| 1 | 1 | | I |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION H. R. 1922 |
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| 5 | 5 | | To amend title XVIII of the Social Security Act to exempt certain drugs |
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| 6 | 6 | | from the part D manufacturer discount program under the Medicare program. |
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| 7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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| 8 | 8 | | MARCH6, 2025 |
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| 9 | 9 | | Mr. G |
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| 10 | 10 | | ARBARINO(for himself, Mrs. HARSHBARGER, and Mr. SUOZZI) intro- |
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| 11 | 11 | | duced the following bill; which was referred to the Committee on Energy |
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| 12 | 12 | | and Commerce, and in addition to the Committee on Ways and Means, |
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| 13 | 13 | | for a period to be subsequently determined by the Speaker, in each case |
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| 14 | 14 | | for consideration of such provisions as fall within the jurisdiction of the |
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| 15 | 15 | | committee concerned |
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| 16 | 16 | | A BILL |
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| 17 | 17 | | To amend title XVIII of the Social Security Act to exempt |
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| 18 | 18 | | certain drugs from the part D manufacturer discount |
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| 19 | 19 | | program under the Medicare program. |
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| 20 | 20 | | Be it enacted by the Senate and House of Representa-1 |
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| 21 | 21 | | tives of the United States of America in Congress assembled, 2 |
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| 22 | 22 | | SECTION 1. SHORT TITLE. 3 |
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| 23 | 23 | | This Act may be cited as the ‘‘Ensuring Access to 4 |
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| 24 | 24 | | Essential Drugs Act’’. 5 |
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| 25 | 25 | | VerDate Sep 11 2014 01:09 Mar 20, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1922.IH H1922 |
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| 26 | 26 | | ssavage on LAPJG3WLY3PROD with BILLS 2 |
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| 27 | 27 | | •HR 1922 IH |
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| 28 | 28 | | SEC. 2. EXEMPTING CERTAIN DRUGS FROM THE PART D 1 |
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| 29 | 29 | | MANUFACTURER DISCOUNT PROGRAM 2 |
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| 30 | 30 | | UNDER THE MEDICARE PROGRAM. 3 |
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| 31 | 31 | | Section 1860D–14C(g)(2) of the Social Security Act 4 |
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| 32 | 32 | | (42 U.S.C. 1395w–114c(g)(2)) is amended— 5 |
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| 33 | 33 | | (1) in subparagraph (A), by striking ‘‘and’’ at 6 |
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| 34 | 34 | | the end; 7 |
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| 35 | 35 | | (2) in subparagraph (B), by striking the period 8 |
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| 36 | 36 | | and inserting ‘‘; and’’; and 9 |
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| 37 | 37 | | (3) by adding at the end the following new sub-10 |
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| 38 | 38 | | paragraph: 11 |
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| 39 | 39 | | ‘‘(C) does not include an orally adminis-12 |
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| 40 | 40 | | tered drug— 13 |
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| 41 | 41 | | ‘‘(i) for which a new drug application 14 |
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| 42 | 42 | | was approved under section 505 of the 15 |
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| 43 | 43 | | Federal Food, Drug, and Cosmetic Act; 16 |
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| 44 | 44 | | and 17 |
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| 45 | 45 | | ‘‘(ii) that has been granted a narrow 18 |
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| 46 | 46 | | exception permitting reclassification as a 19 |
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| 47 | 47 | | noninnovator multiple source drug under 20 |
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| 48 | 48 | | the Medicaid drug rebate program by the 21 |
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| 49 | 49 | | Centers for Medicare & Medicaid Serv-22 |
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| 50 | 50 | | ices.’’. 23 |
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| 51 | 51 | | Æ |
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| 52 | 52 | | VerDate Sep 11 2014 01:09 Mar 20, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H1922.IH H1922 |
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| 53 | 53 | | ssavage on LAPJG3WLY3PROD with BILLS |
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