42 CFR 423.2310 - Condition for coverage of drugs under Part D.

Regulations last checked for updates: Nov 22, 2024

Title 42 - Public Health last revised: Nov 19, 2024

View all text of Subpart W [§ 423.2300 - § 423.2345]

§ 423.2310 - 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 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.

authority: 42 U.S.C. 1302,1306,1395w,and

source: 70 FR 4525, Jan. 28, 2005, unless otherwise noted.

cite as: 42 CFR 423.2310