Condition for coverage of drugs under Part D.

(a) Covered Part D drug coverage requirement. Except as specified in paragraph (b) of this section, in order for coverage to be available under Medicare Part D for applicable drugs of a manufacturer, the manufacturer must do all of the following: (1) Participate in the Coverage Gap Discount Program. (2) Have entered into and have in effect an agreement described in § 423.2315(b). (3) Have entered into and have in effect, under terms and conditions specified by CMS, a contract with the TPA. (b) Exception to covered drug coverage requirement. Paragraph (a) of this section does not apply to an applicable drug if CMS has made a determination that the availability of the applicable drug is essential to the health of beneficiaries enrolled in Medicare Part D. [77 FR 22172, Apr. 12, 2012, as amended at 91 FR 17593, Apr. 6, 2026]