about Financial Concerns

Even if you have health insurance, there may be costs associated with the trial that you will have to pay. This is because some health plans consider some or all clinical trials "experimental" or "investigational" procedures, which they only partially cover, or do not cover at all.

A federal health care reform law—the Patient Protection and Affordable Care Act (ACA)—includes the requirement that private insurers cover the routine patient costs associated with participation in approved clinical trials. See: https://www.asco.org/research-data/clinical-trials/insurance-coverage-clinical-trials.

Routine and Experimental Procedures

Breast cancer clinical trials can include both routine procedure costs and experimental procedure costs.

• Routine care costs typically cover items that would be provided if you received care outside a clinical trial, such as diagnostic procedures, laboratory tests, office visits, intravenous infusions, and inpatient hospital admissions. In many cases, you or your insurance company will be required to pay for costs associated with the care provided in the trial that is considered "routine."
• Experimental procedure costs are those that are associated specifically with the trial. These costs include the experimental medication or treatment, data gathering activities, and the laboratory or radiology tests, like x-rays and CT scans, that are performed specifically for the study. The trial sponsor usually covers these costs.

You can learn more about clinical trials and insurance coverage on the NCI website here and on the American Society of Clinical Oncology (ASCO) website here.

Not All States Are the Same

Some states have passed laws that require insurance companies to cover some or all of the routine care costs associated with cancer clinical trials. Other states have worked with insurers to develop voluntary agreements related to coverage of routine medical care. It is important that you find out not only what the law is in your state but also what your health plan covers. (Note: Some insurers cover clinical trial costs, regardless of what the state requires.)

Before entering a breast cancer clinical trial, you should:

• Review this list of the states that require health plans to cover patient care costs in clinical trials.
• Be aware that even if your state does require coverage, there may still be exceptions. For example, patients covered by self-insured Employee Retirement Income Security Act (ERISA) plans are not guaranteed coverage for benefits and services if they enroll in a clinical trial, regardless of their state's laws.
• Contact your health plan to find out how it handles routine care associated with clinical trials. You can request that they send or email you this information, which will allow you and a member of the research team to review it together. Never enroll in a breast cancer trial until you are fully aware of what your insurance will or will not cover.

HMOs and Clinical Trials

Health Maintenance Organizations (HMOs) often only cover trials that are taking place at one of their "approved" facilities. If the trial you are interested in is not taking place at an approved facility (often referred to as an "out of network" facility), you will probably need to petition your HMO to get them to cover routine care costs. Your petition is most likely to be approved if the trial provides the only care available to you at this point in your treatment. The social worker at the clinical trial site may be able to assist you with your petition. Never enroll in a breast cancer trial until you are fully aware of what your HMO will cover.

Medicare and Clinical Trials

Medicare covers routine care costs for clinical trials. Cancer treatment and diagnostic trials are typically covered if they are funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, cancer cooperative groups, or other federal agencies that fund cancer research. Trials that are not funded by federal agencies must seek approval for Medicare coverage.

Learn more about Medicare and clinical trials:

• Visit the Centers for Medicare and Medicaid website.
• You may also want to review “If You Have Cancer and Have Medicare” on the NCI website.
  Medicare rules are complicated, change frequently, and sometimes have certain exceptions. Never enroll in a breast cancer trial until you are fully aware of what Medicare will cover.
  
  

Veteran Affairs, DoD TRICARE, and Clinical Trials

The Department of Defense (DoD) has partnered with the National Cancer Institute (NCI) to offer Cancer Clinical Trials to eligible TRICARE beneficiaries. You can learn more in this section of the TRICARE website. Additional information is available on the VA’s website. These programs are constantly evolving and are subject to change. Never enroll in a trial until you are fully aware of what the VA or DoD will cover.