FDA-CMS data-sharing deal may mean less than meets the eye

July 12, 2010 by Edward Berger

No matter how free communication becomes between the Food & Drug Administration and the Centers for Medicare and Medicaid Services, it's still going to require a lot of post-approval data to drive coverage decisions.

FDA-CMS data-sharing deal may mean less than meets the eye

The Food & Drug Administration and the Centers for Medicare and Medicaid Services signed a Memorandum of Understanding June 23 intended to promote data-sharing between the two agencies. Announcement of the MOU came from Center for Devices & Radiological Health director Dr. Jeffrey Shuren at a June 24 public workshop on device innovation. The MOU, Shuren said, "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. Industry news sources saw greater potential, however, characterizing the agreement as "a first step toward parallel reviews for marketing approval and Medicare coverage."

FDA and CMS have wanted to share information for years. Indeed, a 2005 policy statement from then-HHS secretary Tommy Thompson presented broad inter-agency information sharing, including parallel review "at the request of an applicant, and with the concurrence of both agencies," as a fait accompli. Perhaps, but such reviews have been few and far between. And Shuren, based on his June 24 comments, is ignorant of any mechanism for performing a parallel review. While there are some highly visible examples of Medicare coverage and payment determinations that were essentially simultaneous with FDA market clearance (e.g. human recombinant erythropoietin for chronic dialysis patients, drug-eluting stents), we can say with certainty that the vast majority of new technologies and drugs have not benefited from the compressed timeline to coverage that is the attraction of a parallel review process.

It's not just the government agencies that have been obstacles to information sharing and/or parallel review, of course. Many reimbursement consultants encourage their clients to meet with CMS early in the clinical development process to introduce an innovative technology, explain their clinical plan and regulatory status and generally set the table for a more expeditious CMS coverage decision process as soon as possible after commercial introduction. At the end of virtually every such meeting, CMS will request written permission from the company to speak with FDA staff about the technology and for access to information in FDA submissions. And many companies gag on the request, refusing to sign off on inter-agency sharing, but offering to consider any data requests submitted directly to them.