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).

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 such services assigned to a new technology ambulatory payment classification (APC) 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 a new technology APC based on the manufacturer's submitted costs (including invoice prices, subscription-based 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 began. The Secretary must also adjust the application process and criteria for new technology APCs to ensure that algorithm-based healthcare services that are distinct from but performed concurrently with, adjunctive to, or part of 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 FDA that uses artificial intelligence, machine learning, or similar software to yield clinical outputs or conclusions for use by a physician in screening, detection, diagnosis, or treatment, or other similar services as determined by the Secretary.

Sec. 2(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 a specific final rule published on November 23, 2022.