Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB249 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 249
5	5	To amend title XVIII of the Social Security Act to facilitate patient access
6	6	to certain pediatric technologies.
7	7	IN THE SENATE OF THE UNITED STATES
8	8	JANUARY24, 2025
9	9	Mrs. B
10	10	LACKBURN(for herself and Mr. LANKFORD) introduced the following
11	11	bill; which 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 facilitate
14	14	patient access to certain pediatric technologies.
15	15	Be it enacted by the Senate and House of Representa-1
16	16	tives of the United States of America in Congress assembled, 2
17	17	SECTION 1. SHORT TITLE. 3
18	18	This Act may be cited as the ‘‘Access to Pediatric 4
19	19	Technologies Act of 2025’’. 5
20	20	SEC. 2. FACILITATING ACCESS TO PEDIATRIC TECH-6
21	21	NOLOGIES. 7
22	22	(a) I
23	23	NGENERAL.—Section 1848 of the Social Secu-8
24	24	rity Act (42 U.S.C. 1395w–4) is amended by adding at 9
25	25	the end the following new subsection: 10
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28	28	•S 249 IS
29	29	‘‘(u) FACILITATINGACCESS TOPEDIATRICTECH-1
30	30	NOLOGIES.— 2
31	31	‘‘(1) I
32	32	N GENERAL.—For each qualifying pedi-3
33	33	atric technology (as defined in paragraph (4)) fur-4
34	34	nished on or after January 1, 2026, the Secretary 5
35	35	shall, upon receipt of a manufacturer request under 6
36	36	paragraph (3), establish national relative value units 7
37	37	under the physician fee schedule established under 8
38	38	this section, to the extent no such national relative 9
39	39	value units have been established for such qualifying 10
40	40	pediatric technology under such fee schedule. 11
41	41	‘‘(2) P
42	42	AYMENT METHODOLOGY .—The Secretary 12
43	43	shall establish national relative value units for a 13
44	44	qualifying pediatric technology under this sub-14
45	45	section— 15
46	46	‘‘(A) in accordance with the payment 16
47	47	methodology established under this section and 17
48	48	applicable regulations; and 18
49	49	‘‘(B) using available data related to the 19
50	50	qualifying pediatric technology, which may in-20
51	51	clude applicable contractor pricing information, 21
52	52	claims data, time and motion studies, invoice 22
53	53	information, or other information used by the 23
54	54	Secretary in establishing payment rates. 24
55	55	‘‘(3) I
56	56	MPLEMENTATION.— 25
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60	60	‘‘(A) IN GENERAL.—Upon written request 1
61	61	to the Secretary from the manufacturer of a 2
62	62	qualifying pediatric technology, the Secretary 3
63	63	shall establish national relative value units 4
64	64	under paragraph (1) through the annual rule-5
65	65	making process for the physician fee schedule 6
66	66	established under this section, in accordance 7
67	67	with the timeline described in subparagraph 8
68	68	(B). 9
69	69	‘‘(B) T
70	70	IMELINE.— 10
71	71	‘‘(i) In the case where the Secretary 11
72	72	receives a request under this paragraph on 12
73	73	or before May 1 of a given year from a 13
74	74	manufacturer with respect to a qualifying 14
75	75	pediatric technology of the manufacturer, 15
76	76	the Secretary shall establish national rel-16
77	77	ative value units for the qualifying pedi-17
78	78	atric technology in the rulemaking process 18
79	79	during that year for the physician fee 19
80	80	schedule established under this section. 20
81	81	‘‘(ii) In the case where the Secretary 21
82	82	receives a request under this paragraph 22
83	83	after May 1 of a given year from a manu-23
84	84	facturer with respect to a qualifying pedi-24
85	85	atric technology of the manufacturer, the 25
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88	88	•S 249 IS
89	89	Secretary shall establish national relative 1
90	90	value units for the qualifying pediatric 2
91	91	technology in the rulemaking process dur-3
92	92	ing the following year for the physician fee 4
93	93	schedule established under this section. 5
94	94	‘‘(C) C
95	95	ONTENT OF MANUFACTURER RE -6
96	96	QUESTS.—A manufacturer submitting a request 7
97	97	under this paragraph with respect to a quali-8
98	98	fying pediatric technology of the manufacturer 9
99	99	shall include in such request information to 10
100	100	verify that the technology is a qualifying pedi-11
101	101	atric technology and to allow the Secretary to 12
102	102	establish national relative value units for such 13
103	103	technology, including (to the extent available) 14
104	104	contractor pricing information, claims data, 15
105	105	time and motion studies, invoice information, or 16
106	106	other relevant information. 17
107	107	‘‘(4) Q
108	108	UALIFYING PEDIATRIC TECHNOLOGY DE -18
109	109	FINED.—In this subsection, the term ‘qualifying pe-19
110	110	diatric technology’ means a medical device that is— 20
111	111	‘‘(A) covered under this title; 21
112	112	‘‘(B) approved, cleared, or authorized 22
113	113	under section 510(k), 513(f)(2), or 515 of the 23
114	114	Federal Food, Drug, and Cosmetic Act (21 24
115	115	U.S.C. 360(k), 360c(f)(2), 360e); 25
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119	119	‘‘(C) described by a temporary Level I 1
120	120	HCPCS Code intended for emerging tech-2
121	121	nologies, services, or procedures; and 3
122	122	‘‘(D)(i) used as part of a procedure pre-4
123	123	dominantly performed on pediatric patients; or 5
124	124	‘‘(ii) has otherwise been specifically de-6
125	125	signed for safe and effective use in pediatric 7
126	126	populations. 8
127	127	‘‘(5) R
128	128	ULE OF CONSTRUCTION .—Nothing in 9
129	129	this subsection shall be construed to require cov-10
130	130	erage of a qualifying pediatric technology under this 11
131	131	title or alter the requirements of section 12
132	132	1862(a)(1)(A).’’. 13
133	133	Æ
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