Medicare Approves Expedited Coverage Plan For ‘Breakthrough’ Medical Devices

On January 14, 2021, Medicare issued a final rule establishing a pathway for a faster process for covering new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in four years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within two years thereafter. The rule was slated to go into effect on March 15, 2021. The final rule also codifies the term “reasonable and necessary.”

The FDA Breakthrough Devices Program was established by the 21st Century Cures . . .