Impact of Insurance Coverage on Clinical Trial Enrollment

  • Health Equity,
  • Payment Models & Affordability
Project Status: Complete

This project evaluated the impact of state Medicaid mandates for coverage of clinical-trial costs & impact of the Affordable Care Act’s Medicaid expansion on racial disparities in clinical trial enrollment. Findings showed an increase in Black or Hispanic clinical trial participants in states that mandated coverage of trial participation.

Cancer clinical trials have vital benefits: evaluating the safety of new therapies, establishing new standards of care, and, in some cases, prolonging patients’ lives. However, members of racial and ethnic minority groups are less likely to participate in clinical trials than Non-Hispanic White patients, which can impede the generalizability of research findings as well as access to therapeutic advances. When looking at health outcomes, the need for greater racial and ethnic equity in trials is even more compelling: Non-Hispanic Black adults continue to have the highest age-adjusted rates of cancer death.

Medicaid beneficiaries, who are low-income and disproportionately from racial and ethnic minority groups, may be particularly vulnerable to financial barriers to clinical trial participation, such as those related to travel expenses, lost time away from work, and direct participation costs. And yet, unlike Medicare and commercial insurers, Medicaid has lacked federally mandated coverage of the routine costs of clinical trial participation. Currently, only 15 states and the District of Columbia have statutes, regulations, and/or policies in place that require Medicaid coverage of routine trial-related costs, such as physician visits and laboratory studies.

Meanwhile, the Patient Protection and Affordable Care Act (ACA) expanded Medicaid coverage to more than 15 million people, which has led to improved access to care, affordability, and health outcomes. In Medicaid expansion states, the uninsured rate for Black adults decreased from 24.4% in 2013 to 14.4% in 2018, while the rate for Hispanic adults in this time period dropped from 40% to 24.9%.

This project will evaluate both the impact of state Medicaid mandates for coverage of routine clinical-trial related costs and the impact of the ACA’s Medicaid expansion on racial and ethnic disparities in clinical trial enrollment. This research will allow for a deeper understanding of inequities in clinical trial participation as well as the impact of state and federal policies on enrollment patterns.

As the first national study on the impact of state Medicaid coverage policies and the ACA’s Medicaid expansion on clinical trial participation, this research will be critical in understanding the relationship between financial barriers to cancer care, insurance policies, and cancer outcomes. Additionally, this research will provide insight to policymakers looking to leverage Medicaid policies to promote equitable access to clinical trials. On the federal level, findings will contribute to the conversation around the Clinical Treatment Act, which will be implemented in 2022 and will mandate coverage of routine costs for Medicaid beneficiaries nationally.

Leonard Davis Institute (Penn LDI)

Project Leads

  • Samuel Takvorian

    MD, MSHP

    Associate Director, PC3I & Director, Program in Patient-Generated Health Data, PC3I

Project Team

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