Bipartisan Senators introduced the Health Tech Investment Act (S. 1399), which would establish a Medicare reimbursement pathway for FDA-cleared medical devices that utilize artificial intelligence and machine learning.
The bill, introduced by Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.), seeks to amend title XVIII of the Social Security Act to “ensure appropriate payment of certain algorithm-based healthcare services under the Medicare program.”
Through the bill, the Secretary of Health and Human Services would assign eligible algorithm-based devices to a new technology ambulatory payment classification (APC), which will be determined based on cost data from the service manufacturer.
Such data would include invoice prices, subscription-based fees, overhead costs, clinical staff expenses and other costs associated with providing service.
The bill says services must remain in the new technology APC for at least five years and cannot be removed until data is available to reassign them appropriately.
The legislation also states that, if approved, the HHS Secretary will adjust the application process and the criteria for new technology APCs to allow AI-enabled services with a defined beginning, middle and end.
The services must also be “distinct from but performed concurrently with, adjunctive to, or provided in any other modality or form as part of an underlying service and require additional resource.”
THE LARGER TREND
Another proposed legislation, H.R.238, focused on the use of AI in healthcare, was introduced earlier this year in the U.S. House of Representatives. It would allow AI and machine learning technology to prescribe drugs approved by the FDA autonomously.
The bill seeks to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to “clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible, to prescribe drugs if authorized by the State involved and approved, cleared or authorized by the Food and Drug Administration and for other purposes.”
If approved, section 503(b) of FFDCA would be amended to recognize AI as a “practitioner licensed by law to administer such drugs.”
