CMS-10305.Non Substantive Change Request Memo_Medicare Part C &D Data Validation_Clean

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: April 24, 2025

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

This memo requests approval of non-substantive changes to the approved information collection, Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(j) (OMB# 0938-1115)

Background

This “Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(j))” 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 contracts they have 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 DVCs who meet minimum qualifications and credentials, which CMS outlines in the “Standards for Selecting Data Validation Contractors” document available at: https://www.cms.gov/medicare/coverage/prescription-drug-coverage-contracting/part-c-and-part-d-data-validation. For the retrospective review in 2026, the DVCs will review data submitted by SOs for the contract year (CY) 2025.

CMS uses validated, plan-reported data to calculate two Star Ratings measures (Medication Therapy Management Program Completion Rate for CMR (Part D) and Special Needs Plan Care Management (Part C), and one Display measure (Grievance Rate (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 determine eligibility for MA 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.

OMB last approved the collection on March 1, 2024, and expires on December 31, 2025.

Overview of Requested Changes

Subsequent to OMB’s approval on March 1, 2024, the Centers for Medicare and Medicaid Services (CMS) updated the Data Validation (DV) Manual to reflect the one new Part D and two new Part C Reporting Requirements Sections that will not undergo DV. In addition, the EES document was updated to reflect the removal of one variable in one Reporting Section for both Part C and D. This non-material/non-substantive change request is to implement these minor changes and replace the current package with the updated version. No other changes are being made, and there are no program changes or burden adjustments.