McKesson 2005 Annual Report Download - page 188

2. Those for or in connection with services or supplies that are, as determined by the Insurance Company in its sole discretion, to be
experimental or investigational. A drug, a device, a procedure, or treatment will be determined to be experimental or investigational if:
a. There are insufficient outcomes data available from controlled clinical trials published in the peer reviewed literature to substantiate its
safety and effectiveness for the disease or injury involved; or
b. If required by the FDA, approval has not been granted for marketing; or
c. A recognized national medical or dental society or regulatory agency has determined, in writing, that it is experimental,
investigational, or for research purposes ; or
d. The written protocol or protocols used by the treating facility, or the protocol or protocols of any other facility studying substantially
the same drug, device, procedure, or treatment, or the written informed consent used by the treating facility or by another facility studying the
same drug, device, procedure, or treatment states that it is experimental, investigational, or for research purposes.
However, this exclusion will not apply with respect to services or supplies (other than drugs) received in connection with a disease; if the
Insurance Company determines that:
i. the disease can be expected to cause death within one year, in the absence of effective treatment; and
ii. the care or treatment is effective for that disease or shows promise of being effective for that disease as demonstrated by scientific
data. In making this determination the Insurance Company will take into account the results of a review by a panel of independent medical
professionals. They will be selected by the Insurance Company. This panel will include professionals who treat the type of disease involved.
Also, this exclusion will not apply with respect to drugs that:
iii. have been granted treatment investigational new drug (IND) or Group c/treatment IND status; or
iv. are being studied at the Phase III level in a national clinical trial sponsored by the National Cancer Institute;
if the Insurance Company determines that available scientific evidence demonstrates that the drug is effective or shows promise of being
effective for the disease.
3. Those for or related to services, treatment, education testing, or training related to learning disabilities or developmental delays.
4. Those for care furnished mainly to provide a surrounding free from exposure that can worsen the person’s disease or injury.
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