Health Tech Investment Act

This bill amends the Medicare program to ensure appropriate payment for certain algorithm-based healthcare services, such as those using artificial intelligence or machine learning, under the Hospital Outpatient Prospective Payment System (OPPS). It establishes special rules for how these services are classified and paid, and codifies a payment policy for software as a service.

Sec. 2, Ensuring appropriate payment of certain algorithm-based healthcare services under the Medicare program: This section adds a new rule to the Social Security Act for algorithm-based healthcare services furnished on or after January 1, 2026. For services assigned to a new technology ambulatory payment classification (a special payment category for new technologies) on or after the bill's enactment, or currently assigned for less than 5 years, the Secretary of Health and Human Services must assign the service to that classification based on costs submitted by the manufacturer (including invoice prices, subscription prices, clinical staff, overhead, and other costs), adjust the classification as needed, and cannot remove the service from that classification until adequate claims data exists for reassignment, which must be at least 5 years after payment begins. The Secretary must also adjust the application process and criteria to ensure that algorithm-based healthcare services that are distinct from but performed with an underlying service and require additional resources meet eligibility requirements. An algorithm-based healthcare service is defined as a service delivered through a device cleared or approved by the Food and Drug Administration that uses artificial intelligence, machine learning, or similar software to yield clinical outputs or conclusions for screening, detection, diagnosis, or treatment, or other similar services as the Secretary determines. Additionally, effective for services provided on or after January 1, 2023, the Secretary must apply the hospital outpatient prospective payment system payment for software as a service policy described in a specific 2022 final rule.