believe that the change to separate payment for these kinds of services 
should be counted as increases that are included in calculating ``net 
reductions'' in expenditures attributable to adjustments for misvalued 
codes. Therefore, we proposed to exclude HCPCS code GRRR1 from the 
misvalued code target.
    Comment: Many commenters did not support our proposal to make 
separate payment for HCPCS code GRRR1 for CY 2018. These commenters 
stated that our proposed valuation of HCPCS code GRRR1 would represent 
a significant payment reduction for the associated services as compared 
with the list of services that they are currently billing in 
association with SRT. Many commenters stated that this new coding would 
inhibit access to care for these services, discouraging the use of SRT 
as a non-surgical alternative to Mohs surgery. Many suggested potential 
coding solutions to these concerns, including: Our proposed G-code 
should include inputs associated with more services, such as those 
associated with the intermediate and complex codes for services such as 
clinical treatment planning, simulating-aided field setting, and 
treatment devices; our proposed code should include inputs for fewer 
services; and the code for planning and management services associated 
with SRT should be billable in multiple units such as for once per day 
or once per lesion, rather than once for a full course of treatment as 
proposed. Some commenters expressed preference for multiple G-codes 
specific to each aspect of SRT delivery rather than a single bundle for 
all associated SRT-related services. More specifically, some commenters 
recommended three G-codes, representing treatment planning, treatment 
devices, and treatment management. According to some commenters, our 
proposal to value the planning and management services associated with 
SRT with one code does not recognize variation in services related to 
factors such as tumor type and location, and if the service is for skin 
cancer or keloid scar. Commenters noted a preference that new coding 
for these services should be developed through the CPT/RUC process. 
Commenters also expressed concerns about specific direct PE inputs, 
such as the clinical labor type assigned to HCPCS code GRRR1, stating 
that radiation therapists, not the staff type ``RN/LPN/MTA'' should be 
applied to this code. There was some disagreement among commenters 
about whether or not qualified medical physicists (QMPs) would 
typically be employed by dermatologists for SRT. A few commenters 
supported our proposal to make payment for planning and management 
services associated with SRT using HCPCS code GRRR1.
    Response: We appreciate the comments. Given the various concerns 
expressed by commenters, and the variety of potential solutions 
offered, we are not finalizing our proposed separate payment and coding 
for planning and management services associated with SRT at this time. 
We expect to continue considering alternative solutions. The impetus 
for making this proposal was based on our understanding that there are 
limits to the appropriate reporting of professional services associated 
with SRT, and the intent of this policy was to address gaps in what the 
current coding allows for in relation to SRT. However, commenters have 
indicated concerns with our proposed coding and valuation, including 
access to care concerns; therefore. Therefore we believe additional 
analysis is necessary and will further consider coding and payment for 
professional services associated with SRT in light of commenter 
concerns, and we are not establishing codes related to planning and 
management services associated with SRT in this final rule. We look 
forward to continuing our dialogue with stakeholders regarding the 
appropriate coding and valuation for SRT-related professional services, 
which we expect to address in future rulemaking.
    Comment: Several commenters stated that CPT code 77401 is 
undervalued and that it should be valued with a physician work 
component.
    Response: We note that our proposed G-code was designed, in part, 
to address feedback that has indicated that the current coding, 
including CPT code 77401, does not adequately account for the 
professional services associated with SRT delivery. We did not propose 
to value CPT code 77401, so we decline to do so now. We look forward to 
addressing these potential coding gaps in future rulemaking.
    After consideration of the comments received, we are not finalizing 
our proposal to make separate payment for the planning and management 
services associated with SRT using HCPCS code GRRR1. We will continue 
our dialogue with stakeholders to address appropriate coding and 
payment for professional services associated with SRT.
    We note that we did not propose and are not making any changes to 
the coding or valuation for CPT code 77401 (radiation treatment 
delivery, superficial and/or ortho voltage, per day) in this final 
rule. Providers can continue to bill CPT code 77401 as appropriate. 
However, under the CPT guidance that has been in effect for several 
years, certain codes used to describe clinical treatment planning, 
treatment devices, isodose planning, physics consultation, and 
radiation treatment management cannot be billed in addition to CPT code 
77401. These planning and management codes, however, can continue to be 
billed in addition to other codes involving other types of radiation 
treatment, such as HCPCS code G6003 (Radiation treatment delivery, 
single treatment area, single port or parallel opposed ports, simple 
blocks or no blocks: up to 5 mev) and CPT code 77523 (Proton treatment 
delivery; intermediate) in accordance with applicable guidance and 
requirements.

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I. Evaluation & Management (E/M) Guidelines and Care Management 
Services

    In recent years, we have sought to recognize significant changes in 
health care practice, especially innovations in the active management 
and ongoing care of chronically ill patients. We have been engaged in 
an ongoing incremental effort to identify gaps in appropriate coding 
and payment for care management/coordination, cognitive services and 
primary care within the PFS. This has included working with the CPT 
Editorial Panel (CPT) to develop and value (or revalue) the following 
service codes:
     Transitional care management (TCM) services (2013).
     Chronic care management services (CCM) (2015, 2017).
     Behavioral health integration (BHI) services (2017).
     Assessment/care planning services for cognitive impairment 
(2017).
     Prolonged E/M services without direct patient contact 
(2017).
    In response to public feedback regarding the initial implementation 
of TCM and CCM, in the CY 2017 PFS final rule (81 FR 80225 through 
80256), we finalized significant administrative burden reduction for 
CCM and focused on limiting as much as possible the ways in which 
Medicare's rules differed from the CPT guidance that generally applies 
for all payers. We also worked with the CPT Editorial Panel and other 
stakeholders to develop coding and improve payment accuracy for BHI, 
cognitive impairment assessment/management, and prolonged services. In 
the CY 2017 PFS final rule (81 FR 80255), we also reiterated our 
commitment to addressing disparities for individuals with disabilities 
and advancing health equity, and noted that we will continue to explore 
improvements in payment accuracy for services furnished to individuals 
with disabilities. We look forward to continued work with stakeholders 
to ensure that the coding and valuation of these services accurately 
reflects the resource costs involved in furnishing these services. In 
the CY 2018 PFS proposed rule (82 FR 34078 through 34080), we solicited 
public comments on ways we might further reduce administrative burden 
for these and similar services under the PFS.
1. E/M Guidelines
a. Background
    Most physicians and other billing practitioners bill patient visits 
to the PFS under a relatively generic set of codes that distinguish 
level of complexity, site of care, and in some cases, between new or 
established patients. These codes are called Evaluation and Management 
(E/M) visit codes. For example, there are generally three levels of 
hospital and nursing facility inpatient E/M visit codes, and five 
levels of office or hospital outpatient E/M visit codes, that vary 
based on complexity. The latter also distinguish whether or not the 
patient is new to the billing practitioner.
    Billing practitioners must maintain information in the medical 
record to document that they have reported the appropriate level of E/M 
visit code. CMS maintains guidelines that specify the kind of 
information that is required to support Medicare payment for each 
level. According to these documentation guidelines, there are three key 
components to selecting the appropriate level:
     History of Present Illness (HPI or History);
     Physical Examination (Exam); and
     Medical Decision Making (MDM).
    There are two versions of the documentation guidelines, commonly 
referenced based on the year of their release (the ``1995'' and 
``1997'' guidelines), available under downloads on the CMS Web site at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. The most substantial differences between 
the two sets of guidelines pertain to requirements for the physical 
exam. The two versions have a slight difference in requirements for 
documenting the history, and no difference in requirements for MDM. In 
documenting a given E/M service, practitioners must use one version of 
the guidelines or the other, with one exception related to extended 
histories (see the Evaluation and Management Services guide available 
on the CMS Web site at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf). These guidelines are very similar to guidelines 
within the CPT codebook for E/M visits. We provide an example of how 
the guidelines distinguish between level 2 and level 3 visits in Table 
17.
    Stakeholders have long maintained that both the 1995 and 1997 
guidelines are administratively burdensome and outdated with respect to 
the practice of medicine, stating that they are too complex, ambiguous, 
and that they fail to distinguish meaningful differences among code 
levels. In general, we agree that there may be unnecessary burden with 
these guidelines and that they are potentially outdated, and believe 
this is especially true for the requirements for the history and the 
physical exam. The guidelines have not been updated to account for 
significant changes in technology, especially electronic health record 
(EHR) use, which presents challenges for data and program integrity and 
potential upcoding given the frequently automated selection of code 
level.
    Although CMS conducts few audits on E/M visits relative to the 
volume of PFS services they comprise, we have repeatedly heard from 
practitioners that compliance with the guidelines is a source of 
significant audit vulnerability and administrative burden. Our prior 
attempts to revise the guidelines met with a lack of stakeholder 
consensus and support, which contributed to the current policy that 
allows practitioners to use either the 1995 guidelines or 1997 
guidelines, resulting in further complexity in determining or selecting 
the applicable requirements.
b. E/M Guidelines Public Comment Solicitation
    We continue to agree with stakeholders that the E/M documentation 
guidelines should be substantially revised. We believe that a 
comprehensive reform of E/M documentation guidelines would require a 
multi-year, collaborative effort among stakeholders. We believe that 
revised guidelines could both reduce clinical burden and improve 
documentation in a way that would be more effective in clinical 
workflows and care coordination. We also think updated E/M guidelines 
coupled with technological advancements in voice recognition, natural 
language processing and user-centered design of EHRs could improve 
documentation for patient care while also meeting requirements for 
billing and population health management. We recognize that achieving 
the goal of reduced clinician burden and improved, meaningful 
documentation for patient care will require both updated E/M 
guidelines, as well as changes in technology, clinician documentation 
practices and workflow. We solicited input from a broad array of 
stakeholders, including patient advocates, on the specific changes we 
should undertake to reform the guidelines, reduce the associated 
burden, and better align E/M coding and documentation with the current 
practice of medicine.
    We specifically sought comment on how we might focus on initial 
changes to the guidelines for the history and physical exam, because we 
believe documentation for these elements may be more significantly 
outdated, and that

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differences in MDM are likely the most important factors in 
distinctions between visits of different levels. We also specifically 
sought comment on whether it would be appropriate to remove our 
documentation requirements for the history and physical exam for all E/
M visits at all levels. We stated that we believed MDM and time are the 
more significant factors in distinguishing visit levels, and that the 
need for extended histories and exams is being replaced by population-
based screening and intervention, at least for some specialties. In 
addition, an increase in the utilization of EHRs, and to some extent, 
shared health information via EHRs, may have changed the character of 
extended patient histories since the guidelines were established. As 
long as a history and physical exam are documented and generally 
consistent with complexity of MDM, we believed there may no longer be a 
need for us to maintain such detailed specifications for what must be 
performed and documented for the history and physical exam (for 
example, which and how many body systems are involved). We sought 
comment on whether clinicians and other stakeholders believe removing 
the documentation requirements for the history and physical exam would 
be a good approach.
    Although we believed that MDM guidelines may also need to be 
updated, we stated our belief that in the near term, it may be possible 
to eliminate the current focus on details of history and physical exam, 
and allow MDM and/or time to serve as the key determinant of E/M visit 
level. We sought public comment on this approach. We also sought 
comment on how such reforms may differentially affect physicians and 
practitioners of different specialties, including primary care 
clinicians, and how we could or should account for such effects as we 
examine this issue.
    We noted that there may still be clinical or legal reasons for 
individual practitioners to document an extended history or physical 
exam (for example, where there are negative findings for certain body 
systems in support of differential diagnosis). We additionally sought 
comment on whether CMS should leave it largely to the discretion of 
individual practitioners to what degree they should perform and 
document the history and physical exam.
    We also welcomed comments on specific ideas that stakeholders may 
have on how to update MDM guidelines to foster appropriate 
documentation for patient care commensurate with the level of patient 
complexity, while avoiding burdensome documentation requirements and/or 
inappropriate upcoding.
    The following is a summary of the public comments received on the 
E/M documentation guidelines, and our responses.
    Comment: We received many comments on potential updates and 
revisions to the E/M documentation guidelines. The comments described 
ways in which the guidelines may be outdated or need to be improved 
upon, for example to better reflect the content of E/M visit work, 
team-based care and the advent of EHRs. The commenters were 
appreciative and generally supportive of CMS undertaking this reform 
effort. Many of the comments reflected agreement with CMS (and other 
payers) that documentation standards are necessary to demonstrate and 
provide a clear record of what was performed in support of payment, as 
well as for legal and clinical reasons. However, commenters did not 
agree on how the current standards should be changed, and different 
specialties expressed different challenges and recommendations 
regarding the guidelines. Many professional specialty associations 
urged CMS to employ a more considered, long-term process such as a task 
force rather than immediate changes.
    There appeared to be some agreement among commenters that the 
documentation requirements for history and physical exam are 
particularly outdated. Commenters stated, for example, that they are 
often required to include or cut-and-paste into the record extraneous 
documentation detail regarding irrelevant history, review of unaffected 
systems, and unnecessary (and in some cases burdensome to the patient) 
physical exam elements, in order to justify an E/M code that most 
adequately reflects their work. They stated that this information 
bloats the medical record unnecessarily, increasing the time it takes 
to find or convey to the reader the most important and relevant 
clinical information at a given point in time. They said this detracts 
significantly from spending time on more important patient care 
activities.
    A few commenters believe that the two elements of history and exam 
could be eliminated entirely, while many commenters believe they needed 
to be retained, but changed or rolled up somehow into MDM. Some 
commenters believe that MDM is under-emphasized or could be assigned 
greater weight, while still recognizing the critical role that history 
and exam continue to play for patients, especially new patients. Some 
commenters believe that new guidelines to support MDM-driven E/M 
documentation need to be in place before requirements for history and 
exam are eliminated. Some specialties (for example, hematology-oncology 
and emergency medicine) explained that ensuring adequate performance 
and documentation of both history and physical exam at every visit is 
critical to their work for clinical, legal, operational, and other 
reasons.
    Some commenters raised the possibility of allowing flexibility at 
the practitioner or organization level. For example, one commenter 
suggested that CMS could encourage the use of unspecified standards, 
while allowing individual physicians to decide what components of a 
history and physical exam are required or should be documented for 
individual patients. Some commenters believe there are clinical reasons 
to include a history and exam in a patient's record, but they are not 
needed to determine the E/M code level. Others advised CMS to eliminate 
all numeric (counted) elements for history and exam in the 
documentation guidelines and allow physicians to document only what is 
relevant to the patient's specific diagnosis.
    There was no consensus among commenters on changes that would need 
to be made to MDM and time rules in order for CMS to rely more on these 
elements (in lieu of history and exam) to justify service level billed. 
Some commenters recommended clarification of ambiguities or more 
uniform interpretation of the current MDM guidelines. Others believe 
the existing criteria for assessing MDM are themselves inadequate, and 
that while MDM should carry the most weight, it is the hardest to 
measure meaningfully and is frequently subjective. Some commenters 
recommended alternatives such as different MDM levels reflecting 
comorbidity or the intensity of a single, highly active medical 
condition. Some believe that MDM was a key determinant but not 
sufficient to stand alone.
    Some commenters sought clarification on what CMS was proposing with 
respect to time. They were unclear how CMS envisioned time coming into 
play in a different way than it currently does. Commenters had 
differing views on the advisable role of time in determining code level 
(alone or in combination with MDM). Some recommended expanding the role 
of time, for example to enumerate time spent with family or spent 
taking extended histories rather than just counseling time. Others 
believe work should not be equated with time, or mentioned that relying 
on

[[Page 53165]]

time alone could create a perverse payment incentive.
    Some commenters recommended, for immediate relief, that history and 
exam should not be audited except where there is uncertainty regarding 
MDM or lack of documentation regarding time. A few commenters suggested 
alternative E/M service components such as the patient's functional 
status, review of medications and care coordination. One commenter 
listed several items they believe deserve CMS' review, even if there is 
not a broad revision to the guidelines, including perceived overly 
comprehensive history and exam requirements for the Level 4/5 
differential; MDM rules that value a new problem higher than an 
existing problem, even when it is clinically more minor; MDM rules that 
do not distinguish medication risk according to how benign the 
medication is; and the level of audit risk or exposure if less 
information (history and exam) would be included in the medical record.
    Some comments discussed the intersection of the guidelines with 
EHRs. Some commenters requested alignment of EHR templates with new 
guidelines, eliminating the need to cut-and-paste medical record 
information, and eliminating information blocking to outside clinicians 
(for example, pharmacists seeking information on patient history). 
There was some support for removing requirements to document social, 
family and past medical history in the medical record at a given visit 
when it is already present within an EHR. Similarly, there was support 
for only requiring full, baseline history and exam at time of first 
visit/consultation, with updates at subsequent visits only to areas of 
changes in condition that affect the treatment plan. There was also 
some support for physicians being allowed to review and cross-
reference, or sign off on, certain documentation entered by ancillary 
staff or technicians, entered directly by patients (such as through a 
patient portal), or captured automatically by devices.
    A number of commenters specified that changes should be effective 
across all E/M codes of all levels. Some specialties requested 
particular consideration of care settings other than just outpatient 
care, such as inpatient or other transitional care settings.
    Many commenters urged CMS to proceed cautiously by making changes 
over a period of multiple years, using a representative task force and 
additional public forums such as open door forums and listening 
sessions prior to implementing broad changes. Some commenters suggested 
that reforming the guidelines is a monumental task that would have a 
far-reaching impact and needs to be done judiciously since, for 
example, commercial payers often follow Medicare rules in this area. 
These commenters stated that, if done correctly, revising the 
guidelines will be a significant undertaking that is likely to last 
several years and require an inclusive, transparent, iterative and 
perhaps transitional process to ensure that all stakeholders across all 
specialties are involved, that a thoughtful examination of options can 
take place, and that the benefits and consequences of any potential 
changes can be identified. Some commenters specified that the CPT 
Editorial Panel, private insurers and EHR vendors should be involved.
    Some commenters recommended clarification and training by CMS of 
unspecified issues on interpretation of current guidelines, but 
requested that CMS seek full input before moving forward with any 
changes, including these clarifications. These commenters stated that 
even minor changes to the codes or their documentation would require 
physicians and practices a great deal of time to understand and 
implement. A number of commenters asked CMS not to make any immediate 
changes for these or similar reasons.
    Response: We thank the commenters for this feedback. We are 
especially appreciative of the commitment from stakeholders to work 
with us on developing and implementing potential changes. We also note 
that commenters frequently suggested that we provide additional avenues 
for collaboration with stakeholders prior to implementing any changes. 
We are currently considering the best approaches for such 
collaboration, and will take the comments into account as we consider 
the issues for future rulemaking.
    In the CY 2018 PFS proposed rule (82 FR 34079), we further noted 
that through letters, meetings, public comment letters in past 
rulemaking cycles, and other avenues, we have heard from many 
stakeholders that the E/M code set itself is outdated and needs to be 
revised. For example, some stakeholders recommend an extensive research 
effort to revise and revalue E/M services, especially the work inputs 
(see 81 FR 46200). In prior rulemaking cycles, we acknowledged the 
limitations of the current E/M code set. In our proposed rule, we 
agreed that the structure of the underlying code set and its valuation 
relative to other PFS services are also important issues that we expect 
to continue to explore, though we stated our immediate focus on 
revision of the current E/M guidelines in order to reduce unnecessary 
administrative burden.
    Comment: Some commenters requested that CMS undertake revision or 
revaluation of the E/M code set itself, without further delay. Some 
commenters expressed that the failure of the current code set to fully 
capture cognitive work is more burdensome than the documentation rules 
and, if addressed, would simultaneously address unnecessary 
administrative burden. They stated that MDM is key to determining level 
of service; however MDM is not just a critical documentation 
requirement. In their view, it is also the critical piece to properly 
define and value E/M services. Some commenters recommended that the 
effort to revise documentation rules should be part of a broader 
initiative to accurately reimburse physicians and other health 
professionals for the work furnished during E/M visits, and that both 
issues are important for transition to value-based payment as 
physicians take on more accountability for their resource utilization. 
Similarly, some commenters believe the code set itself is a separate 
issue from the guidelines, but should be equally addressed by CMS and 
the AMA/CPT Editorial Panel in the longer-term.
    In contrast, other commenters believe that the current valuation of 
all E/M services should be presumed correct, and that the goal of 
reforming the guidelines is to make them consistent with current 
medical practice. Several commenters recommended that CMS consider the 
E/M definitional and valuation issues separate from E/M guideline 
revision. They believe that changes in the guidelines should not 
automatically require a review of current valuation. Also several 
commenters asked CMS to reinstate the specialist consultation codes 
that were discontinued for payment in 2010.
    Response: We thank the commenters for this feedback. We believe the 
public comments illustrate how difficult it is to utilize or rely upon 
such a relatively small set of codes to describe and pay for the work 
of a wide range of physicians and practitioners in many vastly 
different clinical contexts. We also believe the public comments 
illustrate that many of the issues with the E/M documentation 
guidelines are not simply a matter of undue administrative burden. The 
guidelines reflect how work was performed and valued a number of years 
ago, and are intimately related to the definition and description of E/
M work as well as its valuation. Opinions on potential redefinition and 
revaluation of the E/M code set tend to differ by specialty,

[[Page 53166]]

according to the type of work dominating each specialty (for example, 
primary care, so-called ``cognitive'' specialty work, or global 
procedures that have E/M visits bundled in rather than separately 
performed and documented). We expect to continue to work on all of 
these issues with stakeholders in future years though we are 
immediately focused on revision of the current E/M guidelines in order 
to reduce unnecessary administrative burden.
2. Care Management Public Comment Solicitation
    In the CY 2018 PFS proposed rule, we stated our continued interest 
in the ongoing work of the medical community and other stakeholders to 
refine the set of codes used to describe care management services. In 
section II.H of this final rule, we discuss our final policy to adopt 
CPT codes for CY 2018 to replace the G-codes we established for several 
new care management service codes finalized last year, describing 
cognitive impairment assessment and care planning, and behavioral 
health integration services. In CY 2018, these codes will be added to 
the suite of CPT care management service codes we adopted in recent 
years, including transitional care management and chronic care 
management (CCM) services. In our proposed rule, we also reiterated our 
commitment to work with stakeholders on necessary refinements to this 
code set, especially codes that would describe the professional work 
involved in caring for complex patients in additional clinical 
contexts. Also we solicited public comment on ways we might further 
reduce the burden for practitioners reporting care management services, 
including through stronger alignment between CMS requirements and CPT 
guidance for existing and potential new care management service codes.
    We received a few comments on ways CMS might further improve CCM 
services, and approaches that CMS might take more broadly to improve 
payment for care management services. In this section, we discuss the 
comments and respond.
    Comment: We received a few comments requesting a change in the 
coding or payment for CCM services. Several commenters recommended that 
CMS develop add-on codes to break out and pay for smaller clinical 
staff time increments (specifically, breaking out increments of greater 
than 20 minutes of clinical staff time, such as 21-40 minutes and 41-60 
minutes).
    Response: We appreciate the suggestion from commenters. At this 
time, we generally intend to consider pursuing future changes to the 
CPT codes describing chronic care management services, rather than 
create new add-on G codes that would be used alongside current CPT 
codes for CCM services. We urge stakeholders to work through the CPT 
process to make needed changes or create new codes for the CCM code set 
as appropriate.
    Comment: One commenter recommended that CMS not require that a copy 
of the care plan must be given to the patient (or caregiver as 
appropriate). The commenter recommended that CMS instead require that a 
copy of the plan of care must be available to the patient or caregiver.
    Response: In the CY 2017 PFS final rule (81 FR 80250), we revised 
this language to no longer mandate the format in which the care plan 
must be provided (written versus verbal) and, rather, to allow the care 
plan to be provided in a format consistent with patient/caregiver 
preference. We stated that while beneficiaries must be provided a copy 
of the care plan, practitioners may choose to provide the care plan in 
hard copy or electronic form in accordance with patient preferences. We 
believe our current language is more appropriate than the CPT language 
or the language recommended by the commenter because it allows 
flexibility in how the care plan information is transmitted to the 
patient (or caregiver, if appropriate) in accordance with patient needs 
or preference, but ensures to a greater degree that the information is 
actually received by them, whatever the format. We believe a 
requirement merely to make the information ``available'' may not ensure 
that it is actually received and understood. If the patient (or 
caregiver, if appropriate) prefers, the care plan may be provided to 
them via an electronic portal. Also, whatever format is used to provide 
the care plan, we expect that the care plan will be discussed with the 
patient (and/or caregiver as appropriate) as part of the management of 
their care and consistent with the other CCM scope of service elements.
    Comment: One commenter recommended that CMS not require 
documentation of each minute of service provided.
    Response: In addition to CCM, there are many CPT codes that are 
timed codes (having time within their code descriptor). The same rules 
should apply for documentation of time for CCM as for other timed 
services. For program integrity purposes (to ensure timed services are 
actually performed in full, as described and defined by the code(s)), 
we expect practitioners to document in the medical record how they 
spent the qualifying time. In the case of CCM, they must document that 
the required time was spent performing qualifying activities. This is 
routine policy for timed service codes. If practitioners have specific 
questions about the degree to which they must document and time their 
CCM work using the current CPT codes, they should consult their 
Medicare Administrative Contractor.
    Comment: One commenter recommended that CMS reduce the service 
elements for CPT code 99490 to require only one of the following 
service elements to be performed: Comprehensive care management, 
management of care transitions, or home- and community-based care 
coordination.
    Response: The current code descriptors and required scope of 
service elements reflect the results of our notice and comment 
rulemaking with significant contributions from the AMA/CPT Editorial 
Panel. We believe we should continue to require, for each month in 
which the service is billed, all of the service elements that are 
medically necessary for the patient, which we believe is also 
consistent with CPT reporting rules for CCM.
    Comment: One commenter asked CMS to further align its rules with 
CPT reporting rules by removing the requirement to use a certified EHR.
    Response: We continue to believe that use of certified EHR 
technology is vital to ensure that practitioners are capable of 
providing the full scope of CCM services, such as timely care 
coordination and continuity of care (see our prior discussion of this 
issue at 79 FR 67723). The use of certified EHR technology helps ensure 
that members of the interdisciplinary care team have timely access to 
the patient's most updated health information. Also we believe that use 
of certified EHR technology among physicians and other practitioners 
will increase as we move forward to implement the Quality Payment 
Program, including MIPS and Advanced Alternative Payment Models, as 
well as other value-based payment initiatives. Accordingly, we are not 
removing the requirement to use a certified EHR.
    Comment: One commenter recommended that CMS not require an 
initiating visit for any CCM patient. The commenter believes that 
patient consent to receive CCM services could be obtained by a care 
manager verbally by phone.

[[Page 53167]]

    Response: Starting in CY 2017, we removed the requirement for all 
CCM patients to receive initiating visits, instead only requiring it if 
the patient has not been seen within a year prior to commencement of 
CCM. Also we changed the consent requirement to allow verbal consent 
(rather than the written consent we previously required) for all 
patients, including patients who require an initiating visit. In other 
words, consent can already be obtained verbally independent of the 
initiating visit, as long as it is obtained prior to commencement of 
the monthly CCM services. We continue to believe that if the patient 
has not been seen within a year, there should be an initiating visit so 
the billing practitioner can assess or re-assess the patient, gather 
all necessary data to inform the care plan, and perform other 
preparatory work. Therefore we are not changing this requirement. We 
remind stakeholders that consent does not have to be obtained as part 
of an initiating visit and can be done separately, as long as it is 
obtained before the first CCM monthly service commences.
    Comment: We received a few comments on the add-on code (G0506) 
describing practitioner assessment and care planning in conjunction 
with an initiating visit. One commenter said there should not be a 
requirement for the billing practitioner to create the comprehensive 
care plan as part of this code. The commenter believes their role 
should instead be to identify and support patients during the 
enrollment process, and to generally supervise the creation of the CCM 
care plan. Another commenter recommended that CMS allow pharmacists to 
have the care planning in HCPCS code G0506 delegated to them.
    Response: We created HCPCS code G0506 explicitly to separately 
identify and pay for the time and work of the billing practitioner 
reporting the monthly CCM service, to ensure appropriate payment for 
their comprehensive assessment and involvement at the outset of CCM, if 
needed by the patient (81 FR 80245). We did this because we expect that 
much of the subsequent CCM services will be performed incident to the 
professional services of the billing practitioner and we wish to ensure 
appropriate personal involvement of, and payment to, the practitioner 
who is directly reporting CCM. The purpose for adopting this add-on 
code was to describe and provide appropriate payment for work that is 
personally and directly performed by the billing practitioner 
themselves in preparation for furnishing CCM services. Care planning 
that is performed by clinical staff incident to the services of the 
billing practitioner may be counted towards the clinical staff time of 
the monthly CCM service code(s), but cannot be counted towards G0506.
    Comment: One commenter asked CMS to clarify that the CCM planning 
code, HCPCS code G0506, can be billed on a day separate from an E/M 
date of service.
    Response: G0506 is comprised of a face-to-face assessment and care 
planning personally performed only once by the practitioner reporting 
the monthly CCM service, in conjunction with (as an add-on code to) an 
initiating visit. The face-to-face assessment would be performed the 
same day as the initiating visit, but some or all of the care planning 
piece could be performed by the billing practitioner on a subsequent 
day. Accordingly, we would expect the date of service for HCPCS code 
G0506 on the claim to be the same as for the base initiating visit 
code, and we will consider issuing an FAQ specifying this.
    Comment: Several commenters recommended that CMS seek ways to 
eliminate cost sharing for CCM and other care management services. 
These commenters expressed that it is difficult to explain the 
mechanics and benefits of care management to patients, given the added 
cost sharing. They recommended that CMS seek ways to remove the cost 
sharing, for example through designating the services as preventive 
services or working with Congress to accomplish it legislatively.
    Response: As we stated in our CY 2017 PFS final rule (81 FR 80240), 
we appreciate the commenters' concerns and recognize many of the 
challenges associated with patient cost sharing for these kinds of 
services. At this time, we do not have authority to remove cost sharing 
for care management services. We appreciate the commenters' 
acknowledgement of our current limitations and we will continue to 
consider this issue.
    Comment: We received a few comments recommending ways in which we 
might better involve specialists in the provision of CCM or care 
management broadly (such as payment to emergency department physicians 
when they act as primary care practitioners, or payment to multiple 
practitioners involved in managing a given patient at a given time). 
Also a few commenters recommended that CMS allow more than one 
practitioner to bill CCM per month. They believe there were situations 
where more than one practitioner co-manages a patient, or that 
particularly complex patients who would benefit from CCM services also 
benefit from seeing multiple health care providers.
    Response: At this time, only one practitioner can report CCM per 
month, consistent with both CPT guidance and the authorizing statute 
for payment of CCM services (section 1848(b)(8)(B) of the Act). 
However, we agree there may be circumstances in which more than one 
practitioner expends resources managing or helping manage a CCM 
patient. We will continue to explore ways in which we might better 
identify and pay for costs incurred by multiple practitioners who 
coordinate and manage a patient's care within a given month, and are 
interested in hearing more about the relevant circumstances, potential 
gaps in coding, and the exact nature of the work performed or costs 
incurred.

BILLING CODE 4120-01-P

[[Page 53168]]

[GRAPHIC] [TIFF OMITTED] TR15NO17.079

BILLING CODE 4120-01-C

[[Page 53169]]

M. Therapy Caps

1. Outpatient Therapy Caps for CY 2018
    Section 1833(g) of the Act (as amended by section 4541 of the 
Balanced Budget Act of 1997) (Pub. L. 105-33) requires application of 
annual per beneficiary limitations on the amount of expenses that can 
be considered as incurred expenses for outpatient therapy services 
under Medicare Part B, commonly referred to as ``therapy caps.'' There 
is one therapy cap for outpatient occupational therapy (OT) services 
and another separate therapy cap for physical therapy (PT) and speech-
language pathology (SLP) services combined. The therapy caps are 
permanent, meaning that the statute does not specify an end date.
    The therapy cap amounts under section 1833(g) of the Act are 
updated each year based on the MEI. Specifically, the annual caps are 
calculated by updating the previous year's cap by the MEI for the 
upcoming calendar year and rounding to the nearest $10.00. Increasing 
the CY 2017 therapy cap of $1,980 by the CY 2018 adjusted MEI of 1.4 
percent and rounding to the nearest $10.00 results in a CY 2018 therapy 
cap amount of $2,010.
    An exceptions process for the therapy caps has been in effect since 
January 1, 2006. Originally required by section 5107 of the Deficit 
Reduction Act of 2005 (DRA), which amended section 1833(g)(5) of the 
Act, the exceptions process for the therapy caps has been extended 
multiple times through subsequent legislation as described in the CY 
2015 PFS final rule with comment period (79 FR 67730). It was most 
recently extended by section 202 of the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), and is set to 
expire on December 31, 2017. The MACRA extension of the therapy cap 
exceptions process includes the application of the therapy caps to 
outpatient services furnished by hospitals described at section 
1833(a)(8)(B) of the Act by continuing the temporary suspension under 
section 1833(g)(6)(A) of the Act of the statutory exemption for these 
hospital therapy services that first became effective October 1, 2012 
through the enactment of the Middle Class Tax Relief and Jobs Creation 
Act of 2012 (MCTRJCA) (Pub. L. 112-96).
    CMS tracks each beneficiary's incurred expenses annually and counts 
them toward the therapy caps by applying the PFS rate for each service 
less any applicable multiple procedure payment reduction (MPPR) amount. 
As required by section 1833(g)(6)(B) of the Act, added by section 
603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-
240) and extended by subsequent legislation, the PFS-rate accrual 
process is applied to outpatient therapy services furnished by CAHs 
even though they are paid on a cost basis (effective January 1, 2014). 
As we explained in the CY 2016 PFS final rule with comment period, we 
use cost-based rates to track each beneficiary's incurred expenses 
amounts for the outpatient therapy services furnished by the Maryland 
hospitals paid under the Maryland All-Payer Model, currently being 
tested under the authority of section 1115A of the Act (effective 
January 1, 2016). After expenses incurred for the beneficiary's 
outpatient therapy services for the year have exceeded one or both of 
the therapy caps, therapy suppliers and providers use the KX modifier 
on claims for subsequent services to request an exception to the 
therapy caps. By using the KX modifier, the therapist is attesting that 
the services above the therapy caps are reasonable and necessary and 
that there is documentation of medical necessity for the services in 
the beneficiary's medical record. Claims for outpatient therapy 
services over the caps without the KX modifier are denied.
    Since October 1, 2012, under section 1833(g)(5)(C) of the Act as 
amended by the Middle Class Tax Relief and Jobs Creation Act of 2012 
(MCTRJCA) (Pub. L. 112-96), we have been required to apply a manual 
medical review process to therapy claims when a beneficiary's incurred 
expenses for outpatient therapy services exceed a threshold amount of 
$3,700. Just as there are two separate therapy caps, there are two 
separate thresholds of $3,700, one for OT services and one for PT and 
SLP services combined; and incurred expenses are counted towards these 
thresholds in the same manner as the caps. Under section 1833(g)(5) of 
the Act, as amended by section 202(b) of the MACRA, not all claims 
exceeding the therapy thresholds are subject to a manual medical review 
process as they were before. Instead, we are permitted to do a more 
targeted medical review on these claims using factors specified in 
section 1833(g)(5)(E)(ii) of the Act as amended by section 202(b) of 
the MACRA, including targeting those therapy providers with a high 
claims denial rate for therapy services or with aberrant billing 
practices compared to their peers. The manual medical review process 
required under section 1833(g)(5)(C) of the Act expires at the same 
time as the exceptions process for therapy caps, on December 31, 2017. 
For information on the manual medical review process, go to https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/TherapyCap.html.
    The statutory authority for the therapy caps exceptions process 
will expire on December 31, 2017. Under current law, the therapy caps 
will be applicable in accordance with the statute to all outpatient 
therapy settings, except for services furnished and billed by 
outpatient hospitals described under section 1833(a)(8)(B) of the Act. 
Without a therapy caps exceptions process, the statutory limitation 
requires that beneficiaries become financially liable for 100 percent 
of expenses they incur for services that exceed the therapy caps. In 
addition, without a therapy caps exceptions process, the therapy caps 
will be applicable without any further medical review, and any use of 
the KX modifier on claims for these services by providers of outpatient 
therapy services will have no effect.

III. Other Provisions of the Proposed Rule

A. New Care Coordination Services and Payment for Rural Health Clinics 
(RHCs) and Federally-Qualified Health Centers (FQHCs)

1. Overview
    We have been engaged in a multi-year examination of coordinated and 
collaborative care services in professional settings, and as a result 
established codes and separate payment in the Physician Fee Schedule 
(PFS) to separately recognize and pay for these important services. As 
part of this initiative, the CY 2016 PFS proposed rule (80 FR 41708) 
solicited public comments on (1) improving payment for the professional 
work of care management services; (2) establishing separate payment for 
collaborative care, particularly inter-professional consultation 
between primary care physicians, psychiatrists, and other 
practitioners; and (3) assessing whether current PFS payment for 
Chronic Care Management (CCM) services is adequate and whether the 
administrative burden associated with furnishing and billing these 
services should be reduced.
    As a result of the comments we received in response to our request, 
we established in the PFS separate payment for complex CCM services, 
and temporary codes to make separate payment for general behavioral 
health integration (BHI) services and a psychiatric collaborative care 
model (CoCM). We established four G codes to

[[Page 53170]]

describe BHI and psychiatric CoCM services and stated that we would 
consider whether to adopt and establish values for any associated new 
CPT codes being developed under our standard process once those codes 
are active. The separate payment for complex CCM services, general BHI, 
and psychiatric CoCM services were finalized in the CY 2017 PFS final 
rule (81 FR 80225) beginning January 1, 2017, for practitioners billing 
under the PFS. Based on these payments and codes, we proposed revisions 
to the CCM payment for RHCs and FQHCs, and proposed requirements and 
payment for general BHI and psychiatric CoCM services furnished in RHCs 
and FQHCs, beginning on January 1, 2018.
2. Background
a. RHC and FQHC Payment Methodologies
    RHC and FQHC visits are face-to-face encounters between a patient 
and one or more RHC or FQHC practitioners during which time one or more 
RHC or FQHC qualifying services are furnished. RHC and FQHC 
practitioners are physicians, nurse practitioners (NPs), physician 
assistants (PA), certified nurse midwives (CNMs), clinical 
psychologists, and clinical social workers, and under certain 
conditions, a registered nurse or licensed practical nurse furnishing 
care to a homebound RHC or FQHC patient. A Transitional Care Management 
(TCM) service can also be an RHC or FQHC visit, and a Diabetes Self-
Management Training (DSMT) service or a Medical Nutrition Therapy (MNT) 
service furnished by a certified DSMT or MNT provider may also be an 
FQHC visit. Only medically-necessary medical, mental health, or 
qualified preventive health services that require the skill level of an 
RHC or FQHC practitioner are RHC or FQHC billable visits. Services 
furnished by auxiliary personnel (for example, nurses, medical 
assistants, or other clinical personnel acting under the supervision of 
the RHC or FQHC practitioner) are considered incident to the visit and 
are included in the per-visit payment.
    RHCs are paid an all-inclusive rate (AIR) for medically necessary 
medical and mental health services and qualified preventive health 
services furnished on the same day (with some exceptions). In general, 
the A/B Medicare Administrative Contractor (MAC) calculates the AIR for 
each RHC by dividing total allowable costs by the total number of 
visits for all patients. Productivity, payment limits, and other 
factors are also considered in the calculation. Allowable costs must be 
reasonable and necessary and may include practitioner compensation, 
overhead, equipment, space, supplies, personnel, and other costs 
incident to the delivery of RHC services. The AIR is subject to a 
payment limit, except for certain provider-based RHCs that have an 
exception to the payment limit.
    FQHCs were paid under the same AIR methodology until October 1, 
2014, when, in accordance with section 1834(o) of the Act (as added by 
section 10501(i)(3) of the Affordable Care Act), they began to 
transition to an FQHC PPS system in which they are paid based on the 
lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate 
is adjusted for geographic differences in the cost of services by the 
FQHC PPS geographic adjustment factor (GAF). The rate is increased by 
34 percent when an FQHC furnishes care to a patient that is new to the 
FQHC, or to a beneficiary receiving an Initial Preventive Physical 
Examination (IPPE) or has an Annual Wellness Visit (AWV).
    Both the RHC AIR and FQHC PPS payment rates were designed to 
reflect the cost of all services and supplies that an RHC or FQHC 
furnishes to a patient in a single day. The rates are not adjusted for 
the complexity of the patient health care needs, the length of the 
visit, or the number or type of practitioners involved in the patient's 
care.
b. Current CCM Requirements and Payment for RHCs and FQHCs
    In the CY 2016 PFS final rule with comment period (80 FR 71080), we 
finalized policies for payment of CCM services in RHCs and FQHCs. 
Payment for CCM services in RHCs and FQHCs was effective beginning on 
January 1, 2016, for RHCs and FQHCs that furnish a minimum of 20 
minutes of qualifying CCM services during a calendar month to patients 
with multiple (two or more) chronic conditions that are expected to 
last at least 12 months or until the death of the patient, and that 
would place the patient at significant risk of death, acute 
exacerbation/decompensation, or functional decline. The requirement 
that RHC or FQHC services be furnished face-to-face was waived for CCM 
services.
    In the CY 2017 PFS final rule (81 FR 80256), we finalized revisions 
to the CCM requirements for RHCs and FQHCs. Specifically, we revised 
Sec.  405.2413(a)(5) and Sec.  405.2415(a)(5) to state that services 
and supplies furnished incident to CCM and TCM services can be 
furnished under general supervision of an RHC or FQHC practitioner, 
consistent with Sec.  410.26(b)(5), which allows CCM and TCM services 
and supplies to be furnished by clinical staff under general 
supervision when billed under the PFS. We also revised requirements 
pertaining to the provision of CCM services, consistent with the same 
revisions for practitioners billing under the PFS to reduce the burden 
of furnishing these services and promote beneficiary access to these 
services. These revisions were effective beginning on January 1, 2017, 
and included:
     Revising the requirement that CCM be initiated during a 
comprehensive evaluation and management (E/M), AWV, or IPPE visit, to 
require a separately billable initiating visit only for new patients or 
patients that have not had an E/M, AWV, or IPPE visit within the 
previous year;
     Revising the requirement that CCM services be available 
24/7 with an RHC or FQHC practitioner who has access to the patient's 
electronic care plan, to allow 24/7 access to auxiliary personnel with 
a means to make contact with an RHC or FQHC practitioner;
     Removing the restriction on faxing information, and no 
longer requiring that care plan information be available on a 24/7 
basis;
     Removing the requirement that clinical summaries must be 
formatted according to certified EHR technology, and instead requiring 
that the RHC or FQHC create, exchange, and transmit continuity of care 
document(s) in a timely manner with other practitioners and providers;
     Removing the description of the format of the care plan 
that is given to the patient or caregiver; and
     Revising the requirement that RHCs and FQHCs obtain a 
written agreement that the elements of CCM were discussed, to allowing 
this information to be documented in the medical record.
    In the CY 2017 PFS final rule, we stated that although CCM is 
typically associated with primary care conditions, patient eligibility 
is determined by the RHC or FQHC practitioner, and mental health 
conditions are not excluded. We invited comments on whether an 
additional code specifically for mental health conditions is necessary 
for RHCs and FQHCs that want to include beneficiaries with mental 
health conditions in their CCM services. We received a few comments 
regarding mental health services in RHCs and FQHCs and appreciate the 
information that was provided.
    The 2016 and 2017 CCM payment rates for RHCs and FQHCs were set 
annually based on the PFS national non-facility payment rate, and is 
paid when CPT code 99490 is billed alone or with

[[Page 53171]]

other payable services on an RHC or FQHC claim. The 2017 rate for RHCs 
and FQHCs is $42.71 for 20 minutes or more of CCM services. This is the 
only RHC and FQHC service that has been paid in this manner, and RHCs 
and FQHCs are not currently authorized to be paid for any other CCM or 
other care management codes. Also, RHCs and FQHCs cannot bill for CCM 
services for a beneficiary during the same service period as billing 
for TCM or any other program that provides additional payment for care 
management services (outside of the RHC AIR or FQHC PPS payment) for 
the same beneficiary.
    Additional information on CCM requirements is available on the CMS 
Care Management Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html and on the 
CMS RHC and FQHC Web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
c. Payment for Care Management Codes Under the PFS
CCM Services (CPT Code 99487 and CPT Code 99489)
    As we stated in the CY 2017 PFS final rule (81 FR 80244), the 
initial claims data for CCM services billed under the PFS showed that 
although utilization was increasing steadily, use of CPT code 99490 was 
still relatively low, and interviews with practitioners indicated that 
many believed that they were exceeding the 20-minute time threshold for 
billing this code. To pay as accurately as possible and to encourage 
access to CCM services, the CY 2017 PFS final rule established separate 
payment for two additional CCM codes, CPT code 99487 and CPT code 
99489, effective beginning on January 1, 2017, for practitioners 
billing under the PFS. These codes are for complex CCM services that 
reflect additional clinical staff time, more extensive care planning, 
and higher complexity of the patient.
    CPT code 99487 is for complex CCM services. It requires multiple 
(two or more) chronic conditions expected to last at least 12 months, 
or until the death of the patient; chronic conditions that 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; and 60 minutes of clinical staff time directed 
by a physician or other qualified health care professional, per 
calendar month.
    CPT code 99489 is for each additional 30 minutes of clinical staff 
time directed by a physician or other qualified health care 
professional, per calendar month.
    Practitioners paid under the PFS can bill either complex (CPT code 
99487 and CPT code 99489) or non-complex (CPT code 99490) CCM services 
during a given service period, and can submit only one professional 
claim for CCM services for that service period.
General BHI Services (HCPCS Code G0507)
    The types of chronic conditions that are eligible for CCM services 
are not specified and could include chronic mental health or behavioral 
health conditions or chronic cognitive disorders as long as the CCM 
requirements are met. However, because not all behavioral health issues 
fit into the CCM model, and Medicare beneficiaries with behavioral 
health conditions often require extensive care management discussions, 
information-sharing, and planning between a primary care practitioner 
and a behavioral health specialist, the CY 2017 PFS final rule 
established HCPCS code G0507 for 20 minutes or more of general BHI 
services. Payment for this code was effective beginning on January 1, 
2017, for practitioners billing under the PFS. Effective January 1, 
2018, HCPCS code G0507 is replaced by CPT code 99484.
    BHI is a team-based, collaborative approach to care that focuses on 
integrative treatment of patients with primary care and mental or 
behavioral health conditions. As finalized in the CY 2017 PFS final 
rule, requirements for this code include an initial assessment or 
follow-up monitoring (including the use of applicable validated rating 
scales); behavioral health care planning in relation to behavioral/
psychiatric health problems (including revision for patients who are 
not progressing or whose status changes); facilitating and coordinating 
treatment such as psychotherapy, pharmacotherapy, counseling and/or 
psychiatric consultation; and continuity of care with a designated 
member of the care team.
Psychiatric CoCM Services (HCPCS Codes G0502, G0503, and G0504)
    Psychiatric CoCM is a specific model of care provided by a primary 
care team consisting of a primary care provider and a health care 
manager who works in collaboration with a psychiatric consultant. As 
finalized in the CY 2017 PFS final rule, we provide Medicare payment 
for psychiatric CoCM services to practitioners billing under the PFS 
when these services are directed by a treating physician or other 
qualified health care professional. We also finalized that the treating 
physician or other qualified health care professional directs the 
behavioral health care manager, who must be an individual with formal 
education or specialized training in behavioral health, including 
social work, nursing, or psychology, working under the oversight and 
direction of the physician or qualified health care professional. We 
finalized that a psychiatric consultant must be a medical professional 
trained in psychiatry and qualified to prescribe the full range of 
medications. Finally, psychiatric CoCM services may be furnished to 
beneficiaries with any psychiatric or behavioral health condition(s) 
and may include substance use disorders. The three psychiatric CoCM 
codes established in the CY 2017 PFS final rule were G0502, G0503, and 
G0504. Effective January 1, 2018, these codes are replaced by CPT codes 
99492, 99493, and 99494, respectively.
    HCPCS code G0502 is for 70 minutes or more of initial psychiatric 
CoCM services in the first calendar month of behavioral health care 
manager activities, in consultation with a psychiatric consultant, and 
directed by the treating physician or other qualified health care 
professional. Required elements include: outreach to and treatment of a 
patient as directed by the treating physician or other qualified health 
care professional; initial assessment of the patient, including 
administration of validated rating scales, with the development of an 
individualized treatment plan; review by the psychiatric consultant 
with modifications of the plan, if recommended; entering of the patient 
into a registry and tracking patient follow-up and progress using the 
registry (with appropriate documentation), participation in weekly 
caseload consultation with the psychiatric consultant; and provision of 
brief interventions using evidence-based techniques such as behavioral 
activation, motivational interviewing, and other focused treatment 
strategies.
    HCPCS code G0503 is for 60 minutes of subsequent psychiatric CoCM 
services in a subsequent month and includes: Tracking patient follow-up 
and progress using the registry (with appropriate documentation); 
participation in weekly caseload consultation with the psychiatric 
consultant; ongoing collaboration with and coordination of the 
patient's mental health care with the treating physician

[[Page 53172]]

or other qualified health care professional and any other treating 
mental health providers; additional review of progress and 
recommendations for changes in treatment, as indicated, including 
medications, based on recommendations provided by the psychiatric 
consultant; provision of brief interventions using evidence-based 
techniques (such as behavioral activation, motivational interviewing, 
and other focused treatment strategies); monitoring of patient outcomes 
using validated rating scales; and relapse prevention planning with 
patients as they achieve remission of symptoms and/or other treatment 
goals and are prepared for discharge from active treatment.
    HCPCS code G0504 is for each additional 30 minutes of initial or 
subsequent psychiatric CoCM services in a calendar month.
3. Proposed Care Management Requirements and Payment for RHCs and FQHCs
    To ensure that RHC and FQHC patients have access to new care 
management services in a manner consistent with the RHC and FQHC per 
diem payment methodologies, we proposed the establishment of two new G 
codes for use by RHCs and FQHCs. The first new G code, GCCC1, would be 
a General Care Management code for RHCs and FQHCs, with the payment 
amount set at the average of the national non-facility PFS payment 
rates for CCM (CPT codes 99490 and 99487) and general BHI code G0507. 
The second new G code for RHCs and FQHCs, GCCC2, would be a Psychiatric 
CoCM code, with the payment amount set at the average of the national 
non-facility PFS payment rates for CPT codes G0502 and G0503. (We note 
that GCCC1 and GCCC2 were placeholder codes and are replaced by G0511 
and G0512, respectively, effective January 1, 2018). The following is a 
detailed discussion of our proposal, as well as alternatives that we 
considered.
a. Proposed Establishment of a General Care Management Code for RHCs 
and FQHCs
    The RHC AIR and the FQHC PPS rate, which include all costs 
associated with an RHC or FQHC visit, are based on the RHC's and FQHC's 
costs. Although many RHCs and FQHCs have always provided some 
coordination of care within and outside their facilities, the type of 
structured care management services that are now billable under the PFS 
are generally not included in the RHC AIR or the FQHC PPS rate. Because 
CCM services are not required to be face-to-face encounters, and do not 
require the skill level of an RHC or FQHC practitioner, they do not 
meet the requirements for an RHC or FQHC billable visit. In addition, 
RHC and FQHC services cannot be separately billed to the PFS. 
Therefore, in the CY 2016 PFS final rule with comment period, we 
established payment for CCM services at the PFS national non-facility 
rate when CPT code 99490 is billed alone or with other payable services 
on an RHC or FQHC claim to pay for the costs of CCM services that are 
not already captured in the RHC AIR or the FQHC PPS payment.
    When CCM services were first established for RHCs and FQHCs, CPT 
code 99490 was the only CCM code that was billable under the PFS. Now 
that there are additional codes for more complex CCM services and for 
general BHI and psychiatric CoCM services, we believe it is necessary 
to revise our payment approach for payment of care management services.
    RHCs and FQHCs are paid per-visit rates that are not adjusted based 
on the complexity of a service or the time spent furnishing services, 
and the payment rate is not designed to be equal to the payment under 
the PFS for a specific service. We sought to develop a methodology for 
payment of care management services that is consistent with the RHC and 
FQHC payment principles of bundling services and not paying for 
services based on time increments. We also sought to develop a 
methodology that would support the provision of care management 
services without creating additional reporting burdens, while promoting 
beneficiary access to comprehensive CCM and BHI services furnished by 
RHCs and FQHCs.
    Therefore, effective for services furnished on or after January 1, 
2018, we proposed to create General Care Management code GCCC1 for RHCs 
and FQHCs, with the payment amount set at the average of the 3 national 
non-facility PFS payment rates for the CCM and general BHI codes and 
updated annually based on the PFS amounts. The 3 codes are:

 CPT 99490--20 minutes or more of CCM services
 CPT 99487--at least 60 minutes of complex CCM services
 HCPCS G0507--20 minutes or more of BHI services

    RHCs and FQHCs could bill the new General Care Management code when 
the requirements for any of these 3 codes (CPT codes 99490, 99487, or 
HCPCS code G0507) are met. The General Care Management code would be 
billed alone or in addition to other services furnished during the RHC 
or FQHC visit. This code could only be billed once per month per 
beneficiary, and could not be billed if other care management services 
(such as TCM or home health care supervision) are billed for the same 
time period. We note that CPT code 99489 is an add-on code when CPT 
code 99487 is furnished, and is therefore not included as RHCs and 
FQHCs are not paid for additional time once the minimum requirements 
have been met.
    As previously noted, the program requirements for RHCs and FQHCs 
furnishing CCM services were established in the CY 2016 PFS final rule 
with comment period (80 FR 71080) and revised in the CY 2017 PFS final 
rule (81 FR 80256). We did not propose any changes to these 
requirements at this time.
    BHI refers to care management services that integrate behavioral 
health services with primary care and other clinical services. To bill 
for this service using the proposed General Care Management Code for 
RHCs and FQHCs, 20 minutes or more of clinical staff time, directed by 
an RHC or FQHC practitioner, must be furnished per calendar month. We 
proposed the following requirements for RHCs and FQHCs furnishing BHI 
services:
     Initiating Visit: An E/M, AWV, or IPPE visit with an RHC 
or FQHC primary care practitioner (physician, NP, PA, or CNM) occurring 
no more than one-year prior to commencing BHI services. This could be 
the same initiating visit that is used for initiating CCM services, and 
would be billed separately as an RHC or FQHC visit (if the RHC or FQHC 
has not already billed for this visit).
     Beneficiary Consent: Documentation in the medical record 
that the beneficiary has consented to receive BHI services, given 
permission to consult with relevant specialists as needed, and been 
informed that there may be beneficiary cost-sharing, including 
deductible and coinsurance amounts as applicable, for both in-person 
and non-face-to-face services that are provided. The beneficiary 
consent process would also include informing the patient that only one 
practitioner/facility can furnish and be paid for these services during 
a calendar month, and that the patient can stop care coordination 
services at any time (effective at the end of the calendar month). This 
could be obtained at the same time that beneficiary consent is obtained 
for CCM services.
     Billing Requirements: At least 20 minutes of care 
management services

[[Page 53173]]

per calendar month, furnished under the direction of the RHC or FQHC 
primary care physician, NP, PA, or CNM, and furnished by an RHC or FQHC 
practitioner, or by clinical personnel under general supervision. These 
are the same billing requirements as for CCM services. If both CCM and 
BHI services are furnished in the same month, the time would be 
combined and billed as one under the new care coordination code.
     Patient Eligibility: One or more new or pre-existing 
behavioral health or psychiatric conditions being treated by the RHC or 
FQHC primary care practitioner, including substance use disorders, 
that, in the clinical judgment of the RHC or FQHC primary care 
practitioner, warrants BHI services.
     Required Service Elements: An initial assessment or 
follow-up monitoring, including the use of applicable validated rating 
scales; behavioral health care planning in relation to behavioral/
psychiatric health problems, including revision for patients who are 
not progressing or whose status changes; facilitating and coordinating 
treatment such as psychotherapy, pharmacotherapy, counseling and/or 
psychiatric consultation; and continuity of care with a designated 
member of the care team.
    Both CCM and general BHI services are intended to provide a 
structured and coordinated approach to care management that is not 
typically included in the RHC's AIR or the FQHC PPS payment 
methodology. Care management services are directed by the RHC or FQHC 
primary care practitioner, who remains involved through ongoing 
oversight, management, collaboration and reassessment, while care 
management services are typically furnished in a non-face-to-face 
setting primarily by a non-RHC or FQHC practitioner working under 
general supervision requirements. Time spent by administrative or 
clerical staff cannot be counted towards the time required to bill 
these services.
    Table 18 compares the proposed requirements for CCM and general BHI 
services. We believe that even though there are some differences in the 
requirements of CCM and general BHI, grouping them together will help 
to promote integrated care management services for Medicare 
beneficiaries who have either or both primary care and behavioral 
health needs. It will also result in the least amount of reporting 
burden for RHCs and FQHCs because once the 20-minute threshold is met 
for either CCM or general BHI, reporting and tracking of additional 
time increments is not required.
    If this policy had been adopted for CY 2017, the payment amount for 
General Care Management for RHCs and FQHCs would have been 
approximately $61 (CPT 99490 at $42.71, + CPT 99487 at $93.67, + G0507 
at $47.73 = $184.11/3 = $61.37). This is more than the CY 2017 PFS 
national non-facility rates for CPT code 99490 and HCPCS code G0507, 
and less than the PFS national non-facility rate for CPT code 99487. We 
believe that this methodology is consistent with the RHC and FQHC 
payment methodology of averaging costs to determine a payment rate 
rather than paying for each individual service.

  Table 18--Comparison of Proposed CCM and General BHI Requirements and
                       Payment for RHCs and FQHCs
------------------------------------------------------------------------
                                                         General BHI
        Requirements             CCM  (CPT codes      (proposed) (HCPCS
                                99490 and 99487)         code G0507)
------------------------------------------------------------------------
Initiating Visit............  An E/M, AWV, or IPPE  Same.
                               visit occurring no
                               more than one-year
                               prior to commencing
                               care coordination
                               services.
                              Furnished by a        Same.
                               primary care
                               physician, NP, PA,
                               or CNM.
                              Billed as an RHC/     Same.
                               FQHC visit.
Beneficiary Consent.........  Obtained during or    Same.
                               after initiating
                               visit and before
                               provision of care
                               coordination
                               services by RHC or
                               FQHC practitioner
                               or clinical staff.
                              Written or verbal,    Same.
                               documented in the
                               medical record
                              Includes
                               information:
                               On the
                               availability of
                               care coordination
                               services and
                               applicable cost-
                               sharing;
                               That only
                               one practitioner
                               can furnish and be
                               paid for care
                               coordination
                               services during a
                               calendar month;
                               That the
                               patient has right
                               to stop care
                               coordination
                               services at any
                               time (effective at
                               the end of the
                               calendar month);
                               and
                               That the     Same.
                               patient has given
                               permission to
                               consult with
                               relevant
                               specialists.
Billing Requirements........  At least 20 minutes
                               of care
                               coordination
                               services per
                               calendar month that
                               is:
                               Furnished
                               under the direction
                               of the RHC or FQHC
                               primary care
                               physician, NP, PA,
                               or CNM; and.
                               Furnished    Same.
                               by an RHC or FQHC
                               practitioner, or by
                               clinical personnel
                               under general
                               supervision.
Patient Eligibility.........  Multiple (two or      Any behavioral
                               more) chronic         health or
                               conditions expected   psychiatric
                               to last at least 12   condition being
                               months, or until      treated by the RHC
                               the death of the      or FQHC primary
                               patient, and place    care practitioner,
                               the patient at        including substance
                               significant risk of   use disorders,
                               death, acute          that, in the
                               exacerbation/         clinical judgment
                               decompensation, or    of the RHC or FQHC
                               functional decline.   practitioner,
                                                     warrants BHI
                                                     services.

[[Page 53174]]

 
Requirement Service Elements  Includes:             Includes:
                               Structured    Initial
                               recording of          assessment or
                               patient health        follow-up
                               information using     monitoring,
                               Certified EHR         including the use
                               Technology and        of applicable
                               includes              validated rating
                               demographics,         scales;
                               problems,             Behavioral
                               medications, and      health care
                               medication            planning in
                               allergies that        relation to
                               inform the care       behavioral/
                               plan, care            psychiatric health
                               coordination, and     problems, including
                               ongoing clinical      revision for
                               care;.                patients who are
                               24/7 access   not progressing or
                               to physicians or      whose status
                               other qualified       changes;
                               health care          
                               professionals or      Facilitating and
                               clinical staff        coordinating
                               including providing   treatment (such as
                               patients/caregivers   psychotherapy,
                               with a means to       pharmacotherapy,
                               make contact with     counseling and/or
                               health care           psychiatric
                               professionals in      consultation); and
                               the practice to       Continuity
                               address urgent        of care with a
                               needs regardless of   designated member
                               the time of day or    of the care team.
                               day of week, and
                               continuity of care
                               with a designated
                               member of the care
                               team with whom the
                               patient is able to
                               schedule successive
                               routine
                               appointments;.
                              
                               Comprehensive care
                               management
                               including
                               systematic
                               assessment of the
                               patient's medical,
                               functional, and
                               psychosocial needs;
                               system-based
                               approaches to
                               ensure timely
                               receipt of all
                               recommended
                               preventive care
                               services;
                               medication
                               reconciliation with
                               review of adherence
                               and potential
                               interactions; and
                               oversight of
                               patient self-
                               management of
                               medications;.
                              
                               Comprehensive care
                               plan including the
                               creation, revision,
                               and/or monitoring
                               of an electronic
                               care plan based on
                               a physical, mental,
                               cognitive,
                               psychosocial,
                               functional, and
                               environmental
                               (re)assessment and
                               an inventory of
                               resources and
                               supports; a
                               comprehensive care
                               plan for all health
                               issues with
                               particular focus on
                               the chronic
                               conditions being
                               managed;
                               Care plan
                               information made
                               available
                               electronically
                               (including fax) in
                               a timely manner
                               within and outside
                               the RHC or FQHC as
                               appropriate and a
                               copy of the plan of
                               care given to the
                               patient and/or
                               caregiver;
                               Management
                               of care transitions
                               between and among
                               health care
                               providers and
                               settings, including
                               referrals to other
                               clinicians; follow-
                               up after an
                               emergency
                               department visit;
                               and follow-up after
                               discharges from
                               hospitals, skilled
                               nursing facilities,
                               or other health
                               care facilities;
                               timely creation and
                               exchange/transmit
                               continuity of care
                               document(s) with
                               other practitioners
                               and providers;
                              
                               Coordination with
                               home- and community-
                               based clinical
                               service providers,
                               and documentation
                               of communication to
                               and from home- and
                               community-based
                               providers regarding
                               the patient's
                               psychosocial needs
                               and functional
                               deficits in the
                               patient's medical
                               record; and
                               Enhanced
                               opportunities for
                               the patient and any
                               caregiver to
                               communicate with
                               the practitioner
                               regarding the
                               patient's care
                               through not only
                               telephone access,
                               but also through
                               the use of secure
                               messaging,
                               Internet, or other
                               asynchronous non-
                               face-to-face
                               consultation
                               methods.
CY 2017 PFS Non-Facility      CPT 99490--$42.71,    G0507--$47.73.
 Payment.                      CPT 99487--$93.67.
RHC/FQHC Payment for new      Current: $42.71.....  Current: N/A.
 General Care Management G    Proposed: Average of  Proposed: Average of
 code.                         CPT codes 99490,      CPT codes 99490,
                               99487 and G0507 (If   99487 and G0507 (If
                               using the 2017        using the 2017
                               payment amounts,      payment amounts,
                               this would be         this would be
                               $61.37).              $61.37).
------------------------------------------------------------------------

    We expect that utilization of care coordination services will 
continue to increase as more health care practices, including RHCs and 
FQHCs, implement these services. Because the separate payments for the 
complex CCM codes have only been implemented this year for 
practitioners billing under the PFS, we do not have adequate data to 
determine the frequency of billing for CCM codes CPT codes 99487 by 
practitioners billing under the PFS compared with CPT code 99490. 
Although billing practices may vary between physician offices and RHCs 
and FQHCs (and within and between RHCs and FQHCs), we believe that 
utilization patterns under the PFS can provide a reasonable proxy for 
utilization practices in RHCs and FQHCs of care coordination 
utilization. If the PFS data starts to show definitive trends in 
billing certain CCM and BHI codes, or if data becomes available that

[[Page 53175]]

provides information on the extent of these services in RHCs and FQHCs, 
we may consider using a weighted average in determining the payment 
rate in the future. Similarly, if the proposal to create a new care 
management code for RHCs and FQHCs is finalized, and any additional 
care management codes become available on the PFS, we would review the 
new codes to determine if they should also be factored into the RHC and 
FQHC General Care Management Code. Any changes would be undertaken 
through future rulemaking.
b. Proposed Establishment of a Psychiatric CoCM Code for RHCs and FQHCs
    Psychiatric CoCM is a defined model of care that integrates primary 
health care services with care management support for patients 
receiving behavioral health treatment, and includes regular psychiatric 
inter-specialty consultation with the primary care team, particularly 
regarding patients whose conditions are not improving. We recognize 
that the requirements of this model may be challenging for some RHCs 
and FQHCs, especially those who have difficulty maintaining adequate 
primary care and mental health staffing in rural and or underserved 
areas. For those RHCs and FQHCs that choose to offer these services, we 
believe this model may be particularly helpful, especially for patients 
with primary care and mental health conditions who have not benefited 
from standard treatment.
    Effective for services furnished on or after January 1, 2018, we 
proposed to create a psychiatric CoCM code for RHCs and FQHCs, GCCC2, 
with the payment amount set at the average of the 2 national non-
facility PFS payment rates for CoCM codes, to be updated annually based 
on the PFS amounts. The 2 codes are:

 G0502--70 minutes or more of initial psychiatric CoCM services
 G0503--60 minutes or more of subsequent psychiatric CoCM 
services

    RHCs and FQHCs could bill the new psychiatric CoCM code when the 
requirements for any of these 2 codes (G0502 or G0503) are met. The 
psychiatric CoCM code would be billed alone or in addition to other 
services furnished during the RHC or FQHC visit. To prevent duplication 
of payment, this code could only be billed once per month per 
beneficiary, and could not be billed if other care management services, 
including the proposed General Care Management code, are billed for the 
same time period. We note that G0504 is an add-on code when G0503 is 
furnished and is therefore not included as RHCs and FQHCs are not paid 
for additional time once the minimum requirements have been met.
    If this policy had been adopted for CY 2017, the payment amount for 
psychiatric CoCM for RHCs and FQHCs would have been approximately 
$134.58 (G0502 at $142.84 + G0503 at $126.33 = $269.17/2 = $134.58).
    All care management services, including psychiatric CoCM, require a 
separately billable initiating visit (E/M, AWV, or IPPE) for new 
patients or beneficiaries not seen within 1 year prior to commencement 
of care management services. Prior to commencement of psychiatric CoCM 
services, the beneficiary must provide consent for this service, 
including permission to consult with a psychiatric consultant and 
relevant specialists. Advance consent must also include information on 
cost sharing for both face-to-face and non-face-to-face services, and 
acceptance of these requirements must be documented in the medical 
record.
    Patients with mental health, behavioral health, or psychiatric 
conditions, including substance use disorders, who are being treated by 
an RHC or FQHC practitioner, may be eligible for psychiatric CoCM 
services, as determined by the RHC or FQHC practitioner. Psychiatric 
CoCM services, like CCM and general BHI services, are intended to 
provide a structured and coordinated approach to care management that 
is not typically included in the RHC's AIR or the FQHC PPS payment 
methodology.
    The psychiatric CoCM team must include the RHC or FQHC 
practitioner, a behavioral health care manager, and a psychiatric 
consultant. Proposed specific requirements of the psychiatric CoCM team 
are as follows:
Psychiatric CoCM Team--RHC or FQHC Practitioner
    For psychiatric CoCM, the RHC or FQHC practitioner may be a primary 
care physician, NP, PA, or CNM. The psychiatric CoCM requirements of 
the RHC or FQHC practitioner are to:
     Direct the behavioral health care manager and any other 
clinical staff;
     Oversee the beneficiary's care, including prescribing 
medications, providing treatments for medical conditions, and making 
referrals to specialty care when needed; and
     Remain involved through ongoing oversight, management, 
collaboration and reassessment.
Psychiatric CoCM Team--Behavioral Health Care Manager
    For psychiatric CoCM, the behavioral health care manager is a 
designated individual with formal education or specialized training in 
behavioral health such as social work, nursing, or psychology. A 
behavioral health care manager in an RHC or FQHC would be expected to 
have a minimum of a bachelor's degree in a behavioral health field 
(such as in clinical social work or psychology), or be a clinician with 
behavioral health training, including RNs and LPNs. The behavioral 
health care manager furnishes both face-to-face and non-face-to-face 
services under the general supervision of the RHC or FQHC practitioner 
and may be employed by or working under contract to the RHC or FQHC. 
The psychiatric CoCM requirements of the behavioral health care manager 
are:
     Providing assessment and care management services, 
including the administration of validated rating scales; behavioral 
health care planning in relation to behavioral/psychiatric health 
problems, including revision for patients who are not progressing or 
whose status changes; provision of brief psychosocial interventions; 
ongoing collaboration with the RHC or FQHC practitioner; maintenance of 
the registry; acting in consultation with the psychiatric consultant;
     Being available to provide services face-to-face with the 
beneficiary; having a continuous relationship with the patient and a 
collaborative, integrated relationship with the rest of the care team; 
and
     Being available to contact the patient outside of regular 
RHC or FQHC hours as necessary to conduct the behavioral health care 
manager's duties.
Psychiatric CoCM Team--Psychiatric Consultant
    For CoCM, a psychiatric consultant is a medical professional 
trained in psychiatry and qualified to prescribe the full range of 
medications. The psychiatric consultant is not required to be on site 
or to have direct contact with the patient and does not prescribe 
medications or furnish treatment to the beneficiary directly. The CoCM 
requirements of the psychiatric consultant are:
     Participating in regular reviews of the clinical status of 
patients receiving psychiatric CoCM services;
     Advising the RHC or FQHC practitioner regarding diagnosis 
and options for resolving issues with beneficiary adherence and 
tolerance of behavioral health treatment; making

[[Page 53176]]

adjustments to behavioral health treatment for beneficiaries who are 
not progressing; managing any negative interactions between 
beneficiaries' behavioral health and medical treatments; and
     Facilitating referral for direct provision of psychiatric 
care when clinically indicated.
    RHCs and FQHCs could bill the new psychiatric CoCM code, GCCC2, 
when the requirements for HCPCS code G0502 or G0503 are met. This code 
could only be billed once per month per beneficiary, and could not be 
billed if other care management services, including the General Care 
Management code GCCC1, are billed for the same time period.
    As with the proposed General Care Management code GCCC1, we would 
monitor PFS data to determine if a weighted average would be more 
appropriate in determining the psychiatric CoCM payment rate for RHCs 
and FQHCs, and whether any additional codes that may be added to the 
PFS in the future should also be factored into the RHC and FQHC 
psychiatric CoCM code. Any changes would be done through future 
rulemaking.
    Table 19 compares the proposed requirements for general BHI, which 
would be billed using the proposed General Care Management code GCCC1, 
and psychiatric CoCM services, which would be billed using the proposed 
psychiatric CoCM code, GCCC2.

    Table 19--Comparison of Proposed General BHI and Psychiatric CoCM
               Requirements and Payment for RHCs and FQHCs
------------------------------------------------------------------------
                                                      Psychiatric CoCM
                                   General BHI       (proposed)  (HCPCS
        Requirements           (proposed)  (HCPCS      code G0502 and
                                   code G0507)             G0503)
------------------------------------------------------------------------
Initiating Visit............  An E/M, AWV, or IPPE  Same.
                               visit occurring no
                               more than one-year
                               prior to commencing
                               care coordination
                               services.
                              Furnished by a        Same.
                               primary care
                               physician, NP, PA,
                               or CNM.
                              Billed as an RHC or   Same.
                               FQHC visit.
Beneficiary Consent.........  Obtained during or    Same.
                               after initiating
                               visit and before
                               provision of care
                               coordination
                               services by RHC or
                               FQHC practitioner
                               or clinical staff.
                              Written or verbal,    Same.
                               documented in the
                               medical record
                              Includes              Same.
                               information:
                               On the
                               availability of
                               care coordination
                               services and
                               applicable cost-
                               sharing;
                               That only
                               one entity can
                               furnish and be paid
                               for care
                               coordination
                               services during a
                               calendar month;
                               That the
                               patient has the
                               right to stop care
                               coordination
                               services at any
                               time (effective at
                               the end of the
                               calendar month);
                               and
                               That the
                               patient has given
                               permission to
                               consult with
                               relevant
                               specialists.
Billing Requirements........  At least 20 minutes   At least 70 minutes
                               of care management    in the first
                               services per          calendar month, and
                               calendar month that   at least 60 minutes
                               is:                   in subsequent
                               Furnished     calendar months of
                               under the direction   psychiatric CoCM
                               of the RHC or FQHC    services that is:
                               primary care          Furnished
                               physician, NP, PA,    under the direction
                               or CNM; and.          of the RHC or FQHC
                               Furnished     primary care
                               by an RHC or FQHC     practitioner; and
                               practitioner, or by   Furnished
                               clinical personnel    by an RHC or FQHC
                               under general         practitioner or
                               supervision.          behavioral health
                                                     care manager under
                                                     general
                                                     supervision.
Patient Eligibility.........  Any mental,           Same.
                               behavioral health,
                               or psychiatric
                               condition being
                               treated by the RHC
                               or FQHC primary
                               care practitioner,
                               including substance
                               use disorders,
                               that, in the
                               clinical judgment
                               of the RHC or FQHC
                               practitioner,
                               warrants BHI
                               services.
Requirement Elements........  Includes:             Includes:
                               Initial      RHC or FQHC primary
                               assessment or         care practitioner:
                               follow-up             Direct the
                               monitoring,           behavioral health
                               including the use     care manager or
                               of applicable         clinical staff;
                               validated rating      Oversee the
                               scales.               beneficiary's care,
                               Behavioral    including
                               health care           prescribing
                               planning in           medications,
                               relation to           providing
                               behavioral/           treatments for
                               psychiatric health    medical conditions,
                               problems, including   and making
                               revision for          referrals to
                               patients who are      specialty care when
                               not progressing or    needed; and
                               whose status          Remain
                               changes.              involved through
                                             ongoing oversight,
                               Facilitating and      management,
                               coordinating          collaboration and
                               treatment (such as    reassessment.
                               psychotherapy,       Behavioral Health
                               pharmacotherapy,      Care Manager:
                               counseling and/or     Provide
                               psychiatric           assessment and care
                               consultation).        management
                              Continuity of care     services, including
                               with a designated     the administration
                               member of the care    of validated rating
                               team.                 scales; behavioral
                                                     health care
                                                     planning in
                                                     relation to
                                                     behavioral/
                                                     psychiatric health
                                                     problems, including
                                                     revision for
                                                     patients who are
                                                     not progressing or
                                                     whose status
                                                     changes; provision
                                                     of brief
                                                     psychosocial
                                                     interventions;
                                                     ongoing
                                                     collaboration with
                                                     the RHC or FQHC
                                                     practitioner;
                                                     maintenance of the
                                                     registry; acting in
                                                     consultation with
                                                     the psychiatric
                                                     consultant;

[[Page 53177]]

 
                                                     Be
                                                     available to
                                                     provide services
                                                     face-to-face with
                                                     the beneficiary;
                                                     having a continuous
                                                     relationship with
                                                     the patient and a
                                                     collaborative,
                                                     integrated
                                                     relationship with
                                                     the rest of the
                                                     care team; and
                                                     Be
                                                     available to
                                                     contact the patient
                                                     outside of regular
                                                     RHC or FQHC hours
                                                     as necessary to
                                                     conduct the
                                                     behavioral health
                                                     care manager's
                                                     duties.
                                                    Psychiatric
                                                     Consultant:
                                                     Participate
                                                     in regular reviews
                                                     of the clinical
                                                     status of patients
                                                     receiving CoCM
                                                     services;
                                                     Advise the
                                                     RHC or FQHC
                                                     practitioner
                                                     regarding
                                                     diagnosis, options
                                                     for resolving
                                                     issues with
                                                     beneficiary
                                                     adherence and
                                                     tolerance of
                                                     behavioral health
                                                     treatment; making
                                                     adjustments to
                                                     behavioral health
                                                     treatment for
                                                     beneficiaries who
                                                     are not
                                                     progressing;
                                                     managing any
                                                     negative
                                                     interactions
                                                     between
                                                     beneficiaries'
                                                     behavioral health
                                                     and medical
                                                     treatments; and
                                                     Facilitate
                                                     referral for direct
                                                     provision of
                                                     psychiatric care
                                                     when clinically
                                                     indicated.
Cy 2017 PFS Non-Facility      G0507--$47.73.......  G0502--$142.84,
 Payment.                                            G0503--$126.33.
RHC/FQHC Payment for New      Current: N/A........  Current: N/A.
 Psychiatric CoCM G Code.     Proposed: Average of  Proposed: Average of
                               CPT codes 99490,      HCPCS codes G0502
                               99487, and G0507.     and G0503. (If
                               (If using the 2017    using the 2017
                               payment amounts,      payment amounts,
                               this would be         this would be
                               $61.37).              $134.58).
------------------------------------------------------------------------

c. Other Options Considered
    We considered allowing RHCs and FQHCs to bill for the complex CCM 
codes, the BHI code, and the psychiatric CoCM codes by allowing the 
individual CPT or HCPCS codes to be billed on an RHC or FQHC claim, in 
the same manner as we currently allow CPT code 99490 to be billed on a 
claim. We do not believe this approach is in the best interest of RHCs 
and FQHCs. There are now 5 separate care management codes that are 
applicable to RHCs and FQHCs, and more codes could be added in the 
future as we learn more about the benefits of non-face-to-face care 
management services. Each of these codes has specific time increments 
that must be tracked and reported for payment under the PFS. We believe 
that grouping the CCM and BHI codes and the psychiatric CoCM codes into 
2 G codes is more consistent with the RHC and FQHC payment methodology 
of averaging actual costs to determine a payment rate and not paying 
for services based on time increments. It also requires less record 
keeping, monitoring, and coding expertise, while maintaining the same 
quality of care standards.
    We also considered grouping all 5 codes together into one G code, 
or developing 3 G codes--one for the CCM codes, one for the BHI code, 
and one for the psychiatric CoCM codes. We did not choose either of 
these approaches because CCM and BHI are similar services that 
complement each other, and grouping them together is consistent with an 
integrated approach to care with reduced reporting requirements. We 
also believe that psychiatric CoCM is different enough from both CCM 
and BHI in its requirements, particularly in staffing and required 
services, that it warrants a separate G code. We believe that our 
proposal of creating 2 new G codes to encompass the 5 care management 
codes is the best option for RHCs and FQHCs now and in the future if 
new care management codes are developed. We welcomed comments on the 
proposal.
    The following is a summary of the public comments received on our 
proposal to revise the CCM payment for RHCs and FQHCs and establish 
requirements and payment for general BHI and psychiatric CoCM services 
furnished in RHCs and FQHCs, beginning on January 1, 2018. As 
previously noted, the following code changes will be effective January 
1, 2018, and are used in the remainder of this rule:

                           Table 20--Comparison of Proposed and Final HCPCS/CPT Codes
----------------------------------------------------------------------------------------------------------------
                                                                              Final HCPCS/CPT code  (effective
        Description of code           Proposed or current HCPCS/CPT code              January 1, 2018)
----------------------------------------------------------------------------------------------------------------
General Care Management for RHCs    GCCC1                                  G0511
 and FQHCs only.
Psychiatric CoCM code for RHCs and  GCCC2                                  G0512
 FQHCs only.
Psychiatric CoCM Services (first    G0502                                  99492
 70 min).
Psychiatric CoCM Services           G0503                                  99493
 (subsequent 60 min).
Psychiatric CoCM Services (add on)  G0504                                  99494
General BHI Services..............  G0507                                  99484
----------------------------------------------------------------------------------------------------------------


[[Page 53178]]

    Comment: Most commenters were supportive of our proposal. Many 
commenters stated that these changes will increase the availability of 
CCM, BHI, and psychiatric CoCM in RHCs and FQHCs and increase access 
for patients who need these services, especially in rural areas. Many 
commented that the proposal will support efforts to integrate medical 
and behavioral health care and encourage more primary care and 
behavioral health care providers to work together and coordinate care 
to better assist patients with complex, chronic conditions. Many 
commented on the role of RHCs and FQHCs as safety net providers serving 
the Nation's most vulnerable populations, and how important care 
management services are, especially for individuals with complex needs 
and few resources. A few commenters expressed their preference for 
billing each service by separate CPT codes, but most stated that the 
proposed methodology is administratively simple, will reduce reporting 
burden, and is in alignment with current RHC and FQHC billing 
practices. Many commenters also noted that this proposal will build 
upon efforts at addressing substance abuse and the opioid epidemic, 
increasing obesity rates, traumatic brain injury, dementia, and the 
health care needs of an aging population.
    Response: We thank the commenters for their support of the 
proposal.
    Comment: Some commenters noted that patients are often unwilling to 
pay the patient share of care management services and requested CMS 
waive cost-sharing or pursue waivers for these codes.
    Response: We are aware that the copayment and/or deductible in RHCs 
and the copayment in FQHCs can be a barrier for some beneficiaries, but 
we do not have the statutory authority to waive these charges. Because 
these services are typically furnished non face-to-face, and therefore, 
are not visible to the patient, it is important that adequate 
information is provided during the consent process on cost-sharing 
responsibilities and the benefits of care management services. RHCs and 
FQHCs should also provide information on the availability of assistance 
to qualified patients in meeting their cost-sharing obligations, or any 
other programs to provide financial assistance, if applicable.
    Comment: Several commenters asked if psychiatric mental health 
nurse practitioners (PMH-NPs) could serve as the psychiatric consultant 
to RHCs and FQHCs that are furnishing psychiatric CoCM, and recommended 
that they be included based on their education and training or board 
certification. Some commenters stated that this is especially important 
in rural areas where specialists are not readily available, and others 
stated that this would make psychiatrists more readily available for 
patients for which a higher degree of training may be required.
    Response: The psychiatric CoCM program requires a psychiatric 
consultant who is a medical professional trained in psychiatry and 
qualified to prescribe the full range of medications. Their 
responsibilities include participating in regular reviews of the 
clinical status of patients receiving psychiatric CoCM services; 
advising the RHC or FQHC practitioner regarding diagnosis and options 
for resolving issues with beneficiary adherence and tolerance of 
behavioral health treatment; recommending adjustments to behavioral 
health treatment for beneficiaries who are not progressing; managing 
any negative interactions between beneficiaries' behavioral health and 
medical treatments; and facilitating referral for direct provision of 
psychiatric care when clinically indicated.
    PMH-NPs are trained to provide a wide range of mental health 
services, including psychiatric diagnosis and medication treatment for 
psychiatric disorders. Although NPs are authorized to prescribe 
controlled substances, their practice authority varies by state and in 
some states they may have additional requirements or restrictions. We 
believe that a board-certified PMH-NP would meet the requirements to 
serve as a psychiatric consultant for an RHC or FQHC that is furnishing 
psychiatric CoCM services and would assist in making this program more 
widely available, especially in rural areas.
    Comment: Several commenters requested clarification or removal of 
the requirement that the psychiatric CoCM behavioral health care 
manager be available to contact the patient outside of regular RHC or 
FQHC hours as necessary to conduct the behavioral health care manager's 
duties. Commenters questioned if this meant that the health care 
manager must be available 24/7, and if so, they noted this was an 
unreasonable expectation that would present a barrier to implementing 
this program.
    Response: RHCs and FQHCs have processes for patients to contact 
practitioners or access care during non-RHC or FQHC hours, and it was 
not our intention to require or imply that the behavioral health care 
manager be available on a 24/7 basis. To avoid any confusion, this 
requirement will be removed.
    Comment: Several commenters requested clarification of the 
qualifications for the behavioral health care manager. One commenter 
questioned whether a social worker could serve in this role or if a 
master level clinical social worker is required. Another commenter 
stated that some of the health care manager's duties, such as 
administering screening tools, scheduling meetings, and entering data 
for the registry, could be conducted by someone with less education, 
under the supervision of a licensed practitioner. Other commenters 
suggested that licensed clinical social workers, licensed clinical 
professional counsellors, licensed or bachelor level social workers, 
nurses who undergo mental health training or have some experience in 
psychiatric interviewing, certified addiction counselors, or 
occupational therapists should be able to serve as the behavioral 
health care manager.
    Response: As noted in the proposed rule, the behavioral health care 
manager is a designated individual with formal education or specialized 
training in behavioral health such as social work, nursing, or 
psychology. A behavioral health care manager in an RHC or FQHC would be 
expected to have a minimum of a bachelor's degree in a behavioral 
health field (such as in clinical social work or psychology), or be a 
clinician with behavioral health training, including RNs and LPNs. 
Therefore, a clinical social worker is not required to have a masters 
degree in social work to serve as the psychiatric CoCM health manager.
    It is the responsibility of the RHC or FQHC to assure that the 
behavioral health care manager meets the stated requirements, and to 
manage any delegation of duties and supervision as appropriate.
    Comment: Some commenters objected to the requirement that general 
BHI and psychiatric CoCM services be furnished only under the direction 
of an RHC or FQHC primary care physician, NP, PA, or CNM, and 
maintained that excluding CPs and CSWs would create a barrier to 
effective team-based care.
    Response: General BHI and psychiatric CoCM are both team-based, 
collaborative approaches to care that focus on integrative treatment of 
patients with primary care and mental or behavioral health conditions. 
General BHI was established to support extensive care management 
discussions, information-sharing, and planning between a primary care 
practitioner and a behavioral health specialist, while psychiatric CoCM 
is a specific model of care provided by a primary care team

[[Page 53179]]

consisting of a primary care provider and a health care manager who 
works in collaboration with a psychiatric consultant.
    CPs and CSWs are RHC and FQHC practitioners and furnish medically-
necessary, face-to-face services that may be stand-alone billable 
visits in RHCs and FQHCs. They can also serve as the behavioral health 
care manager for general BHI and psychiatric CoCM services. In order to 
facilitate the integration and coordination of the patient's primary 
care and mental or behavioral health conditions, these care management 
services are furnished under the direction of the RHC or FQHC primary 
care practitioner.
    Comment: One commenter suggested that the consulting psychiatrist 
on the psychiatric CoCM team should be able to bill separately for this 
service in addition to the payment to RHCs and FQHCs. Other commenters 
suggested that CPs and CSWs, or the entire behavioral health workforce, 
be able to bill directly for these services.
    Response: The consulting psychiatrist is a member of the 
psychiatric CoCM team, and the RHC and FQHC payment reflects the cost 
of their services. If the consulting psychiatrist were to bill 
separately, Medicare would be overpaying for this service, because the 
cost of the psychiatric consultant is included in the rate for the care 
management codes. We also note that services are billed by the RHC or 
FQHC, and that neither RHC, FQHC practitioners (including CPs and 
CSWs), nor any other clinical personnel, bill directly for services 
furnished in RHCs or FQHCs.
    Comment: One commenter supported the proposed methodology but noted 
more needs to be done to create coding options and reimbursement for 
consultation models where a child and adolescent psychiatrist guides a 
primary care physician in treating behavioral and mental health 
conditions. The commenter stated that these models help to ensure that 
more children and youth in need of behavioral or mental health 
interventions receive the care they need and are an efficient way to 
address severe child and adolescent psychiatrist workforce shortages in 
most areas of the country.
    Response: We agree that there are many children and adolescents in 
need of behavioral or mental health interventions and that many areas 
of the country do not have adequate psychiatric services for children 
and adolescents, but this is outside the scope of this proposal.
    Comment: A commenter noted that RHCs and FQHCs would receive a 
higher payment for CPT 99490 services than an office-based practice, 
and as a result, this code should be revalued.
    Response: The proposed payment methodology for general care 
management services furnished by RHCs and FQHCs is similar to the 
payment methodology for other RHC and FQHC services. In general, RHCs 
and FQHCs are paid a per diem rate that is based on average costs, and 
the payment is not adjusted for time or intensity once the requirements 
are met. This results in a payment rate that is sometimes less and 
sometimes more than the payment for the same services when it is billed 
by an office-based practice under the PFS. We respectfully disagree 
that the proposed RHC and FQHC payment for general care management is a 
reason to revalue CPT 99490, and note that if any of the codes that are 
included in G0511 (CPT codes 99490, 99487, and 99484) are revalued, the 
payment for G0511 would adjust accordingly.
    Comment: One commenter expressed concern that RHCs and FQHCs may 
not offer care management services because the care management codes 
can be used only once per month for a beneficiary and cannot be 
combined with other care management codes. This commenter urged us to 
remove these restrictions and instead actively monitor the use of these 
codes to determine whether overuse occurs.
    Response: While we appreciate the commenter's concern, we 
respectfully disagree that limiting the billing of these codes to once 
per month will impede an RHC or FQHC from offering these services. The 
payment methodology is designed to encourage the use of these services 
by making billing and record keeping as simple as possible while 
providing a favorable payment rate. Once the minimum requirements are 
met, RHCs and FQHCs can bill for this service and would be paid at the 
average rate of the applicable codes, whether or not additional time is 
spent furnishing these services. We believe this approach is likely to 
encourage RHCs and FQHCs to offer these services and is preferable to 
actively monitoring for overuse.
    Comment: One commenter agreed with our intention to monitor the 
frequency of PFS billing for CPT 99487 to determine whether a weighted 
average would be more appropriate for future payment years, and 
suggested that we also monitor the extent that complex chronic care 
management services are provided in RHC and FQHCs.
    Response: We appreciate the comment and will review all available 
data to determine if a weighted average would be more appropriate in 
the future. As we noted in the proposed rule, any changes would be 
undertaken through future rulemaking.
    Comment: One commenter noted that for low-income or limited-English 
proficiency Medicare beneficiaries, care management can lead to more 
effective care, better health outcomes and fewer emergency department 
visits. This commenter suggested that the additional costs of providing 
appropriate care for these populations should be acknowledged and 
payments appropriately adjusted in future rulemaking. Another commenter 
was concerned that the proposed methodology may not accurately reflect 
and compensate RHCs and FQHCs for the additional complexity of care 
coordination for patients who have significant primary care needs and 
requested that we consider comments received from health care providers 
and patient advocates and consider alternative approaches if necessary. 
Another commenter encouraged us to monitor the use of the care 
management codes and any related feedback regarding the financial 
sustainability of the model, and address any challenges and concerns in 
future rulemaking.
    Response: We agree that care management can lead to more effective 
care, better health outcomes and fewer emergency department visits and 
appreciate the concern raised by the commenters. As previously noted, 
we will monitor data as it becomes available and consider a weighted 
average if appropriate. We welcome RHCs, FQHCs, and others to 
communicate to us any information regarding the appropriateness of 
their care management payments as more experience is gained in 
implementing these services.
    Comment: One commenter recommended that in order to maintain 
consistency and avoid confusion for providers, RHCs and FQHCs should 
use the PFS CPT codes for care management services. Another commenter 
stated that in order to avoid creating financial advantages for some 
medical settings over others, coding and payment should be the same for 
RHCs and FQHCs as for physicians billing under the PFS. This commenter 
maintained that creating different coding and payment protocols may 
lead to inequitable payments, and makes it difficult to assess 
differences in payment adequacy.
    Response: RHCs and FQHCs differ significantly from office or 
hospital-based physician practices and have specific purposes, 
characteristics, and requirements that generally do not apply to other 
providers or suppliers. As

[[Page 53180]]

part of the nation's health care safety-net, RHCs and FQHCs are paid 
under a different payment methodology that reflects the costs of 
furnishing care in underserved rural and urban areas. We respectfully 
do not agree that the difference in the payment systems may lead to 
inequitable payments, but rather reflect the needs of these communities 
in providing primary health care to underserved rural and urban 
populations.
    Comment: A commenter asked if certified EHR technology would be 
required for billing G0511 when BHI services are furnished.
    Response: Certified EHR technology is a requirement for CCM, but it 
is not a requirement for general BHI or psychiatric CoCM services. To 
bill the new G0511 code, an RHC or FQHC must meet the requirements for 
either CCM (CPT 99490 or CPT 99487) or general BHI (CPT 99484). If the 
requirements for CPT code 99484 are met, the code can be billed and 
certified EHR technology is not required.
    Comment: One commenter requested that we delay the denial date of 
January 1, 2018, for claims submitted with CPT 99490.
    Response: We wish to clarify that claims with CPT 99490 for 
services furnished on or before December 31, 2017, will be processed 
and paid. Service lines reported with CPT 99490 will be denied for 
dates of service on or after January 1, 2018.
    Comment: A few commenters requested additional information and 
training on the use of these new codes for RHCs and FQHCs be made 
available, and that CMS Connected Care Providers receive training 
materials.
    Response: Additional information on the new care management codes 
for RHCs and FQHCs will be available on the CMS Web site for RHCs 
(https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html) and FQHCs (https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html). This will include 
an MLN article for RHCs and FQHCs, and an update to the Medicare 
Benefit Policy Manual, Chapter 13. These changes will also be presented 
on the national CMS Rural Open Door Forum call, and on the Safety Net 
Open Door Forum call (https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/index.html). Information on becoming a CMS 
Connected Care provider to help raise awareness about the benefits of 
CCM services is available at https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/ccm/become-a-partner.html.
    Comment: Some commenters discussed issues that were outside the 
scope of the proposed rule.
    Response: Comments received that are outside the scope of the 
proposed rule are not addressed in this final rule.
    As a result of the public comments, we are finalizing the revisions 
to CCM payment for RHCs and FQHCs and establishment of requirements and 
payment for general BHI and psychiatric CoCM services furnished in RHCs 
and FQHCs, beginning on January 1, 2018, as proposed, except that we 
are removing the requirement that the behavioral health care manager be 
available to contact the patient outside of regular RHC or FQHC hours 
as necessary to conduct the behavioral health care manager's duties.
4. Implementation
    RHCs and FQHCs will continue to receive payment for CCM services 
when CPT code 99490 is billed alone or with other payable services on 
an RHC or FQHC claim for dates of service on or before December 31, 
2017. Beginning on January 1, 2018, RHCs and FQHCs must use the new 
General Care Management code G0511 when billing for CCM or general BHI 
services, and the new psychiatric CoCM code G0512 when billing for 
psychiatric CoCM services, either alone or with other payable services 
on an RHC or FQHC claim. Service lines submitted using CPT 99490 code 
for dates of service on or after January 1, 2018 will be denied.
    Both the current RHC and FQHC payment rate for CCM, and the 
proposed RHC and FQHC payment rates for General Care Management and 
Psychiatric CoCM codes, are based on the PFS national non-facility 
rates. The PFS rates are updated annually, and the new G codes for RHCs 
and FQHCs would be updated accordingly and finalized when the PFS rates 
are finalized for the year. No geographic adjustment will be applied to 
the General Care Management or Psychiatric CoCM G codes. RHCs and FQHCs 
are required to submit claims for care management services on an 
institutional claim (electronically per the HIPAA compliant ANSI X12 
837I or the Form CMS 1450, also known as the UB-04,) and are not 
authorized to bill care management services separately to the PFS.
5. Regulatory Changes
    As previously noted, Sec.  405.2413(a)(5) and Sec.  405.2415(a)(5) 
was revised effective January 1, 2017, to state that services and 
supplies furnished incident to CCM and TCM services can be furnished 
under general supervision of an RHC or FQHC practitioner, consistent 
with Sec.  410.26(b)(5), which allows CCM and TCM services and supplies 
to be furnished by clinical staff under general supervision when billed 
under the PFS. Sections 405.2413(a)(5) and 405.2415(a)(5) are now 
revised to state that services and supplies incident to the services of 
a physician, NP, PA, or CNM are furnished under the direct supervision 
of a physician, NP, PA, or CNM, except for TCM, General Care 
Management, and Psychiatric CoCM services, which can be furnished under 
general supervision of a physician, NP, PA, or CNM when these services 
or supplies are furnished by auxiliary personnel, as defined in Sec.  
410.26(a)(1).

B. Part B Drug Payment: Infusion Drugs Furnished Through an Item of 
Durable Medical Equipment (DME)

    Section 303(c) of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 
8, 2003) revised the payment methodology for most Medicare-covered Part 
B drugs and biologicals by adding section 1847A to the Act, which 
established a new average sales price (ASP) drug payment methodology 
beginning January 1, 2005. Section 303(b) of the MMA specified payments 
for certain drugs using methodologies other than the ASP pricing 
methodology. Specifically, section 303(b) of the MMA added section 
1842(o)(1)(D)(i) of the Act that required that an infusion drug 
furnished through an item of DME covered under section 1861(n) of the 
Act be paid 95 percent of the average wholesale price (AWP) for that 
drug in effect on October 1, 2003.
    Section 5004(a) of the 21st Century Cures Act (Cures Act) (Pub. L. 
114-255, enacted on December 13, 2016) revised sections 1842(o)(1)(C) 
and (D) of the Act, changing the payment methodology for DME infusion 
drugs from being based on AWP to the methodologies in sections 1847, 
1847A, 1847B, or 1881(b)(13) of the Act, as the case may be for the 
drug or biological. To implement the pricing changes required by 
section 5004(a) of Cures Act, which modifies the payment for DME 
infusion drugs to the amount under section 1847A of the Act (ASP drug 
payment methodology), by the statutorily mandated effective date of 
January 1, 2017, we incorporated the ASP-based infusion drug payment 
amounts into the January 2017 quarterly ASP drug pricing files and 
instructed claims processing contractors to use the updated payment 
limits for DME infusion drugs.
    To conform regulations with the new payment requirements in section

[[Page 53181]]

5004(a) of the Cures Act as they pertain to section 1847A of the Act, 
we proposed revising Sec.  414.904(e)(2). Currently, this describes an 
exception to ASP-based payments and requires pricing DME infusion drugs 
at 95 percent of the 2003 AWP. Consistent with section 5004(a) of the 
Cures Act, the proposed revision limits the exception to infusion drugs 
furnished before January 1, 2017. In addition, we proposed at Sec.  
414.904(e)(2) to delete the phrase ``and is not updated in 2006.'' We 
believe this language is not relevant since the statutory language 
required that the pricing of DME infusion drugs be based on the October 
2003 AWP. Therefore, there was no update for pricing DME infusion drugs 
in 2006, and the proposed revision will serve to simplify the language. 
Effective January 1, 2017, payment limits for these drugs are 
determined under section 1847A of the Act.
    Comment: We received one comment in which the commenter expressed 
concern that immune-compromised beneficiaries will experience access 
issues due to the reduction in payment for certain life-saving 
therapies that are paid for under Medicare Part B and administered via 
DME.
    Response: We appreciate the commenters concern about access to 
infusion drugs furnished through an item of covered DME. Section 
5004(a) of the 21st Century Cures Act requires the change in the 
payment methodology to the ASP methodology for these drugs effective 
January 1, 2017. This provision of the Act does not provide us with the 
flexibility to alter the payment methodology, implementation date or to 
select the drugs or patient populations that will be affected by the 
change.
    After consideration of the public comment received, we are 
finalizing our proposal to revise Sec.  414.904(e)(2) to conform with 
the statutory payment requirements of section 5004(a) of the Cures Act. 
We are also finalizing our proposal to revise Sec.  414.904(e)(2) to 
delete the phrase ``and is not updated in 2006.''

C. Solicitation of Public Comments on Initial Data Collection and 
Reporting Periods for Clinical Laboratory Fee Schedule

1. Background on Medicare Clinical Diagnostic Laboratory Tests Payment 
System Final Rule
    In the June 23, 2016 Federal Register (81 FR 41036) we issued a 
final rule entitled, ``Medicare Program; Medicare Clinical Diagnostic 
Laboratory Tests Payment System,'' to implement the requirements of 
section 1834A of the Act, which requires extensive revisions to the 
Medicare payment, coding, and coverage for clinical diagnostic 
laboratory tests (CDLTs) paid under the Clinical Laboratory Fee 
Schedule (CLFS).
    Under the CLFS final rule, reporting entities are required to 
report to us certain applicable information for their component 
applicable laboratories. The applicable information includes, for each 
CDLT furnished during a data collection period, the specific HCPCS code 
associated with the test, each private payor rate for which final 
payment has been made, and the associated volume of tests performed 
corresponding to each private payor rate. In general, the payment 
amount for a test on the CLFS furnished on or after January 1, 2018, 
will be equal to the weighted median of private payor rates determined 
for the test, based on the applicable information that is collected 
during a data collection period and reported to us during a data 
reporting period.
    In the CLFS final rule, we established a data collection period 
that is the 6 months from January 1 through June 30 during which 
applicable information is collected and that precedes the data 
collection period. We established a data reporting period that is the 
3-month period, January 1 through March 31, during which a reporting 
entity reports applicable information to us and that follows the 
preceding data collection period. The first data collection period was 
January 1, 2016 through June 30, 2016. The first data reporting period 
was January 1, 2017 through March 31, 2017. This 6-month data 
collection period and 3-month data reporting period schedule will be 
repeated every 3 years for CDLTs that are not advanced diagnostic 
laboratory tests (ADLTs), and every year for ADLTS that are not new 
ADLTs.
    For the first data reporting period, industry feedback suggested 
that many reporting entities would not be able to submit a complete set 
of applicable information to us by the March 31, 2017 deadline, and 
that entities required additional time to review collected data, 
address any issues identified during such review, and compile the data 
into our required reporting format. As a result, on March 30, 2017, we 
announced that we would exercise enforcement discretion until May 30, 
2017, with respect to the data reporting period for reporting 
applicable information under the Medicare CLFS and the application of 
the Secretary's potential assessment of civil monetary penalties for 
failure to report applicable information.\1\ The enforcement discretion 
applied to entities that were subject to the data reporting 
requirements finalized in the CLFS final rule (81 FR 41036). We noted 
in the announcement that the 60-day enforcement discretion period was 
the maximum amount of time we could permit to still have sufficient 
time to calculate the CLFS payment rates scheduled to go into effect on 
January 1, 2018.
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    The announcement stated that the enforcement discretion period 
would not prevent reporting entities prepared to report applicable 
information from doing so before May 30, 2017. We explained in the 
announcement that we were committed to the successful implementation of 
the new private payor rate-based CLFS and looked forward to working 
with the laboratory industry to ensure accurate payment rates. In 
recent months, we analyzed the applicable information we received, held 
our Annual Laboratory Public Meeting, met with the Advisory Panel for 
Clinical Diagnostic Laboratory tests twice, and posted preliminary CLFS 
payment rates for calendar year 2018.\2\
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2. Solicitation of Public Comments on Medicare Clinical Diagnostic 
Laboratory Tests Payment System Initial Data Collection and Reporting 
Periods: Summary of Public Comments
    In the proposed rule, we solicited public comments from applicable 
laboratories and reporting entities to better understand the applicable 
laboratories' experiences with the data reporting, data collection, and 
other compliance requirements for the first data collection and 
reporting periods. Specifically, we sought public comment on the 
following questions:
     Was the CMS data reporting system easy to use? Please 
describe your overall experience with navigating the CMS data reporting 
system. For example, describe the aspects of the CMS data reporting 
system that worked well for your reporting entity and/or any problems 
the reporting entity experienced with submitting applicable information 
to us.
     Did the applicable laboratory (or its reporting entity) 
request and receive assistance from our Help Desk regarding the CMS 
data reporting system? Please describe your experience with receiving 
assistance.

[[Page 53182]]

     Did the applicable laboratory (or its reporting entity) 
request and receive assistance from the CMS CLFS Inquiries Mailbox 
regarding policy questions? Please describe your experience with 
receiving assistance.
     Did the applicable laboratory (or its reporting entity) 
use the subregulatory guidance on data reporting provided on the CMS 
CLFS Web site? \3\ If so, was the information presented useful?
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     Was the information that the applicable laboratory was 
required to report readily available in the applicable laboratory's 
record systems?
     Did the reporting entity have a manual, automated, or 
semi-automated remittance process for data reporting?
     If the reporting entity used a manual or semi-automated 
remittance process for data reporting, what percentage of the process 
was manual?
     How much time (hours) was required to assemble and report 
applicable information to CMS?
     Is there any other information that will inform us 
regarding the reporting, recordkeeping, and other compliance 
requirements from the first data collection and reporting periods?
    We stated in the proposed rule that we were soliciting comments to 
better understand applicable laboratories' experiences with the data 
reporting, data collection, and other compliance requirements for the 
first data collection and reporting periods under the new private payor 
rate-based CLFS. We believed industry feedback on these issues would 
help inform us regarding potential refinements to the private payor 
rate-based CLFS for future data collection and reporting periods. A 
summary of the public comments we received on our comment solicitation, 
and our response to those comments, appears below.
    Comment: In response to our solicitation, we received approximately 
40 comments from individuals, health care providers, corporations, 
government agencies, and major laboratory organizations. Commenters 
expressed that the CMS Help Desk for the data reporting system and the 
subregulatory guidance on the CMS CLFS Web site were particularly 
helpful. Some commenters mentioned that using the data reporting system 
was challenging at first but became easier to navigate with more 
experience. One commenter stated that its laboratory organization 
incurred significant additional costs in collecting and reporting 
applicable information due to its large number of manual remittances. 
In addition, commenters provided the following specific 
recommendations:
     Improve the accessibility of the CMS data reporting 
system, for example, by removing certain security measures.
     A few commenters indicated that it was administratively 
burdensome for the reporting entity, that is the Taxpayer 
Identification Number (TIN) level entity, to report applicable 
information individually for each of its component applicable 
laboratories. As an alternative, they suggested that we allow the 
reporting entity to aggregate applicable information for its components 
that are applicable laboratories, and enter the aggregated applicable 
information in the designated column on the CMS data reporting 
template.
     Change the proportion of data that applicable laboratories 
are required to report; for example, allow applicable laboratories to 
report 75 to 80 percent, rather than 100 percent, of their applicable 
information.
     Change the requirement that applicable laboratories must 
report data from claims that require manual remittance processes.
     Streamline the identification of user formatting errors 
and permit real-time file edits in the CMS data reporting system.
     Define terms used in the data reporting system; for 
example, a few commenters requested CMS provide a definition for the 
term ``CMS Certification Number (CCN)''.
    Most of the comments received were out of scope because they did 
not address experiences with the initial data collection and reporting 
periods. For example, some commenters recommended that CMS delay 
implementation of the new private payor rate-based CLFS payment system. 
A few commenters recommended that we redefine the term ``applicable 
laboratory'' to include hospitals, specifically to ensure hospital 
outreach laboratory data is included in the calculation of the new CLFS 
rates.
    Response: We thank the commenters for their feedback and will 
consider the comments for potential future rulemaking or publication of 
subregulatory guidance pertaining to the CLFS data collection and 
reporting periods. No CLFS data collection or reporting changes are 
being proposed or finalized within this final rule. We note that a 
hospital outreach laboratory, that is, a hospital based laboratory that 
furnishes laboratory tests to patients other than inpatients or 
outpatients of the hospital, could be an applicable laboratory if it 
meets the definition of an applicable laboratory in 42 CFR 414.502.

D. Payment for Biosimilar Biological Products Under Section 1847A of 
the Act

    In the CY 2016 Physician Fee Schedule (PFS) final rule with comment 
period, we finalized a proposal to amend the regulation text at Sec.  
414.904(j) to make clear that the payment amount for a biosimilar 
biological product is based on the ASP of all National Drug Codes 
(NDCs) assigned to the biosimilar biological products included within 
the same billing and payment code (80 FR 71096 through 71101). In 
general, this means that products that rely on a common reference 
product's biologics license application (that is, FDA's previous 
finding of safety, purity, and potency for the common reference 
product) are grouped into the same payment calculation for determining 
a single ASP payment limit and that a single HCPCS code is used for 
such biosimilar products. The regulation went into effect on January 1, 
2016.
    The comments received on the 2016 PFS proposed rule indicated that 
stakeholders had varying opinions about Medicare payment for biosimilar 
biological products under Part B. The commenters included individuals, 
pharmaceutical manufacturers, patient advocate groups, providers, 
insurers, and members of Congress. A number of commenters opposed a 
single payment amount for all biosimilars that rely on FDA's finding of 
safety, purity, and potency for a common reference product. Most of 
these commenters believed that the proposed regulation would decrease 
incentives for biosimilar development and that grouping payment for 
biosimilar biological products is inconsistent with the statute. Some 
commenters also expressed concerns that prescribers' choices will be 
limited, that tracking or pharmacovigilance activities will be 
impaired, and that innovation and product development will be harmed, 
leading to market consolidation and increased costs for biosimilar 
biological products. Many commenters who opposed this policy suggested 
that we determine a payment amount for each biosimilar biological 
product. These stakeholders have expressed concerns that the finalized 
policy restricts and threatens the viability of their business models 
and expressed support for a new solution. Some of these stakeholders 
believed that determining a payment for each biosimilar product by 
using individual HCPCS codes, would drive and reward innovators, 
producing the potential cost savings of at least 10-15

[[Page 53183]]

percent compared to the reference biologic ASP necessary for biosimilar 
products to compete with the reference biological.
    However, some commenters supported our proposed regulation, stating 
that the potential marketplace for biosimilar biological products is 
large and it is less risky than the marketplace for reference 
biologicals. Commenters also expressed concern that separate payment 
for each biosimilar biological product would result in less competition 
among manufacturers, which in turn could lead to higher payment amounts 
for Medicare and beneficiaries. Some commenters stated that separate 
billing codes could be perceived as a type of price protection and 
could artificially increase prices for biosimilars. Commenters who 
supported the proposed regulation suggested that we remain mindful of 
our policy as the biosimilar biological product marketplace evolves. 
Several commenters requested that policy decisions be delayed while 
issues such as naming conventions and interchangeability standards are 
finalized by the FDA.
    In 2015, biological products accounted for the majority (65 
percent) of part B spending, which totaled $26 billion including 
Medicare and beneficiary payments (MedPAC Report to Congress June 2017, 
page 37). As CMS expected, since the regulation was finalized in 2015, 
the biosimilar product marketplace has continued to grow, and four 
biosimilar biological products that are paid under Part B have been 
licensed, including one product approved in 2017 that is sharing a 
HCPCS code with another previously licensed biosimilar biological 
product. Based on the number of biosimilar biological products that are 
reported to be nearing approval and the approvals made over that past 2 
years, we anticipate that several more biosimilar biological products 
will be licensed for use in the United States during the next year and 
that during the following years, the marketplace will continue to grow 
steadily, provided that the approved products are marketed without 
delay. We also anticipate that biological products will continue to be 
heavily utilized in Part B. At the same time, we are aware of concerns 
that current Medicare policy may discourage development of new 
biosimilars and other innovation in this area potentially resulting in 
higher costs over time due to a lack of competition in the market 
place.
    In the 2016 PFS final rule, we stated that it is desirable to have 
fair reimbursement in a healthy marketplace that encourages product 
development (80 FR 71101). CMS seeks to promote innovation to provide 
more options to patients and physicians, and competition to drive 
prices down, recognizing that even though these two goals may be 
difficult to achieve concurrently, to delink them would be 
counterproductive.
    Although we believe that the United States biosimilar biological 
product marketplace is still in an early phase (because only a few 
products are on the market), we are interested in assessing the effects 
of Medicare payment policy on this important portion of the Part B drug 
marketplace at this time, particularly for fostering a robust, and 
competitive marketplace and encouraging the innovation that is 
necessary to bring more of these products to the marketplace. It is 
essential to take a measured approach that considers all options given 
the significant federal spending by Medicare on Part B drugs, the 
effect of payment policies on program sustainability for taxpayers, 
health care affordability and access for beneficiaries, and the 
considerable investment the biosimilar industry reports to be making in 
the nascent market (the development cost for a biosimilar product is 
reported by commenters to be approximately $100-200 million). Failure 
to consider the available options could potentially restrict innovation 
in the marketplace, increase costs to the American taxpayer, and limit 
treatment options. With that in mind, it is CMS's goal to further 
evaluate our policies to be sure they allow for market forces to 
provide a robust and comprehensive selection of choices for providers 
and patients at a fair price. Additionally, we are interested in better 
understanding if and how the differences in biological products and 
their current regulatory environment should be reflected in Medicare 
payment policy for biosimilars, particularly as it relates to 
biosimilars that are licensed for fewer than all indications for which 
the reference product is licensed or situations where different 
biosimilars may be licensed for different subsets of indications for 
which the reference product is licensed.
    Thus, in the CY 2018 PFS proposed rule we requested comments 
regarding our Medicare Part B biosimilar biological product payment 
policy. This comment solicitation sought new or updated information on 
the effects of the current biosimilar payment policy that is based on 
experience with the United States marketplace. We stated that we were 
particularly interested in obtaining material, such as market analyses 
or research articles that provide data and insight into the current 
economics of the biosimilar market place. This includes patient, plan, 
and manufacturer data both domestic and, where applicable, from 
European markets that may be more established than, and provide insight 
for, the current United States market.
    We also sought data to demonstrate how individual HCPCS codes could 
impact the biosimilar market, including innovation, the number of 
biosimilar products introduced to the market, patient access, and drug 
spending. Finally, we also sought comment regarding other novel payment 
policies that would foster competition, increase access, and drive cost 
savings in the biological product marketplace. These novel options may 
include legislation, demonstrations, and administrative options. The 
comment solicitation did not include a proposal to change the existing 
payment policy.
    The following is a summary of the public comments received 
regarding the effect of payment policies on competition, access, and 
cost savings in the biological product marketplace and our responses on 
this issue. We received more than 200 comments in response to the 
solicitation. In general, comments were very similar to those received 
during the CY 2016 PFS rulemaking period.
    Comment: Most commenters opposed the current Medicare policy. These 
commenters believe that the policy will impair access to biosimilars, 
and could potentially limit the introduction of biosimilars to the US 
market and would fail to maximize competition and savings. Some 
provided updated information to support the position that greater 
savings will result from the use of unique codes for each biosimilar. 
Some commenters also believed that CMS should change its policy 
effective January 1, 2018.
    Commenters who agreed with the current Medicare policy believed 
that grouping biosimilars would provide savings for beneficiaries and 
for the trust fund through increased competition. These commenters 
believe that separate billing codes do not foster price competition. 
The commenters pointed out that ASP-based payments for groups of 
potentially competing Part B drugs and biologicals remained the same or 
increased between 2012 and 2017. The commenters also pointed out that 
the use of separate billing codes would likely lead to high 
introductory prices. These commenters noted that Part B has already 
experienced a situation where the initial, WAC-based

[[Page 53184]]

payment amount for a biosimilar of infliximab exceeded the ASP-based 
payment for its reference product by about 20 percent. Also, commenters 
contended that the size of the United States biological market and 
associated revenue would provide an incentive for manufacturers to 
continue to introduce products in the US (even if biosimilars continued 
to be grouped together). Finally, some commenters believed that making 
a policy change at this time was not advisable because the United 
States marketplace had not changed significantly since 2016.
    Response: We appreciate all the commenters' input, and we will 
discuss specific topics from the comment solicitation in the comment/
response sections below. We considered these comments as we evaluated 
our current policy and considered changes to it.
    Comment: Many commenters discussed the differences between 
biosimilar biological products, such as the complexity of biological 
molecules and how the manufacturing processes that are necessary to 
produce them create small differences between the products. The 
commenters noted that biosimilars are similar, but not identical, to 
their reference products, and that as a result of potentially subtle 
differences, they may have different therapeutic and adverse effects on 
patients, requiring clinical as well as payment distinctions between 
the products. These commenters believed that Medicare payment policy 
that treats biosimilars like generic drugs by grouping them for payment 
would lead to prescribing choices based on cost rather than clinical 
considerations.
    Several commenters also discussed issues related to the differences 
between products in more detail, as well as the interchangeability of 
biosimilar biological products. Although none of the currently 
available biosimilars are approved as interchangeable (and finalized 
FDA guidance on the subject is not yet available), some commenters 
believed that grouping products for payment could be understood by 
clinicians and patients that the products could be interchangeable. 
Some commenters also pointed out that the current biosimilar approval 
process does not compare biosimilar biological products to each other, 
rather, only similarity to a reference product is established and the 
licensing of a biological product under the biosimilar pathway does not 
mean that the products are interchangeable. Also, commenters noted that 
biosimilar biological products may be approved for fewer indications 
than the reference product and that the approved indications within a 
group of biosimilar biological products with the same reference product 
may vary. Some commenters believed that blended payment for biosimilar 
biological products that do not have all the same indications could 
lead to off-label use.
    Many commenters believed that differences between biosimilar 
biological products that share a common reference product exist and 
stated that such distinctions, which may affect the clinical use of a 
product on specific patients, support the need for separate coding and 
payment for biosimilars under Medicare Part B. Some commenters also 
associated these concerns with concerns about payment for biosimilar 
biological products.
    Several comments discussed the relationship between costs, prices, 
and competition in the biologicals and biosimilars market, as follows. 
Because these products are likely to be expensive and may have 
different acquisition costs, blended payment was perceived by many 
commenters as a significant financial risk to the provider because the 
provider could not be highly certain that the products that would be 
the best choice for a patient would also be likely to be paid above 
acquisition cost. These commenters believed that separate codes would 
lead to more certainty about payment amounts for biosimilar biological 
products. Some commenters were concerned that ``race to the bottom'' 
pricing competition would result from shared codes and lead to prices 
that could not sustain educational efforts and other activities 
associated with marketing new and complex biological products, 
ultimately resulting in manufacturers leaving the United States 
marketplace. The commenters also noted that the development costs for 
these products and their manufacturing facilities are estimated to be 
in the hundreds of millions of dollars.
    Commenters also expressed concern about the lack of competition 
between biosimilars and their reference product. Some commenters who 
disagreed with CMS's current approach of grouping biosimilar biological 
products for payment believed that separate codes would lead to 
opportunities for greater and more direct competition between the 
reference product and its biosimilar versions.
    Other commenters who agreed with current Medicare policy, suggested 
that payment for biosimilars should be based on grouping the reference 
product with its corresponding biosimilars in the same billing and 
payment code and suggested that legislative authority for such a change 
should be sought by CMS. These commenters opined that combining 
reference products and corresponding biosimilar biological products 
into the same billing and payment code would maximize competition for 
items with similar effects. In the absence of authority to expand 
grouped payment to include the reference product, most of these 
commenters agreed with the current approach of grouping biosimilar 
biological products of the same reference product into the same billing 
and payment code.
    Response: We appreciate the commenters' wide range of concerns 
about the differences between biosimilar biological products and how 
payment approaches may influence clinical decisions.
    Many of these concerns were brought up in comments on biosimilars 
made in response to the CY 2016 PFS final rule with comment period. We 
discussed these issues, including differences between small molecule 
drugs and biologicals (including biosimilars), generic drugs, and 
interchangeability in the 2016 final rule. However, as we have further 
considered the Part B biosimilar biological payment policy and this 
year's comments, we have become increasingly concerned about the 
relationship between cost, prices and competition; specifically, many 
commenters' continued unease regarding the effects of our payment 
policy on patient and provider choices, as well as the biosimilar 
marketplace. We have also considered how the payment policy could 
affect market entry of new biosimilar manufacturers. If payment amounts 
limit manufacturers' willingness to invest in the development of new 
biosimilars, it could in the long term, decrease the number of 
biosimilar biological products that are available to prescribe and thus 
impair price competition. Given that the United States' biosimilar 
biological product marketplace is still relatively new, we believe that 
it is important to maintain a payment policy innovation as well as 
reasonable pricing for consumers.
    We agree that current statutory authority does not permit the 
inclusion of the reference product in a payment determination 
calculation for biosimilar biological products paid under Medicare Part 
B.
    Comment: Some commenters did not believe that separate coding for 
each biosimilar product would lead to greater competition or savings. 
These commenters noted that ASP-based payment amounts for biological 
drugs, even those with other comparable products on the market, 
continue to

[[Page 53185]]

increase. Also, they provided specific examples where the payment 
amount for reference products filgrastim and infliximab, which are 
currently paid under Part B (and are coded and paid separately from 
corresponding biosimilar products) have not decreased; these commenters 
expressed concern about a potential lack of competition within the Part 
B marketplace. Some of these commenters also expressed concern about 
the United States experience with high launch prices for biosimilars, 
particularly one situation where the Part B payment amount for a 
biosimilar significantly exceeded the payment amount for a reference 
product. The commenters pointed out that in situations where each 
product has a unique code, high launch prices, particularly while a 
product is paid using Wholesale Acquisition Cost (WAC), would lead to 
higher costs for Medicare and beneficiaries. One commenter also stated 
that combining payment for biosimilar products is consistent with the 
concept of similar payment for similar services.
    Response: We note that section 1847A(c)(4) of the Act authorizes 
WAC based payment during the first quarter of sales and this subject 
has been discussed in rulemaking previously (75 FR 73465). In most 
cases WAC exceeds ASP. However, the duration of a WAC based payment 
amount is limited, and generally, once a full quarter of ASP data is 
available, payments made under section 1847A are based on ASP.
    Comment: Several commenters provided materials that were previously 
submitted with comments on the CY 2016 PFS proposed rule, in response 
to our solicitation of new or updated information on the effects of our 
biosimilars payment policy on the United States marketplace.
    One commenter also provided a revised industry estimate from the 
Biosimilars Forum that projected $50 billion in savings to the Medicare 
program over 10 years under the existing policy and an additional $15 
billion in savings over 10 years if separate codes were used. This 
estimate, which was referenced by a number of other commenters, assumes 
higher uptake of biosimilars (up to 65 percent at 10 years, compared to 
35 percent with current policy) if separate codes are implemented. 
Commenters stated that they believe the separate coding approach would 
create competition and lower prices for the long term. The main reasons 
for this were: Increased physician confidence (mainly associated with 
certainty about the payment amount), a number of manufacturers and 
products in the marketplace, and resources (from the manufacturers) 
that would encourage uptake.
    Response: We thank commenters for the updated estimates.
    Comment: Several commenters also discussed the European biosimilar 
product market. Commenters who support current Medicare policy pointed 
out that the European market as a whole has grown and includes nearly 
30 biosimilar biological products. Another commenter referenced a 
report on the European biosimilar market (The Impact of Biosimilar 
Competition in Europe. QuintilesIMS. May 2017) and described the report 
as indicating that competition reduces prices, and that government 
policies could influence both manufacturer participation in a market as 
well as uptake of products. The report and other commenters who do not 
support current Medicare policy pointed out a specific European example 
from Austria where a tiered pricing policy treats biosimilar biological 
products exactly as generic drugs. A significant payment reduction 
associated with this policy is thought to have contributed to low 
biosimilar biological product utilization and limited access in this 
country.
    Response: We appreciate the examples of approaches used to pay for 
biosimilars in Europe. In general, we believe that the European 
examples provided by commenters help confirm that savings can be 
expected in the United States marketplace with a variety of policy 
approaches because payments for biosimilar products used in Europe are 
determined in a several ways. In other words, several payment 
approaches for biosimilars have yielded savings. We also agree that the 
introduction of new products and savings may be influenced by a 
government's payment policies. We note that payment methodologies for 
drugs and biologicals in many European countries differ, sometimes 
significantly, from payment methodologies for drugs and biologicals in 
the United States. For example, a number of European countries utilize 
a single payer system and some have the authority to set prices, so 
some of these examples may not provide information that is fully 
applicable to the United States market. For example, the description of 
Austria's payment policy for biosimilar biological products is not 
similar to our pricing policy for several reasons. First, Austria uses 
a single payer system that we understand to include mandatory payment 
reductions in certain circumstances. We do not use a tiered pricing 
strategy in Part B and, under the payment methodology in section 1847A 
of the Act, we cannot mandate 40 to 50 percent reductions in payment 
for biosimilar biological products by deeming them generic drugs as 
Austria has done. We believe that many commenters continue to 
misunderstand our position on the relationship between biosimilar 
biological products and generic drugs, that is, we distinguish between 
the two. As we noted in the CY 2016 PFS final rule with comment period, 
our payment policy does not address whether a biosimilar is completely 
or partially analogous to its reference product as a clinical matter 
(80 FR 71100). We have communicated that we appreciated the complexity 
of these products and the potential differences in the clinical 
utilization of biosimilar biological products when they are being used 
to treat individual patients. In summary, we believe that most of the 
examples provided by commenters include helpful information to consider 
as the United States marketplace develops.
    Comment: We also sought comment regarding other novel payment 
policies, legislation, demonstrations, and administrative options that 
would foster competition, increase access, and drive cost savings in 
the biological product marketplace.
    As discussed earlier in this section, several commenters discussed 
code consolidation where reference and corresponding biosimilar 
products would be included in a shared code. Commenters also suggested 
that value based purchasing models, including outcomes-based pricing 
and pricing based on negotiations between a vendor and manufacturers, 
be considered for biosimilar biological products (as well as other 
drugs). One commenter also stated that paying differently for 
biosimilars and interchangeable products may create incentives for 
growth in the marketplace. One manufacturer suggested that the ASP add 
on percentage could be increased to the 15-20 percent range to 
encourage uptake.
    We also received comments that encouraged consistency between Part 
B, Part D and Medicaid, and comments that encouraged streamlining and 
simplification of price reporting, as well as comments on HCPCS coding 
schedules and deadlines, the use of NDCs on claims, pharmacy 
substitution activities, coverage, and the FDA naming conventions for 
biosimilars.
    Response: We appreciate these comments and we plan to consider them 
for future policy decisions. Regarding the ASP add-on percentage for 
biosimilar products, we note that the statute requires the ASP add-on 
to be 6 percent of the reference product. We

[[Page 53186]]

note that some of these issues are generally outside the scope of Part 
B payment policy and that statutory requirements may also constrain 
flexibility to modify or conform policies.
    Comment: Some commenters also noted that the use of a modifier to 
track the manufacturer of a biosimilar biological product was perceived 
as burdensome and suggested that unique codes were more desirable and 
more convenient for tracking. However, several commenters stated that 
the use of modifiers is an acceptable method of tracking biosimilars. 
Both groups appeared to agree that tracking the use of these new and 
complex products was necessary.
    Response: We agree that tracking the use of these new and complex 
products is important. We believe that either method, code and modifier 
combinations or unique codes, can be used for this purpose. We plan to 
continue to monitor Part B biosimilar payment and utilization, 
particularly as they relate to access, including the number of products 
available to beneficiaries with Part B and cost savings associated with 
Medicare and beneficiary payments.
    Comment: Many commenters requested that a change in policy be made 
as soon as possible so that manufacturers would be incentivized to 
enter the United States marketplace as soon as possible. Several 
commenters, including most who supported continuing the current policy 
and others who did not explicitly support either changing or not 
changing policy at this time, believed that there is insufficient 
experience with the United States marketplace to warrant making a 
change in policy at this time, but they suggested that CMS continue to 
examine its policy, and that changes should consider effects on 
patients, providers and manufacturers.
    Response: We appreciate the broad range of possibilities that 
commenters have provided during this rulemaking cycle. We agree that it 
is important to consider and effect policy changes early, as this 
portion of the drug marketplace develops, in order to support a robust 
marketplace that provides choices for providers and patients while 
maximizing savings.
    Comment: Several commenters urged CMS to change the regulation text 
to indicate that separate payment for each biosimilar biological 
product is required, and to do so in this final rule. Some commenters 
believe that there is sufficient legal basis to do so despite the fact 
that CMS did not make a proposal.
    Response: We have not proposed to make a regulation change and we 
will not be doing so in this final rule. We continue to believe, as we 
stated in the CY2016 PFS final rule with comment period, that the 
existing regulation text provides flexibility to accommodate policy 
changes in a new and evolving environment. Specifically, we stated in 
the CY 2016 PFS rule that current regulation text at Sec.  414.904(j) 
would not preclude us from separating some, or all, of a group of 
biosimilars for payment (and the creation of one or more separate HCPCS 
codes) should a program need to do so arise (80 FR 71098). As we have 
stated earlier in this rule, we are particularly concerned about the 
commenters' continuing unease regarding the effects of our payment 
policy on patient and provider choices, and the interaction between the 
payment policy, choice, and the marketplace. In an effort to support a 
more competitive marketplace and greater choice and value for 
beneficiaries, CMS is taking immediate action on this issue. We will 
discuss our reasons further in the paragraphs below.
    We appreciate the many responses that we received to our comment 
solicitation. Comments received about the issue of grouping or 
separating payment for biosimilars of the same reference product were 
sharply divided, and information provided as support for a given 
position was also subject to interpretation. For example, a commenter 
who is opposed to the current policy cited a report (Scott Morton F, 
Boller LT. Enabling Competition in Pharmaceutical Markets. Hutchins 
Center. May 2017as evidence that robust competition could reduce costs 
in the long-term; however, another portion of the report supported 
MedPAC's June 2017 recommendation to pay biosimilars and reference 
products under the same code (which CMS does not have the authority to 
do). We are acknowledging that opinions on the issue of how Part B 
should pay for biosimilar biological products vary, however, as 
discussed below, we believe that the solution discussed in the 
paragraphs below is superior to existing policy.
    As we stated previously, we seek to promote innovation, to provide 
more options to patients and physicians, and to encourage competition 
to drive prices down. We also stated that our goal for the comment 
solicitation was to further evaluate our policies to be sure they allow 
for market forces to provide a robust and comprehensive selection of 
choices for patients at a fair price. Based on the review of the 
comments that are summarized above, we are persuaded that changing the 
Part B biosimilar payment policy to provide for the separate coding and 
payment for products approved under each individual abbreviated 
application, rather than grouping all biosimilars with a common 
reference product into codes, will meet the stated goal. We believe 
that this policy change will encourage greater manufacturer 
participation in the marketplace and the introduction of more 
biosimilar products, thus creating a stable and robust market, driving 
competition and decreasing uncertainty about access and payment. First, 
as we have discussed, we anticipate that this policy change will 
provide physicians with greater certainty about biosimilar payment. We 
are persuaded that, in turn, this will affect utilization of these 
products, creating more demand that would help increase competition 
(compared to the policy that is currently in place). As a result of the 
policy change we anticipate greater access to biosimilar biological 
products and we anticipate that more price competition between more 
products will occur because there will be more products available. The 
change in policy could lead to additional savings for Medicare and its 
beneficiaries over the long-term by increasing the utilization of 
products that are less expensive than reference biologicals. Further, 
carrying out this policy change as early as possible, rather than 
waiting, would maximize the benefits described in this paragraph and 
would bring more certainty to the new and developing marketplace 
promptly.
    In summary, we are persuaded that that there is a program need for 
assigning Part B biosimilar biological products into separate HCPCS 
codes, specifically that this policy change will address concerns about 
a stronger marketplace, access to these drugs in the United States 
marketplace, provider and patient choice and competition. We also 
believe that the change in policy will encourage innovation needed to 
bring more products to the market. We remind readers that our preamble 
language in the CY 2016 PFS rule with comment period (80 FR 71096) 
indicated that policy changes could be forthcoming (80 FR 71098).
    Thus, in this final rule, we are finalizing the policy to 
separately code and pay for biological biosimilar products under 
Medicare Part B; we are not changing regulation text at Sec.  
414.904(j). Effective January 1, 2018, newly approved biosimilar 
biological products with a common reference product will no longer be 
grouped into the same HCPCS code. We will issue detailed guidance on 
coding, including

[[Page 53187]]

instructions for new codes for biosimilars that are currently grouped 
into a common payment code and the use of modifiers. Completion of 
these changes, which will require changes to the claims processing 
systems, is planned to occur as soon as feasible, but should not be 
expected to be complete by January 1, 2018. We anticipate that this 
will be done by mid-2018 and we plan to issue instructions using 
subregulatory means, such as change requests/transmittals to 
contractors and the ASP Web site.
    As suggested by commenters who supported both policy approaches, we 
plan to continue to monitor Part B biosimilar payment and utilization, 
particularly as they relate to access, including the number of products 
available to beneficiaries with Part B and cost savings associated with 
Medicare and beneficiary payments. We also appreciate the comments on 
novel payment policies that would foster competition, increase access, 
and drive cost savings in the biological product marketplace.

E. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

    Section 218(b) of the Protecting Access to Medicare Act (PAMA) 
amended Title XVIII of the Act to add section 1834(q) of the Act 
directing us to establish a program to promote the use of appropriate 
use criteria (AUC) for advanced diagnostic imaging services. The CY 
2016 PFS final rule with comment period addressed the initial component 
of the new Medicare AUC program, specifying applicable AUC. In that 
rule (80 FR 70886), we established an evidence-based process and 
transparency requirements for the development of AUC, defined provider-
led entities (PLEs) and established the process by which PLEs may 
become qualified to develop, modify or endorse AUC. The first list of 
qualified PLEs was posted on the CMS Web site at the end of June 2016 
at which time their AUC libraries became specified applicable AUC for 
purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final 
rule addressed the second component of this program, specification of 
qualified clinical decision support mechanisms (CDSMs). In that rule 
(81 FR 80170), we defined CDSM, identified the requirements CDSMs must 
meet for qualification including an opportunity for preliminary 
qualification for mechanisms still working toward full adherence, and 
established a process by which CDSMs may become qualified. We also 
defined applicable payment systems under this program, specified the 
first list of priority clinical areas and identified exceptions to the 
requirements that ordering professionals consult specified applicable 
AUC when ordering applicable imaging services. The first list of 
qualified CDSMs was posted on the CMS Web site in July 2017.
    The CY 2018 PFS proposed rule proposed the start date of January 1, 
2019 for the Medicare AUC program for advanced diagnostic imaging 
services. It is on and after this date that ordering professionals must 
consult specified applicable AUC using a qualified CDSM when ordering 
applicable imaging services and furnishing professionals must report 
consultation information on the Medicare claim. This rule also proposed 
to modify the policy related to significant hardship exceptions and 
requested public feedback on details regarding how AUC consultation 
information must be included on the Medicare claim. To further this 
iterative process of implementation, we also discussed briefly the 
potential for alignment with other Medicare quality programs.
1. Background
    AUC present information in a manner that links: A specific clinical 
condition or presentation, one or more services and, an assessment of 
the appropriateness of the service(s). For purposes of this program AUC 
is a set or library of individual appropriate use criteria. Each 
individual criterion is an evidence-based guideline for a particular 
clinical scenario. Each scenario in turn starts with a patient's 
presenting symptoms or condition. Evidence-based AUC for imaging can 
assist clinicians in selecting the imaging study that is most likely to 
improve health outcomes for patients based on their individual clinical 
presentation.
    AUC need to be integrated as seamlessly as possible into the 
clinical workflow. CDSMs are the electronic portals through which 
clinicians access the AUC during the patient workup. While CDSMs can be 
standalone applications that require direct entry of patient 
information, they may be more effective when they automatically 
incorporate information such as specific patient characteristics, 
laboratory results, and lists of co-morbid diseases from Electronic 
Health Records (EHRs) and other sources. Ideally, practitioners would 
interact directly with the CDSM through their primary user interface, 
thus minimizing interruption to the clinical workflow.
    Consistent with descriptions of clinical decision support by the 
Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov/professionals/prevention-chronic-care/decision/clinical/index.html), 
and the Office of the National Coordinator for Health Information 
Technology (ONC) (https://www.healthit.gov/policy-researchers-implementers/clinical-decision-support-cds), within health IT 
applications, a CDSM is a functionality that provides persons involved 
in care processes with general and person-specific information, 
intelligently filtered and organized, at appropriate times, to enhance 
health and health care.
2. Statutory Authority
    Section 218(b) of the PAMA added a new section 1834(q) of the Act 
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging 
Services,'' which directs the Secretary to establish a new program to 
promote the use of AUC. Section 1834(q)(4) of the Act requires ordering 
professionals to consult with a qualified CDSM for applicable imaging 
services furnished in an applicable setting and paid for under an 
applicable payment system; and for the furnishing professional to 
include on the Medicare claim information about the ordering 
professional's consultation with a qualified CDSM.
3. Discussion of Statutory Requirements
    There are four major components of the AUC program under section 
1834(q) of the Act, and each component has its own implementation date: 
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of 
the Act); (2) identification of mechanisms for consultation with AUC by 
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by 
ordering professionals, and reporting on AUC consultation by furnishing 
professionals by January 1, 2017 (section 1834(q)(4) of the Act); and 
(4) annual identification of outlier ordering professionals for 
services furnished after January 1, 2017 (section 1834(q)(5) of the 
Act). We did not identify mechanisms for consultation by April 1, 2016. 
Therefore, we did not require ordering professionals to consult CDSMs 
or furnishing professionals to report information on the consultation 
by the January 1, 2017 date.
a. Establishment of AUC
    In the CY 2016 PFS final rule with comment period, we addressed the 
first component of the Medicare AUC program under section 1834(q)(2) of 
the Act--the requirements and process for establishment and 
specification of applicable AUC, along with relevant aspects of the 
definitions under section 1834(q)(1) of the Act. This included

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defining the term PLE and finalizing requirements for the rigorous, 
evidence-based process by which a PLE would develop AUC, upon which 
qualification is based, as provided in section 1834(q)(2)(B) of the Act 
and in the CY 2016 PFS final rule with comment period. Using this 
process, once a PLE is qualified by CMS, the AUC that are developed, 
modified or endorsed by the qualified PLE are considered to be 
specified applicable AUC under section 1834(q)(2)(A) of the Act. We 
defined the term PLE to include national professional medical 
societies, health systems, hospitals, clinical practices and 
collaborations of such entities such as the High Value Healthcare 
Collaborative or the National Comprehensive Cancer Network. Qualified 
PLEs may collaborate with third parties that they believe add value to 
their development of AUC, provided such collaboration is transparent. 
We expect qualified PLEs to have sufficient infrastructure, resources, 
and the relevant experience to develop and maintain AUC according to 
the rigorous, transparent, and evidence-based processes detailed in the 
CY 2016 PFS final rule with comment period.
    In the same rule we established a timeline and process under Sec.  
414.94(c)(2) for PLEs to apply to become qualified. Consistent with 
this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html (OMB Control 
Number 0938-1288).
b. Mechanism for AUC Consultation
    In the CY 2017 PFS final rule, we addressed the second major 
component of the Medicare AUC program--the specification of qualified 
CDSMs for use by ordering professionals for consultation with specified 
applicable AUC under section 1834(q)(3) of the Act, along with relevant 
aspects of the definitions under section 1834(q)(1) of the Act. This 
included defining the term CDSM and finalizing functionality 
requirements of mechanisms, upon which qualification is based, as 
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS 
final rule. We included an opportunity for mechanisms still working 
toward full adherence to these requirements to receive preliminary 
qualification during the preliminary qualification period that begins 
June 30, 2017, and ends when the AUC consulting and reporting 
requirements become effective. The preliminarily qualified CDSMs must 
meet all requirements by that time. We defined CDSM as an interactive, 
electronic tool for use by clinicians that communicates AUC information 
to the user and assists them in making the most appropriate treatment 
decision for a patient's specific clinical condition. Tools may be 
modules within or available through certified EHR technology (as 
defined in section 1848(o)(4) of the Act) or private sector mechanisms 
independent from certified EHR technology or established by the 
Secretary.
    In the CY 2017 PFS final rule we established a timeline and process 
in Sec.  414.94(g)(2) for CDSM developers to apply to have their CDSMs 
qualified. Consistent with this timeline, the first list of qualified 
CDSMs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in conjunction with this rule in July 2017 (OMB 
Control Number 0938-1315).
c. AUC Consultation and Reporting
    The third major component of the Medicare AUC program is in section 
1834(q)(4) of the Act, Consultation with Applicable Appropriate Use 
Criteria. This section establishes, beginning January 1, 2017, the 
requirement for an ordering professional to consult with a qualified 
CDSM when ordering an applicable imaging service that would be 
furnished in an applicable setting and paid for under an applicable 
payment system; and for the furnishing professional to include on the 
Medicare claim information about the ordering professional's 
consultation with a qualified CDSM. The statute distinguishes between 
the ordering and furnishing professional, recognizing that the 
professional who orders an applicable imaging service is usually not 
the same professional who bills Medicare for that service when 
furnished. Since a list of qualified CDSMs was not available by January 
1, 2017, we did not require ordering professionals to meet the 
consultation requirement by that date.
    Section 1834(q)(4)(C) of the Act provides for certain exceptions to 
the AUC consultation and reporting requirements including in the case 
of certain emergency services, inpatient services paid under Medicare 
Part A, and ordering professionals who obtain an exception due to a 
significant hardship. In the CY 2017 PFS final rule, we identified the 
circumstances specific to ordering professionals under which consulting 
and reporting requirements are not required. These include orders for 
applicable imaging services: (1) For emergency services when provided 
to individuals with emergency medical conditions as defined in section 
1867(e)(1) of the Act; (2) for an inpatient and for which payment is 
made under Medicare Part A; and (3) by ordering professionals who are 
granted a significant hardship exception to the Medicare EHR Incentive 
Program payment adjustment for that year under 42 CFR 495.102(d)(4), 
except for those granted such an exception under Sec.  
495.102(d)(4)(iv)(C). We discuss changes to the significant hardship 
exceptions later in this preamble.
    Section 1834(q)(4)(D) of the Act specifies the applicable payment 
systems for the AUC consultation and reporting requirements, and, in 
the CY 2017 PFS final rule we defined them as: (1) The physician fee 
schedule established under section 1848(b) of the Act; (2) the 
prospective payment system for hospital outpatient department services 
under section 1833(t) of the Act; and (3) the ambulatory surgical 
center payment system under section 1833(i) of the Act.
d. Identification of Outliers
    The fourth component of the Medicare AUC program is in section 
1834(q)(5) of the Act, Identification of Outlier Ordering 
Professionals. The identification of outlier ordering professionals 
under this paragraph facilitates a prior authorization requirement for 
outlier professionals beginning January 1, 2020, as specified under 
section 1834(q)(6) of the Act. Given that we proposed a program start 
date of January 1, 2019, we anticipate that implementation of the prior 
authorization component would be delayed. We expect to discuss details 
around outlier calculations and prior authorization in the CY 2019 PFS 
proposed rule. However, we did finalize in the CY 2017 PFS final rule 
the first list of priority clinical areas to guide identification of 
outlier ordering professionals as follows:
     Coronary artery disease (suspected or diagnosed).
     Suspected pulmonary embolism.
     Headache (traumatic and non-traumatic).
     Hip pain.
     Low back pain.
     Shoulder pain (to include suspected rotator cuff injury).
     Cancer of the lung (primary or metastatic, suspected or 
diagnosed).
     Cervical or neck pain.
    As established in Sec.  414.94(e)(4) of our regulations, priority 
clinical areas may be used in the identification of outlier ordering 
professionals. By starting to identify these areas now, we believe 
ordering professionals will have the opportunity to become familiar 
with

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AUC within identified priority clinical areas prior to Medicare claims 
for those services being part of the input for calculating outlier 
ordering professionals.
    We did not include proposals to expand or modify the list of 
priority clinical areas in the CY 2018 PFS proposed rule.
4. Proposals for Continuing Implementation
    In the CY 2018 PFS proposed rule, we proposed to amend Sec.  414.94 
of our regulations, ``Appropriate Use Criteria for Certain Imaging 
Services,'' to reflect the following policies.
a. Consultation by Ordering Professional and Reporting by Furnishing 
Professional Timeline
    We proposed that ordering professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system and ordered on or after January 1, 2019. We proposed 
this effective date for the consulting and reporting requirements to 
allow time for ordering practitioners who are not already aligned with 
a qualified CDSM to research and evaluate the qualified CDSMs so they 
may make an informed decision. Although there will be an additional 
rulemaking cycle before the consulting and reporting requirement is 
effective, we are establishing the date through rulemaking this year 
because we expect practitioners and other stakeholders to begin 
preparing themselves to report and we want to ensure all impacted 
parties have sufficient time to prepare to meet the requirements of 
this program.
    After proposing the timeline and process for qualification of CDSMs 
in the CY 2017 PFS proposed rule (81 FR 46392), we anticipated that 
furnishing professionals may begin reporting as early as January 1, 
2018. However, we received comments that these timelines did not allow 
enough time to address the needs of different stakeholder groups. Some 
commenters requested that we delay the timeline and process to give 
practitioners sufficient time to obtain a qualified CDSM. Other 
commenters cited insufficient time for CDSMs to incorporate 
requirements between the release of the final CDSM requirements and 
January 1, 2018, and requested that we fully implement the program at a 
later date. Additionally, in the CY 2017 PFS final rule (81 FR 80411) 
we discussed commenters' recommendations that we develop and launch an 
educational campaign, including a Town Hall meeting. Some commenters 
requesting additional time suggested that, for purposes of both CDSM 
vendor readiness and practitioner readiness, consulting and reporting 
requirements should not go into effect for an additional 12-18 months 
after the initial list of CMS-qualified CDSMs is posted.
    By proposing that the consulting and reporting requirements begin 
on January 1, 2019, we intended to allow needed time for education and 
outreach efforts, time for practitioners and stakeholders to prepare, 
and time for CDSMs to continue current strides in being more user-
friendly and less burdensome. We note that the statute required 
publication of qualified CDSMs by April 1, 2016, and required AUC 
consultation and reporting by January 1, 2017; therefore, our proposal 
substantially lags the statutory requirements. As noted earlier and in 
previous rulemaking, a delay in the statutory timeline is necessary to 
maximize the opportunity for public comment and stakeholder engagement, 
which is also a statutory requirement, and allow for adequate advance 
notice to practitioners, beneficiaries, AUC developers, and CDSM 
developers. This delay is also important to allow time to test and 
ensure Medicare claims processing systems are ready to accept and 
process claims that include the necessary AUC consultation information. 
Failure to test our own processes could result in claims being denied 
inappropriately or, conversely, being paid inappropriately.
    The following is a summary of the public comments received on the 
proposed effective date for consulting and reporting requirements:
    Comment: Some commenters strongly supported the proposal to begin 
the AUC consultation and reporting requirement in January 2019 and 
further stated that additional delays beyond 2019 are not warranted. 
They asserted that physicians need certainty that the AUC program will 
move forward on a predictable timeline and will not be subject to 
continued changes. Some commenters stated that they are prepared for 
this program to begin and that others will be prepared within one year. 
In contrast, other commenters do not want this AUC program implemented 
in 2019 or at any point in the future. These commenters wanted the 
program to be delayed indefinitely, discontinued or modified to the 
extent that participation be only voluntary as opposed to mandatory. 
Some of these commenters stated that the quality goals of the AUC 
program are duplicative of the quality goals of the Quality Payment 
Program and that the AUC program runs counter to the agency's goal of 
reducing administrative burden for practitioners and providers. Some 
suggested that the Quality Payment Program could serve as a less 
burdensome approach to achieving the same goals. Commenters disagreed 
with the premise behind the AUC consultation and reporting requirement 
that the furnishing professional claim should not be paid when the 
ordering professional failed to perform an AUC consultation.
    Response: We recognize the interest from commenters in better 
understanding our separate and distinct efforts to improve quality, and 
note that such efforts are the result of the distinct statutory 
requirements for the AUC program required in section 1834(q) of the Act 
as added by section 218(b) of the statute and the Quality Payment 
Program required in section 1848(q) of the Act as added by the Medicare 
Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10). 
We agree that the goals of the Quality Payment Program are consistent 
with those of the AUC program. In addition, the AUC program promotes 
AUC to ensure the patient gets the right test at the right time and 
reduces inappropriate imaging. We are required by separate statutory 
authority provisions to implement the AUC program and the Quality 
Payment Program. Section 1834(q) of the Act requires AUC consultation 
information to be included on the furnishing professional's claim in 
order for that claim to be paid; we do not have discretion with respect 
to that requirement.
    Comment: There are commenters that supported the AUC program but 
suggested that CMS participate in further stakeholder engagement. These 
commenters suggested an advisory panel be created to identify a 
reasonable program start date based on the readiness of practitioners, 
facilities, EHRs and CDSMs. Commenters also recommended listening 
sessions, town hall meetings and open door forums for stakeholders to 
share information with CMS about minimizing burden and communicating 
the state of stakeholder readiness.
    Response: We agree that we would benefit from additional 
stakeholder engagement. Over the coming months we will establish 
opportunities for this type of interaction.
    Comment: Although some commenters very clearly expressed strong, 
clear positions either for or against the proposed effective date for 
the AUC consultation and reporting requirements, as well as the AUC 
program more generally, the majority of commenters were more nuanced in 
their

[[Page 53190]]

comments and gave additional opinions regarding not only the start date 
but options as to how the program should begin.
    Response: We will summarize and respond to these comments in a 
later section of this preamble within the relevant sections that 
discuss the voluntary participation and educational and operations 
testing periods we are finalizing in this rule.
    Comment: Numerous commenters requested clarification regarding who 
is required to perform the consultation of AUC through a qualified 
CDSM. Commenters questioned whether a designee within an ordering 
professional's practice could consult on behalf of the ordering 
professional and whether an ordering professional could delegate 
consultation authority to another individual, a third party vendor or 
contracted agent. Several commenters supported this notion, noting that 
state laws allow professionals to delegate to qualified individuals in 
practice under the supervision of a physician the ability to assist 
advanced imaging orders, and URAC states that an organization 
conducting utilization review must accept information from any 
reasonably reliable source that will assist in the certification 
process. One commenter recommended that CMS reinforce the requirement 
that the ordering professional responsible for the order must 
meaningfully interact with AUC at the time of order, but allow the 
market to develop compliant approaches that ensure the educational 
effect of AUC is achieved. Some commenters supported delegation only to 
the ordering professional's staff while other commenters opposed 
allowing consultation by anyone other than the ordering professional, 
which they understand as the clear requirement under section 1834(q) of 
the Act and the current AUC regulations, and are concerned that other 
types of individuals and stakeholders are preparing to circumvent this 
requirement by performing consultations on behalf of ordering 
professionals.
    Response: Section 1834(q)(4)(A)(i) of the Act requires an ordering 
professional to consult with a qualified CDSM. We appreciate the 
varying opinions presented by stakeholders and the number of commenters 
who raised these questions. We will consider developing policy to 
address this issue.
    Comment: Some commenters requested that we clarify how imaging 
replacement orders, where the furnishing professional or radiology 
technician updates or modifies an order based on new information at the 
time of imaging, are handled under the AUC program. Commenters 
questioned whether the furnishing professional can update the order as 
necessary or if they need to consult with the ordering professional or 
AUC again to generate a new determination of appropriateness. One 
commenter requested that CMS provide guidance for situations where the 
furnishing professional performs different or additional tests than 
ordered in accordance with guidance in Medicare publication 100-02, 
Chapter 15, sections 80.6.2-4. Some commenters recommended that 
furnishing professionals have the flexibility to adjust exam parameters 
or modify orders without consulting AUC, submit orders themselves if 
they have relevant patient clinical information, and occasionally use 
AUC as appropriate to demonstrate that a test was warranted.
    Response: We understand that in certain situations updates or 
modifications to orders for advanced diagnostic imaging services may be 
warranted once the beneficiary is under the care of the furnishing 
professional. As a commenter noted, the Medicare Benefit Policy Manual 
(Pub. L. 100-02) addresses rules around these situations in Chapter 15, 
sections 80.6.2-4. We do not believe it was the intent of section 
218(b) of the PAMA to reverse these rules, and we expect furnishing 
professionals and facilities to continue to adhere to them so as to 
avoid additional burden, workflow interruptions and delays in medically 
necessary services.
    In instances when the furnishing professional must update or modify 
the order for an advanced diagnostic imaging service, the AUC 
consultation information provided by the ordering professional with the 
original order should be reflected on the Medicare claim to demonstrate 
that the requisite AUC consultation occurred. In future rulemaking, we 
expect to establish a means to account for instances when the order 
must be updated or modified. We anticipate addressing this issue in 
rulemaking to develop policies relating to the identification of 
outlier ordering professionals, and in order to inform the prior 
authorization component of this program.
    In response to public comments we are further delaying the 
effective date for the AUC consultation and reporting requirements for 
this program from January 1, 2019 as proposed to January 1, 2020. We 
are also finalizing a voluntary period during which early adopters can 
begin reporting limited consultation information on Medicare claims 
from July 2018 through December 2019. During the voluntary period there 
is no requirement for ordering professionals to consult AUC or 
furnishing professionals to report information related to the 
consultation. On January 1, 2020, the program will begin with an 
educational and operations testing period and during this time we will 
continue to pay claims whether or not they correctly include such 
information. Ordering professionals must consult specified applicable 
AUC through qualified CDSMs for applicable imaging services furnished 
in an applicable setting, paid for under an applicable payment system 
and ordered on or after January 1, 2020, and furnishing professionals 
must report the AUC consultation information on the Medicare claim for 
these services ordered on or after January 1, 2020.
Reporting
    Consistent with section 1834(q)(4)(B) of the Act, we also proposed 
that furnishing professionals report the following information on 
Medicare claims for applicable imaging services, furnished in an 
applicable setting, paid for under an applicable payment system as 
defined in Sec.  414.94(b), and ordered on or after January 1, 2019: 
(1) Which qualified CDSM was consulted by the ordering professional; 
(2) whether the service ordered would adhere to specified applicable 
AUC, would not adhere to specified applicable AUC, or whether the 
specified applicable AUC consulted was not applicable to the service 
ordered; and (3) the NPI of the ordering professional (if different 
from the furnishing professional).
    We believe that, unless a statutory exception applies, an AUC 
consultation must take place for every order for an applicable imaging 
service furnished in an applicable setting and paid under an applicable 
payment system. We further believe that section 1834(q)(4)(B) of the 
Act accounts for the possibility that AUC may not be available in a 
particular qualified CDSM to address every applicable imaging service 
that might be ordered; and thus, the furnishing professional can meet 
the requirement to report information on the ordering professional's 
AUC consultation by indicating that AUC is not applicable to the 
service ordered. We remind readers that, as required under Sec.  
414.94(g)(1)(iii), qualified CDSMs must make available, at a minimum, 
AUC that reasonably address common and important clinical scenarios 
within all priority clinical areas. As discussed in the CY 2017 PFS 
final rule (81 FR 80170), the current list of priority clinical areas 
represents about 40 percent of advanced diagnostic

[[Page 53191]]

imaging services paid for by Medicare in 2014. We also remind readers 
that consistent with section 1834(q)(4)(A) of the Act, ordering 
professionals must consult AUC for every advanced diagnostic imaging 
service ordered. Although section 1834(q)(4)(B) of the statute does not 
prohibit qualified CDSMs to return a response of ``not applicable'' if 
a qualified CDSM does not contain specified applicable AUC for the 
service ordered, we expect these situations to be limited in scope and 
number, and to decrease over time. The ``not applicable'' responses 
should decrease as qualified PLEs continue to build out their AUC 
libraries and qualified CDSMs update their content and potentially 
collaborate with more qualified PLEs so as to make available highly 
comprehensive tools.
    Section 1834(q)(4)(B) requires that payment may only be made if the 
claim for the advanced diagnostic imaging service includes the specific 
information discussed in this final rule. This information, to the 
extent feasible, is required across claim types (including both the 
furnishing professional and facility claims) and across all three 
applicable payment systems (PFS, hospital outpatient prospective 
payment system and ambulatory surgical center payment system). In other 
words, we would expect this information to be included on the 
practitioner claim that includes the professional component of the 
imaging service and on the hospital outpatient claim for the technical 
component of the imaging service. Claims for services for which payment 
is not made under the three identified payment systems would not be 
required to include consultation related information.
    To implement this requirement we proposed to establish a series of 
HCPCS level 3 codes. These G-codes would describe the specific CDSM 
that was used by the ordering professional. Ultimately there would be 
one G-code for every qualified CDSM with the code description including 
the name of the CDSM. However, because the claims processing system can 
only recognize new codes quarterly, we may not be able to update the G-
code descriptors simultaneously with the announcement of any new 
qualified CDSMs which is expected to occur in June of each year. To 
ensure that there is a code available to immediately describe newly 
qualified CDSMs, we proposed to establish a generic G-code that would 
be used to report that a qualified CDSM was consulted, but would not 
identify a specific qualified CDSM; clinicians would only be permitted 
to use this code if a more specific named code did not yet exist for 
that clinician's CDSM. Furnishing professionals would report this code 
temporarily until a specific G-code describing the newly qualified CDSM 
by name becomes available. We also proposed to establish a G-code to 
identify circumstances where there was no AUC consultation through a 
qualified CDSM. The description of this code would indicate that a 
qualified CDSM was not consulted by the ordering professional.
    G-codes would be a line-item on both practitioner claims and 
facility claims. We would expect that one AUC consultation G-code would 
be reported for every advanced diagnostic imaging service on the claim. 
If there are two codes billed for advanced imaging services on the 
claim then we would expect two G-codes. Each G-code would be expected, 
on the same claim line, to contain at least one new HCPCS modifier. We 
proposed to develop a series of modifiers to provide necessary 
information as to whether, when a CDSM is used to consult AUC: (1) The 
imaging service would adhere to the applicable appropriate use 
criteria; (2) the imaging service would not adhere to such criteria; or 
(3) such criteria were not applicable to the imaging service ordered. 
We proposed to create additional modifiers to describe situations where 
an exception applies and a qualified CDSM was not used to consult AUC: 
(1) The imaging service was ordered for a patient with an emergency 
medical condition or (2) the ordering professional has a significant 
hardship exception. Based on this proposal we specifically sought 
comments on any additional HCPCS modifiers that might be needed to 
separately identify allowable scenarios for which a qualified CDSM was 
not consulted by the ordering professional.
    The following is a summary of the public comments received on our 
proposals for the information furnishing professionals must report on 
the Medicare claim:
    Comment: Some commenters agreed with the proposed approach of using 
a combination of G-codes and HCPCS modifiers to capture AUC 
consultation information on Medicare claims. Numerous commenters, 
however, stated that the creation of new G-codes and modifiers will 
excessively burden practitioners and their systems. Practitioners and 
facilities will have to dedicate significant staff time and in some 
cases additional full-time staff positions to translating this new 
information into the appropriate codes and ensuring such information is 
appended to Medicare claims. Others noted that CDSMs, EHRs and systems 
that create electronic orders will require additional programming and 
testing. There was also concern that CMS would not be able to keep up 
with timely issuing of G-codes to keep up with newly qualified CDSMs.
    Commenters provided various recommendations to CMS that would avoid 
the combination of reporting through G-codes and modifiers. A commenter 
suggested that only one G-code be developed to generically identify 
that a CDSM consultation occurred without identifying the specific 
mechanism. Another comment pointed out that when the modifiers for 
consultation exceptions are reported (for example, emergency medical 
conditions or hardship exceptions) that the modifier should be 
reporting on the same line as the CPT code for the imaging service as 
opposed to reporting a G-code.
    Many commenters suggested CMS require the unique consultation 
identifier be appended to the Medicare claim instead of using G-code 
and modifier combinations. They suggested CMS, along with stakeholders, 
standardize the identifier to have embedded meaning that is consistent 
across CDSMs. They further supported the reporting of this identifier 
on claims so CMS can match the claim with the richer, more robust 
consultation data that is collected within the CDSM. It is with this 
more complete information that they suggested that outlier ordering 
professionals be identified rather than rely solely on information 
reported on the claim. Commenters generally supported use of the unique 
identifier as the least administratively burdensome approach to 
collecting AUC consultation information on Medicare claims.
    Other commenters suggested a registry to hold all AUC consultation 
information across CDSMs and that the information be available to CMS 
directly from the registry rather than having furnishing professionals 
report information on the claim. They further suggested that a registry 
would also include information about consultations that do not result 
in imaging.
    Response: We agree with many of the commenters in that a less 
burdensome approach to reporting AUC consultation information on 
Medicare claims should be considered. Reporting the unique consultation 
identifier would still be a new burden on the ordering and furnishing 
professionals; however, we are pleased to learn from commenters that it 
is a less burdensome and preferred approach when compared to the 
proposed G-code and modifier combinations. We also agree that

[[Page 53192]]

capturing this identifier on the claim provides the best opportunity to 
access the robust data contained within qualified CDSMs.
    In response to these comments we will not move forward with the G-
code and modifier combinations for reporting which CDSM is consulted, 
adherence, non-adherence or situations where AUC are not applicable. We 
will further explore and pursue use of the unique consultation 
identifier for reporting on Medicare claims. However, in order to use 
such an identifier we must work with stakeholders to develop a standard 
taxonomy. We expect to conduct stakeholder outreach during 2018 so that 
such standardization can be accomplished and will discuss such changes 
in future rulemaking ahead of the 2020 consulting and reporting 
effective date. We do not anticipate including these identifiers on 
claims before then. We will conduct outreach to better explore options 
of where to place such an identifier on practitioner and facility 
claims for advanced imaging services. We will also explore mechanisms 
for CMS and qualified CDSMs to share data.
    Since we intend to move forward to implement the AUC consultation 
and reporting requirement under section 1834(q)(4) using the unique AUC 
consultation identifier, we will not pursue the use of G-codes to 
identify the consulted CDSM. It is our expectation that the information 
required for Medicare claims processing and, ultimately, identification 
of outlier ordering professionals, will be embedded within a 
standardized unique identifier. AUC adherence, non-adherence and not 
applicable responses should also be embedded. Therefore, we will not 
move forward with the creation of modifiers to identify each of those 
AUC consultation result conditions. We do expect that limited use of 
modifiers will be required in the future to identify certain exceptions 
to AUC consultation requirements.
    In another section of this preamble we discuss the voluntary 
reporting period that we proposed to be available from July 2018 
through December 2018, and we are extending in this final rule through 
CY 2019. During the voluntary reporting period, ordering professionals 
are not required to consult AUC and furnishing professionals are not 
required to report consultation information on their Medicare claims. 
Furnishing professionals and facilities reporting AUC consultation 
information during the voluntary reporting period will have one HCPCS 
modifier available to them to report on the line level with the CPT 
code for the advanced diagnostic imaging service. This modifier 
identifies only that AUC was consulted and not the result of the 
consultation. We expect this type of limited reporting will be 
temporary as we move forward to implement the AUC consultation and 
reporting requirements using the unique AUC consultation identifier.
    Comment: A commenter asked whether claims for physicians billing 
Medicare Part B services for advanced imaging services will require AUC 
consultation when the patient is an inpatient.
    Response: When the patient is in an inpatient setting and advanced 
diagnostic imaging services are paid under Medicare Part A, the 
physician's Part B professional claim would not require reporting of an 
AUC consultation. Under section 1834(q)(1)(D) of the Act, the AUC 
consultation and reporting requirements apply only in an ``applicable 
setting'' which includes a physicians' office, hospital outpatient 
department, ambulatory surgical center, or other ``provider-led 
outpatient setting,'' but does not include any inpatient setting. The 
ordering practitioner, in this example, would not be required to 
consult a qualified CDSM.
    Comment: A few commenters asked if orders for advanced diagnostic 
imaging services for patients in critical access hospitals (CAHs) are 
subject to the AUC consultation and reporting requirement.
    Response: Any advanced imaging service furnished within a CAH would 
not be furnished in an applicable setting. Applicable settings 
currently include physician offices, hospital outpatient departments 
and ambulatory surgical centers. CAH patients who are furnished an 
advanced diagnostic imaging service in an applicable setting but the 
claim for that imaging service is not paid under one of the applicable 
payment systems would not require consultation and reporting of the AUC 
consultation. This may apply in situations when a CAH has elected 
Method II billing.
    In response to the public comments, we are not moving forward with 
requiring reporting of AUC consultation information on Medicare claims 
using a combination of G-codes and modifiers. Rather, we will evaluate 
a simplified method of reporting during the voluntary reporting period 
using a single modifier while we work with stakeholders to explore 
using a standardized unique AUC consultation identifier.
    The following is a summary of public comments received on 
communication of AUC consultation information between the ordering and 
furnishing professionals:
    Comment: Commenters suggested options be made available to report 
situations when the furnishing professional attempted to obtain AUC 
consultation information from the ordering professional but the 
information was ultimately not made available. These commenters sought 
an option to report on the furnishing professional claim that the 
information was not provided. Some commented that furnishing 
professionals should not be required to report the ordering 
professional's compliance with the AUC program. They stated that this 
unfairly punishes the furnishing professional.
    Response: We understand that there is a burden placed on furnishing 
professionals since it is their claims that ultimately will not be paid 
if AUC consultation information is not included on the claim form. 
However, section 1834(q)(4)(B) of the Act specifically requires that 
this information be reported on the furnishing professional's claim. We 
will continue to seek opportunities to reduce the reporting burden, 
including use of the unique AUC consultation identifier.
    Comment: Commenters widely requested further timely and detailed 
guidance, clarification, and education on claims processing 
requirements for reporting, certification and documentation. Commenters 
requested specific information and examples on requirements and new 
codes, and on how to report information such as hardship exception 
information on the claim.
    Commenters also requested clarification around a number of specific 
issues. One commenter requested CMS provide instructions on how to 
handle orders written prior to the effective date for the AUC 
consultation and reporting requirement when services are furnished 
after the effective date. One commenter requested clarification around 
claims processing issues if the imaging test ordered does not match the 
test performed because the furnishing professional modifies the order. 
Several commenters requested clarification regarding the obligations on 
ordering and furnishing professionals along with the consequences 
during the educational and operations testing period, and specifically 
asked whether claims will be paid during this period. Commenters also 
requested clarification on which professional is responsible for the 
accuracy of reporting, how CMS will ensure this, and the consequences 
on furnishing professionals if the required information is not obtained 
after the

[[Page 53193]]

educational and operations testing period. Some commenters requested 
clarification on orders for repeat tests (for example, for the same 
test to be performed every three months) and whether the same decision 
support number could be used on each order or if a unique number was 
required for each. One commenter requested we clarify that, when CMS 
qualifies a PLE and their AUC development method, we are also accepting 
the way the resulting level of appropriateness is translated to one of 
the three options identified in our regulations (whether the service 
ordered would adhere to specified applicable AUC, whether the service 
ordered would not adhere to specified applicable AUC, or whether the 
specified applicable AUC consulted was not applicable to the service 
ordered) for the purposes of claims reporting. This commenter noted 
that this is important to assure consistent translation (or mapping) 
regardless of who performs the mapping.
    Response: These comments and requests for clarification are helpful 
and important as we develop and build out our outreach and education 
strategies. We hope to engage in continuous communications with 
stakeholders to address these and other questions that arise. As 
discussed earlier, the AUC consultation and reporting requirements 
begin for services furnished on or after January 1, 2020; so orders 
placed for services that are furnished prior to this date are not 
subject to the AUC consultation and reporting requirement. We are 
exploring claims-reporting options for situations when the imaging 
service is ordered before January 1, 2020 but furnished after January 
1, 2020 and AUC consultation information is not available for inclusion 
on the claim. During the educational and operations testing period, 
beginning January 1, 2020 and continuing through December 31, 2020, 
claims will be paid regardless of whether AUC consultation information 
is correctly included on the claim. We hope practitioners will use this 
time to make good faith efforts to accurately report information on the 
claim so we can learn, adjust, and improve these processes and ordering 
and furnishing professionals can learn and grow accustomed to 
consulting AUC and reporting consultation information. Furnishing 
professionals should expect ordering professionals to communicate 
accurate information about their AUC consultations, so that such 
information is reflected on the Medicare claim beginning January 1, 
2020. We will continue to consider implementation of the exceptions to 
AUC consultation during the voluntary reporting period and in response 
to stakeholder feedback. We continue to explore options for reporting 
this information in the least burdensome and most efficient manner and 
will release specific instructions prior to January 1, 2020.
Voluntary and Educational and Operations Testing Periods
    There are aspects of the AUC program that are novel for ordering 
and furnishing professionals. An AUC consultation by an ordering 
professional and reporting by a furnishing professional has never 
before been required under Medicare Part B with such a broad 
application (all professionals ordering and furnishing advanced 
diagnostic tests). Additional considerations are warranted for the 
complex communication that is required to convey AUC consultation 
information from the ordering professional to the furnishing 
professional and facility that must include that information when 
billing for the service. Billing systems for furnishing professionals 
will also need to include the AUC consultation information onto 
Medicare claims forms. These processes are new for many professionals, 
and there are many areas for potential missteps and errors. For these 
reasons an educational and operations testing period is needed. During 
this period, ordering professionals would consult AUC and furnishing 
professionals would report AUC consultation information on the claim, 
but we would continue to pay claims whether or not they correctly 
include such information. This educational and operations testing 
period allows professionals to actively participate in the program 
while avoiding claims denials during the learning curve. It also gives 
us an opportunity to make any needed claims processing adjustments 
before payments are impacted.
    We believe it is preferable to begin implementation with an 
educational and operations testing period of a year. We do not expect 
to continue this educational and operations testing period beyond the 
first year of the AUC program.
    We sought public comments on all aspects of our proposal, and 
specifically, whether the AUC program requirements should be delayed 
beyond the proposed start date of January 1, 2019. Although our 
proposal to start the AUC program with an educational and operations 
testing period beginning on January 1, 2019 was based in part on 
comments received in prior rulemaking cycles, it was important to 
receive comments to help us understand the current readiness of 
stakeholders. In addition, we proposed that the program begin with an 
educational and operations testing period and were interested in 
comments regarding how long, if longer than one year, such a period 
should be available.
    In our proposals, we expected a voluntary reporting period to be 
available prior to the beginning of the educational and operations 
testing period and anticipated such voluntary period will begin in July 
2018. When the voluntary period becomes available we will make 
announcements through our educational channels such as the CMS Web site 
and listservs. It is important to note that the educational and 
operations testing period is separate from the voluntary reporting 
period. During the voluntary reporting period, AUC consultation and 
reporting are not required. However, for applicable imaging services 
ordered on and after January 1, 2019, we proposed that ordering 
professionals would be required to consult specified applicable AUC and 
furnishing professionals would be required to report AUC consultation 
information on the Medicare claim. We proposed further that the initial 
year of the AUC consultation and reporting requirement would be an 
educational and operations testing period during which we would 
continue to pay claims whether or not they correctly include the 
required information.
    The following is a summary of the public comments received on the 
proposed start date of January 1, 2019, our proposal to begin with a 
year long educational and operations testing period, and the inclusion 
of a voluntary reporting period ahead of the required AUC consultation 
and reporting start date; and our responses to the comments:
    Comment: Of the commenters supporting a 2019 start date the 
majority also supported an educational and operations and testing 
period. Some of those commenters further supported extending the 
educational and operations testing period to two years, indicating that 
two years is necessary for us to learn from the testing and make 
adjustments before fully implementing the AUC program. Other commenters 
supported starting the program in 2020 with the first two years being 
for education and testing. Of the commenters that agreed with including 
an initial period of educational and operations testing, or delaying 
the first year of the program to 2020 or beyond, many cited concerns of 
infrastructure

[[Page 53194]]

readiness, high administrative burden, lack of standards across CDSM 
and EHR vendors, need to educate the affected professionals, time for 
those professionals to overcome technical and workflow challenges, and 
additional time for CMS to provide needed guidance including 
establishing vendor standards for communication between the ordering 
and furnishing professionals. Specifically, some commenters identified 
concern over the lack of interoperability across CDSMs and the lack of 
available CDSMs that are embedded within EHRs as a reason for delaying 
the program start date. Also, they recommended CMS work with ONC to 
establish applicable standards for AUC, CDSMs and their EHR 
integration.
    Although commenters pressed the need for predictability in the 
start of the program and asserted that numerous professionals are ready 
to begin, or are very close to beginning, to use CDSMs, other 
commenters focused on the increased burden associated with this 
program. Those commenters identified the Quality Payment Program as a 
new program that is currently requiring extra resources and has 
recently increased burden on the same practitioners and facilities that 
will be burdened by the AUC program.
    Some commenters suggested that, instead of beginning to implement 
the AUC program broadly, we should begin smaller with focused pilots, 
or a staged or incremental rollout.
    Response: We understand that the AUC program is a new requirement 
that increases the administrative burden on practitioners and 
facilities that order and furnish advanced diagnostic imaging services. 
For example, practitioners that do not have access to a qualified CDSM 
within their EHR may experience greater interruptions to their clinical 
workflows due to issues of interoperability or availability than 
practitioners that do not have to leave their EHR environment to 
consult a qualified CDSM. Allowing additional time for CDSMs and EHRs 
to work together to improve workflow for practitioners may ease some of 
the burden. In addition, we agree that there is value in ONC having a 
role establishing standards for CDSMs and their EHR integration.
    We believe this program can be implemented in a manner that would 
minimize burden, but this will require additional stakeholder outreach, 
collaboration and time. For practitioners and facilities that are ready 
to use qualified CDSMs or that are new to CDSMs and want to practice 
and refine their workflow, we are providing a voluntary period starting 
in July of 2018 that runs through CY 2019.
    Taking into account the comments related to burden and readiness, 
we agree with the commenters recommending that the program begin in 
2020 with an educational and operations testing period. Providing a 
start date for implementation of the AUC consultation and reporting 
requirement will also give some predictability and assurance to 
practitioners. Given our intention to use the educational and 
operations testing period to make needed adjustments to the program as 
well as identify any needs for further guidance and education, we will 
evaluate whether a second educational and operations testing year is 
necessary. We believe it is appropriate to retain this option in the 
event that, to be responsive to stakeholder feedback and the lessons we 
learn, it is expedient to take additional time to fully implement the 
AUC consultations and reporting requirements. However, since we 
currently have qualified PLEs and qualified CDSMs, we expect to be 
prepared to quickly begin a voluntary participation period. Since the 
educational and operations testing period will not start until 2020, we 
are extending the voluntary participation period to 18 months from July 
2018 through December 2019.
    Comment: Of the commenters that referenced the proposal to begin 
the program with a voluntary reporting period, the majority stated 
their support. However, some commenters expressed confusion about the 
voluntary period and the educational and operations testing period. 
They requested clarification regarding what is required of ordering and 
furnishing professionals during those two periods.
    Response: During the voluntary reporting period, consulting 
specified AUC through a qualified CDSM and reporting AUC consultation 
information will be completely optional. AUC consultation information 
will not be required on Medicare claims for advanced diagnostic imaging 
services during the voluntary reporting period. We intend to develop a 
single HCPCS modifier to be used on claims during this period so the 
furnishing professional may use the modifier when AUC consultation 
information is provided by the ordering professional. Currently, we 
expect that the use of the HCPCS modifier will be the extent of 
reporting we can accommodate during the voluntary period. However, we 
anticipate that more specific reporting of AUC consultation information 
will be required when the educational and operations testing period 
begins on January 1, 2020. Since the first year of required AUC 
consultation and reporting will be an educational and operations 
testing period, we will not deny claims that fail to properly include 
AUC consultation information. We expect to adopt and communicate 
additional details and expectations for AUC consultation and reporting 
during the educational and operations testing period through further 
rulemaking and guidance before January 1, 2020.
    Comment: Commenters inquired about the responsibilities of the 
ordering professional and requested guidance on how AUC consultation 
information is to be communicated to the furnishing professional and 
what must be included in the communication. Some commenters recommended 
we require this information to be communicated using a unique 
consultation identifier and require that information to be included on 
the order from the ordering professional to the furnishing 
professional.
    Response: It is the responsibility of the ordering professional to 
consult specified applicable AUC through a qualified CDSM and 
communicate information on that consultation to the furnishing 
professional. We recognize that there are many ways to communicate 
orders (paper, fax, telephone) for advanced diagnostic imaging services 
between ordering and furnishing professionals and we expect that the 
information related to the AUC consultation would be communicated as 
part of the order. If we adopt a policy to require reporting of the 
unique AUC consultation identifier on the furnishing professional's 
claim, then we would expect the ordering professional to include that 
identifier on the order for the advanced diagnostic imaging service. We 
understand that commenters are looking to us to provide prescriptive 
guidance about how AUC consultation information is communicated between 
the ordering and furnishing professionals; however, a first step may be 
to fulfill the need to standardize the taxonomy of the unique 
consultation identifier before we determine the extent to which we will 
establish guidance.
    Comment: Some commenters suggested that CMS establish a proactive 
mechanism to review issues that arise during the voluntary and 
educational and operations testing periods and develop solutions. One 
commenter cited the way CMS handled the ICD-9 to ICD-10 coding 
transition as a suggestion for how to implement AUC coding and claims 
processing. Commenters also suggested using the voluntary reporting

[[Page 53195]]

and the educational and operations testing periods for CMS to offer 
feedback to practitioners, develop targeted education and release data 
to the public.
    Response: We agree with commenters that it would be mutually 
beneficial to develop a learning and feedback loop, so we will explore 
a plan to provide feedback and education to practitioners during the 
voluntary and educational and operations testing periods. We will 
explore this further through additional stakeholder outreach. It is 
unlikely that we will have the same level of resources to devote to 
this program that were available for the ICD-9 to ICD-10 transition, 
but we will consider and work toward developing the ability to monitor 
these claims and provide feedback in a more real-time manner.
    In response to the public comments, and in addition to delaying the 
effective date for requiring AUC consultation and reporting as 
described earlier in this section, we are extending the voluntary 
period through 2019, so it will begin in July 2018 and end at the end 
of December 2019. The voluntary period will then be immediately 
followed by the educational and operations testing period in 2020 
during which claims will not be denied for failure to include proper 
AUC consultation information.
b. Alignment With Other Medicare Quality Programs
    The CY 2017 Merit-based Incentive Payment System and Alternative 
Payment Model final rule with comment period (Quality Payment Program 
final rule) (81 FR 77008) finalized policies to implement a new 
approach to payment for physicians and other eligible clinicians, 
enacted by the MACRA, that rewards the delivery of high-quality patient 
care through two avenues: Advanced Alternative Payment Models (APMs) 
and the Merit-Based Incentive Payment System (MIPS) under the PFS. We 
expect the Quality Payment Program to evolve over multiple years and to 
continue iterating on these policies. We also believe the AUC program 
has the potential to provide new opportunities to improve care delivery 
by supporting and rewarding clinicians as they find new ways to engage 
patients, families and caregivers as well as improving care 
coordination and patient health management.
    Therefore, we proposed in the CY 2018 Updates to the Quality 
Payment Program proposed rule (82 FR 30010) to develop a direct tie 
between MIPS and the AUC program. In that rule, we proposed to give 
MIPS credit in the improvement activities performance category to 
ordering professionals for consulting specified AUC using a qualified 
CDSM as a high-weight improvement activity for the performance period 
beginning January 1, 2018 (82 FR 30484). We believe this will 
incentivize early use of qualified CDSMs to consult AUC by motivated 
eligible clinicians looking to improve patient care and to better 
prepare themselves for the AUC program. Although we proposed that the 
AUC program consultation and reporting requirements would not 
officially begin until January 1, 2019, we are able to adopt this 
proposed improvement activity because the first qualified CDSMs were 
announced in conjunction with the CY 2018 PFS proposed rule; therefore, 
ordering professionals will be able to begin consulting specified, 
applicable AUC using those tools.
    We also considered how the AUC program could serve to support a 
quality measure under the MIPS quality performance category, and sought 
feedback from the public regarding feasibility and value of pursuing 
this idea further.
    The following is a summary of the public comments received on how 
the AUC program could serve to support a quality measure under the MIPS 
quality performance category, and feedback regarding feasibility and 
value of pursuing this idea further; and our responses:
    Comment: Commenters were supportive of the proposed improvement 
activity described in the CY 2018 Quality Payment Program proposed 
rule. Most commenters directly stated that this proposed activity 
should be finalized and maintained as a high weight activity for the 
2018 MIPS performance period and also future years by making the 
improvement activity and associated weight permanent. A few commenters 
simply stated agreement with the proposal to make AUC consultation an 
improvement activity, while other commenters noted that the proposal 
only ties the MIPS improvement activity points to the ordering 
physician, which seems like a step in the correct direction but, alone, 
is unlikely to prompt a significant increase in use of AUC. Commenters 
offered additional proposals to expand the scope of the proposed 
improvement activity including suggestions that: (1) Eligible 
clinicians could receive credit for AUC consultation through both the 
MIPS quality and improvement activities performance categories; (2) we 
should further incentivize the electronic ordering of advanced 
diagnostic imaging services; (3) credit would be awarded if the rate of 
consultation with AUC is 60 percent for first year, or 75 percent for 
the second year similar to IA _PSPA _6 ``Consultation of the 
Prescription Drug Monitoring program''; (4) we should award credit for 
consultation with AUC through CDSMs that have not been qualified; (5) 
we should provide credit to those eligible clinicians providing 
radiological consultative services; (6) credit should be given for 
reporting of the AUC consultation by furnishing professionals; and (7) 
MIPS credit should be awarded to those clinicians directly involved in 
AUC development. One commenter did not support providing a high-level 
improvement activity credit under the MIPS for mandatory clinical 
decision support use stating that such credit is intended for voluntary 
improvement efforts by clinicians, and thus is not appropriate for 
mandated activities. One commenter suggested that it is not appropriate 
to incentivize CDS program adoption with MIPS before at least January 
1, 2019.
    Response: We agree with recommendations that we work closely to 
align quality improvement mechanisms in the Medicare program. The 
improvement activity proposal is addressed in rulemaking for the 
Quality Payment Program. We note that we continue to believe this 
proposal is useful to encourage early adoption of, and maximize the 
movement to, voluntary AUC consultation and reporting as the AUC 
program moves towards full implementation. We recognize that there are 
further opportunities for alignment between the AUC program and the 
Quality Payment Program, but did not propose additional policies in 
rulemaking for CY 2018. Therefore, we will consider these suggestions 
further as we continue to collaborate with other quality improvement 
programs and engage in future rulemaking.
    Comment: Many commenters noted that current AUC program policies 
and proposals are not yet tied to the MIPS quality or cost categories 
in the CY 2018 Quality Payment Program proposed rule. However, 
commenters were divided on the extent to which the AUC program could 
feasibly align with MIPS beyond the proposed improvement activity 
performance category. A few commenters believed that use of a qualified 
CDSM should be incorporated into MIPS only as an improvement activity. 
One commenter noted that, at best, any proposed AUC program quality 
measure would be a process measure, suggesting that measures of 
outcomes are preferable. A few commenters discouraged creation of 
quality measures around the consultation of AUC based on

[[Page 53196]]

administrative claims. Other commenters stated that creating a quality 
measure would be moving closer to more directly tying AUC consultation 
to payment for the ordering professional, potentially through MIPS 
performance scoring, which runs contrary to the statutory requirement 
that the furnishing professionals' claims and payment are directly 
impacted.
    A few commenters stated they look forward to working with us to 
develop and implement appropriate measures that will further align the 
AUC program with the Quality Payment Program. Several commenters 
submitted additional proposals to better align the AUC program to 
additional MIPS performance categories. One commenter believed that if 
the certified EHR technology (CEHRT) requirements were expanded to 
include the requirement for CDSM functionality within computerized 
physician order entry modules, the alignment between the AUC program 
and the MIPS ACI performance category would be further reinforced. A 
few commenters noted the currently available appropriate use measures, 
including measures for cardiac imaging, and suggested that such 
measures could be leveraged as models for applying AUC to more areas of 
advanced diagnostic imaging, which the commenters believed to be 
responsive to the request to align the AUC program with the Quality 
Payment Program. One commenter recommended that any potential quality 
measure developed around AUC would have to meet the standards set for 
other quality measures--reliability, validity, and testing. Specific 
suggestions from commenters also included the framework for creation of 
a new quality measure. For example, commenters suggested that a quality 
measure could assess whether a clinician consults specified, applicable 
AUC using a qualified CDSM or other tool. Another proposal included an 
optional quality measure or bonus points in MIPS if physicians provide 
feedback to PLEs and CDSMs about why they decided to proceed with 
ordering an applicable imaging service when it does not adhere to the 
specified applicable AUC consulted, thus enabling PLEs and CDSMs to 
learn from user experience. Another commenter recommended that CDSMs 
could support such feedback and improvement efforts by including 
applications for practitioners to download to mobile devices, thus 
allowing ordering professionals to consult AUC using an intuitive flow-
chart based interface. One commenter asked that any AUC-related measure 
provide two points for reporting on appropriate use, suggesting that 
such a proposal would further incentivize reporting on an appropriate 
use measure. One commenter suggested that greater alignment with the 
quality performance category of MIPS could be achieved through 
utilization of a Qualified Clinical Data Registry (QCDR) that 
incorporates CDSMs and reports information on the physician's behalf. 
The commenter believed that a registry approach would be simpler, 
provide essential data, and potentially avoid clinician burden as a 
result. Finally, a few commenters strongly urged full alignment of the 
AUC program with the MIPS cost or quality performance categories and 
complete discontinuation of the AUC program and its regulatory burden.
    Response: We thank all the commenters for their consideration and 
feedback about additional MIPS performance categories that could be 
better aligned with the AUC consulting and reporting requirements. We 
appreciate the thoughtful comments on ways we could connect the AUC 
program with the Quality Payment Program in order to reach a less 
burdensome approach to the AUC program, and will also consider these 
suggestions.
    In response to public comments, we have finalized this improvement 
activity in the CY 2018 Updates to the Quality Payment Program final 
rule and note here that the description was updated such that 
clinicians attest that they are consulting specified applicable AUC 
through a qualified CDSM for all applicable imaging services furnished 
in an applicable setting, paid for under an applicable payment system, 
and ordered on or after January 1, 2018.
c. Significant Hardship Exceptions to Consulting and Reporting 
Requirements
    We proposed to modify Sec.  414.94(i)(3) of our regulations to 
reflect the conclusion of application of the payment adjustments under 
the Medicare EHR Incentive Program and to substitute an alignment with 
the advancing care information (ACI) performance category of MIPS. In 
the CY 2017 PFS final rule, for purposes of the AUC program significant 
hardship exceptions, we included the following categories from Sec.  
495.102(d)(4):
     Insufficient Internet Connectivity (as specified in Sec.  
495.102(d)(4)(i)).
     Practicing for less than 2 years (as specified in Sec.  
495.102(d)(4)(ii)).
     Extreme and Uncontrollable Circumstances (as specified in 
Sec.  495.102(d)(4)(iii)).
     Lack of Control over the Availability of CEHRT (as 
specified in Sec.  495.102(d)(4)(iv)(A)).
     Lack of Face-to-Face Patient Interaction (as specified in 
Sec.  495.102(d)(4)(iv)(B)).
    In addition, in the CY 2017 Quality Payment Program final rule, we 
finalized a policy (81 FR 77240-77243) to reweight the ACI performance 
category to zero in the MIPS final score for the year for MIPS eligible 
clinicians who meet the criteria in one of the listed categories of 
Sec.  495.102(d)(4), with the exception of the category for clinicians 
practicing for less than 2 years. Under section 1848(q)(1)(C)(v) of the 
Act, eligible clinicians who first enroll in Medicare during the 
performance period for a year and have not previously submitted claims 
under Medicare are not considered MIPS eligible clinicians, and thus 
are excluded from MIPS. Therefore, many clinicians who have been 
practicing for less than 2 years would be excluded from MIPS on the 
basis that they are new Medicare-enrolled MIPS eligible clinicians as 
defined in Sec.  414.1305. Because these clinicians are not MIPS 
eligible clinicians, they would never meet the criteria for re-
weighting of their MIPS ACI performance category for the year. 
Therefore, to implement a hardship exception for purposes of the AUC 
program that is both operationally consistent and administratively 
efficient, we proposed to remove as a criterion for a significant 
hardship exception for the AUC program the criterion specified in Sec.  
495.102(d)(4)(ii) of our regulations for those practicing for less than 
2 years. We proposed to keep the remaining listed categories including 
insufficient internet connectivity, extreme and uncontrollable 
circumstances, lack of control over availability of CEHRT and lack of 
face to face patient interaction. We noted that section 
1843(q)(4)(C)(iii) of the Act only allows the ordering professional to 
seek a significant hardship exception, not the furnishing professional.
    As such, we proposed to amend the AUC significant hardship 
exception regulation to specify that ordering professionals who are 
granted re-weighting of the ACI performance category to zero percent of 
the final score for the year under MIPS per Sec.  414.1380(c)(2) due to 
circumstances that include the criteria listed in Sec.  
495.102(d)(4)(i), (iii), (iv)(A) and (iv)(B) would be excepted from the 
AUC consultation requirement during the same year that the re-weighting 
applies for purposes of the MIPS payment adjustment.

[[Page 53197]]

    There will be scenarios when a clinician's experience of a 
significant hardship or extraordinary circumstance does not align with 
the prospective identification of these ordering professionals with 
reference to MIPS criteria and processes. However, we believe the 
prospective identification process allows us to apply exceptions in 
real-time for claims submitted for advanced imaging services. There are 
timing differences between the MIPS and the AUC program (the MIPS 
payment adjustment year is based on performance in a prior year while 
the Medicare AUC program requires real-time AUC consultation and 
claims-based reporting). In addition to the timing, there will be 
instances when a clinician who is not a MIPS eligible clinician will 
need to seek a significant hardship exception to the Medicare AUC 
program. To accommodate these two separate scenarios, we proposed to 
establish a process to identify ordering professionals in need of a 
significant hardship exception to the Medicare AUC program requirements 
that is outside the MIPS re-weighting process. For purposes of these 
scenarios, we proposed to use the criteria for clinicians seeking an 
AUC significant hardship exception described under Sec.  495.102(d)(4) 
to include (i), (iii), (iv)(A) and (iv)(B) of our regulations. We 
proposed these criteria to align with the criteria used under MIPS for 
re-weighting under the ACI performance category, and to provide 
predictability and consistency to the determination of significant 
hardship. We further proposed that a significant hardship exception 
from the Medicare AUC program requirements would be granted for no 
longer than 12 months, and that we could establish an exception for a 
shorter period where warranted by the circumstances.
    Therefore we proposed that ordering professionals who have not 
received a re-weighting to zero for the MIPS ACI performance category 
for the year, but experience one of the circumstances described in 
Sec.  495.102(d)(4) to include (i), (iii), (iv)(A) and (iv)(B), may be 
granted an AUC significant hardship exception for no longer than one 
year.
    In addition to these proposals, we invited the public to comment on 
additional circumstances for which it may be appropriate for an 
ordering professional to be granted a significant hardship exception 
under the AUC program.
    The following is a summary of the public comments received on our 
proposed modifications to the AUC program significant hardship 
regulation language, proposal to grant a significant hardship exception 
for no longer than 12 months, and additional circumstances for which it 
may be appropriate for an ordering professional to be granted a 
significant hardship exception under the AUC program; and our 
responses:
    Comment: Many commenters thanked us for adopting policies to 
provide for significant hardship exceptions for the AUC program in the 
CY 2017 PFS final rule, and for working to align AUC program 
significant hardship exceptions with those under the MIPS as proposed 
in the CY 2018 PFS proposed rule. These commenters supported alignment 
between the proposed changes to the AUC significant hardship exception 
policy and the significant hardship exceptions proposed in the CY 2018 
Updates to the Quality Payment Program proposed rule. Several 
commenters requested that CMS finalize these hardships for the AUC 
program as proposed. These commenters further believed that identifying 
ordering professionals with significant hardship exceptions creates 
challenging workflows for furnishing professionals. The furnishing 
professionals must have this information so they are aware which of the 
claims require AUC consultation information to be reported and which do 
not. One commenter expressed specific concern about the increased 
resources and burden of identifying, tracking, and reporting which 
ordering professionals have significant hardship exceptions. One 
commenter explicitly concurred with the proposed AUC program hardship 
exceptions available for certain eligible clinicians as outlined in the 
proposed rule, and with providing for exceptions for periods of no 
longer than 12 months at a time.
    In contrast, a few commenters did not understand why such hardship 
exceptions were proposed within two different programs (the AUC program 
and the MIPS). These same commenters opposed our proposal to exclude 
from the hardship exception categories under the AUC program the 
category for clinicians who have been practicing for fewer than 2 
years. Other commenters expressed concern that under our proposals all 
radiologists who meet the lack of face-to-face patient interaction 
threshold would be excepted from consulting AUC if they order 
applicable imaging services. In addition, many commenters believed that 
certain hardships may justifiably last longer than 12 months and the 
circumstances leading to the initial request for a significant hardship 
may be uncontrollable by the physician. These commenters opposed the 
12-month cap on hardship exemptions and further stated that such an 
approach is unfair, unjustified, and disproportionately affects rural 
providers.
    A few commenters believed it was unreasonable to recognize eligible 
clinicians who have their MIPS ACI performance category re-weighted to 
zero for the reason that the ordering professional practices at 
multiple locations, without also considering an exception for other 
practitioners that face challenges to controlling their CEHRT such as 
ASC-based eligible clinicians. Those commenters support these 
categories as qualifying for a significant hardship exception under the 
AUC program. A few commenters believed that we must also include an 
exception for hospital-based physicians because emergency physicians 
and practitioners could not purchase a CDSM platform or adopt a free 
CDSM platform, for implementation in the hospital because they do not 
have the appropriate authority to make such purchases or to implement a 
new CDSM for the delivery of emergency medical care provided in the 
hospital emergency department setting. To this end, commenters urged 
inclusion of the statutory references to hospital-based physicians and 
ASC-based MIPS eligible clinicians into existing exceptions from AUC 
requirements for MIPS eligible clinicians who have their ACI 
Performance Category reweighted to zero.
    Response: We appreciate the views of commenters that agreed with 
our proposals and those that questioned the extent of alignment we 
proposed with the MIPS re-weighting policies for the ACI performance 
category. In response to public comments that varied widely in content 
and tone, we are not finalizing the proposed changes to the significant 
hardship exceptions in this final rule. Commenters offered extensive 
suggestions for modifications to our proposed updates to the 
significant hardship exceptions under the AUC program. After 
considering these comments, we have decided further evaluation is 
needed before making changes to the significant hardship exception 
regulatory language. We will reflect further on both the public 
comments on our proposals, as well as the policies adopted in the CY 
2018 Quality Payment Program final rule with comment period, before 
proposing any revisions to the significant hardship exceptions for the 
AUC program. In rulemaking for CY 2019, we intend to address policies 
on significant hardship exceptions for the AUC program that take into 
account points raised in public comments, as well as the requirements

[[Page 53198]]

of the statute and the goal to align as closely as possible with other 
quality program exceptions and mechanisms for seeking and obtaining 
exceptions so as to avoid unnecessary administrative burdens. As such, 
we are not revising our regulation at section 414.94(i)(3) in this 
final rule.
    We provide responses to the comments below to inform commenters of 
our current thoughts despite not finalizing the changes we proposed to 
the significant hardship exception under the AUC program.
    Comment: Many commenters encouraged expansion of the scope of 
available significant hardship exceptions. Commenters suggested the 
following additional circumstances for which an ordering professional 
should be granted a significant hardship exception under the AUC 
program: (1) Imaging services ordered as part of clinical research; (2) 
emergency clinicians attempting to meet the current exclusion criteria; 
(3) physicians nearing retirement or dealing with hardships who may not 
have data systems, capital, or the desire to invest in a qualified CDSM 
system necessary to consult AUC; (4) any time when a PLE or CDSM is de-
qualified; (5) for complex medical systems; (6) any physician who does 
not have access to free integrated CDSMs; and (7) physicians whose EHR 
cannot integrate into an existing qualified registry.
    To support some of these requests for additional exceptions, 
commenters noted that a CDSM is a form of health information technology 
that is routinely incorporated into EHR systems, and that costs are 
associated with such integration. Commenters also stated that a free 
tool is an impractical solution for those practices focused on 
investing in upgrading to certified 2015 Edition EHR technology or 
unable to afford acquisition of a CDSM that integrates with an EHR 
system. More than one commenter cited the GAO's 2015 evaluation of the 
Medicare Imaging Demonstration which reported frustration on the part 
of ordering professionals when decision support was not integrated with 
their EHRs. This demonstration was authorized by Congress to test 
whether clinicians would change their ordering patterns (for example, 
reducing inappropriate imaging) as a result of using appropriateness 
guidelines for advanced imaging services through decision support 
systems.
    Response: We appreciate the additional context the commenters 
provided about the rationale to support additional categories of 
significant hardship exceptions under the AUC program. We will take 
these comments into account for future rulemaking. We are not 
finalizing our proposed significant hardship exceptions policies in 
this final rule, and instead intend to address significant hardship 
exceptions for the AUC program through rulemaking for CY 2019.
    Comment: Commenters took interest in the proposed identification of 
a re-weighting policy under the ACI performance category of MIPS for 
MIPS eligible clinicians in small practices. Some commenters noted that 
small, rural, and independent practices are not ready for AUC program 
implementation, adding that AUC features within EHRs will be costly, 
and using these features will take additional time away from patient 
care. One commenter stated that modifications to either the EHR 
environment or the CDSM capabilities may be challenging, even for large 
organizations with greater resources, but especially for small entities 
or practices. Although a few commenters recognized that while the 
statute did not authorize a significant hardship exception category for 
ordering professionals that order a low-volume of advanced imaging 
services, these same commenters also believed that the statute did give 
the Secretary discretion on a case-by-case basis to establish hardship 
exemptions under which low-volume ordering professionals could qualify 
for significant hardship.
    Some commenters requested consideration for exempting ordering 
professionals based on a low-volume threshold of services. One 
commenter requested that if the proposed threshold for what constitutes 
low volume under the CY 2018 Updates to the Quality Payment Program is 
finalized, that these eligible clinicians also be excluded from the AUC 
program. Another commenter submitted an alternative proposal that 
instead of using the same low volume threshold proposed for MIPS a 
threshold that more closely reflects advanced diagnostic imaging 
services and billing would be an acceptable threshold calculation for 
such an exception. Another commenter recommended adaptation of an 
exception similar to those used in the Medicare e-prescribing (eRx) 
program, which allowed individual eligible professionals who had been 
successful electronic prescribers in 2011, and had reported the G8553 
code via claims for less than 10 billable Medicare Part B PFS services 
provided January 1, 2012 through June 30, 2012 to avoid the 2013 eRx 
payment adjustment. In addition, one commenter requested a significant 
hardship exception category for furnishing professionals that furnish a 
low-volume of advanced imaging services, and supported this request 
with the statement that it would be unreasonable to forgo any payment 
for advanced diagnostic imaging services furnished under this program.
    Response: We appreciate the suggestions for additional 
opportunities to align the AUC program with the Quality Payment 
Program. Section 1834(q)(4)(C)(iii) of the Act authorizes the 
Secretary, on a case-by-case basis, to determine, subject to annual 
renewal, that consultation with applicable AUC for an applicable 
imaging service ordered by and ordering professional would result in a 
significant hardship, such as in the case of a professional who 
practices in a rural area without sufficient Internet access. In the CY 
2018 Quality Payment Program proposed rule (82 FR 30076), we proposed 
to re-weight the ACI performance category in MIPS to zero to recognize 
that eligible clinicians who would have struggled to satisfy the 
requirements of meaningful use would also struggle to report within the 
ACI performance category on their CEHRT, for instance if they cannot 
afford or have not adopted EHRs. In contrast, the AUC program did not 
include such considerations, and further made available mechanisms 
independent from CEHRT and free of charge. Therefore we will continue 
to examine the significant hardship exceptions allowed under the 
statute in order to identify appropriate areas of future alignment with 
the Quality Payment Program as applicable to the AUC program.
    Comment: Commenters sought clarification on the processes and 
procedures for the hardship application and approval. Some commenters 
requested a process by which MIPS eligible clinicians could apply for 
an AUC program hardship exemption following the ACI hardship exemption 
application deadline. One commenter requested implementation of a year-
round application process that will cover both the AUC program for the 
ordering professional, and the ACI performance category of MIPS for 
eligible clinicians.
    Response: We thank these commenters for their suggestions and 
considerations for a hardship application and approval process. We 
agree that it is important for a process to be available throughout the 
year. It is important to note that, since publication of our proposals 
in the CY 2018 PFS proposed rule, the 2017 Quality Payment Program 
hardship exception application was posted at: https://cmsqualitysupport.service-now.com/exception_application.do. We look

[[Page 53199]]

forward to working to align our AUC program significant hardship 
exception process with existing processes through future rulemaking.
    Comment: A few commenters observed that all significant hardship 
exceptions include the additional burden furnishing professionals face 
to verify that ordering physicians have in place a significant hardship 
exception at the time a service is ordered. Therefore, commenters 
requested a unique identifier for ordering professionals that have 
obtained a hardship exception and requested such information be 
prospectively publicly available. Commenters noted that this proposal 
would allow significant hardship exceptions to apply in real-time for 
claims submitted for advanced diagnostic imaging services, and 
requested that the furnishing professional's claim should not be denied 
payment if the ordering professional did not in fact have in place a 
significant hardship exception from the AUC consultation requirement. 
Another commenter requested that information on ordering professionals' 
significant hardship status should be published no less frequently than 
every two weeks. One commenter sought clarification about the situation 
where an ordering professional is in the process of applying for a 
hardship but has not yet received a significant hardship exception. 
Another commenter sought clarity as to whether the hardship exception 
applies to the clinician's NPI or the clinician's NPI and TIN.
    Response: We agree that the communication about a significant 
hardship exception from an ordering professional to a furnishing 
professional introduces potential challenges. We will continue to 
explore opportunities to use a more automated process for providing 
additional information to ordering and furnishing professionals in a 
timely manner in order to facilitate such communication and make the 
information readily accessible.
    As stated earlier we will not move forward with the proposed 
significant hardship exceptions and will maintain our regulations at 
Sec.  414.94(i)(3). This current policy provides exceptions from 
consulting and reporting requirements for orders for applicable imaging 
services made by ordering professionals who are granted a significant 
hardship exception to the Medicare EHR Incentive Program payment 
adjustment for that year. The basis for granting a significant hardship 
exception to the ordering professional are identified under Sec.  
495.102(d)(4) of this chapter, and include the following as discussed 
in CY2017 PFS final rule: Lacking sufficient Internet access; 
practicing for less than 2 years, facing extreme and uncontrollable 
circumstances; practicing at multiple locations and demonstrating 
inability to control the availability of CEHRT; and, lacking face-to-
face or telemedicine interaction with patients and a lack of need for 
follow up with patients. We believe that during the voluntary reporting 
period, we will continue to develop our understanding of the workflows 
of both ordering and furnishing professionals, and in particular how we 
can apply section 1834(q)(4)(C)(iii) of the Act to support those 
ordering professionals whose consultation would result in a significant 
hardship.
5. Summary
    Section 1834(q) of the Act includes rapid timelines for 
establishing a Medicare AUC program for advanced diagnostic imaging 
services. The impact of this program is extensive as it will apply to 
every physician or other practitioner who orders or furnishes advanced 
diagnostic imaging services (for example, magnetic resonance imaging 
(MRI), computed tomography (CT) or positron emission tomography (PET)). 
This crosses almost every medical specialty and could have a particular 
impact on primary care physicians since their scope of practice can be 
quite broad. Stakeholders have expressed concern that program 
requirements may inadvertently encourage physicians to order imaging 
services that they do not believe are right for their patients. The 
goal of evidence-based AUC is to assist clinicians in ordering the most 
appropriate imaging service for their patients' specific clinical 
scenarios. However, to ensure we are implementing the program 
effectively, we requested public comment on such potential unintended 
consequences. Additionally, as we continue to develop the AUC program, 
we continue to engage a variety of stakeholders interested in 
participating in the development of AUC. We sought comment about how we 
can continue to engage interested participants, consistent with 
statutory requirements at section 1834(q) of the Act, in developing AUC 
in a transparent and scientifically robust manner. We are particularly 
interested in how qualified PLEs develop or modify AUC in collaboration 
with non-PLE entities and what additional challenges such entities 
might face.
    The following is a summary of the public comments received on 
issues we solicited including potential unintended consequences of the 
AUC program requirements as well as how we can continue to engage 
interested participants, particularly qualified PLEs in collaboration 
with non-PLEs, consistent with statutory requirements at section 
1834(q) of the Act, in developing AUC in a transparent and 
scientifically robust manner and our responses:
    Comment: Many commenters shared their thoughts on potential 
unintended consequences that may result from implementation of the AUC 
program. Some commenters noted issues of patient access and delivery of 
care. Commenters warned of the risk of decreased patient access or 
choices, inappropriate underutilization of imaging studies and harm to 
patients because of such a reduction, inappropriate testing to avoid 
AUC requirements, delays in beneficiaries receiving needed tests or 
even denial of services by furnishing professionals and facilities if 
AUC is not consulted or information is not provided by the ordering 
professional, and healthcare rationing. Commenters also warned that the 
AUC program requirements could result in a shift in referral patterns 
among primary care physicians and cardiologists and cautioned that the 
program requirements could lead to disruptions in physicians' practices 
and workflows and a reduction in patient facing time for providers. 
Commenters also noted the potential for unwarranted financial penalties 
for imaging facilities and increases in the cost of tests as CDSMs may 
recommend higher cost imaging. Commenters noted a risk of impeding 
clinical research involving imaging, particularly research on new 
imaging decision rules, which would dramatically slow the generation of 
relevant published evidence and limit the ability of qualified PLEs to 
expand the scope of coverage and improve the quality of evidence-based 
AUC. One commenter stated that there is no evidence that an unintended 
consequence of AUC consultation is the ordering of imaging services 
that ordering professionals do not believe are right for their 
patients.
    Response: We appreciate the time and energy commenters and 
stakeholders have dedicated to share ideas, suggestions, feedback and 
critiques of our progress in implementing the AUC program. Throughout 
this preamble, we discuss ways to avoid these unintended consequences 
as identified by commenters. We appreciate being alerted to these 
potential unintended consequences so that we can closely monitor and 
mitigate these issues should they arise during the voluntary

[[Page 53200]]

and educational and operations testing as we proceed to implement this 
program.
    Comment: Some commenters expressed concerns regarding the 
definition of PLE codified in Sec.  414.94(b) of our regulations in the 
CY 2016 PFS final rule with comment period and the avenues by which 
entities not meeting the definition PLE can participate in the AUC 
program. These commenters reiterated their previously expressed 
opposition to the regulatory definition of PLE and requested revisions 
to allow participation by more organizations, inclusive of independent 
content developers, which they deem to be more reflective and in the 
spirit of the language in the statute describing a PLE.
    One commenter noted that organizations where practitioners are 
involved in day-to-day management or providing strategic direction and 
can deploy a rigorous evidence-based process for developing AUC should 
be included. Another commenter stated that CMS prioritizes content 
developed by clinicians who see patients over those who specialize in 
reviewing science and developing guidelines so the definition does not 
account for the fact that clinicians who spend most of their time 
seeing patients do not have the capacity to develop and regularly 
update comprehensive care guidelines. One commenter recommended 
revising the definition to include organizations that develop AUC under 
the leadership of a structured group of providers who are actively 
engaged in the practice and delivery of healthcare as the regulatory 
definition is inappropriately restrictive and limits the organizations 
that may contribute to provider-developed AUC.
    Response: We appreciate these comments and recommendations. We 
understand the disagreement with the regulatory definition established 
in the CY 2016 PFS final rule with comment period, but continue to 
believe it is an accurate and appropriate interpretation of the 
provisions added by the statute. We believe there are feasible options 
for AUC content developers to participate in the AUC program regardless 
of organizational structure, and thus, do not believe a modification to 
the regulatory definition of PLE is warranted. Moreover, we did not 
propose to modify the definition of PLE in the CY 2018 PFS proposed 
rule. Therefore, we are making no changes to the definition of PLE this 
year.
    Comment: These commenters also questioned the endorsement pathway 
codified in Sec.  414.94(d) of our regulations in the CY 2016 PFS final 
rule with comment period whereby qualified PLEs may endorse the AUC of 
other qualified PLEs, under agreement by the respective parties, to 
enhance an AUC set. Commenters stated that this pathway is inconsistent 
with statutory language and Congressional intent because the law was 
meant to allow content developers other than national medical 
professional specialty societies and PLEs to participate in the AUC 
program when a national medical professional specialty society or PLE 
endorsed the organization's AUC content. Under the current regulatory 
definition, commenters stated that independent content developers and 
third party entities cannot participate in the AUC program. One 
commenter stated that the endorsement pathway should enable 
practitioners to use third party criteria to comply with the AUC 
program requirements. These commenters requested that the regulations 
be revised to reflect the intent and language in the statute, and to 
allow PLEs to endorse AUC from any author or developer. Another 
commenter recommended that CMS reiterate that each qualified PLE that 
endorses another qualified PLE's AUC must document that it obtained the 
organization's agreement, as some organizations are endorsing AUC 
without an agreement.
    Response: We understand the commenters' views in relation to the 
AUC program statutory provisions and the endorsement pathway, and agree 
that AUC developed by independent content developers, third parties or 
non-PLE authors can play a valuable role under the AUC program. 
However, we do not believe that AUC endorsed by any organization that 
could meet the definition of PLE should be considered specified AUC 
under this program. Rather, we have established specific requirements 
for PLEs to be qualified in order to ensure that any AUC developed, 
modified or endorsed by these organizations are scientifically valid, 
transparent and are created using an evidence based methodology. To 
ensure this requirement of section 1834(q)(2)(B) of the Act is 
fulfilled, we must understand the processes PLEs use to develop or 
modify AUC and are consistent with statutory requirements.
    Comment: One commenter specifically stated that collaboration, as 
discussed in the preamble of the CY 2016 PFS final rule with comment 
period, between an organization that meets the regulatory definition of 
PLE and third-party content developers that do not is unworkable 
because it places unreasonable burdens on the PLEs who are responsible 
for the associated legal, regulatory and compliance burden. In their 
experience, this commenter noted that these issues have prevented 
collaborations from moving forward.
    Another commenter recommended that the efforts of PLEs be monitored 
over the next four years before CMS takes action to establish new 
directives regarding specific AUC and its development. This commenter 
stated that PLEs are expected to establish new methods for 
collaboration over this period of time.
    Another commenter noted that there is benefit to collaboration 
between qualified PLEs and non-qualified PLEs as well as between 
qualified PLEs. This commenter also stated that collaborations with 
non-qualified PLEs have highlighted the anxiety of these organizations 
in being forced to adopt practices that may conflict with established 
local best practices and reinforce that we should focus on eliminating 
unnecessary imaging and construct AUC that acknowledge local 
differences in care settings, expertise and best practices. One 
commenter states that non-PLEs can bring significant, relevant 
experience to the AUC development process and support for physicians 
engaged in medical practice; and that relationships between PLEs and 
non-PLEs can create significant value leading to improved care provided 
they are clearly defined and transparent.
    One commenter recommended that PLEs should be allowed to delegate 
the AUC development process to third parties that demonstrate adherence 
to the AUC program requirements for deploying a multidisciplinary team 
with the requisite expertise, transparency and managing conflicts of 
interest.
    Response: As stated earlier, we strongly agree that non-PLE 
organizations can play a valuable role under the AUC program. We have 
already seen this demonstrated by collaboration arrangements between 
qualified PLEs and third party organizations such as independent 
content developers, and expect these collaborations to continue to grow 
and evolve. We encourage stakeholders to explore options for 
collaboration under the guidelines of this policy.
    Comment: Some commenters expressed their opposition to the 
transparency requirements for qualified PLEs codified in Sec.  
414.94(c)(1) of our regulations in the CY 2016 PFS final rule with 
comment period. Commenters stated that the transparency requirements 
are inappropriate because they require developers to place their 
intellectual property in the public domain and that the statute does 
not include such transparency requirements. One commenter warned

[[Page 53201]]

that if guidelines are made available to the public for free, authors 
will have less incentive to invest resources to keep guidelines updated 
and participation of independent, evidence-based guideline authors with 
no financial stake in the actual delivery of care will be limited. 
Commenters recommended instead that we allow alternative methods for 
making AUC information available upon request. For example, commenters 
suggested that requirements can be met by granting access to providers, 
beneficiaries and CMS to AUC on an as-needed basis or to customers 
through password protected portals.
    Response: We thank commenters for communicating concerns regarding 
transparency and protecting intellectual property. We recognize the 
importance and value of AUC that are developed by all authors and, as 
discussed in previous responses, believe there are opportunities for 
the participation by all content developers. Among other requirements, 
the statute requires that we consider whether criteria (1) have 
stakeholder consensus; (2) are scientifically valid and evidence based; 
and (3) are based on studies that are published and reviewable by 
stakeholders. We believe that to assure the public that all the 
statutory considerations are taken into account, transparency of the 
process is essential. This includes making publicly available the 
people, methodologies, and evidence used by developers. Failing to be 
transparent calls into question the degree to which AUC are indeed 
evidence based. AUC developed using non-evidence based sources could 
result in physicians and patients making the wrong decisions to guide 
care. Transparency allows AUC to be vetted by all stakeholders, 
including the patient and his/her physician, therefore allowing them to 
make informed decisions.
    Because transparency is a critical element of this program, we 
established specific requirements for qualified PLEs to make 
information publicly available through their Web sites. We believe 
qualified PLEs may fulfill transparency requirements and still keep 
track of who is accessing the information on their Web sites, for 
example, some qualified PLEs require users to enter basic information 
and register through the Web site to gain access to AUC information.
    Comment: Most commenters recommended that we undertake increased 
education efforts on the AUC program as a whole, as well as on more 
specific elements, to enable professionals who order and furnish 
advanced diagnostic imaging services to learn about and comply with the 
program. Commenters suggested using a ``town hall'' approach to provide 
further education and engage in listening sessions during the 
educational and operations testing period to understand concerns and 
challenges ordering and furnishing professionals experience. Commenters 
recommended that during the voluntary period, codes and modifiers 
should be adjusted based on solicited feedback from providers and 
feedback on billing practices should be provided including the 
identification of what must be fixed and confirmation when it is fixed.
    Some commenters recommended direct communications with ordering 
professionals to encourage program compliance as well as focused 
education and outreach targeting ordering professionals who may not be 
complying with program requirements during the educational and 
operations testing period. Citing the lack of awareness of the AUC 
program and requirements, one commenter suggested CMS leverage existing 
communication channels to promote awareness as soon as possible and 
allow professionals sufficient time to adopt workflows that can reduce 
administrative burden.
    Response: We thank commenters for the suggestions and 
recommendations regarding outreach and education considerations and 
strategies. This information will assist and inform our planning as we 
move forward with the AUC program and focus more heavily on outreach 
and education efforts. In particular, we look forward to exploring 
opportunities for town halls, listening sessions and ways to leverage 
communication channels and strategies already used successfully by 
other CMS programs.
    We continue to believe the best implementation approach is one that 
is diligent, maximizes the opportunity for public comment and 
stakeholder engagement, and allows for adequate advance notice to 
physicians and practitioners, beneficiaries, AUC developers, and CDSM 
developers. It is for these reasons we proposed to continue a stepwise 
approach, adopted through notice and comment rulemaking. In summary, we 
proposed policies to implement the third component of the AUC program--
the consulting and reporting requirements and the effective date on 
which these requirements would begin. We proposed that ordering 
professionals must begin consulting specified applicable AUC through 
qualified CDSMs for applicable imaging services ordered on and after 
January 1, 2019, and furnishing professionals must begin reporting AUC 
consultation information on Medicare claims for advanced diagnostic 
imaging services for which payment is made under an applicable payment 
system as defined in Sec.  414.94(b) and ordered on or after January 1, 
2019. We also proposed modifications to the significant hardship 
exception to better align these exceptions under the AUC program with 
those under existing quality programs. We invited the public to submit 
comments on these proposals.
    We believe the changes we are adopting to the policies we proposed 
in the CY 2018 PFS proposed rule in response to public comments are 
important to provide more time for ordering and furnishing 
professionals, qualified PLEs, qualified CDSMs, CMS and other 
stakeholders to prepare for and support successful participation in the 
Medicare AUC program. These changes include the following: (1) 
Extending the voluntary reporting period to 18 months starting July 
2018 and continuing through CY 2019; and (2) making the AUC 
consultation and reporting requirements effective for an educational 
and operations testing period beginning on January 1, 2020, instead of 
January 1, 2019 as proposed, to last through CY 2020. We are not 
finalizing the changes to the significant hardship exceptions in this 
final rule as we have decided further evaluation is necessary before 
making changes to our regulations at section 414.94(i)(3). We intend to 
take into consideration the public comments on our proposals, as well 
as policies adopted in CY 2018 rulemaking for the Quality Payment 
Program, and to address significant hardship exceptions for the AUC 
program in rulemaking for CY 2019. We will reevaluate the proposals 
regarding what information must be reported on the Medicare claim and 
will further explore opportunities for stakeholder engagement.
    We will continue to post information on our Web site for this 
program accessible at www.cms.gov/Medicare/Quality-Initiatives/Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program.

F. Physician Quality Reporting System (PQRS) Criteria for Satisfactory 
Reporting for Individual EPs and Group Practices for the 2018 PQRS 
Payment Adjustment

1. Background
    Section 1848(a)(8) of the Act provides that for covered 
professional services furnished by an EP during each of 2015 through 
2018, if the EP does not satisfactorily report data on quality

[[Page 53202]]

measures for covered professional services for the reporting period for 
the year, the PFS amount for services furnished by such professional 
during the year (including the PFS amount for purposes of determining a 
payment based on such amount) shall be equal to the applicable percent 
of the PFS amount that would otherwise apply to such services. For 2016 
through 2018, the applicable percent is 98.0 percent. Thus, individual 
EPs and group practices who did not satisfactorily report data on 
quality measures for the CY 2016 reporting period are subject to a 
downward payment adjustment of 2.0 percent to the PFS payment amount 
for covered professional services they furnish in 2018.
2. Previously Finalized Satisfactory Reporting Criteria for Individual 
EPs and Group Practices for the 2018 PQRS Payment Adjustment
    We previously finalized the satisfactory reporting criteria for 
individual EPs and group practices for the CY 2016 reporting period to 
avoid the 2018 PQRS payment adjustment in the CY 2016 PFS final rule 
(80 FR 71140 through 71250) at Sec.  414.90(j)(8) and (9) and Sec.  
414.90(k)(5).
    Table 18 in the proposed rule summarized the previously finalized 
satisfactory reporting criteria for individual EPs (see 82 FR 34097) at 
Sec.  414.90(j)(8) and Sec.  414.90(k)(5).
    Table 19 in the proposed rule summarized the previously finalized 
satisfactory reporting criteria for group practices via the group 
practice reporting option (GPRO) (see 82 FR 34098 through 34099) at 
Sec.  414.90(j)(9) and Sec.  414.90(k)(5).
3. Modifications to the Satisfactory Reporting Criteria for Individual 
EPs and Group Practices for the 2018 PQRS Payment Adjustment
    Since we finalized these requirements, we have heard from 
stakeholders that EPs have had difficulty with the previously finalized 
satisfactory reporting criteria for the CY 2016 reporting period, which 
was the final reporting period for the PQRS. Specifically, we have 
heard from stakeholders through written communications to CMS that EPs 
have found the requirements complex, and had difficulty in 
understanding the requirements to be a satisfactory reporter for PQRS. 
Stakeholders have also requested that the requirements for the CY 2016 
reporting period be aligned with those of the Quality Payment Program, 
specifically the Merit-based Incentive Payment System (MIPS). In 
particular, we have heard requests to lower the previously finalized 
requirement from 9 measures across 3 NQS domains, where applicable, to 
only 6 measures with no domain requirement associated with these 
measures. While the PQRS and the MIPS are separate programs, we 
understand that stakeholders would like to see greater continuity 
between the final year of the PQRS and the beginning of the MIPS.
    The final reporting period for the PQRS was CY 2016. The Quality 
Payment Program, authorized by the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA), consolidates and replaces three 
existing programs (the Medicare EHR Incentive Program for EPs, the 
PQRS, and the Value-Based Payment Modifier (VM)). There are two ways 
eligible clinicians can participate in this program: (1) Through the 
MIPS; and (2) through Advanced Alternative Payment Models (APMs). The 
initial performance period for the MIPS began on January 1, 2017. Under 
MIPS, there are four connected pillars that affect how MIPS eligible 
clinicians will be paid by Medicare: Quality; Improvement Activities; 
Advancing Care Information; and Cost. For more information on the 
Quality Payment Program, see https://qpp.cms.gov/.
    Although we understand that the data submission period for the CY 
2016 reporting period has already ended and that all data that has been 
submitted to CMS is based on the previously finalized satisfactory 
reporting criteria for the CY 2016 reporting period, we revisited our 
previously finalized policy because we wanted individual EPs and groups 
to be assessed for purposes of the 2018 PQRS payment adjustment based 
on satisfactory reporting criteria that are simpler, more 
understandable, and more consistent with the beginning of MIPS. We 
believe that such criteria will help clinicians more accurately gauge 
their readiness for the beginning of MIPS and transition into the 
Quality Payment Program successfully. Additionally, we want to be 
responsive to the concerns of the clinician community. Therefore, 
although we did not propose to collect any additional data for the CY 
2016 reporting period, we proposed to modify the criteria we would 
apply to the data already submitted for the CY 2016 reporting period to 
determine whether an individual EP or group practice has satisfactorily 
reported for purposes of avoiding the 2018 PQRS payment adjustment (82 
FR 34099).
a. Individual EPs
    Specifically, we proposed to revise the previously finalized 
satisfactory reporting criteria for the CY 2016 reporting period to 
lower the requirement from 9 measures across 3 NQS domains, where 
applicable, to only 6 measures with no domain or cross-cutting measure 
requirement (82 FR 34099). For individual EPs, this would apply to the 
following reporting mechanisms: Claims, qualified registry (except for 
measures groups), QCDR, direct EHR product and EHR data submissions 
vendor product. This would not affect the criteria used to determine 
whether an individual EP or group practice has satisfactorily reported 
for purposes of avoiding the 2017 PQRS payment adjustment, with the 
exception of the criteria applicable to individual EPs and group 
practices reporting using the secondary reporting period established 
under Sec.  414.90(j)(1)(ii) for the 2017 PQRS payment adjustment 
(hereinafter referred to as the ``ACO Secondary Reporting Period''), as 
discussed in section III.F.4. of this final rule.
    Table 20 in the proposed rule summarized our proposed modifications 
to the previously finalized satisfactory reporting criteria for 
individual EPs to avoid the 2018 PQRS payment adjustment, based on data 
previously submitted for the CY 2016 reporting period (82 FR 34100). We 
did not propose to collect any additional data for the CY 2016 
reporting period, as the data submission period for the CY 2016 
reporting period had already ended. As summarized in Table 20 of the 
proposed rule, the NQS domain requirement would no longer apply (82 FR 
34100). No changes were proposed for the measures groups criteria.
    Additionally, we also proposed that individual EPs and group 
practices reporting via claims or qualified registry, as applicable, 
would no longer be required to report a cross-cutting measure and that 
individual EPs and group practices reporting via QCDR would no longer 
be required to report an outcome or ``high priority'' measure (that is, 
for purposes of PQRS, a resource use, patient experience of care, 
efficiency/appropriate use, or patient safety measure) (82 FR 34100). 
We note that what is considered to be a ``high-priority'' measure in 
PQRS is different from what is considered a ``high-priority'' measure 
in MIPS, and we did not propose to align this requirement with MIPS for 
the last year of PQRS as this could cause confusion. Although certain 
MIPS eligible clinicians are required to report at least one outcome or 
other high-priority measure (see Sec.  414.1335(a)(1)(i)), we are also 
not aligning the PQRS requirements with that MIPS requirement because, 
although we agree that outcome and

[[Page 53203]]

high-priority measures are valuable for reporting, we want to revise 
the satisfactory reporting criteria for the last year of PQRS to be 
less complex for individual EPs and groups to understand.
    Lastly, where we proposed to lower the requirement to only 6 
measures, if less than 6 measures apply to the individual EP or group 
practice, each measure that is applicable would need to have been 
reported. We define ``applicable'' to mean measures relevant to a 
particular individual EP's or group practice's services or care 
rendered. As previously finalized, individual EPs and group practices 
would continue to be subject to the measure application validity (MAV) 
process (80 FR 71140 through 71145). The MAV process seeks to identify 
clinically similar measures and creates clusters of measures that can 
be reported if one of the measures in the cluster is reported. We will 
maintain the requirement that each required measure be reported for at 
least 50 percent of the individual EP's or group practice's patients to 
which the measure applies.
    Accordingly, we proposed to revise Sec.  414.90(j)(8) and (k)(5) 
(82 FR 34101). We believe these proposals will result in fewer 
individual EPs being subject to the 2018 PQRS payment adjustment, and 
will impose no additional burden on individual EPs because this data 
has already been submitted to CMS. We requested comment on these 
proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: The majority of commenters supported our proposal to 
revise the previously finalized satisfactory reporting criteria for the 
CY 2016 reporting period to lower the requirement from 9 measures 
across 3 NQS domains, where applicable, to only 6 measures with no 
domain or cross-cutting measure requirement, primarily for its 
alignment with MIPS reporting criteria.
    Response: We appreciate the commenters' feedback, and agree that 
the proposed changes to the reporting criteria are simpler, more 
understandable, and more consistent with the MIPS quality reporting 
requirements, and we are finalizing these changes as proposed.
    Comment: Some commenters supported the proposed changes but urged 
further reduction to reporting criteria, such as considering any 
attempt of reporting to be satisfactory for purposes of avoiding a 
downward payment adjustment.
    Response: While recommendations to further reduce reporting 
criteria were considered, we are finalizing the changes as proposed to 
maintain alignment with MIPS quality reporting requirements. We believe 
that requiring at least 6 measures provides a more accurate reflection 
of the quality of care provided by an individual EP or group practice.
    Comment: A few commenters opposed the proposed changes, as time and 
resources have already been placed into reporting on the previously 
finalized satisfactory reporting criteria for the CY 2016 reporting 
period. Commenters also expressed that changing the requirements from 
the previously finalized satisfactory reporting criteria would reward 
those who did not originally report according to the finalized 
satisfactory reporting criteria, as well as reduce the standard of 
quality that the program was meant to represent.
    Response: We appreciate the commenters' feedback on this proposal. 
While all of the recommendations and rationale provided were 
considered, we are finalizing our proposed modifications to the 
previously finalized satisfactory reporting criteria for CY 2016 as 
proposed to maintain alignment with MIPS quality reporting 
requirements. Based on feedback we received from some stakeholders, we 
believe that these modifications will simplify the requirements for 
some clinicians, as well as provide consistency with the first year of 
MIPS.
    Comment: One commenter supported the proposed changes, but 
recommended the creation of a hardship exemption to relieve 
satisfactory reporters, of any number of measures, from the 2018 
downward payment adjustment.
    Response: We can appreciate the commenter's recommendation. 
However, section 1848(a)(8), (k), and (m) of the Act, which direct us 
to create and implement the PQRS, do not provide for a hardship 
exemption process, nor did we propose to implement such a process. We 
note, however, that individual EPs or group practices may seek an 
informal review of their satisfactory reporting or satisfactory 
participation determination in accordance with Sec.  414.90(m). For 
detailed information about submitting an informal review request, 
please refer to the PQRS Payment Adjustment Information Web page at 
https://www.cms.gov/;Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/PQRS/Payment-Adjustment-Information.html.
    After consideration of the public comments, we are finalizing the 
proposal to revise the previously finalized satisfactory reporting 
criteria for the CY 2016 reporting period to lower the requirement from 
9 measures across 3 NQS domains, where applicable, to only 6 measures 
with no domain or cross-cutting measure requirement. Please see Table 
21 for a summary of our final policies. We are also finalizing the 
revisions at Sec.  414.90(j)(8) and (k)(5) as proposed.

   Table 21--Summary of the Finalized Modifications to the Requirements for the 2018 PQRS Payment Adjustment:
   Individual Reporting Criteria for the Satisfactory Reporting of Quality Measures Data via Claims, Qualified
                      Registry, and EHRs and Satisfactory Participation Criterion in QCDRs
----------------------------------------------------------------------------------------------------------------
                                                                                        Satisfactory reporting
          Reporting period                Measure type         Reporting mechanism             criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016)......  Individual Measures...  Claims................  Report at least 6 measures,
                                                                                      AND report each measure
                                                                                      for at least 50 percent of
                                                                                      the EP's Medicare Part B
                                                                                      FFS patients seen during
                                                                                      the reporting period to
                                                                                      which the measure applies.
                                                                                      If less than 6 measures
                                                                                      apply to the EP, the EP
                                                                                      must report on each
                                                                                      measure that is
                                                                                      applicable, AND report
                                                                                      each measure for at least
                                                                                      50 percent of the Medicare
                                                                                      Part B FFS patients seen
                                                                                      during the reporting
                                                                                      period to which the
                                                                                      measure applies. Measures
                                                                                      with a 0 percent
                                                                                      performance rate will not
                                                                                      be counted (unless they
                                                                                      are inverse measures where
                                                                                      a lower rate reflects
                                                                                      better performance).

[[Page 53204]]

 
12-month (Jan 1-Dec 31, 2016)......  Individual Measures...  Qualified Registry....  Report at least 6 measures,
                                                                                      AND report each measure
                                                                                      for at least 50 percent of
                                                                                      the EP's Medicare Part B
                                                                                      FFS patients seen during
                                                                                      the reporting period to
                                                                                      which the measure applies.
                                                                                      If less than 6 measures
                                                                                      apply to the EP, the EP
                                                                                      must report on each
                                                                                      measure that is
                                                                                      applicable, AND report
                                                                                      each measure for at least
                                                                                      50 percent of the Medicare
                                                                                      Part B FFS patients seen
                                                                                      during the reporting
                                                                                      period to which the
                                                                                      measure applies. Measures
                                                                                      with a 0 percent
                                                                                      performance rate will not
                                                                                      be counted (unless they
                                                                                      are inverse measures where
                                                                                      a lower rate reflects
                                                                                      better performance).
12-month (Jan 1-Dec 31, 2016)......  Individual Measures...  Direct EHR Product or   Report at least 6 measures.
                                                              EHR Data Submission     If an EP's direct EHR
                                                              Vendor Product.         product or EHR data
                                                                                      submission vendor product
                                                                                      does not contain patient
                                                                                      data for at least 6
                                                                                      measures, then the EP must
                                                                                      report all of the measures
                                                                                      for which there is
                                                                                      Medicare patient data. An
                                                                                      EP must report on at least
                                                                                      1 measure for which there
                                                                                      is Medicare patient data.
12-month (Jan 1-Dec 31, 2016)......  Measures Groups.......  Qualified Registry....  No changes.
12-month (Jan 1-Dec 31, 2016)......  Individual PQRS         QCDR..................  Report at least 6 measures
                                      measures and/or non-                            available for reporting
                                      PQRS measures                                   under a QCDR AND report
                                      reportable via a QCDR.                          each measure for at least
                                                                                      50 percent of the EP's
                                                                                      patients seen during the
                                                                                      reporting period to which
                                                                                      the measure applies. If
                                                                                      less than 6 measures apply
                                                                                      to the EP, the EP must
                                                                                      report on each measure
                                                                                      that is applicable, AND
                                                                                      report each measure for at
                                                                                      least 50 percent of the
                                                                                      EP's patients.
----------------------------------------------------------------------------------------------------------------

b. Group Practices
    As discussed previously, although we did not propose to collect any 
additional data for the CY 2016 reporting period, we proposed to modify 
the satisfactory reporting criteria for the CY 2016 reporting period 
for purposes of the 2018 PQRS payment adjustment (82 FR 34101). 
Specifically, we proposed to lower the requirement from 9 measures 
across 3 NQS domains, where applicable, to only 6 measures with no 
domain or cross-cutting measure requirement. For group practices, this 
would apply to the following reporting mechanisms: Qualified registry; 
QCDR; direct EHR product; and EHR data submissions vendor product. This 
proposal would not affect the criteria used to determine whether an 
individual EP or group practice has satisfactorily reported for 
purposes of avoiding the 2017 PQRS payment adjustment, with the 
exception of the criteria applicable to individual EPs and group 
practices reporting using the ACO Secondary Reporting Period, as 
discussed in section III.F.4. of this final rule.
    Table 21 in the proposed rule summarized our proposed modifications 
to the previously finalized satisfactory reporting criteria for group 
practices to avoid the 2018 PQRS payment adjustment, based on data 
previously submitted for the CY 2016 reporting period (82 FR 34101 
through 34102). We did not propose to collect any additional data for 
the CY 2016 reporting period, as the data submission period for the CY 
2016 reporting period has already ended. As summarized in Table 21 of 
the proposed rule, the NQS domain requirement would no longer apply (82 
FR 34101 through 34102). No changes were proposed for the Web Interface 
criteria.
    Additionally, as discussed previously, we proposed that individual 
EPs and group practices reporting via claims and qualified registry, as 
applicable, would no longer be required to report a cross-cutting 
measure and that individual EPs and group practices reporting via QCDR 
would no longer be required to report an outcome or high priority 
measure. We note that what is considered to be a ``high-priority'' 
measure in PQRS is different from what is considered a ``high-
priority'' measure in MIPS, and we did not propose to align this 
requirement with MIPS for the last year of PQRS as this could cause 
confusion. Although certain MIPS eligible clinicians are required to 
report at least one outcome or other high-priority measure (see Sec.  
414.1335(a)(1)(i)), we are also not aligning the PQRS requirements with 
that requirement because, although we agree that outcome and high-
priority measures are valuable for reporting, we want to revise the 
satisfactory reporting criteria for the last year of PQRS to be less 
complex for individual EPs and groups.
    Where we proposed to lower the requirement to only 6 measures, if 
less than 6 measures apply to the individual EP or group practice, each 
measure that is applicable would need to have been reported. We define 
``applicable'' to mean measures relevant to a particular individual 
EP's or group practice's services or care rendered. As previously 
finalized, individual EPs and group practices would continue to be 
subject to the MAV process (80 FR 71140 through 71145). The MAV process 
seeks to identify clinically similar measures and creates clusters of 
measures that can be reported if one of the measures in the cluster is 
reported. We would maintain the requirement that each required measure 
be reported for at least 50 percent of the individual EP's or group 
practice's patients to which the measure applies.
    Lastly, for purposes of the 2018 PQRS payment adjustment, Sec.  
414.90(j)(9)(viii) currently provides that if the CAHPS for PQRS survey 
is applicable to the practice, group practices comprised of 100 or more 
EPs that register to participate in the GPRO must administer the CAHPS 
for PQRS survey, regardless of the GPRO reporting mechanism selected. 
For the reasons discussed previously, we proposed to revise Sec.  
414.90(j)(9)(viii) to provide that such group practices may administer 
the CAHPS for PQRS survey, regardless of the GPRO reporting mechanism 
selected, but are not required to do so. This change would be 
consistent with the data submission criteria for the MIPS quality 
performance category, under which groups may voluntarily elect to 
participate in the CAHPS for MIPS survey (see Sec.  414.1335(a)(3)(i)). 
As summarized in Table 21 of the proposed rule (82 FR 34101 through 
34102), the previously finalized satisfactory reporting criteria for 
group practices

[[Page 53205]]

administering the CAHPS for PQRS survey would continue to apply to 
group practices that elected to administer the survey.
    Accordingly, we proposed to revise Sec.  414.90(j)(9) and (k)(5) 
(82 FR 34102). We believe these proposals will result in fewer group 
practices being subject to the 2018 PQRS payment adjustment, and will 
impose no additional burden on group practices because this data has 
already been submitted to CMS. We requested comment on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: The majority of commenters supported our proposal to lower 
the requirement from 9 measures across 3 NQS domains, where applicable, 
to only 6 measures with no domain or cross-cutting measure requirement 
for group practices using the following reporting mechanisms: Qualified 
registry; QCDR; direct EHR product; and EHR data submissions vendor 
product.
    Response: We appreciate these commenters' support and are 
finalizing these requirements as proposed.
    Comment: A commenter supported the proposed changes but recommended 
reopening of the 2016 PQRS submissions.
    Response: We are not reopening 2016 PQRS data submissions as it is 
technically not feasible while maintaining our program deadlines.
    After consideration of the public comments, we are finalizing the 
proposed changes as proposed. We refer readers to Table 22 to view a 
summary of our final policies. We are also finalizing revisions to 
Sec.  414.90(j)(9) and (k)(5) as proposed.

  Table 22--Summary of Finalized Modifications to the Requirements for the 2018 PQRS Payment Adjustment: Group
          Practice Reporting Criteria for Satisfactory Reporting of Quality Measures Data via the GPRO
----------------------------------------------------------------------------------------------------------------
                                   Group practice                          Reporting      Satisfactory reporting
        Reporting period              size \4\         Measure type        mechanism             criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016)..  25+ EPs..........  Individual GPRO    Web Interface....  No changes.
                                                     Measures in the
                                                     Web Interface.
12-month (Jan 1-Dec 31, 2016)..  25+ EPs that       Individual GPRO    Web Interface +    No changes.
                                  elect CAHPS for    Measures in the    CMS-Certified
                                  PQRS.              Web Interface +    Survey Vendor.
                                                     CAHPS for PQRS.
12-month (Jan 1-Dec 31, 2016)..  2+ EPs...........  Individual         Qualified          Report at least 6
                                                     Measures.          Registry.          measures AND report
                                                                                           each measure for at
                                                                                           least 50 percent of
                                                                                           the group's Medicare
                                                                                           Part B FFS patients
                                                                                           seen during the
                                                                                           reporting period to
                                                                                           which the measure
                                                                                           applies. If less than
                                                                                           6 measures apply to
                                                                                           the group, the group
                                                                                           practice must report
                                                                                           on each measure that
                                                                                           is applicable, AND
                                                                                           report each measure
                                                                                           for at least 50
                                                                                           percent of the
                                                                                           Medicare Part B FFS
                                                                                           patients seen during
                                                                                           the reporting period
                                                                                           to which the measure
                                                                                           applies. Measures
                                                                                           with a 0 percent
                                                                                           performance rate will
                                                                                           not be counted
                                                                                           (unless they are
                                                                                           inverse measures
                                                                                           where a lower rate
                                                                                           reflects better
                                                                                           performance).
12-month (Jan 1-Dec 31, 2016)..  2+ EPs that elect  Individual         Qualified          The group practice
                                  CAHPS for PQRS.    Measures + CAHPS   Registry + CMS-    must have all CAHPS
                                                     for PQRS.          Certified Survey   for PQRS survey
                                                                        Vendor.            measures reported on
                                                                                           its behalf via a CMS-
                                                                                           certified survey
                                                                                           vendor. In addition,
                                                                                           the group practice
                                                                                           must report at least
                                                                                           3 additional measures
                                                                                           using the qualified
                                                                                           registry AND report
                                                                                           each measure for at
                                                                                           least 50 percent of
                                                                                           the group's Medicare
                                                                                           Part B FFS patients
                                                                                           seen during the
                                                                                           reporting period to
                                                                                           which the measure
                                                                                           applies. If less than
                                                                                           3 measures apply to
                                                                                           the group practice,
                                                                                           the group practice
                                                                                           must report on each
                                                                                           measure that is
                                                                                           applicable, AND
                                                                                           report each measure
                                                                                           for at least 50
                                                                                           percent of the
                                                                                           Medicare Part B FFS
                                                                                           patients seen during
                                                                                           the reporting period
                                                                                           to which the measure
                                                                                           applies. Measures
                                                                                           with a 0 percent
                                                                                           performance rate will
                                                                                           not be counted
                                                                                           (unless they are
                                                                                           inverse measures
                                                                                           where a lower rate
                                                                                           reflects better
                                                                                           performance).
12-month (Jan 1-Dec 31, 2016)..  2+ EPs...........  Individual         Direct EHR         Report 6 measures. If
                                                     Measures.          Product or EHR     the group practice's
                                                                        Data Submission    direct EHR product or
                                                                        Vendor Product.    EHR data submission
                                                                                           vendor product does
                                                                                           not contain patient
                                                                                           data for at least 6
                                                                                           measures, then the
                                                                                           group practice must
                                                                                           report all of the
                                                                                           measures for which
                                                                                           there is Medicare
                                                                                           patient data. A group
                                                                                           practice must report
                                                                                           on at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.

[[Page 53206]]

 
12-month (Jan 1-Dec 31, 2016)..  2+ EPs that elect  Individual         Direct EHR         The group practice
                                  CAHPS for PQRS.    Measures + CAHPS   Product or EHR     must have all CAHPS
                                                     for PQRS.          Data Submission    for PQRS survey
                                                                        Vendor Product +   measures reported on
                                                                        CMS-Certified      its behalf via a CMS-
                                                                        Survey Vendor.     certified survey
                                                                                           vendor. In addition,
                                                                                           the group practice
                                                                                           must report at least
                                                                                           3 additional measures
                                                                                           using the direct EHR
                                                                                           product or EHR data
                                                                                           submission vendor
                                                                                           product. If less than
                                                                                           3 measures apply to
                                                                                           the group practice,
                                                                                           the group practice
                                                                                           must report all of
                                                                                           the measures for
                                                                                           which there is
                                                                                           patient data. Of the
                                                                                           additional 3 measures
                                                                                           that must be reported
                                                                                           in conjunction with
                                                                                           reporting the CAHPS
                                                                                           for PQRS survey
                                                                                           measures, a group
                                                                                           practice must report
                                                                                           on at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.
12-month (Jan 1-Dec 31, 2016)..  2+ EPs...........  Individual PQRS    QCDR.............  Report at least 6
                                                     measures and/or                       measures available
                                                     non-PQRS                              for reporting under a
                                                     measures                              QCDR AND report each
                                                     reportable via a                      measure for at least
                                                     QCDR.                                 50 percent of the
                                                                                           group practice's
                                                                                           patients seen during
                                                                                           the reporting period
                                                                                           to which the measure
                                                                                           applies. If less than
                                                                                           6 measures apply to
                                                                                           the group practice,
                                                                                           the group practice
                                                                                           must report on each
                                                                                           measure that is
                                                                                           applicable, AND
                                                                                           report each measure
                                                                                           for at least 50
                                                                                           percent of the group
                                                                                           practice's patients.
----------------------------------------------------------------------------------------------------------------

4. Accountable Care Organization (ACO) Participants Who Report PQRS 
Quality Measures Separately During the Secondary Reporting Period
    As discussed in the CY 2017 PFS final rule (81 FR 80441 through 
80445), individual EPs and group practices who bill under the TIN of an 
ACO participant may report separately from the ACO, if the ACO failed 
to report on behalf of such individual EPs or group practices for the 
applicable reporting period, during the CY 2016 reporting period for 
purposes of the 2017 and 2018 PQRS payment adjustments, as applicable. 
Please note that, in accordance with our previously established 
policies for the ACO Secondary Reporting Period, our finalized 
modifications to the satisfactory reporting criteria for individual EPs 
and group practices for the CY 2016 reporting period would apply to 
such individual EPs and group practices for purposes of the 2017 PQRS 
payment adjustment. We did not receive comments on this aspect of the 
proposal. These modifications will not affect the 2017 PQRS payment 
adjustment for any other individual EP or group practice.
---------------------------------------------------------------------------

    \4\ Please note that the group practice size descriptions have 
been revised for greater consistency with our policy of making the 
CAHPS for PQRS survey voluntary.
---------------------------------------------------------------------------

5. Physician Compare Downloadable Database--Addition of Value Modifier 
(VM) Data
    We previously finalized in the CY 2016 PFS final rule (80 FR 71129 
through 71130) a decision to publicly report three data points for the 
2018 VM based on 2016 data in the Physician Compare downloadable file 
in late 2017:
     2018 VM quality tiers for cost and quality, based on the 
2016 data, noting if the EP or group is high, low, or average on cost 
and quality per the VM.
     A notation of the payment adjustment received based on the 
cost and quality tiers--upward, downward, or neutral--for each EP or 
group.
     An indication if the EP or group was eligible to but did 
not report quality measures to CMS for CY 2016 under PQRS.
    In light of the proposals to change the 2016 reporting criteria to 
avoid the 2018 payment adjustment for PQRS (see section III.F. of this 
final rule) and subsequent VM proposed policies to hold all physician 
groups and solo practitioners who met minimum quality reporting 
requirements harmless from downward payment adjustments for performance 
under quality-tiering for the last year of the program (see section 
III.I. of this final rule), and because the revised policies for PQRS 
and VM in this rule will change the nature of how the PQRS data will be 
used under the VM, we proposed not to report this data specific to the 
VM (82 FR 34103). Given the fact that VM data would have been available 
for posting in the Physician Compare downloadable database for only 1 
year and the VM data may not reflect an EP or group's actual 
performance or payment adjustment given they could have chosen to 
report fewer measures, we believe that proceeding with the posting of 
this data could be confusing for the public.
    Additionally, we have created other VM data files intended to 
promote transparency. For each VM performance year, we will publish a 
Public Use File (PUF) that contains VM performance results of de-
identified practices. Supporting documentation for each PUF contains 
the field name, length, type, label, description, and notes for each 
variable included in the PUF. The Value Modifier program years 2015 and 
2016 (performance year 2013 and 2014) are currently available at 
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/VMPUF/Value-Modifier-PUF.html. In addition, three 
Research Identifiable Files (RIFs) for Value Modifier program years 
2015 and 2016 (performance year 2013 and 2014) are available through 
the Research Data Assistance Center (ResDAC) and will be made available 
for each program year. These files include a practice-level, an NPI-
practice level, and a beneficiary-level file, as described at: https://www.resdac.org/news/cms-creates-set-rif-data-files-support-value-based-payment-modifier-program/2017/06.
    All other previously finalized policies related to 2016 PQRS data 
available for public reporting on Physician Compare in late 2017 remain 
unchanged (80 FR 71116 through 71132). Appreciating this, we believe 
the best course of action is to not move forward with publicly 
reporting this VM data for 2016. All data required to be reported by 
law will remain available for public reporting as previously finalized 
(80 FR 71116

[[Page 53207]]

through 71132). For more information on the public reporting policies 
previously finalized and proposed for MIPS, we refer readers to the 
following two rules: The Medicare Program; Merit-Based Incentive 
Payment System (MIPS) and Alternative Payment Model (APM) Incentive 
Under the Physician Fee Schedule, and Criteria for Physician-Focused 
Payment Models final rule with comment period (81 FR 77390 through 
77399); and Medicare Program; CY 2018 Updates to the Quality Payment 
Program proposed rule (82 FR 30163 through 30170). We requested comment 
on this proposal not to move forward with publicly reporting the VM 
information in the downloadable database and specifically, if we were 
to release this data, how it could be used by the public.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Almost all commenters who specifically addressed the 
proposal not to move forward with reporting the VM data in the 
Physician Compare downloadable database supported this proposal. 
Overwhelmingly, commenters indicated it would be best not to report 
these data, understanding that the policy changes for both PQRS and the 
VM changed the nature of the data available for public reporting. 
Commenters also noted including these data would be confusing for both 
clinicians and patients. And, they also commented that it would be best 
not to include these data for just 1 year.
    Response: We appreciate the comments received and agree with the 
large majority of commenters that indicated these data would 
potentially confuse the public and not add significant value given the 
changes to the PQRS and VM policies. And, we agree that because this 
would be the first and only year the data were available for public 
reporting, it is best to not publicly report the information.
    Comment: A few commenters opposed this proposal and asked CMS to 
move forward with publicly reporting these VM data to support 
transparency and specifically so clinicians could get value from the 
tiering data.
    Some other commenters did question if this type of data was 
consistent with the goals of Physician Compare, generally, and others 
questioned if this type of data was useful for decision-making. For 
transparency purposes, many of these commenters noted the available 
aggregated, de-identified data was sufficient.
    Response: For transparency purposes, as previously noted, these 
data are already available in a PUF that contains VM performance 
results of de-identified practices. Clinicians could use the PUF files 
to evaluate the tiering information as that is included and already 
public. As noted, we agree these data are not the data most likely to 
be evaluated by Physician Compare users when looking to make a decision 
about their health care. But, we anticipate that the audience for the 
downloadable database will be composed primarily of third party data 
users, as well as the clinicians and groups themselves, rather than 
patients and their caregivers. As a result, we appreciate the comment 
regarding usefulness and alignment with Physician Compare goals, but 
also note that the primary goal of the downloadable database is to 
promote transparency. Again, we believe the PUF file is appropriate for 
this purpose.
    As a result of the public comments, we are finalizing this 
proposal, and, as a result, we will not be including VM data in the 
Physician Compare downloadable database related to the 2018 payment 
adjustment.

G. Clinical Quality Measurement for Eligible Professionals 
Participating in the Electronic Health Record (EHR) Incentive Program 
for 2016

1. Background
    Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act 
provide the statutory basis for the Medicare incentive payments made to 
eligible professionals (EPs), Medicare Advantage (MA) organizations 
(for certain qualifying EPs and hospitals), subsection (d) hospitals, 
and critical access hospitals (CAHs) that demonstrate meaningful use of 
certified electronic health record (EHR) technology (CEHRT). Sections 
1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also 
establish downward adjustments to Medicare payments, beginning with 
calendar or fiscal year (FY) 2015, for EPs, MA organizations, 
subsection (d) hospitals, and CAHs that are not meaningful users of 
CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) 
and 1903(t) of the Act provide the statutory basis for the Medicaid 
incentive payments made to EPs and eligible hospitals for the adoption, 
implementation, upgrade, and meaningful use of CEHRT. We have 
implemented these statutory provisions in prior rulemakings to 
establish the Medicare and Medicaid EHR Incentive Programs.
    Under these statutory provisions and the regulations at 42 CFR 
495.4, one of the requirements of being a meaningful EHR user is 
successfully reporting the clinical quality measures selected by CMS to 
CMS or the states, as applicable, in the form and manner specified by 
CMS or the states, as applicable. Section 1848(o)(2)(B)(iii) of the Act 
requires that in selecting clinical quality measures (CQMs) for EPs to 
report under the EHR Incentive Program, and in establishing the form 
and manner of reporting, the Secretary shall seek to avoid redundant or 
duplicative reporting otherwise required, including reporting under 
section 1848(k)(2)(C) of the Act (the Physician Quality Reporting 
System). As such, we have taken steps to establish alignments among 
various quality reporting and payment programs that include the 
submission of CQMs.
2. Clinical Quality Measure (CQM) Requirements for Meaningful Use in 
2016
    Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the 
Act and the definition of ``meaningful EHR user'' at Sec.  495.4, EPs 
must report on CQMs selected by CMS using CEHRT, as part of being a 
meaningful EHR user under the Medicare and Medicaid EHR Incentive 
Programs. In the final rule titled ``Medicare and Medicaid Programs; 
Electronic Health Record Incentive Program--Stage 3 and Modifications 
to Meaningful Use in 2015 Through 2017,'' we finalized the options for 
CQM submission for EPs in the Medicare EHR Incentive Program in 2016 as 
follows (80 FR 62888 through 62889):
     EP Options for Medicare EHR Incentive Program 
Participation (single program Participation--EHR Incentive Program 
only):
    ++ Option 1: Attest to CQMs through the EHR Registration & 
Attestation System.
    ++ Option 2: Electronically report CQMs through Physician Quality 
Reporting System (PQRS) Portal.
     EP Options for Electronic Reporting for Multiple Programs 
(for example: EHR Incentive Program plus PQRS participation):
    ++ Option 1: Report individual EP's CQMs through PQRS Portal.
    ++ Option 2: Report group's CQMs through PQRS Portal.
    (Note: Under option 2, this may include an EP reporting using the 
group reporting option, either electronically using QRDA, or via the 
GPRO Web Interface.)
    For the Medicaid EHR Incentive Program, we specified (80 FR 62888) 
that states would continue to be responsible for determining whether 
and how electronic reporting of CQMs would occur, or if they wish to 
allow reporting through attestation. Any

[[Page 53208]]

changes that states make to their CQM reporting methods must be 
submitted through the state Medicaid Health IT Plan (SMHP) process for 
our review and approval prior to being implemented.
    We maintained a requirement that EPs report 9 CQMs covering at 
least 3 NQS domains (80 FR 62888 through 62889). This requirement was 
established in the final rule titled ``Medicare and Medicaid Programs; 
Electronic Health Record Incentive Program--Stage 2'' (77 FR 54058).
    We also continued (80 FR 62888 through 62889) our existing policy 
that under Medicare, healthcare providers in any year of participation 
for the EHR Incentive Program for 2015 through 2017 may electronically 
report CQM data using the options previously outlined for electronic 
reporting either for single program participation in the Medicare EHR 
Incentive Program, or for participation in multiple programs if the 
requirements of the aligned quality program are also met.
    We noted that an EHR certified for CQMs under the 2014 Edition 
certification criteria does not need to be recertified each time it is 
updated to a more recent version of the eCQMs (80 FR 62889).
3. CQM Requirements for EPs and Groups Under the Medicare EHR Incentive 
Program in 2016
    As we discussed in section III.F. in this final rule, since we 
finalized these requirements, we have heard from stakeholders through 
written communications that EPs and groups have found the previously 
finalized reporting criteria for the CY 2016 reporting period to be 
complex and had difficulty in understanding the requirements to be a 
satisfactory reporter, and these same EPs and groups subsequently 
requested that the CQM reporting requirements for EPs and groups 
participating in the Medicare EHR Incentive Program in 2016 who chose 
to report CQMs electronically through the Physician Quality Reporting 
System (PQRS) Portal be aligned with those of the Quality Payment 
Program, specifically the Merit-based Incentive Payment System (MIPS).
    Therefore, although we did not propose to collect any additional 
data for 2016, we proposed to change the reporting criteria for EPs and 
groups who chose to electronically report CQMs through the PQRS Portal 
for purposes of the Medicare EHR Incentive Program. Specifically, we 
proposed to change the reporting criteria from 9 CQMs covering at least 
3 NQS domains to 6 CQMs with no domain requirement. We proposed this 
change so that the reporting criteria for the Medicare EHR Incentive 
Program would be in alignment with the modified requirement that we 
proposed for the final PQRS reporting period (2016) in section III.F. 
of the proposed rule, as well as the transition year of the Quality 
Payment Program. We proposed that an EP or group who satisfies the 
proposed reporting criteria may qualify for the 2016 incentive payment 
under section 1848(o) of the Act and may avoid the downward payment 
adjustment in 2017 and/or 2018 under section 1848(a)(7)(A) of the Act, 
depending on the EP or group's applicable EHR reporting period for the 
payment adjustment year. This proposed change would help maintain 
alignment with PQRS per the requirement under section 
1848(o)(2)(B)(iii) of the Act for the Secretary to seek to avoid 
redundant or duplicative reporting otherwise required, including 
reporting under section 1848(k)(2)(C) of the Act (the PQRS).
    We did not propose to change the previously finalized requirements 
for CQM reporting in 2016 for eligible hospitals and CAHs; or the 
previously finalized requirements for EPs who chose to report CQMs 
through attestation in 2016 for the Medicare EHR Incentive Program (80 
FR 62888). Our reasoning for not proposing to change the eligible 
hospital or CAH requirements for CQM reporting is because the changes 
proposed for PQRS in section III.F. of the proposed rule and the 
policies established for the transition year of the Quality Payment 
Program would only affect clinicians and groups, and therefore, there 
is no reason to change the established policy for eligible hospitals or 
CAHs. We did not propose to change the requirements for EPs who 
reported CQMs through attestation because those who attested were 
successful; therefore, we believe there is no need to change the 
requirement. Additionally, the Registration and Attestation portal was 
phased out on October 1, 2017, and is no longer available for use.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: The majority of commenters supported CMS' proposal to 
revise the reporting criteria for EPs for the CY 2016 reporting period, 
from 9 measures across 3 NQS domains, to 6 measures with no domain 
requirement for EPs and groups who chose to electronically report CQMs 
through the PQRS Portal for purposes of the Medicare EHR Incentive 
Program in order to align with the changes proposed for PQRS reporting 
requirements for 2016.
    Response: We appreciate the commenters' support for our proposal.
    Comment: One commenter supported the proposed changes but requested 
that CMS establish a new ``Administrative Burden'' category of hardship 
exception for the 2016 meaningful use reporting period.
    Response: We appreciate the commenter's support. We did not 
consider or propose any changes to our existing policy on significant 
hardship exceptions under the Medicare EHR Incentive Program, and 
comments on this topic are outside of the scope of this rulemaking. We 
note, however, that for the 2016 program year, we offered multiple 
categories of hardship exceptions, covering a number of issues that 
participants in the EHR Incentive Program might experience. However, 
the application deadline for EPs requesting a hardship exception closed 
on July 1, 2017. We also note that the policy we are finalizing 
decreases the number of CQMs required for reporting if reported 
electronically through the PQRS portal. Given that both the reporting 
period and the deadline for submission of applications for a hardship 
exception have closed for the CY 2016 reporting year, we are not adding 
additional hardship exceptions at this time.
    Comment: A few commenters opposed the proposed changes, as time and 
resources have already been invested in order to meet the previously 
finalized reporting criteria for the CY 2016 reporting period.
    Response: We appreciate the commenters' feedback on this proposal 
and acknowledge that many EPs have invested time and resources into 
meeting the reporting requirements for the CY 2016 reporting period. 
Under this proposal, there would be no change in status for those who 
successfully met the previously finalized reporting requirements--they 
would continue to be successful reporters.
    After consideration of the public comments, we are finalizing the 
proposal to revise the CQM reporting criteria for EPs from 9 measures 
across 3 NQS domains to 6 measures with no domain requirement for EPs 
and groups who chose to electronically report CQMs through the PQRS 
Portal for purposes of the Medicare EHR Incentive Program in order to 
align with the proposed PQRS reporting requirements for 2016. An EP or 
group who satisfies these revised reporting criteria (as well as other 
EHR Incentive Program requirements) may qualify for the 2016 incentive 
payment under section

[[Page 53209]]

1848(o) of the Act and may avoid the downward payment adjustment in 
2017 and/or 2018 under section 1848(a)(7)(A) of the Act, depending on 
the EP or group's applicable EHR reporting period for the payment 
adjustment year.
    Lastly, we also did not propose to change the previously finalized 
requirements for 2016 for EPs participating in the Medicaid EHR 
Incentive Program. At the time that we published the proposed rule, we 
had already proposed in ``Medicare Program; Hospital Inpatient 
Prospective Payment Systems for Acute Care Hospitals and the Long-Term 
Care Hospital Prospective Payment System and Proposed Policy Changes 
and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific 
Providers; Medicare and Medicaid Electronic Health Record (EHR) 
Incentive Program Requirements for Eligible Hospitals, Critical Access 
Hospitals, and Eligible Professionals; Provider-Based Status of Indian 
Health Service and Tribal Facilities and Organizations; Costs Reporting 
and Provider Requirements; Agreement Termination Notices'' that, for 
2017, Medicaid EPs would be required to report on any six CQMs that are 
relevant to the EP's scope of practice (82 FR 20135). On August 14, 
2017, we finalized that proposal (82 FR 38487). In proposing and 
finalizing that change, we indicated that it is our intention to align 
CQM requirements for Medicaid EPs with the requirements of Medicare 
quality improvement programs, to the extent practicable. However, due 
to the timing of this rulemaking and when any proposed changes for 2016 
would take effect (if finalized), we were concerned that the benefits 
of proposing to extend the policy proposed for Medicare EPs for 2016 to 
Medicaid EPs for 2016 would not be realized, and the burden on states 
to implement such a policy would be significant. There is no negative 
payment adjustment for not participating in the Medicaid EHR Incentive 
Program, so we explained that it was likely that applying the proposed 
policy for Medicare EPs to Medicaid EPs for 2016 would benefit Medicaid 
EPs only if they were able to submit new data to states for a Medicaid 
EHR incentive payment for 2016. Because we anticipated that most states 
would have completed processing and paying 2016 Medicaid EHR incentive 
payments by the time such a proposal (if finalized) would take effect, 
we explained that we believed that applying this change to the Medicaid 
EHR Incentive Program for 2016 would significantly burden states. We 
sought comment on our assessment of the difficulty states might face 
implementing this policy for 2016 for Medicaid EPs, and on the number 
of Medicaid EPs who might benefit if we instead decided to apply this 
policy in the Medicaid EHR Incentive Program for 2016, to the extent 
that doing so would be legally permissible.
    We did not receive any comments related to our request for comment, 
and are not changing the previously finalized CQM reporting 
requirements for 2016 for EPs participating in the Medicaid EHR 
Incentive Program.

H. Medicare Shared Savings Program

    Under section 1899 of the Act, we established the Medicare Shared 
Savings Program (Shared Savings Program) to facilitate coordination and 
cooperation among health care providers to improve the quality of care 
for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of 
growth in expenditures under Medicare Parts A and B. Eligible groups of 
providers and suppliers, including physicians, hospitals, and other 
health care providers, may participate in the Shared Savings Program by 
forming or participating in an Accountable Care Organization (ACO). The 
final rule establishing the Shared Savings Program appeared in the 
November 2, 2011 Federal Register (Medicare Program; Medicare Shared 
Savings Program: Accountable Care Organizations; Final Rule (76 FR 
67802) (hereinafter referred to as the ``November 2011 final rule'')). 
A subsequent major update to the program rules appeared in the June 9, 
2015 Federal Register (Medicare Program; Medicare Shared Savings 
Program: Accountable Care Organizations; Final Rule (80 FR 32692) 
(hereinafter referred to as the ``June 2015 final rule'')). A final 
rule addressing changes related to the program's financial benchmark 
methodology appeared in the June 10, 2016 Federal Register (Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Revised Benchmark Rebasing Methodology, Facilitating 
Transition to Performance-Based Risk, and Administrative Finality of 
Financial Calculations (81 FR 37950) (hereinafter referred to as the 
``June 2016 final rule'')). We have also made use of the annual 
calendar year (CY) Physician Fee Schedule (PFS) rules to address 
quality reporting and certain other issues. In addition, in the CY 2017 
Quality Payment Program final rule (81 FR 77255 through 77256), we 
finalized policies related to the Alternative Payment Model (APM) 
scoring standard under the Merit-Based Incentive Payment System (MIPS), 
which reduces the reporting burden for MIPS eligible clinicians who 
participate in MIPS APMs, such as the Shared Savings Program, by: (1) 
Using the same quality data reported by the ACO using the CMS Web 
Interface for purposes of the Shared Savings Program to score the MIPS 
quality performance category for these eligible clinicians and (2) 
automatically awarding MIPS eligible clinicians a minimum of one-half 
of the total points in the improvement activities performance category; 
and (3) not assessing MIPS eligible clinicians on the cost performance 
category because, through their participation in the ACO, they are 
already being assessed on cost and utilization under the Shared Savings 
Program.
    In the CY 2018 PFS proposed rule (82 FR 34105 through 34110), we 
proposed two modifications to the Shared Savings Program beneficiary 
assignment methodology for performance years beginning on or after 
January 1, 2019: (1) Revisions to the assignment methodology under 42 
CFR part 425, subpart E to reflect the requirement under section 17007 
of the 21st Century Cures Act (Pub. L. 114-255, December 13, 2016), 
that the Secretary determine an appropriate method to assign Medicare 
FFS beneficiaries to an ACO based on their utilization of services 
furnished by rural health clinics (RHCs) or federally qualified health 
centers (FQHCs), and (2) addition of new chronic care management (CCM) 
and behavioral health integration (BHI) service codes to our definition 
of primary care services. In addition, we proposed to revise the 
methodology used in our quality measure validation audits and the way 
the results of these audits may be used to adjust an ACO's sharing rate 
(82 FR 34113 through 34114). We also proposed to reserve the discretion 
to redesignate a measure reported through the CMS Web Interface as pay-
for-reporting when substantive changes are made to the measure under 
the Quality Payment Program (82 FR 34110 through 34113).
    We also addressed proposals intended to reduce application burden 
for stakeholders by reducing certain documentation submission 
requirements included in the initial Shared Savings Program application 
and the application for use of the Skilled Nursing Facility (SNF) 3-Day 
Rule Waiver (82 FR 34114 through 34120). We also proposed to establish 
specific procedures to address situations where a Taxpayer 
Identification Number (TIN) that is an ACO participant in more than one 
ACO begins to submit claims for services used in the beneficiary 
assignment process and becomes out of

[[Page 53210]]

compliance with the ``exclusivity'' requirement in Sec.  425.306(b)(2) 
(82 FR 34120 through 34122). Finally, we proposed that, for performance 
year 2018 and subsequent years, we would only include individually 
beneficiary identifiable payments made under a demonstration, pilot or 
time limited program that are final and not subject to further 
reconciliation in financial calculations related to establishing and 
updating benchmarks and determining performance year expenditures under 
the Shared Savings Program (82 FR 34122 through 34123).
1. Modifications to the Shared Savings Program Beneficiary Assignment 
Methodology
a. Assignment of Beneficiaries to ACOs That Include RHCs and/or FQHCs
(1) Background
(a) General Shared Savings Program Assignment Methodology
    As originally enacted in the Affordable Care Act, section 1899(c) 
of the Act requires us to assign FFS beneficiaries to an ACO 
participating in the Shared Savings Program based on the beneficiary's 
utilization of primary care services rendered by physicians 
participating in the ACO. We refer readers to the CY 2018 PFS proposed 
rule (82 FR 34105 through 34108) for an overview of existing policies 
for assigning beneficiaries to ACOs under the Shared Savings Program 
consistent with the requirements of section 1899(c) of the Act. The 
regulations governing the assignment methodology under the Shared 
Savings Program are in part 425, subpart E. Briefly, in the November 
2011 final rule we adopted a claims-based hybrid approach (called 
preliminary prospective assignment with retrospective reconciliation) 
for assigning beneficiaries to an ACO (76 FR 67851 through 67870), 
which is currently applicable to ACOs participating under Track 1 or 
Track 2 of the Shared Savings Program. Under this approach, 
beneficiaries are preliminarily assigned to an ACO, based on a two-step 
assignment methodology, at the beginning of a performance year and 
quarterly thereafter during the performance year, but the final 
beneficiary assignment is determined after each performance year based 
on where beneficiaries chose to receive a plurality of their primary 
care services during the performance year. Subsequently, in the June 
2015 final rule, we implemented an option for ACOs to participate in a 
new two-sided performance-based risk track, Track 3 (80 FR 32771 
through 32781). Under Track 3, beneficiaries are prospectively assigned 
to an ACO at the beginning of the performance year using the same two-
step methodology used in the preliminary prospective assignment 
approach, based on where the beneficiaries have chosen to receive a 
plurality of their primary care services during a 12-month assignment 
window offset from the calendar year that reflects the most recent 12 
months for which data are available prior to the start of the 
performance year. The ACO is held accountable for beneficiaries who are 
prospectively assigned to it for the performance year. Under limited 
circumstances, a beneficiary may be excluded from the prospective 
assignment list during or after the performance year, such as if the 
beneficiary enrolls in Medicare Advantage during the performance year 
or no longer lives in the United States or U.S. territories and 
possessions.
    Finally, in the CY 2017 PFS final rule (81 FR 80501 through 80510), 
we further enhanced the claims-based beneficiary assignment methodology 
by finalizing a policy under which beneficiaries, beginning in 
performance year 2017, may designate a ``primary clinician'' they 
believe is responsible for coordinating their overall care using 
MyMedicare.gov, a secure, online, patient portal. (We would note that 
although we previously used the term ``main doctor'' in the CY 2017 PFS 
final rule, we are using the more comprehensive term ``primary 
clinician'' in this final rule for consistency with MyMedicare.gov and 
to reflect that beneficiaries can designate healthcare provider types 
other than physicians as responsible for coordinating their overall 
care.) Notwithstanding the assignment methodology in Sec.  425.402(b), 
beneficiaries who designate an ACO professional whose services are used 
in assignment as responsible for their overall care will be 
prospectively assigned to the ACO in which that ACO professional 
participates, provided the beneficiary meets the eligibility criteria 
established at Sec.  425.401(a) and has had at least one primary care 
service during the assignment window with an ACO professional in the 
ACO who is a primary care physician or a physician with one of the 
primary specialty designations included in Sec.  425.402(c). Such 
beneficiaries will be added prospectively to the ACO's list of assigned 
beneficiaries for the subsequent performance year.
(c) Special Assignment Conditions for RHCs and FQHCs
    As we noted in the November 2011 final rule, RHC and FQHC claims 
contain very limited information concerning the individual 
practitioner, or even the type of health professional (for example, 
physician, PA, or NP) who provided the service to the beneficiary 
because this information is not necessary to determine payment rates 
for services in RHCs and FQHCs (76 FR 67858 through 67861). Therefore, 
unlike physician fee schedule claims, there is no direct way for us to 
determine if an RHC or FQHC claim was for a service furnished by a 
physician at the RHC or FQHC. Despite this difference in claims billing 
for RHCs and FQHCs, we established a process that allows primary care 
services furnished in RHCs and FQHCs to be considered in the assignment 
process for any ACO that includes an RHC or FQHC as an ACO participant. 
This process is set forth in Sec.  425.404. The special procedures that 
we have established for using RHC and FQHC services in the assignment 
methodology are discussed in detail in the June 2015 final rule (80 FR 
32755 through 32756). We assign beneficiaries to ACOs that include RHCs 
or FQHCs as ACO participants in a manner generally consistent with how 
we assign beneficiaries to other ACOs based on primary care services 
performed by certain physicians and non-physician practitioners who are 
ACO professionals in the ACO. However, to address the requirement under 
section 1899(c) of the Act that beneficiaries be assigned to an ACO 
based on their use of primary care services furnished by physicians, we 
require ACOs that include RHCs or FQHCs to identify, through an 
attestation, the physicians that directly provide patient primary care 
services in their ACO participant RHCs or FQHCs (see Sec. Sec.  
425.204(c)(5)(iii) and 425.404(a)). We use the combination of the RHC 
or FQHC ACO participant TIN (and another unique identifier, such as a 
CCN, when appropriate) and the NPIs of the RHC or FQHC physicians 
provided to us through the attestation process to identify those 
beneficiaries who received a primary care service from a physician in 
the RHC or FQHC and who are therefore eligible to be assigned to the 
ACO.
    This required attestation process for submitting physician 
identifiers requires more effort to ensure the accuracy of the ACO 
participant list (including the attestation that includes the physician 
identifiers) than the level of effort required for ACOs that do not 
include RHCs and FQHCs. In addition,

[[Page 53211]]

we have recognized that the required attestation process for submitting 
physician identifiers is prone to error because some RHCs and FQHCs 
(particularly rural FQHCs) have multiple locations with potentially 
hundreds of NPIs to report which, in turn, increases the likelihood 
that ACOs that include RHCs or FQHCs as ACO participants will make 
inadvertent clerical errors, such as transposing digits, in submitting 
the required information. Errors that are not identified and corrected 
by the specified deadline for additions to the ACO participant list may 
result in fewer claims being considered for purposes of determining 
eligibility for assignment under the Shared Savings Program than would 
otherwise occur.
(2) Proposals
    Section 17007 of the 21st Century Cures Act amended section 1899(c) 
of the Act (42 U.S.C. 1395jjj(c)) to require the Secretary to assign 
beneficiaries to ACOs participating in the Shared Savings Program based 
not only on their utilization of primary care services furnished by 
physicians but also on their utilization of services furnished by RHCs 
and FQHCs, effective for performance years beginning on or after 
January 1, 2019. The statute provides the Secretary with broad 
discretion to determine how to incorporate services provided by RHCs 
and FQHCs into the Shared Savings Program beneficiary assignment 
methodology.
    As explained in the proposed rule (82 FR 34108), we believe that 
the amendments to section 1899(c) made by 21st Century Cures Act enable 
us to revise the assignment methodology to address the concerns 
expressed by certain stakeholders regarding the burdens placed on ACOs 
that include RHCs and FQHCs as ACO participants. Accordingly, in 
implementing section 17007 of the 21st Century Cures Act, we indicated 
that we believe it would be appropriate to reduce operational burdens 
for ACOs that include RHCs or FQHCs as ACO participants and bring 
greater consistency to the operational method of using claims to assign 
beneficiaries to ACOs. To promote participation of RHCs and FQHCs under 
the Shared Savings Program, we proposed to remove the burdensome 
attestation requirement and instead treat a service reported on an RHC 
or FQHC institutional claim as a primary care service furnished by a 
primary care physician for purposes of the step-wise assignment 
methodology under 42 CFR part 425, subpart E described in the proposed 
rule (82 FR 34105 through 34106). Consistent with the 21st Century 
Cures Act, under this proposal: (1) The requirement for an attestation 
identifying physicians who directly provide primary care services in 
each RHC or FQHC that is an ACO participant and/or ACO provider/
supplier in the ACO would be removed; (2) all RHC and FQHC claims would 
be used to establish beneficiary eligibility to be assigned to the ACO; 
and (3) all RHC and FQHC claims would be included in step 1 of the 
stepwise assignment methodology. We noted that in considering all 
services billed under the TIN of the ACO participant RHC or FQHC, we 
would include services that do not meet the definition of primary care 
services, and such services would not be limited to those provided by a 
primary care physician, as defined under program rules. This means that 
under the proposal, a beneficiary could be furnished any service in an 
RHC or FQHC only by a nurse practitioner, physician assistant, clinical 
nurse specialist, or any other practitioner in the RHC or FQHC and 
still be eligible for assignment to the ACO in which the RHC or FQHC is 
participating.
    More specifically, we proposed the following changes to our 
regulations: (1) Remove Sec.  425.204(c)(5)(iii) in its entirety; (2) 
revise Sec.  425.404; and (3) make conforming changes to the definition 
of primary care physician found at Sec.  425.20. Under our proposal, 
for performance year 2019 and subsequent performance years, ACOs with 
ACO participants that are RHCs and FQHCs would no longer be required to 
submit NPIs or other identifying information for physicians who 
directly provide primary care services in the ACO participant RHCs and 
FQHCs as indicated in Sec.  425.204(c)(5)(iii)(A) and Sec.  425.404(a). 
Therefore, we proposed to remove Sec.  425.204(c)(5)(iii) in its 
entirety. Additionally, we proposed revisions to Sec.  425.404 to 
reflect that for performance year 2019 and subsequent performance 
years, we would assign beneficiaries to ACOs based on services 
furnished in RHCs or FQHCs consistent with the general assignment 
methodology in Sec.  425.402, by treating a service reported on an RHC 
or FQHC institutional claim in the same way as a primary care service 
performed by a primary care physician. We also proposed to remove 
revenue center codes from the definition of primary care services 
(Sec.  425.20) for performance year 2019 and subsequent performance 
years because all RHC and FQHC services will be used for purposes of 
assignment for benchmark and performance years; therefore, it is 
appropriate to modify our definition of primary care services for 
performance year 2019 and subsequent years to no longer include revenue 
center codes. Additionally, because the requirement for an attestation 
under Sec.  425.404 is also referenced in the definition of primary 
care physician in Sec.  425.20, we proposed to make a conforming 
revision to that definition to remove the reference to the attestation 
requirement for performance year 2019 and subsequent years.
    Consistent with how we have implemented other changes to the 
assignment methodology (see, for example, 80 FR 32757 through 32758), 
we proposed to adjust all ACO benchmarks at the start of the first 
performance year in which the new assignment rules are applied so that 
the ACO benchmarks reflect the use of the same assignment rules as will 
apply in the performance year. Also, consistent with how we have 
implemented previous changes to the Shared Savings Program assignment 
methodology, we would use the new methodology each time assignment is 
determined for purposes of performance year 2019, including using the 
new methodology in late CY 2018 to determine the eligibility of ACOs 
wishing to enter into or renew a participation agreement beginning 
January 1, 2019.
    We sought comments on these proposals. We also invited suggestions 
on how we might further support participation of RHCs and FQHCs in the 
Shared Savings Program.
    Comment: Nearly all commenters strongly supported the proposals, 
agreeing that the proposed revisions would decrease administrative 
burdens for ACOs that include RHCs and FQHCs as ACO participants. One 
commenter indicated support for the proposals only in situations where 
the plurality of services is provided by an RHC or FQHC. A few 
commenters appreciated the attempt to reduce burden for ACOs that 
include RHCs and FQHCs as ACO participants but expressed concerns that 
treating all RHC and FQHC claims as primary care services and/or 
including certain specialty services furnished by non-physician 
practitioners (NPPs) could result in unanticipated beneficiary 
assignment results. One of these commenters suggested instituting an 
optional attestation process in which RHCs/FQHCs and NPPs could 
voluntarily attest they furnish specialty services (and not primary 
care services) for purposes of beneficiary assignment and the 
exclusivity requirement under Sec.  425.306(b)(2).
    Response: We appreciate the supportive comments on these proposals. 
We believe these revisions to the assignment methodology will reduce

[[Page 53212]]

administrative burden for ACOs that include RHCs or FQHCs as ACO 
participants and support our policy goal of assigning beneficiaries to 
the entity that is primarily responsible for the beneficiary's overall 
care. Notably, section 1899(c) of the Act, as amended by section 17007 
of the 21st Century Cures Act, does not restrict the RHC and FQHC 
services that may be used in assignment for performance years beginning 
on or after January 1, 2019 to primary care services. Although most 
services provided by RHCs and FQHCs are primary care services, in view 
of the broad statutory reference in section 1899(c)(2) to RHC and FQHC 
``services,'' rather than ``primary care services,'' we believe it is 
appropriate to include all services furnished by RHCs or FQHCs to 
establish beneficiary eligibility to be assigned to an ACO and in the 
stepwise assignment methodology . We recognize the unique needs and 
challenges of rural and underserved communities and the key role played 
by providers and suppliers serving these communities in assuring access 
to health care. RHCs, FQHCs, and other providers furnishing care in 
rural and underserved communities play an important role in the 
nation's health care delivery system by serving as safety net providers 
of primary care and other health care services, and we believe these 
changes will enhance their ability to participate in the Shared Savings 
Program, while also helping to ensure that a beneficiary is assigned to 
an ACO when the ACO participants in that ACO are responsible for the 
beneficiary's overall care. We appreciate the additional suggestions on 
how to assess NPP claims and will continue to consider whether services 
provided in RHCs/FQHCs by NPPs who provide primary care should be 
treated differently for purposes of beneficiary assignment than those 
provided by NPPs who supplement or support specialty practices.
    We are finalizing the revisions to our assignment policies for 
services furnished in FQHCs and RHCs as proposed. Specifically, we are 
finalizing our proposals to: (1) Remove Sec.  425.204(c)(5)(iii) and 
modify Sec.  425.404 to eliminate the requirement, for performance year 
2019 and subsequent performance years, for ACOs that include an RHC or 
FQHC as an ACO participant to provide an attestation identifying 
physicians who directly provide primary care services in each RHC or 
FQHC that is an ACO participant and/or ACO provider/supplier in the 
ACO, and make conforming changes to the definition of primary care 
physician at Sec.  425.20; and (2) for performance year 2019 and 
subsequent performance years, to: (a) Treat a service reported on an 
RHC or FQHC claim as if it were a primary care service performed by a 
primary care physician under the assignment methodology in Sec.  
425.402, and (b) remove revenue center codes from the definition of 
primary care services.
b. Revisions to the Definition of Primary Care Services
(1) Background
    Except as discussed previously in this section of the final rule, 
for services furnished by RHCs and FQHCs for performance years 
beginning on or after January 1, 2019, section 1899(c) of the Act 
requires the Secretary to assign beneficiaries to an ACO ``based on 
their utilization of primary care services'' provided by a physician. 
We currently define primary care services for purposes of the Shared 
Savings Program in Sec.  425.20 as the set of services identified by 
the following HCPCS/CPT codes: 99201 through 99215, 99304 through 99318 
(excluding claims including the POS 31 modifier), 99319 through 99340, 
99341 through 99350, 99495, 99496, 99490, the Welcome to Medicare visit 
(G0402), and the annual wellness visits (G0438 and G0439). In addition, 
we have established a cross-walk for these codes to certain revenue 
center codes used by RHCs and FQHCs (for services furnished prior to 
January 1, 2011) so that their services can be included in the 
beneficiary assignment process. Lastly, we include G0463 for services 
furnished in electing teaching amendment (ETA) hospitals.
(2) Proposals
    In the proposed rule (82 FR 34110), we proposed to revise the 
definition of primary care services currently located in Sec.  425.20 
to include three additional CCM service codes 99487, 99489, and G0506, 
and four BHI service codes G0502, G0503, G0504 and G0507, beginning in 
2018 for performance year 2019 and subsequent performance years and to 
include these codes when performing beneficiary assignment under Sec.  
425.402. The three additional CCM codes reflect the changes in medical 
practice toward advanced primary care and differ from each other only 
in the amount of clinical staff service time provided; the complexity 
of medical decision-making as defined in the Evaluation and Management 
guidelines (determined by the problems addressed by the reporting 
practitioner during the month); and the nature of care planning that 
was performed (establishment or substantial revision of the care plan 
for complex CCM versus establishment, implementation, revision, or 
monitoring of the care plan for non-complex CCM). The BHI codes reflect 
important enhancements in primary care to support improvement and 
integration of care provided for patients receiving behavioral health 
treatment.
    In addition, we proposed to move the list of primary care service 
codes currently listed in the definition of ``primary care services'' 
in Sec.  425.20 to Sec.  425.400(c). We believe Sec.  425.400, which 
specifies general requirements related to the assignment methodology 
and currently contains a cross-reference at Sec.  425.400(c) to the 
definition of primary care services under Sec.  425.20, is the more 
appropriate place to specify the particular primary care codes that 
will be considered in the assignment methodology. We also proposed to 
reorganize the list of service codes, grouping HCPCS codes, G codes, 
and revenue center codes together, respectively, by relevant 
performance year(s). We sought comments on this proposal. In addition, 
we sought comments as to whether there are any additional existing 
HCPCS/CPT codes that we should consider adding to the definition of 
primary care services in future rulemaking for purposes of assignment 
of beneficiaries to ACOs under the Shared Savings Program. Finally, we 
also proposed to remove paragraph (3) from the definition of primary 
care services, rather than move it to Sec.  425.400(c) along with the 
other paragraphs making up the definition of primary care services. 
Paragraph (3) indicates that we will include additional codes 
designated by us as primary care services, including new HCPCS/CPT and 
revenue center codes and any subsequently modified or replacement codes 
for the HCPCS/CPT and revenue center codes identified in the 
definition. We explained that, because we always have the flexibility 
to propose these changes through rulemaking, this provision is 
unnecessary.
    Comment: Nearly all commenters strongly supported this proposal to 
add the specified CCM and BHI codes to the definition of primary care 
services. However, one commenter disagreed with the proposal to include 
CCM as a primary care service, stating that the value of CCM services 
is highly disputed in the ACO community and that CCM services are often 
provided by outside companies with little connection between the 
primary care provider and the beneficiary.
    Response: We appreciate the comments supporting our proposed

[[Page 53213]]

changes to the definition of primary care services. We respectfully 
disagree with the commenter who believes that value of CCM services is 
highly disputed in the ACO community, and note that other commenters, 
including ACOs and ACO stakeholders, expressed strong support for the 
proposal to add the CCM and BHI codes to the definition of primary care 
service. These CCM services are characteristic of the changes in 
medical practice toward advanced primary care, and, therefore, we 
believe that these services should be considered in determining where a 
beneficiary received the plurality of their primary care, and thus in 
determining whether an ACO should be responsible for the overall care 
of that beneficiary.
    Comment: A commenter encouraged CMS to continue to refine the 
primary care codes used in assignment ``in a timely manner as codes are 
finalized for inclusion in the PFS.'' One commenter recommended that 
CMS consider including the advance care planning codes, CPT codes 99497 
and 99498, in the definition of primary care services in future 
rulemaking.
    Response: We appreciate receiving thoughtful suggestions from 
stakeholders regarding our assignment methodology and will consider 
whether CPT codes 99497 and 99498 or any additional existing HCPCS/CPT 
codes should be added to the definition of primary care services in 
future rulemaking for purposes of assignment of beneficiaries to ACOs 
under the Shared Savings Program.
    Comment: One commenter recommended exclusion of the costs of new 
codes such as for CCM from the financial settlements of ACOs. The 
commenter requested that CMS establish a ``revenue neutral threshold 
for the existing codes at the time of the base determination'' so that 
billing CCM and other new patient centered care management codes would 
not impact the ACO's financial performance.
    Response: Section 1899(d)(1)(B) of the Act requires us to consider 
all expenditures for Part A and Part B services in determining an ACO's 
performance year expenditures. At this time, we are not persuaded by 
the commenter's suggestion for the need to adjust expenditures to 
account for CCM or other patient care management codes. As previously 
discussed in the June 2015 Shared Savings Program final rule (80 FR 
32794), we believe that adjusting benchmark and performance year 
expenditures for the effect of all policy changes, including coding 
changes, would create an inaccurate and inconsistent picture of ACO 
spending and may limit innovations in ACOs' redesign of care processes 
or cost reduction strategies. Therefore, we will continue to include 
the costs associated with all Parts A and B claims for assigned 
beneficiaries when determining an ACO's financial performance.
    We are finalizing the policies in this section as proposed, except 
for the minor corrections to Sec.  425.400(c)(1)(iii) and (iv) 
described below. Specifically, we are finalizing our proposals to: (1) 
Revise the definition of primary care services currently located in 
Sec.  425.20 to include three additional CCM service codes 99487, 
99489, and G0506, and four BHI service codes G0502, G0503, G0504 and 
G0507, beginning in 2018 for performance year 2019 and subsequent 
performance years and to include these codes when performing 
beneficiary assignment under Sec.  425.402; (2) move the list of 
primary care service codes currently included in the definition of 
primary care services in Sec.  425.20 to Sec.  425.400(c); (3) 
reorganize the list of service codes, grouping HCPCS codes, G codes, 
and revenue center codes together, respectively, by relevant 
performance year(s); and (4) remove paragraph (3) from the definition 
of primary care services at Sec.  425.20.
    Finally, we note that in the proposed rule, we made a typographical 
error in the proposed regulatory text for Sec.  425.400(c)(1)(iv). 
Consistent with the discussion in the preamble to the proposed rule, we 
had intended the listed primary care codes to apply not only ``for 
performance year 2019,'' but also for subsequent performance years.'' 
In addition, in the proposed regulatory text for Sec.  
425.400(c)(1)(iii), we inadvertently referenced ``performance year 2017 
and 2018'' rather than ``performance years 2017 and 2018.'' We are 
making these minor corrections in this final rule.
2. ACO Quality Reporting
a. Changes to the Quality Measure Set Used in Establishing the Quality 
Performance Standard
(1) Background
    Section 1899(b)(3)(A) of the Act requires the Secretary to 
determine appropriate measures to assess the quality of care furnished 
by ACOs, such as measures of clinical processes and outcomes; patient 
and, wherever practicable, caregiver experience of care; and 
utilization, such as rates of hospital admission for ambulatory 
sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to 
submit data in a form and manner specified by the Secretary on measures 
that the Secretary determines necessary for ACOs to report to evaluate 
the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act 
states that the Secretary shall establish quality performance standards 
to assess the quality of care furnished by ACOs and seek to improve the 
quality of care furnished by ACOs over time by specifying higher 
standards, new measures, or both. We designate the quality performance 
standard that will apply for each performance year. The quality 
performance standard is the overall standard the ACO must meet to be 
eligible for shared savings.
    In the November 2011 final rule (76 FR 67973), we initially 
established a quality performance standard consisting of 33 measures 
across 4 domains (see Sec.  425.502(d)), including patient experience 
of care, care coordination/patient safety, preventive health, and at-
risk population and a methodology for scoring the measures (see Sec.  
425.502(e)). Through the annual rulemaking for the PFS we have reviewed 
and updated the quality measures reported by ACOs, including adding new 
measures and retiring measures that had become redundant or no longer 
met the goals for group reporting, and ensuring that the quality 
measures reported by ACOs through the CMS Web Interface align with the 
measures reported through the CMS Web Interface by group practices in 
other CMS initiatives such as PQRS and the Quality Payment Program. The 
quality measure set currently includes 31 quality measures (see Tables 
42 and 43 at 81 FR 80488 and 80489). We refer readers to the 2018 PFS 
proposed rule for a detailed discussion of ACO quality reporting 
requirements and the process we follow under the Shared Savings Program 
to account for changes to the quality measure set used in establishing 
the quality performance standard (82 FR 34110 through 34111). To avoid 
confusion and duplication of rulemaking, and reduce provider burden, we 
also finalized a policy in the 2017 PFS final rule that future changes 
to the CMS Web Interface measures will be made through rulemaking for 
the Quality Payment Program and will be applicable to ACO quality 
reporting under the Shared Savings Program (81 FR 80499 and 80500). 
Lastly, we finalized a policy in the CY 2016 PFS final rule with 
comment period (80 FR 71269) under which we reserve the right to 
maintain a measure as pay-for-reporting or revert a pay-for-performance 
measure to pay-for-reporting when the measure owner determines the 
measure no longer aligns with clinical practice or continued 
application of the measure may result in patient harm (see Sec.  
425.502(a)(5)).

[[Page 53214]]

(2) Proposals
    As previously noted in the background section, we have a policy 
that future changes to the CMS Web Interface measures will be adopted 
through rulemaking for the Quality Payment Program and will be 
applicable to ACO quality reporting under the Shared Savings Program 
(81 FR 80501). We also note that, as discussed in the CY 2017 Quality 
Payment Program final rule with comment period (81 FR 77136), section 
1848(q)(2)(D)(i)(II) of the Act requires the Secretary to update the 
final list of quality measures from the previous year (and publish an 
updated list in the Federal Register) annually. Updates may include the 
removal of quality measures, the addition of new quality measures, and 
changes to existing quality measures that the Secretary determines have 
gone through substantive changes. In the CY 2017 Quality Payment 
Program final rule with comment period, we indicated that in the future 
we would use rulemaking for the MIPS program to address substantive 
changes to measures (81 FR 77143). On June 20, 2017, we issued a 
proposed rule that included proposals to revise certain policies under 
the Quality Payment Program for CY 2018, including a proposal to make 
substantive changes to several measures reported through the CMS Web 
Interface. For example, we proposed substantive changes to the way 
performance on ACO-17 Tobacco Use: Screening and Cessation Intervention 
is calculated via the CMS Web Interface (see Table E, 82 FR 30469). The 
proposed changes would simply revise the measure specifications to 
measure the percent of tobacco users that received cessation 
counseling; instead of measuring a combined performance rate for 
beneficiaries who were screened for tobacco use and for the subset of 
beneficiaries who are tobacco users that received tobacco cessation 
counseling. In addition, a substantive change was proposed to the 
Influenza Immunization measure (ACO-14); however, the changes would 
apply only to the Registry and EHR data submission methods and not the 
CMS Web Interface reporting method (82 FR 30472). Finally, a 
substantive change was proposed for the Body Mass Index Screening and 
Follow-Up Plan (ACO-16); specifically, we proposed that the frequency 
of documenting BMI would change from 6 to 12 months (82 FR 30471).
    Consistent with the way that we have addressed previous changes to 
measures, we reviewed the proposed substantive changes to the CMS Web 
Interface measures included in the CY 2018 Quality Payment Program 
proposed rule to assess whether the changes, if finalized, would 
warrant a change in how the measures are used to assess ACO performance 
under the Shared Savings Program. As part of this review, we considered 
whether the proposed substantive changes might raise sampling issues or 
require that we recalculate the measure benchmarks for purposes of the 
Shared Savings Program. Based on our review of the Quality Payment 
Program proposals and for the reasons discussed in the CY 2018 PFS 
proposed rule (82 FR 34112), we did not believe the proposed 
``substantive'' changes to the CMS Web Interface measures would require 
that we revert these measures to pay-for-reporting for the 2018 
performance year. Instead, we indicated that we believe it would be 
appropriate under the Shared Savings Program to: (1) Update the measure 
specifications through subregulatory guidance in order to continue to 
align the measures with the measure specifications used under the 
Quality Payment Program and the Million Hearts Initiative, and (2) 
retain the current phase-in schedule for the measures rather than 
redesignating any of the measures as pay-for-reporting.
    However, the statutory directive under the Quality Payment Program 
to address substantive changes to measures in rulemaking and the 
proposals in the CY 2018 Quality Payment Program proposed rule to 
address substantive changes to certain Web Interface measures caused us 
to evaluate what recourse we might have in the future under the Shared 
Savings Program rules to revert a measure to pay-for-reporting in 
instances where a substantive change to the measure makes it 
inappropriate to hold ACOs accountable for performance on that measure. 
We anticipate that there could be future substantive changes to the CMS 
Web Interface measures made under the Quality Payment Program that 
would give us reason to redesignate a measure as pay-for-reporting 
under the Shared Savings Program. Currently, although the Shared 
Savings Program rules afford flexibility to redesignate a measure as 
pay-for-reporting when the measure owner determines the measure no 
longer aligns with clinical practice or causes patient harm, there is 
no discretion to modify how we assess CMS Web Interface measures in the 
event substantive changes are made to those measures under the Quality 
Payment Program that make it inappropriate to hold ACOs accountable for 
performance on the measure. Given the timing of the Quality Payment 
Program proposals in relationship to the timing for when the quality 
performance benchmarks must be established under the Shared Savings 
Program, it may in some cases be necessary to have flexibility to 
designate a pay-for-performance measure as pay-for-reporting outside 
the formal rulemaking process just before or following the start of a 
performance year, consistent with the way in which we have redesignated 
measures in the past when measure owners have made changes after the 
start of a performance year. Accordingly, we believe it would be 
appropriate to modify the Shared Savings Program regulations to provide 
additional flexibility to address substantive changes to CMS Web 
Interface measures that are made under the Quality Payment Program and 
to continue to facilitate alignment of measures with the Quality 
Payment Program and other CMS initiatives.
    Therefore, we proposed to modify Sec.  425.502(a)(5) to include the 
right for CMS to redesignate a measure as pay-for-reporting when a 
substantive change to a CMS Web Interface measure is made under the 
Quality Payment Program that we determine warrants a change in how the 
measure is used to assess ACO performance for purposes of the Shared 
Savings Program. This revision would supplement CMS's existing 
discretion to redesignate a measure as pay-for-reporting when the 
measure owner determines the measure no longer aligns with clinical 
practice or causes patient harm. Specifically, we proposed to revise 
the regulation at Sec.  425.502(a)(5) to reserve CMS's right to 
redesignate CMS Web Interface measures that have undergone a 
substantive change as determined under the Quality Payment Program to 
pay-for-reporting status. Such measures would not necessarily be 
automatically redesignated as pay-for-reporting when a substantive 
change occurs (for example, as indicated previously, we do not believe 
the substantive changes proposed for 2018 present an impediment to 
holding ACOs accountable for performance on these measures in 
performance year 2018 and subsequent years); however, in the future, 
substantive changes made to CMS Web Interface measures under the 
Quality Payment Program (such as when the substantive change to a 
measure results in an issue with sampling, calculating performance, or 
calculating the quality benchmark) may make it inappropriate to hold an 
ACO accountable for performance on the measure for the time needed for 
CMS to obtain the information necessary to

[[Page 53215]]

calculate a quality benchmark for the substantively changed measure in 
advance of a performance year and/or until ACOs gain experience 
reporting the measure, as substantively changed. Although we expect to 
conduct at least a preliminary assessment of any substantive changes to 
the CMS Web Interface measures as part of the annual PFS rulemaking in 
order to determine whether any change to the phase in schedule for a 
measure is warranted, because we cannot always anticipate the types of 
substantive changes that may occur under the Quality Payment Program or 
the effect of those changes on our ability to calculate performance on 
the measure, we believed this proposal would provide us with additional 
flexibility to redesignate existing measures undergoing a substantive 
change as pay-for-reporting on a measure-by-measure basis. We invited 
comments on this proposal.
    Comment: We received relatively few comments on this proposal. 
Those that commented were nearly all supportive. One commenter 
supported the proposal, but cautioned CMS that the discretion to revert 
a measure to pay for reporting should only be exercised in rare and 
necessary circumstances with utmost transparency to the public. One 
commenter questioned why CMS is using pay-for-reporting when results-
based incentives help improve population health and requested a 
transparent and methodological process that would allow for industry 
review and sufficient time to make the related changes.
    Response: We appreciate the support for the proposal. Our intent is 
to revert measures to pay-for-reporting only in those rare 
circumstances where it is necessary to do so to assess ACO quality 
performance appropriately. Any use of this discretion will be done with 
utmost transparency to ACOs. We believe this additional flexibility 
will enable us to more appropriately assess ACO quality performance, by 
ensuring that ACOs are not held accountable for performance on a 
measure when substantive changes to that measure affect our ability to 
assess performance on that measure appropriately. Otherwise, ACOs could 
be inappropriately held accountable for performance on such measures 
until such time as we could undertake rulemaking to modify the pay-for-
performance status of the measure. During our evaluation of a measure 
change, we may determine methods to address that change so that ACOs 
can continue to be assessed on their performance on that measure. For 
instance, as described in the proposed rule, we evaluated the changes 
proposed to the Tobacco Use: Screening and Cessation Intervention in 
the CY 2018 QPP proposed rule, and concluded that we still would be 
able to use data reported on the measure to establish an appropriate 
benchmark that aligns with the updated specifications. As with 
redesignations that occur when the measure owner determines a measure 
no longer aligns with clinical practice or causes patient harm, 
redesignations that occur due to substantive changes to a measure will 
be communicated to ACOs as soon as possible through operational 
documents and other typical methods we use to communicate with ACOs.
    We are finalizing this amendment to our regulations as proposed. 
Specifically, we are modifying Sec.  425.502(a)(5) to include the right 
for us to redesignate a measure as pay-for-reporting when a substantive 
change to a CMS Web Interface measure that is used to assess quality 
performance for the Shared Savings Program is made under the Quality 
Payment Program.
b. Further Refining the Process Used To Validate ACO Quality Data 
Reporting
(1) Background
    In the November 2011 final rule, we adopted a regulation at Sec.  
425.500(e) under which we retained the right to audit and validate the 
quality measure data ACOs submit through the CMS Web Interface (76 FR 
67893 through 67894). Under this original validation process, we 
selected a subset of CMS Web Interface measures and a random sample of 
30 confirmed and completely reported beneficiaries for each measure in 
the subset. The ACO was required to provide medical records to support 
the data reported in the CMS Web Interface for those beneficiaries. A 
measure-specific audit performance rate was then calculated using a 
multi-phased audit process. If, at the conclusion of the third phase of 
the audit, there was a discrepancy greater than 10 percent between the 
quality data reported and the medical records provided during the 
audit, the ACO was not given credit for meeting the quality target for 
any measure(s) for which the mismatch rate existed.
    In the CY 2017 PFS final rule (81 FR 80489 through 80492), we 
revisited the Quality Measures Validation audit process and finalized 
four improvements to our audit process that addressed the number of 
records to be reviewed per measure, the number of audit phases, the 
calculation of an audit match rate, and the consequences if the audit 
match rate falls below 90 percent. Under the revised process, we will 
audit enough medical records to achieve a 90 percent confidence 
interval; conduct the audit in a single phase; and calculate an overall 
audit match rate. If at the conclusion of the audit process the overall 
match rate between the quality data reported and the medical records 
provided by the ACO is less than 90 percent, absent unusual 
circumstances, we will adjust the ACO's overall quality score 
proportional to the ACO's audit performance. The audit-adjusted quality 
score is calculated by multiplying the ACO's overall quality score by 
the ACO's overall audit match rate. For example, if an ACO's quality 
score is 75 percent and the ACO's audit match rate is 80 percent, the 
ACO's audit-adjusted quality score would be 60 percent. The audit-
adjusted quality score is the quality score that will be used to 
determine the percentage of any earned savings that the ACO may share 
or the percentage of any losses for which the ACO is accountable. Under 
the revised audit methodology, our intent was to continue to audit a 
subset of ACOs, which we would identify by looking for data anomalies 
such as high skip rates, although we retained the flexibility to 
randomly select ACOs or specific measures for audit as we have done in 
the past. We also finalized a new requirement at Sec.  425.500(e)(3) 
that an ACO that has an audit match rate of less than 90 percent may be 
required to submit a corrective action plan (CAP) under Sec.  425.216 
for our approval. In addition, we noted that we would maintain the 
right, as described in Sec.  425.500(f), to terminate or impose other 
sanctions on any ACO that does not report quality data accurately, 
completely, or timely. These new policies applied to quality validation 
audits beginning in 2017 with the audits of quality reporting for the 
2016 performance year.
(2) Proposals
    Since publication of the CY 2017 PFS final rule, we have gained 
additional experience with the Quality Measures Validation audits, and 
have performed additional analyses related to these audits. Our 
analysis of the 2016 Quality Measures Validation audit results for 
Shared Savings Program ACOs indicates that the average match rate of 
ACOs audited in calendar year 2016 was 72 percent and the median 
performance was 80 percent. Typically, during the audit, we review 
medical record documentation and work with ACOs to better understand 
the mismatch between what was reported and what was documented and have 
determined through our analyses that ACOs continue to experience 
challenges in understanding certain aspects of the

[[Page 53216]]

measure specifications, coordinating collection of information across 
many different providers and practices, and satisfying the requirements 
for supporting documentation. Many of these errors are not indicative 
of poor quality of care but rather reflect minor errors in process or 
in understanding measure requirements. For instance, we have identified 
errors by individuals abstracting data from the medical record. In one 
case, a medical record abstractor incorrectly misinterpreted the less 
than symbol (<) in the quality measure specifications for the ACO-31 
Heart Failure: Beta Blocker Therapy for Left Ventricular Systolic 
Dysfunction and ACO-33 Angiotensin-Converting Enzyme (ACE) Inhibitor or 
Angiotensin Receptor Blocker (ARB) Therapy, and therefore, abstracted 
the data incorrectly for reporting.
    Under our newly finalized single-phase approach to quality measure 
validation audits, minor errors are more likely to affect the final 
audit results and impact the calculation of shared savings or shared 
losses when the overall match rate is below 90 percent. Additionally, 
we note that the match rate threshold under the Hospital Inpatient 
Quality Reporting (HIQR) Program is 75 percent. The HIQR validates data 
submitted by hospitals, which are entities that generally have more 
experience with quality reporting, greater health record accessibility 
and integration, and a longer history of validation of quality data 
submitted to CMS.
    As we stated in the proposed rule, in light of our analyses of the 
2016 Quality Measures Validation audit results, we believe it is 
appropriate to consider making additional modifications to our Quality 
Measures Validation audit process. First, we are concerned that the 90 
percent match rate adopted in CY 2017 PFS final rule may be too high 
and could inappropriately penalize ACOs that make quality data 
reporting errors that are unrelated to care quality. In the early years 
of phasing in this new audit methodology, we believe that the match 
rate should instead be based on actual ACO experience in order to focus 
on holding ACOs accountable for clinically related mismatches in 
reporting quality measures as they continue to gain experience with how 
to measure, report and improve quality under the program. We believe 
that basing the audit match rate threshold on actual Quality Measures 
Validation audit results would strike an appropriate balance between 
ensuring the accuracy of ACO quality reporting while not unduly 
penalizing ACOs for minor quality reporting errors that are not 
necessarily indicative of poor quality of care. Accordingly, we believe 
it would be appropriate to set the audit match rate threshold based on 
the median match rate (80 percent) for ACOs audited in calendar year 
2016 rather than an alternative approach such as the mean match rate 
because the median match rate would be less affected by data outliers. 
Therefore, we proposed to revise Sec.  425.500(e)(2) to indicate that 
if an ACO has a match rate below 80 percent, absent unusual 
circumstances, we would adjust the ACO's overall quality score 
proportional to the ACO's audit performance.
    Second, we proposed to amend the method by which we adjust an ACO's 
overall quality score to reflect the ACO's audit performance. 
Specifically, we proposed to revise the methodology described in the 
2017 PFS final rule (81 FR 80490) under which the audit-adjusted 
quality score is calculated by multiplying the ACO's overall quality 
score by the ACO's audit match rate. Instead, we proposed that for each 
percentage point difference between the ACO's match rate and the match 
rate considered passing the audit, the ACO's overall quality score 
would be adjusted downward by 1 percent. That is, if we finalize the 
proposal to establish an 80 percent match rate as the threshold for 
passing the Quality Measures Validation audit, and the ACO's match rate 
is 75 percent, then under this proposal we would adjust the ACO's 
overall quality score downward by 5 percent. To illustrate, assuming a 
match rate threshold of 80 percent, an ACO with an overall quality 
score of 90 percent would have an audit-adjusted quality score of 85.50 
percent, that is, (90-[.05 x 90]) = 85.50.
    Finally, we proposed a conforming change to Sec.  425.500(e)(3) to 
reflect the 80 percent threshold such that if at the conclusion of the 
audit process CMS determines there is an audit match rate of less than 
80 percent, the ACO may be required to submit a CAP.
    We invited comment on the proposed refinements to the process used 
to validate ACO quality data reporting and to adjust an ACO's overall 
quality score to reflect the ACO's audit performance. We also sought 
comment on an alternative approach we considered to address the Quality 
Measures Validation audit match rate and the resulting impact on an 
ACO's overall quality score. Consistent with the approach used under 
the HIQR program, we considered revising Sec.  425.500(e)(2) to provide 
that we would adjust the ACO's overall quality score if an ACO has a 
match rate below 75 percent. We did not propose this approach because 
the median match rate for the Quality Measures Validation audits 
conducted in calendar year 2016 was 80 percent, suggesting that a match 
rate of 75 percent may be too low for ACOs.
    Comment: Nearly all commenters were supportive of our proposals to 
make additional modifications to our quality measure validation audit 
process. Commenters stated that the proposal to lower the threshold for 
passing the quality validation audit to an 80 percent match rate would 
be more in line with hospital quality reporting audit rates and would 
be more reasonable, given the current state of documentation in 
clinical records. A few commenters suggested that an audit match rate 
of no higher than 70 percent would be appropriate to ensure that only 
practices with true care quality issues would be targeted for an audit. 
One commenter stated that a match rate of 80 percent seems high for the 
first year given that the average match rate for the audit that 
occurred in CY 2016 was 72 percent. The commenter instead recommended a 
phased-in approach, for example, 75 percent in year 1, 77 percent in 
year 2 and 80 percent in year 3. One commenter disagreed with reducing 
the audit match rate, believing that reducing the match rate would 
reduce both the accuracy and integrity of ACO performance assessment.
    Response: We do not believe it would be necessary or appropriate to 
establish a match rate of less than 80 percent because the results of 
the Quality Measures Validation audits conducted on Shared Savings 
Program ACOs in calendar year 2016 yielded a median match rate of 80 
percent, suggesting that a lower match rate percent may be too low. The 
median match rate indicates that at least half of the audited ACOs 
achieved a match rate equal to or greater than 80 percent. We did not 
propose any changes to our methodology for identifying ACOs for audit, 
as stated earlier, we would identify ACOs for audit by looking for data 
anomalies such as high skip rates. Additionally we have retained the 
flexibility to randomly select ACOs or specific measures for audit. We 
also note that over time, we expect ACOs will become more experienced 
with the quality reporting requirements, improve their quality 
reporting processes and become better clinically integrated. In 
addition, because the audit process involves the exchange of 
information regarding medical record review and communication between 
ACOs and us, the audit process, itself, provides additional education 
on the quality measures and quality reporting. As a result, we expect 
that in the future, quality validation audit results that show a 
significant mismatch between

[[Page 53217]]

the information reported and the underlying medical records will more 
consistently reflect meaningful, clinically related quality reporting 
errors for which ACOs should be held accountable. Accordingly, we will 
periodically review the audit match threshold and seek to increase the 
match rate over time.
    Comment: A commenter requested that CMS institute rigorous 
independent validation and verification procedures to ensure accuracy 
and completeness of self-reported data. The commenter recommended that 
such validation should be conducted by third-party organizations in a 
manner similar to current requirements for Medicare Advantage plans and 
other government healthcare programs.
    Response: Since the inception of the Shared Savings Program, we 
have worked with an independent contractor to conduct the Quality 
Measures Validation audit. The organization currently contracted to 
conduct the audit is a CMS Quality Innovation Network-Quality 
Improvement Organization, and the individuals leading the audit from 
this organization have many years of experience doing medical record 
review and provide us with an independent assessment of the accuracy of 
the data entered into the CMS Web Interface by audited ACOs.
    Comment: We also received a number of additional suggestions about 
policies that were established in prior rulemaking. For example, a few 
commenters expressed concerns about the CMS policy to adjust an ACO's 
overall quality score based on the ACO's audit performance. One of 
these commenters believes CMS over-weights the measures reported 
through the CMS Web Interface to the detriment of CG-CAHPS and claims-
based measures. Another commenter believes that adjusting quality 
scores downward to reflect audit performance is unfair and provides no 
recourse for ACOs. A commenter suggested that further reductions in the 
earned quality score could be problematic given that a significant 
number of the existing measures require performance at or above 90 
percent in order to earn the maximum points available for the measure.
    Response: We thank the commenters for their thoughtful suggestions 
on possible ways we might further improve policies and/or operations 
related to the Quality Measures Validation audits and related 
adjustments to ACOs' overall quality scores. We will consider these 
issues further and may address these suggestions in future rulemaking 
and/or through guidance documents. We would emphasize, however, that we 
continue to believe it is appropriate to adjust an ACO's overall 
quality score based on the ACO's audit performance. The audit adjusted 
quality scores allow us to use more accurate information in the 
reconciliation of the ACO's performance for the prior year. The 
accuracy of an ACO's quality reporting is very important, as reflected 
in the requirement that ACOs completely and accurately report in order 
to be eligible to share in savings. We also continue to believe that 
the weights assigned to measures reported through the CMS Web Interface 
are appropriate relative to the weights assigned to CG-CAHPS and 
claims-based measures. The CMS Web Interface measures make up 
approximately one-half of the quality measure set and represent a 
number of clinically important concepts in the Preventive Health and 
At-Risk Population domains. The CAHPS for ACOs measures are used to 
calculate the Patient/Caregiver Experience domain and the claims-based 
measures are included in the Care Coordination/Patient Safety domain. 
Because the 4 measure domains that comprise the quality score are 
equally weighted, performance on the CMS Web Interface measures in the 
Preventive Health and At-Risk Population domains determines half of the 
ACO's overall quality score. Lastly, while many measures do require 
performance at or above 90 percent in order to earn the maximum points 
available for the measure, as one commenter pointed out, ACOs can earn 
points on measures as long as they perform at or above the minimum 
attainment level of 30 percent or the 30th percentile of the benchmark 
for the measure.
    Comment: A commenter requested a general estimate of the increase 
in the number of charts that will be required to attain a 90 percent 
confidence interval.
    Response: As described in the 2017 PFS final rule (81 FR 80489 
through 80492), we do not expect that more than 50 records would be 
requested per audited measure to achieve a high level of confidence 
that the audited sample is representative of the ACO's quality 
reporting performance. We are not seeking to increase the number of 
records that would need to be audited at this time.
    We are finalizing the policies for ACO Quality Measure Validation 
audits in this section as proposed. Specifically, we are finalizing our 
proposals to: (1) Revise Sec.  425.500(e)(2) to indicate that if an ACO 
has a match rate below 80 percent, absent unusual circumstances, we 
will adjust the ACO's overall quality score proportional to the ACO's 
audit performance; (2) revise the methodology used to calculate an 
ACO's audit-adjusted quality score to provide for a one percent 
reduction to the ACO's overall quality score for each percentage point 
difference between the ACO's audit match rate and the 80 percent match 
rate; and (3) making a conforming change to Sec.  425.500(e)(3) to 
reflect the 80 percent match rate.
3. Reducing Shared Savings Program Application Burden
a. SNF 3-Day Rule Waiver Application Requirement That ACOs Report Their 
Financial Relationships
(1) Background
    The Medicare SNF benefit is for beneficiaries who require a short-
term intensive stay in a SNF, requiring skilled nursing or skilled 
rehabilitation care, or both. Under section 1861(i) of the Act, 
beneficiaries must have a prior inpatient hospital stay of no fewer 
than 3 consecutive days in order to be eligible for Medicare coverage 
of inpatient SNF care. In the June 2015 final rule (80 FR 32804 through 
32806, 32808), we provided ACOs participating in Track 3 with 
additional flexibility to attempt to increase quality and decrease 
costs by allowing these ACOs to apply for a waiver of the SNF 3-day 
rule to permit their prospectively assigned beneficiaries to receive 
coverage for inpatient SNF care without a prior 3-day inpatient 
hospital stay when they are admitted to a ``SNF affiliate,'' that is, a 
SNF with which the ACO has executed a SNF affiliate agreement, and 
certain additional eligibility criteria are met (see Sec.  
425.612(a)(1)). All other provisions of the statute and regulations 
regarding Medicare Part A post-hospital extended care services continue 
to apply. To qualify to use the SNF 3-day rule waiver, ACOs must submit 
a SNF 3-Day Rule Waiver application that includes supplemental 
information sufficient to demonstrate that the ACO has the capacity to 
identify and manage beneficiaries who would be either directly admitted 
to a SNF or admitted to a SNF after an inpatient hospitalization of 
fewer than 3 days. Required application materials and other program 
rules are discussed in detail in the 2018 PFS proposed rule (82 FR 
34114 through 34115). We began accepting SNF 3-Day Rule Waiver 
applications in the summer of 2016 and approved 26 Track 3 ACOs to 
begin using the SNF 3-day rule waiver under the Shared Savings Program 
effective January 1, 2017.

[[Page 53218]]

(2) Proposal
    As discussed in the proposed rule, the SNF 3-day rule waiver 
requirements are primarily based on criteria previously developed under 
the Pioneer ACO Model. As explained in the proposed rule, as a result 
of our recent experience implementing the waiver in the Next Generation 
ACO Model and the Shared Savings Program, we believe that the rules 
governing use of the SNF 3-day rule waiver are generally reasonable. 
However, based on our initial experiences in reviewing SNF 3-Day Rule 
Waiver applications, we believe there are two requirements, in 
particular, that impose an unnecessary burden on applicants, without a 
sufficient benefit to the administration of the Shared Savings Program.
    First, the requirement under Sec.  425.612(a)(1)(i)(A)(4) that an 
ACO submit, as part of its application for the SNF 3-day rule waiver, a 
narrative describing any financial relationships that exist between the 
ACO, SNF affiliates, and acute care hospitals is burdensome for ACOs 
and CMS. As explained in the June 2015 final rule (81 FR 32806), the 
SNF 3-day rule waiver only provides for coverage of SNF services that 
meet all applicable requirements except the requirement for a prior 3-
day inpatient stay. The waiver does not protect financial or other 
arrangements between or among ACOs, ACO participants, ACOs providers/
suppliers, or other individuals or entities providing services to 
Medicare beneficiaries from liability under the fraud and abuse laws or 
any other applicable laws (Sec.  425.612(e)(1)). The Shared Savings 
Program regulations do not prohibit ACOs or SNFs from having financial 
arrangements with acute care hospitals, nor do they require such 
arrangements. Therefore, we have found that the narratives are not 
useful to us for purposes of determining whether to approve a waiver 
request. Based on our experience with the implementation of SNF 3-day 
rule waivers, we proposed to remove the requirement at Sec.  
425.612(a)(1)(i)(A)(4) under which an ACO applying for the SNF 3-day 
rule waiver must submit a narrative describing any financial 
relationships between the ACO, SNF affiliate, and acute care hospitals. 
Removing this requirement would not only reduce burden for ACOs 
applying for the waiver but would also enable us to devote our 
application review resources to a rigorous review of other, more 
relevant application elements. Focusing our resources on the review of 
the information that is most directly relevant to determining an ACO's 
capacity to manage beneficiaries who are admitted to a SNF without a 
prior 3-day inpatient hospital stay, along with ongoing oversight and 
program compliance monitoring of the use of the waiver by approved ACOs 
(as described in section III.G.3.a.(1) of the proposed rule) would also 
allow us to more efficiently use our resources to ensure that the SNF 
3-day rule waiver is being used appropriately and to address any 
potential concerns about use of the waiver. Although we do not believe 
it is necessary for ACOs to submit separate narratives describing their 
financial relationships for purposes of the SNF 3-day rule waiver, in 
the proposed rule we noted that under the Shared Savings Program 
regulations, ACOs, ACO participants, ACO providers/suppliers, and other 
individuals or entities performing functions or services related to ACO 
activities, including SNF affiliates, must maintain and give us access 
to certain documents and information related to items including 
financial arrangements related to ACO activities (Sec.  425.314(b)(1)). 
We also retain broad discretion under Sec.  425.316 to audit ACOs, ACO 
participants, and ACO providers/suppliers for compliance with program 
rules, and the program rules also make clear that waivers under Sec.  
425.612 do not protect financial or other arrangements between or among 
ACOs, ACO participants, ACO providers/suppliers, or other individuals 
or entities providing services to Medicare beneficiaries or otherwise 
limit liability under the fraud and abuse laws or any other applicable 
laws (Sec.  425.612(e)).
    Second, as explained in the proposed rule, we believe that the 
requirement under Sec.  425.612(a)(1)(i)(C) that an ACO submit 
documentation demonstrating that each SNF included on its list of SNF 
affiliates has an overall rating of 3 or higher under the CMS 5-star 
Quality Rating System is unnecessarily burdensome. In order to meet 
this requirement, ACOs typically submit a screen shot from the CMS 
Nursing Home Compare Web site or other Nursing Home Compare information 
that reflects the star rating for each listed SNF. The submission of 
this documentation by the ACO does not add value to our review and 
approval of SNFs included on the ACO's SNF affiliate list. Instead, we 
obtain the information directly from our CMS Nursing Home Compare Web 
site during the application review process. In this way, we ensure that 
the most current information is used during the application review 
process. We also periodically monitor this information after an ACO has 
been approved to use the waiver because SNF affiliates are required to 
maintain an overall rating of 3 stars or higher, under Sec.  
425.612(a)(1)(iii)(A). Because we can obtain the required information 
directly from the CMS Nursing Home Compare Web site, the additional 
documentation submitted by the ACO as part of its application does not 
add value to our ability to review and approve SNF affiliates. 
Accordingly, we proposed to eliminate this documentation submission 
requirement by removing Sec.  425.612(a)(1)(i)(C).
    We sought comments on our proposed changes to the application 
requirements for the SNF 3-day rule waiver. We also welcomed other 
suggestions on how we might further decrease the burden for ACOs 
requesting approval to use the SNF 3-day rule waiver, without 
compromising our ability to ensure that ACOs and their SNF affiliates 
have the capacity to identify and manage beneficiaries receiving 
covered SNF services pursuant to the waiver.
    Comment: Commenters uniformly supported these proposals. One 
commenter suggested eliminating the waiver application to reduce 
burden, and making the waiver available to all ACOs. A few commenters 
were supportive of the proposed changes to the waiver application but 
recommended that CMS ensure it has the resources to assess and monitor 
compliance with the requirement that SNF affiliates have and maintain 
at least a 3-star rating. One commenter encouraged CMS to reinforce in 
the final rule that the requirement for ACO SNF affiliates to have at 
least a 3-star rating is unchanged. In contrast, a few commenters 
recommended elimination of the requirement that SNF affiliates have and 
maintain at least a 3-star rating. For example, one commenter indicated 
that the requirement that SNF affiliates have and maintain at least a 
3-star rating may impede beneficiary access or require beneficiaries to 
receive care at a SNF facility that is a greater distance from their 
family than a closer SNF facility that does not have at least a 3-star 
rating. A few commenters had recommendations related to CMS' 
methodology for determining star ratings. For example, one commenter 
suggested that CMS examine the star rating system, generally, to ensure 
appropriate risk adjustment is incorporated into the scoring 
methodology.
    Response: We appreciate the comments in support of these proposals. 
As we stated in the June 2015 final rule (80 FR 32805), we believe 
incorporating the requirement that a SNF affiliate have

[[Page 53219]]

an overall rating of 3 or higher under the CMS 5-star Quality Rating 
System into the SNF 3-day rule waiver under the Shared Savings Program 
provides beneficiaries with evidence that the SNF affiliate provides 
quality care. As part of the application process, we intend to continue 
to verify that the ACO and its SNF affiliates meet all requirements 
related to the SNF 3-day rule waiver, but we believe that the 
burdensome and duplicative submission of CMS 5-star Quality Rating 
System documentation is not necessary to ensure compliance with the 
requirement that the ACO's SNF affiliates have a star rating of 3 or 
more. We emphasize that we are not removing or modifying the 
requirement in Sec.  425.612(a)(1)(iii)(A) that SNF affiliates must 
have and maintain an overall rating of 3 or higher under the CMS 5-star 
Quality Rating System to remain eligible to partner with an ACO for 
purposes of the SNF 3-day rule waiver; we retain the requirement for 
SNF affiliates to have and maintain a 3-star or higher rating. 
Suggested changes to the methodology that we use for scoring facilities 
on Nursing Home Compare are outside the scope of this final rule though 
we intend to share these comments with the appropriate component within 
CMS.
    Comment: We received several comments that did not directly address 
the proposals in this section but were more generally related to the 
SNF 3-day rule waiver. For example, one commenter expressed concerns 
that beneficiaries do not always know whether and when the ``standard'' 
SNF 3-day rule applies to them or if it has been waived because of 
their assignment to an eligible ACO.
    Response: We thank the commenters for their thoughtful suggestions 
on possible ways we might further improve policies and/or operations 
related to informing beneficiaries regarding the requirements for 
coverage of SNF services and any applicable waiver of the SNF 3-day 
rule. We will consider these issues further and may address these 
suggestions in future rulemaking and/or through guidance documents.
    We are finalizing the changes to the SNF 3-Day Rule waiver 
application procedures in this section as proposed. We are removing 
Sec.  425.612(a)(1)(i)(A)(4), which requires SNF 3-Day Rule Waiver 
applicants to submit a narrative describing any financial relationships 
that exist between the ACO, SNF affiliate, and acute care hospitals. We 
are also finalizing our proposal to remove Sec.  425.612(a)(1)(i)(C), 
which requires an ACO applying for the waiver to submit documentation 
demonstrating that each SNF affiliate on its SNF affiliate list has an 
overall rating of 3 or higher under the CMS 5-star Quality Rating 
System.
b. Modifications to the Shared Savings Program Initial Application
(1) Background
    In order to participate in the Shared Savings Program, 
organizations must meet certain eligibility requirements, including the 
statutory requirement to define processes to promote evidence-based 
medicine and patient engagement, report on quality and cost measures, 
and coordinate care. Additionally, the ACO must demonstrate it meets 
patient-centeredness criteria specified by the Secretary, such as the 
use of patient and caregiver assessments or the use of individualized 
care plans. We discussed and finalized details for ACO eligibility 
criteria, including the four required processes and patient-
centeredness criteria, in the November 2011 final rule (76 FR 67826 and 
67827) and made updates to them in the June 2015 final rule (80 FR 
32722 through 32725). Section 425.204(c)(1) articulates the supporting 
documents and materials an ACO must submit to demonstrate that the ACO 
satisfies the eligibility requirements to participate in the Shared 
Savings Program.
    To obtain a determination regarding whether an ACO meets the 
requirements to participate in the Shared Savings Program, a 
prospective ACO must submit a complete application in the form and 
manner required by us by the deadline established by us (Sec.  
425.202(a)(1)). The content of the application is outlined at Sec.  
425.204. Section 425.204(c) states that as part of the application, and 
upon request thereafter, an ACO must submit to us certain supporting 
documentation to demonstrate that the ACO satisfies the requirements of 
the Shared Savings Program. The supporting documentation required to be 
included in the application is discussed in detail in the proposed rule 
(82 FR 34116 through 34117).
    Once an applicant has submitted the information required under 
Sec.  425.204, we evaluate it to determine whether the applicant 
satisfies the Shared Savings Program requirements. We notify ACO 
applicants during the application review process when information is 
missing or when supplemental documentation or other information is 
necessary to make a determination on the ACO's application and provide 
opportunities for the ACO to submit the requested additional 
information for review. At the end of the application review process, 
we approve or deny the application and notify the ACO of our 
determination.
(2) Proposals
    In conducting Shared Savings Program application reviews, we have 
found that many of the document submission requirements in Sec.  
425.204(c)(1) substantially increase application and review burden 
without lending significant value to our review of an organization's 
application to confirm that the ACO meets the eligibility requirements 
for participation in the Shared Savings Program. We believe it would 
meet program needs and reduce applicant burden if we were to revise 
Sec.  425.204(c)(1) to remove the requirement to submit supporting 
documents or narratives and instead provide that we may request these 
materials if additional information is needed in order to fully assess 
the ACO's application before making a decision to approve or deny the 
application.
    To illustrate, as discussed in the proposed rule, we require under 
Sec.  425.204(c)(1)(ii), as part of the application process, that the 
ACO submit documentation addressing the required processes and patient 
centeredness criteria under Sec.  425.112. This requirement is 
addressed in the Medicare Shared Savings Program Initial Application 
through the requirement that an applicant ACO submit narratives 
describing how it will define, establish, implement, evaluate, and 
periodically update each process (see application on the CMS Web site 
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/for-acos/application-types-and-timeline.html). In 
these narratives, the ACO must also describe certain additional details 
regarding the required processes:
     Process to promote evidence-based medicine. The ACO must 
describe how it will:
    ++ Encourage the use of protocols grounded in evidence-based 
medicine in the case of diagnoses with significant potential for the 
ACO to achieve quality improvements, while taking into account the 
circumstances of individual beneficiaries; and
    ++ Use the internal assessments of this process to continuously 
improve the ACO's care practices.
     Process to promote beneficiary engagement. The ACO must 
describe how it will:
    ++ Evaluate the health needs of its assigned beneficiary population 
(including consideration of diversity in its patient population) and 
develop a

[[Page 53220]]

plan to address the needs of its population;
    ++ Communicate clinical knowledge/evidence-based medicine to 
beneficiaries in a way they can understand;
    ++ Engage beneficiaries in shared decision-making in ways that 
consider beneficiaries' unique needs, preferences, values and 
priorities;
    ++ Establish written standards for beneficiary access and 
communication as well as a process for beneficiaries to access their 
medical records; and
    ++ Use the internal assessments of this process to continuously 
improve the ACO's care practices.
     Process to internally report quality and cost metrics. The 
ACO must describe:
    ++ How the ACO will use these results to improve care and service 
over time; and
    ++ How the ACO will use the internal assessments of this process to 
continuously improve the ACO's care practices.
     Process to promote coordination of care. The ACO must 
describe:
    ++ The ACO's methods and processes to coordinate care throughout an 
episode of care and during care transitions, such as discharge from a 
hospital or transfer of care from a primary care physician to a 
specialist (both inside and outside the ACO).
    ++ The ACO's individualized care program, along with a sample 
individual care plan, and explain how the ACO uses this program to 
promote improved outcomes for, at a minimum, high-risk and multiple 
chronic-condition patients.
    ++ How individual care plans take into account the community 
resources available to beneficiaries.
    ++ Additional target populations that would benefit from 
individualized care plans.
    ++ How the ACO will use the internal assessments of this process to 
continuously improve the ACO's care practices.
    ++ How the ACO will encourage and promote use of enabling 
technologies for improving care coordination for beneficiaries.
    ++ How the ACO intends to partner with long-term and post-acute 
care providers, both inside and outside the ACO, to improve care 
coordination for its assigned beneficiaries.
    As we explained in the proposed rule, as a result of our experience 
in reviewing these narratives, we have determined that while they can 
be helpful to verify that the ACO has established the required 
processes and defined patient-centeredness criteria prior to its entry 
into the Shared Savings Program, the specific details of the processes 
the ACO has established are not particularly important or relevant for 
purposes of assessing whether the ACO is eligible to participate in the 
program. In fact, ACOs have indicated that their initial plans for the 
processes required under Sec.  425.112 as articulated in their program 
application often change as a result of obtaining additional 
information about their ACO participants' and ACO providers/suppliers' 
processes and gaining additional experience during implementation of 
the processes. We believe such improvements to ACO processes based on 
program experience are reasonable to expect and should be encouraged. 
First, under Sec.  425.112(b), ACOs are required to evaluate and 
periodically update each process and as they do so, initially 
implemented processes will necessarily change to accommodate lessons 
learned. Moreover, once the ACO begins to request claims information 
and other CMS data and to incorporate this information into its 
operations, the ACO may discover that certain assumptions it made at 
the time of application should be adjusted to maximally improve the 
quality of care or cost efficiencies for the ACO's assigned population. 
In rare instances, particularly in the early days of the program before 
stakeholders fully understood the implications of program 
participation, we found review of such narratives useful to understand 
the level of an ACO's readiness for participation in the Shared Savings 
Program. However, such narratives have not been particularly useful in 
determining if the ACO meets the requirements for participation in the 
Shared Savings Program. In a vast majority of cases, we now believe it 
is sufficient that the ACO certify at the time of application that it 
has defined the required processes and patient centeredness criteria 
consistent with the requirements specified in section Sec.  425.112. 
Therefore, we believe it would reduce burden for ACOs, without 
compromising our ability to determine whether an ACO meets the criteria 
for participation in the Shared Savings Program, to require that the 
ACO certify that it meets the requirements in Sec.  425.112, and only 
submit a narrative or other documentation describing how the ACO will 
implement the required processes and patient-centeredness criteria upon 
our request. Further, we do not anticipate that this change would have 
a significant effect on beneficiaries receiving services from ACO 
providers/suppliers because as noted earlier, we anticipate that ACOs 
would update each process as they gain experience and, as they do so, 
initially implemented processes that might have been reflected in the 
narrative or other supporting documentation submitted with their 
application would necessarily change to accommodate lessons learned.
    Similarly, as part of the application process, the Shared Savings 
Program regulations require the ACO to submit materials documenting the 
ACO's organization and management structure, including an 
organizational chart, a list of committees (including names of 
committee members) and their structures, and job descriptions for 
senior administrative and clinical leaders (Sec.  425.204(c)(1)(iii)). 
As we indicated in the proposed rule, we have found the organizational 
chart useful for purposes of evaluating if an ACO meets eligibility 
requirements, and anticipate continuing to request this chart from 
applicants; however, we have found that further detail including lists 
of committees and job descriptions for senior administrative and 
clinical leaders have not added particular value to our review and 
approval of applications. Moreover, the receipt of such materials as 
part of the ACO's application has not significantly impacted our 
ability to determine whether the ACO meets the requirements regarding 
leadership and management in Sec.  425.108. We believe, on balance, 
that our need for such detailed information from all applicants is 
outweighed by our desire to reduce application burden. In particular 
circumstances where additional information would aid our review, we 
believe our need for such detailed information can be reasonably met by 
requiring applicants to submit such materials upon our request. As a 
result, we believe it would be less burdensome for us to require ACO 
applicants to certify that, for example, they meet the leadership and 
management requirements found at Sec.  425.108 rather than requiring 
all ACO applicants to submit detailed materials (such as job 
descriptions) or narratives about the ACO's committees and leadership.
    While we do not anticipate having to routinely request such 
materials to supplement our review and approval of ACO applications to 
participate in the Shared Savings Program, we explained in the proposed 
rule that we believe it is important to retain the discretion to do so 
in limited cases where such detail could be useful. Therefore, we 
proposed to make revisions to our application requirements as discussed 
in the proposed rule (82 FR 34117 through 34120). We also noted that in 
cases

[[Page 53221]]

where an ACO is requested to submit additional material for review in 
conjunction with its application, and we find that the material is 
inconsistent with program requirements, then we may deny the ACO's 
application. Similarly, if we discover an inconsistency after the ACO 
has already been approved to participate in the program, the ACO may be 
subject to the pre-termination actions set forth in Sec.  425.216, 
termination under Sec.  425.218, or both.
    In the proposed rule, we also explained that we do not believe it 
is necessary for ACO applicants to submit narratives describing how 
they would distribute shared savings payments or how the proposed plan 
would achieve the specific goals of the Shared Savings Program and the 
general aims of better care for individuals, better health for 
populations, and lower growth in expenditures, as required by Sec.  
425.204(d). Based on our experience, such narratives have not been 
useful in determining if the ACO meets requirements for participation 
in the program or whether an ACO's application should be approved. We 
believe it would be more useful to us and less burdensome for ACOs if 
we were instead to require that, an ACO, as part of its application to 
participate in the Shared Savings Program, certify that it has a method 
and plan to receive shared savings payments and to distribute those 
payments to its ACO participants and ACO providers/suppliers, as 
required by the statute. We note, however, that we continue to believe 
it is useful to stakeholders to know how various ACOs have chosen to 
use or distribute the shared savings they earn. Therefore, we indicated 
that in the interest of transparency, we will continue to require ACOs 
to publicly report information on their dedicated Web pages about their 
shared savings and shared losses, including information about the total 
proportion of shared savings invested in infrastructure, redesigned 
care processes, and other resources to support the three-part aim goals 
of better health for populations, better care for individuals, and 
lower growth in expenditures, including the proportion distributed 
among ACO participants, as required under Sec.  425.308(b)(4).
    In light of our experience with the review of the documentation 
submitted as part of the ACO's initial application, we proposed several 
modifications to our requirements for document submission. We proposed 
to retain all requirements related to ACO eligibility criteria and 
public reporting, as currently specified under the Shared Savings 
Program regulations. However, to reduce application burden without 
compromising our ability to evaluate applications effectively for 
compliance with Shared Savings Program requirements, we proposed to 
modify certain sections of our regulations that require ACOs to submit 
supporting materials and documentation at the time of application. 
Instead of requiring submission of certain materials, narratives, or 
supporting documentation, we proposed to require ACOs to certify that 
they meet the applicable eligibility and documentation requirements as 
specified under our program rules. At the same time, we recognized that 
there have been instances when the review of supporting documentation 
and/or narratives has been helpful in making a determination about an 
ACO's eligibility for participation in the program. Therefore, although 
we proposed to eliminate the general requirement that ACOs submit 
certain documentation as part of their initial application to 
participate in the Shared Savings Program, we proposed to retain the 
right to request the submission of supporting materials and 
documentation in cases when such additional information would be useful 
in making a determination regarding the ACO's application. We indicated 
that we believe that this proposed modification to the regulations 
governing ACO applications would introduce additional flexibility that 
would reduce the level of burden inherent in the Shared Savings Program 
application process while also ensuring we are still able to 
appropriately evaluate an ACO's eligibility for program participation.
    Accordingly, in order to reduce application burden while retaining 
flexibility to obtain additional documentation when necessary to 
determine ACO eligibility and compliance with program rules, we 
proposed to remove the requirements in Sec. Sec.  425.204(c)(1) and 
(d), 425.112(a)(3)(i) and (ii), and 425.112(b)(4)(ii) for the 
submission of certain specified documents and narratives as part of an 
ACO's application to participate in the Shared Savings Program. 
Specifically, we proposed to revise Sec.  425.204(c)(1) to require an 
ACO, as part of its application, to certify that it satisfies the 
Shared Savings Program requirements and to submit, upon CMS request, 
supporting materials (including narratives) and documentation 
demonstrating that the ACO satisfies program requirements indicated in 
proposed revised Sec.  425.204(c). Additionally, we proposed to revise 
Sec.  425.204(d) to indicate that the ACO must certify, as part of its 
application to participate in the Shared Savings Program, that it has a 
mechanism and plan to receive and use payments for shared savings, 
including criteria for distributing shared savings among its ACO 
participants and ACO providers/suppliers. We also proposed to make a 
conforming change to remove paragraphs (d)(1) through (3) of Sec.  
425.204, which relate to the submission of narratives related to the 
ACO's use of shared savings payments. This proposal did not include a 
requirement that the ACO submit information regarding its mechanism and 
plan for receiving and using shared savings upon request. As explained 
in the proposed rule, we do not intend to request this information as 
part of the application process because in our experience, how an ACO 
intends to use or distribute shared savings has not been a relevant 
consideration during any application cycle to determine whether the ACO 
has met the eligibility requirements to participate in the Shared 
Savings Program. However, we noted that we continue to believe that 
information on how an ACO uses and distributes its shared savings is 
useful for the public, and therefore ACOs will continue to be required 
to publicly report this information under Sec.  425.308(b)(4)(ii).
    We also proposed similar changes to the requirements in Sec.  
425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove references to 
the submission of narratives to explain or describe how the ACO will 
implement the required elements of the ACO's care processes and 
patient-centeredness criteria. ACOs must still implement these care 
processes and adopt a focus on patient-centeredness; however, we 
proposed that they would no longer need to submit descriptions of how 
they will satisfy these requirements as part of their initial 
application. We noted, however, that ACOs may still be required to 
submit upon request a description or documentation sufficient to 
describe how the ACO will implement the required processes and patient-
centeredness criteria found at Sec.  425.112 because under the proposed 
revisions to Sec.  425.204(c)(1)(ii), CMS would retain the discretion 
to request such documentation from the ACO at any time.
    In summary, we stated that we believe these modifications to the 
application requirements will significantly reduce the burden of 
applying to participate in the Shared Savings Program without reducing 
our ability to ensure that applicants meet the established

[[Page 53222]]

eligibility requirements. Rather than requiring every applicant to 
submit detailed supporting documents or narratives for all of these 
requirements, we would instead request supporting documents or 
narratives only if additional information is needed in order to fully 
assess an ACO's application before making a decision to approve or deny 
the application. Further, we did not anticipate that the proposed 
modifications to our application requirements would have any effect on 
beneficiaries receiving care from providers and suppliers participating 
in the Shared Saving Program, nor did we believe that the proposed 
changes would affect our program integrity efforts, because we would 
retain discretion to request such information (and more targeted and 
appropriate information) as needed. We sought comment on these 
proposals and on additional ways to reduce burden in the application 
process.
    Comment: Commenters generally expressed widespread support for the 
proposals related to reducing application burden. However, a few 
commenters, including some beneficiary advocates, expressed significant 
concerns about the proposal to remove the requirement that ACOs submit 
documentation related to patient-centeredness as part of their 
applications, stating, for example: ``We believe that it is imperative 
that ACOs be held to the highest possible standard for patient-
centeredness.'' These commenters encouraged CMS to explore alternatives 
to reduce application burden. One of these commenters suggested that 
CMS require an ACO applicant to submit any existing care processes, 
along with a description of its capacity and strategy for evaluating 
and updating these processes. This commenter agreed that it is 
important for CMS to retain the right to request additional 
documentation at any time. Another commenter stated a belief that 
removing the application narratives ``violates the spirit of the MSSP 
ACO model'' and stated that the inclusion of such narratives in the 
application supports care improvement activities by emphasizing the 
importance of the applicant's planning and introspection about its care 
processes.
    Another commenter expressed concern that in the absence of the 
submission of narratives describing required processes and a rigorous 
evaluation by CMS, all health systems would be assessed solely based on 
cost savings and administration. The commenter was concerned that 
absent a requirement for ACOs to detail how they intend to implement 
the required processes, a world-class, integrated health care system 
would, on paper, look the same as a system that had not undertaken 
improvement activities. Similarly, another commenter noted, ``we are 
concerned that replacing the narrative with a certification may result 
in some program applicants simply checking the box to say that they 
have these processes which contain critical patient protections without 
actually considering whether the ACO is prepared to implement them in 
the context of the Shared Savings Program.''
    Response: We agree that ACOs should be held to the highest possible 
standard for patient-centeredness, however, we respectfully disagree 
that the requirement, as part of the application, to submit a narrative 
detailing the ACO's plans for developing patient-centered processes 
accomplishes this goal. We believe that other program elements, like 
the patient experience of care survey measures used to assess ACO 
quality performance and our internal monitoring of utilization, are 
better indicators of how well ACOs are meeting patient-centeredness 
criteria. We intend to continue assessing and monitoring ACO 
performance regarding patient-centeredness and the other required care 
processes. In addition, we note that under the proposed changes to the 
application requirements, which we are finalizing in this rule, we 
retain the flexibility to request submission of various narratives and 
documentation when this additional information is needed to fully 
assess the ACO's application. We will continue to consider whether 
review of certain narratives would help support Shared Savings Program 
goals, and will consider whether it would add value to our ACO 
application review process to request a more refined or targeted 
narrative related to patient-centeredness and the other required care 
processes.
    Comment: A commenter representing physician specialists raised 
concerns about the proposal to no longer require Shared Savings Program 
applicants to submit narratives describing how they would distribute 
shared savings payments. The commenter suggested that CMS should 
require ACOs to distribute shared savings to ACO providers/suppliers. 
Another commenter questioned how CMS would know if the ACO followed the 
plan it set forth if CMS no longer required the ACOs to provide details 
about how any shared savings would be distributed at the outset via 
their application.
    Response: We respectfully disagree with the commenters who believe 
it is necessary for Shared Savings Program applicants to continue to 
submit narratives describing how they would distribute shared savings 
payments in order to permit us to review and approve an ACO's 
eligibility to participate in the program. We believe it is appropriate 
for ACOs to continue to have the freedom to choose how to distribute or 
otherwise use any shared savings they earn, within the confines of the 
agreements they make with ACO participants and ACO providers/suppliers. 
Furthermore, we believe it is the responsibility of the parties signing 
those agreements to understand and enforce the terms of the agreement. 
We note, however, that we are maintaining the requirement for ACOs to 
publicly report on how they use and distribute their shared savings and 
we intend to continue to monitor ACO adherence to that requirement.
    We are finalizing the policies in this section as proposed. 
Specifically, we are finalizing our proposals to: (1) Remove the 
requirements in Sec. Sec.  425.204(c)(1) and (d), 425.112(a)(3)(i) and 
(ii), and 425.112(b)(4)(ii) for the submission of certain specified 
documents and narratives as part of an ACO's application to participate 
in the Shared Savings Program; (2) revise Sec.  425.204(d) to indicate 
that the ACO must certify, as part of its application to participate in 
the Shared Savings Program, that it has a mechanism and plan to receive 
and use payments for shared savings; (3) make a conforming change to 
remove paragraphs (d)(1) through (3) of Sec.  425.204, which relate to 
the submission of narratives related to the ACO's use of shared savings 
payments; and (4) make similar changes to the requirements in Sec.  
425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove references to 
the submission of narratives.
4. Addressing Compliance With ACO Participant TIN Exclusivity 
Requirement
a. Background
    Under the Shared Savings Program, ACO participant TINs are not 
required to be exclusive to one Shared Savings Program ACO unless the 
TIN submits claims for primary care services used to determine the 
ACO's assigned population (Sec.  425.306(b)). The purpose behind this 
requirement is to ensure that we are able to assign a unique set of 
beneficiaries to each ACO participating in the Shared Savings Program. 
Therefore, as part of the Shared Savings Program application process 
and upon an ACO's request to add an ACO participant TIN, we check the 
TIN against all other Shared Savings Program ACO participant lists. If 
the

[[Page 53223]]

TIN appears on the ACO participant list of one or more other ACOs, the 
TIN is considered to be ``overlapping.'' We then determine whether the 
overlap is permissible under our program rules. If the overlap is not 
permissible (because the TIN has a history of billing for primary care 
services used in our assignment methodology) then we require the ACO 
that is seeking to add the TIN to its ACO participant list to rectify 
the overlap by the deadline we have established for making changes to 
the next performance year's ACO participant list. If the overlap is 
permissible (because the TIN does not have a history of billing for 
primary care services used in our assignment methodology) then the ACO 
participant TIN can be approved to be an ACO participant in more than 
one ACO for the performance year. Each time we run the assignment 
algorithm during the course of the performance year, we monitor 
overlaps to ensure that the overlaps continue to be in compliance with 
Sec.  425.306(b).
    In a few instances, we have discovered that ACO participant TINs 
that have been approved to participate in multiple ACOs subsequently 
began billing for primary care services used in assignment during a 
benchmark or performance year. Although our program rules permit us to 
take compliance action against ACOs for violations of Shared Savings 
Program requirements, they do not specifically address what compliance 
actions we would impose on ACOs in instances where an ACO participant 
falls out of compliance with the requirement in Sec.  425.306(b)(2) 
that an ACO participant TIN that submits claims for primary care 
services used in assignment be exclusive to a single ACO during a 
benchmark or performance year, or when non-compliance with this 
requirement is discovered during the 3-month claims runout for a 
benchmark or performance year. Moreover, the program rules do not 
address what modifications to our assignment methodology could be made 
to account for this overlap.
    We believe it is important for ACOs, ACO participants, and ACO 
providers/suppliers to have updated and accurate information regarding 
their participation status in the Shared Savings Program. For example, 
participation in a Shared Savings Program ACO has implications for ACO 
providers/suppliers under the new Quality Payment Program (see 81 FR 
80496 through 80501). The Quality Payment Program replaces a patchwork 
system of Medicare programs with a flexible system that allows eligible 
clinicians to choose from two paths that link payments to quality: MIPS 
and participation in Advanced APMs. The Quality Payment Program, 
through MIPS and the APM incentive, will impact eligible clinicians' 
payments beginning in payment year 2019 based on 2017 reporting.
    Under the CY 2017 Quality Payment Program final rule with comment 
period, eligible clinicians participating in Advanced APMs (including 
Tracks 2 and 3 under the Shared Savings Program) may become Qualifying 
APM Participants and receive a 5 percent APM Incentive Payment if they 
have a sufficient percentage of payments for Part B covered 
professional services, or a sufficient percentage of Medicare patients 
that are attributable to services furnished through an Advanced APM for 
a given performance year. In addition to earning a 5 percent APM 
Incentive Payment, Qualifying APM Participants are not subject to the 
MIPS reporting requirements and payment adjustment for a given 
performance year. As a result, revisions to ACO participant lists that 
occur mid-year or following the end of a benchmark or performance year 
could have widespread implications not only for the ACO, but also for 
its ACO providers/suppliers under the Quality Payment Program.
b. Proposals
    As participation in the Shared Savings Program grows and more ACOs 
and ACO participants join the program, we believe overlapping TINs are 
likely to become more common. We also believe that changes to our 
program rules regarding the claims that will be considered in assigning 
FFS beneficiaries to an ACO (specifically, the policy finalized in the 
June 2015 final rule to exclude services furnished by several physician 
specialty types from the assignment methodology) may result in a 
greater number of permissible ACO participant TIN overlaps (see 80 FR 
32753 and 32754). As a result, we anticipate there could also be an 
increased number of cases where ACO participant TINs with initially 
permissible overlaps could become out of compliance with the 
requirement at Sec.  425.306(b)(2) that an ACO participant TIN be 
exclusive to a single Shared Savings Program ACO if the TIN bills for 
primary care services that are used to assign beneficiaries to the ACO. 
This could occur, for example, if a group practice that initially 
includes only physician specialty types whose services are excluded 
from the assignment methodology were to subsequently employ a non-
physician practitioner who bills for primary care services. We believe 
these types of practice arrangements are becoming increasingly common.
    Therefore, as we stated in the proposed rule, we believe it is 
necessary to streamline our approach to handling such situations in 
order to reduce the burden and uncertainty for ACOs when changes in ACO 
participant billing practices result in an ACO participant falling out 
of compliance with the exclusivity requirement at Sec.  425.306(b)(2). 
Rather than the current policy under which an ACO may be required to 
remove an overlapping ACO participant and recertify its ACO participant 
list for the performance year (thus necessitating redetermination of 
beneficiary assignment and delays in or revisions to benchmark or 
performance year calculations), we believe it would be less disruptive 
for ACOs if we were to permit overlapping TINs that begin billing for 
services used in assignment during a benchmark or performance year 
(including claims for services furnished during the benchmark of 
performance year, but submitted during the 3-month claims runout) to 
remain on the ACO participant lists for all affected ACOs for the 
remainder of the performance year in which we determine that an overlap 
exists. For example, assume that, based on an analysis of claims for 
services furnished in performance year 2018, we were to identify an 
impermissible overlapping TIN in January 2019 after the ACO participant 
lists for performance year 2019 had already been certified. Under this 
proposal, the TIN would be able to remain on the ACO participant lists 
of all affected ACOs for the 2018 performance year as well as the 
remainder of performance year 2019. To ensure that an overlapping TIN 
is not inadvertently used in the assignment algorithm for multiple ACOs 
when determining where a beneficiary received the plurality of primary 
care services, which could result in assignment of the same beneficiary 
to multiple ACOs, we proposed to simply exclude any claims for services 
furnished by the overlapping TIN from the assignment methodology when 
conducting final beneficiary assignment for any benchmark or 
performance year in which the TIN bills Medicare for services used in 
our assignment methodology. The affected ACOs would be required to 
resolve the overlap prior to recertification of their ACO participant 
lists for the subsequent performance year. If the overlap remains 
unresolved when the ACOs certify their ACO participant lists for the 
next

[[Page 53224]]

performance year, we would remove the TIN from the ACO participant 
lists of all ACOs seeking to include the TIN, in accordance with our 
current policy for resolving overlaps. For example, in the hypothetical 
case above, if the overlap were to remain unresolved when the ACOs 
certify their ACO participant lists for performance year 2020, we would 
remove the TIN from the ACO participant lists for all ACOs seeking to 
include the TIN as an ACO participant for performance year 2020.
    Therefore, we proposed to modify our program rules in Sec.  425.306 
and subpart E of part 425 to address this issue. We proposed to modify 
Sec.  425.306(b) to indicate that if, during a benchmark or performance 
year (including the 3-month claims run out period for such benchmark or 
performance year), an ACO participant that participates in more than 
one ACO begins billing for services that would be used in assignment, 
we would not consider any services billed through that TIN when 
performing beneficiary assignment for the applicable benchmark or 
performance year. We also proposed to eliminate the reference to 
``primary care'' in Sec.  425.306(b)(2) when describing the services 
used to determine the ACO's assigned beneficiary population to conform 
with our proposal to implement section 17007 of the 21st Century Cures 
Act under which we would consider all services furnished in RHCs and 
FQHCs in the assignment methodology starting in the 2019 performance 
year. In addition, the ACOs in which the overlapping TIN is an ACO 
participant may be subject to compliance action (as provided under 
Sec.  425.216) or termination under Sec.  425.218. Compliance actions 
may include requiring each ACO that includes the TIN as an ACO 
participant to submit a corrective action plan explaining how the ACO 
plans to work with the overlapping ACO participant to resolve the 
overlap for the next performance year. If the overlap remains 
unresolved by the date specified by us in our request for a corrective 
action plan, we would remove the overlapping ACO participant TIN from 
the ACO participant list of each ACO for the subsequent performance 
year.
    We also proposed to revise our general assignment methodology at 
Sec.  425.400(a)(1) to add new paragraph (a)(1)(iii) to indicate that 
when we determine final assignment after the end of each benchmark or 
performance year, we will exclude claims for services furnished during 
the benchmark or performance year by an ACO participant that 
participates in more than one ACO. We stated that we believe that this 
policy will ensure a uniquely assigned beneficiary population for each 
ACO and prevent the same beneficiaries from being included in 
determining benchmark or performance year expenditures for more than 
one ACO.
    Comment: Commenters were nearly all supportive of our proposed 
changes to our policies for addressing situations in which an 
overlapping ACO participant TIN begins billing for services that are 
used in beneficiary assignment during a benchmark or performance year. 
However, some commenters stated that our proposal to exclude all claims 
for services furnished by an overlapping ACO participant from the 
assignment methodology was overbroad and that such exclusions should be 
limited to instances in which there is a significant overlap. For 
example, one commenter recommended that CMS only exclude a TIN if the 
primary care services are billed over an extended period, for example, 
for more than one-half of the performance year.
    Response: We appreciate receiving the comments in support of this 
proposal and the other thoughtful comments. We do not believe it would 
be appropriate to exclude a TIN only if the services used in assignment 
are billed during more than one-half of the performance year or if the 
overlap is otherwise significant. Such approaches would not ensure a 
uniquely assigned beneficiary population for each ACO and, therefore, 
the same beneficiaries could inappropriately be included in determining 
benchmark or performance year expenditures for more than one ACO.
    Based on a review of the comments, we believe that finalization of 
the proposed policies will ensure that we are able to continue to 
assign a unique set of beneficiaries to each ACO participating in the 
Shared Savings Program and avoid making duplicate shared savings 
payments for ACOs with TINs that participate in more than one ACO, 
while preserving the flexibility that is currently extended to ACO 
participants that do not bill for services used in assignment, and 
recognizing the possibility for mid-year changes in care and billing 
practices by these ACO participants. We believe that implementing the 
proposed changes to our process for addressing ACO participant overlaps 
will improve ACO and ACO participant understanding of our policies and 
requirements regarding ACO participant exclusivity, while also reducing 
burden for ACOs that currently must recertify their ACO participant 
lists and may be subject to retrospective modifications or delays in 
assignment and other related benchmark or performance year 
calculations. Additionally, for purposes of the Quality Payment 
Program, ACO participant TINs and the eligible clinicians that bill 
through those TINs will have greater certainty regarding whether they 
qualify as participating in an APM or Advanced APM for a performance 
year. Under the proposed policy, which we are finalizing, an ACO 
participant will know for the entire performance year with certainty 
that it is participating in a particular APM (or Advanced APM) entity.
    Comment: A commenter suggested that CMS alert ACOs when there is a 
provider or supplier identified as participating in more than one ACO 
so that both ACOs and the affected provider/supplier have an 
opportunity to correct the issue.
    Response: Each time we run the assignment algorithm during the 
performance year, we monitor overlaps to ensure that the overlaps 
continue to be in compliance with Sec.  425.306(b). We notify 
stakeholders when overlaps occur and require them to make appropriate 
corrections. Additionally, ACO participant list information is made 
publicly available at https://data.cms.gov. ACOs can use the Medicare 
Shared Savings Program ACO Participants data sets to identify allowable 
overlaps annually. The data sets also allow an ACO to verify whether 
TINs joining their ACO have the same legal business name as a TIN 
already participating in an ACO.
    Comment: A few commenters expressed general concerns regarding the 
assignment process as it relates to services furnished by specialists.
    Response: While these comments were beyond the scope of the 
proposed rule, we expect to continue to consider and refine the claims-
based assignment process over time, and will take into consideration 
the important role played by specialty practices when assessing any 
potential changes to our assignment methodology.
    We are finalizing the proposed changes to our policies for 
addressing compliance with the ACO participant TIN exclusivity 
requirement as proposed. Specifically, we are finalizing our proposals 
to: (1) Modify Sec.  425.306(b) to indicate that if, during a benchmark 
or performance year (including the 3-month claims run out period for 
such benchmark or performance year), an ACO participant that 
participates in more than one ACO begins billing for services that 
would be used in assignment, we would not consider any services billed 
through that TIN when performing beneficiary assignment for the 
applicable benchmark or

[[Page 53225]]

performance year; (2) eliminate the reference to ``primary care'' in 
Sec.  425.306(b)(2) when describing the services used to determine the 
ACO's assigned beneficiary population; and (3) revise our general 
assignment methodology at Sec.  425.400(a)(1) to add new paragraph 
(a)(1)(iii) to indicate that when we determine final assignment after 
the end of each benchmark or performance year, we will exclude claims 
for services furnished during the benchmark or performance year by an 
ACO participant that participates in more than one ACO.
5. Treatment of Individually Beneficiary Identifiable Payments Made 
Under a Demonstration, Pilot, or Time Limited Program
a. Background
    Under section 1899(d) of Act, ACOs participating in the Shared 
Savings Program are accountable for the total Parts A and B costs for 
the Medicare FFS beneficiaries assigned to the ACO. Therefore, in 
addition to Medicare Parts A and B claims, we include non-claims based 
individually beneficiary identifiable payments made from the Medicare 
Trust Funds when performing financial calculations for the Shared 
Savings Program, including establishing, adjusting, and updating 
financial benchmarks and calculating performance year expenditures. We 
internally track these non-claims based beneficiary identifiable 
payments through a separate CMS system that receives and stores these 
non-claims based payments made from the Medicare Trust Funds under a 
demonstration, pilot or time limited program.
    To date, when we perform ACO benchmarking and financial 
calculations under the Shared Savings Program, we have included (in 
addition to all Medicare Parts A and B claims) all non-claims based 
individually beneficiary identifiable payments for the applicable 
benchmark or performance year that are included in the separate CMS 
system, including any payments made during the 3-month claims run-out 
period for the benchmark or performance year. This means that to date 
we have included in the calculation of historical benchmarks and 
performance year expenditures some interim payments made under a 
demonstration, pilot, or time limited program that will be subject to 
subsequent reconciliation to determine the final payment amount. 
However, because the various demonstrations, pilots, or time limited 
programs may have different operational schedules from the Shared 
Savings Program, it is not possible for us to include all interim and 
final beneficiary identifiable payments made under these initiatives in 
benchmarking and financial reconciliation calculations for the Shared 
Savings Program; and, as a result, these calculations have excluded 
some interim and final non-claims based beneficiary identifiable 
payments made under certain demonstrations, pilots, or time limited 
programs. For example, because of the timing and availability of BPCI 
non-claims based payment amounts, to date we have included only up to 
two quarters of interim payment data for BPCI in ACO benchmarking and 
financial reconciliation calculations for the Shared Savings Program 
and no final payment amounts.
    To date, non-claims based individually beneficiary identifiable 
payments represent a relatively minor proportion of an ACO's total Part 
A and B beneficiary expenditure amounts as determined under the Shared 
Savings Program (mean of 0.09 percent overall impact of ACO non-claims 
based payments on total per capita expenditures and a mean of 137 
person-years in an ACO's assigned beneficiary population with a non-
claims based payment during the year; minimum -0.72 percent, 0 person-
years; maximum 1.24 percent, 1,865 person-years). For the 
demonstrations, pilots, or time limited programs that include interim 
and final reconciliations, the impact of including the non-claims based 
payments could be positive or negative for an ACO for a given 
performance year. Additionally, a preliminary analysis suggests that 
interim payments made under select demonstrations, pilots, or time 
limited programs fluctuate on a quarterly basis. We refer the reader to 
the proposed rule (82 FR 34122 through 34123) for further details about 
the results of this analysis.
    Fluctuations in the non-claims based payments for certain 
initiatives, such as BPCI, have generated stakeholder concern. Further, 
stakeholders note that the impact of including interim payments in 
financial calculations may become greater in the future, given the 
increasingly widespread interest in participation in alternative 
payment models and the growing number of such models being tested 
through the CMS Innovation Center. Stakeholders have therefore 
suggested that we should revise our policies to clarify that only final 
non-claims based payments made within the 3 months claims run out 
period under a demonstration, pilot, or time limited program will be 
included in the calculation of an ACO's benchmark and performance year 
expenditures.
b. Proposals
    Our preliminary analysis, as discussed in the background section, 
suggests that interim non-claims based payments (that is, payments that 
are subject to reconciliation at a later date) made under a 
demonstration, pilot, or time limited program can fluctuate 
significantly from quarter to quarter and may not reflect the actual 
final reconciled payment amount. Thus, as we stated in the proposed 
rule, we agree with the stakeholders who have suggested that only final 
non-claims based payments made under a demonstration, pilot, or time 
limited program should be included in financial calculations related to 
benchmarks and performance year expenditures under the Shared Savings 
Program. We believe this would be a reasonable approach to determining 
Parts A and B expenditures for assigned beneficiaries for both 
benchmark and performance years given the uncertain impact of including 
interim payments that are subject to further reconciliation on 
financial calculations for the Shared Savings Program. We also agree 
that use of interim payments made under a demonstration, pilot, or time 
limited program could have an increasingly large effect on ACO 
benchmarks and performance year expenditure calculations in the future 
given widespread stakeholder interest in participating in alternative 
payment models and CMS interest in testing and expanding additional 
payment models that may lead to higher quality and more coordinated 
care at a lower cost to Medicare.
    Therefore, we proposed to modify our regulations at Sec. Sec.  
425.602(a)(1)(ii), 425.603(c)(1)(ii), and 425.603(e)(2)(ii) to add new 
provisions to indicate that, (1) when establishing benchmarks for 
agreement periods beginning before 2018, we will include all 
individually beneficiary identifiable payments, including interim 
payments, made under a demonstration, pilot, or time limited program, 
(2) for agreement periods beginning in 2018 and subsequent years, we 
would only include individually beneficiary identifiable payments made 
under a demonstration, pilot, or time limited program that are final 
and not subject to further reconciliation, and (3) for the 2018 
performance year and subsequent performance years in agreement periods 
beginning in 2015, 2016, and 2017, the benchmark would be adjusted to 
reflect only individually beneficiary identifiable final payments made 
under

[[Page 53226]]

a demonstration, pilot, or time limited program. Additionally, we 
proposed to add new Sec. Sec.  425.604(a)(6)(ii)(A), 
425.606(a)(6)(ii)(A) and 425.610(a)(6)(ii)(A) indicating that when 
calculating expenditures for performance years before 2018, we will 
include all individually beneficiary identifiable payments, including 
interim payments, made under a demonstration, pilot, or time limited 
program. We also proposed to add new Sec. Sec.  425.604(a)(6)(ii)(B), 
425.606(a)(6)(ii)(B) and 425.610(a)(6)(ii)(B) indicating that when 
calculating expenditures for performance year 2018 and subsequent 
performance years, we would only include individually beneficiary 
identifiable payments made under a demonstration, pilot, or time 
limited program that are final and not subject to further 
reconciliation. To be consistent with our treatment of claims-based 
payments, such final payments would have to be available in the 
separate CMS system by the end of the 3-month claims run out period.
    We invited comments on this proposal.
    Comment: We received few comments on this proposal. Those that 
commented were supportive, agreeing that the proposed approach would 
appropriately help reduce fluctuations in payment amounts from quarter 
to quarter. A few commenters suggested that interim payments provide a 
``signal to final payments.'' In lieu of removing interim payments from 
our financial calculations, these commenters requested that CMS 
indicate the amounts of interim and final beneficiary identifiable 
payments made under demonstrations, pilots or other time-limited 
programs in the ACO financial reports.
    Response: We appreciate the comments in support of this proposal. 
We continue to believe that our proposal to include only final payments 
made under a demonstration, pilot or time limited program is a 
reasonable approach to determining Parts A and B expenditures for 
assigned beneficiaries for both benchmark and performance years given 
the uncertain impact on ACOs' financial calculations of including 
interim payments that will be subsequently revised to reflect the final 
reconciled payment amounts. We are exploring improvements to feedback 
reports and data files provided to ACOs to increase program 
transparency. We appreciate the suggestions regarding including 
payments under a demonstration, pilot, or time limited program in the 
financial reports, and we will take them under advisement as we work to 
further refine the reports.
    We are finalizing the policies in this section as proposed, with 
the exception of a minor revision to Sec.  425.603(e)(2)(ii)(C) to 
address a technical error that was made in the proposed rule. In the 
proposed rule, we inadvertently included a reference to the benchmark 
in the proposed regulatory text for this provision. However, Sec.  
425.603(e) establishes the policies for determining risk adjusted 
county fee-for-service expenditures, which are used in calculating an 
ACO's regional fee-for-service expenditures. In this final rule, we are 
revising the language at Sec.  425.603(e)(2)(ii)(C) to correct this 
reference.
I. Value-Based Payment Modifier and Physician Feedback Program
1. Overview
    Section 1848(p) of the Act requires the establishment of a value-
based payment modifier (VM) that applies to specific physicians and 
groups of physicians the Secretary determines appropriate starting 
January 1, 2015, and to all physicians and groups of physicians by 
January 1, 2017. On or after January 1, 2017, section 1848(p)(7) of the 
Act provides the Secretary discretion to apply the VM to eligible 
professionals (EPs) as defined in section 1848(k)(3)(B) of the Act. 
Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral. 
The VM and Physician Feedback programs continue our initiative to 
recognize and reward clinicians based on the quality and cost of care 
provided to their patients, increase the transparency of health care 
quality information and to assist clinicians and beneficiaries in 
improving medical decision-making and health care delivery. As stated 
in the CY 2016 PFS final rule with comment period (80 FR 71277), the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 
114-10) was enacted on April 16, 2015. Under section 1848(p)(4)(B)(iii) 
of the Act, as amended by section 101(b)(3) of MACRA, the VM shall not 
be applied to payments for items and services furnished on or after 
January 1, 2019. Section 1848(q) of the Act, as added by section 101(c) 
of MACRA, establishes the Merit-based Incentive Payment System (MIPS) 
that shall apply to payments for items and services furnished on or 
after January 1, 2019.
2. Overview of Existing Policies for the VM
    In the CY 2013 PFS final rule with comment period, we discussed the 
goals of the VM and also established that specific principles should 
govern the implementation of the VM (77 FR 69307). We refer readers to 
that rule for a detailed discussion. In the CY 2013 PFS final rule with 
comment period (77 FR 69310), we also finalized policies to phase-in 
the VM by applying it beginning January 1, 2015, to Medicare PFS 
payments to physicians in groups of 100 or more EPs. A summary of the 
existing policies that we finalized for the CY 2015 VM can be found in 
the CY 2014 PFS proposed rule (78 FR 43486 through 43488). 
Subsequently, in the CY 2014 PFS final rule with comment period (78 FR 
74765 through 74787), we finalized policies to continue the phase-in of 
the VM by applying it starting January 1, 2016, to payments under the 
Medicare PFS for physicians in groups of 10 or more EPs. Then, in the 
CY 2015 PFS final rule with comment period (79 FR 67931 through 67966), 
we finalized policies to complete the phase-in of the VM by applying it 
starting January 1, 2017, to payments under the Medicare PFS for 
physicians in groups of 2 or more EPs and to physician solo 
practitioners. In the CY 2016 PFS final rule with comment period (80 FR 
71277 through 71279), we finalized that in the CY 2018 payment 
adjustment period, the VM will apply to non-physician EPs who are 
physician assistants (PAs), nurse practitioners (NPs), clinical nurse 
specialists (CNSs), and certified registered nurse anesthetists (CRNAs) 
in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are 
solo practitioners.
    In the CY 2016 PFS final rule with comment period (80 FR 71280), we 
adopted a two-category approach for the CY 2018 VM based on 
participation in the PQRS by groups and solo practitioners. For the 
purposes of the CY 2018 VM, Category 1 includes the following groups 
and solo practitioners:
    (1) Groups that meet the criteria to avoid the CY 2018 PQRS payment 
adjustment as a group practice participating in the PQRS GPRO;
    (2) Groups that have at least 50 percent of the group's EPs meet 
the criteria to avoid the PQRS payment adjustment for CY 2018 as 
individuals;
    (3) Solo practitioners that meet the criteria to avoid the CY 2018 
PQRS payment adjustment as individuals; and
    (4) Groups and solo practitioners that meet the criteria to avoid 
the CY 2018 PQRS payment adjustment through participation in a Shared 
Savings Program ACO, if the ACO in which they participate successfully 
reports quality data as required by the Shared Savings Program.

[[Page 53227]]

    Category 2 includes those groups and solo practitioners that are 
subject to the CY 2018 VM payment adjustment and do not fall within 
Category 1. Groups in Category 1 have been eligible to receive upward, 
neutral, or downward adjustments under our quality-tiering methodology, 
and groups and solo practitioners in Category 2 receive an automatic 
downward adjustment under the VM.
    In the CY 2016 PFS final rule with comment period (80 FR 71288 to 
71291), we finalized that we will apply the following adjustments to 
payments, for items and services furnished under the Medicare PFS in CY 
2018, to physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or 
more EPs and at least one physician:
     Negative 4 percent (-4.0 percent) for those that fall into 
Category 2.
     Negative 4 percent (-4.0 percent) under the quality-
tiering methodology for those in Category 1 that are classified as low 
quality/high cost and negative 2 percent (-2.0 percent) for those 
classified as either low quality/average cost or average quality/high 
cost.
     An upward adjustment of four times an adjustment factor 
(+4.0x) under the quality-tiering methodology for those in Category 1 
that are classified as high quality/low cost and two times an 
adjustment factor (+2.0x) for those classified as either average 
quality/low cost or high quality/average cost.
    We finalized that we would apply the following adjustments to 
payments, for items and services furnished under the Medicare PFS in CY 
2018, to physician solo practitioners and physicians, PAs, NPs, CNSs, 
and CRNAs in groups with 2 to 9 EPs and at least one physician:
     Negative 2 percent (-2.0 percent) to those that fall into 
Category 2.
     Negative 2 percent (-2.0 percent) under the quality 
tiering methodology for those in Category 1 that are classified as low 
quality/high cost and negative 1 percent (-1.0 percent) for those 
classified as either low quality/average cost or average quality/high 
cost.
     An upward adjustment of two times an adjustment factor 
(+2.0x) under the quality-tiering methodology for those in Category 1 
that are classified as high quality/low cost and one times an 
adjustment factor (+1.0x) for those classified as either average 
quality/low cost or high quality/average cost.
    We finalized that we would apply the following adjustments to 
payments, for items and services furnished under the Medicare PFS in CY 
2018, to non-physician solo practitioners who are PAs, NPs, CNSs, and 
CRNAs and to PAs, NPs, CNSs, and CRNAs in groups comprised solely of 
non-physician EPs:
     Negative 2 percent (-2.0 percent) for those who fall in 
Category 2.
     No downward adjustments under the quality-tiering 
methodology for those in Category 1 in CY 2018.
     An upward adjustment of two times an adjustment factor 
(+2x) under the quality-tiering methodology for those in Category 1 
that are classified as high quality/low cost and one times an 
adjustment factor (+1.0x) for those classified as either average 
quality/low cost or high quality/average cost.
    In the CY 2017 PFS final rule with comment period (81 FR 80520-
80524), we finalized the following, with regard to Medicare Shared 
Savings Program ACO participant TINs whose ACO did not successfully 
report quality data on behalf of its EPs for purposes of PQRS as 
required by the Shared Savings Program under Sec.  425.504 for the CY 
2017 and CY 2018 PQRS payment adjustments:
     For the CY 2017 VM payment adjustment period, we will use 
the data reported to the PQRS by the EPs under the ACO participant TIN 
(as a group or as individuals) outside of the ACO during the secondary 
PQRS reporting period in 2016 to determine whether the TIN would fall 
in Category 1 or Category 2 under the VM.
     We will apply the two-category approach finalized for the 
CY 2017 VM based on participation in the PQRS by groups and solo 
practitioners to determine whether groups and solo practitioners that 
participate in a Shared Savings Program ACO, but report to the PQRS 
outside of the ACO, would fall in Category 1 or Category 2 under the 
VM.
     We will assess the individual EP or group's 2016 data 
submitted outside the ACO and during the secondary PQRS reporting 
period against the reporting requirements for the CY 2018 PQRS payment 
adjustment.
3. Provisions of This Final Rule
    As a general summary, we proposed the following modifications to 
the VM policies for the CY 2018 payment adjustment period:
     Reduce the automatic downward adjustment for groups and 
solo practitioners in Category 2 (those who do not meet the criteria to 
avoid the 2018 PQRS payment adjustment as individual solo 
practitioners, as a group practice, or groups that have at least 50 
percent of the group's EPs meet the criteria as individuals) to 
negative 2 percent (-2.0 percent) for groups with 10 or more EPs and at 
least one physician, and negative 1 percent (-1.0 percent) for groups 
with between 2 to 9 EPs, physician solo practitioners, and for groups 
and solo practitioners that consist only of non-physician EPs.
     Hold all groups and solo practitioners who are in Category 
1 (those who meet the criteria to avoid the 2018 PQRS payment 
adjustment as individual solo practitioners, as a group practice, or 
groups that have at least 50 percent of the group's EPs meet the 
criteria as individuals) harmless from downward payment adjustments 
under quality tiering for the last year of the program.
     To provide a smoother transition to the MIPS and to align 
incentives across all groups and solo practitioners, reduce the maximum 
upward adjustment under the quality-tiering methodology to two times an 
adjustment factor (+2.0x) for groups with 10 or more EPs. This is the 
same maximum upward adjustment under the quality-tiering methodology 
that we finalized and will maintain for groups with between 2 to 9 EPs, 
physician solo practitioners, and for groups and solo practitioners 
that consist only of non-physician EPs.
a. Approach to Setting the VM Adjustment Based on PQRS Participation
    As noted in this final rule, under section 1848(p)(4)(B)(iii) of 
the Act, as amended by section 101(b)(3) of MACRA, the VM shall not be 
applied to payments for items and services furnished on or after 
January 1, 2019. Section 1848(q) of the Act, as added by section 101(c) 
of MACRA, establishes the MIPS that shall apply to payments for items 
and services furnished on or after January 1, 2019. In the interest of 
program alignment and providing a smooth transition between the VM and 
MIPS, as well as aligning with the changes to the policies for 
satisfactory reporting under the final year of PQRS, modifications to 
the CY 2018 VM payment adjustments are described in section III.F. of 
this final rule.
    We did not propose any changes to the policies finalized in the CY 
2016 PFS final rule with comment period (80 FR 71280) for determining 
whether a group or solo practitioner is considered to be Category 1 or 
Category 2 for purposes of the CY 2018 VM. Specifically, we did not 
propose any change to our existing policy that TINs that avoid the 
downward payment adjustment under PQRS (either as a group practice 
participating in the PQRS GPRO or through the individual participation 
of at least 50 percent of the group's EPs, or as a solo practitioner) 
will be considered Category 1 under the VM. These TINs therefore will 
avoid an automatic downward adjustment under the VM.

[[Page 53228]]

b. Payment Adjustment Amount
    We proposed modifications to the VM policies for the CY 2018 
payment adjustment period. As discussed in greater detail below, we 
proposed these modifications based on our general policy goals of 
better alignment and ensuring a smooth transition from the final year 
of the VM (2018) to the first year of MIPS (2019) as well as continuing 
to align the VM with the policies established for the PQRS.
    As stated in the proposed rule (82 FR 34126), to maintain stability 
in the payment adjustment amounts applicable under the VM as we 
transition to the MIPS in 2019, we previously established that we will 
maintain generally the same VM payment adjustment amounts from the CY 
2017 payment adjustment period to the CY 2018 payment adjustment period 
(80 FR 71288 through 71291). Under our existing policy (80 FR 71290), 
the estimated funds derived from the application of the downward 
adjustments to groups and solo practitioners in Category 1 and Category 
2 are available to all groups and solo practitioners eligible for 
upward adjustments under the VM. The upward payment adjustment factor 
(the ``x'' factor) is determined after the performance period has ended 
based on the aggregate amount of downward payment adjustments. As noted 
in the proposed rule (82 FR 34126), despite our efforts to ensure a 
smooth transition from the VM to the MIPS, the 2017 VM adjustment 
factor has resulted in payment adjustments for some groups and solo 
practitioners that are significantly higher than the maximum upward 
adjustment under the MIPS, which will apply to payments starting in 
2019, after the sunset of the VM in 2018. The magnitude of the 2017 VM 
adjustment factor is due in large part to the number of physician 
practices failing to satisfy the criteria to avoid the PQRS payment 
adjustment (Category 2). Furthermore, we believe it is likely that many 
physician practices that fail to meet these criteria and as a result 
are in Category 2 and are subject to automatic downward adjustments 
under the 2018 VM will be excluded from MIPS in 2019, due to the low-
volume threshold. In a MIPS final rule with comment period, we 
estimated that 53 to 57 percent of Medicare clinicians are expected to 
be excluded from MIPS because they are: (1) A qualifying Alternative 
Payment Model participant; (2) an ineligible clinician type; (3) 
meeting the low-volume threshold; or (4) a newly enrolled clinician (81 
FR 77517).
    The 2017 VM adjustment factor is 15.48 percent, which is similar to 
the 2016 VM adjustment factor of 15.92 percent. We would expect, absent 
any policy change, that the 2018 VM adjustment factor would be similar 
or higher. The 2018 VM adjustment factor could potentially be higher 
than the 2017 VM adjustment factor, because non-physician EPs who will 
be subject to the 2018 VM may be less familiar with quality reporting 
and may fail to meet the criteria to avoid the CY 2018 PQRS payment 
adjustment, which would result in a greater number of groups and solo 
practitioners in Category 2. In addition, groups with 2-9 EPs and solo 
practitioner physicians will no longer be held harmless from downward 
adjustments under the quality-tiering methodology in the CY 2018 
payment adjustment period.
    In section III.F. of this final rule, we are finalizing changes to 
certain policies for the 2018 PQRS payment adjustment. We discuss the 
implications of these changes for PQRS with regard to the VM in greater 
detail below.
     Quality-Tiering for groups and solo practitioners in 
Category 1: As noted in section III.F. of this final rule, we proposed 
and are finalizing a change to the reporting criteria for the 2018 PQRS 
payment adjustment. Specifically, we are finalizing our proposal to 
lower the number of measures required and to eliminate the requirement 
for reporting across a number of domains. In the proposed rule, we 
acknowledged that some groups and solo practitioners may have reported 
differently under PQRS, had the proposed PQRS reporting criteria been 
established prior to the reporting period. For example, it is possible 
that groups and solo practitioners may have selected fewer or different 
PQRS measures to report or may have chosen to report through a 
different PQRS reporting mechanism, which could have resulted in a 
higher quality composite score under the VM. Based on these potential 
implications for the VM, we proposed to hold all groups and solo 
practitioners in Category 1 harmless from downward adjustments under 
the quality-tiering methodology in the CY 2018 payment adjustment 
period. This proposal would apply to groups and solo practitioners who 
would have otherwise received downward adjustments based on their 
quality composite score, their cost composite score, or both. The 
reason we proposed to include groups and solo practitioners that would 
otherwise have been subject to a downward adjustment based on their 
cost composite score was that a group or solo practitioner that is 
classified as ``high cost'' based on their cost composite score 
potentially could have reported differently under the PQRS and received 
a quality composite score that would be classified as ``high quality,'' 
if the PQRS reporting criteria proposed in section III.F. of the 
proposed rule had been established prior to the reporting period. A 
high quality/high cost classification would have resulted in a neutral 
adjustment under the VM in 2018.
    In contrast to the existing policy for 2018 where only non-
physician solo practitioners and groups comprised solely of non-
physician EPs would be held harmless from downward adjustments under 
quality-tiering, our proposed policy would mean that all groups and 
solo practitioners that meet the criteria to avoid the 2018 PQRS 
payment adjustment would receive either a neutral or upward adjustment 
based on performance.
    The following is a summary of the public comments received on our 
proposal and our responses:
    Comment: The majority of the commenters supported our proposal. A 
few of the commenters who did not support the proposal stated that they 
believe it would make a retroactive change to existing policy. They 
stated that changes to the program's previously-finalized policies 
would penalize clinicians who fully participated in the program and 
reward those who did not. Other commenters that did not support the 
proposal stated that we should hold all practices that reported at 
least one measure harmless from downward adjustments under the VM or 
that the VM payment adjustment should be zero for all practices.
    Response: We appreciate the commenters' support of our proposal. As 
noted in section III.F. of this final rule, we are finalizing a change 
to the reporting criteria for the 2018 PQRS payment adjustment. We 
believe that our proposed policy would minimize the impact on groups 
and solo practitioners who may have reported differently under PQRS if 
the PQRS reporting criteria had been established prior to the reporting 
period. For the commenters' who did not support the proposal, we note 
that because the statute requires the VM to be implemented in a budget 
neutral manner, the total amount of upward adjustments is based on the 
total amount of downward adjustments. We do not believe it would be 
appropriate to further reduce the available funds for upward 
adjustments by further reducing downward adjustments. We require groups 
and solo practitioners to report quality data to accurately assess 
their performance, and we believe that we

[[Page 53229]]

have set the automatic downward payment adjustment under the VM, as 
discussed later in this section, at a level that reflects the 
importance of participating in the quality reporting process. In 
general, the automatic downward VM payment adjustment is applied in 
addition to the PQRS payment adjustment for groups and solo 
practitioners that do not meet quality reporting criteria to avoid the 
PQRS payment adjustment. Historically the majority of available funds 
for upward adjustments has come from automatic downward adjustments to 
those groups and solo practitioners that fall into Category 2 (those 
who did not meet the quality reporting criteria to avoid the PQRS 
payment adjustment), not from downward adjustments under the quality-
tiering methodology for groups in Category 1 (those who met the quality 
reporting criteria to avoid the PQRS payment adjustment). Based on this 
historical data, we do not have reason to believe this proposal would 
significantly disadvantage groups and solo practitioners who met the 
previously-established PQRS reporting requirements. Additionally, in 
the proposed rule (82 FR 34184), we stated that the preliminary 
estimates indicate that the implementation of all of the proposed 
policies for the CY 2018 VM would reduce the adjustment factor to below 
10 percent. At this level, we believe that the potential upward VM 
payment adjustments we are finalizing for Category 1 groups and solo 
practitioners and the automatic downward payment adjustments we are 
finalizing for Category 2 groups and solo practitioners would still 
provide sufficient recognition and significant payment impact for these 
practices' 2016 quality reporting and performance; therefore, we would 
not want to further reduce the potential upward VM payment adjustments 
by further reducing the amount of the automatic downward payment 
adjustments.
    Furthermore, if we eliminated the downward adjustments for Category 
2 groups and solo practitioners, in addition to finalizing the policy 
to hold all groups and solo practitioners in Category 1 harmless from 
downward adjustments under the quality-tiering methodology in the CY 
2018 payment adjustment period, then there would be no funds available 
for upward adjustments for the high-performing groups and solo 
practitioners.
    Accordingly, we are finalizing as proposed the policy to hold all 
groups and solo practitioners in Category 1 harmless from downward 
adjustments under the quality-tiering methodology in the CY 2018 
payment adjustment period.
    We also proposed to reduce the maximum upward adjustment under the 
quality-tiering methodology in CY 2018 from four times an adjustment 
factor (+4.0x) to two times an adjustment factor (+2.0x) for those 
classified as high quality/low cost and from two times an adjustment 
factor (+2.0x) to one times an adjustment factor (+1.0x), for those 
classified as either average quality/low cost or high quality/average 
cost. This policy would align the upward adjustments for groups with 
ten or more eligible professionals with the existing policy for smaller 
groups and solo practitioners, as well as groups comprised solely of 
non-physician EPs (80 FR 71290). We proposed this change based on our 
concern that the 2018 VM adjustment factor (the ``x'' factor used to 
determine upward adjustments) could potentially be higher than the 2017 
VM adjustment factor, as discussed previously. Lowering the maximum 
upward adjustment in 2018 would mitigate the effect of a high 
adjustment factor and ensure a smoother transition from the VM 
adjustment in 2018 to the MIPS adjustment in 2019. We welcomed public 
comment on this proposal.
    The following is a summary of the public comments received on our 
proposal and our responses:
    Comment: Most commenters supported our proposal. The few commenters 
who did not support the proposal stated that high-performing group 
practices should not have a reduction in their potential upward payment 
adjustment. Some of these commenters further stated that the proposal 
unfairly penalizes high-performing group practices who complied with 
the regulatory requirements and helps those who chose not to comply, 
and one recommended that CMS find an alternative method to ensure that 
high-performing group practices are fairly rewarded.
    Response: We thank the commenters for their support of our 
proposal. We also acknowledge the fairness concerns raised by those 
commenters who did not support the proposal. Our intention in proposing 
this policy was not to penalize groups that had high performance based 
on the previously finalized policy, but as discussed in the proposed 
rule, we were concerned that the 2018 VM adjustment factor could 
potentially be higher than the 2017 VM adjustment factor. This could 
result in a high upward payment adjustment under the VM in 2018 
followed by a significantly lower payment adjustment under MIPS in 
2019. We believe that finalizing this proposal would have the intended 
consequence of lowering the maximum upward adjustment in 2018 as a 
result of a lower adjustment factor and thus ensuring a smoother 
transition from the VM adjustment in 2018 to the positive MIPS 
adjustments in 2019. Therefore, we are finalizing as proposed the 
policy to reduce the maximum upward adjustment under the quality-
tiering methodology in CY 2018 for groups of physicians with 10 or more 
EPs from four times an adjustment factor (+4.0x) to two times an 
adjustment factor (+2.0x) for those classified as high quality/low cost 
and from two times an adjustment factor (+2.0x) to one times an 
adjustment factor (+1.0x), for those classified as either average 
quality/low cost or high quality/average cost. As stated in the 
proposed rule (82 FR 34184), preliminary estimates indicate that the 
implementation of all of the proposed policies for the CY 2018 VM would 
reduce the adjustment factor to below 10 percent. At this level, we 
believe that the final upward adjustments under quality-tiering for 
high-performing groups of physicians with 10 or more EPs would continue 
to reward them appropriately and align their adjustments at the same 
level as groups of physicians with 2 to 9 EPs, physician solo 
practitioners, and groups and solo practitioners consisting of non-
physician EPs only, in addition to ensuring a smoother transition from 
the VM adjustment in 2018 to the MIPS adjustment in 2019.
    Table 23 displays the final 2018 VM adjustments under the quality-
tiering methodology, for groups and solo practitioners in Category 1. 
Under the final policies, groups of any size and composition would be 
subject to the same upward adjustments under quality tiering and would 
be held harmless from any downward adjustments based on performance.

[[Page 53230]]



 Table 23--Final CY 2018 VM Amounts Under the Quality-Tiering Approach for Physicians, PAs, NPs, CNSs, and CRNAs
                           Who Are Solo Practitioners and Those in Groups of Any Size
----------------------------------------------------------------------------------------------------------------
                                                                    Low quality       Average
                          Cost/quality                                  (%)           quality      High  quality
----------------------------------------------------------------------------------------------------------------
Low cost........................................................            +0.0         +1.0x *         +2.0x *
Average cost....................................................            +0.0           +0.0%         +1.0x *
High cost.......................................................            +0.0           +0.0%           +0.0%
----------------------------------------------------------------------------------------------------------------
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their
  average beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where `x' represents
  the upward payment adjustment factor.

    Tables 24 through 26 illustrate how the final policies differ from 
the previously-finalized policies for each group size and composition.

 Table 24--Previous and Final CY 2018 VM Amounts Under the Quality-Tiering Approach for Physicians, NPs, PAs, CNSs, & CRNAs in Groups of Physicians With
                                                                         10+ EPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Cost/quality                                  Low quality                   Average quality                  High quality
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  VM payment adjustment                    Previous  (%)    Final  (%)       Previous          Final         Previous          Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low Cost................................................            +0.0            +0.0         +2.0x *         +1.0x *         +4.0x *         +2.0x *
Average Cost............................................            -2.0            +0.0           +0.0%           +0.0%         +2.0x *         +1.0x *
High Cost...............................................            -4.0            +0.0           -2.0%           +0.0%           +0.0%           +0.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Under existing policy, these groups are eligible for an additional +1.0x if their average beneficiary risk score is in the top 25 percent of all
  beneficiary risk scores, where `x' represents the upward payment adjustment factor.


 Table 25--Previous and Final CY 2018 VM Amounts Under the Quality-Tiering Approach for Physicians, PAs, NPs, CNSs, & CRNAs in Groups of Physicians With
                                                        2-9 EPs and Physician Solo Practitioners
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Cost/quality                                  Low quality                   Average quality                  High quality
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  VM payment adjustment                    Previous  (%)    Final  (%)       Previous          Final         Previous          Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low Cost................................................            +0.0            +0.0         +1.0x *         +1.0x *         +2.0x *         +2.0x *
Average Cost............................................            -1.0            +0.0           +0.0%           +0.0%         +1.0x *         +1.0x *
High Cost...............................................            -2.0            +0.0           -1.0%           +0.0%           +0.0%           +0.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their average beneficiary risk score is in the top
  25 percent of all beneficiary risk scores, where `x' represents the upward payment adjustment factor.


 Table 26--Previous and Final CY 2018 VM Amounts Under the Quality-Tiering Approach for PAs, NPs, CNSs, & CRNAs who are Solo Practitioners or in Groups
                                                          Consisting of Non-Physician EPs Only
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Cost/quality                                  Low quality                   Average quality                  High quality
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  VM payment adjustment                    Previous  (%)    Final  (%)       Previous          Final         Previous          Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low Cost................................................            +0.0            +0.0         +1.0x *         +1.0x *         +2.0x *         +2.0x *
Average Cost............................................            +0.0            +0.0           +0.0%           +0.0%         +1.0x *         +1.0x *
High Cost...............................................            +0.0            +0.0           +0.0%           +0.0%           +0.0%           +0.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their average beneficiary risk score is in the top
  25 percent of all beneficiary risk scores, where `x' represents the upward payment adjustment factor.

     Automatic Downward Adjustments for groups and solo 
practitioners in Category 2. Under the previously finalized policies, 
the total maximum downward adjustment in 2018 under the PQRS and VM 
programs combined would have been negative 6 percent (-6.0 percent), 
while the maximum downward adjustment under MIPS in 2019 is negative 4 
percent (-4.0 percent). In order to ensure a smoother transition to the 
downward payment adjustments under MIPS, we proposed to reduce the 
amount of the automatic downward adjustments applied to payments for 
TINs categorized as Category 2 (those that do not avoid the PQRS 
payment adjustment as individual solo practitioners, as a group 
practice, or as a group that has at least 50 percent of the group's EPs 
meet the criteria to avoid the payment adjustment as individuals).
    For physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more 
EPs and at least one physician, we proposed to reduce the automatic 
downward VM adjustment from negative 4 percent (-4.0 percent) to 
negative 2 percent (-2.0 percent) for those that fall in Category 2, 
meaning they did not meet the criteria to avoid the 2018 PQRS payment 
adjustment.
    For physician, PA, NP, CNS, and CRNA solo practitioners; 
physicians,

[[Page 53231]]

PAs, NPs, CNSs, and CRNAs in groups with 2 to 9 EPs; and for PAs, NPs, 
CNSs, and CRNAs who are in groups comprised solely of non-physician 
EPs, we proposed to reduce the automatic downward VM adjustment from 
negative 2 percent (-2.0 percent) to negative 1 percent (-1.0 percent) 
for those that fall in Category 2.
    We welcomed public comment on these proposals.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Most of the commenters supported our proposals. Some of 
the suggestions provided by commenters who did not support the 
proposals included further reducing the automatic downward payment 
adjustment to -1.0 percent or zero percent for all practices, or 
holding harmless the practices that submitted any quality data (even if 
they did not meet the proposed PQRS reporting requirements). Other 
reasons given for not supporting the proposals were that decreasing the 
automatic downward payment adjustment would disadvantage groups who 
invested resources to succeed under the Value Modifier program by 
rewarding those that did not, and that the previously finalized 
automatic -4.0 percent downward adjustment better aligned with MIPS and 
that the intention of MACRA was not to reduce the downward adjustments 
under the existing programs.
    Response: We thank the commenters who supported the proposal. For 
commenters who suggested that the automatic downward adjustment be 
further reduced or eliminated, we note that because the statute 
requires the VM to be implemented in a budget neutral manner, the total 
amount of upward adjustments is based on the total amount of downward 
adjustments. We discuss above in detail why we do not believe it would 
be appropriate to further reduce the available funds for upward 
adjustments by further reducing or eliminating downward adjustments.
    For the commenter who expressed concern about the impact on groups 
who invested resources in successful participation in the Value 
Modifier program, we acknowledge and appreciate the efforts made by 
those groups and solo practitioners who successfully met the 
previously-finalized PQRS reporting criteria. We believe that the 
proposed policy strikes the appropriate balance between incentivizing 
both quality reporting and the provision of high-quality, efficient 
care and making a smooth transition to MIPS. In response to the comment 
that the previously-finalized negative four percent (-4.0 percent) 
automatic downward adjustment better aligned with MIPS, we note that 
the MIPS replaces three legacy programs, the PQRS, Value Modifier, and 
the Medicare EHR Incentive Program for eligible professionals. Under 
previously-finalized policies for the PQRS and Value Modifier programs, 
the combined total downward adjustment for not meeting the minimum 
quality reporting requirements would have been negative six percent (-
6.0 percent), which would have exceeded the maximum downward adjustment 
of negative four percent (-4.0 percent) in the first year of MIPS. 
Therefore, we are finalizing as proposed that for the CY 2018 payment 
adjustment period: (1) For physicians, PAs, NPs, CNSs, and CRNAs in 
groups with 10 or more EPs and at least one physician, to reduce the 
automatic downward VM adjustment from negative 4 percent (-4.0 percent) 
to negative 2 percent (-2.0 percent) for those that fall in Category 2, 
meaning they did not meet the criteria to avoid the 2018 PQRS payment 
adjustment; and (2) for physician, PA, NP, CNS, and CRNA solo 
practitioners; physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 
to 9 EPs; and for PAs, NPs, CNSs, and CRNAs who are in groups comprised 
solely of non-physician EPs, to reduce the automatic downward VM 
adjustment from negative 2 percent (-2.0 percent) to negative 1 percent 
(-1.0 percent) for those that fall in Category 2.
    Section 1848(p) of the Act does not specify the amount of payment 
that should be subject to the adjustment for the VM; however, section 
1848(p)(4)(C) of the Act requires the VM be implemented in a budget 
neutral manner. In the past, under the VM, we have achieved budget 
neutrality by increasing payments for some groups and solo 
practitioners based on high performance and decreasing them for others 
based on low performance or failing to meet the criteria to avoid the 
PQRS payment adjustment as a group or as individuals. Under the VM 
proposals included in the proposed rule for the CY 2018 payment 
adjustment period, we would not decrease payments to groups and solo 
practitioners based on performance under the quality-tiering 
methodology, provided that they are classified as Category 1 under the 
VM (meaning that they meet the criteria to avoid the CY 2018 PQRS 
payment adjustment as individual solo practitioners, as a group 
practice, or as a group that has at least 50 percent of the group's EPs 
meet the criteria). We would continue to decrease payments to groups 
and solo practitioners in Category 2 (meaning that they did not meet 
the criteria to avoid the CY 2018 PQRS payment adjustment as individual 
solo practitioners, as a group practice, or as a group that has at 
least 50 percent of the group's EPs meet the criteria). Regardless of 
the VM proposals for the CY 2018 payment adjustment period, the 
aggregate expected amount of Medicare spending in any given year for 
physician and non-physician EP services paid under the Medicare PFS 
will not change as a result of the application of the VM. As discussed 
previously, because the VM must be implemented in a budget neutral 
manner, the amount available for upward adjustments for high performers 
would decrease under our proposals. In other words, groups and solo 
practitioners that performed well on cost and quality would receive a 
smaller increase in payment. For this reason, we sought comment on 
whether we have appropriately balanced the interests of high and low-
performing groups and solo practitioners through this proposed change 
to the policy.
    The following is a summary of the public comments received and our 
responses:
    Comment: As discussed above, we received a few comments stating 
that the proposed policies would penalize practices that complied with 
existing requirements and reward those that did not. We also received a 
large number of commenters that supported all of our proposals and 
agreed with our intention to provide a smoother transition to the MIPS 
and to align incentives across all groups and solo practitioners.
    Response: We thank the commenters for their feedback, but we do not 
agree with those who stated that the proposals would penalize practices 
that complied with the previously-established policies and reward those 
who did not. The Value Modifier program will continue to reward high-
performing groups with significant upward payment adjustments in 2018, 
but under the policies we are finalizing in this rule, we will not 
apply downward adjustments to low-performing groups or solo 
practitioners who may have reported differently under the PQRS 
reporting criteria that we are adopting in section III.F. of this final 
rule. Also, we will not apply downward adjustments to groups and solo 
practitioners who are able to satisfy these PQRS reporting criteria by 
reporting six measures, but not nine. Moreover, the VM policies we are 
adopting will provide a smoother transition to MIPS where many of these 
practices may be excluded from MIPS based on the low-volume exclusion. 
As

[[Page 53232]]

stated above, we believe that the potential upward VM payment 
adjustments we are finalizing for Category 1 groups and solo 
practitioners and the automatic downward payment adjustments we are 
finalizing for Category 2 groups and solo practitioners would still 
provide sufficient recognition and significant payment impact for these 
practices' 2016 quality reporting and performance.
    We proposed to make conforming revisions to Sec. Sec.  414.1270, 
and 414.1275(c)(4) and (d)(3) to reflect the proposals described in 
this section. We sought public comment on these changes to the 
regulation text. We did not receive any comments on the proposed 
regulation text; therefore, we are finalizing the revisions as 
proposed.

J. MACRA Patient Relationship Categories and Codes

1. Development of Patient Relationship Categories and Codes To Improve 
Identification of Physician-Patient Relationship
a. Overview
    The Quality Payment Program (QPP) aims to improve health outcomes, 
promote smarter spending, minimize burden of participation, and provide 
fairness and transparency in operations. These aims are centered on 
improving beneficiary outcomes and engaging patients through patient-
centered policies, and enhancing clinician experience through flexible 
and transparent program design and interactions with easy-to-use 
program tools.
    The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) 
(Pub. L. 114-10) was enacted on April 16, 2015. Section 101(f) of MACRA 
amended section 1848 of the Act to create a new subsection (r) entitled 
Collaborating with the Physician, Practitioner, and Other Stakeholder 
Communities to Improve Resource Use Measurement. Section 1848(r)(2) of 
the Act requires the development of care episode and patient condition 
groups, and classification codes for such groups. To facilitate the 
attribution of patients and episodes to one or more clinicians, section 
1848(r)(3) of the Act requires the development of patient relationship 
categories and codes that define and distinguish the relationship and 
responsibility of a physician or applicable practitioner with a patient 
at the time of furnishing an item or service. The categories shall 
include different relationships of the clinician to the patient and 
reflect various types of responsibility for and frequency of furnishing 
care. Pursuant to section 1848(r)(3)(C) of the Act, we posted a draft 
list of patient relationship categories in April 2016 and solicited 
public comment on the categories and the policy principles that were 
used in developing them.\5\ In December 2016, we solicited additional 
comment on potential modifications to these categories based on 
comments received previously, as well as a method to operationalize the 
coding of these categories on the Medicare claim.\6\
---------------------------------------------------------------------------

    \5\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Patient-;Relationship-Categories-and-Codes.pdf (assessed 04/26/
2017).
    \6\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Patient-Relationship-Categories-and-Codes-Posting-FINAL.pdf.
---------------------------------------------------------------------------

2. Operational List of Patient Relationship Categories
    Based on the public comments received and consultation with 
stakeholders and experts regarding the draft list of patient 
relationship categories posted in April 2016 and the list of modified 
patient relationship categories posted in December 2016, we posted the 
operational list of patient relationship categories on May 17, 2017, 
pursuant to section 1848(r)(3)(E) of the Act, which is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/CMS-Patient-Relationship-Categories-and-Codes.pdf The patient relationship 
categories on the operational list are the following:
     Continuous/Broad Services.
     Continuous/Focused Services.
     Episodic/Broad services.
     Episodic/Focused Services.
     Only as Ordered by Another Clinician.
3. Subsequent Revisions
    Section 1848(r)(3)(F) of the Act requires that after the posting of 
the operational list of patient relationship categories and codes, not 
later than November 1st of each year (beginning with 2018), the 
Secretary shall, through rulemaking, make revisions to the operational 
list of patient relationship categories and codes as the Secretary 
determines appropriate. The revisions may be based on experience, new 
information and input from stakeholders. In preparation for potential 
subsequent revisions by November 1, 2018, we sought comment on the 
operational list of patient relationship categories available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/CMS-Patient-Relationship-Categories-and-Codes.pdf.
4. Reporting of Patient Relationship Codes Using Modifiers
    Section 1848(r)(4) of the Act requires that claims submitted for 
items and services furnished by a physician or applicable practitioner 
on or after January 1, 2018, shall, as determined appropriate by the 
Secretary, include the applicable codes established for care episode 
groups, patient condition groups, and patient relationship categories 
under sections 1848(r)(2) and (3) of the Act, as well as the NPI of the 
ordering physician or applicable practitioner (if different from the 
billing physician or applicable practitioner). Applicable practitioners 
are defined in section 1848(r)(9)(B) of the Act as a physician 
assistant, nurse practitioner, and clinical nurse specialist (as such 
terms are defined in section 1861(aa)(5)), and a certified registered 
nurse anesthetist (as defined in section 1861(bb)(2)), and beginning 
January 1, 2019, such other eligible professionals (as defined in 
subsection (k)(3)(B)) as specified by the Secretary.
    We have been planning for the use of procedure code modifiers for 
the reporting of patient relationships codes on Medicare claims. In 
December 2016, as described above, when we solicited comments on the 
potential modifications to the patient relationship categories, we also 
sought comment on the use of Level II Healthcare Common Procedure 
Coding System (HCPCS) Modifiers for the patient relationship codes. 
Public comments indicated that Current Procedural Terminology (CPT) 
Modifiers would be the best way to operationalize the reporting of 
patient relationship codes.\7\
---------------------------------------------------------------------------

    \7\ The CMS Level II HCPCS Coding Workgroup meets regularly 
(generally monthly) to consider requests for new HCPCS codes and 
modifiers. Information on the code request and approval process is 
available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html (assessed 04/26/2017).
---------------------------------------------------------------------------

    We worked with the American Medical Association's (AMA) CPT 
Editorial Panel, which is responsible for maintaining the CPT code set. 
We submitted an application for the CPT modifiers for reporting of the 
patient relationship codes. The CPT Editorial Panel, at their June 2017 
meeting determined that AMA would not include the modifiers in the CPT 
code set, pending future finalization of the modifiers by CMS, whereby 
CMS publishes the modifiers as Level II HCPCS Modifiers. Therefore, we 
proposed the Level II HCPCS Modifiers

[[Page 53233]]

in Table 27 as the patient relationship codes, which we would add to 
the operational list if we adopt them in the final rule.

      Table 27--Patient Relationship HCPCS Modifiers and Categories
------------------------------------------------------------------------
                                                 Patient relationship
         No.              HCPCS  modifier             categories
------------------------------------------------------------------------
1x...................  X1..................  Continuous/broad services.
2x...................  X2..................  Continuous/focused
                                              services.
3x...................  X3..................  Episodic/broad services.
4x...................  X4..................  Episodic/focused services.
5x...................  X5..................  Only as ordered by another
                                              clinician.
------------------------------------------------------------------------

    We proposed that Medicare claims submitted for items and services 
furnished by a physician or applicable practitioner on or after January 
1, 2018, should include the applicable HCPCS modifiers in Table 27, as 
well as the NPI of the ordering physician or applicable practitioner 
(if different from the billing physician or applicable practitioner). 
We anticipated there would be a learning curve with the use of the 
modifiers to report patient relationships, and believed that time would 
be needed to work with clinicians to ensure they gain experience in 
using these modifiers. Therefore, for at least an initial period while 
clinicians gain familiarity, we proposed that the HCPCS modifiers may 
be voluntarily reported on Medicare claims, and the use and selection 
of the modifiers would not be a condition of payment. Claims would be 
paid regardless of whether and how the modifiers are included. We would 
work with clinicians to educate them about the proper use of the 
modifiers.
    We stated that the use of modifiers to report patient relationships 
would not change the meaning of the procedure codes used to report 
items and services and guidelines associated with use of such procedure 
codes. The modifiers would also not be tied or related to intensity of 
services (evaluation and management services). Finally, we noted that, 
although we may work with clinicians to explore incorporating these 
codes into the QPP in future years, the measures we have proposed and 
finalized to date, those we have proposed for 2018, and those we are 
currently developing for future rulemaking for the MIPS performance 
categories do not require patient relationship codes to properly 
measure clinicians' quality and resource use in the Medicare program.
    We solicited comment on our proposal for voluntary reporting of the 
HCPCS modifiers on claims submitted for items and services furnished by 
a physician or applicable practitioner on or after January 1, 2018 and 
on the proposed list of HCPCS modifiers in Table 27.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Generally, commenters expressed support for our proposals 
and agreed this approach would provide significant potential for 
patient relationship codes to improve the attribution of patients to 
clinicians, and to improve the way clinicians are measured and assessed 
in pay-for-performance programs. Many commenters supported our proposal 
to allow clinicians to use the proposed HCPCS modifiers voluntarily at 
first before making it mandatory.
    Response: We thank commenters for their support.
    Comment: Some commenters supported the voluntary aspect of the 
proposal, but were concerned January 1, 2018 would be too early to 
implement even voluntary reporting due to educational, administrative, 
and IT system (structural) challenges. Commenters suggested CMS delay 
implementing mandatory reporting of patient relationship codes until 
adequate training, time for vendors testing the submission of claims, 
stakeholder feedback, burden reduction, and ample studies on the 
reliability and validity of how CMS will use the patient relationship 
categories to attribute patients and their costs to individual 
clinicians under episode-based measures.
    Response: We appreciate the commenters' concerns with the timeline 
for implementation of the use of the proposed HCPCS modifiers. We agree 
that adequate training, including examples and outreach to clinicians, 
is important in the implementation of these modifiers. We believe 
opening up voluntary reporting on January 1, 2018 will allow 
flexibility for clinicians to participate when they are ready. Allowing 
for voluntary reporting, along with stakeholder feedback, will help 
inform further refinement of the modifiers, if necessary. As we stated 
in the proposed rule, the use and selection of the modifiers would not 
be a condition of payment for at least an initial period while 
clinicians become familiar with the modifiers.
    Comment: A few commenters supported the initial voluntary reporting 
approach but suggested that CMS make clear that errors in submitting 
these codes during this voluntary reporting period will not impact 
payment. A commenter suggested that CMS work closely with professional 
associations to educate health professionals and that the training 
include extensive examples of real world clinical scenarios.
    Response: We thank commenters for supporting our initial voluntary 
approach. We confirm that during the period when reporting is 
voluntary, errors related to the use of these patient relationship 
codes will not have payment consequences. We intend to educate 
stakeholders using a wide variety of clinical examples for training 
purposes.
    Comment: Some commenters remained concerned that billing provisions 
such as ``incident to'' may thwart this goal, and requested that the 
name and NPI of the applicable practitioner appear on the claim and be 
able to be tracked throughout the claims process for services billed 
``incident to.''
    Response: We appreciate the concerns voiced with regard to 
accurately identifying the correct clinician that may take care of a 
patient during an episode of care. Our proposed approach would allow 
for multiple clinicians to code for their role in care during the 
episode, and information gathered during the voluntary period can help 
refine the patient relationship categories if necessary.
    Comment: Many commenters expressed concern about the broadness and 
vagueness of the descriptors used in the five categories of the 
proposed HCPCS modifiers, which they believe are open to individual 
interpretation. Some specialty groups stated their belief that the 
patient relationship categories may not be applicable to their 
specialties and suggested that CMS provide further clarification of the 
modifiers or consider additional categories to properly document the 
clinician-patient relationship in all specialty settings. Many 
commenters believe it would be incredibly challenging for the proposed 
modifiers to adequately reflect co-management or team-based care, such 
as multispecialty facilities and academic medical centers, and also in 
situations where the physician's relationship with the patient changes 
over time. The commenters expressed concern regarding who would 
evaluate the self-assignment of patient relationships to ensure that 
the codes are being used correctly across clinicians when multiple 
physicians are in charge of a patient at different points in time, and 
also in most complex clinician-patient relationships. A commenter 
recommended that CMS consider framing the modifiers around the 
clinicians, instead of the care episode.
    Response: We chose broad category descriptions to simplify the 
reporting

[[Page 53234]]

burden for clinicians, as well as allow for broad applicability of 
modifiers across all specialty settings. By allowing for voluntary 
reporting of the HCPCS modifiers for a period of time, we will be able 
to examine trends in their use and further refine the modifiers if 
necessary. The intent of the modifiers is to measure resource use, and 
by focusing on care episodes, multiple clinicians can identify their 
role in the patient's care.
    Comment: Many commenters appreciated CMS for acknowledging that use 
of the proposed HCPCS modifiers may impose additional burden on 
physicians and their support staff. Some commenters expressed concern 
about the effectiveness, feasibility and utility of the patient 
relationship codes, in that including a patient relationship code on 
every single claim, coupled with the clinician confusion resulting from 
the vagueness and complexity of the patient relationship categories, 
would be a significant administrative burden for clinicians, which is 
contrary to the current administration's goals and objectives. Some 
commenters expressed concern that the introduction of these new 
modifiers at the time when the QPP is still in the initial 
implementation and learning period will significantly burden clinicians 
and their staff.
    Response: We acknowledge stakeholders' concerns of administrative 
burden that may come with the introduction of these modifiers. By 
finalizing our proposal to allow voluntary reporting of the modifiers 
for at least an initial period, we hope the information we learn during 
this period will help us minimize burden for clinicians in reporting 
these modifiers. We believe providing the training resources and 
feedback needed to minimize clinician burden during this learning 
period will help clinicians as they learn how to use the modifiers. The 
voluntary period also will allow clinicians to participate at their own 
pace.
    Comment: Several commenters recommended that CMS provide more 
detailed information regarding cost measures (resource use) and episode 
group measures so they can provide meaningful comments on the proposed 
HCPCS modifiers. The commenters stated, that without clear information 
on how the episode-based measures will be structured, they cannot 
assess whether the patient relationship categories are appropriate for 
the measures.
    Response: We recognize that additional information on cost measures 
would help commenters in evaluating the patient relationship 
categories. While we are still developing episode-based measures, the 
patient relationship categories and codes can help as we define cost 
measures in the future. The current cost measures in MIPS and those in 
immediate development do not use these patient relationship codes. We 
believe additional experience and analysis will be needed before we 
incorporate the codes into cost measures. We plan to engage clinicians 
in the use of these codes as we gain experience with their use and 
submission.
    Comment: Many commenters applauded CMS for acknowledging the 
process is a learning curve and ample education and training is needed. 
They recommended that CMS incorporate transparency and stakeholder 
feedback and engagement in their education and attribution methodology 
work. They believe that given the administrative complexity of 
implementing the modifiers and incorporating them into CMS' payment 
systems, studies and testing must be done on fully developed cost and 
resource use measures to be able to accurately attribute patient 
relationships to healthcare cost to individual physicians. A commenter 
believes refinements are needed to ensure the modifiers become a useful 
and reliable mechanism to attribute costs of care to clinicians without 
adding significant burden.
    Response: We thank the commenters for their feedback. By 
implementing a voluntary approach to reporting the patient relationship 
categories, we intend to use the information collected, along with 
education and outreach to further refine the modifiers if necessary. We 
are committed to education and outreach during and after the voluntary 
period. The training and feedback, we believe, will enhance the 
understanding of the patient relationship categories and provide a 
mechanism for use of the modifiers without additional burden. We intend 
to integrate transparency in all operations that go into education and 
training on the use of the modifiers and the attribution methodology 
work.
    After consideration of the public comments, we are finalizing our 
proposal to use the Level II HCPCS Modifiers in Table 27 as the patient 
relationship codes, which we will add to the operational list of 
patient relationship categories available at www.cms.hhs.gov/medhcpcsgeninfo. We are finalizing our proposal that Medicare claims 
submitted for items and services furnished by a physician or applicable 
practitioner on or after January 1, 2018, should include the applicable 
HCPCS modifiers in Table 27, as well as the NPI of the ordering 
physician or applicable practitioner (if different from the billing 
physician or applicable practitioner). We are finalizing our proposal 
that for at least an initial period while clinicians gain familiarity, 
the HCPCS modifiers may be voluntarily reported, and the use and 
selection of the modifiers will not be a condition of payment. By 
allowing for a voluntary approach to reporting, we will gain 
information about the patient relationship codes, allow for a long 
period of education and outreach to clinicians on the use of the codes, 
and inform our ability to refine the codes as necessary.

K. Changes to the Medicare Diabetes Prevention Program (MDPP) Expanded 
Model

1. Background
a. Authority for and Establishment of the MDPP Expanded Model
    In the November 15, 2016 Federal Register, we issued a final rule 
to implement aspects of the Medicare Diabetes Prevention Program (MDPP) 
expanded model (81 FR 80459 through 80475 and 80552 through 80558) as 
part of the CY 2017 Physician Fee Schedule (PFS) final rule. Section 
1115A(c) of the Act provides the Secretary with the authority to 
expand, through rulemaking (including implementation on a nationwide 
basis), the duration and scope of a model that is being tested under 
section 1115A(b) of the Act if certain determinations specified in the 
Act are made, taking into account the evaluation of the model under 
section 1115A(b)(4) of the Act. The MDPP expanded model is an expansion 
of CMS' Center for Medicare and Medicaid Innovation's (Innovation 
Center) Diabetes Prevention Program (DPP) model test under the 
authority of section 1115A of the Act. The Secretary expanded the DPP 
model test in duration and scope under the authority of section 
1115A(c) of the Act. For further information on the DPP model test, and 
the associated National DPP administered by the Centers for Disease 
Control and Prevention (CDC), we refer readers to the CY 2017 PFS final 
rule and the following Web sites: https://Innovation.cms.gov/initiatives/Health-Care-Innovation-Awards/ and https://www.cdc.gov/diabetes/prevention/index.html.
    The aim of the MDPP expanded model is to continue to test a method 
of prevention of the onset of type 2 diabetes among Medicare 
beneficiaries with an indication of prediabetes as defined by the MDPP 
beneficiary eligibility criteria (finalized at Sec.  410.79(c)(1)). 
Services available

[[Page 53235]]

through the MDPP expanded model are MDPP services furnished in 
community and health care settings by coaches, such as trained 
community health workers or health professionals. We have designated 
services under the MDPP expanded model to be covered as additional 
preventive services under Medicare, as defined in section 1861(ddd) of 
the Act.
    For a detailed discussion of the DPP model test and the development 
of aspects of the MDPP expanded model, we refer readers to the CY 2017 
PFS proposed rule (``Proposed Expansion of the Diabetes Prevention 
Program (DPP) Model'') (81 FR 46413 through 46418), and the CY 2017 PFS 
final rule (81 FR 80459 through 80475).
    In the CY 2017 PFS final rule, we responded to and incorporated 
certain suggestions from the public comments we received that were 
within the scope of the MDPP proposals presented in the CY 2017 PFS 
proposed rule. We indicated in that final rule (81 FR 80459) that the 
MDPP expanded model would be implemented through at least two rounds of 
rulemaking. In the CY 2017 PFS final rule, we finalized MDPP policies 
that will enable CDC-recognized organizations to prepare for 
enrollment, including finalizing the framework for the MDPP expanded 
model, timeline and definitions for the MDPP expanded model (codified 
at Sec.  410.79(a) and (b)), beneficiary eligibility criteria (codified 
at Sec.  410.79(c) and (d)), supplier eligibility criteria and supplier 
enrollment requirements (codified at Sec.  424.59, proposed to be 
redesignated as Sec.  424.205). We also identified several issues, 
including some issues raised by commenters that we deferred to future 
rulemaking.
b. Summary of Provisions Finalized in the CY 2017 PFS Final Rule
    In the CY 2017 PFS final rule (81 FR 80465 through 80468), we 
finalized the structure of MDPP services. We provided that the MDPP 
core benefit consists of at least 16 weekly core sessions over months 1 
through 6 and at least 6 monthly core maintenance sessions over months 
7 through 12, furnished regardless of weight loss (Sec.  410.79(b) and 
(c)(2)). We also finalized that Medicare will cover ongoing maintenance 
sessions after the 12-month core set of MDPP services if beneficiaries 
achieve and maintain the required minimum weight loss of 5 percent. In 
the CY 2018 PFS proposed rule, we proposed to further revise the 
structure of MDPP services as a 3-year service period, generally 
contingent upon a beneficiary's attainment of two performance goals: 
Achievement and maintenance of weight loss and attendance at a certain 
number of MDPP sessions (82 FR 34131 through 34132).
    As used in this final rule, the term ``MDPP services period'' 
refers to the time period in which MDPP services are furnished under 
the MDPP expanded model over a minimum of 12 consecutive months and a 
maximum of 24 consecutive months from the date of the first core 
session the beneficiary attends. We use the term ``set of MDPP 
services'' to include the entirety of MDPP services available under the 
MDPP expanded model, including core sessions, core maintenance 
sessions, and, subject to Sec.  410.79(c)(3), ongoing maintenance 
sessions offered over the course of the MDPP services period. For 
purposes of this final rule and the expanded model, MDPP services are 
covered under the ``additional preventive services'' benefit category 
under section 1861(ddd)(1) of the Act and paid from the Medicare Part B 
Trust Fund. As indicated in the CY 2017 PFS, we intended to begin 
supplier enrollment before MDPP services became available, and we 
finalized an expanded model start date of January 1, 2018.
    In the CY 2018 PFS proposed rule, we proposed a new start date for 
the furnishing of MDPP services within the expanded model of April 1, 
2018 (82 FR 34157 through 34158). That is, MDPP suppliers will not be 
able to furnish MDPP services, or to receive payment for these 
services, prior to April 1, 2018. We note that we proposed the supplier 
enrollment and compliance policies become effective on January 1, 2018. 
This stated that the change to delay the furnishing of MDPP services 
would allow time for organizations to enroll in Medicare before they 
begin furnishing and billing for MDPP services.
    In the CY 2017 PFS final rule (81 FR 80459), we described a 
possible payment structure for MDPP services, but deferred full 
development of the payment structure to future rulemaking. In section 
III.K.2.d. of this final rule, we discuss our payment structure for 
MDPP services. This finalized payment structure took into consideration 
the significant number of public comments we received in response to 
the possible payment structure we described in the CY 2017 PFS proposed 
rule, as well as comments received on the CY 2018 PFS proposed rule. We 
also proposed payment policies for instances in which an MDPP 
beneficiary switches MDPP suppliers in the CY 2018 PFS proposed rule.
    In the CY 2017 PFS final rule (81 FR 80471 through 80474), we 
required CDC-recognized organizations that will bill Medicare for MDPP 
services to enroll in Medicare as MDPP suppliers. We also finalized the 
requirements for coaches furnishing MDPP services. We finalized 
policies regarding CDC Diabetes Prevention Recognition Program (DPRP) 
full recognition for MDPP suppliers and we indicated an intention to 
propose policies in future rulemaking regarding whether a DPP 
organization without full CDC recognition could enroll as an MDPP 
supplier. We are finalizing an interim MDPP preliminary recognition 
standard in section III.K.2.e. of this final rule. Also, in this 
section of this final rule, we are finalizing revisions to the supplier 
eligibility and enrollment requirements, including establishment of 
standards and implementation of appropriate program integrity 
safeguards. In section III.K.2.f. of this final rule, we are finalizing 
policies related to MDPP beneficiary engagement incentives furnished by 
MDPP suppliers.
    In the CY 2017 PFS final rule (81 FR 80459), we deferred 
establishing policies related to organizations delivering ``virtual'' 
DPP services, where services are not furnished in person. In section 
III.K.3. of this final rule, we explain that the MDPP expanded model 
covers in-person MDPP services (other than ad hoc virtual make-up 
sessions discussed in section III.K.2.c.iv.(3) of this final rule), and 
thus, explain why we are not currently finalizing any policies related 
to MDPP services furnished 100 percent virtually and state that we are 
considering a separate model under CMS's Innovation Center authority to 
test and evaluate virtual DPP services.
2. Policy Changes
a. Changes to Effective Date of MDPP Services
    In the CY 2017 PFS final rule, we established at Sec.  410.79(a) 
that MDPP services would be available on January 1, 2018. In the CY 
2018 PFS proposed rule, we proposed to change Sec.  410.79(a) to state 
that MDPP services would be available on April 1, 2018. We proposed 
this change because we want to ensure that MDPP suppliers have 
sufficient time to enroll in Medicare after the effective date of the 
CY 2018 PFS final rule.
    Therefore, beneficiaries will not be able to receive MDPP services 
immediately on January 1, 2018 due to the time needed for supplier 
enrollment. For this reason, we proposed April 1, 2018 as the expanded 
model start date, which we believe allows a sufficient

[[Page 53236]]

amount of time (90 days) for eligible suppliers to enroll in Medicare 
before furnishing and billing for MDPP services. As a result of this 
proposed change, we stated that the following regulatory provisions, if 
finalized, would be effective April 1, 2018: Sec.  414.84 related to 
payment for MDPP services; and Sec.  424.210 related to beneficiary 
engagement incentives. We proposed that all other sections, if 
finalized, will be effective on January 1, 2018, including the policies 
proposed in section III.K.2.e. of the proposed rule related to supplier 
enrollment and compliance. We invited public comments on these 
proposals.
    The following is a summary of the public comments received on this 
new proposed expanded model start date and whether 90 days is a 
sufficient amount of time for organizations to enroll in Medicare and 
prepare to furnish and bill for MDPP services and our responses:
    Comment: Many commenters supported the proposed model start date of 
April 1, 2018. The commenters stated that a 90-day delay from January 
1, 2018, was both reasonable and necessary to ensure MDPP suppliers 
would be ready to deliver services by April 1, 2018. Other commenters 
stated that enrollment of DPP organizations into the MDPP as of January 
1, 2018, would allow sufficient time for organizations to apply, 
receive a supplier determination, comply with requirements, and 
ultimately, operate starting April 1, 2018. One commenter appreciated 
the alignment of the MDPP's implementation in Apri1 2018 with the CDC's 
recently-proposed DPRP standards that will allow DPP suppliers to 
prepare for enrollment as Medicare suppliers.
    One commenter expressed concerns about delaying the availability of 
the services until April and recommended CMS keep the implementation 
date of January 1, 2018. The commenter stated that because the MDPP was 
first discussed in the 2017 rulemaking cycle and CMS had finalized a 
January 1, 2018 start date, CMS and suppliers alike had ample time to 
plan, enroll, and prepare to operationalize this program. The commenter 
suggested CMS work with speed and efficiency to make these services 
available on January 1, 2018, as the agency had previously finalized 
given the obesity and diabetes prevalence in the United States.
    A few commenters suggested CMS delay the model start date beyond 
April 1, 2018, including several requests to delay until January 1, 
2019. Most of the commenters stated the delay was necessary to allow 
Medicare Advantage (MA) organizations sufficient time to contract with 
MDPP suppliers thereby ensuring adequate coverage for their members. 
One commenter suggested delaying the start date to July 1st or October 
1st 2018 to allow additional time for suppliers to be trained and in 
place when the service becomes available to Medicare beneficiaries.
    Response: We appreciate all of the comments received on the 
proposed new effective date for MDPP services and thank the commenters 
for their recommendations. We note that we cannot make the MDPP service 
available to beneficiaries until there are MDPP suppliers enrolled in 
Medicare who can meet beneficiary demand for the service. Suppliers 
have been awaiting detailed requirements in order to enroll into 
Medicare as MDPP suppliers. Those requirements are finalized in this 
rule which becomes effective January 1, 2018. In response to commenters 
recommending a January 1, 2019 start date, CMS does not believe it is 
prudent to further delay the availability of this preventive service 
for the majority of Medicare beneficiaries, who are in Fee for Services 
(FFS). Additionally, DPP stakeholders have been preparing to offer this 
service to Medicare beneficiaries since the service was first proposed 
in the CY 2017 PFS proposed rule and finalized in CY 2017 PFS final 
rule (81 FR 80459). There are currently over 1500 organizations 
actively pursuing or maintaining DPP recognition through the CDC's DPRP 
which includes nearly a 90 percent increase between September 2015 and 
March 2017 alone. These organizations have made significant investments 
in pursuit of recognition and represent a growing supply of 
organizations that meet the qualifications specified in this rule to 
deliver the DPP to Medicare beneficiaries. At Sec.  410.79(a), we are 
finalizing that MDPP services will be available under the MDPP expanded 
model as a Part B service for eligible Medicare beneficiaries beginning 
on April 1, 2018. Because MDPP services are a Part B service, all 
Medicare health plans (which include plans offered by Medicare 
Advantage Organizations, cost plans offered under sections 1833 and 
1853 of the Act, and PACE organizations), are required to cover MDPP 
services for eligible beneficiaries. As a Part B service, Medicare 
health plans are required to provide beneficiaries with coverage of all 
MDPP services using medical necessity criteria that authorize coverage 
on at least the same terms as Original Medicare. In the CY 2017 final 
rule (81 CFR 80468 through 80470) and in section III.K.2.c of this 
final rule, we establish specific beneficiary eligibility requirements 
that regulate the coverage of MDPP services as a basic benefit. 
Therefore, notwithstanding other requirements under this final rule, MA 
plans must authorize coverage of MDPP on at least the same terms as 
those established in Sec.  410.79(c) and (d) of this final rule. We 
note that Medicare health plans may generally also provide more 
generous coverage than Original Medicare as a supplemental benefit.
    Comment: We received several comments related to our proposed delay 
of the start date for MDPP services from January 1, 2018 to April 1, 
2018 that addressed whether such a delay would likewise delay the 
effective date for MA plans. The majority of commenters who provided 
comments on the delay with respect to MA plans recommended that CMS 
further delay the start date for MDPP services beyond the April 1 date, 
recommending new start dates ranging from June 1, 2018 to January 1, 
2019. Concerns underlying the request for this additional delay were 
related to the number of MDPP suppliers available to contract with MA 
plans for MDPP services, the short timeline in which to negotiate and 
implement contracts with MDPP suppliers for an April 1 start date, and 
other operational challenges underlying the implementation of a new 
covered service between the November 2017 publication of the MDPP final 
rule and the April 1, 2018 start date. Other commenters supported the 
delayed start date in MDPP services from January 1, 2018 to April 1, 
2018, citing the need for additional time to contract with MDPP 
suppliers and their desire to align with the proposed start date for 
Original Medicare.
    Response: While we understand that Medicare Advantage Organizations 
have significant concerns regarding their ability to construct a 
network of adequate coverage for MDPP, we remind MAOs that, as a Part B 
service, Sec.  422.112 permits MA plans to limit coverage to services 
from a network of providers so long as the MAO ensures that all covered 
services--which will include MDPP services--are available and 
accessible under the MA plan; an MAO must arrange for out-of-network 
access to specialty care when network providers are unavailable or 
inadequate to meet enrollees' medical needs. We further note that for 
section 1876 cost plans, Sec.  417.416 requires that an Health 
Maintenance Organization or Comprehensive Medical Plan must furnish 
required services--which will include MDPP services--to its Medicare 
enrollees through providers and suppliers that meet applicable Medicare

[[Page 53237]]

statutory definitions and implementing regulations. The HMO or CMP must 
also ensure that the required services for which the Medicare enrollee 
has contracted are available and accessible and are furnished in a 
manner that ensures continuity. Therefore, we decline to accept 
commenters' recommendations to further delay the effective date for MA 
plans. As indicated in a November 23, 2016 Health Plan Management 
System (HPMS) memo, because MDPP is a Part B service, all Medicare 
health plans, including plans offered by Medicare Advantage plans, are 
required to cover the service for eligible beneficiaries. In this 
section, we are finalizing that MDPP services will be available under 
the MDPP expanded model as a Part B item/service for eligible Medicare 
beneficiaries, in both Original Medicare and Medicare health plans, 
beginning on April 1, 2018. Additional information on this topic will 
be released in future guidance, as appropriate.
    Comment: In addition to a number of comments supporting a delay to 
the original start date for MDPP services of January 1, 2018, we 
received several comments requesting that CMS provide additional 
guidance and information on the implementation and operationalization 
of MDPP in the Medicare Advantage setting, with most comments focused 
on the impact of the proposed delay in the start date for MDPP services 
to April 1, 2018 on the implementation of MDPP services in Medicare 
Advantage.
    Response: In response to requests from MAOs to provide additional 
guidance on the implementation of MDPP in MA, we have provided a number 
of responses to MAOs seeking clarification on the implementation of 
MDPP in the preamble of this final rule. As appropriate, we will 
provide additional information to MAOs on the implementation of MDPP in 
future guidance.
    Comment: Several commenters expressed concern that Evidence of 
Coverage documents developed by MA plans, which were required to be 
delivered to MA enrollees by September 30th of 2017 prior to the 
finalization of this rule, may have been published without including 
MDPP services as an available covered service or may have indicated 
that MDPP services would be available per the January 1, 2018 date 
finalized in the CY 2017 final rule and not the April 1st, 2018 date in 
the CY 2018 proposed rule.
    Response: At the time these EOCs were published, the MDPP Expanded 
Model was to become effective January 1, 2018 with a proposed rule to 
change the effective date to April 1, 2018; therefore, an EOC that 
indicates a January 1, 2018 start date for MDPP services was accurate 
at the time it was published. As we are finalizing our proposed 
effective date change to April 1, 2018 in this final rule, MA plans 
that have not included MDPP services in beneficiary documentation such 
as an EOC or have provided an effective date of January 1, 2018 should 
consult Sec.  422.111(d) and follow existing guidance at Medicare 
Managed Care Manual 60.7 ``Other Mid-Year Changes Requiring Enrollee 
Notification.''
    After considering the public comments, we are finalizing, at Sec.  
410.79(a), the policy as proposed with an effective date of April 1, 
2018 for furnishing MDPP services. Based on the many comments received 
in support of the proposed date, we believe the 90-day period will 
allow eligible organizations adequate time to enroll in Medicare as 
MDPP suppliers and furnish the services to eligible beneficiaries 
beginning April 1, 2018.
b. Changes to the Set of MDPP Services
    In the CY 2017 PFS final rule, we established the parameters of 
MDPP services. The policies and terms in this final rule seek to 
clarify, build on, and at times change these previously finalized 
policies. In particular, we proposed to refine and add terms related to 
the different aspects of ``MDPP services.'' In the CY 2018 PFS proposed 
rule, we proposed to refine the term ``MDPP services'' to refer to 
structured health behavior change sessions that are furnished under the 
MDPP expanded model with the goal of preventing diabetes among Medicare 
beneficiaries with prediabetes, and that follow a CDC-approved 
curriculum (Sec.  410.79(b)). The sessions provide practical training 
in long-term dietary change, increased physical activity, and problem-
solving strategies for overcoming challenges to maintaining weight loss 
and a healthy lifestyle.
    In the preamble to the CY 2017 PFS final rule, we referenced the 
set of MDPP services covered under the expanded model as the ``MDPP 
benefit.'' In the CY 2018 PFS proposed rule, we proposed to update this 
terminology. In cases where we would have previously referred to the 
term ``benefit'' to describe the entire set of MDPP sessions covered 
under the MDPP model, we proposed to use the phrase ``set of MDPP 
services.'' ``Set of MDPP services'' means the series of MDPP sessions, 
composed of core sessions, core maintenance sessions, and ongoing 
maintenance sessions, offered over the course of the MDPP services 
period (proposed Sec.  410.79(b)).
    In cases where we would have previously used the term ``benefit'' 
to describe a period of time, we proposed to refer to the ``MDPP 
services period.'' The MDPP services period means the time period, 
beginning on the date an MDPP beneficiary attends his or her first core 
session, over which the set of MDPP services is furnished to the MDPP 
beneficiary, to include the core services period described in Sec.  
410.79(c)(2)(i) and, subject to Sec.  410.79(c)(3), one or more ongoing 
maintenance session intervals during the ongoing services period 
described in Sec.  410.79(c)(2)(ii) (Sec.  410.79(b)). The duration of 
the MDPP services period is discussed further in section III.K.2.c.iv. 
of this final rule. As noted throughout this section, the term 
``benefit'' would no longer be used. We proposed to remove the term 
``MDPP core benefit'' from the list of definitions.
    In the CY 2017 PFS final rule, we included a definition for ``core 
sessions'' that referred to the set of core sessions covered under the 
MDPP expanded model. We proposed to revise the definition for ``core 
sessions,'' and instead define the singular ``core session'' as an MDPP 
service that is furnished by an MDPP supplier to an MDPP beneficiary 
during months 1 through 6 of the MDPP services period, is approximately 
1 hour in length, and adheres to a CDC-approved DPP curriculum for core 
sessions (Sec.  410.79(b)). We believe that having a definition for the 
individual core session would be more uniform with other MDPP 
definitions, which are defined in the singular form. We proposed to 
revise the definition of ``core maintenance session'' as an MDPP 
service that is furnished by an MDPP supplier to an MDPP beneficiary 
during a core maintenance session interval, is approximately 1 hour in 
length, and adheres to a CDC-approved DPP curriculum for maintenance 
sessions (under Sec.  410.79(b)).
    We proposed to revise the definition of an ``ongoing maintenance 
session'' as an MDPP service that is furnished by an MDPP supplier to 
an MDPP beneficiary during an ongoing maintenance session interval; is 
approximately 1 hour in length and adheres to a CDC-approved DPP 
curriculum for maintenance sessions (Sec.  410.79(b)). The time period 
over which MDPP suppliers offer ongoing maintenance sessions, which 
differs from our previously finalized policy, is discussed in section 
III.K.2.b.i. of this final rule.
    We proposed to add a definition for ``MDPP session,'' which means a 
core session, a core maintenance session, or

[[Page 53238]]

an ongoing maintenance session (Sec.  410.79(b)).
    We invited public comments on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters expressed support for the revised 
definitions and one commenter stated they were familiar with the terms 
``core'' and ``maintenance'' in their current practice. Some commenters 
appreciated that the terms were aligned with the Centers for Disease 
Control and Prevention approved DPP curriculum with the addition of 
ongoing maintenance sessions. One commenter recommended CMS redefine 
the MDPP Services Period to include a core services period of 1 year 
and an ongoing maintenance services period of 1 year with the proposed 
3-year MDPP payment model adjusted to reflect such changes. One 
commenter stated that CMS proposes that the core services period 
consist of two primary subsets: (a) Core sessions, which consist of 16 
sessions offered at least one week apart during months one through 6, 
and (b) core maintenance sessions, which are provided during months 7 
through 12. Because a Medicare beneficiary could, as a technical 
matter, complete the 16 sessions by the end of month 4, the commenter 
requested that CMS clarify the proposed regulatory language to take 
into account the fact that core maintenance sessions could be provided 
during months 5 through 12 (as opposed to only during months 7 through 
12). In other words, the commenter was requesting that CMS clarify that 
months 5 through 6 could include either core sessions or core 
maintenance sessions, depending on the beneficiary and the pace at 
which that beneficiary participates in the MDPP. One commenter stated 
they were pleased that eligible beneficiaries will now be offered 16-
weekly core sessions and 6 monthly core maintenance sessions regardless 
of their level of weight loss during the first 12 months.
    Response: We appreciate the comments received on the proposed 
definitions for the MDPP Services Period. As we discuss more in section 
III.K.2.b.i of this final rule, we are finalizing that the ongoing 
maintenance services period will only be 1 year, and therefore, we 
agree with the comment to redefine the MDPP Services Period to include 
a core services period of 1 year and an ongoing maintenance services 
period of 1 year and will be modifying the definition to account for 
this change. Lastly, we clarify that monthly core maintenance sessions 
cannot begin prior to month 7 during the first 12 months because a core 
maintenance session interval is defined as occurring in months 7 
through 12 of the MDPP services period. We understand that 
beneficiaries will complete the core sessions at different paces and 
some may complete 16 weekly sessions in the first 4 months; however, 16 
weekly sessions is the minimum number of sessions to be furnished 
during months 1-6. Our definition of the MDPP Services Period being 
finalized at Sec.  410.79(b) and (c)(2)(i), specifies that MDPP 
suppliers must furnish at least 16 core sessions during months 1-6 and 
that these core sessions must be offered at least 1 week apart. This 
definition allows flexibility to suppliers in terms of the frequency 
that core sessions may be offered. Suppliers can offer core sessions 
less frequently than weekly so they are spread more evenly across 
months 1-6 or they can offer them weekly. If a supplier chooses to 
offer them weekly and a beneficiary completes 16 sessions in months 1 
through 4, the supplier will need to offer additional sessions during 
months 5 and 6 in order to avoid a 2-month break in service for the 
beneficiary. In this case, the number of additional core sessions 
offered is left to the discretion of the supplier. However given the 
evidence from the CDC's DPRP that it takes an average of 17 DPP 
sessions attended for an individual in the DPP to exceed the required 
minimum weight loss,\8\ and the importance of the first 6 months in 
achieving weight loss as discussed in more depth in section 
K.III.2.d.iii.(3) of this final rule, we believe most beneficiaries who 
attend 16 sessions by month 4 would require high engagement during 
those 2 months in order to achieve or maintain weight loss by month 7.
---------------------------------------------------------------------------

    \8\ CDC's Diabetes Prevention Recognition Program dataset as of 
March 1, 2017.
---------------------------------------------------------------------------

    Comment: Although unrelated to the current proposals regarding 
changes to the MDPP set of services, many commenters expressed support 
for Medicare's expansion of MDPP services as a Part B additional 
preventive service, and one commenter requested that CMS encourage 
Medicare Advantage Organizations to cover MDPP as they do other 
preventive and screening services. However, one commenter stated that 
the mandate of the MDPP beyond Medicare Part B to Medicare Advantage 
and PACE plans unduly restricts these plan providers and requested the 
ability to seek a waiver that would remove the requirement that an MA 
plan provide MDPP services if the MA plan is able to show that 
alternative prediabetes outreach is available to plan enrollees that 
may better fit the plan's service delivery model.
    Response: We clarify in this final rule that under 42 CFR 
422.100(a), MAOs offering MA plans must provide enrollees in that plan 
with coverage of all basic benefits, which are defined at Sec.  422.100 
(c)(1) as all Medicare-covered services, except hospice services. In 
the CY 2017 PFS final rule, we finalized our proposal to expand the 
duration and scope of the DPP model test through the MDPP expanded 
model under section 1115A(c) of the Act, as well as our proposal to 
designate MDPP services as ``additional preventive services'' as 
defined by section 1861(ddd) of the Act. Thereafter, in a November 
23rd, 2016 HPMS memo, we stated that, as a Part B additional preventive 
service, MDPP services will be covered for eligible Medicare 
beneficiaries under Medicare health plans. We reiterate here that this 
includes Medicare Advantage plans. The commenter did not offer an 
explanation as to why the requirement that Medicare Advantage plans 
provide MDPP services to enrollees is more restrictive than coverage of 
any other new or existing Part B covered service that would be required 
under Sec.  422.100(a), and we can see no reason that MDPP, in 
particular, would be more restrictive on plan providers than previous 
Part B services provided to enrollees as basic benefits under Sec.  
422.100(a). Furthermore, while we applaud MA plans that currently 
provide prediabetes outreach, we note that there is no current 
mechanism by which CMS may review existing prediabetes outreach or 
programs and then make a determination to waive particular MA plans 
from the requirements of Sec.  422.100(a) as they relate to MDPP 
services. As such, we decline to do so here. We note that MA plans are 
free to provide existing prediabetes services and outreach that do not 
qualify as MDPP services as a supplemental benefit available to 
enrollees.
    Comment: We received requests from commenters to provide 
flexibility to modify the curriculum that MA plans must provide to MA 
enrollees to meet the MDPP services coverage requirement. One commenter 
requested the removal of a specific curriculum element--the requirement 
that ongoing maintenance sessions be approximately one hour in length. 
Both commenters requested clarification as to whether MA plans may 
provide modified curriculums for MDPP services provided to MA enrollees 
so long as

[[Page 53239]]

they are similar to the CDC DPRP curriculum described at Sec.  
410.79(b).
    Response: Although these commenters did not comment on any specific 
proposals on the changes to the MDPP set of services, we believe it is 
appropriate to respond to provide clarifications in this final rule 
with respect to MDPP services more generally. We decline to accept the 
commenter's recommendation to remove the requirement that MDPP 
suppliers must provide ongoing maintenance sessions that are 
approximately one hour in length. In the CY 2017 PFS final rule, we 
agreed with commenters that our former proposal of a one-hour 
requirement may be too rigid when compared against CDC-approved DPP 
curricula that vary in approach and mode of delivery. We noted that 
``approximately one-hour in duration'' is an appropriate requirement 
for in-person sessions because completion of a curriculum topic may 
vary depending on factors such as number of attendees, how the program 
is delivered, beneficiaries' assessed need, the curriculum topic, and 
the approach to the curriculum. As stated in the CY 2017 PFS final 
rule, we do not believe the CDC DPRP Standard that ``each session must 
be of sufficient duration to convey the session content'' is an 
auditable requirement, and therefore, we declined to adopt it for MDPP 
because having auditable requirements is a critical component of our 
program integrity efforts (81 CFR 80468). We believe our previous 
amendment to the session duration (formerly Sec.  410.79(c)(2)(i) and 
(c)(2)(ii), and redesignated at Sec.  410.79(b) in this final rule) is 
satisfactory and that our rationale applies equally to MDPP suppliers 
providing MDPP services to MA enrollees. Therefore, we are not 
modifying the requirement that ongoing maintenance sessions must be 
``approximately one-hour in duration.''
    We also decline to adopt commenters' recommendation to permit MA 
plans flexibility in providing MDPP services so long as the curriculum 
is similar to the CDC DPRP curriculum described at Sec.  410.79(b) as 
we believe adequate flexibility is already available to any MDPP 
supplier. As finalized in this final rule, MDPP services must meet the 
definition established at Sec.  410.79(b) defining MDPP services as 
``structured health behavior change sessions that are furnished under 
the MDPP expanded model with the goal of preventing diabetes among 
Medicare beneficiaries with prediabetes, and that follow a CDC-approved 
curriculum. The sessions provide practical training in long-term 
dietary change, increased physical activity, and problem solving 
strategies for overcoming challenges to maintaining weight loss and a 
healthy lifestyle.'' We also finalized in the CY 2017 PFS final rule 
that MDPP suppliers may, consistent with their CDC DPRP recognition, 
use either the CDC-preferred curriculum as designated by the CDC DPRP 
Standards or an alternative curriculum approved for use in DPP by the 
CDC (81 CFR 80467). The CDC preferred curriculum is available at http://www.cdc.gov/diabetes/prevention/lifestyle-program/curriculum.html. 
Therefore, MDPP suppliers, including those contracting with an MA plan 
or an MA plan itself when that MAO is enrolled in Medicare as an MDPP 
supplier, may choose to develop and use an alternative curriculum for 
MDPP services so long as the MDPP supplier has first had the curriculum 
approved by the CDC DPRP.
    Comment: We received one comment that requested additional 
clarification on how MA plans will be required to report encounters for 
MDPP services to CMS.
    Response: This question was asked in the context of a general 
request for CMS to provide additional guidance to MA plans regarding 
the implementation of MDPP in MA. Given this context, we believe that 
this could be a question about reporting this specific type of data to 
CMS under Sec.  422.310, which requires MA plans to report data (for 
risk adjustment purposes) about services provided to MA enrollees. 
While unrelated to the changes to the set of MDPP services, we note 
that the application of Sec.  422.310 in this context is not within the 
scope of the MDPP rule. We believe that there is no reason to treat 
MDPP services differently from other services furnished by an MA plan 
for which the data requirements of Sec.  422.310 apply. We further note 
that additional guidance to MA organizations will be forthcoming.
    After considering the public comments, we will finalize all 
definitions as proposed with the exception of the MDPP Services Period. 
In response to public comments, we are finalizing the definition of the 
MDPP Services Period as consisting of a core services period of 1 year 
and an ongoing maintenance services period of 1 year at (Sec.  
410.79(c)(2)).
i. Ongoing Maintenance Session Time Limit
    In the CY 2017 PFS final rule, we finalized that ``MDPP eligible 
beneficiaries'' (a term we proposed to remove and replace with ``MDPP 
beneficiary,'' as described further in section III.K.2.c. of this final 
rule) would have Medicare coverage for ongoing maintenance sessions for 
an unspecified length of time, provided that they maintained the 
required minimum weight loss, which is 5 percent weight loss from 
baseline. Based on public comments indicating the limited 
administrative and operational capability of many MDPP suppliers to 
provide ongoing maintenance sessions for an individual indefinitely (81 
FR 80467), we stated our intent to propose a limit on the number or 
duration of ongoing maintenance sessions to be covered in the set of 
MDPP services in future rulemaking.
    In the CY 2018 PFS proposed rule, we proposed a 2-year limit on 
Medicare coverage for ongoing maintenance sessions (Sec.  
410.79(c)(2)(ii)). The CMS Chief Actuary noted in the certification of 
the expansion of the DPP model test that continued participation in a 
DPP after 3 years has generally been untested. In addition, a DPP 
clinical trial conducted by the National Institutes of Health from 1996 
to 2001 followed participants in a DPP for 3 years and found that, at 
the end of the study, diabetes incidence was reduced by 58 percent in 
the group that received a DPP lifestyle intervention when compared to 
the placebo group.\9\ Based on the lack of evidence about DPP services 
beyond 3 years and evidence of positive effects from DPP participation 
for 3 years, in the CY 2018 PFS proposed rule, we proposed a total MDPP 
services period of up to 3 years (consisting of 1 year of core sessions 
and core maintenance sessions, followed by up to 2 years of ongoing 
maintenance sessions, (Sec.  410.79(b)).
---------------------------------------------------------------------------

    \9\ Available at http://www.nejm.org/doi/full/10.1056/NEJMoa012512.
---------------------------------------------------------------------------

    We considered alternatives to this proposal, such as limiting 
Medicare coverage for ongoing maintenance sessions to 1 year, which 
would limit the total MDPP services period to 2 years. Because the CDC 
DPRP does not require organizations to offer ongoing maintenance 
sessions, we also considered not covering ongoing maintenance sessions 
at all, which would limit the total MDPP services period to 1 year. 
However, we believe that beneficiaries can benefit from maintenance 
sessions beyond the 6 months of core maintenance sessions because 
weight loss is difficult to achieve and can be even more difficult to 
sustain. We believe that the behavior changes necessary to sustain 
weight loss will be more deeply ingrained through beneficiary 
participation in ongoing maintenance sessions. Existing evidence

[[Page 53240]]

also supports the effectiveness of participation in a DPP through 3 
years.
    We did not consider alternatives that would extend Medicare 
coverage for ongoing maintenance sessions beyond 2 years, and 
therefore, create an MDPP services period that would last longer than 3 
years. Therefore, we proposed to continue to include ongoing 
maintenance sessions, but with a limit of up to 2 years. As stated 
earlier, we believe there is not enough evidence available to support 
the effectiveness of participation in a DPP beyond 3 years. We also 
believe, based on public comments received in response to the CY 2017 
PFS proposed rule, that many suppliers have limited administrative and 
operational capacity to offer MDPP ongoing maintenance sessions 
indefinitely to all MDPP beneficiaries who maintain eligibility. As 
noted in section III.K.2.e.iv.4 of this final rule, an example of a 
capacity limit could include a situation where an MDPP supplier has met 
its class size maximum and therefore could not accept additional 
beneficiaries. We invited public comments on our proposal and the 
alternatives we considered.
    The following is a summary of the public comments received on our 
proposal and the alternatives we considered and our responses:
    Comment: We received several comments on the proposed time limit 
for ongoing maintenance sessions. Many commenters recommended limiting 
ongoing maintenance sessions to 1 year and defining the MDPP Set of 
Services as a 2-year service period. The majority of these commenters 
suggested that a 2-year service period better aligned with the evidence 
base, reduced supplier risk and administrative burden, and still 
allowed for adequate time for ongoing support to participants. One 
commenter stated that they support general limits to ongoing 
maintenance sessions, but expressed that by adding a third year to the 
overall MDPP services period, CMS is further expanding the DPP model 
test and the CDC National Diabetes Prevention Program curriculum 
without sufficient evidence to show that the benefit to beneficiaries 
would outweigh the burden on suppliers to continue to staff a third 
year of the program. Another commenter stated the scientific evidence 
to suggest an additional 24 months for ongoing maintenance sessions 
following the achievement of the 5 percent weight loss is unclear. In 
addition, some commenters expressed concern about MDPP suppliers 
delivering sessions to dwindling numbers of individuals over time and 
stated this was not a cost-effective approach, and could diminish the 
morale among those attending the ongoing maintenance sessions. One 
commenter suggested opportunities for MDPP beneficiaries to elect 
sessions beyond month 24 (possibly covered by the beneficiary's own 
funds). Another commenter stated they recognize the importance of 
ongoing maintenance classes, but find it unrealistic to have 
participants commit to a 3-year program. They stated that in their 
experience it is difficult to maintain retention in a 12-month program, 
and the effectiveness of the sessions furnished in a third year would 
diminish.
    Response: Upon consideration of the comments received, we agree 
that limiting the ongoing maintenance sessions to 12 months following 
the 12-month core program will reduce administrative burden and 
financial risk for suppliers while still providing 1 year of ongoing 
support and maintenance to help solidify behavior change in MDPP 
participants. Although there is evidence to support the effectiveness 
of participation in a DPP through 3 years, we acknowledge that evidence 
does not specifically address whether our proposed 2 years of ongoing 
maintenance is superior to 1 year of ongoing maintenance in 
establishing long-term behavior change or reduced incidence of type 2 
diabetes. However, we maintain our belief that evidence supports 
requiring ongoing maintenance sessions after the core services period 
as discussed in a subsequent response to comments in this section.
    In addition, we appreciate the commenters who pointed out that the 
absence of new curriculum for ongoing maintenance sessions posed a 
significant threat to the continued engagement of beneficiaries for a 
full 24 months. We agree with the assertion made by commenters that the 
core maintenance curriculum could become too repetitive during a second 
year of ongoing maintenance resulting in increasingly lower levels of 
participation among beneficiaries during later intervals. Based on the 
comments received on our proposals, we also better understand how this 
could contribute to dwindling enrollment during the ongoing maintenance 
years and how dwindling enrollment could create significant financial 
hardships for suppliers. We agree that it would be difficult and 
possibly economically unsustainable to secure space, staff coaches, and 
produce materials for classes that were not well attended due to a 
steady decrease in participants over the course of the ongoing 
maintenance period. From these comments, we believe finalizing a 2-year 
requirement for the ongoing services period could have a negative 
impact on the number of DPP organizations that choose to enroll as MDPP 
suppliers due to the estimated financial hardships of this requirement.
    Therefore, we believe that a modification to our policy to require 
1 year of ongoing maintenance following the core services period is 
both supported by current evidence and responds to the practical 
considerations of implementing MDPP services by MDPP suppliers.
    Comment: A few commenters recommended that ongoing maintenance 
sessions be available in perpetuity with some suggesting a 
restructuring of the ongoing maintenance sessions. One commenter 
suggested that CMS reconsider its proposed 2-year time limit on 
Medicare coverage for ongoing maintenance sessions. This commenter 
stated an appreciation for CMS' intent to control costs, but suggested 
that some Medicare beneficiaries may continue to benefit from MDPP for 
longer periods of time. Another commenter suggested that all 
beneficiaries who complete the program should be eligible for a 
lifetime of maintenance support independent of weight loss goal 
achievement. The commenter suggested the delivery of ongoing 
maintenance sessions could be restructured to include 2-3 sessions per 
year as needed.
    Response: We disagree with the commenters that recommended we make 
ongoing maintenance sessions available in perpetuity. There is no 
evidence to suggest that ongoing maintenance sessions offered in 
perpetuity would provide any additional health benefit to Medicare 
beneficiaries. Similarly, and taking other public comments into 
account, there is no evidence to demonstrate a demand from 
beneficiaries for ongoing maintenance sessions in perpetuity. Lastly, 
there is no evidence to support that 2-3 sessions per year would be 
adequate for maintaining weight loss, and we do not believe this level 
of engagement is sufficient to warrant continued coverage of the MDPP 
services (please see more detailed discussion on session attendance 
during the ongoing services period in section III.K.2.c.iv.(b) of this 
final rule).
    Comment: Some commenters supported the proposed 2-year time limit 
for ongoing maintenance sessions. One commenter supported CMS's 
proposal to provide 2 years of ongoing maintenance sessions for a total 
of 3 years of MDPP services. This commenter stated that patients 
require ongoing support to make long-lasting

[[Page 53241]]

behavioral changes, and since appropriate care plans and interventions 
may change over time, this item is most important for continued patient 
and program success. Another commenter stated that it is helpful, too, 
to cover the 2 years of maintenance after the core and core maintenance 
part of the DPP. The commenter stated that people do not change and 
maintain significant behavioral changes without this added opportunity 
for maintenance and support.
    Response: We agree that maintaining significant behavioral change 
is challenging and requires ongoing maintenance and support. The 
evidence is less clear in terms of exactly how long ongoing maintenance 
is needed to sustain significant behavior change. Given this lack of 
clarity on the optimal length of maintenance coupled with the many 
comments we received from DPP organizations and other DPP stakeholders 
with keen insight into the delivery of DPP, we have chosen to finalize 
one of our alternatives and limit ongoing maintenance to 1 year.
    Comment: Some commenters did not support the inclusion of ongoing 
maintenance sessions at all. Many of these commenters suggested that 
DPP organizations may not have the capacity to deliver ongoing 
maintenance sessions as proposed by CMS, and at this time, there is not 
a CDC curriculum for this program phase. Another commenter stated that 
ongoing maintenance beyond 12 months should not be required by MDPP 
suppliers as a condition for payment. A few commenters suggested that 
while individuals often need ongoing support to maintain behavior 
change, individuals start dropping out of programs at 12 months. Other 
commenters recommended that CMS more closely align the MDPP services 
period with the CDC Diabetes Recognition Program curriculum and 
requirements which do not include any ongoing maintenance sessions. One 
commenter stated that to date, the evidence-base regarding DPP has been 
based on a 1-year program, and therefore, recommend that the program 
should remain a 1-year program. Lastly, a few commenters appreciated 
the importance of ongoing maintenance sessions in supporting the 
sustainability of participant outcomes but stated that the proposed 
level of reimbursement under the MDPP would not support the cost of 
additional human and material resources that would be needed to follow 
Medicare participants for an additional 2 years.
    Response: We disagree that the evidence-base regarding DPP has been 
based on a 1-year program. In developing our length of service 
proposals, we performed an extensive literature review of the evidence, 
consulted with current DPP providers, the CDC's National Diabetes 
Prevention Program (DPP) staff, physicians, and a large commercial 
insurer. This research provided us with the evidence to support 
anywhere from a 1-year DPP program to a 3-year DPP program. We 
acknowledge that the CDC's National DPP does not currently extend 
beyond a 12-month program; however, as a payer, we are interested in 
taking an approach, which has been supported by the existing evidence 
base and public commenters, that we believe is most likely to sustain 
the behavior change beyond 12 months.
    After considering the public comments, we are finalizing the length 
of the MDPP Services Period as a 2-year MDPP services period, 
specifically finalizing that after year 1, suppliers of MDPP would have 
to offer 1 year of ongoing maintenance sessions to beneficiaries who 
continue to meet attendance/weight loss goals. Finalizing this 
alternate proposal reduces administrative burden and financial risk to 
suppliers while providing up to 1 year of additional support to 
beneficiaries. Based on our research and echoed by many of the public 
comments, we received in response to our CY2018 PFS proposed rule, we 
believe 12 months of ongoing maintenance should solidify the behavior 
change and help to ensure that weight loss outcomes are sustained.
ii. MDPP Services Period Clarifications
    At Sec.  410.79(b), we proposed to remove the existing definition 
of ``maintenance session bundle,'' and to establish new definitions for 
``core maintenance session interval,'' and ``ongoing maintenance 
session interval,'' which we believe will more directly reflect the 
structure of the set of MDPP services, as well as support the policies 
in this final rule. Through these definition changes, we were seeking 
to clarify the differences between the two types of intervals. We 
proposed to define ``core maintenance session interval'' as one of the 
two consecutive 3-month time periods during months 7 through 12 of the 
MDPP services period, during which an MDPP supplier offers an MDPP 
beneficiary at least 1 core maintenance session per month. We proposed 
to define ``ongoing maintenance session interval'' as one of the up to 
eight consecutive 3-month time periods during the ongoing services 
period described in Sec.  410.79(c)(2)(ii), during which an MDPP 
supplier offers at least 1 ongoing maintenance session to an MDPP 
beneficiary per month.
    We made the proposal to use the term ``interval'' instead of 
``bundle'' because the performance payments are tied to attendance and 
weight loss performance goals and, in aggregate, constitute the payment 
to MDPP suppliers for furnishing MDPP services during the MDPP services 
period, but they do not provide specific payments for a particular 
subset of sessions. Therefore, we believe that the term ``bundle'' is 
not appropriate for describing performance payments for these time 
intervals. The new terms would allow us to more appropriately describe 
the relationship of the performance payments to the specific time 
periods where performance is measured. Furthermore, we proposed to 
define ``make-up session'' as a core session, a core maintenance 
session, or an ongoing maintenance session furnished to an MDPP 
beneficiary when the MDPP beneficiary misses a regularly scheduled core 
session, core maintenance session, or ongoing maintenance session 
(Sec.  410.79(b)). We proposed to define ``virtual make-up session'' as 
a make-up session that is not furnished in person and that is furnished 
in a manner consistent with the DPRP standards for virtual sessions 
(Sec.  410.79(b)). Policies describing the parameters of make-up 
sessions and virtual make-up sessions are described further in section 
III.K.2.c.iv.(3) of this final rule.
    We proposed an additional term that helps describe key aspects of 
the MDPP expanded model: ``performance goal.'' This term refers to an 
attendance or weight loss goal that an MDPP beneficiary must achieve 
during the MDPP services period for an MDPP supplier to be paid a 
performance payment (Sec.  414.84(a)). Because we proposed this term 
that more broadly speaks to the performance goals of this expanded 
model, we proposed to remove the definition of ``maintenance of weight 
loss.'' We also proposed to move the definition of ``coach'' from Sec.  
410.79(b) to Sec.  424.205(a) (we proposed in section III.K.2.e to 
redesignate Sec.  424.59, Requirements for Medicare Diabetes Prevention 
Program suppliers to Sec.  424.205). We proposed to revise the 
definition of ``MDPP supplier'' to mean an entity that is enrolled in 
Medicare to furnish MDPP services as provided in Sec.  424.59 
(redesignated as Sec.  424.205).
    We did not receive comments on the proposed revisions to these 
definitions, and therefore, we are finalizing these revisions as 
proposed with the exception of the definition for ``ongoing maintenance 
session interval.'' In order to align with the finalization of the

[[Page 53242]]

MDPP Services Period as a 2-year period, we are finalizing the 
definition of the ongoing maintenance session interval as one of the up 
to four consecutive 3-month time periods during the ongoing services 
period described in Sec.  410.79(c)(2)(ii), during which an MDPP 
supplier offers at least 1 ongoing maintenance session to an MDPP 
beneficiary per month.
c. Changes Related to Beneficiary Eligibility
    In the CY 2017 PFS final rule, we established the eligibility 
criteria for Medicare beneficiaries to have coverage of the set of MDPP 
services, codified at Sec.  410.79(c)(1) and (d), respectively. We 
previously finalized that an individual who met these criteria would be 
referred as an ``MDPP eligible beneficiary.'' However, in the CY 2018 
PFS proposed rule, we proposed to remove this term, and instead, add 
the definition of ``MDPP beneficiary'' to mean a Medicare beneficiary 
who meets the criteria specified in Sec.  410.79(c)(1)(i), who has 
initiated the MDPP services period by attending the first core session, 
and for whom the MDPP services period has not ended as specified in 
Sec.  410.79(c)(3) (Sec.  410.79(b)). We believe that this revised 
definition will provide more clarity about when a beneficiary qualifies 
to receive MDPP services. We proposed to remove the definition of 
``MDPP eligible beneficiary'' to avoid confusion between the two 
definitions, and we proposed conforming changes to Sec.  410.79 to 
remove the term ``MDPP eligible beneficiary'' and use the term ``MDPP 
beneficiary'' in its place, where appropriate.
    In the CY 2017 PFS final rule (81 FR 80470), we specified at Sec.  
410.79(c)(1) that Medicare beneficiaries are eligible for MDPP services 
if they meet all of the following criteria:
     Are enrolled in Medicare Part B.
     Have, as of the date of attendance at the first core 
session, a body mass index (BMI) of at least 25 if not self-identified 
as Asian or a BMI of at least 23 if self-identified as Asian (please 
see our discussion of BMI parameters in the CY 2017 PFS final rule at 
81 FR 80468).
     Have, within the 12 months prior to attending the first 
core session, a hemoglobin A1c test with a value between 5.7 and 6.4 
percent, a fasting plasma glucose of 110-125 mg/dL, or a 2-hour plasma 
glucose of 140-199 mg/dL (oral glucose tolerance test).
     Have no previous diagnosis of type 1 or type 2 diabetes 
(other than gestational diabetes).
     Do not have end-stage renal disease (ESRD).
    In the CY 2018 PFS proposed rule, we proposed changes to these 
eligibility criteria at Sec.  410.79(c)(1) to clarify the eligibility 
limitations related to previous type 1 or type 2 diabetes diagnosis 
(described further in section III.K.2.c.ii. of this final rule), move 
and edit the regulation text that specifies that each beneficiary can 
only receive the set of MDPP services once in their lifetime (described 
further in section III.K.2.c.iii. of this final rule), and make changes 
so that the provisions are specific to an individual beneficiary. We 
also clarify some of the eligibility criteria.
    Comment: We received a variety of comments on referral pathways for 
MDPP services, though we did not specifically propose any new policies 
regarding referrals. Some commenters supported the policy that CMS 
allow multiple referral pathways for beneficiaries, including self-
referral, referral by a physician, and referral from community-based 
organizations. One commenter who supported these multiple referral 
pathways also noted that beneficiaries who self-refer or are referred 
by community programs to MDPP may not fully benefit from care 
coordination by their primary care provider on their diabetes care. 
This commenter urged CMS to consider a mechanism to ensure that the 
beneficiary's primary care provider be notified of the beneficiary's 
participation in MDPP in cases where the primary care provider is not 
the referring person or entity.
    MedPAC opposed the policy of multiple referral pathways, preferring 
instead that only a clinician referral be allowed, and required, for 
each MDPP beneficiary. MedPAC noted that clinician referrals would help 
ensure clinical appropriateness of MDPP services or integration with 
other medical services and health maintenance goals. They were also 
concerned that multiple referral pathways would assist in leading to 
broad expansion of MDPP services and up-take, far beyond the population 
for which it is appropriate. MedPAC offered the example of an MDPP 
supplier conducting an MDPP session for a large group of beneficiaries 
at a nursing home, without consideration of whether a general weight 
loss target is clinically appropriate for each beneficiary in that 
group. Other commenters noted that there was no mention in the proposed 
rule of a provider referral mechanism or reimbursement, and recommended 
creating patient referral codes.
    Response: We note that in the CY 2017 PFS final rule we finalized 
that Medicare beneficiaries who meet the MDPP eligibility criteria may 
obtain MDPP services by self-referral, community-referral, or health 
care practitioner-referral. Since we did not propose any changes to the 
referral policy in this rule, we are not finalizing any changes to this 
policy, but reemphasize our position regarding beneficiary referrals to 
and from MDPP services. We note that MDPP is a preventive service. 
Given that preventive services are generally underutilized,\10\ 
facilitating broad access to MDPP services is important. In addition, 
the MDPP expanded model has been certified by the CMS Office of the 
Actuary to be cost-saving, and therefore, we believe eliminating 
barriers, such as clinician referrals, will facilitate access to this 
cost-saving preventive service. We also note that Medicare 
beneficiaries can always consult with their health care provider about 
whether MDPP services are clinically appropriate for the beneficiary.
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    \10\ See, for example: Partnership for Prevention, ``Preventive 
Care: A National Profile on Use, Disparities, and Health Benefits,'' 
Robert Wood Johnson Foundation (2007), https://www.rwjf.org/content/dam/farm/reports/reports/2007/rwjf13325; Maciosek, et al., ``Greater 
Use of Preventive Services in U.S. Health Care Could Save Lives at 
Little or No Cost,'' Health Affairs 29, no. 9 (2010): 1656-1660, 
http://content.healthaffairs.org/content/29/9/1656.full.pdf+html; 
Farley, et al., ``Deaths Preventable in the U.S. by Improvements in 
Use of Clinical Preventive Services,'' American Journal of 
Preventive Medicine 38, no. 6 (2010): 600-609, http://www.sciencedirect.com/science/article/pii/S0749379710002072.
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    We acknowledge the concerns from MedPAC regarding uptake of MDPP 
services beyond the population for which it is appropriate. We believe 
the requirement for MDPP suppliers to maintain CDC preliminary or full 
recognition will provide some level quality assurance. Specifically, 
maintenance of CDC recognition will require MDPP suppliers to continue 
to achieve performance standards based on attendance and average weight 
loss among participants. If an MDPP supplier chose to enroll large 
numbers of individuals who were clinically inappropriate for MDPP (for 
example, who lack the cognitive capability to implement the behavior 
changes), these practices may drive down their average performance 
data, and negatively affect the supplier's ability to maintain CDC 
recognition. Nevertheless, we are establishing monitoring mechanisms 
such that if a supplier was offering MDPP services to large numbers 
beneficiaries for whom the services may not be appropriate, we could 
identify this supplier and take appropriate administrative action.
    Comment: Two commenters asked whether MA plans can modify

[[Page 53243]]

beneficiary eligibility requirements for MA enrollees. The first 
commenter asked for clarification on whether an MA plan may impose 
additional eligibility requirements for MA enrollees, such as the 
requirement that an enrollee have a primary care physician referral to 
access MDPP services or to require a blood test prior to authorizing 
MDPP services. The second requested that we provide MA plans with the 
flexibility to provide or arrange for MDPP services as deemed 
appropriate by the plans, which the commenter identified as the 
standard for other Parts A and B services.
    Response: While we did not propose any additional policies 
regarding referrals or alternative MDPP beneficiary eligibility 
criteria, we respond to commenters here to clarify this issue. Under 
Sec.  422.100(a), MA plans are required to provide enrollees in that 
plan with coverage of Medicare-covered services. As a Part B Medicare-
covered service, Sec.  422.100(f) requires CMS to ensure that an MA 
plan's coverage of MDPP services meets CMS fee-for-service rules 
described in this final rule and the CY 2017 PFS final rule. 
Additionally, Sec.  422.101(b)(2) requires MAOs to comply with general 
coverage guidelines included in original Medicare manuals and 
instructions unless superseded by MA regulations or guidance in 
connection with coverage of basic benefits.
    In response to commenter's request to require physician referrals 
for MDPP services, we note that previous MDPP guidance, the CY 2017 PFS 
final rule, intentionally does not include a requirement for a 
physician referral to be eligible for coverage. In that rule, we 
finalized that we would not require any specific type of referral for 
the MDPP expanded model test in order to ensure broad program access 
(81 CFR 80471). In finalizing this policy, we noted that we understood 
the value of coordinating results from the MDPP with a beneficiary's 
primary care provider, however, we declined to require this type of 
coordination because we believe it creates an additional burden for 
this new supplier type that will discourage DPP organizations from 
enrolling in Medicare as MDPP suppliers. Furthermore, regarding 
commenter's request to allow MA plans to arrange for MDPP services as 
deemed appropriately by the plan, we understand the commenter to be 
requesting that MA plans be permitted to arrange for MDPP services as 
deemed medically necessary by the plan, as is the current standard. 
While general coverage guidelines included in original Medicare manuals 
and instructions may permit MAOs to arrange for other Parts A and B 
services as deemed medically necessary by the plan, in the CY 2017 
final rule (81 CFR 80468 through 80470) and in this section of this 
final rule we explicitly designate a set of criteria for determining 
eligibility for MDPP services. Therefore, to ensure access to MDPP 
services as a Medicare covered service is consistent with coverage 
available in Original Medicare, we decline to permit MA plans to modify 
the eligibility requirements established in this final rule when 
determining the eligibility of a plan enrollee for coverage of MDPP 
services.
    Comment: Some commenters raised concerns that obtaining 
documentation for clinical blood values from beneficiaries to determine 
their eligibility prior to furnishing MDPP services will present 
challenges to MDPP suppliers. One commenter in particular raised 
concerns with requiring blood tests from every beneficiary, citing this 
as a structural barrier for beneficiary participation and a burden on 
MDPP suppliers who may not be able to afford to delay MDPP sessions for 
individuals who are missing the required documentation. This commenter 
recommended that CMS adopt CDC's National DPP requirement that at least 
50 percent of participants qualify for the DPP based on blood values, 
and allow the remaining 50 percent to participate based on a risk 
assessment. This commenter also noted that the National DPP allows 
blood values to be collected and documented after an individual begins 
DPP sessions, and requested that CMS allow MDPP beneficiaries up to 30 
days after the first core session to provide their blood test results 
given that the beneficiary meets all other MDPP eligibility criteria.
    Response: We note that we finalized beneficiary eligibility 
criteria, including criteria for blood test results, in the CY 2017 PFS 
final rule. Since we did not propose any changes to the blood test 
requirements in this rule, we are not finalizing any changes but are 
clarifying our policy. We acknowledge that the CDC enforces the blood 
test eligibility criteria at the organizational level. However, since 
Medicare will be paying for individuals receiving a service, it is 
necessary that we enforce eligibility on an individual basis as well. 
We also acknowledge that CDC allows blood values to be collected and 
documented after an individual begins DPP sessions. We considered 
allowing this policy for MDPP beneficiaries. However, if a beneficiary 
began MDPP services and was later determined ineligible due to their 
blood values, we have no way to prevent an MDPP supplier from charging 
the beneficiary for the services already received. We do not want to 
allow situations where a beneficiary could potentially be held liable 
for a service he/she thought was covered by Medicare, so we are not 
pursuing a change to this policy.
    As we did not propose any substantive changes to the beneficiary 
eligibility policies, including referral pathways and blood test 
documentation, we are not finalizing any changes to these policies.
i. Clarifying MDPP Eligibility Criteria Related to Gestational Diabetes 
and End-Stage Renal Disease (ESRD)
    In the CY 2018 PFS proposed rule (82 FR 34133), we noted that we 
are not excluding beneficiaries with a prior history of gestational 
diabetes from eligibility for MDPP services, while beneficiaries with a 
prior history of a diagnosis of type 1 or type 2 diabetes are 
ineligible. The eligibility criteria are intended to identify a 
beneficiary at high risk for the development of type 2 diabetes in an 
individual that has not been diagnosed with type 1 or type 2 diabetes. 
Gestational diabetes is a condition that develops during pregnancy and 
typically resolves after delivery, although an individual with a 
history of gestational diabetes is at increased risk of subsequent type 
2 diabetes development and may benefit from the set of MDPP services. 
Because of the clinical differences between gestational diabetes and 
type 1 or type 2 diabetes, we determined that it was appropriate not to 
exclude a beneficiary with a prior history of gestational diabetes from 
eligibility for MDPP services.
    We also proposed (82 FR 34133) that a beneficiary who is diagnosed 
with ESRD after having begun receiving MDPP services would lose 
eligibility. We do not believe MDPP services are appropriate for 
beneficiaries with ESRD because beneficiaries with ESRD require 
dialysis, and the nutrition requirements for individuals on dialysis 
are very specific and therefore the MDPP curriculum will not apply.\11\ 
We believe that a beneficiary receiving MDPP

[[Page 53244]]

services who develops ESRD will be best suited by ceasing to receive 
MDPP services and receiving attention by other health care 
professionals specifically suited to address his or her condition. 
Additionally, individuals with ESRD were not included in the DPP model 
test. We noted that suppliers can use the online HIPAA Eligibility 
Transaction System (HETS) to verify if a beneficiary has ESRD by 
checking his or her eligibility status as a Part B or ESRD Medicare 
beneficiary. Suppliers can find more information on this system at 
https://www.cms.gov/hetshelp/. We recognized that some Medicare 
beneficiaries may have other serious conditions, such as heart disease 
or cancer, and therefore may also have specific dietary requirements. 
We recommended that beneficiaries with complex dietary needs consult 
their health care provider as to whether they should participate in 
MDPP.
---------------------------------------------------------------------------

    \11\ WE Mitch, ``Beneficial responses to modified diets in 
treating patients with chronic kidney disease,'' Kidney 
International Supplements April, 94 (2005): S133-5, https://www.ncbi.nlm.nih.gov/pubmed/15752230. J Rysz et al., ``The Effect of 
Diet on the Survival of Patients with Chronic Kidney Disease,'' 
Nutrients 9, no. 5 (2017): E495, https://www.ncbi.nlm.nih.gov/pubmed/28505087. ME Chen et al., ``Correlations of dietary energy 
and protein intakes with renal function impairment in chronic kidney 
disease patients with or without diabetes,'' The Kaohsiung Journal 
of Medical Sciences 33, no. 5 (2017):252-259, https://www.ncbi.nlm.nih.gov/pubmed/28433072.
---------------------------------------------------------------------------

    In summary, we noted that a beneficiary must maintain Medicare Part 
B coverage and not have ESRD throughout the duration of the MDPP 
services period to remain eligible to receive coverage for MDPP 
services. In conjunction with our proposal in the proposed rule related 
to diabetes diagnosis (explained further in section III.K.2.c.ii. of 
this final rule), we noted that a beneficiary must meet the eligibility 
requirements related to prediabetes and diabetes (including BMI, blood 
test results, and no diagnosis of diabetes other than gestational 
diabetes) as of the date of attendance at the first core session.
    We invited public comments on these clarifications. The following 
is a summary of the public comments received on these clarifications 
and our responses:
    Comment: Commenters noted their support for the clarifications 
related to gestational diabetes and End-Stage Renal Disease (ESRD) 
eligibility criteria. One commenter requested that CMS integrate checks 
on ESRD at the federal level. Another commenter requested that CDC and 
CMS align eligibility criteria related to gestational diabetes. The 
commenter noted that CDC does not allow individuals who previously had 
gestational diabetes to participate in DPP, whereas CMS does allow 
beneficiaries who previously had gestational diabetes to participate in 
MDPP. One commenter requested clarification on whether an individual 
with a history of gestational diabetes must still meet prediabetes and 
BMI eligibility requirements to participate in MDPP.
    Response: We appreciate commenters' support for the clarifications 
about gestational diabetes and ESRD eligibility criteria. CMS currently 
has a system that suppliers can use to check whether an individual has 
Medicare coverage by way of ESRD, called the HIPAA Eligibility 
Transaction System (HETS). Suppliers can find more information on this 
system at https://www.cms.gov/hetshelp/. Medicare suppliers can also 
determine this information by contacting their Medicare Administrative 
Contractor (MAC). We note, however, that the HETS system may only 
identify beneficiaries entitled to Medicare by way of ESRD, as 
described in Sec.  406.13 of this chapter. Beneficiaries who are 
entitled to Part B benefits by aging into Medicare, who then develop 
ESRD, are not captured as having ESRD in HETS. Therefore, we clarify 
that MDPP suppliers can rely on self-reported ESRD status for 
beneficiaries who age into Medicare. We view this process as similar to 
the other self-reported eligibility criteria we noted in the CY 2017 
final rule (81 CFR 80469), including a history of type 1 or type 2 
diabetes diagnosis. As noted in Sec.  424.205(d)(11), before the 
initial core session is furnished, the MDPP supplier must disclose 
detailed information about the set of MDPP services to each MDPP 
beneficiary to whom it wishes to begin furnishing MDPP services. This 
information must include beneficiary eligibility requirements under 
Sec.  410.79(c)(1), which include ESRD status and history of type 1 or 
type 2 diabetes diagnosis. We intend to include in guidance that this 
disclosure should inform beneficiaries to report this information to 
their MDPP supplier.
    In response to the commenter who noted a discrepancy in eligibility 
criteria between CDC and CMS regarding individuals with a previous 
diagnosis of gestational diabetes, we believe that the commenter was 
mistaken. CDC has always allowed women with a previous diagnosis of 
gestational diabetes to participate in the National DPP. If a woman has 
a previous diagnosis of gestational diabetes and meets the BMI and age 
criteria, she is eligible for the National DPP and would not need a 
blood test or an elevated risk test score.\12\ Similarly, if a Medicare 
beneficiary has had a previous diagnosis of gestational diabetes and 
meets all other MDPP eligibility criteria, the beneficiary is eligible 
to receive MDPP services, as described at Sec.  410.79(c)(1)(i)(E).
---------------------------------------------------------------------------

    \12\ Centers for Disease Control and Prevention, ``Centers for 
Disease Control and Prevention Diabetes Prevention Recognition 
Program Standards and Operation Procedures,'' CDC (2015), https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
---------------------------------------------------------------------------

    We also note that the DPRP Standards allow women who become 
pregnant and develop gestational diabetes to continue participation in 
the national DPP. Similarly, we clarify if a Medicare beneficiary 
becomes pregnant and develops gestational diabetes while receiving MDPP 
services, that beneficiary may continue participation in MDPP (as long 
as the beneficiary continues to meet the applicable performance goals 
required for eligibility). We encourage commenters to look to the final 
2018 DPRP Standards, when available, for any updated information on how 
gestational diabetes is treated for the purposes of CDC performance 
data reporting.
    Because we did not propose any policies, we are not making any 
modifications to the beneficiary eligibility criteria related to 
gestational diabetes and ESRD, at Sec.  410.79(c)(1)(i)(E) and 
(c)(1)(i)(F), respectively.
ii. Diabetes Diagnosis During the MDPP Services Period
    In the CY 2017 PFS final rule, we finalized at Sec.  410.79(c)(1) 
that to be eligible for coverage for the set of MDPP services, a 
Medicare beneficiary must have prediabetes, as shown through a 
qualifying BMI and blood test results, and must have no previous 
diagnosis of type 1 or type 2 diabetes (other than gestational 
diabetes). We received public comments in response to the CY 2017 PFS 
proposed rule that asked whether a beneficiary would remain eligible 
for the set of MDPP services if the beneficiary developed type 2 
diabetes during the MDPP services period. In the CY 2017 PFS final 
rule, we deferred action in response to these public comments and are 
now addressing them in this final rule.
    We proposed in the CY 2018 PFS proposed rule (82 FR 34133 through 
34134) that the diabetes diagnosis exclusion applies only at the time 
of the first core session (that is, if a beneficiary develops diabetes 
during the MDPP services period, it would not affect the beneficiary's 
eligibility to continue receiving MDPP services). Specifically, we 
proposed to revise the eligibility requirements for MDPP services to 
state that a beneficiary has, as of the date of attendance at the first 
core session, no previous diagnosis of diabetes, other than gestational 
diabetes (Sec.  410.79(c)(1)(i)(E)). This policy proposed was based in 
part on the fact that the DPP model test, which demonstrated cost 
savings, did not exclude from the model individuals

[[Page 53245]]

who developed type 2 diabetes. Additionally, whereas suppliers can 
check HETS to verify if a beneficiary has Medicare coverage by way of 
ESRD, and can rely on self-report for beneficiaries who age into 
Medicare and then develop ESRD, we believe requiring a supplier to 
reassess other beneficiary eligibility criteria such as diabetes status 
and blood test results, and subsequently removing those who no longer 
meet the eligibility criteria is impractical and unduly burdensome.
    Alternatively, we considered deeming any beneficiary who develops 
diabetes during the MDPP services period to be ineligible to continue 
to receive coverage for MDPP services because these services are 
intended to be preventive. If a beneficiary progresses to type 2 
diabetes, other treatment options, such as Diabetes Self-Management 
Training (DSMT), may be more appropriate than services that seek to 
prevent a condition the beneficiary already has. However, it is 
important to note that the receipt of MDPP services does not preclude a 
beneficiary from accessing other treatments for diabetes during the 
time period that the beneficiary is covered for MDPP services. An MDPP 
beneficiary who ultimately also receives DSMT at some time during the 
MDPP services period because he or she develops diabetes after 
beginning the set of MDPP services will receive different types of 
information and training. For example, a beneficiary receiving DSMT 
furnished by certified diabetes educators acquires knowledge for self-
care and life style changes including blood sugar monitoring, insulin 
usage, medication management, and crisis management. In contrast, MDPP 
services will be furnished by trained coaches who teach beneficiaries 
with prediabetes how to lower their risk of progressing to type 2 
diabetes with methods that do not include medication or other 
interventions for beneficiaries diagnosed with diabetes. Despite some 
common elements, the interventions for the MDPP expanded model and the 
DSMT benefit target different populations and furnish different 
services.
    We sought public comments on our proposal and whether individuals 
who develop type 2 diabetes during the MDPP services period should 
continue to be eligible for coverage of MDPP services for the full 
duration of the MDPP services period.
    The following is a summary of the public comments received on the 
proposal that if a beneficiary develops type 2 diabetes during the MDPP 
services period, it would not affect the beneficiary's eligibility to 
continue receiving MDPP services and our responses:
    Comment: The majority of commenters supported the proposal to allow 
beneficiaries who develop diabetes while receiving MDPP services to 
continue to be eligible for MDPP for the remainder of the MDPP Services 
Period. The commenters noted that MDPP services will continue to be 
beneficial to beneficiaries with diabetes, that the MDPP curriculum 
varies from other Medicare-covered diabetes curriculum, such as DSMT, 
and that it would be impractical and unduly burdensome for suppliers to 
continually verify a beneficiary's diabetes status and blood test 
results. Of those who supported the proposal, some commenters requested 
that MDPP suppliers also refer beneficiaries who develop diabetes to 
their health care provider while other commenters requested that MDPP 
suppliers inform the beneficiary of Medicare-covered diabetes services, 
such as DSMT. Some commenters remained neutral on the proposal, either 
requesting further clarification or recommending that CMS continue 
testing this policy to ensure beneficiary access, clinical goals, and 
program savings. One commenter disagreed with the proposal and 
recommended that individuals who develop diabetes only remain eligible 
for MDPP services until the end of the type of session the beneficiary 
is receiving (that is, core sessions, core maintenance sessions, or 
ongoing maintenance sessions). This commenter suggested that MDPP 
suppliers be required to refer beneficiaries who develop diabetes to 
medical nutrition therapy and DSMT services, noting concern that these 
beneficiaries may not receive the necessary referrals and underutilize 
these benefits.
    Response: We agree with the commenters who noted that MDPP services 
will continue to be beneficial to beneficiaries with diabetes, that the 
MDPP curriculum varies from other Medicare-covered diabetes curriculum, 
such as DSMT, and that it would be impractical and unduly burdensome 
for suppliers to continually verify a beneficiary's diabetes status and 
blood test results. We also note that the DPP model test, which 
demonstrated cost savings, did not exclude from the model individuals 
who developed diabetes. We clarify, for those who recommended continued 
testing, that CMS will monitor this policy over time and make 
adjustments if necessary. We clarify that we believe it is most 
appropriate for MDPP suppliers to recommend that beneficiaries who 
develop diabetes during the MDPP services period see their primary 
health care provider who is best suited to develop a treatment plan for 
beneficiaries, which could include continuation or discontinuation of 
MDPP services, or other diabetes-related health care services such as 
DSMT. As finalized in last year's final rule, and discussed further at 
section III.K.2.c of this final rule, however, we are not requiring 
MDPP suppliers to refer beneficiaries to health care providers. 
Additionally, an MDPP supplier (and the MDPP beneficiary) may be 
unaware that the beneficiary has developed diabetes, and therefore, we 
do not believe that mandatory referrals are appropriate. We note that 
the receipt of MDPP services does not preclude a beneficiary from 
accessing other treatments for diabetes during the time period that the 
beneficiary is covered for MDPP services, but emphasize the importance 
of beneficiaries who develop diabetes to consult with their health care 
provider on the most appropriate treatment plan for their diabetes, 
which may or may not include MDPP services.
    Comment: Some commenters noted data reporting discrepancies between 
CDC and CMS. They noted that the proposed 2018 DPRP standards suggest 
that DPP programs no longer submit data to CDC on participants that 
have received a type 2 diabetes diagnosis while receiving DPP services, 
whereas CMS will continue to collect data on, and pay for services for, 
these individuals. Commenters noted that this will cause a gap in MDPP 
suppliers' required crosswalk between a beneficiary's DPRP data and 
billing documentation for CMS. Commenters recommended that CDC and CMS 
align their data submission guidelines to best track and support these 
beneficiaries.
    Response: We appreciate the comments on this difference in data 
submission requirements. As with other parts of the MDPP expanded 
model, we are coordinating closely to align with CDC to ensure there 
are not major discrepancies between our programs. We encourage 
commenters to look to the final 2018 DPRP standards, when available, 
for any updated information on data reporting regarding individuals who 
develop type 2 diabetes while receiving DPP services.
    Comment: Some commenters noted incorrect information in the CY 2018 
PFS proposed rule. In discussing the alternative considered to our 
proposed diabetes diagnosis policy, we stated, ``[f]or example, a 
beneficiary receiving DSMT furnished by certified diabetes educators 
acquires knowledge for self-care and life style changes including

[[Page 53246]]

blood sugar monitoring, insulin usage, medication management, and 
crisis management'' (emphasis added). Commenters brought to our 
attention that the National Standards for Diabetes Self-Management 
Education and Support do not require health professionals to hold a 
certification in diabetes education to offer DSMT services and 
recommended we replace ``certified diabetes educators'' with a more 
appropriate phrase, such as ``health professionals who have experience 
in diabetes education.''
    Response: We appreciate commenters bringing this to our attention.
    In response to the comments, we are finalizing our proposal, 
without modification, that the diabetes diagnosis exclusion applies 
only as of the date of attendance at the first core session, (that is, 
if a beneficiary develops diabetes during the MDPP services period, it 
would not affect the beneficiary's eligibility to continue receiving 
MDPP services) at Sec.  410.79(c)(1)(i)(E).
iii. Once-Per-Lifetime Set of Services
    In the CY 2017 PFS final rule, we specified that coverage for the 
set of core MDPP services is available only once per lifetime for each 
MDPP beneficiary (codified at Sec.  410.79(d)(1)). In the CY 2018 PFS 
proposed rule, we proposed to delete Sec.  410.79(d)(1) and move this 
provision to Sec.  410.79(c)(1)(i)(B) to place it with other MDPP 
beneficiary eligibility criteria. We also proposed to edit this 
provision to specify that coverage for the full set of MDPP services, 
inclusive of ongoing maintenance sessions as opposed to only core MDPP 
services, is available only once per lifetime per MDPP beneficiary (82 
FR 34134). Since we had proposed to limit the ongoing services period 
to 2 years (which we are finalizing as 1 year), we believed that this 
revision is necessary to clarify that coverage for the entire set of 
MDPP services is subject to this limitation--otherwise, the once-per-
lifetime limitation has no practical effect because an MDPP beneficiary 
could continue to attend ongoing maintenance sessions long after the 
MDPP beneficiary has completed the core services period. In addition, 
for the reasons stated previously, we do not have evidence to support 
coverage of MDPP services for more than 3 years. We also are clarifying 
that the once-per-lifetime coverage limit applies to a beneficiary who 
receives a set of MDPP services under the MDPP model expansion. This 
limitation would not apply to beneficiaries who participated in a DPP 
as part of the DPP model test unless they receive the set of MDPP 
services under the MDPP expanded model. We invited public comments on 
our proposal.
    The following is a summary of the public comments received on the 
proposed provision that coverage for the full set of MDPP services, 
inclusive of ongoing maintenance sessions as opposed to only core MDPP 
services, is available only once-per-lifetime per MDPP beneficiary and 
our responses:
    Comment: The majority of commenters opposed the once-per-lifetime 
limit on MDPP services, generally, including the previously finalized 
once-per-lifetime limit on the core set of services finalized in the CY 
2017 PFS final rule and the proposed limit on the ongoing services. 
Some commenters only supported the lifetime limit if maintenance 
sessions were to be available for all beneficiaries regardless of 
weight loss, or if all beneficiaries who complete the core services can 
receive 2-3 maintenance sessions per year. Other commenters recommended 
that beneficiaries be able to access MDPP services annually, similar to 
what is allowed in some private plans. Commenters who opposed the once-
per-lifetime limit stated that the limit will decrease access to MDPP 
services, especially for those beneficiaries that need the most 
assistance. These commenters noted that behavior changes take time and 
often require multiple attempts or ongoing support. They additionally 
noted that major life events may prevent a beneficiary from 
participating.
    Some commenters recommended that beneficiaries be allowed to re-
enroll in MDPP services. Others recommended providing exceptions to the 
once-per lifetime limit in the case of a major life event, allowing a 
6- to 12-month waiting period for a beneficiary to re-enroll in MDPP 
after stopping (similar to Medicare's obesity counseling benefit), or 
both approaches. One commenter recommended that CMS allow MDPP 
beneficiaries to participate in an introductory session where 
beneficiaries can learn the requirements of the program and coaches can 
assess a beneficiary's readiness for change before initiating core 
sessions. The commenter recommended that CMS allow a beneficiary the 
opportunity to withdraw within 30 days from the start of the core 
services period without triggering the once-per-lifetime limitation so 
that those MDPP beneficiaries who may not be ready to complete the 
program may withdraw from MDPP and participate at a later time. Another 
commenter suggested that CMS and CDC identify and encourage the use of 
a validated ``readiness to change'' assessment instrument and a ``life 
stress'' assessment instrument to engage beneficiaries in a shared 
decision-making process so that individuals commit to the MDPP at a 
time they are most likely to succeed in the program. Some commenters 
also encouraged CMS to study the effect of allowing beneficiaries to 
enroll in the program multiple times.
    Response: We recognize that behavior changes take time and often 
require multiple attempts or ongoing support. We also understand 
concerns that major life events may prevent a beneficiary from 
participating during the MDPP services period. However, we finalized in 
the CY 2017 PFS final rule that the core set of MDPP services would 
only be available once-per-lifetime per MDPP beneficiary (previously at 
Sec.  410.79(d)(1); now at Sec.  410.79(c)(1)(i)(B)). The MDPP model 
expansion was designed to permit access to MDPP services to the 
greatest extent possible within the limits of how MDPP could be 
expanded. We also believe that having MDPP services available once-per-
lifetime will better engage beneficiaries to make behavior changes than 
if they could re-start services again at any time. We believe that this 
same rationale applies to ongoing maintenance sessions and continue to 
believe the once-per-lifetime limit is the most appropriate policy at 
this time, particularly given the added flexibilities beneficiaries 
have to use make-up sessions.
    In finalizing the once-per-lifetime limitation on MDPP services in 
the CY 2017 PFS final rule, we added in flexibility for beneficiaries 
by not including any attendance requirements for beneficiary 
eligibility in the first year of core services following the first core 
session. Therefore, beneficiaries can attend as many or as few sessions 
as the beneficiary wishes in the first year, and as long as they meet 
the 5 percent weight loss goal in months 10-12, they are eligible for 
ongoing maintenance sessions. If an unexpected or life-altering event 
does occur during the core services period, the beneficiary is not 
required to attend a certain number of sessions. The beneficiary can 
take a break and begin attending MDPP sessions again within the first 
year. The beneficiary could also still be eligible for ongoing 
maintenance sessions, as long as the beneficiary begins attending 
sessions again and meets the 5 percent weight loss goal in months 10-
12. Additionally, in this rule, we are finalizing the ability for 
beneficiaries to attend in-person or virtual make-up sessions if they 
miss a regularly scheduled session. We believe that these policies 
provide flexibility for beneficiaries who experience difficulty

[[Page 53247]]

attending sessions during both the core services and ongoing services 
periods in light of the once-per-lifetime service limitation.
    We appreciate the comments received recommending the allowance of 
an introductory session and 30-day window to withdraw, as well as the 
use of an assessment tool to assess if the beneficiary is ready to 
start MDPP services, so that the beneficiary can understand the 
eligibility requirements and determine if he or she is ready to begin. 
We note that suppliers may speak to beneficiaries about their readiness 
while assessing them for eligibility or before the beneficiary begins 
MDPP services. This could include the use of any tools that the 
supplier may have to help a beneficiary make their own determination 
about whether to commit to the MDPP services period or not. However, 
MDPP suppliers may not use these tools to screen beneficiaries for 
their perceived ability to successfully complete the MDPP performance 
goals. Selecting beneficiaries based on these purposes would not comply 
with the MDPP supplier standard proposed (and which we are finalizing) 
in Sec.  424.205(d)(8), which prohibits an MDPP supplier from denying 
an MDPP beneficiary access to MDPP services during the MDPP services 
period, including on the basis of the beneficiary's weight, health 
status, or achievement of performance goals, with few exceptions. We 
also note that in Sec.  424.205(d)(11), which we are finalizing in this 
final rule, the supplier standards require MDPP suppliers to provide an 
MDPP beneficiary information about the MDPP set of services prior to 
beginning furnishing such services. This information must include 
eligibility requirements throughout the MDPP services period, including 
the once-per-lifetime limitation. We believe that this information will 
supply the beneficiary with the necessary information to make an 
informed decision on whether to begin MDPP services.
    We acknowledge commenters' concerns on life altering events 
precluding a beneficiary's participation and understand that there will 
be circumstances that preclude an individual from participating. As 
stated previously, we believe the ability for a beneficiary to attend 
in-person and virtual make up sessions could assist in some of these 
circumstances. Additionally, because only 2.4 percent of participants 
in the DPP model test re-enrolled in the model while the model test was 
still active, we believe that the number of beneficiaries requesting to 
re-enroll in MDPP will be quite small. However, we plan to monitor the 
once-per-lifetime limitation to consider whether an exceptions policy 
for beneficiaries who experience life-altering events is necessary, and 
if appropriate, we will address this issue in future rulemaking.
    In the CY 2017 PFS final rule, we stated that beneficiaries could 
self-report to MDPP suppliers that they had not previously received 
MDPP services. We recognize that self-reported information may not be 
the most reliable source for MDPP suppliers to use before submitting 
claims for MDPP beneficiaries, and there is a risk that information 
that is inaccurately self-reported could result in the denial of 
payments for MDPP services. In the CY 2018 PFS proposed rule, we noted 
that we were considering ways MDPP suppliers would be able to reliably 
verify if a beneficiary has received MDPP services from another 
supplier, such as through a standardized tracker (82 FR 34134), and we 
sought public comments on any additional ways MDPP suppliers could 
access this information. We noted that we intend to provide 
administrative guidance on any resources to assist MDPP suppliers in 
identifying beneficiaries' previous receipt of covered MDPP sessions, 
as appropriate.
    The following is a summary of the public comments received on ways 
that MDPP suppliers can reliably verify if a beneficiary has received 
coverage of MDPP services from another supplier and our responses:
    Comment: Commenters generally raised concerns about the use of 
beneficiary self-reported data, noting that such data is often 
unreliable. Commenters also noted that verifying previous MDPP service 
use would require a sophisticated tracking system and urged CMS to work 
with MDPP suppliers to ensure accurate tracking of eligibility and 
progress through the MDPP services period. To this end, we received 
comments on a variety of ways for MDPP suppliers to verify if a 
beneficiary has previously received MDPP services from another 
supplier.
    Some commenters requested that CMS document whether an individual 
has previously received MDPP services, and make this information 
available to MDPP suppliers to check a beneficiary's previous MDPP 
service use, at the federal level. One commenter suggested that CMS 
could build a beneficiary-level database that would contain information 
about MDPP status. The database could include the beneficiary's first 
name, last name, and birthdate so that MDPP suppliers could look up a 
beneficiary based on those three variables in order to identify his or 
her eligibility and program status based on time-to-date and MDPP 
sessions already furnished in the MDPP services period. The commenter 
recommended against the use of social security numbers in this context, 
due to data security concerns. For looking up beneficiaries where those 
three pieces of information identify multiple individuals, the 
commenter suggested that a hotline could be set up and MDPP suppliers 
could call in to verify eligibility of a specific beneficiary for MDPP 
services. Another commenter similarly recommended building a master 
database for MDPP suppliers to use to verify MDPP use, and that CMS 
permit self-reporting until such a database exists. One commenter noted 
that CMS could consider leveraging state and local health information 
exchanges, where they exist, to transfer beneficiary information on 
MDPP service use.
    Commenters were divided on CMS designing a paper tracker, such as 
the one mentioned in the CY 2018 PFS proposed rule, that beneficiaries 
could take with them to a new supplier to share information. One 
commenter recommended that CMS develop such a tracker to assist in data 
sharing between MDPP suppliers. However, this commenter also noted that 
for potential, small, and new DPP suppliers that typically have limited 
staff, the administrative processes involved with such a tracker may be 
burdensome. Another commenter raised concerns about such a tracker, 
noting that beneficiaries could lose their trackers and possibly modify 
results.
    Response: We appreciate the suggestions on ways that MDPP suppliers 
can determine a beneficiary's prior use of MDPP services for the 
purposes of verifying eligibility. We recognize that self-reported data 
is not always reliable; however, we did state in the CY 2017 PFS final 
rule that beneficiaries could self-report to MDPP suppliers about their 
previous MDPP service use.
    We agree that a beneficiary-level data system could provide a 
useful way for MDPP suppliers to check whether an MDPP beneficiary had 
previously received MDPP services both before a beneficiary starts 
receiving MDPP services and when an MDPP beneficiary switches MDPP 
suppliers. When we considered creating such a data system, we 
recognized that it would need to contain data beyond what we will 
receive in claims data (such as baseline weight), and therefore, would 
require that MDPP suppliers continuously submit updated beneficiary 
information to us to populate the system. We believe

[[Page 53248]]

that creating such a system would post a significant burden that would 
outweigh the benefit for MDPP suppliers. Moreover, other commenters 
have urged us to pursue a more streamlined interaction between CDC and 
CMS DPP-related data systems.
    Given these various stakeholder views and our considerations about 
what a data system would entail, we believe that creating an additional 
data system for MDPP suppliers to verify beneficiary eligibility would 
be inconsistent with commenters' general requests for fewer, rather 
than additional, data submission requirements (please see more 
information at III.K.2.d.v of this final rule). Thus, we do not intend 
on creating a beneficiary-level data system at this time. Instead, we 
are exploring an electronic mechanism using claims data and existing 
CMS systems that MDPP suppliers could access to verify beneficiaries' 
prior receipt of MDPP services and plan to provide additional 
information on this mechanism in future guidance, as appropriate. In 
addition, we are still considering developing a paper tracker that an 
MDPP beneficiary can take with them between suppliers to prevent 
disruption in MDPP services. However, as described in section 
III.K.2.d.v of this final rule, a supplier accepting a new beneficiary 
in the middle of his or her services period would need to obtain the 
beneficiary's previous MDPP records to verify data such as baseline 
weight or weight loss from baseline that is necessary before the new 
supplier could submit any performance payments. Obtaining this 
documentation would be necessary to satisfy the MDPP supplier 
requirement at Sec.  424.205(g) that an MDPP supplier shall maintain 
documentation that includes services furnished and body weight 
measurements.
    Comment: We received several comments regarding the MDPP's once-
per-lifetime limit and its application and operationalization within 
Medicare Advantage. One commenter asked whether an MA plan could 
provide introductory classes or offer a waiting period after a 
beneficiary has received MDPP services before the once-per-lifetime 
limit is implicated, or if MA plans could provide accommodations for 
extenuating circumstances that may interfere with a beneficiary's 
ability to complete the program as an exception to the once-per 
lifetime requirement.
    Response: As in Original Medicare, the once-per-lifetime limit is 
implicated for an MA enrollee upon the receipt of MDPP services. The 
rationale for this policy can be found in the CY 2017 PFS final rule 
(81 CFR 80470) and section III.K.2.c.iii of this final rule. Under 
Sec.  422.100(a), MA plans are required to provide enrollees in that 
plan with coverage of Medicare-covered services. As a Part B Medicare-
covered service, Sec.  422.100(a) requires MA plans to provide coverage 
of MDPP services to plan enrollees. Additionally, Sec.  422.100(f) goes 
on to require that CMS must ensure that an MA plan's coverage of MDPP 
services meets CMS fee-for-service rules, which are described here in 
this final rule and the CY 2017 PFS final rule. These rules explicitly 
require that, to be eligible for coverage for MDPP services, a 
beneficiary must not have previously received the set of MDPP services 
in his or her lifetime. Therefore, the once-per-lifetime per 
beneficiary limit applies equally to MA enrollees, and we decline to 
permit MA plans to implement a ``waiting period'' after an enrollee has 
received MDPP services without implicating the lifetime limit on MDPP 
services. We note, however, that nothing in this final rule or the CY 
2017 PFS final rule (81 CFR 80170 through 80562) prevents an MA plan 
from making available to its enrollees additional or more extensive 
MDPP-like services as a supplemental benefit. For instance, where an MA 
plan believes that its prediabetic enrollees could benefit from 
introductory classes that, while not MDPP services, would allow the 
enrollee to decide whether to go on to receive MDPP services, an MA 
plan may elect to provide those classes as a supplemental benefit. 
Similarly, where an enrollee has begun MDPP services and is unable to 
complete the program due to extenuating circumstances, an MA plan may 
elect to make available to that enrollee other, MDPP-like services as a 
supplemental benefit.
    Comment: Two commenters suggested that CMS facilitate data sharing 
among MDPP suppliers, such as by constructing a master database that 
MDPP suppliers and Medicare Advantage Organizations could consult to 
determine whether a given Medicare beneficiary or MA enrollee 
previously received MDPP services. Commenters indicated that such data 
sharing abilities would be useful when a beneficiary moves from 
Original Medicare to an MA plan or between MAOs. Without this database, 
one commenter recommended that CMS permit self-reporting from 
beneficiaries as a means for MA plans to determine whether the 
beneficiary has or has not utilized the once-per-lifetime set of 
services when determining a beneficiary's eligibility for MDPP 
services.
    Response: As discussed in this section, we are exploring existing 
CMS systems that MDPP suppliers could access to verify if beneficiaries 
have previously received MDPP services and intend to release additional 
details through guidance. We intend that this would also allow any MDPP 
supplier that is furnishing MDPP services to an MA enrollee to 
determine whether a given beneficiary has previously received MDPP 
services under Original Medicare, regardless if the MDPP supplier 
seeking the verification is the plan itself or has contracted with an 
MA plan to provide MDPP services to enrollees. We emphasize that when 
determining whether an enrollee is eligible for MDPP services, MA plans 
should treat the once-per-lifetime limit for MDPP as they would similar 
services, such as mammograms, that are available on a time-limited 
basis. Additional information on this matter will be released in future 
guidance, as appropriate.
    After consideration of the public comments, we are finalizing the 
once-per-lifetime limitation on MDPP services as proposed at Sec.  
410.79(c)(1)(i)(B). However, we plan to monitor this policy to consider 
whether an exceptions policy for beneficiaries who experience life-
altering events is necessary, and if appropriate, we will address this 
issue in future rulemaking. We did not make any proposals regarding 
ways that MDPP suppliers can reliably verify if a beneficiary has 
received coverage of MDPP services from another supplier, and intend to 
release future guidance on this, as appropriate.
iv. Eligibility Throughout the MDPP Services Period
    In the CY 2017 PFS final rule, we specified the minimum number and 
frequency of sessions that MPP suppliers must offer to MDPP 
beneficiaries (codified at Sec.  410.79(c)(2)(i) and (c)(2)(ii)). We 
finalized that MDPP suppliers must furnish ongoing maintenance session 
intervals to MDPP eligible beneficiaries who have maintained 5 percent 
weight loss from their baseline weight as measured during the previous 
maintenance session interval. As defined at Sec.  410.79(b), ``baseline 
weight'' is the MDPP beneficiary's body weight recorded during that 
beneficiary's first core session.
    However, because in the CY 2018 PFS proposed rule, we proposed to 
tie payment for MDPP services to the beneficiary's achievement of 
performance goals, we proposed additional changes to tie the 
beneficiary's eligibility for continued coverage of ongoing maintenance

[[Page 53249]]

session intervals to his or her achievement of performance goals, 
namely requiring a minimum level of attendance (82 FR 34134 through 
34135). Because our proposed policies for payment and coverage differ 
somewhat, we are addressing them separately below.
(1) MDPP Services Period
    As discussed in section III.K.2.b. of this final rule, we are 
revising Sec.  410.79(c)(2), which describes MDPP services periods, to 
specify that the MDPP services period means the time period, beginning 
on the date an MDPP beneficiary attends his or her first core session, 
over which the set of MDPP services is furnished to the MDPP 
beneficiary, to include the core services period described in Sec.  
410.79(c)(2)(i) and, subject to Sec.  410.79(c)(3), up to 4 ongoing 
maintenance session intervals during the ongoing services period 
described in Sec.  410.79(c)(2)(ii).
    We proposed to revise Sec.  410.79(c)(2) to specify that there are 
2 service periods in which Medicare will cover MDPP services for a 
beneficiary: The core services period; and the ongoing services period 
(82 FR 34134 through 34135). Together these would make up the MDPP 
services period. The core services period is the first 12 months of the 
MDPP services period, and consists of core sessions and core 
maintenance sessions. There are 16 core sessions that are offered at 
least a week apart in months 1 through 6, beginning on the date of 
attendance at the first core session. Core maintenance sessions are 
offered at least once per month in months 7 through 12 of the core 
services period. We proposed to move the requirements for MDPP 
suppliers to offer these services to Sec.  424.205(d)(10) because they 
are more appropriately included among other requirements for MDPP 
suppliers. Consistent with our policies finalized in the CY 2017 PFS 
final rule, we do not condition coverage for the core services period 
upon weight loss or attendance. However, we note that an MDPP 
beneficiary must attend at least 1 core session to initiate the MDPP 
services period.
    These proposals were consistent with CDC's 1-year curriculum, 
divided into two 6-month periods. We recognize that framing the MDPP 
services period in terms of months may cause some confusion because the 
CDC terminology uses weeks. However, we stated that we believe that 
framing the MDPP services period in months would better align with our 
payment structure. We did not make eligibility for the core maintenance 
sessions contingent upon an attendance-based performance goal; because 
the CDC DPP curriculum covers 12 months of sessions, we stated that we 
believe that coverage for the 12 months of the core services period 
should be available to all MDPP beneficiaries, regardless of 
attendance. The 12-month CDC DPP curriculum is based on evidence from 
the original DPP randomized clinical trial, and the curriculum used in 
that trial, which achieved a 58 percent reduction in type 2 diabetes 
risk (with 71 percent reduction in those over age 60).\13\
---------------------------------------------------------------------------

    \13\ WC Knowler et al., ``Reduction in the incidence of type 2 
diabetes with lifestyle intervention or metformin,'' New England 
Journal of Medicine 346, 6 (2002): 393-403, https://www.ncbi.nlm.nih.gov/pubmed/11832527. The Diabetes Prevention 
Program (DPP) Research Group, ``The Diabetes Prevention Program,'' 
Diabetes Care 25, 12 (2002): 2165-2171, http://care.diabetesjournals.org/content/25/12/2165.long.
---------------------------------------------------------------------------

    As discussed in section III.K.2.e.iv.4 of this final rule, MDPP 
suppliers must offer a minimum of 16 core sessions, no more frequently 
than once each week, in months 1 through 6, and at least 1 core 
maintenance session each month in months 7 through 12 of the core 
services period. However, some MDPP suppliers may choose to furnish 
more than the minimum number of sessions, and these coverage parameters 
would allow beneficiaries to receive more than the minimum number of 
sessions if the MDPP supplier elects to furnish them.
    We did not receive comments on the proposed description revisions 
for the MDPP services periods, and therefore, are finalizing these 
proposals at Sec.  410.79(c)(2). However, we note that we are 
finalizing changes at Sec.  410.79(c)(2) to reflect that we are 
finalizing shortening the ongoing services period from 2 years to 1 
year. We are also finalizing the movement of requirements for MDPP 
suppliers to offer these services to Sec.  424.205(d)(10) because they 
are more appropriately included among other requirements for MDPP 
suppliers.
(2) Ongoing Services Period
    As discussed in section III.K.2.b.i. of this final rule, we 
proposed at Sec.  410.79(c)(2)(ii) that the ongoing services period 
consists of up to eight 3-month ongoing maintenance session intervals 
offered during months 13 through 36 of the MDPP services period; 
however, we are modifying this proposal to finalize that the ongoing 
services period consists of up to four 3-month ongoing maintenance 
session intervals offered during months 13 through 24 of the MDPP 
services period. Medicare's coverage of the ongoing services period is 
subject to limitations discussed subsequently in this section.
(a) Eligibility for the Ongoing Services Period
    Our existing regulations at Sec.  410.79(b) state that Medicare 
will cover MDPP services in the first 12 months of the MDPP services 
period, without regard to a beneficiary's achievement of performance 
goals, whereas Sec.  410.79(d)(2) specifies that, for coverage of 
ongoing maintenance sessions, the beneficiary must have achieved weight 
loss of 5 percent from his or her baseline weight. In the CY 2018 PFS 
proposed rule, we proposed to delete Sec.  410.79(d)(2) and move this 
provision to Sec.  410.79(c)(1) with other MDPP beneficiary eligibility 
criteria. We also proposed to add paragraph (c)(1)(ii) to Sec.  410.79 
to specify that beneficiaries must also attend at least one in-person 
core maintenance session in months 10 through 12 of the MDPP services 
period and achieve or maintain required minimum weight loss at a 
minimum of one in-person session during the final core maintenance 
session interval to be eligible for coverage of the first ongoing 
maintenance session interval. We proposed to establish that a 
beneficiary must attend at least one in-person core maintenance session 
in months 10 through 12 of the MDPP services period because, as stated 
in the CY 2017 PFS final rule, an MDPP beneficiary must achieve at 
least 5 percent weight loss from baseline at least once during the 
previous maintenance session interval to have coverage of an ongoing 
maintenance session.
    Because we proposed that weight measurements used for determining 
beneficiary eligibility for coverage or supplier payment must be taken 
in person by an MDPP supplier at an MDPP core maintenance or ongoing 
maintenance session (Sec.  410.79(c)(1)(iv)), a beneficiary must attend 
at least one in-person core maintenance session during months 10 
through 12 to have his or her weight measured to determine whether he 
or she qualifies for coverage of the first ongoing maintenance session 
interval. We believe that in-person measurements are the most feasible 
method for weight ascertainment at this time for services where the 
beneficiary would have regular in-person sessions with the MDPP 
supplier. We believe that self-reported weight loss is not reliable for 
the purposes of determining continued coverage of MDPP services for a 
beneficiary. We invited public comments on these proposals.
    The following is a summary of the public comments received on 
eligibility for the ongoing services period and our responses:

[[Page 53250]]

    Comment: We received a variety of comments on our proposal that 
weight measurement must be taken in-person at an MDPP session, although 
they were in relation to the proposed policy regarding virtual make-up 
sections discussed in section III.K.2.c.iv.3.b of the proposed rule (82 
FR 34136 through 34137). Some commenters supported the proposal, while 
others requested alternate forms of weight measurement, such as via 
Bluetooth-enabled scales or self-reported weight.
    Response: As discussed further in section III.K.2.c.iv.3.b of this 
final rule, while we recognize the use of Bluetooth-enabled scales for 
virtual weight reporting in some DPP programs, we believe that virtual 
weight reporting is not appropriate or necessary for a predominantly 
in-person model (we are using the term ``Bluetooth-enabled'' as we 
understand it described in the CDC DPRP as a scale that uses a 
cellular, wireless, Bluetooth, or other electronic connection to 
automatically send weight data to the supplier). Except for the limited 
number of virtual-make up sessions, MDPP sessions are required to be 
offered and attended in person and corresponding weight are also 
required to be taken in-person. We also believe that self-attested 
weight measurement is generally unreliable, and therefore believe that 
in-person weight measurement is the most reliable and appropriate form 
of weight measurement for the MDPP expanded model.
    After consideration of the comments received, we are finalizing the 
eligibility criteria for the ongoing services period as proposed at 
Sec.  410.79(c)(1)(ii). We are also finalizing changes to the 
definition of ``ongoing maintenance session interval'' at Sec.  
410.79(b) to reflect shortening the ongoing services period from 2 
years to 1 year.
(b) Eligibility for Ongoing Maintenance Session Intervals 2 Through 8
    In addition to achieving weight loss performance goals, as 
previously finalized in the CY 2017 PFS final rule Sec.  410.79(d)(2) 
(now finalized at Sec.  410.79(c)(1)(ii) and (c)(1)(iii)), we proposed 
that beneficiaries must also meet an attendance-related performance 
goal in order for Medicare to cover ongoing maintenance session 
intervals. We proposed to add paragraph (c)(1)(iii) to Sec.  410.79 to 
specify that for coverage of ongoing maintenance session intervals 2 
through 8, an MDPP beneficiary must attend at least three ongoing 
maintenance sessions during the previous ongoing maintenance session 
interval, at least one of which must be an in-person ongoing 
maintenance session to record an in-person weight measurement, in 
addition to maintaining 5 percent weight loss from baseline at least 
once during the previous ongoing maintenance session interval.
    We believe that adding an attendance-related performance goal 
during the ongoing services period is important because it will provide 
an incentive to keep MDPP beneficiaries engaged after the core services 
period. MDPP beneficiaries who meet the specified attendance and weight 
loss goals will have Medicare coverage of ongoing maintenance sessions, 
which are a part of the set of MDPP services, but not a part of the CDC 
DPP curriculum. We believe that the subsequent attendance goal 
requirements during ongoing maintenance session intervals will motivate 
beneficiaries to take on more individual responsibility for their 
behavior changes over time because coverage of these services is 
dependent upon their attendance and achievement and maintenance of 
weight loss.
    In addition, this policy closely aligns with our policy for 
supplier payment for ongoing maintenance session intervals. As 
described further in section III.K.2.d.iii.5. of this final rule, we 
proposed that a supplier would be paid for furnishing an ongoing 
maintenance session interval only if the MDPP beneficiary both attended 
three sessions, as well as maintained a 5 percent weight loss from 
baseline measured at least once in that interval. However, in light of 
our proposal to pay MDPP suppliers upon the beneficiary's attendance of 
three ongoing maintenance sessions (in addition to maintaining at least 
a 5 percent weight loss), we believe that we similarly need to have 
attendance goals for beneficiaries to continue to have coverage of 
ongoing maintenance sessions and mitigate the supplier's risk of 
providing services without payment. Without requiring attendance, an 
MDPP beneficiary who maintained 5 percent weight loss but only attended 
two ongoing maintenance sessions in an ongoing maintenance session 
interval would be eligible for coverage of ongoing maintenance 
sessions, but the supplier would not receive payment for furnishing 
that ongoing maintenance session interval. In effect, the MDPP supplier 
could be required to furnish up to 12 months (finalized in this final 
rule at Sec.  410.79(c)(2)(ii)) of MDPP services without payment. For 
this reason, we proposed to require beneficiaries to attend all three 
sessions within an ongoing maintenance session interval to have 
coverage of the subsequent interval.
    We considered an alternative where a beneficiary would have 
continued coverage of ongoing maintenance session intervals if he or 
she attends at least one in-person ongoing maintenance session during 
an ongoing maintenance session interval, as long as that beneficiary 
maintained at least 5 percent weight loss from baseline at least once 
during that interval. However, we do not believe that this alternative 
would align with our proposed supplier payment requirements for ongoing 
maintenance sessions discussed in section III.K.2.d.iii.5 of this final 
rule, which would require suppliers to furnish, and the beneficiary to 
attend, all three sessions of the ongoing maintenance session interval 
for the supplier to receive payment for that interval. We invited 
public comments on our proposal and the alternative we considered.
    The following is a summary of the public comments received on our 
proposal to add attendance requirements for beneficiary eligibility for 
ongoing maintenance session intervals 2-8 and our responses:
    Comment: The majority of commenters noted that beneficiary 
eligibility requirements for ongoing maintenance session intervals are 
too strict and requested flexibility in eligibility requirements for 
the ongoing services period. Some commenters noted that the eligibility 
requirements would be especially difficult for certain populations, 
such as those that face socio-economic barriers or individuals in rural 
areas who may lack transportation options or other services required to 
attend MDPP sessions.
    Many commenters noted that requiring perfect attendance at ongoing 
maintenance sessions (that is, 3 out of 3 ongoing maintenance sessions 
per interval) places too much burden on beneficiaries. These commenters 
noted that requiring perfect attendance at ongoing maintenance sessions 
is an unrealistic expectation, given that certain life events, often 
beyond the beneficiary's control, could prevent the beneficiary from 
attending a session. These commenters noted that this fact, combined 
with the limited number of allowed virtual make-up sessions and the 
once-per-lifetime limitation on MDPP services, could limit beneficiary 
access to MDPP services. These factors have the potential to 
permanently disqualify the beneficiary from receiving additional MDPP 
services, even if the beneficiary maintained weight loss. Additionally, 
commenters noted that MDPP suppliers may need to offer additional 
ongoing maintenance

[[Page 53251]]

sessions beyond the minimum to ensure that beneficiaries meet 
attendance goals; however, offering these extra sessions would be 
costly and may limit MDPP supplier participation, further limiting 
beneficiary access.
    Commenters who provided this information on the challenge of having 
perfect attendance often recommended allowing beneficiaries to maintain 
eligibility if they attend 2 out of 3, rather than 3 out of 3, ongoing 
maintenance sessions per interval, in addition to maintaining 5 percent 
weight loss. Some commenters recommended that beneficiaries only be 
required to attend 1 out of 3 ongoing maintenance sessions per 
interval, in addition to maintaining 5 percent weight loss, to be 
eligible for the next interval.
    Response: After consideration of the public comments received with 
respect to beneficiary eligibility for ongoing services, we acknowledge 
that requiring a beneficiary to have perfect attendance to be eligible 
for the next interval is strict, and that allowing some flexibility is 
reasonable. When considering comments on this policy, we considered how 
changing attendance requirements for eligibility would affect 
beneficiaries' engagement and our ability to determine whether the 
maintenance of weight loss is attributable to the sessions attended 
during the ongoing services period. As noted in our proposal, we 
considered an alternative of requiring at least 1 session attended per 
interval; however, we do not believe that requiring attendance at only 
1 MDPP session per interval provides enough MDPP sessions to be 
attributable to the outcome of maintained weight loss. A beneficiary 
who can only attend 1 session over the course of 3 months may be 
engaged in other activities that are contributing more to his or her 
weight loss maintenance than MDPP, and we do not believe continued 
coverage of ongoing maintenance sessions is appropriate in this case. 
However, we believe that weight loss maintained by a beneficiary who 
attends at least 2 monthly sessions (with the option of attending all 3 
sessions offered by an MDPP supplier within an interval) can be 
reasonably attributed to the receipt of ongoing maintenance services. 
Suppliers have the option (but are not required) to offer both in-
person and virtual make-up sessions, which offer the beneficiary 
additional flexibility with attendance. If a beneficiary is not able to 
attend a regularly scheduled ongoing maintenance session, the 
beneficiary may have the ability to attend a make-up session at another 
time (as described in section III.K.1.c.iv.(3) of this final rule).
    We also understand based on comments that there could be scenarios 
in which attendance at an in-person monthly session may be challenging 
and impractical for a beneficiary, due to transportation barriers or 
some other life event, and if the supplier did not offer make-up 
sessions (because they are not required), the beneficiary could lose 
coverage for the next interval even if they are engaged and maintain 
weight loss. We also understand that if MDPP suppliers believe 
additional ongoing maintenance sessions beyond the monthly sessions are 
needed to ensure that beneficiaries meet attendance goals, this would 
be costly and potentially limit supplier participation. Although make-
up sessions are an option for MDPP suppliers, we share the concern 
commenters raised about the potential burden placed on suppliers to 
make accommodations for beneficiaries who miss a session in order to 
maintain their eligibility.
    Since the performance goals of the MDPP expanded model are more 
heavily weighted towards outcomes (that is, weight loss) than process 
measures (that is, attendance), and the specific outcome during the 
ongoing services period is maintenance of weight loss, which is 
required both for the ongoing maintenance session interval performance 
payment and coverage of the next ongoing maintenance session interval, 
we believe reducing the attendance requirements by 1 session allows 
sufficient flexibility to beneficiaries and suppliers without 
misattributing a beneficiary's maintenance of weight loss to other 
activities occurring outside of MDPP, during the ongoing services 
period. While in section III.K.2.d.iii.(3) of this final rule we 
describe our final policy which increases the attendance-based 
performance payment amounts for core sessions, we believe that placing 
more emphasis on weight loss maintenance, rather than attendance, 
during the ongoing services period maintains the integrity of the 
program while providing beneficiaries and suppliers more flexibility. 
We believe this modification will still provide an incentive to keep 
MDPP beneficiaries engaged after the core services period.
    We note that we are aligning these eligibility requirements with 
our finalized payment structure, described more in section III.K.2.d.3 
of this final rule. As discussed in section III.K.2.c.iv.2.b of the CY 
2018 PFS proposed rule, we find it important to align attendance goals 
for beneficiaries to maintain eligibility for ongoing maintenance 
sessions with performance goals required for payment during ongoing 
maintenance sessions. Without requiring the same number of attendance 
goals, an MDPP beneficiary who maintained 5 percent weight loss but 
only attended two ongoing maintenance sessions in an ongoing 
maintenance session interval would be eligible for coverage of ongoing 
maintenance sessions, but the supplier would not receive payment for 
furnishing that ongoing maintenance session interval. In effect, the 
MDPP supplier could be required to furnish up to 12 months (finalized 
in this final rule at Sec.  410.79(c)(2)(ii)) of MDPP services without 
payment. To alleviate this concern, we are aligning our finalized 
payment policies, described more in section III.K.2.d.3 of this final 
rule, to align with our finalized eligibility policies.
    After consideration of the public comments, we are finalizing that 
an MDPP beneficiary must attend at least 2 ongoing maintenance sessions 
per ongoing maintenance session interval (and achieve a 5 percent 
weight loss during at least one in-person session during the interval) 
to be eligible for subsequent ongoing maintenance session interval 
after the first. This policy will be finalized at Sec.  
410.79(c)(1)(iii).
    Comment: A number of commenters requested modification to a 
previously finalized policy that stated that ongoing maintenance 
sessions are available only if the MDPP eligible beneficiary has 
achieved maintenance of weight loss (a policy finalized previously at 
Sec.  410.79(d)(2); now at Sec.  410.79(c)(1)). Many of these 
commenters noted that a 5 percent weight loss seemed too high and 
recommended alternatives to the 5 percent weight loss goal to determine 
continued eligibility for ongoing maintenance session intervals, such 
as attendance alone or HbA1c level. One commenter suggested allowing 
beneficiaries to reach the 5 percent weight loss goal once every 6 
months, rather than 3 months, to maintain eligibility for the next 
ongoing maintenance session interval.
    Response: We appreciate commenters' concerns that maintaining 5 
percent weight loss during each ongoing maintenance session interval to 
be eligible for the next interval will be difficult for some 
beneficiaries. We also appreciate the comments received that suggest 
lowering the weight loss criteria or using different criteria. However, 
we note that we finalized our weight loss policy in the CY 2017 PFS 
final rule (previously at Sec.  410.79(d)(2); now at Sec.  
410.79(c)(1)) as it relates to eligibility

[[Page 53252]]

for ongoing maintenance sessions, and did not propose any adjustments 
to the 5 percent weight loss goal in this year's proposed rule. In last 
year's final rule, we noted that the requirement that beneficiaries 
maintain 5 percent weight loss is consistent with the weight loss goal 
tested in the DPP model test, and was factored into the Secretary's 
determination to expand the model and the Chief Actuary's certification 
that MDPP expansion would not result in an increase of Medicare 
spending. Therefore, we are not changing the requirement that 
beneficiaries must maintain the 5 percent minimum weight loss in order 
to be eligible for ongoing maintenance sessions. To account for the 
fact that weight does fluctuate, and to allow beneficiaries more 
flexibility, we finalized last year that beneficiaries need only meet 
the 5 percent weight loss goal at 1 session during a 3-month interval. 
We believe that this allows beneficiaries the opportunity for weight 
fluctuation within an interval, while maintaining the MDPP goals of 
continued lifestyle change over time.
    Comment: We received comments that CMS should grant flexibility to 
certain tribal health programs to determine their own diabetes 
prevention measures of success. These commenters noted that the 5 
percent weight loss goal is too stringent and that weight loss alone 
does not adequately reflect the overall progress a participant is 
making toward lasting lifestyle changes and the prevention of diabetes. 
These commenters also recommended separate categories for weight loss 
goals for men and women, citing sedentary lifestyle and metabolism 
barriers of Native women, and that Native women struggle with weight 
loss more than Native men because of hormonal body changes and gradual 
lean muscle loss that come with age.
    Response: We appreciate this request for flexibility from tribal 
communities. However, we note that the MDPP expanded model is an 
expansion of the DPP model test, which was based on the CDC National 
DPP. We are relying on measures that were shown to be successful in the 
DPP model test, which includes the same percentage achievement of 
weight loss for men and women, and the MDPP expanded model relies on 
these measures for eligibility during the ongoing services period. 
However, we will continue consultation with tribal communities and 
attempt to address their concerns as appropriate.
    After consideration of the public comments, we are finalizing that 
an MDPP beneficiary must only attend 2 ongoing maintenance sessions per 
ongoing maintenance session interval (and maintain 5 percent weight 
loss during one in-person session) to be eligible for the next ongoing 
maintenance session interval. This policy will be finalized at Sec.  
410.79(c)(1)(iii).
(c) Limitations on the Set of MDPP Services
    In the CY 2018 PFS proposed rule, we proposed to add Sec.  
410.79(c)(3) to specify that coverage of the MDPP services period would 
end upon completion of the core services period for a beneficiary that 
is not eligible for the first ongoing maintenance session interval as 
proposed under Sec.  410.79(c)(1)(ii); that is, if the beneficiary does 
not attend at least 1 in-person core maintenance session during the 
second core maintenance session interval and/or does not achieve the 
required minimum weight loss during this interval (82 FR 34136). For 
any beneficiary who is eligible for at least 1 ongoing maintenance 
sessions interval, but who does not meet the requirements for coverage 
of a subsequent interval based on failure to meet attendance or weight 
loss goals proposed at Sec.  410.79(c)(1)(iii), the beneficiary's 
coverage of the set of MDPP services would end upon completion of his 
or her current ongoing maintenance session interval. It is important to 
note that performance payments, discussed in section III.K.2.d.iii.5. 
of this final rule, will be tied to the achievement of the same 
performance goals a beneficiary must meet to have coverage for the 
ongoing maintenance session intervals. Therefore, if an MDPP 
beneficiary does not meet weight loss or attendance goals to have 
coverage of the subsequent ongoing maintenance session interval, the 
supplier will not receive payment for that ongoing maintenance session 
interval or any subsequent performance payments related to that 
beneficiary.
    We did not receive comments on our proposal to add specifications 
on when coverage of the MDPP services period ends, and therefore, are 
finalizing our policies as proposed at Sec.  410.79(c)(3). We note that 
we are finalizing changes at Sec.  410.79(c)(3) to reflect shortening 
the ongoing services period from 2 years to 1 year (so now there are 
only four intervals).
(d) Beneficiaries Who Change MDPP Suppliers During the MDPP Services 
Period
    In the CY 2017 PFS final rule (81 FR 80470), we confirmed that a 
beneficiary may change MDPP suppliers at any time. However, we deferred 
to future rulemaking specific policies to address coverage of and 
payment for MDPP services when beneficiaries change MDPP suppliers. In 
the CY 2018 PFS proposed rule, we clarified that a beneficiary may 
change MDPP suppliers at any time during his or her MDPP services 
period, subject to beneficiary eligibility requirements (82 FR 34136). 
Based on evidence from the CDC DPRP, we believe that the instances of 
beneficiaries changing MDPP suppliers will be relatively infrequent. 
However, we intend to monitor how often beneficiaries change MDPP 
suppliers, as well as MDPP suppliers' billing patterns to detect any 
aberrant billing patterns suggestive of fraudulent or discriminatory 
practices. Payment policies related to when a beneficiary changes MDPP 
suppliers are discussed in section III.K.2.d.v. of this final rule.
    The following is a summary of the public comments received on our 
clarifications about beneficiaries changing suppliers and our 
responses:
    Comment: We received some comments noting that beneficiaries may 
switch suppliers more often than we anticipate, given the mobility of 
the ``baby boom'' generation and the fact that many seniors are 
``snowbirds,'' traveling south for the winter. Other commenters 
requested clarification about when MDPP beneficiaries may switch 
suppliers.
    Response: We clarify that beneficiaries are generally not required 
to switch suppliers. However, if the beneficiary chooses to switch MDPP 
suppliers, the beneficiary may do so at any time and for any reason 
within the MDPP services period (which includes both the core services 
period and ongoing services period).
    Since we did not propose any changes to the policy that 
beneficiaries may change suppliers at any time during the MDPP services 
period, we are not finalizing any changes to this policy.
(3) Make-Up Sessions
(a) General Requirements
    In the CY 2018 PFS proposed rule, we proposed at Sec.  410.79(d)(1) 
that suppliers may offer make-up sessions to an MDPP beneficiary who 
missed a regularly scheduled session (82 FR 34136 through 34137). We 
proposed to define, at Sec.  410.79(b), ``make-up session'' to mean a 
core session, core maintenance session, or ongoing maintenance session 
furnished to an MDPP beneficiary when the MDPP beneficiary misses a 
regularly scheduled core session, core maintenance session, or ongoing 
maintenance session. We proposed that make-up sessions may be delivered 
in person or virtually, although virtual make-up sessions are subject 
to

[[Page 53253]]

additional requirements in this rule (and the term ``virtual make-up 
session'' is separately defined). We proposed the availability of make-
up sessions to be consistent with CDC's DPRP Standards and to ensure 
that MDPP beneficiaries have the opportunity to receive the full DPRP 
curriculum, even if they are unable to attend a particular regularly 
scheduled MDPP session.
    We proposed that the curriculum delivered during a make-up session 
must address the same CDC-approved DPP curriculum topic as the session 
that the beneficiary missed (Sec.  410.79(d)(1)(i)). To be consistent 
with CDC's proposed 2018 DPRP Standards,\14\ we proposed that the MDPP 
supplier may furnish to the beneficiary a maximum of one make-up 
session on the same day as a regularly scheduled session (proposed at 
Sec.  410.79(d)(1)(ii)), and the MDPP supplier may furnish to the 
beneficiary a maximum of one make-up session per week at Sec.  
410.79(d)(1)(iii)).
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    \14\ Available at https://www.federalregister.gov/documents/2017/07/14/2017-14792/proposed-data-collection-submitted-for-public-comment-and-recommendations
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(b) Virtual Make-Up Sessions
    There is a growing area of research examining the effectiveness of 
DPP delivered virtually. CDC began recognizing Virtual DPP 
organizations in 2015 and emerging evidence suggests that virtual 
delivery of DPP services can show similarly successful participant 
weight loss and health benefits to DPP delivered in other settings, 
including among Medicare-age participants.\15\ Since CDC's DPRP 
Standards permit virtual make-up sessions, and we recognize that MDPP 
beneficiaries may encounter situations where they are unable to attend 
in-person make-up sessions, we proposed to allow MDPP suppliers to 
offer a limited number of virtual make-up sessions (Sec.  
410.79(d)(2)). We proposed to define ``virtual make-up session'' in 
Sec.  410.79(b) as a make-up session that is not furnished in person 
and that is furnished in a manner consistent with the DPRP standards 
for virtual sessions. All requirements in Sec.  410.79(d)(1) apply to 
virtual make-up sessions. In addition, we proposed that virtual make-up 
sessions are subject to additional requirements.
---------------------------------------------------------------------------

    \15\ See, for example: F Chen et al., ``Clinical and Economic 
Impact of a Digital, Remotely-Delivered Intensive Behavioral 
Counseling Program on Medicare Beneficiaries at Risk for Diabetes 
and Cardiovascular Disease.'' PLoS ONE 11, 10 (2016), https://doi.org/10.1371/journal.pone.0163627. W Su et al., ``Return on 
Investment for Digital Behavioral Counseling in Patients With 
Prediabetes and Cardiovascular Disease.'' Preventing Chronic Disease 
13 (2016), http://dx.doi.org/10.5888/pcd13.150357. J Ma et al., 
``Translating the Diabetes Prevention Program lifestyle intervention 
for weight loss into primary care: a randomized trial.'' JAMA Intern 
Med. 173, 2 (2013): 113-21, https://www.ncbi.nlm.nih.gov/pubmed/23229846. CS Sepah et al., ``Translating the diabetes prevention 
program into an online social network: Validation against CDC 
standards.'' The Diabetes Educator 40, 4 (2014): 435-443, https://www.ncbi.nlm.nih.gov/pubmed/24723130.
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    First, as indicated by the applicable definition, we proposed 
virtual make-up sessions must be furnished in a manner consistent with 
CDC's DPRP Standards for virtual sessions (Sec.  410.79(d)(2)(i)). To 
align with CDC's DPRP Standards, virtual make-up sessions refer to any 
modality, or method of furnishing MDPP services, that is not in person. 
This includes, but is not limited to:
    (1) Furnishing services online where the behavior change program is 
furnished 100 percent online, with participants accessing course 
resources and a coach via a computer, laptop, tablet, smart phone, or 
other device with Internet access. This modality requires that the MDPP 
beneficiary have an Internet connection to participate in all aspects 
of the virtual make-up session;
    (2) Furnishing services online with other means of support by a 
coach (for example, telecommunications, video conferencing). This 
modality requires that the MDPP beneficiary have an Internet connection 
for some aspects of the virtual make-up session, but not all; and
    (3) Distance learning, where a coach is present in one location and 
participants are calling, video-conferencing, or otherwise using 
telecommunications technology to access the coach from another 
location. This modality does not require that the MDPP beneficiary have 
an Internet connection for any of the aspects of the virtual make-up 
session.
    By defining MDPP virtual make-up sessions as being consistent with 
CDC's DPRP Standards for virtual sessions, we allowed our proposed 
definition to change over time as such standards are updated.
    Second, we proposed that a supplier may only offer virtual make-up 
sessions based on an individual MDPP beneficiary's request (Sec.  
410.79(d)(2)(ii)). A supplier may not cancel a regularly scheduled MDPP 
session and offer the session to all MDPP beneficiaries virtually. 
However, the supplier may cancel a regularly scheduled MDPP session and 
offer the session to all MDPP beneficiaries in person. We believe that 
this is necessary to ensure that the MDPP expanded model remains a 
model predominantly furnished in person. Individual beneficiary needs 
may be accommodated, but suppliers should not use virtual make-up 
sessions as a means to move toward virtually-delivered MDPP sessions 
more generally.
    Third, to further ensure that MDPP services are largely furnished 
in-person, we proposed at Sec.  410.79(d)(2)(iii) that a supplier may 
offer: (a) No more than 4 virtual make-up sessions within the core 
services period to an MDPP beneficiary, of which no more than 2 virtual 
make-up sessions may be core maintenance sessions; and (b) no more than 
3 virtual make-up sessions that are ongoing maintenance sessions to an 
MDPP beneficiary during any rolling 12-month time period. At Sec.  
410.79(d)(3), we proposed that these same limitations on the number of 
virtual make-up sessions also apply for the purposes of determining 
whether a beneficiary has attended a sufficient number of MDPP sessions 
in order to be eligible for ongoing maintenance sessions (Sec.  
410.79(c)(1)) and for assessing whether a beneficiary has met the 
attendance-related performance goals used to determine whether an MDPP 
supplier is eligible to receive a performance payment (Sec.  
414.84(b)). The limitation on the number of virtual make-up sessions is 
not applicable to in-person make-up sessions.
    We assume not all suppliers will have the ability to offer virtual 
make-up sessions, and we are not requiring suppliers to offer virtual 
make-up sessions. Conversely, an MDPP supplier could offer only virtual 
make-up sessions and no in-person make up sessions if the supplier 
chooses as long as the proposed limits for these sessions are not 
exceeded. We believe that allowing fewer than these proposed number of 
virtual make-up sessions will make it difficult for suppliers to meet 
DPRP Standards, and therefore remain enrolled as an eligible MDPP 
supplier. However, the DPP model test only offered in-person sessions 
(no virtual sessions) and therefore the MDPP expanded model is intended 
to predominantly offer services in person. Allowing more than the 
proposed number of virtual make-up sessions would not support an 
evaluation of an in-person MDPP model, as described further in this 
section. We sought comment on our proposals and specifically on the 
proposed limitations on virtual make-up sessions.
    We considered the following alternatives to this proposal. We 
considered not allowing any make-up sessions to be furnished virtually. 
However, we believe that this would place undue restrictions on MDPP 
suppliers who are willing and offer virtual make-up sessions to MDPP

[[Page 53254]]

beneficiaries, particularly if these are offered to other DPP 
participants who are not Medicare beneficiaries.
    We also considered allowing an MDPP supplier to furnish between 1 
and 3 sessions within the core services period and either 1 or 2 
ongoing maintenance sessions each year as virtual make-up sessions per 
MDPP beneficiary. However, we believe that allowing fewer sessions to 
be furnished as virtual make-up sessions than proposed would not 
provide sufficient flexibility for MDPP suppliers to meet CDC's DPRP 
Standards, which require organizations to meet attendance requirements 
for their panel of participants. Organizations may struggle to meet 
DPRP attendance requirements without the flexibility to provide virtual 
make-up sessions.
    We also considered permitting suppliers to offer any number of 
virtual make-up sessions, and for attendance at any number of virtual 
make-up sessions to count toward attendance goals. However, as stated 
previously, since the DPP model test only offered DPP services in 
person, the MDPP expanded model is intended to predominantly offer MDPP 
sessions in person as well. Therefore we believe that it is important 
to limit the number of virtual make-up sessions so that MDPP 
beneficiaries are predominantly receiving MDPP sessions in person.
    We proposed that the payment policies detailed in section 
III.K.2.d. of this final rule apply to virtual make-up sessions. 
Specifically, as indicated in sections III.K.2.c.iv and 
III.K.2.d.iii.10.b. of this final rule, weight measurements used for 
the purposes of determining the achievement or maintenance of weight 
loss for weight loss performance payments, or for determining 
eligibility for coverage of ongoing maintenance sessions, would be 
required to be taken at an in-person session, not during a virtual 
make-up session. As noted at Sec.  410.79(d)(3), make-up sessions are 
counted toward performance goals for both eligibility and payment, 
which specify that at least one ongoing maintenance session per ongoing 
maintenance session interval must be attended in person for the 
purposes of in-person weight measurement. We sought public comments on 
these proposals and the alternatives considered.
    The following is a summary of the public comments received on our 
proposals regarding make-up sessions, and specifically on the 
limitations on virtual make-up sessions, and our responses:
    Comment: We received some comments on make-up sessions generally, 
both virtual and in-person. One commenter supported CMS' proposal to 
allow for same day make-up sessions, finding them to be operationally 
feasible by allowing patients to come early or stay late to make up a 
session. Another commenter noted that furnishing to the beneficiary a 
maximum of one-make-up session on the same day as a regularly scheduled 
session may pose a barrier to beneficiaries if they cannot make the 
regular session on the same day and recommended an option to allow a 
window for make-up sessions of 1-2 business days for either virtual or 
in-person make-up sessions. A third commenter generally agreed with the 
proposed definitions and options for make-up sessions, noting that the 
proposal was feasible to provide and would encourage beneficiaries to 
receive the necessary educational component and coach support.
    Response: We appreciate commenters' support of the proposals. In 
response to the commenter who noted that furnishing a maximum of one-
make-up session on the same day as a regularly scheduled session may 
pose a barrier to beneficiaries if they cannot make the regular session 
on the same day, we believe that the commenter was misunderstanding the 
proposal. Make-up sessions are not required to be offered on the same 
day as a regularly scheduled session. However, to be consistent with 
CDC's proposed 2018 DPRP Standards,\16\ if the MDPP supplier wishes to 
offer a make-up session on the same day as a regularly scheduled 
session, we clarify our intent is for suppliers may furnish a maximum 
of one make-up session on the same day as a regularly scheduled 
session. The intent of this policy is to allow most make-up sessions to 
be scheduled on different days than regularly scheduled session, since 
beneficiaries may not be able to attend a make-up session on the same 
day as a regularly scheduled session. The only limitations on when 
make-up sessions can be offered is that any core make-up session is 
considered a core session, and therefore must occur during months 1-6. 
Similarly, any core maintenance make-up session is considered a core 
maintenance session and must occur during months 7-12.
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    \16\ Available at https://www.federalregister.gov/documents/2017/07/14/2017-14792/proposed-data-collection-submitted-for-public-comment-and-recommendations.
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    Comment: The majority of commenters who commented on these policies 
supported the use of virtual make-up sessions. The additional 
commenters requested clarification about weight measurement for, and 
monitoring of, virtual make-up sessions. Of those who supported the use 
of virtual make-up sessions, there were an equal number of comments 
supporting and opposing the proposed limitations on virtual make-up 
sessions (that is, that a supplier may offer no more than 4 virtual 
make-up sessions within the core services period, of which no more than 
2 may be core maintenance sessions; and no more than 3 virtual make-up 
sessions that are ongoing maintenance sessions during any rolling 12-
month time period). Those who supported the limitations noted that the 
limits would foster compliance and adherence to program goals. Those 
who opposed the limitations requested that CMS either raise the allowed 
number of virtual make-up sessions or allow exceptions to the proposed 
limitations on virtual make-up sessions if the beneficiary cannot come 
in person. These commenters stated that an increased number of allowed 
virtual make-up sessions would increase access to MDPP services and 
improve beneficiary choice of supplier, and noted that the use of 
virtual DPP has a strong evidence base.
    Response: While we recognize that there is an emerging evidence 
base demonstrating effectiveness of virtual DPP, we do not believe that 
we should allow a greater number of virtual make-up sessions than 
proposed, or allow exceptions to the proposed limitations at this time. 
As noted in this rule, the DPP model test only offered in-person 
sessions (no virtual sessions) and therefore the MDPP expanded model is 
intended to predominantly offer services in person. Allowing more than 
the proposed number of virtual make-up sessions would not support an 
evaluation of an in-person MDPP curriculum. However, we believe it is 
appropriate to permit some virtual make-up sessions because, as 
discussed in this rule, we understand, based on research into current 
practices at CDC DPRP recognized DPP providers, that it is difficult 
for DPP suppliers to meet DPRP recognition without the allowance of at 
least some virtual make-up sessions, and organizations must meet DPRP 
Standards to become MDPP suppliers. Therefore, in order to have a 
sufficient number of MDPP suppliers to ensure access to MDPP services, 
and to also ensure fidelity with the original DPP model test, we 
believe that a supplier's ability to furnish a limited number of 
virtual make-up sessions is necessary.
    Comment: One commenter requested clarification on monitoring the 
use of virtual make-up sessions. The commenter asked if there will be 
an

[[Page 53255]]

additional HCPCS code or modifier used to indicate virtual visits since 
there is a proposed limit to the number of visits the beneficiary can 
receive virtually.
    Response: We do plan to monitor virtual make-up sessions through 
the claims system to indicate when a beneficiary has received the 
maximum number of virtual make-up sessions permitted. In order to 
collect information on virtual make-up sessions, we are creating a 
modifier that suppliers will include on claims to indicate the use of 
virtual make-up sessions. This modifier is discussed further in section 
III.K.2.d.iii.10.c of this final rule. We intend to provide information 
on how to use this modifier on claims submitted by MDPP suppliers in 
conjunction with other billing instructions in future guidance.
    Comment: We received multiple comments on weight measurement for 
virtual make-up sessions. Some commenters supported the proposal that 
weight measurement must be taken in person. One commenter encouraged 
the allowance of beneficiary attestation for weight measurement 
associated with virtual make-up sessions, including reporting via 
Bluetooth-enabled scales, which allows the weight measurement taken on 
the scale to be transmitted to the supplier. This commenter also 
recommended that CMS allow weight measurements to be taken at any in-
person visit with any member of a care delivery team (regardless of 
whether the weight measurement is with the MDPP supplier) as long as 
the weight measurement occurs within a month of the associated core 
maintenance session or ongoing maintenance session.
    Response: While we recognize the use of Bluetooth-enabled scales 
for virtual weight reporting in some DPP programs, we believe that 
virtual weight reporting is not appropriate or necessary for a 
predominantly in-person model. Except for the limited number of 
virtual-make up sessions, MDPP sessions are required to be offered and 
attended in person and corresponding weight are also required to be 
taken in-person. We also believe that self-attested weight measurement 
is generally unreliable,\17\ and therefore, believe that in-person 
weight measurement is the most reliable and appropriate form of weight 
measurement for the MDPP expanded model.
---------------------------------------------------------------------------

    \17\ See, for example: Gorber, et. al, ``A Comparison of Direct 
vs. Self-Report Measures for Assessing Height, Weight and Body Mass 
Index: A Systematic Review,'' Obesity Reviews 8, no. 4 (July 2007): 
307-26, https://www.ncbi.nlm.nih.gov/pubmed/17578381; Engstrom, et. 
al, ``Accuracy of Self-Reported Height and Weight in Women: An 
Integrative Review of the Literature,'' Journal of Midwifery and 
Women's Health 48, no. 5 (Sept-Oct 2003): 338-45, https://www.ncbi.nlm.nih.gov/pubmed/14526347; Lin, et. al, ``Accuracy and 
Reliability of Self-Reported Weight and Height in the Sister 
Study,'' Public Health Nutrition 15, no. 6 (June 2012): 989-999, 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3511620/.
---------------------------------------------------------------------------

    We appreciate the commenter's request for flexibility by allowing 
weight measurement to be taken in-person, but outside of an MDPP 
session, by any member of a care delivery team within a month of the 
MDPP session. However, we believe that requiring weight measurement to 
be taken by an MDPP supplier during an MDPP session is the most 
appropriate and reliable method for weight measurement to ensure 
accuracy. We have not proposed any program integrity safeguards about 
transferring weight measurement between providers, suppliers, or care 
delivery teams, nor do we expect MDPP suppliers to have systems in 
place to facilitate such information transfer. We also believe that 
weight must be measured on the same date and at the time of the MDPP 
session to ensure that weight measurement falls within the correct time 
frame or interval for the purposes of eligibility and payment. If a 
member of the beneficiary's care delivery team is also part of the MDPP 
supplier's organization, for example serving as the DPP coordinator or 
coach, then this type of arrangement is appropriate, as long as the 
conditions for weight measurement are met.
    Comment: One commenter sought clarification on if a beneficiary who 
completed a virtual make-up session could come in to an MDPP supplier 
in person at another time to have their weight measured and counted for 
that session. The commenter noted that this may be particularly 
important if that weight measurement is needed for the MDPP supplier to 
submit a claim for payment.
    Response: As noted in proposed Sec.  410.79(c)(1)(iv), which we are 
finalizing as proposed, weight measurements used to determine the 
achievement or maintenance of the required minimum weight loss must be 
taken in person by an MDPP supplier during an MDPP session. 
Additionally, as discussed in section III.K.2.d.iii.10.b of this final 
rule, we also are finalizing at Sec.  414.84(b) that all performance 
payments associated with weight loss require weight measurement to 
conducted in person at an MDPP session. We believe it is important that 
weight measurements occur on the date of an MDPP session so that they 
fall within the correct interval for the purposes of eligibility and 
payment. Thus, a beneficiary could not complete a virtual make-up 
session and come in to an MDPP supplier in person at another time to 
have his or her weight measured and counted for that session.
    We re-emphasize that that virtual make-up sessions cannot be used 
to record weight for the purposes of beneficiary eligibility for or 
during ongoing services period or payment, due to the concerns we have 
laid in this section out regarding any measurement that is not taken in 
person. This is why we are finalizing in this final rule, discussed in 
section III.K.2.c.iv.a and III.K.2.c.iv.b, that a beneficiary must 
attend at least one in-person core maintenance session during the final 
core maintenance session interval and at least one in-person ongoing 
maintenance session during each ongoing maintenance session interval in 
order to have weight recorded in person for the purposes of eligibility 
and payment (Sec.  410.79(c)(1)(ii) and (c)(1)(iii)).
    After consideration of the public comments received, we are 
finalizing our proposals on make-up sessions at Sec.  410.79(d). We are 
finalizing changes to these policies to reflect shortening the ongoing 
services period from 2 years to 1 year.
d. Payment for MDPP Services
i. MDPP Payment Discussion in Prior Rulemaking
    In the CY 2017 PFS proposed rule (81 FR 46415 through 46416), we 
discussed a potential MDPP payment structure and the associated payment 
amounts and sought information from the public to inform future MDPP 
proposals. We received a number of public comments on these topics and 
considered this information in the development of our proposals for the 
MDPP payment structure, payment amounts, and related issues.
ii. Conceptual Framework for Payment for MDPP Services
    We proposed to pay for the set of MDPP services through a 
performance-based payment methodology that makes periodic performance 
payments to MDPP suppliers during the MDPP services period. The 
aggregate of all performance payments constitutes the total 
performance-based payment amount for the set of MDPP services. We 
proposed a maximum total performance payment amount per beneficiary for 
the set of MDPP services of $810. Performance payments would be made to 
MDPP suppliers periodically during the course of a beneficiary's MDPP 
services period based upon a number of factors, including the 
beneficiary's completion of a specified number of MDPP sessions and the 
achievement of

[[Page 53256]]

the required minimum weight loss that is associated with a reduced 
incidence of type 2 diabetes, rather than individual payments being 
made upon the furnishing of any service as is typical of FFS payment 
methodologies in the Medicare program.
    The aggregate amount of the performance payments proposed would 
equal the total performance-based payment amount for the set of MDPP 
services during the MDPP services period, including core sessions, core 
maintenance sessions, and ongoing maintenance sessions. Even though 
these performance payments would be made periodically and in amounts 
that would not be evenly distributed across the course of sessions 
furnished during the MDPP services period, payment for each session 
would be included in the total performance-based payment amount. For 
example, the proposed performance payment of $25 that would be paid to 
MDPP suppliers upon furnishing the first MDPP core session is 
relatively large on a per-session basis compared to other attendance-
based performance payments (as calculated on a per-session basis) 
ranging from approximately $3 to $20 made during the MDPP services 
period. However, the performance payment for the first core session 
would make payment for some of the MDPP supplier resources used in 
furnishing the first session, as well as make a partial prospective 
payment attributable to the MDPP supplier furnishing subsequent 
sessions.
    Once the required minimum weight loss is achieved and the 12-month 
core services period, described at proposed Sec.  410.79(c)(2)(i), 
concludes, we would make additional 3-month interval performance 
payments for ongoing maintenance sessions when the required minimum 
weight loss is maintained, whereas no additional interval performance 
payments would be made for ongoing maintenance sessions if the required 
minimum weight loss is not maintained. Finally, when a beneficiary 
achieves a significant percentage of weight loss, specifically a level 
of 5 percent (the required minimum weight loss) or 9 percent, we 
proposed to make additional performance payments to the MDPP supplier. 
This proposal would provide performance payments in addition to the 
performance payments we may have already made for the previous MDPP 
sessions furnished to the beneficiary because those sessions resulted 
in the beneficiary achieving the weight loss performance goal.
    In total, based on our consultation with DPP organizations holding 
commercial contracts, review of information related to DPP 
organizations that currently hold or are in the process of obtaining 
CDC recognition, and comments received on the discussion of the payment 
structure and payment amounts for the set of MDPP services included in 
the CY 2017 PFS proposed rule (81 FR 46415 through 46416), we believed 
that the proposed performance-based payment methodology would pay MDPP 
suppliers appropriately for the resources used in furnishing MDPP 
services throughout the MDPP services period. We noted that we sought 
public comment on the payment structure and payment amounts for the set 
of MDPP services in the CY 2017 PFS proposed rule, and we used the 
information provided by commenters in developing the proposed 
performance-based payments included in the CY 2018 PFS proposed rule 
(82 FR 34138 through 34152).
    In the proposed performance-based payment structure, it is 
important to note that a beneficiary's performance goals would not be 
considered in the same way for beneficiary coverage and supplier 
payment during each specific period within the MDPP services period. 
During the core services period, a beneficiary would not be required to 
achieve attendance and/or weight loss performance goals for coverage of 
MDPP services, although a beneficiary would be required to achieve 
specified performance goals for an MDPP supplier to receive performance 
payments during this period. In contrast, achieving performance goals 
would be required for both coverage of MDPP services and performance 
payments during the ongoing services period.
    For example, a supplier would be required to offer a minimum of 16 
core sessions during the core services period according to Sec.  
410.79(c)(2)(i), but a beneficiary would not need to achieve an 
attendance or weight loss performance goal to be eligible for coverage 
of core maintenance sessions. However, MDPP supplier performance 
payments during the core services period would be based on the 
beneficiary's achievement of attendance and/or weight loss performance 
goals. During the ongoing services period, achievement of performance 
goals would affect both coverage and supplier payment. We noted that a 
beneficiary would need to attend at least 1 core session to initiate 
the core services period, and attend at least 1 core maintenance 
session during the final core maintenance session interval to determine 
whether he or she has achieved the required minimum weight loss to have 
coverage of ongoing maintenance sessions. Because we proposed, as 
discussed in section III.K.2.d.iii.4 of the proposed rule (82 FR 34143 
through 34145) to make a performance payment for core maintenance 
sessions only when the beneficiary attends at least 3 sessions within a 
3-month interval, it is possible that an MDPP supplier would not be 
paid a separate performance payment for the second core maintenance 
session interval, but the beneficiary would still have coverage of the 
first ongoing maintenance session interval. This would occur if the 
beneficiary attended only 1 or 2 core maintenance sessions during the 
second core maintenance session interval and achieved or maintained the 
required minimum weight loss as measured at 1 of those 2 sessions.
iii. Performance Payments for MDPP Services
(1) Overview of Public Comments on Discussion of Payment for MDPP 
Services in Prior Rulemaking
    Commenters on the discussion of payment for MDPP services in the CY 
2017 PFS proposed rule (81 FR 46415 through 46416) expressed a variety 
of perspectives on the performance-based payment methodology presented 
in that proposed rule. We describe the comments on the prior discussion 
as background for our proposals for the performance-based payment 
methodology for MDPP services that was included in the CY 2018 PFS 
proposed rule (82 FR 34137 through 34155).
    In summary, commenters on the CY 2017 PFS proposed rule recommended 
that a sustainable payment rate structure for MDPP services should 
mirror performance-based payment models in the existing employer 
marketplace. They requested that we not tie Medicare payment to weight 
loss or that we make separate weight loss and attendance payments; that 
we tie payment to aggregate, rather than individual, beneficiary weight 
loss; or that we tie payment to other factors besides or in addition to 
weight loss. Some commenters requested that we provide information on 
how the payment rates included in the CY 2017 PFS proposed rule 
discussion were determined due to their concerns that the amount of 
MDPP payments was not consistent with payments for other similar 
services. Multiple commenters urged that higher payments be made at the 
beginning of the MDPP services period to cover program start-up costs, 
that we decrease supplier financial risk by providing sufficient 
payment for beneficiaries who do not achieve weight loss performance

[[Page 53257]]

goals, and that we implement risk-stratification of payments to reduce 
the risk of MDPP suppliers preferentially seeking to furnish MDPP 
services to low-risk beneficiaries most likely to achieve weight loss 
and avoiding high-risk beneficiaries.
    The proposed MDPP payment structure in the CY 2018 PFS proposed 
rule was generally similar to that which was discussed in the CY 2017 
PFS proposed rule (81 FR 46415 through 46416). However, the proposed 
performance payment amounts for core sessions, core maintenance session 
3-month intervals, and ongoing maintenance session 3-month intervals 
differed somewhat based on our consideration of the comments received 
in response to the CY 2017 PFS proposed rule in the context of our 
policy goal to prioritize the achievement and maintenance of the 
required minimum weight loss that is associated with a reduction in the 
incidence of type 2 diabetes. We proposed a payment structure for MDPP 
services that is performance-based in relation to two meaningful 
performance goals.
    First, the proposed payment structure valued beneficiary weight 
loss most significantly. Weight loss is a key indicator of success 
among individuals enrolled in a DPP due to the strong association 
between weight loss and reduction in the risk of type 2 diabetes.\18\ 
Second, the proposed payment structure valued beneficiary attendance 
because, in the DPP model test, session attendance was associated with 
greater weight loss. According to the second year independent 
evaluation of the DPP model test, those beneficiaries who attended at 
least 1 core session lost an average of 7.6 pounds, while beneficiaries 
who attended at least 4 core sessions lost an average of 9 pounds. Body 
mass index was reduced from 32.9 to 31.5 among Medicare beneficiaries 
who attended at least 4 core sessions.\19\
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    \18\ RF Hamman et al., ``Effects of Weight Loss with Lifestyle 
Intervention on Risk of Diabetes,'' Diabetes Care 29, no. 9 (2006): 
2102-2107.
    \19\ Hinnant L, Razi S, Lewis R, Sun A, Alva M, Hoerger T, 
Jacobs S, Halpern M. Evaluation of the Health Care Innovation 
Awards: Community Resource Planning, Prevention, and Monitoring, 
Annual Report 2015. Awardee-Level Findings: YMCA of the USA; 2016. 
Table 17. Average/Frequencies Health Outcomes of all Participants 
through Q11, p. 36. RTI Project Number 0212790.010.001.004, Contract 
HHSM-500-2010-00021I. Sponsored by the Centers for Medicare & 
Medicaid Services.
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    In addition to weight loss, we considered linking other criteria 
such as hemoglobin A1c level to MDPP performance payments, or using 
aggregate, instead of individual, weight loss for MDPP payments. 
However, the MDPP expanded model was determined to meet the statutory 
requirements for expansion, with certification of the DPP model test 
based on findings that demonstrated that weight loss was associated 
with reductions in Medicare expenditures. Although elevated hemoglobin 
A1c levels were included as part of the beneficiary eligibility 
criteria in the DPP model test, hemoglobin A1c levels were not 
evaluated post-intervention in that model. Therefore, we did not 
propose to use hemoglobin A1c blood values in the performance-based 
payment methodology for MDPP services under the MDPP expanded model, 
which is based on certification of the DPP model test. We further noted 
that the CDC does not require post-MDPP services hemoglobin A1c blood 
values to be determined as part of its 2015 DPRP Standards or its 
proposed 2018 DPRP Standards, and we aim to align with the CDC's DPRP 
Standards as much as possible. While 5 percent weight loss is 
considered a performance measure for CDC recognition, the CDC does not 
examine pre-post DPP differences in hemoglobin A1c as part of its DPRP 
Standards.
    The proposed MDPP payment structure would incentivize MDPP 
suppliers to prioritize the achievement and maintenance of beneficiary 
weight loss by furnishing MDPP services, and provide a balance between 
performance-based payments related to weight loss and session 
attendance. We believed that it would be inappropriate for payment to 
be tied to attendance alone because weight loss is more directly 
associated with a reduction in the incidence of type 2 diabetes than 
attendance at MDPP sessions. We further believed that the proposed 
performance-based payment structure based on individual beneficiary 
success, rather than average weight loss across all MDPP beneficiaries 
who receive MDPP services from an MDPP supplier, would maximize the 
focus of MDPP suppliers on the achievement of the performance goals for 
all beneficiaries, including those beneficiaries who experience 
challenges with achieving attendance and/or weight loss performance 
goals. Therefore, we did not believe it would be appropriate to use 
aggregate beneficiary information (that is, average weight loss) in the 
proposed performance-based payment methodology.
(2) Overall Approach to Setting Performance Payment Amounts
    We proposed to establish the rules governing payment for MDPP 
services at new Sec.  414.84. At proposed Sec.  414.84(a), we proposed 
to define ``performance goal'' as an attendance or weight loss goal 
that an MDPP beneficiary must achieve for an MDPP supplier to be paid a 
performance payment. We proposed to define ``performance payment'' as a 
payment to an MDPP supplier for furnishing certain MDPP services when 
an MDPP beneficiary achieves the applicable performance goal. These 
definitions were used in our proposals for payment of MDPP services.
    To align with the once-per-lifetime policy, we proposed at Sec.  
414.84(b) that each performance payment made based on attendance of a 
specified number of core sessions, for a specific 3-month core 
maintenance or ongoing maintenance interval during the MDPP services 
period, or for achieving a weight loss performance goal, would be made 
only once per MDPP beneficiary.
    The following is a summary of the public comments received on the 
proposals for the definitions of performance goal and performance 
payment for MDPP services and our responses:
    Comment: Several commenters recommended that CMS use additional 
outcome measures other than weight loss or use other measures of 
performance in addition to attendance as performance goals in the 
performance-based payment methodology for MDPP services. The commenters 
urged CMS to use laboratory values, such as a reduction in hemoglobin 
A1c or fasting blood glucose, either in addition to or instead of 
weight loss as measures of a DPP organization's effectiveness, noting 
that changes in these laboratory values would reflect improvement in 
the blood values that are used to diagnose diabetes. The commenters 
reasoned that if a DPP organization can help a beneficiary improve on 
these lab values, the beneficiary's risk of type 2 diabetes would be 
reduced. One commenter added that although body weight was the 
measurement of success in the DPP Randomized Control Trial and is a 
DPRP standard, due to it being a non-invasive and cost-effective 
measurement of reduction in risk of type 2 diabetes, there is also an 
evidence-based correlation between a reduction in hemoglobin A1c value 
and the risk of developing type 2 diabetes. Another commenter, who 
cited that its own DPP organization has experienced numerous examples 
of individuals who did not meet the milestone of a 5 percent weight 
loss but were able to reduce their hemoglobin A1c value into a lower 
prediabetes zone or, in some instances, to a normal range, recommended 
that the proposed weight loss performance

[[Page 53258]]

payments be tied to weight loss or a reduction in hemoglobin A1c.
    Other commenters expressed concern that the focus on weight loss as 
the MDPP supplier's outcome valued in the performance-based payment 
methodology could lead to weight cycling, which could in turn lead to 
health risks for beneficiaries other than type 2 diabetes. The 
commenters claimed that weight loss and attendance are confounded 
measures when both are used as performance goals in the payment 
methodology because they are linked. They urged CMS to avoid double 
counting by using attendance alone as the performance goal for 
performance payments instead of both weight loss and attendance.
    Some commenters encouraged CMS to focus the performance goals 
valued in the payment methodology on improving beneficiary behaviors 
rather than weight loss. Several commenters recommended that certain 
DPP organizations, including tribal health programs, have the 
flexibility to determine their own diabetes prevention measures of 
success that would be the performance goals upon which payment would be 
based. In addition to advocating that CMS utilize hemoglobin A1c blood 
values to assess DPP outcomes, a few commenters suggested that CMS 
consider adopting other variables, including reduced hypertension risk, 
lower BMI, increased intake of healthy foods, increased rate of 
physical activity, or successful reduction of other risk factors. The 
commenters claimed that incorporating these variables in the MDPP 
expanded model performance-based payment methodology would reflect 
beneficiary adherence to healthy behaviors taught in the DPP 
curriculum. One commenter recommended that CMS supplement performance 
payments for core sessions with an additional payment for those 
sessions that include physical activity, in order accommodate and 
recognize beneficiaries who may fluctuate in weight loss due to thyroid 
and hormonal imbalances, stress, sleep disorders, or gastrointestinal 
issues, but who are otherwise achieving improved healthy behaviors 
through physical activity. Finally, another commenter urged CMS to 
explore, via a pilot, additional measures that reflect a possible 
mechanism associated with an MDPP supplier's success in furnishing MDPP 
services, such as increased beneficiary self-efficacy or activation and 
reduced social isolation, which the commenter noted would be likely to 
have spillover benefits for general health.
    Response: We appreciate the commenters' recommendations about 
additional outcomes and other parameters that could be used as 
performance goals in the MDPP expanded model payment model to recognize 
a DPP organization's success that benefits the health of beneficiaries. 
As we stated in the proposed rule (82 FR 34189), we considered linking 
other criteria such as hemoglobin A1c level to MDPP performance 
payments. However, the MDPP expanded model was determined to meet the 
statutory requirements for expansion, with certification of the DPP 
model test based on findings that demonstrated that weight loss was 
associated with reductions in Medicare expenditures. Although elevated 
hemoglobin A1c levels were included as part of the beneficiary 
eligibility criteria in the DPP model test, hemoglobin A1c levels were 
not evaluated post-intervention in that model so we do not have 
information from the DPP model test about the relationship between 
hemoglobin A1c levels and reductions in Medicare expenditures upon 
which a determination about whether the MDPP expanded model meets the 
statutory requirements for expansion could be made. In addition, the 
CDC does not require post-MDPP services hemoglobin A1c blood values to 
be determined as part of its 2015 DPRP Standards, or the proposed 2018 
DPRP Standards, and we aim to align with the CDC's DPRP Standards as 
much as possible. Therefore, we will not use hemoglobin A1c blood 
values as a performance goal in the performance-based payment 
methodology for MDPP services.
    In response to the commenters who expressed concern about the 
potential for negative health effects of a focus on weight loss as a 
performance goal for the MDPP expanded model, we note that 
certification of the DPP model test was based on findings that 
demonstrated that weight loss was associated with reductions in 
Medicare expenditures, and the DPP Randomized Control Trial showed that 
people at risk for developing type 2 diabetes can prevent or delay the 
onset of type 2 diabetes by losing a modest amount of weight through 
diet and exercise. The CDC's DPRP Standards, where 5 percent weight 
loss is considered a performance measure, were developed with this 
science in mind. Therefore, we continue to believe that weight loss is 
an appropriate performance goal for use in the MDPP expanded model 
performance-based payment methodology.
    In addition, while we acknowledge that there is an association 
between attendance and weight loss, the two performance goals proposed 
for use in the MDPP payment methodology, we remain committed to valuing 
weight loss in the methodology based on the evidence that achievement 
of the required minimum weight loss leads to a reduction in the 
incidence of type 2 diabetes. Weight loss is a key indicator of success 
among individuals enrolled in a DPP due to the strong association 
between weight loss and reduction in the risk of type 2 diabetes.\20\ 
The MDPP expanded model was determined to meet the statutory 
requirements for expansion, with certification of the DPP model test 
based on findings that demonstrated that weight loss was associated 
with reductions in Medicare expenditures. We note that while there is a 
positive association between attendance at MDPP sessions and weight 
loss, which underpins the rationale for offering MDPP services to 
Medicare beneficiaries in the MDPP expanded model, attendance is not a 
full proxy for the required minimum weight loss outcome that leads 
directly to a reduction in the incidence of type 2 diabetes. For 
example, while in the DPP model test the number of DPP sessions 
attended had a statistically significant marginal effect on the percent 
of weight loss, session attendance did not fully account for the 
percent of weight loss.\21\ Specifically, the average effect of 
attending one additional session was a 0.43 percentage point increase 
in weight loss. However, the results showed that a participant who 
attended 9 or more sessions on average experienced a 6.24 percentage 
increase in weight loss compared to participants attending fewer than 9 
sessions, which is a higher percentage point increase in weight loss 
than would be predicted based on the number of sessions attended alone. 
Therefore, we continue to believe it is appropriate to use both 
attendance and weight loss as the MDPP expanded model performance goals 
in the MDPP performance-based payment methodology, so we are finalizing 
these performance goals.
---------------------------------------------------------------------------

    \20\ RF Hamman et al., ``Effects of Weight Loss with Lifestyle 
Intervention on Risk of Diabetes,'' Diabetes Care 29, no. 9 (2006): 
2102-2107.
    \21\ RTI International.Evaluation of the Health Care Innovation 
Awards: Community Resource Planning, Prevention, and Monitoring, 
Third Annual Report Addendum 2017: Awardee-Level Findings: YMCA of 
the USA. Evaluation of the Health Care Innovation Awards: Community 
Resource Planning, Prevention, and Monitoring Third Annual Report--
March 2017.
---------------------------------------------------------------------------

    For the same reasons that we are not using hemoglobin A1c as a 
performance goal for the MDPP expanded model, we also will not include 
any of the other additional parameters recommended by the commenters to 
value a DPP

[[Page 53259]]

organization's success in the MDPP performance-based payment 
methodology, nor will we allow each DPP organization to develop its own 
measures of success for Medicare payment purposes under the MDPP 
expanded model. None of these parameters related to healthy beneficiary 
behaviors, such as an increased rate of physical activity or increased 
intake of health foods, were evaluated in the DPP model test to assess 
their potential relationship to reductions in Medicare expenditures. 
Therefore, they are not being adopted for use in the MDPP expanded 
model because they were not used in the determination that the MDPP 
expanded model meets the statutory requirements for expansion. However, 
we encourage each MDPP supplier to assess the needs and experiences of 
the beneficiaries it serves in the context of the MDPP services 
furnished by the supplier to create, implement, and evaluate its own 
DPP organization's performance metrics, including process and outcome 
measures, in the context of the goals of the MDPP expanded model so 
that the MDPP supplier can identify areas of success and opportunities 
for improvement in its DPP services.
    We will not supplement performance payments for core sessions with 
additional payments for specific modalities (such as physical activity) 
offered during sessions, because the MDPP expanded model methodology is 
already performance-based in nature. Although health behavior changes, 
including dietary changes and physical activity, are components of the 
DPP curriculum taught during sessions, the MDPP expanded model was 
certified based on the close link between weight loss outcomes and a 
reduced incidence of type 2 diabetes and lower Medicare expenditures. 
Therefore, it would not be appropriate for us to specifically value in 
the performance-based payment methodology intermediate health behavior 
changes such as physical activity changes. Moreover, we are finalizing 
the requirements for the MDPP expanded model in this final rule, and 
therefore, are not pursuing through this rulemaking other models or 
pilots that reflect possible additional mechanisms associated with an 
MDPP supplier's success in reducing a beneficiary's incidence of type 2 
diabetes.
    After considering the public comments received, we are finalizing 
the proposals, without modification, for the definitions of performance 
goal and performance payment at Sec.  414.84(a).
(a) Total Amount and Distribution of Performance Payments Across the 
Set of MDPP Services
    As displayed in Table 28, we proposed a maximum total performance 
payment amount per beneficiary for the set of MDPP services of $810. 
This amount is the aggregate of the maximum proposed performance 
payments for core sessions, core maintenance sessions, and ongoing 
maintenance sessions furnished to MDPP beneficiaries who achieve weight 
loss of at least 9 percent over the proposed 36 months of the MDPP 
services period. This performance payment amount would be made for a 
minimum of 46 MDPP sessions required to be offered to the beneficiary 
in the set of MDPP services. Although CMS would make performance 
payments to MDPP suppliers at intervals throughout the MDPP services 
period in varying amounts, payment for each session furnished would be 
included in the total performance payment amount a supplier was paid 
for the set of MDPP services furnished to an MDPP beneficiary.
    Although we did not propose that payment for MDPP services utilize 
a fee-for-service payment methodology, we noted that, estimated on a 
per-session basis, the maximum MDPP payment amount for achievement of 
all the performance goals would equate to approximately $18 per 
session. For comparison, Medicare pays under the PFS approximately $10 
(excluding physician work and malpractice) for CPT code 98962 
(Education and training for patient self-management by a qualified, 
nonphysician health care professional using a standardized curriculum, 
face-to-face with the patient (could include caregiver/family) each 30 
minutes; 5-8 patients), a service that may bear some resemblance to an 
MDPP session furnished by an MDPP supplier, although an MDPP session 
would be furnished by a coach (not necessarily a health care 
professional), has a duration of 1 hour, and has no explicit limitation 
on group size.
    However, this estimated per-session MDPP payment amount would 
result only from the furnishing of MDPP services to those beneficiaries 
who achieve all of the attendance and weight loss performance goals 
under the proposed performance-based payment methodology for MDPP 
services. For beneficiaries who do not achieve all of the performance 
goals, the estimated per-session MDPP payment amount would generally be 
significantly lower, with the amount based upon the actual attendance 
and weight loss performance of the beneficiary. The differences between 
the estimated MDPP per-session payment amounts and between the MDPP and 
PFS payment amounts would result from the proposed performance-based 
methodology for MDPP services based on the MDPP beneficiary's 
achievement of performance goals, that differs from the PFS where 
payments are based on suppliers' relative resources used to furnish 
services. We believed that the estimated per-session MDPP payment 
amounts under our proposal for beneficiaries who achieve specified 
attendance and weight loss performance goals were appropriate in the 
context of a performance-based payment methodology for the set of MDPP 
services.
    Finally, we noted that there are also some administrative costs 
that MDPP suppliers would bear to enroll in Medicare and ensure 
compliance with the requirements for furnishing MDPP services. The 
total MDPP performance payment across all Medicare beneficiaries would 
provide some payment for the resources that would be used by MDPP 
suppliers to meet the administrative requirements for furnishing MDPP 
services.
    In terms of the proposed distribution of the maximum total 
performance payment amount for MDPP services across the types of 
performance payments, as discussed in detail in sections 
III.K.2.d.iii.(3) and (4) of the proposed rule (82 FR 34141 through 
34145) and displayed in Table 28, we proposed that, for those 
beneficiaries achieving the highest core services period performance 
goals, approximately 13 percent of the maximum of $810 would be paid 
for attendance at core sessions during the initial 6 months of the core 
services period, while approximately 15 percent would be paid for core 
maintenance sessions during months 7 to 12 of the core services period. 
We believed that payment of a similar percentage of the maximum total 
performance payment amount during the initial 6 months of the core 
services period for beneficiaries who meet attendance performance goals 
and during months 7 to 12 for beneficiaries who meet both weight loss 
and attendance performance goals would be appropriate to balance 
performance payment for attendance and weight loss throughout the core 
services period.
    In addition, as discussed in detail in section III.K.2.d.iii.(5) of 
the proposed rule (82 FR 34145 through 34146), we proposed that 
approximately 49 percent of the maximum of $810 would be paid for 
ongoing maintenance sessions over a

[[Page 53260]]

24-month period, or 24.5 percent per each 12-month period, for those 
beneficiaries who maintain the required minimum weight loss. The focus 
of ongoing maintenance sessions is on maintenance of weight loss that 
has already been achieved, and there would typically be an established 
relationship between the MDPP supplier and the MDPP beneficiary during 
the ongoing services period. Therefore, the totality of MDPP sessions 
furnished during this 24-month period would result in a slightly lower 
performance payment per 12-month period than the totality of those 
sessions furnished when the required minimum weight loss is achieved 
during the 12 months of the core services period, when 28 percent of 
the maximum total performance payment amount would be paid.
    Finally, due to the importance of weight loss as a meaningful 
outcome of MDPP services because of its association with a reduction in 
the incidence of type 2 diabetes, as discussed in detail in section 
III.K.2.d.iii.(6) of the proposed rule (82 FR 34146), we proposed that 
23 percent of the maximum total performance payment amount would be 
paid for weight loss performance payments to provide additional 
payments for MDPP sessions that are effective (that is, lead to 
specified percentages of weight loss). We noted that, in the DPP model 
test, 44.7 percent of participants achieved 5 percent weight loss, 
which under our proposal would result in a weight loss performance 
payment of approximately 20 percent of the maximum total performance 
payment amount.\22\ Moreover, according to estimates from CDC's DPRP, 
approximately 12 percent of program participants attending at least 2 
sessions achieved 9 percent or greater weight loss.\23\
---------------------------------------------------------------------------

    \22\ National Council of Young Men's Christian Associations, 
Measurement and Monitoring Report. CMS Health Care Innovation 
Awards, Round One, Sixteenth Quarterly Reporting Period (16QR), 
April, May, and June 2016.
    \23\ CDC's Diabetes Prevention Recognition Program dataset as of 
March 1, 2017.
---------------------------------------------------------------------------

    Table 28 summarizes the proposed maximum total amount and 
distribution of performance payments for the set of MDPP services.

  Table 28--Proposed Maximum Total Amount and Distribution of Performance Payments for the Set of MDPP Services
----------------------------------------------------------------------------------------------------------------
                                                                  Maximum performance
                                                                 payment for  achieving   Percentage of  maximum
                  Type of performance payment                      attendance  and/or       total  performance
                                                                      weight loss          payment  amount  (%)
                                                                   performance goals
----------------------------------------------------------------------------------------------------------------
Core sessions.................................................                     $105                       13
Core maintenance session intervals............................                      120                       15
Ongoing maintenance session intervals.........................                      400                       49
Weight loss...................................................                      185                       23
                                                               -------------------------------------------------
    Total performance payment.................................                      810                      100
----------------------------------------------------------------------------------------------------------------

    We invited public comments on our proposals for the maximum total 
performance payment amount and the distribution of performance payments 
for MDPP services across the set of MDPP services.
    The following is a summary of the public comments received on the 
proposals for the maximum total performance payment amount and the 
distribution of performance payments for MDPP services across the set 
of MDPP services and our responses:
    Comment: Many commenters supported the proposal of a performance-
based payment methodology for MDPP services based on the performance 
goals of session attendance and weight loss. The commenters agreed that 
incentivizing MDPP suppliers, including coaches, and MDPP beneficiaries 
to work toward achievement of these performance goals would be valuable 
to the success of MDPP services in reducing the incidence of type 2 
diabetes among MDPP beneficiaries. Several commenters further stated 
that the MDPP expanded model is consistent with other value-based 
payment models and would be an improvement over fee-for-service 
payment, although they acknowledged that the proposed payment structure 
was more complicated.
    A few commenters recommended that CMS make a payment for each MDPP 
session, at least for the first 12 months of the MDPP services period. 
In addition, several of the commenters urged CMS to couple this payment 
policy with a bonus for achievement of the required minimum weight loss 
at the end of the core services period. Another commenter requested 
that CMS provide information on how the proposed performance payment 
amounts were determined, similar to information published in the 
Medicare PFS rules for any services covered under the Part B Medicare 
program. The commenter observed that the proposal for the MDPP expanded 
model contained extensive information on payment amounts but did not 
clearly explain the derivation of the proposed performance payment 
amounts. One commenter stated that services reported under the Medicare 
program using CPT code 98962 (Education and training for patient self-
management by a qualified, nonphysician health care professional using 
a standardized curriculum, face-to-face with the patient (could include 
caregiver/family) each 30 minutes; 5-8 patients), a CPT code CMS 
referenced in the proposed rule, have been proven to be ineffective in 
changing behavior, yet the supplier is paid the full PFS amount 
regardless of outcomes. The commenter noted that trained DPP coaches 
have shown excellent results and, therefore, should be paid equal to or 
more on an hourly basis as the service reported under this CPT code, 
which the commenter stated would equate to $20 per hour.
    One commenter urged CMS to reconfigure the proposed performance-
based payment methodology to allow for add-on payments based on 
practice size and geographic location. The commenter noted that an 
additional payment for solo or small practices, as well as for 
practices in rural or underserved areas, would significantly expand the 
reach and effectiveness of MDPP services and enable primary care 
physicians to continue to drive the health care system through a focus 
on

[[Page 53261]]

preventive services that reduce costs and improve care.
    Another commenter recommended that CMS pay all MDPP suppliers, or 
at a minimum community-based organizations and small suppliers, based 
on aggregate, rather than individual, beneficiary performance on 
attendance and weight. Several commenters emphasized their perspective 
that performance-based payment that relies heavily on individual 
patient outcomes would be most likely to succeed when directed at large 
institutions with multiple sources of revenue where reallocation, 
cross-subsidy, and assuming financial risk are possible. The commenters 
noted that small MDPP suppliers would be unlikely to be able to support 
performance-based payment structures such as CMS proposed for the MDPP 
expanded model that are premised on a very low payment per evidence-
based service, with small sample sizes that make performance payments 
based on individual beneficiary achievement of performance goals 
unreliable.
    Another commenter noted that evidence to support the effectiveness 
of pay-for-performance through using the achievement of individual 
patient outcomes to financially incentivize the appropriate delivery of 
evidence-based services is mixed. The commenter claimed that there are 
some reports of no impact on the delivery of evidence-based services 
and other reports of initial improvements that fail to be sustained in 
comparison with changes in the practices of other providers over time. 
The commenter stated that pay-for-performance methodologies for 
individual health care providers have largely been based on process 
measures about the delivery of appropriate services, rather than the 
patient outcomes that result. They concluded that moving to pay-for-
performance for an outcome measure like weight loss for Medicare 
payment as CMS proposed for the MDPP expanded model is an experimental 
rather than an evidence-based payment strategy, while MDPP services 
themselves are evidence-based and, therefore, should be paid through an 
evidence-based approach.
    Response: We continue to believe that a comprehensive performance-
based payment methodology is appropriate for the MDPP expanded model, 
where all payments are made in direct relation to the achievement of 
performance goals, rather than on a per-session basis. The MDPP 
performance-based payment methodology makes available performance 
payments for the achievement of weight loss, specifically the required 
minimum weight loss in the first 12 months of the MDPP services period 
and the achievement of 9 percent weight loss any time during the MDPP 
services period. This is consistent with the recommendations of several 
commenters that a weight loss ``bonus'' be available, although we are 
not accompanying weight loss performance payments with per-session 
payments as further recommended by those commenters.
    Given the differences between such a performance-based payment 
methodology and payment under the FFS Medicare payment methodologies, 
we are not able to provide information on determining MDPP performance 
payment amounts that is similar to information published in the 
Medicare PFS rules for other Part B services where payments are related 
to the relative resources used by suppliers to furnish those services, 
nor are comparisons to payment on an hourly basis with PFS services 
possible. The MDPP expanded model uses a fundamentally different 
payment methodology than the FFS Medicare payment methodologies because 
it provides a balance of performance-based payments related to weight 
loss and session attendance, and does not use a resource-based payment 
methodology for MDPP services. We respond specifically to comments on 
the proposed distribution of performance payments across the set of 
MDPP services in the subsequent response in this section and provide 
more information about our final performance payment and bridge payment 
amounts in sections III.K.2.d.iii.(3) through (6) and III.K.2.d.v. of 
this final rule.
    Under the performance-based methodology, we believe it is 
appropriate to pay MDPP suppliers, regardless of size or geographic 
location, the same performance payment for each beneficiary who 
achieves the same performance goals because achievement of the required 
minimum weight loss leads to a reduced incidence of type 2 diabetes for 
beneficiaries.
    Moreover, payment of performance payments based on aggregate 
beneficiary achievement of performance goals would not sufficiently 
incentivize MDPP suppliers to engage all beneficiaries in working to 
achieve the performance goals of the MDPP expanded model. We 
acknowledge that MDPP suppliers furnishing MDPP services to a small 
number of beneficiaries may experience more payment variation than 
larger suppliers under our proposed methodology that relies on the 
achievement of performance goals by individual beneficiaries to 
determine the payment amounts. However, we maintain our strong interest 
in incentivizing MDPP suppliers to work to engage all beneficiaries in 
achieving the attendance and weight loss performance goals of the MDPP 
expanded model, despite our understanding that this may put some 
suppliers at greater financial risk than others. Therefore, we will not 
provide performance payments based on aggregate beneficiary achievement 
of performance goals.
    We note that the MDPP expanded model was determined to meet the 
statutory requirements for expansion, with certification of the DPP 
model test based on findings that weight loss was associated with 
reductions in Medicare expenditures. In response to the commenter who 
was concerned that the MDPP expanded model performance-based payment 
methodology is not evidence-based, we emphasize that we intend to 
evaluate the MDPP expanded model, which will pay for MDPP services 
under this payment methodology, using a combination of encounter and 
claims data to analyze the long-term utilization of services by 
beneficiaries who have received MDPP services. Moreover, we will 
continue to assess whether the MDPP expanded model is expected to 
improve the quality of care without increasing spending, reduce 
spending without reducing the quality of care, or improve the quality 
of care and reduce spending, and we will terminate or modify the MDPP 
expanded model if the expanded model is not expected to meet these 
criteria.
    Comment: While many commenters supported the proposed maximum 
performance payment of $810 per MDPP beneficiary, multiple commenters 
opposed the proposed distribution of performance payments over the set 
of MDPP services. The commenters noted that the sum of the proposed 
performance payments for the first 12 months of the MDPP services 
period was too low, especially for beneficiaries who did not achieve 
the required minimum weight loss but to whom MDPP suppliers would be 
required to offer sessions throughout that time period. The commenters 
noted that the MDPP payment structure should take into account the 
weight loss trajectory of typical individuals receiving DPP services, 
where weight loss occurs slowly over many months, and should also 
ensure ongoing financial support for the MDPP supplier that must 
provide access to MDPP services and teach the DPP curriculum to 
beneficiaries while the beneficiaries are working to lose weight.

[[Page 53262]]

    Many commenters acknowledged that they anticipated significant 
attrition of MDPP beneficiaries over the maximum 36-month MDPP services 
period. The commenters expected that MDPP suppliers would not receive 
the full $400 that CMS proposed as the maximum aggregate performance 
payment for ongoing maintenance session intervals in the ongoing 
services period during months 13 to 36 as Medicare beneficiaries 
reduced their participation in MDPP services because they were no 
longer eligible for coverage based on their lack of adherence to 
attendance requirements over the long duration of the period. Most 
commenters with this perspective also urged CMS either not to include 
ongoing maintenance sessions in the MDPP expanded model or to reduce 
the proposed 24 months of the ongoing services period to 12 months. 
Under both scenarios, the commenters urged CMS to redistribute the 
performance payments that would have been made for ongoing maintenance 
session intervals to increase performance payments during the first 12 
months of the MDPP services period, especially to core session 
performance payments.
    Multiple commenters requested that MDPP suppliers be paid when MDPP 
supplier resources are used. They stressed that MDPP suppliers incur 
significant cost prior to the first core session, including hiring and 
training coaches, printing the CDC curriculum and nutrition logs, and 
potentially securing class space. The commenters claimed that most MDPP 
supplier costs (for example, administration, staffing, beneficiary 
engagement, marketing, materials, and recruitment) are expended up 
front in the initial 6 months of the MDPP services period, regardless 
of whether beneficiaries achieve the required minimum weight loss 
performance goal. Under the proposal, the commenters concluded that 
MDPP suppliers would be faced with covering their initial DPP expenses 
without timely payment, which could preclude some entities from 
becoming MDPP suppliers.
    Several commenters urged CMS to pay MDPP suppliers based on 
attendance alone for the full 12-month core services period, with 
higher amounts in the first 6 months because they claimed that the 
majority of the costs associated with professional staff labor are 
incurred in this time period due to the DPP curriculum being delivered 
in weekly sessions. Other commenters recommended that the large 
majority of payment for MDPP services, up to 70 percent for those 
beneficiaries achieving 5 percent weight loss, be paid during the first 
12 months of a beneficiary's MDPP services period. Some commenters 
stated that the performance payment should be based on completion of 
the 12-month core services period, rather than on the achievement of 
weight loss goals that may be affected by factors outside the MDPP 
beneficiary's or MDPP supplier's control.
    A number of commenters estimated the MDPP supplier cost of 
furnishing MDPP services for the core services period as greater than 
$500 per beneficiary. One commenter claimed that payment to DPP 
organizations in the DPP model test, in the NIH Randomized Control 
Trial, and the private sector were all substantially higher than the 
average proposed first year per beneficiary payment of $255 that a 
high-performing DPP organization would anticipate under the MDPP 
expanded model (to calculate the $255 average payment, the commenter 
assumed 50 percent of beneficiaries achieve 5 percent weight loss, and 
all beneficiaries attend 16 sessions in months 1 to 6 and 6 sessions in 
months 7 to 12). Another commenter further observed that the DPP model 
test did not include the significant administrative, operational, and 
reporting requirements necessary to become a Medicare supplier and 
adhere to the MDPP expanded model requirements that CMS proposed. The 
commenters concluded that the significant disparity between the 
proposed payment for MDPP services and actual needed MDPP supplier 
investment would impact the MDPP expanded model outcomes, including the 
MDPP beneficiary's achievement of performance goals and the MDPP 
supplier's fidelity to the quality of its DPP, in addition to reducing 
the cost-effectiveness and efficiency of MDPP services.
    Moreover, several commenters claimed that the significant MDPP 
supplier infrastructure that would be required by CMS' proposals and 
the associated administrative costs to sustain a 12- to 36-month MDPP 
services period for each MDPP beneficiary would create a burden for 
most community-based DPP organizations, resulting in barriers to 
participation in the MDPP expanded model for small or new DPP 
organizations. Therefore, they reasoned that the proposed distribution 
of performance payments may be inadequate to support MDPP suppliers in 
general and may be biased towards organizations with greater resources. 
The commenters concluded that this bias could further restrict an 
already limited in-person network of DPP organizations and reduce the 
opportunity for competition among DPP organizations.
    Other commenters reported that a typical performance bonus is 10 to 
20 percent of a person's salary for achieving exemplary results, 
whereas CMS proposed that 85 percent of the maximum total performance 
payment amount for MDPP services would be based on the achievement of 
the required minimum weight loss. Several commenters stated that the 
goal of securing CDC's DPRP full recognition should be a sufficient 
incentive for MDPP supplier engagement in beneficiary weight loss 
efforts, because ultimately without this recognition, the DPP 
organization would not be eligible to be an MDPP supplier that can 
furnish and bill for MDPP services.
    Response: We refer readers to sections III.K.2.d.iii.(3) through 
(6) of this final rule for discussion of our final policies and payment 
amounts for the specific types of performance payments under the MDPP 
expanded model. We also refer readers to section III.K.2.b.i. of this 
final rule for discussion of our final policy that establishes a 
maximum 12-month ongoing services period, rather than the 24-month 
timeframe we proposed. In addition, in a previous response to public 
comments in this section, we provided our rationale for adopting a 
performance-based payment methodology for MDPP services in general, 
where payment will be based on the achievement of attendance and weight 
loss performance goals.
    We appreciate the information provided by the commenters about the 
amount of payment made by other payers for DPP services, as well as 
their estimates of MDPP supplier costs for furnishing MDPP services. 
However, we note that unlike FFS Medicare payment methodologies, we are 
not providing payments for MDPP services based on the relative 
resources used by MDPP suppliers but rather using a performance-based 
payment methodology that is based on the individual MDPP beneficiary's 
achievement of performance goals. We also do not believe that it would 
be appropriate to set payment for MDPP services based primarily on 
historical payments received by DPP organizations under clinical trials 
or other models where the beneficiary population and other program 
requirements and activities were not the same as those under the MDPP 
expanded model. For example, the design features of the NIH Randomized 
Control Trial differ from the MDPP expanded model, including the 
personnel teaching the curriculum

[[Page 53263]]

and the settings where DPP services were furnished. Moreover, we are 
aware of similar payment structures being used by commercial insurers 
and accepted by DPP organizations; however, the specific payment 
amounts vary substantially, and we continue to believe the performance 
payment amounts for MDPP services are appropriate under the MDPP 
expanded model.
    However, we agree with commenters that the distribution of the 
maximum total performance payment amount over the set of MDPP services 
should be revised to shift a higher percentage to the core services 
period, especially the first 6 months of the MDPP services period. We 
believe this shift is appropriate in view of the frequent sessions that 
must be offered to MDPP beneficiaries by MDPP suppliers during months 1 
to 6 for beneficiary achievement of attendance performance goals and 
the aggressive pursuit of performance goals that we expect to occur 
during the first 12 months of the MDPP services period, where coverage 
for MDPP services ends altogether if the beneficiary does not achieve 
the required minimum weight loss within that 12-month time period. 
Based on the information provided by the commenters, we believe this 
revised distribution better accounts for the weight loss trajectory of 
the typical MDPP beneficiary, where weight loss occurs slowly over many 
months, while ensuring ongoing financial support for the MDPP supplier 
that must provide access to MDPP services and teach the DPP curriculum 
to beneficiaries while the beneficiaries are working to lose weight.
    We are specifically increasing the performance payments for 
attendance at 4 and 9 core sessions and the core maintenance session 
interval performance payments for those beneficiaries who do not 
achieve or maintain the required minimum weight loss, consistent with 
the requests of some commenters as discussed in detail in sections 
III.K.2.d.iii.(3) and (4) of this final rule, respectively. In 
comparison with the approximately 50 percent that we proposed, these 
changes result in about 70 percent of the maximum total performance 
payment amount for the MDPP services period being available during the 
first 12 months of the MDPP services period for beneficiaries who 
achieve the required minimum weight loss within the first 6 months, as 
some commenters also requested.
    We considered making the distributional changes to shift a higher 
percentage of the maximum total performance payment amount for the set 
of MDPP services to the core services period by redistributing only 
those performance payments that would have been made during months 1 to 
24 of the MDPP services period, in order to shift a higher percentage 
of those payments to the first 6 months of the core services period. 
However, such a redistribution would have required reducing the 
performance payments for core maintenance and ongoing maintenance 
session intervals from the amounts we proposed, while commenters 
supported the proposed amounts or recommended higher payment amounts, 
as discussed in sections III.K.2.d.iii.(4) and (5) of this final rule. 
It would also have reduced the maximum total performance payment amount 
to $610 from the $810 that we proposed, due to the elimination of 
ongoing maintenance session interval performance payments of $50 per 
interval for the 4 intervals that would have occurred during months 25 
to 36 of the MDPP services period.
    Instead, we are shifting a higher percentage of the maximum total 
performance payment amount to the core services period by partially 
redistributing the performance payments that would have been made 
during months 25 to 36 of the MDPP services period to the core services 
period because the ongoing services period has been reduced from 24 to 
12 months. This approach allows us to finalize performance payments for 
core maintenance and ongoing maintenance session intervals that are no 
lower than the amounts we proposed and results in a smaller reduction 
to $670 for the maximum total performance payment amount.
    In considering opportunities to revise the performance payment 
amounts in response to the perspectives provided by the commenters, we 
intend for our redistribution to have a minimal impact on the estimated 
Medicare expenditures for MDPP services; therefore, we are not 
redistributing the full amount of $200 that would have been the maximum 
performance payment amount for months 25 to 36 of the MDPP services 
period. Rather, we are only partially redistributing payments from the 
full amount of $200 because our expectation (based on the results of 
the DPP model test and information from the commenters) is that a 
higher number of beneficiaries will attend the sessions during the core 
services period than the number who would have attended the sessions 
during months 25 to 36 of the ongoing services period, due both to 
beneficiary attrition over the long duration of the MDPP services 
period and the coverage requirements for beneficiaries during the 
ongoing services period. Thus, we believe that redistributing the full 
amount of $200 to the core services period would result in 
significantly higher expenditures for the MDPP expanded model than a 
partial redistribution that more closely reflects performance payments 
we would have made if the ongoing services period continued through 
month 36. Therefore, in order to maintain a similar estimate of 
aggregate Medicare expenditures for MDPP services under our final 
distribution of performance payments, the final maximum total 
performance payment amount is necessarily lower than the $810 we 
proposed.
    The partial redistribution of $60 to the performance payments for 
attendance at 4 and 9 core sessions and $10 to the core maintenance 
session interval performance payments for beneficiaries who do not 
achieve or maintain the required minimum weight loss means that the 
final maximum total performance payment amount for a beneficiary is 
$670 under the MDPP expanded model. As was also true for our proposals, 
in the context of estimates of future Medicare savings from the MDPP 
expanded model, the redistribution of dollars across the set of MDPP 
services under our final policies takes into account estimates of total 
Medicare expenditures under the MDPP expanded model for MDPP 
beneficiaries and estimates of future reductions in spending for those 
beneficiaries that would occur from their reduced incidence of type 2 
diabetes.
    Based on the final performance payments displayed in Table 29, and 
assuming 50 percent of an MDPP supplier's MDPP beneficiaries achieve 
the required minimum weight loss within the first 6 months of the core 
services period (the assumption made by one commenter for ease of 
estimation, which we also use because it is close to the 44.7 percent 
of participants in the DPP model test who achieved 5 percent weight 
loss and) \24\ and maintain this weight loss through months 7 to 12, 
the average MDPP supplier total performance payment amount per 
beneficiary for the first 12 months of the MDPP services period is $320 
under our final policies, compared with $255 under our proposed 
policies. In the MDPP expanded model performance-based payment 
methodology, this increase in the estimated average MDPP supplier total 
performance payment amount per

[[Page 53264]]

beneficiary for the core services period more substantially recognizes 
beneficiary achievement of the attendance and weight loss performance 
goals during this 12-month timeframe that result in a reduced incidence 
of type 2 diabetes. In addition, we note that these payment changes 
also result in the opportunity for MDPP suppliers, including those 
suppliers that are small or new DPP organizations, to receive a larger 
amount of performance payments in the first 12 months of a 
beneficiary's MDPP services period that may help reduce DPP 
organizations' financial barriers to enrollment in Medicare and, 
therefore, increase access to MDPP services for Medicare beneficiaries. 
We believe the revised distribution of performance payments shortens 
the time MDPP suppliers must bear the resource costs of enrolling in 
Medicare and furnishing MDPP services without receiving significant 
payments from Medicare, thereby increasing the likelihood that 
additional organizations with fewer resources will be able to enroll in 
Medicare and furnish MDPP services.
---------------------------------------------------------------------------

    \24\ National Council of Young Men's Christian Associations, 
Measurement and Monitoring Report. CMS Health Care Innovation 
Awards, Round One, Sixteenth Quarterly Reporting Period (16QR), 
April, May, and June 2016.
---------------------------------------------------------------------------

    As explained previously, we are not redistributing to the other 
performance payments amounts the full amount of $200 that would have 
been the maximum total per-beneficiary performance payment for months 
25 to 36 of the MDPP services period. This means that the final maximum 
total performance amount for a beneficiary is $670 under the MDPP 
expanded model, lower than the $810 we proposed. The final lower 
maximum total performance payment amount results from our expectation 
that the ongoing maintenance session interval performance payments for 
months 25 to 36 of the MDPP services period would have been made for 
fewer beneficiaries than the increased performance payments that will 
be made in the first 12 months of the MDPP services period under our 
final policies, due both to beneficiary attrition over the long 
duration of the MDPP services period and the policy that performance 
payments for ongoing maintenance session intervals require the 
beneficiary to meet both attendance and weight loss performance goals 
during each interval. As was also true for our proposals, in the 
context of estimates of future Medicare savings from the MDPP expanded 
model, the redistribution of dollars across the set of MDPP services 
under our final policies takes into account estimates of total Medicare 
expenditures under the MDPP expanded model for MDPP beneficiaries and 
estimates of future reductions in spending for those beneficiaries that 
would occur from their reduced incidence of type 2 diabetes.
    After considering the public comments received, we are finalizing 
the proposals for the maximum total performance payment amount and the 
distribution of performance payments for MDPP services across the set 
of MDPP services, with modifications. Based on our discussions in 
sections III.K.2.d.iii.(3) through (6) of this final rule regarding 
weight loss performance payments and changes to the performance 
payments for core sessions, core maintenance session intervals for 
beneficiaries who do not achieve or maintain the required minimum 
weight loss, and ongoing maintenance session intervals to reflect the 
final 12-month ongoing services period policy (discussed in section 
III.K.2.b.i of this final rule), the final maximum total performance 
payment amount for the set of MDPP services is $670. The changes to the 
specific types of performance payments in this final rule that sum to 
the maximum total performance payment amount for the set of MDPP 
services result in a substantial increase in the percentage of the 
maximum total performance payment amount available during the 12-month 
core services period. The largest absolute percentage increase by type 
of performance payment is in the first 6 months of the MDPP services 
period when core sessions are furnished. There is also a significant 
absolute percentage decrease in the maximum total performance payment 
amount for ongoing maintenance session intervals, which reflects the 
shortening of the ongoing services period duration from 24 months to 12 
months. The final maximum total performance payment amount and 
distribution of performance payments for MDPP services are displayed in 
Table 29.

         Table 29--Final Maximum Total Amount and Distribution of Performance Payments for MDPP Services
----------------------------------------------------------------------------------------------------------------
                                                                  Maximum performance
                                                                 payment for  achieving   Percentage of  maximum
                  Type of performance payment                      attendance  and/or       total  performance
                                                                      weight loss          payment  amount  (%)
                                                                   performance goals
----------------------------------------------------------------------------------------------------------------
Core sessions.................................................                     $165                       25
Core maintenance session intervals............................                      120                       18
Ongoing maintenance session intervals.........................                      200                       30
Weight loss...................................................                      185                       27
                                                               -------------------------------------------------
    Total performance payment.................................                      670                      100
----------------------------------------------------------------------------------------------------------------

(b) Payment Considerations Related to Coverage of MDPP Services for 
Beneficiaries With Social Risk Factors
    In the CY 2018 PFS proposed rule (82 FR 34141), we discussed our 
understanding that social risk factors such as income, education, race 
and ethnicity, employment, disability, community resources, and social 
support play a major role in health. The Office of the Assistant 
Secretary for Planning and Evaluation (ASPE) and the National Academies 
of Sciences, Engineering, and Medicine recently released reports on the 
issue of accounting for social risk factors in CMS programs.\25\ \26\ 
We have previously sought public comment on accounting for social risk 
factors in CMS programs, primarily on the topics of quality measurement 
and reporting, such as in the Request for Information Regarding 
Implementation of the Merit-Based Incentive Payment System, Promotion 
of Alternative Payment Models, and Incentive Payments for Participation 
in Eligible Alternative Payment Models published in the October 1, 2015 
Federal Register (80 FR 59105, 59109, 59110, and 59113).
---------------------------------------------------------------------------

    \25\ Available at https://aspe.hhs.gov/sites/default/files/pdf/253971/ASPESESRTCfull.pdf.
    \26\ Available at http://nationalacademies.org/hmd/Reports.aspx?filters=inmeta:activity=Committee+on+Accounting+for+SES+in+Medicare+Payment+Programs.
---------------------------------------------------------------------------

    In the CY 2017 PFS final rule (81 FR 80466), we acknowledged 
commenters' concerns regarding the potential unintended consequences if 
the MDPP expanded model were to result in low-

[[Page 53265]]

income or other disadvantaged populations having less access to ongoing 
maintenance sessions due to their failure to achieve or maintain the 
weight loss performance goal required for coverage of these sessions. 
In addition, through listening sessions, stakeholders provided us with 
anecdotal information suggesting that racial and ethnic minorities and 
low socioeconomic status populations lose about 1 percent less weight, 
on average, than higher socioeconomic groups and non-Hispanic whites.
    We proposed an MDPP payment structure for the set of MDPP services 
that is similar to the structure presented in the CY 2017 PFS proposed 
rule (81 FR 46416), where performance payments are tied to attendance 
at MDPP sessions and/or weight loss. Based on information provided to 
us by stakeholders, we acknowledged that tying performance payment to a 
specific threshold of weight loss and/or attendance may make achieving 
the performance goals required for the highest performance payments and 
beneficiary eligibility for coverage of ongoing maintenance sessions 
more challenging for MDPP suppliers furnishing services to individuals 
with social risk factors. We noted that our proposal for beneficiary 
engagement incentives as discussed in section III.K.2.f. of the 
proposed rule (82 FR 34166 through 34171) would provide MDPP suppliers 
with the flexibility under certain conditions to furnish in-kind 
patient engagement incentives, such as transportation, to support 
beneficiaries in achieving the MDPP expanded model performance goals, 
including session attendance and weight loss. We expected that these 
beneficiary engagement incentives may be helpful to MDPP suppliers 
furnishing services to beneficiaries, including those with social risk 
factors that could increase their risk of not achieving the MDPP 
performance goals.
    We did not propose to risk-adjust MDPP payments for social risk 
factors or to adopt additional special payment policies to specifically 
encourage MDPP suppliers to furnish sessions to beneficiaries with 
social risk factors because, for the MDPP expanded model, we do not 
believe that such approaches are necessary to ensure access to MDPP 
services for all beneficiaries. This is because we believe that the 
proposed performance goals upon which the performance payments for the 
set of MDPP services would be based, as well as the payment policies 
that recognize that weight loss is a gradual process that may occur 
slowly over the 12 months of the core services period, should allow 
MDPP suppliers sufficient time to work with all eligible beneficiaries, 
including beneficiaries with social risk factors, toward achieving the 
attendance and weight loss performance goals of the MDPP expanded 
model. However, we noted that we may consider proposing additional 
payment policies for the MDPP expanded model in the future, as 
appropriate.
    We requested comments about social risk factors in the context of 
the set of MDPP services that could inform any future considerations of 
additional payment policies for the MDPP expanded model. We also 
invited public comments on other types of strategies that we could 
utilize throughout the testing of the MDPP expanded model to assist 
MDPP suppliers in providing robust access to MDPP services for 
beneficiaries with social risk factors, such as learning activities to 
share best practices among MDPP suppliers in providing the set of MDPP 
services.
    The following is a summary of the public comments received on 
social risk factors in the context of MDPP services and other types of 
strategies that we could utilize through the testing of the MDPP 
expanded model to assist MDPP suppliers in providing access to MDPP 
services for beneficiaries with social risk factors and our responses:
    Comment: Several commenters expressed concern that the proposed 
performance-based payment methodology did not include risk-
stratification of payments for MDPP services. The commenters noted the 
proposed payment approach could potentially lead MDPP suppliers to 
cherry-pick beneficiaries and/or service delivery locations based on 
the probability that the patient population would attend more sessions, 
be more adherent to the education and counseling they receive, and be 
more likely to lose weight, while avoiding communities with a high 
percentage of beneficiaries with social risk factors who might find DPP 
attendance and adherence more challenging. The commenters noted that 
such MDPP supplier practices resulting from the proposed MDPP 
performance-based payment methodology could compromise the advancement 
of the goals of the MDPP expanded model, and may generate greater 
inequities and lack of MDPP services access for individuals who already 
experience a disproportionately higher risk for type 2 diabetes. One 
commenter expressed concerns about the unknown relation of the proposed 
pay-for-performance strategy to health disparities and sought 
acknowledgement from CMS that the proposal is an experimental approach 
that has a weak evidence-base. The commenter requested that CMS include 
references to the data in the final rule regarding the effects on 
disparities on which the proposals for the MDPP expanded model were 
based.
    The commenters urged CMS to take into account the socioeconomic 
status of MDPP beneficiaries and how this may impact their achievement 
of performance goals more generally, and risk-adjust for these factors. 
One commenter suggested that CMS provide a supplemental payment of 25 
percent to MDPP suppliers for furnishing MDPP services in geographies 
or to groups who, based on the literature, have a higher prevalence of 
type 2 diabetes in their community, and/or are less likely to complete 
the set of MDPP services. The commenter recommended that this 
supplemental payment should be tied to aggregate attendance, rather 
than weight loss, in order to promote the delivery of MDPP services by 
community-based organizations that can make ancillary supportive 
services available to beneficiaries that the commenter stated may lead 
to greater success in priority communities. As an alternative to this 
approach, the commenter presented options for tying enhanced payments 
to individual MDPP suppliers that would pay suppliers different amounts 
based on the specific population enrolled with a DPP organization.
    Other commenters who acknowledged that CMS did not propose to move 
forward with risk-adjustment for social risk factors in the MDPP 
expanded model in CY 2018 encouraged CMS to be mindful of how social 
influences may impact some MDPP beneficiaries and encouraged the Agency 
to consider risk-adjustment or other methods to appropriately account 
for social risk factors in future years in the performance-based 
payment methodology. In contrast, several commenters noted that risk-
stratification of payments based on social risk factors is not 
necessary for the success of the MDPP expanded model and may lead to 
discrimination in the model.
    Many commenters presented social factors that they state influence 
health, including income, education, race and ethnicity, employment, 
disability, and social supports. Other commenters cited research which 
suggested that addressing socioeconomic factors increases both the 
sustainability and impact on overall health of efforts to prevent and 
manage chronic conditions, particularly type 2 diabetes. One commenter 
identified the following social risk factors as potentially influencing 
patient outcomes

[[Page 53266]]

experience by DPP organizations: Transportation issues and their impact 
on consistent participation with face-to-face programs; socioeconomic 
status and its impact on access to healthy food choices and the ability 
to participate in safe physical activity; and educational and cognitive 
level and its impact on understanding key concepts of the DPP and 
decision-making skills. Another commenter stated that 22 percent of its 
DPP organization's participants are below the federal poverty 
guidelines and are achieving, on average, weight loss that is nearly a 
percentage point lower than participants with household income above 
the federal poverty line.
    Several commenters stressed their commitment to furnishing MDPP 
services to all individuals who qualify for these services, regardless 
of their ability to pay or the timeline in which they achieve 
performance goals, including working hard to address issues like access 
and affordability that may make it difficult for people to enroll and 
continue to receive services from the DPP organization. The commenters 
emphasized that MDPP suppliers must be willing to put time and 
resources into additional or customized services to meet the needs of 
communities with social risk factors and drive people to enroll and 
continue to participate in a lengthy behavior change program like the 
set of MDPP services. Several commenters encouraged CMS to continue to 
align with the CDC's DPRP Standards to encourage and/or incentivize 
MDPP suppliers, through transparent policies, to furnish MDPP services 
in low-income areas.
    One commenter recommended that CMS develop a list of social risk 
factors for MDPP suppliers to capture so suppliers can develop a 
process to query beneficiaries about these issues. Several commenters 
stated that while the MDPP expanded model proposals regarding 
beneficiary engagement incentives would provide MDPP suppliers with 
some flexibility to support different beneficiary needs, it is unclear 
if this policy will be sufficient to allow MDPP suppliers to 
appropriately assist low-income or other disadvantaged populations who 
have less access to programs and resources.
    Response: We appreciate the feedback from the commenters on social 
risk factors in the context of MDPP services, as well as on strategies 
that we could utilize throughout the testing of the MDPP expanded model 
to assist MDPP suppliers in providing access to MDPP services for 
beneficiaries with social risk factors. We also appreciate the support 
of some of the commenters for our proposals regarding beneficiary 
engagement incentives to provide MDPP suppliers with additional 
flexibility to support different beneficiary needs.
    In response to the commenter who requested that CMS present 
references to the data about the effects on disparities on which the 
proposals for the MDPP expanded model were based, we note that we have 
adapted model policies to support national expansion and in response to 
public comments; therefore, we do not currently have existing evidence 
specific to the effects on disparities of the totality of model design 
parameters that are being finalized in this final rule. To the extent 
possible with existing data, sub-group analyses, including beneficiary 
characteristics such as race and ethnicity, will be conducted at part 
of the evaluation of the MDPP expanded model.
    We will review the information about social risk factors provided 
by the commenters, as well as our early implementation experience with 
the MDPP expanded model and other information we receive in the future 
from stakeholders, as we consider potential proposals for additional 
payment policies for the MDPP expanded model in the future.
(3) Performance Payments for Core Sessions
    The payment structure presented in the CY 2017 PFS proposed rule 
(81 FR 46415 through 46416) would have made attendance-based payments 
of $25 for the first core session, $50 for 4 total core sessions, and 
$100 for 9 total core sessions. Based on our consideration of 
information provided in the public comments on CY 2017 PFS proposed 
rule and our increased emphasis in the performance payments on the 
achievement and maintenance of the required minimum weight loss as the 
outcome of MDPP services, our proposal for the attendance-based 
performance payments for 4 and 9 core sessions differed from these 
payment amounts. We proposed that an MDPP supplier would be paid a $25 
performance payment the first time it furnishes an MDPP session to an 
MDPP beneficiary as displayed in Table 30. This performance payment 
would be available once per beneficiary for the beneficiary's first 
core session.
    We proposed that an MDPP supplier would be paid the performance 
payment upon furnishing the first core session to a beneficiary who 
initiates the MDPP services period, regardless of whether the MDPP 
supplier qualifies for any of the additional performance payments for 
that beneficiary. Additional performance payments would depend upon the 
beneficiary's achievement of the performance goals for attendance and/
or weight loss. We believed that making the first performance payment 
based on beneficiary attendance at the first core session would be 
appropriate because the MDPP supplier would use significant resources 
to furnish the first session, including collecting administrative 
information on the beneficiary who is not already known to the 
supplier, regardless of whether the beneficiary goes on to receive 
further MDPP services from that supplier.
    On a per-session basis, the performance payment for the first MDPP 
core session would be the highest performance payment amount for any 
core session during the core services period. Of note, the first core 
session performance payment also would provide some payment for MDPP 
supplier activities to encourage the beneficiary's attendance at 
additional core sessions following the first session. Such supplier 
activities could include sending electronic messages or making reminder 
phone calls about upcoming sessions or providing transportation to the 
next session under the beneficiary engagement incentives policy 
proposed in section III.K.2.f. of the proposed rule (82 FR 34166 
through 34171). It is only through attendance at the first core session 
with an MDPP supplier that a beneficiary initiates the MDPP services 
period and has the potential to achieve weight loss through receiving 
MDPP services.
    Further, we proposed that suppliers would be paid a performance 
payment for the interval (which we refer to as an ``interval 
performance payment'' to distinguish it from other performance 
payments, such as the performance payment upon an MDPP beneficiary's 
achievement of the required minimum weight loss, that would not require 
attendance at multiple sessions) upon a beneficiary's attendance at 4 
total core sessions, and again upon a beneficiary's attendance at 9 
total core sessions--that is, attendance of 5 more core sessions after 
having attended his or her first 4. We proposed an interval performance 
payment of $30 upon a beneficiary attending 4 core sessions and an 
interval performance payment of $50 upon a beneficiary attending 9 core 
sessions as displayed in Table 30. Although an MDPP supplier must offer 
at least 16 core sessions to a beneficiary during the initial 6 months 
of the MDPP core services period, we did not propose any other interval 
performance payment for the core sessions after the performance payment 
for attendance at 9 core sessions. We noted that while these

[[Page 53267]]

payment amounts would be somewhat lower than the payment amounts for 
these milestones presented in the CY 2017 PFS proposed rule (81 FR 
46415 through 46416), they follow a similar pattern of a higher payment 
amount associated with attendance at a larger cumulative number of core 
sessions to provide a significant financial incentive for MDPP 
suppliers to encourage MDPP beneficiary attendance at core sessions in 
the first 6 months of the core services period.
    On a per-session basis, the payments for attendance at 4 total core 
sessions and 9 total core sessions would be approximately $10 and $4 to 
$10, respectively, depending upon the number of sessions attended by 
the beneficiary beyond the 9 required for the second interval 
performance payment up to the maximum of 16 core sessions that must be 
offered to the beneficiary by the MDPP supplier during the initial 6 
months of the MDPP core services period. Because the performance 
payments for core sessions would be based solely on the achievement of 
attendance performance goals, we believed that these per-session 
performance payment amounts that would be lower than the proposed 
performance payment amount for the first core session would still be 
appropriate because we expected that fewer MDPP supplier resources 
would be used to furnish sessions to beneficiaries with whom the MDPP 
supplier has an established relationship. The per-session payment 
amounts for core sessions were set based on attendance at these 
sessions, which is associated with ultimate achievement of the required 
minimum weight loss.
    We proposed to make the first interval performance payment for core 
sessions when the beneficiary has attended 4 core sessions for the 
following reasons. First, beneficiary attendance at 4 core sessions was 
a significant attendance milestone in the evaluation of the DPP model 
test, which provided evidence that meeting this milestone is tied to 
weight loss outcomes.\27\ According to the second year independent 
evaluation of the DPP model test, those beneficiaries who attended at 
least 1 core session lost an average of 7.6 pounds while beneficiaries 
who attended at least 4 core sessions lost an average of 9 pounds. BMI 
was reduced from 32.9 to 31.5 among Medicare beneficiaries who attended 
at least 4 core sessions. Second, in examining CDC's DPRP participant 
trend data, we found that a higher percentage of participants drop out 
after 3 core sessions as compared to those who drop out after 4 core 
sessions, meaning that if a beneficiary completes the 4th core session, 
he or she is more likely to remain in the DPP for the 12-month 
program.\28\ Therefore, we believed that making the first interval 
performance payment after beneficiary attendance at 4 core sessions 
would be appropriate.
---------------------------------------------------------------------------

    \27\ Hinnant L, Razi S, Lewis R, Sun A, Alva M, Hoerger T, 
Jacobs S, Halpern M. Evaluation of the Health Care Innovation 
Awards: Community Resource Planning, Prevention, and Monitoring, 
Annual Report 2015. Awardee-Level Findings: YMCA of the USA; 2016. 
Table 17. Average/Frequencies Health Outcomes of all Participants 
through Q11, p. 36. RTI Project Number 0212790.010.001.004, Contract 
HHSM-500-2010-00021I. Sponsored by the Centers for Medicare & 
Medicaid Services.
    \28\ CDC's Diabetes Prevention Recognition Program dataset as of 
March 1, 2017.
---------------------------------------------------------------------------

    We proposed to make the second interval performance payment when 
the beneficiary has attended 9 core sessions because attending a higher 
amount of sessions in the initial 6 months of the MDPP core services 
period, beginning at session 9, has been shown to greatly improve 
weight loss outcomes. Specifically, according to CDC data, there is a 
125 percent increase in weight loss comparing beneficiaries who attend 
4 to 8 sessions (1.6 percent weight loss on average) and beneficiaries 
who attend 9 to 16 sessions (3.6 percent weight loss on average).\29\ 
Therefore, we believed that attendance at 9 sessions reflects 
clinically meaningful attendance at core sessions and would provide an 
incentive to MDPP suppliers to encourage beneficiaries to continue into 
the second 6 months of the MDPP core services period, which is when the 
5 percent weight loss from baseline is usually achieved or exceeded. 
Additionally, 9 is the number of core sessions, on average, that a 
participant must attend in CDC's National DPP in the first 6 months for 
a CDC-recognized organization to achieve full CDC recognition.
---------------------------------------------------------------------------

    \29\ CDC's Diabetes Prevention Recognition Program dataset as of 
February 28, 2017.
---------------------------------------------------------------------------

    MDPP suppliers would be paid these performance payments when 
beneficiaries achieve these core session attendance performance goals, 
regardless of weight loss. Although we proposed to base performance 
payments during the MDPP services period substantially on weight loss, 
which is directly associated with a significant decrease in the 
incidence of type 2 diabetes, we recognized that weight loss is a 
gradual process and that MDPP suppliers would utilize resources to 
furnish MDPP services during the period of time when the beneficiary is 
losing weight. Therefore, we proposed that performance payments for 
beneficiary attendance at core sessions during the first 6 months of 
the core services period be based on attendance only.
    The proposed maximum total performance payment to MDPP suppliers 
for furnishing MDPP core sessions would be $105 per beneficiary, as 
displayed in Table 30.

 Table 30--Proposed Attendance-Based Performance Payments for MDPP Core
                                Sessions
------------------------------------------------------------------------
                                                     Attendance-based
                Performance goal                   performance payment
                                                     per beneficiary
------------------------------------------------------------------------
1st core session attended (performance payment)                      $25
4 total core sessions attended (interval                              30
 performance payment)..........................
9 total core sessions attended (interval                              50
 performance payment)..........................
                                                ------------------------
    Maximum total performance payment for core                      $105
     sessions..................................
------------------------------------------------------------------------

    We considered alternatives to this payment structure for core 
sessions, such as making higher payments for attendance at the earlier 
sessions to provide MDPP suppliers with additional funds for the 
resources necessary for start-up of the MDPP expanded model. We stated 
that although we understood that there are some up-front supplier costs 
associated with implementing the MDPP expanded model, we believed that 
these costs would disproportionately be related to start-up and not 
generally be ongoing costs borne by the MDPP supplier. In

[[Page 53268]]

addition, because we expected that many MDPP suppliers are currently 
offering DPPs through contracts with commercial payers, MDPP suppliers 
may be able to minimize start-up costs by relying on their relevant 
experience with offering other DPPs. Finally, we believed that our 
proposal for payment of MDPP core sessions already included substantial 
payment for session attendance early in a beneficiary's participation 
with the MDPP supplier, considering that MDPP suppliers would be paid 
an initial $25 performance payment for the first core session attended 
by the beneficiary and would then be paid performance payments for 
beneficiary attendance of up to 9 core sessions, regardless of weight 
loss. We noted that increasing the initial payments for attendance at 
MDPP sessions would shift the nature of the payment for the set of MDPP 
services from a performance-based structure based on a balance of 
attendance and weight loss considerations toward a payment structure 
that is based on attendance at each session furnished.
    The proposed attendance-based performance payments for MDPP core 
sessions were included at proposed Sec.  414.84(b)(1), (2), and (3). We 
invited public comments on these proposals. We also invited public 
comments on the alternative considered.
    The following is a summary of the public comments received on the 
proposals for attendance-based performance payments for MDPP core 
sessions and the alternative considered and our responses:
    Comment: Many commenters urged CMS to increase the proposed $25 
performance payment for the first core session. They explained that 
many potential MDPP suppliers are not medical providers in a way 
similar to most clinicians who commonly work within practices already 
set up for Medicare, where the practice is fully HIPAA compliant and 
staff have already been trained in fraud, waste and abuse, false 
claims, and other policies specific to governmental programs. The 
commenters claimed that there is a necessary and essential MDPP 
supplier cost to being Medicare ``ready'' that is not always similarly 
incurred in the commercial payer context, especially when in some 
circumstances the billing of commercial payers is conducted by invoice, 
not claim, and those payment arrangements are therefore less costly to 
the DPP organization than submitting claims for Medicare payment. The 
commenters stated that each MDPP supplier will have additional set up 
costs, not only in areas of staffing and training, but in meeting basic 
requirements of the MDPP expanded model such as the acquisition of 
medical record systems and Medicare enrollment.
    Several commenters requested that CMS review its proposed payment 
structure for core sessions and, in their view, better balance the 
amount of money an MDPP supplier would receive for the first session by 
moving portions of the proposed performance payments for attendance at 
the fourth session and ninth core session, as well as for core 
maintenance session intervals, earlier in a beneficiary's MDPP services 
period to increase payment for the first core session. Another 
commenter urged CMS to rebalance the attendance-based performance 
payments for the core sessions to provide 25 percent for the first core 
session to cover outreach and other start-up costs.
    Response: We note that some of the costs identified by the 
commenters are one-time set up costs, such as the acquisition of 
medical record systems, that will not be incurred again once the 
organization is enrolled as an MDPP supplier and furnishing MDPP 
services on an ongoing basis. We do not believe that increasing the 
performance payment for the first core session for all MDPP 
beneficiaries would be appropriate to provide organizations with 
additional funds for these startup costs in a performance-based payment 
methodology.
    As discussed in section III.K.2.d.ii. of this final rule, we will 
provide payment for the set of MDPP services through a performance-
based payment methodology that makes periodic performance payments to 
MDPP suppliers during the MDPP services period. The aggregate of all 
performance payments constitutes the total performance-based payment 
amount for the set of MDPP services. We understand that MDPP suppliers 
will experience some early set up costs and ongoing costs for 
activities such as outreach to get Medicare beneficiaries to obtain 
MDPP services from the supplier and that the MDPP supplier may need to 
bear these resource costs before receiving significant payment from 
Medicare for MDPP services. We appreciate that the timing of the 
performance payments and MDPP suppliers' use of resources for 
furnishing MDPP services are not fully aligned. Because the MDPP 
expanded model relies on a performance-based payment methodology that 
is heavily weighted toward the outcome of the required minimum weight 
loss that is associated with a reduced incidence of type 2 diabetes, 
MDPP suppliers will need to bear these resource costs until suppliers 
begin to receive significant performance payments from CMS. However, we 
expect that the total performance payment amounts received by MDPP 
suppliers for the set of MDPP services will provide funds to MDPP 
suppliers for carrying out these initial and ongoing activities, not 
just the payment for the first core session furnished to an MDPP 
beneficiary in the MDPP services period.
    We note that the proposed performance payment for the first core 
session of $25 was the highest performance payment, on a per-session 
basis, of any of the other proposed core session performance payments. 
As discussed in the subsequent response to comments, we are finalizing 
higher performance payments for attendance at 4 and 9 core sessions 
than we proposed, but $25 is still higher than those final core session 
performance payments on a per-session basis. Therefore, we believe that 
the $25 performance payment for beneficiary attendance at the first 
core session already recognizes some of the startup costs and the more 
intense resources used by MDPP suppliers early in their participation 
as MDPP suppliers and in the beneficiary's MDPP services period, 
respectively.
    In addition, given the performance goal of attendance at only one 
core session for the first core session performance payment, we believe 
that a performance payment higher than $25 for the first core session 
could incentivize MDPP suppliers to furnish the first core session to a 
large number of beneficiaries who are eligible for MDPP services but 
who may not have a full understanding of the DPP and its expectations 
or who are not ready to commit to the full DPP. Such an MDPP supplier 
practice could result in fewer beneficiaries benefiting from MDPP 
services by achieving the required minimum weight loss that reduces 
their risk of type 2 diabetes. Thus, we continue to believe that a 
performance payment of $25 for attendance at the first core session is 
the most appropriate payment amount for beneficiary achievement of this 
attendance performance goal.
    Comment: Several commenters urged CMS to make significantly higher 
core session performance payments, noting that the most intense MDPP 
supplier administrative activities occur during the first 6 months of 
the core services period, specifically teaching the health behavior 
change, motivating individuals to lose 5 percent of their weight, and 
encouraging session attendance. The commenters emphasized that 
significant MDPP supplier activities are required to furnish the weekly 
core sessions that

[[Page 53269]]

must be offered in the first 6 months of the MDPP services period, 
further noting that these activities lessen beginning in month 7 when 
sessions must be offered only a minimum of monthly. They claimed that 
most supplier costs, such as administrative costs, staffing, 
beneficiary engagement, marketing, materials, and recruitment are 
incurred up front in the initial 6 months of the MDPP services period 
and are experienced by the MDPP supplier regardless of beneficiaries' 
achievement of the required minimum weight loss in that 6-month time 
period. Under the proposal, the commenters expressed concern that MDPP 
suppliers would be faced with covering the initial overhead expenses 
without the opportunity to receive sufficient, timely performance 
payments.
    Therefore, the commenters recommended that CMS reallocate 
performance payments from the performance payments for 5 percent weight 
loss and core maintenance session intervals to the first 16 weeks of 
the MDPP services period when the majority of costs are incurred by the 
DPP organization. Some commenters specifically recommended the 
redistribution of $60 to payment for core sessions from the proposed 
$160 performance payment for achievement of the required minimum weight 
loss, which would result in a total performance payment for attendance 
at core sessions of $165, compared to the $105 that CMS proposed (the 
sum of the performance payments for attendance at the first, 4, and 9 
core sessions).
    Some commenters supported making core session performance payments 
after beneficiary attendance at the fourth and ninth core sessions as 
CMS proposed, based on the evidence cited by the commenters that if a 
beneficiary completes his or her fourth core session, he or she is more 
likely to remain in the DPP for the full 12-month core services period.
    Response: We agree with the commenters that the 4 and 9 core 
session attendance performance goals represent milestones that reflect 
the increased likelihood that the MDPP beneficiary will complete the 
12-month core services period and, therefore, achieve the required 
minimum weight loss.
    We appreciate the detailed information presented by the commenters 
on the critical need to appropriately engage beneficiaries in the first 
6 months of the MDPP services period in order to support beneficiaries 
in achieving the core session attendance performance goals, as well as 
the information on the number and intensity of MDPP supplier activities 
necessary during this period in order to meet these goals. After 
reviewing these descriptions, we believe that it is appropriate to 
increase the final performance payment amounts from the proposed $30 
and $50 for attendance at 4 and 9 core sessions, respectively. The 
increased core session attendance-based payment amounts reflect the 
importance of these core session attendance milestones to ultimate MDPP 
beneficiary achievement of the required minimum weight loss, given the 
association between greater session attendance and achievement of 
weight loss. In addition, we note that as a result of these performance 
payment increases during the first 6 months of the MDPP services 
period, greater payment for beneficiaries who achieve the performance 
goals will be available to MDPP suppliers in months 1 to 6 of the core 
services period that may result in more timely and substantial 
financial support during that time period for the high intensity of 
supplier activities needed to promote further beneficiary achievement 
of performance goals. We recognize that MDPP suppliers will be working 
diligently throughout this 6-month period to engage beneficiaries, 
encourage attendance, teach the weekly DPP curriculum, and support 
beneficiary behavior change through beneficiary engagement incentives 
and other activities.
    Therefore, in view of our final policy that shortens the maximum 
ongoing services period from 24 to 12 months as discussed in section 
III.K.2.b.i. of this final rule, we will redistribute some of the funds 
that would have been available for ongoing maintenance session interval 
performance payments for months 25 to 36 of the MDPP services period to 
the 4 and 9 core session attendance-based performance payments.
    Because we consider both these milestones to be of similar 
importance in recognizing beneficiary achievement of attendance 
performance goals that are associated with completion of the 12-month 
core services period and achievement of the required minimum weight 
loss, we are increasing both performance payments by 70 to 80 percent 
from the proposed amounts, resulting in final attendance-based 
performance payments for 4 and 9 core sessions of $50 and $90, 
respectively. While the commenters did not specifically recommend these 
payment amounts for attendance at 4 and 9 core sessions, several 
commenters specifically urged us to increase the total payment for core 
sessions (attendance at the first, 4, and 9 core sessions) from the 
$105 that we proposed to $165, which would represent a substantial 
increase in the performance payments for core session attendance. As 
discussed in the previous response to comments, we are not increasing 
the performance payment for attendance at the first core session from 
the $25 payment amount that we proposed. However, we will increase the 
total attendance-based payment for core sessions from $105 to $165 as 
recommended by the commenters through proportionately similar increases 
in the performance payments for attendance at 4 and 9 core sessions.
    We believe that increasing the final 4 and 9 session attendance-
based performance payments by 70 to 80 percent from the proposed 
amounts represents a significant increase in the performance payments 
for attendance at 4 and 9 core sessions that is consistent with the 
requests of the commenters for increased total payment for attendance 
at core sessions. Moreover, the final performance payment amounts 
appropriately recognize the importance of meeting these core session 
attendance milestones that are linked to the achievement of the 
required minimum weight loss that leads to a reduction in incidence of 
type 2 diabetes and reduced Medicare expenditures.
    After considering the public comments received, we are finalizing 
the proposals for the performance payments for core sessions at Sec.  
414.84(b)(1), (2), and (3), with modifications. We are finalizing the 
performance payment for the first core session attended at $25 as we 
proposed. We are increasing the performance payment for 4 core sessions 
attended to $50 and the performance payment for 9 core sessions 
attended to $90. These final performance payment amounts result in a 
total attendance-based performance payment amount for MDPP services 
furnished to an MDPP beneficiary in the first 6 months of the core 
services period of $165, an increase of approximately 60 percent over 
the proposed total performance payment amount of $105 for the 6-month 
period of core sessions. The final attendance-based performance 
payments for MDPP core sessions are displayed in Table 31.

[[Page 53270]]



   Table 31--Final Attendance-Based Performance Payments for MDPP Core
                                Sessions
------------------------------------------------------------------------
                                                     Attendance-based
                Performance goal                   performance payment
                                                     per beneficiary
------------------------------------------------------------------------
1st core session attended (performance payment)                      $25
4 total core sessions attended (interval                              50
 performance payment)..........................
9 total core sessions attended (interval                              90
 performance payment)..........................
                                                ------------------------
    Maximum total performance payment for core                       165
     sessions..................................
------------------------------------------------------------------------

(4) Performance Payments for Core Maintenance Session Intervals
    We proposed that performance payments for core maintenance sessions 
would be tied to the beneficiary's achievement of attendance and weight 
loss performance goals during a core maintenance session interval. A 
core maintenance session interval, as we proposed to define it at Sec.  
410.79(b), would mean one of the two consecutive 3-month time periods 
during months 7 through 12 of the MDPP services period, during which an 
MDPP supplier offers at least 1 core maintenance session per month to 
an MDPP beneficiary.
    The payment structure presented in the CY 2017 PFS proposed rule 
(81 FR 46415 through 46416) would have required the MDPP beneficiary to 
attend 3 core maintenance sessions and achieve or maintain a minimum 5 
percent weight loss for a $45 payment to be made to an MDPP supplier 
for the core maintenance session interval. If 5 percent weight loss was 
not achieved or maintained during the core maintenance session 
interval, no separate performance payment would be made. MDPP suppliers 
would still have been required to offer (and furnish if the beneficiary 
attended) MDPP services during core maintenance intervals to 
beneficiaries regardless of weight loss. Based on our consideration of 
information provided in the public comments on the CY 2017 PFS proposed 
rule and our increased emphasis in the performance payments on the 
achievement and maintenance of the required minimum weight loss as the 
outcome of MDPP services, our proposal for the performance payments for 
core maintenance sessions differed from the payment amounts included in 
the CY 2017 PFS proposed rule (81 FR 46415 through 46416).
    For the MDPP expanded model, we proposed performance payments 
amounts for core maintenance session intervals that would value 
achievement of both session attendance and the required minimum weight 
loss, with an emphasis on achieving the weight loss performance goal. 
We proposed that an MDPP supplier would be paid a performance payment 
for a core maintenance session interval if a beneficiary achieves the 
performance goal of attending at least 3 core maintenance sessions 
during the interval. The specific performance payment amount would be 
determined by whether the beneficiary has also achieved or maintained 
the required minimum weight loss within the interval. The achievement 
or maintenance of the required minimum weight loss within the 3-month 
core maintenance session interval would be determined based on a 
measurement taken in-person during any 1 session within that 3-month 
interval. We proposed that MDPP suppliers would be paid a performance 
payment for no more than 2 core maintenance session intervals for each 
MDPP beneficiary.
    As discussed previously, we recognized that weight loss is a 
process that may still be ongoing for some beneficiaries during the 
final months of the core services period. According to an analysis of 
participant data from CDC's DPRP, the longer a participant remains in 
the lifestyle change program, the greater his or her average weight 
loss achieved.\30\ Findings indicate that it takes an average of 17 DPP 
sessions attended to exceed the required minimum weight loss, and the 9 
percent or greater weight loss goal is more likely to be achieved upon 
attending 19 sessions on average. This average number of sessions 
exceeds the 16 core sessions that must be offered to the MDPP 
beneficiary during the first 6 months of the MDPP services period and 
emphasizes the importance of core maintenance sessions to achievement 
of meaningful weight loss goals.
---------------------------------------------------------------------------

    \30\ CDC's Diabetes Prevention Recognition Program dataset as of 
March 1, 2017.
---------------------------------------------------------------------------

    Of further note, the National DPP's core maintenance sessions were 
developed based on results from the original 2002 DPP Randomized 
Control Trial and CDC's DPRP Standards were developed with this science 
in mind.\31\ Core maintenance sessions are integral for the expected 
reduction in the incidence of type 2 diabetes to be experienced by MDPP 
beneficiaries. These findings were recently confirmed in a literature 
review on combined diet and physical activity programs to prevent type 
2 diabetes conducted by the Community Preventive Services Task Force 
that reiterated the year-long intensity and duration of the National 
DPP.\32\
---------------------------------------------------------------------------

    \31\ Available at https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp/Documents/DPP_508.pdf.
    \32\ Available at http://www.thecommunityguide.org/diabetes/combineddietandpa.html.
---------------------------------------------------------------------------

    Therefore, we believed that providing no performance payment to 
MDPP suppliers for furnishing core maintenance sessions to 
beneficiaries who have not achieved the required minimum weight loss 
prior to or during months 7 to 12 of the core services period could 
reduce the opportunity for MDPP beneficiaries to achieve the weight 
loss performance goal. Such a payment methodology could reduce the 
likelihood that MDPP suppliers would continue to work to engage 
beneficiaries in the weight loss process if those beneficiaries had not 
achieved the required minimum weight loss after completion of the 
initial 6 months of the MDPP core services period. We noted that, as 
finalized in the CY 2017 PFS final rule (81 FR 80459), suppliers must 
offer a minimum of 1 core maintenance session per month in months 7 to 
12 of the core services period to eligible beneficiaries, regardless of 
the beneficiary's weight loss. We further believed that it would be 
possible for some beneficiaries to have achieved the required minimum 
weight loss performance goal by the time the core sessions have been 
completed, and we wanted to incentivize MDPP suppliers to work toward 
the weight loss performance goal in that timeframe. However, we 
believed that it would also be appropriate to place some value on 
achieving attendance performance goals alone through performance 
payments for core maintenance session intervals so that MDPP suppliers 
continue to work to engage all beneficiaries in striving to achieve the 
required minimum weight loss performance goal.

[[Page 53271]]

    As discussed in section III.K.2.d.iii.(2)(a) of the proposed rule 
(82 FR 34139 through 34141), we proposed that the maximum total 
performance payment for MDPP core maintenance sessions would be $120 
for beneficiaries who achieve both the attendance and weight loss 
performance goals during months 7 to 12 of the core services period. 
Specifically, we proposed to pay MDPP suppliers $60 for a core 
maintenance session interval if a beneficiary attends 3 sessions and 
achieves or maintains the required minimum weight loss during that 
interval, and to pay MDPP suppliers $10 for a core maintenance session 
interval if the beneficiary attends 3 sessions but does not achieve or 
maintain the required minimum weight loss during that core maintenance 
session interval.
    As compared to the payment amounts with and without achievement or 
maintenance of the required minimum weight loss that were presented for 
core maintenance session intervals in the CY 2017 PFS proposed rule (81 
FR 46415 through 46416), these proposed payment amounts are both 
higher. As discussed previously, we believed that it would be 
appropriate in months 7 to 12 of the core services period to provide 
some performance payment for achievement of attendance performance 
goals even if the required minimum weight loss is not achieved, in 
order to provide the greatest opportunity for beneficiaries to achieve 
the required minimum weight loss over the full core services period. In 
addition, we proposed a higher payment amount for core maintenance 
session intervals with achievement or maintenance of the required 
minimum weight loss to recognize that achievement and maintenance of 
the required minimum weight loss are necessary for the reduced 
incidence of type 2 diabetes and to encourage MDPP suppliers to work to 
engage beneficiaries in achieving weight loss and sustaining their 
weight loss over time.
    Proposed performance payments for the core maintenance session 
intervals are displayed in Table 32. On a per-session basis, these 
payments would be approximately $20 and $3, respectively. Although both 
of these payment amounts would provide payment to MDPP suppliers for 
the resources involved with furnishing core maintenance sessions, we 
believed that the relatively high per-session performance payment of 
$20 in comparison to the per-session performance payment amounts for 
core sessions would be appropriate due to the achievement or 
maintenance of both the required minimum weight loss and beneficiary 
attendance at core maintenance sessions, as compared to core sessions 
where the performance payment would be based solely on attendance. On 
the other hand, we believed that the relatively low per-session payment 
amount in our core maintenance session interval performance payment 
proposal for core maintenance sessions for those beneficiaries who do 
not achieve the weight loss performance goal, while providing some 
performance payment for attendance at core maintenance sessions by 
beneficiaries still working to achieve the required minimum weight 
loss, would be appropriate because these sessions have not yet resulted 
in those beneficiaries achieving the weight loss performance goal.

                 Table 32--Proposed Performance Payments for Core Maintenance Session Intervals
----------------------------------------------------------------------------------------------------------------
                                                                  Performance payment      Performance payment
                                                                 per beneficiary  (with      per beneficiary
                                                                     achievement or        (without achievement
                       Performance goal                              maintenance of         or maintenance of
                                                                    required minimum         required minimum
                                                                      weight loss)             weight loss)
----------------------------------------------------------------------------------------------------------------
3 sessions attended in first core maintenance session interval                      $60                      $10
 (months 7-9 of the MDPP core services period)................
3 sessions attended in second core maintenance session                               60                       10
 interval (months 10-12 of the MDPP core services period).....
                                                               -------------------------------------------------
Maximum total performance payment for core maintenance session                      120                       20
 intervals (two consecutive 3-month intervals over months 7-12
 of the MDPP core services period)............................
----------------------------------------------------------------------------------------------------------------

    The proposed core maintenance session interval performance payments 
for core maintenance sessions were included at proposed Sec.  
414.84(b)(4). We invited public comments on these proposals.
    The following is a summary of the public comments received on the 
proposals for core maintenance session interval performance payments 
for core maintenance sessions and our responses:
    Comment: Many commenters disagreed with the proposal that an MDPP 
beneficiary must attend 3 core maintenance sessions in each 3-month 
core maintenance session interval for an MDPP supplier to be paid the 
core maintenance session interval performance payment for that 
interval. The commenters observed that because MDPP suppliers must 
offer, at a minimum, monthly sessions to MDPP beneficiaries during 
months 7 to 12 of the core services period, the payment proposal would 
require a beneficiary to achieve 100 percent attendance every 3 months 
in order for the MDPP supplier to be paid the performance payment. The 
commenters stated that this is a very high attendance goal that is 
unlikely to be met, which would result in MDPP suppliers not being paid 
for MDPP services they are required to offer and some of which the 
beneficiary attended. One commenter further reasoned that this 
attendance performance is unnecessary because it was not required in 
the DPP model test which still realized cost savings for Medicare.
    The commenters speculated that in order to promote 100 percent 
attendance of 3 sessions in a 3-month core maintenance session 
interval, MDPP suppliers might have to offer more sessions in that 
interval to accommodate the schedules of the MDPP beneficiaries. They 
added that offering additional sessions would lead to greater MDPP 
supplier cost that would not be covered by the proposed performance 
payments for core maintenance session intervals. Therefore, the 
commenters urged CMS to change the attendance requirement for core 
maintenance session intervals from 3 to 2 sessions in order for 
performance payments to be made, in order to address scenarios where 
beneficiaries were unable to attend one monthly session in a 3-month 
period of

[[Page 53272]]

time during months 7 through 12 of the core services period.
    Several commenters recommended that CMS increase the performance 
payments for core maintenance session intervals, especially for 
beneficiaries who have not achieved or maintained the required minimum 
weight loss. The commenters opposed the use of combined weight loss and 
attendance performance goals to determine the performance payment 
amount for the interval during months 7 through 12 of the core services 
period. Most commenters addressing this issue recommended that CMS make 
the same performance payment, suggesting values that ranged from the 
proposed $60 to higher amounts such as $72.50, for core maintenance 
session intervals for beneficiaries who achieved or maintained the 
requirement minimum weight loss and those who did not meet the weight 
loss performance goal because MDPP suppliers are required to offer 
these sessions to all MDPP beneficiaries.
    The commenters stated that providing the same payment for core 
maintenance session intervals, regardless of the achievement of the 
weight loss performance goal, would better align beneficiary 
eligibility with payment for core maintenance sessions. Under such an 
approach, similar to the first 6 months of the core services period, 
performance payments in months 7 through 12 would be attendance-based 
in order not to penalize MDPP suppliers financially for the MDPP 
beneficiary's weight loss performance because weight loss could 
reasonably occur over the first 12 months of the MDPP core services 
period, not just the first 6 months. The commenters described 
significant administrative costs for necessary MDPP supplier activities 
during months 7 through 12, including the required tracking of Medicare 
beneficiaries, in-person weigh-ins, and outreach to enrollees to ensure 
attendance is high. The commenters stated that these administrative 
activities could actually increase the MDPP supplier's per-session 
costs in comparison with months 1 through 6 of the core services period 
where core sessions must be offered weekly to MDPP beneficiaries.
    Response: We appreciate the recommendations of the commenters 
regarding the performance goals for core maintenance session interval 
performance payments, as well as the performance payment amounts for 
beneficiaries who have achieved or maintained the required minimum 
weight loss and those who have not achieved the weight loss performance 
goal. In terms of promoting alignment between beneficiary eligibility 
and payment during months 7 to 12 of the core services period, because 
we are using a performance-based payment methodology for payment of 
MDPP services and MDPP services are covered for all beneficiaries in 
months 7 to 12 of their MDPP services period, it is not possible to 
fully align eligibility and payment. This contrasts with ongoing 
maintenance session interval performance payments discussed in section 
III.K.2.d.iii.(5) of this final rule where the performance payment for 
a given interval and beneficiary coverage of the subsequent ongoing 
maintenance session interval are aligned because both depend upon 
beneficiary maintenance of the required minimum weight loss and 
attendance at 2 sessions in the ongoing maintenance session interval.
    We continue to believe that it is important after making 
attendance-based performance payments for months 1 to 6 of the MDPP 
services period to begin to base performance payments in part on the 
achievement of weight loss beginning in month 7 of the core services 
period, a time by which we expect some beneficiaries to have achieved 
the required minimum weight loss outcome goal for MDPP services. Our 
expectation is supported by findings from the CDC's DPRP that it takes 
an average of 17 DPP sessions attended to exceed the required minimum 
weight loss.\33\ Given that MDPP suppliers must offer a minimum of 16 
sessions during the first 6 months of the MDPP services period, we 
believe it is reasonable to expect that a number of MDPP beneficiaries 
will have achieved the required minimum weight loss by month 7 of the 
core services period. On the other hand, we recognize that weight loss 
is a process that may still be ongoing for some beneficiaries during 
the final months of the core services period. Therefore, we believe it 
is appropriate to maintain performance goals for performance payment 
for core maintenance session intervals that rely both on attendance and 
the achievement or maintenance of the required minimum weight loss to 
encourage high engagement of MDPP suppliers with the MDPP beneficiaries 
to whom they are offering sessions toward the goal of achieving or 
maintaining the required minimum weight loss.
---------------------------------------------------------------------------

    \33\ CDC's Diabetes Prevention Recognition Program dataset as of 
March 1, 2017.
---------------------------------------------------------------------------

    Thus, we do not believe it would be appropriate to make a 
performance payment of $60 for session attendance alone in months 7 to 
12 of the core services period at the same payment amount that we are 
finalizing for beneficiaries who meet both the attendance and weight 
loss performance goals. However, we appreciate the interest of the 
commenters in a substantial increase from the $10 that we proposed as 
the core maintenance session interval performance payment for 
beneficiaries who are attending sessions that must be offered by the 
MDPP supplier and still working to achieve the required minimum weight 
loss. Given the considerable expected engagement of MDPP suppliers with 
MDPP beneficiaries who are still working to achieve the required 
minimum weight loss at the end of the first 6 months of the core 
services period, we agree with the commenters that it would be 
appropriate to provide a higher core maintenance session interval 
performance payment for beneficiaries who meet the attendance 
performance goal for these intervals but have not yet achieved the 
required minimum weight loss. However, we also intend for our 
performance-based payment amounts for months 7 to 12 of the core 
services period to financially incentivize high engagement of MDPP 
suppliers with the MDPP beneficiaries to whom they are offering 
sessions toward the goal of achieving or maintaining the required 
minimum weight loss.
    Therefore, we believe that a performance payment of $15 for core 
maintenance session interval performance payments for those 
beneficiaries who do not achieve or maintain the required minimum 
weight loss during the interval but meet the interval attendance 
performance goal appropriately balances these objectives. We note that 
this payment amount reflects a significant increase of 50 percent over 
our proposed payment amount, yet the sizeable difference between the 
$60 and $15 performance payments that continues to exist for core 
maintenance session interval performance payments for beneficiaries who 
do or do not achieve or maintain the required minimum weight loss, 
respectively, will strongly incentivize MDPP suppliers to engage with 
MDPP beneficiaries to work toward achieving or maintaining the required 
minimum weight loss throughout the 3-month core maintenance session 
intervals.
    Because MDPP suppliers must offer, at a minimum, monthly core 
maintenance sessions to all MDPP beneficiaries during months 7 to 12, 
regardless of the beneficiary's attendance or achievement of weight 
loss, we agree with the commenters that it is appropriate to reduce the

[[Page 53273]]

attendance requirement for the performance payments during this time 
period from 3 to 2 sessions per interval. Lowering the required session 
attendance for the performance payments during this time will provide 
additional flexibility to beneficiaries to allow them to balance life 
events and MDPP session attendance, without beneficiary decisions 
resulting in financial consequences for MDPP suppliers that must offer 
sessions regardless of actual attendance. We believe that attendance of 
2 sessions in a core maintenance session interval still represents 
substantial beneficiary engagement and, because we also provide payment 
that differs in relation to achievement of the weight loss performance 
goal during core maintenance session intervals, this flexibility does 
not discourage MDPP beneficiaries and MDPP suppliers from a high level 
of engagement during months 7 to 12 of the core services period.
    Comment: Several commenters urged CMS to fully align eligibility 
and performance payment for core maintenance session intervals, similar 
to the proposal for eligibility and payment for ongoing maintenance 
session intervals. For example, if an MDPP beneficiary did not meet the 
attendance performance goal for the first core maintenance session 
interval performance payment, the commenters recommended that the 
beneficiary not be covered for the second core maintenance session 
interval. Under such an approach, the MDPP supplier would not be 
required to continue to use its resources to offer additional core 
maintenance sessions to the beneficiary whose attendance was too low to 
result in a performance payment being made to the MDPP supplier.
    Response: As the commenters observed, eligibility and payment are 
aligned for ongoing maintenance session intervals where a beneficiary 
must meet the performance goals for the performance payment for an 
interval, namely attendance at 2 sessions and maintenance of the 
required minimum weight loss, to be eligible for the subsequent ongoing 
maintenance session interval as discussed in section 
III.K.2.c.iv.(1)(b) of this final rule. However, with respect to core 
maintenance sessions intervals, in the CY 2017 PFS final rule (81 FR 
80465), we finalized the MDPP core benefit for all MDPP beneficiaries 
as 12 consecutive months consisting of at least 16 weekly core sessions 
over months 1 to 6 and at least 6 monthly core maintenance sessions 
over months 6 to 12 that must be offered to each MDPP beneficiary 
regardless of attendance or weight loss.
    We made no proposals to change the coverage policy under 
circumstances where an MDPP beneficiary's attendance at sessions that 
must be offered by the MDPP supplier is too low to result in a 
performance payment to that supplier. We further note that the CDC DPRP 
Standards require that DPP-eligible individuals be able to access the 
core maintenance sessions, regardless of weight loss, in order for an 
organization to maintain CDC DPRP recognition. Our final policy at 
Sec.  424.205(b)(1) specifies that to enroll in Medicare as an MDPP 
supplier, an entity must have and maintain MDPP preliminary recognition 
or full CDC DPRP recognition. Therefore, we are not requiring the 
achievement of attendance or weight loss performance goals during the 
first core maintenance session interval for the MDPP beneficiary to 
have coverage of the second core maintenance session interval, which is 
consistent with the CDC DPRP Standards for core maintenance session 
access. Because the achievement of performance goals is required for 
performance payments for core maintenance session intervals, 
eligibility and payment are not aligned during months 7 through 12 of 
the MDPP services period.
    After considering the public comments received, we are finalizing 
the proposals for core maintenance session interval performance 
payments for core maintenance sessions at Sec.  414.84(b)(4), with 
modifications. We will pay MDPP suppliers $60 for a core maintenance 
session 3-month interval if a beneficiary attends at least 2 sessions 
during the interval and achieves or maintains the required minimum 
weight loss during that interval, and pay MDPP suppliers $15 for a core 
maintenance session interval if the beneficiary attends at least 2 
sessions but does not achieve or maintain the required minimum weight 
loss during that core maintenance session interval. The final 
performance payments for core maintenance session intervals are 
displayed in Table 33.

                   Table 33--Final Performance Payments for Core Maintenance Session Intervals
----------------------------------------------------------------------------------------------------------------
                                                                  Performance payment      Performance payment
                                                                 per beneficiary  (with      per beneficiary
                                                                     achievement or        (without achievement
                       Performance goal                              maintenance of         or maintenance  of
                                                                    required minimum         required minimum
                                                                      weight loss)             weight loss)
----------------------------------------------------------------------------------------------------------------
2 sessions attended in first core maintenance session interval                      $60                      $15
 (months 7-9 of the MDPP core services period)................
2 sessions attended in second core maintenance session                               60                       15
 interval (months 10-12 of the MDPP core services period).....
                                                               -------------------------------------------------
Maximum total performance payment for core maintenance session                      120                       30
 intervals (two consecutive 3-month intervals over months 7-12
 of the MDPP core services period)............................
----------------------------------------------------------------------------------------------------------------

(5) Performance Payments for Ongoing Maintenance Session Intervals
    Similar to our proposal for the payment of core maintenance session 
intervals described previously, we proposed to make performance 
payments to MDPP suppliers for 3-month ongoing maintenance session 
intervals. This payment would be made when suppliers furnish ongoing 
maintenance sessions during the 24 months of the ongoing services 
period after the 12-month MDPP core services period ends. We proposed 
that an MDPP supplier would be paid a performance payment for an 
ongoing maintenance session interval if an MDPP beneficiary achieves 
the performance goals of attending at least 3 ongoing maintenance 
sessions and maintaining the required minimum weight loss from baseline 
measured in-person during a session at least once within that interval. 
Under this proposal, an MDPP supplier would not be paid a performance 
payment unless the beneficiary has achieved both of these

[[Page 53274]]

performance goals within that 3-month interval. An ongoing maintenance 
session interval, as we proposed to define it at Sec.  410.79(b), would 
mean one of the up to eight consecutive 3-month time periods during the 
ongoing services period, during which an MDPP supplier offers at least 
1 ongoing maintenance session to an MDPP beneficiary per month.
    The payment structure presented in the CY 2017 PFS proposed rule 
(81 FR 46415 through 46416) would have required the MDPP beneficiary to 
attend 3 ongoing maintenance sessions and maintain the required minimum 
weight loss for a $45 payment to be made to an MDPP supplier for the 
ongoing maintenance session interval. Based on our consideration of 
information provided in the public comments on the CY 2017 PFS proposed 
rule and our increased emphasis in the performance payments on the 
achievement and maintenance of weight loss as the outcome of MDPP 
services, our proposal for the performance payment for ongoing 
maintenance session intervals differed from that payment amount.
    We proposed that MDPP suppliers could be paid up to 8 performance 
payments of $50 each for ongoing maintenance session intervals. Just 
like the other proposals for performance payments, we proposed this 
payment in CY 2018 dollars to ensure consistency in calendar year 
dollars among performance payments for a given calendar year. However, 
we noted that no ongoing maintenance session interval payments, 
available only for intervals in the ongoing services period during 
months 13 through 36 of an MDPP beneficiary's MDPP services period, 
would be made in CY 2018 based on our proposal discussed in section 
III.K.2.a. of the proposed rule (82 FR 34141) that MDPP services be 
available on April 1, 2018. Under this proposal, MDPP services would 
only be available for 9 months of CY 2018 so no MDPP beneficiaries 
would attend ongoing maintenance sessions in CY 2018. The first ongoing 
maintenance session interval performance payments would be made in CY 
2019 and would equal $50 adjusted by the percent change in the Consumer 
Price Index for All Urban Consumers (CPI-U) (U.S. city average) for the 
12-month period ending June 30th, 2018, as discussed in section 
III.K.2.d.iii.(9) of the proposed rule (82 FR 34147 through 34148).
    This proposed payment amount would be somewhat higher than the 
potential payment discussed in the CY 2017 PFS proposed rule (81 FR 
46415 through 46416) to recognize that maintenance of the required 
minimum weight loss is necessary for the reduced incidence of type 2 
diabetes and to encourage MDPP suppliers to work to engage 
beneficiaries in sustaining their weight loss over time. The maximum 
total performance payment for MDPP ongoing maintenance sessions would 
be $400, as displayed in Table 34. On a per-session basis, this payment 
would be approximately $17, which we believed would be appropriate for 
MDPP suppliers that furnish ongoing maintenance sessions to 
beneficiaries who maintain the required minimum weight loss during 
ongoing maintenance session interval. We noted that this per-session 
payment amount would be somewhat lower than the $20 per-session payment 
amount included in the core maintenance session interval performance 
payment for beneficiaries who achieve attendance and weight loss 
performance goals during the 3-month intervals in months 7 to 12 of the 
MDPP core services period. Like the proposed performance payment for 
core maintenance session intervals, the proposed performance payment 
for ongoing maintenance session intervals would value both attendance 
and weight loss. However, we believed it is likely that the required 
minimum weight loss would be first achieved during core maintenance 
session intervals, and we also believed that a somewhat higher per-
session payment amount would be appropriate under these circumstances. 
In contrast, we believed that a somewhat lower per-session payment 
amount for ongoing maintenance sessions during intervals where the 
required minimum weight loss is maintained, rather than achieved, would 
be appropriate.
    We considered an alternative policy in which an MDPP supplier would 
receive a payment for an ongoing maintenance session interval so long 
as the beneficiary attended at least 1 ongoing maintenance session 
during the interval and maintained the required minimum loss. In this 
scenario, we considered that the MDPP supplier would still be required 
to offer at least 2 additional ongoing maintenance sessions (at least 
one per month) to the beneficiary over the 3-month interval. However, 
we believed that the goal of ongoing maintenance sessions is to promote 
both sustained beneficiary engagement and weight loss and, therefore, 
we believed that ongoing maintenance session interval performance 
payments should be tied to achieving both attendance and weight loss 
performance goals.
    The proposed payment policy also would align with the coverage 
limitations for ongoing maintenance sessions at Sec.  410.79(c)(1)(iii) 
in that beneficiaries also would be required to attend all 3 sessions 
within a given ongoing maintenance session 3-month interval to be 
covered for the subsequent 3-month interval. We noted that the proposed 
coverage and payment policies would be aligned for ongoing maintenance 
session intervals, where attendance at 3 sessions within an interval 
would be required for a performance payment as well as for coverage of 
ongoing maintenance sessions in the next interval. In contrast, MDPP 
suppliers would be required to offer core maintenance sessions in both 
core maintenance session intervals for all beneficiaries, regardless of 
a beneficiary's attendance at core maintenance sessions, although 
attendance would be required for a performance payment to be made for 
the core maintenance session interval.

                Table 34--Proposed Performance Payments for Ongoing Maintenance Session Intervals
----------------------------------------------------------------------------------------------------------------
                                                                  Performance payment      Performance payment
                                                                 per beneficiary  (with      per beneficiary
                       Performance goal                           maintenance of  the      (without maintenance
                                                                   required  minimum         of the required
                                                                      weight loss)         minimum weight loss)
----------------------------------------------------------------------------------------------------------------
3 sessions attended in 1 ongoing maintenance session interval.                      $50                       $0
Maximum total performance payment for ongoing maintenance                           400               * 0 to 350
 session intervals (8 consecutive 3-month intervals over
 months 13-36 of the MDPP ongoing services period)............
----------------------------------------------------------------------------------------------------------------
* = The specific payment amount depends on whether the beneficiary has coverage of 1 to 7 ongoing maintenance
  session intervals, as well as whether the beneficiary meets the performance goals for the performance payment
  for that ongoing maintenance session interval.


[[Page 53275]]

    The proposed ongoing maintenance session interval performance 
payments for ongoing maintenance sessions were included at proposed 
Sec.  414.84(b)(5). We invited public comments on these proposals. We 
also invited public comments on the alternative considered.
    The following is a summary of the public comments received on the 
proposals for ongoing maintenance session interval performance payments 
for ongoing maintenance sessions and the alternative considered and our 
responses:
    Comment: Some commenters supported the proposed $50 ongoing 
maintenance session interval performance payment, which they believe is 
appropriate given the MDPP supplier resources that would be used to 
furnish sessions during those intervals. One commenter, who also 
advocated for an increase in the performance payments for core sessions 
in order to increase the maximum total performance payment amount 
available in the first 12 months of the MDPP services period to meet 
the MDPP supplier financial need for sustaining its DPP, further urged 
CMS to reduce the ongoing maintenance session interval performance 
payment from $50 to $45.
    Several commenters expressed concern that if an MDPP beneficiary in 
an ongoing maintenance session 3-month interval does not achieve the 3 
session attendance goal and/or does not maintain the required minimum 
weight loss, the MDPP supplier would not receive the performance 
payment for that interval. The commenters stated that MDPP suppliers 
would expend resources to furnish MDPP services to the MDPP beneficiary 
during the 3-month interval but bear the financial risk under the 
proposal of not getting paid if the beneficiary fails to attend at 
least 3 sessions and maintain the required minimum weight loss. They 
further noted that to achieve beneficiary attendance of 3 sessions 
during the 3-month interval, MDPP suppliers would likely have to offer 
more than 3 ongoing maintenance sessions to MDPP beneficiaries during 
that time period. The commenters urged CMS to change the attendance 
requirement for performance payment for ongoing maintenance session 
intervals to 2 of the 3 sessions that must be offered, in order to help 
more beneficiaries stay in the DPP and reduce the financial risk to the 
MDPP supplier. Particularly over the 24-month long ongoing services 
period that CMS proposed, the commenters stated that monthly 
beneficiary attendance could be hard to sustain and in actuality not be 
important, especially if the MDPP beneficiary maintains the required 
minimum weight loss throughout that time period.
    Response: As discussed in section III.K.2.b.i. of this final rule, 
we are finalizing the ongoing services period as 12 months, rather than 
the 24-month duration that we proposed. In addition, as discussed in 
section III.K.2.c.iv., we are finalizing the policy that the 
eligibility for coverage of a subsequent ongoing maintenance session 3-
month interval during months 16 to 24 of the MDPP services period 
depends both on beneficiary attendance at 2 ongoing maintenance 
sessions in the prior ongoing maintenance session interval and 
maintenance of the required minimum weight loss.
    In the proposed rule (82 FR 34145), we considered an alternative 
policy in which an MDPP supplier would receive a performance payment 
for an ongoing maintenance session interval so long as the beneficiary 
attended at least 1 ongoing maintenance session during the interval and 
maintained the required minimum weight loss, which is similar to the 
requests of some of the commenters that the performance payment require 
attendance at 2 ongoing maintenance sessions, rather than 3. However, 
we note that we continue to believe that the goal of ongoing 
maintenance sessions is to promote both sustained beneficiary 
engagement and weight loss and, therefore, we believe that ongoing 
maintenance session interval performance payments should be tied to 
achieving both weight loss and significant attendance performance 
goals. However, because MDPP suppliers must offer, at a minimum, 
monthly ongoing maintenance sessions to all MDPP beneficiaries with 
coverage of each 3-month ongoing maintenance session interval during 
months 13 to 24 of the MDPP services period, regardless of the 
beneficiary's attendance or maintenance of weight loss, we believe it 
is appropriate to reduce the attendance requirement for the performance 
payments during this time period from 3 to 2 sessions per interval.
    Our reasoning for this decision is similar to our rationale for 
finalizing a core maintenance session interval attendance performance 
goal of 2 sessions for the core maintenance session interval 
performance payments as discussed in section III.K.2.d.iii.(4) of this 
final rule. Lowering the required session attendance for the 
performance payments during the ongoing services period will provide 
additional flexibility to beneficiaries to allow them to balance life 
events and DPP session attendance, without the decisions of 
beneficiaries who maintain the required minimum weight loss resulting 
in financial consequences for MDPP suppliers that must offer sessions 
regardless of actual attendance. We believe that attendance of 2 
sessions in an ongoing maintenance session 3-month interval still 
represents substantial beneficiary engagement that promotes the 
integration of behavior change longer-term into a beneficiary's 
lifestyle in order for him or her to maintain the required minimum 
weight loss.
    We also believe that the final shorter ongoing services period 
makes beneficiary attendance at 2 sessions in each 3-month interval 
feasible. We acknowledge that the MDPP supplier bears some risk that an 
MDPP beneficiary who must be offered a minimum of 3 sessions during an 
ongoing maintenance session interval will not attend 2 sessions and/or 
will not maintain the required minimum weight loss during that interval 
so the MDPP supplier would not receive an ongoing maintenance session 
interval performance payment for that interval for that beneficiary. 
However, we pay for the set of MDPP services through a performance-
based payment methodology that makes periodic performance payments to 
MDPP suppliers during the MDPP services period, and the aggregate of 
all performance payments constitutes the total performance-based 
payment amount for the set of MDPP services.
    Moreover, we continue to believe that maintaining the required 
minimum weight loss is an appropriate performance goal that must be met 
for an ongoing services interval performance payment to be made, given 
that the first ongoing maintenance session interval begins 12 months 
after the beginning of the MDPP services period. At that point at least 
half way through the maximum length of the beneficiary's MDPP services 
period, providing a performance payment for attendance alone would not 
be consistent with our emphasis in the MDPP expanded model on the 
achievement of the outcome of weight loss.
    We note that the final attendance and weight loss performance goals 
for ongoing maintenance session interval performance payments are 
aligned with beneficiary eligibility for the subsequent ongoing 
maintenance session interval, a consistency that will incentivize MDPP 
suppliers to sustain their efforts regarding beneficiary engagement and 
minimize MDPP supplier and beneficiary confusion about MDPP services 
during the ongoing services period. Due to this alignment, the MDPP

[[Page 53276]]

supplier financial risk during the ongoing services period is limited 
to a maximum of 3 sessions in a single ongoing maintenance service 
interval, because eligibility and performance payment are aligned 
during this period. If a beneficiary does not meet the attendance and 
weight loss performance goals for an interval performance payment, the 
beneficiary is not eligible for coverage of ongoing maintenance 
sessions in the next interval, so the MDPP supplier is not required to 
offer additional sessions to the beneficiary.
    We appreciate the support of the commenters for the proposed 
ongoing maintenance session interval performance payment amount of $50. 
Given our emphasis in the MDPP expanded model on the achievement of the 
required minimum weight loss that results in a reduced incidence of 
type 2 diabetes, we believe it is appropriate to adopt this payment 
amount under the performance-based payment methodology because the 
performance payment is only made if the beneficiary maintains the 
required minimum weight loss. Reducing the payment amount would lessen 
our emphasis on maintaining weight loss, which would be contrary to our 
interest in improving the health of beneficiaries through MDPP services 
that ultimately lead to lower Medicare expenditures.
    After considering the public comments received, we are finalizing 
the proposals for ongoing maintenance session interval performance 
payments for ongoing maintenance sessions at Sec.  414.84(b)(5), with 
modifications. We will pay MDPP suppliers $50 for an ongoing 
maintenance session 3-month interval if a beneficiary attends at least 
2 sessions during the interval and maintains the required minimum 
weight loss during that interval. The final performance payments for 
ongoing maintenance session intervals are displayed in Table 35.

                 Table 35--Final Performance Payments for Ongoing Maintenance Session Intervals
----------------------------------------------------------------------------------------------------------------
                                                                  Performance payment      Performance payment
                                                                 per beneficiary  (with      per beneficiary
                       Performance goal                           maintenance of  the    (without maintenance of
                                                                   required  minimum       the required  minimum
                                                                      weight loss)             weight loss)
----------------------------------------------------------------------------------------------------------------
2 sessions attended in 1 ongoing maintenance session interval                       $50                       $0
 and required minimum weight loss maintained..................
Maximum total performance payment for ongoing maintenance                           200               * 0 to 150
 session intervals (4 consecutive 3-month intervals over
 months 13-24 of the MDPP ongoing services period)............
----------------------------------------------------------------------------------------------------------------
* = The specific payment amount depends on whether the beneficiary has coverage of 1 to 4 ongoing maintenance
  session intervals, as well as whether the beneficiary meets the performance goals for the performance payment
  for that ongoing maintenance session interval.

(6) Weight Loss Performance Payments
    We proposed that if a beneficiary achieves the required minimum 
weight loss measured at any session attended during the core services 
period, an MDPP supplier would be paid the weight loss performance 
payment of $160 displayed in Table 36. As discussed in section 
III.K.2.d.iii.(2)(a) of the proposed rule (82 FR 34139 through 34141), 
we proposed that 23 percent of the maximum total performance payment 
amount for the set of MDPP services would be paid for the achievement 
of weight loss, regardless of session attendance, because weight loss 
is the most important outcome for the MDPP expanded model. The proposed 
performance payment of $160 for the required minimum weight loss, which 
constitutes approximately 90 percent of the maximum total weight loss 
performance payment, was proposed to be the large majority of the 
available weight loss performance payment based on the strong evidence 
for the association of the required minimum weight loss with a 
reduction in the incidence of type 2 diabetes.
    We noted that this association is evidenced by the CDC's National 
DPP, which is based on the 2002 DPP Randomized Control Trial and 
follow-up efficacy trials.\34\ All of the trials found that the greater 
the intensity and duration of the diabetes prevention program--with 1 
year being the most effective program ``dose''--the greater the 
reduction in the incidence of type 2 diabetes. Specially, persons at 
high-risk for type 2 diabetes who participated in a year-long lifestyle 
change program, focused on modest weight loss (5-7 percent), 
experienced a 58 percent lower incidence of type 2 diabetes than those 
who did not receive the lifestyle intervention. The DPP Randomized 
Control Trial, as well as the DPP model test, involved the provision of 
16 weekly core sessions and 6 monthly core maintenance sessions (all 
approximately 1 hour in length), similar to the set of core services in 
the MDPP expanded model. We recognized that not all beneficiaries would 
be able to achieve the required minimum weight loss within the first 6 
months, which is the period when core sessions are furnished. 
Therefore, we believed that our proposed policy for payment of the 
performance payment upon achievement of the required minimum weight 
loss any time during the 12 months of the MDPP core services period 
would allow MDPP suppliers the greatest flexibility to work throughout 
the full MDPP core services period with beneficiaries who face 
difficulty in achieving this weight loss performance goal.
---------------------------------------------------------------------------

    \34\ Available at https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp/Documents/DPP_508.pdf.
---------------------------------------------------------------------------

    We also proposed that, in addition to the weight loss performance 
payment for the required minimum weight loss, an MDPP supplier would be 
paid an additional weight loss performance payment of $25 if the 
beneficiary achieves at least 9 percent weight loss from his or her 
baseline weight at any time during the MDPP services period as 
displayed in Table 36. We proposed this additional weight loss 
performance payment based on information from stakeholders that 
commercial payers paying for DPPs frequently include an incentive 
payment for 9 percent weight loss as an incentive to try to encourage 
greater and/or continued weight loss and behavior change. We believed 
that making an additional weight loss performance payment for 9 percent 
weight loss at any time during the MDPP services period would provide 
an additional incentive for MDPP suppliers to continue weight loss 
efforts with beneficiaries, especially during the ongoing services 
period, which may extend for a period of up to 24 months.
    We proposed that MDPP suppliers may submit claims for these weight 
loss performance payments on the date when the beneficiary first 
reaches the

[[Page 53277]]

required minimum or 9 percent weight loss, as measured in-person during 
a session, respectively, and each weight loss performance payment would 
be paid to only one supplier and only once per beneficiary. In the 
unusual circumstance where the beneficiary achieved 9 percent weight 
loss as the first weight loss change measured from baseline, the MDPP 
supplier could bill and be paid both the 5 percent and 9 percent weight 
loss performance payments.

           Table 36--Proposed Weight Loss Performance Payments
------------------------------------------------------------------------
                                                            Performance
                    Performance goal                        payment per
                                                            beneficiary
------------------------------------------------------------------------
5 percent weight loss (required minimum weight loss)....            $160
9 percent weight loss...................................              25
                                                         ---------------
    Maximum total performance payment for weight loss...             185
------------------------------------------------------------------------

    The proposed weight loss performance payments were included at 
proposed Sec.  414.84(b)(6) and (7). We invited public comments on 
these proposals.
    The following is a summary of the public comments received on the 
proposals for weight loss performance payments and our responses:
    Comment: While generally supportive of weight loss performance 
payments for the achievement of weight loss during the MDPP services 
period, several commenters recommended that CMS make performance 
payments for a lower percentage of weight loss than the 5 percent 
weight loss that CMS proposed, either as additional incremental weight 
loss performance payments or in place of the proposed performance 
payment for 5 percent weight loss. Those commenters advocating for 
additional incremental weight loss performance payments for lower 
percentages of weight loss believe this approach would allow MDPP 
suppliers to be paid for continued DPP support when a beneficiary 
achieves 3 percent and 4 percent weight loss. Under such a methodology, 
the commenters claimed that MDPP suppliers and MDPP beneficiaries would 
be able to work toward a more achievable early weight loss performance 
goal that would also sustain the MDPP suppliers' operations. The MDPP 
supplier would receive a performance payment when the early weight loss 
performance goal is achieved, thereby enabling the MDPP supplier to 
help beneficiaries reach even greater weight loss from baseline. A few 
commenters further urged CMS to make an additional performance payment 
for any MDPP beneficiary who achieves the required minimum weight loss 
and then maintains that level of weight loss at the end of the core 
services period.
    Several commenters recommended that CMS gradually phase-in the 
percentage of weight loss required for the first weight loss 
performance payment during implementation of the MDPP expanded model, 
to allow MDPP suppliers to follow a learning curve in starting up their 
DPP. One scenario described by the commenters would provide a 
performance payment for 3 percent weight loss in the DPP organization's 
first year in the MDPP expanded model, 4 percent in the second year, 
and 5 percent in the third year and thereafter.
    A few commenters requested that CMS eliminate the weight loss 
performance payment entirely to help avoid putting MDPP suppliers 
serving low-resources communities at immediate risk. Alternatively, the 
commenters suggested that CMS could guarantee the amount of weight loss 
performance payment for MDPP suppliers below a certain volume of 
beneficiaries, while making the payment for weight loss based on actual 
performance for MDPP suppliers of a larger size or to MDPP suppliers in 
a pooled group so that random variation in beneficiary weight loss 
could be overcome. Another commenter noted that a beneficiary's weight 
can fluctuate during the MDPP services period and, as such, a general 
downward trend in weight may be a more valid measure of progress than a 
percentage weight loss over a prescribed interval.
    One commenter pointed out that professional care guidelines about 
weight loss do not translate population health averages to individual 
treatment targets, and in using 5 percent weight loss as the 
performance goal to determine payment for an individual Medicare 
beneficiary, the commenters observed that CMS did not value the 
significant health benefit for individual beneficiaries of lower levels 
of weight loss. The commenter further noted that the 5 percent weight 
loss performance payment per MDPP beneficiary did not align with the 
CDC's DPRP Standards, which are DPP-wide achievement of an average of 5 
percent weight loss across those patients who attend 4 or more 
sessions.
    Several commenters urged CMS to reduce the proposed amount of the 5 
percent weight loss performance payment to approximately 10 percent of 
the maximum available total performance payment per beneficiary from 
the 20 percent CMS proposed and redistribute the dollars to attendance-
based payments for sessions during the core services period.
    Response: With regard to the potential for lowering the weight loss 
performance payment goal to 3 percent or 4 percent or, alternatively, 
making incremental weight loss performances for 3 percent, 4 percent, 
and 5 percent weight loss, we note that the MDPP expanded model was 
determined to meet the statutory requirements for expansion, where 
certification of the DPP model test was based on findings that 
demonstrated that 5 percent weight loss was associated with reductions 
in Medicare expenditures. Therefore, the goal of the MDPP expanded 
model is at least 5 percent weight loss for each beneficiary, which is 
expected to lead to a reduction in the incidence of type 2 diabetes. We 
do not have data to support an expanded model that does not require the 
achievement and maintenance of the required minimum weight loss, so we 
do not believe it would be appropriate to make a weight loss 
performance payment for achievement of weight loss that is less than 5 
percent, to guarantee the weight loss performance payment for all 
beneficiaries served by small MDPP suppliers, or to eliminate the 
weight loss performance payment entirely in favor of solely attendance-
based performance payments. In addition, we expect there to be some 
natural, small downward or upward fluctuations in a beneficiary's 
weight as measured over time, in relation to fluid intake, the 
composition of recent meals, hormonal changes, or other factors. We 
believe that making a weight loss performance payment based on a one-
time in-person weight measurement at a session for less than a 5 
percent weight loss would risk Medicare making a weight loss 
performance payment when a beneficiary has experienced a natural 
downward weight fluctuation rather than true weight loss that has the 
potential to be sustained.
    Furthermore, because there is no specific number of beneficiaries 
per MDPP supplier, we do not believe it would be appropriate to make 
weight loss performance payments based on program-wide achievement of 5 
percent weight loss, rather than individual beneficiary weight loss, 
because this would reduce an MDPP supplier's incentive to actively help 
each beneficiary to meet the required minimum weight loss, particular 
if a few beneficiaries lost a large percentage of their weight. While 
we aim to maintain consistency to the extent possible with CDC's DPRP 
Standards, we note that standards for full recognition status, which 
require

[[Page 53278]]

meeting weight loss and attendance standards that are measured at the 
aggregate rather than individual level, are set to ensure the quality 
and integrity of the services furnished by the DPP organization. In 
contrast, the performance-based payment methodology for the MDPP 
expanded model establishes performance goals for beneficiaries so 
Medicare can make performance payments based on claims submitted by 
MDPP suppliers for MDPP services furnished to individual beneficiaries 
who achieve those performance goals. We believe that these differences 
between the DPP organization-wide rationale for the DPRP Standards and 
the performance goals for payment for MDPP services furnished to 
individual MDPP beneficiaries under the MDPP expanded model lead to 
reasonable differences in the measurement of 5 percent weight loss for 
these two purposes.
    In response to the commenters who urged us to reduce the proposed 5 
percent weight loss performance payment from 20 percent to 10 percent 
of the maximum total performance payment amount per beneficiary and 
redistribute the dollars to attendance-based payments in the core 
services period, we continue to emphasize that the achievement and 
maintenance of the required minimum weight loss is the outcome of MDPP 
services that is associated with a reduction in the incidence of type 2 
diabetes. Therefore, we do not believe it would be appropriate to 
reduce the amount of the performance payment for 5 percent weight loss 
to less than the $160 we proposed, because that would reduce the 
emphasis on the weight loss outcome in the performance payments.
    However, as discussed in section III.K.2.d.iii.(5) of this final 
rule, the maximum total performance payment for ongoing maintenance 
session intervals has been reduced due to the shortening of the ongoing 
services period from the 24 months that we proposed to 12 months in 
this final rule. Dollars for performance payments that would have been 
made for ongoing maintenance session intervals in months 25 to 36 of 
the MDPP services period have been partially redistributed to 
attendance-based performance payments for core sessions during the 
first 6 months of the MDPP services period, as discussed in section 
III.K.2.d.iii.(3) of this final rule. This is consistent with the 
interests of the commenters who requested a redistribution of a portion 
of the 5 percent weight loss performance payment in order to increase 
attendance-based payments for sessions in the core services period. 
Finally, we note that because the maximum total performance payment 
amount per beneficiary is $670 as discussed in section 
III.K.2.d.iii.(2)(a) of this final rule, which is lower than the $810 
that we proposed, the final $160 5 percent weight loss performance 
payment is actually a higher percentage (24 percent) than the proposed 
20 percent of the maximum total performance payment amount.
    Comment: While several commenters supported the proposal to make a 
weight loss performance payment for 9 percent weight loss at any point 
in time during the MDPP services period, a number of commenters opposed 
this additional weight loss performance payment that is in addition to 
the proposed performance payment for the required minimum weight loss. 
The commenters noted that the CDC DPRP target is 5 percent weight loss 
and, while they acknowledge the potential value to beneficiary health 
of greater weight loss beyond the 5 percent, they believe that making a 
performance payment for a weight loss of 9 percent under the MDPP 
expanded model goes beyond the core DPRP framework and initial research 
and may not be realistic or appropriate for many MDPP beneficiaries. 
One commenter who urged CMS not to finalize the 9 percent weight loss 
performance payment further suggested that the $25 represented in this 
performance payment be distributed to higher core maintenance session 
payments for beneficiaries who did not achieve or maintain the required 
minimum weight loss in the 3-month core maintenance session intervals.
    Response: While we acknowledge the concerns of some commenters that 
the proposed $25 performance payment for 9 percent weight loss is not 
included as a standard in the CDC's DPRP, we continue to agree with 
other commenters that making an additional weight loss performance 
payment for 9 percent weight loss at any time during the MDPP services 
period will provide an additional incentive for MDPP suppliers to 
continue weight loss efforts with MDPP beneficiaries, especially during 
the ongoing services period which may extend for a period of up to 12 
months after the end of the core services period. We also understand 
that commercial payers paying for DPPs frequently include an incentive 
payment for 9 percent weight loss as an incentive to try to encourage 
greater and/or continued weight loss and behavior change.
    We recognize that 9 percent weight loss may not be realistic or 
appropriate for every MDPP beneficiary. However, by finalizing the 
performance payment for 9 percent weight loss as $25, which is less 
than 4 percent of the maximum total performance payment amount 
available for an MDPP beneficiary, we will not provide such a high 
incentive to MDPP suppliers that we risk MDPP suppliers encouraging 
continued weight loss for those beneficiaries who are unlikely to 
benefit from weight loss beyond the required minimum.
    After considering the public comments received, we are finalizing 
our proposals, without modification, for the weight loss performance 
payments at Sec.  414.84(b)(6) and (7). The final weight loss 
performance payments are displayed in Table 37.

            Table 37--Final Weight Loss Performance Payments
------------------------------------------------------------------------
                                                            Performance
                    Performance goal                        payment per
                                                            beneficiary
------------------------------------------------------------------------
5 percent weight loss (required minimum weight loss)....            $160
9 percent weight loss...................................              25
                                                         ---------------
    Maximum total performance payment for weight loss...             185
------------------------------------------------------------------------

(7) Summary Table of Performance Payments for the Set of MDPP Services
    In summary, for furnishing MDPP services during the MDPP services 
period, we proposed that MDPP suppliers could be paid a minimum of $25 
per beneficiary (if the beneficiary attends the first core session) and 
a maximum total of $810 per beneficiary (if the beneficiary achieves 
all performance goals, maintains eligibility for 36 months, and does 
not change MDPP suppliers). Table 38 summarizes all of the proposed 
performance payments for the set of MDPP services that were discussed 
in sections III.K.2.d.iii.(3) through (6) of the proposed rule (82 FR 
34141 through 34146).

[[Page 53279]]



  Table 38--Proposed Performance Payments for the Set of MDPP Services
------------------------------------------------------------------------
                                       Performance        Performance
                                       payment per        payment per
                                       beneficiary        beneficiary
         Performance goal               (with the         (without the
                                     required minimum   required minimum
                                       weight loss)       weight loss)
------------------------------------------------------------------------
1st core session attended.........                   $25
4 total core sessions attended....                   30
9 total core sessions attended....                   50
                                   -------------------------------------
3 sessions attended in first core                * 60                 10
 maintenance session interval
 (months 7-9 of the MDPP core
 services period).................
3 sessions attended in second core               * 60                 10
 maintenance session interval
 (months 10-12 of the MDPP core
 services period).................
5 percent weight loss achieved....                160                  0
9 percent weight loss achieved....                 25                  0
3 sessions attended in ongoing                   * 50               ** 0
 maintenance session interval (8
 consecutive 3-month intervals
 over months 13-36 of the MDPP
 ongoing services period).........
                                   -------------------------------------
    Total performance payment.....                810                125
------------------------------------------------------------------------
* The required minimum weight loss from baseline must be achieved or
  maintained during the core maintenance session 3-month interval or
  maintained during the ongoing maintenance session 3-month interval.
** A beneficiary attends at least 1 core session during the core
  services period to initiate the MDPP services period; must attend at
  least 1 session during the final core maintenance session 3-month
  interval; and must achieve or maintain the required minimum weight
  loss at least once during the final core maintenance session 3-month
  interval to have coverage of the first ongoing maintenance session
  interval. Then, a beneficiary must attend at least 3 sessions and
  maintain the required minimum weight loss at least once during an
  ongoing maintenance session 3-month interval to have coverage of the
  next ongoing maintenance session interval.

    Comment: One commenter requested that MDPP services be paid at a 
higher payment amount when medical professionals, who currently already 
furnish other services to Medicare beneficiaries, furnish MDPP sessions 
than when unlicensed coaches teach the sessions, due to the additional 
training medical professionals have received.
    Response: As finalized in the CY 2017 PFS final rule (81 FR 80479), 
MDPP services must be furnished by trained coaches, including trained 
community health workers and health professionals, who teach 
beneficiaries with prediabetes how to lower their risk of progressing 
to type 2 diabetes with methods that do not include medication or other 
interventions for beneficiaries diagnosed with diabetes. While any 
individual may be eligible to become a DPP coach, provided that they 
meet requirements and trainings as dictated by the CDC's DPRP 
Standards, an individual can only become an eligible coach for purposes 
of furnishing MDPP services after having their required identifying 
information submitted on an MDPP supplier's enrollment application, 
being screened by CMS or its contractors, and as a result, being 
determined to be eligible to furnish MDPP services on behalf of an MDPP 
supplier as discussed in section III.K.3.e.iv.(2) of this final rule. 
Thus, all DPP coaches, whether or not they are licensed health 
professionals who also furnish other services to Medicare 
beneficiaries, must meet the same DPRP Standards and the other 
requirements established in this final rule to be eligible coaches who 
can furnished MDPP services.
    We proposed that the payment methodology for MDPP services be 
performance-based in relation to the achievement of the performance 
goals of session attendance and weight loss. While we acknowledge that 
licensed health professionals have training and a scope of practice 
that extends beyond community health workers who are trained DPP 
coaches, for purposes of the performance payments for MDPP services we 
see no reason to value in the payment methodology the MDPP 
beneficiary's achievement of the same performance goals differently 
based on additional credentials of the coach who furnished the session 
that resulted in the performance goal being met. The literature does 
not demonstrate that DPP sessions furnished by coaches with additional 
credentials result in greater achievement of patient outcomes than 
sessions furnished by coaches without additional credentials, where all 
coaches meet the CDC's DPRP Standards.35 36 37 38 Therefore, 
we expect that each MDPP supplier will consider the characteristics of 
the most effective coaches furnishing MDPP services to its MDPP 
beneficiaries, including whether or not specific coaches have 
additional credentials, in relation to the resources used by the MDPP 
supplier to pay those coaches, and the MDPP supplier will make 
decisions about the specific coaches to include on the supplier's 
roster accordingly.
---------------------------------------------------------------------------

    \35\ D Vojta et al., ``A Coordinated National Model for Diabetes 
Prevention: Linking Health Systems to an Evidence-Based Community 
Program,'' American Journal of Preventive Medicine 44, no. 4 Suppl 4 
(2013): S301-S306.
    \36\ Mohammed K. Ali et al., ``How Effective were Lifestyle 
Interventions in Real-World Settings that were Modeled on the 
Diabetes Prevention Program?'' Health Affairs 31, no.1 (2012): 67-
75.
    \37\ L Ruggiero et al., ``Community-Based Translation of the 
Diabetes Prevention Program's Lifestyle Intervention in an 
Underserved Latino Population,'' The Diabetes EDUCATOR 37, no. 4 
(2011); 564-572.
    \38\ JA Katula et al., ``The Healthy Living Partnerships to 
Prevent Diabetes Study 2-Year Outcomes of a Randomized Controlled 
Trial,'' American Journal of Preventive Medicine 44, no. 4S4 (2013): 
S324-S332.
---------------------------------------------------------------------------

    Comment: Several commenters recommended that MA plans be given 
flexibility in making MDPP services available to their eligible plan 
enrollees, including, but not limited to, contracting directly with a 
vendor who in turn contracts with approved entities that furnish the 
CDC-approved DPP curriculum with payment arrangements that may or may 
not be the same as the payment methodology CMS proposed. With respect 
to payment for MDPP services furnished to MA plan enrollees, the 
commenters requested that MA plans be permitted to utilize the payment 
framework proposed by CMS, use a value-based performance contracting 
arrangement, or put in place any other alternative payment arrangement 
that meets the needs of the MA plan and their eligible plan enrollees 
in the communities in which

[[Page 53280]]

they operate. The commenters urged CMS to clarify that the detailed 
proposed payment framework applies only to MDPP services furnished to 
Medicare fee-for-service beneficiaries.
    Response: We appreciate the recommendations from the commenters 
about MA plan flexibilities that may be used in making MDPP services 
available to their eligible plan enrollees, including their requests 
for clarification about the relationship between the proposed 
performance-based payment methodology for MDPP services and payment for 
MDPP services furnished to MA plan enrollees. Under section 
1854(a)(6)(B)(iii) of the Act, CMS is prohibited from requiring an MAO 
to contract with specific providers and from requiring specific price 
or payment structures under the contracts with network providers; these 
provisions are reflected in the regulation at Sec.  422.256(a)(2)(ii). 
However, the Act, at sections 1852(a)(2) and (k)(1) and 1866(a)(1)(O) 
of the Act, also imposes requirements that MAOs pay out-of-network 
providers (that is, providers that do not contract with the MAO) and 
that such providers accept as payment in full the amount that would 
have been paid under original (fee-for-service) Medicare when the out-
of-network provider furnishes covered services to an MA plan enrollee.
    Therefore, we are not adopting any requirements to govern how an 
MAO pays its network providers--either in amount or structure--for MDPP 
services and believe that existing law adequately addresses when an 
out-of-network provider furnishes covered MDPP services. We note that 
as it appears unlikely that any MDPP services would be furnished as 
emergency or urgently needed services, we anticipate that the out-of-
network payment requirements would be applicable only for MA private 
fee-for-service plans, MA point-of-service (POS) plans, or MA preferred 
provider organization (PPO) plans that regularly cover out-of-network 
services. Under these existing authorities, MA plans currently have 
flexibility in their payment methodologies for Part B services 
furnished to MA plan enrollees through network providers. Because MDPP 
services are covered under Part B, MA plans will have this same payment 
flexibility for MDPP services furnished by network providers to MA plan 
enrollees.
    Table 39 summarizes all of the final performance payments for the 
set of MDPP services that were individually finalized in sections 
III.K.2.d.iii.(3) through (6) of this final rule.

    Table 39--Final Performance Payments for the Set of MDPP Services
------------------------------------------------------------------------
                                       Performance        Performance
                                       payment per        payment per
                                       beneficiary        beneficiary
         Performance goal               (with the         (without the
                                     required minimum   required minimum
                                       weight loss)       weight loss)
------------------------------------------------------------------------
1st core session attended.........                   $25
4 total core sessions attended....                   50
9 total core sessions attended....                   90
                                   -------------------------------------
2 sessions attended in first core                * 60                 15
 maintenance session interval
 (months 7-9 of the MDPP core
 services period).................
2 sessions attended in second core               * 60                 15
 maintenance session interval
 (months 10-12 of the MDPP core
 services period).................
5 percent weight loss achieved....                160                  0
9 percent weight loss achieved....                 25                  0
2 sessions attended in ongoing                   * 50               ** 0
 maintenance session interval (4
 consecutive 3-month intervals
 over months 13-24 of the MDPP
 ongoing services period).........
                                   -------------------------------------
    Total performance payment.....                670                195
------------------------------------------------------------------------
* The required minimum weight loss from baseline must be achieved or
  maintained during the core maintenance session 3-month interval or
  maintained during the ongoing maintenance session 3-month interval.
** A beneficiary attends at least 1 core session during the core
  services period to initiate the MDPP services period; must attend at
  least 1 session during the final core maintenance session 3-month
  interval; and must achieve or maintain the required minimum weight
  loss at least once during the final core maintenance session 3-month
  interval to have coverage of the first ongoing maintenance session
  interval. Then, a beneficiary must attend at least 2 sessions and
  maintain the required minimum weight loss at least once during an
  ongoing maintenance session 3-month interval to have coverage of the
  next ongoing maintenance session interval.

(8) Considerations Related to Potential Future Geographic Adjustment of 
MDPP Payments
    Although Medicare is a national program, it frequently adjusts fee-
for-service payments to hospitals, physicians, and other providers and 
suppliers according to the geographic locations in which they furnish 
services. These adjustments generally account for differences in the 
relative costs of doing business in different geographic areas compared 
to the national average. For example, section 1886(d)(3)(E) of the Act 
requires that, as part of the methodology for determining prospective 
payments to hospitals, the Secretary must adjust the standardized 
amounts for area differences in hospital wage levels by a factor 
(established by the Secretary) reflecting the relative hospital wage 
level in the geographic area of the hospital compared to the national 
average hospital wage level. This adjustment factor for hospitals is 
the wage index, and we currently define hospital geographic areas 
(labor market areas) based on the definitions of Core-Based Statistical 
Areas (CBSAs) established by the Office of Management and Budget. 
Similarly, a geographic adjustment is also made for services paid under 
the PFS, and a geographic practice cost index (GPCI) has been 
established for every Medicare PFS payment locality, many of which are 
statewide, for each of the three components of a service's relative 
value units (that is, the relative value units for work, practice 
expense, and malpractice).
    We proposed to make performance-based payments to MDPP suppliers in 
intervals based on achievement of performance goals, rather than fee-
for-service payments for individual services furnished. Although we 
intended for those performance payments to make

[[Page 53281]]

payment to MDPP suppliers for MDPP services that involve the use of 
supplier resources, we stated that we were unsure if there is notable 
variation in the relative costs of furnishing MDPP services among 
geographic areas. Because the DPP model test was carried out in only 
eight states, we did not have the data to determine whether there are 
geographic differences nationwide. In addition, because a substantial 
portion of the proposed MDPP performance payments would be based on the 
beneficiary's achievement of weight loss performance goals, we were 
uncertain about the appropriateness of geographically adjusting such 
performance-based payments.
    Therefore, we did not propose geographic adjustment of performance 
payments for MDPP services. However, we invited public comments on 
issues related to geographic adjustment of payment for MDPP services in 
the context of the MDPP performance-based payment methodology, 
including appropriate sources of information for determining any 
geographic cost differences. We noted that we may consider proposing 
additional payment policies for the MDPP expanded model in the future. 
We requested that commenters submitting information on these issues 
provide justification, including any relevant analysis, to support any 
suggestions regarding potential future geographic adjustment of 
performance-based payments for MDPP services.
    The following is a summary of the public comments received on 
issues related to geographic adjustment of payment for MDPP services in 
the context of the proposed MDPP performance-based payment methodology, 
including appropriate sources of information for determining any 
geographic cost differences, and our responses:
    Comment: Several commenters recommended that CMS consider varying 
the payment structure for MDPP suppliers in differing geographic 
markets in which MDPP suppliers operate, given the potential effects 
the region may have on operating costs. One commenter explained that 
any business, including an MDPP supplier, relies on varying market 
analyses based on region, such as urban versus rural, and on factors 
such as environment, legislation and competition, in establishing the 
parameters of the business. The commenter stated that business 
processes result in differing administrative and operational costs 
based on region and organizational structure that the commenter noted, 
if not addressed through the MDPP payment structure, would impact MDPP 
supplier sustainability and network adequacy, including the delivery of 
MDPP services to populations of greatest need. Another commenter noted 
that the major cost drivers of DPPs are salaries, which are highly 
variable across the U.S. A commenter acknowledged the DPP model test 
was conducted in limited geographic areas but believes CMS has enough 
experience with geographic payment adjustments in performance- based 
payment structures to apply such adjustments to payments for these 
services. The commenters urged CMS to consider geographic adjustment of 
payment for MDPP services now or in the future, emphasizing that the 
geographic adjustment of payment for MDPP services would be consistent 
with methodologies used for other services paid under the Medicare 
program.
    Response: We note that the commenters recommending geographic 
adjustment of payment for MDPP services did not provide specific 
sources of information for determining geographic cost differences for 
MDPP services. Moreover, they did not suggest any specific geographic 
adjustment methodology in the context of the MDPP performance-based 
methodology that fundamentally differs from the resource-based payment 
methodologies that apply to most other services paid under the Medicare 
fee-for-service program.
    We will review the suggestions provided by the commenters, as well 
as our early implementation experience with the MDPP expanded model and 
other information we receive in the future from stakeholders, as we 
consider proposing additional payment policies for the MDPP expanded 
model in the future, as appropriate.
    Comment: While not specifically related to geographic adjustment, 
one commenter requested that CMS consider using authority provided in 
section 1853(c)(7) of the Act to make adjustments in payment rates to 
MA plans for benefit changes directed through national coverage 
determinations or legislative action to recognize the uncertainty in 
which MA plans operated when developing their CY 2018 bids.
    Response: We decline to make an adjustment in payment rates for 
benefit changes related to MDPP services and believe that we lack 
authority to do so in this specific circumstance in this final rule. 
Under section 1853(c)(7) of the Act, adjustments in payment rates to MA 
plans are available only where a change in benefits or services results 
from a national coverage determination or a legislative change and the 
service or benefit required to be provided is projected by the 
Secretary to result in a significant increase in the costs to 
Medicare+Choice of providing benefits under contracts entered into 
under section 1857 of the Act. MDPP services meet neither of these 
requirements.
    First, MDPP services are available under the MDPP expanded model, 
which has been expanded in duration and scope under section 1115A(c) of 
the Act. Therefore, while a new service, coverage of MDPP services does 
not result from a legislative change or a national coverage 
determination. Second, we recognize that MA plans may negotiate 
contracts with MDPP suppliers that require the MA plan to pay more than 
the payments finalized in this final rule (that would pay MDPP 
suppliers a maximum total performance payment amount of $670 in CY 
2018, as described in section III.K.2.d.iii.(2)(a) of this final rule, 
for furnishing MDPP services to fee-for-service beneficiaries). 
However, even where an MA plan enters into a contract that pays MDPP 
suppliers an amount that is substantially higher than the amount that 
would result from the policies finalized in this final rule, the costs 
associated with MDPP services objectively fail to rise to the level of 
a ``significant increase'' in the costs of providing benefits under 
contracts entered into under section 1857 of the Act. Further, the CY 
2017 PFS final rule adopting the set of MDPP services as an additional 
preventive benefit under Part B (published in the November 15, 2016 
Federal Register) and guidance to MAOs were both issued prior to the 
June 5, 2017 bid deadline date for CY 2018, so MAOs had adequate notice 
to incorporate these costs into bids for CY 2018 coverage.
(9) Updating MDPP Payment Amounts
    To account for inflation, we proposed to update MDPP payment 
amounts annually based on the CPI-U. The CPI-U is a measure of the 
average change over time in prices paid for a market basket of consumer 
goods and services, and is a measure of economy-wide inflation. There 
are no statutory requirements for the update factor for payments for 
MDPP services so there is no requirement that a productivity adjustment 
be applied to the MDPP services update factor as there are for certain 
other Medicare-covered items and services where prices are updated by 
the CPI-U, such as the Clinical Laboratory Fee Schedule; Durable 
Medical Equipment, Prosthetics/Orthotics, and Supplies Fee Schedule; 
Ambulance Fee Schedule; and

[[Page 53282]]

Ambulatory Surgical Center payment system.
    We considered using other indices such as the Medicare Economic 
Index (MEI) to update the MDPP payment amounts. The MEI measures price 
changes in the inputs required to operate a self-employed physician 
practice. We did not believe that the MEI would be appropriate to 
update MDPP payment amounts because MDPP suppliers are not similar to 
self-employed physician practices. We noted that the CPI-U by 
definition is an economy-wide measure of inflation and, therefore, in 
the absence of an appropriate specific index for MDPP services, we 
believed the CPI-U to be the most technically appropriate index 
available to update payments for MDPP services. We further noted that 
the CPI-U is used to update Medicare payments for other Medicare-
covered items and services, such as ambulance, clinical laboratory, and 
ambulatory surgical center services.
    We proposed to update MDPP performance payments and the bridge 
payment (a proposed one-time payment to an MDPP supplier for furnishing 
its first session to an MDPP beneficiary who has previously received 
MDPP services from a different MDPP supplier as discussed in detail in 
section III.K.2.d.v. of the proposed rule (82 FR 34153 through 34155)) 
that may be paid to MDPP suppliers in the following manner:
     Beginning in CY 2019 and each year forward, the 
performance payment and bridge payment amounts would be adjusted by the 
12-month percent change in the CPI-U (U.S. city average) for the period 
ending June 30th of the year preceding the update year. The percent 
change update would be calculated based on the level of precision of 
the index as published by the Bureau of Labor Statistics and applied 
based on one decimal place of precision. The annual MDPP services 
payment update would be published by CMS transmittal.
    The proposed methodology to update MDPP performance payments and 
the bridge payment was included at proposed Sec.  414.84(d). We invited 
public comments on this proposal.
    The following is a summary of the public comments received on the 
proposal for the methodology to update MDPP performance payments and 
the bridge payment and our responses:
    Comment: Several commenters supported the proposal to update MDPP 
performance payment and bridge payment amounts annually using the CPI-
U.
    Response: We appreciate the support of the commenters for the 
proposed methodology to update MDPP performance payments and the bridge 
payment annually using the CPI-U.
    After considering the public comments received, we are finalizing 
the proposal, without modification, to update MDPP performance payments 
and the bridge payment at Sec.  414.84(d).
(10) MDPP Supplier Billing and Payment for MDPP Services
(a) Payment for MDPP Services on an Assignment-Related Basis
    We proposed that performance payments and bridge payments to MDPP 
suppliers for MDPP services would be made only on an assignment-related 
basis in accordance with Sec.  424.55. As described in Chapter 1, 
Section 30.3 of the Medicare Claims Processing Manual,\39\ CMS 
identifies a number of supplier and practitioner types who furnish 
services under the Medicare program and who are required to accept 
assignment for all Medicare claims for their services. This means that 
they must accept the Medicare allowed amount as payment in full for 
their services, regardless of whether the supplier is a participating 
or non-participating provider in the Medicare program. In these 
circumstances, the beneficiary's liability is limited to any applicable 
deductible plus the 20 percent coinsurance if coinsurance applies to 
the service. CMS currently mandates assignment for claims from multiple 
types of suppliers and practitioners, including clinical diagnostic 
laboratory services and physician lab services; physician services to 
individuals dually entitled to Medicare and Medicaid; and services of 
physician assistants, nurse practitioners, clinical nurse specialists, 
nurse midwives, certified registered nurse anesthetists, clinical 
psychologists, clinical social workers, registered dietitians/
nutritionists, anesthesiologist assistants, and mass immunization 
roster billers. The beneficiary (or the person authorized to request 
payment on the beneficiary's behalf) is not required to assign the 
claim to the supplier in order for an assignment to be effective, and 
when these claims are inadvertently submitted as unassigned, Medicare 
Administrative Contractors (MACs) process them as assigned.
---------------------------------------------------------------------------

    \39\ Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c01.pdf.
---------------------------------------------------------------------------

    Consistent with our established requirements for these other types 
of suppliers, some of whom are similar to MDPP suppliers in that they 
furnish a limited breadth of Medicare-covered services, we believed 
that it would be appropriate to require all MDPP suppliers, whether 
they are participating or not participating in Medicare, to accept 
assignment. We also believed that making performance payments for MDPP 
services solely on an assignment-related basis would be the most 
appropriate methodology, given the proposed performance-based MDPP 
payment methodology which would be based on the achievement of weight 
loss and/or attendance performance goals and not based on the MDPP 
supplier resource expended to furnish individual MDPP services. We 
further noted that as finalized in the CY 2017 PFS final rule (81 FR 
80464), MDPP services are additional preventive services under section 
1861(ddd) of the Act and, therefore, consistent with section 
1833(a)(1)(W) of the Act, are not subject to the Medicare Part B 
coinsurance or deductible. Under our proposal, Medicare would pay 100 
percent of the Medicare allowed charge for MDPP services furnished to 
MDPP beneficiaries, and a beneficiary would have no liability for 
covered MDPP services. MDPP suppliers would be required to accept the 
Medicare allowed charge as payment in full and would not be able to 
bill or collect from the beneficiary any amount.
    Finally, to minimize the potential administrative burden on 
beneficiaries related to payment for MDPP services on an assignment-
related basis, we proposed that for purposes of claims for services 
submitted by an MDPP supplier, Medicare would deem such claims to have 
been assigned by the beneficiary (or the person authorized to request 
payment on the beneficiary's behalf) and the assignment accepted by the 
MDPP supplier. This proposed treatment of claims from MDPP suppliers in 
new Sec.  424.55(d) would be consistent with the current exception in 
Sec.  424.55(c) regarding payment to a supplier, which specifies that 
when payment under the Act can only be made on an assignment-related 
basis or when payment is for services furnished by a participating 
physician or supplier, the beneficiary (or the person authorized to 
request payment on the beneficiary's behalf) is not required to assign 
the claim to the supplier in order for an assignment to be effective.
    The proposed assignment-related basis for performance payments and 
bridge payments made to MDPP suppliers was included at proposed Sec.  
414.84(b) and (c). The proposal not to require the beneficiary to 
assign the claim for MDPP services to the MDPP supplier in order for 
assignment to be

[[Page 53283]]

effective was included at proposed Sec.  424.55(d). We invited comments 
on these proposals.
    The following is a summary of the public comments received on the 
proposals for the assignment-related basis for performance payments and 
bridge payments made to MDPP suppliers and the proposal not to require 
the beneficiary to assign the claim for MDPP services to the MDPP 
supplier in order for assignment to be effective and our responses:
    Comment: Several commenters supported the proposal to make 
performance payments and bridge payments to MDPP suppliers on an 
assignment-related basis. One commenter specifically supported the 
proposal not to require the beneficiary to assign the claim for MDPP 
services to the MDPP supplier in order for the supplier to be paid 
directly by Medicare, claiming that this approach would reduce 
unnecessary paperwork and administrative burden for both the MDPP 
beneficiary and the MDPP supplier.
    Response: We appreciate the commenters' support for our proposals 
for the assignment-related basis for performance payments and bridge 
payments made to MDPP suppliers and the proposal not to require the 
beneficiary to assign the claim for MDPP services to the MDPP supplier 
in order for assignment to be effective.
    After considering the public comments received, we are finalizing 
the proposals, without modification, to make performance payments and 
bridge payments to MDPP suppliers on an assignment-related basis at 
Sec.  414.84(b) and (c). In additional, we are finalizing the proposal, 
without modification, not to require the beneficiary to assign the 
claim for MDPP services to the MDPP supplier in order for assignment to 
be effective at Sec.  424.55(d).
(b) Requirements for Payment of Bridge Payments and Performance 
Payments
    We proposed that MDPP suppliers may only submit claims for a 
performance payment or bridge payment for MDPP services when all of the 
requirements for the payment are met. Claims for services that do not 
meet these requirements will not be paid. In accordance with Sec.  
424.80, we reminded MDPP suppliers that there are exceptions to the 
prohibition of reassignment of claims by suppliers for certain 
arrangements provided the applicable requirements are met. We noted 
that Medicare may pay an agent who furnishes billing and collection 
services to the supplier if the conditions of Sec.  424.80(b)(5) are 
met.
    Proposed requirements for performance payments and the bridge 
payment included that the MDPP services were furnished to a beneficiary 
eligible for MDPP services as specified at Sec.  410.79(c) and that the 
MDPP supplier complies with all applicable enrollment and program 
requirements. In addition, we proposed that the MDPP services must be 
furnished by an eligible coach on or after his or her coach eligibility 
start date and, if applicable, before his or her coach eligibility end 
date, and the MDPP supplier must submit the National Provider 
Identifier (NPI) of the coach on MDPP claims. We described additional 
details on how eligible coach information would be processed in section 
III.K.2.d.iii.(10)(d) of the proposed rule (82 FR 34151 through 34152). 
All specific additional proposed requirements for the performance 
payment or bridge payment, as discussed in sections III.K.2.d.iii.(3) 
through (6) and III.K.2.d.v. of the proposed rule (34141 through 34146 
and 34153 through 34155), would also need to be met.
    In order to submit a claim for a performance payment under the MDPP 
expanded model, the billing supplier is required to have documentation 
in the beneficiary's MDPP record, as specified in proposed Sec.  
424.205(g), that all requirements for the payment, including the 
achievement of the performance goal(s) applicable to the performance 
payment, have been met. We noted that the billing supplier's MDPP 
record for the beneficiary may include a copy of the beneficiary's MDPP 
record from a previous MDPP supplier that has been provided to the 
billing supplier at the request of the MDPP beneficiary. If an MDPP 
supplier is submitting a claim for an interval performance payment 
based on attendance at more than one session, this copy of the MDPP 
record from the previous MDPP supplier may be used as part of the 
billing supplier's documentation demonstrating that the attendance or 
weight loss performance goal for the performance payment was achieved. 
We noted that as we finalized at Sec.  424.59(b) in the CY 2017 PFS 
final rule (proposed to be redesignated and amended at Sec.  
424.205(g)), MDPP suppliers are required to maintain and handle any 
personally identifiable information (PII) and protected health 
information (PHI) in compliance with HIPAA, other applicable state and 
federal privacy laws, and CMS standards. Therefore, MDPP suppliers must 
follow these rules, as applicable, when providing any copies of 
information from a beneficiary's MDPP records to another MDPP supplier.
    We proposed that any weight loss measurement taken and recorded by 
an MDPP supplier for the purposes of performance payments must be taken 
in-person during an MDPP core session, core maintenance session, or 
ongoing maintenance session by the MDPP supplier during the MDPP 
services period. We believed that in-person measurements would be the 
most feasible method for weight ascertainment at this time for services 
because the beneficiary would attend regular in-person sessions with 
the MDPP supplier. Moreover, we believed that self-reported weight loss 
would not be reliable for the purposes of performance payment in the 
MDPP expanded model. This proposal also would apply to our proposed 
policy regarding virtual make-up sessions, described in detail in 
section III.K.2.c.iv.(3) of the proposed rule (82 FR 34136 through 
34137), meaning that weight loss could not be measured or reported 
during a virtual make-up session for the purpose of the MDPP supplier 
submitting a claim for a performance payment. We also proposed to 
require that weight loss be measured in-person at an MDPP session to 
align with CDC's DPRP standards, which require for in-person sessions 
that weight be measured in-person at the session.
    In addition, we noted that the achievement or maintenance of the 
required minimum weight loss that determines the performance payment 
amount for a core maintenance session interval and the maintenance of 
the required minimum weight loss that determines whether a performance 
payment for an ongoing maintenance session interval would be made must 
be determined by an in-person weight measurement at a session furnished 
during the applicable interval. Thus, for these interval performance 
payments, achievement of the performance goal for minimum weight loss 
would not need to be determined based on attendance at a session 
furnished by the MDPP supplier billing for that performance payment. 
However, as discussed previously, if achievement of the performance 
goal for minimum weight loss was measured at a session furnished by a 
previous MDPP supplier in the interval, the subsequent supplier must 
have documentation through a copy of the beneficiary's MDPP record from 
that previous supplier that the weight loss performance goal was met in 
the interval to bill for the interval performance payment. Finally, the 
performance payments for the required

[[Page 53284]]

minimum and 9 percent weight loss would only be billed by the MDPP 
supplier furnishing the session at which the weight loss performance 
goal is met during an in-person session.
    Furthermore, we proposed that the beneficiary must achieve the 
applicable attendance performance goal for core session, core 
maintenance session interval, or ongoing maintenance session interval 
performance payments upon attendance at a session furnished by the MDPP 
supplier billing for that specific performance payment. An MDPP 
supplier could only bill for a performance payment on the date the 
beneficiary has achieved all performance goals associated with that 
performance payment. We noted that in order to bill for an interval 
performance payment that is based on attendance, the MDPP supplier that 
furnished the session where the attendance goal is met would bill for 
the performance payment, even if that supplier did not itself furnish 
all sessions attended by the MDPP beneficiary during that interval. In 
these circumstances, as discussed previously, if attendance at a 
session furnished by a previous MDPP supplier occurred in the interval, 
the subsequent supplier must have documentation through a copy of the 
beneficiary's MDPP record from that previous supplier of the session 
attendance in order to bill for the interval performance payment based 
on attendance at that session. An MDPP supplier may not bill for an 
interval performance payment when the MDPP supplier does not furnish 
the session where the attendance goal is met.
    For all interval performance payments, we proposed that the 
performance payment would be based on the date the MDPP supplier 
furnished the session where the interval attendance performance goal is 
met. Thus, for those intervals where the performance payment would be 
based on MDPP beneficiary session attendance that spans 2 calendar 
years, the interval performance payment would be the amount applicable 
to the later calendar year, reflecting the annual update from the prior 
year as discussed in section III.K.2.d.iii.(9) of the proposed rule (82 
FR 34147 through 34148).
    The proposed conditions for payment by CMS of performance payments 
and bridge payments to MDPP suppliers were included at proposed Sec.  
414.84(b) and (c). We invited public comments on these proposals.
    We received no public comments specific to the proposed conditions 
for payment of performance payments and bridge payments to MDPP 
suppliers.
    We are finalizing the proposals, without modification, for the 
conditions for payment of performance payments and bridge payments to 
MDPP suppliers at Sec.  414.84(b) and (c).
(c) Reporting HCPCS G-Codes on Claims for MDPP Services
    We proposed to establish 19 unique Healthcare Common Procedure 
Coding System (HCPCS) G-codes so that MDPP suppliers may submit claims 
for payment when all the requirements for billing the codes have been 
met. Our proposal for the HCPCS G-codes is displayed in Table 40.
    We noted that each MDPP supplier would be able to bill one of the 
18 payable HCPCS G-codes on the date when all the requirements for 
billing the code have been met, including the session attendance for 
specific core and ongoing maintenance session intervals and achievement 
and/or maintenance of weight loss, as applicable to the specific HCPCS 
G-code. One of the proposed HCPCS G-codes would be nonpayable and 
assigned a payment amount of $0 because it would only be reported on a 
claim that also includes a payable HCPCS G-code for MDPP services as 
described subsequently.
    HCPCS G-codes GXXX1 through GXXX3 and GXXX8 through GXX17 may each 
be paid only once in a beneficiary's lifetime, and the Medicare claims 
processing system would ensure that no more than one of each specific 
performance payment per beneficiary reported with these HCPCS G-codes 
is made. In addition, because only one performance payment may be made 
for each core maintenance session interval per beneficiary, the claims 
processing system would also ensure that no more than one unit of HCPCS 
code GXXX4 or GXXX6 and no more than one unit of HCPCS code GXXX5 or 
GXXX7 was paid in a beneficiary's lifetime.
    Due to these lifetime limitations on payment for certain HCPCS 
codes for each beneficiary, in the circumstances where two MDPP 
suppliers furnished sessions during the MDPP services period and both 
MDPP suppliers met all requirements for billing the same HCPCS G-code, 
based on our operational processes, we would pay the first valid claim 
received and deny the second claim. The first valid claim received for 
a beneficiary for a given HCPCS G-code with a lifetime limitation would 
be determined through the CMS' Common Working File (CWF), which 
processes claims for all MACs.
    Based on information from the CDC's national DPP, we expected that 
circumstances where a beneficiary changes MDPP suppliers during the 
MDPP services period would be uncommon. In addition, in view of the 
typical structure of DPPs where core sessions are offered weekly for 
the first 6 months of the core services period, and then offered 
monthly, we believed it would be rare for more than one MDPP supplier 
to meet the requirements for billing for the same once-per-lifetime 
performance payment. However, as an example an MDPP beneficiary could 
maintain the required minimum weight loss throughout the first core 
maintenance session interval and attend 3 sessions furnished by one 
MDPP supplier in the first 1\1/2\ months of the first core maintenance 
interval, and then change to another supplier and attend 3 more core 
maintenance sessions furnished by a subsequent MDPP supplier before the 
end of that interval. While both MDPP suppliers would meet the 
requirements for billing HCPCS code GXXX6, we would only pay the first 
claim for the HCPCS G-code that was submitted. The second claim for 
HCPCS code GXXX6 received by us would be denied. We expected that our 
operational processes would result in MDPP suppliers submitting claims 
for HCPCS G-codes as soon as the sessions are furnished that meet all 
of the requirements for billing for the particular performance payment, 
and that this practice would generally result in the performance 
payment being made to the MDPP supplier that furnished the first 
session where the performance goals were met.
    Finally, as discussed in section III.K.2.d.v. of the proposed rule 
(82 FR 34153 through 34155), we did not propose to limit the number of 
bridge payments, which would be reported with HCPCS code GXX18, that 
may be paid for an MDPP beneficiary who changes MDPP suppliers during 
the MDPP services period.

[[Page 53285]]



           Table 40--Proposed HCPCS G-Codes for MDPP Services
------------------------------------------------------------------------
                                Proposed
Proposed  HCPCS G-Code  for      payment     Description of MDPP service
      MDPP  services *           amount
------------------------------------------------------------------------
GXXX1......................             $25  1st core session attended.
GXXX2......................              30  4 total core sessions
                                              attended.
GXXX3......................              50  9 total core sessions
                                              attended.
GXXX4......................              10  3 core maintenance sessions
                                              attended in months 7-9
                                              (weight loss goal not
                                              achieved or maintained).
GXXX5......................              10  3 core maintenance sessions
                                              attended in months 10-12
                                              (weight loss goal not
                                              achieved or maintained).
GXXX6......................              60  3 core maintenance sessions
                                              attended in months 7-9 and
                                              weight loss goal achieved
                                              or maintained.
GXXX7......................              60  3 core maintenance sessions
                                              attended in months 10-12
                                              and weight loss goal
                                              achieved or maintained.
GXXX8......................             160  5 percent weight loss from
                                              baseline achieved.
GXXX9......................              25  9 percent weight loss from
                                              baseline achieved.
GXX10......................              50  3 ongoing maintenance
                                              sessions attended in
                                              months 13-15 and weight
                                              loss goal maintained.
GXX11......................              50  3 ongoing maintenance
                                              sessions attended in
                                              months 16-18 and weight
                                              loss goal maintained.
GXX12......................              50  3 ongoing maintenance
                                              sessions attended in
                                              months 19-21 and weight
                                              loss goal maintained.
GXX13......................              50  3 ongoing maintenance
                                              sessions attended in
                                              months 22-24 and weight
                                              loss goal maintained.
GXX14......................              50  3 ongoing maintenance
                                              sessions attended in
                                              months 25-27 and weight
                                              loss goal maintained.
GXX15......................              50  3 ongoing maintenance
                                              sessions attended in
                                              months 28-30 and weight
                                              loss goal maintained.
GXX16......................              50  3 ongoing maintenance
                                              sessions attended in
                                              months 31-33 and weight
                                              loss goal maintained.
GXX17......................              50  3 ongoing maintenance
                                              sessions attended in
                                              months 34-36 and weight
                                              loss goal maintained.
GXX18......................              25  Bridge payment--first
                                              session furnished by MDPP
                                              supplier to an MDPP
                                              beneficiary who has
                                              previously received MDPP
                                              services from a different
                                              MDPP supplier.
GXX19......................               0  MDPP session reported as a
                                              line-item on a claim for a
                                              payable MDPP services
                                              HCPCS G-code for a session
                                              furnished by the billing
                                              supplier that counts
                                              toward achievement of the
                                              attendance performance
                                              goal for the payable MDPP
                                              services HCPCS G-code.
------------------------------------------------------------------------
* Illustrative HCPCS G-code numbers were placeholders to allow for
  comment on the CY 2018 PFS proposed rule. Final HCPCS codes for MDPP
  services under the MDPP expanded model are included in Table 41 of
  this final rule.

    We also stated that we plan to issue specific billing instructions 
to MDPP suppliers for those 14 proposed HCPCS G-codes (excluding GXXX1, 
GXXX8, GXXX9, GXX18, and GXX19) that represent an interval performance 
payment where attendance at more than 1 session is required for the 
performance payment to be made. Suppliers would report the applicable 
HCPCS G-code as a line-item on the claim on the date the session was 
furnished where the interval attendance goal was met. On the same 
claim, suppliers would also report 1 line-item of HCPCS code GXXX19 for 
each other session furnished by the supplier during the interval that 
was not previously reported on a claim but that counts toward 
achievement of the attendance performance goal for the applicable HCPCS 
G-code.
    When billing for a HCPCS G-code that represents a cumulative number 
of MDPP sessions where some sessions already have been reported on a 
previous claim, only the sessions not previously reported on a claim 
would be reported by the MDPP supplier. For example, HCPCS code GXXX3 
(9 total core sessions attended) would be used to bill for 9 core 
sessions attended, and the line-item of HCPCS code GXXX3 would 
represent the 9th core session furnished. Separate line-items of HCPCS 
code GXX19 would be reported on the same claim only for the 5th through 
8th core sessions furnished by the MDPP supplier. Claims for HCPCS 
codes GXXX1 (1st core session attended) and GXXX2 (4 core sessions 
attended) would already have been submitted, and those claims would 
have included line-items for the 1st core session, and for the 2nd, 
3rd, and 4th core sessions.
    We believed that instructing MDPP suppliers to report a line-item 
for each session on a single claim submitted for an interval 
performance payment would simplify the tracking and administrative 
activities of MDPP suppliers and the reporting of the coach NPI on 
claims for MDPP services furnished to beneficiaries as discussed in 
section III.K.2.d.iii.(10)(d) of the proposed rule (82 FR 34151 through 
34152). We further believed that there should be no significant 
administrative burden for MDPP suppliers to include information on all 
sessions they furnished on interval performance payment claims for two 
reasons. First, the documentation requirements for MDPP sessions at 
Sec.  424.205(g), including the beneficiary's eligibility, specific 
session topics attended, the NPI of the coach who furnished the session 
attended, the date and place of service of sessions attended, and 
weight, would require the MDPP supplier to document and retain this 
information. Therefore, MDPP suppliers would have documentation of the 
date of each session and the NPI of the furnishing coach for reporting 
on each line-item on the claim for the interval performance payment. 
Second, MDPP suppliers would be instructed not to submit separate 
claims for each session represented in an interval performance payment. 
All sessions would be reported on the single claim that would be 
submitted for the interval performance payment.
    In the case of an MDPP supplier submitting a claim for an interval 
performance payment where the billing supplier did not furnish all the 
sessions attributable to the interval because another supplier had 
furnished some of the first sessions in the interval, the billing 
supplier would report on the claim only the sessions it furnished. 
However, the supplier would need to maintain MDPP records documenting 
that all requirements, including session attendance and achievement or 
maintenance of weight loss, if applicable, for billing the HCPCS G-code 
for the interval for the beneficiary were met. Any sessions covered by 
the interval performance payment HCPCS G-code but not furnished by the 
supplier submitting the claim for that interval would not be reported 
as separate line-items on the claim. However, the billing supplier 
would need to maintain in the beneficiary's MDPP record a copy of his 
or her MDPP record from the previous supplier in order to consider 
sessions furnished by the previous supplier in determining that the 
performance goal(s) for the interval performance payment were met.

[[Page 53286]]

    Although the NPIs of the coaches who furnished such sessions that 
would not be reported as separate line-items would also not be recorded 
on the claim, the billing supplier would still be required to maintain 
documentation in the beneficiary's MDPP record of the NPI of each coach 
who furnished each session through a copy of the beneficiary's MDPP 
record about those sessions from the previous supplier. Therefore, upon 
medical review, CMS and its contractors would be able to review and 
assess the remaining coaches who furnished sessions to Medicare 
beneficiaries associated with a claim submitted for a given interval 
performance payment HCPCS G-code, but who do not have an NPI reported 
on the claim. Because we expected it to be uncommon for suppliers not 
to furnish all sessions attributable to an interval and due to the 
administrative burden that could result from a requirement that an MDPP 
supplier report specific information on sessions on a claim that the 
particular supplier did not itself furnish, we believed that the 
program integrity risk associated with the limitation in the 
completeness of information from administrative claims data under this 
scenario would be low. However, we would monitor the completeness of 
reporting line-items on claims for interval performance payments and 
may consider revising our billing instructions in the future if we 
determine that we lack information from administrative claims on a 
significant number of sessions furnished to MDPP beneficiaries.
    We invited public comments on the proposals to create 19 HCPCS G-
codes for billing for the performance payments and bridge payment.
    The following is a summary of the public comments received on the 
proposals to create 19 HCPCS G-codes for billing for the performance 
payments and bridge payment and our responses:
    Comment: Several commenters observed that the general proposed 
billing process appeared to be simple based on the use of the CMS-1500 
claim form and the proposed 19 unique HCPCS G-codes specific to the 
MDPP expanded model. However, many commenters expressed concern about 
the complexity of the proposed coding and billing procedures, as well 
as the accompanying administrative burden on MDPP suppliers to generate 
and submit correct claims for MDPP services. Several commenters stated 
that the proposal would require the entity billing for MDPP services to 
know whether or not the MDPP beneficiary has achieved his or her 
performance goals and how far along the beneficiary is in the MDPP 
services period in order to accurately bill for MDPP services. The 
commenters claimed that the complexity of the proposals would be 
unlikely to drive value in the MDPP expanded model and concluded that 
the extensive billing processes could discourage organizations from 
participating in the model because those processes would require more 
time and effort than DPPs have capacity to provide under their current 
business model. One commenter further added that the administrative 
requirements of the claims submission processes for submitting 19 HCPCS 
G-codes for a single beneficiary for MDPP services furnished over time 
would especially not be cost-effective for small, community-based 
nonprofit organizations in the context of the proposed performance 
payment amounts for MDPP services.
    A number of commenters recommended that CMS reduce the number of 
HCPCS G-codes for MDPP services from the 19 new codes proposed. Several 
commenters urged CMS to provide payment for each MDPP session furnished 
by streamlining coding to only establish a separate HCPCS G-code for 
each type of session (core, core maintenance, and ongoing maintenance), 
coupled with a performance payment when the required minimum weight 
loss is achieved, in order to substantially simplify coding and 
billing. One commenter requested that CMS align the MDPP expanded model 
HCPCS codes and billing requirements with established Medicare diabetes 
self-management education and training services codes and billing 
policies. Another commenter reasoned that the more CMS can simplify the 
coding requirements for the MDPP expanded model and work to align the 
billing and coding processes with private health plans, the better the 
chance of broader, more meaningful access to and participation in MDPP 
services for patients. In contrast, a commenter reported that the 
claims submission and payment processes have been difficult to date for 
DPP organizations to implement under current private health plan 
processes and, therefore, encouraged CMS to streamline its proposed 
processes.
    Several commenters urged CMS to pay separately for the MDPP 
supplier administrative resources necessary to deliver MDPP services, 
including the preparation and submission of claims. One commenter noted 
that community-based organizations may be unfamiliar with Medicare 
billing requirements and recommended that CMS provide separate payment 
for an entity that serves as an Integrator between MDPP suppliers, CMS, 
and other payers.
    Response: We acknowledge the large number of new HCPCS G-codes that 
we proposed to require to provide payment for the multiple types of 
performance payments and the bridge payment that we are finalizing for 
the MDPP expanded model. While this is a significant number of codes 
specific to the MDPP expanded model to be reported by an MDPP supplier 
on the CMS-1500 claim form when the performance goal(s) for the 
performance payments or the requirements for the bridge payment are met 
for MDPP services furnished to an MDPP beneficiary, we agree with those 
commenters who stated generally that the reporting of HCPCS G-codes for 
MDPP services on the CMS-1500 claim form should be straightforward. 
Many types of suppliers paid under the PFS for services currently 
report CPT and alpha-numeric HCPCS codes that describe those services 
on the CMS-1500 claim form without substantial problems.
    We also understand that entities that enroll in Medicare as MDPP 
suppliers and have not previously billed Medicare for services will 
have a learning curve in preparing claims. However, we view this 
learning as unavoidable with the enrollment as MDPP suppliers of 
different types of organizations that do not already furnish other 
types of services to Medicare beneficiaries. We are committed to 
providing clear guidance to MDPP suppliers on coding and billing for 
MDPP services to support suppliers' implementation of the most 
efficient and accurate processes for their respective organizations.
    Claim preparation and submission is the responsibility of the MDPP 
supplier or their billing agent, and Medicare may pay the MDPP supplier 
or an agent who furnishes billing and collection services to the 
supplier if the conditions of Sec.  424.80(b)(5) are met. We will not 
make separate payments to MDPP suppliers for the administrative 
activities related to claims preparation and submission, nor will we 
provide separate payments to an entity that serves as an Integrator 
between CMS, MDPP suppliers, and other payers. MDPP suppliers will bear 
the cost of these activities.
    As several commenters recognized, one of the more significant 
challenges for MDPP suppliers in billing correctly will be identifying 
and tracking where the beneficiary is in the MDPP services period, 
which defines what MDPP services must be offered to the beneficiary, as 
well as the HCPCS G-codes that can be reported for

[[Page 53287]]

performance payments during that timeframe. This may be especially 
difficult when the MDPP beneficiary switches suppliers during the MDPP 
services period and the subsequent supplier does not yet have the 
beneficiary's MDPP records from the previous supplier. Another 
challenge for MDPP suppliers will be identifying when MDPP 
beneficiaries have met all the performance goals for the performance 
payment such that the MDPP supplier may submit a claim for the relevant 
HCPCS G-code that may be paid. These particular tasks result from the 
once-per-lifetime limitation on MDPP services and the performance-based 
payment methodology under the MDPP expanded model. In contrast, under 
the Medicare fee-for-service payment methodologies, most services are 
billed individually as they are furnished, without regard to the 
achievement of performance goals, and most services do not have a once-
per-lifetime limitation, especially a limitation that applies to 
services that may be furnished over many months.
    In terms of the alignment of the MDPP expanded model HCPCS G-codes 
and billing requirements with those currently used for diabetes self-
management education and training services, we note that diabetes self-
management education and training services are subject to different 
requirements than MDPP services that are paid based on a performance-
based payment methodology specifically established for this expanded 
model. Therefore, the codes and billing requirements for these 
different services are not aligned. In terms of alignment with 
processes used by private payers, the commenters did not provide 
specific information regarding these processes that we understand, in 
some cases, are based on invoices and not based on claims. While we 
appreciate the interest of the commenters in using similar claims 
processes for all patients in a DPP, regardless of payer, to reduce 
confusion and administrative burden on the MDPP supplier, this is not 
feasible given the specific requirements that apply to MDPP services 
furnished under the MDPP expanded model and the standard CMS claims 
processing systems upon which the MACs rely to process and pay Medicare 
claims.
    Regarding the requests of some commenters that we reduce the number 
of HCPCS G-codes to have only a single code for each type of session, 
we note that our operational processes will edit in the claims 
processing system to ensure that we make only a maximum of one of each 
type of performance payment per beneficiary due to the lifetime 
limitation on MDPP services. Moreover, only the MDPP supplier 
submitting the claim for a performance payment will know whether or not 
the beneficiary has achieved or maintained the required minimum weight 
loss, as the beneficiary's weight is not submitted on administrative 
claims. Because the majority of the performance payments are in some 
way related to the achievement or maintenance of the required minimum 
weight loss, either through identifying whether or not any performance 
payment should be made or determining the specific performance payment 
amount to be paid, and the MDPP supplier has documentation of the 
beneficiary's weight for each session furnished in-person, we believe 
the MDPP supplier is in the best position to prepare an accurate claim 
that identifies the specific performance payment that applies to the 
MDPP services furnished to the beneficiary.
    Therefore, each performance payment and the bridge payment require 
separate payable HCPCS G-codes to be reported on claims to allow 
editing in the claims processing system for the once-per-lifetime 
limitation on the performance payment and to apply the policies for the 
bridge payment. Additionally, a nonpayable HCPCS G-code must be 
reported as a separate line-item on a claim for a payable HCPCS G-code 
for each additional session furnished by the billing supplier that 
counts toward achievement of the attendance performance goal for the 
payable HCPCS G-code so that we are able to monitor for compliance with 
the attendance requirement for the performance payment. While we 
proposed 19 new HCPCS G-codes for the MDPP expanded model, because we 
are finalizing an ongoing services period maximum duration of 12 
months, rather than the 24 months that we proposed, 4 of the proposed 
HCPCS G-codes for reporting MDPP services in months 25 to 36 of the 
ongoing services period are not needed. Therefore, we are establishing 
15 new HCPCS G-codes, effective April 1, 2018, for the MDPP expanded 
model. The final HCPCS G-codes and their long descriptors are displayed 
in Table 41.
    Comment: One commenter requested that CMS clarify whether another 
HCPCS G-code or a specific HCPCS modifier will be established as a way 
to indicate on claims whether one of the sessions reported was a 
virtual make-up session in view of the proposal to limit the number of 
virtual make-up sessions.
    Response: We are finalizing limitations on the number of virtual 
make-up sessions as discussed in section III.K.2.c.iv.(3)(b) of this 
final rule. So that we can monitor for compliance with these 
limitations, we are also establishing new HCPCS code modifier VM 
(Medicare Diabetes Prevention Program (MDPP) Virtual Make-up Session.) 
to be appended to the HCPCS G-code on each claim line-item that 
represents a virtual make-up session. Because the HCPCS G-codes for the 
first core session and weight loss performance payments require that a 
weight be measured in-person at the session that is reported on the 
line-item for those HCPCS codes, only 12 of the 15 final HCPCS G-codes 
for the MDPP expanded model may be reported with HCPCS modifier VM as 
indicated in Table 41.
    Comment: One commenter disagreed with the operational plan that if 
two MDPP suppliers both meet the requirements for billing a single 
HCPCS G-code with a one unit lifetime limitation, CMS would only pay 
the first claim for the HCPCS G-code that was submitted. The commenter 
stated this is not a viable solution for reconciling the submission of 
two claims from different MDPP suppliers for the same HPCPCS G-code and 
may result in confusion and discord among MDPP suppliers.
    Response: While we appreciate the commenter's concern about our 
paying the first claim received for a HCPCS G-code when a different 
MDPP supplier later submits a claim for the same code, we do not have 
the straightforward operational capacity to further adjudicate timely 
the decision about which MDPP supplier should receive the payment for 
the once-per-lifetime HCPCS G-code if two MDPP suppliers submit a claim 
for the same HCPCS G-code. Conceptually, we believe it is appropriate 
that payment be made to the MDPP supplier that furnished the first 
session that meets all of the requirements for billing for the 
performance payment reported with that HCPCS code. Our planned 
operational practice of paying the first claim received would generally 
result in the performance payment being made to the MDPP supplier that 
furnished the first session where the performance goals were met 
because MDPP suppliers would be incentivized to submit claims for HCPCS 
G-codes as soon as the sessions are furnished that meet all of the 
requirements for billing for the particular performance payment. 
Therefore, in general we believe that the appropriate supplier would be 
paid the performance payment reported with the HCPCS G-code.
    We will monitor the frequency of circumstances where we receive two 
claims from different MDPP suppliers for the same performance payment 
for the same MDPP beneficiary and, if

[[Page 53288]]

indicated, compare the date of the session reported on each paid and 
unpaid claim where the performance goals for the payment were met. If 
we see frequent circumstances where the payment was not made to the 
MDPP supplier that furnished the first session where the performance 
goals were met, we may consider revisions to this policy so that we are 
able to specifically reconcile claims for the same performance payment 
from different MDPP suppliers. However, we remain concerned that any 
adjudication of these circumstances could require us to hold claims for 
MDPP services without payment for a period of time and generally delay 
performance payments to MDPP suppliers, which could result in greater 
MDPP supplier confusion and burden.
    Comment: One commenter requested that CMS confirm that an MDPP 
supplier can submit a claim for the 5 percent weight loss performance 
payment on the date that the beneficiary achieves the weight loss goal 
any time during the 12-month core services period. The commenter 
explained that one section of the proposed rule suggested that only 
attendance-based performance payments would be made in the first 6 
months of the MDPP services period, whereas another section stated that 
the 5 percent weight loss performance payment could be made upon 
achievement of the required minimum weight loss any time during the 12 
months of the core services period.
    Response: We appreciate the commenter's request for clarification 
about the time period during the MDPP services period when the 5 
percent weight loss performance payment can be billed and paid. The 5 
percent weight loss performance payment may be billed by the MDPP 
supplier on the date it furnishes any session during the 12 months of 
the core services period when 5 percent weight loss is achieved by the 
MDPP beneficiary. We note that other than the weight loss performance 
payments, during the first 6 months of the core services period the 
core session performance payments are the only other type of 
performance payments that can be made and they are solely based on the 
achievement of attendance performance goals.
    Comment: One commenter encouraged CMS to develop billing templates 
for MDPP coaches because coaches are not billing specialists, yet the 
coaches teach the DPP curriculum.
    Response: We define a coach in the MDPP expanded model as an 
individual who furnishes MDPP services on behalf of an MDPP supplier as 
an employee, contractor, or volunteer. While we understand that coaches 
teach the DPP curriculum to MDPP beneficiaries during sessions, we only 
make performance payments for the beneficiary's achievement of 
attendance and/or weight loss performance goals or the bridge payment 
to MDPP suppliers. Thus, MDPP suppliers or their billing agents must 
prepare and submit claims for Medicare for payments under the MDPP 
expanded model. Coaches will not submit claims to Medicare and, 
therefore, will not need to have billing templates.
    Comment: One commenter requested that CMS clarify whether, under 
the circumstances when an MDPP beneficiary completes the full 12-month 
core services period without achieving or maintaining the required 
minimum weight loss but requests to continue with ongoing maintenance 
sessions furnished by the MDPP supplier, the MDPP supplier is permitted 
to bill the beneficiary for those ongoing maintenance sessions. 
Similarly, the commenter requested that CMS clarify whether the MDPP 
supplier can bill the beneficiary for sessions after the beneficiary 
completes the 36 months of eligibility for MDPP services but remains 
eligible for the DPP.
    Response: We recognize that beneficiaries who are no longer 
eligible for MDPP services as specified at Sec.  410.79(c)(1) and (2) 
may still wish to continue participating in DPP sessions. In these 
cases, MDPP suppliers may decide whether to continue offering such 
services and whether to bill the individual for such services. In cases 
where the claim is assigned, section 1879(b) of the Act establishes 
certain requirements for suppliers that wish to charge beneficiaries 
for the cost of a non-covered service. This section, however, only 
addresses the Medicare denial reasons specified in sections 1862(a)(1), 
1862(a)(9), and 1879(g) of the Act. Because MDPP services fall under 
section 1861(ddd) and thus section 1879(b) of the Act does not address 
the denial reason in the commenter's question, the requirements in 
section 1879 are not applicable. Therefore, MDPP suppliers that opt to 
offer services beyond the set of MDPP services for which the 
beneficiary is eligible may charge the beneficiary for those services, 
and may do so without requiring the beneficiary to sign an Advanced 
Beneficiary Notice of Noncoverage (ABN). Although the MDPP supplier 
standard at Sec.  424.205(d)(11) requires MDPP suppliers to disclose 
MDPP-related information to beneficiaries at the onset of services, 
including what is covered and MDPP eligibility criteria, we highly 
encourage MDPP suppliers to provide notification to a beneficiary when 
his or her eligibility for MDPP services ends and when continued 
receipt of DPP services would result in a beneficiary's out-of-pocket 
expense.
    Given the commenter's questions about the circumstances when an 
MDPP supplier may charge a beneficiary for DPP services furnished when 
the beneficiary is not eligible for MDPP services, we want to further 
clarify which DPP services are considered covered as a part of the set 
of MDPP services and, therefore, charging beneficiaries for these 
services furnished during the MDPP services period would not be 
permitted. As defined at Sec.  410.79(a) and (c)(2), the core services 
period consists of, at least 16 core sessions offered at least one week 
apart during months 1 through 6 of the MDPP services period (emphasis 
added)'' and two core maintenance session intervals, which mean two 
consecutive 3-month time periods during months 7 through 12 of the MDPP 
services period, during which an MDPP supplier offers an MDPP 
beneficiary at least one core maintenance session per month (emphasis 
added). Similar, as defined at Sec.  410.79(a) and (c)(2), during the 
ongoing services period an MDPP supplier offers at least 1 ongoing 
maintenance session to an MDPP beneficiary per month (emphasis added).
    These provisions establish the minimum number of sessions an MDPP 
supplier must offer during these months as a part of the set of MDPP 
services, as required at Sec.  424.205(d)(10), but do not establish an 
upper limit on the number of MDPP sessions that can be offered under 
these time periods. An MDPP supplier may offer sessions beyond what are 
required under the MDPP expanded model. However, any additional MDPP 
services offered beyond the minimum required during the core and 
ongoing services periods would still be subject to the requirements at 
Sec.  410.79(a) and (c)(2) and, as an additional preventive service, no 
cost-sharing can be applied to MDPP services. Thus, an MDPP supplier 
may not charge an MDPP beneficiary for any additional MDPP services 
furnished beyond the minimum that must be offered during the core 
services period or during the ongoing services period, provided that 
the beneficiary is eligible for MDPP services and is in his or her MDPP 
services period.
    After considering the public comments received, we are finalizing 
the proposals to establish new HCPCS

[[Page 53289]]

G-codes for reporting MDPP services under the MDPP expanded model, with 
modifications. Because we are finalizing the ongoing services period 
duration of 12 months, rather than the 24 months that we proposed, 4 of 
the proposed HCPCS G-codes for reporting MDPP services in months 25 to 
36 of the ongoing services period are not needed. Therefore, we are 
adopting 15 new HCPCS G-codes, effective April 1, 2018, for the MDPP 
expanded model. In addition, the descriptions of the HCPCS G-codes for 
core maintenance and ongoing maintenance session interval performance 
payments have been modified to reflect the final attendance performance 
goal of 2 sessions for each interval, as discussed further in sections 
III.K.2.d.iii.(4) and (5) of this final rule. The final HCPCS G-codes, 
long descriptors, indication of whether or not each code may be 
reported with modifier VM as a virtual make-up session, and their 
payment amounts are displayed in Table 41.

                                Table 41--Final MDPP Expanded Model HCPCS G-Codes
----------------------------------------------------------------------------------------------------------------
                                                                       May be  reported with
          HCPCS G-code                    Long descriptor          modifier VM  (virtual make-up  Final  payment
                                                                              session)                 amount
----------------------------------------------------------------------------------------------------------------
G9873...........................  First Medicare Diabetes          No...........................             $25
                                   Prevention Program (MDPP) core
                                   session was attended by an
                                   MDPP beneficiary under the
                                   MDPP Expanded Model (EM). A
                                   core session is an MDPP
                                   service that: (1) Is furnished
                                   by an MDPP supplier during
                                   months 1 through 6 of the MDPP
                                   services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for core sessions.
G9874...........................  Four total Medicare Diabetes     Yes..........................              50
                                   Prevention Program (MDPP) core
                                   sessions were attended by an
                                   MDPP beneficiary under the
                                   MDPP Expanded Model (EM). A
                                   core session is an MDPP
                                   service that: (1) Is furnished
                                   by an MDPP supplier during
                                   months 1 through 6 of the MDPP
                                   services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for core sessions.
G9875...........................  Nine total Medicare Diabetes     Yes..........................              90
                                   Prevention Program (MDPP) core
                                   sessions were attended by an
                                   MDPP beneficiary under the
                                   MDPP Expanded Model (EM). A
                                   core session is an MDPP
                                   service that: (1) Is furnished
                                   by an MDPP supplier during
                                   months 1 through 6 of the MDPP
                                   services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for core sessions.
G9876...........................  Two Medicare Diabetes            Yes..........................              15
                                   Prevention Program (MDPP) core
                                   maintenance sessions (MS) were
                                   attended by an MDPP
                                   beneficiary in months (mo) 7-9
                                   under the MDPP Expanded Model
                                   (EM). A core maintenance
                                   session is an MDPP service
                                   that: (1) Is furnished by an
                                   MDPP supplier during months 7
                                   through 12 of the MDPP
                                   services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for maintenance sessions. The
                                   beneficiary did not achieve at
                                   least 5% weight loss (WL) from
                                   his/her baseline weight, as
                                   measured by at least one in-
                                   person weight measurement at a
                                   core maintenance session in
                                   months 7-9.
G9877...........................  Two Medicare Diabetes            Yes..........................              15
                                   Prevention Program (MDPP) core
                                   maintenance sessions (MS) were
                                   attended by an MDPP
                                   beneficiary in months (mo) 10-
                                   12 under the MDPP Expanded
                                   Model (EM). A core maintenance
                                   session is an MDPP service
                                   that: (1) Is furnished by an
                                   MDPP supplier during months 7
                                   through 12 of the MDPP
                                   services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for maintenance sessions. The
                                   beneficiary did not achieve at
                                   least 5% weight loss (WL) from
                                   his/her baseline weight, as
                                   measured by at least one in-
                                   person weight measurement at a
                                   core maintenance session in
                                   months 10-12.
G9878...........................  Two Medicare Diabetes            Yes..........................              60
                                   Prevention Program (MDPP) core
                                   maintenance sessions (MS) were
                                   attended by an MDPP
                                   beneficiary in months (mo) 7-9
                                   under the MDPP Expanded Model
                                   (EM). A core maintenance
                                   session is an MDPP service
                                   that: (1) Is furnished by an
                                   MDPP supplier during months 7
                                   through 12 of the MDPP
                                   services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for maintenance sessions. The
                                   beneficiary achieved at least
                                   5% weight loss (WL) from his/
                                   her baseline weight, as
                                   measured by at least one in-
                                   person weight measurement at a
                                   core maintenance session in
                                   months 7-9.
G9879...........................  Two Medicare Diabetes            Yes..........................              60
                                   Prevention Program (MDPP) core
                                   maintenance sessions (MS) were
                                   attended by an MDPP
                                   beneficiary in months (mo) 10-
                                   12 under the MDPP Expanded
                                   Model (EM). A core maintenance
                                   session is an MDPP service
                                   that: (1) Is furnished by an
                                   MDPP supplier during months 7
                                   through 12 of the MDPP
                                   services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for maintenance sessions. The
                                   beneficiary achieved at least
                                   5% weight loss (WL) from his/
                                   her baseline weight, as
                                   measured by at least one in-
                                   person weight measurement at a
                                   core maintenance session in
                                   months 10-12.
G9880...........................  The MDPP beneficiary achieved    No...........................             160
                                   at least 5% weight loss (WL)
                                   from his/her baseline weight
                                   in months 1-12 of the MDPP
                                   services period under the MDPP
                                   Expanded Model (EM). This is a
                                   one-time payment available
                                   when a beneficiary first
                                   achieves at least 5% weight
                                   loss from baseline as measured
                                   by an in-person weight
                                   measurement at a core session
                                   or core maintenance session.
G9881...........................  The MDPP beneficiary achieved    No...........................              25
                                   at least 9% weight loss (WL)
                                   from his/her baseline weight
                                   in months 1-24 under the MDPP
                                   Expanded Model (EM). This is a
                                   one-time payment available
                                   when a beneficiary first
                                   achieves at least 9% weight
                                   loss from baseline as measured
                                   by an in-person weight
                                   measurement at a core session,
                                   core maintenance session, or
                                   ongoing maintenance session.

[[Page 53290]]

 
G9882...........................  Two Medicare Diabetes            Yes..........................              50
                                   Prevention Program (MDPP)
                                   ongoing maintenance sessions
                                   (MS) were attended by an MDPP
                                   beneficiary in months (mo) 13-
                                   15 under the MDPP Expanded
                                   Model (EM). An ongoing
                                   maintenance session is an MDPP
                                   service that: (1) Is furnished
                                   by an MDPP supplier during
                                   months 13 through 24 of the
                                   MDPP services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for maintenance sessions. The
                                   beneficiary maintained at
                                   least 5% weight loss (WL) from
                                   his/her baseline weight, as
                                   measured by at least one in-
                                   person weight measurement at
                                   an ongoing maintenance session
                                   in months 13-15.
G9883...........................  Two Medicare Diabetes            Yes..........................              50
                                   Prevention Program (MDPP)
                                   ongoing maintenance sessions
                                   (MS) were attended by an MDPP
                                   beneficiary in months (mo) 16-
                                   18 under the MDPP Expanded
                                   Model (EM). An ongoing
                                   maintenance session is an MDPP
                                   service that: (1) Is furnished
                                   by an MDPP supplier during
                                   months 13 through 24 of the
                                   MDPP services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for maintenance sessions. The
                                   beneficiary maintained at
                                   least 5% weight loss (WL) from
                                   his/her baseline weight, as
                                   measured by at least one in-
                                   person weight measurement at
                                   an ongoing maintenance session
                                   in months 16-18.
G9884...........................  Two Medicare Diabetes            Yes..........................              50
                                   Prevention Program (MDPP)
                                   ongoing maintenance sessions
                                   (MS) were attended by an MDPP
                                   beneficiary in months (mo) 19-
                                   21 under the MDPP Expanded
                                   Model (EM). An ongoing
                                   maintenance session is an MDPP
                                   service that: (1) Is furnished
                                   by an MDPP supplier during
                                   months 13 through 24 of the
                                   MDPP services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for maintenance sessions. The
                                   beneficiary maintained at
                                   least 5% weight loss (WL) from
                                   his/her baseline weight, as
                                   measured by at least one in-
                                   person weight measurement at
                                   an ongoing maintenance session
                                   in months 19-21.
G9885...........................  Two Medicare Diabetes            Yes..........................              50
                                   Prevention Program (MDPP)
                                   ongoing maintenance sessions
                                   (MS) were attended by an MDPP
                                   beneficiary in months (mo) 22-
                                   24 under the MDPP Expanded
                                   Model (EM). An ongoing
                                   maintenance session is an MDPP
                                   service that: (1) Is furnished
                                   by an MDPP supplier during
                                   months 13 through 24 of the
                                   MDPP services period; (2) is
                                   approximately 1 hour in
                                   length; and (3) adheres to a
                                   CDC-approved DPP curriculum
                                   for maintenance sessions. The
                                   beneficiary maintained at
                                   least 5% weight loss (WL) from
                                   his/her baseline weight, as
                                   measured by at least one in-
                                   person weight measurement at
                                   an ongoing maintenance session
                                   in months 22-24.
G9890...........................  Bridge Payment: A one-time       Yes..........................              25
                                   payment for the first Medicare
                                   Diabetes Prevention Program
                                   (MDPP) core session, core
                                   maintenance session, or
                                   ongoing maintenance session
                                   furnished by an MDPP supplier
                                   to an MDPP beneficiary during
                                   months 1-24 of the MDPP
                                   Expanded Model (EM) who has
                                   previously received MDPP
                                   services from a different MDPP
                                   supplier under the MDPP
                                   Expanded Model. A supplier may
                                   only receive one bridge
                                   payment per MDPP beneficiary.
G9891...........................  MDPP session reported as a line- Yes..........................               0
                                   item on a claim for a payable
                                   MDPP Expanded Model (EM) HCPCS
                                   code for a session furnished
                                   by the billing supplier under
                                   the MDPP Expanded Model and
                                   counting toward achievement of
                                   the attendance performance
                                   goal for the payable MDPP
                                   Expanded Model HCPCS code.
                                   (This code is for reporting
                                   purposes only).
----------------------------------------------------------------------------------------------------------------

    In the CY 2018 PFS proposed rule (82 FR 34151), we also invited 
public comment on matters related to billing instructions for MDPP 
suppliers that we plan to issue to require the reporting of additional 
session line-items on claims for MDPP services so that information on 
the date and coach NPI for each session furnished by the billing 
supplier would be submitted on claims. However, we noted that we intend 
to provide additional claims submission instructions in guidance.
    The following is a summary of the public comments received on 
matters related to billing instructions for MDPP suppliers that we plan 
to issue to require reporting additional session line-items on claims 
for MDPP services so that information on the date and coach NPI for 
each session furnished by the billing supplier would be submitted on 
claims and our responses:
    Comment: Several commenters emphasized the need for CMS to provide 
additional detailed instructions on billing requirements for coding, 
charting, and charges so that MDPP suppliers are prepared for an audit. 
One commenter provided specific recommendations for items CMS should 
include in future billing instructions, regardless of the final HCPCS 
G-codes established for the MDPP expanded model. These items included: 
A table with the HCPCS G-codes and their payment amounts; groupings of 
HCPCS G-codes most likely to be billed together; a sample completed 
CMS-1500 claim form for various scenarios; and ICD-10-CM diagnosis 
codes to be reported on claims for MDPP services.
    Response: We appreciate the interest of the commenters in ensuring 
that MDPP suppliers, many of whom may not have previously billed 
Medicare for services, have sufficient information to accurately and 
correctly prepare all elements of claims for submission to Medicare in 
accordance with the final policies of the MDPP expanded model. We share 
the interest of the commenters and recognize the importance of 
comprehensive, clear billing instructions to streamline the work of 
MDPP suppliers that will submit claims and MACs who will process those 
claims for payment of MDPP services. We will be issuing specific 
billing instructions for MDPP services in

[[Page 53291]]

advance of the April 1, 2018 start date of the MDPP expanded model. We 
will consider the suggestions of the commenter regarding the contents, 
as well as information and requests provided to us by other 
stakeholders, as we develop and refine comprehensive billing 
instructions for MDPP suppliers. Finally, we note that we expect a 
learning curve for MDPP suppliers and MACs with respect to claims for 
MDPP services, and we are prepared to provide further billing 
instructions or clarify the instructions already provided as the MDPP 
expanded model begins to be implemented and claims are prepared, 
submitted, and processed for the first time.
(d) Reporting the Coach National Provider Identifier (NPI) on Claims
    In the CY 2017 PFS final rule, we established the policy that 
coaches will not enroll in Medicare for purposes of furnishing MDPP 
services, but that they will be required to obtain NPIs. Further 
details on these policies are described in section III.K.2.e.iii. of 
the proposed rule (82 FR 34158 through 34166).
    As stated in Chapter 26, Section 10.4 of the Medicare Claims 
Processing Manual,\40\ the NPI of the rendering provider is to be 
reported as Item 24J on the line-item for each service reported on the 
CMS-1500 claim form. Our proposal in section III.K.2.d.iii.(10)(c) of 
the proposed rule (82 FR 34149 through 34151) would require that, in 
the circumstances of a claim for an interval performance payment for 
MDPP services, each session furnished by the billing supplier be 
reported as a separate line-item on the claim. In addition, we proposed 
to require MDPP suppliers to report the NPI of the coach who furnished 
the session as Item 24J on the line-item for each session reported on 
claims for performance payments for MDPP services. Under our proposal, 
the coach who furnished the session would be the rendering provider for 
purposes of reporting on the CMS-1500 claim form.
---------------------------------------------------------------------------

    \40\ Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c26.pdf.
---------------------------------------------------------------------------

    Although only MDPP suppliers, not coaches, would be subject to 
potential Medicare administrative actions related to payments the 
suppliers may receive, we believed that our proposal to require the NPI 
of the coach who furnished the session to be reported as the rendering 
provider for each line-item HCPCS G-code on a claim for MDPP services 
would provide us with a number of program integrity protections, 
including the ability to monitor MDPP coach activity to identify 
suspected fraud or other improper payments and to determine the need 
for medical review or investigation as appropriate. We would only 
process claims for payment of MDPP services when all of the coach NPIs 
reported on the claim are associated with eligible coaches who have 
been submitted on the coach roster in the MDPP supplier's enrollment 
application, and when all of the coaches have successfully completed 
Medicare's screening processes. We would also only process claims for 
payment of MDPP services furnished by a coach on or after his or her 
coach eligibility start date, and, if applicable, prior to his or her 
coach eligibility end date, as the definitions of these terms were 
included in proposed Sec.  424.205(a).
    Without such program integrity protections, we would lack a 
sufficient method to verify that payment is being made for services 
furnished by a coach who has met the requirements outlined in section 
III.K.2.e.iii. of the proposed rule (82 FR 34158 through 34166). This 
verification would help protect both Medicare beneficiaries and the 
Medicare Trust Funds. Including coach NPIs on claims could also 
encourage accuracy in reporting on the achievement of beneficiary 
attendance and/or weight loss performance goals because both CMS and 
MDPP suppliers would be able to identify on the claim in question which 
coaches furnished the sessions attributable to the performance payment. 
In addition, because the accuracy of information reported on the claim 
would ultimately be the MDPP supplier's responsibility and the MDPP 
supplier would attest to the accuracy of each claim submitted, 
including the relevant coach NPIs on the claim could assist the MDPP 
supplier when conducting internal monitoring of claim accuracy.
    These proposed requirements for reporting the coach NPI as the 
rendering provider on session line-items included on claims for 
performance payments and bridge payments to MDPP suppliers were 
included at proposed Sec.  414.84(b) and (c). We invited public 
comments on these proposals.
    The following is a summary of the public comments received on the 
proposals for the requirements for reporting the coach NPI as the 
rendering provider on session line-items included on claims for 
performance payments and bridge payments to MDPP suppliers and our 
responses:
    Comment: Several commenters supported the proposal to require MDPP 
suppliers to report the NPI of the coach who furnishes an MDPP session 
on the claim line-item for that session. One commenter noted that 
because coaches will not have to individually enroll in Medicare but 
will be required to obtain an individual NPI, the coach NPI information 
for each session will be available, making the proposed reporting 
approach feasible for MDPP suppliers.
    Response: We appreciate the commenters' support for our proposed 
requirements for reporting the coach NPI as the rendering provider on 
session line-items included on claims submitted by MDPP suppliers for 
performance payments and bridge payments. After considering the 
comments received, we are finalizing the proposal, without 
modification, for reporting the coach NPI as the rendering provider on 
session line-items included on claims for performance payments and 
bridge payments to MDPP suppliers at Sec.  414.84(b) and (c).
iv. Comparison of Final Supplier Requirements for Furnishing the Set of 
MDPP Services and Supplier Payment
    As in the DPP model test under section 1115A(b) of the Act, MDPP 
services are based on a CDC-approved DPP curriculum and, therefore, 
MDPP suppliers must offer sessions in accordance with that curriculum. 
We are finalizing a performance-based payment methodology for MDPP 
services, which ties most payments to outcomes--in this case, weight 
loss and session attendance--to help incentivize suppliers to be 
engaged in their beneficiaries' weight loss efforts. Given this 
methodology, we recognize that there will be an inherent amount of 
supplier financial risk, and that coverage of sessions and supplier 
requirements and payment will not always align under the MDPP expanded 
model final polices. This section clarifies how these elements fit 
together in the MDPP expanded model under its final policies, as 
displayed in Table 42.

[[Page 53292]]



                                Table 42--Final Set of MDPP Services and Payment
----------------------------------------------------------------------------------------------------------------
                                         MDPP beneficiary         MDPP supplier must
           MDPP services             eligibility for coverage           offer            MDPP supplier payment
----------------------------------------------------------------------------------------------------------------
Core sessions (months 1 to 6 of     An eligible beneficiary     At least 16 core        $25 performance
 the MDPP services period).          has Medicare coverage of    sessions, furnished    payment for beneficiary
                                     core sessions in the        no more frequently     attendance at the first
                                     first 6 months of the       than once per week,    core session.
                                     MDPP core services          over the first 6       $50 interval
                                     period, regardless of       months of the          performance payment
                                     attendance or weight loss.  beneficiary's MDPP     after the beneficiary
                                    * Note: To start the MDPP    services period.       has attended a total of
                                     services period, the                               4 core sessions.
                                     beneficiary attends his                            $90 interval
                                     or her first core                                  performance payment
                                     session, which begins the                          after the beneficiary
                                     beneficiary's MDPP                                 has attended a total of
                                     services period timeline                           9 core sessions.
                                     of a maximum of 24 months.                        * Note: All payments for
                                                                                        core sessions are
                                                                                        independent of
                                                                                        beneficiary weight loss.
Core maintenance sessions (months   Beneficiary has coverage    At least 1 core         $15 payment if a
 7 to 12 of the MDPP services        of core maintenance         maintenance session    beneficiary attends 2
 period).                            sessions in months 7 to     per month in months    sessions within a 3-
                                     12 of the MDPP services     7 to 12 of the MDPP    month core maintenance
                                     period, regardless of       services period.       session interval but
                                     attendance or weight loss.                         does not achieve or
                                                                                        maintain the required
                                                                                        minimum weight loss at
                                                                                        least once within that 3-
                                                                                        month core maintenance
                                                                                        session interval; or
                                                                                        $60 if a
                                                                                        beneficiary attends 2
                                                                                        sessions and achieves or
                                                                                        maintains the required
                                                                                        minimum weight loss at
                                                                                        least once within that 3-
                                                                                        month core maintenance
                                                                                        session interval.
                                                                                       * Note: There are 2
                                                                                        consecutive core
                                                                                        maintenance session
                                                                                        intervals.
Ongoing maintenance sessions        Beneficiary has coverage    At least 1 ongoing      $50 payment if a
 (months 13 to 24 of the MDPP        of ongoing maintenance      maintenance session    beneficiary attends 2
 services period).                   sessions in the first       per month for up to    sessions and maintains
                                     ongoing maintenance         12 months, if the      the required minimum
                                     session interval (months    beneficiary            weight loss from
                                     13 to 15 of the MDPP        maintains              baseline at least once
                                     services period) if:        eligibility to have    within a 3-month ongoing
                                     He or she           coverage of ongoing    maintenance session
                                     attended at least 1         maintenance sessions.  interval.
                                     session during the final                          * Note: There are up to
                                     core maintenance session                           four consecutive ongoing
                                     interval (months 9 to 12                           maintenance session
                                     of the MDPP services                               intervals.
                                     period) and had weight
                                     measured.
                                     He or she
                                     achieved or maintained
                                     the required minimum
                                     weight loss at least once
                                     during the final core
                                     maintenance session
                                     interval (months 10 to 12
                                     of the MDPP services
                                     period).
                                    A beneficiary has coverage
                                     of a subsequent ongoing
                                     maintenance session
                                     interval (for up to 9
                                     months after the end of
                                     the first ongoing
                                     maintenance session
                                     interval) if:
                                     He or she
                                     attended at least 2
                                     sessions and maintained
                                     the required minimum
                                     weight loss from baseline
                                     at least once during the
                                     previous ongoing
                                     maintenance session
                                     interval.
----------------------------------------------------------------------------------------------------------------

    Once an MDPP supplier enrolls in Medicare to furnish MDPP services, 
it must offer the set of MDPP services in accordance with the MDPP 
supplier standards (noted in section III.K.2.e.iv.(4) of this final 
rule and at Sec.  424.205(d)), including that it must offer at least 16 
core sessions, furnished no more frequently than once per week, over 
the first 6 months of the MDPP core services period; at least 1 core 
maintenance session per month over months 7 to 12 of the MDPP core 
services period; and at least 1 ongoing maintenance session per month 
for up to 12 additional months (months 13 through 24 of the MDPP 
services period), if the beneficiary maintains eligibility for coverage 
of ongoing maintenance sessions. We recognize that beneficiaries might 
not attend these sessions. However, they must be made available, in 
accordance with CDC's DPRP Standards, to beneficiaries as long as they 
are eligible for coverage of MDPP services. We further note that the 
set of MDPP services must be furnished in compliance with all 
applicable federal laws and regulations.
    Although a beneficiary is not required to use MDPP services at all, 
the MDPP services period is initiated by the beneficiary attending his 
or her first core session, which begins the MDPP services period 
timeline. To qualify for coverage of ongoing maintenance sessions, a 
beneficiary also needs to attend at least 1 session during the final 
core maintenance session interval where in-person weight measurement is 
performed that demonstrates the achievement or maintenance of the 
required minimum weight loss.
    All of the final performance payments except for the weight loss 
performance payments require the achievement of an attendance 
performance goal, and if a beneficiary does not achieve attendance 
performance goals, an MDPP supplier will not be paid a performance 
payment that relies on achieving those goals. For example, if a 
beneficiary does not attend 2 sessions in the first core maintenance 
session interval, a supplier will not be paid a performance payment for 
the interval that spans months 7 to 9 of the MDPP core services period. 
However, a supplier must offer at least 1 core maintenance session per 
month to the beneficiary to ensure that the beneficiary has the 
opportunity to attend. Furthermore, although the

[[Page 53293]]

weight loss performance payments are based solely on the achievement of 
the required minimum or 9 percent weight loss, we note that all weight 
loss measurements must be obtained in-person at a session so that if a 
beneficiary does not attend a session where weight loss can be measured 
and compared to baseline, the MDPP supplier will not be paid a 
performance payment that relies on achieving a weight loss performance 
goal.
v. Payment Policies When a Beneficiary Changes MDPP Suppliers
    In the CY 2017 PFS final rule (81 FR 80470), we confirmed that a 
beneficiary may change MDPP suppliers at any time. However, we deferred 
specific policies regarding attribution of beneficiaries who change 
MDPP suppliers as related to payment to future rulemaking. We 
subsequently made proposals for payment policies when a beneficiary 
changes MDPP suppliers during the MDPP services period in the proposed 
rule (82 FR 34153 through 34155).
    At proposed Sec.  414.84(a), we proposed to define ``bridge 
payment'' as a one-time payment to an MDPP supplier for furnishing its 
first MDPP services session to an MDPP beneficiary who has previously 
received one or more MDPP services from a different MDPP supplier. We 
used this definition in the proposed MDPP payment policies for the 
circumstances when a beneficiary changes MDPP suppliers for any reason 
during the MDPP services period after the beneficiary has attended at 
least the first core session.
    In cases where the beneficiary changes MDPP suppliers, there would 
be a shift in accountability for offering the set of MDPP services for 
which the beneficiary is eligible for coverage from one MDPP supplier 
to a subsequent MDPP supplier. Similar to our proposal for a 
performance payment to an MDPP supplier that furnishes the first core 
session to an MDPP beneficiary who initiates the MDPP services period 
as discussed in section III.K.2.d.iii.(3) of the proposed rule (82 FR 
34141 through 34143), we proposed that an MDPP supplier would be paid a 
bridge payment of $25 for furnishing its first session to an MDPP 
beneficiary who has previously received MDPP services from a different 
MDPP supplier, regardless of whether the MDPP supplier is paid any 
performance payments for that beneficiary. A subsequent MDPP supplier 
would be paid this bridge payment after furnishing the first session to 
a beneficiary and billing the appropriate HCPCS G-code only if the 
supplier did not furnish the first core session to the MDPP 
beneficiary.
    We believed that making a bridge payment that would be the same 
amount as the performance payment for the first core session discussed 
in section III.K.2.d.iii.(3) of the proposed rule (82 FR 34141 through 
34143) would be appropriate because we expected the MDPP supplier's 
resources used to be similar under both of these circumstances. The 
subsequent supplier would expend resources for furnishing a first 
session to a beneficiary, including collecting administrative 
information on the beneficiary who is not already known to the 
supplier, regardless of whether the beneficiary goes on to receive 
further MDPP sessions from that supplier.
    We proposed that the bridge payment would be paid to the subsequent 
MDPP supplier any time a beneficiary changes suppliers during the MDPP 
services period, regardless of when during the core services period or 
ongoing services period the beneficiary changes MDPP suppliers. The 
bridge payment was not intended to be a performance payment, which 
could be paid to the subsequent MDPP supplier in addition to the bridge 
payment if a beneficiary achieves a performance goal while receiving 
MDPP services from that the subsequent supplier. Rather, the bridge 
payment would account for the financial risk a subsequent MDPP supplier 
takes on by furnishing services to a beneficiary changing MDPP 
suppliers during the MDPP services period. We believed that when 
suppliers furnish MDPP services to MDPP beneficiaries in these 
circumstances, they generally would not have the same opportunity for 
performance payments that they would have if the beneficiary had been 
receiving MDPP services from the supplier from the beginning of the 
MDPP services period because certain performance goals, such as the 
required minimum weight loss, might already have been achieved by the 
beneficiary. The proposed bridge payment policy would play an important 
role in ensuring access to MDPP services and freedom of choice of MDPP 
suppliers for those beneficiaries who either choose to or must change 
suppliers during the MDPP services period.
    If we were to only make performance payments for MDPP services as 
proposed in sections III.K.2.d.iii.(3) through (6) of the proposed rule 
(82 FR 34141 through 34146) and not make a bridge payment to a 
subsequent supplier when an MDPP beneficiary changes suppliers during 
the MDPP services period, access problems could result due to the 
number of scenarios where subsequent MDPP suppliers offering and 
furnishing MDPP services would be paid no performance payment for the 
sessions furnished. We provided the following examples to illustrate 
such scenarios.
     A beneficiary changes from MDPP supplier A to MDPP 
supplier B after attending core session 4; attends core sessions 5 to 8 
with supplier B; and then decides not to attend any more MDPP sessions. 
Supplier B does not meet the requirements for billing for the 
performance payment for the 9th core session because only 8 core 
sessions were attended, despite supplier B offering and furnishing core 
sessions 5 to 8.
     A beneficiary who has not met the required minimum weight 
loss performance goal changes from MDPP supplier A to MDPP supplier B 
after completing the first 3-month core maintenance session interval; 
attends 2 core maintenance sessions in months 9 through 12 with 
supplier B; and then fails to attend the 3rd core maintenance session 
in this interval. Supplier B does not meet the requirements for billing 
for the performance payment for the second core maintenance session 
interval despite offering and furnishing core maintenance sessions and 
the beneficiary eligibility for coverage of MDPP services then ends 
after month 12, the end of the core services period.
    We believed that circumstances like these examples where subsequent 
MDPP suppliers would receive no payment for sessions furnished to MDPP 
beneficiaries who change suppliers during the MDPP services period in 
the absence of the bridge payment policy could lead to those MDPP 
suppliers preferentially seeking to furnish the remaining MDPP services 
during the MDPP services period to beneficiaries who have either 
already achieved the required minimum weight loss, or whom they believe 
will attend sessions and achieve weight loss, because the required 
minimum weight loss is tied to eligibility for ongoing maintenance 
sessions and higher performance payment for core maintenance session 
intervals.
    We noted that we proposed in section III.K.2.e.iv.(4) of the 
proposed rule (82 FR 34163 through 34164) that MDPP suppliers may not 
deny access to MDPP services to eligible beneficiaries based on any 
reason other than the supplier's own capacity limits to furnish MDPP 
services to additional beneficiaries and on a discretionary basis if a 
beneficiary significantly disrupts the session for other participants 
or becomes abusive. However, MDPP suppliers could comply with this 
access requirement,

[[Page 53294]]

while still preferentially seeking to furnish the remaining MDPP 
services in the MDPP services period to MDPP beneficiaries they believe 
are most likely to achieve the performance goals. To ensure beneficiary 
freedom of choice of MDPP supplier, including the choice to change 
suppliers, we believed that our proposal to make a bridge payment would 
help mitigate the likelihood of MDPP suppliers acting on such 
preferences. The subsequent supplier would be paid a bridge payment for 
a beneficiary who changes suppliers, even if the beneficiary does not 
achieve performance goals that result in a performance payment being 
made to the subsequent supplier.
    We considered an alternative policy in which the bridge payment 
would only be made in circumstances where the subsequent supplier would 
not be paid a performance payment that is based on attendance at the 
first session furnished by that supplier. For example, under this 
alternative if a beneficiary attends the first session during the 
ongoing maintenance session interval for months 13 through 15 at one 
MDPP supplier and then changes to a subsequent MDPP supplier that 
furnishes 2 additional ongoing maintenance sessions within that same 
interval and the beneficiary maintains the required minimum weight 
loss, the subsequent supplier would not be paid the $25 bridge payment 
but would be paid the ongoing maintenance session interval performance 
payment for months 13 through 15. The subsequent supplier would only be 
paid the $25 bridge payment if the beneficiary did not maintain the 
required minimum weight loss for the performance payment for that 
ongoing maintenance session interval. We did not propose this 
alternative because we believed it would be appropriate to make a 
bridge payment for the first session furnished by the subsequent 
supplier that expends resources for furnishing a session to a 
beneficiary not previously known to that supplier, unrelated to whether 
or not the beneficiary achieves a performance goal that results in a 
performance payment being paid to the subsequent supplier.
    We proposed that an MDPP supplier could be paid either one 
performance payment for furnishing the first core session or one bridge 
payment per beneficiary, but not both. We proposed this policy because 
we believed that the potential to be paid both a performance payment 
for the first core session and a bridge payment, or multiple bridge 
payments, for the same beneficiary, could increase the risk of MDPP 
suppliers encouraging discontinuous care patterns. Such patterns could 
hinder the achievement of the required minimum weight loss that leads 
to a reduction in the incidence of type 2 diabetes and could lead to 
increased Medicare expenditures for MDPP services. Financial incentives 
resulting from the potential for multiple bridge payments to a single 
supplier for one beneficiary could lead MDPP suppliers to encourage 
beneficiaries to repeatedly change among them between sessions during 
the MDPP services period so that the suppliers may repeatedly bill for 
bridge payments. We believed that limiting the bridge payment to one 
per beneficiary per supplier and making it available for payment only 
if the performance payment for the first core session was not paid to 
that same supplier helps mitigate this risk. However, we did not 
propose to limit the number of MDPP suppliers that may be paid a bridge 
payment for a particular beneficiary because we are not proposing to 
limit beneficiary freedom of choice for MDPP suppliers. We proposed 
only to limit the bridge payments that a particular MDPP supplier may 
be paid for each MDPP beneficiary to one.
    Although this proposed limit was intended to provide some 
protection against MDPP suppliers encouraging certain care patterns for 
the purposes of their financial gain alone, we understood there may be 
organizations enrolled in Medicare as the same supplier type but under 
separate MDPP supplier enrollment records that are part of a larger 
franchise or umbrella organization with shared financial interests. We 
noted that there is some program integrity risk that these 
organizations could coordinate to bill multiple bridge payments that 
would ultimately increase total MDPP payments to separately enrolled 
MDPP suppliers to serve the financial interests of the umbrella 
organization. This scenario could occur if MDPP suppliers 
systematically encourage beneficiaries to change suppliers for the 
purpose of being paid the bridge payment.
    Although we believed that organizations under a larger umbrella 
organization may have a greater financial incentive and opportunity to 
engage in this behavior, we understood that any two or more MDPP 
suppliers could coordinate in this way, potentially affecting large 
numbers of MDPP beneficiaries. To mitigate this risk, we proposed to 
prohibit MDPP suppliers and other individuals or entities performing 
functions or services related to MDPP services on an MDPP supplier's 
behalf from unduly coercing an MDPP beneficiary's decision to change or 
not to change to a different MDPP supplier, including through the use 
of pressure, intimidation, or bribery as described further in section 
III.K.2.e.iv.(4) of the proposed rule (82 FR 34163 through 34164). We 
would monitor MDPP supplier billing patterns to detect how frequently 
bridge payments are paid and to determine whether patterns exists that 
may suggest fraudulent activity regarding bridge payment claim 
submissions across suppliers, conducting audits, medical reviews, and 
investigations as appropriate.
    In the CY 2017 PFS final rule, we finalized at Sec.  410.79(b) that 
a beneficiary's baseline weight refers to the MDPP beneficiary's body 
weight recorded during that beneficiary's first core session. This 
definition applies to determine weight loss throughout the MDPP 
services period. Additionally, the once-per-lifetime policy finalized 
at Sec.  410.79(d)(1) applies if a beneficiary changes MDPP suppliers, 
and the services furnished by the subsequent supplier would begin where 
the beneficiary left off with the previous supplier. We recognized that 
these policies could require the beneficiary to request that a copy of 
his or her MDPP record be provided by the previous supplier to the 
subsequent supplier so that the subsequent supplier could determine 
whether the beneficiary achieves or maintains the required minimum 
weight loss and has information about the MDPP services already 
furnished. We also finalized at Sec.  424.59(b) (proposed to be 
redesignated and amended as Sec.  424.205(g)) that an MDPP supplier 
shall maintain documentation that includes services furnished and body 
weight measurements. Finally, we finalized at Sec.  424.59(b) (proposed 
to be redesignated and amended as Sec.  424.205(g)) that MDPP suppliers 
are required to maintain and handle any beneficiary PII and PHI in 
compliance with HIPAA, other applicable privacy laws and CMS standards. 
Any sharing of information from a beneficiary's MDPP record between 
MDPP suppliers must follow these rules, as applicable.
    The proposed bridge payment was included at proposed Sec.  
414.84(c). We invited public comments on this proposal and the 
alternative considered. The following is a summary of the public 
comments received on the proposals for the bridge payment, and the 
alternative considered and our responses:
    Comment: Many commenters supported the proposal to make a bridge 
payment to the subsequent MDPP supplier when a beneficiary switches

[[Page 53295]]

suppliers after receiving MDPP services from a previous supplier. The 
commenters stated that beneficiaries should be permitted to change MDPP 
suppliers during the course of the MDPP services period and, therefore, 
the bridge payment both supports beneficiary freedom choice to access 
his or her chosen DPP organization and provides some payment to the 
subsequent MDPP supplier enrolling the beneficiary in its DPP. The 
commenters claimed that the bridge payment would make a payment for 
some of the additional resources used by the MDPP supplier to establish 
the beneficiary within its DPP, as well as incentivize MDPP suppliers 
to take on beneficiaries midway through their MDPP services period. In 
contrast to this perspective, one commenter noted that bridge payments 
would not support continuity in the MDPP services period and have the 
potential to encourage fraud or ``cherry-picking'' of beneficiaries 
because beneficiaries could change MDPP suppliers at will. The 
commenter expressed concern that providing bridge payments would 
interfere with the ability of MDPP suppliers to have accurate tracking 
of progress through the DPP and across MA plans.
    One commenter stated that although CMS proposed that only one 
bridge payment per MDPP supplier per beneficiary would be made, they 
believe that a performance payment for the first core session and a 
bridge payment to the same MDPP supplier may be needed under some 
circumstances, as well as two bridge payments to an MDPP supplier for 
an MDPP beneficiary under other circumstances. The commenter described 
the example of a beneficiary who enrolls with an MDPP supplier in 
Colorado, moves to Florida for the winter where the beneficiary 
continues MDPP services with another MDPP supplier in that state, and 
then returns to Colorado and wants to complete the DPP with the first 
MDPP supplier. The commenter pointed out the under the proposal, the 
Florida MDPP supplier would receive a bridge payment while the Colorado 
MDPP supplier would not, despite the need for the Colorado supplier to 
reengage the beneficiary when the beneficiary returned to Colorado 
after spending the winter in Florida. Therefore, the commenter urged 
CMS to allow a performance payment for the first core session and a 
bridge payment to be made for a single MDPP beneficiary to an MDPP 
supplier, as well as to allow two bridge payments per beneficiary per 
supplier to be made.
    One commenter who expressed concern about the amount of switching 
between MDPP suppliers that could occur during a beneficiary's 36-month 
long MDPP services period urged CMS to limit changing suppliers to no 
more than two switches per beneficiary during any 1 year of the MDPP 
services period. Another commenter requested that CMS clarify how it 
will track how many times beneficiaries switch MDPP suppliers and 
whether there would be any limit on the number of times a beneficiary 
could switch MDPP suppliers.
    Response: We appreciate the support of many of the commenters for 
our proposal to make one bridge payment per beneficiary per MDPP 
supplier during the MDPP services period. As we clarified in the CY 
2017 PFS final rule (81 FR 80470), beneficiaries will be able to change 
MDPP suppliers at any time in order to ensure beneficiary freedom of 
choice of supplier under the MDPP expanded model.
    Given this established policy which allows beneficiaries to change 
MDPP suppliers at any time during the MDPP services period, our bridge 
payment proposal was intended to partially account for the financial 
risk a subsequent MDPP supplier takes on by furnishing services to a 
beneficiary changing MDPP suppliers during the MDPP services period. We 
appreciate the concerns of the commenter about the potential for 
beneficiaries to change MDPP suppliers at will, thereby reducing 
continuity of care and the ability of MDPP suppliers to track the 
progress of MDPP beneficiaries in their DPPs. However, we understand 
from many commenters that beneficiaries switching MDPP suppliers during 
the MDPP services period may occur for a variety of reasons, including 
the relatively frequent circumstances where beneficiaries reside 
seasonally in different areas of the country. Therefore, we continue to 
believe that providing one bridge payment per beneficiary per MDPP 
supplier of $25 does not financially incentivize MDPP suppliers to 
encourage unnecessary switching but, instead, responds to the needs of 
beneficiaries and MDPP suppliers by reducing potential barriers to 
switching.
    Furthermore, we expect that our different payment policies for core 
sessions, core maintenance session intervals, and ongoing maintenance 
session intervals that rely upon attendance at several sessions within 
a period of time and for weight loss performance payments will 
encourage the transfer of MDPP beneficiary records from a previous 
supplier to the subsequent supplier, which should facilitate continuity 
of care throughout the beneficiary's MDPP services period. For example, 
in order for a subsequent MDPP supplier to bill for a weight loss 
performance payment, to bill correctly for a core maintenance session 
interval performance payment, or to determine a beneficiary's 
eligibility for coverage and payment of an ongoing maintenance session 
interval, the subsequent MDPP supplier will need to acquire the MDPP 
beneficiary record from the previous supplier to have documentation of 
the beneficiary's baseline weight. In addition, in order to bill for an 
interval performance payment that requires attendance at multiple 
sessions and fully reflects the beneficiary's session attendance, the 
subsequent MDPP supplier will need to acquire the MDPP beneficiary 
record from the previous supplier to have documentation of sessions 
furnished by that supplier that count towards achievement of the 
attendance performance goal for the interval performance payment that 
will be billed by the subsequent MDPP supplier.
    In response to the commenter who presented a scenario where one 
supplier furnished MDPP services to a beneficiary, the beneficiary then 
switched to a subsequent supplier that furnished sessions and was paid 
a bridge payment, and the beneficiary then switched back to the first 
MDPP supplier, we do not believe it would be appropriate to make a 
bridge payment to the first supplier in this scenario. We do not 
believe the financial risk or the supplier resources required for the 
first supplier to resume accountability for a beneficiary's MDPP 
services when that supplier already has a relationship with the 
beneficiary are so substantial that making a bridge payment to the 
first supplier would be appropriate, given that the first supplier 
would already have been paid the performance payment for the 
beneficiary's first core session. In addition, financial incentives 
resulting from the potential for two (or more) bridge payments to a 
single supplier for one beneficiary could lead MDPP suppliers to 
encourage beneficiaries to unnecessarily change among them between 
sessions during the MDPP services period so that the suppliers may bill 
for bridge payments. We believe that limiting the bridge payment to one 
per beneficiary per supplier and making it available for payment only 
if the performance payment for the first core session was not paid to 
that same supplier helps mitigate this risk.
    We also do not believe it would be appropriate to limit the number 
of times a beneficiary can switch MDPP suppliers during the MDPP 
services period in order to preserve beneficiary access to care and 
freedom of choice.

[[Page 53296]]

We further believe that our final methodologies for performance 
payments and bridge payments do not incentivize beneficiaries to change 
MDPP suppliers nor MDPP suppliers to encourage beneficiaries to switch 
suppliers. While beneficiaries have full freedom of choice of MDPP 
suppliers during the MDPP services period, MDPP beneficiaries have no 
incentive under the policies of the MDPP expanded model itself to 
change MDPP suppliers during the MDPP services period. Furthermore, 
because we are limiting our bridge payment to only one per MDPP 
beneficiary per MDPP supplier that has not already received a 
performance payment for the first core session, MDPP suppliers do not 
have a financial incentive to encourage beneficiaries to unnecessarily 
change among them between sessions during the MDPP services period so 
that the suppliers may bill for bridge payments. Finally, as discussed 
in section III.K.2.d.iii.(10)(c) of this final rule, we are finalizing 
a HCPCS G-code for the bridge payment that will be submitted on a claim 
to CMS for the first session furnished by the subsequent supplier to an 
MDPP beneficiary who has previously received one or more MDPP services 
from a different MDPP supplier. Therefore, we will be able to obtain 
information about the number and pattern of beneficiaries switching 
MDPP suppliers during the MDPP services period from our analysis of 
administrative claims data.
    Comment: Several commenters urged CMS to increase the proposed 
bridge payment amount of $25 because they believe it underestimates the 
amount of time and resources an MDPP supplier would need to spend to 
onboard a beneficiary to a subsequent MDPP supplier. One commenter 
claimed that successful transition of an individual from one MDPP 
supplier to another would require individual communication and research 
on the beneficiary's participation to date, production of new 
materials, and more administrative time than would be covered by the 
proposed bridge payment amount. The commenters requested that the 
bridge payment amount be increased to accurately reflect the time and 
effort of the subsequent MDPP supplier required for transitioning an 
MDPP beneficiary to that supplier.
    Response: We appreciate the information provided by the commenters 
about the subsequent MDPP supplier resources that would be required for 
a successful transition of an MDPP beneficiary from one MDPP supplier 
to a subsequent MDPP supplier. We understand that the subsequent MDPP 
supplier will need to gather information about the beneficiary's 
participation to date in MDPP services, including obtaining the 
beneficiary's MDPP records from the previous supplier, in order to 
furnish the appropriate sessions and curriculum to the beneficiary.
    However, we continue to believe a bridge payment in the amount of 
$25 is appropriate for the MDPP expanded model. While we acknowledge 
based on the commenters' description that the activities and resources 
required for a subsequent MDPP supplier to enroll an MDPP beneficiary 
in its DPP are somewhat different from those of the previous MDPP 
supplier that furnished the MDPP beneficiary's first core session, we 
continue to believe there is sufficient similarity between furnishing 
the first core session in the MDPP services period and furnishing the 
first session to an MDPP beneficiary who has previously received MDPP 
services from another supplier that the payment amounts should be the 
same.
    We note that as discussed in section III.K.2.d.iii.(3) of this 
final rule, we are finalizing $25 as the performance payment for the 
first core session. In addition, as discussed in section III.K.2.d.ii. 
of this final rule, we are paying for the set of MDPP services through 
a performance-based payment methodology that makes periodic performance 
payments to MDPP suppliers during the MDPP services period. The 
aggregate of all performance payments constitutes the total 
performance-based payment amount for the set of MDPP services. The 
subsequent MDPP supplier, like the previous MDPP supplier, will have 
the opportunity to be paid performance payments based on where the 
beneficiary is in the MDPP services period when the beneficiary enrolls 
with the subsequent MDPP supplier and on the performance goals achieved 
by the beneficiary which receiving MDPP services from the subsequent 
supplier. The aggregate of the bridge payment and performance payments 
to the subsequent supplier will constitute the total performance-based 
payment amount for the MDPP services furnished to the MDPP beneficiary 
by the subsequent MDPP supplier.
    Comment: Several commenters requested that CMS clarify how the 
performance payments would be made when a beneficiary switches MDPP 
suppliers during the MDPP services period, expressing concern about the 
adequacy of payment depending on the timing of the switch. A number of 
commenters provided the example of a beneficiary switching from 
supplier A to supplier B during the ongoing services period, after the 
beneficiary has already met the required minimum weight loss and many 
of the available performance payments have already been made to 
supplier A. The commenters noted that supplier B would then be 
responsible for offering ongoing maintenance sessions throughout the 
ongoing services period, which would require the use of supplier B's 
capital for which the remaining performance payments that may be made 
for MDPP services furnished to the beneficiary by supplier B may not be 
sufficient.
    One commenter requested clarification about a specific scenario 
where the commenter was concerned that supplier B's payment could be 
penalized when a beneficiary switches suppliers. In the example 
presented by the commenter, the beneficiary attends 16 core sessions 
(months 1 to 6) with supplier A and achieves and maintains the required 
minimum weight loss. The beneficiary transfers to supplier B closer to 
her home and, in transferring, misses the first monthly (month 7) core 
maintenance session, but then attends 3 sessions (months 8 to 10) in a 
row. The commenter requested that CMS clarify if supplier B would still 
receive a bridge payment, since the month 7 session was not attended. 
The commenter further requested that CMS provide information about 
whether supplier B would be paid for the full second core maintenance 
session interval if the beneficiary completes 3 sessions in months 11 
to 13; whether supplier B should bill only for months 10 to 12; or 
whether performance payments for core maintenance sessions intervals 
would not be made to supplier B because the beneficiary did not attend 
the month 7 session.
    Response: With respect to the commenters concerned about MDPP 
suppliers having sufficient capital to offer ongoing maintenance 
sessions to beneficiaries who switch suppliers during the ongoing 
services period after most performance payments have been made, we 
believe the bridge payment provides appropriate payment for the first 
ongoing maintenance session furnished to the beneficiary by the 
subsequent supplier. The subsequent supplier then must offer ongoing 
maintenance sessions in accordance with the beneficiary's coverage of 
ongoing maintenance session intervals and will be paid ongoing 
maintenance session interval performance payments if the beneficiary 
achieves the performance goals of attendance and maintenance of the 
required minimum weight loss for the interval.

[[Page 53297]]

    Because the beneficiary has already achieved the required minimum 
weight loss and ongoing maintenance sessions must only be offered 
monthly to the beneficiary, we do not believe that the resources used 
by the subsequent supplier are so substantial that subsequent suppliers 
will be unable to offer these sessions to beneficiaries. An MDPP 
beneficiary who has achieved the required minimum weight loss will 
already be knowledgeable about the health behavior changes taught in 
MDPP sessions and will have experienced success incorporating these 
changes in a meaningful way in his or her own life such that weight 
loss results. Thus, we expect that subsequent MDPP suppliers offering 
monthly sessions to these beneficiaries during the ongoing services 
period will not have to work particularly hard to engage these 
beneficiaries. In addition, the subsequent MDPP supplier knows they 
will be paid a bridge payment for the first session furnished and they 
may also be paid ongoing maintenance session interval performance 
payments if the beneficiary meets the performance goals for those 
payments in the future.
    In the specific scenario where the beneficiary transfers to 
subsequent supplier B and misses the month 7 core maintenance session 
but resumes attending monthly sessions in month 8, supplier B can bill 
the bridge payment for its first session furnished to the beneficiary, 
which would be the month 8 core maintenance session. With respect to 
the beneficiary's month count that defines the core maintenance session 
interval in the core services period, that does not change based on 
when the beneficiary attends core maintenance sessions furnished by any 
MDPP supplier. Therefore, the beneficiary's core maintenance session 
intervals would always be months 7 to 9 and months 10 to 12 from the 
date the first core session was furnished to the beneficiary by 
supplier A.
    As finalized in section III.K.2.d.iii.(4) of this final rule, we 
are adopting a 2-session attendance performance goal for the core 
maintenance session interval performance payment. Therefore, in the 
specific scenario described by the commenter where the beneficiary 
switches suppliers and does not attend any core maintenance session in 
month 7, but attends core maintenance sessions in months 8 and 9 
furnished by supplier B, in addition to the bridge payment to supplier 
B, supplier B would also bill and be paid for the appropriate HCPCS G-
code for the first core maintenance session interval (months 7 to 9) 
based on whether or not the required minimum weight loss was maintained 
(in the commenter's scenario, the required minimum weight loss was 
achieved with supplier A prior to month 7, and 2 core maintenance 
sessions were furnished by supplier B in months 8 and 9). Similarly, 
and regardless of the beneficiary's attendance at core maintenance 
sessions in months 7 to 9, supplier B would bill and be paid for the 
appropriate HCPCS G-code for the second core maintenance session 
interval (months 10 to12) if the beneficiary attends at least 2 
sessions furnished by supplier B in that 3-month period and the 
interval performance payment amount would be based on whether or not 
the required minimum weight loss was maintained.
    After considering the public comments received, we are finalizing 
the proposals, without modification, for the bridge payment at Sec.  
414.84(c).
    In the proposed rule (82 FR 34155), we also discussed ways to 
streamline the sharing of information between suppliers about a 
beneficiary's progress in the MDPP services period when a beneficiary 
switches suppliers, such as through the development of a model tracker 
that logs the contact information of a beneficiary's previous supplier 
and/or coach, and the beneficiary's attendance and weight loss. 
Beneficiaries could take the tracker with them if they change suppliers 
during the MDPP services period. Such a tracker would not supplant the 
previous supplier's beneficiary MDPP record which the subsequent 
supplier would need to have a copy of in order to consider sessions 
furnished by the previous supplier in determining whether the 
subsequent supplier could bill for a performance payment that was based 
in part on those prior sessions as discussed in section 
III.K.2.d.iii.(10)(b) of the proposed rule (82 FR 34148 through 34149). 
If the subsequent supplier did not have the beneficiary's MDPP record 
from the previous supplier, the subsequent supplier could not use 
information from the sessions furnished by the previous supplier, such 
as weight or session attendance, to determine that the performance 
goals for a performance payment were met so that the subsequent 
supplier could bill for the performance payment. However, it might help 
facilitate the process for subsequent suppliers to enroll beneficiaries 
partway through the MDPP services period while the subsequent supplier 
is coordinating with the previous supplier to obtain a copy of the 
beneficiary's MDPP record from that supplier. We invited public 
comments on additional ways this data sharing could be streamlined 
between suppliers.
    The following is a summary of the public comments received on 
additional ways information sharing could be streamlined between 
suppliers regarding beneficiaries switching MDPP suppliers during the 
MDPP services period and our responses:
    Comment: Several commenters claimed that switching among MDPP 
suppliers may be more common than CMS appeared to have anticipated in 
the proposed rule discussion about bridge payments. They expressed 
concern about the operational implications of managing the MDPP 
services period for Medicare beneficiaries across hundreds of MDPP 
suppliers when MDPP beneficiaries change suppliers, circumstances that 
the commenters speculated may lead to disruptions for the beneficiary 
and added cost for the MDPP supplier.
    The commenters requested that CMS provide greater detail on how the 
handoff between an MDPP beneficiary's current MDPP supplier to a 
subsequent MDPP supplier should occur when a beneficiary changes 
suppliers. Specifically, they sought additional written guidance on the 
required information to be transmitted and the format and method of 
transmission in order for a proper transition of a beneficiary from one 
MDPP supplier to the subsequent MDPP supplier to occur, especially 
given their expectation that transitions may be common for Medicare 
beneficiaries who live in different locations in the summer and winter 
months. The commenters urged CMS to provide this guidance to avert 
potential HIPAA issues when transferring protected health information 
among MDPP suppliers, especially when many MDPP suppliers will be new 
to the healthcare environment and lack prior experience with performing 
HIPAA compliant transfers.
    While several commenters described a number of challenges related 
to the transfer of beneficiary information between MDPP suppliers and 
requested additional guidance from CMS, one commenter presented an 
approach to facilitating the transfer of information that would be 
based on encouraging beneficiaries to switch among MDPP suppliers 
within a supplier network that uses a shared data-management solution. 
The commenter reported that there are several DPP organizations all 
around the country that use a single data platform. They suggested that 
DPP organizations within a single supplier network could develop a 
simple process within their current platform that would allow the MDPP 
services information to be transferred from one supplier to

[[Page 53298]]

another within the supplier network. The commenter claimed that this 
approach would be more secure and less costly than CMS developing a 
comprehensive database or having individual MDPP suppliers transfer 
beneficiaries' MDPP records to other MDPP suppliers via fax or mail. 
However, they acknowledged that this approach could result in other 
concerns, such as favoring supplier networks, and further noted that 
there are areas of the country that even these larger supplier networks 
do not reach, which would result in the need for a backup solution for 
information transfer.
    Response: We appreciate the commenters raising issues related to 
information transfer when MDPP beneficiaries switch suppliers during 
the MDPP services period, and in particular for suggesting potential 
solutions to mitigate the challenges in this regard under the policies 
of the MDPP expanded model. We recognize that given the maximum 24-
month long duration of the MDPP services period, MDPP suppliers should 
anticipate and prepare for beneficiaries switching between suppliers.
    We appreciate that certain networks have independently worked 
towards use of a single data platform by all DPP organizations in the 
network that could facilitate the transfer of MDPP services information 
for beneficiaries who may switch among suppliers in a single network.
    While we are not adopting any specific MDPP beneficiary information 
transfer policies or data systems at this time, we acknowledge the 
concerns raised by the commenters about subsequent MDPP suppliers 
having correct and timely information about MDPP beneficiaries 
enrolling in the subsequent supplier's DPP in the middle of the MDPP 
services period, given our policy that allows full beneficiary freedom 
of choice of MDPP supplier. As discussed in more detail in section 
III.K.2.c.iii of this final rule, we are exploring using existing CMS 
systems for MDPP suppliers to verify beneficiaries' use of prior MDPP 
services and plan to provide additional information on this mechanism 
in future guidance, as appropriate. However, this eligibility check 
will not supplant the need for MDPP suppliers to maintain documentation 
as described at Sec.  424.205(g). We note that health care providers 
often exchange clinical data when their patients seek care from 
different providers, and we do not view the need for subsequent MDPP 
suppliers to obtain beneficiary-level MDPP services data from a 
previous MDPP supplier as a unique circumstance.
    We remind subsequent MDPP suppliers that in order to submit a claim 
for a performance payment under the MDPP expanded model, the billing 
supplier must have documentation in the beneficiary's MDPP record that 
all requirements, including the achievement of the performance goal(s) 
applicable to the performance payment, have been met. The billing 
supplier's MDPP record for the beneficiary may include a copy of the 
beneficiary's MDPP record from a previous MDPP supplier that has been 
provided to the billing supplier at the request of the MDPP 
beneficiary. If an MDPP supplier is submitting a claim for a 
performance payment based on the achievement or maintenance of the 
required minimum weight loss or an interval performance payment based 
on attendance at more than one session, the copy of the MDPP record 
from the previous MDPP supplier may be used as part of the billing 
supplier's documentation demonstrating that the attendance or weight 
loss performance goal for the performance payment was achieved.
    In terms of how MDPP suppliers transfer beneficiary data in a 
HIPAA-compliant manner, we recommend that MDPP suppliers consult with 
counsel to determine whether they qualify as a HIPAA-covered entity, 
and, if so, how to manage and transfer data appropriately based on 
applicability of HIPAA, other applicable state and federal privacy 
laws, and CMS standards as required. Resources already exist to help 
provide guidance on these issues and are available at https://www.hhs.gov/hipaa/for-professionals/index.html and https://www.healthit.gov/providers-professionals/ehr-privacy-security.
e. Supplier Enrollment and Compliance
i. Preliminary Recognition
    The current CDC 2015 Diabetes Prevention Recognition Program (DPRP) 
Standards do not have standards for preliminary recognition. In the CY 
2017 PFS final rule, we indicated that we would align the CDC's DPRP 
Standards and the set of MDPP services, to the extent possible. It will 
not be possible for CMS to permit DPP organizations to enroll as MDPP 
suppliers based on achievement of any new CDC standard through this 
rulemaking because any updates to the CDC Standards are not expected to 
go into effect until 2018.
    However, our intent is to allow organizations that do not yet have 
full recognition, but have demonstrated a capacity to furnish DPP 
services, to enroll in Medicare as of the effective date of the 
enrollment policies in this rule. We believe this will increase access 
to MDPP services. For this reason, we proposed, at Sec.  424.205(c), to 
establish an MDPP interim preliminary recognition standard to permit 
DPP organizations who meet this standard to enroll in Medicare even if 
they do not have full CDC recognition. This MDPP interim preliminary 
recognition standard will be hereafter referred to as ``interim 
preliminary recognition.'' As we stated in CY 2017 PFS final rule, our 
intent with this policy is to bridge the gap until such time as any CDC 
preliminary recognition standards are established following publication 
of the their DPRP Standards in 2018. Once we have established the 
transition process with CDC, we would expect DPP organizations that 
seek to enroll into Medicare to obtain CDC preliminary recognition, but 
MDPP suppliers who have enrolled in Medicare with interim preliminary 
recognition would maintain their enrollment eligibility as an MDPP 
supplier.
(1) MDPP Interim Preliminary Recognition Standard
    We proposed, at Sec.  424.205(c)(1)(ii)(B), that DPP organizations 
with pending CDC recognition that meet the following additional 
criteria would meet the interim preliminary recognition standard:
     The organization must continue to follow the current 2015 
CDC DPRP Standards for data submission and submit a full 12 months of 
performance data to CDC on at least one completed cohort (see Appendix 
D, 2015 CDC DPRP Standards, https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf). For this purpose, a completed cohort is a set 
of participants that entered into a lifestyle change program that has a 
fixed first and last session and runs for 12 months. An organization 
can have multiple cohorts running at the same time:
     The 12-month data submission to CDC includes at least 5 
participants who attended at least 3 sessions in the first 6 months, 
and whose time from first session attended to last session of the 
lifestyle change program was at least 9 months; and
     Of the participants eligible for evaluation in the first 
criterion, at least 60 percent attended at least 9 sessions in months 1 
through 6 and at least 60 percent attended at least 3 sessions in 
months 7 through 12.
    All data requirements reflect current reporting requirements to 
progress from pending recognition to full recognition through CDC's 
DPRP; no new data collection would be required.
    To implement the interim preliminary recognition standard, DPP 
organizations

[[Page 53299]]

with pending recognition would submit data following CDC's typical 
recognition process. For the current standards, this includes data 
submission every 12 months, during the month of the anniversary of the 
effective date. The organization's data submission should include: (1) 
Data for all sessions attended by participants from the approval date 
to the day before the first anniversary of the effective date, (if the 
organization has a 2016 effective date; this should include at least 6 
months of participant data) or data for all sessions attended by 
participants from the last anniversary of the effective date to the day 
before the next anniversary of the effective date (if an organization's 
effective date is before 2016); and (2) one record for each session 
attended by each participant during the preceding year. CDC would 
perform a new assessment, interim preliminary recognition, on our 
behalf. Our interim preliminary recognition will be evaluated by CDC 
based on those data submissions that use the timetables and submission 
deadlines that currently apply for CDC recognition. For interim 
preliminary recognition governed under this regulation, CDC would 
provide us with its recommendation as to which organizations have met 
the recognition standards for interim preliminary recognition, but we, 
using our authority, would make the final decision. CMS would not make 
any determination for recognition status governed under current or 
future CDC DPRP recognition processes. We believe that such an approach 
would minimize burden for DPP organizations, promote consistency in the 
application of the standards, and allow for a smooth transition if and 
when CDC adopts preliminary recognition standards. We intend to release 
additional guidance on the details of this process once the CDC 2018 
Standards are released.
(2) MDPP Supplier Enrollment Under the MDPP Interim Preliminary 
Recognition Standard
    Our regulations at Sec.  424.59 (redesignated and amended at Sec.  
424.205 in this final rule) specify that a DPP organization with full 
CDC recognition is eligible for enrollment as an MDPP supplier if it 
also meets all of the other conditions for enrollment in Sec.  
424.59(a) (redesignated and amended at Sec.  424.205(b) in this final 
rule). We proposed that organizations that meet the MDPP interim 
preliminary recognition standard, in section III.K.2.e.i.(1) of this 
final rule, and meet all other enrollment conditions would also be 
eligible to enroll as an MDPP supplier.
    We also proposed that DPP organizations would be eligible to enroll 
as an MDPP supplier if they meet CDC DPRP Standards for preliminary 
recognition, once any such standards go into effect (Sec.  
424.205(c)(2)(i)). We anticipate that CDC's preliminary recognition 
standards will be established on or after January 1, 2018. After the 
effective date of any updated CDC standards, we proposed that MDPP 
suppliers who have enrolled in Medicare with MDPP interim preliminary 
recognition would continue to be eligible for MDPP enrollment (assuming 
they continue to meet all other requirements for enrollment, described 
in Sec.  424.205(b)). We intend to ensure that any transition an MDPP 
supplier may make from interim preliminary recognition to CDC 
preliminary recognition does not disrupt its status as an MDPP 
supplier. We will address possible transition issues in future 
rulemaking or guidance, as appropriate.
    We considered an alternative to wait until new CDC DPRP Standards 
are effective to allow organizations other than those with full 
recognition to enroll as MDPP suppliers. However, as indicated in the 
CY 2017 PFS final rule, based on CDC data we believe that waiting until 
the new DPRP Standards are effective would limit the number of 
organizations with demonstrated capacity to furnish the set of MDPP 
services from enrolling in Medicare when enrollment starts and offering 
MDPP services once they become effective. We invited public comments on 
this MDPP interim preliminary recognition standard, including 
performance standards, and the use of this standard as a condition for 
enrollment in Medicare, and the alternative considered.
    The following is a summary of the public comments received on the 
MDPP interim preliminary recognition standard, including performance 
standards, and the use of this standard as a condition for enrollment 
in Medicare proposal and the alternative considered and our responses:
    Comment: The majority of commenters supported requiring MDPP 
organizations to obtain CDC DPRP Recognition, including any preliminary 
recognition standard CDC finalizes and interim preliminary recognition. 
Commenters appreciated the provision of more information on the 
proposed interim preliminary recognition standard and noted the 
importance of having the interim preliminary recognition process in 
place to increase the capacity of MDPP.
    A commenter requested that a master database of those organizations 
that meet this new standard be made publicly available well in advance 
of the effective date of when MDPP services can be delivered and 
payments made to give suppliers more time to appropriately arrange for 
the MDPP on behalf of its members.
    Response: We appreciate and acknowledge the need for both 
beneficiaries and clinicians to have access to information on MDPP 
enrolled suppliers. We note that the CDC currently publishes a registry 
of recognized DPP organizations online (https://nccd.cdc.gov/ddt_dprp/registry.aspx). We intend to make information on MDPP suppliers 
enrolled for the purposes of the MDPP expanded model publicly available 
through a Web site and intend to release guidance, as appropriate, on 
where this information will be located.
    Comment: There was agreement among some commenters that DPP 
organizations that have applied for CDC recognition and have delivered 
the program for at least 12 months are more likely to demonstrate 
commitment and results to offer MDPP services. However, several 
commenters expressed concern about the interim preliminary recognition 
requirement to submit 12 months of data to CDC because their 
communities do not collect the data when there is no support or funding 
for this type of program. They also commented that a majority of 
partnering programs lack awareness of the process, the criteria, and 
the period of time it takes programs to become CDC-recognized. Another 
commenter requested that individuals included in the data set should 
attend four sessions, and not three, in months 1-6 to better align with 
scientific literature about CDC's threshold of four or more sessions 
attended as well as previous and current DPRP standards. For an 
example, the commenter noted, there is a body of knowledge within 
organizations and in the scientific literature about CDC's threshold of 
four or more sessions attended and that it does not make sense to 
change this threshold, especially when there is lack of data (none was 
provided by CMS or CDC's DPRP in their proposed 2018 standards) to 
support the change. Finally, we received a comment recommending that 
interim preliminary recognition be phased out over time as CDC updates 
its standards and the program matures.
    Response: We acknowledge that it may be difficult for some 
organizations that need financial support while they are collecting 
data to obtain CDC DPRP Recognition. We understand from our

[[Page 53300]]

coordination with CDC that some organizations obtain financial support 
from grants through various sources and that there are currently over 
100 payers and/or employers offering coverage for the National DPP in 
selected markets. Despite the time and resources it takes to achieve 
CDC recognition, we continue to believe the MDPP preliminary 
recognition standard is an appropriate minimum standard for DPP 
organizations to obtain prior to enrollment as an MDPP supplier.
    To increase awareness of the process, the criteria, and the period 
of time it takes programs to become CDC-recognized and then implement 
MDPP, we intend to provide MDPP supplier support through webinars and 
other types of guidance and education tools. We will continue to 
coordinate with CDC to provide relevant resources regarding both CDC 
recognition as it relates to the MDPP expanded model for organizations 
preparing to become MDPP suppliers.
    We disagree that there is a lack of data about the inclusion of 
individuals who attend 3 sessions (versus 4) as part of the DPRP data 
submission. CDC DPRP data show no difference in average percent weight 
loss for those who attend 3 sessions compared to 4, and therefore we 
believe including participants who have attended at least 3 sessions as 
compared to 4 will provide data to make an appropriate assessment for 
the purposes of MDPP preliminary recognition. Furthermore, by allowing 
organizations to submit data on individuals who have attended 3 
sessions (versus 4), we are increasing the number of organizations who 
are potentially eligible to achieve interim preliminary recognition.
    In response to the comments about phasing out interim preliminary 
recognition as CDC updates its Standards, we reiterate our intent to 
align data requirements with CDC Standards. The proposed CDC 2018 
Standards include the same requirements for CDC preliminary recognition 
as we proposed for interim preliminary recognition.\41\ As described in 
section III.K.2.e.i.2 of this final rule, after the effective date of 
these updated CDC Standards, MDPP suppliers who have enrolled in 
Medicare with interim preliminary recognition would continue to be 
eligible for MDPP enrollment (assuming they continue to meet all other 
requirements for enrollment, described in Sec.  424.205(b)). We intend 
to phase out interim preliminary recognition and ensure that any 
transition an MDPP supplier may make from interim preliminary 
recognition to CDC preliminary recognition does not disrupt its status 
as an MDPP supplier. We will address possible transition issues in 
future rulemaking or guidance, as appropriate.
---------------------------------------------------------------------------

    \41\ https://www.gpo.gov/fdsys/pkg/FR-2017-07-14/pdf/2017-14792.pdf.
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    Comment: One commenter raised concerns about what would happen to 
beneficiaries whose MDPP suppliers lost their MDPP supplier status due 
to loss of CDC DPRP recognition and recommended allowing organizations 
who move from ``preliminary'' to ``pending'' after 24 months to 
continue to serve MDPP participants but not be able to enroll any new 
beneficiaries. If after the 12 months of work to improve outcomes the 
organization is not successful, then at least the beneficiary would be 
through the first year of the program and would move to a new supplier 
for ongoing maintenance.
    Response: Last year, we finalized in Sec.  424.59(d) that the loss 
of CDC DPRP recognition will result in revocation of a supplier's MDPP 
billing authority. An example of when this might happen is when an 
organization is unable to meet the requirements for full recognition 
after having been in MDPP preliminary recognition for 24 months. In 
this rule, we maintained the policy, but modified the language to take 
into account the addition of interim preliminary recognition, such 
that, if an MDPP supplier does not satisfy any of the enrollment 
requirements (finalized at Sec.  424.59(a) and proposed to be 
redesignated and amended at Sec.  424.205(b)), which include having 
preliminary or full recognition, their enrollment would be revoked 
(proposed at Sec.  424.205(h)(1)(i)(B)).
    We disagree that allowing MDPP suppliers whose MDPP billing 
authority has been revoked should still provide MDPP services to 
beneficiaries. When their supplier's MDPP billing authority has been 
revoked beneficiaries may switch to a new MDPP supplier so they can 
complete their program.
    Comment: Regarding interim preliminary recognition and CDC 
preliminary recognition, a commenter recommended that we should allow 
organizations to submit for preliminary recognition when the first year 
of data are collected, on a rolling basis. For an example, with the new 
standards requiring data submissions every 6 months, the commenter 
noted that organizations starting their program in the first 5 months 
of the program would be punished by waiting until they were 18 months 
into the program, which is when their next data reporting submission 
would occur. Another commenter noted that while the current interim 
preliminary recognition standard focuses on the attendance of the DPP 
cohort, there is no performance metric associated with the criteria.
    Response: In response to the comment about timing of the 12-month 
data submission for preliminary recognition, the commenter is correct 
that it is possible that an organization may not have a full 12 months' 
worth of data needed for preliminary recognition at the 12-month data 
submission point. In this case, organizations could submit the 12 
months of data needed for preliminary recognition at the next 6-month 
data submission interval, or 18 months from their effective date, to 
achieve preliminary status. The interim preliminary recognition 
finalized in this rule represents a new category of recognition that 
does not include a weight loss requirement and provides an intermediate 
step on the path to full recognition. We believe the time it takes to 
achieve interim preliminary recognition is reasonable since it has 
reduced the amount of time it may take an organization initiating the 
CDC recognition process to enroll as an MDPP supplier from 36 months 
(full recognition) to 12-18 months (MDPP interim preliminary 
recognition).
    In response to the comment regarding establishing a performance 
metric for interim preliminary recognition, we proposed standards for 
interim preliminary recognition (which are the same standards CDC has 
proposed for preliminary recognition in their 2018 DPRP standards) that 
rely on attendance based measures, not weight loss. We discussed in the 
CY 2017 PFS final rule (section III.J.7.b of this final rule) that we 
believed that full recognitions status, which relies on weight loss 
measures, would be challenging for many organizations to meet initially 
and, without broadening the eligibility for an MDPP supplier to enroll, 
we may limit the number of MDPP suppliers available for beneficiaries 
to access MDPP services. We continue to believe the standards we are 
finalizing for interim preliminary recognition will adequately assess 
DPP organizations' capacity to become MDPP suppliers, and thereby 
increase the numbers of eligible organizations that beneficiaries can 
access for MDPP services.
    Updates to the CDC Standards are not expected to go into effect 
until 2018, and we are working closely with CDC on maintaining our 
alignment between interim preliminary recognition and its proposed 
standards in the 2018 DPRP Standards.
    Comment: Some commenters requested that the Special Diabetes 
Program for Indians (SDPI) Diabetes

[[Page 53301]]

Prevention (DP) program be certified as grandfathered in to provide 
services and receive reimbursement through the MDPP given that it 
continues to achieve similar results as the National Institutes of 
Health DPP lifestyle intervention group.
    Response: For the purpose of the MDPP services, CDC-recognition is 
being used for supplier eligibility because the Secretary's 
determination to expand the DPP model test was based on the CDC-
approved program. Consequently, we are not considering other 
accrediting bodies or standards at this time, nor are we considering 
grandfathering in programs so they can receive payments for MDPP 
services without meeting the standards finalized in this rule or 
finalized in the CY 2017 PFS final rule.
    We acknowledge the major contributions of the Special Diabetes 
Programs for Indians (SDPI) Diabetes Prevention Program (DPP) 
Demonstration Projects and the many resources--such as the SDPI 
Diabetes Prevention Toolkit--insights, and lessons learned these 
projects have contributed on both a local and national level. However, 
we decline grandfathering in the SDPI programs and making an exception 
to the MDPP requirements. We do not believe a separate type of 
recognition can be created for SDPI programs without compromising our 
intent to rely on the CDC's DPRP. Through the DPRP, CDC is responsible 
for carrying out a quality assurance function at the national level. 
Under the CDC's DPRP, we will enroll CDC-recognized organizations that 
are standardized in delivering the evidence-based behavior change 
program with quality and fidelity to the original science and 
subsequent translation studies achieving the outcomes proven to prevent 
or delay onset of type 2 diabetes. The nine requirements in the DPRP 
Standards apply equally to all organizations that apply for CDC 
recognition, regardless of size, experience, capacity, or populations 
served. We know from CDC that DPRP data collected to date indicate that 
all types of organizations are successful in achieving full 
recognition, and that CDC could not meet its obligation to ensure 
quality of recognized organizations enrolling as MDPP suppliers if each 
organization was allowed to use a different set of measures.
    We recommend that tribal organizations work with CDC to help tribal 
organizations offering the SDPI lifestyle change program, meet the DPRP 
Standards set by CDC. We welcome continued consultation with tribes and 
tribal organizations as required by the CMS Tribal Consultation 
Policy.\42\
---------------------------------------------------------------------------

    \42\ Centers for Medicare & Medicaid Services, ``CMS Tribal 
Consultation Policy,'' Centers for Medicare & Medicaid Services, 
2015, https://www.cms.gov/Outreach-and-Education/American-Indian-Alaska-Native/AIAN/Downloads/CMSTribalConsultationPolicy2015.pdf.
---------------------------------------------------------------------------

    Comment: While unrelated to the specific proposed policy on 
preliminary recognition and supplier enrollment, we received several 
comments regarding our previously finalized proposal in the CY 2017 PFS 
final rule to require Medicare-enrolled suppliers to furnish MDPP 
services. One commenter expressed uncertainty as to whether the 
Medicare enrollment requirement in the CY 2017 PFS final rule created a 
new requirement for all Medicare Advantage providers and suppliers to 
be enrolled in Medicare by January 1, 2019. This commenter further 
inquired whether this requirement would apply to coaches and other 
personnel or suppliers who may provide MDPP services, noting that this 
requirement would be burdensome if applied to MDPP and should be lifted 
for MDPP services.
    Response: While we did not propose any new policies related to the 
requirement for any organization seeking to furnish and receive payment 
for MDPP services to enroll as an MDPP supplier, we are responding to 
comments regarding enrollment and Medicare Advantage to clarify this 
issue. Regarding commenter's recommendation to lift the requirement 
that coaches who provide MDPP services be Medicare-enrolled, we clarify 
the requirements of coaches who provide MDPP services to beneficiaries. 
In the CY 2017 PFS final rule, we finalized the requirements for 
coaches furnishing MDPP services and established that coaches will not 
enroll in Medicare for purposes of furnishing MDPP services, but that 
they would be required to obtain NPIs (81 CFR 80479).
    Regarding other commenters' recommendations to lift the requirement 
that suppliers who provide MDPP services be Medicare-enrolled, we 
decline to adopt the commenters' proposals to eliminate the Medicare 
enrollment requirement for MDPP supplier-MAOs or for MDPP suppliers 
with whom MAOs contract to furnish MDPP services. In the CY 2017 PFS 
final rule, we also finalized the requirement that CDC-recognized 
organizations that will bill Medicare for MDPP services must enroll in 
Medicare as MDPP suppliers. MAOs must comply with 42 CFR part 422, 
subpart E in their relationships with providers; regulations in that 
subpart generally prohibit employing or contracting with individuals 
who are excluded from Medicare and require MA organizations to provide 
basic benefits (that is, Part A and Part B services) only through 
health care providers that meet the applicable requirements of Title 
XVIII. We previously issued guidance following the CY 2017 PFS final 
rule in a November 23, 2016 HPMS guidance memo that we now reiterate. 
In that HPMS memo, we established that, in order to provide MDPP 
services, a Medicare health plan such as an MA plan, may choose to 
contract with an organization that is Medicare-enrolled as an MDPP 
supplier, or become Medicare-enrolled as an MDPP supplier itself. MA 
plans that choose to contract with outside Medicare-enrolled MDPP 
suppliers should follow their normal protocols in accordance with 
applicable regulations. Medicare health plans that choose to become 
Medicare-enrolled MDPP suppliers are subject to the supplier enrollment 
eligibility requirements finalized in this final rule at Sec.  424.205.
    Comment: One commenter pointed out that for a Medicare Advantage 
Organization with an MA plan that is part of an integrated system with 
pending CDC-recognition, the Medicare-enrollment requirement would 
interfere with the MAO's ability to contract with providers with which 
the MAO has existing risk-based relationship that can be aligned with 
the MAO's incentives with providers.
    Response: As stated previously in this section, we finalized the 
requirement that CDC-recognized organizations that will bill Medicare 
for MDPP services must first enroll in Medicare as MDPP suppliers. This 
policy was followed by an HPMS memo that reiterated that, in order to 
provide MDPP services, a Medicare health plan such as an MA plan, may 
choose to contract with an organization that is Medicare-enrolled as an 
MDPP supplier, or become Medicare-enrolled as an MDPP supplier itself. 
In response to this commenter's concern related to MAOs that operate MA 
plans as part of an integrated network, where an MA plan is part of 
such a network and is either not interested in enrolling in Medicare as 
an MDPP or supplier or has not yet achieved the CDC-recognition 
required to enroll in Medicare, there is no Medicare prohibition that 
would prevent an MA plan from contracting with Medicare-enrolled MDPP 
suppliers under terms that would integrate these suppliers into the 
existing network or impose risk-based relationships on the newly 
contracted supplier.

[[Page 53302]]

    Comment: We received several comments expressing concern about a 
given MA plan's ability to meet network adequacy requirements based on 
the number of organizations that are currently eligible to enroll in 
Medicare as MDPP suppliers (which requires CDC recognition). Commenters 
noted that some geographic locations may not have an MDPP supplier with 
which an MA plan may contract to provide MDPP services to its enrollees 
by the proposed effective date of April 1, 2018. Under these 
circumstances, commenters noted that eligible beneficiaries may not 
find these travel distances feasible or safe and that it is unlikely 
that coaches will be able to regularly travel hundreds of miles to a 
class. One commenter noted that, while there are organizations 
currently in the process of obtaining CDC recognition, the state of 
Utah is currently without any CDC-recognized organization that has 
advanced beyond pending status. This commenter additionally noted that 
there is currently no way of knowing which organizations will achieve 
preliminary recognition status in time for an MA plan to establish 
contracts by the April 1, 2018 start date. We also received comments 
that specifically recommended that CMS relieve MA plans of the 
requirement to submit network adequacy information and include MDPP-
qualified providers in network adequacy reviews for the same reasons 
stated above related to the perceived lack of MDPP suppliers to meet 
these requirements.
    Response: In response to concerns expressed by MAOs regarding their 
ability to meet network adequacy standards for MA plans, we note that 
when a particular provider-type or facility-type (such as MDPP 
suppliers) is absent from a service area, an MA plan must provide 
enrollees with a level of access to Medicare-covered services that is 
consistent with prevailing community patterns of care under Sec.  
422.112(a)(10). As part of its evaluation of network adequacy in 
connection with this standard, CMS looks to several factors, including 
the number and distribution of health care providers in both commercial 
plans and in Original Medicare capable of furnishing the covered 
services. In some instances, delivery of covered services consistent 
with community patterns of care can mean that in order to receive a 
Medicare-covered service, an MA plan enrollee might have to travel to a 
provider/facility that is geographically distant from his or her plan's 
service area. The MA plan would not be required to cover travel 
expenses in this case (but may elect to cover such expenses as a 
supplemental benefit) as long as the MA plan is referring the enrollee 
to providers in a manner consistent with community patterns of care. We 
therefore decline to relieve MA plans of any general network adequacy 
requirements, or the requirement to provide access to MDPP services.
    After considering the public comments, we are finalizing our 
proposals, without modification, for MDPP preliminary recognition under 
the MDPP expanded model at Sec.  424.210(c).
ii. Enrollment and Billing Effective Dates
(1) Date MDPP Suppliers May Begin Enrollment
    As described in section III.K.2.a. of the CY 2018 proposed rule (82 
FR 34131), we proposed to change the start date of the MDPP expanded 
model to April 1, 2018. All other policies not related to the 
furnishing or billing of MDPP services would, if finalized, be 
effective January 1, 2018. Thus, although MDPP suppliers would not be 
able to begin furnishing MDPP services on January 1, 2018, MDPP 
supplier enrollment would begin on January 1, 2018, if these proposals 
are finalized. In the CY 2017 PFS final rule, we established that any 
organization wishing to furnish MDPP services must enroll as an MDPP 
supplier, regardless of any existing enrollment in Medicare. As 
indicated in section J.4. of the CY 2017 PFS final rule, we believe 
that including an effective date for enrollment that precedes the 
implementation date for MDPP services is necessary to allow 
organizations sufficient time to enroll as MDPP suppliers. Thus, MDPP 
services would only become available after there is sufficient time to 
enroll MDPP suppliers that will furnish those services.
    The following is a summary of the public comments received on the 
date MDPP suppliers are able to enroll.
    Comment: Of the comments we received on this issue, the majority 
expressed support for the enrollment start date of January 1, 2018. In 
their agreement, some commenters stipulated that having a 90-day period 
between when MDPP supplier enrollment began and when enrolled suppliers 
could begin furnishing MDPP services would provide both a reasonable 
and necessary timeframe for organizations to enroll and ensure 
compliance. One commenter in support of this policy urged that CMS 
maintain this timeline. The same commenter specifically requested that, 
though implied, CMS clarify that the enrollment period for MDPP 
suppliers does not begin on January 1, 2018 and end of April 1, 2018. 
Other commenters in support of this policy urged that CMS provide 
guidance materials and resources to help prospective MDPP supplier 
applicants prepare for and ultimately enroll into Medicare. Commenters 
requested that this information be made available as soon as possible, 
with one commenter specifically requesting that CMS issue a timeline 
under which prospective MDPP supplier applicants should expect CMS to 
release such information.
    Response: We clarify that though MDPP supplier enrollment begins on 
January 1, 2018, enrollment in Medicare occurs on a rolling basis with 
no current or expected end date when MDPP supplier applications would 
no longer be accepted. Prospective MDPP supplier applicants should 
submit their enrollment application on or after January 1, 2018 once 
they are ready to do so. Given the time it takes to successfully 
process an enrollment application and potential delays in that process, 
we encourage prospective MDPP supplier applicants to apply as soon as 
feasible for the organization.
    Comment: One commenter did not believe that any delay was necessary 
given that organizations were already enrolled and prepared to begin 
furnishing MDPP services.
    Response: We believe the commenter may have misunderstood 
previously finalized policies in the CY 2017 PFS final rule. We clarify 
that only entities enrolled as MDPP suppliers may furnish MDPP services 
to beneficiaries. Thus, regardless of any previous enrollment in 
Medicare, all entities wishing to furnish these services must enroll as 
an MDPP supplier on or after January 1, 2018.
    After consideration of the comments received on the MDPP supplier 
enrollment start date, we are finalizing this policy as proposed. MDPP 
supplier enrollment shall begin on January 1, 2018, when the policies 
in Sec.  424.205 that enable MDPP supplier enrollment become effective.
(2) Effective Date of MDPP Suppliers' Billing Privileges
    Under Sec.  424.502, the definition of enroll/enrollment means 
``the process that Medicare uses to establish eligibility to submit 
claims for Medicare-covered items and services, and the process that 
Medicare uses to establish eligibility to order or certify Medicare-
covered items and services.'' Thus, the purpose of enrollment is to 
establish billing privileges in Medicare. In accordance with our 
proposal that MDPP services will be available

[[Page 53303]]

beginning on April 1, 2018 (82 FR 34131), we proposed that MDPP 
suppliers may not have an effective date of billing privileges that 
precedes the date that MDPP services become available (82 FR 34157 
through 34158 and proposed at Sec.  424.205(e)(2)). Given that it 
typically takes 45-60 days for an enrollment application days to be 
processed, if an MDPP supplier submitted its application in January, 
the application may be approved prior to when MDPP services become 
available on April 1, 2018. For this reason, we specified that, under 
no circumstances would an MDPP supplier have an effective date for 
billing privileges for MDPP services prior to April 1, 2018.
    We proposed that for MDPP supplier enrollment applications that are 
submitted and subsequently approved, the effective date for billing 
privileges would be the date the application was submitted. However, 
for applications submitted and subsequently approved prior to April 1, 
2018, we proposed that the effective date for billing privileges would 
be April 1, 2018. This is consistent with other suppliers like 
physicians, non-physician practitioner organizations, ambulance 
suppliers, and independent diagnostic testing facilities (IDTFs). 
However, unlike physicians, non-physician practitioner organizations, 
and ambulance suppliers who may bill for services for a limited period 
of time--generally for about thirty days--prior to their effective date 
if circumstances precluded enrollment in advance of providing services 
to Medicare beneficiaries, MDPP suppliers would not be permitted to 
retrospectively bill for services rendered prior to their effective 
date for billing privileges. Given that MDPP suppliers do not furnish 
services with immediate impacts on health like the aforementioned Part 
B suppliers, we chose to utilize the approach of IDTFs. We proposed 
that as a condition of enrollment, MDPP suppliers would be required to 
certify in their enrollment application that they are in compliance and 
will continue to remain in compliance with all MDPP supplier standards 
that we described in section III.K.2.e.iv of the proposed rule (82 FR 
34159 through 34160). Therefore, an MDPP supplier could begin 
furnishing services on the date the application was submitted, with the 
goal of having their application subsequently approved. However, we 
proposed that payment for those services would depend upon whether the 
enrollment application is subsequently approved.
    We proposed that for any enrollment application that is denied 
under Sec.  424.530(a)(1) for non-compliance, but then subsequently 
approved due to the submission of a corrective action plan (CAP), the 
effective date of enrollment would be the date of the CAP submission. 
This is also consistent with practices for existing suppliers, and 
institutes an appropriate safeguard for Medicare beneficiaries and the 
program at-large by prohibiting services from being furnished from 
suppliers who are non-compliant. We acknowledged, however, that if a 
supplier began furnishing services the date it submitted its 
application, but was then denied enrollment, it would not be paid for 
any services it furnished prior to the date it submitted the CAP, if 
approved. However, as described in section III.K.2.e.iv of this final 
rule (Sec.  424.205(d)), upon submitting its enrollment application, an 
MDPP supplier certifies that--to its knowledge--it meets and agrees to 
continue to meet the following MDPP supplier standards, and all other 
applicable Medicare requirements. Thus, at the time the MDPP supplier 
applicant submits its application, it should believe that its 
enrollment application will be approved. Examples of actions the MDPP 
supplier could take to improve its certainty and increase the 
probability that the application will be approved may include reviewing 
any MDPP supplier supporting documentation to fully understand MDPP 
supplier enrollment requirements and accompanying CMS guidance or 
supplier support materials, confirming compliance with the MDPP 
supplier standards in this rule (including conducting background checks 
for those who would be screened by CMS during the enrollment process as 
required under Sec.  424.518(c) and Sec.  424.205(d)(3)), and 
conducting a thorough review of the enrollment application to ensure 
the submitted application is accurate.
    We also proposed that if an MDPP supplier adds a new administrative 
location (defined and discussed further section III.K.2.e.iii.(2) of 
this section of the final rule) that resulted in a new enrollment 
record or Provider Transaction Access Number (PTAN), the effective date 
for billing privileges would be the date the MDPP supplier began its 
MDPP operations at that location. We believe that this is appropriate 
given that it follows a similar approach for an effective date that 
applies to when physician organizations, non-physician practitioner 
organizations, ambulance suppliers, and IDTFs add a new practice 
location to an existing enrollment record. Though the definition of 
administrative location differs from that of practice location, it 
provides a similar function. We sought comments on these proposals.
    We received no comments on our proposals on the effective date for 
billing privileges, and are finalizing these policies as proposed under 
Sec.  424.205(f).
iii. Enrollment Application
(1) Enrollment Application Type Applicable to MDPP Suppliers
    We proposed to require the use of a new, CMS-approved enrollment 
application specific to MDPP suppliers. We believe that the creation of 
a new application will be more easily navigated by and reduce the 
burden on new, non-traditional suppliers because the new enrollment 
application will only solicit information relevant to the MDPP supplier 
type. As this new enrollment application is being created specifically 
for the MDPP expanded model, we have determined that this new 
enrollment application is exempt from the Paperwork Reduction Act in 
accordance with section 1115A(d)(3) of the Act. Further, this 
enrollment application would be considered an ``enrollment 
application'' for purposes of part 424 subpart P, and therefore, all 
existing regulations and administrative guidance that govern the CMS-
855 enrollment applications would apply to this new form, unless 
otherwise specified. We also considered an alternative option to amend 
the current CMS-855B Medicare Enrollment Application for Clinics/Group 
Practices and Certain Other Suppliers (CMS-855B) for MDPP supplier 
enrollment, but we determined that the existing length and complexity 
of the CMS-855B enrollment application and its applicability to other 
non-MDPP suppliers may add burdens or unnecessary confusion to MDPP 
suppliers given that many sections of the current CMS-855B enrollment 
application would not apply to MDPP suppliers. In addition, we would 
need to add new sections to solicit information specific to MDPP 
suppliers, which would only further increase the length of the CMS-855B 
enrollment application. We invited public comments on this proposal.
    The following is a summary of the public comments received on the 
proposal to require the use of a new, CMS-approved enrollment 
application specific to MDPP suppliers and our responses:
    Comment: The majority of comments received on creating a new, MDPP 
specific enrollment form supported this proposal. However, the emphasis 
of

[[Page 53304]]

these comments expressed a strong desire for simplicity and that CMS 
make the form available as soon as possible. Commenters stipulated that 
given that many prospective MDPP suppliers will lack experience with 
Medicare enrollment, simplicity and plain language would facilitate 
their ability to enroll with ease. Similarly, commenters expressed that 
early access to the form would substantially help prospective MDPP 
applicants prepare for enrollment. In addition to the early access to 
the form itself, commenters also urged CMS to provide resources and 
guidance to prospective MDPP suppliers to facilitate their ability to 
successfully enroll.
    Response: We appreciate all of the comments and support regarding 
our proposal to create a new, MDPP supplier-specific enrollment 
application based off of the Form CMS-855-B, as well as other 
commenters who provided suggestions or other considerations. We 
reemphasize that we proposed to create an MDPP specific enrollment 
application rather than amend the current Form CMS-855-B specifically 
to simplify the application to the extent possible and focus the 
information collected on MDPP supplier-related information. We continue 
to believe that this approach strikes the appropriate balance between 
acquiring necessary information from MDPP supplier applicants and doing 
so in a manner that is clear and as straightforward as possible.
    We understand commenters' requests to have expedited access to the 
enrollment application. Given that many policies related to or 
specified on the application are being finalized through this rule, we 
cannot publish the enrollment application prior to the publication of 
this final rule. However, we agree that having access to the 
application prior to the enrollment start date will better assist 
prospective MDPP suppliers preparing to enroll in Medicare, and will 
plan to release the application as soon as possible following the 
publication of this final rule. For this reason, we specified in our 
proposal that we intend for the information collected on the MDPP 
supplier enrollment application to build off of what is collected on 
the 855-B for all supplier types, and proposed additional information 
collection requirements specific to MDPP suppliers in this rule. Until 
we are able to make the new enrollment application available, we 
believe that reviewing the existing 855B enrollment form should begin 
assisting prospective MDPP suppliers in their enrollment preparation. 
In an effort to disclose information on the enrollment application at 
our earliest opportunity, we can announce that the MDPP enrollment 
application will be entitled Form CMS-20134, Medicare Enrollment 
Application, MDPP Suppliers. Additional information on the enrollment 
application's availability will be announced publicly via the CMS Web 
site and other methods as applicable and appropriate.
    Comment: Another commenter suggested that once MDPP suppliers 
successfully enroll, that CMS create a list of all enrolled MDPP 
suppliers as a method of providing resources to prospective MDPP 
beneficiaries. The commenter noted that such a resource would be 
particularly necessary given that not all suppliers with CDC 
recognition will enroll as an MDPP supplier, and thus, having a 
separate list of available suppliers would facilitate beneficiary 
access.
    Response: We agree with the commenter's suggestion and will explore 
the possibility of creating this list and making it available to 
facilitate access. Further details on these efforts will be released 
through the CMS Web site as appropriate and when available.
    Comment: In addition to supportive comments and suggestions for 
ways CMS could facilitate prospective applicant's completion of the 
enrollment application, certain commenters expressed confusion with our 
proposals, or commented on proposals outside of the scope of this rule. 
One commenter noted that CMS was requesting comments on whether 
existing Medicare providers and suppliers that wish to bill for MDPP 
services would have to inform Medicare of the intention and satisfy all 
other requirements but would not need to enroll a second time. This 
commenter did not support this policy, and therefore, did not support 
the creation of a new enrollment application. Similarly, a handful of 
commenters expressed concern about this previously finalized policy, 
and urged CMS to reconsider the requirement to reenroll, particularly 
for FQHCs and enrolled physicians.
    We clarify that we are not considering exemptions for MDPP supplier 
enrollment. We appreciate commenters who expressed a desire for CMS to 
reconsider the policies previously finalized in the CY 2017 PFS, but 
these policies are out of scope of the proposed rule, and we are not 
reconsidering previously finalized policies at this time. For our 
rationale on this previous policy decision, please reference section 
III.J.7.a of the CY 2017 PFS final rule where we addressed these 
comments.
    After considering the public comments, we are finalizing the 
proposal to create an MDPP supplier specific enrollment application, as 
proposed.
(2) Information on MDPP Enrollment Application
    On the new MDPP enrollment application, we intend to solicit 
information specific to MDPP suppliers, as well as information 
consistent with existing reporting requirements applicable to all 
suppliers who enroll through the CMS-855B enrollment application, while 
excluding all reporting requirements that do not apply to MDPP 
suppliers. As a Medicare supplier enrolling under part 424 subpart P, 
MDPP suppliers are required to provide complete and accurate 
information on the MDPP enrollment application, or be subject to 
enrollment denial under Sec.  424.530(a)(4) or revocation under Sec.  
424.535(a)(4). This requirement would include all information solicited 
on the MDPP-specific enrollment application. The MDPP-specific 
enrollment application is under development and will be available prior 
to its use. While the application is being developed, we indicate some 
of the information we intend to include on the MDPP enrollment 
application, as further described in this section.
    As finalized in the CY 2017 PFS final rule, Sec.  424.59(a)(5) 
requires that MDPP suppliers submit the active and valid NPIs of all 
coaches who will furnish services on the supplier's behalf, as well as 
their first name, last name, and SSN (in the proposed rule, Sec.  
424.59(a)(5) was proposed to be redesignated and amended at Sec.  
424.205(b)(4)). We proposed, at Sec.  424.205(b)(4), to require that 
MDPP suppliers provide this identifying information of the coaches 
directly through the enrollment application. This information will be 
used to complete background checks of the coaches. To accompany the 
coach identifying information, we proposed to require MDPP suppliers to 
provide an eligibility start and end date, if applicable, for each 
coach on the supplier's roster. Coach eligibility start and end dates 
are described at length in section III.K.2.e.iv.(2). As described in 
more detail in section III.K.2.e.iv., the background checks would be 
used to prevent MDPP suppliers from allowing coaches to furnish MDPP 
services when certain adverse histories may indicate potential to harm 
Medicare beneficiaries or undermine program integrity. We outline 
further details on our proposed enforcement of this provision in 
section III.K.2.e.iv. of this final rule.

[[Page 53305]]

    To enable us to conduct background checks of coaches, we proposed 
that MDPP suppliers also submit to CMS the date of birth of all coaches 
who will furnish MDPP services (Sec.  424.205(b)(4)). Combined with 
other identifying information, date of birth plays a critical role in 
validating an individual's identity. By collecting date of birth, we 
would be able to more accurately screen coaches, including accurately 
conducting a background check, and distinguishing them in the Provider 
Enrollment, Chain and Ownership System (PECOS). In addition, we want to 
ensure that we have the capability to most accurately identify 
individuals reported on the form. To mitigate potential confusion or 
error found when individuals have common names, we are proposing to 
collect coach's middle initial (if applicable) on the enrollment 
application (Sec.  424.205(b)(4)). We believe that this will help to 
lessen the possibility that CMS or its contractors misattribute the 
background of one individual for another.
    We proposed, at Sec.  424.205(d)(4), that MDPP suppliers would 
identify their administrative location(s) by reporting these 
location(s) on their enrollment application. We proposed, at Sec.  
424.205(a), to define administrative location as the physical location 
associated with the supplier's operations, from where coaches are 
dispatched or based, and where MDPP services may or may not be 
furnished. We proposed that an MDPP supplier must have at least one 
such administrative location, and report any additional administrative 
locations of the supplier, if MDPP services are either furnished at 
these locations and/or if the location reflects from where coaches are 
dispatched or based. For example, if an MDPP supplier operated 2 
locations, but only 1 of the 2 locations associated with the entity 
offered MDPP, only the location offering MDPP would be considered an 
administrative location. If coaches began offering MDPP in community 
settings (described in the subsequent paragraph and defined at Sec.  
424.205(a), but were dispatched and/or based out of the other non-
administrative location, then this location would then be considered 
under the definition of an administrative location, and would need to 
be reported on the MDPP enrollment application within 90 days of the 
change. Given that MDPP suppliers are categorized as high risk under 
Sec.  424.518, these administrative locations may be subject to site 
visits prior to approval of an enrollment application. Collecting 
information on the MDPP supplier's administrative location (regardless 
whether they furnish services in this location) is important because we 
may utilize this information to verify that the organization is 
operational per requirements under proposed Sec.  424.205(d)(4) and 
(6), discussed in detail in section III.K.2.e.iii.(3) of this final 
rule.
    Although we recognize that many suppliers furnish MDPP services 
outside of their administrative locations in community settings, we 
proposed to only require enrollment of the administrative locations. In 
Sec.  424.205(a), we define ``community setting'' as a location where 
the MDPP supplier furnishes MDPP services outside of their 
administrative locations. A community setting is a location open to the 
public, not primarily associated with the supplier. Community settings 
may include, for example, church basements or multipurpose rooms in 
recreation centers. When determining whether a location is considered 
an administrative location or a community setting, MDPP suppliers 
should consider whether their organizational entity is the primary user 
of that space and whether coaches are based or dispatched from this 
location. If so, the location would be considered an administrative 
location, even if this location dually serves as a community setting. 
In comparison, community settings are locations not primarily 
associated with the supplier where many activities occur, including 
MDPP services.
    We sought public comments on these proposals.
    The following is a summary of the public comments received on these 
proposals regarding what information CMS will collect on the MDPP 
supplier enrollment application and our responses:
    Comment: Several commenters expressed disagreement with previously 
finalized policies out of scope of these proposals, including MDPP 
suppliers collecting information on MDPP coaches, requiring coaches to 
obtain NPIs, and tracking and reporting coach NPIs to CMS. One 
commenter broadly requested that CMS reconsider these policies citing a 
preference for a less intrusive way for staff to participate. Another 
suggested that instead of issuing and tracking coaches through NPIs, 
CMS should allow DPP organizations to self-regulate their coaches using 
their own management practices. Another commenter expressed a broad 
concern regarding the burden of the recordkeeping requirements under 
MDPP, listing the tracking and submission of coach NPIs as one of these 
burdens.
    Response: These comments are out of scope of this final rule. None 
of the comments received addressed the policies in the proposed rule, 
which built on previously finalized policies in the CY 2017 PFS final 
rule. We do not intend to change these policies at this time.
    In the absence of public comments on our proposal to collect the 
date of birth and middle initials, if applicable, of MDPP coaches or 
our proposal to collect coach identifying information from their roster 
through the MDPP supplier enrollment application, we are finalizing 
these policies as proposed.
    Comment: Several commenters requested clarity and expressed concern 
related to differences between an administrative location and community 
setting.
    Response: A location may either meet the definition of an 
administrative location or a community setting based on whether or not 
the MDPP supplier is the primary user of that space, including both 
MDPP services and any other services provided by the supplier. The 
difference can be easily illustrated by examining two scenarios where 
MDPP services are furnished in a community center, and the community 
center can qualify as either an administrative location or a community 
setting, depending on the circumstance. For example, if the MDPP 
supplier is also a community-based organization which primarily 
operates at a community center which offers many services including 
MDPP, the address of the community center would fall under the 
definition of an administrative location which, as proposed under Sec.  
424.205(a), means a physical location associated with the MDPP 
supplier's operations. However, if an advocacy organization is enrolled 
as an MDPP supplier and opts to furnish services in a community center 
to increase beneficiary access or because the location where their 
primary business operations occur does not have sufficient space to 
hold a group meeting, the address of the community center would qualify 
as a community setting, because, as proposed under Sec.  424.205(a), a 
community setting means a location where the MDPP supplier furnishes 
MDPP services outside of their administrative locations, that is open 
to the public, and not primarily associated with the supplier. To make 
the distinction between these two definitions more clear, we will amend 
our proposed definition of an administrative location to include a 
physical location associated with the MDPP supplier's operations where 
it is the primary operator in the space, from where coaches are 
dispatched or based,

[[Page 53306]]

and where MDPP services may or may not be furnished.
    Comment: Specifically, one commenter requested that CMS confirm 
that MDPP services furnished by an enrolled MDPP supplier can be 
offered in a setting that is not exclusively used for MDPP services, 
meaning that the location may be co-located with other non-covered MDPP 
services.
    Response: We confirm the commenters' interpretation that MDPP 
suppliers may furnish MDPP services in locations where other, non-MDPP 
services occur.
    Comment: Another commenter disagreed with the requirement that MDPP 
suppliers have at least one administrative location. Though this 
requirement was proposed in the MDPP supplier standards, the comment 
stemmed from the stakeholders' understanding of the proposed definition 
of administrative location, and thus it is discussed in this section of 
the rule. The commenter stipulated that requiring that MDPP suppliers 
have at least one administrative location does not align with how some 
DPP organizations currently deliver and schedule sessions. The 
commenter noted that DPP organizations may not have an administrative 
location where coaches remain throughout the day and are scheduled or 
dispatched from, but rather, that a program coordinator (who may or may 
not also serve as a lifestyle coach) determines which coach will staff 
a series of sessions and the corresponding location.
    We do not agree with the commenter who noted that our proposed 
definitions of administrative locations do not align with how DPP 
organizations currently operate. Though the commenter suggested a 
program coordinator, not a coach, may dispatch coaches to furnish 
sessions, this scenario would not disqualify the location from where 
the coordination dispatched the coach from being an administrative 
location. We clarify that we take no policy position on who dispatches 
the coaches, be they another coach, program coordinator, or other 
personnel working on behalf of the MDPP supplier. Our proposed 
definition of the administrative location means any physical location 
associated with the suppliers' primary business operations, regardless 
of whether coaches furnish MDPP services from that location or not. If 
the location serves as the supplier's primary operations, but MDPP 
services are furnished elsewhere, we assume that the supplier or 
individuals working on its behalf will dispatch coaches from this 
location, potentially house MDPP related materials at this location, or 
utilize this location to store records. We purposefully sought to 
define administrative location to accommodate the non-traditional 
nature and diversity of settings among current DPP organizations.
    After considering the public comments, we are finalizing the 
requirement to report an MDPP supplier's administrative location(s) and 
community setting(s) on the enrollment application with minor 
amendments to the definition of an administrative location to provide 
greater clarity.
(3) Updating Information on MDPP Enrollment Application
    We proposed, at Sec.  424.205(d)(5), that MDPP suppliers must 
update their enrollment application within 30 days of any changes of 
ownership, changes to the coach roster, or new final adverse action 
history of any individual or entity required to report such information 
on the enrollment application. We proposed that MDPP suppliers report 
all other changes to information required on the enrollment application 
within 90 days of the reportable event. Timely reporting and updating 
of information plays a critical role in our ability to protect Medicare 
beneficiaries and protect the integrity of the Medicare program and 
Trust Funds. We believe that these requirements are fair and consistent 
with existing reporting requirements for other Medicare suppliers.
    All suppliers are required to report changes of ownership and new 
adverse action history within 30 days. Adding the requirement that any 
changes to the coach roster be reported within 30 days is consistent 
with IDTFs requirements at Sec.  410.33(g)(2). Although IDTFs differ 
from MDPP suppliers in many ways, IDTFs must report a roster of 
supervising physicians who serve functions on the supplier's behalf and 
must also report changes to this roster within 30 days. Given this 
similarity with IDTFs, we modeled our approach after this process. 
However, we note that while MDPP suppliers would be required to submit 
changes to the coach roster within 30 days, we would encourage them to 
submit such changes as soon as possible, due to reasoning explained 
further in section III.K.2.e.iv.(2) of this final rule.
    We invited public comments on these proposals. We received no 
comments on our proposals relating to the timelines under which MDPP 
suppliers must update their enrollment applications, and thus are 
finalizing these policies as proposed at Sec.  424.205(d)(5).
(4) Enrollment Application Fee
    In the CY 2017 PFS final rule, we finalized that MDPP suppliers 
would enroll in Medicare. We solicited comments on, but did not propose 
or finalize, an applicable application fee associated with the MDPP 
supplier's enrollment. In this final rule, we proposed to amend the 
definition of ``institutional provider'' as defined under Sec.  
424.502, to include MDPP suppliers such that, Sec.  424.514, which 
governs the application fee, would similarly apply to MDPP suppliers. 
``Institutional providers'' that are initially enrolling in Medicare, 
revalidating their enrollment, or adding a new Medicare practice 
location are required to submit a fee with their enrollment 
application. We highlight that while we proposed to include MDPP 
suppliers as an institutional provider, MDPP suppliers utilize 
administrative locations, not practice locations, and therefore the fee 
would not apply when adding a new administrative location to an 
existing enrollment record. The application fee is adjusted annually, 
and additional information about how the adjustment is calculated may 
be found in the November 7, 2016 Federal Register notice establishing 
the calendar year 2017 application fee (81 FR 78159). For calendar year 
2017, the application fee is $560. Section 1866(j)(2)(C) of the Act 
requires the Secretary to impose a fee on each institutional provider 
of medical or other items or services or supplier. This fee would be 
used for program integrity efforts including to cover the cost of 
screening and to carry out the provisions of sections 1866(j) and 1128J 
of the Act. Given that section 1866(j)(2)(C) of the Act does not 
require individual practitioners, such as physicians and nurse 
practitioners, to pay an enrollment application fee, we have previously 
determined that an ``institutional provider'' includes any provider or 
supplier that submits a paper Medicare enrollment application using the 
CMS-855A, CMS-855B (not including physician and non-physician 
practitioner organizations), CMS-855S or associated Internet-based 
PECOS enrollment application.\43\ MDPP suppliers are entities, and not 
individual practitioners. We believe that they would similarly qualify 
as a ``provider of medical or other items or services'' used to define 
institutional providers. Taken together, we believe that the definition 
of institutional provider would also apply to MDPP

[[Page 53307]]

suppliers. Given that the CY 2017 PFS final rule established that MDPP 
suppliers would be screened under high categorical risk (codified at 
Sec.  424.59(a)(3), redesignated as Sec.  424.205(b)(3)(i)), the 
application fee would play an important role in executing particular 
aspects of the high-risk screening. As we noted in the CY 2017 PFS 
final rule, any organization that faces financial difficulty related to 
the application fee may apply for a hardship exception. For more 
information on the hardship exemption, see https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM7350.pdf. We solicited comments on this 
proposal.
---------------------------------------------------------------------------

    \43\ See CMS-6028-FC for further discussion, 76 FR 5862 and 5907 
through 5908 (Feb. 2, 2011).
---------------------------------------------------------------------------

    The following is a summary of the public comment received on the 
proposal to amend the definition of institutional provider for the 
purposes of applying an enrollment application fee, as well as our 
response.
    Comment: We only received one comment on this proposal, which 
supported requiring MDPP suppliers to pay a $560 enrollment application 
fee.
    Response: We clarify that the application fee amounted to $560 in 
2017; however, this amount may vary from year-to-year based on 
adjustments made under the Consumer Price Index for Urban Areas (CPI-
U). We encourage prospective MDPP supplier applicants to remain abreast 
of any changes in that amount. CMS publishes an annual Federal Register 
notice regarding an update of the enrollment application fee.
    After considering the public comments, we are finalizing our 
amendment to the definition of institutional providers to include MDPP 
suppliers. Though the meaning of the proposal remains the same, now 
that we have finalized the creation of an MDPP supplier specific form, 
CMS-2013, we will amend the language at Sec.  424.502 from the proposed 
which referenced any enrollment application designated for MDPP 
suppliers to refer to CMS-20134.
iv. MDPP Supplier Standards
    We proposed to establish standards that MDPP suppliers must meet 
and remain in compliance with to be eligible to receive payment under 
the MDPP expanded model (described in 82 FR 34159 through 34160 and 
proposed at Sec.  424.205(d)). These supplier standards would build on 
the conditions for enrollment established under existing Sec.  
424.59(a) (which in this final rule is redesignated and amended at 
Sec.  424.205(b)), as well as any existing Medicare requirements that 
apply to all suppliers. We proposed that an MDPP supplier wishing to 
participate in the MDPP expanded model must adhere to current Medicare 
MDPP supplier requirements as outlined in Sec.  424.59 (redesignated as 
Sec.  424.205), as well as all other requirements that apply to 
Medicare providers and suppliers. MDPP suppliers may choose to utilize 
a third party administrator, billing agent, or other entity to comply 
with the requirements of Sec.  424.59 (redesignated as Sec.  424.205). 
Regardless of any use of such entities, any failure to comply with the 
standards of Sec.  424.205(d) or other relevant Medicare requirements, 
may result in an enrollment denial under Sec.  424.530(a)(1), 
revocation of the MDPP supplier for non-compliance under Sec.  
424.535(a)(1) or other revocation authority, as appropriate (as in 
Sec.  424.205(g)). Consistent with existing regulations, we proposed 
that MDPP suppliers would have appeal rights under part 498.
    We stated that we believe that the standards outlined in this 
section are generally consistent with standards established for other 
Medicare suppliers while adding safeguards to help ensure compliance 
with MDPP rules and regulations specific to this expanded model. 
Because this expanded model would pay MDPP suppliers based on a 
beneficiary's achievement of performance goals, we stated that we 
believe that it is prudent to include additional requirements 
consistent with the Office of Inspector's General's compliance 
guidance,\44\ to promote adherence to applicable statutes, regulations, 
and program requirements and help reduce fraud, waste, and abuse. In 
addition to the standards, the MDPP expanded model will be routinely 
monitored for compliance with supplier standards, consistent with 
section 1893 of the Act (42 U.S.C. 1395ddd). Although we recognized 
that these standards may be new for MDPP suppliers and would impose 
additional requirements on these organizations that they may not 
otherwise face, both individually and collectively, we stated that 
these standards play an important role in ensuring the integrity of the 
Medicare program and the safety of our beneficiaries. Therefore, given 
the goals of these standards to mitigate fraud, waste, or abuse to the 
Medicare program and its beneficiaries, we stated that we believe that 
they are appropriate for governing MDPP suppliers and do not place an 
undue burden on suppliers. We invited public comments on our approach, 
as well as any unintended consequences or burdens that we may have not 
considered.
---------------------------------------------------------------------------

    \44\ https://oig.hhs.gov/compliance/compliance-guidance/.
---------------------------------------------------------------------------

    The following is a summary of the public comments and our responses 
regarding the proposal to establish standards for MDPP suppliers' 
general eligibility to furnish services to Medicare beneficiaries and 
program integrity safeguards that would protect both Medicare 
beneficiaries and the Medicare program:
    Comment: Several commenters provided feedback on the proposal to 
establish MDPP supplier standards. The majority of these commenters 
expressed concern that by imposing additional requirements, the 
standards would pose additional burdens on MDPP suppliers. One 
commenter stated that the extensive requirements may delay access. 
Others expressed strong sentiments against CMS' decision to impose MDPP 
supplier standards. One commenter indicated that these impositions may 
deter organizations from deciding to enroll as MDPP suppliers even if 
beneficiaries already served by these organizations could benefit from 
MDPP services. Rather than establishing MDPP supplier standards to 
protect against fraud, waste, and abuse, one commenter recommended that 
CMS conduct random audits and site visits.
    Response: We recognize that supplier standards pose additional 
burdens for MDPP suppliers; however, we believe that these standards 
play an important role in ensuring against fraud, waste, and abuse in 
the Medicare program as well as fidelity to the expanded model. 
Additionally, we have sought to structure these standards such that 
compliance would be feasible, and at times, even seamless for suppliers 
to abide by. For example, our proposals regarding MDPP suppliers' 
operational status were not intended to impose new requirements, but to 
notify prospective MDPP applicants of the standards by which they will 
be evaluated. We believe that MDPP suppliers that are operational, as 
opposed to organizations who wish to appear operational, will not need 
to make any changes in order to be able to meet these standards. 
Therefore, we do not agree with the commenter that overall, the 
supplier standard would pose any additional burden on these suppliers, 
dissuade legitimate and operational suppliers from choosing to 
participate, or even significantly delay enrollment. Though we 
recognize that implementing criteria for eligible coaches could result 
in an enrollment delay should a coach submitted on a suppliers' 
enrollment application be determined by CMS to be ineligible, the 
eligibility criteria narrowly focuses on excluding coaches

[[Page 53308]]

with felony convictions for actions that, if repeated in MDPP, could 
jeopardize the integrity of the program and/or the safety of its 
beneficiaries. Therefore, we believe that any delays caused by an 
ineligible coach are justified.
    Comment: A few commenters expressed general support for the 
standards, noting that they were appropriate, and with few exceptions, 
generally straightforward to implement. Though MedPAC did not expressly 
support the proposed supplier standards, they recommended that CMS use 
all program integrity tools available to monitor MDPP suppliers, 
including significant oversight from the Office of Inspector General 
and limitations on supplier enrollment.
    Response: We agree with commenters' views of the appropriateness of 
our proposals, the importance of implementing program integrity tools 
for this novel supplier type, and that the characterization of MDPP 
supplier standards as straightforward to implement.
    Comment: Instead of establishing MDPP supplier standards to protect 
against fraud, waste, and abuse, one commenter recommended that CMS 
conduct random audits and site visits.
    Response: We disagree with one commenter's characterization of 
audits and site visits as an alternative to MDPP supplier standards as 
the two support one another. Where the MDPP supplier standards 
establish some of the requirements under which MDPP suppliers must 
abide, an audit or site visit gives CMS an opportunity to ensure that 
an MDPP supplier is in compliance with such requirements. Furthermore, 
given the novelty of the expanded model and this new supplier type 
created to support its delivery, as well as concerns raised by MedPAC 
and others, we believe that establishing MDPP supplier standards 
provides important program integrity safeguards for a range of 
programmatic objectives.
    For example, some of the MDPP supplier standards provide preemptive 
measures to dissuade organizations that may seek to enroll as an MDPP 
supplier without planning to actually furnish services, but instead, 
with the intention of fraudulently billing Medicare for MDPP services 
not rendered. For example, requiring a working phone number that is 
listed in association with the supplier and having a physical location 
with signage associated with the supplier's legal business or doing 
business as name. These standards have also been implemented with other 
supplier types to avoid ``shell'' companies from being able to enroll. 
The supplier standard proposed at Sec.  424.205(d)(1) prevents an 
organization with a for-cause termination in Medicaid from replicating 
the same behavior in Medicare that had them terminated in Medicaid. A 
supplier standard at Sec.  424.205(d)(8) prohibits the MDPP supplier 
from proactively selecting beneficiaries who they perceive to be more 
likely to successfully meet the performance goals, which would 
subsequently generate more funds for the supplier. Another supplier 
standard at Sec.  424.205(d)(10) ensures that an MDPP supplier offers 
all services for which an MDPP beneficiary is eligible, which would 
prevent a supplier that may otherwise seek to cease providing the time 
investment of offering services to a beneficiary who they believe is 
unlikely to meet performance goals, and therefore resulting in less 
reimbursement for the supplier. We have included safeguards to ensure 
that MDPP suppliers do not engage in this type of discriminatory 
behavior that could limit access for certain beneficiaries who would 
benefit from receiving MDPP on the basis of the supplier's own 
financial benefit.
    We believe that establishing these standards also plays an 
important role in enabling CMS to enforce certain actions and take 
appropriate administrative action when a supplier fails to comply.
    Though MedPAC did not comment on these standards directly, we 
believe that the both the standards supplier standards and our ability 
to deny or revoke an MDPP suppliers' enrollment if they fail to comply 
aligns with their recommendation to utilize all available program 
integrity tools.
    Comment: Many commenters requested that CMS provide technical 
assistance, subregulatory guidance, and other resources to help ensure 
MDPP supplier compliance and facilitate the enrollment process, 
particularly given that many MDPP suppliers may be enrolling in 
Medicare for the first time. One commenter specifically requested that 
documents utilize plain and directive language to facilitate 
understanding and correct implementation of the requirements. One 
commenter suggested that the MDPP expansion model create a level of 
technical assistance that occurs with other Innovation Center models, 
for example, Comprehensive Primary Care Model Plus.
    Response: We thank commenters for highlighting the need for 
guidance and other MDPP supplier support resources. We appreciate the 
feedback in how we can facilitate MDPP suppliers' understanding of 
proposed MDPP supplier standards and in doing so, better equip MDPP 
suppliers to comply with our regulations. We similarly recognize the 
need to provide resources to support MDPP suppliers' success and are in 
the process of developing materials. We will also be establishing a 
Help Desk, which we believe will provide some of the guidance 
commenters requested. We will explore additional opportunities to 
assist suppliers, and will provide notification of any materials as 
they become available either through our Web site or through our MDPP 
list serv.
    After considering the public comments received, we are finalizing 
our policy to establish MDPP supplier standards at Sec.  424.205(d), as 
proposed. Note that the specific MDPP supplier standard proposals 
outlined in the paragraphs of Sec.  424.205(d) are discussed further 
through this section of the final rule.
(1) Medicaid Terminations
    In addition to establishing standards for MDPP suppliers with 
respect to their delivery of MDPP services, we also proposed standards 
for MDPP suppliers' general eligibility to furnish services to Medicare 
beneficiaries. These standards would establish program integrity 
safeguards that would protect both Medicare beneficiaries and the 
Medicare program. We proposed that MDPP suppliers must not currently 
have their billing privileges terminated for-cause from any State 
Medicaid program or be excluded from any State Medicaid program (Sec.  
424.205(d)(2)). If a supplier's Medicaid billing privileges are 
currently terminated from or the supplier is excluded from any State 
Medicaid program, we stated that we do not believe that supplier should 
be able to furnish Medicare services. We stated that we believe that 
this is warranted given that a supplier's improper behavior in another 
federal health care program may be duplicated in Medicare. We stated 
that we believe that this requirement would mitigate the MDPP expanded 
model's susceptibility to fraud, waste, and abuse. Consistent with all 
standards in this section, any MDPP supplier who does not meet this 
requirement would be subject to a Medicare enrollment denial or 
revocation. We believe that this standard would serve to ensure 
continuity of safeguards across federal health care programs, and will 
help preserve the integrity of the Medicare program and protect 
beneficiaries by prohibiting suppliers found to be noncompliant in one 
federal health care program from enrolling in and furnishing services 
in another.

[[Page 53309]]

    We sought comments on this proposal.
    We received no comments on our proposal prohibiting that MDPP 
suppliers from being terminated for-cause or being excluded from a 
State Medicaid agency. Therefore, we are finalizing policies to prevent 
MDPP suppliers from having previous terminations or exclusions from 
State Medicaid Agencies as proposed at Sec.  424.205(d)(2).
(2) Ineligible Coaches: Individuals Prohibited From Furnishing MDPP 
Services to Medicare Beneficiaries
    At Sec.  424.205(d)(3), we proposed that the MDPP supplier must 
report coach information on its enrollment application and the MDPP 
supplier must only permit MDPP services to be furnished by individual 
coaches who meet the eligibility criteria. At Sec.  424.205(e)(1), we 
proposed that MDPP coach eligibility criteria require that a coach must 
not:
     Currently have his or her Medicare billing privileges 
revoked and whose reenrollment bar has not yet expired. We believe that 
this proposed supplier standard would protect beneficiaries from 
receiving MDPP services from individuals already prohibited from 
furnishing other Medicare services. If an individual is precluded from 
maintaining enrollment in Medicare for a non-MDPP service, we believe 
that it is prudent that they similarly not furnish MDPP services.
     Currently have his or her Medicaid billing privileges 
terminated for-cause or be excluded from any State Medicaid Agency 
(Sec.  424.205(e)(1)(ii)). We believe that this proposed supplier 
standard is warranted given that an individual's improper behavior in 
another federal health care program may be duplicated in Medicare. We 
do not believe that we should permit MDPP suppliers to allow coaches 
with current for-cause terminations or exclusions in Medicaid to 
furnish MDPP services to Medicare beneficiaries.
     Currently be excluded from any other federal health care 
program, as defined in Sec.  1001.2 of this chapter, in accordance with 
section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act. This 
includes, but is not limited to, the Office of Inspector General 
(OIG)'s List of Excluded Individuals and Entities (LEIE). We proposed 
this supplier standard for similar reasons we proposed not to permit 
coaches with revocations from Medicare or current exclusions from 
Medicaid to furnish MDPP services.
     Currently be debarred, suspended, or otherwise excluded 
from participating in any other federal procurement or non-procurement 
program or activity in accordance with the Federal Acquisition 
Streamlining Act implementing regulations and the Department of Health 
and Human Services non-procurement common rule at 45 CFR part 76. We 
note that this includes individuals who have an active status on the 
General Service Administration's System for Award Management list. We 
may also utilize the Bureau of the Fiscal Service, U.S. Department of 
the Treasury's Do Not Pay (DNP) List as a resource for determining 
which individuals fall under this category. The Improper Payments 
Elimination and Recovery Improvement Act (IPERIA) of 2012 established 
the DNP to support Federal agencies with their efforts to prevent and 
detect improper payments by aggregating various data sources for pre-
award, pre-payment eligibility verification. Data sources included in 
this list include Credit Alert System, Death Master File, LEIE, Office 
of Foreign Assets Control (OFAC), System for Award Management (SAM) 
Entity Registration Records, and SAM Exclusion Records. We believe that 
we may utilize the DNP as a method of determining whether a coach is 
excluded from participating in any other federal procurement or 
nonprocurement programs. Although coaches will not directly be 
receiving payment from us for furnishing MDPP services, we do not 
believe that payment should be made to MDPP suppliers for services 
furnished by individuals excluded from federal procurement or 
nonprocurement programs, particularly given that MDPP payments rely on 
beneficiary's achievement of performance goals that the coaches will 
document. Although the MDPP supplier is ultimately responsible for 
attesting to all claims submitted for MDPP services, we do not believe 
that it would be prudent to permit MDPP suppliers to allow coaches 
excluded from other federal procurement programs to furnish MDPP 
services.
     Have, in the previous 10 years, one of the following state 
or federal felony convictions:
    ++ Crimes against persons, such as murder, rape, assault, and other 
similar crimes for which the individual was convicted, as defined under 
42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
    ++ Financial crimes, such as extortion, embezzlement, income tax 
evasion, insurance fraud and other similar crimes for which the 
individual was convicted, as defined under Sec.  1001.2, had a guilty 
plea or adjudicated pretrial diversion.
    ++ Any felony that placed the Medicare program or its beneficiaries 
at immediate risk, such as a malpractice suit that results in the 
individual being convicted, as defined under Sec.  1001.2, having a 
guilty plea or having adjudicated pretrial diversion of criminal 
neglect or misconduct.
    ++ Any felonies that for which the individual was convicted, as 
defined under Sec.  1001.2, had a guilty plea or adjudicated pretrial 
diversion that would result in mandatory exclusion under section 
1128(a) of the Act.
    We proposed that CMS will screen each individual identified on the 
roster of coaches included with the supplier's enrollment application 
to verify that the individual coach does not meet any of these 
conditions and that the coach can provide MDPP services on behalf of an 
MDPP supplier (Sec.  424.205(e)(2)). We proposed these requirements as 
a means to ensure the integrity and safety of the Medicare program and 
the beneficiaries whom we serve. We have selected these types of felony 
convictions based on the risk we believed they could pose to the 
Medicare program and our beneficiaries. Additionally, it is consistent 
with existing criteria that we use to determine felonies that are 
detrimental to the best interest of the program and its beneficiaries 
as described in Sec.  424.535(a)(3)(ii). Although we selected these 
criteria to be consistent with how we evaluate other individuals, we 
also sought to create a more definite list such that MDPP suppliers 
would have the ability to conduct background checks on coaches prior 
to, as well as potentially after enrolling in Medicare, to avoid 
receiving an enrollment denial or revocation due to failure to meet 
this standard. Although coaches are not directly enrolled, and 
therefore, not directly receiving payment, we stated that we believe 
that it is prudent to prohibit MDPP suppliers from utilizing 
individuals convicted of certain felonies to furnish services to 
Medicare beneficiaries. Because coaches will be directly interacting 
with beneficiaries, recording their attendance and weight loss, we 
believe that a coach's trustworthiness is vital. Consequentially, we do 
not believe that such coaches should have a criminal history such as 
those described in Sec.  424.535(a)(3)(ii).
    Coaches that meet any of these criteria would be considered 
ineligible to furnish MDPP services, and therefore, could not be on an 
MDPP supplier's roster. Coaches whose information was submitted in an 
MDPP supplier's enrollment application, screened, and

[[Page 53310]]

determined as not meeting any of these criteria would be considered 
eligible coaches. Although the MDPP supplier is the entity that is 
enrolled in Medicare and submits claims, coaches furnish MDPP services, 
directly interacting with the beneficiary and documenting attendance 
and weight loss. Therefore, we stated that we believe that precluding 
individual coaches who meet any of the ineligibility criteria from 
directly furnishing MDPP services to Medicare beneficiaries would both 
help reduce fraud, waste, and abuse that could occur in the MDPP 
expanded model, as well as protect beneficiaries from harm.
    If after screening, CMS or its contractors determine that a coach 
is eligible to furnish MDPP services, the coach would be assigned an 
eligibility start date, similar to a supplier's enrollment effective 
date. We proposed to define coach eligibility start date as follows: 
The start date indicated by the MDPP supplier when submitting an 
eligible coach's information on the MDPP enrollment application (Sec.  
424.205(a)). On the enrollment application, the MDPP supplier will 
include a date indicating when the coach began furnishing MDPP 
services. Consistent with Sec.  424.205(d)(5), the MDPP supplier must 
report changes to the coach roster on its enrollment application, 
including any new coaches added, within 30 days of such a change. Thus, 
the start date associated with any new coach information must be within 
30 days of the date the MDPP supplier actually reports the change on 
its application. If the coach has not yet begun furnishing MDPP 
services, the MDPP supplier should indicate the date the supplier is 
reporting the information. Though the date reflects either when the 
coach began furnishing services or when the coach could ultimately be 
determined as eligible to begin furnishing services, after the 
enrollment application was submitted, CMS must still determine whether 
the coach is eligible (Sec.  424.205(e)(2). If we determine the coach 
to be eligible, then his or her eligibility start date would be the 
date the MDPP supplier indicated on its enrollment application. We 
described in III.K.2.d.(10)(d) of the proposed rule (82 FR 34149 
through 34152) that payment can be made for services furnished by this 
coach on or after his or her eligibility start date.
    However, if a coach was determined to be ineligible at the onset, 
the coach would have its eligibility start and end date on the same 
date, effectively never being eligible to furnish MDPP services. If the 
coach later became ineligible, he or she would be assigned an 
eligibility end date. Consistent with Sec.  414.84, payment for MDPP 
services is made only if such services are furnished by an eligible 
coach, on or after his or her coach eligibility start date and, if 
applicable, before his or her coach eligibility end date, to an MDPP 
beneficiary. This could pose a situation in which an MDPP supplier 
could submit an updated coach roster that includes a new coach, and 
allow him or her to begin furnishing services based on the belief that 
he or she is eligible. Should, after screening, CMS or its contractors 
determine that the coach is ineligible, the MDPP supplier could be 
revoked for non-compliance. Though the MDPP supplier would have an 
opportunity to submit a corrective action plan that removes the 
ineligible coach from their enrollment application, any claims for 
services furnished by the ineligible coach would be denied, and the 
MDPP supplier would not be paid for such services. For this reason, we 
encourage suppliers to report changes to the coach roster as soon as 
possible. If the MDPP supplier submits a claim that includes a coach 
NPI for a coach we have not yet determined to be an eligible coach for 
furnishing MDPP services as of the date of service, the claim will be 
rejected, and the supplier will need to refile the claim with the same 
information once CMS has made the eligibility determination. If at that 
time, CMS determined the coach to be ineligible, the claim for the 
service provided by the coach will be denied, as described in section 
III.K.2.d.iii.(10)(d) of the proposed rule (82 FR 34149 through 34152).
    We stated that we believe that the majority of the coach 
ineligibility criteria described in this section is crafted in such a 
way that the MDPP supplier could, with reasonable certainty, conduct an 
independent background check on the coach, to determine whether he or 
she meets the ineligibility criteria. If the MDPP supplier has any 
uncertainty about whether the coach meets the ineligibility criteria, 
they may wish to preclude the coach from furnishing services to 
Medicare beneficiaries until CMS determines that the coach is eligible. 
This would avoid a potential situation of a coach furnishing services 
for which the MDPP supplier could not get paid. If the MDPP supplier 
believes the coach is eligible and wishes to allow the coach to furnish 
services prior CMS determining his or her eligibility, then the MDPP 
supplier would assume the risk not receiving payment for claims for 
serviced rendered by the ineligible coach.
    If a coach no longer provides MDPP services for an MDPP supplier, 
the supplier must remove that coach from its roster and indicate the 
date of such event to designate an eligibility end date for that coach. 
If the MDPP supplier voluntarily terminates its Medicare enrollment or 
is revoked, CMS will automatically reflect the date of this action as 
the coach's eligibility end date for that MDPP supplier. We proposed to 
define coach ineligibility end date as follows, the end date indicated 
by the MDPP supplier in submitting a change to the supplier's MDPP 
enrollment application that removed the coach's information, or the 
date the supplier itself was revoked from or withdrew its Medicare 
enrollment as an MDPP supplier.
    We proposed that CMS or its contractors would determine whether 
coaches submitted on MDPP rosters satisfy the previously stated 
criteria by using the identifying information MDPP suppliers submit on 
their enrollment applications (including any changes that MDPP 
suppliers would be required to report). This information would be 
checked against internal and publicly available data sources. We 
proposed that, upon identification of evidence that a coach met any 
ineligibility criteria, we may take administrative action to deny or 
revoke the MDPP supplier's enrollment as appropriate under Sec. Sec.  
424.530(a)(1) and 424.535(a)(1) (proposed at Sec.  424.205(g)(1)(ii)). 
Consistent with existing enrollment denial and revocation actions, we 
would notify the prospective or enrolled MDPP supplier via an 
enrollment denial or revocation notification and include the specific 
reason for the administrative action. The enrollment denial or 
revocation notification detailing the findings and the reasoning for 
the determination would follow requirements under Sec.  488.18. 
Consistent with similar processes at Sec. Sec.  424.530(c) and 
424.535(e), we proposed that an MDPP supplier could respond to the 
enrollment denial or revocation by submitting a corrective action plan 
(CAP) that would include the removal of the coach from its roster 
within 30 days of receiving the enrollment denial or revocation 
notification, and therefore, come into compliance and enroll or 
maintain its enrollment status. If MDPP suppliers believe that the 
decision was made in error, they could exercise existing appeal rights 
under part 498.
    We also proposed that if we determine that an MDPP supplier has 
continued to allow an ineligible coach to furnish MDPP services after 
having submitted a CAP removing the coach from its roster to enroll or 
maintain

[[Page 53311]]

enrollment in Medicare, we would revoke the MDPP supplier without the 
opportunity for additional corrective action. This authority, outlined 
in Sec.  424.205(h)(1)(v), would allow us to revoke an MDPP supplier 
for knowingly using an ``ineligible coach'' to furnish MDPP services. 
``Knowingly,'' in this context, means that the supplier received an 
enrollment denial or revocation notice based on failing to meet 
supplier standards at Sec.  424.205(d)(3) (related to ineligible 
coaches), was provided notice by CMS or contractors working on its 
behalf of this action including the reason(s) for the administrative 
action, submitted a CAP to remove the coach, but continued to allow the 
coach to provide MDPP services in violation of the CAP. We proposed to 
define an ``ineligible coach'' in Sec.  424.205(a) as an individual 
whom CMS has screened and has determined ineligible to furnish MDPP 
services on behalf of an MDPP supplier based on the standard specified 
in Sec.  424.205(e), and we proposed in the same paragraph to define 
``eligible coach'' in Sec.  424.205(a) as an individual who CMS has 
screened and has determined can furnish MDPP services on behalf of an 
MDPP supplier based on the standard specified in Sec.  424.205(e).
    Although any individual may be eligible to become a DPP coach, 
provided that they meet requirements and trainings as dictated by the 
CDC's DPRP Standards, an individual can only become an eligible coach 
for purposes of furnishing MDPP services after having their required 
identifying information submitted on an MDPP supplier's enrollment 
application, being screened by CMS or its contractors, and as a result, 
being determined to be eligible to furnish MDPP services on behalf of 
an MDPP supplier. If CMS or its contractors deem a coach ineligible, 
this would apply only to the furnishing of MDPP services and would not 
preclude the DPP organization from continuing to allow this individual 
to furnish administrative services or DPP sessions to non-Medicare 
beneficiaries. However, serving as a coach for Medicare beneficiaries 
would be prohibited and would be subject the MDPP supplier to this 
revocation authority.
    We proposed this new revocation authority due to the novel program 
integrity risks that would be posed by MDPP suppliers who knowingly 
continue to permit ineligible coaches to furnish MDPP services to 
Medicare beneficiaries. We stated that we believe that this new basis 
for revocation is necessary because coaches are not enrolled in 
Medicare, even though they will undergo background checks by CMS or its 
contractors and must meet specified criteria. Although we considered 
using existing revocation authorities under Sec.  424.535(a)(1) 
(related to noncompliance), Sec.  424.535(a)(4) (related to false or 
misleading information), and Sec.  424.535(a)(9) (related to failure to 
report), we determined that these authorities were too general for 
purposes of specifically addressing MDPP coaches who become ineligible 
to furnish MDPP services. We proposed that this revocation authority 
would follow similar requirements under Sec.  424.535(c), (g), and (h). 
We stated that we do not believe that Sec.  424.535(e) (related to 
reversal of the revocation) should apply in this case, given that the 
MDPP supplier already had an opportunity to remove the coach from their 
roster by submitting a CAP, but continued to allow the ineligible coach 
to furnish MDPP services. The proposals that we would apply from the 
provisions of Sec.  424.535 stated in this section are as follows:
     The revocation becomes effective 30 days after CMS or the 
CMS contractor mails notice of its determination to the MDPP supplier;
     For the revocation authority, MDPP suppliers are barred 
from participating in the Medicare program from the date of the 
revocation until the end of the re-enrollment bar, which begins 30 days 
after CMS or its contractor mails notice of the revocation and lasts a 
minimum of 1 year, but not greater than 3 years, depending on the 
severity of the basis for revocation; and
     A revoked MDPP supplier must, within 60 calendar days 
after the effective date of revocation, submit all claims for items and 
services furnished before the date of the revocation letter.
    We believe that these proposals would appropriately govern this new 
revocation authority, given the consistency with existing revocation 
authorities. Given these consistencies, we stated that we do not 
believe that these proposals place an undue burden on MDPP suppliers, 
and any burden established would be warranted given the violation of 
the supplier standards that jeopardize both the integrity of the 
Medicare program and the safety of its beneficiaries.
    We invited public comments on these proposals.
    Comment: Many commenters provided general feedback related to coach 
requirements. Two commenters criticized coach-related proposals for 
differing so significantly from CDC's DPRP requirements.
    Response: We have sought to align the MDPP expanded model with 
CDC's DPRP standards in many ways, largely in regards to the set of 
services itself--the curriculum, the setting in which it is provided, 
the qualifications of those who offer it. We recognize that the goals 
of CDC requirements and our requirements overlap, but differ in certain 
respects. For example, the DPRP requirements primarily serve as quality 
assurance aimed to ensure that DPP organizations can effectively offer 
DPP to its participants. Given the focus on the efficacy, CDC requires 
submission of significant performance data beyond what is required by 
CMS, for example, participants reported minutes of physical activity. 
Where CDC's requirements for DPP organizations aims to ensure quality, 
CMS's requirements aim to protect the integrity of the Medicare program 
and the beneficiaries it serves through ensuring compliance. We rely on 
CDC requirements where appropriate for quality purposes, for example, 
we defer to CDC requirements to determine what credentialing or 
training coaches must acquire to successfully furnish DPP sessions. 
However, these requirements do not address potential program integrity 
concerns such as how to prevent a coach from harming beneficiaries or 
the Trust Funds. Thus, we have proposed the coach ineligibility 
criteria to fill this gap. In absence of any alternative approaches to 
address program integrity concerns that could harm Medicare 
beneficiaries or the program at large, we are not amending these 
proposals.
    Comment: Although one commenter acknowledged that background tests 
may take time and delay enrollments, they did not recommend that CMS 
change this policy as a result of this delay.
    Response: We acknowledge that an MDPP supplier may experience a 
delay in their enrollment should CMS determine that a coach on their 
enrollment application is ineligible, however, we believe that this 
delay would be necessary and appropriate to prevent ineligible coaches 
from furnishing services to Medicare beneficiaries.
    Comment: One commenter suggested that the proposal assigns MDPP 
suppliers responsibility to credential MDPP coaches. When the commenter 
referenced credentialing requirements, they included oversight and 
guaranteeing the quality and competency of individual coaches. Given 
the proposal that having an ineligible coach could cause a denial or 
revocation of an MDPP supplier's enrollment, this commenter highlighted 
a need for a standardized credentialing

[[Page 53312]]

process for MDPP coaches that would provide oversight to ensure the 
quality, consistent delivery and fidelity of the MDPP set of services, 
as well as to appropriate program integrity standards and requirements.
    Response: In response to the commenter's concern, we are providing 
some clarity on our proposals and some distinctions between a coach 
being eligible as compared to being credentialed, which we believe will 
address the commenter's concerns raised. The commenter suggested that 
because CMS holds the MDPP supplier accountable for knowing whether or 
not their coaches are eligible, then MDPP suppliers are effectively 
credentialing MDPP coaches. We disagree with this characterization of 
credentialing, which typically means that, based on an achievement or 
demonstration of competency, an individual is deemed qualified for a 
certain activity. We have previously determined that, consistent with 
CDC DPRP standards, coaches do not require any specific license or 
credentials that would deem them qualified to furnish DPP. We believe 
that the CDC is most appropriately suited to specify minimum training 
requirements for coaches and we do not wish to add any requirements for 
coaches to fulfill for the purposes of MDPP. Instead, our proposals 
seek the inverse. Rather than proposing additional requirements, for 
example a credential, and only allowing individuals with that 
credential to qualify as an eligible coach, we are allowing all 
individuals to be eligible to be a coach, with the exception of 
individuals with certain histories, which are detailed atSec.  
424.205(e)(1). We proposed these exceptions to protect the safety and 
integrity of the Medicare program and the beneficiaries we serve. 
Though the nuance may seem insignificant, we believe it is an important 
distinction given that requiring credentials has historically limited 
access for certain benefits, as raised by certain commenters with 
respect to requiring specific training.
    While the commenter is correct in that our proposals will hold 
suppliers accountable for having ineligible coaches on their roster, 
and thus MDPP suppliers should independently verify eligibility, we 
disagree with the commenter's view that MDPP suppliers have this 
responsibility rather than CMS. Our proposal under Sec.  424.205(e)(2) 
highlights that CMS ultimately determines coach eligibility through 
screening. Thus, while the commenter highlighted a need for a 
standardized, national credentialing body for MDPP suppliers, we view 
this as a method of quality assurance to determine an individual's 
capability to successfully meet the requirements of being a coach. As 
previously stated in a separate comment response, we rely on CDC to 
implement quality assurance related to MDPP, and they have not created 
a national credentialing system or suggested that doing so would 
improve the quality of the program. In contrast, concerns exist that 
the creation of such a system would create a barrier to entry that 
could ultimately drive down the number of available coaches. In the 
absence of the CDC identifying a need for such a system, we believe 
that CMS conducting screening for MDPP coaches to determine eligibility 
would sufficiently address program integrity concerns without creating 
a bottleneck in the supply of coaches. Though not equivalent to 
creating a national credentialing system our proposals would establish 
a standard and streamlined system to check for MDPP coach eligibility 
run by CMS, and not individual suppliers. Therefore, we will not modify 
our proposals.
    Comment: One commenter recommended that given that all coaches are 
required to have NPIs, CMS should create a new taxonomy code 
specifically for ``lifestyle change coach.'' The commenter raised 
concerns that, absent such a policy change, coaches will select a wide 
variety of taxonomies and that given that MDPP coaches do not require 
credentialing or licensure, it is possible that none of the existing 
taxonomies may apply. The commenter suggested that a single taxonomy 
with accompanying guidance to MDPP coaches could eliminate confusion in 
the NPI application process and facilitate tracking of coaches.
    Response: We thank the commenter for the thoughtful consideration 
of the most appropriate taxonomy designation for MDPP coaches who 
obtain an NPI. In the CY 2017 PFS, we previously suggested that Health 
Educator [174H00000X] may be appropriate for MDPP suppliers. Though we 
have no current plans to track MDPP coaches through the taxonomy 
associated with their NPIs at this time, we recognize the commenter's 
concern and acknowledge that a new taxonomy code specific to MDPP 
suppliers may be more appropriate than current options, and may also 
result in a more straightforward process. We will explore the 
possibility and appropriateness of this suggestion, and will provide 
updates through guidance and other MDPP supplier support materials, as 
appropriate.
    Comment: One commenter who expressed disagreement with the proposed 
coach eligibility criteria given that they did not align with CDC DPRP 
standards later went on to urge CMS to require that coaches be 
supervised by a licensed medical professionals as an alternative to 
coach eligibility requirements.
    Response: Though supervision by a licensed medical provision has 
been previously discussed and not finalized in the CY 2017 PFS final 
rule, and is therefore out of scope as a standalone requirement, using 
this as an alternative to the coach eligibility requirements differs 
slightly from our previous consideration of this policy. While we do 
not believe that CDC's DPRP standards are appropriate for program 
integrity safeguards and have thus proposed coach ineligibility 
criteria to avoid any program integrity risks, we do believe that CDC 
is more appropriately suited to determine credentialing requirements of 
the individuals furnishing the curriculum it oversees for the DPP. The 
commenter's proposal that CMS should require licensed medical 
professionals to supervise coaches does not align with CDC's DPRP 
standards, and thus, we do not believe it is necessary to add that 
requirement from a quality standpoint. Furthermore, we do not believe 
that supervision by a licensed medical professional would address all 
of the same program integrity risks that are mitigated by the coach 
eligibility criteria.
    Comment: We received a number of comments on policies previously 
discussed as a part of the CY 2017 PFS final rule. Most commonly, 
commenters urged CMS to reconsider requiring coaches have a form of 
credentialing or medical license, or that they be supervised by an 
individual with either. Two commenters urged against requiring certain 
coach training requirements that they believed were costly and could 
potentially limit the number of coaches available to furnish MDPP 
services. Additionally, we received a comments opposing that coaches 
obtain national provider identifiers (NPIs).
    Response: Each of these topics were previously discussed and final 
determinations made through the CY 2017 PFS final rule, and therefore, 
comments are out of scope of the policies proposed in this rule. More 
information on our previous discussion of these policies can be found 
in section III.J.7 of the CY 2017 PFS final rule. In response to 
commenters' concerns regarding the potential barriers of coach 
training, we clarify that MDPP does not require training beyond current 
CDC DPRP requirements. Should the commenter have additional questions 
or

[[Page 53313]]

concerns related to DPRP requirements, we encourage them to share this 
feedback with appropriate contacts at the CDC.
    After considering the public comments, we are finalizing all 
polices related to MDPP coach eligibility as proposed at paragraphs 
Sec.  424.205(d)(3), (e), and (h)(1)(v).
(3) Ensuring MDPP Suppliers Are Legitimate, Operational Organizations
    We proposed a number of requirements that would help ensure that 
MDPP suppliers are operational, have the resources necessary to furnish 
MDPP services, and are in compliance with MDPP supplier standards. At 
Sec.  424.205(d)(4), we proposed that, regardless of whether the MDPP 
supplier furnishes services solely in community settings, it must 
maintain at least one administrative location (82 FR 34163). All 
administrative locations maintained by the MDPP supplier must be on an 
appropriate site available to the public and must be reported on the 
CMS-approved enrollment application. We proposed that this 
administration location may not be a private residence. We proposed 
that an appropriate site must have signage posted on the exterior of 
the building, as well as be open for business and have employees, 
staff, or volunteers present during operational hours. For the purposes 
of this requirement, such signage may include, for example, the MDPP 
supplier's legal business name or its ``doing business as'' (DBA) name, 
as well as hours of operation. This proposal sought to utilize 
measurable objective indicators to determine that organizations are 
legitimately operating and able to furnish MDPP services to Medicare 
beneficiaries. We stated that we believe that, regardless of whether 
the MDPP supplier furnishes services at its administrative location, 
establishing a physical location is necessary for associated 
requirements for furnishing MDPP services, including recordkeeping 
requirements, training facilities, and storage for any educational 
materials distributed during sessions.
    We proposed, at Sec.  424.205(d)(6), that a MDPP supplier must 
maintain a primary business telephone number listed under the name of 
the organization in public view. Public view could signify, for 
example, that the phone number is listed on a Web site, on flyers and 
materials. This policy would require that calls must not automatically 
go to the answering machine or utilize an answering service during 
posted business hours. The purpose of this requirement is to help 
verify that the organization is a legitimate organization and not 
simply posing as an organization and seeking to bill Medicare 
fraudulently.
    We further proposed, at Sec.  424.205(d)(7), that an MDPP supplier 
must not knowingly sell to or allow another individual or entity to use 
its billing number, consistent with Sec.  424.535(a)(7). We included 
this proposal to avoid a situation in which another entity uses an 
existing MDPP supplier's billing number. We stated that we believe that 
this policy plays an important role in ensuring that payments are only 
being made to the intended recipient who has met all of the supplier 
and compliance standards and that we continue to hold entities 
responsible for maintaining compliance. Otherwise, we risk making 
payments to suppliers potentially engaging in fraudulent or potentially 
harmful behavior.
    We stated that we believe that the requirements in this section 
would not pose an undue burden on MDPP suppliers as they are minimum 
requirements for any functional, operational organization. By 
establishing these requirements, we believe that we would ensure that 
MDPP suppliers that do not meet the baseline requirements for an 
operational organization would not be permitted to furnish MDPP 
services to or receive payment for such services. We proposed, at Sec.  
424.205(d)(15), that an MDPP supplier must permit CMS or its agents to 
conduct onsite inspections to ascertain the supplier's compliance with 
these standards. Although we believe that any operational business that 
truly furnishes MDPP services would be able to meet these requirements, 
we invited public comments on any aspects of these standards.
    The following is a summary of the public comments received on our 
proposals for requirements that would help ensure that MDPP suppliers 
are operational, have the resources necessary to furnish MDPP services, 
and are in compliance with MDPP supplier standards and our responses:
    Comment: Many commenters provided helpful feedback on the 
applicability, or in some cases, the inability to apply these proposals 
in certain scenarios. Many commenters expressed concern with the 
requirement that MDPP suppliers have signage on the exterior of the 
building. Specially, commenters noted that many organizations lack the 
ability to post such signage, for example those in historical 
buildings, those in large, multi-story office buildings, as well as 
those leasing space who are not permitted to affix signage. One 
commenter suggested that as alternative to requiring signage, having 
the supplier's name listed in the building directory, if available, 
should suffice as an alternative method to meet this policy goal. The 
same commenter went on to suggest that CMS should leave advertisement 
decisions for the suppliers to implement rather than stipulate 
requirements, and that CMS should not impose such stringent 
requirements under the guise of preventing fraud, waste, and abuse. As 
an alternative, the supplier suggested that CMS conduct random audit 
and site visits to determine operational status.
    Response: We appreciate the commenters' feedback about the 
challenges a signage requirement may pose on MDPP suppliers who are 
operational, but who lack the ability to affix signage on the exterior 
of the administrative location where they primarily operate. It was not 
our intention to impose a new requirement on MDPP suppliers or to 
require signage as a specified form of advertising. Rather, we intended 
this proposal to indicate to MDPP suppliers what criteria they would be 
checked against and be held accountable for during a site visit that is 
aimed at determining operational status. Given that MDPP suppliers 
enroll upon high categorical risk, a site visit is required as a 
prerequisite to enrollment. This site visit seeks to ensure both the 
veracity of what is reported on the applicant's enrollment form and to 
verify that the organization is operational.
    Based on commenters' feedback, we understand that the proposed 
policy would not serve its intended goal, and therefore, we will amend 
the proposal to allow multiple methods that an MDPP supplier could use 
to demonstrate its association with a specific location. We believe 
that by restructuring the MDPP supplier requirement to require that 
MDPP suppliers have signage posted on the exterior of the building or 
suite, in a building directory, or on materials located inside of the 
building provides sufficient flexibility such that any MDPP supplier 
who truly is operational would not need to change their current 
operations in order to meet this supplier standard.
    Comment: One commenter disagreed with the proposal that MDPP 
suppliers must have employees, staff, or volunteers present during 
operational hours. This commenter did not support this proposal based 
on inconsistency with previous DPP requirements under the CDC and with 
how many in-person community programs operationalize their programs. 
One commenter indicated that current DPP organizations

[[Page 53314]]

do not operationalize their in-person programs in a way where 
employees, staff, or volunteers were present at an administrative 
location during operational hours.
    Response: We do not agree with the commenter that functioning DPP 
organizations could not meet this requirement. We appreciate the 
commenter for expressing these concerns and notifying CMS that not all 
MDPP suppliers operate their business with individuals present during 
stated operational hours. The commenter did not describe where 
employees, staff, or volunteers of the MDPP supplier operated during 
operational hours, if not at the administrative location itself; 
therefore, we have limited information to better understand how to 
structure this requirement in way that could determine whether or not a 
prospective MDPP supplier applicant truly operated its business without 
requiring current DPP organizations to change their business 
operations. Though we can conceive of scenarios in which an MDPP 
supplier has stated operational hours, but furnishes an MDPP session at 
a community location, and therefore, may not be present at the 
administrative location during stated operational hours, we do not 
believe that removing this requirement altogether would be appropriate. 
Furthermore, we clarify that we are not imposing specific operational 
requirements on the MDPP supplier. Thus, each MDPP supplier can 
determine and disclose its operational hours when it plans to 
physically be at the administrative location. An MDPP supplier who 
operates many services outside of their administrative location can 
also disclose when its operational hours are either telephonic or in a 
location other than its administrative location. We also highlight the 
significant flexibility we are providing in this supplier standard in 
that employees, staff or volunteers can fulfill this requirement, and 
we take no position as to whether these individuals serve as MDPP 
coaches or in another function for the supplier. The intent of this 
proposal was to ensure that an MDPP supplier maintains operational 
hours and truly fulfills these hours. We do not agree with the 
commenter that functioning DPP organizations could not meet this 
requirement, thus, we will finalize this policy as proposed.
    Comment: A number of commenters disagreed with the requirement that 
MDPP suppliers maintain a primary business telephone that operates 
either at an administrative location or directly where services are 
furnished. In particular, commenters did not agree with the discussion 
in the preamble of the proposed rule which indicated that the proposed 
requirement would not allow calls to automatically go to the answering 
machine or the utilization of an answering service during posted 
business hours. Many commenters highlighted that it is an unrealistic 
expectation to never allow a call to go to some form of message system, 
even during business hours. Though multiple commenters expressed 
practical concerns with this requirement, one commenter went as far as 
to suggest that this proposal could potentially dissuade prospective 
MDPP supplier applicants from their decision to enroll. This commenter 
recommended establishing a call back standard, for example, that MDPP 
suppliers must return calls within 1 business day.
    Response: We agree with commenters that a requirement that every 
phone call be answered during operational hours would be burdensome, 
unrealistic, and extend far beyond the intention behind the proposal. 
We want to clarify that the proposal at Sec.  424.205(d)(6) only 
requires that MDPP suppliers have a telephone that operates at an 
administrative location or the location where MDPP services are being 
furnished, and that the associated telephone number must be listed with 
either the legal or doing business as name of the supplier in public 
view, including on Web sites, flyers, and materials. However, we 
understand why commenters expressed concern that we were also requiring 
that phone calls to this number be answered and not automatically go to 
a machine based on language in the preamble that provided rationale for 
our proposal.
    To clarify, when we noted that the proposal at Sec.  424.205(d)(6), 
would require that calls must not automatically go to the answering 
machine or utilize an answering service during posted business hours, 
we did not intend to add this as a standalone requirement. This 
sentence was intended to convey that by requiring MDPP suppliers to 
maintain a primary business telephone that operates either at 
administrative locations or directly where services are furnished, MDPP 
suppliers could not, by default use an answering machine or answering 
service as their primary contact number. We did not mean to suggest 
that MDPP suppliers may never use an answering machine. Thus, while we 
expect that MDPP suppliers may allow phone calls to go to an answering 
machine or service during operational hours, we believe the standard as 
proposed at Sec.  424.205(d)(6) will achieve the intended goal of 
providing a mechanism to ensure that MDPP suppliers are operational. We 
believe that this clarification addresses concerns raised by 
commenters, and we thus will finalize the policy as proposed.
    After considering the public comments, we are finalizing the policy 
requiring MDPP suppliers to have at least one administrative location 
at an appropriate site, as proposed at Sec.  424.205(d)(4); however, we 
are modifying Sec.  424.205(d)(4)(i) to allow for increased flexibility 
for signage requirements. After clarifying commenters' confusion about 
telephone requirements, we are finalizing policies as proposed at Sec.  
424.205(d)(6). We received no comments on the proposal that MDPP 
suppliers may not knowingly sell to or allow another individual or 
entity to use its supplier billing number, and thus are finalizing as 
proposed at Sec.  424.205(d)(7).
(4) Beneficiary Access
    We proposed, at Sec.  424.205(d)(8), that MDPP suppliers may not 
deny access to MDPP services to eligible beneficiaries based on any 
reason other than the supplier's own self-determined and published 
capacity limits to furnish MDPP services to additional people and, on a 
discretionary basis, if a beneficiary significantly disrupts the 
session for other participants or becomes abusive (82 FR 34163 through 
34164). Given that we do not yet currently have data on optimal class 
size for MDPP services, we are currently allowing MDPP suppliers to 
self-determine any upper limitation on class size. Should they 
establish such a limit and intend to turn beneficiaries away once the 
capacity limit is reached, the MDPP supplier must have previously made 
this limit publicly available; for example, denoting the limit in any 
brochures, Web sites, or other materials that outline their MDPP 
services. We proposed that MDPP suppliers must maintain a record of the 
number of eligible Medicare beneficiaries turned away for each of these 
reasons, as well as the date the beneficiary was informed. We further 
proposed that if an MDPP supplier denies a Medicare beneficiary access 
citing disruptive or abusive behavior, details of the occurrence(s), 
including date(s) of the behavior, any remediation efforts taken by the 
supplier, and final action (for example, dismissal from an MDPP session 
or denial from future sessions) must be documented in the beneficiary's 
MDPP records and adhere to documentation requirements outlined in Sec.  
424.205(g). We note that one supplier's decision to dismiss a 
beneficiary for this purpose would not prevent that beneficiary from 
switching to another MDPP supplier.

[[Page 53315]]

    We stated that we will seek to monitor compliance with this 
requirement, and investigate further if necessary, based on beneficiary 
complaints, rates of access denials citing capacity limits in 
comparison to estimated capacity based on claims submitted, as well as 
monitoring claims for success rates for achieving performance goals 
that are higher than what would be expected for a typical Medicare 
population. Illustrative examples of capacity limits could include that 
the MDPP supplier has met its self-determined and published class size 
maximum, or that the supplier is providing MDPP sessions in cohorts and 
does not have a new or upcoming cohort at the time the beneficiary is 
seeking MDPP services. Furnishing MDPP services in a cohort means that 
the DPP curriculum is delivered among a single group, or cohort, from 
start to finish with sessions furnished in a specific order, and not 
allowing any new individuals to join once the cohort has begun.
    Given that our payment structure for MDPP services relies on the 
achievement of weight loss and attendance goals, there may be 
incentives for MDPP suppliers to seek to serve only those beneficiaries 
for which they are more likely to earn performance payments. This, in 
turn, could result in discriminatory treatment of beneficiaries. 
Through this supplier standard, we would expressly prohibit MDPP 
suppliers from conditioning access to MDPP services on the basis of a 
beneficiary's weight or health status (except as provided in our 
regulations). We also would prohibit MDPP suppliers from conditioning 
access to MDPP services on the basis of a beneficiary's achievement of 
performance goals, except where the beneficiary becomes ineligible for 
additional sessions as a result of not meeting those goals, as 
discussed elsewhere in this final rule. We stated that we believe that 
it is appropriate to prohibit suppliers from denying access to MDPP 
services except in certain limited circumstances. If a supplier were to 
deny access to a beneficiary citing lack of capacity, but then furnish 
MDPP services to a different beneficiary, this may signal a violation 
of such standards. In addition, and for the same reasons, we proposed 
to prohibit MDPP suppliers, including any coaches or entities 
performing functions or furnishing services related to MDPP services on 
their behalf, from unduly coercing a beneficiary's decision to change 
or not change to a different or specific MDPP supplier, including 
through the use of pressure, intimidation, or bribery in Sec.  
424.205(d)(9). Information that may result in a beneficiary changing to 
a different MDPP supplier provided in response to a beneficiary's 
request for information would not violate this provision.
    The CY 2017 PFS final rule, at Sec.  424.79, established the set of 
services included in the expanded model, but did not stipulate that 
once a supplier began furnishing such services to a beneficiary, that 
it must continue to offer them to the beneficiary as a part of the MDPP 
expanded model. We proposed, at Sec.  424.205(d)(10), that MDPP 
suppliers must offer and provide beneficiary access to the entire set 
of MDPP services for which beneficiaries are eligible. This includes 
the requirement that suppliers offer at least 16 in-person core 
sessions, no more frequently than once per week, over the first 6 
months of the core services period and offer at least 6 core 
maintenance sessions, at least once per month, over months 7 through 12 
of the core services period (Sec.  410.79(c)(2)(i)). For beneficiaries 
to whom the supplier has begun furnishing MDPP services, and who meet 
the eligibility requirements for ongoing maintenance sessions described 
in Sec.  410.79(c)(1)(ii) and (iii), MDPP suppliers are required to 
offer 24 ongoing maintenance sessions, furnished at least once per 
month over the course of months 13 through 36 of the MDPP services 
period, in 3-month consecutive increments. These requirements would 
also apply to any MDPP supplier which begins furnishing MDPP services 
to a beneficiary that had begun the MDPP services period with a 
different MDPP supplier. Should this MDPP supplier begin furnishing 
services to a beneficiary at any point during the 3-year MDPP services 
period, it must continue to offer the services for which the 
beneficiary is eligible but has not yet received. For example, if a 
beneficiary changed suppliers after the core sessions in month 6, the 
subsequent supplier would be required to offer core maintenance 
sessions for months 7 through 12, and ongoing maintenance sessions 
should the beneficiary remain eligible for these services.
    We also solicited public comments on a potential future policy to 
require a specific class size limit for MDPP sessions. Although we 
acknowledge that MDPP services may be successfully furnished in group 
settings, we stated that we believe that it is important to ensure that 
the group's size is appropriately set such that each beneficiary gains 
the necessary interaction with the coach furnishing the session to 
properly learn the curriculum. We considered different mechanisms to 
ensure this program objective, and requested public comments on 
considerations to date. The mechanism that currently seems most viable 
would require a limitation on the number of total attendees in a given 
session taught by an individual coach. Based on CDC's experience with 
the DPP program and review of the literature on appropriate class sizes 
for educational settings, we considered including a class size 
limitation of 30 participants per coach in a given session (including 
Medicare beneficiaries). Given that limited data currently exist on 
this type of requirement among DPP sessions, we solicited public 
comments on what an appropriate class size limitation would be, 
including any evidence to support such a proposal.
    Furthermore, we solicited public comments on how MDPP suppliers who 
furnish sessions in no specific sequential order and allow drop ins 
would balance the requirement of providing beneficiary access with a 
class size requirement for a given session. For example, if a supplier 
offers classes multiple times a week and gives beneficiaries 
flexibility regarding when to participate, we questioned whether a 
certain class size limitation could force a supplier to turn away a 
beneficiary seeking to attend a session at a time when attendance is 
high, and in so doing potentially discourage attendance at MDPP 
classes. In addition, we are unsure of any implications that would 
result from establishing a class size restriction for MDPP services 
while acknowledging that MDPP beneficiaries may participate in DPP 
sessions with non-Medicare beneficiaries who may not face the same 
class size limitation. Given these considerations, we solicited public 
comments on how we could structure a proposal in the future that would 
achieve the programmatic goals of effectively furnishing the DPP 
curriculum to Medicare beneficiaries in a manner and setting that 
contributes to positive behavioral changes and ultimately less 
progression to type 2 diabetes. In providing comments on this approach, 
we encouraged the submission of data and evidence to justify what 
specific class size would be appropriate for MDPP suppliers.
    The following provides a summary of and our response to the public 
comments received on our proposals to prohibit MDPP suppliers from 
denying access to MDPP beneficiaries with limited exceptions, to 
require that MDPP suppliers document when they deny a beneficiary 
access under two of these exceptions, and to prohibit MDPP suppliers or 
individuals working on its

[[Page 53316]]

behalf from unduly coercing a beneficiary's decision to or not to 
switch to a different MDPP supplier.
    Comment: One commenter supported that CMS did not define the 
capacity limit for MDPP suppliers. The commenter agreed that MDPP 
suppliers should have the flexibility to determine the optimal class 
size to effectively deliver MDPP services.
    Response: In the absence of data to support a specific class size, 
we agree with the commenter that providing MDPP suppliers' flexibility 
to determine capacity limits, such as a supplier's capacity to 
accommodate or effectively serve a given number of participants per 
cohort, which is appropriate for its method of delivery is the correct 
policy decision at this time. We believe that most MDPP suppliers, in 
absence of a specified limit, will identify a reasonable size class 
size that enables a sufficient level of beneficiary engagement that 
results in sustained attendance and weight loss.
    Comment: MedPAC, however, contended that the proposal should have 
specified a class size. Their concerns on class size compounded with 
other concerns, including but not limited to not requiring eligible 
individuals to receive referrals from physicians or non-physician 
practitioners for MDPP services. To illustrate their concerns, they 
presented a specific scenario of a coach furnishing a large MDPP 
session in a nursing home without consideration of the clinical 
inappropriateness of MDPP services and the targeted weight loss for 
each individual in attendance.
    Response: Though we acknowledge MedPAC's concerns that allowing 
class size flexibility would allow MDPP suppliers to furnish services 
in large class sizes, we do not wish to impose a specific class size 
limitation without data to support such a decision. Further, we do not 
agree that our policy decisions could result in the scenario MedPAC 
illustrated in their comment. We discuss a response to their concerns 
about referrals in section III.K.2.c of this final rule.
    Furthermore, we believe that even in absence of a specific policy 
imposed by CMS, MDPP suppliers have incentives to furnish MDPP in 
smaller class sizes that are more conducive to engaging beneficiaries 
in behavioral change practices that will lead to weight loss and 
lowered diabetes risk. We believe that the payment structure rewards 
MDPP suppliers when MDPP beneficiaries meet weight loss goals. Thus, 
high levels of beneficiary engagement are to the benefit of both MDPP 
suppliers and beneficiaries, in order to achieve this weight loss. 
Based on experience with performance in the DPP indicating that 
beneficiary engagement plays a critical role with sustained attendance 
and weight loss, we believe that MDPP suppliers have greater incentives 
to furnish sessions in smaller settings with high levels of engagement 
than to furnish sessions with a high volume of participants, but low 
levels of engagement.
    In addition to the importance of both sustained attendance and 
weight loss for MDPP payment, it also plays a significant role in 
maintaining CDC recognition. If suppliers conduct large sessions, 
beneficiary engagement is likely to be lower. Stakeholders have 
suggested that this may result in decreased attendance and/or failure 
to lose weight. If a supplier is furnishing MDPP services in extremely 
large classes where a large proportion of participants either do not 
attend or lose 5 percent of their body weight, this will negatively 
impact DPRP performance data that are necessary to maintaining 
recognition status. Should a supplier lose its recognition status, it 
will no longer be eligible for enrollment in Medicare.
    Taken together, we believe that MDPP suppliers have larger 
incentives--both financial for MDPP reimbursement and sustainability of 
recognition status based on DPRP performance requirements--to furnish 
small sessions rather than large sessions. If some suppliers initially 
offer larger classes, we believe that lower per beneficiary 
reimbursement and threat of lost CDC recognition will motivate 
suppliers to self-correct. Regardless of this belief, we will monitor 
for activities that would indicate if an MDPP supplier is furnishing 
services in an overly large group. As a result of this monitoring and/
or if we receive evidence to support an appropriate class size 
limitation, we may reconsider imposing a class size limit at a later 
date.
    Comment: A number of other commenters responded to the request for 
information on suggested class sizes. In making their recommendations, 
many commenters noted that beneficiaries require a fairly high level of 
engagement in order to successfully adopt behavior changes that 
ultimately result in weight loss and decreased risk of type 2 diabetes. 
Two commenters recommended a maximum class size of 15, another 
recommended 20, another a minimum of 5 and maximum of 25, and a final 
with 30. One commenter recommended that the beneficiary to coach ratio 
not exceed 1:12-14, though they did not respond to the other challenges 
we outlined with imposing such a ratio.
    Response: We thank the comments for providing this level of detail 
on their suggested class size and will consider these responses in the 
future should we decide to reconsider this proposal.
    Comment: One commenter with experience offering the National DPP 
requested an additional exception that would allow MDPP suppliers to 
deny beneficiaries from joining an existing MDPP cohort that had 
already met three or four times. The commenter indicated that their 
experience providing the National DPP showed that the initial classes 
work to establish a group dynamic, and adding an individual to a 
recently established group can disrupt that dynamic.
    Response: We understand the commenter to be requesting the addition 
of another exemption under Sec.  424.205(d)(8), which prohibits MDPP 
suppliers from denying an MDPP beneficiary access to MDPP services 
during the MDPP services period. We decline to adopt the commenter's 
recommendation as we stated in the proposal that this would constitute 
a capacity limit: ``Illustrative examples of capacity limits could 
include that the MDPP supplier has met its self-determined and 
published class size maximum, or that the supplier is providing MDPP 
sessions in cohorts and does not have a new or upcoming cohort at the 
time the beneficiary is seeking MDPP services.''
    Though we specifically utilized the word capacity in order to 
capture the diversity of MDPP delivery styles, we understand that by 
framing this requirement as ``lacking capacity'' may have signified 
that a maximum number of participants had been reached, though in the 
scenario raised by the commenter, an MDPP supplier may consider 
furnishing MDPP services through cohorts, and once they have commenced, 
the capacity can be considered reached for additional MDPP 
beneficiaries. To more appropriately capture the above listed examples 
of capacity, we will modify the proposal such that an MDPP supplier may 
deny access to a beneficiary if the MDPP supplier lacks the self-
determined and publicly-posted capacity. Though we discussed the need 
to publicly post the capacity in our proposal, we would like to 
emphasize this point by including it in our regulation. Additionally, 
we are changing the language from ``an additional'' beneficiary to ``a 
given beneficiary'' in the circumstance where an MDPP supplier 
establishes a minimum capacity to which to furnish services to 
beneficiaries, given that

[[Page 53317]]

MDPP services are offered in group setting and some MDPP supplier may 
determine that an optimal capacity for engagement includes both a 
minimum and maximum number of participants. Other forms of capacity 
requirements are discussed further in this section in response to other 
commenters. We would like to clarify that, denying an MDPP beneficiary 
access to a specific MDPP session due to capacity reasons, even if the 
MDPP supplier offered the beneficiary access to a different session at 
a later date would constitute a denial of MDPP services under Sec.  
424.205(d)(8)(i)(B) until that beneficiary ultimately received MDPP 
services from the supplier.
    Comment: One commenter requested that CMS allow integrated systems 
that develop and provide approved MDPP services to serve only their own 
enrollees.
    Response: While the commenter did not point to a specific proposal 
that would prohibit an integrated system from serving only its own 
enrollees, we believe that the commenter is referencing the prohibition 
on denying beneficiaries access to MDPP services under Sec.  
424.205(d)(8). Additionally, as the commenter specifically addresses 
``enrollees'' we believe the commenter is contemplating Medicare 
Advantage enrollees in an MA plan who receive services and are provided 
coverage for those services within an integrated system. Under Sec.  
424.205(d)(8), an MDPP supplier must not deny an MDPP beneficiary 
access to MDPP services during the MDPP services period described in 
Sec.  410.79(c)(2) of this chapter, including on the basis of the 
beneficiary's weight, health status, or achievement of performance 
goals, unless the denial falls under one of three exemptions listed at 
Sec.  424.205(d)(8)(i)(A)-(C). In the commenter's example, denying 
access to MDPP beneficiaries other than the MDPP supplier's own 
enrollees would clearly violate the prohibition established in Sec.  
424.205(d)(8), as the MDPP supplier is affirmatively denying access to 
MDPP services for all non-enrollees. Therefore, to be permissible, the 
MDPP supplier's denial of non-enrollees must qualify as an exception 
under Sec.  424.205(d)(8)(i).
    The exceptions found at Sec.  424.205(d)(8)(i)(A) (beneficiary no 
longer meets eligibility criteria for MDPP services) and Sec.  
424.205(d)(8)(i)(C) (MDPP beneficiary significantly disrupts the 
session for other MDPP beneficiaries or becomes abusive) would not 
apply to the example provided by the commenter. However, Sec.  
424.205(d)(8)(i)(B) warrants further discussion. Under this provision, 
an MDPP supplier may deny an MDPP beneficiary access to MDPP services 
where the MDPP supplier lacks the self-determined and publicly-posted 
capacity to furnish MDPP services to a given MDPP beneficiary. A 
supplier's ``capacity'' to furnish MDPP services encompasses several 
categories of capabilities that ultimately impact a supplier's capacity 
to furnish MDPP services to a MDPP beneficiary. For instance, a 
supplier could lack capacity to furnish MDPP services to a given MDPP 
beneficiary where the MDPP supplier lacks adequate physical space to 
accommodate the MDPP beneficiary if the MDPP supplier determines that 
its enrollment is at capacity for the space. Additionally, a supplier 
could lack capacity to furnish MDPP services to a given MDPP 
beneficiary where there are a finite number of coaches to hire to 
provide MDPP services, which in turn would reasonably limit the number 
of MDPP cohorts or classes that the MDPP supplier could provide as well 
as the number of MDPP beneficiaries that the MDPP supplier could 
accommodate.
    Furthermore, an MDPP supplier could lack capacity to furnish MDPP 
services to a MDPP beneficiary where the MDPP supplier lacks business 
processes that would be required to furnish services to a MDPP 
beneficiary. In such a case, the MDPP supplier would need to determine 
that the burden of implementing the necessary business process rises to 
the level of a capacity limitation within the meaning of Sec.  
424.205(d)(8)(i)(B). It is this type of capacity that we believe to be 
at issue in the example provided by the commenter as where an MA plan 
that is part of an integrated system furnishes MDPP services to MA plan 
enrollees in the role of an MDPP supplier, the MA plan may lack a 
number of business processes that would be required to furnish MDPP 
services to non-enrollees and bill Original Medicare on a fee-for-
service basis for those services.
    Some of these required business processes could not reasonably be 
determined to rise to the level of a capacity limitation, such as the 
need for the MDPP supplier to develop processes to request and receive 
medical information from non-enrollees to determine eligibility for 
MDPP services. As an integrated system that is both payer and provider, 
the MDPP supplier would not need such processes as it would be able to 
pull lab values or recorded weights to determine eligibility for MDPP 
services from the enrollee's own health records kept by the system. 
Yet, such processes would be in place for the MA plan of which the MDPP 
supplier is apart given that the plan would commonly need to request 
and accept medical information on new enrollees. So, while this is an 
example of a business process that the MDPP supplier would be required 
to develop to serve non-enrollees, it likely does not rise to the level 
of a capacity limitation if it is a business process that the MA plan 
as a whole already has in place for the MDPP supplier to adopt as well.
    However, the need for other business processes could reasonably be 
determined to rise to the level of a capacity limitation. For instance, 
MA plans do not bill Original Medicare on a fee-for-service basis for 
services provided to enrollees, and therefore lack the capacity to 
perform an operational requirement that would be necessary if the MA 
plan, as part of an integrated system, were to furnish MDPP services to 
non-enrollees under their MDPP supplier role. Given the administrative 
burdens associated with implementing the business processes required to 
bill fee-for-service Medicare, an MDPP supplier in this instance would 
be reasonable in determining that the complete lack of such a business 
process would rise to the level of a capacity limitation. As we believe 
that commenter's example is permitted under an existing exception to 
Sec.  424.205(d)(8), we decline to adopt commenter's recommendation to 
articulate an additional, specific exception for an MDPP supplier that 
is part of an MA plan operating within an integrated system that wishes 
to exclusively provide MDPP services to its enrollees. However, we may 
continue to evaluate this issue for future rulemaking, as appropriate.
    Comment: One commenter expressed concern regarding the exception 
that MDPP suppliers may deny access to MDPP services if a beneficiary 
is disruptive or abusive. The commenter questioned whether allowing 
MDPP suppliers to deny access based on behavioral issues would 
disproportionately affect individuals with serious mental illnesses 
(SMI) who may be more likely to be disruptive based on their SMI. Given 
that certain classes of medications used to treat SMI are known to 
increase the risk of both obesity and diabetes, individuals with SMI 
who would likely benefit from diabetes risk prevention may be more 
likely to be denied access based on this exception to the supplier 
standard. While the commenter did not explicitly suggest removing this 
exception, but instead, highlighted a potential issue with only 
offering in-person sessions delivered in a group to individuals with 
SMI, the commenter suggested that a

[[Page 53318]]

virtual model may more appropriately suit the needs of individuals with 
SMI.
    Response: We recognize the concerns raised by the commenter 
regarding the potential unintended consequences of such a proposal. In 
proposing the exemption to allow suppliers to deny access to an MDPP 
beneficiary who significantly disrupts a session for other 
beneficiaries or becomes abusive, we in no way intended to discriminate 
against individuals who, because of a condition, medication, or illness 
may be more prone to disruptive or abusive behavior. In the context of 
MDPP, disruptive behavior would entail preventing the information from 
being appropriately conveyed from the coach to other participants. 
Examples may include repeated interruptions unrelated to the session 
content, playing music or video content unrelated to MDPP during a 
session, or raising discussions on topics unrelated to MDPP or its 
content. Should the beneficiary's communications relate to the MDPP 
content (for example, a beneficiary asking many clarifying questions 
about the material), this would not qualify as disruptive behavior in 
an MDPP group session. Abusive behavior would entail behavior that 
results in physical, emotional, or psychological harm to those 
participating in the MDPP session, include an MDPP coach, beneficiary, 
or other MDPP personnel. For example, any violent behavior or bullying 
could constitute abusive behavior in this context. Given that MDPP is 
furnished in group settings where one beneficiary's action can affect 
others, we believe that allowing MDPP suppliers to remove beneficiaries 
who engage in these behaviors is particularly appropriate.
    Though we do not wish to subject other Medicare beneficiaries to 
disruptive or abusive behaviors, we agree with the commenter that 
individuals with those behaviors, either as a result of SMI or 
otherwise, who are eligible for MDPP services generally should have 
access to such services. MDPP sessions are furnished by coaches who do 
not have medical training beyond what the DPRP requires. Should an 
individual with SMI become abusive, it does not seem appropriate to 
require that the supplier continue to furnish services to that 
beneficiary. In such a scenario, the beneficiary may be better suited 
to be under the care of a professional with specific training to 
appropriately work with beneficiaries with SMI. Furthermore, given that 
MDPP coaches furnish sessions in a group setting, we must also consider 
the needs of all participating beneficiaries. With these considerations 
in mind, we believe that our original proposal is appropriate.
    Comment: We received one comment on our proposal to require 
documentation when a beneficiary is denied for any reason other than 
losing eligibility. This commenter disagreed with this proposal, citing 
that it creates yet another administrative requirement and burden on 
MDPP suppliers.
    Response: While we recognize that this requires additional 
recordkeeping by suppliers, we believe that it serves an important 
purpose to dissuade MDPP suppliers from denying access based on any 
reasons other than those allowed. With such a requirement, CMS would be 
able to review MDPP suppliers' records related to denial of access to 
beneficiaries to ensure compliance. Given the performance-based nature 
of the MDPP payment, we believe some MDPP suppliers may wish to attract 
beneficiaries they perceive as more likely to achieve attendance and 
weight loss performance goals and may wish to deny those who they 
perceive as being less likely. We do not want to encourage cherry 
picking among suppliers where such behaviors occur, and thus are not 
altering our proposal.
    Furthermore, we would like to take this opportunity to clarify our 
proposal. Under Sec.  424.205(d)(8)(ii), an MDPP supplier must maintain 
a record of the number of MDPP beneficiaries for whom it declined 
access for the reasons outlined in Sec.  424.205(d)(8)(i)(B) and (C), 
to include the date each such beneficiary was declined access. If a 
beneficiary is denied under Sec.  424.305(d)(8)(i)(B), stating in the 
record ``self-determined capacity'' alone as the reason the beneficiary 
was denied would not sufficiently address the documentation 
requirements. As stated in the proposal, we intended this documentation 
to provide insight into the specific capacity reasons a beneficiary was 
denied to ensure that it aligned with the MDPP supplier's previously 
published capacity limits.
    Comment: We did not receive any comments on proposals at Sec.  
424.205(9) which prevented an undue coercion of an MDPP beneficiary's 
decision to change or not to change to a different MDPP supplier. We 
similarly received no comments on the proposal at Sec.  424.205(10) 
requiring that the MDPP supplier furnish all services for which an MDPP 
beneficiary is eligible.
    Response: Given no feedback on these proposals, we are finalizing 
as proposed.
    After considering the public comments, we are finalizing the 
policies as proposed under Sec.  424.205(d)(8) as proposed except to 
modify Sec.  424.205(d)(8)(i)(B) to state the MDPP supplier lacks the 
self-determined and publicly-posted capacity to furnish MDPP services 
to a given MDPP beneficiary. Given no feedback from commenters, are 
finalizing Sec.  424.205(d)(9) and Sec.  424.205(d)(10) as proposed, 
with a modification to Sec.  424.205(d)(10) to align with changes in 
proposals at Sec.  410.79(c)(2) where ongoing maintenance sessions are 
only available for eligible beneficiaries for one year, rather than the 
proposed two.
(5) Disclosure
    We proposed, at Sec.  424.205(d)(11), that MDPP suppliers must 
provide information about the MDPP expanded model to each beneficiary 
to whom it wishes to begin furnishing MDPP services (82 FR 34164 
through 34165). This included detailed information on coverage for the 
set of MDPP services, the once-per-lifetime limit, on eligibility 
requirements, and the MDPP supplier standards. We recognized that many 
aspects of the MDPP expanded model are novel for both beneficiaries and 
suppliers, and we desire that both parties are well informed. 
Therefore, we stated that we believe that requiring the supplier to 
fully disclose information about the MDPP expanded model, coverage, and 
the MDPP supplier standards will help inform all parties. We intend to 
provide a specific template for the MDPP supplier to use to disclose 
this information to the beneficiaries. For this reason, we stated that 
we do not believe that requiring this type of disclosure places a 
significant burden on the supplier. Although we believed that this 
approach will help to address the policy goals of the MDPP expanded 
model, we invited public comments on this approach, particularly upon 
the provision of a standard CMS disclosure notification as compared to 
CMS providing MDPP suppliers with information they could use to their 
own disclosure notification materials. Along these lines, we highlight 
that we also intend to publish information on the MDPP expanded model 
in the 2019 Medicare & You Handbook.
    We invited public comments on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: We received one comment regarding our supplier standard 
requiring MDPP suppliers to disclose information to beneficiaries about 
the program. The commenter expressed full agreement with our proposal, 
and endorsed the potential CMS-created template to ensure consistency 
of messaging. In particular, this

[[Page 53319]]

commenter requested that any such information be provided during the 
2018 enrollment period. Additionally, the commenter suggested that MDPP 
model information be included in the 2019 Medicare & You Handbook.
    Response: We appreciate the support for our proposed policy and 
thank the commenter for expressing specific suggestions regarding how 
CMS can best equip suppliers to comply with this comment in a manner 
that is consistent across all MDPP suppliers. We will consider these 
suggestions as we create any resources to MDPP suppliers, and will 
release information through guidance as appropriate.
    We are clarifying in this final rule that the disclosure 
requirements we proposed at Sec.  424.205(d)(11) specified that, before 
the initial core session is furnished, the MDPP supplier must disclose 
detailed information about the set of MDPP services to each MDPP 
beneficiary to whom it wishes to begin furnishing MDPP services. At 
Sec.  424.205(d)(11)(i) and (d)(11)(ii), this requirement then goes on 
to specify that this disclosure must include eligibility requirements 
as outlined under Sec.  410.79(c)(1) and the MDPP supplier standards 
overall. In our proposal, we intended that detailed information about 
the set of MDPP services included which services, at minimum, were 
covered in the MDPP set of services. Given that the supplier standard 
proposed and finalized at Sec.  424.205(d)(10) outlines these services, 
and MDPP suppliers must disclose their standards to beneficiaries, we 
believe that under our ordinary proposal, MDPP suppliers have provide 
MDPP coverage information to beneficiaries. However, to avoid any 
potential uncertainly, we are amending our proposed supplier standard 
to explicitly require that the MDPP supplier disclose MDPP coverage 
information, in addition to information on eligibility and MDPP 
supplier requirements. Though we believe that this requirement was 
already implicit in the proposal, we believe that clarifying this point 
to more overtly stipulate that MDPP suppliers disclose coverage 
information will only help MDPP suppliers understand and comply with 
the disclosure requirements. Furthermore, we believe that providing 
this clarity to ensure that all suppliers are disclosing MDPP coverage 
information to beneficiaries aligns with the request that CMS make 
efforts to standardize practices across suppliers. Given the discussion 
on MDPP suppliers' ability to furnish more than the minimum required 
sessions during the core services period, but their inability to charge 
beneficiaries as discussed further in section III.K.2.d.iii.(10)(c) of 
this rule, we believe that this adjustment to our proposal is warranted 
to ensure MDPP beneficiaries are as informed as possible.
    After considering the public comments, we are finalizing the 
supplier standard regarding disclosure as proposed at Sec.  
424.205(d)(11), with a modification to specifically highlight that 
detailed information about the set of MDPP services not only includes 
eligibility and supplier standards, as previously proposed, but also 
minimum coverage requirements under Sec.  410.79(c)(2).
(6) Beneficiary Complaints
    We proposed at Sec.  424.205(d)(12) that MDPP suppliers must answer 
Medicare beneficiaries' questions about MDPP services and respond to 
MDPP related complaints within a reasonable timeframe in Sec.  
424.205(d)(12) (82 FR 34165). We also proposed that MDPP suppliers 
implement a complaint resolution protocol and maintain documentation of 
all beneficiary contact regarding such complaints, including the name 
and Medicare Beneficiary Identifier of the beneficiary, a summary of 
the complaint, related correspondences, notes of actions taken, and the 
names and/or NPIs of individuals who took such action on behalf of the 
MDPP supplier. We proposed that this information must be kept at a 
supplier's administrative location and made available to CMS or its 
contractors upon request. These records would adhere to the same 
recordkeeping requirements in Sec.  424.205(g), and therefore, would 
need to be maintained for 10 years. Although other records are 
typically required to be held only for 7 years (per Sec.  424.516(f)), 
given that the MDPP expanded model includes beneficiary engagement 
incentives (described further in section III.K.2.f.v.) which require an 
extended documentation requirement, we considered it important to align 
all recordkeeping requirements for the MDPP expanded model. As noted 
earlier in this section, we proposed at Sec.  424.205(d)(15) that an 
MDPP supplier must allow CMS or its agents to conduct recordkeeping 
reviews to ascertain the supplier's compliance with these standards, as 
well as documentation requirements as outlined in Sec.  424.205(g).
    We stated that we believe our proposal that MDPP suppliers must 
answer, respond to, and document beneficiary complaints and resolutions 
establishes a tracking mechanism to determine whether or not suppliers 
are adequately addressing beneficiary concerns. We find this 
requirement particularly important given that complaint procedures 
provide a good way to ensure best practices by suppliers. Although we 
acknowledged that this method requires the MDPP suppliers to self-
attest to their response to complaints, we stated that requiring such 
documentation as a required Medicare standard can help to build 
accountability to following through with complaint resolution. 
Additionally, mandating that suppliers take and maintain records of 
complaints may help to address situations where beneficiaries raise 
issues with us directly after failing to receive resolution from the 
supplier.
    We stated that we believe that requiring this documentation would 
provide an additional mechanism for us to ensure that the supplier is 
fully disclosing information pertinent to the supplier standards, 
specifically those regarding beneficiary access, and other concerns. As 
an additional benefit of this policy, if a beneficiary is denied 
access, the MDPP supplier would be required to demonstrate the 
reasoning behind this approach, and we could have an opportunity to 
review if this reasoning complied with the standard under Sec.  
424.205(d)(8).
    This approach is consistent with supplier standards for other 
Medicare suppliers, including those for Durable Medical Equipment 
Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. Given that CMS 
has imposed similar standards regarding supplier responsibility for 
addressing beneficiaries' complaints among other supplier types, we 
stated that we do not believe that requiring a similar such requirement 
poses an undue burden on MDPP suppliers. Rather, we believed that this 
approach can facilitate beneficiary satisfaction with the services 
suppliers furnish by requiring that beneficiary complaints are 
acknowledged, resolved, and tracked appropriately. We stated that we 
believe that this approach will help ensure that the supplier is 
meeting beneficiaries' needs as they relate to the MDPP expanded model. 
In addition, we stated that we believe that this will help ensure the 
integrity of the MDPP expanded model.
    We invited public comments on these proposals.
    We received no comments on our proposals requiring that MDPP 
suppliers respond to MDPP beneficiaries' questions and concerns within 
a timely manner or that they complete and maintain a complaint 
resolution protocol. Similarly, we

[[Page 53320]]

received no comments on any of our proposed recordkeeping requirements 
to document beneficiary complaints. Thus, we are finalizing the MDPP 
supplier standards related to beneficiary complaints under Sec.  
424.205(d)(12) as proposed.
(7) MDPP Expanded Model Evaluation Compliance
    In the CY 2017 PFS final rule, we finalized a requirement for MDPP 
suppliers to maintain and submit to CMS a crosswalk file that 
documented how the beneficiary identifiers submitted to CMS for billing 
and the beneficiary identifiers submitted to CDC for session-level 
performance data linked to the same beneficiary as a documentation 
retention and provision requirement (formerly Sec.  424.59(b), 
redesignated and amended at Sec.  424.205(d)(13)) in this final rule) 
(82 FR 34165 through 34166). CMS will use this crosswalk for evaluation 
purposes so CMS can review session level data that MDPP suppliers 
provide to CDC to supplement the claims data we receive directly from 
MDPP suppliers. We indicated that we would provide additional 
information on format and frequency of this reporting requirement in 
future rulemaking or administrative guidance as appropriate. We 
proposed the maintenance and submission of the crosswalk as an MDPP 
supplier standard and are providing additional details regarding the 
format and frequency.
    We proposed that the crosswalk file would contain Medicare Health 
Insurance Claims Numbers or Medicare Beneficiary Identifiers and the 
unique participant identifier assigned by the organization, for the 
purposes of CDC performance data reporting, for each beneficiary 
receiving MDPP services (Sec.  424.205(d)(13)). Beneficiaries for whom 
at least one Medicare claim was submitted by an MDPP supplier would be 
required to be included in the crosswalk. We proposed that the 
crosswalk be supplied to CMS, or our contractor, beginning 6 months 
after the organization begins furnishing MDPP services, and quarterly 
thereafter. The crosswalk would be maintained in a spreadsheet (for 
example, an Excel file or a CSV file), in a form and manner as 
specified by CMS. We invited public comments on this approach.
    The following is a summary of the public comments received on this 
approach and our responses.
    Comment: We received one comment on our supplier standard related 
to the crosswalk. The commenter did not request a specific change to 
the proposal, but expressed concern regarding the administrative burden 
of having to submit performance data to CDC and the crosswalk to CMS. 
Their specific concern centered on having two separate data submission 
requirements to two distinct entities--performance data to CDC and the 
crosswalk to CMS. They stipulated that these requirements would pose an 
administrative burden to all MDPP suppliers, though they particularly 
highlighted smaller suppliers and those new to Medicare.
    Response: In the CY 2017 PFS, we proposed and finalized that MDPP 
suppliers would need to submit a document cross-walking beneficiary 
identifiers in Medicare with their CDC participant ID submitted on 
performance data to CDC. In this rule, we did not propose new data 
submissions, but simply incorporated this finalized requirement into 
the MDPP supplier standards. Thus, the commenters' concern on the 
burden of needing to submit both performance data to CDC, as well as 
the crosswalk to CMS is out of scope with this rule. Should the 
commenter wish to revisit our rationale for this approach, it may do so 
in section III.J.4.f of the CY 2017 PFS final rule.
    Rather that propose any new requirements in this rule, we sought to 
provide clarity on the information that MDPP suppliers must submit on 
the crosswalk and its frequency. In efforts to streamline data 
submission requirements for the crosswalk across all MDPP suppliers, we 
are further clarifying the requirement we outlined in the proposed rule 
(82 FR 34165 through 34166), that data must be submitted 6 months after 
an MDPP supplier begins furnishing services, and quarterly thereafter. 
Rather than apply crosswalk submission dates on a per supplier basis, 
which could conceivably result in different suppliers submitting their 
crosswalks each month of the year, moving forward, we intend to 
establish four distinct periods where MDPP supplier crosswalks are 
accepted. With this change in mind, we are adapting our proposal such 
that MDPP suppliers will become eligible to submit their crosswalk 
beginning 6 months after they begin furnishing services and must submit 
at the closest quarter, and continue submitting on a quarterly basis 
thereafter. We hope that streamlining the submission periods across all 
suppliers will decrease confusion among suppliers and work to alleviate 
some of the burden associated with the crosswalk submission. We will 
provide details on this submission process through guidance, as 
appropriate.
    Additionally, to enable evaluation of MDPP services for a 
beneficiary's entire MDPP services period (that is, up to 2 years), we 
proposed that MDPP suppliers must submit performance data for any 
beneficiaries who attend ongoing maintenance sessions in a manner and 
form as specified by CMS (proposed Sec.  424.205(d)(14)). This proposal 
served to ensure that MDPP suppliers provide session-level data for 
ongoing maintenance sessions that are consistent with the data they are 
already providing to CDC for the core MDPP services period. This 
requirement is necessary given that session-level performance data 
plays a critical role in the Innovation Center's evaluation of the 
entirety of the MDPP expanded model. Without such data, the Innovation 
Center would lack any streamlined method of obtaining session-level 
data for ongoing maintenance sessions furnished to MDPP beneficiaries. 
We proposed that this performance data must align with the performance 
date elements as required by CDC for the DPRP standards. We solicited 
public comments on this approach.
    We received no comments on our proposal requiring MDPP suppliers to 
submit session-level data, consistent with performance data MDPP 
suppliers are already providing to CDC, for ongoing maintenance 
sessions. Thus, without any stakeholder input on this policy, we are 
finalizing as proposed at Sec.  424.205(d)(14). However, in light of 
concerns regarding the multiple and distinct data submission 
requirements MDPP suppliers must submit to CMS and CDC, we clarify that 
such MDPP suppliers shall submit any performance data for ongoing 
maintenance sessions, as required under Sec.  424.205(d)(14) to CDC 
along with the performance data they would already provide per the DPRP 
standards. We recognize stakeholders concerns raised both in this rule 
and in our previous policy proposals regarding potential burden 
associated with multiple and distinct submission requirements, and thus 
we will plan to align our requirements for data submission under this 
requirement with the DPRP data submission requirements for the initial 
core services period. We believe that this alignment with CDC will 
alleviate some of the potential burden associated with this MDPP 
supplier standard. We will release additional information through 
guidance, as appropriate.
    We are finalizing our policies as proposed at Sec.  424.205(d)(13) 
and (14). However, this rule provided an update to the manner and form 
MDPP suppliers must submit the crosswalk Sec.  424.205(d)(13) that 
would provide greater consistency across suppliers.

[[Page 53321]]

v. MDPP Supplier Revalidation
    In the CY 2017 PFS final rule, we specified that newly enrolling 
MDPP suppliers as high categorical risk in accordance with Sec.  
424.518(c), but we did not address the risk level of MDPP suppliers 
upon revalidation. Section 6401(a) of the Affordable Care Act 
established that all Medicare suppliers must revalidate their 
enrollments as a program integrity measure. Upon revalidation, 
suppliers are screened for their continued enrollment in Medicare. 
Although MDPP suppliers enroll at the high risk level, we proposed, at 
Sec.  424.205(b)(3)(ii), that MDPP suppliers would revalidate under a 
moderate risk level in accordance with Sec.  424.518(b)(2). We believe 
that this approach is appropriate, given that fingerprint-based 
criminal history record checks through the Federal Bureau of 
Investigation's (FBI) Integrated Automated Fingerprint Identification 
System (IAFIS) requirement for ``high'' categorical risk will have 
already been completed upon initial enrollment. In addition, we believe 
that this approach is appropriate, given its consistency with other 
providers and suppliers who initially enroll under ``high'' categorical 
risk, but revalidate under ``moderate'' categorical risk, such as 
DMEPOS suppliers and Home Health Agencies. We also proposed, at Sec.  
424.205(b)(6), as a condition of enrollment, that MDPP suppliers must 
revalidate their enrollment every 3 years, consistent with DMEPOS 
suppliers who are initially screened under ``high'' categorical risk 
screening level (82 FR 34166). We welcomed public comments on these 
proposals.
    The following is a summary of the public comments on the proposals 
to require that MDPP suppliers revalidate every 3 years at moderate 
categorical risk:
    Comment: Generally, commenters supported the proposal that MDPP 
suppliers' risk categorization decrease from high to moderate upon 
revalidation. One of the commenters who supported this proposal 
justified its support because of its alignment with requirements for 
other high risk suppliers.
    Response: We appreciate the support provided for this proposal and 
are finalizing the requirement that MDPP suppliers pass screening at 
moderate categorical risk upon revalidation.
    Comment: One commenter raised concerns about designating MDPP 
suppliers as high categorical risk upon initial enrollment, a proposal 
which we finalized in the CY 2017 PFS final rule, no commenters opposed 
the current proposal regarding revalidating at moderate risk.
    Response: This policy was not proposed in the rule, and therefore, 
is out of scope. Though we may consider revisiting MDPP supplier risk 
level upon initial enrollment in the future, we have no current plans 
to do so at this time. For our rationale for finalizing this policy, 
please refer to section III.J.7.a of the CY 2017 PFS final rule.
    Comment: In response to the proposal that MDPP suppliers revalidate 
every 3 years, some commenters supported this proposal. Generally, 
those that expressed support for this policy did so in combination with 
the proposal that MDPP suppliers revalidate at moderate risk level, 
meaning that they treated the two proposals as a single policy without 
acknowledging specific support for the frequency of revalidation. As 
mentioned previously, one of the commenters in support of the proposal 
justified their support given its consistency with other high risk 
suppliers.
    Response: We appreciate commenters' support for our proposal. 
Though we agree with commenters that the proposal for MDPP suppliers to 
revalidate at moderate categorical risk every 3 years aligns with 
existing policies for Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (DMEPOS) suppliers, which also initially enroll 
at high categorical risk, we also acknowledge that Home Health 
Agencies, which similarly initially enroll at high categorical risk, 
revalidate at moderate risk level every 5 years.
    Comment: A few commenters did not support revalidation every 3 
years, given concerns that the frequency of revalidation was high, 
particularly with respect to the duration of the MDPP services period. 
While one commenter simply requested that MDPP suppliers revalidate 
less frequently than every 3 years, another specifically proposed that 
CMS require MDPP suppliers to revalidate every 5 years. Both commenters 
stated that requiring MDPP suppliers to revalidate as frequently as 
every 3 years would pose unnecessary burdens.
    Response: Given the novelty of the MDPP supplier type, our 
expectation that most MDPP suppliers will be non-traditional heath care 
providers, and general concerns about the potential vulnerabilities of 
fraud and abuse raised by MedPAC and others, we have sought to design 
stringent program integrity policies that will enable us to detect, 
monitor, and ultimately limit the ability for potential fraud, waste, 
or abuse from organizations which enroll as MDPP suppliers.
    While a similar number of commenters expressed support for our 
original proposal, as well as recommended an alternative proposal that 
would require less frequent revalidations, we considered this proposal 
within the context of broader comments regarding the high degree of 
supplier burden as a result of our cumulative requirements. Though not 
expressly made in response to this proposal on revalidation, commenters 
frequently noted that the number of MDPP supplier requirements and 
burden from those requirements could potentially dissuade prospective 
MDPP suppliers from deciding to enroll. In light of these concerns and 
our desire to enable a strong supplier base to meet beneficiary demand 
for MDPP services, we looked for opportunities where we could alter 
requirements for MDPP suppliers to alleviate supplier burden without 
posing vulnerabilities to the integrity of the Medicare program or the 
safety of our beneficiaries. Ultimately, we determined that decreasing 
the frequency with which MDPP suppliers revalidate could achieve this 
balance. As such, we are modifying our proposal such that MDPP 
suppliers will be required to revalidate every 5 years, instead of the 
proposed 3 years. That said, we acknowledge MedPAC's concerns against 
the potential for fraud and abuse, as well as their encouragement to 
apply all program integrity safeguards possible for this new expanded 
model and the suppliers who furnish it. Therefore, we will continue to 
monitor the level of risk posed by MDPP suppliers and will consider 
revalidating more frequently in the future, if appropriate.
    Additionally, given the novelty of this model expansion, we are 
considering utilizing a provisional period of enhanced oversight 
authority under section 1866(j)(3) of the Act to monitor for program 
integrity safeguards. Should we take this approach, CMS would assume 
the responsibility of conducting any oversight action as a way of 
avoiding adding any increased burden to MDPP suppliers. We believe that 
this approach to require that MDPP suppliers revalidate less 
frequently, and instead, for CMS to assume responsibility for enhanced 
monitoring demonstrates our commitment to respond to stakeholder 
comments to both protect the Medicare program and its beneficiaries 
against fraud, waste, and abuse and also to avoid unnecessary burdens 
to the suppliers who service our beneficiaries.
    After considering the public comments, we are finalizing our 
proposal at Sec.  424.205(b)(3)(ii) that

[[Page 53322]]

MDPP upon revalidation, MDPP suppliers must pass moderate categorical 
risk. To make MDPP supplier risk levels more clear, we are adding 
Prospective (newly enrolling) MDPP suppliers to high categorical risk 
at Sec.  424.518(c)(1)(iii) and revalidating MDPP suppliers to the 
moderate risk level at Sec.  424.518(b)(1)(xi). Based on feedback from 
suppliers' broader request for less administrative burden, we are 
finalizing a modification of our proposal at Sec.  424.204(d)(6) such 
that MDPP suppliers must revalidate every 5 years.
vi. Documentation Retention and Provisions Requirements
    We proposed that the following requirements would apply to records 
related to a MDPP supplier's compliance with the MDPP expanded model 
(codified at Sec.  424.59(b), redesignated as amended at Sec.  
424.205(g)) (82 FR 34166). We stated that we believe that these 
proposals would increase supplier recordkeeping accuracy, and clarify 
documentation retention requirements. Specifically, we proposed that an 
MDPP supplier must:
     Provide to CMS or its contractors, the OIG, and the 
Comptroller General or their designee(s) scheduled and unscheduled 
access to all books, contracts, records, documents, and other evidence 
sufficient to enable the audit, evaluation, inspection, or 
investigation of the supplier's compliance with MDPP requirements, 
including the MDPP expanded model requirements for in-kind beneficiary 
incentive engagements found in Sec.  424.210 in the event that the MDPP 
supplier chooses to offer such incentives to any MDPP beneficiary.
     Maintain all such books, contracts, records, documents, 
and other evidence for a period of 10 years from the last day of the 
MDPP beneficiary's receipt of MDPP services furnished by the MDPP 
supplier or from the date of completion of any audit, evaluation, 
inspection, or investigation, whichever is later, unless--
    ++ CMS determines that there is a special need to retain a 
particular record or group of records for a longer period and notifies 
the MDPP supplier at least 30 calendar days before the normal 
disposition rate; or
    ++ There has been a dispute or allegation of fraud or similar 
fault, as defined at Sec.  405.902, against the MDPP supplier, in which 
case the records must be maintained for an additional 6 years from the 
date of any resulting final resolution of the dispute or allegation of 
fraud or similar fault.
    We stated that we believe these proposals increase the likelihood 
of operationalizing MDPP program integrity strategies that include 
audits, evaluations, inspections, or investigations, and that they 
provide additional clarity on documentation retention for ongoing 
program integrity. In addition, in the CY 2017 PFS we established 
supplier requirements for documentation and recordkeeping (codified at 
Sec.  424.59(b), redesignated and amended at Sec.  424.205(g). In this 
final rule, we are revising these requirements to improve clarity. We 
proposed at Sec.  424.205(g)(1) and (g)(2) to require that 
documentation must be established contemporaneous to the furnished MDPP 
services, which we believe is important for accuracy. We also proposed 
that for the initial core session, these records must include the 
following organizational information:
     The organizational name, CDC DPRP organization number, and 
organizational NPI;
     Basic beneficiary information including but not limited to 
beneficiary name, HICN, and age; and
     Evidence that each such beneficiary satisfied the 
eligibility requirements under Sec.  410.79(c) at the time of service.
    For each additional session, we proposed that these records must 
include:
     Documentation of the type of session, whether a core 
session, a core maintenance session, an ongoing maintenance session, an 
in-person make-up session, or a virtual make-up session.
     Identification of which CDC-approved DPRP curriculum was 
associated with each session.
     The NPI of the coach who furnished the session.
     The date and place of service of the session.
     Each MDPP's beneficiary's weight and date weight taken, in 
a form and manner as specified by CMS.
    We stated that we believe that this information will play an 
important role in documenting the provision of MDPP services and 
fidelity to the requirements established for the expanded model. 
Finally, at Sec.  424.205(g)(4), we proposed that MDPP suppliers must 
maintain and handle any beneficiary Personally Identifiable Information 
(PII) and Personal Health Information (PHI) in compliance with HIPAA, 
other state and federal privacy laws, and CMS standards. We believe 
these proposals will improve supplier recordkeeping accuracy and lessen 
the possibility of incomplete records and supplier recordkeeping 
variations.
    We invited public comments on our proposed documentation and 
maintenance of records requirements, including whether additional or 
different requirements may provide better program integrity safeguards.
    The following is a summary of the public comments received on our 
proposal for documentation and maintenance of records requirements, 
including whether additional or different requirements may provide 
better program integrity safeguards and our responses:
    Comment: The majority of commenters who provided feedback on this 
section did so generally across the recordkeeping requirements overall. 
For example, a few commenters did not support the documentation 
requirements proposed in this rule, and instead, urged CMS to 
reconsider the necessity of the requirements. The commenter did not 
specify which requirements they believed to be unnecessary. These 
commenters suggested that requiring MDPP suppliers to maintain 
significant documentation may pose burdens to MDPP suppliers, 
particularly smaller organizations. One commenter drew a parallel to 
the recordkeeping-related burden experienced by suppliers who offer 
chronic care management. Though no commenter recommended that CMS 
remove any specific documentation requirements, one commenter suggested 
that if CMS chose not to minimize burdensome requirements, which 
included, but was not limited to recordkeeping-related proposals, some 
form of compensation should be provided to support the necessary 
infrastructure costs required in recordkeeping.
    Response: While we recognize commenters' concerns regarding the 
level of burden posed by MDPP supplier requirements overall, and in 
particular documentation requirements, we believe that recordkeeping 
plays an integral role in CMS' ability to investigate and eventually 
protect against fraud, waste, or abuse in the program. While CMS does 
not want to impose unnecessary burdens on MDPP suppliers, we consider 
our proposed recordkeeping requirements as necessary means for both 
accountability for MDPP suppliers and ability to verify compliance for 
CMS. Thus, will not be adopting commenters request for less 
recordkeeping requirements and will be finalizing the policies as 
proposed.
    Comment: One commenter criticized the proposed documentation 
requirements stating that they omitted a range of variables that could 
predict an MDPP beneficiary's likelihood of losing weight over the core 
services period. The additional variables suggested by the commenter 
included the number of

[[Page 53323]]

weigh-ins per week, the number of steps per day, the percentage of 
weeks with 5 or more food logs, the number of highly active minutes per 
week, and the number of coach interactions. The commenter urged CMS to 
reconsider whether MDPP suppliers should report this data to CMS so 
that it could be utilized to determine the efficacy of the program.
    Response: While CMS appreciates that a commenter suggested 
additional data be submitted to determine the efficacy of the MDPP 
expanded model, we do not believe that an evaluation to test the 
efficacy of the MDPP expanded model would require the additional 
variables suggested by the commenter. Thus, we are not adopting the 
suggestion to require MDPP suppliers document additional predictors of 
weight loss. While we do not see a need to require such documentation, 
we encourage MDPP suppliers to utilize and record any additional data 
that they believe will be valuable or will help predict a 
beneficiaries' success. Collecting this data through the MDPP 
beneficiaries' services period may assist the MDPP supplier or coach in 
determining how best to engage beneficiaries and assist them in 
achieving lasting behavioral change that will decrease their risk of 
type 2 diabetes. At this time, however, we are not finalizing any 
documentation requirements beyond what we proposed.
    Comment: Several commenters requested that CMS provide guidance, 
technical assistance, and clarifications with regards to recordkeeping 
requirements. Two commenters generally requested that CMS provide more 
guidance on maintaining information on MDPP sessions provided to 
beneficiaries. One of these commenters had specific questions on when 
MDPP suppliers could submit certain claims, and requested that CMS 
provide further guidance with regard to the necessary documentation to 
support claims payment.
    Response: Considering these requirements, coupled with the 
expectation that many MDPP suppliers will lack previous experience as a 
Medicare enrolled supplier, we are working to create resources that 
would facilitate MDPP suppliers' ability to comply with the 
recordkeeping requirements outlined in this rule. In considering these 
resources, we also intend to provide guidance on how to appropriately 
document services to support claims payment, as required under Sec.  
424.205(g)(5).
    Comment: One commenter raised questions regarding documentation 
requirements if an MDPP supplier provided more than the minimum amount 
of sessions required. In a scenario where an MDPP supplier may have 
provided the total number of MDPP sessions required over the course of 
the MDPP services period within the first 6 months, the commenter 
wanted to understand how the supplier should document ``PA minutes'' in 
the second 6 months, when they believed that participants are less 
likely to self-report ``PA minutes'' in the second 6 months. Though the 
commenter did not indicate what PA stood for, given the context of 
MDPP, we assume this refers to ``physical activity.''
    Response: The proposed requirement under Sec.  424.205(g)(2) 
requires that MDPP suppliers document various aspects of each MDPP 
session furnished to an MDPP beneficiary, therefore, these 
documentation requirements would apply to any session delivered to an 
MDPP beneficiary as a part of the MDPP services period, even if an MDPP 
supplier furnishes more MDPP sessions than are required under Sec.  
410.79(c)(2). We clarify that we are not requiring any documentation of 
physical activity minutes, though the DPRP standards may require 
documentation of this variable, and any questions regarding the DPRP 
standards are beyond the scope of this rule and should be directed to 
the CDC.
    Comment: One commenter requested clarification on whether MDPP 
suppliers who store records in electronic medical records would 
sufficiently meet these proposals. Specifically, the commenter 
requested clarification on whether the use of an electronic medical 
record which could produce a report would comply with the proposal at 
Sec.  424.205(g), which required that MDPP suppliers provide to CMS, a 
contractor acting on CMS' behalf, the Office of the Inspector General, 
and the Comptroller General or their designee(s) scheduled and 
unscheduled access to the MDPP supplier's records, including, but not 
limited to, all books, contracts, records, documents, and other 
evidence sufficient to enable the audit, evaluation, inspection, or 
investigation of the MDPP supplier's compliance. The commenter 
preferred the approach of retaining records electronically given it 
does not rely on generating hard copies and assumes a similar approach 
to the reporting format required of the DPRP. The commenter also 
requested whether maintaining the documentation in an electronic 
medical record would comply with the requirement at Sec.  
424.205(g)(6), requiring MDPP suppliers to maintain all records 
required under Sec.  424.205(g) for a period of 10 years from the last 
day of the MDPP beneficiary's receipt of MDPP services provided by the 
MDPP supplier, with limited exceptions.
    Response: We do not require documentation or medical records in 
paper form and encourage the use of a secured electronic medical record 
system. Without familiarity with the specific electronic medical record 
system and the reports it may generate, we are not able to confirm 
whether the commenter's specific approach would satisfy the 
requirements as outlined under Sec.  424.205(g). In determining whether 
the system will comply with the requirements, organizations should 
evaluate whether their system may collect and obtain the required 
information securely, as required under Sec.  424.205(g)(4) and for the 
duration as required under Sec.  424.205(g)(6). If so, organizations 
should evaluate whether the information in this system can be provided 
to CMS, a contractor acting on CMS' behalf, the Office of the Inspector 
General, and the Comptroller General or their designee(s), as required. 
Identifying whether the supplier's current recordkeeping system can 
meet these requirements may help prospective MDPP suppliers evaluate 
their readiness to comply with the documentation retention 
requirements. Additionally, we are exploring possible resources CMS 
could create to help enable MDPP suppliers to understand how to comply 
with recordkeeping requirements in this section.
    Comment: A commenter requested clarification on how to apply HIPAA 
requirements to an MDPP supplier when the supplier also provided 
additional, non-MDPP services as a part of a larger, non-health related 
business. In this scenario, the commenter suggested that the supplier 
could designate itself a hybrid covered entity under HIPAA such that 
HIPAA requirements would only apply to its covered functions. The 
commenter requested that CMS confirm this understanding.
    Response: We proposed the requirement at Sec.  424.205(g)(4) 
requiring an MDPP supplier to maintain and handle any beneficiary PII 
and PHI in compliance with HIPAA, other applicable state and federal 
privacy laws, and CMS standards as a means to protect any PII or PHI 
the MDPP supplier obtains. The intention of this requirement was to 
highlight that to protect beneficiary privacy, an array of federal and 
state privacy laws, including HIPAA, exist, as well as certain CMS 
standards, and CMS expects that MDPP suppliers would protect 
beneficiary information as required by these policies. Though in the CY 
2017 PFS

[[Page 53324]]

final rule, we finalized a similar requirement on HIPAA compliance, we 
proposed to modify this language to more broadly include applicable 
federal and state privacy laws as well. We did not intend to apply any 
new provisions that would not already apply to an MDPP supplier. 
Instead, though MDPP suppliers are already required to comply with all 
existing laws, including those related to privacy, we sought to 
highlight the need to comply with privacy-related laws, given that we 
anticipate that MDPP suppliers may not necessarily have previous 
experience in health care. MDPP suppliers will need to consult with 
their own counsel to determine their obligations and options under the 
HIPAA regulatory scheme, as well as other applicable privacy laws, such 
as state laws.
    To more clearly state that the requirement at Sec.  424.205(g), we 
are amending the language to require that MDPP suppliers maintain and 
handle any beneficiary information related to MDPP, including 
Personally Identifiable Information (PII) and Protected Health 
Information (PHI), as appropriate under HIPAA, other applicable state 
and federal privacy laws, and CMS standards. That said, we would 
highlight the ``related to MDPP services'' language. We hope that this 
language more clearly explains that this provisions applies only to 
beneficiary information related to MDPP, and not information collected 
by the MDPP supplier for other services they may provide. Any data an 
MDPP supplier would receive as a function of their non-MDPP related 
business would not be ``related to MDPP services'' if those non-MDPP 
business functions are truly separate from the MDPP ones. We believe 
that this clarification addresses the commenter's concern of how they 
would handle information related to their non-MDPP activities. 
Additionally, we hope that shifting the language from ``in compliance 
with'' to ``as required under'' more clearly signals that we are not 
imposing any additional requirements to comply with laws or standards 
that would not otherwise already apply to the MDPP supplier's handling 
or maintenance of beneficiary information. We proposed a requirement at 
Sec.  424.205(g)(4) to be more consistent with language at Sec.  
424.205(g), and to state that an MDPP supplier must maintain all 
documentation related to participation in the MDPP in accordance with 
all applicable Federal and State laws. We recommend that any 
prospective MDPP supplier applicants consult with counsel to determine 
whether they qualify as a HIPAA Covered Entity, and, if so, how it will 
comply with HIPAA as applicable to beneficiary information related to 
MDPP as opposed to other information collected for non-MDPP related 
purposes.
    After considering the public comments, we are finalizing the 
proposals under Sec.  424.205(g) with a modification at Sec.  
424.205(g) for additional clarity. We are finalizing that under Sec.  
424.205(g)(4), MDPP suppliers must maintain and handle any beneficiary 
information related to MDPP, including PII and PHI, as would be 
required under HIPAA, other applicable state and federal privacy laws, 
and CMS standards.
f. Beneficiary Engagement Incentives Under the MDPP Expanded Model
    In the proposed rule (82 FR 34166), we stated our belief that the 
MDPP expanded model would encourage MDPP suppliers to furnish high 
quality and engaging health behavior change services to MDPP 
beneficiaries that lead to improved beneficiary health and reductions 
in Medicare spending. We believe that one mechanism that may be useful 
to the MDPP suppliers in achieving these goals would be allowing MDPP 
suppliers to furnish certain in-kind items and services to their MDPP 
beneficiaries during the core services period and ongoing services 
period (described at proposed Sec.  410.79(c)(2)). Under such an 
approach, the costs of these beneficiary engagement incentives would be 
borne by the MDPP supplier. However, we believe that certain conditions 
on these incentives would be necessary to ensure that they would be 
furnished solely for the purpose of achieving the MDPP goal of engaging 
beneficiaries in making sustainable, healthy behavior changes to reduce 
their risk of type 2 diabetes.
    We proposed to establish the rules governing the furnishing of 
beneficiary engagement incentives to MDPP beneficiaries under the MDPP 
expanded model at new Sec.  424.210. As discussed in section III.K.2.a. 
of the proposed rule (82 FR 34131), we proposed that MDPP services 
would be available beginning on April 1, 2018.
i. Definitions Specific to Beneficiary Engagement Incentives
    We proposed that if an MDPP supplier offers an in-kind beneficiary 
engagement incentive, the item or service offered as an incentive must 
be furnished by an MDPP supplier to an MDPP beneficiary during the 
engagement incentive period. An engagement incentive period would begin 
when an MDPP supplier furnishes any MDPP service to an MDPP 
beneficiary. We proposed at Sec.  424.210(a) that the term ``engagement 
incentive period'' means the period of time during which an MDPP 
supplier may furnish in-kind beneficiary engagement incentives to a 
given MDPP beneficiary to whom the MDPP supplier is furnishing MDPP 
services. The engagement incentive period would end upon the earliest 
of the following: The beneficiary's MDPP services period ends (as 
specified in proposed Sec.  410.79(c)(3)) for any reason; the MDPP 
supplier knows the MDPP beneficiary will no longer be receiving MDPP 
services from the MDPP supplier; or the MDPP supplier has not had 
direct contact, either in person, by telephone, or via other 
telecommunications technology, with the MDPP beneficiary for more than 
90 consecutive calendar days during the MDPP services period.
    We proposed that items and services may only be furnished as in-
kind beneficiary engagement incentives during the engagement incentive 
period. This was to ensure that the flexibilities that MDPP suppliers 
would have under these proposed regulations to furnish free items and 
services to Medicare beneficiaries only apply while the beneficiary is 
an MDPP beneficiary being offered MDPP services by that MDPP supplier. 
Once the MDPP beneficiary's engagement incentive period ends with an 
MDPP supplier, all existing laws and regulations would apply to the 
furnishing of free items and services to a Medicare beneficiary by the 
entity that is an MDPP supplier. Limiting the furnishing of beneficiary 
engagement incentives under the MDPP expanded model to the engagement 
incentive period with a particular MDPP supplier would serve as a 
safeguard against the furnishing of free items and services to Medicare 
beneficiaries to steer them toward particular providers, suppliers, or 
other services, rather than to engage MDPP beneficiaries in healthy 
behavior changes that reduce their incidence of type 2 diabetes.
    During the course of the MDPP services period, we noted that an 
MDPP beneficiary may begin and end multiple engagement incentive 
periods, and, to the extent feasible, the MDPP beneficiary would not be 
in more than one engagement incentive period at the same time. For 
example, where, after receiving MDPP services from MDPP supplier A, an 
MDPP beneficiary notifies MDPP supplier A that he or she has chosen to 
receive MDPP services from MDPP supplier B and subsequently receives 
MDPP services from MDPP supplier B, the first engagement incentive 
period ends when

[[Page 53325]]

MDPP supplier A is told by the MDPP beneficiary that he or she will no 
longer attend MDPP services with MDPP supplier A. A new engagement 
incentive period begins when the MDPP beneficiary receives his or her 
first MDPP service from MDPP supplier B. Additionally, where an MDPP 
beneficiary begins an engagement incentive period with an MDPP supplier 
and the engagement incentive period has ended because the MDPP supplier 
has not had direct contact, either in person, by telephone, or via 
other telecommunications technology, with the MDPP beneficiary for 90 
consecutive days during the MDPP services period, should that MDPP 
beneficiary receive MDPP services from that MDPP supplier on day 100, a 
new engagement incentive period would begin.
    These proposals for the definitions specific to beneficiary 
engagement incentives were included at proposed Sec.  424.210(a). We 
invited public comments on these proposed definitions specific to 
furnishing in-kind beneficiary engagement incentives.
    The following is a summary of the public comments received on the 
proposals for definitions specific to furnishing in-kind beneficiary 
engagement incentives and our responses:
    Comment: One commenter urged CMS to begin the engagement incentive 
period 30 to 90 days prior to the start of MDPP services to allow for 
recruitment of beneficiaries into the DPP, rather than beginning the 
period when an MDPP supplier furnishes any MDPP service to an MDPP 
eligible beneficiary as CMS proposed.
    Response: We continue to believe it is important to limit the 
furnishing of beneficiary engagement incentives under the MDPP expanded 
model to the time period when an MDPP beneficiary is receiving MDPP 
services from a particular MDPP supplier as a safeguard against the 
furnishing of free items and services to Medicare beneficiaries to 
steer them toward particular providers, suppliers, or other services, 
rather than to engage MDPP beneficiaries in healthy behavior changes 
that reduce their incidence of type 2 diabetes. In addition, as 
discussed subsequently in this section, an MDPP beneficiary may be made 
aware of the availability of the item or service at the time the MDPP 
beneficiary could reasonably benefit from it during the engagement 
incentive period, in order to safeguard against the advertisement of 
in-kind patient engagement incentives to beneficiaries based on their 
perceived ability to achieve the performance goals for attendance and 
weight loss. Thus, we do not believe it would be appropriate for the 
engagement incentive period to begin before an MDPP beneficiary 
receives any MDPP service from a particular MDPP supplier because such 
an approach would increase the risk of beneficiary steering.
    Comment: One commenter stated that the proposal to define the end 
of the engagement incentive period would be difficult to 
operationalize, especially if a particular engagement incentive extends 
for a fixed period of time, such as a month-long gym membership, that 
would extend beyond the end of the engagement incentive period. The 
commenter added that the proposed definition also has implications for 
beneficiaries changing suppliers, such as when a month-long gym 
membership provided by supplier A to an MDPP beneficiary could overlap 
the new engagement incentive period that would begin once the 
beneficiary switches to supplier B for MDPP services.
    Response: While we recognize the challenges identified by the 
commenter in operationalizing the proposed definition of the end of the 
engagement incentive period, we continue to believe that defining the 
beginning and end of the engagement incentive period to bound the time 
period during which a beneficiary can be furnished beneficiary 
engagement incentives by an MDPP supplier provides an important program 
safeguard with respect to the flexibilities that allow MDPP suppliers 
to furnish such items and services. We understand that in some 
scenarios, a particular beneficiary engagement incentive that was 
furnished to an MDPP beneficiary could theoretically be used for a 
period of time after the engagement incentive period ends. However, we 
do not believe this possibility necessitates changing our definition of 
engagement incentive period to allow the continued use of the incentive 
beyond the time when the MDPP supplier is furnishing MDPP services to 
the MDPP beneficiary. If an engagement incentive period ends for any 
reason while a beneficiary otherwise could continue to use an 
incentive, such as a month-long gym membership, we expect the MDPP 
supplier to notify the beneficiary that the engagement incentive period 
has ended and that the beneficiary may no longer use the incentive at 
no cost under the provisions of the MDPP expanded model. We also expect 
the MDPP supplier to notify any other relevant organization, such as a 
gym for which a free membership was furnished by the MDPP supplier to 
the beneficiary during the engagement incentive period, to cancel the 
beneficiary's ability to use the incentive.
    After considering the public comments received, we are finalizing 
the proposals, without modification, for the definitions specific to 
furnishing in-kind beneficiary engagement incentives at Sec.  
424.210(a).
ii. General Conditions for Beneficiary Engagement Incentives
    We proposed, at Sec.  424.210(b), that an MDPP supplier may choose 
to furnish items or services as in-kind beneficiary engagement 
incentives to an MDPP beneficiary only during the engagement incentive 
period, subject to a number of additional conditions as program 
safeguards. Under this proposal, the in-kind items and services 
furnished as beneficiary engagement incentives under the MDPP expanded 
model would not be Medicare-covered items or services, nor would they 
be any cost-sharing amounts for Medicare-covered items or services.
    We proposed that the engagement incentive must be furnished 
directly by an MDPP supplier or by an agent of the MDPP supplier under 
the MDPP supplier's direction and control, such as a coach, to an MDPP 
beneficiary. As established in the Sec.  410.79(b) in the CY 2017 PFS 
final rule, coach refers to an individual who furnishes MDPP services 
on behalf of an MDPP supplier as an employee, contractor, or volunteer. 
We considered whether this policy on beneficiary engagement incentives 
should extend to entities other than MDPP suppliers and their agents 
that may refer to or furnish MDPP services during an engagement 
incentive period. However, given that MDPP suppliers maintain the 
responsibility to ensure the integrity of MDPP programs and would be 
best positioned to comply with beneficiary engagement incentive 
documentation and technology retrieval requirements proposed at Sec.  
424.210(e) and (c), respectively, we believed that they would be best 
suited to furnished beneficiary engagement incentives.
    We proposed that the item or service furnished as a beneficiary 
engagement incentive must be reasonably connected to the CDC-approved 
curriculum taught by an MDPP supplier to an MDPP beneficiary during a 
core session, a core maintenance session, or an ongoing maintenance 
session. For example, under this proposal, an MDPP supplier could 
furnish beneficiary engagement incentives such as gym memberships to 
reduce barriers associated with beneficiary achievement of physical 
activity recommended as part of the CDC-approved curriculum, but they

[[Page 53326]]

could not furnish theater tickets, which would bear no reasonable 
connection to the CDC-approved curriculum. Similarly, MDPP suppliers 
may offer incentives such as onsite child care when the MDPP 
beneficiary attends MDPP services or transportation vouchers to the 
site of MDPP services that may reduce barriers to beneficiary 
attendance at MDPP services, but they could not furnish attendance 
awards such as movie tickets or retail gift cards, which would have no 
reasonable connection to the CDC-approved curriculum. Likewise, this 
proposal would allow MDPP suppliers to furnish equipment that is 
reasonably necessary for the curriculum being taught to the 
beneficiary, such as digital scales to track and document patient 
weight or pedometers to track physical activity, but not broadly used 
technology that is more valuable to the beneficiary, such as a 
smartphone. If an MDPP supplier were to furnish a smartphone at no cost 
to an MDPP beneficiary, a reasonable inference arises that the 
technology would not be reasonably connected to the curriculum being 
taught to the beneficiary. Among other things, this safeguard would 
preclude incentives that might serve to induce beneficiaries 
inappropriately to receive other services than MDPP services from the 
MDPP supplier.
    We also proposed that the beneficiary engagement incentive must be 
a preventive care item or service, or an item or service that advances 
a clinical goal for an MDPP beneficiary as described in section 
III.K.2.f.iv. of the proposed rule (82 FR 34169 through 34170) by 
engaging him or her in better managing his or her own health. This 
would ensure that a relationship between the incentive and the goals of 
the MDPP expanded model exists so that the beneficiary engagement 
incentive is necessary for testing the MDPP expanded model. Under this 
proposed condition, we noted that beneficiary engagement incentives may 
not be offered to an MDPP beneficiary as a reward for achievement of a 
specified outcome, such as losing weight or attending a certain number 
of sessions, unless the beneficiary engagement incentive meets all the 
proposed conditions, including that it is reasonably connected to the 
CDC-approved DPP curriculum furnished to the MDPP beneficiary during a 
core session, a core maintenance session, or an ongoing maintenance 
session by the MDPP supplier and that it is a preventive care item or 
service or it advances a clinical goal for an MDPP beneficiary by 
engaging him or her in better managing his or her own health. 
Furnishing in-kind patient engagement incentives upon achievement of an 
outcome may not advance a clinical goal for an MDPP beneficiary by 
engaging him or her in better managing his or her own health unless 
there are clinical goals that the incentive itself can continue to 
advance.
    We further proposed that the item or service furnished as a 
beneficiary engagement incentive must not be tied to the receipt of 
items or services outside the MDPP services, and that the item or 
service must not be tied to the receipt of items or services from a 
particular provider, supplier, or coach. These provisions would provide 
safeguards against the furnishing of in-kind beneficiary engagement 
incentives to steer beneficiaries toward certain providers, suppliers, 
or coaches for services outside MDPP services.
    We noted that in some circumstances, an item or service may be 
linked to an MDPP supplier and be offered to the MDPP supplier's MDPP 
beneficiaries as part of the CDC-approved curriculum that must be 
furnished during the MDPP services period, rather than being offered to 
steer the MDPP beneficiary to a particular provider, supplier, or 
coach. In these situations, we believed that the item or service may be 
furnished as a beneficiary engagement incentive without violating the 
requirement that the item or service not be tied to the receipt of the 
items or services from a particular provider, supplier, or coach. For 
instance, where an MDPP supplier offers a gym membership as a 
beneficiary engagement incentive, we understood that the gym membership 
must be tied to a particular supplier of services so that the 
beneficiary can use the membership. However, in this case, the gym 
membership would be linked to the MDPP supplier that, in compliance 
with the curriculum that must be furnished during the MDPP services 
period, would be teaching MDPP beneficiaries how to utilize a physical 
fitness regime to meet the MDPP goal of reducing an MDPP beneficiary's 
risk of developing diabetes, rather than being furnished to steer the 
MDPP beneficiary to a particular supplier. Therefore, we believed that 
gym memberships may be furnished as a beneficiary engagement incentive 
without violating the requirement that the item or service not be tied 
to the receipt of items or services from a particular provider, 
supplier, or coach, as long as the gym membership is reasonably 
connected to the CDC-approved curriculum and not being furnished to 
steer the MDPP beneficiary to a particular supplier.
    We proposed that, in general, the availability of the items or 
services furnished as beneficiary engagement incentives must not be 
advertised or promoted as in-kind beneficiary engagement incentives 
available to an MDPP beneficiary receiving MDPP services from the MDPP 
supplier. However, an MDPP beneficiary may be made aware of the 
availability of the items or services at the time the MDPP beneficiary 
could reasonably benefit from them during the engagement incentive 
period. This condition would provide a safeguard against the 
advertisement of in-kind patient engagement incentives to beneficiaries 
based on their perceived ability to meet the performance goals of 
attendance and weight loss as described at proposed Sec.  414.84(a) and 
associated with the MDPP performance payments proposed at Sec.  
414.84(b). The proposed payment structure for MDPP services largely 
would rely on the achievement of these performance goals. Therefore, 
advertising patient engagement incentives to encourage participation of 
MDPP-eligible beneficiaries most likely to meet the attendance and 
weight loss performance goals could produce financial gain for MDPP 
suppliers that would not be related to the quality and efficacy of the 
MDPP supplier's MDPP services.
    In addition, prohibiting the advertisement or promotion of in-kind 
beneficiary engagement incentives available to an MDPP beneficiary 
receiving MDPP services from the MDPP supplier (except that an MDPP 
beneficiary may be made aware of the availability of the items or 
services at the time the MDPP beneficiary could reasonably benefit from 
them during the engagement incentive period) would provide a safeguard 
against using the incentive to steer a beneficiary toward a particular 
MDPP supplier. Beneficiaries would not be made aware of the 
availability of beneficiary engagement incentives until the MDPP 
beneficiary was in an engagement incentive period, which would begin 
when an MDPP supplier furnished its first MDPP service to the 
beneficiary. At that point in time, the beneficiary would have already 
selected that MDPP supplier to furnish his or her MDPP services so the 
incentive could not be used to steer the beneficiary to that MDPP 
supplier. We noted that we did not intend for beneficiary engagement 
incentives proposed for the MDPP expanded model to alter an MDPP 
supplier's market share for an MDPP or non-MDPP item or service.
    Finally, we proposed that the cost of the items or services offered 
as in-kind

[[Page 53327]]

beneficiary engagement incentives must not be shifted to another 
federal health care program, as defined at section 1128B(f) of the Act. 
This requirement would affirm that the cost of any beneficiary 
engagement incentive offered by an MDPP supplier is the sole 
responsibility of the MDPP supplier, and the furnishing of a 
beneficiary engagement incentive, for instance, must not result in 
increased payments to the MDPP supplier by federal health care programs 
for other items or services.
    These proposals for the general conditions for in-kind beneficiary 
engagement incentives were included at proposed Sec.  424.210(b). We 
invited public comments on these proposed general conditions for 
furnishing beneficiary engagement incentives. In addition, we invited 
public comments on additional or alternative program integrity 
safeguards.
    The following is a summary of the public comments received on the 
proposals for the general conditions for in-kind beneficiary engagement 
incentives and our responses:
    Comment: Many commenters supported the proposal to allow MDPP 
suppliers to furnish beneficiary engagement incentives that support 
beneficiaries in their pursuit of the clinical goals of the MDPP. The 
commenters stated that items or services that are not traditionally 
covered by Medicare may significantly improve beneficiary access and 
use of MDPP services and even further enhance the savings potential of 
the MDPP expanded model, and that the findings from such incentive use 
may be studied by CMS to inform the agency's consideration of 
engagement incentives in other parts of the Medicare program. Several 
commenters noted in further support of CMS' proposal that MA plans 
already provide beneficiaries with non-covered items and services, 
which the commenters stated have helped those plans lower chronic 
disease costs among their plan enrollees. The commenters reasoned that 
this MA plan cost experience in furnishing non-covered items and 
services to plan enrollees was consistent with the goal of the MDPP 
expanded model to reduce Medicare expenditures for MDPP beneficiaries 
with prediabetes.
    Response: We appreciate the support from many commenters for our 
proposal to allow MDPP suppliers to furnish in-kind beneficiary 
engagement incentives that we believe may be useful in augmenting the 
effects of high quality health behavior change services furnished to 
MDPP beneficiaries that lead to improved beneficiary health and 
reductions in Medicare spending. We agree that these incentives have 
the potential to increase beneficiary engagement in MDPP services and 
health behavior change that lead to achievement and maintenance of the 
required minimum weight loss which is associated with a reduction in 
the incidence of type 2 diabetes.
    Comment: In the context of their view that the proposed performance 
payments to MDPP suppliers for MDPP services were low, several 
commenters speculated that it would be unlikely that MDPP suppliers 
would have sufficient funds to furnish beneficiary engagement incentive 
in-kind since they would be functioning at a financial deficit. The 
commenters stated that not all supplier organizations would have the 
resources available to furnish such incentives that could engage more 
beneficiaries and result in greater rates of attendance and weight 
loss, thereby placing these lower-resource suppliers at a distinct 
disadvantage for maintaining full CDC recognition of their DPPs, which 
would in turn affect the availability of the program for Medicare 
beneficiaries, as well as other eligible participants.
    To address their concerns about MDPP suppliers having funds to 
furnish beneficiary engagement incentives, several commenters 
recommended that CMS alter the proposal that the costs of the 
beneficiary engagement incentives be borne by the MDPP supplier. The 
commenters urged CMS to pay MDPP suppliers for furnishing beneficiary 
engagement incentives such as transportation, child care for 
grandchildren, and other incentives that support session attendance, 
especially for MDPP suppliers serving high-risk populations. One 
commenter observed that CMS currently allows payment to be made for 
transportation to medical appointments in some Medicaid populations. 
Another commenter advocated for direct payment by CMS to MDPP suppliers 
for tools such as digital scales and fitness trackers, noting they are 
useful to DPP participants, whether enrolled in virtual or in-person 
programs.
    Finally, one commenter stated that consumer engagement in services 
and programs occurs in a well-designed, evidence-based program that 
offers easily accessible services that consumers need. The commenter 
urged CMS to shift its focus away from the detailed proposed conditions 
for beneficiary engagement incentives that could be furnished by MDPP 
suppliers to engage MDPP beneficiaries to instead focus on establishing 
the right MDPP services, making appropriate MDPP services payments, and 
minimizing the administrative burden associated with becoming an MDPP 
supplier.
    Response: MDPP suppliers are not required to furnish beneficiary 
engagement incentives, although we proposed a framework for in-kind 
beneficiary engagement incentives to allow MDPP suppliers the 
flexibility to furnish these incentives under certain conditions to 
ensure that they would be furnished solely for the purpose of achieving 
the MDPP goal of engaging beneficiaries in making sustainable, health 
behavior changes to reduce their risk of type 2 diabetes. As part of 
each DPP organization's decision-making about offering in-kind 
beneficiary engagement incentives under the MDPP expanded model, we 
expect that each MDPP supplier will consider the potential additional 
value of these incentives to MDPP beneficiaries and its operations. 
Relevant considerations may include whether greater beneficiary 
engagement may lead to a greater likelihood that beneficiaries will 
achieve the performance goals and, therefore, higher Medicare 
performance payments to the supplier, in the context of the resource 
costs of the incentives that would be borne by the MDPP supplier.
    We understand that some MDPP suppliers may not have funds available 
that allow them to furnish beneficiary engagement incentives to MDPP 
beneficiaries, especially early in the supplier's experience furnishing 
MDPP services. However, once an MDPP supplier begins to receive 
performance payments from CMS for MDPP beneficiary achievement of 
performance goals, the supplier may have more information about the 
potential for beneficiary engagement incentives to reduce barriers to 
MDPP beneficiary achievement of performance goals, as well as 
additional funds that may be used for these incentives. For those MDPP 
suppliers with funds that may potentially be used to furnish in-kind 
incentives, this experience may allow the MDPP supplier to make a more 
informed decision on furnishing beneficiary engagement incentives 
versus other MDPP supplier investments that have the potential to 
improve beneficiaries' achievement of performance goals under the MDPP 
expanded model.
    While we acknowledge the suggestions of some commenters that CMS 
pay directly for certain beneficiary engagement incentives, we do not 
believe it would be appropriate in the context of the performance-based 
payment methodology for MDPP services discussed in section III.K.2.d. 
of this final rule for CMS to pay MDPP

[[Page 53328]]

suppliers individually for specific incentives furnished to 
beneficiaries. Instead, we believe that MDPP suppliers are best 
positioned to determine the potential value of beneficiary engagement 
incentives toward achievement of performance goals by the MDPP 
beneficiaries they are serving and, in the context of the performance-
based payment methodology for MDPP services, MDPP suppliers should 
appropriately bear the cost of the beneficiary engagement incentives 
they choose to furnish.
    Comment: One commenter requested additional clarification of the 
meaning of ``furnished directly'' in the proposed condition, ``The item 
or service must be furnished directly to an MDPP beneficiary by an MDPP 
supplier or by an agent of the MDPP supplier, such as a coach, under 
the MDPP supplier's direction and control.'' The commenter asked CMS to 
specify how MDPP suppliers could contract with other entities to 
provide items that cannot be furnished by the MDPP supplier, such as 
gym memberships or transportation services.
    Response: The commenter's request for clarification was made in the 
context of MDPP suppliers considering establishing contractual 
relationships with other entities to provide items as beneficiary 
engagement incentives that the MDPP supplier is unable to furnish. For 
purposes of this proposed condition, we consider that an entity under 
contract with an MDPP supplier to furnish items or services specified 
by the MDPP supplier for an MDPP beneficiary as beneficiary engagement 
incentives would be an agent of the MDPP supplier. The proposed 
condition permits beneficiary engagement incentives to be furnished 
directly to an MDPP beneficiary by an agent of the MDPP supplier, as 
long as the agent is under the MDPP supplier's direction and control 
when furnishing the incentive. Thus, we believe that this condition 
does not limit MDPP suppliers' ability to contract with entities to 
provide items as beneficiary engagement incentives, as long as the 
contractual relationship complies with all applicable laws and 
regulations, including those specific to beneficiary engagement 
incentives under the MDPP expanded model.
    Comment: One commenter who expressed appreciation for the proposed 
program safeguard that the item or service must be reasonably connected 
to the CDC-approved DPP curriculum furnished to the MDPP beneficiary 
during a core session, a core maintenance session, or ongoing 
maintenance session furnished by the MDPP supplier also identified the 
potential for confusion resulting from the phrase ``reasonably 
connected to the CDC-approved DPP curriculum.'' The commenter urged CMS 
to review beneficiary engagement incentives suggested by MDPP suppliers 
and provide additional guidance on the types of incentives that are 
``reasonably connected to the CDC-approved DPP curriculum'' and those 
that would not meet this condition.
    Response: We appreciate the commenter's support for this proposal. 
However, because only the MDPP supplier knows the specific CDC-approved 
DPP curriculum that is furnished to an MDPP beneficiary during a 
particular session and in view of the large number of types of 
potential beneficiary engagement incentives, we are not able to further 
clarify the types of beneficiary engagement incentives that would be 
reasonably connected to the DPP curriculum furnished to a particular 
MDPP beneficiary during a session. We note that as finalized at Sec.  
424.205(g)(2)(ii), the MDPP supplier must maintain documentation of 
each MDPP session furnished to an MDPP beneficiary that identifies 
which CDC-approved DPRP curriculum was associated with that session. 
Thus, the MDPP supplier will have available the information necessary 
to make a determination about whether a specific beneficiary engagement 
incentive being considered for an MDPP beneficiary meets this 
condition.
    If the MDPP supplier determines that the incentive being considered 
is reasonably connected to the DPP curriculum furnished to a 
beneficiary during a session, the MDPP supplier must also make a 
determination about whether the incentive meets the other requirements 
for beneficiary engagement incentives under the MDPP expanded model 
before deciding whether or not to furnish the item or service to the 
beneficiary as a beneficiary engagement incentive. Through information 
from claims for MDPP services and the MDPP supplier documentation 
required under the MDPP expanded model, we plan to monitor beneficiary 
engagement incentives furnished to MDPP beneficiaries by MDPP suppliers 
for compliance with the final conditions for the incentives, including 
that incentives furnished to MDPP beneficiaries are reasonably 
connected to the DPP curriculum furnished to those beneficiaries during 
sessions.
    Comment: One commenter questioned how a beneficiary engagement 
incentive could meet the proposed condition that it be reasonably 
connected to the CDC-approved DPP curriculum and also be a preventive 
care item or service, which the commenter noted is another condition 
that each beneficiary engagement incentive must also meet. The 
commenter stated that not all items would meet both criteria and 
provided the example of a digital scale that would be connected to the 
DPP curriculum but is not itself a preventive care item or service.
    Response: We believe the commenter may have misunderstood our 
proposal related to the condition for beneficiary engagement incentives 
that includes reference to a preventive care item or service. We 
proposed that the item or service must be a preventive care item or 
service or an item or service that advances a clinical goal for an MDPP 
beneficiary by engaging him or her in better managing his or her own 
health. The proposed clinical goals of the MDPP expanded model are 
attendance at core sessions, core maintenance sessions, or ongoing 
maintenance sessions; weight loss; long-term dietary change; and 
adherence to long-term health behavior changes. While we agree with the 
commenter that a digital scale is not a preventive care item or 
service, it is an item that may advance the clinical goal of weight 
loss for an MDPP beneficiary. Therefore, we believe it is possible for 
a digital scale and other items and services furnished as beneficiary 
engagement incentives to both be reasonably connected to the CDC-
approved DPP curriculum furnished to an MDPP beneficiary during a core 
session, core maintenance session, or ongoing maintenance session by 
the MDPP supplier and be an item or service that advances a clinical 
goal for an MDPP beneficiary by engaging him or her in better managing 
his or her health.
    Comment: Several commenters expressed concern about the potential 
for MDPP suppliers to shift the cost of beneficiary engagement 
incentives to MDPP beneficiaries. The commenters requested that CMS 
solicit additional public input on this topic, noting that it may be 
difficult for MDPP suppliers to amass the resources needed to provide 
such incentives without cost-shifting before the supplier receives 
payment for MDPP services based on claims that are submitted to 
Medicare. The commenters urged CMS to clarify that MDPP suppliers are 
prohibited from requiring MDPP beneficiaries to shoulder any of the 
costs of beneficiary engagement incentives and that incentive 
structures that financially penalize beneficiaries for lack of 
adherence to health behavior changes taught in the DPP curriculum or

[[Page 53329]]

failure to achieve a performance goal are not permitted.
    Response: We appreciate the interest of the commenters in ensuring 
that the costs of beneficiary engagement incentives furnished to MDPP 
beneficiaries by MDPP suppliers are borne by the suppliers, as we 
proposed, and not shifted to beneficiaries. We note that our proposal 
for beneficiary engagement incentives specifies that these are items 
and services that may be furnished in-kind by MDPP suppliers and, 
therefore, MDPP suppliers would bear the costs of the incentives.
    In response to the concerns about MDPP suppliers lacking sufficient 
resources to furnish beneficiary engagement incentives early on in the 
MDPP services period before receiving performance payments, we note 
that there is no requirement that MDPP suppliers furnish beneficiary 
engagement incentives. Thus, MDPP suppliers could wait until they have 
amassed enough payments to bear the costs of the incentives or forgo 
furnishing incentives to MDPP beneficiaries altogether.
    We proposed at Sec.  424.210(b)(7) that the cost of the item or 
service furnished as a beneficiary engagement incentive must not be 
shifted to another Federal health care program, as defined at section 
1128B(f) of the Act, but did not explicitly prohibit cost-shifting to 
MDPP beneficiaries. Shifting the cost of beneficiary engagement 
incentives to MDPP beneficiaries would not be permitted under our 
proposal, and we agree with the commenters that MDPP beneficiaries 
should not bear any of these costs. Therefore, in view of the concerns 
of the commenters over the potential for MDPP suppliers to shift the 
costs of beneficiary engagement incentives to MDPP beneficiaries and 
our interest in safeguarding against such a shift, we believe it would 
be appropriate to add an additional condition in new Sec.  
424.210(b)(8) to specify that the cost of the item or service furnished 
as a beneficiary engagement incentive must not be shifted to an MDPP 
beneficiary. For example, under this condition the beneficiary 
engagement incentive structure used by an MDPP supplier may not 
financially penalize an MDPP beneficiary through a cost to the 
beneficiary for lack of adherence to health behavior changes taught in 
the DPP curriculum or failure to achieve performance goals.
    As we stated in the proposed rule (82 FR 34168) in the context of 
our proposal that the beneficiary engagement incentive must be a 
preventive care item or service, or an item or service that advances a 
clinical goal for an MDPP beneficiary by engaging him or her in better 
managing his or her own health, beneficiary engagement incentives may 
not be offered to an MDPP beneficiary as a reward for achievement of a 
specified outcome, such as losing weight or attending a certain number 
of sessions, unless the beneficiary engagement incentive meets all the 
proposed conditions, including that it is reasonably connected to the 
CDC-approved DPP curriculum furnished to the MDPP beneficiary during a 
core session, a core maintenance session, or an ongoing maintenance 
session by the MDPP supplier. Similarly, beneficiary engagement 
incentive structures that financially penalize beneficiaries for lack 
of adherence to health behavior changes taught in the DPP curriculum or 
failure to achieve a performance goal would not meet the requirements 
for beneficiary engagement incentives under the MDPP expanded model, 
including that the item or service be a preventive care item or service 
or an item or service that advances a clinical goal for an MDPP 
beneficiary by engaging him or her in betting managing his or her own 
health. Such an approach would shift all or part of the cost of the 
beneficiary engagement incentive to the MDPP beneficiary, which is 
explicitly not permitted under the new condition we are finalizing at 
Sec.  424.210(b)(8).
    Comment: A few commenters requested that CMS closely monitor the 
use and impact of beneficiary engagement incentives to ensure they are 
not being used as a reward for reaching certain MDPP goals or in any 
way that may be discriminatory. Other commenters recommended that CMS 
provide more information on how it will enforce the regulations 
regarding beneficiary engagement incentives.
    Response: We plan to monitor beneficiary engagement incentives 
furnished to MDPP beneficiaries by MDPP suppliers under the MDPP 
expanded model for compliance with the final conditions for the 
incentives. Should issues of non-compliance with the conditions or 
other concerns arise, CMS will utilize established enforcement 
mechanisms to address these issues.
    Comment: Many commenters strongly supported the proposal to 
disconnect furnishing beneficiary engagement incentives from the 
achievement of outcomes under the MDPP expanded model.
    Response: We appreciate the commenters' support for separating the 
provision of beneficiary engagement incentives by MDPP suppliers to 
MDPP beneficiaries from the beneficiary's achievement of outcomes. 
However, we note that we did not propose to completely disconnect 
furnishing beneficiary engagement incentives from the achievement of 
specific outcomes in all cases. Instead, we proposed that beneficiary 
engagement incentives may not be offered to an MDPP beneficiary as a 
reward for achievement of a specified outcome, such as losing weight or 
attending a certain number of sessions, unless the beneficiary 
engagement incentive meets all the proposed conditions, including that 
it is reasonably connected to the CDC-approved DPP curriculum furnished 
to the MDPP beneficiary during a core session, a core maintenance 
session, or an ongoing maintenance session by the MDPP supplier. That 
is, if a beneficiary engagement incentive meets all of the proposed 
conditions for such incentives and is offered to the MDPP beneficiary 
as a reward for the achievement of a specified outcome, we would 
consider that beneficiary engagement incentive to be permitted under 
the MDPP expanded model. We continue to believe that our proposed 
policy is appropriate because it ensures that the beneficiary 
engagement incentive itself is a preventive care item or service or an 
item or service that advances a clinical goal by engaging a beneficiary 
in better managing his or her own health, including under those 
circumstances where the incentive is offered by the MDPP supplier as a 
reward for the achievement of an outcome.
    Comment: One commenter observed that CMS did not propose to limit 
the aggregate retail value of items and services furnished as 
beneficiary engagement incentives that are not items of technology, 
which the commenter noted could invite competition among MDPP suppliers 
for beneficiaries based on the value of the incentives and not based on 
quality or clinical outcomes of the MDPP services furnished by the MDPP 
supplier.
    Response: As the commenter stated, we did not propose a maximum 
aggregate retail value limit for beneficiary engagement incentives 
other than items and services involving technology that are furnished 
to an MDPP beneficiary by an MDPP supplier. We do not believe the risk 
of misuse of non-technology items and services furnished as beneficiary 
engagement incentives warrants the greater administrative burden on 
MDPP suppliers that would result from limiting the aggregate retail 
value of these items and services. Such an aggregate limit would 
require documentation of all beneficiary engagement incentives of any 
retail

[[Page 53330]]

value, thereby significantly increasing the MDPP supplier 
administrative burden beyond that required by our proposal for 
documentation of only those incentives with a retail value of greater 
than $25. In contrast, we believe that items and services involving 
technology, which we address in detail subsequently in this section, 
have a higher risk of misuse so we proposed enhanced safeguards for 
those types of incentives, including a maximum aggregate retail value 
limit of $1,000 per beneficiary from a single MDPP supplier during the 
MDPP services period.
    In addition, we proposed a number of other conditions for 
beneficiary engagement incentives discussed throughout this section 
that provide program safeguards, including protection against 
competition among MDPP suppliers for beneficiaries based on the value 
of incentives and not based on the quality or clinical outcomes of MDPP 
services.
    Comment: One commenter stated that smaller MDPP suppliers that 
furnish MDPP services with equally effective outcomes as larger MDPP 
suppliers may not be able to sustain their programs if Medicare 
beneficiaries are lured to receive MDPP services at the larger 
suppliers by the beneficiary engagement incentives offered by these 
bigger organizations. While the commenter acknowledged CMS' intent to 
disallow advertisement of available incentives, the commenter reasoned 
that in the community individuals talk to one another, and thus, word 
would spread within the community. The commenter urged CMS to further 
clarify the difference between MDPP suppliers furnishing a specific 
non-covered item or service as a beneficiary engagement incentive and 
CMS' intent that use of specific incentives would not ``steer'' 
particular beneficiaries away from or to the supplier furnishing the 
incentive.
    Response: We proposed that the availability of the item or service 
must not be advertised or promoted as an in-kind beneficiary engagement 
incentive available to an MDPP beneficiary receiving MDPP services from 
the MDPP supplier except that an MDPP beneficiary may be made aware of 
the availability of the item or service at the time the MDPP 
beneficiary could reasonably benefit from it during the engagement 
incentive period. While we understand that individuals within 
communities speak to one another so that a person may become aware of 
beneficiary engagement incentives furnished by certain MDPP suppliers 
before the individual becomes an MDPP beneficiary, we believe this 
condition still provides a reasonable safeguard against MDPP suppliers 
acting directly to recruit beneficiaries for MDPP services based on the 
availability of a beneficiary engagement incentive. Beneficiaries would 
not be made aware by the MDPP supplier of the availability of 
beneficiary engagement incentives until the MDPP beneficiary was in an 
engagement incentive period, which would begin when the MDPP supplier 
furnished its first MDPP service to the beneficiary. At that point in 
time, the beneficiary would have already selected that MDPP supplier to 
furnish his or her MDPP services so the incentive could not be used to 
steer the beneficiary to that MDPP supplier.
    Comment: One commenter generally supported the concept of not 
advertising beneficiary engagement incentives to deter MDPP suppliers 
from encouraging Medicare beneficiary participation in their DPP only 
for purposes of gaining the incentives. However, the commenter further 
reasoned that the MDPP supplier's having the ability to advertise some 
incentives (including transportation and childcare) that remove 
barriers to session attendance could enable more Medicare beneficiaries 
to participate in MDPP services. The commenter concluded that 
transportation and childcare are not incentives but instead services 
that reduce barriers and should be in another category with different 
rules tied to them.
    Response: Regarding the commenter's recommendation that we apply 
different rules to certain beneficiary engagement incentives, such as 
transportation or childcare, that advance the clinical goal of 
attendance at MDPP services rather than the clinical goal of weight 
loss, long-term dietary change, or adherence to long-term health 
behavior changes, we disagree that we should treat these types of 
incentives differently by allowing them to be advertised to Medicare 
beneficiaries. If advertised to beneficiaries by an MDPP supplier prior 
to the start of the beneficiary's engagement incentive period, 
incentives such as transportation or childcare could steer 
beneficiaries toward that particular MDPP supplier. We believe that in-
kind items and services furnished by MDPP suppliers to MDPP 
beneficiaries to reduce barriers to session attendance are similar to 
other beneficiary engagement incentives that advance different clinical 
goals of the MDPP expanded model because they assist the beneficiary in 
better managing his or her own health. An MDPP supplier may make a 
beneficiary aware of a beneficiary engagement incentive at the time the 
MDPP beneficiary could reasonably benefit from it during the engagement 
incentive period, and we believe this condition provides sufficient 
flexibility for MDPP suppliers to be able to remove attendance barriers 
when beneficiaries participate in MDPP services.
    Comment: Several commenters requested that CMS clarify whether 
certain items and services would be permitted to be furnished as 
beneficiary engagement incentives to MDPP beneficiaries by MDPP 
suppliers under the proposal. One commenter reported that some managed 
care organizations and DPP organizations have experienced success 
providing retail gift cards to socially at-risk populations. The 
commenter further explained that individuals may use the retail gift 
cards at their discretion to buy healthy food, scales, pedometers, 
work-out shoes and clothes, thereby reducing the burden on DPP 
organizations, as not all direct service suppliers have the capacity to 
buy equipment in sufficient quantities or to buy different types of 
items that anticipate each beneficiary's need. Another commenter urged 
CMS to permit supermarket gift cards to be furnished as a beneficiary 
engagement incentive, reasoning that these would allow some 
beneficiaries to purchase more produce and healthy foods.
    Response: We disagree with the commenters' suggestion that we 
globally permit retail gift cards to be considered as a form of 
beneficiary engagement incentive under the MDPP expanded model. Because 
we are testing the model to determine if MDPP services improve the 
quality and reduce the cost of health care for Medicare beneficiaries, 
we continue to believe that it is important to maintain the 
requirements of a reasonable connection between the item or service 
furnished as a beneficiary engagement incentive and the CDC-approved 
DPP curriculum furnished to the MDPP beneficiary during MDPP services 
and that the item or service must be a preventive care item or service 
or an item or service that advances a meaningful clinical goal for the 
MDPP beneficiary. These conditions both protect against MDPP suppliers' 
incentives to influence the beneficiary's choice of MDPP supplier and 
other types of care and ensure that the MDPP expanded model is 
implemented in accordance with consistent standards across MDPP 
suppliers in order to allow for evaluation of the model.
    Therefore, regarding the potential for retail gift cards, including 
supermarket gift cards, to be furnished by MDPP suppliers as 
beneficiary engagement incentives, we encourage MDPP suppliers 
considering furnishing these items to assess whether the specific gift

[[Page 53331]]

cards meet all the requirements for beneficiary engagement incentives, 
including that they are reasonably connected to the CDC-approved 
curriculum and advance a clinical goal for the MDPP beneficiary. 
Whether these requirements are met may be related to the particular 
retailer at which the beneficiary could purchase items with the gift 
card. To the extent the retailer sells a large variety of items and a 
substantial percentage of those items would not meet the requirements 
for beneficiary engagement incentives if furnished directly to the MDPP 
beneficiary by the MDPP supplier, we would consider a gift card 
furnished by an MDPP supplier to that retailer not to meet the 
beneficiary engagement incentive conditions under the MDPP expanded 
model.
    Comment: One commenter stated that incentives targeted to food 
access and physical activity access support the goals of the MDPP 
expanded model and requested that CMS clarify that MDPP suppliers would 
be permitted to offer these items as beneficiary engagement incentives.
    Response: Beneficiary engagement incentives targeted to food access 
or physical activity access would be permitted to be offered as 
beneficiary engagement incentives only if the specific item or service 
meets all of the requirements for beneficiary engagement incentives 
finalized for the MDPP expanded model. These types of potential 
incentives need to be assessed by the MDPP supplier that is considering 
offering them with respect to their connection to the CDC-approved DPP 
curriculum furnished to the MDPP beneficiary at sessions and their 
potential to advance the MDPP expanded model clinical goals for the 
MDPP beneficiary, as well as with regard to the other conditions for 
beneficiary engagement incentives.
    Comment: One commenter recommended that CMS clarify that certain 
items or services would not be beneficiary engagement incentives, and 
therefore, would not be subject to the conditions for these incentives. 
The items and services the commenter requested be excluded from the 
requirements for beneficiary engagement incentives were: assistance in 
enrolling in public benefits; assistance connecting to emergency food 
services (for example, food pantries); and provision of meals during 
the MDPP session.
    Response: To the extent that MDPP suppliers want to assist MDPP 
beneficiaries in enrolling in public benefits, connect MDPP 
beneficiaries to emergency food services, or provide meals during MDPP 
sessions at the MDPP supplier's expense. The MDPP supplier must 
determine whether furnishing the item or service meets the requirements 
of all applicable laws and regulations. The conditions for beneficiary 
engagement incentives under the MDPP expanded model are intended to 
provide MDPP suppliers with additional flexibilities to furnish in-kind 
items and services, rather than further limiting an MDPP supplier's 
provision of items and services beyond existing laws and regulations.
    Comment: One commenter, who supported the proposal to allow 
beneficiary engagement incentives to be furnished to increase 
beneficiary engagement toward achieving the goals of MDPP services, 
sought confirmation from CMS that if a beneficiary engagement incentive 
is furnished to an MDPP beneficiary covered under an MA plan, this 
action would not violate the guidance in the Medicare Managed Care 
Manual, Chapters 3 and 4, for MA program rules.
    Response: We appreciate the commenter's support for our proposal to 
allow MDPP suppliers to furnish beneficiary engagement incentives to 
MDPP beneficiaries under certain conditions, as well as their request 
for clarification about the relationship between these provisions and 
MA program rules. We are clarifying that the beneficiary engagement 
incentive regulations at Sec.  424.210 strictly apply to MDPP services 
furnished under the MDPP expanded model, including when furnished or 
covered by an MA plan. Because the beneficiary engagement incentive 
regulations are more specific than the Medicare Advantage Rewards and 
Incentives Program regulations at Sec.  422.134 (outlined in Chapter 4 
of the Medicare Managed Care Manual) and the corresponding Rewards and 
Incentives Program marketing guidelines (outlined in Chapter 3 of the 
Medicare Managed Care Manual), the MDPP regulations will apply to MDPP 
services furnished under the MDPP expanded model.
    After considering the public comments received, we are finalizing 
the proposals for the general conditions for in-kind beneficiary 
engagement incentives at Sec.  424.210(b), with modifications. We are 
adding another condition for beneficiary engagement incentives at Sec.  
424.210(b)(8) that specifies that the cost of the item or service must 
not be shifted to an MDPP beneficiary.
iii. Technology Furnished to an MDPP Beneficiary
    In some cases, items or services involving technology may be useful 
as beneficiary engagement incentives because they can advance a 
clinical goal of the MDPP expanded model by engaging an MDPP 
beneficiary in managing his or her health. However, in the proposed 
rule (82 FR 34169) we stated our belief that specific enhanced 
safeguards are necessary for these items and services to prevent abuse.
    First, we proposed that items or services involving technology 
furnished by an MDPP supplier to its MDPP beneficiary may not, in the 
aggregate, exceed $1,000 in retail value for any one MDPP beneficiary. 
We believed that this proposed limit would be appropriate, in 
conjunction with our proposed enhanced requirements for items of 
technology with a retail value greater than $100 as discussed 
subsequently. The proposed $1,000 limitation would allow sufficient 
MDPP supplier flexibility to furnish items or services involving 
technology as beneficiary engagement incentives to improve the 
likelihood of the beneficiary's achievement and maintenance of the 
required minimum weight loss.
    For example, under this proposal, an MDPP beneficiary who begins 
receiving MDPP services from an MDPP supplier and who, after receiving 
MDPP services from that MDPP supplier, is furnished items or services 
of technology with a total retail value of $1,000 may not receive 
additional items or services of technology from that MDPP supplier. 
Therefore, an MDPP beneficiary may receive from an MDPP supplier a 
tablet valued at $700 that is preloaded with weight loss and fitness 
tracking apps that would support the beneficiary's weight loss goals 
under the MDPP expanded model and also receive from the same MDPP 
supplier a fitness tracking watch valued at $200 that uploads and 
monitors fitness data to the tablet, but he or she could not then 
receive additional items of technology from the MDPP supplier with an 
aggregate retail value greater than $100 as this would exceed the 
$1,000 limit.
    In addition, we proposed that if the same MDPP beneficiary chooses 
to receive MDPP services from another MDPP supplier, the subsequent 
supplier would be under no obligation to determine the value of any 
items or services of technology furnished to the MDPP beneficiary by 
other MDPP suppliers, and may furnish items or services of technology 
to the MDPP beneficiary so long as those items or services furnished by 
the subsequent

[[Page 53332]]

supplier are the minimum necessary to advance a clinical goal for the 
MDPP beneficiary, are furnished during the engagement incentive period, 
and do not, in aggregate, exceed $1,000 in retail value.
    We further proposed that items or services involving technology 
furnished to an MDPP beneficiary must be the minimum necessary to 
advance a clinical goal for MDPP beneficiaries as discussed in section 
III.K.2.f.iv. of the proposed rule (82 FR 34169 through 34170).
    We proposed enhanced requirements for items of technology exceeding 
$100 in retail value as an additional safeguard against misuse of these 
items as beneficiary engagement incentives. In the proposed rule (82 FR 
34169), we stated our belief that it would be inappropriate for MDPP 
suppliers to furnish items of technology with a retail value of over 
$100 for beneficiaries' permanent use because the high value of these 
items could unduly influence the beneficiary to continue to receive 
MDPP services from that supplier, or to receive items or services from 
the supplier other than MDPP services. Therefore, we proposed that 
items of technology with a retail value of over $100 would remain the 
property of the MDPP supplier and be retrieved from the MDPP 
beneficiary at the end of the engagement incentive period. We did not 
believe that this requirement would substantially increase the 
administrative burden on MDPP suppliers because a central facilitator 
of the success of an MDPP beneficiary in meeting MDPP performance goals 
is the MDPP supplier's ability to maintain contact with the MDPP 
beneficiary and engage him or her in MDPP services. We noted that items 
of technology with a retail value of $100 or less could be furnished as 
beneficiary engagement incentives and would remain the property of the 
beneficiary. In the case of these items of a technology with a lower 
retail value, we believed that the administrative burden of retrieving 
these items would outweigh the program integrity benefits of retrieval.
    We further proposed that the MDPP supplier must document all 
technology retrieval attempts, including the ultimate date of 
retrieval. However, because we understood that MDPP suppliers may not 
always be able to retrieve these items, such as when a beneficiary dies 
or moves to another geographic area, documented, diligent, good faith 
attempts to retrieve items of technology would be deemed to meet the 
retrieval requirement.
    Our proposals for enhanced requirements for technology furnished to 
MDPP beneficiaries as beneficiary engagement incentives under the MDPP 
expanded model were included at proposed Sec.  424.210(c). We invited 
public comments on our proposed requirements for beneficiary engagement 
incentives that involve technology and welcomed comments on additional 
or alternative program integrity safeguards for this type of 
beneficiary engagement incentive, including whether the proposed 
financial thresholds were reasonable, necessary, and appropriate.
    The following is a summary of the public comments received on the 
proposals for the requirements for beneficiary engagement incentives 
that involve technology and our responses:
    Comment: Several commenters encouraged CMS to provide more 
information on the evidence base for the $100 maximum retail value 
threshold for items involving technology that can remain the property 
of the beneficiary and the $1,000 aggregate limit on the retail value 
of items and services involving technology that can be furnished as 
beneficiary engagement incentives by one MDPP supplier to an MDPP 
beneficiary, including whether there are a similar beneficiary 
engagement incentive amount thresholds used elsewhere in Medicare or 
another program.
    Response: We appreciate the interest of the commenters in 
additional information on the proposed $100 maximum retail value 
threshold for items involving technology that can remain the property 
of the beneficiary and the proposed $1,000 aggregate limit on the 
retail value of items and services involving technology that are 
furnished as beneficiary engagement incentives. We note that we 
finalized through notice and comment rulemaking these same thresholds 
for other Innovation Center payment models, including the Comprehensive 
Care for Joint Replacement Model (80 FR 73436). We refer readers to 
that discussion for further information on our reasoning for finalizing 
the thresholds for that model, which is similar to our rationale for 
these thresholds under the MDPP expanded model.
    For example, we believe that the $100 retail value retrieval 
threshold for items involving technology would allow some types of 
electronic tablets that could be furnished to an MDPP beneficiary for 
activity and dietary monitoring during an engagement incentive period 
to remain the property of the beneficiary for permanent use following 
the end of that period. In addition, we believe the $1,000 aggregate 
limit on the retail value of items and services involving technology 
that may be furnished by one MDPP supplier to an MDPP beneficiary is 
sufficiently high to allow MDPP suppliers the flexibility to furnish a 
wide range of items and services involving technology that advance the 
goals of the MDPP expanded model, without significantly risking 
suppliers furnishing more broadly used technology that is more valuable 
to the beneficiary than reasonably necessary for the DPP curriculum 
being taught.
    Comment: In the context of a commenter's request that CMS not limit 
the MDPP services period to once-per-lifetime per beneficiary, the 
commenter asked that CMS clarify whether the $1,000 technology 
incentive limit could ``reset'' if the MDPP beneficiary resumes MDPP 
services with an MDPP supplier after a long absence.
    Response: As we stated in the proposed rule (82 FR 34169), the 
$1,000 aggregate retail value limit for items and services involving 
technology that may be furnished to any one MDPP beneficiary by any one 
MDPP supplier would not otherwise be affected by the engagement 
incentive period. In addition, we finalized the once-per-lifetime MDPP 
services period in the CY 2017 PFS final rule (81 FR 80470). Therefore, 
if an MDPP beneficiary begins and ends multiple engagement incentive 
periods with the same MDPP supplier spread apart after an absence that 
would be limited in the context of the maximum 24-month duration of the 
MDPP services period finalized in section III.K.2.b.i. of this final 
rule, we see no reason to allow the $1,000 aggregate retail value limit 
for items and services involving technology to ``reset'' at the 
beginning of a new engagement incentive period with the same MDPP 
supplier within the MDPP services period due to the risk that a high 
value technology incentive could be used to steer a beneficiary back to 
that MDPP supplier if we allowed the limit to ``reset.''
    Comment: Because CMS proposed that the cost of beneficiary 
engagement incentives be borne by MDPP suppliers as in-kind incentives 
and that CMS would not pay for these incentives, several commenters 
urged CMS not to set any retail value dollar threshold for items 
involving technology that can remain the property of a beneficiary. The 
commenters stated that MDPP suppliers should not be required to 
retrieve any items from MDPP beneficiaries after the engagement 
incentive period ends, especially since CMS did not offer guidance on 
what should happen with these recovered items, such as refurbishing 
them for

[[Page 53333]]

future use that could risk PII being stored and transmitted. The 
commenters claimed that the proposed technology retrieval requirements 
and resulting returned equipment would have limited value to the 
ongoing work and effort of MDPP suppliers, especially because 
technology quickly becomes obsolete. They noted that in addition to 
contacting beneficiaries who may have discontinued their participation 
in MDPP services with the MDPP supplier that furnished the technology, 
MDPP suppliers would have to develop costly, administratively 
burdensome processes for maintenance, documentation, and tracking of 
inventory, which most likely would require a system different from 
their existing MDPP documentation systems. The commenters concluded 
that the proposed technology retrieval requirements would have the 
unintended consequence of a high level of effort invested by MDPP 
suppliers with marginal returns, so they recommended that CMS not 
finalize this proposal.
    One commenter who urged CMS not to adopt a retail value dollar 
threshold for items that can remain the property of the beneficiary 
provided a list of potential beneficiary engagement incentives, 
including pedometers, water bottles, memberships at health clubs and 
exercise facilities, blood sugar monitors, slow cookers, and stretch 
bands, and claimed that it would not currently be the practice of DPP 
organizations to collect these items after the end of the program 
because reusing them is not practical and storing them would serve no 
purpose.
    Response: We do not believe it would be appropriate to eliminate 
the retrieval threshold for items involving technology altogether, even 
for those items involving technology that may provide additional health 
benefits to beneficiaries after the engagement incentive period ends 
and/or lead to reduced expenditures on health care in the future. It 
would be inappropriate for MDPP suppliers to furnish items involving 
technology with a retail value of over $100 for beneficiaries' 
permanent use because the high value of such items could unduly 
influence the beneficiary to continue to receive MDPP services from the 
MDPP supplier. We do not believe the potential longer-term benefits of 
continued use or the administrative burden of retrieving items 
involving technology with a retail value in excess of $100 outweigh the 
program integrity benefits of retrieval.
    In response to the commenter who disagreed with the retrieval of 
items involving technology of any retail value and provided a list of 
potential beneficiary engagement incentives where the commenter 
concluded that these items would generally not be reused and their 
storage would serve no purpose upon retrieval, we emphasize that the 
threshold of $100 maximum retail value for items that can remain in the 
MDPP beneficiary's permanent possession applies only to items involving 
technology, not to other types of beneficiary engagement incentives. We 
do not believe that the list of potential incentives provided by the 
commenter generally included items involving technology with a retail 
value of greater than $100 to which retrieval would apply.
    Finally, we note that items involving technology with a retail 
value of greater than $100 that are furnished as beneficiary engagement 
incentives under the MDPP expanded model would always be the property 
of the MDPP supplier, and it would be up to the MDPP supplier to make 
all decisions about the item's treatment upon return and further use. 
To the extent the item of technology returned to the MDPP supplier 
includes PII, MDPP suppliers are required to maintain and handle any 
PII and PHI in compliance with HIPAA, as applicable, other applicable 
state and federal privacy laws, and CMS standards.
    Comment: Several commenters urged CMS to increase the $100 
threshold for the maximum retail value of items involving technology 
that can remain the property of the beneficiary to a $200 threshold in 
order for MDPP suppliers to furnish items involving technology for 
beneficiary permanent use, such as wearable trackers and other 
beneficiary engagement incentives that often cost more than $100 per 
item. The commenters reasoned that the permanent use of these items 
involving technology could help beneficiaries sustain weight loss and 
healthy behaviors after MDPP services ended and, therefore, could be 
important for the maximum long-term reduction in the incidence of type 
2 diabetes to be achieved.
    Response: While we understand the administrative burden on MDPP 
suppliers that tracking and retrieval requires, we believe that a 
higher retrieval threshold, such as $200, is not warranted. As stated 
previously, it would be inappropriate for MDPP suppliers to furnish 
items involving technology with a retail value of over $100 for 
beneficiaries' permanent use because the high value of these items 
could unduly influence the beneficiary to continue to receive MDPP 
services from the MDPP supplier. We do not believe the potential 
longer-term benefits of continued use or the administrative burden of 
retrieving items involving technology with a retail value in excess of 
$100 outweigh the program integrity benefits of retrieval. We further 
note that wearable trackers with a retail value of less than $100 are 
widely available, so we do not believe that maintaining the retrieval 
threshold at $100 poses a significant risk that MDPP suppliers will be 
unable to furnish wearable trackers, the specific example cited by the 
commenters, to MDPP beneficiaries for their permanent use.
    Comment: Several commenters requested that CMS address what the 
commenters observed may be an inconsistency between two separate 
discussions in the proposed rule. The commenters pointed out that in 
one location CMS stated, ``This proposal would allow MDPP suppliers to 
furnish equipment that is reasonably necessary for the curriculum being 
taught to the beneficiary, such as digital scales to track and document 
patient weight or pedometers to track physical activity, but not 
broadly used technology that is more valuable to the beneficiary, such 
as a smartphone.'' The commenters further observed that in the specific 
proposal regarding the maximum retail value for items and services 
involving technology furnished by an MDPP supplier to an MDPP 
beneficiary, CMS stated, ``An MDPP beneficiary may receive from an MDPP 
supplier a tablet valued at $700 that is preloaded with weight loss and 
fitness tracking apps that would support the beneficiary's weight loss 
goals under the MDPP expanded model and also receive from the same MDPP 
supplier a fitness tracking watch valued at $200 that uploads and 
monitors fitness data to the tablet . . .'' The commenters requested 
that CMS clarify its apparent distinction between smartphones and other 
forms of mobile technologies with apps.
    Response: We appreciate the request for clarification about the 
discussions in the proposed rule that included examples of smartphones 
and tablets, two types of mobile technologies. We proposed that items 
or services involving technology must be the minimum necessary to 
advance a clinical goal for an MDPP beneficiary. We continue to believe 
this requirement is appropriate as a program safeguard against items 
involving technology being furnished to steer beneficiaries toward 
particular MDPP suppliers or other services, coupled with the 
additional requirement that items involving technology with a retail 
value greater than $100 must remain the property of the MDPP supplier 
and,

[[Page 53334]]

therefore, cannot remain in the permanent possession of the 
beneficiary. As to whether individual items of equipment, including 
mobile technologies with apps such as tablets or smartphones, meet the 
requirements for beneficiary engagement incentives that are items and 
services involving technology, we believe that the principal uses of 
the items must be considered in making such a determination. As we 
stated in the proposed rule (82 FR 34168), we do not believe that a 
smartphone, which is broadly used technology with uses that generally 
extend far beyond the DPP curriculum and clinical goals of the MDPP 
expanded model, would be reasonably necessary for the DPP curriculum 
being taught to the MDPP beneficiary, and we further do not believe 
that a smartphone would be the minimum technology necessary to advance 
a clinical goal for the MDPP beneficiary.
    In the proposed rule (82 FR 34169), we included an example of an 
MDPP beneficiary who receives from an MDPP supplier a tablet valued at 
$700 that is preloaded with weight loss and fitness tracking apps that 
would support the beneficiary's weight loss goals under the MDPP 
expanded model. It was our expectation that the principal use for such 
a tablet would be related to the DPP curriculum being taught to the 
MDPP beneficiary and the advancement of the MDPP expanded model's 
clinical goals for that beneficiary. To the extent the tablet is also 
populated with apps whose uses extend far beyond the DPP curriculum and 
clinical goals of the MDPP expanded model, consistent with our 
discussion of a smartphone, we do not believe such a tablet would be 
reasonably necessary for the DPP curriculum being taught to the MDPP 
beneficiary, and we further do not believe it would be the minimum 
technology necessary to advance a clinical goal for the MDPP 
beneficiary.
    Comment: One commenter reported that a major barrier to a 
beneficiary's attendance at MDPP services may be unstable access to a 
consistent phone number, and further speculated that while providing a 
smartphone might not solve this issue, assisting the beneficiary in 
signing up for a publicly available free cell phone could be a major 
tool for improved attendance. The commenter expressed concern that this 
assistance could be discouraged by the smartphone example included in 
the proposed rule.
    Response: Given that one of the clinical goals of the MDPP expanded 
model is MDPP beneficiary session attendance, if an MDPP supplier 
believes erratic access to a consistent phone number creates a barrier 
to MDPP session attendance for a particular MDPP beneficiary, it is 
possible that furnishing a basic cell phone or assisting a beneficiary 
in signing up for a publicly available free cell phone would meet the 
requirements for beneficiary engagement incentives under the MDPP 
expanded model. However, we do not believe that a smartphone, which is 
broadly used technology with uses that generally extend far beyond the 
DPP curriculum and clinical goals of the MDPP expanded model, would be 
reasonably necessary for the DPP curriculum being taught to the MDPP 
beneficiary, and we further do not believe it would be the minimum 
technology necessary to advance a clinical goal for an MDPP 
beneficiary.
    After considering the public comments received, we are finalizing 
the proposals, without modification, for enhanced requirements for 
items and services involving technology furnished to MDPP beneficiaries 
as beneficiary engagement incentives under the MDPP expanded model at 
Sec.  424.210(c).
iv. Clinical Goals of the MDPP Expanded Model
    As established at Sec.  410.79(b) in the CY 2017 PFS final rule, 
MDPP services furnished to MDPP beneficiaries must follow a CDC-
approved curriculum, which outlines required and recommended topics for 
structured health behavior change sessions offered as MDPP services 
with the goal of preventing diabetes through long-lasting health 
behavior change. MDPP suppliers seeking recognition under the CDC's 
DPRP must furnish either the CDC-preferred curriculum, based on the 
current evidence base, or may develop their own curriculum. MDPP 
suppliers that wish to develop their own curriculum must submit it to 
the CDC for approval. This requirement ensures that all curricula 
furnished to MDPP beneficiaries meet the DPRP's curriculum content 
requirements and are based on evidence from efficacy and effectiveness 
trials consistent with the current evidence base. To be consistent with 
the current evidence base, all curricula offered by MDPP suppliers must 
furnish MDPP services focused on the overarching goal of preventing 
type 2 diabetes in persons at high risk for diabetes because they have 
prediabetes. This requires MDPP suppliers to emphasize the need to make 
lasting health behavior changes, rather than simply completing a one-
time set of MDPP services that result in the required minimum weight 
loss during the MDPP services period. MDPP services must also emphasize 
long-term improvements in nutrition and physical activity that 
contribute to beneficiaries sustaining weight loss. Therefore, in the 
proposed rule (82 FR 34170) we stated our belief that in-kind patient 
engagement incentives may appropriately be furnished to support and 
motivate MDPP beneficiaries in achieving dietary and health behavior 
change and to teach MDPP beneficiaries to problem-solve strategies to 
overcome challenges to maintaining weight loss and healthy behaviors, 
as well as to assist MDPP beneficiaries in meeting the attendance and 
weight loss performance goals of the MDPP expanded model.
    Therefore, we proposed that the following would be the clinical 
goals of the MDPP expanded model, which may be advanced through 
beneficiary engagement incentives:
     Beneficiary attendance at MDPP core sessions, core 
maintenance sessions, or ongoing maintenance sessions during the MDPP 
services period.
     Beneficiary weight loss.
     Long-term dietary change for the beneficiary.
     Beneficiary adherence to long-term health behavior 
changes.
    We noted that under this proposal, the MDPP supplier may not 
furnish multiple free meals or meal replacement services to an MDPP 
beneficiary over a substantial portion of the engagement incentive 
period because such a practice would not advance a clinical goal for an 
MDPP beneficiary by engaging him or her in better managing his or her 
own health.
    When a beneficiary engagement incentive does not qualify as a 
preventive care item or service, our proposals for the clinical goals 
of the MDPP expanded model that a beneficiary engagement incentive must 
be intended to advance were included at proposed Sec.  424.210(d). We 
invited public comments on our proposed clinical goals of the MDPP 
expanded model, as well as whether the advancement of additional or 
different clinical goals through beneficiary engagement incentives may 
better advance the overarching goals of the MDPP expanded model, while 
maintaining appropriate program integrity safeguards.
    We received no public comments on the proposals for the clinical 
goals of the MDPP expanded model.
    We are finalizing the proposals, without modification, for the 
clinical goals of the MDPP expanded model that a beneficiary incentive 
must be intended to advance at Sec.  424.210(d).

[[Page 53335]]

v. Documentation of Beneficiary Engagement Incentives
    As a program safeguard against misuse of beneficiary engagement 
incentives under the MDPP expanded model, we proposed that, in addition 
to the documentation requirements for MDPP suppliers at proposed Sec.  
424.205(g), MDPP suppliers must maintain documentation of items and 
services furnished as beneficiary engagement incentives that 
individually exceed $25 in retail value. We recognized that an MDPP 
beneficiary could receive many incentives that are each of low dollar 
value but in the aggregate constitute an excessively high value to the 
beneficiary. Therefore, we believed that it would be important to 
incorporate a documentation threshold at a modest level for all 
beneficiary incentives in order to monitor compliance with the proposed 
conditions for furnishing these items and services. Moreover, we 
believed that the proposed $25 retail value threshold would strike an 
appropriate balance between beneficiary and program protections and 
MDPP supplier administrative burden.
    In addition, we proposed to require that the documentation must be 
established contemporaneously with the furnishing of the items and 
services and must include at least the date the incentive was 
furnished; the identity of the beneficiary to whom the item or service 
was furnished; the agent of the supplier that furnished the item or 
service, if applicable; a description of the item or service; the 
retail value of the beneficiary engagement incentive; and documentation 
establishing that the item or service was furnished to the MDPP 
beneficiary during the engagement incentive period.
    In addition to the requirements in the previous paragraph, we 
further proposed that the documentation regarding items or services 
furnished to the MDPP beneficiary for use on an ongoing basis during 
the engagement incentive period, including items of technology 
exceeding $100 in retail value, must also include contemporaneous 
documentation establishing that the MDPP beneficiary is in the 
engagement incentive period throughout the time period that the MDPP 
beneficiary possesses or has access to the item or service furnished by 
the MDPP supplier. For example, if an MDPP supplier furnishes a gym 
membership to an MDPP beneficiary, the MDPP supplier would need to 
maintain contemporaneous documentation establishing that the MDPP 
beneficiary is in the engagement incentive period throughout the time 
period that the MDPP beneficiary has access to the gym via the 
membership furnished by the MDPP supplier.
    In addition to the above requirements, we further proposed that the 
documentation regarding items of technology exceeding $100 in retail 
value that MSPP suppliers would be required to retrieve from the MDPP 
beneficiary must also include contemporaneous documentation of any 
attempts to retrieve the item of technology furnished by the MDPP 
supplier from the MDPP beneficiary as required at proposed Sec.  
424.210(c)(3)(ii). We reiterated that under our proposal documented, 
diligent, good faith attempts to retrieve items of technology would be 
deemed to meet the retrieval requirement. Finally, we proposed that the 
MDPP supplier must retain and provide access to the required 
documentation in accordance with proposed Sec.  424.205(g).
    Our proposals for the documentation requirements for beneficiary 
engagement incentives under the MDPP expanded model were included at 
proposed Sec.  424.210(e). We invited public comments on our proposed 
documentation requirements, including whether additional or different 
documentation requirements may provide better program integrity 
safeguards.
    The following is a summary of the public comments received on the 
proposals for the documentation requirements for beneficiary engagement 
incentives under the MDPP expanded model and our responses:
    Comment: Several commenters urged CMS to require MDPP suppliers to 
document all beneficiary engagement incentives furnished to MDPP 
beneficiaries, not just those items and services with a retail value 
greater than $25, to further the goal of data collection about the 
incentives used.
    In contrast, other commenters stated that the proposal to require 
documentation of beneficiary engagement incentives that are in-kind 
with a retail value of greater than $25 would lead to an undue 
reporting burden for MDPP suppliers because of the large number of 
these incentives that could be furnished to an MDPP beneficiary. The 
commenters further stated the documentation burden would be 
particularly onerous for small suppliers with limited infrastructure 
and staffing. Multiple commenters claimed that while the administrative 
burden posed by the proposed documentation and tracking requirements 
would be large, the documentation would be of limited value to the 
ongoing work and effort of MDPP suppliers. The commenters urged CMS to 
not require documentation of beneficiary engagement incentives of any 
retail value.
    Response: We appreciate the diversity of perspectives of the 
commenters on our proposed documentation requirements for beneficiary 
engagement incentives in the MDPP expanded model. We proposed to 
require MDPP suppliers to document certain information about 
beneficiary engagement incentives with a retail value of greater than 
$25 to allow us to monitor compliance with the proposed conditions for 
furnishing these items and services, while striking an appropriate 
balance between beneficiary and program protections and MDPP supplier 
administrative burden. We recognized that an MDPP beneficiary could 
receive many incentives that are each of low dollar value but in the 
aggregate constitute an excessively high value to the beneficiary. 
While we did not propose to limit the aggregate value of non-technology 
items and services that may be furnished as beneficiary engagement 
incentives to an MDPP beneficiary by an MDPP supplier, documentation of 
items with a retail value greater than $25 would allow us to monitor 
compliance with the conditions for these incentives, which safeguard 
against misuse of beneficiary engagement incentives in the MDPP 
expanded model.
    We do not believe it would be appropriate to require documentation 
of all beneficiary engagement incentives of any retail value for 
purposes of data collection about incentives as recommended by some 
commenters, in view of the greater administrative burden this would 
place upon MDPP suppliers. We also do not believe that requiring no 
documentation of beneficiary engagement incentives of any retail value 
would be appropriate because we would be unable to monitor for 
compliance with the conditions for furnishing these items or services.
    Given the substantial flexibilities we will be affording MDPP 
suppliers to furnish beneficiary engagement incentives under the MDPP 
expanded model, we believe that requiring documentation of items and 
services with a retail value of greater than $25 is a reasonable 
responsibility for MDPP suppliers to assume. Our rationale for 
establishing documentation requirements for beneficiary engagement 
incentives is based on establishing program safeguards against misuse 
of beneficiary engagement incentives under the MDPP expanded model and 
not based primarily on the

[[Page 53336]]

value of documentation of beneficiary engagement incentives to the 
ongoing work and effort of MDPP suppliers. The documentation threshold 
of $25 reflects our interest in balancing the additional administrative 
burden on MDPP suppliers resulting from the documentation requirements 
for beneficiary engagement incentives with the beneficiary and program 
protections that will result. Finally, while under the MDPP expanded 
model MDPP suppliers are not required to maintain documentation for 
beneficiary engagement incentives with a retail value of less than or 
equal to $25, we encourage MDPP suppliers to maintain such 
documentation for other purposes as they see fit.
    Comment: One commenter observed that the proposed documentation 
requirements for beneficiary engagement incentives included many of the 
same variables as those required for claims submission, such as the 
date the incentive was furnished and the identity of the beneficiary to 
whom the item or service was furnished. The commenter claimed that 
documentation of beneficiary engagement incentives furnished to MDPP 
beneficiaries could more easily be achieved by adding a `non-covered' 
(or otherwise) HCPCS service code(s) or code modifier(s) to the 
proposed coding and billing structure for MDPP services. Under the 
commenter's recommended approach, such a code or code modifier included 
on a claim would reflect that a beneficiary engagement incentive had 
been furnished by the MDPP supplier during the period of time where 
sessions were furnished that were reported on the claim for a 
performance payment. The commenter reasoned that this approach to 
documentation would: (1) Reduce the administrative burden on the DPP 
supplier; (2) promote the use of automation in health care 
administration; (3) promote program integrity safeguards through the 
Medicare claims system; (4) mitigate the risk of incentives as an 
inducement for MDPP supplier selection; and (5) support the 
comprehensive evaluation of the use of incentives under the MDPP 
expanded model.
    Response: While we appreciate the potential benefits, including the 
availability of comprehensive information on incentives, of adopting 
the commenter's suggestion that we establish new HCPCS codes and/or 
modifiers that could be reported on claims in order to identify when 
beneficiary engagement incentives were furnished, we disagree with the 
commenter that this approach would reduce the administrative burden on 
the MDPP supplier or provide a sufficient program safeguard by 
mitigating the risk of incentives being furnished as an inducement for 
MDPP supplier selection.
    In order to monitor for compliance with the conditions for these 
incentives, we need information on the date the incentive was 
furnished; the identity of the beneficiary to whom the item or service 
was furnished; the agent of the supplier that furnished the item or 
service, if applicable; a description of the item or service; the 
retail value of the beneficiary engagement incentive; and documentation 
establishing that the item or service was furnished to the MDPP 
beneficiary during the engagement incentive period. The complexity of 
the coding that would be required to allow all of this information to 
be reported on administrative claims would be great, and we believe 
such a reporting methodology for beneficiary engagement incentives 
would lead to significantly greater administrative burden on MDPP 
suppliers than our proposed documentation approach. Therefore, we do 
not believe it would be feasible for MDPP suppliers to report on 
administrative claims all of the information about beneficiary 
engagement incentives that is necessary for us to monitor compliance 
with the conditions for these incentives that have been adopted to 
protect beneficiaries and the program from their misuse.
    Comment: Several commenters urged CMS to collect data on 
beneficiary engagement incentives from MDPP suppliers to study the 
effects of the various engagement incentives furnished to MDPP 
beneficiaries, including the amount and type of incentive; whether 
beneficiaries receiving the incentives actually maintained 
participation in MDPP services; and whether identified beneficiary 
engagement incentives contributed to beneficiaries meeting the weight 
loss performance goal or achieving other positive outcomes under the 
MDPP expanded model. The commenters stated that these data are needed 
to inform both effective incentive designs that could be offered to 
MDPP beneficiaries and best practices for future use.
    Response: We appreciate the interest of the commenters in expanding 
the evidence-base on the use of beneficiary engagement incentives in 
payment models, both the MDPP expanded model and other innovative 
payment models. As discussed previously in this section, we are not 
requiring documentation of all beneficiary engagement incentives of any 
retail value in view of the greater administrative burden this would 
place upon MDPP suppliers. We also do not currently have a mechanism 
for collecting data from MDPP suppliers on beneficiary engagement 
incentives. While we agree with the commenters that this information 
could be useful in informing future incentive designs, MDPP suppliers 
are already expected to submit a significant amount of information to 
CMS on claims and under the requirement to submit a crosswalk 
(finalized in this final rule at Sec.  424.205(d)(13)) under the MDPP 
expanded model that will inform the evaluation of the model overall, 
including the totality of its design features which include the 
voluntary provision of beneficiary engagement incentives. Therefore, we 
believe that requiring MDPP suppliers to submit detailed information on 
the type and amount of all incentives that are furnished to MDPP 
beneficiaries would place an undue documentation and reporting burden 
on suppliers. Instead, we expect that MDPP suppliers choosing to offer 
in-kind beneficiary engagement incentives, where the costs of these 
incentives are borne by the supplier, will be reviewing their 
experiences in their own DPP and making adjustments to their incentive 
practices based on their analysis of the MDPP performance of the 
population they are serving.
    After considering the public comments received, we are finalizing 
the proposals, without modification, for the documentation requirements 
for beneficiary engagement incentives under the MDPP expanded model at 
Sec.  424.210(e). Table 43 summarizes the final documentation 
requirements for beneficiary engagement incentives under the MDPP 
expanded model.

[[Page 53337]]



     Table 43--Final Beneficiary Engagement Incentive Documentation
                              Requirements
------------------------------------------------------------------------
    Beneficiary engagement
          incentive                    Documentation requirement
------------------------------------------------------------------------
Item or service with retail     Contemporaneous documentation
 value greater than $25.        that includes at least:
                               [ssquf] The date the incentive was
                                furnished.
                               [ssquf] The identity of the MDPP
                                beneficiary to whom the item or service
                                was furnished.
                               [ssquf] Documentation establishing that
                                the item or service was furnished to the
                                MDPP beneficiary during the engagement
                                incentive period.
                               [ssquf] The agent of the supplier that
                                furnished the item or service, if
                                applicable.
                               [ssquf] A description of the item or
                                service.
                               [ssquf] The retail value of the item or
                                service.
                                Documentation regarding items or
                                services that are furnished to the MDPP
                                beneficiary for use on an ongoing basis
                                during the engagement incentive period,
                                including items involving technology
                                exceeding $100 in retail value, must
                                also include contemporaneous
                                documentation establishing that the MDPP
                                beneficiary is in the engagement
                                incentive period throughout the time
                                period that the MDPP beneficiary
                                possesses or has access to the item or
                                service furnished by the MDPP supplier.
                                The documentation regarding
                                items involving technology exceeding
                                $100 in retail value must also include
                                contemporaneous documentation of any
                                attempt to retrieve the technology.*
                                The MDPP supplier must retain
                                and provide access to the documentation.
------------------------------------------------------------------------
* = Items involving technology with a retail value greater than $100
  remain the property of the MDPP supplier and must be retrieved from
  the MDPP beneficiary at the end of the engagement incentive period.

vi. Compliance With Fraud and Abuse Laws
    Certain arrangements between MDPP suppliers and beneficiaries may 
implicate the civil monetary penalty (CMP) law (sections 1128A(a)(5), 
(b)(1) and (b)(2) of the Act), or the Federal Anti-kickback statute 
(section 1128B(b)(1) and (2) of the Act). In many cases, arrangements 
that implicate these laws can be structured to comply with them by 
using existing safe harbors and exceptions. Section 1115A(d)(1) of the 
Act authorizes the Secretary to waive certain specified fraud and abuse 
laws as may be necessary solely for purposes of testing of models under 
section 1115A(b) of the Act. A waiver is not needed for an arrangement 
that does not implicate the fraud and abuse laws or that implicates the 
fraud and abuse laws, but either fits within an existing exception or 
safe harbor, as applicable, or does not otherwise violate the law. 
Accordingly, under section 1115A(d)(1) of the Act, the Secretary will 
consider whether waivers of certain fraud and abuse laws are necessary 
for the MDPP expanded model. Such waivers, if any, would be promulgated 
separately from this proposed regulation by OIG (as to sections 1128A 
and 1128B of the Act), to which the respective authorities have been 
delegated.
    Because of the close nexus between the final regulations governing 
the structure and operations of the MDPP expanded model and the 
development of any fraud and abuse waivers necessary to carry out the 
provisions of the model, CMS and OIG may, when considering the need for 
or scope of any waivers, consider comments submitted in response to the 
proposed rule and the provisions of the final rule. No waivers of any 
fraud and abuse authorities are being issued in this final rule.
3. Virtual DPP and the MDPP Expanded Model
    The CDC's DPRP Standards allow evidence-based DPP curricula to be 
furnished through a variety of modes, including through remote 
technologies. Similar to the description noted in section 
III.K.2.c.iv.3 of this final rule with respect to virtual make-up 
sessions, virtual DPP refers to any modality, or method of furnishing 
MDPP services, that is not in person. This includes, but is not limited 
to:
    (1) Furnishing services online where the behavior change program is 
furnished 100 percent online, with participants accessing course 
resources and lifestyle coach via a computer, laptop, tablet, smart 
phone, or other device with internet access. This modality requires an 
internet connection to participate in all aspects of the DPP;
    (2) Furnishing services online with other means of support by a 
coach (for example, telecommunications, video conferencing). This 
modality requires an internet connection for some aspects of the DPP, 
but not all; and
    (3) Distance learning, where a coach is present in one location and 
participants are calling, video-conferencing, or otherwise using 
telecommunications technology to access the coach from another 
location. This modality does not require any internet connection for 
any of the aspects of the DPP.
    These types of delivery modes are hereafter referred to as 
``virtual,'' and DPP furnished exclusively through these modes with no 
in-person delivery is hereafter referred to as ``virtual DPP.''
    We acknowledge that the public comments in response to the MDPP 
expanded model in the CY 2017 PFS proposed rule supported the inclusion 
of virtual DPP in the MDPP expanded model. Many commenters stated that 
this proposal would increase access to MDPP services, referenced 
emerging evidence that suggests virtual DPP may be as effective as DPP 
furnished in a community setting, and stated that virtual delivery may 
be preferable to some beneficiaries. In the CY 2017 PFS final rule, we 
deferred policies pertinent to virtual DPP to future rulemaking.
    Although in the CY 2018 PFS proposed rule, we proposed to allow a 
limited number of virtual make-up sessions in the MDPP expanded model 
(82 FR 34136 through 34137), we did not propose to include virtual DPP 
services (that is, DPP furnished exclusively through remote 
technologies with no in-person delivery), (82 FR 34171 through 34172). 
We considered including virtual DPP services in the MDPP expanded 
model; however, the DPP model test that was used to make the 
statutorily required determination for expansion did not include 
virtual DPP services. Instead, we noted that we are considering a 
separate model under CMS's Innovation Center authority to test and 
evaluate virtual DPP services. Consistent with our regular practice for 
Innovation Center models, we would release details on any model test 
for virtual DPP services separately.
    We noted that some DPP organizations currently offer DPP services 
through a combination of in-person and virtual delivery. We are 
finalizing to only allow this combination of delivery subject to the 
requirements on virtual make-up

[[Page 53338]]

sessions, discussed in section III.K.2.c.iv.3 of this final rule. The 
combined-delivery DPP services that are currently offered are intended 
to offer a participant DPP services through both online and in-person 
methods. The MDPP expanded model, in contrast, is intended to offer 
participants in-person DPP services primarily, but allows a limited 
number of virtual make-up sessions on an individual basis. As discussed 
in section III.K.2.c.iv.3 of this final rule, there is substantial 
research on the effectiveness of DPP furnished virtually, and emerging 
evidence on DPP delivered virtually suggests that virtual delivery can 
show similarly successful participant weight loss and health benefits 
to DPP delivered in other settings, including among Medicare-age 
participants. However, since the DPP model test only included in-person 
delivery, we are finalizing a limit on the number of virtually-
delivered make-up sessions to the limits discussed in section 
III.K.2.c.iv.3 of this final rule.
    An organization may furnish separate DPPs where some participants 
receive only in-person DPP services, others receive only virtual DPP 
services, and others receive a combination program where some sessions 
are offered in person and others virtually. If an organization that 
offers multiple distinct DPPs through different delivery modes enrolls 
as an MDPP supplier, we proposed that only DPP services furnished in 
person will be paid in the MDPP expanded model, with the exception of 
virtual make-up sessions as discussed in section III.K.2.c.iv.3 of this 
final rule.
    The following is a summary of the public comments received on 
virtual DPP services and our responses:
    Comment: We received many comments on virtual DPP services. The 
majority of commenters supported the use of virtual DPP services, 
either in the MDPP expanded model or in a separate virtual model test. 
These commenters noted that virtual options will expand access to DPP 
for individuals in rural areas, who are homebound, or who lack 
transportation options, and that including virtual DPP services would 
increase beneficiary choice of service provision and flexibility of 
program location. Commenters noted that virtual DPP has proven 
successful and has a strong evidence base, and some commenters noted 
that including virtual DPP in the expanded model would improve the 
effectiveness of MDPP services. Some commenters provided 
recommendations for a virtual DPP model test. Many commenters requested 
that CMS allow Medicare Advantage plans to offer virtual DPP services 
and requested clarity about the provision of virtual DPP services for 
MA plans. Only 2 commenters supported only including virtual DPP as a 
limited number of make-up sessions or deferring virtual DPP policies.
    Response: We appreciate the comments received related to virtual 
DPP; however, we note that we did not propose any policies related to 
exclusively virtual services. We will, however, be clarifying issues 
regarding virtual DPP services and MA plan members in future guidance. 
The development of new voluntary Innovation Center payment and service 
delivery models is not typically performed through notice and comment 
rulemaking, but we intend to utilize the comments received, as 
appropriate, to inform the development of any virtual model test that 
occurs as part of broader CMS efforts to promote expanded access to 
remote and telehealth services.
    Comment: We received several comments requesting that CMS permit MA 
plans to provide both in-person and fully virtual MDPP services to 
enrollees as part of the MDPP Expanded Model. These MAOs noted that 
virtual services would provide more access to MDPP services for MA plan 
enrollees and would ensure the MA enrollees have a choice in how to 
access MDPP services.
    Response: We believe that the reasons stated in this section 
regarding the exclusion of fully virtual MDPP services from the 
expanded model apply equally to the Medicare Advantage setting, and 
therefore, MA plans will not be able to provide fully virtual MDPP 
services to enrollees as a means to satisfy the requirement that an MA 
plan provide basic benefit MDPP services to its enrollees. However, we 
note that MA plans may continue to offer coverage of fully virtual 
MDPP-like services to enrollees as a supplemental benefit.
4. Evaluation
    We intend to evaluate the MDPP expanded model using a combination 
of encounter and claims data to analyze the long-term utilization of 
services by beneficiaries who have received the MDPP services. As 
discussed in the CY 2017 PFS final rule, we will continue to assess 
whether the MDPP expanded model is expected to improve the quality of 
care without increasing spending, reduce spending without reducing the 
quality of care, or improve the quality of care and reduce spending, 
and we will terminate or modify the MDPP expanded model if the expanded 
model is not expected to meet these criteria.
    Among other possible questions we might explore, our analysis will 
specifically look at long-term utilization and expenditures that might 
suggest subsequent treatment of diabetes. We intend to use beneficiary-
level encounter data and program data furnished by CDC and will match 
these data to Medicare claims using the crosswalk finalized at Sec.  
424.59(b)(3) of the CY 2017 PFS final rule (redesignated and amended at 
Sec.  424.205(d)(13)). As with other Innovation Center model evaluation 
reports (which are currently published online at https://innovation.cms.gov/Data-and-Reports/index.html), we intend to publish 
the MDPP expanded model evaluation annual reports publicly on a CMS Web 
site. We refer readers to the supplier requirements discussed under 
section III.K.2.e.iv.(7) of this final rule regarding supplier 
compliance with this requirement, as well as specifications on the 
timing and format of the crosswalk. Although CMS did not propose 
specific evaluation criteria in this rule, and therefore, did not seek 
comment on the evaluation approach, CMS acknowledges the comments 
received. Some commenters requested that CMS test and evaluate the 
impact of changes to lifetime limits, diabetes diagnosis, incentives, 
and the ongoing maintenance session framework. A few commenters 
requested CMS evaluate the effects of the various incentives furnished 
to MDPP beneficiaries, including the amount and type of incentive and 
whether beneficiaries receiving the incentives actually maintained 
participation. Other commenters suggested that CMS evaluate the total 
cost of care for MDPP services based on various personnel types (for 
example, community health workers, RDNs, CDEs, other qualified health 
care professionals) as well as study the effectiveness of various 
methods of delivery of the MDPP services based on personnel. Some 
commenters recommended analyses stratified by income and race as a 
means to ensure that the program is reaching all eligible Medicare 
beneficiaries and that these programs are able to achieve good outcomes 
for these populations. A few commenters suggested incorporating risk-
adjustment for social factors or other methods to appropriately account 
for social risk factors in future years. One commenter requested that 
CMS continue to support further innovation and evaluation of these 
services through additional model tests and other pilots within 
Medicare and other populations who could benefit, specifically 
including children covered by Medicaid and the Children's Health 
Insurance Program. One

[[Page 53339]]

commenter requested a continuous feedback loop among all entities 
involved in the MDPP on evaluation findings.
    Response: CMS appreciates all of the recommendations commenters 
provided. These comments will be considered in informing the evaluation 
design.

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

1. General
    Section 1877 of the Act prohibits a physician from referring a 
Medicare beneficiary for certain designated health services (DHS) to an 
entity with which the physician (or a member of the physician's 
immediate family) has a financial relationship, unless an exception 
applies. Section 1877 of the Act also prohibits the DHS entity from 
submitting claims to Medicare or billing the beneficiary or any other 
entity for Medicare DHS that are furnished as a result of a prohibited 
referral.
    Section 1877(h)(6) of the Act and Sec.  411.351 of our regulations 
specify that the following services are DHS:
     Clinical laboratory services.
     Physical therapy services.
     Occupational therapy services.
     Outpatient speech-language pathology services.
     Radiology services.
     Radiation therapy services and supplies.
     Durable medical equipment and supplies.
     Parenteral and enteral nutrients, equipment, and supplies.
     Prosthetics, orthotics, and prosthetic devices and 
supplies.
     Home health services.
     Outpatient prescription drugs.
     Inpatient and outpatient hospital services.
2. Annual Update to the Code List
a. Background
    In Sec.  411.351, we specify that the entire scope of four DHS 
categories is defined in a list of CPT/HCPCS codes (the Code List), 
which is updated annually to account for changes in the most recent CPT 
and HCPCS Level II publications. The DHS categories defined and updated 
in this manner are:
     Clinical laboratory services.
     Physical therapy, occupational therapy, and outpatient 
speech-language pathology services.
     Radiology and certain other imaging services.
     Radiation therapy services and supplies.
    The Code List also identifies those items and services that may 
qualify for either of the following two exceptions to the physician 
self-referral prohibition:
     EPO and other dialysis-related drugs furnished in or by an 
ESRD facility (Sec.  411.355(g)).
     Preventive screening tests, immunizations, or vaccines 
(Sec.  411.355(h)).
    The definition of DHS at Sec.  411.351 excludes services for which 
payment is made by Medicare as part of a composite rate (unless the 
services are specifically identified as DHS and are themselves payable 
through a composite rate, such as home health and inpatient and 
outpatient hospital services). With respect to ESRD services, for 
purposes of the physician self-referral law, we interpret the 
``composite rate'' as the per-treatment payment amount under the ESRD 
prospective payment system (PPS). The methodology used to calculate the 
ESRD PPS per-treatment payment amount incorporates the cost of drugs 
paid under the ESRD PPS using the transitional drug add-on payment 
adjustment (TDAPA). (See https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R1889OTN.pdf.) Thus, TDAPA drugs 
incorporated into the per-treatment payment amount are not DHS for 
purposes of the physician self-referral law. Because TDAPA drugs are 
included in the ESRD PPS ``composite rate'' and not considered 
``designated health services,'' they need not be included on the list 
of CPT/HCPCS codes that are eligible for use with the exception at 
Sec.  411.355(g). We refer readers to the CY 2018 End-Stage Renal 
Disease Prospective Payment System final rule for more information.
    Additionally, ESRD-related oral-only drugs, which are drugs or 
biologicals with no injectable equivalents or other forms of 
administration other than an oral form, were scheduled to be paid under 
ESRD PPS beginning January 1, 2014 (75 FR 49044). However, there have 
been several delays of the implementation of payment of these drugs 
under ESRD PPS. Most recently, on December 19, 2014, section 204 of the 
Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014 
(ABLE) (Pub. L. 113-295) was enacted and delayed the inclusion of these 
oral-only drugs under the ESRD PPS until 2025. Until that time, such 
drugs furnished in or by an ESRD facility are not paid as part of a 
composite rate and thus, are DHS.
    We revised the description of the CPT/HCPCS codes related to the 
exceptions at Sec. Sec.  411.355(g) and (h) to reflect more accurately 
the purpose for including these codes on the Code List. The revisions 
are intended to clarify that these sections of the Code List are not 
lists of CPT/HCPCS codes to which the physician self-referral law 
simply does not apply; rather, rather they are comprehensive lists of 
designated health services to which the exceptions at Sec.  411.355(g) 
and (h) may apply. The exception at Sec.  411.355(g) protects certain 
designated health services that are dialysis-related outpatient 
prescription drugs furnished in or by an ESRD facility and that satisfy 
the requirements of the exception. The exception at Sec.  411.355(h) 
protects certain designated health services that are furnished as 
preventive screening tests, immunizations, or vaccines and that satisfy 
the requirements of the exception. As noted at Sec.  411.355(g)(1) and 
(h)(4), the exceptions may be utilized only for designated health 
services included in the applicable sections of the Code List. The 
revised section descriptions reflect the language of Sec.  
411.355(g)(1) and (h)(4). These Code List sections represent the entire 
universe of CPT/HCPCS codes eligible for the exceptions at Sec.  
411.355(g) and (h), and the exceptions may not be utilized to protect 
referrals and claims submission for any other designated health service 
or category of designated health services.
    The Code List was last updated in Tables 45 and 46 of the CY 2017 
PFS final rule (81 FR 80534).
b. Response to Comments
    We received no comments relating to the Code List that became 
effective January 1, 2017.
c. Revisions Effective for CY 2018
    The updated, comprehensive Code List effective January 1, 2018, is 
available on our Web site at http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.html.
    Additions and deletions to the Code List conform it to the most 
recent publications of CPT and HCPCS Level II and to changes in 
Medicare coverage policy and payment status.
    Tables 44 and 45 identify the additions and deletions, 
respectively, to the comprehensive Code List that become effective 
January 1, 2018. Tables 44 and 45 also identify the additions and 
deletions to the list of codes used to identify the items and services 
that may qualify for the exception in Sec.  411.355(g) (regarding 
dialysis-related outpatient prescription drugs furnished in or by an 
ESRD facility) and in Sec.  411.355(h) (regarding preventive screening 
tests, immunizations, and vaccines).

[[Page 53340]]



Table 44--Additions to the Physician Self-Referral List of CPT \1\ HCPCS
                                  Codes
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
                      Clinical Laboratory Services
------------------------------------------------------------------------
{No additions{time}
------------------------------------------------------------------------
 Physical Therapy, Occupational Therapy, and Outpatient Speech-Language
                           Pathology Services
------------------------------------------------------------------------
97763 Orthc/prostc mgmt sbsq enc.
G0515 Cognitive skills development.
------------------------------------------------------------------------
              Radiology and Certain Other Imaging Services
------------------------------------------------------------------------
71045 X-ray exam chest 1 view.
71046 X-ray exam chest 2 views.
71047 X-ray exam chest 3 views.
71048 X-ray exam chest 4+ views.
74018 X-ray exam abdomen 1 view.
74019 X-ray exam abdomen 2 views.
74021 X-ray exam abdomen 3+ views.
------------------------------------------------------------------------
                 Radiation Therapy Services and Supplies
------------------------------------------------------------------------
               Drugs Used by Patients Undergoing Dialysis
------------------------------------------------------------------------
{No additions{time} .
------------------------------------------------------------------------
         Preventive Screening Tests, Immunizations and Vaccines
------------------------------------------------------------------------
90756 CCIIV4 vacc abx free im.
90682 RIV4 vacc recombinant dna im.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2017 AMA. All rights
  are reserved and applicable FARS/DFARS clauses apply.


  Table 45--Deletions From the Physician Self-Referral List of CPT \1\
                               HCPCS Codes
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
                      Clinical Laboratory Services
------------------------------------------------------------------------
{No deletions{time}
------------------------------------------------------------------------
 Physical Therapy, Occupational Therapy, and Outpatient Speech-Language
                           Pathology Services
------------------------------------------------------------------------
97532 Cognitive skills development.
97762 C/O for orthotic/prosth use.
------------------------------------------------------------------------
              Radiology and Certain Other Imaging Services
------------------------------------------------------------------------
71010 Chest x-ray.
71015 Chest x-ray.
71020 Chest x-ray.
71021 Chest x-ray.
71022 Chest x-ray.
71023 Chest x-ray and fluoroscopy.
71030 Chest x-ray.
71034 Chest x-ray and fluoroscopy.
71035 Chest x-ray.
74000 X-ray exam of abdomen.
74010 X-ray exam of abdomen.
74020 X-ray exam of abdomen.
78190 Platelet survival kinetics.
G0202 Scr mammo bi incl cad.
G0204 Dx mammo incl cad bi.
G0206 Dx mammo incl cad uni.
------------------------------------------------------------------------
                 Radiation Therapy Services and Supplies
------------------------------------------------------------------------
77422 Neutron beam tx simple.
------------------------------------------------------------------------
               Drugs Used by Patients Undergoing Dialysis
------------------------------------------------------------------------
{No deletions{time}
------------------------------------------------------------------------
         Preventive Screening Tests, Immunizations and Vaccines
------------------------------------------------------------------------
G0202 Scr mammo bi incl cad.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2017 AMA. All rights
  are reserved and applicable FARS/DFARS clauses apply.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 
35), we are required to publish a 30-day notice in the Federal Register 
and solicit public comment before a collection of information 
requirement is submitted to the Office of Management and Budget (OMB) 
for review and approval.
    We solicited comments in the notice of proposed rulemaking that 
published in the Federal Register on July 21, 2017 (82 FR 33950). For 
the purpose of transparency, we are republishing the discussion of the 
information collection requirements along with responses to the public 
comments that we received.

A. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2016 National Occupational Employment and Wage 
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 46 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.

                          TABLE 46--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                     Fringe
                                                                 Mean hourly      benefits and       Adjusted
          Occupation title                Occupation  code       wage  ($/hr)    overhead costs  hourly wage  ($/
                                                                                     ($/hr)            hr)
----------------------------------------------------------------------------------------------------------------
Family and General Practitioner.....  29-1062................           96.54            96.54           193.08
----------------------------------------------------------------------------------------------------------------

    As indicated, we are adjusting our employee hourly wage estimates 
by a factor of 100 percent. This is necessarily a rough adjustment, 
both because fringe benefits and overhead costs vary significantly from 
employer to employer, and because methods of estimating these costs 
vary widely from study to study. Nonetheless, there is no practical 
alternative and we believe that doubling the hourly wage to estimate 
total cost is a reasonably accurate estimation method.

B. Information Collection Requirements (ICRs)

1. ICRs Regarding the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model
    In Sec. Sec.  410.79, 414.84, 424.200, 424.205, 424.210, 424.502, 
424.516, 424.518 and 424.55 of this final rule, we finalize policies 
necessary to implement the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model, which is aimed at preventing the onset of type 2 
diabetes among Medicare beneficiaries with an indication of 
prediabetes. Section 1115A(d)(3) of the Act exempts Innovation Center 
model tests and expansions, which include the MDPP expanded model, from 
the provisions of the PRA. Specifically, this section provides that the 
provisions of the PRA does not apply to the testing and evaluation of 
Innovation Center models or to the expansion of such models.
2. ICRs Regarding Appropriate Use Criteria for Advanced Diagnostic 
Imaging Services (Sec.  414.94)
    We proposed to revise Sec.  414.94(i)(3) by reiterating the 
availability of a significant hardship exception for

[[Page 53341]]

ordering professionals who demonstrate a significant hardship 
consistent with the criteria listed under Sec.  495.102(d)(4)(i), 
(d)(4)(iii), (d)(4)(iv)(A) or (d)(4)(iv)(B). As discussed in section 
III.E. of this final rule, we are not finalizing our proposals to 
revise Sec.  414.94(i)(3). Consistent with a final rule that published 
on November 14, 2016 (81 FR 79865 through 79866) the hardship exception 
process involves the completion of an application which imposes no 
burden beyond the provision of identifying information and attesting to 
the applicable information. In this regard, the application is not 
``information'' as defined under 5 CFR 1320.3(h), and therefore, is 
exempt from requirements of the PRA.
    Consistent with section 1834(q)(4)(A) of the Act (as amended by 
section 218(b) of the PAMA), Sec.  414.94(j) proposed to require that 
ordering professionals consult specified applicable AUC through a 
qualified clinical decision support mechanism (CDSM) for applicable 
imaging services ordered on or after January 1, 2019. We proposed a 
one-time burden associated with a possible 6-month voluntary consulting 
period beginning sometime in 2018, as well as a mandatory annual burden 
beginning January 1, 2019. In response to public comments requesting 
more time to prepare before requiring AUC consultation and claims 
reporting, we have finalized an effective date of January 1, 2020, for 
the consulting requirement under this program. The voluntary consulting 
period will begin as early as July 2018 and last through 2019, thus 
extending the 6-month period proposed to 18 months.
    General practitioners make up a large group of practitioners who 
order applicable imaging services and would be required to consult AUC 
under this program so we use ``family and general practitioner'' from 
the BLS occupation title (see Wages, above) to calculate the following 
cost estimates. As noted in our response to comments, we conducted an 
initial analysis of recalculations based on volume weighted averages 
specific to different specialties using the BLS May 2016 National 
Occupational Employment and Wage Estimates, which would include both 
higher paid physicians and lower paid non-physician practitioners as 
advanced diagnostic imaging services are ordered by a variety of 
medical professionals. For these estimates and using Medicare claims 
data derived from the Chronic Conditions Warehouse 2014 Part B non-
institutional claim which we have used in prior rulemaking to inform 
existing policy under this program, we identified five occupations in 
the BLS estimates that most closely align with the practitioner 
specialties that order applicable imaging services. Because the BLS 
occupations do not provide all specialty specific estimates, the most 
specific occupations we were able to use to describe practitioner 
specialties that order applicable imaging services and their respective 
weighting based on order percentages identified in an analysis of the 
claims data are as follows: Physicians and Surgeons, All Others 
(69.57%), Internist, General (14.06%), Family and General Practitioners 
(10.53%), Physician Assistants (3.13%) and Nurse Practitioners (2.71%). 
Using these weights and the wage estimates for these practitioners, our 
burden estimates would be slightly lower. As such and because the 
program has not yet begun, we determined that the original methodology 
using Family and General Practitioners was a reasonable estimate. We 
will continue to monitor our estimates and could revisit for more 
precision once the program has begun.
    During the 18-month voluntary participation period, we estimate 
10,230,000 responses in the form of consultations based on market 
research from current applicants for the qualification of their CDSMs 
for advanced diagnostic imaging services. Based on feedback from CDSMs 
with experience in AUC consultation as well as standards recommended by 
the Office of the National Coordinator (ONC) and the Healthcare 
Information Management Systems Society (HIMSS), we estimate it would 
take 2 minutes at $193.08/hr for a family and general practitioner to 
use a qualified CDSM to consult specified applicable AUC. Per 
consultation, we estimate 2 minutes (0.033 hr) at a cost of $6.37 
(0.033 hr x $193.08/hr). In aggregate, we estimate a one-time burden of 
337,590 hours (0.033 hr x 10,230,000 consultations) at a cost of 
$65,181,877.20 (337,590 hr x $193.08/hr).
    Annually, we estimate 112,530 hours (337,590 hr/3 yr) at a cost of 
$21,727,292.40 ($65,181,877.20/3 yr). We are annualizing the one-time 
burden (by dividing our estimates by OMB's 3-year approval period) 
since we do not anticipate any additional burden after the 18-month 
voluntary participation period ends.
    Beginning January 1, 2020, we anticipate 43,181,818 responses in 
the form of consultations based on the aforementioned market research, 
as well as Medicare claims data for advanced diagnostic imaging 
services. As noted above, we estimate it would take 2 minutes (0.033 
hr) at $193.08/hr for a family and general practitioner to use a 
qualified CDSM to consult specified applicable AUC. In this regard, we 
estimate 0.033 hours per consultation at a cost of $6.37 (0.033 hr x 
$193.08/hr). In aggregate, we estimate an annual burden of 1,425,000 
hours (0.033 hr x 43,181,818 consultations) at a cost of $275,139,000 
(1,425,000 hr x $193.08/hr).
    The consultation requirements and burden have been submitted to OMB 
for approval under control number 0938-New (CMS-10654).
    Consistent with section 1834(q)(4)(B) of the Act, we also proposed 
to implement a one-time 6-month voluntary reporting period beginning 
sometime in 2018, as well as a mandatory annual reporting requirement 
beginning January 1, 2019. Specifically, Sec.  414.94(k) proposed to 
require that furnishing professionals report on the Medicare claims for 
advanced diagnostic imaging services, paid for under an applicable 
payment system (as defined in Sec.  414.94(b)) and ordered on or after 
January 1, 2019, the following information: (1) Identify which 
qualified CDSM was consulted by the ordering professional; (2) identify 
whether the service ordered would adhere to specified applicable AUC, 
would not adhere to specified applicable AUC, or whether specified 
applicable AUC was not applicable to the service ordered; and (3) 
identify the NPI of the ordering professional (if different from the 
furnishing professional). As noted earlier in this section, in response 
to public comment the voluntary period has been extended to 18 months 
and the effective date for the AUC consulting and reporting 
requirements will be January 1, 2020. The reporting requirement will 
not have any impact on any Medicare claim forms because the forms' 
currently approved data fields, instructions, and burden are not 
expected to change. Consequently, there is no need for review by OMB 
under the authority of the PRA.
    The timing and implementation of the voluntary consultation and 
reporting period is dependent on the readiness of the Medicare claims 
systems to accept and process claims including AUC consultation 
information. Currently, 99 percent of all Medicare claims are submitted 
electronically as a result of The Administrative Simplification 
Compliance Act amendment to section 1862(a) of the Act, which 
prescribes that no payment may be made under Part B of the Medicare 
Program for any expenses incurred for items or services for which a 
claim is received in a non-electronic form. Consequently, absent an 
applicable exception, paper claims

[[Page 53342]]

received by Medicare will not be paid. Continued developments in the 
deployment of CDSMs has produced research \45\ and best practices 
46 47 48 supporting our position that any such changes made 
to respondent IT systems would be a usual and customary business 
practice whose burden is exempt from the requirements of the PRA under 
5 CFR 1320.3(b).
---------------------------------------------------------------------------

    \45\ CDC Health Information Innovation Consortium, May 17 2016, 
available at https://www.cdc.gov/ophss/chiic/forums/2016-05-17_index.html.
    \46\ ONC eCQI resource for process improvement: bit.ly/
oncecqicds.
    \47\ CMS CDS tipsheet: bit.ly/cmscdstips.
    \48\ HIMSS CDS Guidebook Series: www.himss.org/cdsguide.
---------------------------------------------------------------------------

    Based on the proposed consulting and reporting requirements, we 
received comments on our proposed estimates. We have included a summary 
of the comments received below, and note that we have finalized our 
policy in Sec.  414.94(j) and (k) (82 FR 34195). We are largely 
adopting the proposed collection of information provisions with minimal 
changes to reflect the extension of the voluntary reporting period 
discussed earlier in this section.
    Comment: Commenters acknowledged that the annual burden estimated 
for the program appears to outweigh the Congressional Budget Office 
estimated savings. A few commenters stated we should also compensate 
physicians for consulting AUC and recommended an imaging service 
volume-weighted average as an alternative to estimates based on the 
hourly rate of a family and general practitioner. Another commenter 
requested the estimate use a volume weighted average that includes 
specific specialties that are paid at a higher rate than family and 
general practitioner since they are paid at a lower rate. A few 
commenters stated the estimated 2 minutes was inaccurate, and instead 
proposed an additional 3-5 minutes to consult AUC. One commenter noted 
that such estimates were based on the Medicare Imaging Demonstration 
report to Congress (Timbie et al., Medicare Imaging Demonstration Final 
Evaluation: Report to Congress. Rand Health Q. 2015 Jul 15;5(1):4.). 
Other commenters disagreed and stated that impact on the workflow of 
ordering professionals would be minimal, and acknowledged that current 
processes are doing a poor job of reducing inappropriate utilization to 
protect Medicare beneficiaries.
    Response: As discussed earlier in this section, we conducted an 
initial analysis of recalculations based on volume weighted averages 
specific to different specialties again using the BLS May 2016 National 
Occupational Employment and Wage Estimates, which included both higher 
paid physicians as suggested by the commenter and lower paid non-
physician practitioners because advanced diagnostic imaging services 
are ordered by a variety of medical professionals and our claims data 
analysis supports such inclusion. The resulting estimates for both the 
collection of information and regulatory impact analysis were slightly 
lower than our original estimates using the mean hourly wage for family 
and general practitioner, so we did not adjust the estimates using 
specialty specific information. However, as the AUC program evolves we 
will continue to assess the burden and reevaluate the estimates, and we 
will update this PRA package as necessary going forward.
    Comment: Some commenters recommended that we revisit the estimates 
to include the communication between ordering professional to the 
furnishing professional, as well as the reporting of AUC consultation 
information by the furnishing professional. Commenters stated that the 
proposed estimate does not include any time for the work the furnishing 
professional would perform to: (1) Validate information sent from the 
ordering professional; (2) recognize ordering professionals with a 
significant hardship exception; (3) training; and (4) add new or 
additional health IT interoperability between EHR systems. One 
commenter requested that additional consideration be made for costs to 
purchase or subscribe to specific proprietary CDSM products, and costs 
to build or incorporate software interfaces.
    Response: We appreciate these commenters' views and agree that 
furnishing professionals will incur burden attributed to the AUC 
program. However, we do not foresee such burden being incurred during 
the voluntary reporting period. We note that during the voluntary 
reporting period that begins July 2018, furnishing professionals are 
not expected to change how they currently interact and communicate with 
ordering professionals and any information related to an AUC 
consultation will be communicated using existing methods. We also point 
out that in the CY 2019 PFS rule we will revisit the significant 
hardship exception to continue working toward alignment with MIPS. 
While we do not expect ordering professionals in need of a significant 
hardship exception to participate in the voluntary period, a 
significant hardship exception process will not be operationalized in 
time for the 2018 voluntary reporting period, therefore furnishing 
professionals will not have the ability to identify ordering 
professionals with the exception as none will have been granted yet. 
Generally, we expect very few changes to be made in the early part of 
the voluntary period, particularly in CY 2018. Rather, the voluntary 
period is most likely to be used by ordering professionals that are 
already consulting AUC using a qualified CDSM and be reported by 
furnishing professionals that are already within the same EHR system as 
the ordering professionals. With respect to costs incurred for IT, the 
AUC program has a qualified CDSM available free of charge and the 
statute does not provide for additional compensation to affected 
professionals to ensure compliance with program requirements. We will 
update estimates as necessary to reflect changes to this program as it 
moves from voluntary participation to required participation at which 
time we expect to see changes in behavior to comply with reporting 
requirements.
3. ICRs Regarding the Medicare Shared Savings Program (Part 425)
    Section 1899(e) of the Act provides that chapter 35 of title 44 of 
the U.S. Code, which includes such provisions as the PRA, does not 
apply to the Shared Savings Program.
C. Summary of Annual Burden Estimates and Requirements

                                                        Table 47--Annual Requirements and Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Total      Labor cost
                                                             OMB                                       Burden per     annual         of       Total cost
                 Regulation section(s)                     Control      Respondents      Responses      response      burden     reporting      ($) *
                                                             No.                                        (hours)      (hours)       ($/hr)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   414.94(j) (voluntary consultations).............    0938--New      10,230,000       3,410,000        0.033      112,530       193.08   21,727,292
                                                                                      (10,230,000/3)

[[Page 53343]]

 
Sec.   414.94(j) (mandatory consultations).............  ...........      43,181,818      43,181,818        0.033    1,425,000       193.08  275,139,000
                                                        ------------------------------------------------------------------------------------------------
    Total..............................................  ...........      53,411,818      46,591,818  ...........    1,537,530  ...........  296,866,292
--------------------------------------------------------------------------------------------------------------------------------------------------------
* With respect to the PRA, this rule would not impose any non-labor costs.

    We have submitted a copy of this rule to OMB for its review of the 
rule's information collection and burden requirements. The requirements 
are not effective until they have been approved by the OMB.
    To obtain copies of the supporting statement and any related forms 
for the collections discussed above, please visit CMS's Web site at Web 
site address https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or call the Reports 
Clearance Office at 410-786-1326.

V. Regulatory Impact Analysis

A. Statement of Need

    This final rule makes payment and policy changes under the Medicare 
PFS and implements required statutory changes under the Medicare Access 
and CHIP Reauthorization Act of 2015 (MACRA), the Achieving a Better 
Life Experience Act (ABLE), the Protecting Access to Medicare Act of 
2014 (PAMA), section 603 of the Bipartisan Budget Act of 2015, and the 
Consolidated Appropriations Act of 2016. This final rule also makes 
changes to payment policy and other related policies for Medicare Part 
B, Part D, and Medicare Advantage.

B. Overall Impact

    We examined the impact of this rule as required by Executive Order 
12866 on Regulatory Planning and Review (September 30, 1993), Executive 
Order 13563 on Improving Regulation and Regulatory Review (February 2, 
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. 
L. 96-354), section 1102(b) of the Social Security Act, section 202 of 
the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-
4), Executive Order 13132 on Federalism (August 4, 1999), the 
Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 
on Reducing Regulation and Controlling Regulatory Costs (January 30, 
2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We estimate, as discussed in this section, that the PFS provisions 
included in this final rule would redistribute more than $100 million 
in 1 year. Therefore, we estimate that this rulemaking is 
``economically significant'' as measured by the $100 million threshold, 
and hence also a major rule under the Congressional Review Act. 
Accordingly, we prepared an RIA that, to the best of our ability, 
presents the costs and benefits of the rulemaking. The RFA requires 
agencies to analyze options for regulatory relief of small entities. 
For purposes of the RFA, small entities include small businesses, 
nonprofit organizations, and small governmental jurisdictions. Most 
hospitals, practitioners and most other providers and suppliers are 
small entities, either by nonprofit status or by having annual revenues 
that qualify for small business status under the Small Business 
Administration standards. (For details see the SBA's Web site at http://www.sba.gov/content/table-small-business-size-standards (refer to the 
620000 series)). Individuals and states are not included in the 
definition of a small entity.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other providers, and 
suppliers are considered to be small entities, based upon the SBA 
standards. There are over 1 million physicians, other practitioners, 
and medical suppliers that receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section, as well as elsewhere in this 
final rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    For example, the effects of changes to payment rates for 
practitioners, other providers, and suppliers are discussed in V.C. of 
this final rule. Alternative options considered to the proposed payment 
rates are discussed generally in section V.F of this final rule, while 
specific alternatives for individual codes are discussed throughout 
this rule, especially in section II.H.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. We did not prepare an 
analysis for section 1102(b) of the Act because we determined, and the 
Secretary certified, that this final rule would not have a significant 
impact on the operations of a substantial number of small rural 
hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2017, that 
threshold is approximately $148 million. This final rule will impose no 
mandates on state, local, or tribal governments or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments,

[[Page 53344]]

preempts state law, or otherwise has Federalism implications. Since 
this regulation does not impose any costs on state or local 
governments, the requirements of Executive Order 13132 are not 
applicable.
    Executive Order 13771, entitled Reducing Regulation and Controlling 
Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This 
final rule is considered an E.O. 13771 regulatory action because it is 
expected to result in regulatory costs.
    We prepared the following analysis, which together with the 
information provided in the rest of this preamble, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this final rule; details the costs and benefits of the rule; analyzes 
alternatives; and presents the measures we would use to minimize the 
burden on small entities. As indicated elsewhere in this final rule, we 
are implementing a variety of changes to our regulations, payments, or 
payment policies to ensure that our payment systems reflect changes in 
medical practice and the relative value of services, and implementing 
statutory provisions. We provide information for each of the policy 
changes in the relevant sections of this final rule. We are unaware of 
any relevant federal rules that duplicate, overlap, or conflict with 
this final rule. The relevant sections of this final rule contain a 
description of significant alternatives if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of expenditures for the year 
to differ by more than $20 million from what expenditures would have 
been in the absence of these changes. If this threshold is exceeded, we 
make adjustments to preserve budget neutrality.
    Our estimates of changes in Medicare expenditures for PFS services 
compare payment rates for CY 2017 with payment rates for CY 2018 using 
CY 2016 Medicare utilization. The payment impacts in this final rule 
reflect averages by specialty based on Medicare utilization. The 
payment impact for an individual practitioner could vary from the 
average and would depend on the mix of services he or she furnishes. 
The average percentage change in total revenues would be less than the 
impact displayed here because practitioners and other entities 
generally furnish services to both Medicare and non-Medicare patients. 
In addition, practitioners and other entities may receive substantial 
Medicare revenues for services under other Medicare payment systems. 
For instance, independent laboratories receive approximately 83 percent 
of their Medicare revenues from clinical laboratory services that are 
paid under the Clinical Laboratory Fee Schedule.
    The annual update to the PFS conversion factor (CF) was previously 
calculated based on a statutory formula; for details about this 
formula, we refer readers to the CY 2015 PFS final rule with comment 
period (79 FR 67741 through 67742). Section 101(a) of the MACRA 
repealed the previous statutory update formula and amended section 
1848(d) of the Act to specify the update adjustment factors for 
calendar years 2015 and beyond. For CY 2018, the specified update is 
0.5 percent before applying other adjustments.
    Section 220(d) of the PAMA added a new paragraph 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 net 
reduction in expenditures for the year is equal to or greater than the 
target for the 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. 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. We estimate the 
CY 2018 net reduction in expenditures resulting from adjustments to 
relative values of misvalued codes to be 0.41 percent. Since this 
amount does not meet the 0.5 percent target under section 
1848(c)(2)(O)(v) of the Act, payments under the fee schedule must be 
reduced by the difference between the target for the year and the 
estimated net reduction in expenditures, known as the target recapture 
amount. As a result, we estimate that the CY 2018 target recapture 
amount will produce a reduction to the conversion factor of -0.09 
percent.
    To calculate the final conversion factor for this year, we 
multiplied the product of the current year conversion factor and the 
update adjustment factor by the target recapture amount and the budget 
neutrality adjustment described in the preceding paragraphs. We 
estimate the CY 2018 PFS conversion factor to be 35.9996, which 
reflects the budget neutrality adjustment under section 
1848(c)(2)(B)(ii)(II), the 0.5 percent update adjustment factor 
specified under section 1848(d)(18) of the Act, and the -0.09 percent 
target recapture amount required under section 1848(c)(2)(O)(iv) of the 
Act. We estimate the CY 2018 anesthesia conversion factor to be 
22.1887, which reflects the same overall PFS adjustments with the 
addition of anesthesia-specific PE and MP adjustments.

    Table 48--Calculation of the Final CY 2018 PFS Conversion Factor
------------------------------------------------------------------------
 
------------------------------------------------------------------------
CY 2017 Conversion Factor.........  ....................         35.8887
Statutory Update Factor...........  0.50 percent          ..............
                                     (1.0050).
CY 2018 RVU Budget Neutrality       -0.10 percent         ..............
 Adjustment.                         (0.9990).
CY 2018 Target Recapture Amount...  -0.09 percent         ..............
                                     (0.9991).
CY 2018 Conversion Factor.........  ....................         35.9996
------------------------------------------------------------------------


 Table 49--Calculation of the Final CY 2018 Anesthesia Conversion Factor
------------------------------------------------------------------------
 
------------------------------------------------------------------------
CY 2017 National Average            ....................         22.0454
 Anesthesia.
Conversion Factor.................
Statutory Update Factor...........  0.50 percent          ..............
                                     (1.0050).

[[Page 53345]]

 
CY 2018 RVU Budget Neutrality       -0.10 percent         ..............
 Adjustment.                         (0.9990).
CY 2018 Target Recapture Amount...  -0.09 percent         ..............
                                     (0.9991).
CY 2018 Anesthesia Fee Schedule     0.34 percent          ..............
 Practice Expense and Malpractice    (1.0034).
 Adjustment.
CY 2018 Conversion Factor.........  ....................         22.1887
------------------------------------------------------------------------

    Table 50 shows the payment impact on PFS services of the proposals 
contained in this final rule. To the extent that there are year-to-year 
changes in the volume and mix of services provided by practitioners, 
the actual impact on total Medicare revenues would be different from 
those shown in Table 50 (CY 2018 PFS Estimated Impact on Total Allowed 
Charges by Specialty). The following is an explanation of the 
information represented in Table 50.
     Column A (Specialty): Identifies the specialty for which 
data are shown.
     Column B (Allowed Charges): The aggregate estimated PFS 
allowed charges for the specialty based on CY 2016 utilization and CY 
2017 rates. That is, allowed charges are the PFS amounts for covered 
services and include coinsurance and deductibles (which are the 
financial responsibility of the beneficiary). These amounts have been 
summed across all services furnished by physicians, practitioners, and 
suppliers within a specialty to arrive at the total allowed charges for 
the specialty.
     Column C (Impact of Work RVU Changes): This column shows 
the estimated CY 2018 impact on total allowed charges of the changes in 
the work RVUs, including the impact of changes due to potentially 
misvalued codes.
     Column D (Impact of PE RVU Changes): This column shows the 
estimated CY 2018 impact on total allowed charges of the changes in the 
PE RVUs.
     Column E (Impact of MP RVU Changes): This column shows the 
estimated CY 2018 impact on total allowed charges of the changes in the 
MP RVUs, which are primarily driven by the required five-year review 
and update of MP RVUs.
     Column F (Combined Impact): This column shows the 
estimated CY 2018 combined impact on total allowed charges of all the 
changes in the previous columns. Column F may not equal the sum of 
columns C, D, and E due to rounding.

                 Table 50--CY 2018 PFS Estimated Impact on Total Allowed Charges by Specialty *
----------------------------------------------------------------------------------------------------------------
                                                  Impact of work   Impact of PE    Impact of MP      Combined
            Specialty                 Allowed       RVU changes     RVU changes     RVU changes       impact
                                   charges (mil)     (percent)       (percent)       (percent)     (percent) **
(A)                                          (B)             (C)             (D)             (E)             (F)
----------------------------------------------------------------------------------------------------------------
TOTAL...........................         $93,149               0               0               0               0
ALLERGY/IMMUNOLOGY..............             247               0              -3               0              -3
ANESTHESIOLOGY..................           2,018              -1               0               0              -1
AUDIOLOGIST.....................              66               0               0               0               0
CARDIAC SURGERY.................             312               0               0               0               0
CARDIOLOGY......................           6,705               0              -1               0               1
CHIROPRACTOR....................             779               0               1               0               1
CLINICAL PSYCHOLOGIST...........             762               0               2               0               2
CLINICAL SOCIAL WORKER..........             670               0               3               0               3
COLON AND RECTAL SURGERY........             167               0               0               0               0
CRITICAL CARE...................             334               0               0               0               0
DERMATOLOGY.....................           3,485               0               1               0               1
DIAGNOSTIC TESTING FACILITY.....             773               0              -4               0              -4
EMERGENCY MEDICINE..............           3,191               0               0               0               0
ENDOCRINOLOGY...................             480               0               0               0               0
FAMILY PRACTICE.................           6,350               0               0               0               0
GASTROENTEROLOGY................           1,801               0               0               0               0
GENERAL PRACTICE................             458               0               0               0               0
GENERAL SURGERY.................           2,170               0               0               0               0
GERIATRICS......................             212               0               0               0               0
HAND SURGERY....................             201               0               0               0               0
HEMATOLOGY/ONCOLOGY.............           1,809               0               0               0               0
INDEPENDENT LABORATORY..........             690               0              -1               0              -1
INFECTIOUS DISEASE..............             656               0               0               0               1
INTERNAL MEDICINE...............          11,107               0               0               0               0
INTERVENTIONAL PAIN MGMT........             834               0               0               0               0
INTERVENTIONAL RADIOLOGY........             360               0               0               0               0
MULTISPECIALTY CLINIC/OTHER PHYS             140               0               0               0               0
NEPHROLOGY......................           2,270               0               0               0               0
NEUROLOGY.......................           1,554               0               0               0               0
NEUROSURGERY....................             811               0               0               0               0
NUCLEAR MEDICINE................              50               0               0               0               0
NURSE ANES/ANES ASST............           1,243              -2               0               0              -2
NURSE PRACTITIONER..............           3,566               0               0               0               0
OBSTETRICS/GYNECOLOGY...........             662               0               0               0               0
OPHTHALMOLOGY...................           5,498               0               1               0               0

[[Page 53346]]

 
OPTOMETRY.......................           1,269               0               0               0               0
ORAL/MAXILLOFACIAL SURGERY......              57               0              -1               0              -1
ORTHOPEDIC SURGERY..............           3,801               0               0               0               0
OTHER...........................              29               0               0               0               0
OTOLARNGOLOGY...................           1,237               0              -1               0              -2
PATHOLOGY.......................           1,154               0               0               0              -1
PEDIATRICS......................              64               0               0               0               0
PHYSICAL MEDICINE...............           1,112               0               0               0               0
PHYSICAL/OCCUPATIONAL THERAPY...           3,807               1              -2               0              -2
PHYSICIAN ASSISTANT.............           2,242               0               0               0               0
PLASTIC SURGERY.................             384               0               0               0               1
PODIATRY........................           1,994               0               1               0               1
PORTABLE X-RAY SUPPLIER.........             102               0               1               0               1
PSYCHIATRY......................           1,247               0               1               0               1
PULMONARY DISEASE...............           1,761               0               0               0               0
RADIATION ONCOLOGY AND RADIATION           1,745               0               1               0               1
 THERAPY CENTERS................
RADIOLOGY.......................           4,896               0               0               0               0
RHEUMATOLOGY....................             554               0               1               0               1
THORACIC SURGERY................             358               0               0               0               0
UROLOGY.........................           1,777               0               0               0              -1
VASCULAR SURGERY................           1,125               0              -1               0              -1
----------------------------------------------------------------------------------------------------------------
* Column F may not equal the sum of columns C, D, and E due to rounding.

2. CY 2018 PFS Impact Discussion
a. Changes in RVUs
    The most widespread specialty impacts of the final RVU changes are 
generally related to the changes to RVUs for specific services 
resulting from the Misvalued Code Initiative, including finalized RVUs 
for new and revised codes. The estimated impacts for some specialties, 
including behavioral health specialists, radiation oncology, and 
podiatry, reflect increases relative to other physician specialties. 
These increases can largely be attributed to increases in value for 
particular services following the recommendations from the American 
Medical Association (AMA)'s Relative Value Scale Update Committee (RUC) 
and CMS review and the change in allocation of indirect practice 
expense RVUs for office-based, face-to-face behavioral health services.
    The estimated impacts for several specialties, including diagnostic 
testing facilities, allergy/immunology, physical/occupational therapy, 
otolaryngology, anesthesiology, and nurse anesthetists reflect 
decreases in payments relative to payment to other physician 
specialties as a result of revaluation of individual procedures 
reviewed by the AMA's RUC and CMS, decreases in relative payment as a 
result of the updates to prices for particular medical supplies, and 
continued implementation of previously finalized code-level reductions 
that are being phased-in over several years. For independent 
laboratories, it is important to note that these entities receive 
approximately 83 percent of their Medicare revenues from services that 
are paid under the Clinical Laboratory Fee Schedule. As a result, the 
estimated 1 percent reduction for CY 2018 is only applicable to 
approximately 17 percent of the Medicare payment to these entities.
    The estimated impacts for many specialties are increases relative 
to the rates published in the proposed rule due to the decision to 
retain the professional liability premium data (from CY 2015) that was 
used for CY 2017, as opposed to utilizing the updated data for CY 2018 
that were used to calculate the rates in the proposed rule. The 
estimated decrease to the physical/occupational therapy specialty as 
compared to the impacts in the proposed rule resulted from the decision 
to finalize the direct PE inputs recommended by the Health Care 
Professionals Advisory Committee (HCPAC) for approximately two dozen 
therapy codes reviewed in CY 2018, as opposed to retaining the CY 2017 
direct PE inputs for these codes as proposed.
    We often receive comments regarding the changes in RVUs displayed 
on the specialty impact table, including comments received in response 
to the proposed rates. We remind stakeholders that although the 
estimated impacts are displayed at the specialty level, typically the 
changes are driven by the valuation of a relatively small number of new 
and/or potentially misvalued codes. The percentages in the table are 
based upon aggregate estimated PFS allowed charges summed across all 
services furnished by physicians, practitioners, and suppliers within a 
specialty to arrive at the total allowed charges for the specialty, and 
compared to the same summed total from the previous calendar year. They 
are therefore averages, and may not necessarily be representative of 
what is happening to the particular services furnished by a single 
practitioner within any given specialty.
b. Impact
    Column F of Table 50 displays the estimated CY 2018 impact on total 
allowed charges, by specialty, of all the RVU changes. A table showing 
the estimated impact of all of the changes on total payments for 
selected high volume procedures is available under ``downloads'' on the 
CY 2018 PFS final rule Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these 
procedures for sake of illustration from among the procedures most 
commonly furnished by a broad spectrum of specialties. The change in 
both facility rates and the nonfacility rates are shown. For an 
explanation of facility and nonfacility PE, we refer readers to 
Addendum A on the CMS Web site at http://www.cms.gov/

[[Page 53347]]

Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.

D. Effect of Changes Related to Telehealth

    As discussed in section II.D. of this final rule, we are adding 
several new codes to the list of Medicare telehealth services. Although 
we expect these changes to have the potential to increase access to 
care in rural areas, based on recent telehealth utilization of services 
already on the list, including services similar to the proposed 
additions, we estimate there will only be a negligible impact on PFS 
expenditures from the proposed additions. For example, for services 
already on the list, they are furnished via telehealth, on average, 
less than 0.1 percent of the time they are reported overall.
    In addition, as discussed in section II.D. of this final rule, we 
are making CPT code 99091 separately payable for CY 2018. We note that 
this change will be implemented in a budget neutral manner, and we 
estimate that there will be a negligible impact on PFS expenditures 
from making this code separately payable.

E. Effect of Changes to Payment to Provider-Based Departments (PBDs) of 
Hospitals Paid Under the PFS

    As discussed in section II.G of this final rule, for CY 2018, we 
are finalizing a PFS Relativity Adjuster of 40 percent, meaning that 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
would be paid under the PFS at a rate that is 40 percent of the OPPS 
rate. We estimate that this change will result in total Medicare Part B 
savings of $12 million for CY 2018 relative to maintaining the CY 2017 
PFS Relativity Adjuster for CY 2018.

F. Other Provisions of the Final Regulation

1. New Care Coordination Services and Payment for RHCs and FQHCs
    As discussed in section III.A of this final rule, we finalized the 
establishment of two new G codes for use by RHCs and FQHCs. The first 
new G code is a General Care Management code for RHCs and FQHCs with 
the payment amount set at the average of the 3 national non-facility 
PFS payment rates for the CCM and general BHI codes. The second new G 
code for RHCs and FQHCs is a Psychiatric CoCM code with the payment 
amount set at the average of the 2 national non-facility PFS payment 
rates for psychiatric CoCM services. The payment rate for each code 
will be updated annually, based on the national non-facility PFS 
payment rates for each code contained in the G code.
    The methodology for payment of care coordination services is 
consistent with the RHC and FQHC payment principles of not paying for 
services based on time increments. It does not create additional 
reporting burden and is expected to promote beneficiary access to 
comprehensive care management services furnished by RHCs and FQHCs.
    Establishment of the RHC and FQHC General Care Management code, 
which includes all levels of CCM and general BHI services, is projected 
to increase Medicare spending by $2.2 million in CY 2018 and by $25.5 
million over 10 years. This estimate is based on the proposed per 
service allowed charge increase (from approximately $42.71 to $61.37) 
applied to historical 2017 CCM and BHI volume in RHCs and FQHCs. This 
volume was adjusted with an assumed 10 percent behavioral volume 
increase to reflect the increase in allowed charges per service.
    Establishment of the RHC and FQHC Psychiatric CoCM code, which 
includes all levels of psychiatric CoCM services, is projected to 
increase Medicare spending by approximately $100,000 in CY 2018 and 
$4.0 million over 10 years. Because psychiatric CoCM is not billable 
currently by RHCs or FQHCs and is also new to practitioners billing 
under the PFS, this estimate is based on first quarter 2017 PFS 
psychiatric CoCM claims of 0.06 percent of psychiatric E/M visits, 
adjusted to an ultimate average rate of 0.28 percent based on the 
pattern of increase in CCM services in the PFS found in the first two 
and a half years of implementation. This rate was then applied to the 
number of 2017 RHC and FQHC mental health visits to get an estimate of 
CoCM volume, and then projected forward on a per-capita basis. PFS 
price updates were applied to the initial approximate $135 psychiatric 
CoCM payment amount to project future costs.
    The combined increase in Medicare spending for both new G codes is 
estimated to be approximately $2.2 million in 2018, and approximately 
$29.5 million over 10 years. Although these services are expected to 
increase quality and improve efficiency over time, the programs are 
still new and the data is not available yet to demonstrate any cost 
savings. Therefore, no healthcare cost reductions were assumed as a 
result of increased care management.

        Table 51--Calendar Years 2018-2027 Projected Spending Impact of New General Care Management and Psychiatric CoCM Codes for RHCs and FQHCs
                                                                     [Millions] \49\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                       CY                           2018     2019     2020     2021     2022     2023     2024     2025     2026      2027     2018-2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Care Management.........................      2.2      2.3      2.4      2.5      2.5      2.6      2.7      2.7      2.8         2.9   25.5
Psychiatric CoCM................................      0.1      0.4      0.4      0.4      0.4      0.4      0.4      0.5      0.5         0.5    4.0
                                                 -------------------------------------------------------------------------------------------------------
    Total.......................................      2.3      2.7      2.8      2.9      2.9      3.0      3.1      3.2      3.3         3.4   29.5
--------------------------------------------------------------------------------------------------------------------------------------------------------

    As discussed in section III.A. of this final rule, we considered 3 
other options (for example, allowing any of the 7 codes to be 
separately added to a claim, bundling all 7 codes into one G code, and 
developing 3 separate G codes--one each for CCM, BHI, and CoCM 
services). We estimated that there would be no significant difference 
in the costs among the options because all of the options considered 
include the same services paid at the same rate and no data is 
available to estimate a different rate of billing for each code.
---------------------------------------------------------------------------

    \49\ Figures may not sum to totals due to rounding.
---------------------------------------------------------------------------

2. Payment for DME Infusion Drugs
    As discussed in section III.B. of this final rule, we are 
finalizing our proposal to conform the regulation text at Sec.  
414.904(e)(2) to section 5004 of the Cures Act, which transitioned 
payment for DME infusion drugs from AWP-based pricing to the ASP-
pricing methodology on January 1, 2017. Table 52 shows the effect of 
changes in drug payments to DME suppliers. We estimate adoption of the 
ASP+6 pricing methodology will result in total Medicare Part B savings 
ranging over the 10-year period from $40 million in FY 2017 to $110 
million in FY 2026

[[Page 53348]]

with a 10-year total Medicare Part B savings of $960 million.

                          Table 52--Impact of Cures Section 5004 on Payment for Infusion Drugs Furnished Through an Item of DMS
                                                                      [In millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                10-yr
                 FY                     2017     2018     2019     2020     2021     2022     2023     2024     2025     2026   5-yr impact  impact 2017-
                                                                                                                                 2017- 2021      2026
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits............................     (50)    (110)    (130)    (130)    (130)    (130)    (150)    (150)    (150)    (150)        (550)      (1,280)
Premium Offset......................       10       30       30       30       30       30       40       40       40       40          130          320
                                     -------------------------------------------------------------------------------------------------------------------
    Total Part B....................     (40)     (80)    (100)    (100)    (100)    (100)    (110)    (110)    (110)    (110)        (420)        (960)
--------------------------------------------------------------------------------------------------------------------------------------------------------

3. Payment for Biosimilar Biological Products Under Section 1847A of 
the Act
    In section III.D. of this rule we discussed the payment of 
biosimilar biological products under section 1847A of the Act. We 
explained that under the current Medicare Part B policy, the payment 
amount for a biosimilar biological product is based on the ASP of all 
National Drug Codes (NDCs) assigned to the biosimilar biological 
products included within the same billing and payment code. However, in 
this final rule, we are finalizing the policy to separately code and 
pay for biological biosimilar products under Medicare Part B. Effective 
on January 1, 2018, newly approved biosimilar biological products with 
a common reference product will no longer be grouped into the same 
billing code.
    In the 2016 PFS rule, we stated that we anticipate that biosimilar 
biological products will have lower ASPs than the corresponding 
reference products (80 FR 71362). We also expected that Medicare would 
realize savings from the utilization of biosimilar biological products. 
However, we have limited experience under Medicare Part B with 
biosimilar biological products that have been approved under the FDA's 
biosimilar approval pathway. There are four approved Part B 
biosimilars: limited claims data on two is available, the third product 
was marketed in July 2017, the fourth is not yet marketed, and it is 
not clear when marketing will begin. Further, it is not clear how many 
more biosimilar products will be approved, when approval and marketing 
of various products will occur, what the market penetration of 
biosimilars in Medicare Part B will be, and what the cost differences 
between the biosimilars as well as the price differences between the 
biosimilars and the reference products will be. Therefore, with limited 
data, we are not able to quantify with certainty the potential savings 
or costs to Medicare Part B from changes to current policy. Similarly, 
we are not able to quantify the impact, if any, on physician offices 
that administer biosimilar biological products or the costs to 
beneficiaries.
    Based on our limited experience with the first two biosimilar 
products marketed in the United States, filgrastim and infliximab, once 
ASP-based payment amounts take effect, savings (relative to the 
reference product) are realized under the current policy. However, as 
discussed in section III.D. of this rule, we believe that a policy that 
could potentially increase provider and patient choice is superior to 
existing policy and may lead to additional cost savings. If payment 
amounts limit manufacturers' willingness to invest in the development 
of new biosimilars, it could in the long term decrease the number of 
biosimilar biological products that are available to prescribe and thus 
impair price competition. Given that the United States' biosimilar 
biological product marketplace is still relatively new, it is important 
to have a payment policy that supports innovation, as well as 
reasonable pricing for consumers. The change in policy is expected to 
lead to greater competition and more products in the marketplace. We 
present a hypothetical example below to illustrate what would need to 
occur in the market for this policy change to achieve cost savings for 
Medicare.
    We have assumed that biosimilar biological products will provide 
between 5 and 30 percent cost savings relative to the reference 
biological product. These differences are consistent with our limited 
experience in Part B with the biosimilar version of filgrastim and very 
limited experience with the first biosimilar version of infliximab, as 
well as comments received in the rule and estimates in the lay press. 
Uptake rates for the current policy are also consistent with our 
limited experience and commenters estimates. For simplicity and the 
purpose of this example, we have assumed that the Medicare payment 
amounts for biosimilar biological products will be comparable in both 
the grouped and separate code scenario. The slightly higher payment 
amounts for biosimilar biological products under the separate code 
scenario at year 1 (compared to payments for a grouped code) are 
expected because first quarter payment for each separately coded 
product would be based on Wholesale Acquisition Cost (WAC). However, 
this would be offset by a greater number of licensed biosimilar 
biological products by year 10 and higher uptake by year 10. The 
overall savings from using separate codes is expected to be greater 
over the 5 year period because the greater number of biosimilar 
biological products available in the marketplace is expected to provide 
greater choice for providers, and this should result in greater uptake 
of the products. In summary, Table 53 is intended to illustrate that at 
year 10 compared to current policy, separate codes are anticipated to 
decrease reference product prices (or at least keep them stable) and 
increase the number of products and uptake of biosimilars at year 10. 
In order to more clearly illustrate these points we assumed that 
payment amounts in this example would remain stable. However, as stated 
in section II.D. of this rule, over the long term, if the policy leads 
to greater competition and more products in the marketplace, we believe 
that it is reasonable to anticipate that the higher initial payments 
will be offset by savings. A greater uptake of products with a lower 
payment amount than a reference product is expected to yield overall 
savings. We note that savings could also occur from lower payment 
amounts due to increased competition.

[[Page 53349]]



      Table 53--Hypothetical Comparison of Grouped and Separate Payment for Biosimilar Biological Products
----------------------------------------------------------------------------------------------------------------
                                   Grouped payment using one HCPCS code     Separate codes for each biosimilar
                                 -------------------------------------------------------------------------------
                                        Year 1              Year 10             Year 1              Year 10
----------------------------------------------------------------------------------------------------------------
Reference Product Payment Amount  Stable or slight    Stable or increase  Stable............  Stable or
                                   increase.                                                   decrease.
Biosimilar Product Payment        10% below           10-30% below        5-10% below         10-30% below
 Amount.                           reference product.  reference product.  reference product.  reference product
Number of Licensed Biosimilars..  1-2...............  2-3...............  1-3...............  3-4.
Uptake of Biosimilars...........  10%...............  10-20%............  10%...............  >20%.
----------------------------------------------------------------------------------------------------------------

    The economics literature seems to indicate that the competition and 
pricing outcomes of reference pricing policies are quite dependent on 
market characteristics and other parameters. (See, for example, Brekke 
et al., 2007, Kanavos et al., 2008, Zweim[uuml]ller's discussion of 
Kanavos et al., and Danzon and Ketcham, 2004.) \50\ Due to time and 
other resource constraints, the results of this literature have not 
been incorporated into the illustrative calculation above and not been 
used to develop quantitative estimates of the biosimilars pricing 
provisions of this final rule. Other questions that could be a part of 
further analysis in this area, as the market develops include:
---------------------------------------------------------------------------

    \50\ Brekke, Kurt R., Ingrid K[ouml]nigbauer and Odd Rune 
Straume. ``Reference Pricing of Pharmaceuticals.'' Journal of Health 
Economics 26(3), 613-642. May 2007. Danzon, Patricia M. and Jonathan 
D. Ketcham. ``Reference Pricing of Pharmaceuticals for Medicare: 
Evidence from Germany, the Netherlands, and New Zealand.'' Forum for 
Health Economics & Policy 7(1). January 2004. Kanavos, Panos, Joan 
Costa-Font and Elizabeth Seeley. ``Competition in Off-Patent Drug 
Markets: Issues, Regulation and Evidence.'' Economic Policy 23(55), 
500-544. July 2008. (Discussion by Josef Zweim[uuml]ller begins on 
page 537.)
---------------------------------------------------------------------------

     Could small-molecule pharmaceutical pricing, utilization 
and models apply to the biosimilar product context? Although the 
literature on biosimilars is currently much less extensive than the 
literature on small-molecule drugs, are there studies that are relevant 
to the policy question of Medicare's biosimilars pricing?
     To what extent can experience with nationwide reference 
pricing (for example, in Europe) inform pricing policy implemented by 
Medicare, which is one of several payers?
     What are the key parameters for determining the optimal 
tradeoff between short-run price savings and long-run incentives to 
innovate? What insights on this question can be gleaned from the 
optimal patent exclusivity literature or other strains of research?
4. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
    We are finalizing the effective date of January 1, 2020 on which 
the appropriate use criteria (AUC) consulting and reporting 
requirements will begin, and extending the voluntary consulting and 
reporting period to 18 months. We are not finalizing the proposed 
modifications to the significant hardship exception, but anticipate 
proposing policies in rulemaking for CY 2019 to address commenters' 
concerns and better align exceptions under the AUC program with those 
under existing quality programs. In the COI section of this document, 
we estimate the consulting requirement to result in an annual burden of 
1,425,000 hours at a cost of $275,139,000. These updates to the AUC 
program will not result in claims denials in CY 2018, and thus, these 
proposals would not impact CY 2018 physician payments under the PFS. 
The Congressional Budget Office estimates that section 218 of the PAMA 
would save approximately $200 million over 10 years from FY 2014 
through 2024, which could be the result of identification of outlier 
ordering professionals and also includes section 218(a) of the PAMA, 
which is a payment deduction for computed tomography equipment that is 
not up to a current technology standard. CMS has not estimated a score 
as such consultation and reporting is not required for FY 2018. Because 
we have not yet proposed a mechanism or calculation for outlier 
ordering professional identification and prior authorization, we are 
unable to quantify that impact at this time. We will provide an impact 
statement when applicable in future rulemaking.
5. Physician Quality Reporting System Criteria for Satisfactory 
Reporting for Individual EPs
a. Burden Estimate for PQRS Reporting
    We previously discussed the burden estimate for PQRS regarding the 
satisfactory reporting criteria for the CY 2016 reporting period, which 
applies to the 2018 PQRS payment adjustment, in the CY 2016 PFS final 
rule (see 80 FR 71362 through 71367). The burden estimates for 
reporting that data have not changed since these data for the CY 2016 
reporting period have already been reported; therefore, there are no 
added burden estimates for the policy change discussed in section III.F 
of this final rule.
b. Burden Savings Estimated Based on PQRS Measures Reduction Policy
    Amending the policy to reduce the amount of measures needed to 
satisfactorily report to avoid the 2018 PQRS payment adjustment from 9 
measures across 3 NQS domains to 6 measures (see section III.F. of this 
final rule) would increase the amount of satisfactory reporters for the 
CY 2016 reporting period, which would decrease those subject to the 
2018 PQRS payment adjustment. Using data from the CY 2015 reporting 
period as the basis for our estimates, there were roughly 525,000 
eligible professionals who failed the PQRS reporting requirements for 
the CY 2015 reporting period and received a downward payment adjustment 
in 2017 (see https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_PQRS_Experience_Report.pdf). 
We estimate that, based on 2015 results, approximately 4.5 percent of 
EPs that received a downward payment adjustment would be found 
successful under the amended policy, and therefore, would avoid the 
payment penalty. This equates to an estimated 23,625 EPs that would no 
longer be subject to the 2018 PQRS payment adjustment based on PQRS 
data for the CY 2015 reporting period.
    Based on the estimated average payment adjustment of $937.02 in 
program year 2015, which was negative 2 percent based on 2015 PFS 
charges, an estimated ($937.02 x 23,625 = $22,137,097.50) would be the 
amount all EPs would receive as a result of not being subject to the 
2018 PQRS payment adjustment due to the amended policy in this final 
rule for the CY 2016

[[Page 53350]]

reporting period, which applies to the 2018 PQRS payment adjustment.
6. Medicare EHR Incentive Program for EPs
a. Burden Estimate for the Medicare EHR Incentive Program for EPs 
Reporting
    Previous burden impacts were discussed in the Medicare EHR 
Incentive Program Stage 2 final rule (77 FR 54126 through 54133). The 
burden estimates for reporting that data have not changed; therefore, 
there are no added burden estimates for the policy change discussed in 
section III.G. of this final rule.
b. Burden Savings Estimated Based on Amended Medicare EHR Incentive 
Program Policy
    The changes in section III.G. of this final rule for the Medicare 
EHR Incentive Program for EPs reporting CQMs would have no additional 
estimated impacts as they would neither increase or decrease the number 
of successful meaningful EHR users in the Medicare EHR Incentive 
Program for EPs. Under this policy, the number of CQMs required to meet 
EHR Incentive Program requirements would not change for those EPs 
reporting their CQMs by attestation, thus the previously reported 
burden estimates for those EPs remains unchanged. For those EPs 
submitting CQMs electronically, this policy would reduce their 
reporting requirement from 9 measures across 3 NQS domains to 6 
measures with no domain requirement. Based on our analysis of the data 
already reported for CY 2016, no additional EPs would have successfully 
demonstrated meaningful use.
7. Medicare Shared Savings Program
    We proposed certain modifications to our rules regarding ACO 
assignment and financial calculations, quality measures and quality 
validation audits, TIN overlaps, and application requirements. 
Specifically we proposed: (1) Modifications to how services furnished 
by RHCs and FQHCs are used for purposes of beneficiary assignment to an 
ACO as a result of the 21st Century Cures Act, including reducing 
reporting burden for ACOs that include RHCs and FQHCs; (2) 
modifications to the assignment methodology to include new chronic care 
management and behavioral health integration codes in our definition of 
primary care services; (3) a policy to improve the quality validation 
audit process and, absent unusual circumstances, to use the results to 
proportionally modify an ACO's overall quality score; (4) a policy to 
address substantive changes to quality measures made under the Quality 
Payment Program; (5) revisions to our application requirements to 
reduce burden for ACO applicants seeking to participate in the Shared 
Savings Program and for ACOs applying to use the SNF 3-Day Rule Waiver; 
(6) changes to our ACO participant TIN overlap policies, specifically, 
to address situations in which overlapping ACO participant TINs begin 
billing for services that are used in beneficiary assignment during a 
benchmark or performance year; and (7) a policy to use only final 
beneficiary identifiable non-claims based payments in establishing 
benchmarks and performing financial reconciliation.
    We are finalizing these proposed policies in this final rule. 
Although we believe the final policies will reduce burden for 
participating ACOs and applicants, we do not anticipate any significant 
economic impact for these policies in terms of overall program costs or 
savings.
8. Value-Based Payment Modifier and the Physician Feedback Program
    Section 1848(p) of the Act requires that we establish a value-based 
payment modifier (VM) and apply it to specific physicians and groups of 
physicians the Secretary determines appropriate starting January 1, 
2015, and to all physicians and groups of physicians by January 1, 
2017. Section 1848(p)(4)(C) of the Act requires the VM to be budget 
neutral. Budget-neutrality means that, in aggregate, the increased 
payments to high performing physicians and groups equal the reduced 
payments to low performing physicians and groups, as well as those 
physicians and groups that failed to avoid the PQRS payment adjustment 
as a group or as individuals. The final payment adjustment period for 
the Value Modifier will be CY 2018 after which it will be replaced by 
the payment adjustments under the Merit-based Incentive Payment System 
(MIPS).
    In the CY 2016 PFS final rule with comment period (80 FR 71277 and 
71279), we established that, beginning with the CY 2018 payment 
adjustment period, the VM will apply to nonphysician EPs who are 
physician assistants (PAs), nurse practitioners (NPs), clinical nurse 
specialists (CNSs), and certified registered nurse anesthetists (CRNAs) 
in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are 
solo practitioners.
    We also previously finalized that, in CY 2018, the VM will be 
waived for groups and solo practitioners, as identified by their 
Taxpayer Identification Number (TIN), if at least one EP who billed for 
Medicare PFS items and services under the TIN during 2016 participated 
in the Pioneer ACO Model, the Comprehensive Primary Care initiative, 
Next Generation ACO Model, the Oncology Care Model, or the 
Comprehensive ESRD Care Initiative in 2016 (80 FR 71286 through 71288).
    In the CY 2016 PFS final rule with comment period (80 FR 71280), we 
adopted a two-category approach for the CY 2018 VM based on 
participation in the PQRS by groups and solo practitioners. For the 
purposes of the CY 2018 VM, Category 1 represents groups and solo 
practitioners subject to the VM who met the criteria to avoid the CY 
2018 PQRS payment adjustment (a) as a group practice participating in 
the PQRS GPRO, (b) groups that had at least 50 percent of the group's 
EPs meet the criteria to avoid the CY 2018 PQRS payment adjustment as 
individuals, (c) solo practitioners that met the criteria to avoid the 
CY 2018 PQRS payment adjustment as individuals, and (d) groups and solo 
practitioners that participated in a Shared Savings Program ACO, if the 
ACO in which they participated successfully reported quality data as 
required by the Shared Savings Program. Category 2 represents those 
groups and solo practitioners that are subject to the CY 2018 VM 
payment adjustment and do not fall within Category 1.
    In section III.I. of this final rule, we are finalizing the 
proposed policy to reduce the CY 2018 VM payment adjustment amount for 
groups and solo practitioners in Category 2. We are finalizing that the 
automatic payment adjustment would be reduced from -4.0 percent to -2.0 
percent for physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or 
more EPs and at least one physician and from -2.0 percent to -1.0 
percent for physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 to 9 
EPs; PAs, NPs, CNSs, and CRNAs in groups comprised solely of 
nonphysician EPs; and physicians, PAs, NPs, CNSs, and CRNAs who are 
solo practitioners.
    Additionally, in section III.I. in this final rule, we are 
finalizing the proposed policy that, under quality-tiering, which is 
the methodology for evaluating performance on quality and cost measures 
for the VM, there will be no downward adjustments for groups or solo 
practitioners in Category 1 for the VM for CY 2018. We are also 
finalizing the proposed policy to reduce the maximum upward adjustment 
under the quality-tiering methodology in CY 2018 for physicians, PAs, 
NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one 
physician that are

[[Page 53351]]

Category 1 from four times an adjustment factor (+4.0x) to two times an 
adjustment factor (+2.0x) for those classified as high quality/low cost 
and from two times an adjustment factor (+2.0x) to one times an 
adjustment factor (+1.0x) for those classified as either average 
quality/low cost or high quality/average cost. This final policy aligns 
the upward adjustment for groups of 10 or more EPs with those 
previously finalized for smaller groups and solo practitioners, as well 
as groups comprised solely of non-physician EPs and provides a smoother 
transition to MIPS.
    As in previous years of the program, under the quality-tiering 
methodology, each group and solo practitioner's quality and cost 
composites will continue to be classified into high, average, and low 
categories depending upon whether the composites are at least one 
standard deviation above or below the mean and statistically different 
from the mean. We will compare their quality of care composite 
classification with the cost composite classification to determine 
their VM adjustment for the CY 2018 payment adjustment period according 
to the amounts in Table 54.

  Table 54--CY 2018 VM Amounts Under the Quality-Tiering Approach for Physicians, PAs, NPs, CNSs, and CRNAs Who
                                       Are in Groups or Solo Practitioners
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                          Cost/quality                             Low  quality       quality      High  quality
----------------------------------------------------------------------------------------------------------------
Low cost........................................................           +0.0%         * +1.0x         * +2.0x
Average cost....................................................           +0.0%           +0.0%         * +1.0x
High cost.......................................................           +0.0%           +0.0%           +0.0%
----------------------------------------------------------------------------------------------------------------
* Groups and solo practitioners eligible for an additional +1.0x if reporting measures and average beneficiary
  risk score is in the top 25 percent of all beneficiary risk scores, where `x' represents the upward payment
  adjustment factor.

    Under the quality-tiering methodology, for groups and solo 
practitioners that participated in a Shared Savings ACO that 
successfully reports quality data for CY 2016, the cost composite will 
be classified as ``Average'' and the quality of care composite will 
continue to be based on ACO-level quality measures. We will compare 
their quality of care composite classification with the ``Average'' 
cost composite classification to determine their VM adjustment for the 
CY 2018 payment adjustment period. For groups and solo practitioners 
that participate in a Shared Savings Program ACO that did not 
successfully report quality data for CY 2016 and are Category 1 as a 
result of quality data reported to the PQRS outside of the ACO, the 
quality and cost composites will continue to be classified as 
``Average''.
    To achieve budget neutrality, we first aggregate the automatic 
downward payment adjustments of -1.0 percent or -2.0 percent for groups 
and solo practitioners subject to the VM that fall within Category 2. 
Using the aggregate downward payment adjustment amount, we then 
calculate the upward payment adjustment factor (x). Additionally, as we 
have done when calculating the upward payment adjustment factor for the 
2017 VM, we will also incorporate adjustments made for estimated 
changes in physician behavior, including anticipated changes in the 
volume and/or intensity of services delivered and shifting of services 
to TINs that receive higher VM adjustments, and estimated impact of 
pending PQRS and VM informal reviews. These calculations will be done 
after the performance period has ended and announced around the start 
of the payment adjustment year after the informal review period ends.
    On September 18, 2017, we made the 2016 Annual QRURs available to 
all groups and solo practitioners based on their performance in CY 
2016. We also completed a preliminary analysis (based on results 
included in the 2016 Annual QRURs and prior to accounting for the 
informal review process) of the impact of the VM in CY 2018 on 
physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 or more EPs and 
physicians, PAs, NPs, CNSs, and CRNAs who are solo practitioners based 
on their performance in CY 2016. A summary of the results for groups 
and solo practitioners subject to the 2018 VM is presented below.
    There are 180,621 groups and solo practitioners (as identified by 
their TIN) consisting of 1,121,857 physicians, PAs, NPs, CNSs, and 
CRNAs whose payments under the Medicare PFS will be subject to the VM 
in the CY 2018 payment adjustment period. These counts include both 
TINs that participated in a Shared Savings Program ACO in CY 2016 and 
TINs that did not. Of all the physicians, PAs, NPs, CNSs, and CRNAs 
subject to the CY 2018 VM, approximately 75 percent (838,376) are in 
TINs that met the criteria for inclusion in Category 1 and are subject 
to the quality-tiering methodology in order to calculate their CY 2018 
VM; and approximately 25 percent (283,481) are in TINs that are 
Category 2.
    Physicians, PAs, NPs, CNSs, and CRNAs in Category 2 TINs with 
between 1 to 9 EPs and at least one physician and PAs, NPs, CNSs, and 
CRNAs in Category 2 TINs comprised solely of non-physician EPs will be 
subject to an automatic -1.0 percent payment adjustment, while 
physicians, PAs, NPs, CNSs, and CRNAs in Category 2 TINs with 10 or 
more EPs and at least one physician will be subject to an automatic -
2.0 percent payment adjustment under the VM during the CY 2018 payment 
adjustment period for failing to meet the criteria to avoid the CY 2018 
PQRS payment adjustment. The number of physicians, PAs, NPs, CNSs, and 
CRNAs receiving an automatic downward payment adjustment because their 
TIN failed to meet the criteria to avoid the PQRS adjustment declined 
by 8 percentage points to 25 percent for the 2018 VM (based on 2016 
performance), down from 33 percent for the 2017 VM, despite the 
expansion of the VM from all physicians to all physicians and NPs, PAs, 
CNSs, and CRNAs in the 2018 payment year. We believe it is likely that 
many TINs that failed to meet the criteria to avoid the PQRS adjustment 
and as a result are in Category 2 and are subject to automatic downward 
payment adjustments under the CY 2018 VM will be excluded from MIPS in 
CY 2019, due to the low-volume threshold. Furthermore, the lower 
percent of clinicians who do not meet the criteria to avoid the PQRS 
adjustment, coupled with lower downward adjustments and upward 
adjustments based on performance will likely result in payment 
adjustments that are more in line with MIPS level adjustments.
    For physicians, PAs, NPs, CNSs, and CRNAs (838,376) that are in 
Category 1 TINs (77,337) in CY 2018, Table 55 shows their distribution 
into the various

[[Page 53352]]

quality and cost tiers. The results show that 3,121 TINs consisting of 
19,862 physicians, PAs, NPs, CNSs, and CRNAs will receive an upward 
payment adjustment; and 74,216 TINs consisting of 818,514 physicians, 
PAs, NPs, CNSs, and CRNAs will receive a neutral payment adjustment 
under the VM in CY 2018. Out of those receiving a neutral payment 
adjustment in CY 2018, 7,387 TINs consisting of 88,706 physicians, PAs, 
NPs, CNSs, and CRNAs were held harmless from downward adjustments.

  Table 55--Preliminary Distribution of Category 1 TINs (and Physicians, PAs, NPs, CNSs, and CRNAs in the TINs)
                                              Under the CY 2018 VM
                          [77,337 TINs; 838,376 physicians, PAs, NPs, CNSs, and CRNAs]
----------------------------------------------------------------------------------------------------------------
           Cost/quality                   Low quality              Average quality            High quality
----------------------------------------------------------------------------------------------------------------
Low Cost.........................  +0.0% (18 TINs; 2,522      +1.0x (57 TINs; 1,017     +2.0x (5 TINs; 218
                                    clinicians).               clinicians).              clinicians).
                                                              +2.0x * (68 TINs; 4,245   +3.0x * (11 TINs; 51
                                                               clinicians).              clinicians).
Average Cost.....................  +0.0% (5,721 TINs; 61,628  +0.0% (66,780 TINs;       +1.0x (2,158 TINs;
                                    clinicians).               727,032 clinicians).      10,132 clinicians).
                                                                                        +2.0x * (822 TINs; 4,199
                                                                                         clinicians).
High Cost........................  +0.0% (499 TINs; 7,689     +0.0% (1,167 TINs;        +0.0% (31 TINs; 254
                                    clinicians).               19,389 clinicians).       clinicians).
----------------------------------------------------------------------------------------------------------------
* These TINs were eligible for an additional +1.0x for reporting measures and having an average beneficiary risk
  score in the top 25 percent of all beneficiary risk scores.
The term `clinicians' refers to the physicians, PAs, NPs, CNSs, and CRNAs in the TINs.

    The numbers presented above are preliminary numbers and may be 
subject to change as a result of the informal review process. In early 
2018, after the conclusion of the informal review period, we will 
release updates to the number of TINs receiving upward, neutral, and 
downward adjustments, along with the adjustment factor for the CY 2018 
VM on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/2016-QRUR.html. 
Preliminary estimates indicated that the implementation of the 
finalized policies discussed above would reduce the adjustment factor 
to below 10 percent.
9. MACRA Patient Relationship Categories and Codes
    We proposed that Medicare claims submitted for items and services 
furnished by a physician or applicable practitioner on or after January 
1, 2018, should voluntarily include any of these five HCPCS modifiers: 
X1 (Continuous/broad services), X2 (Continuous/focused services) X3 
(Episodic/broad services, X4 (Episodic/focused services) and X5 (Only 
as ordered by another physician). In addition to the modifiers, 
Medicare claims should include the NPI of the ordering physician or 
applicable practitioner (if different from the billing physician or 
applicable practitioner). Our plan is not to tie the collection of the 
codes with payment until we are sure clinicians have gained ample 
experience and education in using these modifiers. Therefore, there is 
no impact to CY 2018 physician payments under the PFS. There may be a 
burden associated with clinicians and their administrative staff having 
to learn which codes to use and how to submit them properly.
a. Collection of Information Burden Cost Estimate
    CMS will provide a voluntary 25-minute training/instruction manual 
and a one-time 60-minute (1 hour) webinar for practice manager or 
billing/coding staff who seek further knowledge to be able to report 
these new HCPCS modifiers correctly. Although there are a total of five 
HCPCS modifiers, we expect one out of the five usually will be 
reported.
    For a practice manager or billing/coding staff who may voluntarily 
study the whole 25 minutes training document, we estimate a one-time 
total cost burden of training of $150.00 x 0.25hrs = $37.50 for the 
reading of the coding manual, and a burden of $150.00 x 1hr = $150.00 
for participating in the webinar (or later watching the recorded 
webinar videos), totaling an overall burden of training of $150.00 + 
$37.50 = $187.50. The practice manager or billing/coding staff who may 
decide to study only one HCPCS modifier or only the whole training 
manual or participate in just the webinar may experience a lesser 
burden than the estimate provided above, resulting in a lower 
information burden cost.
10. Effects of Proposals Relating to the Medicare Diabetes Prevention 
Program Expanded Model
    In section III.K of the preamble of this final rule, we discuss our 
proposals to further implement the MDPP expanded model under the 
authority of section 1115A of the Act, which authorizes the Innovation 
Center to test innovative payment and service delivery models to reduce 
program expenditures while preserving or enhancing the quality of care 
furnished to Medicare, Medicaid and CHIP beneficiaries. The MDPP 
expanded model was established in the November 15, 2016 MDPP final rule 
(81 CFR 80459 through 80483) as an additional preventive service with a 
model effective date of January 1, 2018. Many of the policies for the 
MDPP expanded model were deferred to future rulemaking and, therefore, 
are being finalized in this rule. On March 14, 2016, the Office of the 
Actuary (OACT) published a certification memorandum setting out the 
conditions for expansion of the Medicare Diabetes Prevention Program 
(MDPP). This regulatory impact assessment is not an updated 
certification; rather, it is based on estimates of this final rule and 
provides a revised 10-year savings estimate of $182 million which 
differs slightly from the 10-year savings estimate of $186 million 
included in the proposed rule. The $4 million reduction in savings can 
be explained by two factors. First, CMS is finalizing more payment for 
the MDPP services based on beneficiary attendance and weight loss. 
Thus, this increases projected costs and reduces projected savings. 
Second, we are finalizing a MDPP service period of 2 years. A shortened 
period of maintenance sessions available slightly reduces long term 
program effectiveness while also reducing potential savings. However, 
reducing the program length from 3 years to 2 years cuts the total 
possible payment for each participant from $810 to $670 which offsets 
most of the costs of higher performance payments and reduced 
effectiveness.
    Diabetes affects more than 25 percent of Americans aged 65 or older 
and its prevalence is projected to increase approximately two-fold for 
all U.S. adults (ages 18-79) by 2050 if current trends continue.\51\ 
Furthermore, the risk

[[Page 53353]]

of progression to type 2 diabetes in an individual with prediabetes is 
5-10 percent per year, or 5-20 times higher than in individuals with 
normal blood glucose.\52\ We estimate that Medicare spent $42 billion 
more in the single year of 2016 on fee-for-service, non-dual eligible, 
over age 65 beneficiaries with diabetes and related comorbidities than 
it would have spent if those beneficiaries did not have diabetes, 
including $20 billion more for Part A, $17 billion more for Part B, and 
$5 billion more for Part D.\53\ The goal of the MDPP expanded model is 
to reduce the incidence rate of type 2 diabetes among Medicare 
beneficiaries with prediabetes through a structured behavioral change 
program where the primary outcome is weight loss. Weight loss is a key 
indicator of success among persons enrolled in a Diabetes Prevention 
Program due to the strong association between weight loss and reduction 
in the risk of type 2 diabetes. In reducing the incidence rate of type 
2 diabetes we expect to reduce Medicare spending while improving 
quality of care for eligible beneficiaries. In this final rule, we 
finalized a value-based payment structure for the MDPP expanded model. 
Instead of traditional fee-for-service payment, our payment structure 
shifts risk from Medicare to the rendering supplier by making payments 
for MDPP services to MDPP suppliers based on the achievement of 
performance goals.
---------------------------------------------------------------------------

    \51\ Centers for Medicare & Medicaid Services, ``Chronic 
Conditions Among Medicare Beneficiaries, Chartbook: 2012 Edition,'' 
Centers for Medicare & Medicaid Services, 2012, https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/chronic-conditions/downloads/2012chartbook.pdf. James Boyle, et al., 
``Projection of the Year 2050 Burden of Diabetes in the US Adult 
Population: Dynamic Modeling of Incidence, Mortality, and Pre- 
Diabetes Prevalence,'' Population Health Metrics 8, no. 29 (2010): 
1-12.
    \52\ X Zhang et al., ``A1C Level and Future Risk of Diabetes: A 
Systematic Review,'' Diabetes Care 33, no. 7 (2010): 1665-1673.
    \53\ Erkan Erdem and Holly Korda, ``Medicare Fee- For-Service 
Spending for Diabetes: Examining Aging and Comorbidities,'' Diabetes 
& Metabolism 5, no. 3 (2014); The Boards of Trustees: Federal 
Hospital Insurance and Federal Supplementary Medical Insurance Trust 
Funds, ``2016 Annual Report of the Boards of Trustees of the Federal 
Hospital Insurance and Federal Supplementary Medical Insurance Trust 
Funds,'' Centers for Medicare & Medicaid Services, 2016, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFu2016.pdf.; and CMS estimates.
---------------------------------------------------------------------------

a. Anticipated Effects
(1) Effects on Beneficiaries
    The MDPP expanded model is expected to have a positive impact on 
beneficiaries' health that will generally lead to reduced beneficiary 
spending on Part A, Part B, and Part D health care services over time 
due to a reduced need for Part A, Part B, and Part D services. This 
regulatory impact analysis does not include anticipated savings from 
Medicare Part D. As a new preventive service, the MDPP services are 
available to eligible Medicare beneficiaries without cost-sharing. The 
CDC estimates that approximately 50 percent of adults aged 65 and over 
living in the United States have prediabetes and that awareness of the 
condition among those who have it is relatively low--approximately 15 
percent for the general population.\54\ Therefore, we anticipate that 
up to 3 million Medicare beneficiaries who are aware of their 
prediabetes would be eligible for the MDPP services at the start of the 
MDPP expanded model. This estimate does not take into account any 
increased beneficiary awareness of their prediabetes due to the 
availability of MDPP services. We also expect there to be pent-up 
demand, with the number of beneficiaries utilizing the MDPP services 
greater in the initial few years (roughly 65,000 to 110,000 per year) 
but then leveling off afterwards (to a base demand of roughly 50,000 
participants per year).
---------------------------------------------------------------------------

    \54\ https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
---------------------------------------------------------------------------

    To arrive at our participation estimate we developed projections 
for pent-up demand and ongoing demand. To develop the projection for 
pent-up demand we first analyzed data from the CDC National Diabetes 
Prevention Recognition Program (DPRP). Specifically, we analyzed State-
by-State DPRP in-person utilization for ages 65 or older in 2015. 
Because the Health Care Innovation Award (HCIA) DPP model test was 
still serving beneficiaries during this period, and the HCIA DPP 
organizations are also part of the DPRP, we used its enrollment data to 
inform what Medicare beneficiary participation may look like when 
Medicare pays for MDPP services. Given that HCIA participation seemed 
to drive most of the DPRP participation in an HCIA awardee's region, we 
determined that a well-defined HCIA region would be a reasonable proxy 
for the rest of the nation. We found the state with the highest HCIA 
saturation, and calculated the percentage of fee for service 
beneficiaries that received services from a DPRP DPP. This percentage 
was applied to all fee for service beneficiaries nationwide in order to 
get a national pent-up demand estimate. We added this pent-up demand to 
a stable level of demand based on the number of new beneficiaries 
utilizing the obesity management benefit each year. Given the limited 
nationwide Medicare DPP participation data, there is a great amount of 
uncertainty in these estimates.
    We believe that the eligibility criteria for continued 
participation in the set of MDPP services incentivizes beneficiaries to 
lose 5-percent body weight from baseline. Beneficiaries are 
incentivized to lose weight because continued eligibility for the 
services after the first 12 months is contingent upon achieving 5-
percent weight loss and the set of MDPP services is a once per lifetime 
set of services. In addition to prevention of type 2 diabetes, we 
believe participating beneficiaries would likely receive other possible 
health benefits including prevention of obesity for those who are 
overweight upon receiving MDPP services, prevention of sleep apnea, and 
reduced risk for heart disease, coronary artery disease and stroke.\55\ 
Furthermore, we believe the MDPP expanded model could improve mental 
health and wellbeing by affording beneficiaries social interaction with 
their peers during sessions and could lead to reduced social isolation. 
\56\ The

[[Page 53354]]

prevention of type 2 diabetes and these other potential health benefits 
of MDPP services may result in reduced beneficiary expenditures for 
health care services over time as services will not be needed to treat 
health conditions that are avoided.
---------------------------------------------------------------------------

    \55\ Orchard, T.J., et al. (2005). ``The effect of metformin and 
intensive lifestyle intervention on the metabolic syndrome: the 
Diabetes Prevention Program randomized trial.'' Ann Intern Med 
142(8): 611-619; Orchard, T.J., et al. (2013). ``Long-term effects 
of the Diabetes Prevention Program interventions on cardiovascular 
risk factors: a report from the DPP Outcomes Study.'' Diabet Med 
30(1): 46-55; Li, G., et al. (2014). ``Cardiovascular mortality, 
all-cause mortality, and diabetes incidence after lifestyle 
intervention for people with impaired glucose tolerance in the Da 
Qing Diabetes Prevention Study: a 23-year follow-up study.'' Lancet 
Diabetes Endocrinol 2(6): 474-480; Mudaliar, U., et al. (2016). 
``Cardiometabolic Risk Factor Changes Observed in Diabetes 
Prevention Programs in US Settings: A Systematic Review and Meta-
analysis.'' PLoS Med 13(7): e1002095; Kuna, S.T., et al. (2013). 
``Long-term effect of weight loss on obstructive sleep apnea 
severity in obese patients with type 2 diabetes.'' Sleep 36(5): 641-
649a; Mitchell, L. J., et al. (2014). ``Weight loss from lifestyle 
interventions and severity of sleep apnoea: a systematic review and 
meta-analysis.'' Sleep Med 15(10): 1173-1183; Thomasouli, M.A., et 
al. (2013). ``The impact of diet and lifestyle management strategies 
for obstructive sleep apnoea in adults: a systematic review and 
meta-analysis of randomised controlled trials.'' Sleep Breath 17(3): 
925-935; U.S. Department of Health and Human Services. 2008 Physical 
Activity Guidelines for Americans. Washington (DC): U.S. Department 
of Health and Human Services; 2008. ODPHP Publication No. U0036. 
Available at: http://www.health.gov/paguidelines; U.S. Department of 
Health and Human Services and U.S. Department of Agriculture. 2015--
2020 Dietary Guidelines for Americans. 8th Edition. December 2015. 
Available at http://health.gov/dietaryguidelines/2015/guidelines/.
    \56\ Florez, H., et al. (2012). ``Impact of lifestyle 
intervention and metformin on health-related quality of life: the 
diabetes prevention program randomized trial.'' J Gen Intern Med 
27(12): 1594-1601; Ackermann, R. T., et al. (2009). ``Changes in 
health state utilities with changes in body mass in the Diabetes 
Prevention Program.'' Obesity (Silver Spring) 17(12): 2176-2181; 
Weinhold, K. R., et al. (2015). ``A Randomized Controlled Trial 
Translating the Diabetes Prevention Program to a University 
Worksite, Ohio, 2012-2014.'' Preventing Chronic Disease 12: E210.
---------------------------------------------------------------------------

(2) Effects on the Market
    Currently, more than 1,400 organizations nationally are providing 
DPP services with some level of recognition through the CDC. Service 
delivery is primarily to individuals with private or employer-sponsored 
insurance, as well as some Medicare Advantage plans. The majority of 
existing DPP organizations are not participating in the Medicare 
program. We anticipate that the addition of MDPP services as new 
preventive services in Medicare would result in growth in the market, 
including growth in the number of individuals served per year by 
existing DPP suppliers, as well as the introduction of new suppliers 
into the market. There are burdens associated with obtaining CDC 
recognition and enrolling into Medicare as an MDPP supplier. There is 
also burden associated with submitting claims to Medicare for payment. 
Below we have provided an estimate of the financial burden to 
suppliers.
(3) Burden Related to Information Collection Requirements
(a) Wage Estimates
    To derive average costs for use throughout the subsequent sections, 
we used data from the U.S. Bureau of Labor Statistics' May 2016 
National Occupational Employment and Wage Estimates for all salary 
estimates (https://www.bls.gov/oes/current/oes_nat.htm). Table 56 
presents the mean hourly wage, the cost of fringe benefits and overhead 
(calculated at 100 percent of salary), and the adjusted hourly wage.

                          Table 56--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    benefits  and     Adjusted
                Occupation title                       code        wage  ($/hr)    overhead  ($/   hourly  wage
                                                                                        hr)           ($/hr)
----------------------------------------------------------------------------------------------------------------
Medical records and health information                   29-2071           19.93           19.93           39.84
 technician.....................................
Office and administrative support worker........         43-9000           16.31           16.31           32.62
Billing and posting Clerk.......................         43-3011           18.09           18.09           36.18
----------------------------------------------------------------------------------------------------------------

(b) Interim Preliminary Recognition
    Our regulations at Sec.  424.205 provide that an entity is eligible 
to enroll in Medicare as an MDPP supplier if it has MDPP interim 
preliminary recognition, as determined by CMS. In order to receive MDPP 
interim preliminary recognition, we finalized that the entity must have 
pending CDC recognition and must submit a full 12 months of data on at 
least one completed cohort of participants to CDC (among other 
criteria). In order to receive pending recognition from CDC, 
organizations are required to submit an application for recognition to 
CDC and agree to CDC's curriculum, duration and intensity requirements. 
CMMI plans to engage CDC's services to assist CMMI in administering its 
interim preliminary recognition standard. CMMI would make the final 
determination of which entities qualify to receive interim preliminary 
recognition.
    The burden associated with the preceding requirements is the time 
for MDPP supplier staff to: Submit an application for pending 
recognition to CDC and then collect and submit a full 12 months of data 
(including session attendance, body weight documentation, physical 
activity minutes documentation, and weight loss achieved) on at least 
one completed cohort of participants to CDC for the purposes of being 
evaluated for interim preliminary recognition.
    We estimate that it will take a medical records and health 
information technician 12 hours, at $39.84/hour to collect and report 
these data for one cohort of participants, and an office or 
administrative worker 1 hour, at $32.62/hour, to complete the CDC 
application for pending recognition. The estimated cost per supplier to 
achieve interim preliminary recognition is $510.70.
(c) Supplier Standards
    Our regulations at Sec.  424.205 and Sec.  424.59 will require that 
an MDPP supplier certify in its enrollment application that it meets a 
set of standards. This application will be designated as CMS-20134. As 
this new enrollment application is being created specifically for the 
MDPP expanded model, we have determined that it is exempt from the 
Paperwork Reduction Act in accordance with section 1115A(d)(3) of the 
Act. We estimate that it will take an office or administrative support 
worker 3 hours, at $32.62/hour, to complete the MDPP supplier 
enrollment application using the internet-based Provider Enrollment, 
Chain and Ownership System (PECOS). The provider/supplier enrollment 
fee for CY 2017 is $560. We note that in accordance with Sec.  424.514 
MDPP suppliers may submit a written request to CMS for a hardship 
exception to the application fee. CMS determines such exceptions on a 
case-by-case basis. The estimated cost to complete the MDPP supplier 
enrollment application, without a hardship exception, is $654.62. If a 
provider is granted a hardship exception from the enrollment fee, then 
the estimated cost to complete the enrollment process is $94.62.
    We also note that access to the HIPAA Eligibility Transaction 
System (HETS), which a supplier could use to check factors of 
eligibility for the MDPP services, including the beneficiary's Part B 
eligibility and whether the beneficiary is eligible for Medicare based 
on end-stage renal disease (as described in Sec.  406.13), is free to 
suppliers, as long as they are active Medicare fee-for-service 
providers or suppliers in PECOS.
    Suppliers also will be required to maintain documentation of all 
beneficiary contact regarding complaints or questions, as specified in 
Sec.  424.205(d)(11), and maintain and submit to CMS a crosswalk file 
that indicates how participant identifications for the purposes of CDC 
performance data correspond to beneficiary identifiers (Medicare 
Beneficiary Identifiers or beneficiary health insurance claims numbers) 
for each beneficiary receiving MDPP services. We estimate that creating 
and maintaining documentation of beneficiary contact regarding 
complaints or questions will take an

[[Page 53355]]

office or administrative support worker 1 hour, at $32.62/hour, per 
complaint or question request to create and maintain documentation of 
the request. We have no way to estimate how many complaints or 
questions MDPP suppliers will receive from beneficiaries, and we expect 
that may differ based on many factors, so we have not included an 
overall cost in this burden estimate. Further, we estimate that it will 
take an office and administrative support worker approximately 4 hours, 
at $32.62/hour, to create and submit the crosswalk file for a cohort of 
100 beneficiaries participating in the MDPP services, for a total cost 
of $130.48 per cohort of 100 beneficiaries. The crosswalk is to be 
submitted quarterly. Therefore, for a year of delivering the set of 
MDPP services the estimated total cost to create and submit the 
crosswalk file would be $521.92 per cohort of 100 beneficiaries. We 
believe the incremental costs to meet this requirement would decrease 
with the addition of beneficiaries to a cohort, because the work and 
time to establish the file and submit it would be the same for a cohort 
of 100 and a cohort of 1,000. What would be different is the collection 
of the information from the beneficiaries, and the addition of these 
data points to the file. We estimate that, for every additional 100 
beneficiaries added to the file, the office and administrative support 
worker would add 1 hour, at $32.62/hour. We estimate the total 
incremental cost over 1 year for each additional 100 beneficiaries 
above the cohort of 100 beneficiaries is $130.48.
    Our regulations at Sec.  424.205 also will require that suppliers 
meet a set of standards that includes maintaining a physical facility 
on an appropriate site and maintaining a primary business telephone 
that is operating at the appropriate site. Because we have no way to 
estimate how many beneficiaries each MDPP supplier may provide the set 
of MDPP services to, and we expect this will differ based on many 
factors, including but not limited to the size of the supplier, the 
number of coaches the supplier employs, the physical space the supplier 
uses to furnish MDPP services, and the supplier's geographic location, 
we have not included an overall cost for these requirements in this 
burden estimate.
(d) Payment for MDPP Services
    Our regulations at Sec.  414.84 specify the payments MDPP suppliers 
may be eligible to receive for furnishing MDPP services and meeting 
performance targets related to beneficiary weight loss and/or 
attendance. MDPP suppliers would be paid by CMS by submitting claims 
for MDPP beneficiaries using claim form CMS-1500 (https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1500.pdf), and as a condition 
for payment, claims submitted by MDPP suppliers must be for services 
furnished to eligible beneficiaries in accordance with Sec.  414.84(b) 
and (c). Our regulations at Sec.  424.205 will require MDPP suppliers 
to include an attestation that the MDPP beneficiary for which it is 
submitting a claim has met the performance goals. Section Sec.  424.205 
also requires MDPP suppliers to report the NPI of the coach on MDPP 
claims as a program integrity safeguard. To meet these requirements for 
submitting claims, we estimate that it would take a billing and posting 
clerk 10 minutes per beneficiary to fill out the claim form and submit 
it to CMS at $36.18/hour. Based on this time and wage, we estimate the 
total cost per beneficiary per claim to be $6.03. As mentioned 
previously, we have no way to estimate how many beneficiaries to whom 
each MDPP supplier may furnish MDPP services. Therefore, we have not 
included an estimate of the overall cost of submitting claims in the 
burden estimate.
(4) Effects on the Medicare Program
(a) Estimated 10-Year Impact of MDPP
    The set of MDPP services is an optional set of services for 
beneficiaries who meet the eligibility requirements described elsewhere 
in the final rule. MDPP services will be furnished by a new supplier 
type in Medicare. The CDC recognizes DPPs nationwide; these programs 
effectively deliver lifestyle-changing services that reduce the 
incidence of type 2 diabetes. The number of CDC-recognized DPPs is 
growing rapidly, increasing by nearly 90 percent from September 2015 to 
March 2017. The historical participation rate suggests that the vast 
majority of these organizations are not serving a significant volume of 
new participants, aside from those served in the DPP model test.
    This estimate is based on the initial methodology used for the 
estimate of the MDPP expanded model as set out in the certification 
memorandum, but with differences in several program features including 
the payment parameters. It also includes the impact of improved 
longevity among those who participate in the MDPP expanded model. This 
cost of improved longevity was ignored for certification purposes, as 
noted in that memorandum.
    The model is dependent on the number of eligible participants, the 
annual take-up rate, and the savings per participant, all of which are 
uncertain. The methodology determines gross savings as the result of an 
assumed reduction in the number of beneficiaries transitioning from 
prediabetes to diabetes and a marginal cost difference between the 
individuals with diabetes and those that are prediabetic. The Office of 
the Actuary assumed that the initial savings per beneficiary for 
avoiding diabetes is $3,000 per year. The progression rate from 
prediabetes to diabetes absent the intervention is expected to be 
roughly 5 percent per year. Based on observed results, we assume that 
the set of MDPP services will reduce the progression rate among those 
receiving the services by 50 percent in the first year and that the 
reduction will be 5 percent less in each subsequent year until leveling 
off at a rate of 5 percent. Due to a cessation of payments for 
participating beneficiaries after 2 years, there is an additional 
reduction of 5 percent in the third year. The program costs in this 
estimate include payments to MDPP suppliers in the initial year of the 
MDPP services period and in the maintenance year. Overall, the payments 
under the expanded model would occur for a maximum of 2 years, but the 
expected reduction in medical costs would occur over a long period 
following the intervention. For the leading cohort of 2018, we would 
expect savings in excess of costs by 2019 (the second year), with 
cumulative savings by 2021 (after 3 years). Yearly net savings reduce 
slightly each subsequent year but do not result in a cost to Medicare 
during the 10-year projection window.
    Table 57 shows the 10-year impact of the MDPP expanded model, net 
of payments to MDPP providers but gross of any other model costs, based 
on our expected enrollment per year. The 10-year impact is a savings to 
Medicare of $182 million. The estimate is expected to cross into a 
cumulative savings to Medicare in the sixth year of the MDPP expanded 
model.

[[Page 53356]]



            Table 57--Estimated 10-Year Impact of MDPP on Net Claims Costs, Payments to Providers, and Net Savings for CYs 2018 Through 2027
                                                     [In millions, negative values indicate savings]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                        Year                           2018     2019     2020     2021     2022     2023     2024     2025     2026     2027     Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Net Claim Costs....................................      -$5     -$16     -$29     -$40     -$51     -$59     -$65     -$69     -$70     -$70      -$472
Provider Payments..................................       23       45       39       26       24       25       26       26       27       28        290
Annual Net Savings.................................       19       30       10      -14      -27      -34      -39      -42      -43      -42       -182
Cumulative Net Savings.............................       19       48       59       44       18      -16      -55      -97      -14     -182  .........
--------------------------------------------------------------------------------------------------------------------------------------------------------

(b) Sensitivity Testing
    MDPP is a new Medicare expanded model that was tested in the HCIA 
DPP model using a small percentage of the population. As a result, the 
estimated impact from the expanded MDPP model is very uncertain. In 
particular, it is unknown how many beneficiaries will be interested in 
participating in MDPP and how quickly MDPP suppliers available will be 
able to serve those individuals. To understand how various 
participation scenarios would affect the financial results, we have 
prepared the estimates under two other participation scenarios. The 
first shows the results if half of the beneficiaries shown in the best 
estimate participate, and the second uses twice as many beneficiaries. 
The details are shown in Tables 58 and 59.

  Table 58--Scenario Test of MDPP 10-Year Impact of Half the Expected Participants on Net Claims Costs, Payments to Providers, and Net Savings for CYs
                                                                    2018 Through 2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
                        Year                           2018     2019     2020     2021     2022     2023     2024     2025     2026     2027     Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Net Claim Costs....................................      -$2      -$8     -$14     -$20     -$25     -$29     -$32     -$34     -$35     -$35      -$236
Provider Payments..................................       12       23       19       13       12       12       13       13       14       14        145
Annual Net Savings.................................        9       15        5       -7      -13      -17      -20      -21      -21      -21        -91
--------------------------------------------------------------------------------------------------------------------------------------------------------


 Table 59--Scenario Test of MDPP 10-Year Impact of Double the Expected Participants on Net Claims Costs, Payments to Providers, and Net Savings for CYs
                                                                    2018 Through 2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
                        Year                           2018     2019     2020     2021     2022     2023     2024     2025     2026     2027     Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Net Claim Costs....................................      -$9     -$31     -$58     -$81    -$101    -$117    -$129    -$137    -$140    -$139      -$944
Provider Payments..................................       46       91       78       52       48       50       51       53       55       56        580
Annual Net Savings.................................       37       59       20      -29      -53      -68      -78      -84      -86      -83       -364
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In conclusion, we estimate that the 10-year impact of the MDPP 
expanded model, net of payments to MDPP providers but gross of any 
other program costs, based on our expected enrollment per year would be 
a savings to Medicare of $182 million. The estimate is expected to 
cross into a cumulative savings to Medicare in the sixth year of the 
MDPP expanded model.
    Comment: MedPAC commented that OACT certified the DPP for expansion 
into the FFS program based on the payment schedule CMS initially 
proposed--with a maximum amount per beneficiary of $630. CMS has not 
provided detail regarding whether the newly proposed payment amount and 
schedule would still meet the Actuary's certification.
    Response: OACT has certified that the MDPP expanded model, as 
implemented in this final rule is expected to reduce (or not increase) 
net program spending. The memo may be accessed at https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/ActuarialStudies/Downloads/Diabetes-Prevention-Recertification-2017-11-01.pdf.
    Comment: One commenter suggested that CMS underestimated pent-up 
demand for the DPP service stating that even the highest saturation 
Health Care Innovation Award (HCIA) is likely a low-end estimate of 
pent-up demand, connected to inadequate funding during the award 
period.
    Response: We acknowledge that there is some uncertainty with our 
beneficiary participation estimates given that this is a new preventive 
service being furnished by a new type of Medicare supplier. We derived 
our participation estimates using data from the HCIA model test because 
that is the best data available to inform our estimates. We provide 
sensitivity analysis that examines the impact of a higher-than-expected 
rate of utilization.
    Comment: One commenter stated that while the burden estimates may 
be accurate for clinical practices with existing infrastructure, they 
underestimate the start-up (for example, recognition) and ongoing (for 
example, record-keeping) costs for new community-based suppliers 
without existing infrastructure and staff training. The commenter 
suggested that CMS create a mechanism for verifying differentials in 
overhead and staffing costs for clinical and community-based suppliers. 
Another commenter stated that the proposed rule seemed to account for 
all of the start-up costs with the exception of delivering the program 
itself. A third commenter similarly noted that the burden estimates did 
not include the total cost of delivering the MDPP services.
    Response: We were only able to include burden estimates that were 
not expected to vary widely between suppliers, for example the cost of 
enrolling as a Medicare supplier. We did not include burden estimates 
for hiring and training coaches or other start-up costs because there 
will be great variability between suppliers for these costs. There is 
great variability for a number of reasons including but not limited to 
the size of the supplier, the number of coaches the supplier employs, 
the physical space the supplier uses to furnish MDPP services,

[[Page 53357]]

the supplier's geographic location, and the number of beneficiaries 
they will serve. In addition there are no restrictions in terms of 
labor categories/educational background for coaches. Coaches can be 
anything from health care professionals to trained lay persons. For 
these reasons we cannot provide burden estimates in these areas.
    We acknowledge that costs will be higher for suppliers that are new 
to delivering DPP as costs would be higher for starting up any new 
business. In addition, our performance-based payment structure does not 
incorporate start-up costs as such costs are typically considered the 
cost of doing business.

F. Alternatives Considered

    This final rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when discretion has been 
exercised, presents rationale for our final policies and, where 
relevant, alternatives that were considered. For purposes of the 
payment impact on PFS services of the policies contained in this final 
rule, we presented the estimated impact on total allowed charges by 
specialty. The alternatives we considered, as discussed in the 
preceding preamble sections, would result in different payment rates, 
and therefore, result in different estimates than those shown in Table 
49 (CY 2018 PFS Estimated Impact on Total Allowed Charges by 
Specialty).

G. Impact on Beneficiaries

    There are a number of changes in this final rule that would have an 
effect on beneficiaries. In general, we believe that many of these 
changes, including those intended to improve accuracy in payment 
through regular updates to the inputs used to calculate payments under 
the PFS, would have a positive impact and improve the quality and value 
of care provided to Medicare beneficiaries.
    For example, in finalizing our policies to provide separate payment 
for codes describing the insertion and removal of drug implants to 
treat opioid addiction, as well as a code describing remote patient 
monitoring, we are improving Medicare beneficiary access to these 
important services. This rule also finalizes policies necessary for the 
implementation of the Medicare Diabetes Prevention Program expanded 
model which is expected to improve the quality of patient care for 
Medicare beneficiaries and make MDPP services available to 
beneficiaries in addition to existing Medicare services. MDPP services 
are designated under the MDPP expanded model to be covered as 
additional preventive services under Medicare, as defined in section 
1861(ddd) of the Act, and therefore not subject to cost-sharing. These 
new covered services for beneficiaries under the MDPP expanded model 
will have a positive impact on the health of beneficiaries because they 
are expected to be effective in preventing diabetes onset through 
attendance of MDPP sessions and weight loss. More details can be found 
in section III.K of this final rule, and the CY 2017 PFS (81 CFR 80170 
through 80562). These and all other improvements to payment accuracy 
that we are finalizing for CY 2018 are described in greater detail in 
this final rule.
    Most of the aforementioned proposed policy changes could result in 
a change in beneficiary liability as relates to coinsurance (which is 
20 percent of the fee schedule amount, if applicable for the particular 
provision after the beneficiary has met the deductible). To illustrate 
this point, as shown in our public use file Impact on Payment for 
Selected Procedures available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/, the CY 2017 national payment amount in the 
nonfacility setting for CPT code 99203 (Office/outpatient visit, new) 
was $109.46, which means that in CY 2017, a beneficiary would be 
responsible for 20 percent of this amount, or $21.89. Based on this 
final rule, using the CY 2018 CF, the CY 2018 national payment amount 
in the nonfacility setting for CPT code 99203, as shown in the Impact 
on Payment for Selected Procedures table, is $109.80, which means that, 
in CY 2018, the final beneficiary coinsurance for this service would be 
$21.96.

H. Estimating Regulatory Familiarization Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this rule, we should 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on last year's rule will be the number of reviewers of this 
rule. We acknowledge that this assumption may understate or overstate 
the costs of reviewing this rule. It is possible that not all 
commenters reviewed last year's rule in detail, and it is also possible 
that some reviewers chose not to comment on the rule. For these reasons 
we thought that the number of past commenters would be a fair estimate 
of the number of reviewers of this rule. We welcomed any comments on 
the approach in estimating the number of entities which will review 
this rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this rule, and 
therefore for the purposes of our estimate we assume that each reviewer 
reads approximately 50 percent of the rule. We sought comments on this 
assumption.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $105.16 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average 
reading speed, we estimate that it would take approximately 8.0 hours 
for the staff to review half of this rule. For each facility that 
reviews the rule, the estimated cost is $841 (8.0 hours x $105.16). 
Therefore, we estimated that the total cost of reviewing this 
regulation is $2,169,780 ($841 x 2,580 reviewers).

I. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 60 and 61 
(Accounting Statements), we have prepared an accounting statement. This 
estimate includes growth in incurred benefits from CY 2017 to CY 2018 
based on the FY 2018 President's Budget baseline.

Table 60--Accounting Statement: Classification of Estimated Expenditures
------------------------------------------------------------------------
           Category                            Transfers
------------------------------------------------------------------------
CY 2018 Annualized Monetized   Estimated increase in expenditures of
 Transfers.                     $0.3 billion for PFS CF update.
From Whom to Whom?...........  Federal Government to physicians, other
                                practitioners and providers and
                                suppliers who receive payment under
                                Medicare.
------------------------------------------------------------------------


[[Page 53358]]


   Table 61--Accounting Statement: Classification of Estimated Costs,
                          Transfer, and Savings
------------------------------------------------------------------------
                   Category                             Transfer
------------------------------------------------------------------------
CY 2018 Annualized Monetized Transfers of      $0.1 billion.
 beneficiary cost coinsurance..
From Whom to Whom?...........................  Beneficiaries to Federal
                                                Government.
------------------------------------------------------------------------


                              Table 62--Estimated Costs, Cost Savings and Benefits
----------------------------------------------------------------------------------------------------------------
                     Category                                   Costs                 Cost savings or benefits
----------------------------------------------------------------------------------------------------------------
ICR Burden........................................  $296 million.................
MDPP..............................................  .............................  $182 million.
Regulatory Familiarization........................  * $2 million.................
----------------------------------------------------------------------------------------------------------------
* Regulatory familiarization costs occur upfront only, whereas other impacts listed in the table are expected to
  continue into the future.

J. Conclusion

    The analysis in the previous sections, together with the remainder 
of this preamble, provided an initial Regulatory Flexibility Analysis. 
The previous analysis, together with the preceding portion of this 
preamble, provides a Regulatory Impact Analysis. In accordance with the 
provisions of Executive Order 12866, this regulation was reviewed by 
the Office of Management and Budget.

List of Subjects

42 CFR Part 405

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medical devices, Medicare, Reporting and 
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural 
areas, X-rays.

42 CFR Part 414

    Administrative practice and procedure, Biologics, Drugs, Health 
facilities, Health professions, Kidney diseases, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare, Reporting and recordkeeping requirements.

42 CFR Part 425

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
1. The authority citation for part 405 continues to read as follows:

    Authority: Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874, 
1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a), 
1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and 
1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 
263a).

0
2. Section 405.2413 is amended by revising paragraph (a)(5) to read as 
follows:


Sec.  405.2413   Services and supplies incident to a physician's 
services.

    (a) * * *
    (5) Furnished under the direct supervision of a physician, except 
that services and supplies furnished incident to Transitional Care 
Management, General Care Management, and the Psychiatric Collaborative 
Care Model can be furnished under general supervision of a physician 
when these services or supplies are furnished by auxiliary personnel, 
as defined in Sec.  410.26(a)(1) of this chapter.
* * * * *

0
3. Section 405.2415 is amended by revising paragraph (a)(5) to read as 
follows:


Sec.  405.2415   Incident to services and direct supervision.

    (a) * * *
    (5) Furnished under the direct supervision of a nurse practitioner, 
physician assistant, or certified nurse-midwife, except that services 
and supplies furnished incident to Transitional Care Management, 
General Care Management, and the Psychiatric Collaborative Care model 
can be furnished under general supervision of a nurse practitioner, 
physician assistant, or certified nurse-midwife, when these services or 
supplies are furnished by auxiliary personnel, as defined in Sec.  
410.26(a)(1) of this chapter.
* * * * *

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
4. The authority citation for part 410 is revised to read as follows:

    Authority:  Secs. 1102, 1834, 1871, 1881, and 1893 of the Social 
Security Act (42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd).

0
5. Section 410.79 is amended by--
0
a. Revising the section heading and paragraph (a).
0
b. Under paragraph (b):
0
i. Revising the definition of ``Baseline weight'';
0
ii. Removing the definition of ``Coach'';
0
iii. Revising the definition of ``Core maintenance session'';
0
iv. Adding in alphabetical order a definition for ``Core maintenance 
session interval'';
0
v. Revising the definition of ``Core session'';
0
vi. Removing the definitions of ``Maintenance of weight loss''and 
``Maintenance session bundle'';
0
vii. Adding in alphabetical order the definitions for ``Make-up 
session''and ``MDPP beneficiary'';
0
viii. Removing the definitions of ``MDPP core benefit'', and ``MDPP 
eligible beneficiary'';
0
ix. Revising the definition of ``MDPP services'';
0
x. Adding in alphabetical order definitions for ``MDPP services 
period'', and ``MDPP session'';
0
xi. Revising the definitions of ``MDPP supplier'' and ``Medicare 
Diabetes Prevention Program (MDPP)'';
0
xii. Adding in alphabetical order a definition for ``Ongoing 
maintenance session interval'';
0
xiii. Revising the definition of ``Ongoing maintenance sessions'';

[[Page 53359]]

0
xiv. Adding in alphabetical order definitions for ``Set of MDPP 
services'' and ``Virtual make-up session''; and
0
c. Revising paragraphs (c) and (d).
    The revisions and additions read as follows:


Sec.  410.79   Medicare Diabetes Prevention Program expanded model: 
Conditions of coverage.

    (a) Medicare Diabetes Prevention Program (MDPP) services will be 
available beginning on April 1, 2018.
    (b) * * *
    Baseline weight means the MDPP beneficiary's body weight recorded 
during that beneficiary's first core session.
* * * * *
    Core maintenance session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during 
a core maintenance session interval;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for maintenance 
sessions.
    Core maintenance session interval means one of the two consecutive 
3-month time periods during months 7 through 12 of the MDPP services 
period, during which an MDPP supplier offers an MDPP beneficiary at 
least one core maintenance session per month.
    Core session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during 
months 1 through 6 of the MDPP services period;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for core sessions.
* * * * *
    Make-up session means a core session, a core maintenance session, 
or an ongoing maintenance session furnished to an MDPP beneficiary when 
the MDPP beneficiary misses a regularly scheduled core session, core 
maintenance session, or ongoing maintenance session.
    MDPP beneficiary means a Medicare beneficiary who meets the 
criteria specified in paragraph (c)(1)(i) of this section, who has 
initiated the MDPP services period by attending the first core session, 
and for whom the MDPP services period has not ended as specified in 
paragraph (c)(3) of this section.
    MDPP services means structured health behavior change sessions that 
are furnished under the MDPP expanded model with the goal of preventing 
diabetes among Medicare beneficiaries with prediabetes, and that follow 
a CDC-approved curriculum. The sessions provide practical training in 
long-term dietary change, increased physical activity, and problem-
solving strategies for overcoming challenges to maintaining weight loss 
and a healthy lifestyle.
    MDPP services period means the time period, beginning on the date 
an MDPP beneficiary attends his or her first core session, over which 
the set of MDPP services is furnished to the MDPP beneficiary, to 
include the core services period described in paragraph (c)(2)(i) and, 
subject to paragraph (c)(3) of this section, one or more ongoing 
maintenance session intervals during the ongoing services period 
described in paragraph (c)(2)(ii) of this section.
    MDPP session means a core session, a core maintenance session, or 
an ongoing maintenance session.
    MDPP supplier means an entity that is enrolled in Medicare to 
furnish MDPP services as provided in Sec.  424.205 of this chapter.
    Medicare Diabetes Prevention Program (MDPP) refers to a model test 
expanded under section 1115A(c) of the Act that makes MDPP services 
available to MDPP beneficiaries.
* * * * *
    Ongoing maintenance session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during 
an ongoing maintenance session interval;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for maintenance 
sessions.
    Ongoing maintenance session interval means one of the up to four 
consecutive 3-month time periods during the ongoing services period 
described in paragraph (c)(2)(ii) of this section, during which an MDPP 
supplier offers at least one ongoing maintenance session to an MDPP 
beneficiary per month.
* * * * *
    Set of MDPP services means the series of MDPP sessions, composed of 
core sessions, core maintenance sessions, and subject to paragraph 
(c)(3) of this section, ongoing maintenance sessions, offered over the 
course of the MDPP services period.
    Virtual make-up session means a make-up session that is not 
furnished in person and that is furnished in a manner consistent with 
the DPRP standards for virtual sessions.
    (c) Coverage for MDPP services--(1) Beneficiary eligibility. (i) A 
Medicare beneficiary is eligible for MDPP services offered during the 
core services period described in paragraph (c)(2)(i) of this section 
if the beneficiary meets all of the following criteria:
    (A) Is enrolled under Medicare Part B;
    (B) Attended the first core session within the most recent 12-month 
time period and, prior to attending this first core session, had not 
previously received the set of MDPP services in his or her lifetime;
    (C) Has, on the date of attendance at the first core session, a 
body mass index (BMI) of at least 25 if not self-identified as Asian or 
a BMI of at least 23 if self-identified as Asian;
    (D) Has received, within the 12-month time period prior to the date 
of attendance at the first core session, a hemoglobin A1c test with a 
value of between 5.7 and 6.4 percent, a fasting plasma glucose test 
with a value of between 110 and 125 mg/dL, or a 2-hour plasma glucose 
test (oral glucose tolerance test) with a value of between 140 and 199 
mg/dL;
    (E) Has, as of the date of attendance at the first core session, no 
previous diagnosis of diabetes, other than gestational diabetes; and
    (F) Does not have end-stage renal disease (ESRD).
    (ii) An MDPP beneficiary is eligible for the first ongoing 
maintenance session interval only if the beneficiary:
    (A) Attends at least one in-person core maintenance session during 
the final core maintenance session interval; and
    (B) Achieves or maintains the required minimum weight loss at a 
minimum of one in-person core maintenance session during the final core 
maintenance session interval.
    (iii) An MDPP beneficiary is eligible for a subsequent ongoing 
maintenance session interval only if the beneficiary:
    (A) Attends at least two ongoing maintenance sessions during the 
previous ongoing maintenance session interval, including at least one 
in-person ongoing maintenance session; and
    (B) Maintains the required minimum weight loss at a minimum of one 
in-person ongoing maintenance session furnished during the previous 
ongoing maintenance session interval.
    (iv) Weight measurements used to determine the achievement or 
maintenance of the required minimum weight loss must be taken in person 
by an MDPP supplier during an MDPP session.
    (2) MDPP services period. An MDPP beneficiary's MDPP services 
period is composed of the following periods and intervals:
    (i) The core services period, which is the first 12 months of the 
MDPP services period, and consists of:
    (A) At least 16 core sessions offered at least one week apart 
during months

[[Page 53360]]

1 through 6 of the MDPP services period; and
    (B) Two 3-month core maintenance session intervals offered during 
months 7 through 12 of the MDPP services period.
    (ii) Subject to paragraph (c)(3) of this section, the ongoing 
services period, which consists of up to four 3-month ongoing 
maintenance session intervals offered during months 13 through 24 of 
the MDPP services period.
    (3) Limitations on the MDPP services period. (i) The MDPP services 
period ends upon completion of the core services period described in 
paragraph (c)(2)(i) of this section, unless the MDPP beneficiary 
qualifies for the first ongoing maintenance session interval, in 
accordance with paragraph (c)(1)(ii) of this section.
    (ii) If the MDPP beneficiary qualifies for the first ongoing 
maintenance session interval as described in paragraph (c)(3)(i) of 
this section, the MDPP services period ends upon completion of this 
first ongoing maintenance session interval or any subsequent ongoing 
maintenance session interval, unless the beneficiary meets the 
eligibility requirements under paragraph (c)(1)(iii) of this section.
    (iii) Unless sooner ended in accordance with this paragraph (c)(3), 
the MDPP services period ends automatically upon the completion of the 
fourth ongoing maintenance session interval.
    (d) Make-up sessions. (1) An MDPP supplier may offer a make-up 
session to an MDPP beneficiary who missed a regularly scheduled 
session. If an MDPP supplier offers one or more make-up sessions to an 
MDPP beneficiary, each such session must be furnished in accordance 
with the following requirements:
    (i) The curriculum furnished during the make-up session must 
address the same CDC-approved DPP curriculum topic as the regularly 
scheduled session that the beneficiary missed;
    (ii) The MDPP supplier may furnish to the beneficiary a maximum of 
one make-up session on the same day as a regularly scheduled session; 
and
    (iii) The MDPP supplier may furnish to the beneficiary a maximum of 
one make-up session per week.
    (2) An MDPP supplier may offer virtual make-up sessions only if 
consistent with the requirements in paragraph (d)(1) of this section. 
Virtual make-up sessions are also subject to the following 
requirements:
    (i) Virtual make-up sessions must be furnished in a manner 
consistent with the DPRP standards for virtual sessions;
    (ii) An MDPP supplier may only offer virtual make-up sessions based 
on an individual MDPP beneficiary's request; and
    (iii) An MDPP supplier may offer to an MDPP beneficiary:
    (A) No more than 4 virtual make-up sessions within the core 
services period described in paragraph (c)(2)(i) of this section, of 
which no more than 2 virtual make-up sessions are core maintenance 
sessions; and
    (B) No more than 3 virtual make-up sessions that are ongoing 
maintenance sessions.
    (3) Make-up sessions furnished in accordance with paragraph (d)(1) 
of this section that an MDPP beneficiary attends in person are counted 
toward meeting the attendance requirements described in paragraph 
(c)(1) of this section and toward achieving the performance goals 
described in Sec.  414.84(b) of this chapter as if the MDPP beneficiary 
attended a regularly scheduled session. Virtual make-up sessions 
furnished in accordance with paragraph (d)(2) of this section are also 
counted toward such attendance requirements and performance goals, 
subject to the following limitations:
    (i) The MDPP beneficiary receives no more than 4 virtual make-up 
sessions within the core services period described in paragraph 
(c)(2)(i) of this section, of which no more than 2 virtual make-up 
sessions may be core maintenance sessions; and
    (ii) The MDPP beneficiary receives no more than 3 virtual make-up 
sessions that are ongoing maintenance sessions.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
6. The authority citation for part 414 continues to read as follows:

    Authority: Secs. 1102, 1871, and 1881(b)(l) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).

0
7. Section 414.84 is added to read as follows:


Sec.  414.84   Payment for MDPP services.

    (a) Definitions. In addition to the definitions specified at Sec.  
410.79(b) and Sec.  424.205(a) of this chapter, the following 
definitions apply to this section.
    Bridge payment means a one-time payment to an MDPP supplier for 
furnishing its first MDPP session to an MDPP beneficiary who has 
previously received one or more MDPP services from a different MDPP 
supplier.
    Performance goal means an attendance or weight loss goal that an 
MDPP beneficiary must achieve during the MDPP services period for an 
MDPP supplier to be paid a performance payment.
    Performance payment means a payment made to an MDPP supplier for 
furnishing certain MDPP services to an MDPP beneficiary when the MDPP 
beneficiary achieves the applicable performance goal.
    (b) Performance payment. CMS makes one or more types of performance 
payments to an MDPP supplier as specified in this paragraph (b). Each 
type of performance payment is made only if the beneficiary achieves 
the applicable performance goal and only once per MDPP beneficiary. A 
performance payment is made only on an assignment-related basis in 
accordance with Sec.  424.55 of this chapter, and MDPP suppliers must 
accept the Medicare allowed charge as payment in full and may not bill 
or collect from the beneficiary any amount. CMS will make a performance 
payment only to an MDPP supplier that complies with all applicable 
enrollment and program requirements and only for MDPP services that are 
furnished by an eligible coach, on or after his or her coach 
eligibility start date and, if applicable, before his or her coach 
eligibility end date. As a condition of payment, the MDPP supplier must 
report the NPI of the coach who furnished the session on the claim for 
the MDPP session. The seven types of performance payments are as 
follows:
    (1) Performance Goal 1: Attends the first core session that 
initiates the MDPP services period. CMS makes a performance payment to 
an MDPP supplier if an MDPP beneficiary attends the first core session, 
which initiates the MDPP services period, and that first core session 
was furnished by that supplier. An MDPP supplier that has been paid 
this performance payment for an MDPP beneficiary is not eligible to be 
paid a bridge payment described in paragraph (c) of this section for 
that MDPP beneficiary. The amount of this performance payment is 
determined as follows:
    (i) For a first core session furnished April 1 through December 31, 
2018. $25.
    (ii) For a first core session furnished during a calendar year 
subsequent to CY 2018. The performance payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.
    (2) Performance Goal 2: Attends four core sessions. CMS makes a 
performance payment to an MDPP supplier if an MDPP beneficiary achieves 
attendance at the fourth core session upon attendance at a core session 
furnished by that supplier. The

[[Page 53361]]

amount of this performance payment is determined as follows:
    (i) For a fourth core session furnished April 1 through December 
31, 2018. $50.
    (ii) For a fourth core session furnished during a calendar year 
subsequent to CY 2018. The performance payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.
    (3) Performance Goal 3: Attends nine core sessions. CMS makes a 
performance payment to an MDPP supplier if an MDPP beneficiary achieves 
attendance at the ninth core session upon attendance at a core session 
furnished by that supplier. The amount of this performance payment is 
determined as follows:
    (i) For a ninth core session furnished April 1 through December 31, 
2018. $90.
    (ii) For a ninth core session furnished during a calendar year 
subsequent to CY 2018. The performance payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.
    (4) Performance Goal 4: Attends two core maintenance sessions 
during a core maintenance session interval. CMS makes a performance 
payment to an MDPP supplier if an MDPP beneficiary attends two core 
maintenance sessions in a core maintenance session interval and 
achieves attendance at the second core maintenance session upon 
attendance at a core maintenance session furnished by that supplier. 
CMS makes this performance payment to an MDPP supplier only once per 
MDPP beneficiary per core maintenance session interval. The amount of 
this performance payment is determined as follows:
    (i) If the beneficiary also achieves or maintains the required 
minimum weight loss as measured in-person during a core maintenance 
session furnished during the applicable core maintenance session 
interval:
    (A) For a second core maintenance session furnished April 1 through 
December 31, 2018. $60.
    (B) For a second core maintenance session furnished during a 
calendar year subsequent to CY 2018. The performance payment amount 
specified in this paragraph for the prior year, adjusted as specified 
in paragraph (d) of this section.
    (ii) If the beneficiary does not achieve or maintain the required 
minimum weight loss as measured in-person during a core maintenance 
session furnished during the applicable core maintenance session 
interval:
    (A) For a second core maintenance session furnished April 1 through 
December 31, 2018. $15.
    (B) For a second core maintenance session furnished during a 
calendar year subsequent to CY 2018. The performance payment amount 
specified in this paragraph for the prior year, adjusted as specified 
in paragraph (d) of this section.
    (5) Performance Goal 5: Attends two ongoing maintenance sessions 
and maintains the required minimum weight loss during an ongoing 
maintenance session interval. CMS makes a performance payment to an 
MDPP supplier if an MDPP beneficiary attends two ongoing maintenance 
sessions during an ongoing maintenance session interval, achieves 
attendance at that second ongoing maintenance session upon attendance 
at an ongoing maintenance session furnished by that supplier, and 
achieves or maintains the required minimum weight loss as measured in-
person during an ongoing maintenance session furnished during the 
applicable ongoing maintenance session interval. CMS makes this 
performance payment to an MDPP supplier only once per MDPP beneficiary 
per ongoing maintenance session interval. The amount of this 
performance payment is determined as follows:
    (i) For a second ongoing maintenance session furnished April 1 
through December 31, 2018. $50.
    (ii) For a second ongoing maintenance session furnished during a 
calendar year subsequent to CY 2018. The performance payment amount 
specified in this paragraph for the prior year, adjusted as specified 
in paragraph (d) of this section.
    (6) Performance Goal 6: Achieves the required minimum weight loss. 
CMS makes a performance payment to an MDPP supplier for an MDPP 
beneficiary who achieves the required minimum weight loss as measured 
in-person during a core session or core maintenance session furnished 
by that supplier. The amount of this performance payment is determined 
as follows:
    (i) For a core session or core maintenance session, as applicable, 
furnished April 1 through December 31, 2018. $160.
    (ii) For a core session or core maintenance session, as applicable, 
furnished during a calendar year subsequent to CY 2018. The performance 
payment amount specified in this paragraph for the prior year, adjusted 
as specified in paragraph (d) of this section.
    (7) Performance Goal 7: Achieves 9-percent weight loss. CMS makes a 
performance payment to an MDPP supplier for an MDPP beneficiary who 
achieves at least a 9-percent weight loss as measured in-person during 
a core session, core maintenance session, or ongoing maintenance 
session furnished by that supplier. The amount of this performance 
payment is determined as follows:
    (i) For a core session, core maintenance session, or ongoing 
maintenance session, as applicable, furnished April 1 through December 
31, 2018. $25.
    (ii) For a core session, core maintenance session, or ongoing 
maintenance session, as applicable, furnished during a calendar year 
subsequent to CY 2018. The performance payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.
    (c) Bridge payment. CMS makes a bridge payment to an MDPP supplier 
only for a core session, core maintenance session, or ongoing 
maintenance session furnished to an MDPP beneficiary who has previously 
received MDPP services from a different MDPP supplier. An MDPP supplier 
that has previously been paid either a bridge payment or a performance 
payment for an MDPP beneficiary is not eligible to be paid a bridge 
payment for that beneficiary. A bridge payment is made only on an 
assignment-related basis in accordance with Sec.  424.55 of this 
chapter, and MDPP suppliers must accept the Medicare allowed charge as 
payment in full and may not bill or collect from the beneficiary any 
amount. CMS will make a bridge payment only to an MDPP supplier that 
complies with all applicable enrollment and program requirements, and 
only for MDPP services furnished by an eligible coach, on or after his 
or her coach eligibility start date and, if applicable, before his or 
her coach eligibility end date. As a condition of payment, the MDPP 
supplier must report the NPI of the coach who furnished the session on 
the claim for the MDPP session. The amount of the bridge payment is 
determined as follows:
    (1) For a core session, core maintenance session, or ongoing 
maintenance session, as applicable, furnished April 1 through December 
31, 2018. $25.
    (2) For a core session, core maintenance session, or ongoing 
maintenance session, as applicable, furnished during a calendar year 
subsequent to CY 2018. The bridge payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.

[[Page 53362]]

    (d) Updating performance payments and the bridge payment. The 
performance payments and bridge payment will be adjusted each calendar 
year by the percent change in the Consumer Price Index for All Urban 
Consumers (CPI-U) (U.S. city average) for the 12-month period ending 
June 30th of the year preceding the update year. The percent change 
update will be calculated based on the level of precision of the index 
as published by the Bureau of Labor Statistics and applied based on one 
decimal place of precision. The annual MDPP services payment update 
will be published by CMS transmittal.

0
8. Section 414.90 is amended by revising paragraphs (j)(8)(i)(A)(1)(i), 
(j)(8)(ii)(A)(1)(i), (j)(8)(ii)(A)(2), (j)(8)(iii) and (iv), and 
(j)(9)(ii) through (vi) and (viii), adding a heading to paragraph 
(k)(3) introductory text, revising paragraph (k)(5)(i), and adding 
paragraph (k)(5)(ii) to read as follows:


Sec.  414.90   Physician Quality Reporting System (PQRS).

* * * * *
    (j) * * *
    (8) * * *
    (i) * * *
    (A) * * *
    (1)(i) Report at least 6 measures and report each measure for at 
least 50 percent of the eligible professional's Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. If less than 6 measures apply to the eligible 
professional, the eligible professional must report on each measure 
that is applicable, and report each measure for at least 50 percent of 
the Medicare Part B Fee-for-Service patients seen during the reporting 
period to which the measure applies. Measures with a 0 percent 
performance rate will not be counted (unless they are inverse measures 
where a lower rate reflects better performance).
* * * * *
    (ii) * * *
    (A) * * *
    (1)(i) Report at least 6 measures and report each measure for at 
least 50 percent of the eligible professional's Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. If less than 6 measures apply to the eligible 
professional, the eligible professional must report on each measure 
that is applicable, and report each measure for at least 50 percent of 
the Medicare Part B Fee-for-Service patients seen during the reporting 
period to which the measure applies.
* * * * *
    (2) Measures with a 0 percent performance rate or measures groups 
containing a measure with a 0 percent performance rate will not be 
counted (unless they are inverse measures where a lower rate reflects 
better performance).
* * * * *
    (iii) Via EHR direct product. For the 12-month 2018 PQRS payment 
adjustment reporting period, report 6 measures. If an eligible 
professional's direct EHR product or EHR data submission vendor product 
does not contain patient data for at least 6 measures, then the 
eligible professional must report all of the measures for which there 
is Medicare patient data. An eligible professional must report on at 
least 1 measure for which there is Medicare patient data.
    (iv) Via EHR data submission vendor. For the 12-month 2018 PQRS 
payment adjustment reporting period, report at least 6 measures. If an 
eligible professional's direct EHR product or EHR data submission 
vendor product does not contain patient data for at least 6 measures, 
then the eligible professional must report all of the measures for 
which there is Medicare patient data. An eligible professional must 
report on at least 1 measure for which there is Medicare patient data.
    (9) * * *
    (ii) Via qualified registry. For a group practice of 2 or more 
eligible professionals, for the 12-month 2018 PQRS payment adjustment 
reporting period, report at least 6 measures and report each measure 
for at least 50 percent of the group practice's Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. If less than 6 measures apply to the group practice, 
the group practice must report on each measure that is applicable, and 
report each measure for at least 50 percent of the Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. Measures with a 0 percent performance rate would not 
be counted (unless they are inverse measures where a lower rate 
reflects better performance).
    (iii) Via EHR direct product. For a group practice of 2 or more 
eligible professionals, for the 12-month 2018 PQRS payment adjustment 
reporting period, report 6 measures. If the group practice's direct EHR 
product or EHR data submission vendor product does not contain patient 
data for at least 6 measures, then the group practice must report all 
of the measures for which there is Medicare patient data. A group 
practice must report on at least 1 measure for which there is Medicare 
patient data.
    (iv) Via EHR data submission vendor. For a group practice of 2 or 
more eligible professionals, for the 12-month 2018 PQRS payment 
adjustment reporting period, report 6 measures. If the group practice's 
direct EHR product or EHR data submission vendor product does not 
contain patient data for at least 6 measures, then the group practice 
must report all of the measures for which there is Medicare patient 
data. A group practice must report on at least 1 measure for which 
there is Medicare patient data.
    (v) Via a certified survey vendor in addition to a qualified 
registry. For a group practice of 2 or more eligible professionals that 
elects to report via a certified survey vendor in addition to a 
qualified registry for the 12-month 2018 PQRS payment adjustment 
reporting period, the group practice must have all CAHPS for PQRS 
survey measures reported on its behalf via a CMS-certified survey 
vendor. In addition, the group practice must report at least 3 
additional measures using the qualified registry and report each 
measure for at least 50 percent of the group practice's Medicare Part B 
Fee-for-Service patients seen during the reporting period to which the 
measure applies. If less than 3 measures apply to the group practice, 
the group practice must report on each measure that is applicable, and 
report each measure for at least 50 percent of the Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. Measures with a 0 percent performance rate would not 
be counted (unless they are inverse measures where a lower rate 
reflects better performance).
    (vi) Via a certified survey vendor in addition to a direct EHR 
product or EHR data submission vendor. For a group practice of 2 or 
more eligible professionals that elects to report via a certified 
survey vendor in addition to a direct EHR product or EHR data 
submission vendor for the 12-month 2018 PQRS payment adjustment 
reporting period, the group practice must have all CAHPS for PQRS 
survey measures reported on its behalf via a CMS-certified survey 
vendor. In addition, the group practice must report at least 3 
additional measures using the direct EHR product or EHR data submission 
vendor product. If less than 3 measures apply to the group practice, 
the group practice must report all of the measures for which there is 
patient data. Of the additional 3 measures that must be reported in 
conjunction with reporting the CAHPS for PQRS survey measures, a group 
practice must report

[[Page 53363]]

on at least 1 measure for which there is Medicare patient data.
* * * * *
    (viii) If the CAHPS for PQRS survey is applicable to the practice, 
group practices comprised of 100 or more eligible professionals that 
register to participate in the GPRO may administer the CAHPS for PQRS 
survey, regardless of the GPRO reporting mechanism selected.
    (k) * * *
    (3) Satisfactory participation criteria for individual eligible 
professionals for the 2016 PQRS payment adjustment. * * *
* * * * *
    (5) * * *
    (i) Individual eligible professional. For the applicable 12-month 
reporting period, report at least 6 measures available for reporting 
under a QCDR and report each measure for at least 50 percent of the 
eligible professional's patients seen during the reporting period to 
which the measure applies. If less than 6 measures apply to the 
eligible professional, the eligible professional must report on each 
measure that is applicable, and report each measure for at least 50 
percent of the eligible professional's patients.
    (ii) Group practices. For the applicable 12-month reporting period, 
report at least 6 measures available for reporting under a QCDR and 
report each measure for at least 50 percent of the group practice's 
patients seen during the reporting period to which the measure applies. 
If less than 6 measures apply to the group practice, the group practice 
must report on each measure that is applicable, and report each measure 
for at least 50 percent of the group practice's patients. If a group 
practice reports the CAHPS for PQRS survey measures, apply reduced 
criteria as follows: 3 measures, as applicable.
* * * * *

0
9. Section 414.94 is amended by adding paragraphs (j) and (k) to read 
as follows:


Sec.  414.94   Appropriate use criteria for advanced diagnostic imaging 
services.

* * * * *
    (j) Consulting. Ordering Professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system and ordered on or after January 1, 2020.
    (k) Reporting. Furnishing Professionals must report the following 
information on Medicare claims for advanced diagnostic imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system defined in paragraph (b) of this section, and ordered on 
or after January 1, 2020:
    (1) The qualified CDSM consulted by the ordering professional.
    (2) Information indicating:
    (i) Whether the service ordered would adhere to specified 
applicable AUC;
    (ii) Whether the service ordered would not adhere to specified 
applicable AUC; or
    (iii) Whether the specified applicable AUC consulted was not 
applicable to the service ordered.
    (3) The NPI of the ordering professional who consulted specified 
applicable AUC as required in paragraph (j) of this section, if 
different from the furnishing professional.

0
10. Section 414.904 is amended by revising paragraph (e)(2) to read as 
follows:


Sec.  414.904  Average sales price as the basis for payment.

* * * * *
    (e) * * *
    (2) Infusion drugs furnished through a covered item of durable 
medical equipment. The payment limit for an infusion drug furnished 
before January 1, 2017, through a covered item of durable medical 
equipment is calculated using 95 percent of the average wholesale price 
in effect on October 1, 2003.
* * * * *

0
11. Section 414.1270 is amended by revising paragraph (d)(1) to read as 
follows:


Sec.  414.1270  Determination and calculation of the Value-Based 
Payment Modifier adjustments.

* * * * *
    (d) * * *
    (1) A downward payment adjustment of -1.0 percent will be applied 
to a solo practitioner, a group with two to nine eligible 
professionals, and a group consisting only of nonphysician eligible 
professionals subject to the value-based payment modifier and no 
physicians; and a downward payment adjustment of -2.0 percent will be 
applied to a group with 10 or more eligible professionals and at least 
one physician if, during the applicable performance period as defined 
in Sec.  414.1215, the following apply:
    (i) For groups:
    (A) Such group does not meet the criteria as a group to avoid the 
PQRS payment adjustment for CY 2018 as specified by CMS; and
    (B) Fifty percent of the eligible professionals in such group do 
not meet the criteria as individuals to avoid the PQRS payment 
adjustment for CY 2018 as specified by CMS.
    (ii) For solo practitioners, such solo practitioner does not meet 
the criteria as an individual to avoid the PQRS payment adjustment for 
CY 2018 as specified by CMS.
* * * * *

0
12. Section 414.1275 is amended by revising paragraphs (c)(4), 
(d)(3)(i) and (ii) to read as follows:


Sec.  414.1275   Value-based payment modifier quality-tiering scoring 
methodology.

* * * * *
    (c) * * *
    (4) The following value-based payment modifier percentages apply to 
the CY 2018 payment adjustment period, for physicians, physician 
assistants, nurse practitioners, clinical nurse specialists, and 
certified registered nurse anesthetists who are solo practitioners or 
who are in groups of any size:

     CY 2018 Value-Based Payment Modifier Amounts for the Quality-Tiering Approach for Physicians, Physician
    Assistants, Nurse Practitioners, Clinical Nurse Specialists, and Certified Registered Nurse Anesthetists
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                          Cost/quality                              Low quality       quality      High quality
----------------------------------------------------------------------------------------------------------------
Low Cost........................................................           +0.0%         * +1.0x         * +2.0x
Average Cost....................................................           +0.0%           +0.0%         * +1.0x
High Cost.......................................................           +0.0%           +0.0%           +0.0%
----------------------------------------------------------------------------------------------------------------
* Eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average
  beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where `x' represents the
  upward payment adjustment factor.


[[Page 53364]]

    (d) * * *
    (3) * * *
    (i) Classified as high quality/low cost receive an upward 
adjustment of +3x (rather than +2x); and
    (ii) Classified as either high quality/average cost or average 
quality/low cost receive an upward adjustment of +2x (rather than +1x).

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
13. The authority citation for part 424 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

0
14. Section 424.55 is amended by adding paragraph (d) to read as 
follows:


Sec.  424.55   Payment to the supplier.

* * * * *
    (d) For purposes of claims for services submitted by an MDPP 
supplier (as defined at Sec.  410.79(b) of this chapter), Medicare 
deems such claims to have been assigned by the beneficiary (or the 
person authorized to request payment on the beneficiary's behalf) and 
the assignment accepted by the MDPP supplier.


Sec.  424.59   [Removed]

0
15. Remove Sec.  424.59.

0
16. Subpart I, consisting of Sec. Sec.  424.200 through 424.210, is 
added to read as follows:
Subpart I--Requirements for Medicare Diabetes Prevention Program 
Suppliers and Beneficiary Engagement Incentives Under the Medicare 
Diabetes Prevention Program Expanded Model
Sec.
424.200 Scope.
424.205 Requirements for Medicare Diabetes Prevention Program 
suppliers.
424.210 Beneficiary engagement incentives under the Medicare 
Diabetes Prevention Program expanded model.

Subpart I--Requirements for Medicare Diabetes Prevention Program 
Suppliers and Beneficiary Engagement Incentives Under the Medicare 
Diabetes Prevention Program Expanded Model


Sec.  424.200   Scope.

    This subpart specifies the requirements for Medicare Diabetes 
Prevention Program suppliers and beneficiary engagement incentives 
under the Medicare Diabetes Prevention Program expanded model.


Sec.  424.205   Requirements for Medicare Diabetes Prevention Program 
suppliers.

    (a) Definitions. In addition to the definitions specified at Sec.  
410.79(b) and Sec.  414.84(a) of this subchapter, the following 
definitions apply to this section:
    Administrative location means a physical location associated with 
the MDPP supplier's operations where they are the primary operator in 
the space, from where coaches are dispatched or based, and where MDPP 
services may or may not be furnished.
    Coach means an individual who furnishes MDPP services on behalf of 
an MDPP supplier as an employee, contractor, or volunteer.
    Coach eligibility end date means the end date indicated by the MDPP 
supplier in submitting a change to the supplier's MDPP enrollment 
application in accordance with paragraph (d)(5) of this section that 
removed the coach's information, or the date the supplier itself was 
revoked from or withdrew its Medicare enrollment as an MDPP supplier.
    Coach eligibility start date, means the start date indicated by the 
MDPP supplier when submitting the coach's information on the MDPP 
enrollment application.
    Community setting means a location where the MDPP supplier 
furnishes MDPP services outside of their administrative locations. A 
community setting is a location open to the public not primarily 
associated with the supplier. Community settings may include, for 
example, church basements or multipurpose rooms in recreation centers.
    Eligible coach means an individual who CMS has screened and has 
determined can provide MDPP services on behalf of an MDPP supplier in 
accordance with paragraph (e) of this section.
    Ineligible coach means an individual whom CMS has screened and has 
determined cannot provide MDPP services on behalf of an MDPP supplier 
in accordance with paragraph (e) of this section.
    MDPP interim preliminary recognition means a status that CMS has 
granted to an entity in accordance with paragraph (c) of this section.
    (b) Conditions for MDPP supplier enrollment. An entity may enroll 
as an MDPP supplier only if it satisfies the following requirements and 
all other applicable Medicare enrollment requirements:
    (1) Has either an MDPP preliminary recognition, as defined in 
paragraph (c)(1) of this section or a full CDC DPRP recognition.
    (2) Maintains an active and valid TIN and NPI at the organizational 
level.
    (3) Has passed screening requirements as follows:
    (i) Upon initial enrollment, at a ``high'' categorical risk in 
accordance with Sec.  424.518(c)(2); and
    (ii) Upon revalidation, at a ``moderate'' categorical risk in 
accordance with Sec.  424.518(b)(2).
    (4) Maintains, and submits to CMS through the CMS-approved 
enrollment application, a roster of all coaches who will be furnishing 
MDPP services on the entity's behalf that includes each coach's first 
and last names, middle initial (if applicable), date of birth, Social 
Security Number (SSN), active and valid NPI, coach eligibility start 
date, and coach eligibility end date (if applicable). This roster must 
be updated in accordance with paragraph (d)(5) of this section.
    (5) Meets and certifies in its CMS-approved enrollment application 
that it meets and will continue to meet the supplier enrollment 
standards described in paragraph (d) of this section.
    (6) Revalidates its Medicare enrollment every 5 years after the 
effective date of enrollment.
    (c) MDPP preliminary recognition. For the purposes of this section, 
an MDPP preliminary recognition may include either:
    (1) Any preliminary recognition established by CDC for the purposes 
of the DPRP; or
    (2) An MDPP interim preliminary recognition.
    (i) MDPP interim preliminary recognition application period. 
Entities may apply to CDC for CMS' MDPP interim preliminary by 
submitting information at the time and in the form and manner specified 
by CMS.
    (ii) MDPP Interim preliminary recognition requirements. An entity 
may qualify for MDPP interim preliminary recognition if--
    (A) The entity has pending CDC recognition.
    (B) The entity submits a full 12 months of performance data to CDC 
on at least one completed cohort. The 12 month data submission includes 
at least 5 participants who attended at least 3 sessions in the first 6 
months and whose time from first session attended to last session of 
the lifestyle change program was at least 9 months, at least 60 percent 
of whom attended at least 9 sessions in months 1 through 6, and at 
least 60 percent of whom attended at least 3 sessions in months 7 
through 12.
    (d) Medicare Diabetes Prevention Program supplier standards. An 
MDPP supplier must meet and must certify in its CMS-approved enrollment 
application that it meets and will continue to meet the following 
standards.

[[Page 53365]]

    (1) The MDPP supplier must have and maintain MDPP preliminary 
recognition, as defined under paragraph (c)(1) of this section, or a 
full CDC DPRP recognition.
    (2) The MDPP supplier must not currently have its billing 
privileges terminated for-cause or be excluded by a State Medicaid 
agency.
    (3) The MDPP supplier must not include on the roster of coaches, 
described in paragraph (b)(4) of this section and updated in accordance 
with paragraph (d)(5) of this section, nor permit MDPP services to be 
furnished by, any individual coach who meets any of ineligibility 
criteria outlined in paragraph (e)(1) of this section.
    (4) The MDPP supplier must maintain at least one administrative 
location. All administrative locations maintained by the MDPP supplier 
must be located at an appropriate site and be reported on the CMS-
approved enrollment application. An appropriate site for such an 
administrative location would include all of the following 
characteristics:
    (i) Signage posted on the exterior of the building or suite, in a 
building directory, or on materials located inside of the building. 
Such signage may include, for example, the MDPP supplier's legal 
business name or DBA, as well as hours of operation.
    (ii) Open for business during stated operational hours.
    (iii) Employees, staff, or volunteers present during operational 
hours; and
    (iv) Not a private residence.
    (5) The MDPP supplier must update its enrollment application within 
30 days of any changes of ownership, changes to the coach roster 
(including due to coach ineligibility or because the coach is no longer 
an employee, contractor, or volunteer of the MDPP supplier), and final 
adverse action history, and report all other changes, including but not 
limited to changes in the MDPP supplier's administrative location(s), 
to CMS within 90 days of the reportable event.
    (6) The MDPP supplier must maintain a primary business telephone 
that operates either at administrative locations described in paragraph 
(d)(4) of this section or directly where services are furnished, if 
services are furnished in community settings. The associated telephone 
number must be listed with either the legal or doing business as name 
of the supplier in public view, including on Web sites, flyers, and 
materials.
    (7) The MDPP supplier must not knowingly sell to or allow another 
individual or entity to use its supplier billing number.
    (8) Subject to paragraph (d)(8)(i) of this section, the MDPP 
supplier must not deny an MDPP beneficiary access to MDPP services 
during the MDPP services period described in Sec.  410.79(c)(2) of this 
chapter, including on the basis of the beneficiary's weight, health 
status, or achievement of performance goals.
    (i) Suppliers may deny an MDPP beneficiary access to MDPP services 
during the MDPP services period only under one of the following 
conditions:
    (A) The MDPP beneficiary no longer meets the eligibility criteria 
for MDPP services under Sec.  410.79(c)(1) of this chapter.
    (B) The MDPP supplier lacks the self-determined publicly-posted 
capacity to furnish MDPP services to a given MDPP beneficiary.
    (C) The MDPP supplier determines that the MDPP beneficiary 
significantly disrupts the session for other MDPP beneficiaries or 
becomes abusive.
    (ii) MDPP suppliers must maintain a record of the number of MDPP 
beneficiaries for whom it declined access away for the reasons outlined 
in paragraphs (d)(8)(i)(B) and (C) of this section, to include the date 
each such beneficiary was declined access. For beneficiaries who were 
declined access for the reasons described in paragraph (d)(8)(i)(C) of 
this section, the MDPP supplier must document details of the 
occurrence(s), including date(s) of the behavior, any remediation 
efforts taken by the MDPP supplier, and final action (for example, 
dismissal from an MDPP session or denial from future sessions) in the 
beneficiary's MDPP records.
    (9) The MDPP supplier and other individuals or entities performing 
functions or services related to MDPP services on the MDPP supplier's 
behalf must not unduly coerce an MDPP beneficiary's decision to change 
or not to change to a different MDPP supplier, including through the 
use of pressure, intimidation, or bribery.
    (10) Except as allowed under paragraph (d)(8) of this section, the 
MDPP supplier must offer an MDPP beneficiary no fewer than all of the 
following:
    (i) 16 in-person core sessions no more frequently than weekly for 
the first 6 months of the MDPP services period, which beginnings on the 
date of attendance at the first such core session.
    (ii) 1 in-person core maintenance session each month during months 
7 through 12 (6 months total) of the MDPP services period.
    (iii) 1 in-person ongoing maintenance session each month for months 
13 through 24 of the MDPP services period, as long as the beneficiary 
maintains eligibility to receive such services in accordance with Sec.  
410.79(c)(1)(ii) and (iii) of this chapter.
    (11) Before the initial core session is furnished, the MDPP 
supplier must disclose detailed information about the set of MDPP 
services to each MDPP beneficiary to whom it wishes to begin furnishing 
MDPP services. Such information must include all of the following:
    (i) Eligibility requirements under Sec.  410.79(c)(1) of this 
chapter, including the once-per-lifetime nature of MDPP services.
    (ii) Minimum coverage requirements under Sec.  410.79(c)(2).
    (iii) The MDPP supplier standards as specified in paragraph (d) of 
this section.
    (12) The MDPP supplier must answer MDPP beneficiaries' questions 
about MDPP services and respond to MDPP-related complaints within a 
reasonable timeframe. An MDPP supplier must implement a complaint 
resolution protocol and maintain documentation of all beneficiary 
contact regarding such complaints, including the name and Medicare 
Beneficiary Identifier of the beneficiary, a summary of the complaint, 
related correspondences, notes of actions taken, and the names and/or 
NPIs of individuals who took such actions on behalf of the MDPP 
supplier. Failure to maintain a complaint resolution protocol or to 
retain information regarding MDPP related complaints in accordance with 
paragraph (g) of this section may be considered evidence that the MPPP 
supplier standards have not been met. This information must be kept at 
each administrative location and made available to CMS or its 
contractors upon request.
    (13) The MDPP supplier must maintain a crosswalk file which 
indicates how beneficiary identifications for the purposes of CDC 
performance data requirements correspond to corresponding beneficiary 
health insurance claims numbers or Medicare Beneficiary Identifiers for 
each MDPP beneficiary receiving MDPP services from the MDPP supplier. 
The MDPP supplier must submit the crosswalk file to CMS or its 
contractor.
    (14) The MDPP supplier must submit performance data for MDPP 
beneficiaries who attend ongoing maintenance sessions with data 
elements consistent with the CDC's DPRP standards for data elements 
required for the core services period.
    (15) The MDPP supplier must allow CMS or its agents to conduct 
onsite inspections or recordkeeping reviews in order to ascertain the 
MDPP supplier's

[[Page 53366]]

compliance with these standards, and must adhere to the documentation 
requirements as outlined in paragraph (g) of this section.
    (e) Coach eligibility--(1) Criteria. To furnish MDPP services to a 
beneficiary, an MDPP coach must not:
    (i) Currently have Medicare billing privileges revoked and be 
currently subject to the reenrollment bar.
    (ii) Currently have its Medicaid billing privileges terminated for-
cause or be excluded by a State Medicaid agency.
    (iii) Currently be excluded from any other Federal health care 
program, as defined in 42 CFR 1001.2, in accordance with section 1128, 
1128A, 1156, 1842, 1862, 1867 or 1892 of the Act.
    (iv) Currently be debarred, suspended, or otherwise excluded from 
participating in any other Federal procurement or nonprocurement 
program or activity in accordance with the Federal Acquisition 
Streamlining Act implementing regulations and the Department of Health 
and Human Services nonprocurement common rule at 45 CFR part 76.
    (v) Have, in the previous 10 years, one of the following State or 
Federal felony convictions:
    (A) Crimes against persons, such as murder, rape, assault, and 
other similar crimes for which the individual was convicted, as defined 
under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial 
diversion.
    (B) Financial crimes, such as extortion, embezzlement, income tax 
evasion, insurance fraud and other similar crimes for which the 
individual was convicted, as defined under 42 CFR 1001.2, had a guilty 
plea or adjudicated pretrial diversion.
    (C) Any felony that placed Medicare or its beneficiaries at 
immediate risk, such as a malpractice suit that results in the 
individual being convicted, as defined under 42 CFR 1001.2, had a 
guilty plea or adjudicated pretrial diversion of criminal neglect or 
misconduct.
    (D) Any felonies for which the individual was convicted, as defined 
under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial 
diversion that would result in mandatory exclusion under section 
1128(a) of the Act.
    (2) CMS determination of coach eligibility. CMS will screen each 
individual identified on the roster of coaches included with the 
supplier's enrollment application described in paragraph (b)(4) of this 
section and updated in accordance with paragraph (d)(5) of this section 
to verify that the individual coach does not meet any of the conditions 
specified in paragraph (e)(1) of this section and that the coach can 
provide MDPP services on behalf of an MDPP supplier. For each 
individual coach successfully screened by CMS, his or her eligibility 
start date becomes effective and remains effective until an MDPP 
supplier or CMS takes action that results in an eligibility end date.
    (f) Effective date for billing privileges. (1) For MDPP suppliers 
initially enrolling and for newly established administrative locations 
that result in a new enrollment record or Provider Transaction Access 
Number, the effective date for Medicare billing privileges for MDPP 
suppliers is--
    (i) The later of--
    (A) The date of filing of a Medicare enrollment application that 
was subsequently approved by a Medicare contractor;
    (B) The date of filing of a corrective action plan that was 
subsequently approved by a Medicare contractor; or
    (C) The date that the supplier first began furnishing services at a 
new administrative location that resulted in a new enrollment record or 
Provider Transaction Access Number.
    (ii) Under no circumstances should the effective date of billing 
privileges for any MDPP supplier be prior to April 1, 2018.
    (2) For any newly established administrative locations that do not 
result in a new enrollment record or Provider Transaction Access 
Number, the existing billing privilege effective date for their 
Provider Transaction Access Number will apply, but not earlier than 
April 1, 2018.
    (g) Documentation retention and provision requirements. An MDPP 
supplier must maintain all documentation related to participation in 
the MDPP in accordance with all applicable Federal and State laws. The 
MDPP supplier must provide to CMS, a contractor acting on CMS' behalf, 
the Office of the Inspector General, and the Comptroller General or 
their designee(s) scheduled and unscheduled access to the MDPP 
supplier's records, including, but not limited to, all books, 
contracts, records, documents, and other evidence sufficient to enable 
the audit, evaluation, inspection, or investigation of the MDPP 
supplier's compliance with the MDPP expanded model's requirements, 
including the MDPP expanded model requirements for in-kind beneficiary 
incentive engagements in Sec.  424.210 of this chapter in the event 
that the MDPP supplier chooses to offer such incentives to any MDPP 
beneficiary.
    (1) The documentation for the first core session must be 
established contemporaneous with the furnishing of MDPP services and 
must include at least all of the following:
    (i) Organizational information, including MDPP supplier name, CDC 
DPRP number, and NPI.
    (ii) Basic beneficiary information for each MDPP beneficiary in 
attendance, including but not limited to beneficiary name, HICN, or 
MBI, age.
    (iii) Evidence that each such beneficiary satisfied the eligibility 
requirements under Sec.  410.79(c) of this chapter at the time of 
service.
    (2) The documentation for each MDPP session attended by an MDPP 
must be established contemporaneous with the furnishing of MDPP 
services and must include at least all of the following:
    (i) Documentation of the type of session, whether a core session, a 
core maintenance session, an ongoing maintenance session, an in-person 
make-up session, or a virtual make-up session.
    (ii) Identification of which CDC-approved DPRP curriculum was 
associated with the session.
    (iii) The NPI of the coach who furnished the session.
    (iv) The date and place of service of the session.
    (v) Each MDPP's beneficiary's weight and date weight taken, in a 
form and manner as specified by CMS.
    (3) If an MDPP supplier chooses to offer in-kind beneficiary 
engagement incentives to MDPP beneficiaries as permitted under Sec.  
424.210, the records maintained by the MDPP supplier in accordance with 
this section must also include the information required by Sec.  
424.210(e).
    (4) An MDPP supplier is required to maintain and handle any 
beneficiary information related to MDPP, including Personally 
Identifiable Information (PII) and Protected Health Information (PHI), 
as would be required under HIPAA, other applicable state and federal 
privacy laws, and CMS standards.
    (5) The MDPP supplier's records must include an attestation from 
the MDPP supplier that, as applicable, the MDPP beneficiary for which 
it is submitting a claim--
    (i) Has attended their first, fourth or ninth core session, as 
applicable, if the claim submitted is for a performance payment under 
Sec.  414.84(b)(1), (2), or (3) of this chapter.
    (ii) Has attended at least three core maintenance sessions, 
achieved required minimum weight loss, or both, as applicable, if the 
claim submitted is for a performance payment under Sec.  414.84(b)(4) 
of this chapter.
    (iii) Has achieved the required minimum weight loss and attended at 
least three ongoing maintenance

[[Page 53367]]

sessions within an ongoing maintenance session interval, if the claim 
submitted is for a performance payment under Sec.  414.84(b)(5) of this 
chapter, if the claim submitted is for a performance payment under 
Sec.  414.84(b)(6) of this chapter.
    (iv) Has achieved required minimum weight loss as measured in-
person during a core session or core maintenance session furnished by 
that supplier, if the claim submitted is for a performance payment 
under Sec.  414.84(b)(6) of this chapter.
    (v) Has achieved at least a 9-percent weight loss percentage as 
measured in-person during a core session, core maintenance session, or 
ongoing maintenance session furnished by that supplier, if the claim 
submitted is for a performance payment under Sec.  414.84(b)(7) of this 
chapter.
    (6) The MDPP supplier must maintain all records required under this 
section for a period of 10 years from the last day of the MDPP 
beneficiary's receipt of MDPP services provided by the MDPP supplier or 
from the date of completion of any audit, evaluation, inspection, or 
investigation, whichever is later, unless either of the following 
apply:
    (i) CMS determines that there is a special need to retain a 
particular record or group of records for a longer period and notifies 
the MDPP supplier at least 30 calendar days before the normal 
disposition rate; or
    (ii) There has been a dispute or allegation of fraud or similar 
fault against the MDPP supplier, in which case the records must be 
maintained for an additional 6 years from the date of any resulting 
final resolution of the dispute or allegation of fraud or similar 
fault, as defined at Sec.  405.902 of this chapter.
    (h) Denial or revocation of MDPP supplier enrollment. (1) An MDPP 
supplier is subject to enrollment denial or revocation of its MDPP 
supplier enrollment for one or more of the following reasons:
    (i) Failure to meet enrollment requirements. The MDPP supplier does 
not satisfy the conditions specified in paragraph (b) of this section.
    (A) An enrollment denial under this paragraph (h)(1)(i) is 
considered an enrollment denial under Sec.  424.530(a)(1).
    (B) A revocation under this paragraph (h)(1)(i) is considered a 
revocation under Sec.  424.535(a)(1).
    (C) An MDPP supplier that does not satisfy the requirements in 
paragraph (b)(1) of this section may become eligible to bill for MDPP 
services again if it successfully achieves MDPP preliminary recognition 
or full CDC DPRP recognition, and successfully enrolls again in 
Medicare as an MDPP supplier after any applicable reenrollment bar has 
expired.
    (ii) Failure to meet MDPP supplier standards. The MDPP supplier 
fails to meet the standards specified in paragraph (d) of this section.
    (A) An enrollment denial under this paragraph (h)(1)(ii) is 
considered an enrollment denial under Sec.  424.530(a)(1).
    (B) A revocation under this paragraph (h)(1)(ii) is considered a 
revocation under Sec.  424.535(a)(1).
    (iii) Application of existing enrollment denial reasons. One of the 
enrollment denial reasons specified in Sec.  424.530(a) applies.
    (iv) Application of existing revocation reasons. One of the 
revocation reasons specified in Sec.  424.535(a) applies.
    (v) Use of an ineligible coach. (A) The MDPP supplier knowingly 
allows an ineligible coach to furnish MDPP services to Medicare 
beneficiaries. Knowingly means that the MDPP supplier received an 
enrollment denial or revocation notice based on failing to meet the 
standard specified in Sec.  424.205(d)(3), was provided notice by CMS 
or contractors working on its behalf of this coach's ineligibility 
including the reason(s) for ineligibility, submitted a corrective 
action plan (CAP) to remove the coach and become compliant therefore 
maintaining its enrollment, but continued to allow the coach to provide 
MDPP services in violation of the CAP.
    (B) Revocation under this paragraph (h)(1)(v) is subject to the 
following requirements:
    (1) The revocation becomes effective 30 days after CMS or the CMS 
contractor mails notice of its determination to the MDPP supplier.
    (2) For the revocation authority under this paragraph (h)(1)(v), 
MDPP suppliers are barred from participating in the Medicare program 
from the date of the revocation, which begins 30 days after CMS or its 
contractor mails notice of the revocation, until the end of the 
reenrollment bar, which lasts a minimum of 1 year, but not greater than 
3 years, depending on the severity of the basis for revocation.
    (3) A revoked MDPP supplier must, within 60 calendar days after the 
effective date of revocation, submit all claims for items and services 
furnished before the date of the revocation letter.
    (2) An MDPP supplier may appeal an enrollment denial or revocation 
decision in accordance with the procedures specified in part 498 of 
this chapter. References to suppliers in that section apply to MDPP 
suppliers.


Sec.  424.210   Beneficiary engagement incentives under the Medicare 
Diabetes Prevention Program expanded model.

    (a) Definitions. In addition to the definitions specified at Sec.  
410.79(b) and Sec.  424.205(a) of this chapter, the following 
definition applies to this section:
    Engagement incentive period means the period of time during which 
an MDPP supplier may furnish in-kind beneficiary engagement incentives 
to a given MDPP beneficiary to whom the MDPP supplier is furnishing 
MDPP services. This period begins when an MDPP supplier furnishes any 
MDPP service to an MDPP eligible beneficiary and ends when one of the 
following occurs, whichever occurs first:
    (i) The MDPP beneficiary's MDPP services period ends as described 
in Sec.  410.79(c)(3) of this chapter.
    (ii) The MDPP supplier knows the MDPP beneficiary will no longer be 
receiving MDPP services from the MDPP supplier.
    (iii) The MDPP supplier has not had direct contact, either in-
person, by telephone, or via other telecommunications technology, with 
the MDPP beneficiary for more than 90 consecutive calendar days during 
the MDPP services period.
    (b) General. An MDPP supplier may choose to furnish an item or 
service as an in-kind beneficiary engagement incentive to an MDPP 
beneficiary only during the engagement incentive period, subject to the 
following conditions:
    (1) The item or service must be furnished directly to an MDPP 
beneficiary by an MDPP supplier or by an agent of the MDPP supplier, 
such as a coach, under the MDPP supplier's direction and control.
    (2) The item or service must be reasonably connected to the CDC-
approved DPP curriculum furnished to the MDPP beneficiary during a core 
session, core maintenance session, or ongoing maintenance session 
furnished by the MDPP supplier.
    (3) The item or service must be a preventive care item or service 
or an item or service that advances a clinical goal, as specified in 
paragraph (d) of this section, for an MDPP beneficiary by engaging him 
or her in better managing his or her own health.
    (4) The item or service must not be tied to the receipt of items or 
services outside of the MDPP services.
    (5) The item or service must not be tied to the receipt of items or 
services from a particular provider, supplier, or coach.
    (6) The availability of the item or service must not be advertised 
or promoted as an in-kind beneficiary

[[Page 53368]]

engagement incentive available to an MDPP beneficiary receiving MDPP 
services from the MDPP supplier except that an MDPP beneficiary may be 
made aware of the availability of the item or service at the time the 
MDPP beneficiary could reasonably benefit from it during the engagement 
incentive period.
    (7) The cost of the item or service must not be shifted to another 
Federal health care program, as defined at section 1128B(f) of the Act.
    (8) The cost of the item or service must not be shifted to an MDPP 
beneficiary.
    (c) Technology furnished to an MDPP beneficiary. In-kind 
beneficiary engagement incentives involving technology furnished by an 
MDPP supplier to an MDPP beneficiary are subject to the following 
conditions:
    (1) Items or services involving technology may not, in the 
aggregate, exceed $1,000 in retail value for any one MDPP beneficiary.
    (2) Items or services involving technology must be the minimum 
necessary to advance a clinical goal, as specified in paragraph (d) of 
this section, for an MDPP beneficiary.
    (3) Items involving technology exceeding $100 in retail value 
must--
    (i) Remain the property of the MDPP supplier; and
    (ii) Be retrieved from the MDPP beneficiary at the end of the 
engagement incentive period. The MDPP supplier must document all 
retrieval attempts, including the ultimate date of retrieval, in 
accordance with paragraph (e)(3) of this section. Documented diligent, 
good faith attempts to retrieve items of technology will be deemed to 
meet the retrieval requirement.
    (d) Clinical goals of the MDPP expanded model. The following are 
the clinical goals for MDPP beneficiaries that may be advanced through 
in-kind beneficiary engagement incentives:
    (1) Attendance at core sessions, core maintenance sessions, or 
ongoing maintenance sessions.
    (2) Weight loss.
    (3) Long-term dietary change.
    (4) Adherence to long-term health behavior changes.
    (e) Documentation of beneficiary engagement incentives. In addition 
to the documentation requirements at Sec.  424.205(g), an MDPP supplier 
must maintain documentation of items and services furnished as in-kind 
beneficiary engagement incentives that exceed $25 in retail value.
    (1) The documentation must be established contemporaneous with the 
furnishing of the in-kind items and services and must include at least 
the following:
    (i) The date the item or service is furnished.
    (ii) The identity of the MDPP beneficiary to whom the item or 
service is furnished.
    (iii) The agent of the MDPP supplier that furnished the item or 
service, if applicable.
    (iv) A description of the item or service.
    (v) The retail value of the item or service.
    (vi) Documentation establishing that the item or service was 
furnished to the MDPP beneficiary during the engagement incentive 
period.
    (2) Documentation regarding items or services that are furnished to 
the MDPP beneficiary for use on an ongoing basis during the engagement 
incentive period, including items involving technology exceeding $100 
in retail value, must also include contemporaneous documentation 
establishing that the MDPP beneficiary is in the engagement incentive 
period throughout the time period that the MDPP beneficiary possesses 
or has access to the item or service furnished by the MDPP supplier.
    (3) The documentation regarding items involving technology 
exceeding $100 in retail value must also include contemporaneous 
documentation of any attempt to retrieve the item as required by 
paragraph (c)(3)(ii) of this section.
    (4) The MDPP supplier must retain and provide access to the 
documentation required in this section in accordance with Sec.  
424.205(g).

0
17. Section 424.502 is amended by revising the definition for 
``Institutional provider'' to read as follows.


Sec.  424.502  Definitions.

* * * * *
    Institutional provider means any provider or supplier that submits 
a paper Medicare enrollment application using the CMS-855A, CMS-855B 
(not including physician and nonphysician practitioner organizations), 
CMS-855S, CMS-20134, or an associated Internet-based PECOS enrollment 
application.
* * * * *

0
18. Section 424.516 is amended by revising paragraph (e) introductory 
text to read as follows.


Sec.  424.516   Additional provider and supplier requirements for 
enrolling and maintaining active enrollment status in the Medicare 
program.

* * * * *
    (e) Reporting requirements for all other providers and suppliers. 
Reporting requirements for all other providers and suppliers not 
identified in paragraphs (a) through (d) of this section, with the 
exception of MDPP suppliers whose reporting requirements are 
established at Sec.  424.205(d), must report to CMS the following 
information within the specified timeframes:
* * * * *

0
19. Section 424.518 is amended by adding paragraphs (b)(1)(xi) and 
(c)(1)(iii) to read as follows:


Sec.  424.518   Screening levels for Medicare providers and suppliers.

* * * * *
    (b) * * *
    (1) * * *
    (xi) Revalidating MDPP suppliers.
* * * * *
    (c) * * *
    (1) * * *
    (iii) Prospective (newly enrolling) MDPP suppliers
* * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
20. The authority citation for part 425 continues to read as follows:

    Authority:  Secs. 1102, 1106, 1871, and 1899 of the Social 
Security Act (42 U.S.C. 1302, 1306 1395hh, and 1395jjjj).

0
21. Section 425.20 is amended by revising the definitions of ``Primary 
care physician'' and ``Primary care services'' to read as follows:


Sec.  425.20   Definitions.

* * * * *
    Primary care physician means:
    (1) For performance years 2012 through 2015, a physician included 
in an attestation by the ACO as provided under Sec.  425.404 for 
services furnished in an FQHC or RHC, or a physician who has a primary 
care specialty designation of internal medicine, general practice, 
family practice, or geriatric medicine;
    (2) For performance years 2016 through 2018, a physician included 
in an attestation by the ACO as provided under Sec.  425.404 for 
services furnished in an FQHC or RHC, or a physician who has a primary 
care specialty designation of internal medicine, general practice, 
family practice, geriatric medicine, or pediatric medicine; and
    (3) For performance year 2019 and subsequent years, a physician who 
has a primary care specialty designation of internal medicine, general 
practice, family practice, geriatric medicine, or pediatric medicine.
    Primary care services means the set of services identified by the 
HCPCS and revenue center codes designated under Sec.  425.400(c).
* * * * *

0
22. Section 425.112 is amended --
0
a. In paragraph (a)(3)(i) by removing the phrase ``Explain how it will 
require

[[Page 53369]]

ACO participants'' and adding in its place the phrase ``Require ACO 
participants'';
0
b. In paragraph (a)(3)(ii) by removing the phrase ``Explain how it will 
employ its internal assessments'' and adding in its place the phrase 
``Employ its internal assessments''; and
0
c. Revising paragraph (b)(4)(ii).
    The revision reads as follows:


Sec.  425.112   Required processes and patient-centeredness criteria.

* * * * *
    (b) * * *
    (4) * * *
    (ii) Have a written plan to:
    (A) Implement an individualized care program that promotes improved 
outcomes for, at a minimum, the ACO's high-risk and multiple chronic 
condition patients.
    (B) Identify additional target populations that would benefit from 
individualized care plans. Individualized care plans must take into 
account the community resources available to the individual.
    (C) Encourage and promote use of enabling technologies for 
improving care coordination for beneficiaries. Enabling technologies 
may include one or more of the following:
    (1) Electronic health records and other health IT tools.
    (2) Telehealth services, including remote patient monitoring.
    (3) Electronic exchange of health information.
    (4) Other electronic tools to engage beneficiaries in their care.
    (D) Partner with long-term and post-acute care providers, both 
inside and outside the ACO, to improve care coordination for its 
assigned beneficiaries.

0
23. Section 425.204 is amended by--
0
a. Revising paragraph (c)(1) introductory text;
0
b. Removing paragraph (c)(5)(iii);
0
c. Redesignating paragraph (c)(5)(iv) as new paragraph (c)(5)(iii); and
0
d. Revising paragraph (d).
    The revisions read as follows:


Sec.  425.204   Content of the application.

* * * * *
    (c) * * *
    (1) As part of its application, an ACO must certify that the ACO 
satisfies the requirements set forth in this part. Upon request, the 
ACO must submit the following supporting materials to demonstrate that 
it satisfies the requirements set forth in this part:
* * * * *
    (d) Distribution of savings. As part of its application to 
participate in the Shared Savings Program, an ACO must certify it has a 
mechanism and plan to receive and use payments for shared savings, 
including criteria for distributing shared savings among its ACO 
participants and ACO providers/suppliers.
* * * * *

0
24. Section 425.306 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  425.306   Participant agreement and exclusivity of ACO 
participants.

* * * * *
    (b) * * *
    (2) Each ACO participant that submits claims for services used to 
determine the ACO's assigned population under subpart E of this part 
must be exclusive to one Shared Savings Program ACO. If, during a 
benchmark or performance year (including the 3-month claims runout for 
such benchmark or performance year), an ACO participant that 
participates in more than one ACO submits claims for services used in 
assignment under subpart E of this part, then:
    (i) CMS will not consider any services billed through the TIN of 
the ACO participant when performing assignment under subpart E of this 
part for the benchmark or performance year.
    (ii) The ACO may be subject to the pre-termination actions set 
forth in Sec.  425.216, termination under Sec.  425.218, or both.

0
25. Section 425.400 is amended by adding paragraph (a)(1)(iii) and 
revising paragraph (c) to read as follows:


Sec.  425.400   General.

    (a) * * *
    (1) * * *
    (iii) In determining final assignment for a benchmark or 
performance year, CMS will exclude any services furnished during the 
benchmark or performance year that are billed through the TIN of an ACO 
participant that is an ACO participant in more than one ACO.
* * * * *
    (c) Primary care services for purposes of assigning beneficiaries 
are identified by selected HCPCS/CPT codes, or revenue center codes.
    (1) Primary care service codes are as follows:
    (i) For performance years 2012 through 2015:
    (A) CPT codes:
    (1) 99201 through 99215.
    (2) 99304 through 99340.
    (3) 99341 through 99350.
    (B) HCPCS codes G0402 (the code for the Welcome to Medicare visit) 
and G0438 and G0439 (codes for the annual wellness visits).
    (C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by 
FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
    (ii) For performance year 2016 as follows:
    (A) CPT codes:
    (1) 99201 through 99215.
    (2) 99304 through 99340.
    (3) 99341 through 99350.
    (4) 99495, 99496, and 99490.
    (B) HCPCS codes:
    (1) G0402 (the code for the Welcome to Medicare visit) and
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0463 for services furnished in ETA hospitals.
    (C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by 
FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
    (iii) For performance years 2017 and 2018 as follows:
    (A) CPT codes:
    (1) 99201 through 99215.
    (2) 99304 through 99318 (excluding claims including the POS 31 
modifier).
    (3) 99319 through 99340.
    (4) 99341 through 99350.
    (5) 99495, 99496, and 99490.
    (B) HCPCS Codes:
    (1) G0402 (the code for the Welcome to Medicare visit) and
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0463 for services furnished in ETA hospitals.
    (C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by 
FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
    (iv) For performance year 2019 and subsequent performance years as 
follows:
    (A) CPT codes:
    (1) 99201 through 99215.
    (2) 99304 through 99318 (excluding claims including the POS 31 
modifier).
    (3) 99319 through 99340.
    (4) 99341 through 99350.
    (5) 99487 and 99489.
    (6) 99495, 99496, and 99490.
    (B) HCPCS Codes:
    (1) G0402 (the code for the Welcome to Medicare visit) and
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0463 for services furnished in ETA hospitals.
    (4) G0506 (code for chronic care management).
    (5) G0502, G0503, G0504 and G0507 (codes for behavioral health 
integration).

0
26. Section 425.404 is amended by--
0
a. Amending the introductory text by removing the phrase ``with two 
special conditions:'' and adding in its place the phrase ``with special 
conditions:'';

[[Page 53370]]

0
b. Revising paragraphs (a) and (b).
    The revisions read as follows:


Sec.  425.404   Special assignment conditions for ACOs including FQHCs 
and RHCs.

* * * * *
    (a) For performance years 2012 through 2018--
    (1) Such ACOs are required to identify, through an attestation, 
physicians who directly provide primary care services in each FQHC or 
RHC that is an ACO participant and/or ACO provider/supplier in the ACO.
    (2) Under the assignment methodology in Sec.  425.402, CMS treats a 
service reported on an FQHC/RHC claim as a primary care service--
    (i) If the claim includes a HCPCS or revenue center code that meets 
the definition of primary care services under Sec.  425.20;
    (ii) Performed by a primary care physician if the NPI of a 
physician identified in the attestation provided under paragraph (a)(1) 
of this section is reported on the claim for a primary care service (as 
described in paragraph (a)(2)(i) of this section) as the attending 
provider; and
    (iii) Performed by a non-physician ACO professional if the NPI 
reported on the claim for a primary care service (as described in 
paragraph (a)(2)(i) of this section) as the attending provider is an 
ACO professional but is not identified in the attestation provided 
under paragraph (a)(1) of this section.
    (b) For performance year 2019 and subsequent performance years, 
under the assignment methodology in Sec.  425.402, CMS treats a service 
reported on an FQHC/RHC claim as a primary care service performed by a 
primary care physician.


Sec.  425.500   [Amended]

0
27. Section 425.500 is amended by--
0
a. In paragraph (e)(2) by removing the phrase ``of this section is less 
than 90 percent, absent unusual circumstances,'' and adding in its 
place the phrase ``of this section is less than 80 percent, absent 
unusual circumstances,''; and
0
b. In paragraph (e)(3) by removing the phrase ``determines there is a 
match rate of less than 90 percent, the ACO'' and adding in its place 
the phrase ``determines there is a match rate of less than 80 percent, 
the ACO''.


Sec.  425.502   [Amended]

0
28. Section 425.502 is amended in paragraph (a)(5) by removing the 
phrase ``or causes patient harm.'' and adding in its place the phrase 
``or causes patient harm, or when there is a determination under the 
Quality Payment Program that the measure has undergone a substantive 
change.''

0
29. Section 425.602 is amended by adding paragraphs (a)(1)(ii)(A) 
through (C) to read as follows:


Sec.  425.602   Establishing, adjusting, and updating the benchmark for 
an ACO's first agreement period.

    (a) * * *
    (1) * * *
    (ii) * * *
    (A) For agreement periods beginning before 2018, this calculation 
considers all individually beneficiary identifiable payments, including 
interim payments, made under a demonstration, pilot or time limited 
program.
    (B) For agreement periods beginning in 2018 and subsequent years, 
this calculation considers individually beneficiary identifiable final 
payments made under a demonstration, pilot or time limited program.
    (C) For the 2018 performance year and subsequent performance years 
in agreement periods beginning in 2015, 2016 and 2017, the benchmark is 
adjusted to reflect only individually beneficiary identifiable final 
payments made under a demonstration, pilot or time limited program.
* * * * *

0
30. Section 425.603 is amended by adding paragraphs (c)(1)(ii)(A) 
through (C) and (e)(2)(ii)(A) through (C) to read as follows:


Sec.  425.603   Resetting, adjusting, and updating the benchmark for a 
subsequent agreement period.

* * * * *
    (c) * * *
    (1) * * *
    (ii) * * *
    (A) For agreement periods beginning before 2018, considers all 
individually beneficiary identifiable payments, including interim 
payments, made under a demonstration, pilot or time limited program.
    (B) For agreement periods beginning in 2018 and subsequent years, 
considers individually beneficiary identifiable final payments made 
under a demonstration, pilot or time limited program.
    (C) For the 2018 and 2019 performance years in agreement periods 
beginning in 2017, the benchmark is adjusted to reflect only 
individually beneficiary identifiable final payments made under a 
demonstration, pilot or time limited program.
* * * * *
    (e) * * *
    (2) * * *
    (ii) * * *
    (A) For agreement periods beginning before 2018, considers all 
individually beneficiary identifiable payments, including interim 
payments, made under a demonstration, pilot or time limited program.
    (B) For agreement periods beginning in 2018 and subsequent years, 
considers individually beneficiary identifiable final payments made 
under a demonstration, pilot or time limited program.
    (C) For the 2018 and 2019 performance years in agreement periods 
beginning in 2017, risk adjusted county fee-for-service expenditures 
are adjusted to reflect only individually beneficiary identifiable 
final payments made under a demonstration, pilot or time limited 
program.
* * * * *

0
31. Section 425.604 is amended by adding paragraphs (a)(6)(ii)(A) and 
(B) to read as follows:


Sec.  425.604   Calculation of savings under the one-sided model.

    (a) * * *
    (6) * * *
    (ii) * * *
    (A) For performance years beginning before 2018, these calculations 
will take into consideration all individually beneficiary identifiable 
payments, including interim payments, made under a demonstration, pilot 
or time limited program.
    (B) For performance year 2018 and subsequent performance years, 
these calculations will take into consideration individually 
beneficiary identifiable final payments made under a demonstration, 
pilot or time limited program.
* * * * *

0
32. Section 425.606 is amended by adding paragraphs (a)(6)(ii)(A) and 
(B) to read as follows:


Sec.  425.606   Calculation of shared savings and losses under Track 2.

    (a) * * *
    (6) * * *
    (ii) * * *
    (A) For performance years beginning before 2018, these calculations 
will take into consideration all individually beneficiary identifiable 
payments, including interim payments, made under a demonstration, pilot 
or time limited program.
    (B) For performance year 2018 and subsequent performance years, 
these calculations will take into consideration individually 
beneficiary identifiable final payments made under a demonstration, 
pilot or time limited program.
* * * * *

0
33. Section 425.610 is amended by adding paragraphs (a)(6)(ii)(A) and 
(B) to read as follows:

[[Page 53371]]

Sec.  425.610   Calculation of shared savings and losses under Track 3.

    (a) * * *
    (6) * * *
    (ii) * * *
    (A) For performance years beginning before 2018, these calculations 
will take into consideration all individually beneficiary identifiable 
payments, including interim payments, made under a demonstration, pilot 
or time limited program.
    (B) For performance year 2018 and subsequent performance years, 
these calculations will take into consideration individually 
beneficiary identifiable final payments made under a demonstration, 
pilot or time limited program.
* * * * *


Sec.  425.612   [Amended]

0
34. Section 425.612 is amended by removing paragraphs (a)(1)(i)(A)(4) 
and (a)(1)(i)(C).

    Dated: October 23, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: October 24, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-23953 Filed 11-2-17; 4:15 pm]
BILLING CODE 4120-01-P