UChicago physician shapes Illinois policy to ensure clinical trial coverage for Medicaid users

Clinical trials offer important treatment options for some patients and, now, newly passed legislation permits low-income Illinoisans to participate at no extra cost.

Researchers design clinical trials to safely test new drugs, devices, vaccines or ways of using known treatments. Well-structured clinical trials require the collection of large sample sets. If a clinical trial leaves out segments of the population, disparities in care could worsen.

“In order to get broad representation in clinical trials and achieve health equity, we need to remove as many barriers as possible,” said Blase Polite, MD, a medical oncologist at the University of Chicago Medicine Comprehensive Cancer Center. “The more inclusive our clinical trials are, the better we are able to understand, treat, diagnose and prevent cancer among diverse groups.”

Overcoming a financial barrier

Medicaid and the Children’s Health Insurance Program (CHIP), both federal health insurance options for low-income individuals, provide healthcare coverage for three million individuals in Illinois and nearly 20% of Americans. Although certain aspects of Medicaid coverage are overseen federally, individual states are allowed freedom in the management of these programs, meaning that Medicaid benefits are not uniform across the nation. One aspect of Medicaid coverage that can vary from state to state is coverage for clinical trial participation.

We need to fix the barriers at a system level to increase participation.

The Affordable Care Act (ACA) ensures that when an individual with a private health insurance plan enrolls in a clinical trial, their insurance is responsible for “routine care costs,” for example, a doctor’s visit or a CT scan. (Any charges for the experimental therapies, such as the cost of the drug or vaccine being tested, are paid for by the sponsor of the clinical trial.) Medicare patients also have this protection under an executive order signed by President Clinton.

For Medicaid patients — who are not protected under the ACA provision — it isn’t so cut and dry. While, for the most part, Medicaid does cover routine care costs when patients participate in a clinical trial, there has been no legal protection for this provision. In other words, there was nothing to stop Medicaid from deciding not to pay for routine care after a patient enters a clinical trial. This can create a financial barrier to clinical trial participation.

“The data suggest if people are offered trials without significant financial risk to them, they will go on clinical trials at a very high rate,” Polite said. “We need to fix the barriers at a system level to increase participation.”

Changing the rules

Polite has been working for almost 10 years to tackle the issue. He initially began this effort as the chair of the government relations committee for the American Society of Clinical Oncology (ASCO). Although the legislation has been introduced at the federal level, it has yet to be passed, necessitating state-level regulation.

Polite published a