Thursday, March 23, 2023

Very Brief Blog: Breakthrough Coverage Introduced as 2023 Legislation

During the Trump administration, there was proposed legislation to trigger CMS coverage of breakthough devices, and there was a corresponding rule-making and program at Medicare, which didn't require Hill action.

The clouds darkened.  The bill never passed.  And the Trump program was nixed or deep-sixed by the Biden administration. End of MCIT - Medicare Coverage for Innovative Technology.

The lawmaking approach to MCIT is back.
  • See legislation from DelBene, Wenstrup, and others, press release here.
  • March 22, 2023
  • Find the legislative text here.  
  • Find the introduced bill as 2023 HR 1691 here, 
    • The bill applies back to FDA approvals on 3/15/2021 or later.
    • BT devices are "Deemed" to be reasonable and necessary for 4 years.
    • The four years are timed from "update of the payment system" for the device.
    • Payment mechanisms may include NTAP (hospital add-on).  
    • CMS has 3 months to produce a new code for the devices.