CMS Could Streamline Coverage For Breakthrough Medtech Under House Proposal

Newly introduced bill would seek to smooth the Medicare coverage and reimbursement pathway for breakthrough devices.

Newly proposed legislation in the US House could help innovative medtech products get market pick-up more quickly by permitting three years of transitional coverage by Medicare for products designated by FDA as “breakthrough devices."

The “Ensuring Patient Access To Critical Breakthrough Products Act,” H.R. 5997, introduced June 5 by Reps. Suzan Delbene, D-Washington,...

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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

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Debate On FDA User Fee Reauthorization Begins To Take Shape

 
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A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

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