Clinical Trials

Financial Considerations

Many patients assume new treatments studied in clinical trials will be too expensive for them to participate. Frequently, this is not the case. Although there are costs associated with receiving clinical trial therapies, costs are associated with receiving any cancer treatment. Before you dismiss this valuable treatment option, make sure you understand how all the components will be paid for. Then you can make a more informed decision.

When you receive the Informed Consent form for the trial, look it over carefully. A detailed list of the costs covered by the trial and those you or your insurer are responsible for will be included. Before you sign the form, it is extremely important to address all your concerns about cost and payment. The clinical trial administrators understand this and will expect you to have questions.

Costs are typically separated into routine patient care and research. Routine patient care usually includes expenses related to doctor visits, hospital stays and some testing procedures. They are part of standard care, which would be included in any type of treatment. In a clinical trial, these are usually covered by your health insurance. Research costs, which are directly related to the clinical trial and include drugs and procedures, are typically covered by the trial sponsor.

If you are unsure if your insurance covers the expenses of a clinical trial, review your policy and contact your insurance company. Also, verify if the costs not covered through the clinical trial will be covered by your health insurance plan, or if they will be your responsibility.

Even if you don’t have insurance or are underinsured, assistance may be available. Ask the clinical trial administrators about patient assistance programs. Many patient advocacy organizations may help offset the costs and navigate the often confusing financial part of cancer treatment.

Fran Castellow, MSEd, Patient Advocate Foundation, believes no patient should have to struggle with financial obstacles alone. According to Fran, “Our expert case managers work alongside the patient or caregiver to identify solutions to problems surrounding insurance, medical debt and many other challenges, as well as helping them better afford their out-of-pocket costs.”

Also, learn about federal and state requirements associated with clinical trials. Some government programs may offer assistance:

  • Medicare covers portions of clinical research studies, such as trials designed to evaluate a cancer drug’s effectiveness. Medicare Part A and/or Part B may cover some things, such as office visits and tests, in certain qualifying clinical research studies. Talk with your clinical trial administrators before proceeding to ensure you understand their recommendations, the costs and the covered expenses.
  • TRICARE is the Department of Defense’s health care program. In partnership with the National Cancer Institute (NCI), the Department of Defense now covers participation in Phase I, II and III NCI-sponsored cancer clinical trials as a TRICARE benefit.
  • The U.S. Department of Veterans Affairs (VA) allows eligible veterans to participate in NCI-sponsored clinical trials at VA medical centers.

 

Glossary: Terms to Know

The terms used when talking about clinical trials and insurance coverage can be difficult to understand. These definitions may help.

Case manager: A social worker, trained financial counselor, nurse or some combination of various fields of expertise who offers a range of services. Services available include navigating insurance approvals, finding support services and advocating for your care, from screening and care coordination to transportation needs, insurance claims and discharge planning.

Claim: A request for payment based on the terms of the insurance policy.

Coinsurance: The percentage of medical care that you are financially responsible for paying after meeting the deductible.

Control group: The participants who receive the standard-of-care treatment being compared with one or more treatments being tested.

Copay: The fixed amount that must be paid for specific types of medical care, usually at time of service.

Deductible: The amount that must be paid before insurance begins paying.

Eligibility criteria: The guidelines defining who can participate in the clinical trial based on age, gender, health status, type and stage of cancer, previous treatments and other factors.

Enrollment: The number of participants in a clinical study. The estimated enrollment is the number of participants that the researchers need for the study.

Explanation of benefits (EOB): A statement your health insurance company provides to explain which medical treatments and/or services were paid on your behalf.

HIPAA: The Health Insurance Portability and Accountability Act is a law that protects the privacy of your personal medical information.

In-network: Health care providers or facilities associated with a health insurance plan. In-network provider fees are typically less than out-of-network provider fees.

Informed Consent form: A document that contains information about the clinical trial, including the potential benefits, risks and the alternatives to the research being conducted. Participants are required to sign the form before enrolling in a trial.

Intervention: A process or action that is the focus of a clinical trial. Interventions include drugs, medical devices, procedures, vaccines and other products that are either investigational or already available.

Out-of-network: Health care providers or facilities not associated with a health insurance plan. These fees are typically more than in-network provider fees.

Out-of-pocket costs: Medical care expenses you are responsible for paying. These costs may include deductibles, coinsurances and copayments for covered services, plus all costs for services that aren’t covered.

Precertification: The process of getting approved from an insurance company for specific services, procedures or treatments before having them.

Premium: The amount you pay each month for health insurance.

Protocol: The set of rules that every participating clinic, hospital, university and cancer center must follow in a clinical trial, including the eligibility criteria, tests and procedures, medications and dosages and length of study.

Recruitment status: Indicates whether a clinical study is currently open (accepting participants).

Reimbursement: Compensation or repayment from your insurance company for health care services you paid out of pocket.

Sponsor: The organization or person, also referred to as sponsor- investigator, who oversees the clinical trial and is responsible for analyzing the study data.

Standard of care: The drug or treatment that experts agree is the most widely used and appropriate therapy for a particular type and stage of cancer.

U.S. Food and Drug Administration (FDA): The government agency that protects many areas of public health, including making sure that new drugs, treatment approaches, medical devices and equipment are safe and effective.

Some definitions courtesy of the website of the National Cancer Institute (www.cancer.gov)

 

 

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