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Learn About Clinical Trials

  • Updated: 06/08/2009

Insurance Coverage: Indiana

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 Bill 1382

Effective: July 1, 2009

What clinical trials are covered?

Phase I, II, III or IV clinical trials that are conducted to prevent, diagnose, or treat cancer, as approved or funded by one of the following:

  • U.S. National Institutes of Health
  • A cooperative group of research facilities that has an established peer review program that is approved by an NIH Institute or Center
  • U.S. Food and Drug Administration
  • U.S. Department of Defense
  • U.S. Department of Veterans Affairs
  • The Institutional Review Board of an institution in Indiana that has a multiple project assurance contract approved by the NIH Office for Protection from Research Risks
  • A qualified research entity that meets the criteria for NIH Center support grant eligibility

Who is required to pay?

Coverage is required under a state employee health plan, the state Medicaid program, a policy of accident and sickness insurance, and a health maintenance organization contract.

Other key provisions:

  • There must be no clearly superior, non-investigational alternative care method, and available clinical or preclinical data must provide a reasonable basis from which to believe that the care method used in the research study is at least as effective as any non-investigational alternative care method.
  • Routine care costs - defined as the costs of medically necessary services related to the care method that is under evaluation in a clinical trial - must be covered if the same costs would be covered were they incurred outside of a clinical trial.
  • With slight variations for Medicaid, health plans may exclude coverage for:
    • the service, item, or drug that is being tested in the clinical trial
    • treatments that are not part of the usual and customary standard of care required to administer or support the health care service, item, or drug that is the subject of the clinical trial
    • health care services, items, or drugs used solely for data collection and analysis needs and not in the direct clinical management of the patient
    • investigational drugs or devices that have not been approved for market by FDA
    • transportation, lodging, food, or other expenses for the patient or a family member or companion for travel to or from the facility where the trial is conducted
    • services, items, or drugs provided free of charge to patients by the clinical trial sponsors
    • services, items, or drugs that are eligible for reimbursement from a source other than the health insurer, including the sponsor of the clinical trial.

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