Patients enrolled in Medicaid with blood cancers and disorders often lack coverage for participation in clinical trials. Clinical trials may provide a patient with a life-saving therapy or cure for their disease. For patients enrolled in clinical trials, their insurance covers the standard or routine cost of care, with the clinical trial sponsor often paying for the cost of the experimental drug or treatment. Medicaid is the health insurance program in the United States for people and families with limited income and resources, and people living with a disability. It is funded by state and federal governments, and eligibility requirements vary by state.
Patients who use Medicaid as their primary insurer also make up a significant portion of those who receive a transplant through National Marrow Donor Program (NMDP)/Be The Match. Without this coverage, Medicaid patients may lose the opportunity to try treatments provided through clinical trials, which may be an opportunity for life.
History of Medicaid Coverage for Clinical Trials
In 2000, Medicare issued a national coverage decision on clinical trials, authorizing payment for routine patient care costs and medical complications associated with participation in a clinical trial.
A brief from the Centers for Medicare and Medicaid (CMS) states that routine costs for clinical trials are covered by Medicaid to the extent that they are covered in a state plan - leaving the responsibility for coverage with each individual state.
In 2010, the Patient Protection and Affordable Care Act (ACA) mandated that health plans cannot keep patients from joining a clinical trial, cannot limit or deny coverage of routine costs to patients who join an approved clinical trial and cannot increase costs because a patient joins a clinical trial.
Our Work to Ensure Equal Access
Without coverage for routine costs, Medicaid patients are unable to enroll in clinical trials. This leaves millions of Americans with Medicaid plans without the option for a potentially curative treatment through a clinical trial.
Starting in 2020, we are working at a state-level to require coverage of clinical trial participation to allow patients with transplant-treatable diseases on Medicaid the same opportunity to access clinical trials as all other insured patients.
In addition to allowing access to potentially life-saving treatment, this would increase the number of people eligible to enroll in clinical trials, thus diversifying the recruitment pool of study participants and increasing the efficacy and potential curative impact of the new and emerging therapies for a greater number of Americans.