Clinical Trials and Insurance: Understanding Your Coverage

Currently, a very small percentage of eligible patients actually participate in clinical trials, research studies required by the U.S. Food and Drug Administration to prove safety and efficacy of new medications.  While many concerns may discourage patients from considering clinical trials, the biggest deterrent is often whether insurance will cover the costs associated with participation. If you’re interested in joining in a clinical trial but uncertain whether your insurance will cover it, read on to learn how to determine your plan’s clinical trials coverage and how to appeal a denial.

Some costs of a clinical trial may be covered by the trial’s sponsor, which can be a government agency, a pharmaceutical company, or even the National Cancer Institute (NCI). This information can be found in the informed-consent document that you’ll sign when you are accepted into the clinical trial.

Clinical Trials and Insurance Coverage

Once you have decided to participate in a clinical trial, you’ll undergo admission testing to make sure that you are indeed eligible. If so, the clinical trial provider can make a formal request to your health insurance company for approval or preauthorization. If you haven’t already done so, this is a good time to read your insurance policy or plan summary to make sure that you understand the specifics of your coverage.

It’s not uncommon for health plans to limit participation in clinical trials or to exclude them altogether. To see if clinical trial preauthorizations are denied, look for terms like investigational or experimental. Plans may also specify the type of trials they will cover. For instance, only NCI studies or trials within Phases III or IV may be covered. Your insurance company will normally notify both you and the requesting institution of its decision regarding your participation.

If your insurance company denies your preauthorization request, you may appeal that decision. You can start the appeal process yourself, or a nurse, study coordinator, patient advocate, or other medical professional can help you with your appeal. It’s important that whoever formally appeals your denial is knowledgeable about the trial as well as your treatment plan and insurance policy. All insurance plans, including Medicare and Medicaid, have an appeal process for denied preauthorization of benefits and claims. They may vary slightly, but the overall principles are consistent.

The Appeal Process

Although the appeal process can often be confusing and arduous for the patient, the necessary steps are usually explained in your policy or plan summary. Be sure to read your policy carefully. If you can’t locate it, request a copy in writing from your employer or insurance agent.

The first step in any appeal process is to get a written copy of the denial of your initial request. This is critical because the appeal must address the specific reason for the denial. For example, if you send an appeal to the insurance company, stating that the trial you are requesting is medically necessary for you, but the reason the insurer initially denied your request was because it was not an NCI-sponsored trial, your appeal would not address the reason for the denial and would likely be ineffective. Unfortunately, such an unsuccessful appeal would delay your ability to start the clinical trial.

Knowing who actually carries your insurance coverage as well as the specific benefits and limitations of your plan is vital during an appeal. For example, you may work for a large employer that has structured your health plan as “self-funded” with a third-party administrator (TPA). The TPA administers the health plan on behalf of the employer. The outward appearance to you as well as to any providers you use is that the TPA is the insurance company, but that’s not really the case in this example. If your company is “self-funded,” you may have additional avenues to pursue in your appeal process.

It is important to note that self-funded plans are not subject to local or state laws and are regulated by federal laws. In such a case, you may live in a state that mandates clinical trail access to its citizens, yet you work for a company that is not obligated to comply with state laws. Many states have enacted laws regarding clinical trial access. You can learn more about your state by contacting your state insurance commissioner’s office. In 2002 Medicare began covering costs related to clinical trial participation, and many state Medicaid programs extended similar coverage.

The Patient Advocate Foundation (PAF) has authored a full-length publication titled Your Guide to the Appeals Process, which is available in English and Spanish. You can download this guide from or request a copy by calling PAF directly. This easy-to-read guide features sample appeal letters, specific strategies to use when negotiating the internal and external appeals processes, and precise instructions to follow when all appeals have been exhausted and it’s time for the next step. It offers insight into the principles that PAF case managers use to overturn coverage denials. The PAF publications and services are provided at no cost to patients with chronic, life-threatening, or debilitating conditions. If you need assistance with issues related to clinical trial participation or would like a copy of any of the PAF publications, call PAF toll-free at (800) 532-5274.

By Donna Sternberg, RN, OCN, Vice President of Patient Services and
Connie Slayton, BSN, Senior Case Manager; with
Nancy Davenport Ennis, President and CEO, Patient Advocate Foundation