Medical device lobbyists and lawmakers have united in recent months over legislation that would make it easier to bill Medicare for artificial intelligence-based devices used in health care. They want to grease the squeaky wheels of reimbursement for “algorithm-based health services,” many of which have seen limited adoption despite getting cleared by the Food and Drug Administration.
Some clinical AI products could reach the market through an even more streamlined mechanism, though, if another pathway for innovative medical devices is created.
Since the first Trump administration, politicians and regulators have pitched the idea of automatic Medicare coverage for “breakthrough” devices, an FDA designation that aims to encourage innovation for unmet patient needs. The Centers for Medicare and Medicaid Services proposed, and then scrapped, a rule that would offer up to four years of coverage for FDA-authorized breakthroughs. But the idea has recently resurfaced in proposed legislation, with support from health agency leaders. FDA commissioner Marty Makary has said he is working with CMS administrator Mehmet Oz to advance immediate Medicare reimbursement for breakthroughs, “so they don’t have to go through their own repeat duplicative process.”
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