[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1399 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
S. 1399
To amend title XVIII of the Social Security Act to ensure appropriate
payment of certain algorithm-based healthcare services under the
Medicare program.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 9, 2025
Mr. Rounds (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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Health Tech Investment Act''.
SEC. 2. ENSURING APPROPRIATE PAYMENT OF CERTAIN ALGORITHM-BASED
HEALTHCARE SERVICES UNDER THE MEDICARE PROGRAM.
(a) In General.--Section 1833(t) of the Social Security Act (42
U.S.C. 1395l(t)) is amended--
(1) in paragraph (2)(E), by inserting ``and new technology
ambulatory payment classification of algorithm-based healthcare
services under paragraph (16)(H)'' after ``(16)(G)''; and
(2) in paragraph (16), by adding at the end the following
new subparagraph:
``(H) Special rule for certain algorithm-based
healthcare services.--
``(i) In general.--In the case of a covered
OPD service furnished on or after January 1,
2026, that is an algorithm-based healthcare
service (as defined in clause (ii)) that is
assigned to a new technology ambulatory payment
classification (as described in the final rule
entitled `Medicare Program; Changes to the
Hospital Outpatient Prospective Payment System
for Calendar Year 2002' published by the
Department of Health and Human Services on
November 30, 2001 (66 Fed. Reg. 59897)) on or
after the date of the enactment of this
subparagraph or for which, as of such date, is
currently and has been assigned to a new
technology ambulatory payment classification
for a period of less than 5 years, the
Secretary--
``(I) shall ensure that such
service is assigned to a new technology
ambulatory payment classification based
on the cost of such service as
submitted by the manufacturer of such
service in a form and manner specified
by the Secretary, including costs for
the technology based on invoice prices,
subscription-based prices, clinical
staff, overhead, and other costs
associated with providing the service;
``(II) shall adjust the new
technology ambulatory payment
classification pursuant to subclause
(I) as necessary; and
``(III) may not remove such service
from the new technology ambulatory
payment classification as determined
under subclauses (I) and (II) until the
Secretary determines that adequate
claims data exists to reassign such
service to another ambulatory payment
classification (which in no case may be
before such service has received
payment under the assigned new
technology ambulatory payment
classification for at least 5 years).
``(ii) Adjustment.--The Secretary shall
adjust the application process and criteria for
the new technology ambulatory payment
classification to ensure that, in addition to
currently eligible algorithm-based healthcare
services, algorithm-based healthcare services
that otherwise meet the eligibility
requirements for such classification and are
distinct from but performed concurrently with,
adjunctive to, or provided in any other
modality or form as part of an underlying
service and require additional resources,
meet--
``(I) the eligibility requirement
that they are distinct new procedures
with a beginning, middle, and end; or
``(II) any subsequent similar new
technology ambulatory payment
classification eligibility requirement.
``(iii) Definition of algorithm-based
healthcare service.--For purposes of this
subparagraph, the term `algorithm-based
healthcare service' means a service delivered
through a device cleared or approved by the
Food and Drug Administration that uses
artificial intelligence, machine learning, or
other similarly designed software to yield
clinical outputs or generate clinical
conclusions for use by a physician or
practitioner in the screening, detection,
diagnosis, or treatment of an individual's
condition or disease, or any such other similar
service as the Secretary determines appropriate
in consultation with appropriate
organizations.''.
(b) Codifying OPPS Payment for Software as a Service.--Effective
for services provided on or after January 1, 2023, the Secretary of
Health and Human Services shall apply the hospital outpatient
prospective payment system payment for software as a service policy
described in the final rule entitled, ``Medicare Program: Hospital
Outpatient Prospective Payment and Ambulatory Surgical Center Payment
Systems and Quality Reporting Programs; Organ Acquisition; Rural
Emergency Hospitals: Payment Policies, Conditions of Participation,
Provider Enrollment, Physician Self-Referral; New Service Category for
Hospital Outpatient Department Prior Authorization Process; Overall
Hospital Quality Star Rating; COVID-19'' published by the Department of
Health and Human Services on November 23, 2022 (87 Fed. Reg. 71748).
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