Clinical Research and Clinical Trial Professional and Technical Fee Billing: Difference between revisions

Only qualified clinical trials are eligible for reimbursement for routine costs under Medicare. In order to be a qualified trial, the trial must meet three mandatory criteria and have other desirable characteristics [https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart].

*Trial evaluates an item or service that falls within a Medicare benefit category (e.g. physicians' service, durable medical equipment, diagnostic test) that is not statutorily excluded from coverage (e.g. cosmetic surgery, hearing aids);

*Trial has therapeutic intent.  

*Participants must be individuals with diagnosed disease rather than healthy volunteers, except for trials involving diagnostic intervention that require proper control groups.<br />

*The principal purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes;

*The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use;