Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a) (CMS-10261)

Forms and Documents

Document Name	Status
CMS-10261_Supporting Statement_A.docx Supporting Statement A	2025-09-18
Non Substantive Change Request Memo _Medicare Part C Reporting Requiremnts_Final_9.18.docx Justification for No Material/Nonsubstantive Change	2025-09-18

IC Document Collections

IC ID	Document Title	Status
186859	Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a) Instruction	Modified

ICR Details

OMB Control No: 0938-1054	ICR Reference No: 202509-0938-015
Status: Received in OIRA	Previous ICR Reference No: 202410-0938-024
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a) (CMS-10261)
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: 09/19/2025

	Requested	Previously Approved
Expiration Date	01/31/2028	01/31/2028
Responses	7,830	7,830
Time Burden (Hours)	222,575	222,575
Cost Burden (Dollars)	0	0

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Abstract: CMS' regulatory authority to establish reporting requirements for Part C Medicare Advantage (MA) organizations is described in 42 CFR 422.516 (a). It is noted that each MA organization must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, and while safeguarding the confidentiality of the doctor-patient relationship, statistics and other information with respect to the following: (1) The cost of its operations. (2) The patterns of utilization of its services. (3) The availability, accessibility, and acceptability of its services. (4) To the extent practical, developments in the health status of its enrollees. (5) Other matters that CMS may require.

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Authorizing Statute(s): PL: Pub.L. 110 - 275 164 Name of Law: MIPPA
  

Citations for New Statutory Requirements: None

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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 56754	07/09/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 85539	10/28/2024
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a)

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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	7,830	7,830	0	0	0	0
Annual Time Burden (Hours)	222,575	222,575	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: 09/19/2025

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