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Learn About Clinical Trials

  • Posted: 06/25/2010

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Insurance Coverage: Florida


For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.

Agreement: Florida Clinical Trial Compact (PDF 698 kb)

Effective: July 1, 2010

What clinical trials are covered?

Phase II, Phase III, or Phase IV clinical trials for cancer if a physician who is authorized to provide covered healthcare services to the insured under the insured’s health benefit plan contract recommends participation in the cancer clinical trial. The clinical trial must have a meaningful potential to benefit the insured. The trial’s endpoints shall not be defined exclusively to test toxicity, but shall have a therapeutic intent. To be covered, the clinical trial must either involve a drug that is exempt under federal regulations from a new drug application or must be a trial that is approved by

  • A cooperative group or one of the National Institutes of Health;
  • U.S. Food and Drug Administration (FDA), in the form of an investigational new drug application;
  • U.S. Department of Defense;
  • U.S. Department of Veterans Affairs;
  • National Cancer Institute; or
  • An accredited institutional review board of any accredited school of medicine, nursing, or pharmacy or licensed children’s specialty hospital in Florida.

Who is required to pay?

Health insurance providers who have signed the compact, voluntarily agreeing to provide this coverage. These providers include Humana, Blue Cross Blue Shield Florida, AvMed Health Plans, Vista Healthplan, Aetna, CIGNA, and UnitedHealth Group Florida.

Other key provisions

  • “Routine patient care costs” means the costs of health care services, including drugs, items, devices, and services that would be covered under the patient’s health plan if they were provided outside of a cancer clinical trial. This includes health care services required
    • Solely for the provision of the investigational drug, item, device or service;
    • For clinically appropriate monitoring of the investigational item or service; or
    • For “reasonable and necessary care arising from the provision of the investigational drug, item, device, or service, including the diagnosis or treatment of complications.”
  • “Routine patient care costs” excludes the costs of
    • Drugs or devices not approved by the FDA for use associated with the cancer clinical trial;
    • Nonclinical expenses, such as travel, housing, and companion expenses;
    • Items or services provided solely for data collection and analysis purposes and not used in the patient’s clinical management;
    • Health care services that would otherwise be excluded from coverage under the patient’s health plan;
    • Health care services customarily provided free of charge to trial enrollees by the trial sponsors; and
    • The cost of an oncologic drug, if the trial’s purpose is to study the use of the drug in the particular cancer in question or to study the administration of the drug in a new manner.
  • Coverage of patient care costs such as additional tests that may or may not be fully covered by the trial sponsor or research institution and other reimbursement issues must be resolved by the trial sponsor and the patient’s health plan. 
  • Deductibles or copayments may apply to routine patient care costs in a clinical trial, subject to the terms of the patient’s health plan.
  • Insurers may restrict coverage for cancer clinical trials to hospitals and physicians in Florida unless the trial protocol for the cancer clinical trial is not available at a Florida hospital or with a Florida-licensed physician.
  • Insurers are not required to pay for the services of an out-of-network provider unless the patient’s health plan covers out-of-network services. Insurers will pay the negotiated rate or what the insurer would otherwise pay a non-participating provider, less applicable out-of-network cost sharing.
  • Insurers are not required to cover benefits in a clinical trial that would not otherwise be covered under the patient’s health plan for other conditions.
  • Insurers are not liable for services provided under the terms of this agreement.

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