Health Tech Investment Act
Sponsored By: Senator Mike Rounds
Introduced
Summary
Algorithm-based healthcare services under Medicare would get a clear payment and classification pathway. The bill would add rules to assign FDA-cleared AI and machine learning clinical software to a New Technology Ambulatory Payment Classification (NTAPC) and lock in Software as a Service payments under the hospital outpatient prospective payment system.
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- Hospitals and clinicians: Hospitals could bill and receive separate outpatient payments when they use AI/ML clinical software that meets the bill's definition. Eligible services furnished on or after January 1, 2026 may not be removed from the NTAPC until they have received payment under that classification for at least five years.
- Manufacturers and vendors: The Secretary must base NTAPC assignment on cost data submitted by the manufacturer. That data can include invoice or subscription prices, clinical staff costs, overhead, and other technology-related costs.
- Medicare program and hospitals: The bill directs CMS to expand NTAPC criteria so services that are distinct but provided alongside other procedures can qualify. It also codifies OPPS payment for Software as a Service effective January 1, 2023, using the Department of Health and Human Services final rule published November 23, 2022.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Medicare outpatient pay rules for SaaS
If enacted, this bill would require HHS to apply Medicare hospital outpatient payment rules for software-as-a-service. The rule referenced was published November 23, 2022. The change would apply to outpatient services provided on or after January 1, 2023. Hospitals and software vendors would get clearer payment rules. Medicare outpatients could see changes in billing or access as a result.
Medicare payment for algorithm-based tools
If enacted, the bill would define an "algorithm-based healthcare service" as an FDA-cleared device using AI, machine learning, or similar software to produce clinical outputs for clinicians. For covered outpatient services on or after January 1, 2026, qualifying services assigned to the new technology ambulatory payment classification (NTAPC) would be paid based on manufacturer-submitted cost data, including invoice or subscription prices, staff, overhead, and other costs. The Secretary must adjust NTAPC payments as needed and may not remove a service from that class until there are adequate claims data and it has been paid under the NTAPC for at least five years. The Secretary must also change NTAPC eligibility rules so adjunctive or concurrent algorithm services that need extra resources can qualify.
Sponsors & CoSponsors
Sponsor
Mike Rounds
SD • R
Cosponsors
Martin Heinrich
NM • D
Sponsored 4/9/2025
Marsha Blackburn
TN • R
Sponsored 4/9/2025
Christopher Coons
DE • D
Sponsored 6/17/2025
Jim Banks
IN • R
Sponsored 6/24/2025
Roll Call Votes
No roll call votes available for this bill.
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