Trials and Tribulations

If you are a federal employee or a dependent of one and you develop cancer, your best hope for a cure could be a clinical trial. But don't expect your insurance carrier to cover your routine health costs if you choose to enroll in such a trial.

According to the American Cancer Society, about 1.4 million people will be diagnosed with cancer this year. But last year, only 36,000 of those diagnosed enrolled in a clinical trial.

Clinical trials represent the final testing stage for medications, therapies and treatments before they are approved for widespread use, and often are the only hope for cancer patients, said Jennifer Carlson, director of government relations at The Ohio State University Comprehensive Cancer Center.

Patients often are given the option of enrolling in clinical trials after Food and Drug Administration-approved treatments fail, Carlson said. While the experimental treatment is paid for by the drug company, the patient's routine care -- hospital visits, blood work, X-rays, etc. -- is left to insurance carriers, many of which refuse to cover the costs. The result is that patients must either foot the bill or forgo the trial.

The issue came to light in part because of a campaign by Craig Freeman, a federal employee at Wright Patterson Air Force Base in Dayton, Ohio. Freeman's insurance company under the Federal Employees Health Benefits Program -- Anthem Blue Cross Blue Shield - told his wife it would deny routine coverage if she entered a clinical trial.

Anthem BCBS is hardly the only insurance provider with rules surrounding coverage of participants in clinical trials and other experimental treatments. In an analysis of the health plans under FEHBP in all 50 states and the District of Columbia, one phrase rang true in every plan brochure: "Things we don't cover … experimental or investigational procedures, treatments, drugs or devices."

Mike Orenstein, a spokesman for the Office of Personnel Management, which runs FEHBP, said "in some circumstances," insurance carriers will cover the routine costs associated with clinical trials, though that is not usually the case.

Last month, Freeman's story inspired Rep. Deborah Pryce, R-Ohio, to unveil legislation that would prevent insurance companies from denying routine care coverage to cancer patients who seek treatment in a clinical trial.

"Often, the patients' only hope rests in a clinical trial, and this bill will allow them to focus their energies on beating this dreaded disease, not dealing with the red tape of insurance companies," she said in a statement.

It's unclear how Pryce's proposal would affect premium costs. Carlson said many studies in peer-reviewed journals have concluded that the routine care costs when a patient participates in a clinical trial are no more or less than when a patient receives standard cancer therapy. "The intent of clinical trials is not only to find better cure rates, but also to evaluate methods for delivery of medication that are less toxic with fewer side effects, which has the added benefit of being less costly for the insurer," Carlson said.

Freeman's story has a somewhat happy ending. After having three appeals for coverage denied by his insurance carrier, he appealed to OPM. While that appeal was pending, Freeman and his wife were slated to appear at a Capitol Hill press conference in support of Pryce's bill.

The night before their scheduled appearance, their insurance carrier approved the coverage -- three months after the initial appeal, Freeman said. "The bottom line here is that every federal employee under this federal health insurance program can be excluded from a clinical trial," he said. "We have to change this."

If you have been denied coverage through your insurance carrier, you can appeal the decision with the company within the time period specified in your plan. Information on the timeliness of appeals can be found in your plan brochure. If the appeal is unsuccessful, you can then file a further appeal with OPM. But be sure to include copies of documents that support your claim and all correspondence between you and your insurance carrier.