42 CFR 460.190 and 460.192 described CMSâs 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.
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.
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:
(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;
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.
Trial Year and Routine Audits