CONDITION FOR COVERAGE OF DRUGS UNDER THIS PART^[545]

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—

(1) participate in the Medicare coverage gap discount program under section 1860D–14A;

(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^[546].

(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,^[547] there were extenuating circumstances.

(d) Definition of Manufacturer.—In this section, the term “manufacturer” has the meaning given such term in section 1860D–14A(g)(5).

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^[545]  P.L. 111-148, §3301(a), added this new section 1860D-43, effective March 23, 2010.

^[546]  P.L. 111-152, §1101(b)(1)(A), struck out “July 1, 2010” and inserted “January 1, 2011”, effective March 30, 2010.

^[547]  P.L. 111-152, §1101(b)(1)(B), struck out “July 1, 2010 and ending on December 31, 2010” and inserted “January 1, 2011 and December 31, 2011”, effective March 30, 2010.