MedCity News January 13, 2021
The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed “breakthrough devices.” The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned that this could cause patient harm.
The Centers for Medicare and Medicaid has finalized a new rule that will fast-track coverage for products that the Food and Drug Administration deems as “breakthrough.” But some provider and payer groups have expressed concerns that this move may ultimately put seniors at risk.
The Medicare Coverage of Innovative Technology (MCIT) final rule creates a new, accelerated Medicare coverage pathway for products approved by the FDA via its expedited...