Collection of Prescription Drug Data from MA-PD, PDP and Fallout Plans/Sponsors for Medicare Part D Payments (CMS-10174) - IRA

Forms and Documents

Document Name	Status
PRA comment response.pdf Supplementary Document	2023-07-17
Crosswalk CMS-10174_07-06-2023 Clean.pdf Supplementary Document	2023-07-17
CMS-10174 - Supporting Statement A_.docx Supporting Statement A	2023-07-17

IC Document Collections

IC ID	Document Title	Status
43675	Collection of Drug Event Data from Contracted Part D Providers For Payments Instruction	Modified
261111	Expansion of the PDE File Layout and Addition of New PDE Fields (New) Instruction	New

ICR Details

OMB Control No: 0938-0982	ICR Reference No: 202306-0938-007
Status: Received in OIRA	Previous ICR Reference No: 202108-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Collection of Prescription Drug Data from MA-PD, PDP and Fallout Plans/Sponsors for Medicare Part D Payments (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: 07/18/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2025
Responses	1,499,065,636	1,499,238,090
Time Burden (Hours)	62,918	2,998
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: PL: Pub.L. 117 - 169 11001 Name of Law: Inflation Reduction Act of 2022

---

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:
	88 FR 27896	05/03/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 45428	07/17/2023
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Collection of Drug Event Data from Contracted Part D Providers For Payments
Expansion of the PDE File Layout and Addition of New PDE Fields (New)

---

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,499,065,636	1,499,238,090	856	0	-173,310	0
Annual Time Burden (Hours)	62,918	2,998	59,920	0	0	0
Annual Cost Burden (Dollars)	0	0	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: No

Burden Reduction Due to:

Short Statement: The Part D contracts have increased from 739 to 856 and the average number of PDE submissions per year decreased. The adjustment decreases our response figure by 173,310 responses CMS will expand the PDE file layouts from their current 512-byte length to 1000 bytes, to be implemented effective January 1, 2025. This expansion is being implemented to accommodate future business needs, including but not limited to, updates necessary for the IRA. This new one time expansion adds 59,920 burden hours to the total burden of the package.

---

Annual Cost to Federal Government: $13,000,000

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

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/18/2023

---