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Medicaid does not pay for the ancillary services most trial members need.
For many serious conditions, there are no proven therapies, so the best — and sometimes only — available treatment is an experimental therapy being tested in a clinical trial. My wife Kristin, for example, has been living with a type of cancer (metastatic ocular melanoma) that has both a poor prognosis and no proven treatment. Fortunately, she is enrolled in an open-label clinical trial — one where the participants know what treatment they are getting — of two drugs that are approved for other forms of cancer but are investigational for hers.
Nearly two years into the trial, Kristin’s tumors, which had been growing rapidly, have stabilized, even shrunk a bit, and she is tolerating the treatment well. Her participation is possible only because our employer-provided health insurance covers the little-known but potentially prohibitive costs of the routine care that is required, but not paid for, by such trials. This routine care includes oncologist visits, lab tests, and scans to measure tumor progression. The drug company sponsoring the trial pays for the study drugs and the costs of running the trial.
The Affordable Care Act (ACA) currently requires private health insurance to pay for the routine care associated with participation in clinical trials of treatments for cancer and other life-threatening conditions. The costs of routine care associated with participating in clinical trials for life-threatening conditions are also covered by Medicare, the federal health program for those 65 and older.
That leaves two big groups uncovered: the uninsured, and enrollees in Medicaid, the federal-state program for low-income people, which covers one in five Americans. Providing health coverage to the uninsured — the primary aim of the ACA — remains an elusive goal, and the law continues to face court challenges. A prior Supreme Court ruling upheld provisions of the ACA, but this and other provisions of the law might not survive future court challenges.
Fortunately, the lack of coverage by state Medicaid programs for the routine care required for clinical trial participation is a much more manageable problem than covering the uninsured. In fact, the Medicaid programs of 15 states and Washington, D.C., already cover these costs. Pending bipartisan federal legislation, the Clinical Treatment Act — which has a both House version (HR 913), and a Senate version (S. 4742) — would require all state Medicaid programs to cover these costs. Enactment of this legislation is crucial for two reasons.
First, in the absence of the law, as many as 38 million Medicaid enrollees — a large portion of whom are from racial and ethnic minority and other underserved groups — are categorically blocked from receiving potentially lifesaving experimental treatments because their state’s Medicaid program does not cover the routine care that is required for trial participation.
Medicaid enrollees tend to be low-income, underserved and vulnerable, and already face significant barriers to trial participation such as low health literacy, lack of trust in the health care system, and unmet logistical needs for trial participation such as lodging, meals, dependent care and transportation. Eliminating this significant financial roadblock to trial participation is an essential step to improve clinical trial access to Medicaid enrollees and reduce the health disparities that they experience.
Second, people from racial and ethnic minority groups, low-income persons, and other underserved groups continue to be woefully underrepresented in therapeutic clinical trials. As a result, the knowledge gained from trials may be less applicable to members of these groups than to whites and to those with higher incomes. Passage of the Clinical Treatment Act will help to improve the relevance of the knowledge gained from clinical trials to these underserved groups, who often bear the heaviest burdens of cancer and other life-threatening illnesses. The COVID-19 pandemic has highlighted the critical need for diverse participation in therapeutic clinical trials by populations hit especially hard by the virus.
Kristin continues to do well, for now, in the trial of the experimental regimen that by all appearances seems to be prolonging her life. The scenario that we would have faced, if we instead had been covered by Medicaid and this experimental therapy had been unavailable, is simply unthinkable. The Clinical Treatment Act needs to be enacted without delay.
Sean Hennessy, PharmD, PhD, is a senior fellow at the Leonard Davis Institute of Health Economics and a professor of epidemiology at the University of Pennsylvania. Follow him on Twitter @HennessySean.