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AdvaMed Applauds Bipartisan Senate Letter Urging CMS to Establish a Reimbursement Pathway for AI-Enabled Medical Devices

WASHINGTON – This week, AdvaMed, the Medtech Association, applauded a bipartisan group of Senators for urging the Centers for Medicare & Medicaid Services (CMS) to develop a formalized payment pathway for algorithm-based health care services (ABHS) in the upcoming Hospital Outpatient Prospective Payment Systems (HOPPS) rulemaking cycle. ABHS are FDA-cleared medical devices that rely on artificial intelligence (AI) and machine learning (ML) to produce clinical information to aid in patient diagnosis or treatment.

Scott Whitaker, president and CEO of AdvaMed said: “Ensuring patients have access to innovative AI-enabled clinical technology requires a formalized Medicare reimbursement pathway to provide manufacturers the certainty to deploy technology and providers the ability to invest in it. AdvaMed applauds these Senators for their commitment to ensure seniors benefit from proven medical innovation and looks forward to working with the Congress and CMS to realize the promise that FDA cleared, AI-enabled clinical technology can have to improve patient care.”   

The letter, led by the Senate AI Caucus Chairs, Senators Martin Heinrich (D-NM) and Mike Rounds (R-SD) and also signed by U.S. Senators Marsha Blackburn (R-TN) and Todd Young (R-IN), stated, “To ensure future innovation and to protect access to ABHS for Medicare beneficiaries, we urge CMS to develop a formal payment pathway for ABHS. We urge CMS to codify in regulation its existing Software-as-a-Service (SAAS) payment policy that the agency articulated in the calendar year 2023 Medicare HOPPS Final Rule to provide stability and certainty moving forward.”

The letter also included a note that,“ABHS can improve care delivery by providing clinicians with new or additional information about a patient’s specific clinical presentation. For example, ABHS can identify and qualify cancer, assess signs of liver disease, and measure the caliber of coronary arteries via medical technology not otherwise available to healthcare providers. These devices will improve patient outcomes, and some ABHS are now part of the standard of care for certain conditions.”

The letter continued that without a formalized reimbursement pathway for ABHS: “Manufacturers face an uncertain regulatory landscape, and providers must balance the benefit of ABHS against unpredictable payment policies.” The Senators go on to further write that while CMS provides separate payment for a limited number of ABHS, CMS should adopt a uniform payment policy to increase efficiency and include more of the hundreds of FDA-approved or cleared ABHS medical devices.

The full letter is available here.