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 Sens. 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.