[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Proposed Rules]
[Pages 30983-30984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13891]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 422

[CMS-4185-N4]
RIN 0938-AT59


Medicare and Medicaid Programs; Risk Adjustment Data Validation

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

ACTION: Proposed rule; request for additional comment; announcement of 
the release of additional data.

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SUMMARY: This document summarizes actions taken to date, requests 
public comment on additional subjects, and announces that CMS is 
releasing additional material, including study data, related to the 
Risk Adjustment Data Validation (RADV) provisions of the proposed rule 
titled ``Medicare and Medicaid Programs; Policy and Technical Changes 
to the Medicare Advantage, Medicare Prescription Drug Benefit, Program 
of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, 
and Medicaid Managed Care Programs for Years 2020 and 2021'' that was 
published in the November 1, 2018 Federal Register, 83 FR 55037. The 
comment period for the RADV provisions of this proposed rule ends on 
August 28, 2019.

DATES: The comment period for CMS RADV provisions (that is, section 
II.C.2. of the November 1, 2018 proposed rule and proposed Sec. Sec.  
422.300, 422.310(e) and 422.311(a) of the regulation text) closes at 5 
p.m. on August 28, 2019.

ADDRESSES: In commenting, please refer to file code CMS-4185-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-4185-P, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-4185-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Jonathan Smith (410) 786-4671 or 
Joanne Davis (410) 786-5127.

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

I. Request for Public Comment

    On November 1, 2018, we published a proposed rule containing 
provisions related to the Risk Adjustment Data Validation (RADV) audit 
program, 83 FR 55037 through 55041 and 55077, including the proposal 
not to apply a Fee-for-Service Adjuster (FFS Adjuster) in any RADV 
extrapolated audit methodology. That proposal rested on two grounds. 
First, we conducted a study which indicated that diagnosis error in FFS 
claims data does not lead to systematic payment error in the Medicare 
Advantage (MA) program. Second, we suggested that it would be 
inequitable to correct any systematic errors made in the payments to 
audited plans only. We continue to welcome public comment on this 
proposal. We are also seeking comment on whether 42 U.S.C. 1395w-23--
and in particular clause (a)(1)(C), which requires risk adjustment in 
subclause (a)(1)(C)(i), mandates a downward adjustment of risk scores 
in subclause (a)(1)(C)(ii), and includes provisions about risk 
adjustment for special needs individuals with chronic health conditions 
in subclause (a)(1)(C) (iii)--mandates an FFS Adjuster, prohibits an 
FFS Adjuster, or should otherwise be read to inform our proposal not to 
apply an FFS Adjuster in any RADV extrapolated audit methodology.

II. Summary of Prior Notices

    Since we published the FFS Adjuster Study on October 26, 2018,\1\ 
we have published several related notices.
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    \1\ The Executive Summary and Technical Appendix of the study 
are both available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-Risk-Adjustment-Data-Validation-Program/Resources.html.
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    On December 27, 2018 (83 FR 66661), we announced an extension of 
the comment period for the RADV provisions until April 30, 2019 and a 
plan to release data underlying the October 26, 2018 FFS Adjuster 
Study.
    On March 6, 2019 (84 FR 8069), we announced the release of data 
underlying the FFS Adjuster Study, both through the Office of 
Enterprise Data Analytics (OEDA) and on the Private Plans Team website. 
Data made available to the public through a data use agreement included 
all of the following:
     An input file originating from a dataset that Research 
Triangle Institute (RTI) supplied. It represents the calibration data 
that RTI used for the Centers for Medicare and Medicaid Services 
Hierarchical Condition Category (CMS-HCC) model version that CMS used 
to calculate 2009 MA payments.
     An input file containing medical record review findings 
from a RADV-like review that CMS undertook on a sample of calendar year 
2008 medical records.
     FFS data containing 10 datasets that represent the entire 
5 percent sample of all final 2004 and 2005 diagnosis codes used for MA 
model calibrations through 2011.
     An HCC file containing the mapping from International 
Classification of Disease, 9th Revision diagnosis code to Version 12 of 
the CMS-HCC model. Diagnosis codes have been modified to remove 
decimals.
     A file consolidating MA data for beneficiaries who meet 
eligibility criteria for Contract-Level Risk RADV audits from three 
sources: The adjusted Monthly Membership Report (MMR), the Model Output 
File (MOF), and the CMS Enrollment Database (EDB).
     A file consolidating MA data for beneficiaries who did not 
meet all eligibility criteria for the Contract-Level RADV audits from 
three sources--adjusted MMR, MOF, and CMS EDB.
     Additional documentation and data related to the RADV FFS 
Adjuster Study was posted on the Private Plans Team website at https://
www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/
Medicare-Risk-

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Adjustment-Data-Validation-Program/Resources.html. This data included a 
RADV Data Dictionary and Provisional Coefficients workbook.
    On April 30, 2019 (84 FR 18215), we announced an additional 
extension of the comment period for the RADV provision until August 28, 
2019. We also announced that we would be releasing additional data 
underlying the FFS Adjuster Study, including additional data containing 
Protected Health Information, to all parties who entered an applicable 
data use agreement and paid the required fee. This data has been 
available since June 14, 2019. The forms and instructions to request 
this data and previously released data remain available via the CMS 
website at https://www.cms.gov/research-statistics-data-and-systems/files-for-order/limiteddatasets/. Updates to existing documentation 
related to the study data, as well as additional data without Protected 
Health Information, were posted on the CPI Private Plans Team website 
on April 25, 2019.

III. Release of Additional Study Material and Further Request for 
Public Comment

    We have now replicated the FFS Adjuster Study and published a 
summary of that replication as an addendum to the study at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-Risk-Adjustment-Data-Validation-Program/Resources.html. The 
results of the replication are broadly consistent with the initial 
implementation of the study. The purpose of this replication was to 
allow us to both test our initial results and release a more complete 
set of underlying data. Certain intermediate data elements not saved as 
part of the implementation of the initial study have been preserved and 
published in the addendum or at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-Risk-Adjustment-Data-Validation-Program/Resources.htm. In addition, the 
addendum contains further discussion of the study's assumptions and 
methodology. We are also releasing the programming language used to 
implement the replication of the study, available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-Risk-Adjustment-Data-Validation-Program/Resources.html, along 
with a description of the technical requirements for use of that 
programming language. It is our intention that the release of this 
programming language, together with the earlier release of the data 
used as inputs, will allow for robust public comment on the FFS 
Adjuster Study.
    We welcome public comment on that subject, and all subjects raised 
in this notice and the notices discussed previously, until 5 p.m. on 
August 28, 2019.

    Dated: June 21, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-13891 Filed 6-27-19; 8:45 am]
BILLING CODE 4120-01-P