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 Request for Additional Information (RAI)/PO Response	Form and Instruction	Modified	Available
Form CMS-10630 CAP Template	Form and Instruction	Modified	Available
Form CMS-10630 Service Determination Request (SDR) Cover Sheet	Form	Modified	Available
Form CMS-10630 RequiredSpecialistContracts	Form and Instruction	Modified	Available
Form CMS-10630 Plan of Care	Form and Instruction	Modified	Available
Form CMS10630 Participant Rights	Form and Instruction	Modified	Available
Form CMS-10630 Grievance Recognition and Notification	Form and Instruction	Modified	Available
Form CMS-10630 Arranging Services	Form and Instruction	Modified	Available
Form CMS-10630 Appeals Effectuation	Form and Instruction	Modified	Available
Form CMS-10630 Appeal Recognition	Form and Instruction	Modified	Available
Form CMS-10630 Special Recommendations	Form and Instruction	Modified	Available
Form CMS-10630 Required Services	Form and Instruction	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	Available
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 and Instruction	Modified	Available
Form CMS-10630 Personnel Impact Analysis Template	Form and Instruction	Modified	Repair queued
Form CMS-10630 Clinical Appropriateness and Care Planning Impact Analysis Template	Form and Instruction	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 and Instruction	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
CMS10630_CrosswalkofChanges_Final.pdf	Supplementary Document	Uploaded 2026-02-11	Available
CMS-10630_ResponseToComments_30-day.pdf	Supplementary Document	Uploaded 2026-02-11	Available
2025_NPA_CMS_2026 Audit Protocol_30-Day Comment Letter_SMB-Signed.pdf	Public Comments	Uploaded 2025-08-13	Available
PC_202507-0938-006_081325_050357_1.pdf	Public Comments	Uploaded 2025-08-13	Available
PC_202507-0938-006_081225_125903_1.pdf	Public Comments	Uploaded 2025-08-12	Available
Comments Template_PACE 2026 Audit Protocol - 30 Day_Final.pdf	Public Comments	Uploaded 2025-08-04	Available
PC_202507-0938-006_080425_074240_1.pdf	Public Comments	Uploaded 2025-08-04	Available
CMS10630-SupportingStatement_Final Clean.docx	Supporting Statement A	Uploaded 2026-02-11	Available
CMS10630-SupportingStatement_A.docx	Supporting Statement A	Uploaded 2025-07-14	Repair queued
PACE Southeast Michigan.pdf	Public Comments	Uploaded 2025-02-20	Repair queued
On Lok Senior Health Services - On Lok.pdf	Public Comments	Uploaded 2025-02-21	Available
National PACE Association NPA.pdf	Public Comments	Uploaded 2025-02-20	Available
myPlace PACE.pdf	Public Comments	Uploaded 2025-02-18	Available
MultiCare Health System.pdf	Public Comments	Uploaded 2025-02-20	Repair queued
Habitat Health.pdf	Public Comments	Uploaded 2025-02-19	Available
Aging and Long-Term Support Administration ALTSA.pdf	Public Comments	Uploaded 2025-02-18	Available
CMS10630_CrosswalkofChanges_30-day.pdf	Supplementary Document	Uploaded 2025-07-07	Repair queued
CMS10630_CrosswalkofChanges_30-day.pdf	Supplementary Document	Uploaded 2025-07-07	Repair queued
CMS-10630_ResponseToComments_60-day.pdf	Supplementary Document	Uploaded 2025-07-07	Available
CMS-10630_ResponseToComments_60-day.pdf	Supplementary Document	Uploaded 2025-07-07	Repair queued
CMS10630_CrosswalkofChanges_2026_60-day.pdf	Supplementary Document	Uploaded 2025-07-07	Available
CMS10630_CrosswalkofChanges_2026_60-day.pdf	Supplementary Document	Uploaded 2025-07-07	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Request for Additional Information (RAI)/PO Response
225129	Trial Year and Routine Audits	Form and Instruction	Modified	CAP Template
225129	Trial Year and Routine Audits	Form	Modified	Service Determination Request (SDR) Cover Sheet
225129	Trial Year and Routine Audits	Form and Instruction	Modified	RequiredSpecialistContracts
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Plan of Care
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Participant Rights
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Grievance Recognition and Notification
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Arranging Services
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Appeals Effectuation
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Appeal Recognition
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Special Recommendations
225129	Trial Year and Routine Audits	Form and Instruction	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 and Instruction	Modified	Clinical Appropriateness and Care Planning Impact Analysis Template
225129	Trial Year and Routine Audits	Form and Instruction	Modified	Personnel Impact Analysis Template
225129	Trial Year and Routine Audits	Form and Instruction	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 and Instruction	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: 202507-0938-006
Status: Active	Previous ICR Reference No: 202205-0938-008
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 with change	Conclusion Date: 02/12/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/16/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2029	36 Months From Approved	02/28/2026
Responses	40	0	40
Time Burden (Hours)	26,840	0	31,200
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:
	89 FR 104545	12/23/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 31209	07/14/2025
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, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS-10630, CMS10630, 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 ,   Appeal Recognition ,   Appeals Effectuation ,   Arranging Services ,   Grievance Recognition and Notification ,   Participant Rights ,   Plan of Care ,   RequiredSpecialistContracts ,   Service Determination Request (SDR) Cover Sheet ,   CAP Template ,   Request for Additional Information (RAI)/PO Response

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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	40	0	0	0	0
Annual Time Burden (Hours)	26,840	31,200	0	-4,360	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: CMS estimates that the total burden associated with the 2026 protocol is reduced to 671 hours per PACE organization. This was burden decrease was completed due to comment feedback to meaningfully decrease respondent time and effort to prepare, review and submit collection instruments.

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Annual Cost to Federal Government: $14,706,560

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: 07/16/2025

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