The newly introduced bill would create a Medicare payment system for AI-enabled devices.
US Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM), co-chairs of the Senate Artificial Intelligence Caucus, today introduced legislation aimed at improving health outcomes for Medicare patients by encouraging the use of artificial intelligence (AI)-enabled medical devices.
The Health Tech Investment Act establishes a reimbursement pathway for medical devices authorized by the US Food and Drug Administration (FDA) that rely on AI and machine learning, also known as algorithm-based healthcare services.
“Medicare patients deserve access to the life-changing care that artificial intelligence-enabled devices can offer,” says Rounds in a release. “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 use of AI in healthcare is quickly becoming the standard of care, with practitioners using algorithm-based healthcare services to detect and diagnose diseases sooner and advance better patient outcomes. The FDA has over 600 AI-enabled medical devices, but the Center for Medicare & Medicaid Services lacks standard or consistent methods for covering and paying for these products. This inconsistency will, in the long run, impact the adoption and patient access to medically appropriate AI technologies across the country, according to the senators.
Key Measures in the Bill
The Health Tech Investment Act will assign all FDA approved AI-enabled medical devices to a New Technology Ambulatory Payment Classification in the Hospital Outpatient Prospective Payment System a minimum of five years so that adequate data regarding delivery and service costs is acquired before assignment of a permanent payment code.
Specifically, the Health Tech Investment Act would:
- Develop a formalized payment pathway for algorithm-based healthcare services FDA-cleared medical devices.
- Provide patients with access to AI-enabled clinical technology.
- Provide manufacturers and providers with the certainty they need to invest in developing next-generation healthcare technologies and bringing them to market.
- Improve patient outcomes, providing resources for providers to meet algorithm-based healthcare services standards of care.
Support for Reimbursement Framework
This legislation is endorsed by AdvaMed, Alliance for Aging Research, Brem Foundation to Defeat Breast Cancer, Focused Ultrasound Foundation, National Health Council, National Psoriasis Foundation, Patients Rising, and Right Scan Right Time.
“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,” says Scott Whitaker, president and CEO of AdvaMed, in a release. “We thank Senators Rounds and Heinrich for their leadership and strongly urge Congress to pass this bipartisan legislation. It is critical to advancing the medical progress upon which patients depend and which is being driven by medtech.”
In the previous Congress, the Senate and House Appropriations Committee and bipartisan Senate and House AI Task Forces each addressed the importance of establishing a payment pathway for AI-enabled medical devices in policy reports and roadmaps.
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