New Legislation Expands Access to Clinical Trials

Medicaid beneficiaries—particularly those from diverse communities that have been historically marginalized—have long been under-represented in clinical trials due to factors such as participation costs, time away from work, and travel expenses. Beginning January 2022, CMS will be required under the Clinical Treatment Act—part of the $2.3 trillion omnibus spending and relief package passed by Congress in 2020—to cover for Medicaid patients the “routine costs” (e.g., doctor visits, diagnostic tests, and hospital stays) associated with participating in clinical trials.

Under the Affordable Care Act, these costs are already covered for patients with Medicare and private insurance for the treatment of cancer and other life-threatening illnesses. Although twelve states and the District of Columbia have already adopted regulations or policies that require Medicaid to cover the costs of participating in clinical trials, such coverage does not exist on a national level, which leaves more than 42 million people in 38 states potentially without coverage for clinical trial expenses. With the enactment of the Clinical Treatment Act in 2022, the coverage gap for low-income and underserved populations wanting to access clinical trials will be addressed.

To leverage this coverage mandate now to address barriers to care in the community and reduce inequities in clinical trial participation, states and provider organizations can:

• Provide access to affordable transportation via Medicaid’s nonemergency medical transportation (NEMT) program for underserved groups, ask CMS to deny state waivers that limit access to the NEMT benefit, increase awareness of the benefit, and reduce unnecessary benefit restrictions (e.g., type of ride, distance, number of rides).

• Ask states to invest Medicaid funding in patient navigation programs that help individuals enroll in clinical trials, help patients navigate complex trial enrollment processes, and help increase the participation of under-represented groups in clinical trials.

• Call for the NIH and the FDA to pilot strategies for creating standardized reporting and increased accountability for holding clinical trials. Ask that they enforce equitable access to clinical trials by potentially withholding funds from NCI-designated cancer centers that fail to demonstrate unbiased recruitment, access, participation, and retention in clinical trials, particularly within historically underserved populations.

Oncology state societies should determine which of the above strategies may best promote equitable access to clinical trials in their state and identify opportunities to advocate with stakeholders.

Building upon the need for equitable cancer clinical trial availability, the ACCC Community Oncology Research Institute (ACORI) was established to connect community cancer centers, share resources, and ultimately close the gap in cancer research. ACORI will develop education that promotes strategies and solutions to achieve health equity as well as investigate persistent areas of disparities in cancer clinical trial participation. This call to action for increased diversity and equity in clinical trials will stand as a high-priority area for the ACORI Task Force in 2022 and beyond.