Edwards Lifesciences ($EW) CEO Mike Mussallem advocated for a more efficient regulatory and reimbursement system for medical devices before the congressional House Committee on Energy and Commerce yesterday, pointing out that the U.S. was the 42nd country to approve the Irvine, CA-based company's Sapien artificial heart valve for frail, high-risk patients.
"The balanced ecosystem that has supported innovation in the U.S. is being eroded by an increasingly costly and cumbersome risk-averse culture in our regulatory and payment systems," he told the committee members, according to his prepared remarks.
However, the CEO praised FDA for issuing a number of guidance documents over the past year on topics including priority review for premarket submissions, expedited access for certain devices requiring a PMA and balancing premarket and postmarket data collection.
"The biggest issue here is that FDA needs the resources and support to move faster on these initiatives. Drs. Hamburg and Shuren have a complex bureaucracy to manage, and they need the mandate to make change quickly. Congress could lend support to FDA by providing additional resources to FDA to help expedite these changes and give them room to innovate," he said.
Mussallem devoted a large part of his speech to post-market regulations and review via data registries. "When registries are done right, they can yield extremely useful information about patient outcomes and device benefits," he said, adding that Edwards benefited from the transcatheter valve therapy registry created by the Society of Thoracic Surgeons and American College of Cardiology; the information helped to expand the indications of Sapien, making it available to a wider audience.
But the registry has resulted in tradeoffs: "Many physicians have told us that it takes longer to fill out the TVT Registry form than it does to perform the procedure," he said.
"In addition to the significant financial commitment manufacturers must make to support the development and ongoing operations of registries, hospitals are charged ongoing fees to participate. In a time of extreme budget pressure, we need to ensure that this process is not so costly and burdensome that the long-term prospects of the registry diminish over time," he continued. To achieve the right balance, Mussallem recommended following AdvaMed's principles on medical device data registries.
Data dissemination is another area of concern with registries, he said: "Too often, well-intended advocates have driven sensational headlines, citing cherry-picked data or anecdotal incidents that have received outsized attention."
Finally, on the economic incentives and reimbursement front, he testified that accountable care organizations and bundling payment models, if implemented successfully "could help ensure that patients receive better-coordinated and higher quality care, while also restraining rising costs. If implemented poorly, hospital value-based purchasing strategies could tilt toward simply restricting access and creating new barriers for patients and physicians as they seek advanced, clinically appropriate care."
He urged the Centers for Medicare and Medicaid Services to use its Coverage with Evidence Development protocol judiciously. "CMS should be careful that CED does not become more of a burden to patient access than a tool for data development, particularly in cases where sufficient clinical evidence has already been developed--if so, the evidence requirement simply adds unnecessary time and cost," he said.
Today, the head of FDA's device arm, CDRH, and leaders from healthcare companies including Abbott are testifying to the committee, as part of the 21st Century Cures initiative, chaired by Rep. Fred Upton (R-MI).
- read his prepared remarks
- watch the ongoing testimony
Editor's Note: The story was corrected with the correct spelling of the CEO's name. We apologize for the error.