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

Forms and Documents

Document Name	Status
Form CMS-10630 Trial Year and Routine Audits Form	New
2017Comment_Response_30 day_03.07.17_CLEAN.docx Supplementary Document	2017-03-21
PRA_Crosswalk_PACE.pdf Supplementary Document	2017-01-12
2017Comment_Response.pdf Supplementary Document	2017-01-12
CMS-10630 - Supporting Statement A - Passback3_MOEG CLEAN.docx Supporting Statement A	2017-03-21

IC Document Collections

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

ICR Details

OMB Control No: 0938-1327	ICR Reference No: 201612-0938-020
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: The PACE Organization (PO) Monitoring and Audit Process in 42 CFR Part 460 (CMS-10630)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/24/2017
	Date Received in OIRA: 01/12/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2020	36 Months From Approved
Responses	72	0	0
Time Burden (Hours)	17,280	0	0
Cost Burden (Dollars)	0	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): None

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:
	81 FR 51916	08/05/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 87039	12/02/2016
Did the Agency receive public comments on this ICR? No

---

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	Clinical Appropriateness for IDT Documentation Impact Analysis Template ,   Clinical Appropriateness for Providers Impact Analysis Template ,   PACE Audit Process and Data Request Protocol ,   PACE Supplemental Questions ,   Pre-Audit Issue Summary ,   Service Delivery Impact Analysis Template ,   Appeals Impact Analysis Template ,   Grievances Impact Analysis Template ,   Root Cause Analysis Template ,   Clinical Appropriateness for Comprehensive Care Impact Analysis Template ,   Clinical Appropriateness for Emergencies Impact Analysis Template ,   Clinical Appropriateness for Medical Record Documentation Impact Analysis Template ,   Clinical Appropriateness for Restraints Impact Analysis Template ,   Clinical Appropriateness for Care Planning Impact Analysis Template ,   Clinical Appropriateness for Assessments Impact Analysis Template ,   Clinical Appropriateness for Infections Impact Analysis Template ,   Clinical Appropriateness for Transportation Impact Analysis Template ,   Personnel Impact Analysis Template

---

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	72	0	0	72	0	0
Annual Time Burden (Hours)	17,280	0	0	17,280	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: Not applicable, this is a new ICR.

---

Annual Cost to Federal Government: $2,139,212

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

---

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: 01/12/2017

---