Medical Research: A Consumer's Guide for Participation

APPENDIX B
providing clinical trial treatment, and there
must be a reasonable expectation that the clinical
trial treatment will be superior to the
noninvestigational alternatives.
• Requires coverage of FDA-approved drugs and
devices used in cancer clinical trials even if
those drugs and devices have not been
approved for use in treatment of the patient’s
particular condition.
• Health benefit plans may limit coverage of
routine care costs of patients in phase II trials
to those facilities within the plans’ provider
network.
• For individually underwritten health plans, the
phase II provision is not mandatory but must
be offered as an option.
New Hampshire
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.
Nevada
Legislation: Senate Bill 29
Effective: January 1, 2006 (extends legislation in
effect since January 2004 to include phase I cancer
clinical trials)
What clinical trials are covered? Phase I clinical trials
for the treatment of cancer, and phase II, III, and IV
clinical trials for the treatment of cancer or chronic
fatigue syndrome that are approved by one of the
following:
• National Institutes of Health (NIH)
• NIH cooperative group
• U.S. Food and Drug Administration (FDA)
• U.S. Department of Veterans Affairs
• U.S. Department of Defense
Who is required to pay? Private insurers and managed
care plans.
Other key provisions:
• There is no medical treatment available that is
considered more appropriate treatment than
the treatment provided in the clinical trial.
• Trial must be conducted in Nevada
New Jersey
Agreement: New Jersey Consensus Agreement
Effective: December 1999
What clinical trials are covered? All phases of cancer
clinical trials run by:
• National Institutes of Health (NIH)
• NIH cooperative group or center
• U.S. Food and Drug Administration
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
Who is required to pay? All insurers in the state,
including those affiliated with the New Jersey
Association of Health Plans.
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