Sept. 25, 2009 

Medicare Should Deny Payment for Knee Device That FDA Improperly Approved

FDA Investigation Found That Agency Managers Overruled Scientists After Political Pressure

WASHINGTON, D.C. - Medicare should deny reimbursement for a knee device that the Food and Drug Administration (FDA) approved after political pressure from the manufacturer and members of Congress, Public Citizen said today in a letter sent to Medicare officials.

There is no proof that the Menaflex Collagen Scaffold device made by ReGen Biologics provides any clinical benefit for patients undergoing cartilage removal, Public Citizen said in the letter in which it opposed ReGen’s application to Medicare for a “national coverage determination.” Public Citizen made the sole public objection to the device when it was undergoing FDA review

An FDA internal investigation made public Thursday acknowledged undue pressure from four New Jersey members of Congress to approve the device and that the then-FDA commissioner took the unusual step of intervening in the process, subverting the customary FDA advisory committee processes.

Public Citizen’s letter reviewed a gold standard, randomized controlled trial in which the company compared patients undergoing cartilage removal and device implantation with cartilage removal alone. This trial provided no evidence of effectiveness on any of the three major clinical outcomes.

“Just as a physician would be hard-pressed to justify implanting a device not proven to have any clinical benefit, Medicare should be hard-pressed to justify reimbursing for it,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group.

READ Public Citizen’s letter.

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