[Federal Register Volume 86, Number 201 (Thursday, October 21, 2021)]
[Proposed Rules]
[Pages 58245-58246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 422, 423, 438, and 498

[CMS-4185-RCN]
RIN 0938-AK02


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; Extension 
of Timeline To Finalize a Rulemaking

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Extension of timeline.

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SUMMARY: The Social Security Act (the Act) requires us to publish a 
Medicare final rule no later than 3 years after the publication date of 
the proposed rule. This document announces an extension of the timeline 
for publication of a Medicare final rule in accordance with the Act, 
which allows us to extend the timeline for publication of the 
``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'' final rule 
under exceptional circumstances.

DATES: As of October 21, 2021, the timeline for publication of a rule 
to finalize the November 1, 2018 proposed rule (83 FR 54982) is 
extended until November 1, 2022.

FOR FURTHER INFORMATION CONTACT: Joseph Strazzire, (410) 786-2775.

SUPPLEMENTARY INFORMATION: On November 1, 2018 (83 FR 54982), we 
published a proposed rule, ``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-

[[Page 58246]]

For-Service, and Medicaid Managed Care Programs for Years 2020 and 
2021,'' that would revise the Medicare Advantage (MA) Risk Adjustment 
Data Validation (RADV) regulations to improve program efficiency and 
payment accuracy. The proposed rule discussed the Secretary's authority 
to: (1) Extrapolate in the recovery of RADV overpayments, starting with 
payment year 2011 contract-level audits; and (2) not apply a fee-for-
service (FFS) adjuster to the RADV overpayment determinations.
    Section 1871(a)(3)(A) of the Act requires the Secretary to 
establish and publish a regular timeline for the publication of final 
regulations based on the previous publication of a proposed regulation. 
In accordance with section 1871(a)(3)(B) of the Act, the timeline may 
vary among different regulations based on differences in the complexity 
of the regulation, the number and scope of comments received, and other 
relevant factors, but may not be longer than 3 years except under 
exceptional circumstances. In addition, in accordance with section 
1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted 
publication date of the final regulation if the Secretary, no later 
than the regulation's previously established proposed publication date, 
publishes a notice with the new target date for publication, and such 
notice includes a brief explanation of the justification for the 
variation.
    The final rule for the November 1, 2018 proposed rule should be 
published by November 1, 2021. However, we are unable to meet the 3-
year timeline for publication of the previously referenced RADV-audit 
related provisions because of exceptional circumstances. Specifically, 
on October 26, 2018, just prior to the publication of the proposed 
rule, we published the FFS Adjuster Study. On December 27, 2018, we 
announced an extension of the comment period for the proposed RADV 
provisions of the rule until April 30, 2019 and a plan to release data 
underlying the FFS Adjuster study. On March 6, 2019 we announced the 
release of data underlying the FFS Adjuster study. On April 30, 2019, 
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. 
Finally, on June 28, 2019, we released additional material related to 
the FFS Adjuster Study, and made a further request for public comment. 
Based on extensive public comments received on the proposed rule and 
subsequent FFS Adjuster study and related data along with delays 
resulting from the agency's focus on the COVID-19 public health 
emergency, we determined that additional time is needed to address the 
complex policy and operational issues that were raised.
    This document extends the timeline for publication of the final 
rule for 1 year, until November 1, 2022.

Karuna Seshasai,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2021-22908 Filed 10-20-21; 8:45 am]
BILLING CODE 4120-01-P