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
CMS-10631 - Supporting Statement A.docx Supporting Statement A	2018-11-09
Response to Public Comments_01092018.docx Supplementary Document	2018-02-28
PACE Paper Application_Updates for 2019_TRACKED_60-day_11222017_Modified 01172018_FINAL.docx Supplementary Document	2018-02-28
2019_Summary of Changes_ FINAL_01182018.docx Supplementary Document	2018-02-28

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: 201802-0938-007
Status: Historical Active	Previous ICR Reference No: 201610-0938-001
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
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/06/2018
	Date Received in OIRA: 03/01/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved	03/31/2020
Responses	109	0	89
Time Burden (Hours)	7,226	0	4,576
Cost Burden (Dollars)	0	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): None

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:
	82 FR 41966	09/05/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 5776	02/09/2018
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
Support of State Readiness Review (POs)	CMS-10631	PACE Application
Application Requirements (POs)	CMS-10631	PACE Application
State Readiness Review (States)	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 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	109	89	0	10	10	0
Annual Time Burden (Hours)	7,226	4,576	0	1,810	840	0
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: However, CMS has reconsidered its approach to the application process specific to SAEs and therefore, in addition to certain minor tweaks, is making modifications to the application and the requirements for application submission. The number of SAE applications submitted to CMS for approval has increased over time, and 35 SAE applications, on average, are now expected to be submitted annually. Details regarding the revisions, as well as the rationale for those changes, are provided below in sections 1, 8, and 15 of the Supporting Statement.

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Annual Cost to Federal Government: $172,341

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: 03/01/2018

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