In 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
(3) have entered into and have in effect, under terms and conditions specified by the Secretary, a contract with a third party that the Secretary has entered into a contract with under subsection (d)(3) of such section.
Subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011.
Subsection (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
(2) the Secretary determines that in the period beginning on January 1, 2011, and 1 December 31, 2011, there were extenuating circumstances.
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.)
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Last modified: October 26, 2015