Should the medical device industry pay user fees to CMS?

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.

Although Yared stopped short of saying that user fees were the solution to a more collaborative relationship with CMS, there was an implication that industry should be charged to find a way to get the answers it wants (i.e. more transparency and predictability) from CMS and other payers.

“This is the right question for industry to ask,” said Mike Mussallem, CEO of Edwards Lifesciences, who moderated the panel. “Whether we should to go to Congress or think about other creative solutions, I don’t know, but industry certainly has a responsibility to help get payers to a place where we are working together.”

User fees could be one answer, Yared said. And Mussallem added the caveat that this is a brand new concept, and they had no idea what members would think.

“There could be other answers.” Yared laughed,” “It could be that Jeff is going to take some of his resources and share them with Tamara.”

He continued more seriously, “There is tremendous stress right now – the money is drying up.” He urged Jenkins to give feedback saying “We need quick success stories to engage with investors.“

A lot of ideas have been put on the table, added Shuren, to figure out what collectively makes sense.

The panel otherwise focused on how industry can better engage with CMS, “If you want presumptive payer decisions,” Jenkins said, “CMS and other payers have to be involved. They have to be in the room to have the conversation.”

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