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

Forms and Documents

Document Name	Status
Form CMS-10630 Trial Year and Routine Audits Form	Modified
CMS10630-SupportingStatement_A.docx Supporting Statement A	2025-07-14
CMS10630_CrosswalkofChanges_30-day.pdf Supplementary Document	2025-07-07
CMS-10630_ResponseToComments_60-day.pdf Supplementary Document	2025-07-07
CMS10630_CrosswalkofChanges_2026_60-day.pdf Supplementary Document	2025-07-07

IC Document Collections

IC ID	Document Title	Status
225129	Trial Year and Routine Audits Form	Modified

ICR Details

OMB Control No: 0938-1327	ICR Reference No: 202507-0938-006
Status: Received in OIRA	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	Date Submitted to OIRA: 07/16/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2025
Responses	40	40
Time Burden (Hours)	31,200	31,200
Cost Burden (Dollars)	0	0

---

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.

---

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

---

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:
	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

---

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

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 ,   Required Services ,   Service Determination Request (SDR) Cover Sheet ,   CAP Template ,   Request for Additional Information (RAI)/PO Response

---

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	40	40	0	0	0	0
Annual Time Burden (Hours)	31,200	31,200	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:

---

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

---

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: 07/16/2025

---