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

submitted 91 years ago by Pub. L. 111-148 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 364 words · no verdicts yet

in plain englishAI-generated · not legal advice

A translation hasn’t been published for this section yet. The official text below is complete and authoritative.

the actual law source: uscode.house.gov ↗public domain
(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 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 section 1395w–114a of this title.

(b) Effective date

Paragraphs (1)(A), (2)(A), and (3) of subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011, and before January 1, 2025, and paragraphs (1)(B) and (2)(B) of such subsection shall apply to covered part D drugs dispensed under this part on or after January 1, 2025.

(c) Authorizing coverage for drugs not covered under agreements
(1) In general

Subject to paragraph (2), subsection (a) shall not apply to the dispensing of a covered part D drug if—

(A)

the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or

(B)

the Secretary determines that in the period beginning on January 1, 2011, and 1December 31, 2011, there were extenuating circumstances.

(2) Exception

Paragraph (1)(A) shall not apply to a covered part D drug of a manufacturer for any period described in section 5000D(c)(1) of the Internal Revenue Code of 1986 with respect to the manufacturer.

(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.

Source credit: (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.)

history & why it existsrecord from the source credit
  • 1935Enacted · Pub. L. 111-148 · 124 Stat. 461
  • 2010Amended · Pub. L. 111-152 · 124 Stat. 1037
  • 2022Amended · Pub. L. 117-169 · 136 Stat. 1853, 1892

A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-148 on 1935-08-14.

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