The Centers for Medicare and Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") plan to sign an agreement to ensure that Medicare reimbursement is available by the time new FDA-approved drugs and devices enter the market. Lester Crawford, acting commissioner of the FDA, has indicated that he and CMS Administrator Mark McClellan want to sign a formal agreement to create a more efficient and predictable process for coordinating FDA approvals with Medicare reimbursement. He declined, however, to comment on which medicines or devices would be covered by such an agreement. McClellan has stated that an agreement will speed up the Medicare process and that preference may be given to breakthrough products. Such an agreement will likely have a significant impact on the introduction of new medical technology into the market because health care providers are currently reluctant to use newly-approved products until they are sure Medicare will cover the costs and private insurers often follow Medicare's lead with regard to reimbursement for new technology.
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