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 316

Effective: January 1, 2010

What clinical trials are covered?

Insurers are required to provide coverage for routine patient care costs in clinical trials provided that the trial is

• Funded by one of the following:
  • National Institutes of Health
  • Centers for Disease Control and Prevention
  • Agency for Healthcare Quality and Research
  • Centers for Medicare and Medicaid Services
  • U.S. Department of Defense
  • U.S. Department of Veteran Affairs
• Supported by a center or cooperative group funded by one of the above agencies
  
  
• Conducted as an investigational new drug application, an investigational device exemption, or a biologics license application subject to approval by the U.S. Food and Drug Administration, or exempt by federal law from the requirement to submit an investigational new drug application to the FDA.
  

Who is required to pay?

All individual and group health benefit plans, including health maintenance organizations.

Other key provisions

• "Routine costs" means medically necessary conventional care, items, or services that would be covered by the health benefit plan outside of a clinical trial.

• Routine costs do not include the cost of the drug, device, or service being tested in the clinical trial unless the drug, device, or service would be covered for that indication outside of a clinical trial.

• Routine costs also do not include items or services that are:
  • required solely to provide the drug, device, or service being tested
  • required solely for clinically appropriate monitoring of the drug, device, or service being tested
  • required solely to prevent, diagnose, or treat complications arising from the drug, device, or service being tested
  • provided solely for data collection and analysis purposes
  • customarily provided by the trial sponsor free of charge to any participant
  • not covered by the health plan outside of a clinical trial.
    
    
• Patients taking part in covered clinical trials pay the same deductibles, copayments, coinsurance, and other fees associated with their care that they would pay if they were not taking part in a clinical trial.