Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB339 Compare Versions

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Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 339
5	5	To amend title XVIII of the Social Security Act to provide for Medicare
6	6	coverage of multi-cancer early detection screening tests.
7	7	IN THE SENATE OF THE UNITED STATES
8	8	JANUARY30, 2025
9	9	Mr. C
10	10	RAPO(for himself, Mr. BENNET, Mr. SCOTTof South Carolina, and Mr.
11	11	W
12	12	YDEN) introduced the following bill; which was read twice and referred
13	13	to the Committee on Finance
14	14	A BILL
15	15	To amend title XVIII of the Social Security Act to provide
16	16	for Medicare coverage of multi-cancer early detection
17	17	screening tests.
18	18	Be it enacted by the Senate and House of Representa-1
19	19	tives of the United States of America in Congress assembled, 2
20	20	SECTION 1. SHORT TITLE. 3
21	21	This Act may be cited as the ‘‘Nancy Gardner Sewell 4
22	22	Medicare Multi-Cancer Early Detection Screening Cov-5
23	23	erage Act’’. 6
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26	26	•S 339 IS
27	27	SEC. 2. MEDICARE COVERAGE OF MULTI-CANCER EARLY 1
28	28	DETECTION SCREENING TESTS. 2
29	29	(a) C
30	30	OVERAGE.—Section 1861 of the Social Security 3
31	31	Act (42 U.S.C. 1395x) is amended— 4
32	32	(1) in subsection (s)(2)— 5
33	33	(A) by striking the semicolon at the end of 6
34	34	subparagraph (JJ) and inserting ‘‘; and’’; and 7
35	35	(B) by adding at the end the following new 8
36	36	subparagraph: 9
37	37	‘‘(KK) multi-cancer early detection screening 10
38	38	tests (as defined in subsection (nnn));’’; and 11
39	39	(2) by adding at the end the following new sub-12
40	40	section: 13
41	41	‘‘(nnn) M
42	42	ULTI-CANCEREARLYDETECTIONSCREEN-14
43	43	INGTESTS.— 15
44	44	‘‘(1) I
45	45	N GENERAL.—The term ‘multi-cancer 16
46	46	early detection screening test’ means a test fur-17
47	47	nished to an individual for the concurrent detection 18
48	48	of multiple cancer types across multiple organ sites 19
49	49	on or after January 1, 2028, that— 20
50	50	‘‘(A) is cleared under section 510(k), clas-21
51	51	sified under section 513(f)(2), or approved 22
52	52	under section 515 of the Federal Food, Drug, 23
53	53	and Cosmetic Act; 24
54	54	‘‘(B) is— 25
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57	57	•S 339 IS
58	58	‘‘(i) a genomic sequencing blood or 1
59	59	blood product test that includes the anal-2
60	60	ysis of cell-free nucleic acids; or 3
61	61	‘‘(ii) a test based on samples of bio-4
62	62	logical material that provides results com-5
63	63	parable to those obtained with a test de-6
64	64	scribed in clause (i), as determined by the 7
65	65	Secretary; and 8
66	66	‘‘(C) the Secretary determines is— 9
67	67	‘‘(i) reasonable and necessary for the 10
68	68	prevention or early detection of an illness 11
69	69	or disability; and 12
70	70	‘‘(ii) appropriate for individuals enti-13
71	71	tled to benefits under part A or enrolled 14
72	72	under part B. 15
73	73	‘‘(2) NCD
74	74	PROCESS.—In making determina-16
75	75	tions under paragraph (1)(C) regarding the coverage 17
76	76	of a new test, the Secretary shall use the process for 18
77	77	making national coverage determinations (as defined 19
78	78	in section 1869(f)(1)(B)) under this title.’’. 20
79	79	(b) P
80	80	AYMENT ANDSTANDARDS FOR MULTI-CANCER 21
81	81	E
82	82	ARLYDETECTIONSCREENINGTESTS.— 22
83	83	(1) I
84	84	N GENERAL.—Section 1834 of the Social 23
85	85	Security Act (42 U.S.C. 1395m) is amended by add-24
86	86	ing at the end the following new subsection: 25
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89	89	•S 339 IS
90	90	‘‘(aa) PAYMENT AND STANDARDS FOR MULTI-CAN-1
91	91	CEREARLYDETECTIONSCREENINGTESTS.— 2
92	92	‘‘(1) P
93	93	AYMENT AMOUNT .—The payment 3
94	94	amount for a multi-cancer early detection screening 4
95	95	test (as defined in section 1861(nnn)) is— 5
96	96	‘‘(A) with respect to such a test furnished 6
97	97	before January 1, 2031, equal to the payment 7
98	98	amount in effect on the date of the enactment 8
99	99	of this subsection for a multi-target stool 9
100	100	screening DNA test covered pursuant to section 10
101	101	1861(pp)(1)(D); and 11
102	102	‘‘(B) with respect to such a test furnished 12
103	103	on or after January 1, 2031, equal to the lesser 13
104	104	of— 14
105	105	‘‘(i) the amount described in subpara-15
106	106	graph (A); or 16
107	107	‘‘(ii) the payment amount determined 17
108	108	for such test under section 1834A. 18
109	109	‘‘(2) L
110	110	IMITATIONS.— 19
111	111	‘‘(A) I
112	112	N GENERAL.—No payment may be 20
113	113	made under this part for a multi-cancer early 21
114	114	detection screening test furnished during a year 22
115	115	to an individual if— 23
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118	118	•S 339 IS
119	119	‘‘(i) as of January 1 of such year, 1
120	120	such individual has attained the age speci-2
121	121	fied in subparagraph (B) for such year; or 3
122	122	‘‘(ii) such a test was furnished to the 4
123	123	individual during the previous 11 months. 5
124	124	‘‘(B) A
125	125	GE SPECIFIED.—For purposes of 6
126	126	subparagraph (A)(i), the age specified in this 7
127	127	subparagraph is— 8
128	128	‘‘(i) for 2028, 68 years of age; and 9
129	129	‘‘(ii) for a succeeding year, the age 10
130	130	specified in this subparagraph for the pre-11
131	131	ceding year, increased by 1 year. 12
132	132	‘‘(3) S
133	133	TANDARDS FOLLOWING USPSTF RAT -13
134	134	ING.—In the case of a multi-cancer early detection 14
135	135	screening test that is recommended with a grade of 15
136	136	A or B by the United States Preventive Services 16
137	137	Task Force, beginning on the date on which cov-17
138	138	erage for such test is provided pursuant to section 18
139	139	1861(ddd)(1), the preceding provisions of this sub-19
140	140	section shall not apply.’’. 20
141	141	(2) C
142	142	ONFORMING AMENDMENTS .— 21
143	143	(A) Section 1833 of the Social Security 22
144	144	Act (42 U.S.C. 1395l) is amended— 23
145	145	(i) in subsection (a)— 24
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148	148	•S 339 IS
149	149	(I) in paragraph (1)(D)(i)(I), by 1
150	150	striking ‘‘section 1834(d)(1)’’ and in-2
151	151	serting ‘‘subsection (d)(1) or (aa) of 3
152	152	section 1834’’; and 4
153	153	(II) in paragraph (2)(D)(i)(I), by 5
154	154	striking ‘‘section 1834(d)(1)’’ and in-6
155	155	serting ‘‘subsection (d)(1) or (aa) of 7
156	156	section 1834’’; and 8
157	157	(ii) in subsection (h), by striking ‘‘sec-9
158	158	tion 1834(d)(1)’’ and inserting ‘‘sub-10
159	159	sections (d)(1) and (aa) of section 1834’’. 11
160	160	(B) Section 1862(a) of the Social Security 12
161	161	Act (42 U.S.C. 1395y(a)) is amended— 13
162	162	(i) in paragraph (1)— 14
163	163	(I) in subparagraph (O), by 15
164	164	striking ‘‘and’’ at the end; 16
165	165	(II) in subparagraph (P), by 17
166	166	striking the semicolon at the end and 18
167	167	inserting ‘‘, and’’; and 19
168	168	(III) by adding at the end the 20
169	169	following new subparagraph: 21
170	170	‘‘(Q) in the case of multi-cancer early detection 22
171	171	screening tests (as defined in section 1861(nnn)), 23
172	172	which are not reasonable and necessary for the con-24
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175	175	•S 339 IS
176	176	current detection of multiple cancer types across 1
177	177	multiple organ sites;’’; and 2
178	178	(ii) in paragraph (7), by striking ‘‘or 3
179	179	(P)’’ and inserting ‘‘(P), or (Q)’’. 4
180	180	(c) R
181	181	ULE OFCONSTRUCTIONRELATING TOOTHER 5
182	182	C
183	183	ANCERSCREENINGTESTS.—Nothing in this section, in-6
184	184	cluding the amendments made by this section, shall be 7
185	185	construed— 8
186	186	(1) in the case of an individual who undergoes 9
187	187	a multi-cancer early detection screening test, to af-10
188	188	fect coverage under part B of title XVIII of the So-11
189	189	cial Security Act for other cancer screening tests 12
190	190	covered under such title, such as screening tests for 13
191	191	breast, cervical, colorectal, lung, or prostate cancer; 14
192	192	or 15
193	193	(2) in the case of an individual who undergoes 16
194	194	another cancer screening test, to affect coverage 17
195	195	under such part for a multi-cancer early detection 18
196	196	screening test or the use of such a test as a diag-19
197	197	nostic or confirmatory test for a result of the other 20
198	198	cancer screening test. 21
199	199	Æ
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