Organ Procurement Organization's Health Insurance Benefits Agreement and Supporting Regulations 42 CFR 486.301-486.348 (CMS-576 and CMS-576A)

Forms and Documents

Document	Type	Status	Availability
Form CMS-576A Organ Procurement Organization's Health Insurance Benefits Agreement and Supporting Regulations 42 CFR 486.301-486.348	Form and Instruction	Modified	Repair queued
CMS-576 and CMS-576A Responses to 60 Day Comments.09.12.23.docx	Supplementary Document	Uploaded 2023-10-18	Repair queued
CMS-576 and CMS-576A Supporting Statement 09.11.23.docx	Supporting Statement A	Uploaded 2023-10-18	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
8133	Organ Procurement Organization's Health Insurance Benefits Agreement and Supporting Regulations 42 CFR 486.301-486.348	Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0512	ICR Reference No: 202310-0938-001
Status: Received in OIRA	Previous ICR Reference No: 201910-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Organ Procurement Organization's Health Insurance Benefits Agreement and Supporting Regulations 42 CFR 486.301-486.348 (CMS-576 and CMS-576A)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/18/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	16	0
Time Burden (Hours)	32	0
Cost Burden (Dollars)	0	0

---

Abstract: Organizations seeking designation from CMS as a qualified and approved Organ Procurement Organization (OPO), as per §§ 371(a) and 1138 of the Social Security Act (“the Act”) must complete and submit the CMS-576 form, titled “Organ Procurement Organization (OPO) Request for Designation As An OPO Under § 1138 Of The Social Security Act.” After designation as an OPO, the organization must sign a “Health Insurance Benefits Agreement” (CMS-576A form) in order to be reimbursed by Medicare for their services.

---

Authorizing Statute(s): Statute at Large: 19 Stat. 372
   Statute at Large: 18 Stat. 1138
  

Citations for New Statutory Requirements: None

---

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 38513	06/13/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 71570	10/17/2023
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Organ Procurement Organization's Health Insurance Benefits Agreement and Supporting Regulations 42 CFR 486.301-486.348	CMS-576A, CMS-576	Health Insurance Benefits Agreement ,   ORGAN PROCUREMENT ORGANIZATION (OPO) REQUEST FOR DESIGNATION AS AN OPO

---

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	16	0	0	-42	0	58
Annual Time Burden (Hours)	32	0	0	3	0	29
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The time burden for the CMS-576A form has been reduced. The previous PRA package estimated the number of respondents for the CMS-576A form to be 58. It was further estimated that it would take 30 minutes to complete the CMS- 576A form and the total annual time burden across all respondents was estimated to be 29 hours. In the current PRA package, we estimate that for the CMS-576A form, there are 56 respondents every 4 years or 15 respondents annually. We have further estimated that it would take 30 minutes to complete each CMS-576A form and 7.5 hours annually to complete all CMS-576A forms across all 15 respondents. We also estimate that the cost burden for completion of each CMS-576A form would be $58 and the total annual cost burden across all respondents would be $864. Also, in the current PRA package, we estimate that for the CMS-576 form, there would be 1 respondent annually for OPOs that are undergoing a CHOW, merger or consolidation. We estimate that it would take approximately 24 hours to complete the CMS-576 form and that the total annual time burden across all respondents would also be 24 hours. We estimate that the cost burden for each CMS-576 form would be $2,765 and the total annual cost burden across all respondents would also be $2,765.

---

Annual Cost to Federal Government: $447

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

---

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: 10/18/2023

---