Clinical Trials

Financial Considerations

A piece of the clinical trial puzzle involves understanding who is responsible for which expenses. Patients often assume that because clinical trials include experimental therapies they will be too expensive. Frequently, this is not the case. Keep in mind that there are costs associated with any type of cancer treatment.

The costs related to clinical trials are typically separated into two categories.

  • Routine patient care, which applies to any type of cancer treatment including those used in clinical trials, usually involves expenses related to doctor visits, hospital stays and some testing procedures.
  • Research costs are directly related to the clinical trial and are typically covered by the trial sponsor. They include drugs and procedures.

When you receive the Informed Consent form for the trial, look it over carefully because 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 will expect you to have questions, and they are prepared to answer them.

Understanding the Expenses Paid by Insurance

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

Costs that typically are not covered by insurance include the cost of the treatment or procedure being studied in the trial and any procedure only needed to collect data for the study.

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

Exploring Government Assistance

It is important to check into federal and state programs associated with clinical trials. Government programs may assist with clinical trial costs. Following are some federal programs that may help pay the costs.

  • The Patient Protection and Affordable Care Act (ACA), a federal law that regulates health plans and insurance, covers routine clinical trial costs. Clinical trials covered under the ACA must be designed to study new ways to prevent, detect or treat cancer or other life-threatening illnesses. Check whether your insurance plan covers costs outside of your health plan’s network.
  • 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, such as office visits and tests, in certain qualifying clinical research studies. Medicare Advantage plans may pay the difference in your out-of-pocket costs between it and traditional Medicare. 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

These definitions may help you better communicate with your health insurance provider and clinical trial administrators when discussing costs and coverage.

Case manager: A personal advocate who collaborates with health care professionals and nonmedical personnel to help patients overcome various financial, logistical and other common barriers to care.

Claim: A request for payment you make to your insurance provider based on the terms of your policy.

Coinsurance: The percentage of medical care expenses you are responsible for paying after meeting your deductible.

Copay: The fixed amount, according to your insurance plan, that you must pay for specific types of medical care, usually at the time of service.

Deductible: The amount that you must pay for medical expenses before your insurance begins paying.

Eligibility criteria: The guidelines defining who can participate in the clinical trial based on several factors, which may include age, type and stage of cancer and treatment history.

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

Financial counselor: A person who works with patients and their families to reduce stress or hardships related to treatment costs. This may include setting up payment plans, finding cost-saving methods and improving access to services.

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 your health insurance plan. Their 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. You are required to review the document and sign the form to enroll in the trial.

Out-of-network: The term given to health care providers or facilities not associated with your insurance plan. Their fees are typically more than in-network fees.

Out-of-pocket costs: Medical expenses you are responsible for paying. This may include deductibles, coinsurances and copayments for covered services, plus all costs for services not covered by your insurance plan or other entities.

Precertification: The process of getting approved by your insurance company for specific services, procedures or treatments before you have them.

Premium: The amount you pay monthly for health insurance.

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

 

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