Organization Culture Must Support Clinical Trials as Routine Care

A session at the ACCC annual meeting addressed some of the top reimbursement issues associated with clinical trials and some strategies for how to manage them.

Many organizations face challenges when it comes to reimbursement for treatment associated with clinical trials. At the Association for Community Cancer Centers 40th Annual National Meeting, David Evans, RN, MSN, MBA, of Washington University School of Medicine, Siteman Cancer Center, was asked to discuss some of the top reimbursement issues and some strategies for how to address them.

Traditionally, cancer programs should expect a third party payer to cover the routine cost of cancer care for patients enrolled in a clinical trial. Routine care is typically defined as items and services consistent with the coverage that would be provided to a patient if that patient were to not participate in a clinical trial. This expectation is based on language from Medicare’s National Coverage Decision, the Patient Protection and Affordable Care Act, and from state laws mandating clinical trial coverage. In most cases, the trial sponsor provides the patient with the investigational drug, device, or service.

Unfortunately, Evans said, cancer programs are often told by third party payers that they do not cover experimental treatment, ie, the clinical trial, leaving many programs feeling helpless to get their patients coverage to participate.

Despite there being other possible reimbursement issues, Evans said that getting third party payers to acknowledge that clinical trials are a routine part of care is, in his mind, one of the only reimbursement issues that really matters.  

It is important to build an organizational culture that is prepared to fight back against this statement, Evans repeated during the session.

“When told that they do not cover experimental treatment, ask them instead if they cover the routine cost of cancer care,” Evans said. “Then make the case that routine care is all you are asking them to cover.”

In some cases, making a case that trial participation is part of the routine care of the patient can be bolstered by a letter from the treating physicians explaining why the treatment is medically necessary, or by sending medical journal articles that show possible patient benefits from the treatment that is being tested.

In addition, having an advocate or staff within your organization who is familiar with the process of advocating for coverage of clinical trials for patients can also be a tremendous help. Evans also mentioned that having a budget that clearly differentiates between the routine costs and research costs, and is reviewed by Medicare Coverage Analysis, is a great asset in working to secure insurance approval.