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Learn About Clinical Trials

  • Posted: 09/30/2010

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Insurance Coverage: Kentucky

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.


Legislation: Senate Bill 18

Effective: July 15, 2010

What clinical trials are covered?

Health benefit plans are prohibited from excluding coverage for routine patient health care costs incurred in the course of a cancer clinical trial if those costs would be covered outside of a cancer clinical trial. “Cancer clinical trial” means a trial that is approved by:

  • The National Institutes of Health (NIH) or any institutional review board recognized by the NIH
  • The U.S. Food and Drug Administration (FDA)
  • The U.S. Department of Defense
  • The U.S. Veterans Administration

and that does one of the following:

  • Tests how to administer a health care service, item, or drug for the treatment of cancer
  • Tests responses to a health care service, item, or drug for the treatment of cancer
  • Compares the effectiveness of health care services, items, or drugs for the treatment of cancer with that of other health care services, items, or drugs for the treatment of cancer
  • Studies new uses of health care services, items, or drugs for the treatment of cancer

Who is required to pay?

All health benefit policies, plans, and contracts.

Other key provisions

  • "Routine patient health care costs" means all health care services, items, and drugs for the treatment of cancer except:
    • The health care service, item, or investigational drug that is the subject of the cancer clinical trial
    • Any treatment modality outside the usual and customary standard of care required to administer or support the health care service, item, or investigational drug that is the subject of the cancer clinical trial
    • Any health care service, item, or drug provided solely to satisfy data collection and analysis needs that is not used in the direct clinical management of the patient
    • An investigational drug or device not approved for marketing by the FDA
    • Transportation, lodging, food, or other expenses for the patient or a family member or companion of the patient associated with travel to or from a facility providing the cancer clinical trial
    • Any services, items, or drugs provided by the cancer clinical trial sponsors free of charge for any new patient
    • Any services, items, or drugs eligible for reimbursement by a person other than the insurer, including the sponsor of the clinical trial.
  • Coverage of routine patient health care costs is subject to all terms, conditions, restrictions, exclusions, and limitations that apply to other coverage under the patient’s policy, plan, or contract.
  • Health benefit policies, plans, or contracts are neither required to nor prohibited from offering cancer clinical trial services by a participating provider.
  • Health benefit policies, plans, or contracts are not required to reimburse services performed in a cancer clinical trial by a nonparticipating provider at the same rate as services performed by a participating provider.

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