Health Policy$ense

Expanding Medicaid’s Support for Equitable Access to Clinical Trials

New Coverage Mandate for Routine Costs

Samuel U. Takvorian
Samuel Takvorian is an LDI Senior Fellow, an instructor in the Division of Hematology and Oncology at Penn’s Perelman School of Medicine, and a faculty member in the Penn Center for Cancer Care Innovation.

One important barrier to equitable participation in clinical trials is coming down: as of January 2022, Medicaid will be required to cover routine costs associated with clinical trials, something that Medicare and commercial insurers already do. In the New England Journal of Medicine, my colleagues and I propose three ways we can leverage the new Medicaid policy to further reduce inequities in access to clinical trials, using enhanced transportation benefits, patient navigators, and greater accountability measures.

Members of ethnic and racial minority groups have long been underrepresented in clinical trials, due to a number of patient, provider, and system factors. A history of neglect and mistreatment of vulnerable populations by health care systems has fostered mistrust in these systems. Clinicians and researchers carry with them implicit biases, and vulnerable populations may be excluded from study eligibility without good reason. Further, there are financial barriers such as the costs of clinic visits, travel-related expenses, and time away from work to participate in trials. Insurance coverage of routine costs associated with clinical trials, such as physician visits, hospital stays, and diagnostic tests, is especially important for Medicaid beneficiaries, who are low-income and disproportionately from racial and ethnic minority groups.

Because no federally mandated Medicaid coverage for routine trial costs existed before Congress passed legislation in December 2020, just 15 states have mandated coverage of these costs, as shown in Figure 1.  

Map of States Mandating Coverage of Routine Trial Enrollment Costs
Figure 1. States Mandating Coverage of Routine Trial Enrollment Costs, 2020. Source: Takvorian et al., New England Journal of Medicine, 2021 (reprinted from Association for Clinical Oncology)

To leverage the coverage mandate and ensure the success of this new provision, we recommend three steps to state and federal policymakers:

  1. Use Medicaid’s nonemergency medical transportation (NEMT) benefit to ensure affordable access to appointments associated with clinical trials. This optional benefit could play an important role in facilitating trial participation for underserved groups that disproportionately report transportation-related challenges, including low-income, elderly, and racial and ethnic minority populations.
  2. Use Medicaid funding for patient-navigation programs to help people gain entry to clinical trials and negotiate the complex trial participation process. Navigator programs have the potential to increase and maintain accrual of minority patients in clinical trials. Serving as an important bridge between the community and academic medical centers, patient navigators are well positioned not only to improve health care access and the availability of social supports, but also to engender community-level trust in health care systems among historically marginalized populations.
  3. Implement stronger accountability measures for health systems and researchers. A coverage mandate alone will not assure equitable access to clinical trials. Federal agencies should pilot and evaluate new mechanisms that promote accountability for increasing participation of minorities in research. For example, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) could withhold a portion of funding from National Cancer Institute-designated cancer centers that fall short of equitable access to and participation in clinical trials.

Working together, federal and state policymakers, health systems, and researchers can ensure that the new legislation achieves its promise of reducing inequities in clinical trials, thereby improving access to new therapies and treatments for all people who could benefit from them.

PC3I Logo

This post is cross-posted with the Penn Center for Cancer Care Innovation (PC3I).

The paper, A Hidden Opportunity — Medicaid’s Role in Supporting Equitable Access to Clinical Trials, was authored by Samuel U. Takvorian, Carmen Guerra, and William Schpero, and appeared online in New England Journal of Medicine on May 22, 2021