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Routine sharing of data between FDA and CMS will be possible for the first time under a June 23 memorandum of understanding that could serve as a first step toward parallel reviews for marketing approval and Medicare coverage.
CDRH Director Jeff Shuren announced the pact June 24 at a public workshop on device innovation, but the document, signed by FDA Commissioner Margaret Hamburg and CMS Acting Administrator Marilyn Tavenner, is not yet publicly available.
The memorandum "will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions," Shuren said at the Gaithersburg, Md., gathering.
As part of the effort, the two agencies are "seriously exploring the ability to start, at a manufacturer's request, a Medicare national coverage determination process while the medical device is still under pre-market review at FDA," Shuren said. "Such an approach could reduce the time from FDA approval to CMS coverage and payment for some devices."
He also noted that the agencies may eventually consider defining certain circumstances when an FDA determination on safety and effectiveness is adequate for CMS to pay for a new technology "without additional evidence."
Shuren stressed, however, that only expanded information sharing has been agreed upon at this point. Parallel review is "not a done deal," he said
The collaboration, which extends across FDA product categories, is also not limited to pre-market data, Shuren noted. CMS' coverage-with-evidence-development policies, for instance, could aid FDA post-market data collection, he explained. FDA is already exploring use of Medicare claims data as a surveillance tool.
Formal Pact Is A Long Time Coming
The idea of expanded FDA-CMS data sharing and parallel reviews has been discussed for years.
Government officials have periodically announced near-term plans for an FDA-CMS memorandum of understanding with no apparent result.
Late last year, Sen. Chuck Grassley, R-Iowa, pressed FDA to be more forthcoming in providing non-public pre-market review information to its sister agency.
Industry's view on FDA-CMS data sharing has generally been mixed.
On one hand, there is enthusiasm for the prospect of securing reimbursement more quickly.
Interest in some type of process for seeking reimbursement in parallel with FDA pre-market reviews was aroused, in particular, after Johnson & Johnson/Cordis was able to secure Medicare reimbursement for its Cypher drug-eluting stent immediately upon FDA approval in 2003, based on interactions with CMS during the PMA process.
In recent years, companies have been putting more emphasis on collecting economic and comparative data prior to FDA approval to support reimbursement.
But firms worry about the potential for trade secret data held by FDA to seep out if it is shared with CMS, since the latter agency does not have the same statutory obligations for confidentiality.
"We believe it is important to preserve the currently separate and distinct regulatory missions and review processes of CMS and FDA, as well as the confidentiality of all company trade secrets and other proprietary data provided by manufacturers," said Ann-Marie Lynch, AdvaMed's executive VP for payment and health care delivery policy.
Jack Lasersohn, a general partner with the Vertical Group and National Venture Capital Association board member, said that a parallel path for coverage and FDA review is the "most important thing CMS can do." But, he warned, "This will be enormously challenging to implement. There are many issues that we have to work through."
Shuren stressed that if the agencies move forward with parallel reviews, they would be voluntary and it would be up to the sponsor to initiate the process.
- David Filmore and Jessica Bylander | 
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