1 | 1 | | II |
---|
2 | 2 | | 119THCONGRESS |
---|
3 | 3 | | 1 |
---|
4 | 4 | | STSESSION S. 694 |
---|
5 | 5 | | To amend title XVIII of the Social Security Act to provide a phase-in |
---|
6 | 6 | | for plasma-derived products under the manufacturer discount program. |
---|
7 | 7 | | IN THE SENATE OF THE UNITED STATES |
---|
8 | 8 | | FEBRUARY24, 2025 |
---|
9 | 9 | | Mr. T |
---|
10 | 10 | | ILLIS(for himself and Mr. KELLY) introduced the following bill; which |
---|
11 | 11 | | was read twice and referred to the Committee on Finance |
---|
12 | 12 | | A BILL |
---|
13 | 13 | | To amend title XVIII of the Social Security Act to provide |
---|
14 | 14 | | a phase-in for plasma-derived products under the manu- |
---|
15 | 15 | | facturer discount program. |
---|
16 | 16 | | Be it enacted by the Senate and House of Representa-1 |
---|
17 | 17 | | tives of the United States of America in Congress assembled, 2 |
---|
18 | 18 | | SECTION 1. SHORT TITLE. 3 |
---|
19 | 19 | | This Act may be cited as the ‘‘Preserving Life-saving 4 |
---|
20 | 20 | | Access to Specialty Medicines in America Act’’ or the 5 |
---|
21 | 21 | | ‘‘PLASMA Act’’. 6 |
---|
22 | 22 | | SEC. 2. PHASE-IN FOR PLASMA-DERIVED PRODUCTS UNDER 7 |
---|
23 | 23 | | MANUFACTURER DISCOUNT PROGRAM. 8 |
---|
24 | 24 | | Section 1860D–14C(g)(4) of the Social Security Act 9 |
---|
25 | 25 | | (42 U.S.C. 1395w–114c(g)(4)) is amended— 10 |
---|
26 | 26 | | VerDate Sep 11 2014 07:16 Mar 13, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S694.IS S694 |
---|
27 | 27 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
---|
28 | 28 | | •S 694 IS |
---|
29 | 29 | | (1) in subparagraph (A), in the matter pre-1 |
---|
30 | 30 | | ceding clause (i), by striking ‘‘and (C)’’ and insert-2 |
---|
31 | 31 | | ing ‘‘, (C), and (D)’’; 3 |
---|
32 | 32 | | (2) by redesignating subparagraphs (D) and 4 |
---|
33 | 33 | | (E) as subparagraphs (E) and (F), respectively; and 5 |
---|
34 | 34 | | (3) by inserting after subparagraph (C) the fol-6 |
---|
35 | 35 | | lowing: 7 |
---|
36 | 36 | | ‘‘(D) P |
---|
37 | 37 | | HASE-IN FOR PLASMA -DERIVED 8 |
---|
38 | 38 | | PRODUCTS.— 9 |
---|
39 | 39 | | ‘‘(i) I |
---|
40 | 40 | | N GENERAL.—For 2026 and 10 |
---|
41 | 41 | | subsequent years, subject to clause (iv), in 11 |
---|
42 | 42 | | the case of an applicable drug of a manu-12 |
---|
43 | 43 | | facturer that is a plasma-derived product 13 |
---|
44 | 44 | | (as defined in clause (ii)), and that is mar-14 |
---|
45 | 45 | | keted as of August 16, 2022, and dis-15 |
---|
46 | 46 | | pensed for an applicable beneficiary, the 16 |
---|
47 | 47 | | term ‘discounted price’ means the specified 17 |
---|
48 | 48 | | plasma-derived product percent (as defined 18 |
---|
49 | 49 | | in clause (iii)) of the negotiated price of 19 |
---|
50 | 50 | | the applicable drug of the manufacturer. 20 |
---|
51 | 51 | | ‘‘(ii) P |
---|
52 | 52 | | LASMA-DERIVED PRODUCT.—In 21 |
---|
53 | 53 | | this subparagraph, the term ‘plasma-de-22 |
---|
54 | 54 | | rived product’ means an applicable drug 23 |
---|
55 | 55 | | that is a biological product that is derived 24 |
---|
56 | 56 | | from human whole blood or plasma. 25 |
---|
57 | 57 | | VerDate Sep 11 2014 07:16 Mar 13, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S694.IS S694 |
---|
58 | 58 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 |
---|
59 | 59 | | •S 694 IS |
---|
60 | 60 | | ‘‘(iii) SPECIFIED PLASMA -DERIVED 1 |
---|
61 | 61 | | PRODUCT PERCENT .—In this subpara-2 |
---|
62 | 62 | | graph, the term ‘specified plasma-derived 3 |
---|
63 | 63 | | product percent’ means, with respect to a 4 |
---|
64 | 64 | | year— 5 |
---|
65 | 65 | | ‘‘(I) for an applicable drug that 6 |
---|
66 | 66 | | is a plasma-derived product dispensed 7 |
---|
67 | 67 | | for an applicable beneficiary who has 8 |
---|
68 | 68 | | not incurred costs, as determined in 9 |
---|
69 | 69 | | accordance with section 1860D– 10 |
---|
70 | 70 | | 2(b)(4)(C), for covered part D drugs 11 |
---|
71 | 71 | | in the year that are equal to or exceed 12 |
---|
72 | 72 | | the annual out-of-pocket threshold 13 |
---|
73 | 73 | | specified in section 1860D– 14 |
---|
74 | 74 | | 2(b)(4)(B)(i) for the year— 15 |
---|
75 | 75 | | ‘‘(aa) for 2026, 99 percent; 16 |
---|
76 | 76 | | ‘‘(bb) for 2027, 98 percent; 17 |
---|
77 | 77 | | ‘‘(cc) for 2028, 95 percent; 18 |
---|
78 | 78 | | ‘‘(dd) for 2029, 92 percent; 19 |
---|
79 | 79 | | and 20 |
---|
80 | 80 | | ‘‘(ee) for 2030 and each 21 |
---|
81 | 81 | | subsequent year, 90 percent; and 22 |
---|
82 | 82 | | ‘‘(II) for an applicable drug that 23 |
---|
83 | 83 | | is a plasma-derived product dispensed 24 |
---|
84 | 84 | | for an applicable beneficiary who has 25 |
---|
85 | 85 | | VerDate Sep 11 2014 07:16 Mar 13, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S694.IS S694 |
---|
86 | 86 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 |
---|
87 | 87 | | •S 694 IS |
---|
88 | 88 | | incurred costs, as determined in ac-1 |
---|
89 | 89 | | cordance with section 1860D– 2 |
---|
90 | 90 | | 2(b)(4)(C), for covered part D drugs 3 |
---|
91 | 91 | | in the year that are equal to or exceed 4 |
---|
92 | 92 | | the annual out-of-pocket threshold 5 |
---|
93 | 93 | | specified in section 1860D– 6 |
---|
94 | 94 | | 2(b)(4)(B)(i) for the year— 7 |
---|
95 | 95 | | ‘‘(aa) for 2026, 99 percent; 8 |
---|
96 | 96 | | ‘‘(bb) for 2027, 98 percent; 9 |
---|
97 | 97 | | ‘‘(cc) for 2028, 95 percent; 10 |
---|
98 | 98 | | ‘‘(dd) for 2029, 92 percent; 11 |
---|
99 | 99 | | ‘‘(ee) for 2030, 90 percent; 12 |
---|
100 | 100 | | ‘‘(ff) for 2031, 85 percent; 13 |
---|
101 | 101 | | and 14 |
---|
102 | 102 | | ‘‘(gg) for 2032 and each 15 |
---|
103 | 103 | | subsequent year, 80 percent. 16 |
---|
104 | 104 | | ‘‘(iv) L |
---|
105 | 105 | | IMITATIONS.—This subpara-17 |
---|
106 | 106 | | graph shall not apply with respect to the 18 |
---|
107 | 107 | | following: 19 |
---|
108 | 108 | | ‘‘(I) C |
---|
109 | 109 | | ERTAIN DRUGS DISPENSED 20 |
---|
110 | 110 | | TO LIS BENEFICIARIES.—An applica-21 |
---|
111 | 111 | | ble drug described in subparagraph 22 |
---|
112 | 112 | | (B)(i). 23 |
---|
113 | 113 | | VerDate Sep 11 2014 07:16 Mar 13, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S694.IS S694 |
---|
114 | 114 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 5 |
---|
115 | 115 | | •S 694 IS |
---|
116 | 116 | | ‘‘(II) SPECIFIED SMALL MANU -1 |
---|
117 | 117 | | FACTURERS.—An applicable drug de-2 |
---|
118 | 118 | | scribed in subparagraph (C)(i).’’. 3 |
---|
119 | 119 | | Æ |
---|
120 | 120 | | VerDate Sep 11 2014 07:16 Mar 13, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S694.IS S694 |
---|
121 | 121 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB |
---|