As government pressure to reduce healthcare spending increases, gaps in Medicare coverage for participation in clinical trials is a potential barrier that could compromise the ability to conduct valuable medical research. Cancer Care — Economics (CC&E) recently spoke with Lisa R. Pitler, JD, MS, RN, Senior Director of the Research and Clinical Trials Administration Office at Rush University Medical Center, Chicago. Ms. Pitler discussed the necessity of effective and compliant billing plans for clinical trials.
CC&E: In a nutshell, how does Medicare cover reimbursement for participation in cancer clinical trials?
MS. PITLER: As of Sept. 19, 2000, the Medicare National Coverage Determination (NCD) on Clinical Trials ensures Medicare beneficiaries access to qualifying clinical trials and coverage for reasonable and necessary items and services to treat complications, providing the clinical trial has therapeutic intent and enrolls patients with a diagnosed disease, and the item or service falls within a Medicare benefit category and is not statutorily excluded from coverage. To qualify for Medicare coverage, a trial must meet the criteria stated and be FDA approved.
CC&E: What is the distinction of routine care in Medicare's coverage policy?
MS. PITLER: Medicare currently defines routine care as items or services that would normally be provided absent a clinical trial, services required solely for the provision of an investigational item or service, and care needed to diagnose and treat trial-related complications. However, routine care hasn't been defined precisely enough to satisfy the divergent opinions among clinical investigators, compliance personnel, and attorneys.
Simply put, if you have seven lung cancer patients on clinical trial and you have seven lung cancer patients who, for various reasons, wouldn't qualify for the trial, would you provide them with the same kind of care? That's the kind of routine care question we've been looking at.
It's important that clinicians understand that even though Medicare might not cover certain treatments, it's not a judgment of the quality of their care, but simply an analysis of what can be billed for and reimbursed.
