II
119THCONGRESS
1
STSESSION S. 1399
To amend title XVIII of the Social Security Act to ensure appropriate
payment of certain algorithm-based healthcare services under the Medi-
care program.
IN THE SENATE OF THE UNITED STATES
APRIL9, 2025
Mr. R
OUNDS(for himself, Mr. HEINRICH, and Mrs. BLACKBURN) introduced
the following bill; which was read twice and referred to the Committee
on Finance
A BILL
To amend title XVIII of the Social Security Act to ensure
appropriate payment of certain algorithm-based
healthcare services under the Medicare 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 ‘‘Health Tech Invest-4
ment Act’’. 5
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SEC. 2. ENSURING APPROPRIATE PAYMENT OF CERTAIN 1
ALGORITHM-BASED HEALTHCARE SERVICES 2
UNDER THE MEDICARE PROGRAM. 3
(a) I
NGENERAL.—Section 1833(t) of the Social Se-4
curity Act (42 U.S.C. 1395l(t)) is amended— 5
(1) in paragraph (2)(E), by inserting ‘‘and new 6
technology ambulatory payment classification of al-7
gorithm-based healthcare services under paragraph 8
(16)(H)’’ after ‘‘(16)(G)’’; and 9
(2) in paragraph (16), by adding at the end the 10
following new subparagraph: 11
‘‘(H) S
PECIAL RULE FOR CERTAIN ALGO -12
RITHM-BASED HEALTHCARE SERVICES .— 13
‘‘(i) I
N GENERAL.—In the case of a 14
covered OPD service furnished on or after 15
January 1, 2026, that is an algorithm- 16
based healthcare service (as defined in 17
clause (ii)) that is assigned to a new tech-18
nology ambulatory payment classification 19
(as described in the final rule entitled 20
‘Medicare Program; Changes to the Hos-21
pital Outpatient Prospective Payment Sys-22
tem for Calendar Year 2002’ published by 23
the Department of Health and Human 24
Services on November 30, 2001 (66 Fed. 25
Reg. 59897)) on or after the date of the 26
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enactment of this subparagraph or for 1
which, as of such date, is currently and 2
has been assigned to a new technology am-3
bulatory payment classification for a pe-4
riod of less than 5 years, the Secretary— 5
‘‘(I) shall ensure that such serv-6
ice is assigned to a new technology 7
ambulatory payment classification 8
based on the cost of such service as 9
submitted by the manufacturer of 10
such service in a form and manner 11
specified by the Secretary, including 12
costs for the technology based on in-13
voice prices, subscription-based prices, 14
clinical staff, overhead, and other 15
costs associated with providing the 16
service; 17
‘‘(II) shall adjust the new tech-18
nology ambulatory payment classifica-19
tion pursuant to subclause (I) as nec-20
essary; and 21
‘‘(III) may not remove such serv-22
ice from the new technology ambula-23
tory payment classification as deter-24
mined under subclauses (I) and (II) 25
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until the Secretary determines that 1
adequate claims data exists to reas-2
sign such service to another ambula-3
tory payment classification (which in 4
no case may be before such service 5
has received payment under the as-6
signed new technology ambulatory 7
payment classification for at least 5 8
years). 9
‘‘(ii) A
DJUSTMENT.—The Secretary 10
shall adjust the application process and 11
criteria for the new technology ambulatory 12
payment classification to ensure that, in 13
addition to currently eligible algorithm- 14
based healthcare services, algorithm-based 15
healthcare services that otherwise meet the 16
eligibility requirements for such classifica-17
tion and are distinct from but performed 18
concurrently with, adjunctive to, or pro-19
vided in any other modality or form as 20
part of an underlying service and require 21
additional resources, meet— 22
‘‘(I) the eligibility requirement 23
that they are distinct new procedures 24
with a beginning, middle, and end; or 25
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‘‘(II) any subsequent similar new 1
technology ambulatory payment classi-2
fication eligibility requirement. 3
‘‘(iii) D
EFINITION OF ALGORITHM - 4
BASED HEALTHCARE SERVICE .—For pur-5
poses of this subparagraph, the term ‘algo-6
rithm-based healthcare service’ means a 7
service delivered through a device cleared 8
or approved by the Food and Drug Admin-9
istration that uses artificial intelligence, 10
machine learning, or other similarly de-11
signed software to yield clinical outputs or 12
generate clinical conclusions for use by a 13
physician or practitioner in the screening, 14
detection, diagnosis, or treatment of an in-15
dividual’s condition or disease, or any such 16
other similar service as the Secretary de-17
termines appropriate in consultation with 18
appropriate organizations.’’. 19
(b) C
ODIFYINGOPPS PAYMENT FORSOFTWARE AS 20
ASERVICE.—Effective for services provided on or after 21
January 1, 2023, the Secretary of Health and Human 22
Services shall apply the hospital outpatient prospective 23
payment system payment for software as a service policy 24
described in the final rule entitled, ‘‘Medicare Program: 25
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Hospital Outpatient Prospective Payment and Ambulatory 1
Surgical Center Payment Systems and Quality Reporting 2
Programs; Organ Acquisition; Rural Emergency Hos-3
pitals: Payment Policies, Conditions of Participation, Pro-4
vider Enrollment, Physician Self-Referral; New Service 5
Category for Hospital Outpatient Department Prior Au-6
thorization Process; Overall Hospital Quality Star Rating; 7
COVID–19’’ published by the Department of Health and 8
Human Services on November 23, 2022 (87 Fed. Reg. 9
71748). 10
Æ
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