2021 US Code
Title 26 - Internal Revenue Code
Subtitle D - Miscellaneous Excise Taxes
Front Matter
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EDITORIAL NOTES
AMENDMENTS
2011—Pub. L. 111–347, title III, §301(a)(2), Jan. 2, 2011, 124 Stat. 3666, added item for chapter 50. 2010—Pub. L. 111–148, title X, §10907(c), Mar. 23, 2010, 124 Stat. 1020, added item for chapter 49. Pub. L. 111–148, title IX, §9017(b), Mar. 23, 2010, 124 Stat. 872, which directed amendment of analysis by adding item for chapter 49, was not executed in view of Pub. L. 111–148, title X, §10907(a), Mar. 23, 2010, 124 Stat. 1020, which provided that the amendments made by section 9017 of Pub. L. 111–148 were deemed null, void, and of no effect. Pub. L. 111–148, title I, §1501(c), title VI, §6301(e)(2)(B)(ii), Mar. 23, 2010, 124 Stat. 249, 747, added items for chapters 34 and 48 and struck out former item for chapter 34 "Documentary stamp taxes". 2004—Pub. L. 108–357, title VIII, §802(c)(2), Oct. 22, 2004, 118 Stat. 1568, added item for chapter 45. 1990—Pub. L. 101–508, title XI, §11801(b)(17), Nov. 5, 1990, 104 Stat. 1388–522, struck out item for chapter 37 "Sugar, coconut and palm oil". 1989—Pub. L. 101–239, title VI, §6202(b)(4)(B), title VII, §7841(d)(4), Dec. 19, 1989, 103 Stat. 2233, 2428, substituted semicolon for comma in item for chapter 42 and struck out "large" after "Certain" in item for chapter 47. 1988—Pub. L. 100–418, title I, §1941(b)(3)(A), Aug. 23, 1988, 102 Stat. 1324, struck out item for chapter 45 "Windfall profit tax on domestic crude oil". 1987—Pub. L. 100–203, title X, §10712(c)(8), Dec. 22, 1987, 101 Stat. 1330–467, substituted "and certain other tax-exempt organizations" for "black lung benefit trusts" in item for chapter 42. 1986—Pub. L. 99–509, title IX, §9319(d)(2), Oct. 21, 1986, 100 Stat. 2012, added item for chapter 47. 1984—Pub. L. 98–369, div. A, title I, §67(d)(2), July 18, 1984, 98 Stat. 587, added item for chapter 46. 1983—Pub. L. 97–424, title V, §512(b)(2)(B), Jan. 6, 1983, 96 Stat. 2177, substituted "Retail excise taxes" for "Special fuels" in item for chapter 31. 1982—Pub. L. 97–248, title III, §310(b)(4)(B), Sept. 3, 1982, 96 Stat. 598, added item for chapter 39. 1980—Pub. L. 96–510, title II, §211(b), Dec. 11, 1980, 94 Stat. 2801, added item for chapter 38. Pub. L. 96–223, §101(a)(2), Apr. 2, 1980, 94 Stat. 250, added item for chapter 45. 1978—Pub. L. 95–227, §4(c)(2)(C), Feb. 10, 1978, 92 Stat. 22, inserted ", black lung benefit trusts" after "foundations" in item for chapter 42. 1976—Pub. L. 94–455, title XIII, §1307(d)(3)(A), title XVI, §1605(c), title XIX, §§1904(b)(7)(E), (10)(G), 1952(n)(6), Oct. 4, 1976, 90 Stat. 1728, 1755, 1815, 1818, 1846, substituted "41. Public charities" for "41. Interest equalization tax" added item for chapter 44 and struck out items for chapters "38. Import taxes" and "39. Regulatory taxes". 1974—Pub. L. 93–406, title II, §1016(b)(2), Sept. 2, 1974, 88 Stat. 932, added item for chapter 43. 1969—Pub. L. 91–172, title I, §101(j)(59), Dec. 30, 1969, 83 Stat. 532, added item for chapter 42. 1964—Pub. L. 88–563, §2(b), Sept. 2, 1964, 78 Stat. 841, added item for chapter 41. STATUTORY NOTES AND RELATED SUBSIDIARIES IMPOSITION OF ANNUAL FEE ON BRANDED PRESCRIPTION PHARMACEUTICAL MANUFACTURERS AND IMPORTERS Pub. L. 111–148, title IX, §9008, Mar. 23, 2010, 124 Stat. 859, as amended by Pub. L. 111–152, title I, §1404(a), Mar. 30, 2010, 124 Stat. 1064, provided that: "(a) Imposition of Fee.— "(1) In general.—Each covered entity engaged in the business of manufacturing or importing branded prescription drugs shall pay to the Secretary of the Treasury not later than the annual payment date of each calendar year beginning after 2010 a fee in an amount determined under subsection (b). "(2) Annual payment date.—For purposes of this section, the term 'annual payment date' means with respect to any calendar year the date determined by the Secretary, but in no event later than September 30 of such calendar year. "(b) Determination of Fee Amount.— "(1) In general.—With respect to each covered entity, the fee under this section for any calendar year shall be equal to an amount that bears the same ratio to the applicable amount as— "(A) the covered entity's branded prescription drug sales taken into account during the preceding calendar year, bear to "(B) the aggregate branded prescription drug sales of all covered entities taken into account during such preceding calendar year. "(2) Sales taken into account.—For purposes of paragraph (1), the branded prescription drug sales taken into account during any calendar year with respect to any covered entity shall be determined in accordance with the following table:
"(3) Secretarial determination.—The Secretary of the Treasury shall calculate the amount of each covered entity's fee for any calendar year under paragraph (1). In calculating such amount, the Secretary of the Treasury shall determine such covered entity's branded prescription drug sales on the basis of reports submitted under subsection (g) and through the use of any other source of information available to the Secretary of the Treasury. "(4) Applicable amount.—For purposes of paragraph (1), the applicable amount shall be determined in accordance with the following table:
"(c) Transfer of Fees to Medicare Part B Trust Fund.—There is hereby appropriated to the Federal Supplementary Medical Insurance Trust Fund established under section 1841 of the Social Security Act [42 U.S.C. 1395t] an amount equal to the fees received by the Secretary of the Treasury under subsection (a). "(d) Covered Entity.— "(1) In general.—For purposes of this section, the term 'covered entity' means any manufacturer or importer with gross receipts from branded prescription drug sales. "(2) Controlled groups.— "(A) In general.—For purposes of this subsection, all persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 or subsection (m) or (o) of section 414 of such Code shall be treated as a single covered entity. "(B) Inclusion of foreign corporations.—For purposes of subparagraph (A), in applying subsections (a) and (b) of section 52 of such Code to this section, section 1563 of such Code shall be applied without regard to subsection (b)(2)(C) thereof. "(3) Joint and several liability.—If more than one person is liable for payment of the fee under subsection (a) with respect to a single covered entity by reason of the application of paragraph (2), all such persons shall be jointly and severally liable for payment of such fee. "(e) Branded Prescription Drug Sales.—For purposes of this section— "(1) In general.—The term 'branded prescription drug sales' means sales of branded prescription drugs to any specified government program or pursuant to coverage under any such program. "(2) Branded prescription drugs.— "(A) In general.—The term 'branded prescription drug' means— "(i) any prescription drug the application for which was submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)), or "(ii) any biological product the license for which was submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)). "(B) Prescription drug.—For purposes of subparagraph (A)(i), the term 'prescription drug' means any drug which is subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)). "(3) Exclusion of orphan drug sales.—The term 'branded prescription drug sales' shall not include sales of any drug or biological product with respect to which a credit was allowed for any taxable year under section 45C of the Internal Revenue Code of 1986. The preceding sentence shall not apply with respect to any such drug or biological product after the date on which such drug or biological product is approved by the Food and Drug Administration for marketing for any indication other than the treatment of the rare disease or condition with respect to which such credit was allowed. "(4) Specified government program.—The term 'specified government program' means— "(A) the Medicare Part D program under part D of title XVIII of the Social Security Act [42 U.S.C. 1395w–101 et seq.], "(B) the Medicare Part B program under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.], "(C) the Medicaid program under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.], "(D) any program under which branded prescription drugs are procured by the Department of Veterans Affairs, "(E) any program under which branded prescription drugs are procured by the Department of Defense, or "(F) the TRICARE retail pharmacy program under section 1074g of title 10, United States Code. "(f) Tax Treatment of Fees.—The fees imposed by this section— "(1) for purposes of subtitle F of the Internal Revenue Code of 1986, shall be treated as excise taxes with respect to which only civil actions for refund under procedures of such subtitle shall apply, and "(2) for purposes of section 275 of such Code, shall be considered to be a tax described in section 275(a)(6). "(g) Reporting Requirement.—Not later than the date determined by the Secretary of the Treasury following the end of any calendar year, the Secretary of Health and Human Services, the Secretary of Veterans Affairs, and the Secretary of Defense shall report to the Secretary of the Treasury, in such manner as the Secretary of the Treasury prescribes, the total branded prescription drug sales for each covered entity with respect to each specified government program under such Secretary's jurisdiction using the following methodology: "(1) Medicare part d program.—The Secretary of Health and Human Services shall report, for each covered entity and for each branded prescription drug of the covered entity covered by the Medicare Part D program, the product of— "(A) the per-unit ingredient cost, as reported to the Secretary of Health and Human Services by prescription drug plans and Medicare Advantage prescription drug plans, minus any per-unit rebate, discount, or other price concession provided by the covered entity, as reported to the Secretary of Health and Human Services by the prescription drug plans and Medicare Advantage prescription drug plans, and "(B) the number of units of the branded prescription drug paid for under the Medicare Part D program. "(2) Medicare part b program.—The Secretary of Health and Human Services shall report, for each covered entity and for each branded prescription drug of the covered entity covered by the Medicare Part B program under section 1862(a) of the Social Security Act [42 U.S.C. 1395y(a)], the product of— "(A) the per-unit average sales price (as defined in section 1847A(c) of the Social Security Act [42 U.S.C. 1395w–3a(c)]) or the per-unit Part B payment rate for a separately paid branded prescription drug without a reported average sales price, and "(B) the number of units of the branded prescription drug paid for under the Medicare Part B program. The Centers for Medicare and Medicaid Services shall establish a process for determining the units and the allocated price for purposes of this section for those branded prescription drugs that are not separately payable or for which National Drug Codes are not reported. "(3) Medicaid program.—The Secretary of Health and Human Services shall report, for each covered entity and for each branded prescription drug of the covered entity covered under the Medicaid program, the product of— "(A) the per-unit ingredient cost paid to pharmacies by States for the branded prescription drug dispensed to Medicaid beneficiaries, minus any per-unit rebate paid by the covered entity under section 1927 of the Social Security Act [42 U.S.C. 1396r–8] and any State supplemental rebate, and "(B) the number of units of the branded prescription drug paid for under the Medicaid program. "(4) Department of veterans affairs programs.—The Secretary of Veterans Affairs shall report, for each covered entity and for each branded prescription drug of the covered entity the total amount paid for each such branded prescription drug procured by the Department of Veterans Affairs for its beneficiaries. "(5) Department of defense programs and tricare.—The Secretary of Defense shall report, for each covered entity and for each branded prescription drug of the covered entity, the sum of— "(A) the total amount paid for each such branded prescription drug procured by the Department of Defense for its beneficiaries, and "(B) for each such branded prescription drug dispensed under the TRICARE retail pharmacy program, the product of— "(i) the per-unit ingredient cost, minus any per-unit rebate paid by the covered entity, and "(ii) the number of units of the branded prescription drug dispensed under such program. "(h) Secretary.—For purposes of this section, the term 'Secretary' includes the Secretary's delegate. "(i) Guidance.—The Secretary of the Treasury shall publish guidance necessary to carry out the purposes of this section. "(j) Effective Date.—This section shall apply to calendar years beginning after December 31, 2010. "(k) Conforming Amendment.—[Amended section 1395t of Title 42, The Public Health and Welfare.]" [Pub. L. 111–152, title I, §1404(b), Mar. 30, 2010, 124 Stat. 1064, provided that: "The amendments made by this section [amending section 9008 of Pub. L. 111–148, set out above] shall take effect as if included in section 9008 of the Patient Protection and Affordable Care Act [Pub. L. 111–148]."] IMPOSITION OF ANNUAL FEE ON MEDICAL DEVICE MANUFACTURERS AND IMPORTERSPub. L. 111–148, title IX, §9009, Mar. 23, 2010, 124 Stat. 862, as amended by Pub. L. 111–148, title X, §10904(a), Mar. 23, 2010, 124 Stat. 1016, provided for the imposition of an annual fee on medical device manufacturers and importers in calendar years beginning after 2010, prior to repeal by Pub. L. 111–152, title I, §1405(d), Mar. 30, 2010, 124 Stat. 1065. [Pub. L. 111–152, title I, §1405(d), Mar. 30, 2010, 124 Stat. 1065, provided that the repeal of section 9009 of Pub. L. 111–148, formerly set out above, is effective as of Mar. 23, 2010.] IMPOSITION OF ANNUAL FEE ON HEALTH INSURANCE PROVIDERSPub. L. 111–148, title IX, §9010, title X, §10905(a)–(f), Mar. 23, 2010, 124 Stat. 865, 1017–1019, as amended by Pub. L. 111–152, title I, §1406(a), Mar. 30, 2010, 124 Stat. 1065; Pub. L. 114–113, div. P, title II, §201, Dec. 18, 2015, 129 Stat. 3037; Pub. L. 115–120, div. D, §4003(b), Jan. 22, 2018, 132 Stat. 38, which imposed an annual fee on certain entities that provided health insurance for any United States health risk, was repealed by Pub. L. 116–94, div. N, title I, §502(a), Dec. 20, 2019, 133 Stat. 3119. [Pub. L. 116–94, div. N, title I, §502(b), Dec. 20, 2019, 133 Stat. 3119, provided that, "The amendment made by this section [repealing section 9010 of Pub. L. 111–148, formerly set out above] shall apply to calendar years beginning after December 31, 2020."] |
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1 Section numbers editorially supplied. |
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| United States Code, 2018 Edition, Supplement 3, Title 26 - INTERNAL REVENUE CODE | ||||||||||||||||||||||||||||||||||
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| Title 26 - INTERNAL REVENUE CODE Subtitle D - Miscellaneous Excise Taxes - Front Matter |
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| 78 Stat. 841 83 Stat. 532 88 Stat. 932 90 Stat. 1728 92 Stat. 22 94 Stat. 250, 2801 96 Stat. 598, 2177 98 Stat. 587 100 Stat. 2012 101 Stat. 1330-467 102 Stat. 1324 103 Stat. 2233 104 Stat. 1388-522 118 Stat. 1568 124 Stat. 249, 859, 862, 865, 872, 1016, 1020, 1064, 1065, 3666 129 Stat. 3037 132 Stat. 38 133 Stat. 3119 |
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| Public Law 88-563, Public Law 91-172, Public Law 93-406, Public Law 94-455, Public Law 95-227, Public Law 96-223, Public Law 96-510, Public Law 97-248, Public Law 97-424, Public Law 98-369, Public Law 99-509, Public Law 100-203, Public Law 100-418, Public Law 101-239, Public Law 101-508, Public Law 108-357, Public Law 111-148, Public Law 111-152, Public Law 111-347, Public Law 114-113, Public Law 115-120, Public Law 116-94 |
