H.R. 6197 — Health Tech Investment Act

This section amends the Medicare hospital outpatient prospective payment system (OPPS) by (1) establishing special payment rules, effective for covered outpatient department services furnished on or after January 1, 2026, for algorithm-based healthcare services (i.e., services delivered through an FDA-cleared or approved device using artificial intelligence, machine learning, or similar software to generate clinical outputs for screening, detection, diagnosis, or treatment), requiring the Secretary to assign such services (if eligible for or currently assigned to a new technology ambulatory payment classification for less than five years) to a new technology APC based on manufacturer-submitted costs (including invoice prices, subscriptions, clinical staff, and overhead), adjust as necessary, and prohibit reassignment until adequate claims data exists (in no case before five years of payment under the new technology APC); and (2) directing 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 further codifies the OPPS payment policy for software-as-a-service as described in the November 23, 2022, final rule (87 Fed. Reg. 71748), effective for services furnished on or after January 1, 2023. (OPPS pays hospitals a bundled amount per ambulatory payment classification group for outpatient services; new technology APCs provide temporary enhanced payments for novel procedures or services lacking sufficient cost data for standard grouping.)