Section 1101(d)(1) of the Health Care and Education Reconciliation Act of 2010, referred to in subsec. (b)(4)(B)(i)(V), is section 1101(d)(1) of Pub. L. 111–152, which amended this section.

The Public Health Service Act, referred to in subsec. (b)(4)(C)(iii)(I)(dd), is act July 1, 1944, ch. 373, 58 Stat. 682. Part B of title XXVI of the Act is classified generally to part B (§ 300ff–21 et seq.) of subchapter XXIV of chapter 6A of this title. For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables.

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009, referred to in (b)(9)(C), is section 7002(e)(4) of Pub. L. 111–148, which is set out in a note under section 262 of this title.

2022—Subsec. (a)(2)(A)(i)(I). Pub. L. 117–169, § 11201(e)(1)(A), substituted “or, for a year preceding 2025, an increase in the initial” for “, or an increase in the initial”.

Subsec. (b)(1)(A). Pub. L. 117–169, § 11406(a)(1)(A), substituted “paragraphs (8) and (9)” for “paragraph (8)” in introductory provisions.

Pub. L. 117–169, § 11401(a)(1)(A), substituted “Subject to paragraph (8), the coverage” for “The coverage” in introductory provisions.

Subsec. (b)(2)(A). Pub. L. 117–169, § 11406(a)(1)(B)(i), substituted “paragraphs (8) and (9)” for “paragraph (8)” in introductory provisions.

Pub. L. 117–169, § 11401(a)(1)(B)(i), inserted “and paragraph (8)” after “and (E)” in introductory provisions.

Pub. L. 117–169, § 11202(a)(1)(A), substituted “, (D), and (E)” for “and (D)” in introductory provisions.

Pub. L. 117–169, § 11201(a)(1)(A), inserted “for a year preceding 2025 and for costs above the annual deductible specified in paragraph (1) and up to the annual out-of-pocket threshold specified in paragraph (4)(B) for 2025 and each subsequent year” after “paragraph (3)” in introductory provisions.

Subsec. (b)(2)(C)(i). Pub. L. 117–169, § 11406(a)(1)(B)(ii), substituted “, (8), and (9)” for “and (8)” in introductory provisions.

Pub. L. 117–169, § 11401(a)(1)(B)(ii), substituted “paragraphs (4) and (8)” for “paragraph (4)” in introductory provisions.

Pub. L. 117–169, § 11201(a)(1)(B)(i), inserted “for a year preceding 2025,” after “paragraph (4),” in introductory provisions.

Subsec. (b)(2)(C)(ii)(III). Pub. L. 117–169, § 11201(a)(1)(B)(ii), substituted “through 2024” for “and each subsequent year”.

Subsec. (b)(2)(D)(i). Pub. L. 117–169, § 11406(a)(1)(B)(iii), substituted “, (8), and (9)” for “and (8)” in introductory provisions.

Pub. L. 117–169, § 11401(a)(1)(B)(iii), substituted “paragraphs (4) and (8)” for “paragraph (4)” in introductory provisions.

Pub. L. 117–169, § 11201(a)(1)(C)(i)(I), inserted “for a year preceding 2025,” after “paragraph (4),” in introductory provisions.

Subsec. (b)(2)(D)(i)(I)(bb). Pub. L. 117–169, § 11201(a)(1)(C)(i)(II), substituted “each of years 2019 through 2024” for “a year after 2018”.

Subsec. (b)(2)(D)(ii)(V). Pub. L. 117–169, § 11201(a)(1)(C)(ii), substituted “each of years 2019 through 2024” for “2019 and each subsequent year”.

Subsec. (b)(2)(E). Pub. L. 117–169, § 11202(a)(1)(B), added subpar. (E).

Subsec. (b)(3)(A). Pub. L. 117–169, § 11406(a)(1)(C), substituted “(8), and (9)” for “and (8)” in introductory provisions.

Pub. L. 117–169, § 11401(a)(1)(C), substituted “(4), and (8)” for “and (4)” in introductory provisions.

Pub. L. 117–169, § 11201(a)(2)(A), inserted “for a year preceding 2025,” after “and (4),” in introductory provisions.

Subsec. (b)(3)(A)(ii). Pub. L. 117–169, § 11201(a)(2)(B), substituted “for each of years 2007 through 2024” for “for a subsequent year”.

Subsec. (b)(4)(A)(i). Pub. L. 117–169, § 11406(a)(1)(D), substituted “paragraphs (8) and (9)” for “paragraph (8)” in introductory provisions.

Pub. L. 117–169, § 11401(a)(1)(D), substituted “Subject to paragraph (8), the coverage” for “The coverage” in introductory provisions.

Pub. L. 117–169, § 11201(a)(3)(A)(i), inserted dash after “is equal to” in introductory provisions, designated remainder of existing provisions as subcl. (I), inserted “for a year preceding 2024,” before “the greater of—”, redesignated former subcls. (I) and (II) as items (aa) and (bb), respectively, of subcl. (I) and realigned margins, and added subcl. (II).

Subsec. (b)(4)(A)(ii). Pub. L. 117–169, § 11201(a)(3)(A)(ii), substituted “clause (i)(I)(aa) shall be” for “clause (i)(I) shall be” and inserted at end “The Secretary shall continue to calculate the dollar amounts specified in clause (i)(I)(aa), including with the adjustment under this clause, after 2023 for purposes of section 1395w–114(a)(1)(D)(iii) of this title.”

Subsec. (b)(4)(B)(i)(V). Pub. L. 117–169, § 11201(a)(3)(B)(i)(I), struck out “or” at end.

Subsec. (b)(4)(B)(i)(VI). Pub. L. 117–169, § 11201(a)(3)(B)(i)(II), substituted “for each of years 2021 through 2024” for “for a subsequent year” and semicolon for period at end.

Subsec. (b)(4)(B)(i)(VII), (VIII). Pub. L. 117–169, § 11201(a)(3)(B)(i)(III), added subcls. (VII) and (VIII).

Subsec. (b)(4)(B)(ii). Pub. L. 117–169, § 11201(a)(3)(B)(ii), substituted “clause (i)” for “clause (i)(II)”.

Subsec. (b)(4)(C). Pub. L. 117–169, § 11202(a)(2)(A), substituted “subparagraph (E) or subparagraph (F)” for “subparagraph (E)” in introductory provisions.

Subsec. (b)(4)(C)(i). Pub. L. 117–169, § 11201(a)(3)(C)(i), substituted “and, for a year preceding 2025, for amounts” for “and for amounts”.

Subsec. (b)(4)(C)(iii). Pub. L. 117–169, § 11201(a)(3)(C)(ii), inserted dash after “if such costs” in introductory provisions, designated remainder of existing provisions as subcl. (I), redesignated former subcls. (I) to (IV) as items (aa) to (dd), respectively, of subcl. (I) and realigned margins, and added subcl. (II).

Subsec. (b)(4)(C)(iii)(I)(dd). Pub. L. 117–169, § 11401(c)(2), added item (dd) referring to section 1395w–115(h) of this title.

Subsec. (b)(4)(E). Pub. L. 117–169, § 11201(a)(3)(D), substituted “For each of years 2011 through 2024, in applying” for “In applying”.

Subsec. (b)(4)(F). Pub. L. 117–169, § 11202(a)(2)(B), added subpar. (F).

Subsec. (b)(8). Pub. L. 117–169, § 11401(a)(1)(E), added par. (8).

Subsec. (b)(9). Pub. L. 117–169, § 11406(a)(1)(E), added par. (9).

Subsec. (c)(1)(C). Pub. L. 117–169, § 11201(e)(1)(B), struck out “at initial coverage limit” after “payment for costs” in heading and inserted “for a year preceding 2025 or the annual out-of-pocket threshold specified in subsection (b)(4)(B) for the year for 2025 and each subsequent year” after “subsection (b)(3) for the year” in introductory provisions and in cl. (i).

Subsec. (c)(4). Pub. L. 117–169, § 11202(b), added par. (4).

Subsec. (c)(5). Pub. L. 117–169, § 11401(a)(2), added par. (5).

Subsec. (c)(6). Pub. L. 117–169, § 11406(a)(2), added par. (6).

Subsec. (d)(1)(A). Pub. L. 117–169, § 11201(e)(1)(C), substituted “or, for a year preceding 2025, an initial” for “or an initial”.

Subsec. (d)(1)(B). Pub. L. 117–169, § 11001(b)(1)(D)(i), inserted “, subject to subparagraph (D),” after “negotiated prices”.

Subsec. (d)(1)(D). Pub. L. 117–169, § 11001(b)(1)(D)(ii), added subpar. (D).

Subsec. (e)(1)(C). Pub. L. 117–328 added subpar. (C).

2018—Subsec. (b)(2)(D)(i)(I). Pub. L. 115–123, § 53116(a)(1), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: “equal to the difference between the applicable gap percentage (specified in clause (ii) for the year) and the discount percentage specified in section 1395w–114a(g)(4)(A) of this title for such applicable drugs; or”.

Subsec. (b)(2)(D)(ii)(V), (VI). Pub. L. 115–123, § 53116(a)(2), substituted “2019” for “2020” in subcl. (VI), redesignated subcl. (VI) as (V), and struck out former subcl. (V) which read as follows: “2019 is 80 percent; and”.

2010—Subsec. (b)(2)(A). Pub. L. 111–152, § 1101(b)(3)(A), substituted “Subject to subparagraphs (C) and (D), the coverage” for “The coverage”.

Subsec. (b)(2)(B). Pub. L. 111–152, § 1101(b)(3)(B), substituted “subparagraphs (A)(ii), (C), and (D)” for “subparagraph (A)(ii)”.

Subsec. (b)(2)(C), (D). Pub. L. 111–152, § 1101(b)(3)(C), added subpars. (C) and (D).

Subsec. (b)(3)(A). Pub. L. 111–152, § 1101(b)(3)(D), substituted “paragraphs (2)(C), (2)(D), and (4)” for “paragraph (4)”.

Pub. L. 111–148, § 3315(1), which directed substitution of “paragraphs (4) and (7)” for “paragraph (4)” in introductory provisions, was repealed by Pub. L. 111–152, § 1101(a)(2). See Construction of 2010 Amendment note below.

Subsec. (b)(4)(B)(i)(II) to (VI). Pub. L. 111–152, § 1101(d)(1), added subcls. (II) to (V) and redesignated former subcl. (II) as (VI).

Subsec. (b)(4)(C). Pub. L. 111–148, § 3314(a), in cl. (ii), substituted “subject to clause (iii), such costs shall be treated as incurred only if” for “such costs shall be treated as incurred only if” and struck out “, under section 1395w–114 of this title, or under a State Pharmaceutical Assistance Program” after “on behalf of the individual),”, and added cl. (iii).

Pub. L. 111–148, § 3301(c)(1)(A), substituted “Except as provided in subparagraph (E), in applying” for “In applying” in introductory provisions.

Subsec. (b)(4)(E). Pub. L. 111–152, § 1101(b)(3)(E), inserted before period at end “, except that incurred costs shall not include the portion of the negotiated price that represents the reduction in coinsurance resulting from the application of paragraph (2)(D)”.

Pub. L. 111–148, § 3301(c)(1)(B), added subpar. (E).

Subsec. (b)(7). Pub. L. 111–152, § 1101(d)(2), added par. (7).

Pub. L. 111–148, § 3315(2), which directed addition of par. (7), was repealed by Pub. L. 111–152, § 1101(a)(2). As enacted, text read as follows:

“(A) In general.—For the plan year beginning on January 1, 2010, the initial coverage limit described in paragraph (3)(B) otherwise applicable shall be increased by $500.

“(B) Application.—In applying subparagraph (A)—

“(i) except as otherwise provided in this subparagraph, there shall be no change in the premiums, bids, or any other parameters under this part or part C;

“(ii) costs that would be treated as incurred costs for purposes of applying paragraph (4) but for the application of subparagraph (A) shall continue to be treated as incurred costs;

“(iii) the Secretary shall establish procedures, which may include a reconciliation process, to fully reimburse PDP sponsors with respect to prescription drug plans and MA organizations with respect to MA–PD plans for the reduction in beneficiary cost sharing associated with the application of subparagraph (A);

“(iv) the Secretary shall develop an estimate of the additional increased costs attributable to the application of this paragraph for increased drug utilization and financing and administrative costs and shall use such estimate to adjust payments to PDP sponsors with respect to prescription drug plans under this part and MA organizations with respect to MA–PD plans under part C; and

“(v) the Secretary shall establish procedures for retroactive reimbursement of part D eligible individuals who are covered under such a plan for costs which are incurred before the date of initial implementation of subparagraph (A) and which would be reimbursed under such a plan if such implementation occurred as of January 1, 2010.

“(C) No effect on subsequent years.—The increase under subparagraph (A) shall only apply with respect to the plan year beginning on January 1, 2010, and the initial coverage limit for plan years beginning on or after January 1, 2011, shall be determined as if subparagraph (A) had never applied.”

See Construction of 2010 Amendment note below.

2008—Subsec. (e)(1). Pub. L. 110–275, § 182(a)(1)(A), substituted “(as defined in paragraph (4))” for “(as defined in section 1396r–8(k)(6) of this title)” in concluding provisions.

Subsec. (e)(2)(A). Pub. L. 110–275, § 175(a), inserted “other than subparagraph (I) of such section (relating to barbiturates) if the barbiturate is used in the treatment of epilepsy, cancer, or a chronic mental health disorder, and other than subparagraph (J) of such section (relating to benzodiazepines),” after “agents),”.

Subsec. (e)(4). Pub. L. 110–275, § 182(a)(1)(B), which directed amendment of subsec. (e)(1) in the matter following subpar. (B) by adding par. (4) at the end, was executed by adding par. (4) at end of subsec. (e), to reflect the probable intent of Congress.

2006—Subsec. (e)(1). Pub. L. 109–432 inserted “(and, for vaccines administered on or after January 1, 2008, its administration)” after “section 262 of this title” in concluding provisions.

2005—Subsec. (e)(2)(A). Pub. L. 109–91, § 103(a)(2), inserted at end “Such term also does not include a drug when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration.”

Pub. L. 109–91, § 103(a)(1), inserted before period at end “, as such sections were in effect on December 8, 2003”.

Pub. L. 111–148, title III, § 3301(c)(2), Mar. 23, 2010, 124 Stat. 468, provided that: “The amendments made by this subsection [amending this section] shall apply to costs incurred on or after July 1, 2010.”

Pub. L. 111–148, title III, § 3314(b), Mar. 23, 2010, 124 Stat. 479, provided that: “The amendments made by subsection (a) [amending this section] shall apply to costs incurred on or after January 1, 2011.”

Pub. L. 110–275, title I, § 175(b), July 15, 2008, 122 Stat. 2581, provided that: “The amendments made by subsection (a) [amending this section] shall apply to prescriptions dispensed on or after January 1, 2013.”

Pub. L. 110–275, title I, § 182(a)(2), July 15, 2008, 122 Stat. 2583, provided that: “The amendments made by this subsection [amending this section] shall apply to plan years beginning on or after January 1, 2009.”

Pub. L. 109–91, title I, § 103(c), Oct. 20, 2005, 119 Stat. 2092, provided that: “The amendment made by subsection (a)(1) [amending this section] shall take effect as if included in the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173) and the amendment made by subsection (a)(2) [amending this section] shall apply to coverage for drugs dispensed on or after January 1, 2007.”

Pub. L. 117–169, title I, § 11401(d), Aug. 16, 2022, 136 Stat. 1898, provided that: “Nothing in this section [amending this section and sections 1395w–114 and 1395w–115 of this title and enacting provisions set out as a note below] shall be construed as limiting coverage under part D of title XVIII of the Social Security Act [42 U.S.C. 1395w–101 et seq.] for vaccines that are not recommended by the Advisory Committee on Immunization Practices.”

Pub. L. 111–152, title I, § 1101(a)(2), Mar. 30, 2010, 124 Stat. 1037, provided that: “Section 3315 of the Patient Protection and Affordable Care Act [section 3315 of Pub. L. 111–148, amending this section] (including the amendments made by such section) is repealed, and any provision of law amended or repealed by such sections [sic] is hereby restored or revived as if such section had not been enacted into law.”

Pub. L. 109–91, title I, § 103(b), Oct. 20, 2005, 119 Stat. 2092, provided that: “Nothing in this section [amending this section and enacting provisions set out as a note under this section] shall be construed as preventing a prescription drug plan or an MA–PD plan from providing coverage of drugs for the treatment of sexual or erectile dysfunction as supplemental prescription drug coverage under section 1860D–2(a)(2)(A)(ii) of the Social Security Act (42 U.S.C. 1395w–102(a)(2)(A)(ii)).”

Pub. L. 117–169, title I, § 11201(f), Aug. 16, 2022, 136 Stat. 1892, provided that: “The Secretary shall implement this section [enacting sections 1395w–114c and 1395w–114d of this title and amending this section and sections 1395w–24, 1395w–104, 1395w–111, 1395w–113, 1395w–114, 1395w–114a, 1395w–115, 1395w–116, 1395w–131, 1395w–132, 1395w–151, 1395w–153, and 1396r–8 of this title], including the amendments made by this section, for 2024, 2025, and 2026 by program instruction or other forms of program guidance.”

Pub. L. 117–169, title I, § 11202(c), Aug. 16, 2022, 136 Stat. 1895, provided that: “The Secretary shall implement this section [amending this section], including the amendments made by this section, for 2025 by program instruction or other forms of program guidance.”

Pub. L. 117–169, title I, § 11401(e), Aug. 16, 2022, 136 Stat. 1898, provided that: “The Secretary shall implement this section [amending this section and sections 1395w–114 and 1395w–115 of this title and enacting provisions set out as a note above], including the amendments made by this section, for 2023, 2024, and 2025, by program instruction or other forms of program guidance.”

Pub. L. 117–169, title I, § 11406(d), Aug. 16, 2022, 136 Stat. 1904, provided that: “The Secretary shall implement this section [amending this section and sections 1395w–114 and 1395w–115 of this title] for plan years 2023, 2024, and 2025 by program instruction or other forms of program guidance.”

Pub. L. 109–432, div. B, title II, § 202(a), Dec. 20, 2006, 120 Stat. 2986, provided that: “Notwithstanding any other provision of law, in the case of a vaccine that is a covered part D drug under section 1860D–2(e) of the Social Security Act (42 U.S.C. 1395w–102(e)) and that is administered during 2007, the administration of such vaccine shall be paid under part B of title XVIII of such Act [42 U.S.C. 1395j et seq.] as if it were the administration of a vaccine described in section 1861(s)(10)(B) of such Act (42 U.S.C. 1395w(s)(10)(B) [probably should be 1395x(s)(10)(B)]).”