Bill > S1399

This bill amends Medicare payment rules to create a new process for reimbursing algorithm-based healthcare services, which are defined as medical services delivered through FDA-cleared devices using artificial intelligence, machine learning, or similar software to generate clinical outputs or conclusions. Under the bill, starting January 1, 2026, the Department of Health and Human Services must assign these services to a "new technology ambulatory payment classification" based on the full cost submitted by the service's manufacturer, including technology, staff, overhead, and other associated expenses. The bill requires that such services remain in this special payment classification for at least two years and cannot be removed until adequate claims data exists to reassign them. Additionally, the bill expands eligibility for this classification to include algorithm-based services that are performed concurrently with or as part of another service but require additional resources. The legislation also codifies existing hospital outpatient prospective payment system policies for software-as-a-service, effective January 1, 2023. The overall goal is to ensure appropriate and comprehensive reimbursement for emerging healthcare technologies that leverage advanced computational methods.

Budget and Finance

https://www.congress.gov/bill/119th-congress/senate-bill/1399/all-info