(a) General. Within 90 days after receipt of a complete waiver request, CMS takes one of the following actions, in the form and manner specified by CMS:

(1) Approves the waiver request.

(2) Conditionally approves the waiver request and notifies the PACE applicant.

(3) Denies the waiver request and notifies the PACE organization or PACE applicant of the basis for the denial.

(b) Additional information requested. A waiver request is only considered complete when CMS receives all information necessary to make a determination regarding approval or denial. If CMS determines that the waiver request is not complete because it does not include sufficient information to make a determination, CMS will request additional information from the PACE organization or PACE applicant. The 90-day time limit in paragraph (a) of this section will start when CMS receives the complete waiver request.

(c) Waiver approval. A waiver request is deemed approved if CMS fails to act on the request within 90 days after CMS receives a complete waiver request.

(d) Withdrawal of CMS approval for good cause.

(1) CMS in consultation with the State administering agency may withdraw approval of a waiver for good cause.

(2) If the waiver approval is withdrawn, CMS must notify the PACE organization or PACE applicant and the State administering agency that approval of a waiver has been withdrawn and the reason for doing so and must specify the effective date of the withdrawal in the notice.

[84 FR 25672, June 3, 2019]