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 10

Effective: September 2010

What clinical trials are covered?

A clinical trial related to cancer, including leukemia, lymphoma, and bone marrow stem cell disorders, if the study is approved by an institutional review board that complies with federal law and by one or more of the following:

• United States Department of Health and Human Services, National Institutes of Health, or its institutes or centers
• United States Food and Drug Administration
• United States Department of Defense United States Department of Veterans Affairs
• A nongovernmental research entity abiding by current NIH guidelines

Who is required to pay?

Specified individual and group insurers, including health maintenance organizations and public employee health plans.

Other key provisions

• Insurers are required to provide coverage only if the patient's treating physician determines that there is no clearly superior noninvestigational treatment alternative, and available clinical or preclinical data provide a reasonable expectation that the treatment provided in the clinical trial will be at least as efficacious as any non-investigational alternative.
  
  
• The coverage must be subject to the standard policy provisions applicable to other benefits, including deductible, coinsurance, or copayment provisions.
  
  
• The coverage is required to include payment for the cost of:
  • prevention, diagnosis, treatment, and palliative care of cancer
  • medical care for an approved clinical trial related to cancer that would otherwise be covered under a plan if the medical care were not in connection with an approved clinical trial related to cancer
  • items or services necessary to provide an investigational item or service
  • the diagnosis or treatment of complications
  • a drug or device approved by the FDA without regard to whether the FDA approved the drug or device for use in treating a patient's particular condition, but only to the extent that the drug or device is not paid for by the manufacturer, distributor, or provider of the drug or device
  • services necessary to administer a drug or device under evaluation in the clinical trial
  • transportation for the patient that is primarily for and essential to the medical care.
  
  
• The coverage is prohibited from including the cost of:
  • a drug or device that is associated with the clinical trial that has not been approved by the FDA
  • housing, companion expenses, or other nonclinical expenses associated with the clinical trial
  • an item or service provided solely to satisfy data collection and analysis and not used in the clinical management of the patient
  • an item or service excluded from coverage under the patient's plan
  • an item or service paid for or customarily paid for through grants or other funding.