Because clinical research often takes place in conjunction with routine clinical care of the patient, it is vital to ensure clinical and research procedures are handled appropriately and in compliance with legal requirements.
A Medicare Coverage Analysis is required for any proposed clinical trial in which any tests, procedures, or interventions might be performed on study subjects and invoiced to third party payers. The analysis involves determining the underlying eligibility of the study for Medicare coverage (qualifying clinical trial) and a review of every clinical event specified in the protocol to determine which can be invoiced to Medicare. It is imperative, then, to perform a Medicare Coverage Analysis for any proposed clinical trial regardless of the funding source.
The CTU consults with investigators while preparing the Medicare Coverage Analysis so the principal investigator’s expertise and insights are reflected. The Medicare Coverage Analysis should always be conducted in parallel with a study’s budget development to allow knowledge of what items and services can appropriately be billed to third party payers. A properly performed Medicare Coverage Analysis helps to protect researchers and the university against violations of the False Claims Act and other regulations.
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