View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-0512
ICR Reference No:
202310-0938-001
Status:
Active
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
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/29/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/18/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2025
36 Months From Approved
Responses
16
0
0
Time Burden (Hours)
32
0
0
Cost Burden (Dollars)
0
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 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
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
Agency Contact:
Denise King 410 786-1013 Denise.King@cms.hhs.gov
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
An official website of the United States government
The .gov means it's official.
The site is secure.
