Clinical trials are the lifeblood of new drug and treatment development. Trials allow us to learn what developing drugs and treatment are both safe and effective. Many drug developers complain about their inability to attract enough volunteers to reach a sample size that will allow them to draw statistically valid conclusions. Everyday there are trials that fail, not because there is a problem with the trial drug, but because the developer cannot accrue an adequate sample.
Volunteer subjects for clinical trials take a significant personal risk and sometimes an additional financial burden at a time they can least afford it. In blinded phase III trials, subjects do not know if they are going to receive the trial drug or the placebo. They do not know what side effects they might encounter, they do not know about possible toxic effects they could experience from the trial drug and they do not know if the drug or treatment will provide them with a positive result (efficacy).
Despite these very significant risks trial subjects undertake, only about half of the states in the United States require private insurance carriers to provide routine medical coverage for the subjects of clinical trials! Routine patient care costs are the costs of care such as doctor visits, hospital stays, clinical lab tests, x-rays and scans, etc. that a trial subject might incur. Studies have shown that these costs are not appreciably higher than the actual costs for patients who are not enrolled in trials. Insurance carriers refusing to extend this coverage often argue that the treatments are “experimental” and reject these claims.
Currently, about 26 states have passed legislation or instituted special agreements mandating that health plans pay the cost of at least routine medical care required while participating in the trial. To see which states currently mandate coverage go to: https://web.archive.org/web/20101221133323/http://www.cancer.gov/clinicaltrials/ctlaws-home
In those other states the insurance carrier often deny coverage, leaving the major risk taker, the trial volunteer, to shoulder not only the risks inherent in the trial, but also the additional financial burden that the routine care will cost. Fortunately, Medicare does provide limited coverage to those of us over the age of 65 years by paying some of the routine patient care costs.
If you do participate in a trial, you may face the issue of how to cover the costs of your routine medical care. Even if you have health insurance, your plan may not cover all of the costs related to receiving these “experimental” treatments. The National Cancer Society (NCI) has posted some recommendations on how to deal with this problem at: http://www.cancer.gov/clinicaltrials/understanding/insurance-coverage.
It is absurd that there are still a large number of states that have not required insurance carriers to cover routine patient costs during a clinical trial. Until this change happens, we will continue to struggle to recruit an adequate number of participants in clinical trials.
Joel T Nowak MA, MSW
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