Triage: Insurance Coverage for Cancer Clinical Trials

by Ashley Toro, Triage Cancer Intern

Beginning in 2014, private insurers will be required to provide coverage for the routine costs associated with clinical trials.  Although there are 30 states, and the District of Columbia, that already require insurance companies to cover these types of costs, the Affordable Care Act (ACA) levels the playing field for all states.  If a state has a more protective law than the ACA, the state law rules. “Routine costs” would include all items and services that the insurer would cover for a patient not enrolled in a clinical trial.  This is an exciting step in encouraging participation and ensuring access to clinical trials for the cancer community.

The National Cancer Institute has stated that clinical trials are important because they “are the way in which new and more effective cancer treatments are discovered and proven. If a new treatment proves effective in a clinical trial, it can become a new standard of care.”  A 2010 NIH report found that 70% of children with cancer enrolled in a clinical trial, compared to only 3-5% of adult patients, many of whom choose not to enroll because their insurer would not cover their participation.

Under the ACA, a private insurer:

  • may not deny a qualified individual participation in an approved clinical trial with respect to the treatment of cancer;
  • may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and
  • may not discriminate against the individual on the basis of the individual's participation in the trial.

One important exception to the new federal law will be those covered by “grandfathered” insurance plans.  A grandfathered plan is one that existed on March 23, 2010 and has not made significant changes that reduce benefits or increase costs to the insured.  Grandfathered plans are not subject to all the rights and protections available under the ACA. The American Society of Clinical Oncology estimates that by 2014, 36-66% of patients covered by large employers will remain on grandfathered plans.  20-51% of patients covered by small employers will remain grandfathered and “the number is likely to decrease over time as plans change benefits and costs.”

With these important changes in federal law taking effect in 2014, patients will have greater rights to participate in clinical trials without fear that their insurer will deny their access.  This will impact not only the individual’s quality and choices when it comes to their cancer treatment, but also the research and development of new cancer treatments.

If you are unsure if your plan is grandfathered, click to find out more here.

As a side note, in 2000, President Clinton enacted law that required Medicare to cover routine costs associated with participation in clinical trials.

To learn more about clinical trials available through the National Institute of Health (the federal government's principal agency for biomedical research), click here.

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