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OMB Control No: 0938-1451	ICR Reference No: 202509-0938-022
Status: Received in OIRA	Previous ICR Reference No: 202307-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Part D Manufacturer Discount Program Agreement - IRA (CMS-10846)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 09/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	40	659
Time Burden (Hours)	320	4,613
Cost Burden (Dollars)	0	0

Abstract: Section 11201 of the Inflation Reduction Act of 2022 (IRA), eliminates the coverage gap phase of the Part D benefit and sunsets the coverage gap discount program after December 31, 2024, and amends the Social Security Act (the Act) to add §1860D-14C, requiring the Secretary to establish a new Medicare Part D manufacturer discount program (Discount Program) beginning January 1, 2025. Under the Discount Program, participating manufacturers are required to provide discounts on their “applicable drugs” (brand drugs, biologics, and biosimilars) both in the initial coverage phase and in the catastrophic coverage phase of the Part D benefit. Section 1860D-14C(d)(1) of the Act requires CMS to implement and administer the Discount Program, including determining discounted amounts, and ensuring that discounts are applied appropriately and payments/reimbursements are timely made. As with the existing coverage gap discount program, a CMS contractor will serve as the third party administrator (TPA) and facilitate payment processing. Information in this collection is needed to set up agreements between manufacturers and CMS, as required under §1860D-14C(a) of the Act. Such agreements are required in order for manufacturers to participate in the Discount Program and, under §1860D43(a), for their applicable drugs to be covered under Part D beginning in 2025. Information that will be collected from manufacturers in the Health Plan Management System (HPMS) (Appendix A) is needed to create and execute Discount Program agreements and to determine which manufacturers qualify as a specified manufacturer or specified small manufacturer for phased-in discounts, as described at §1860D-14C(g)(4). Banking information collected by the TPA from manufacturers and plan sponsors (Appendix B) is needed to prepare invoices and process financial transactions (deposits and payments) through the automated clearing house (ACH).

Authorizing Statute(s): US Code: 42 USC 1395w-114c Name of Law: Manufacturer discount program
PL: Pub.L. 117 - 117 11201 Name of Law: Inflation Reduction Act of 2022

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 26301	06/20/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 46895	09/30/2025
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Part D Manufacturer Discount Program	CMS-10846, CMS-10846	HPMS Data Entry Fields , TPA Data Entry Fields

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	40	659	-619
Annual Time Burden (Hours)	320	4,613	-4,293
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Burden has decreased due to the removal of the one-time burden associated with program implementation, which took place in 2024. CMS is using an annual burden going forward based on the estimated number (40) of manufacturers that will newly join the Discount Program each year, and the number of new Part D plan contracts that are established each year.

Annual Cost to Federal Government: $2,050,411

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

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