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: House File 2075 (PDF 37 kb), Summary (PDF 73 kb)

Effective: July 1, 2010

What clinical trials are covered?

Cancer clinical trials are covered if they involve the scientific study of a new therapy for the treatment of cancer in humans and consist of a scientific plan of treatment that includes specified goals, a rationale, and background for the plan; criteria for patient selection; specific directions for administering therapy and monitoring patients; a definition of quantitative measures for determining treatment response; and methods for documenting and treating adverse reactions. In addition:

• The treatment must be provided with therapeutic intent (that is, aimed at improving a patient’s survival or quality of life);
• The trial must be authorized or approved by
  • The National Institutes of Health,
  • The U.S. Food and Drug Administration,
  • The U.S. Department of Defense, or
  • The U.S. Department of Veterans Affairs;
• The proposed treatment must be reviewed and approved by the applicable qualified Institutional Review Board; and
• The available clinical or preclinical data must indicate that the treatment will be at least as effective as the standard therapy and is anticipated to constitute an improvement in therapeutic effectiveness for the treatment of the disease in question.

Who is required to pay?

Individual or group third-party provider contracts or policies.

Other key provisions

• The patient must be referred to the cancer clinical trial by two physicians who specialize in oncology.
• Routine patient care costs incurred for cancer treatment in an approved cancer clinical trial must be covered to the same extent that coverage is provided for treating any other injury, disease, or condition under that policy.
• Routine patient care costs are defined as medically necessary services or treatments that are a benefit under a contract or policy providing for third-party payment or prepayment of health or medical expenses that would be covered if the patient were receiving standard cancer treatment.
• Routine patient care costs do not include
  • Any treatments, procedures, drugs, devices, services, or items that are the subject of the approved cancer clinical trial or any other investigational treatments, procedures, drugs, devices, services, or items;
  • Non-health care services that the patient is required to receive as a result of participation in the trial;
  • Costs associated with managing the research associated with the trial;
  • Costs that would not be covered by insurer if non-investigational treatments were provided;
  • Any services, procedures, or tests provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient participating in the trial;
  • Costs paid for, or not charged for, by the clinical trial providers;
  • Transportation, lodging, food, or other expenses for the patient, a family member, or companion that are associated with travel to or from a facility where a clinical trial is conducted;
  • Services, items, or drugs that are eligible for reimbursement from a source other than a patient’s contract or policy, including the sponsor of the clinical trial;
  • Costs associated with trials designed exclusively to test toxicity or disease pathophysiology; or
  • Costs of extra treatments, services, procedures, tests, or drugs that would not be performed or administered except for participation in the cancer clinical trial.

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