FEDERAL · 42 U.S.C. · Chapter 7
Condition for coverage of drugs under this part
Current through Pub. L. 119-102
(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—
(A)for 2011 through 2024, the Medicare coverage gap discount program under section 1395w–114a of this title; and
(B)for 2025 and each subsequent year, the manufacturer discount program under section 1395w–114c of this title;
(2)have entered into and have in effect—
(A)for 2011 through 2024, an agreement described in subsection (b) of section 1395w–114a of this title with the Secretary; and
(B)for 2025 and each subsequent year, an agreement described in subsection (b) of section 1395w–114c of this title with the Secretary; and
(3)have entered into and have in effect, under terms an
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History
(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; Pub. L. 117–169, title I, §§11001(b)(1)(G)(i), 11201(e)(7), Aug. 16, 2022, 136 Stat. 1853, 1892.)
Editorial Notes
Editorial Notes
References in Text
Section 5000D(c)(1) of the Internal Revenue Code of 1986, referred to in subsec. (c)(2), is classified to section 5000D(c)(1) of Title 26, Internal Revenue Code.
Amendments
2022—Subsec. (a)(1). Pub. L. 117–169, §11201(e)(7)(A)(i), added par. (1) and struck out former par. (1) which read as follows: "participate in the Medicare coverage gap discount program under section 1395w–114a of this title;".
Subsec. (a)(2). Pub. L. 117–169, §11201(e)(7)(A)(ii), added par. (2) and struck out former par. (2) which read as follows: "have entered into and have in effect an agreement described in subsection (b) of such section with the Secretary; and".
Subsec. (a)(3). Pub. L. 117–169, §11201(e)(7)(A)(iii), substituted "section 1395w–114a of this title" for "such section".
Subsec. (b). Pub. L. 117–169, §11201(e)(7)(B), added subsec. (b) and struck out former subsec. (b). Prior to amendment, text read as follows: "Subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011."
Subsec. (c). Pub. L. 117–169, §11001(b)(1)(G)(i), designated existing provisions as par. (1) and inserted heading, substituted "Subject to paragraph (2), subsection" for "Subsection" in introductory provisions, redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added par. (2).
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,".
References in Text
Section 5000D(c)(1) of the Internal Revenue Code of 1986, referred to in subsec. (c)(2), is classified to section 5000D(c)(1) of Title 26, Internal Revenue Code.
Amendments
2022—Subsec. (a)(1). Pub. L. 117–169, §11201(e)(7)(A)(i), added par. (1) and struck out former par. (1) which read as follows: "participate in the Medicare coverage gap discount program under section 1395w–114a of this title;".
Subsec. (a)(2). Pub. L. 117–169, §11201(e)(7)(A)(ii), added par. (2) and struck out former par. (2) which read as follows: "have entered into and have in effect an agreement described in subsection (b) of such section with the Secretary; and".
Subsec. (a)(3). Pub. L. 117–169, §11201(e)(7)(A)(iii), substituted "section 1395w–114a of this title" for "such section".
Subsec. (b). Pub. L. 117–169, §11201(e)(7)(B), added subsec. (b) and struck out former subsec. (b). Prior to amendment, text read as follows: "Subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011."
Subsec. (c). Pub. L. 117–169, §11001(b)(1)(G)(i), designated existing provisions as par. (1) and inserted heading, substituted "Subject to paragraph (2), subsection" for "Subsection" in introductory provisions, redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added par. (2).
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,".