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.
(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
 P.L. 111-148, §3301(a), added this new section 1860D-43, effective March 23, 2010.
 P.L. 111-152, §1101(b)(1)(A), struck out “July 1, 2010” and inserted “January 1, 2011”, effective March 30, 2010.
 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.