(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, the following:
(i) Review of participants' charts.
(ii) Interviews with staff.
(iii) Interviews with participants and caregivers.
(iv) Interviews with contractors.
(v) Observation of program operations, including marketing, participant services, enrollment and disenrollment procedures, grievances, and appeals.
(2) A comprehensive assessment of an organization's fiscal soundness.
(3) A comprehensive assessment of the organization's capacity to furnish all PACE services to all participants.
(4) Any other elements that CMS or the State administering agency find necessary.