Source: https://www.law.cornell.edu/uscode/text/42/1395w%E2%80%93102
Timestamp: 2019-06-19 20:59:53
Document Index: 311357902

Matched Legal Cases: ['§ 1395', 'art 1', '§ 1395', '§ 1395', '§\u202f1395', '§\u202f1860', '§\u202f101', '§\u202f103', '§\u202f202', '§\u202f175', '§\u202f3301', '§\u202f1101', '§\u202f53116', '§\u202f300', '§\u202f53116', '§\u202f53116', '§\u202f1101', '§\u202f1101', '§\u202f1101', '§\u202f1101', '§\u202f3315', '§\u202f1101', '§\u202f1101', '§\u202f3314', '§\u202f3301', '§\u202f1101', '§\u202f3301', '§\u202f1101', '§\u202f3315', '§\u202f1101', '§\u202f182', '§\u202f175', '§\u202f182', '§\u202f103', '§\u202f103', '§\u202f3301', '§\u202f3314', '§\u202f175', '§\u202f182', '§\u202f103', '§\u202f1101', '§\u202f103', '§\u202f202']

42 U.S. Code § 1395w–102 - Prescription drug benefits | US Law | LII / Legal Information Institute
U.S. Code › Title 42 › Chapter 7 › Subchapter XVIII › Part D › Subpart 1 › § 1395w–102
42 U.S. Code § 1395w–102 - Prescription drug benefits
§ 1395w–102.
(1) In generalFor purposes of this part and part C, the term “qualified prescription drug coverage” means either of the following:
(A) In generalSubject to subparagraph (B), qualified prescription drug coverage may include supplemental prescription drug coverage consisting of either or both of the following:
(3) Basic prescription drug coverageFor purposes of this part and part C, the term “basic prescription drug coverage” means either of the following:
(b) Standard prescription drug coverageFor 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:
(A) In generalThe coverage has an annual deductible—
(A) 25 percent coinsuranceSubject to subparagraphs (C) and (D), the coverage has coinsurance (for costs above the annual deductible specified in paragraph (1) and up to the initial coverage limit under paragraph (3)) that is—
actuarially equivalent (using processes and methods established under section 1395w–111(c) of this title) to an average expected payment of 25 percent of such costs.
(i) In generalExcept as provided in paragraph (4), 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—
actuarially equivalent (using processes and methods established under section 1395w–111(c) of this title) to an average expected payment of such percentage of such costs for covered part D drugs that are not applicable drugs under section 1395w–114a(g)(2) of this title.
(ii) Generic-gap coinsurance percentageThe generic-gap coinsurance percentage specified in this clause for—
(i) In generalExcept as provided in paragraph (4), 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—
(I) 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, in the case of a year after 2018, 50 percent); or
actuarially equivalent (using processes and methods established under section 1395w–111(c) of this title) to an average expected payment of such percentage of such costs, for covered part D drugs that are applicable drugs under section 1395w–114a(g)(2) of this title.
(ii) Applicable gap percentageThe applicable gap percentage specified in this clause for—
2018 is 85 percent; and
2019 and each subsequent year is 75 percent.
(A) In generalExcept as provided in paragraphs (2)(C), (2)(D), and (4), the coverage has an initial coverage limit on the maximum costs that may be recognized for payment purposes (including the annual deductible)—
(i) In generalThe 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 the greater of—
a copayment of $2 for a generic drug or a preferred drug that is a multiple source drug (as defined in section 1396r–8(k)(7)(A)(i) of this title) and $5 for any other drug; or
(i) In generalFor purposes of this part, the “annual out-of-pocket threshold” specified in this subparagraph—
(IV) for each of years 2016 through 2019, is equal to the amount specified in this subparagraph for the previous year, increased by the lesser of—
(C) ApplicationExcept as provided in subparagraph (E), in applying subparagraph (A)—
(iii) such costs shall be treated as incurred and shall not be considered to be reimbursed under clause (ii) if such costs are borne or paid—
(i) Procedures for exchanging informationIn 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—
(c) Alternative prescription drug coverage requirementsA 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:
(C) Assuring standard payment for costs at initial coverage limitThe 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, of an amount equal to at least the product of—
the amount by which the initial coverage limit described in subsection (b)(3) for the year exceeds the deductible described in subsection (b)(1) for the year; and
100 percent minus the coinsurance percentage specified in subsection (b)(2)(A)(i).
(1) In generalExcept as provided in this subsection, for purposes of this part, the term “covered part D drug” means—
a drug that may be dispensed only upon a prescription and that is described in subparagraph (A)(i), (A)(ii), or (A)(iii) of section 1396r–8(k)(2) of this title; or
(3) Application of general exclusion provisionsA prescription drug plan or an MA–PD plan may exclude from qualified prescription drug coverage any covered part D drug—
for which payment would not be made if section 1395y(a) of this title applied to this part; or
(A) In generalFor purposes of paragraph (1), the term “medically accepted indication” has the meaning given that term—
(i) in the case of a covered part D drug used in an anticancer chemotherapeutic regimen, in section 1395x(t)(2)(B) of this title, except that in applying such section—
subject to subparagraph (B), the compendia described in section 1396r–8(g)(1)(B)(i)(III) of this title shall be included in the list of compendia described in clause (ii)(I) section 1395x(t)(2)(B) of this title; and
in the case of any other covered part D drug, in section 1396r–8(k)(6) of this title.
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 meets [1] the requirement in the third sentence of section 1395x(t)(2)(B) of this title.
(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–2, as added Pub. L. 108–173, title I, § 101(a)(2), Dec. 8, 2003, 117 Stat. 2075; amended Pub. L. 109–91, title I, § 103(a), Oct. 20, 2005, 119 Stat. 2092; Pub. L. 109–432, div. B, title II, § 202(b), Dec. 20, 2006, 120 Stat. 2986; Pub. L. 110–275, title I, §§ 175(a), 182(a)(1), July 15, 2008, 122 Stat. 2581, 2583; Pub. L. 111–148, title III, §§ 3301(c)(1), 3314(a), 3315, Mar. 23, 2010, 124 Stat. 467, 478, 479; Pub. L. 111–152, title I, § 1101(a)(2), (b)(3), (d), Mar. 30, 2010, 124 Stat. 1037–1039; Pub. L. 115–123, div. E, title XII, § 53116(a), Feb. 9, 2018, 132 Stat. 306.)
[1]  So in original. Probably should be “meet”.
The Public Health Service Act, referred to in subsec. (b)(4)(C)(iii)(IV), 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.
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:
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. 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. 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)]).”