§ 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 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.
• (b) Subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011 .
• (c) 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 1 So in original. Probably should be followed by “ending on”. December 31, 2011 , there were extenuating circumstances.
• (d) In this section, the term “manufacturer” has the meaning given such term in section 1395w–114a(g)(5) of this title .