AGENCY:

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

ACTION:

Proposed rule; extension of comment period and the announcement of the release of additional data.

SUMMARY:

This document extends the comment period for 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. The comment period for the RADV provision of this proposed rule, which would end on April 30, 2019, is extended by 120 days until August 28, 2019. This document also announces that CMS will be releasing additional data underlying the FFS Adjuster Study released October 26, 2018.

DATES:

The comment period for RADV provisions (that is, section II.C.2. of the November 1, 2018 proposed rule and proposed §§ 422.300, 422.310(e) and 422.311(a) of the regulations text), published on November 1, 2018 (83 FR 54982), and extended on December 27, 2018 (83 FR 66661), is further extended to 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.

Extension of the Public Comment Period

In the November 1, 2018 proposed rule (83 FR 54982) 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,” we included preamble language and regulatory provisions regarding the proposed Risk Adjustment Data Validation audit methodology and the proposal not to apply a Fee-For-Service (FFS) Adjuster. We posted a FFS Adjuster Study on October 26, 2018.

In the March 6, 2019 Federal Register (84 FR 8069), we published a document titled “Medicare Program; Release of Data Underlying Risk Adjustment Data Validation Provisions” that announced the release of data underlying the proposed policies regarding the use of extrapolation in MA Risk Adjustment Data Validation (RADV) audits and the Fee-for-Service (FFS) Adjuster.

CMS is announcing the release of additional data underlying the October 26, 2018 FFS Adjuster Study. Updates to existing documentation related to the study data, as well as additional data without Personally Identifiable Information, were posted on the CPI Private Plans Team website on April 25, 2019. Additional data containing Protected Health Information are being made available by CMS to all parties who have entered into an applicable data use agreement and to those parties who can request this information if they agree to enter into an applicable data use agreement. CMS expects to release that data by June 14th. This will be the final release of data from the October 26, 2018 FFS Adjuster Study.

In addition to releasing this additional data from the previously published study, CMS intends to replicate that study, publish the results, and release associated data. Doing so will allow CMS to both test its initial results and release a more complete set of underlying data. Certain intermediate data elements not saved in the implementation of the initial study would be preserved in the replication and made available through publication.

In order to maximize the opportunity for the public to provide meaningful input to CMS, we believe it is important to allow additional time for the public to prepare comments on the RADV provisions of the proposed rule. In addition, we believe granting a 120-day extension to the public comment period in this instance would further our overall objective to obtain public input and to generate information that will be useful to our agency's decision makers. Therefore, this document announces the extension of the public comment period until August 28, 2019 for the RADV provisions included in the November 1, 2018 proposed rule (83 FR 55037 through 55041 and 55077).