WHAT THE LAW DOINCongress, in plain words

The law › Title 42, The Public Health and Welfare › Chapter 7

42 U.S.C. 1395w-3a: Use of average sales price payment methodology

Created in 2003 by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173). Changed by 6 later laws. 2 bills in this Congress would change it.

1 part of federal rules cite it as their authority, written by Centers for Medicare & Medicaid Services, Department of Health and Human Services (1).

This Congress

  • H.R. 5768 Skin Substitute Access and Payment Reform Act · introduced · would change (a), (b)
  • H.R. 4299 Protecting Patient Access to Cancer and Complex Therapies Act · introduced · would change (j)

How it got here

2022

  • Pub. L. 117–169, §11001(b)(1)(A), inserted "or in the case of such a drug or biological product that is a selected drug (as referred to in section 1320f–1(c) of this title), with respect to a price applicability period (as defined in section 1320f(b)(2) of this title), 106 percen… Law text · (b)
  • Pub. L. 117–169, §11403, designated existing provisions as subpar. (A) and inserted heading, substituted "Subject to subparagraph (B), the amount" for "The amount" in introductory provisions, redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A)… Law text · (b)
  • Pub. L. 117–169, §11102(b)(1), substituted "subsection (i), section 1396r–8 of this title, or section 1395w–114b of this title" for "subsection (i) or section 1396r–8 of this title". Law text · (c)
  • Pub. L. 117–169, §11101(c)(1), inserted "subsection (i) or" before "section 1396r–8 of this title". Law text · (c)
  • Pub. L. 117–169, §11402, designated existing provisions as subpar. (A) and inserted heading; substituted "Subject to subparagraph (B), in the case" for "In the case" in introductory provisions; redesignated former subpars. (A) and (B) and cls. (i) and (ii) of each subpar. as cls. (i… Law text · (c)
  • Pub. L. 117–169, §11101(a), added subsec. (i) and redesignated former subsec. (i) as (j). Law text · (i), (j)

2021

  • Pub. L. 117–58 added subsec. (h) and redesignated former subsec. (h) as (i). (Infrastructure Investment and Jobs Act) Law text · (h), (i)

2020

  • Pub. L. 116–260, §401(a)(1)(A), inserted "or subsection (f)(2), as applicable" before period at end. (Consolidated Appropriations Act, 2021) Law text · (b)
  • Pub. L. 116–260, §401(a)(1)(B), inserted "or subsection (f)(2), as applicable," before "determined by" in introductory provisions. (Consolidated Appropriations Act, 2021) Law text · (b)
  • Pub. L. 116–260, §401(a)(1)(C), inserted "or subsection (f)(2), as applicable," before "determined by" in introductory provisions. (Consolidated Appropriations Act, 2021) Law text · (b)
  • Pub. L. 116–260, §401(b)(2), substituted ", except that, for purposes of subsection (f)(2), the Secretary may, if the Secretary determines appropriate, exclude repackagers of a drug or biological from such term." for period at end. (Consolidated Appropriations Act, 2021) Law text · (c)
  • Pub. L. 116–260, §401(b)(1)(A), substituted "Misrepresentation" for "In general" in heading. (Consolidated Appropriations Act, 2021) Law text · (d)
  • Pub. L. 116–260, §401(b)(1)(D), added subpar. (B). Former subpar. (B) redesignated (E). (Consolidated Appropriations Act, 2021) Law text · (d)
  • Pub. L. 116–260, §401(b)(1)(B), substituted "subparagraph (A), (B), or (C)" for "subparagraph (B)". (Consolidated Appropriations Act, 2021) Law text · (d)
  • Pub. L. 116–260, §401(b)(1)(D), added subpars. (C) and (D). (Consolidated Appropriations Act, 2021) Law text · (d), (D)
  • Pub. L. 116–260, §401(b)(1)(C), redesignated subpar. (B) as (E). (Consolidated Appropriations Act, 2021) Law text · (d)
  • Pub. L. 116–260, §401(a)(2), designated existing provisions as par. (1), inserted heading, and added par. (2). (Consolidated Appropriations Act, 2021) Law text · (f)
  • Pub. L. 116–260, §405, added subsec. (g) and redesignated former subsec. (g) as (h). (Consolidated Appropriations Act, 2021) Law text · (g), (h)

2019

  • Pub. L. 116–39 substituted "payable under this section—" for "payable under this section for the drug or biological based on—" in introductory provisions, added subpars. (A) and (B), and struck out former subpars. (A) and (B) which read as follows: (Sustaining Excellence in Medicaid Act of 2019) Law text · (c)

2010

  • Pub. L. 111–148, §3139(a)(1)(A), added subpar. (C). (Patient Protection and Affordable Care Act) Law text · (b)
  • Pub. L. 111–148, §3139(a)(1)(B), added par. (8). (Patient Protection and Affordable Care Act) Law text · (b)
  • Pub. L. 111–148, §3139(a)(2), added subpars. (H) and (I). (Patient Protection and Affordable Care Act) Law text · (c), (I)

2007

  • Pub. L. 110–173, §112(b)(1), inserted "paragraph (7) and" after "Subject to" in introductory provisions. (Medicare, Medicaid, and SCHIP Extension Act of 2007) Law text · (b)
  • Pub. L. 110–173, §112(a)(1), inserted "for a multiple source drug furnished before April 1, 2008, or 106 percent of the amount determined under paragraph (6) for a multiple source drug furnished on or after April 1, 2008" after "paragraph (3)". (Medicare, Medicaid, and SCHIP Extension Act of 2007) Law text · (b)
  • Pub. L. 110–173, §112(a)(2), inserted "for single source drugs and biologicals furnished before April 1, 2008, and using the methodology applied under paragraph (6) for single source drugs and biologicals furnished on or after April 1, 2008," after "paragraph (3)". (Medicare, Medicaid, and SCHIP Extension Act of 2007) Law text · (b), (B)
  • Pub. L. 110–173, §112(a)(3), added par. (6). (Medicare, Medicaid, and SCHIP Extension Act of 2007) Law text · (b)
  • Pub. L. 110–173, §112(b)(2), added par. (7). (Medicare, Medicaid, and SCHIP Extension Act of 2007) Law text · (b)

Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.