Clinical Trials

Medicare may provide extended coverage and reimbursement for certain investigational devices and services related to the use of those devices. Coverage is contingent upon meeting regulatory criteria and Florida medical director's approval.

The IDE coding and cost form is required when submitting a request for an IDE or an IDE Extension.

FCSO may consider coverage of a humanitarian use device, intended to benefit a small patient population, when the provider follows the specific guidelines and submits the appropriate documentation.

Medicare may provide coverage and reimbursement for certain investigational devices and services related to the use of those devices. Coverage is contingent upon meeting regulatory criteria and contractor's approval.

CMS has revised the implementation date of change request 6185 to December 1, 2008. In addition, the transmittal numbers, CR release date, and the Web addresses for accessing CR 6185 were revised. All other information remains the same. [MM6185]

Clinical trials are research studies designed to evaluate the safety and effectiveness of medical care. They are key to understanding the appropriate use of medical interventions of all types and informing payers about what services to cover.