|Clinical Trials: What is the Financial Impact?|
Clinical trials are an important treatment option for many people with cancer. It is important for you to discuss with your doctor why and when to consider enrolling in a clinical trial. The financial implications are important when making this decision. See the Clinical Trials page for more information and to find a clinical trial at an NCCN Member Institution, as well as the Guide to Clinical Trials and Demystifying Common Clinical Trial Myths.
A clinical trial is a type of research study that tests how well a new medical treatment works in people. Clinical trials often test a new drug to find out if it works better than another treatment currently being used (often called the “standard of care”). Clinical trials may also test new methods of screening, prevention, or diagnosis.
A clinical trial typically focuses on one particular type of cancer and may be especially valuable for someone who has not been helped by treatments currently used. In some cases, people who have not responded to other treatments may respond to the new drug.
Some insurance companies will not pay for any medical expenses when the insured person is receiving treatment as part of a clinical trial. This may occur because the companies believe that the treatment, however promising, has not yet been proven to be effective in a large study.
Although the following information refers to clinical trials studying a new drug, it also applies to trials investigating a new test, procedure, or combination of treatments.
For clinical trials studying a drug that has not yet been approved by the FDA, certain costs are directly related to the evaluation. These are called “research costs.”
Research costs include items such as the drug itself and tests or services needed to meet the research sponsor’s requirements. For example, monthly lab tests may be required to monitor how the new drug is processed by the body. These services are needed only because the patient is participating in the clinical trial. The drug and the lab tests are usually paid for by the study sponsor and should not be billed to you or your insurance company.
Services that would be provided even if you were not participating in the clinical trial are called “routine costs.” Routine costs include items or services, such as medications to treat symptoms, lab tests, X-rays, and physician visits. Costs for the treatment of any side effects or complications from the study drug are usually considered routine costs as well.
Many large commercial (that is, not government-sponsored) insurance plans pay for the routine costs associated with clinical trials. However, because coverage can vary widely, you should check your health plan document before enrolling in a clinical trial.
Your health plan benefits are usually described in detail in a document called a “Summary Plan Description” or “Certificate of Coverage.” If you are unable to find information on clinical trial coverage or if you don’t clearly understand your coverage, contact your health insurer by calling customer service, or talk to someone in your employer’s human resources department to find out what your health plan will and won’t cover.
If your health insurance doesn’t cover your treatment costs as part of a clinical trial, the trial sponsor (often a drug company) may pick up some or all of your expenses. Public or private resources may also be available to help. Ask your doctor or research nurse to help you determine your options.
Employer-sponsored health care plans
Many people have coverage through their employer. There are two different types of employer-sponsored health care plans: “fully-insured” and “self-funded” plans.
In a fully-insured plan, the employer purchases health insurance from a company that pays for employees’ medical expenses and charges the employer a fee that covers both the medical expenses and administrative costs, such as customer service and claims processing.
In a self-funded plan, the employer pays the cost of covered medical expenses, and the insurance company charges a fee that covers administrative costs only. This is important because self-funded plans are not subject to state insurance mandates (described below), such as those that require health insurance policies to cover certain types of services.
Employers that choose to be self-funded can decide for themselves whether they want to provide certain benefits. For example, they can decide if they want to cover routine costs of clinical trials.
If you don’t have coverage through an employer, you may need to find an individual insurance policy. Individual health insurance policies typically do not cover routine costs of care when care is provided as part of a clinical trial.
In September 2000, Federal legislation was passed that mandated the coverage of routine costs for “qualified” clinical trials for Medicare enrollees. Qualified clinical trials include those funded by the National Institutes of Health (NIH), including the National Cancer Institute, Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, U.S. Department of Defense , and U.S. Department of Veterans Affairs. Information is available on Medicare’s Clinical Trials National Coverage Determination.
Traditional Medicare covers routine costs of care when the enrollee participates in a clinical trial. It also pays for treatment needed due to any side effects or complications resulting from participating in a clinical trial. However, Medicare—like commercial insurance—does not pay for “research costs.”
Medicare Advantage plans
A Medicare Advantage Plan is an alternative to traditional Medicare coverage in which beneficiaries receive their Medicare benefits through a private health insurance company. Medicare Advantage Plans often feature lower out-of-pockets costs and additional benefits.
If you are enrolled in a Medicare Advantage Plan and choose to participate in a clinical trial, your medical expenses will be covered by traditional Medicare, not by the Medicare Advantage Plan. In other words, your coverage will revert to traditional Medicare. This means that, in most cases, you will be responsible for paying 20% of the eligible costs of care. This is called coinsurance.
Many people who enroll in traditional Medicare also purchase a “supplemental policy” that pays many of their out-of-pocket expenses. However, because Medicare Advantage enrollees are not eligible for (and usually do not need) supplemental policies, Medicare Advantage beneficiaries may find it too expensive to participate in a clinical trial.
Many states have passed laws mandating coverage of routine costs associated with clinical trials, while others are still working on legislation. The types of trials that are covered and the types of mandated coverage (if any) vary from state to state. Some states require that all clinical trials be covered, while others require coverage for only certain phases of clinical trials. Learn about whether your state has a clinical trial mandate.
Finding out moreIf you are thinking about participating in a clinical trial, you should discuss the financial implications with the hospital financial counselor or your physician’s billing staff. Your physician or research nurse may also have information about your options.
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