A Need Met

Federal healthcare legislation addresses routine care during clinical trials

BY JENNIFER CARLSON, Assistant Vice President for Government Affairs, The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute

Jennifer CarlsonIn March, President Obama signed into law a historic bill that extends healthcare coverage to millions of Americans who previously could not afford to purchase it. Included in the legislation is a provision ensuring coverage for individuals who participate in approved clinical trials. The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) was instrumental in adding that component of the bill, which was modeled after a clinical trials bill passed by the Ohio legislature in 2008.

Clinical trials are the cornerstone of cancer research. They lead to better treatments, improve patient survival and have a positive effect on the nation’s economy as well as on the local economy.

Without clinical trials we cannot discover new cancer drugs and better treatments, and without volunteers we cannot conduct trials.

But running a clinical trial from start to finish is complicated and expensive. While the nation’s cancer centers, represented by the Association of American Cancer Institutes, work to untangle red tape and other factors that can derail trials, a serious obstacle has remained largely beyond their control—the cost to patients of participating in trials.

This is why the language about clinical trial coverage, sponsored by Senators Sherrod Brown (D-Ohio) and Kay Bailey Hutchison (R-Texas), was so important to include in the federal healthcare reform act.

Commercial health insurers often refuse to pay the cost of routine care that is associated with a clinical trial, arguing that the trial is “experimental” and thus optional or unnecessary. Consequently, many patients experience financial difficulties that prevent them from participating in trials. That, in turn, negatively affects the clinical study and patients’ ability to receive promising treatments that are available only through trials, and it slows the development of new cancer therapies.

Routine costs associated with clinical trials include physician visits, blood work, hospital stays and X-rays. These costs would usually be reimbursed by the insurer if the patient were not participating in a clinical trial. The experimental portion of the trial—usually a new drug—is provided at no charge to the patient or the insurer.

About 30 percent of the insured volunteers participating in clinical trials at the OSUCCC – James experience such insurance claim denials of payment for routine care. Denials tend to occur with Medicare Advantage, HMO and PPO plans, and with insurance plans that are based outside the state where the trial is conducted.

Since 1994, 27 states and the District of Columbia have passed laws requiring insurance coverage for routine patient-care costs when patients participate in clinical trials. Another five states have established cooperative agreements with insurers to do so. However, beyond the patchwork nature of such coverage, some of these laws do not necessarily require insurers to cover all cancer patients, such as those in phase I or II clinical trials, or those with employer self-insured plans, in which a large company self-insures its employees.

Clearly, only a federal policy can guarantee that someone will be there to pay for the routine costs for cancer patients who enroll in a potentially life-saving clinical trial.

With no more than 5 percent of adult cancer patients participating in clinical trials, attracting volunteers to trials has been a long-standing struggle for cancer researchers. And yet, thanks in large part to advances realized through clinical trials, two-thirds of cancer patients now survive at least five years after diagnosis, compared with only half of patients a generation ago.

By 2020, the country will be in the midst of a massive demographic shift that will double the number of Americans age 65, moving 78 million people into the age group at highest risk for cancer. Fortunately, we are now in a better position to increase participation in clinical trials and prevent more cancer deaths.

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