I 119THCONGRESS 1 STSESSION H. R. 1476 To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. IN THE HOUSE OF REPRESENTATIVES FEBRUARY21, 2025 Mr. H UDSON(for himself, Mr. DAVISof North Carolina, Mr. MURPHY, and Mr. P ETERS) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manu- facturer discount program. Be it enacted by the Senate and House of Representa-1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Preserving Life-saving 4 Access to Specialty Medicines in America Act’’ or the 5 ‘‘PLASMA Act’’. 6 VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1476.IH H1476 ssavage on LAPJG3WLY3PROD with BILLS 2 •HR 1476 IH SEC. 2. PHASE-IN FOR PLASMA-DERIVED PRODUCTS UNDER 1 MANUFACTURER DISCOUNT PROGRAM. 2 Section 1860D–14C(g)(4) of the Social Security Act 3 (42 U.S.C. 1395w–114c(g)(4)) is amended— 4 (1) in subparagraph (A), in the matter pre-5 ceding clause (i), by striking ‘‘and (C)’’ and insert-6 ing ‘‘, (C), and (D)’’; 7 (2) by redesignating subparagraphs (D) and 8 (E) as subparagraphs (E) and (F), respectively; and 9 (3) by inserting after subparagraph (C) the fol-10 lowing: 11 ‘‘(D) P HASE-IN FOR PLASMA -DERIVED 12 PRODUCTS.— 13 ‘‘(i) I N GENERAL.—For 2026 and 14 subsequent years, subject to clause (iv), in 15 the case of an applicable drug of a manu-16 facturer that is a plasma-derived product 17 (as defined in clause (ii)), and that is mar-18 keted as of August 16, 2022, and dis-19 pensed for an applicable beneficiary, the 20 term ‘discounted price’ means the specified 21 plasma-derived product percent (as defined 22 in clause (iii)) of the negotiated price of 23 the applicable drug of the manufacturer. 24 ‘‘(ii) P LASMA-DERIVED PRODUCT.—In 25 this subparagraph, the term ‘plasma-de-26 VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1476.IH H1476 ssavage on LAPJG3WLY3PROD with BILLS 3 •HR 1476 IH rived product’ means an applicable drug 1 that is a biological product that is derived 2 from human whole blood or plasma. 3 ‘‘(iii) S PECIFIED PLASMA -DERIVED 4 PRODUCT PERCENT .—In this subpara-5 graph, the term ‘specified plasma-derived 6 product percent’ means, with respect to a 7 year— 8 ‘‘(I) for an applicable drug that 9 is a plasma-derived product dispensed 10 for an applicable beneficiary who has 11 not incurred costs, as determined in 12 accordance with section 1860D– 13 2(b)(4)(C), for covered part D drugs 14 in the year that are equal to or exceed 15 the annual out-of-pocket threshold 16 specified in section 1860D– 17 2(b)(4)(B)(i) for the year— 18 ‘‘(aa) for 2026, 99 percent; 19 ‘‘(bb) for 2027, 98 percent; 20 ‘‘(cc) for 2028, 95 percent; 21 ‘‘(dd) for 2029, 92 percent; 22 and 23 ‘‘(ee) for 2030 and each 24 subsequent year, 90 percent; and 25 VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1476.IH H1476 ssavage on LAPJG3WLY3PROD with BILLS 4 •HR 1476 IH ‘‘(II) for an applicable drug that 1 is a plasma-derived product dispensed 2 for an applicable beneficiary who has 3 incurred costs, as determined in ac-4 cordance with section 1860D– 5 2(b)(4)(C), for covered part D drugs 6 in the year that are equal to or exceed 7 the annual out-of-pocket threshold 8 specified in section 1860D– 9 2(b)(4)(B)(i) for the year— 10 ‘‘(aa) for 2026, 99 percent; 11 ‘‘(bb) for 2027, 98 percent; 12 ‘‘(cc) for 2028, 95 percent; 13 ‘‘(dd) for 2029, 92 percent; 14 ‘‘(ee) for 2030, 90 percent; 15 ‘‘(ff) for 2031, 85 percent; 16 and 17 ‘‘(gg) for 2032 and each 18 subsequent year, 80 percent. 19 ‘‘(iv) L IMITATIONS.—This subpara-20 graph shall not apply with respect to the 21 following: 22 ‘‘(I) C ERTAIN DRUGS DISPENSED 23 TO LIS BENEFICIARIES.—An applica-24 VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1476.IH H1476 ssavage on LAPJG3WLY3PROD with BILLS 5 •HR 1476 IH ble drug described in subparagraph 1 (B)(i). 2 ‘‘(II) S PECIFIED SMALL MANU -3 FACTURERS.—An applicable drug de-4 scribed in subparagraph (C)(i).’’. 5 Æ VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H1476.IH H1476 ssavage on LAPJG3WLY3PROD with BILLS