(a) In generalIn order for coverage to be available under this part for covered part D drugs (as defined in section 1395w–102(e) of this title) of a manufacturer, the manufacturer must—
(1)
participate in the Medicare coverage gap discount program under section 1395w–114a of this title;
(2)
have entered into and have in effect an agreement described in subsection (b) of such section with the Secretary; and
(b) Effective date
Subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011.
(c) Authorizing coverage for drugs not covered under agreementsSubsection (a) shall not apply to the dispensing of a covered part D drug if—
(1)
the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or
(d) Definition of manufacturer
In this section, the term “manufacturer” has the meaning given such term in section 1395w–114a(g)(5) of this title.
(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–43, as added Pub. L. 111–148, title III, § 3301(a), Mar. 23, 2010, 124 Stat. 461; amended Pub. L. 111–152, title I, § 1101(b)(1), Mar. 30, 2010, 124 Stat. 1037.)