42 U.S.C. 1396r-8: Payment for covered outpatient drugs

2022

• Pub. L. 117–169, §11001(b)(1)(G)(ii), inserted at end "The preceding sentence shall not apply to a single source drug or innovator multiple source drug of a manufacturer for any period described in section 5000D(c)(1) of the Internal Revenue Code of 1986 with respect to the manufact… Law text · (a)
• Pub. L. 117–169, §11102(b)(3), substituted ", section 1320f–1(f) of this title, including rebates under paragraph (4) of such section, or section 1395w–114b of this title" for "or section 1320f–1(f) of this title, including rebates under paragraph (4) of such section". Law text · (b)
• Pub. L. 117–169, §11101(c)(3), inserted "and the rebate" after "the payment amount". Law text · (b)
• Pub. L. 117–169, §11002(b), substituted "or to carry out section 1395w–3b of this title or section 1320f–1(f) of this title, including rebates under paragraph (4) of such section" for "or to carry out section 1395w–3b of this title". Law text · (b)
• Pub. L. 117–169, §11201(e)(8)(A), inserted before period at end "or under the manufacturer discount program under section 1395w–114c of this title". Law text · (c)
• Pub. L. 117–169, §11001(b)(2)(A), substituted "subject to clause (ii)(V), any prices charged" for "any prices charged". Law text · (c)
• Pub. L. 117–169, §11102(b)(2), substituted ", section 1395w–3a(i) of this title, or section 1395w–114b of this title" for "or section 1395w–3a(i) of this title". Law text · (c)
• Pub. L. 117–169, §11101(c)(2), inserted "or section 1395w–3a(i) of this title" after "this section". Law text · (c)
• Pub. L. 117–169, §11001(b)(2)(B), added subcl. (V). Law text · (c)
• Pub. L. 117–169, §11201(e)(8)(B), inserted before period at end "or under section 1395w–114c of this title". Law text · (k)
• Pub. L. 117–169, §11001(b)(3), added subcl. (VI). Law text · (k)
• Pub. L. 117–169, §11101(c)(4), added subcl. (VII). Law text · (k)
• Pub. L. 117–169, §11102(b)(4), added subcl. (VIII). Conforming amendments striking "and" at the end of subcl. (VI) and substituting semicolon for period at the end of subcl. (VII) could not be executed as directed after the amendment by Pub. L. 117–169, §11101(c)(4)(B), … Law text · (k)

2021

• Pub. L. 117–2, §9816, inserted "and before January 1, 2024," after "December 31, 2009,". (American Rescue Plan Act of 2021) Law text · (c)
• Pub. L. 117–2, §9811(a)(4)(B), added subpar. (E). (American Rescue Plan Act of 2021) Law text · (d)

2020

• Pub. L. 116–260, §401(c)(1), inserted at end of concluding provisions "For purposes of applying clause (iii), for calendar quarters beginning on or after January 1, 2022, a drug or biological described in the flush matter following such clause includes items, services, supplies, … (Consolidated Appropriations Act, 2021) Law text · (b)
• Pub. L. 116–260, §401(c)(2), substituted "section 1395rr(b)(14)(B) of this title" for "section 1395rr(b)(13)(A)(ii) of this title" in concluding provisions. (Consolidated Appropriations Act, 2021) Law text · (b)
• Pub. L. 116–260, §112(b)(5), (6), in concluding provisions, substituted "1395w–104(c)(2)(G) of this title" for "1395w–104(c)(2)(E) of this title" and inserted at end "Any information disclosed to the Executive Director of the Medicare Payment Advisory Commission or the Executive … (Consolidated Appropriations Act, 2021) Law text · (b)
• Pub. L. 116–260, §112(b)(1), substituted "subsection (a)(6)(A)" for "subsection (a)(6)(A)(ii)" in introductory provisions. (Consolidated Appropriations Act, 2021) Law text · (b)
• Pub. L. 116–260, §112(b)(2)–(4), added cl. (vii). (Consolidated Appropriations Act, 2021) Law text · (b)
• Pub. L. 116–159 added subpar. (D). (Continuing Appropriations Act, 2021 and Other Extensions Act) Law text · (d)

2019

• Pub. L. 116–16, §6(b)(2), inserted ", including amounts received by a State under subsection (c)(4)," after "in any quarter". (Medicaid Services Investment and Accountability Act of 2019) Law text · (b)
• Pub. L. 116–16, §6(a)(1)(A), inserted "and drug product" after "price" in heading. (Medicaid Services Investment and Accountability Act of 2019) Law text · (b)
• Pub. L. 116–16, §6(a)(1)(B)(i), (ii), struck out "and" at end of cl. (ii) and substituted semicolon for period at end of cl. (iii). (Medicaid Services Investment and Accountability Act of 2019) Law text · (b), (iii)
• Pub. L. 116–16, §6(a)(1)(B)(iii), (iv), added cl. (v). (Medicaid Services Investment and Accountability Act of 2019) Law text · (b)
• Pub. L. 116–16, §6(a)(1)(C)(i), (2)(B), inserted ", including information related to drug pricing, drug product information, and data related to drug pricing or drug product information," after "provides false information" and substituted "subsections (a), (b), (f)(3), and (f… (Medicaid Services Investment and Accountability Act of 2019) Law text · (b)
• Pub. L. 116–16, §6(a)(1)(C)(ii), added cls. (iii) and (iv). (Medicaid Services Investment and Accountability Act of 2019) Law text · (b), (iv)
• Pub. L. 116–16, §6(a)(1)(C)(iii), added cl. (vi). (Medicaid Services Investment and Accountability Act of 2019) Law text · (b)
• Pub. L. 116–16, §6(b)(1), added par. (4). (Medicaid Services Investment and Accountability Act of 2019) Law text · (c)
• Pub. L. 116–59, §1603(a), substituted "Exclusion" for "Inclusion" in heading and "the manufacturer's new drug application" for "a new drug application" and "exclusive" for "inclusive" in text. (Continuing Appropriations Act, 2020, and Health Extenders Act of 2019) Law text · (k)
• Pub. L. 116–16, §6(c)(1), substituted "paragraph (4)" for "paragraph (5)" in introductory provisions. (Medicaid Services Investment and Accountability Act of 2019) Law text · (k)
• Pub. L. 116–16, §6(c)(2)(B), substituted ", including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4)," for "(not including any drug described in paragraph (5))". (Medicaid Services Investment and Accountability Act of 2019) Law text · (k)
• Pub. L. 116–16, §6(c)(2)(A), (C), substituted "is marketed" for "was originally marketed" and "a new drug application" for "an original new drug application" and inserted ", unless the Secretary determines that a narrow exception applies (as described in section 447.502 of ti… (Medicaid Services Investment and Accountability Act of 2019) Law text · (k)
• Pub. L. 116–16, §6(c)(2)(A), (D), substituted "a new drug application" for "an original new drug application" and inserted ", including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4)," after "… (Medicaid Services Investment and Accountability Act of 2019) Law text · (k)
• Pub. L. 116–59, §1603(b), struck out "manufacturers," before "repackers," and "manufacturer's and" before "distributor's warehouses,". (Continuing Appropriations Act, 2020, and Health Extenders Act of 2019) Law text · (k)

2018

• Pub. L. 115–123 added cls. (i) to (iii) and struck out introductory provisions and former cls. (i) to (iii) which read as follows: "In the case of a drug that is a line extension of a single source drug or an innovator multiple source drug that is an oral solid dosage form, the r… (Bipartisan Budget Act of 2018) Law text · (c)
• Pub. L. 115–271, §1004(b)(1)(A), substituted "of section 1396a(a)(54)" for "of section 1396b(i)(10)(B)", struck out ", by not later than January 1, 1993," after "shall provide", and substituted "gross overuse, excessive utilization, inappropriate or medically unnecessary care, or… (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (g)
• Pub. L. 115–271, §1004(b)(1)(B), substituted "gross overuse, excessive utilization, inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization" for "gross overuse, or inappropriate or medically unnecessary care". (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (g)

2016

• Pub. L. 114–198 inserted before period at end of concluding provisions ", but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation". (Comprehensive Addiction and Recovery Act of 2016) Law text · (c)

2015

• Pub. L. 114–74, §602(a)(1), substituted "Except as provided in subparagraph (C), the amount" for "The amount". (Bipartisan Budget Act of 2015) Law text · (c)
• Pub. L. 114–74, §602(a)(2), added subpar. (C). (Bipartisan Budget Act of 2015) Law text · (c)

2010

• Pub. L. 111–309 substituted a period for "and a children's hospital described in section 1395ww(d)(1)(B)(iii) of this title which meets the requirements of clauses (i) and (iii) of section 256b(b)(4)(L) of this title and which would meet the requirements of clause (ii) of such se… (Medicare and Medicaid Extenders Act of 2010) Law text · (a)
• Pub. L. 111–148, §2501(c)(2)(A)(i), inserted ", including such drugs dispensed to individuals enrolled with a medicaid managed care organization if the organization is responsible for coverage of such drugs" after "for such period". (Patient Protection and Affordable Care Act) Law text · (b)
• Pub. L. 111–148, §2501(a)(2), added subpar. (C). (Patient Protection and Affordable Care Act) Law text · (b)
• Pub. L. 111–148, §2501(c)(2)(A)(ii), inserted "including such information reported by each medicaid managed care organization," after "for which payment was made under the plan during the period,". (Patient Protection and Affordable Care Act) Law text · (b)
• Pub. L. 111–148, §2503(b)(1)(B), which directed insertion, in the second sentence, of "(relating to the weighted average of the most recently reported monthly average manufacturer prices)" after "(D)(v)" was executed by making the insertion in concluding provisions to reflect the… (Patient Protection and Affordable Care Act) Law text · (b)
• Pub. L. 111–148, §2503(b)(1)(A), which directed, in the first sentence, addition of cl. (iv) after cl. (iii), was executed by adding cl. (iv) after cl. (iii) to reflect the probable intent of Congress. (Patient Protection and Affordable Care Act) Law text · (b)
• Pub. L. 111–148, §2503(b)(2), substituted "the weighted average of the most recently reported monthly average manufacturer prices and the average retail survey price determined for each multiple source drug in accordance with subsection (f)" for "average manufacturer prices". (Patient Protection and Affordable Care Act) Law text · (b)
• Pub. L. 111–148, §2501(a)(1)(A), struck out "and" at end of subcl. (IV), inserted "and before January 1, 2010" after "December 31, 1995," and substituted "; and" for period at end in subcl. (V), and added subcl. (VI). (Patient Protection and Affordable Care Act) Law text · (c)
• Pub. L. 111–148, §2501(a)(1)(B), added cl. (iii). (Patient Protection and Affordable Care Act) Law text · (c)
• Pub. L. 111–148, §3301(d)(2), inserted ", or any discounts provided by manufacturers under the Medicare coverage gap discount program under section 1395w–114a of this title" before period at end. (Patient Protection and Affordable Care Act) Law text · (c)
• Pub. L. 111–152, §1206(a), amended subpar. (C) generally. Prior to amendment, text read as follows: (Health Care and Education Reconciliation Act of 2010) Law text · (c)
• Pub. L. 111–148, §2501(d)(1), added subpar. (C). (Patient Protection and Affordable Care Act) Law text · (c)
• Pub. L. 111–148, §2501(e), added subpar. (D). (Patient Protection and Affordable Care Act) Law text · (c)
• Pub. L. 111–148, §2501(b), struck out "and" at end of cl. (i), inserted "and before January 1, 2010," after "December 31, 1993," and substituted "; and" for period at end in cl. (ii), and added cl. (iii). (Patient Protection and Affordable Care Act) Law text · (c)
• Pub. L. 111–148, §2502(a)(1), redesignated subpar. (F) as (E) and struck out former subpar. (E) which read as follows: "Agents when used to promote smoking cessation." (Patient Protection and Affordable Care Act) Law text · (d)
• Pub. L. 111–148, §4107(b), inserted ", except, in the case of pregnant women when recommended in accordance with the Guideline referred to in section 1396d(bb)(2)(A) of this title, agents approved by the Food and Drug Administration under the over-the-counter monograph process fo… (Patient Protection and Affordable Care Act) Law text · (d)
• Pub. L. 111–148, §2502(a)(1)(B), redesignated subpar. (G) as (F). Former subpar. (F) redesignated (E). (Patient Protection and Affordable Care Act) Law text · (d)
• Pub. L. 111–148, §2502(a)(1), redesignated subpars. (H) and (K) as (G) and (H), respectively, and struck out subpars. (I) and (J) which read as follows: (Patient Protection and Affordable Care Act) Law text · (d)
• Pub. L. 111–148, §2502(a)(2), added par. (7). (Patient Protection and Affordable Care Act) Law text · (d)
• Pub. L. 111–148, §2503(a)(1)(A), struck out "(or, effective January 1, 2007, two or more)" after "three or more". (Patient Protection and Affordable Care Act) Law text · (e)
• Pub. L. 111–148, §2503(a)(1)(B), added par. (5) and struck out former par. (5). Prior to amendment, text read as follows: "Effective January 1, 2007, in applying the Federal upper reimbursement limit under paragraph (4) and section 447.332(b) of title 42 of the Code of Federal Regul… (Patient Protection and Affordable Care Act) Law text · (e)
• Pub. L. 111–148, §2503(c)(1), inserted "with respect to a retail community pharmacy," before "the determination". (Patient Protection and Affordable Care Act) Law text · (f)
• Pub. L. 111–148, §2503(c)(2), substituted "retail community pharmacies" for "retail pharmacies". (Patient Protection and Affordable Care Act) Law text · (f)
• Pub. L. 111–148, §2501(c)(2)(B), added par. (1) and struck out former par. (1) which read as follows: "Covered outpatient drugs dispensed by health maintenance organizations, including medicaid managed care organizations that contract under section 1396b(m) of this title, are not su… (Patient Protection and Affordable Care Act) Law text · (j)
• Pub. L. 111–148, §2503(a)(2)(A), substituted "by—" for "by wholesalers for drugs distributed to the retail pharmacy class of trade." and added cls. (i) and (ii). (Patient Protection and Affordable Care Act) Law text · (k)
• Pub. L. 111–148, §2503(a)(2)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: "The average manufacturer price for a covered outpatient drug shall be determined without regard to customary prompt pay discounts extended to wholesale… (Patient Protection and Affordable Care Act) Law text · (k)
• Pub. L. 111–226 inserted at end ", unless the drug is an inhalation, infusion, instilled, implanted, or injectable drug that is not generally dispensed through a retail community pharmacy; and". (______Act of____) Law text · (k)
• Pub. L. 111–152, §1101(c), added subcl. (V). (Health Care and Education Reconciliation Act of 2010) Law text · (k)
• Pub. L. 111–148, §2503(a)(2)(C), substituted "retail community pharmacies" for "the retail pharmacy class of trade". (Patient Protection and Affordable Care Act) Law text · (k)
• Pub. L. 111–148, §2503(a)(3)(A), substituted "the United States" for "the State". (Patient Protection and Affordable Care Act) Law text · (k)
• Pub. L. 111–148, §2503(a)(3)(B), inserted "and" after semicolon at end of cl. (i), substituted period for "; and" at end of cl. (ii), and struck out cl. (iii) which read as follows: "a drug product is considered to be sold or marketed in a State if it appears in a published natio… (Patient Protection and Affordable Care Act) Law text · (k)
• Pub. L. 111–148, §2503(a)(4), added pars. (10) and (11). (Patient Protection and Affordable Care Act) Law text · (k), (11)

2009

• Pub. L. 111–8, §221(a)(1), added subcls. (IV) and (V) and redesignated former subcl. (IV) as (VI). (Omnibus Appropriations Act, 2009) Law text · (c)
• Pub. L. 111–8, §221(a)(2), added cl. (iv). (Omnibus Appropriations Act, 2009) Law text · (c)

2006

• Pub. L. 109–171, §6004(a), inserted before period at end "and a children's hospital described in section 1395ww(d)(1)(B)(iii) of this title which meets the requirements of clauses (i) and (iii) of section 256b(b)(4)(L) of this title and which would meet the requirements of clause… (Deficit Reduction Act of 2005) Law text · (a)
• Pub. L. 109–171, §6002(a), added par. (7). (Deficit Reduction Act of 2005) Law text · (a)
• Pub. L. 109–171, §6001(b)(1)(B), inserted "Beginning July 1, 2006, the Secretary shall provide on a monthly basis to States under subparagraph (D)(iv) the most recently reported average manufacturer prices for single source drugs and for multiple source drugs and shall, on at lea… (Deficit Reduction Act of 2005) Law text · (b)
• Pub. L. 109–171, §6003(a)(1), added cl. (i) and struck out former cl. (i) which read as follows: "not later than 30 days after the last day of each month of a rebate period under the agreement (beginning on or after January 1, 1991), on the average manufacturer price (as defin… (Deficit Reduction Act of 2005) Law text · (b)
• Pub. L. 109–171, §6001(b)(1)(A), (c)(2), inserted "month of a" after "last day of each" and ", customary prompt pay discounts extended to wholesalers," after "(k)(1) of this section)". (Deficit Reduction Act of 2005) Law text · (b)
• Pub. L. 109–171, §6003(a)(2), inserted "(including for such drugs that are sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act)" after "drugs". (Deficit Reduction Act of 2005) Law text · (b)
• Pub. L. 109–171, §6001(d)(1), inserted ", and, for calendar quarters beginning on or after January 1, 2007 and only with respect to the information described in subclause (III), for covered outpatient drugs" before period at end. (Deficit Reduction Act of 2005) Law text · (b)
• Pub. L. 109–171, §6001(b)(2), added cls. (iv) and (v). (Deficit Reduction Act of 2005) Law text · (b), (v)
• Pub. L. 109–171, §6003(b)(1)(A), inserted "(including the lowest price available to any entity for any such drug of a manufacturer that is sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act)" after "or innovator multiple… (Deficit Reduction Act of 2005) Law text · (c)
• Pub. L. 109–171, §6003(b)(1)(B), added subcl. (IV). (Deficit Reduction Act of 2005) Law text · (c)
• Pub. L. 109–171, §6001(d)(2), added subpar. (D). (Deficit Reduction Act of 2005) Law text · (c)
• Pub. L. 109–171, §6001(a)(1), which directed substitution of "Subject to paragraph (5), the Secretary" for "The Secretary" and insertion of "(or, effective January 1, 2007, two or more)" after "three or more" in subsec. (e)(4), was executed to the last par. of subsec. (e) to reflect… (Deficit Reduction Act of 2005) Law text · (e)
• Pub. L. 109–171, §6001(a)(2), added par. (5). (Deficit Reduction Act of 2005) Law text · (e)
• Pub. L. 109–171, §6001(e), added subsec. (f). (Deficit Reduction Act of 2005) Law text · (f)
• Pub. L. 109–171, §6001(f)(1), which directed insertion of "(or its successor publications)" after "United States Pharmacopoeia-Drug Information", was executed by making insertion after "United States Pharmacopeia-Drug Information" to reflect the probable intent of Congress. (Deficit Reduction Act of 2005) Law text · (g)
• Pub. L. 109–171, §6001(f)(2), inserted ", or to require verification of the offer to provide consultation or a refusal of such offer" before period at end of concluding provisions. (Deficit Reduction Act of 2005) Law text · (g)
• Pub. L. 109–171, §6001(c)(1), designated existing provisions as subpar. (A), inserted heading, substituted "Subject to subparagraph (B), the term" for "The term", struck out ", after deducting customary prompt pay discounts" before period at end, and added subpar. (B). (Deficit Reduction Act of 2005) Law text · (k)
• Pub. L. 109–171, §6003(b)(2), as amended by Pub. L. 109–432, added subpar. (C). (Deficit Reduction Act of 2005) Law text · (k)
• Pub. L. 109–171, §6001(a)(4), substituted "is" for "are" in subcls. (I), (II), and (III). (Deficit Reduction Act of 2005) Law text · (k)
• Pub. L. 109–171, §6001(a)(3), substituted "at least 1 other drug product" for "are 2 or more drug products" in introductory provisions. (Deficit Reduction Act of 2005) Law text · (k)

2005

• Pub. L. 109–91 added subpar. (K). (QI, TMA, and Abstinence Programs Extension and Hurricane Katrina Unemployment Relief Act of 2005) Law text · (d)

2003

• Pub. L. 108–173, §303(i)(4)(A), inserted "or under part B of subchapter XVIII" after "section 1396b(a) of this title". (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (a)
• Pub. L. 108–173, §303(i)(4)(B), added cl. (iii) and concluding provisions. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)
• Pub. L. 108–173, §303(i)(4)(C), inserted "and manufacturer's average sales price" after "average manufacturer price" in heading and "and manufacturer's average sales prices (including wholesale acquisition cost) if required to make payment" after "manufacturer prices" in text. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)
• Pub. L. 108–173, §303(i)(4)(D)(i), inserted "(other than the wholesale acquisition cost for purposes of carrying out section 1395w–3a of this title)" after "subsection (a)(6)(A)(ii)" in introductory provisions. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)
• Pub. L. 108–173, §105(b), which directed insertion of "and drug pricing data reported under the first sentence of section 1395w–141(i)(1) of this title" after "section 1395w–104(c)(2)(E) of this title" in last sentence, was executed by making the insertion after "or 1395w–104(c)(2)(E) of this title… (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)
• Pub. L. 108–173, §101(e)(4), inserted concluding provisions. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)
• Pub. L. 108–173, §303(i)(4)(D)(ii), inserted ", to carry out section 1395w–3a of this title (including the determination and implementation of the payment amount), or to carry out section 1395w–3b of this title" after "this section". (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)
• Pub. L. 108–173, §1002(a), inserted "(including inpatient prices charged to hospitals described in section 256b(a)(4)(L) of this title)" before semicolon at end. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (c)
• Pub. L. 108–173, §103(e)(1), added subcls. (V) and (VI). (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (c), (VI)
• Pub. L. 108–173, §1002(b), added cl. (iii). (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (c)
• Pub. L. 108–173, §900(e)(1)(K), (L), which directed substitution of "The Secretary" for "HCFA" in subsecs. (e)(4) and (f)(2), was executed to the last par. of subsec. (e) to reflect the probable intent of Congress. See 1993 Amendment note below. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (e)
• Pub. L. 108–173, §101(e)(9)(A), inserted "and" at end. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (g)
• Pub. L. 108–173, §101(e)(9)(B), struck out subcl. (IV) which read as follows: "American Medical Association Drug Evaluations; and". (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (g)

1999

• Pub. L. 106–113, §1000(a)(6) [title VI, §606(a)], substituted "shall become effective as of the date on which the agreement is entered into or, at State option, on any date thereafter on or before" for "shall not be effective until". (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2000) Law text · (a)
• Pub. L. 106–113, §1000(a)(6) [title VI, §608(u)(1)], substituted "individual's" for "individuals". (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2000) Law text · (g)
• Pub. L. 106–113, §1000(a)(6) [title VI, §608(u)(2)], substituted "the operation of this section" for "the the operation of this section". (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2000) Law text · (i)
• Pub. L. 106–113, §1000(a)(6) [title VI, §608(u)(3)(A)], substituted "distributors" for "distributers". (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2000) Law text · (k)
• Pub. L. 106–113, §1000(a)(6) [title VI, §608(u)(3)(B)], substituted "pharmaceutically" for "pharmaceuutically". (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2000) Law text · (k)

1997

• Pub. L. 105–33, §4756, added subcl. (III) and redesignated former subcl. (III) as (IV). (Balanced Budget Act of 1997) Law text · (g), (IV)
• Pub. L. 105–33, §4701(b)(2)(A)(x), substituted "health maintenance organizations, including medicaid managed care organizations" for "* * * Health Maintenance Organizations, including those organizations". (Balanced Budget Act of 1997) Law text · (j)

1993

• Pub. L. 103–66, §13602(a)(2)(A)(i)(II), which directed amendment of subpar. (A) by substituting "dispensed after December 31, 1990, for which payment was made under the State plan for such period" for "dispensed under the plan during the quarter (or other period as the Secretary … · (b)
• Pub. L. 103–66, §13602(a)(2)(A)(i)(I), substituted "for a rebate period" for "each calendar quarter (or periodically in accordance with a schedule specified by the Secretary)". · (b)
• Pub. L. 103–66, §13602(a)(2)(A)(ii), substituted "each rebate period" for "each calendar quarter" and "units of each dosage form and strength and package size" for "dosage units", inserted "after December 31, 1990, for which payment was made" after "dispensed", and substituted "d… · (b)
• Pub. L. 103–66, §13602(a)(2)(A)(iii), substituted "rebate period under the agreement" for "quarter" in two places. · (b)
• Pub. L. 103–66, §13602(a)(1), added subsec. (c) and struck out former subsec. (c) which related to determination of amount of rebate for certain drugs. · (c)
• Pub. L. 103–18 substituted "such drug, except that for the calendar quarter beginning after September 30, 1992, and before January 1, 1993, the amount of the rebate may not exceed 50 percent of such average manufacturer price;" for "such drug;" in par. (1)(B)(ii)(II). · (c)
• Pub. L. 103–66, §13602(a)(1), added subsecs. (d) and (e), struck out former subsecs. (d) consisting of pars. (1) to (8) relating to limitations on coverage of drugs, (e) relating to denial of Federal financial participation in certain cases, and (f)(1) relating to reductions in… · (d), (e), (f)
• Pub. L. 103–66, §13602(a)(2)(B)(i), substituted "rebate period" for "calendar quarter" and inserted before period at end ", after deducting customary prompt pay discounts". · (k)
• Pub. L. 103–66, §13602(a)(2)(B)(ii)(III), in concluding provisions, substituted "for which a National Drug Code number is not required by the Food and Drug Administration or a drug or biological used" for "which is used" and inserted at end "Any drug, biological product, or insulin … · (k)
• Pub. L. 103–66, §13602(a)(2)(B)(ii)(I), struck out "* * * *emergency room visits" after "services". · (k)
• Pub. L. 103–66, §13602(a)(2)(B)(ii)(II), which directed amendment of subpar. (F) by substituting "services and services provided by an intermediate care facility for the mentally retarded" for "services", was executed by making the substitution for "sevices" to reflect the probab… · (k)
• Pub. L. 103–66, §13602(a)(2)(B)(iii), substituted "or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i)." for ", which appears in peer-reviewed medical literature or which is accepte… · (k)
• Pub. L. 103–66, §13602(a)(2)(B)(iv), substituted "rebate period" for "calendar quarter" in introductory provisions. · (k)
• Pub. L. 103–66, §13602(a)(2)(B)(v), added par. (8) and redesignated former par. (8) as (9). · (k), (9)

1992

• Pub. L. 102–585, §601(b)(1), substituted "manufacturer), and must meet the requirements of paragraph (5) (with respect to drugs purchased by a covered entity on or after the first day of the first month that begins after November 4, 1992) and paragraph (6)" for "manufacturer)". · (a)
• Pub. L. 102–585, §601(b)(2), added pars. (5) and (6). · (a), (6)
• Pub. L. 102–585, §601(b)(3), substituted "this paragraph or under an agreement with the Secretary of Veterans Affairs described in subsection (a)(6)(A)(ii)" for "this paragraph", "Secretary or the Secretary of Veterans Affairs" for "Secretary", and "except—" and cls. (i) to (iii)… · (b)
• Pub. L. 102–585, §601(b)(4)(i), (ii), substituted "the calendar quarter beginning at least 60 days" for "such period" and "the manufacturer provides notice to the Secretary." for "of the notice as the Secretary may provide (but not beyond the term of the agreement)." · (b)
• Pub. L. 102–585, §601(b)(4)(iii), added cls. (iv) and (v). · (b), (v)
• Pub. L. 102–585, §601(c)(1), which directed the substitution of "October 1, 1992," for "January 1, 1993,", was executed by making the substitution in introductory provisions and in subcl. (II), to reflect the probable intent of Congress. · (c)
• Pub. L. 102–585, §601(c)(2), (3), added cls. (ii) to (v) and struck out former cl. (ii) which read as follows: "for quarters (or other periods) beginning after December 31, 1992, the greater of— · (c), (d), (e), (f), (g), (h), (i), (j), (k), (l), (m), (n), (o), (p), (q), (r), (s), (t), (u), (v)
• Pub. L. 102–585, §601(a), substituted "(excluding any prices charged on or after October 1, 1992, to the Indian Health Service, the Department of Veterans Affairs, a State home receiving funds under section 1741 of title 38, the Department of Defense, the Public Health Service, o… · (c)