Non-Substantive Justification Memo

To: Jamie Wilson

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: William Parham

Office of Strategic and Regulatory Affairs

PRA Staff

Date: February 27, 2024

Subject: Non-Substantive Change Request – Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) (OMB# 0938-1115)

This memo requests approval of non-substantive changes to the approved information collection, Authorization to Disclose Personal Health Information (OMB# 0938-1115)

Background

This “Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))” forms will be used by Data Validation Contractors (DVCs) to evaluate the quality of data submitted by plans for the Medicare Parts C and D Reporting Requirements. The Centers for Medicare and Medicaid Services (CMS) established reporting requirements for Medicare Part C and Part D sponsoring organizations (Medicare Advantage Organizations [MAOs], Cost Plans, and Medicare Part D sponsors) under the authority described in 42 CFR 422.516(a) and 423.514(a), respectively. Under these reporting requirements, each sponsoring organization must submit Medicare Part C, Medicare Part D, or Medicare Part C and Part D data (depending on the type of contracts they have in place with CMS).

In order for the reported data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations (SOs). To maintain the independence of the validation process, sponsoring organizations do not use their own staff to conduct the data validation process. SOs are responsible for hiring external, independent data validation contractors (DVCs) who meet a minimum set of qualifications and credentials, which CMS outlines in the “Standards for Selecting Data Validation Contractors” document. For the retrospective review in 2025, the DVCs will review data submitted by SOs for contract year (CY) 2024.

CMS uses validated, plan-reported data to calculate two Star Ratings measures (Medication Therapy Management Programs (Part D)), Special Needs Plans Care Management (Part C)), and one Display measure (Grievances (Part C and D)). For more information please see the Star Ratings and Display technical notes posted here https://www.cms.gov/medicare/health-drug-plans/part-c-d-performance-data. Star Ratings are used to calculate Quality Bonus Payments, which are discussed in more detail in the Advance Notices and Rate Announcements published at: https://www.cms.gov/medicare/payment/medicare-advantage-rates-statistics/announcements-and-documents.

The collection was last approved by OMB on November 13, 2023, and expires on December 31, 2025.

Overview of Requested Changes

Subsequent to OMB’s approval on November 13, 2023, the Centers for Medicare and Medicaid Services (CMS) updated the Data Validation (DV) Manual to reflect a new Part C Reporting Requirements reporting section that will not undergo DV and made a change to Appendix E to better match what is already reflected in the DV Manual. No changes are being made to Appendix B/EES document. This non-material/non-substantive change request is to implement these minor changes and replace the current package with the updated version. There are no other changes being made at this time and there are no program changes or burden adjustments.