42 U.S.C. § 1395w-102
For purposes of this part and part C, the term "qualified prescription drug coverage" means either of the following:
Standard prescription drug coverage (as defined in subsection (b)) and access to negotiated prices under subsection (d).
Coverage of covered part D drugs which meets the alternative prescription drug coverage requirements of subsection (c) and access to negotiated prices under subsection (d), but only if the benefit design of such coverage is approved by the Secretary, as provided under subsection (c).
Subject to subparagraph (B), qualified prescription drug coverage may include supplemental prescription drug coverage consisting of either or both of the following:
A reduction in the annual deductible, a reduction in the coinsurance percentage or, for a year preceding 2025, an increase in the initial coverage limit with respect to covered part D drugs, or any combination thereof, insofar as such a reduction or increase increases the actuarial value of benefits above the actuarial value of basic prescription drug coverage.
Nothing in this paragraph shall be construed as affecting the application of subsection (c)(3).
Coverage of any product that would be a covered part D drug but for the application of subsection (e)(2)(A).
A PDP sponsor may not offer a prescription drug plan that provides supplemental prescription drug coverage pursuant to subparagraph (A) in an area unless the sponsor also offers a prescription drug plan in the area that only provides basic prescription drug coverage.
For purposes of this part and part C, the term "basic prescription drug coverage" means either of the following:
The provisions of section 1395w-22(a)(4) of this title shall apply under this part in the same manner as they apply under part C.
Nothing in this subsection shall be construed as changing the computation of incurred costs under subsection (b)(4).
For purposes of this part and part C, the term "standard prescription drug coverage" means coverage of covered part D drugs that meets the following requirements:
Subject to paragraphs (8) and (9), the coverage has an annual deductible-
Any amount determined under subparagraph (A)(ii) that is not a multiple of $5 shall be rounded to the nearest multiple of $5.
Subject to subparagraphs (C), (D), and (E) and paragraphs (8) and (9), the coverage has coinsurance (for costs above the annual deductible specified in paragraph (1) and up to the initial coverage limit under paragraph (3) 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) that is-
Nothing in this part shall be construed as preventing a PDP sponsor or an MA organization from applying tiered copayments under a plan, so long as such tiered copayments are consistent with subparagraphs (A)(ii), (C), and (D).
Except as provided in paragraphs (4), (8), and (9), for a year preceding 2025, the coverage for an applicable beneficiary (as defined in section 1395w-114a(g)(1) of this title) has coinsurance (for costs above the initial coverage limit under paragraph (3) and below the out-of-pocket threshold) for covered part D drugs that are not applicable drugs under section 1395w-114a(g)(2) of this title that is-
The generic-gap coinsurance percentage specified in this clause for-
Except as provided in paragraphs (4), (8), and (9), for a year preceding 2025, the coverage for an applicable beneficiary (as defined in section 1395w-114a(g)(1) of this title) has coinsurance (for costs above the initial coverage limit under paragraph (3) and below the out-of-pocket threshold) for the negotiated price (as defined in section 1395w-114a(g)(6) of this title) of covered part D drugs that are applicable drugs under section 1395w-114a(g)(2) of this title that is-
The applicable gap percentage specified in this clause for-
For plan years beginning on or after January 1, 2025, each PDP sponsor offering a prescription drug plan and each MA organization offering an MA-PD plan shall provide to any enrollee of such plan, including an enrollee who is a subsidy eligible individual (as defined in paragraph (3) of section 1395w-114(a) of this title), the option to elect with respect to a plan year to pay cost-sharing under the plan in monthly amounts that are capped in accordance with this subparagraph.
For each month in the plan year for which an enrollee in a prescription drug plan or an MA-PD plan has made an election pursuant to clause (i), the PDP sponsor or MA organization shall determine a maximum monthly cap (as defined in clause (iv)) for such enrollee.
With respect to an enrollee who has made an election pursuant to clause (i), for each month described in clause (ii), the PDP sponsor or MA organization shall bill such enrollee an amount (not to exceed the maximum monthly cap) for the out-of-pocket costs of such enrollee in such month.
In this subparagraph, the term "maximum monthly cap" means, with respect to an enrollee-
The following requirements shall apply with respect to the option to make an election pursuant to clause (i) under this subparagraph:
The Secretary shall provide information to part D eligible individuals on the option to make such election through educational materials, including through the notices provided under section 1395b-2(a) of this title.
An enrollee in a prescription drug plan or an MA-PD plan may make such an election-
Each PDP sponsor offering a prescription drug plan or MA organization offering an MA-PD plan-
If an enrollee fails to pay the amount billed for a month as required under this subparagraph-
Nothing in this subparagraph shall be construed as prohibiting a PDP sponsor or an MA organization from billing an enrollee for an amount owed under this subparagraph.
Any unsettled balances with respect to amounts owed under this subparagraph shall be treated as plan losses and the Secretary shall not be liable for any such balances outside of those assumed as losses estimated in plan bids.
Except as provided in paragraphs (2)(C), (2)(D), (4), (8), and (9), for a year preceding 2025, the coverage has an initial coverage limit on the maximum costs that may be recognized for payment purposes (including the annual deductible)-
Any amount determined under subparagraph (A)(ii) that is not a multiple of $10 shall be rounded to the nearest multiple of $10.
Subject to paragraphs (8) and (9), the coverage provides benefits, after the part D eligible individual has incurred costs (as described in subparagraph (C)) for covered part D drugs in a year equal to the annual out-of-pocket threshold specified in subparagraph (B), with cost-sharing that is equal to-
For a year after 2006, the dollar amounts specified in clause (i)(I)(aa) shall be equal to the dollar amounts specified in this subparagraph for the previous year, increased by the annual percentage increase described in paragraph (6) for the year involved. Any amount established under this clause that is not a multiple of a 5 cents shall be rounded to the nearest multiple of 5 cents. 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.
For purposes of this part, the "annual out-of-pocket threshold" specified in this subparagraph-
Any amount determined under clause (i) that is not a multiple of $50 shall be rounded to the nearest multiple of $50.
Except as provided in subparagraph (E) or subparagraph (F), in applying subparagraph (A)-
In order to accurately apply the requirements of subparagraph (C)(ii), the Secretary is authorized to establish procedures, in coordination with the Secretary of the Treasury and the Secretary of Labor-
A PDP sponsor or an MA organization may periodically ask part D eligible individuals enrolled in a prescription drug plan or an MA-PD plan offered by the sponsor or organization whether such individuals have or expect to receive such third-party reimbursement. A material misrepresentation of the information described in the preceding sentence by an individual (as defined in standards set by the Secretary and determined through a process established by the Secretary) shall constitute grounds for termination of enrollment in any plan under section 1395w-21(g)(3)(B) of this title (and as applied under this part under section 1395w-101(b)(1)(B)(v) of this title) for a period specified by the Secretary.
For each of years 2011 through 2024, in applying subparagraph (A), incurred costs shall include the negotiated price (as defined in paragraph (6) of section 1395w-114a(g) of this title) of an applicable drug (as defined in paragraph (2) of such section) of a manufacturer that is furnished to an applicable beneficiary (as defined in paragraph (1) of such section) under the Medicare coverage gap discount program under section 1395w-114a of this title, regardless of whether part of such costs were paid by a manufacturer under such program, 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).
In applying subparagraph (A), with respect to an enrollee who has made an election pursuant to clause (i) of paragraph (2)(E), costs shall be treated as incurred if such costs are paid by a PDP sponsor or an MA organization under the option provided under such paragraph.
Nothing in this part shall be construed as preventing a PDP sponsor or an MA organization offering an MA-PD plan from reducing to zero the cost-sharing otherwise applicable to preferred or generic drugs.
The annual percentage increase specified in this paragraph for a year is equal to the annual percentage increase in average per capita aggregate expenditures for covered part D drugs in the United States for part D eligible individuals, as determined by the Secretary for the 12-month period ending in July of the previous year using such methods as the Secretary shall specify.
The annual percentage increase specified in this paragraph for a year is equal to the annual percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending in July of the previous year.
For plan years beginning on or after January 1, 2023, with respect to an adult vaccine recommended by the Advisory Committee on Immunization Practices (as defined in subparagraph (B))-
For purposes of this paragraph, the term "adult vaccine recommended by the Advisory Committee on Immunization Practices" means a covered part D drug that is a vaccine licensed under section 351 of the Public Health Service Act [42 U.S.C. 262] for use by adult populations and administered in accordance with recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
For plan year 2023 and subsequent plan years, the deductible under paragraph (1) shall not apply with respect to any covered insulin product.
For plan years 2023 and 2024, the coverage provides benefits for any covered insulin product, regardless of whether an individual has reached the initial coverage limit under paragraph (3) or the out-of-pocket threshold under paragraph (4), with cost-sharing for a month's supply that does not exceed the applicable copayment amount.
For a plan year beginning on or after January 1, 2025, the coverage provides benefits for any covered insulin product, prior to an individual reaching the out-of-pocket threshold under paragraph (4), with cost-sharing for a month's supply that does not exceed the applicable copayment amount.
In this paragraph, the term "covered insulin product" means an insulin product that is a covered part D drug covered under the prescription drug plan or MA-PD plan that is approved under section 355 of title 21 or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262] and marketed pursuant to such approval or licensure, including any covered insulin product that has been deemed to be licensed under section 351 of the Public Health Service Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 and marketed pursuant to such section.
In this paragraph, the term "applicable copayment amount" means, with respect to a covered insulin product under a prescription drug plan or an MA-PD plan dispensed-
With respect to a month's supply of a covered insulin product dispensed during the period beginning on January 1, 2023, and ending on March 31, 2023, a PDP sponsor offering a prescription drug plan or an MA organization offering an MA-PD plan shall reimburse an enrollee within 30 days for any cost-sharing paid by such enrollee that exceeds the cost-sharing applied by the prescription drug plan or MA-PD plan under subparagraph (B)(i) at the point-of-sale for such month's supply.
A prescription drug plan or an MA-PD plan may provide a different prescription drug benefit design from standard prescription drug coverage so long as the Secretary determines (consistent with section 1395w-111(c) of this title) that the following requirements are met and the plan applies for, and receives, the approval of the Secretary for such benefit design:
The actuarial value of the total coverage is at least equal to the actuarial value of standard prescription drug coverage.
The unsubsidized value of the coverage is at least equal to the unsubsidized value of standard prescription drug coverage. For purposes of this subparagraph, the unsubsidized value of coverage is the amount by which the actuarial value of the coverage exceeds the actuarial value of the subsidy payments under section 1395w-115 of this title with respect to such coverage.
The coverage is designed, based upon an actuarially representative pattern of utilization, to provide for the payment, with respect to costs incurred that are equal to the initial coverage limit under subsection (b)(3) for the year 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, of an amount equal to at least the product of-
The deductible under the coverage shall not exceed the deductible amount specified under subsection (b)(1) for the year.
The coverage provides the coverage required under subsection (b)(4).
The maximum monthly cap on cost-sharing payments shall apply to coverage with respect to an enrollee who has made an election pursuant to clause (i) of subsection (b)(2)(E) under the option provided under such subsection.
The coverage is in accordance with subsection (b)(8).
The coverage is provided in accordance with subsection (b)(9).
Under qualified prescription drug coverage offered by a PDP sponsor offering a prescription drug plan or an MA organization offering an MA-PD plan, the sponsor or organization shall provide enrollees with access to negotiated prices used for payment for covered part D drugs, regardless of the fact that no benefits may be payable under the coverage with respect to such drugs because of the application of a deductible or other cost-sharing or, for a year preceding 2025, an initial coverage limit (described in subsection (b)(3)).
For purposes of this part, negotiated prices, subject to subparagraph (D), shall take into account negotiated price concessions, such as discounts, direct or indirect subsidies, rebates, and direct or indirect remunerations, for covered part D drugs, and include any dispensing fees for such drugs.
The prices negotiated by a prescription drug plan, by an MA-PD plan with respect to covered part D drugs, or by a qualified retiree prescription drug plan (as defined in section 1395w-132(a)(2) of this title) with respect to such drugs on behalf of part D eligible individuals, shall (notwithstanding any other provision of law) not be taken into account for the purposes of establishing the best price under section 1396r-8(c)(1)(C) of this title.
In applying this section, in the case of a covered part D drug 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), the negotiated prices used for payment (as described in this subsection) shall be no greater than the maximum fair price (as defined in section 1320f(c)(3) of this title) for such drug and for each year during such period plus any dispensing fees for such drug.
A PDP sponsor offering a prescription drug plan or an MA organization offering an MA-PD plan shall disclose to the Secretary (in a manner specified by the Secretary) the aggregate negotiated price concessions described in paragraph (1)(B) made available to the sponsor or organization by a manufacturer which are passed through in the form of lower subsidies, lower monthly beneficiary prescription drug premiums, and lower prices through pharmacies and other dispensers. The provisions of section 1396r-8(b)(3)(D) of this title apply to information disclosed to the Secretary under this paragraph.
To protect against fraud and abuse and to ensure proper disclosures and accounting under this part and in accordance with section 1395w-27(d)(2)(B) of this title (as applied under section 1395w-112(b)(3)(C) of this title), the Secretary may conduct periodic audits, directly or through contracts, of the financial statements and records of PDP sponsors with respect to prescription drug plans and MA organizations with respect to MA-PD plans.
Except as provided in this subsection, for purposes of this part, the term "covered part D drug" means-
and such term includes a vaccine licensed under section 262 of this title (and, for vaccines administered on or after January 1, 2008, its administration) and any use of a covered part D drug for a medically accepted indication (as defined in paragraph (4)).
Such term does not include drugs or classes of drugs, or their medical uses, which may be excluded from coverage or otherwise restricted under section 1396r-8(d)(2) of this title, other than subparagraph (E) of such section (relating to smoking cessation agents), 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), or under section 1396r-8(d)(3) of this title, as such sections were in effect on December 8, 2003. 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.
A drug prescribed for a part D eligible individual that would otherwise be a covered part D drug under this part shall not be so considered if payment for such drug as so prescribed and dispensed or administered with respect to that individual is available (or would be available but for the application of a deductible) under part A or B for that individual.
A prescription drug plan or an MA-PD plan may exclude from qualified prescription drug coverage any covered part D drug-
Such exclusions are determinations subject to reconsideration and appeal pursuant to subsections (g) and (h), respectively, of section 1395w-104 of this title.
For purposes of paragraph (1), the term "medically accepted indication" has the meaning given that term-
On and after January 1, 2010, subparagraph (A)(i)(II) shall not apply unless the compendia described in section 1396r-8(g)(1)(B)(i)(III) of this title meets3 the requirement in the third sentence of section 1395x(t)(2)(B) of this title.
For purposes of applying subparagraph (A)(ii), the Secretary shall revise the list of compendia described in section 1396r-8(g)(1)(B)(i) of this title as is appropriate for identifying medically accepted indications for drugs. Any such revision shall be done in a manner consistent with the process for revising compendia under section 1395x(t)(2)(B) of this title.
1So in original.
2So in original. There are two items (dd).
3So in original. Probably should be "meet".
42 U.S.C. § 1395w-102
EDITORIAL NOTES
REFERENCES IN TEXTSection 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.
AMENDMENTS2022-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".
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2010 AMENDMENT 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."
EFFECTIVE DATE OF 2008 AMENDMENT 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."
EFFECTIVE DATE OF 2005 AMENDMENT 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."
CONSTRUCTION OF 2022 AMENDMENT 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."
CONSTRUCTION OF 2010 AMENDMENT 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."
CONSTRUCTION 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))."
IMPLEMENTATION OF PUB. L. 117-169 FOR CERTAIN YEARS 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."
PAYMENT FOR ADMINISTRATION OF PART D VACCINES IN 2007 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)])."
- Advisory Committee
- The term "Advisory Committee" means the Green Building Advisory Committee established under section 484.1
- Secretary
- The term "Secretary" means the Secretary of Housing and Urban Development.1 See References in Text note below.
- United States
- The term "United States" means (but only for purposes of subparagraphs (A) and (B) of this paragraph) the fifty States and the District of Columbia.
- person
- The term "person" means an individual, a trust or estate, a partnership, or a corporation.
- practices
- The term "practices" means design, financing, permitting, construction, commissioning, operation and maintenance, and other practices that contribute to achieving zero-net-energy buildings or facilities.