42 U.S. Code § 1395w–153 - Condition for coverage of drugs under this part

(a) In general
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) 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  [1] December 31, 2011, there were extenuating circumstances.
(d) Definition of manufacturer
In this section, the term “manufacturer” has the meaning given such term in section 1395w–114a (g)(5) of this title.

[1]  So in original. Probably should be followed by “ending on”.


(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–43, as added Pub. L. 111–148, title III, § 3301(a),Mar. 23, 2010, 124 Stat. 461; amended Pub. L. 111–152, title I, § 1101(b)(1),Mar. 30, 2010, 124 Stat. 1037.)

2010—Subsec. (b). Pub. L. 111–152, § 1101(b)(1)(A), substituted “January 1, 2011” for “July 1, 2010”.
Subsec. (c)(2). Pub. L. 111–152, § 1101(b)(1)(B), substituted “January 1, 2011, and December 31, 2011,” for “July 1, 2010, and ending on December 31, 2010,”.

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42 CFR - Public Health



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