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Summary

Participation in a clinical trial is generally free of charge. Generally the sponsor of the trial pays for the actual drug and special tests required by a clinical trial. However, there may be costs associated with a trial that may or may not be fully covered by the trial sponsor and /or research institution. Which expenses are covered varies among trials. Discuss this issue with the trial sponsor and your doctor.

Patient care costs associated with a clinical trial fall into two main categories: Usual Care Costs and Extra Care Costs.

  • Usual care costs:  Are those that are traditionally covered by a health plan such as private insurance or Medicare. These may include doctor visits, hospitalizations, lab tests such as blood tests, and x-rays, or other services that are typically provided when receiving standard treatment or participating in a clinical trial. Usual care costs are usually covered by health plans. 
  • Extra care costs:  Are those costs that directly relate to participation in a clinical trial. For example, extra care costs include additional tests that may be required to monitor your progress. The provider of the trial may not always cover these extra expenses. In such cases, the trial sponsor and your health plan need to resolve these coverages.Extra care costs may not be covered. 
  • The question comes down to your particular coverage, and the specific trial and costs in question.

If the trial in which you are interested is being conducted at more than one site near you, check to see which site covers more of your costs. Some sites may even provide money for transportation, food or child care. If it appears that significant costs will not be covered, see: How To Get Your Insurance Company To Say Yes To Paying The Costs Of A Clinical Trial.

Help with costs associated with clinical trials is provided by several organizations including the national Children's Cancer Society (www.childrenscancer.org offsite link). Mercy Medical Airlift (www.mercymedical.org offsite link) and Angel Flight America (www.angelflightamerica.org offsite link) can help with travel arrangements. 

When thinking about your costs for entering a trial: If you have to travel to get to the trial, include the cost of transportation. If you have to stay over in a different location, include the cost of lodging and meals.

For information with respect to different types of health insurance, see:

NOTE: Over the last few years a number of insurance companies have begun to change their policies with respect to coverage of clinical trials. Some government employees are now covered for clinical trials (Department of Defense), as well as those individuals covered under the Department of Veterans Affairs.  Many insurance companies are now paying for trial associated costs, or are willing to make a determination on a case-by-case basis.

Medicare

Medicare pays for routine patient care costs associated with certain clinical trials. According to the Health Care Finance Administration, clinical trials automatically qualify if they are conducted under an investigational new drug application (IND) reviewed by the FDA, or if the trials are supported or funded by:

  • The National Institutes of Health
  • The Centers for Disease Control
  • The Health Care Finance Administration
  • The Department of Defense
  • The Veterans Administration
  • The Agency for Healthcare Research and Quality

If a trial is not supported by any of the agencies listed above, it must meet the following criteria to qualify for Medicare coverage:

  • The purpose of the trial must be the evaluation of a service or item that falls under general Medicare coverage (such as physicians services, durable medical equipment, diagnostic testing). Medicare will not cover trials studying procedures or items that are not generally paid for by Medicare (such as cosmetic surgery, hearing aids).
  • The purpose of a trial must have therapeutic treatment intent or study the effectiveness of diagnostic procedures.
  • Healthy volunteers may only participate in diagnostic intervention trials (as control groups).
  • Eligibility for treatment studies requires that participants be diagnosed with a related medical condition.
  • The principal purpose of the trial is to test whether the treatment potentially improves the participants' health outcomes.
  • The trial is well supported by available scientific and medical information, or it is intended to clarify or establish the health outcomes of treatments already in common clinical use.
  • The trial doesn't unjustifiably duplicate existing studies.
  • The trial design is appropriate to answer the research question being asked in the trial.
  • A credible organization or individual capable of successfully executing the trial sponsors the trial.
  • The trial is in compliance with Federal regulations relating to the protection of human subjects.
  • All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Medicare does cover the following routine costs associated with those clinical trials that meet with Medicare's criteria:

  • All items or services that are typically covered for the standard treatment of a condition (in other words, treatment that would be provided if there were no clinical trial).
  • Items or services required solely for the purpose of the study (such as the cost of administering an unapproved chemotherapy drug), and the associated costs of tests monitoring the effects, or the prevention of complications.
  • Items or services needed for reasonable and necessary care arising from complications, as a result of the treatment being studied - in particular, for the diagnosis or treatment of the complication.

Medicare does not cover the following costs associated with clinical trials:

  • The cost of the treatment or drug being studied (this cost is generally covered by the trial sponsor).
  • Tests or other services designed solely to satisfy data collection and analysis for the trial, and are not used for direct management or treatment of the participant's condition (such as monthly CT scans for a condition usually requiring only a single scan).
  • The costs for services or items that are customarily provided free of charge by the trial sponsor.
Medicare encourages participation in clinical trials. If a situation doesn't meet the Medicare requirements, call your Medicare contractor and speak with a claims representative.

Medicaid

There are no Federal regulations regarding coverage of clinical trials.

If you have Medicaid, you have to check to find out what happens in your state. When you find out, please let us know so we can share the information. E mail: Survivorship A to Z.

Private Health Insurance Coverage

Insurance providers have specific policies regarding the types of treatments that will be covered. Most will pay for treatment, early-detection or diagnosis trials. Prevention trials are generally not covered.

A survey of the American Society of Clinical Oncology in Atlanta involving 8,000 oncologists (cancer doctors) concluded that 95% of oncologists submitted insurance claims for their patients participating in clinical trials. Fewer than 10% of those claims were rejected.

Several states, including Maryland and Rhode Island, mandate that health insurance coverage extend to clinical trials for people with a life threatening condition.To learn whether your state is one of them, see the American Cancer Society: Clinical Trials: State Laws Regarding Insurance Coverage offsite link.  

If whether your insurer will pay the costs not covered by a clinical trial is a deciding factor for joining a trial, find out the facts before you join. Speak with the doctor in charge of the trial, the trial coordinator oryour own doctorto determine whether insurance companies typically cover the cost associated with the particular tiral in which you are interested. If payment has not been an issue, you may choose to take a "wait and see" approach. However, if there have been problems with obtaining insurance payment, see: How To Get Your Insurance Company To Say Yes To Paying For The Costs Of A Clinical Trial.