Medicare Coverage Analysis Worksheet
Medicare Coverage Analysis Worksheet

To determine whether your trial meets the requirements to qualify for Medicare coverage of routine costs, the Medicare Coverage Analysis is required to be performed prior to the initiation of the clinical trial to assure the proper billing of services.

The preliminary analysis may be performed by the Principal Investigator (PI) or designated representative. After the preliminary analysis has been done, the summary determination should be retained in your study records to assure the proposed billing schedule is in compliance with federal billing regulations.

NOTE: If you are conducting a clinical trial involving an investigational device, please go to: http://researchcompliance.iu.edu/qio/qio_crbc.html for information regarding approval for reimbursement from Medicare for costs related to the device.