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OMB Control No: 0938-0982	ICR Reference No: 202609-0938-018
Status: Received in OIRA	Previous ICR Reference No: 202403-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Collection of Prescription Drug Event Data From Contracted Part D Providers for Payment (CMS-10174) - IRA
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 10/02/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2027
Responses	1,627,799,680	1,499,065,636
Time Burden (Hours)	11,208	62,918
Cost Burden (Dollars)	0	0

Abstract: CMS requires contracted Part D providers to submit prescription drug event (PDE) records as required by the Medicare Prescription Drug Improvement, and Modernization Act of 2003. The PDE data is then used in the Payment Reconciliation System to perform the annual Part D payment reconciliation, any PDE data within the Coverage Gap Phase of the Part D benefit is used for invoicing in the CGDP, and the data are part of the report provided to the Secretary of the Treasury for Section 9008. Section 11102 of the Inflation Reduction Act of 2022 establishes a Part D inflation rebate by manufacturers of certain single source drugs and biologicals with prices increasing at a rate faster than the rate of inflation. CMS will use data reported under sections 1860D-15(c)(1)(C) and (d)(2), in part, to rank drugs by total expenditures under Part D in order to select drugs for negotiation and to identify units to calculate inflation rebates. We also intend to use the PDE data submissions from Part D sponsors to fulfill our statutory obligations under the Social Security Act. This includes the use of PDE data to fulfill obligations or operationalize any future legislative changes to the Social Security Act that impact the Part D program. CMS is notifying users that it will also use data reported under sections 1860D-15(c)(1)(C) and (d)(2) to implement the Medicare Drug Negotiation Program and to calculate inflation rebates as required by the Inflation Reduction Act of 2022, as well as to fulfill our statutory obligations under the Social Security Act. This includes the use of PDE data to fulfill obligations or operationalize any future legislative changes to the Social Security Act that impact the Part D program.

Authorizing Statute(s): Statute at Large: 18 Stat. 1860
   PL: Pub.L. 108 - 173 101 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   PL: Pub.L. 117 - 169 11001 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:
	91 FR 46786	07/24/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 62519	10/01/2026
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,627,799,680	1,499,065,636	138	128,733,906
Annual Time Burden (Hours)	11,208	62,918	-51,968	258
Annual Cost Burden (Dollars)	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Burden has increased as a result of increased Part D contracts per year to reflect more current data and growth in Medicare beneficiaries enrolled in Part D.

Annual Cost to Federal Government: $23,400,000

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. Yes

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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