Thursday, August 21, 2025

AdvaMed, Others, Urge Coverage of Breakthrough Devices

 AdvaMed and other groups have released a public letter asking CMS to restore rapid coverage of FDA-approved "Breakthrough Devices."   Similar coverage, called MCIT, was finalized by the first Trump admnistration but deleted by the Biden administration.

Find the information here:

  • AdvaMed press release here.
  • MedTechDive coverage here.
    • Also, MedTechDive on the breadth of the BT program here.
  • The actual PDF letter here.
    • Also refers to a legislative approach, S 1717.
    • The Senate bill could allow statutory changes not available to CMS alone.