Medical Research: A Consumer's Guide for Participation

Maine
Legislation: 24-A: Maine Insurance Code
Effective: 1999
What clinical trials are covered? Clinical trials
enrolling individuals who have a life-threatening or
serious illness for which no standard treatment is
effective. Trial must be approved and funded by any
one of the following:
• National Institutes of Health (NIH)
• NIH-sponsored cooperative group or center
• U.S. Department of Health and Human
Services
Who is required to pay? Managed care organizations
and private insurers.
Other key provisions:
• Participation must offer meaningful potential
for significant clinical benefit to the enrollee.
• Referring physician must conclude that trial
participation is appropriate.
Massachusetts
Legislation: House Bill 4376 (Chapter 257)
Effective: January 2003
What clinical trials are covered? All phases of cancer
treatment trials. Trial must be peer-reviewed and
approved by one of the following:
• National Institutes of Health (NIH)
• NIH-sponsored cooperative group or center
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• U.S. Food and Drug Administration
• A qualified non-government research entity
Who is required to pay? All health plans issued or
renewed after January 1, 2003.
Other key provisions:
• Insurers must provide payment for services
that are “consistent with the usual and
customary standard of care” provided under
the trial’s protocol and that would be covered
if the patient did not participate in the trial.
Michigan
Agreement: Michigan Consensus Agreement
Effective: February 2002
What clinical trials are covered? Phase II and III
cancer clinical trials that are sponsored or approved
by any one of the following:
• National Institutes of Health (NIH)
• National Cancer Institute
• U.S. Food and Drug Administration
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• Centers for Medicare and Medicaid Services
• Centers for Disease Control and Prevention
• The agreement also would cover any side
effects from the clinical trial treatment,
including hospitalization costs.
Who is required to pay? Private insurance plans,
HMOs and the Michigan Medicaid Program.
Other key provisions:
• Coverage for Phase I trials is under
consideration.
Missouri
Legislation: Senate Bill 1026; Senate Bills 567 & 792
Effective: August 28, 2002 (S.B. 1026); May 12, 2006
(S.B. 567 & 792)
What clinical trials are covered? Phase II, III or IV
clinical trials for the prevention, early detection, or
treatment of cancer as approved or funded by one of
the following:
• 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
• An Institutional Review Board in Missouri that
has been approved by the U.S. Department of
Health and Human Services
• A qualified research entity that meets the
criteria for NIH Center support grant eligibility
Who is required to pay? All health benefit plans operating
in the state.
Other key provisions:
• There must be identical or superior noninvestigational
treatment alternatives available before
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