(a) Trial period review. During the trial period, CMS, in cooperation with the State administering agency, conducts comprehensive annual reviews of the operations of a PACE organization to ensure compliance with the requirements of this part.

(b) Scope of review. The review includes the following:

(1) An onsite visit to the PACE organization, which may include, but is not limited to, observation of program operations;

(2) Detailed analysis of the entity's substantial compliance with all significant requirements of sections 1894 and 1934 of the Act and this part, which may include review of marketing, participant services, enrollment and disenrollment, and grievances and appeals.

(3) A comprehensive assessment of an organization's fiscal soundness.

(4) A comprehensive assessment of the organization's capacity to furnish all PACE services to all participants.

(5) Any other elements that CMS or the State administering agency find necessary.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]