In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recent issues impacting the proposed reimbursement for products that have been granted breakthrough device status from the FDA. With talk of too many devices being given BDP status along with the fact that a newly cleared device can still be viewed as experimental, the reimbursement policy is going through some additional review. Specifically, the following questions are addressed:

• Can you please explain the details of the BDP reimbursement policy that was being proposed?
• Can you provide some specifics on what’s driving this reevaluation of the policy?
• As I mentioned in the introduction, are there too many devices gaining BDP status? I mean, as we’ve discussed in the past, the fact that 510k devices are even eligible for a breakthrough designation seems ridiculous. What’s your opinion on this?
• What’s meant by the comments regarding a newly approved or cleared device being unproven?
• How is this policy reevaluation impacting medical device companies and their regulatory strategies?

Listen to this episode and see what you think of the BDP reimbursement delay and if changes could impact your regulatory strategy. 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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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