FDA has issued 1,284 breakthrough device designations. Medicare is not obligated to pay for a single one. That gap has now produced three separate federal policy attempts in five years.
The first attempt, Medicare Coverage of Innovative Technology, promised automatic national coverage the day FDA authorized a breakthrough device. It was repealed in November 2021 before one device ever received coverage under it.
The second attempt, Transitional Coverage for Emerging Technologies, capped at five candidates a year. Two years in, the public count is one device enrolled. One.
The third attempt just landed in the Federal Register. The new pathway promises a proposed coverage decision the same day FDA authorizes and a final one in 60 to 90 days. Comment period closes October 13.
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