The PACE Organization Application Process in 42 CFR Part 460 (CMS-10631)

Forms and Documents

Document Name	Status
Form CMS-10631 Waiver Requests (States) Form and Instruction	Modified
Form CMS-10631 Waiver Requests (POs) Form and Instruction	Modified
Form CMS-10631 State Readiness Review (States) Form and Instruction	Modified
Form CMS-10631 Support of State Readiness Review (POs) Form and Instruction	Modified
Form CMS-10631 Application Requirements (POs) Form and Instruction	Modified
PACE Summary of Changes_Off Cycle PRA_2024.docx Supplementary Document	2024-11-08
CMS-10631 - Supporting Statement_clean.docx Supporting Statement A	2024-11-08
Responses to 60-day comments_CMS-10631_102924clean.docx Supplementary Document	2024-11-08

IC Document Collections

IC ID	Document Title	Status
223826	Waiver Requests (States) Form and Instruction	Modified
223824	Waiver Requests (POs) Form and Instruction	Modified
223823	State Readiness Review (States) Form and Instruction	Modified
223822	Support of State Readiness Review (POs) Form and Instruction	Modified
223821	Application Requirements (POs) Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1326	ICR Reference No: 202411-0938-003
Status: Received in OIRA	Previous ICR Reference No: 202204-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: The PACE Organization Application Process in 42 CFR Part 460 (CMS-10631)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/12/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2025
Responses	109	109
Time Burden (Hours)	7,271	7,271
Cost Burden (Dollars)	0	0

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Abstract: Initial application requirements for the PACE program are currently set forth in 42 CFR 460.12 and in the PACE Manual, Ch. 17. Until recently, the submission of initial and SAE PACE applications and supporting information was in paper format. These applications are often hundreds of pages long, expensive to reproduce and transmit, and administratively inefficient, as staff reviewing different parts of the application are located in different physical locations and must receive hard copies of the material. However, beginning in 2016, initial PACE applications are being submitted via a new automated, electronic submission process. As with initial applications, an application also must be submitted for a PO that seeks to expand its service area and/or add a new service site, and with OMB approval, an automated application process will now also be required of PACE organizations submitting service area expansion applications. In pursuing this new information collection package, we are extracting this component only from the existing OMB approval for the PACE program (CMS-R-244, OMB Control Number 0938-0790).

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Authorizing Statute(s): US Code: 42 USC 395eee Name of Law: PAYMENTS TO, AND COVERAGE OF BENEFITS UNDER, PROGRAMS OF ALL–INCLUSIVE CARE FOR THE ELDERLY (PACE
   US Code: 42 USC 1396u–4 Name of Law: PROGRAM OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
  

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 63954	08/06/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 88782	11/08/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Application Requirements (POs)	CMS-10631	PACE Application
State Readiness Review (States)	CMS-10631	PACE Application
Support of State Readiness Review (POs)	CMS-10631	PACE Application
Waiver Requests (POs)	CMS-10631	PACE Application
Waiver Requests (States)	CMS-10631	PACE Application

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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	109	109	0	0	0	0
Annual Time Burden (Hours)	7,271	7,271	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: $248,626

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: 11/12/2024

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