S. 1399 — Health Tech Investment Act

This section amends the Medicare hospital outpatient prospective payment system (OPPS), which pays hospitals a predetermined amount for groups of outpatient services via ambulatory payment classifications (APCs), to establish special payment rules for certain algorithm-based healthcare services (i.e., FDA-cleared or approved services using artificial intelligence, machine learning, or similar software to generate clinical outputs for screening, detection, diagnosis, or treatment). Specifically, it (1) requires the Secretary, for such services furnished on or after January 1, 2026, and assigned (or newly assigned on or after enactment) to a new technology APC for less than five years, to base the APC payment on manufacturer-submitted costs (including invoice or subscription prices, clinical staff, overhead, and other costs), adjust as necessary, and retain the service in that APC for at least five years or until adequate claims data exists for reassignment; and (2) directs the Secretary to adjust new technology APC eligibility criteria to include such services performed concurrently with, adjunctive to, or as part of an underlying service if they otherwise qualify and require additional resources. This section also codifies, effective for services on or after January 1, 2023, the OPPS payment policy for software-as-a-service from the November 23, 2022, final rule (87 Fed. Reg. 71748).