Justification for a Nonsubstantive Change

To: Jamie Wilson

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: Valerie Yingling

Medicare Drug Benefit & C&D Data Group (MDBG)

Centers for Medicare and Medicaid Services (CMS)

Date: August 7, 2025

Subject: Non-Substantive Change Request – Part D Drug Management Program (CMS-10874, OMB 0938-1465)

This memo requests approval of a non-substantive change to correct variable text in our active Alternate Second Notice.

Background

Section 1860D-4(c)(5)(A) of the Act requires that Part D sponsors have a DMP for beneficiaries at risk of abuse or misuse of FADs. The information in this collection is necessary for sponsor conformance with DMP requirements at § 423.153(f), including communicating with prescribers and pharmacies, informing beneficiaries that they have been identified as a PARB or ARB, and informing beneficiaries and CMS whether a beneficiary’s access to FADs will be restricted to a selected prescriber and/or network pharmacy(ies) and/or through a beneficiary-specific point-of-sale claim edit.

Overview of Requested Changes

This August 2025 iteration proposes to correct variable text in our active Alternate Second Notice. The variable text reads “As of the date of this notice, you’re eligible to use the quarterly Medicare Special Enrollment period because you receive Extra Help with your prescription drug costs” when it should read “As of the date of this notice, you’re eligible to use the monthly Medicare Special Enrollment period to enroll in a standalone Part D plan because you receive Extra Help with your prescription drug costs”. The change revises the frequency of the special enrollment period for dual- or other LIS-eligible individuals from quarterly to monthly and narrows the applicability of the special enrollment period to only enrollment in standalone Part D plans. The change aligns with our April 23, 2024 (89 FR 30448) final rule (CMS-4205-F, RIN 0938-AV24), specifically regarding amendments at 42 CFR § 423.38(c)(4).

A clean version of the corrected Alternate Second Notice is attached to this non-substantive collection of information request along with a Crosswalk of the change and a Redline version of the corrected Alternate Second Notice.

We are not proposing changes to our active burden estimates.

We are not proposing changes to our active Supporting Statement.

We are not proposing any changes to any of our other active collection of information instruments.