Dossier
clinical improvement
Coverage of clinical improvement in the Nexus archive.
- STAT+: Medicare eliminates key pathways used by ‘breakthrough’ devices for extra payments
Medicare is eliminating alternative pathways that allowed FDA-designated 'breakthrough' medical devices to qualify for supplemental payments without proving clinical improvement. The Centers for Medicare and Medicaid Services finalized a rule requiring such devices to demonstrate substantial clinical improvement starting in fiscal year 2028.