§ 1395w–153. Condition for coverage of drugs under this part

• (a) 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—
    • (A) for 2011 through 2024, the Medicare coverage gap discount program under section 1395w–114a of this title ; and
    • (B) for 2025 and each subsequent year, the manufacturer discount program under section 1395w–114c of this title ;
  • (2) have entered into and have in effect—
    • (A) for 2011 through 2024, an agreement described in subsection (b) of section 1395w–114a of this title with the Secretary; and
    • (B) for 2025 and each subsequent year, an agreement described in subsection (b) of section 1395w–114c of this title 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 section 1395w–114a of this title .
• (b) Paragraphs (1)(A), (2)(A), and (3) of subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011 , and before January 1, 2025 , and paragraphs (1)(B) and (2)(B) of such subsection shall apply to covered part D drugs dispensed under this part on or after January 1, 2025 .
• (c)
  • (1) Subject to paragraph (2), subsection (a) shall not apply to the dispensing of a covered part D drug if—
    • (A) the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or
    • (B) the Secretary determines that in the period beginning on January 1, 2011 , and 1 1 So in original. Probably should be followed by “ending on”. December 31, 2011 , there were extenuating circumstances.
  • (2) Paragraph (1)(A) shall not apply to a covered part D drug of a manufacturer for any period described in section 5000D(c)(1) of the Internal Revenue Code of 1986 with respect to the manufacturer.
• (d) In this section, the term “manufacturer” has the meaning given such term in section 1395w–114a(g)(5) of this title .