§423.2310. Condition for coverage of drugs under Part D.
42 C.F.R. § 423.2310
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:
Participate in the Coverage Gap Discount Program.
Have entered into and have in effect an agreement described in § 423.2315(b).
Have entered into and have in effect, under terms and conditions specified by CMS, a contract with the TPA.
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.
Notes, amendments, and revision history
Amendments
[77 FR 22172, Apr. 12, 2012, as amended at 91 FR 17593, Apr. 6, 2026]
Source
Source: 77 FR 22172, Apr. 12, 2012, unless otherwise noted.
Authority
Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
Source
Source: 70 FR 4525, Jan. 28, 2005, unless otherwise noted.
Amendments
[77 FR 22172, Apr. 12, 2012, as amended at 91 FR 17593, Apr. 6, 2026]