A new bill introduced in the U.S. Congress aims to establish a steady reimbursement pathway for medical devices authorized by the U.S. Food and Drug Administration (FDA) that use AI and machine learning, including those used in radiology.
The Health Tech Investment Act (S. 1399) was introduced by Senator Mike Rounds (R-SD) on April 9. The bipartisan bill would amend title XVIII of the Social Security Act to set up appropriate payment of certain algorithm-based healthcare services under the Medicare program.
“Medicare patients deserve access to the life-changing care that artificial intelligence-enabled devices can offer,” said Rounds in a prepared statement. “There is currently no clear Medicare payment system for these devices, meaning that it can take years to be approved and paid out by Medicare accurately. This legislation would create that system, improving diagnoses and encouraging the adoption of AI devices in clinical settings.”
The FDA continues to evaluate emerging AI technologies in the health space, with radiology leading all other health specialties in FDA clearances. Over three-fourths of all clinical AI in the U.S. cleared by the FDA are used in radiology.
However, the U.S. Center for Medicare & Medicaid Services (CMS) does not have standard or consistent methods for covering and paying for these products, Rounds said. Bill proponents say this inconsistency will negatively impact clinical AI adoption and patient access to these tools.
The Health Tech Investment Act would assign all FDA-approved AI-enabled medical devices to a new technology ambulatory payment classification (APC) in the Hospital Outpatient Prospective Payment System (OPPS) for a minimum of five years. This period would allow for adequate data about delivery and service costs to be collected before assignment of a permanent payment code.
Bill proponents added that the act would also spur manufacturers and providers to develop these technologies and bring them to market.
The Advanced Medical Technology Association (AdvaMed) is applauding the introduction of the act, saying that it will help expand opportunities for patients and physicians to benefit from these devices.
“With AI-enabled medical technologies already making remarkable strides in patient care, and with even more incredible strides ahead of us, now is the time to establish a predictable reimbursement pathway,” said Scott Whitaker, AdvaMed president and CEO. “It is critical to advancing the medical progress upon which patients depend and which is being driven by medtech.”
In a statement, AdvaMed Medical Imaging Division Board of Directors Chair David Pacitti said that he applauded the bill’s co-sponsors for their leadership in establishing improved payment pathways for innovative AI software and devices to increase adoption and expand patient access.
“Introduction of the Health Tech Investment Act is an important step towards expanding patient access to AI solutions in screening, diagnosing, and treating cancer, neurovascular, cardiovascular, and other diseases,” said Pacitti, who is also president of Siemens Medical Solutions USA and Head of the Americas for Siemens Healthineers.
AdvaMed also cited talks in the previous Congress, where the Senate and House Appropriations Committee and bipartisan Senate and House AI Task Forces each discussed the importance of setting up a payment pathway for AI-enabled medical devices.
The bill was cosponsored by Senators Martin Heinrich (D-NM) and Marsha Blackburn (R-TN). The full bill text can be found here.
