CONDITION FOR COVERAGE OF DRUGS UNDER THIS PART
Sec. 1860D-43 . [42 U.S.C. 1395w-153] (a) In General.—In order for coverage to be available under this part for covered part D drugs (as defined in section 1860D–2(e)) of a manufacturer, the manufacturer must—
(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) 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 Agreements.—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 December 31, 2011, there were extenuating circumstances.