Should the medical device industry pay user fees to CMS?

[Image with slight modifications courtesy of tara hunt on Flickr, per Creative Commons 4.0 license]

Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA?

That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by AdvaMed. Yared made the suggestion during a talk with Tamara Syrek Jensen, director of the coverage and analysis group at CMS, and Dr. Jeff Shuren, director of CDRH.

Yared focused on industry’s responsibility to ensure better predictability from payers. He discussed the evolution of MDUFMA, the user fee payment system with FDA that many have credited with a significant turn-around in the ability for medtech companies to get better access and measurable decision-making from CDRH.

“With MDUFMA, we fought it,” Yared noted. “We didn’t want to pay. And it took four iterations and 10 years to get it right.” But, he said, FDA took those resources and made changes to create a more inclusive and available FDA.

Get the full story on our sister site Medical Design & Outsourcing. 

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