The PACE Organization (PO) Monitoring and Audit Process in Part 460 of 42 CFR (CMS-10630)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10630 Special Recommendations	Form	Modified	Available
Form CMS-10630 Required Services	Form	Modified	Available
Form CMS-10630 Coordination of Care	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Service Delivery Request Impact Analysis Template	Form	Modified	Repair queued
Form CMS-10630 Service Delivery Request Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Root Cause Analysis Template	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Personnel Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Grievances Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Service Delivery Request and Appeals Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Audit Survey	Form and Instruction	Modified	Available
Form CMS-10630 Corrective Action Plan (CAP) Process	Form	Modified	Available
Form CMS-10630 PACE Audit Process and Data Request Protocol	Form and Instruction	Modified	Available
Form CMS-10630 PACE Supplemental Questionnaire	Form	Modified	Available
Form CMS-10630 Summary of any pre-audit issues	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Appeals Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form	Modified	Available
Form CMS-10630 Trial Year and Routine Audits	Form	Modified	Repair queued
CMS10630SupportingStatement.docx	Supporting Statement A	Uploaded 2022-05-10	Repair queued
2023Crosswalk60DayComments.pdf	Supplementary Document	Uploaded 2022-05-09	Repair queued
PACE2023PRACrosswalk.pdf	Supplementary Document	Uploaded 2022-05-09	Repair queued
CommentsResponsesCMS10630.pdf	Supplementary Document	Uploaded 2022-05-09	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
225129	Trial Year and Routine Audits	Form	Modified	Special Recommendations
225129	Trial Year and Routine Audits	Form	Modified	Required Services
225129	Trial Year and Routine Audits	Form	Modified	Coordination of Care
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Service Delivery Request Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Service Delivery Request Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Root Cause Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Personnel Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Grievances Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Service Delivery Request and Appeals Impact Analysis Template
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Audit Survey
225129	Trial Year and Routine Audits	Form	Modified	Corrective Action Plan (CAP) Process
225129	Trial Year and Routine Audits	Form and Instruction	Modified	PACE Audit Process and Data Request Protocol
225129	Trial Year and Routine Audits	Form	Modified	PACE Supplemental Questionnaire
225129	Trial Year and Routine Audits	Form	Modified	Summary of any pre-audit issues
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Appeals Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form	Modified

ICR Details

OMB Control No: 0938-1327	ICR Reference No: 202205-0938-008
Status: Historical Active	Previous ICR Reference No: 201911-0938-013
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: The PACE Organization (PO) Monitoring and Audit Process in Part 460 of 42 CFR (CMS-10630)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/02/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/10/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2025	36 Months From Approved	02/28/2023
Responses	40	0	35
Time Burden (Hours)	31,200	0	21,000
Cost Burden (Dollars)	0	0	0

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Abstract: 42 CFR 460.190 and 460.192 described CMS’s regulatory authority to monitor, through audit or other means, the Programs for All-Inclusive Care of the Elderly (PACE). This monitoring includes review of books, contracts, medical records, patient care documentation and any other records that pertain to any aspect of services performed, reconciliation of benefit liabilities, and determination of amounts payable. CMS developed a strategy to address our oversight and audit responsibilities. We have combined both the trial year and ongoing audit protocols into one universal audit protocol that is streamlined and outcomes based to reduce the financial and administrative burdens for both CMS and PACE organizations.

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Authorizing Statute(s): US Code: 42 USC 1395eee Name of Law: Social Security Act
   US Code: 42 USC 1396u–4 Name of Law: Social Security Act
  

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:
	86 FR 72244	12/21/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 28014	05/10/2022
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Trial Year and Routine Audits	CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630	Clinical Appropriateness and Care Planning Impact Analysis Template ,   Appeals Impact Analysis Template ,   Clinical Appropriateness and Care Planning Impact Analysis Template ,   Summary of any pre-audit issues ,   PACE Supplemental Questionnaire ,   PACE Audit Process and Data Request Protocol ,   Corrective Action Plan (CAP) Process ,   Audit Survey ,   Service Delivery Request and Appeals Impact Analysis Template ,   Clinical Appropriateness and Care Planning Impact Analysis Template ,   Grievances Impact Analysis Template ,   Clinical Appropriateness and Care Planning Impact Analysis Template ,   Clinical Appropriateness and Care Planning Impact Analysis Template ,   Personnel Impact Analysis Template ,   Clinical Appropriateness and Care Planning Impact Analysis Template ,   Clinical Appropriateness and Care Planning Impact Analysis Template ,   Root Cause Analysis Template ,   Service Delivery Request Impact Analysis Template ,   Service Delivery Request Impact Analysis Template ,   Clinical Appropriateness and Care Planning Impact Analysis Template ,   Clinical Appropriateness and Care Planning Impact Analysis Template ,   Coordination of Care ,   Required Services ,   Special Recommendations

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ICR Summary of Burden

table that charts list 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	40	35	0	5	0	0
Annual Time Burden (Hours)	31,200	21,000	0	10,200	0	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: Burden has increased to due to an increase in participation POs (35 to 40), data collection instruments increased from 22 to 24 documents and increase regarding the timeframe for administration of the audit. As a result, the total number of hours spent on audit from 2020 to 2023 will increase from 600 hours total to 780 hours total per PO.

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Annual Cost to Federal Government: $9,950,090

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: 05/10/2022

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