For more information about insurance coverage of clinical trial costs, see this
feature's main page:
States That Require Health Plans to Pay for Clinical Trial Costs.
Legislation: Senate Bill 409
Effective: January 2001
What clinical trials are covered?
Phase I, II, III, and IV trials for cancer and other life-threatening conditions, with coverage for Phase I and II trials to be decided on a case-by-case basis. Coverage is required for clinical trials that are approved by:
- National Institutes of Health (NIH)
- NIH cooperative group or center
- U.S. Food and Drug Administration
- U.S. Department of Veterans Affairs
- U.S. Department of Defense
- An Institutional Review Board of an institution in New Hampshire with a Multiple Project Assurance (MPA) from the U.S. Department of Health and Human Services' Office for Human Research Protections
Coverage is also required for reasonable and medically necessary services to administer the drug or device under evaluation in the clinical trial.
Who is required to pay?
Private insurers and specified managed care plans.
Other key provisions:
- Trials are covered when standard treatment has been or would be ineffective or does not exist, or when there is no clearly superior noninvestigational alternative.
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