Device Makers Move to the Front of the Coverage Line
CMS filed a new device coverage pathway at 4:15 on Friday afternoon: a proposed national coverage determination the same day FDA authorizes the device, and the two-year-old TCET pathway closed to new candidates. In the same week, its own auditor asked for a national policy on sacroiliac joint injections and CMS said no.
On August 12, 2024, CMS published the notice creating the Transitional Coverage for Emerging Technologies pathway, at 89 FR 65724. Device makers had asked for it since the Medicare Coverage of Innovative Technology rule was repealed in 2021.
TCET stops taking new candidates on Tuesday, two years less one day after it started. What replaces it went on public inspection at 4:15pm Friday.
"Who gets a national coverage decision, and who gets seven contractors deciding separately?"
That question ran through everything CMS and its auditor published this week, in both directions.
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