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;
(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”.
Source
(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.)
Amendments
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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