Clinical Trials

Financial Considerations

It is important to realize there are certain costs associated with participating in a clinical trial, just as there are with any type of treatment. Some costs will be paid for by the trial organizer, others may be covered by your health insurance provider and the rest will likely be your out-of-pocket responsibility. Knowing what to expect before you join the trial may help avoid the added stress of unknown charges.

A detailed list of the costs covered by the clinical trial and those you or your insurer are responsible for will be included in the Informed Consent form. 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.

Clinical trial costs are typically designated as routine patient care or research. Routine patient care commonly 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.

Carefully review your insurance policy so you know the rules and procedures to follow and what is covered. Then contact your insurance company to confirm what you’ve read and ask additional questions, such as if the costs not covered by the clinical trial will be covered by your health insurance plan.

You are encouraged not to dismiss a clinical trial until you’ve looked into the financial resources that are available, even if you are uninsured or underinsured. Ask the clinical trial administrators about patient assistance programs, and explore the resources available to you. Many organizations are available to help offset the costs and help you 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. “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, check into 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.

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

 

 

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