Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB1399 Compare Versions

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Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 1399
5	5	To amend title XVIII of the Social Security Act to ensure appropriate
6	6	payment of certain algorithm-based healthcare services under the Medi-
7	7	care program.
8	8	IN THE SENATE OF THE UNITED STATES
9	9	APRIL9, 2025
10	10	Mr. R
11	11	OUNDS(for himself, Mr. HEINRICH, and Mrs. BLACKBURN) introduced
12	12	the following bill; which was read twice and referred to the Committee
13	13	on Finance
14	14	A BILL
15	15	To amend title XVIII of the Social Security Act to ensure
16	16	appropriate payment of certain algorithm-based
17	17	healthcare services under the Medicare program.
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 ‘‘Health Tech Invest-4
22	22	ment Act’’. 5
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25	25	•S 1399 IS
26	26	SEC. 2. ENSURING APPROPRIATE PAYMENT OF CERTAIN 1
27	27	ALGORITHM-BASED HEALTHCARE SERVICES 2
28	28	UNDER THE MEDICARE PROGRAM. 3
29	29	(a) I
30	30	NGENERAL.—Section 1833(t) of the Social Se-4
31	31	curity Act (42 U.S.C. 1395l(t)) is amended— 5
32	32	(1) in paragraph (2)(E), by inserting ‘‘and new 6
33	33	technology ambulatory payment classification of al-7
34	34	gorithm-based healthcare services under paragraph 8
35	35	(16)(H)’’ after ‘‘(16)(G)’’; and 9
36	36	(2) in paragraph (16), by adding at the end the 10
37	37	following new subparagraph: 11
38	38	‘‘(H) S
39	39	PECIAL RULE FOR CERTAIN ALGO -12
40	40	RITHM-BASED HEALTHCARE SERVICES .— 13
41	41	‘‘(i) I
42	42	N GENERAL.—In the case of a 14
43	43	covered OPD service furnished on or after 15
44	44	January 1, 2026, that is an algorithm- 16
45	45	based healthcare service (as defined in 17
46	46	clause (ii)) that is assigned to a new tech-18
47	47	nology ambulatory payment classification 19
48	48	(as described in the final rule entitled 20
49	49	‘Medicare Program; Changes to the Hos-21
50	50	pital Outpatient Prospective Payment Sys-22
51	51	tem for Calendar Year 2002’ published by 23
52	52	the Department of Health and Human 24
53	53	Services on November 30, 2001 (66 Fed. 25
54	54	Reg. 59897)) on or after the date of the 26
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57	57	•S 1399 IS
58	58	enactment of this subparagraph or for 1
59	59	which, as of such date, is currently and 2
60	60	has been assigned to a new technology am-3
61	61	bulatory payment classification for a pe-4
62	62	riod of less than 5 years, the Secretary— 5
63	63	‘‘(I) shall ensure that such serv-6
64	64	ice is assigned to a new technology 7
65	65	ambulatory payment classification 8
66	66	based on the cost of such service as 9
67	67	submitted by the manufacturer of 10
68	68	such service in a form and manner 11
69	69	specified by the Secretary, including 12
70	70	costs for the technology based on in-13
71	71	voice prices, subscription-based prices, 14
72	72	clinical staff, overhead, and other 15
73	73	costs associated with providing the 16
74	74	service; 17
75	75	‘‘(II) shall adjust the new tech-18
76	76	nology ambulatory payment classifica-19
77	77	tion pursuant to subclause (I) as nec-20
78	78	essary; and 21
79	79	‘‘(III) may not remove such serv-22
80	80	ice from the new technology ambula-23
81	81	tory payment classification as deter-24
82	82	mined under subclauses (I) and (II) 25
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85	85	•S 1399 IS
86	86	until the Secretary determines that 1
87	87	adequate claims data exists to reas-2
88	88	sign such service to another ambula-3
89	89	tory payment classification (which in 4
90	90	no case may be before such service 5
91	91	has received payment under the as-6
92	92	signed new technology ambulatory 7
93	93	payment classification for at least 5 8
94	94	years). 9
95	95	‘‘(ii) A
96	96	DJUSTMENT.—The Secretary 10
97	97	shall adjust the application process and 11
98	98	criteria for the new technology ambulatory 12
99	99	payment classification to ensure that, in 13
100	100	addition to currently eligible algorithm- 14
101	101	based healthcare services, algorithm-based 15
102	102	healthcare services that otherwise meet the 16
103	103	eligibility requirements for such classifica-17
104	104	tion and are distinct from but performed 18
105	105	concurrently with, adjunctive to, or pro-19
106	106	vided in any other modality or form as 20
107	107	part of an underlying service and require 21
108	108	additional resources, meet— 22
109	109	‘‘(I) the eligibility requirement 23
110	110	that they are distinct new procedures 24
111	111	with a beginning, middle, and end; or 25
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114	114	•S 1399 IS
115	115	‘‘(II) any subsequent similar new 1
116	116	technology ambulatory payment classi-2
117	117	fication eligibility requirement. 3
118	118	‘‘(iii) D
119	119	EFINITION OF ALGORITHM - 4
120	120	BASED HEALTHCARE SERVICE .—For pur-5
121	121	poses of this subparagraph, the term ‘algo-6
122	122	rithm-based healthcare service’ means a 7
123	123	service delivered through a device cleared 8
124	124	or approved by the Food and Drug Admin-9
125	125	istration that uses artificial intelligence, 10
126	126	machine learning, or other similarly de-11
127	127	signed software to yield clinical outputs or 12
128	128	generate clinical conclusions for use by a 13
129	129	physician or practitioner in the screening, 14
130	130	detection, diagnosis, or treatment of an in-15
131	131	dividual’s condition or disease, or any such 16
132	132	other similar service as the Secretary de-17
133	133	termines appropriate in consultation with 18
134	134	appropriate organizations.’’. 19
135	135	(b) C
136	136	ODIFYINGOPPS PAYMENT FORSOFTWARE AS 20
137	137	ASERVICE.—Effective for services provided on or after 21
138	138	January 1, 2023, the Secretary of Health and Human 22
139	139	Services shall apply the hospital outpatient prospective 23
140	140	payment system payment for software as a service policy 24
141	141	described in the final rule entitled, ‘‘Medicare Program: 25
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144	144	•S 1399 IS
145	145	Hospital Outpatient Prospective Payment and Ambulatory 1
146	146	Surgical Center Payment Systems and Quality Reporting 2
147	147	Programs; Organ Acquisition; Rural Emergency Hos-3
148	148	pitals: Payment Policies, Conditions of Participation, Pro-4
149	149	vider Enrollment, Physician Self-Referral; New Service 5
150	150	Category for Hospital Outpatient Department Prior Au-6
151	151	thorization Process; Overall Hospital Quality Star Rating; 7
152	152	COVID–19’’ published by the Department of Health and 8
153	153	Human Services on November 23, 2022 (87 Fed. Reg. 9
154	154	71748). 10
155	155	Æ
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