Health Insurance Benefit Agreement and Supporting Regulations (CMS-1561/1561A)

Forms and Documents

Document Name	Status
Form CMS-1561 Health Insurance Benefit Agreement and Supporting Regulations at 42 CFR Part 489 and 491 Form and Instruction	Modified
1561-1561A- Non-substantive change memo.docx Justification for No Material/Nonsubstantive Change	2025-11-25
CMS-1561 - Supporting Statement A. 08.18.23.docx Supporting Statement A	2023-12-07

IC Document Collections

IC ID	Document Title	Status
8630	Health Insurance Benefit Agreement and Supporting Regulations at 42 CFR Part 489 and 491 Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0832	ICR Reference No: 202511-0938-018
Status: Received in OIRA	Previous ICR Reference No: 202312-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Health Insurance Benefit Agreement and Supporting Regulations (CMS-1561/1561A)
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: 11/26/2025

	Requested	Previously Approved
Expiration Date	01/31/2027	01/31/2027
Responses	2,050	2,050
Time Burden (Hours)	2,050	2,050
Cost Burden (Dollars)	0	0

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Abstract: Applicants to the Medicare program are required to agree to provide services in accordance with Federal requirements. The CMS-1561 and 1561A are essential for CMS to ensure that applicants are in compliance with the requirements. Applicants will be required to sign the completed form and provide operational information to CMS to assure that they continue to meet the requirements after approval.

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Authorizing Statute(s): PL: Pub.L. 115 - 271 2005(d) Name of Law: Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients
   US Code: 42 USC 491 Name of Law: Certification of Certain Health Facilities
   US Code: 42 USC 489 Name of Law: Allowable Charges
  

Citations for New Statutory Requirements: PL: Pub.L. 115 - 271 2005(d) Name of Law: Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients

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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:
	88 FR 67300	09/29/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 84820	12/06/2023
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
Health Insurance Benefit Agreement and Supporting Regulations at 42 CFR Part 489 and 491	CMS-1561, CMS-1561A	Health Insurance Benefits Agreement ,   Health Insurance Benefits Agreement for RHC

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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	2,050	2,050	0	0	0	0
Annual Time Burden (Hours)	2,050	2,050	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: $57,390

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: 11/26/2025

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