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Institutes of Health, Glossary of Terms for Human Subjects Protection and Inclusion Issues, adopted by reference in 7 AAC 160.900; • for which inadequate available clinical or preclinical data exists to provide a reasonable expectation that the proposed service is at least as safe and effective as one not under experiment orinvestigation; • for which an expert has issued an opinion that additional information is needed to assess the safety or efficacy ofthe proposed service; • for which final approval from the appropriate governmental body has not been granted for the specific indications for which the use of the service is being proposed; however, if a drug has received final approval from the United States Food and Drug Administration (FDA) for any indication, final approval is not required for the specific indication for which use is being proposed if o the prescription or order was issued by a licensed health care provider within the scope of the provider's license; o prior authorization was obtained from the department if required under 7 AAC 105 - 7 AAC 160; or o the condition being treated with the drug is not otherwise excluded as a use of thedrug; or • whose use is not in accordance with customarystandards of medical practice;

h. For missed appointments; however, the provider maycharge the recipient;

i. For interpreter services;

j. For infertility services;

k. For impotence therapy and services;

l. For treatment, therapy, surgery, or other procedures related to gender reassignment;

m. For sterilization for recipients under twenty-one (21) years of age and hysterectomies performed solely for sterilization purposes;

n. For nonsurgical weight reduction or maintenance treatment