Reimbursing Breakthrough Designation Products—Mike on Medtech

Reimbursing Breakthrough Designation Products—Mike on Medtech

Mike Drues and Sean Fenske review the attempts being made to pay for innovative technology as designated by the FDA’s Breakthrough program.

By Sean Fenske, Editor-in-Chief01.02.24
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that’s occurred with regard to getting reimbursement tied to the FDA’s Breakthrough Designation Program (BDP). It’s been planned, called off by CMS, put into proposed legislation, but we still don’t have a definitive solution. Specifically, the following questions are addressed:

  • Can you please explain what the Breakthrough Device Designation program is?
  • When did the reimbursement component come into play with regard to the BDP?
  • Why is it important for a BDP device to have reimbursement tied to it upon regulatory approval/clearance?
  • What concerns did CMS have regarding the reimbursement portion of the BDP?
  • This year, we’ve seen proposed legislation from Congress to force CMS to pay for devices that gain the BDP designation. What’s going on with these?
  • Does the ridiculously low number of devices associated with the TCET demonstrate an underlying problem with all of this?
  • What about the proposed “reasonable and necessary” caveat that’s also associated with the TCET? Do we need to clarify what this means or just replace it entirely?
  • What are the takeaways?

Listen to this discussion and see how you feel about the latest proposed reimbursement plan. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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