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
CMS-1561 - Supporting Statement A (2019 Final Rule Version 5) CLEAN.docx Supporting Statement A	2020-03-25

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: 201911-0938-007
Status: Active	Previous ICR Reference No: 201707-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Health Insurance Benefit Agreement and Supporting Regulations (CMS-1561/1561A)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/06/2020
	Date Received in OIRA: 11/15/2019
Terms of Clearance: We expect the next clearance to include a fillable, fileable form and no longer require a wet signature.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2023	36 Months From Approved	01/31/2021
Responses	3,088	0	2,454
Time Burden (Hours)	3,088	0	2,454
Cost Burden (Dollars)	0	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): US Code: 42 USC 489 Name of Law: Allowable Charges
   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
  

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:
0938-AT72	Final or interim final rulemaking	84 FR 62998	11/15/2019

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 40482	08/14/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 62998	11/15/2019
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 Approved	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	3,088	2,454	634	0	0	0
Annual Time Burden (Hours)	3,088	2,454	634	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: Our November 15, 2019 final rule (RIN 0938-AT72, CMS-1715-F) amended 42 CFR part 489 to include OTPs as a provider as required by section 1866(e)(3) of the Act. We are proposing that the requirements under part 489, which include limitation of charges to beneficiaries, would apply to OTPs. Specifically, we are proposing to add OTPs to the list of providers in § 489.2 and that the provider agreements apply to OTPs only to furnish OUD treatment services. In that regard OTPs would be required to complete Provider Agreement CMS-1561 or CMS-1561A in order to enroll in Medicare. The burden for reporting and completing the Provider Agreement is based on SAMHSA statistics. We generally estimate that there are about 1,700 already certified and accredited OTPs eligible for Medicare enrollment initially; and approximately 200 OTPs would become certified by SAMHSA in the next 3 years (or roughly 67 per year). Annually, we estimate an average of 635 additional respondents ([1,767 OPTs for year 1 + 67 OTPs for year 2 + 67 OTPs for year 3)/3 years]).

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Annual Cost to Federal Government: $80,540

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? Uncollected

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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: 11/15/2019

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