Medicare Part D Reporting Requirements and Supporting Regulations in MMA Title I, Part 423, §423.514(a) (CMS-10185) - IRA

Forms and Documents

Document Name	Status
CY 2025 Part D Reporting Requirements Non-Substantive Changes Crosswalk_DRAFT_20241023_508ed.xlsx Supplementary Document	2024-11-01
Non Substantive Change Request Memo _10.23.2024_.docx Justification for No Material/Nonsubstantive Change	2024-11-01
CY2022 to CY2025 Crosswalk.xlsx Supplementary Document	2024-07-25
30 Day Comment Responses_071824.docx Supplementary Document	2024-07-25
CMS-10185 - Supporting Statement A_July 2024.docx Supporting Statement A	2024-07-25
CY2022 to CY2025 Crosswalk_.pdf Supplementary Document	2024-05-20
60 day Comment Responses_5.10.24.pdf Supplementary Document	2024-05-20

IC Document Collections

IC ID	Document Title	Status
8853	Medicare Part D Reporting Requirements Instruction	Modified

ICR Details

OMB Control No: 0938-0992	ICR Reference No: 202411-0938-001
Status: Received in OIRA	Previous ICR Reference No: 202405-0938-020
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Part D Reporting Requirements and Supporting Regulations in MMA Title I, Part 423, §423.514(a) (CMS-10185) - IRA
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/01/2024

	Requested	Previously Approved
Expiration Date	08/31/2027	08/31/2027
Responses	14,325	14,325
Time Burden (Hours)	23,094	23,094
Cost Burden (Dollars)	0	0

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Abstract: 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). The Center for Medicare (CM) has identified the appropriate data needed to effectively monitor the Medicare Prescription Drug Benefit through these Part D reporting requirements. Changes to the currently approved data collection instrument reflect new executive orders, legislation, as well as recent changes to Agency policy and guidance. One example is the reporting section, Medicare Prescription Payment Plan, which will support the Inflation Reduction Act’s (Section 1860D-2(b)(2)(E) of the Social Security Act, as added by section 11202 of the IRA) provision that all Medicare Part D sponsors offer their Part D enrollees the option to pay their out-of-pocket (OOP) Part D drug costs through monthly payments over the course of the plan year. .

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Authorizing Statute(s): Statute at Large: 1 Stat. 423
   PL: Pub.L. 117 - 169 11202 Name of Law: The Inflation Reduction Act’s (IRA)
  

Citations for New Statutory Requirements: PL: Pub.L. 117 - 169 11202 Name of Law: The Inflation Reduction Act’s (IRA)

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 7398	02/02/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 45898	04/24/2024
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Medicare Part D Reporting Requirements

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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	14,325	14,325	0	0	0	0
Annual Time Burden (Hours)	23,094	23,094	0	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:

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Annual Cost to Federal Government: $300,000

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.     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

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Common Form ICR:  No

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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: 11/01/2024

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