Congress Aims to Expand Access to Clinical Trials

November 16, 2020

New legislation could make it easier for people to participate in clinical trials regardless of their economic situation.

Under the Clinical Treatment Act, introduced by Senators Richard Burr (R-NC) and Ben Cardin (D-MD),  Medicaid would cover routine costs associated with clinical trials. These include expenses such as doctor’s visits and lab work. 

The legislation would bring Medicaid in line with other health plans, most of which already cover routine clinical trials costs. The trial sponsor covers the cost of the medication being tested, while the patient takes on co-pays and other expenses out of pocket. 

By requiring Medicaid to cover routine costs like other insurers, the legislation would make trials participation more feasible for the 75 million people insured by Medicaid. Professional associations and patient advocacy groups alike have praised the measure. 

“Simply stated, this change will bring access to treatment for life-threatening conditions within reach for thousands of patients,” said Jeffrey B. VanDeusen, MD, PhD, a medical oncologist and member of the Alliance for Patient Access’s Oncology Therapy Access Working Group. “Participation in a clinical trial may be the last hope for someone with late-stage cancer that continues to progress, despite having tried every available treatment.”

Several organizations also have emphasized the legislation’s ability to increase diversity in clinical trials. 

“Medicaid recipients include people of minority groups and diverse ethnic backgrounds,” reads an action alert from the Melanoma Research Foundation. “Diversity is crucial to ensure that data collected in clinical trials is valid and generalizable.”

The American Society of Clinical Oncology noted that racial and ethnic minorities are “not well represented in clinical trials, limiting the applicability of trial results.” But addressing the coverage barrier would “improve the validity of clinical research data and speed the availability of new treatments,” improving outcomes for all patients.

Representatives Ben Ray Luján (D-NM) and Gus Bilirakis (R-FL) sponsored the House version of the Clinical Treatment Act in 2019. It received bipartisan support from dozens of co-sponsors.

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