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Monday, December 28, 2015 2:38:20 PM
• Conducted pursuant to an FDA, NIH, NCI, or Cancer-cooperative group approved Phase I, II or
Phase III Clinical Trial. In the event a covered person is not formally a participant in the approved
Clinical Trial, such treatment or therapy must be administered under the direction of a physician,
follow the protocols and procedures utilized in the trial and be delivered at a facility that has been
designated as a participant under the approved FDA, NIH, NCI, or Cancer-cooperative group for
Phase I, II or Phase III Clinical Trial
• Where the illness is encountered so infrequently that no formal trials exist, if the proposed
treatment is considered promising care by knowledgeable experts in the field and is supported by
evidence of efficacy in the peer reviewed literature, such treatment will be allowed when
performed within a facility that actively participates in approved FDA, NIH, NCI, or Cancercooperative
group Phase I, II or Phase III Clinical Trials.
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