Non-Substantive 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: October 24, 2024

Subject: Non-Substantive Change Request – Medicare Part D Reporting Requirements (42 CFR §423.514(a)) (OMB# 0938-0992)

This memo requests approval of non-substantive changes to the approved information collection (OMB# 0938-0992)

BACKGROUND

Section 1860D–12(b)(3)(D) of the Act provides broad authority for the Secretary to add terms to the contracts with Part D sponsors, including terms that require the sponsor to provide the

Secretary with information as the Secretary may find necessary and appropriate. Pursuant to our statutory authority, we codified these information collection requirements for Part D sponsors in regulation at 42 CFR §423.514(a).

42 CFR §423.514(a) requires each Part D sponsor to have a procedure for developing, compiling, evaluating, and reporting to CMS, its enrollees, and the public. This includes statistics on the cost of operations, service utilization patterns, service availability and

acceptability, fiscal soundness, personal performance measurements, and any other information CMS requires.

OVERVIEW OF REQUESTED CHANGES

Subsequent to OMB’s approval on August 1, 2024, the Centers for Medicare and Medicaid Services (CMS) updated the Medicare CY 2025 Part D Reporting Requirements. The update was made to correct a clerical error by removing one data element in the Coverage

Determinations, Redeterminations (including At–Risk Redeterminations under a Drug

Management Program), and Reopenings (CDR) reporting requirement section. This update

ensures consistency in reporting the CDR section data at the contract level. No other changes are being made, and no program changes or burden adjustments exist.