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by the FDA to be lawfully marketed for the proposed use, if the Prescription Drug Product has been
recognized as safe and effective for treatment of a particular indication in one or more of the publications
or literature listed below:

· The AMA Drug Evaluations, a publication of the American Medical Association;
· The AHFS (American Hospital Formulary Service) Drug Information, a publication of the American
Society of Health System Pharmacists;

· Drug Information for the Health Care Provider, a publication of the United States Pharmacopoeia
Convention; or

· medical literature may be accepted in place of the above compendia if all of the following apply:
· two articles from major peer-reviewed professional medical journals have recognized, based on
scientific or medical criteria, the drug's safety and effectiveness for treatment of the indication for
which it has been prescribed;
· no article from a major peer-reviewed professional medical journal has concluded, based on
scientific or medical criteria, that the drug is unsafe or ineffective or that the drug's safety and
effectiveness cannot be determined for the treatment of the indication for which it has been
prescribed; and
· each article meets the uniform requirements for manuscripts submitted to biomedical journals
established by the International Committee of Medical Journal Editors or is published in a journal
specified by the United States Department of Health and Human Services as accepted peer-
reviewed medical literature;

· Prescription Drug Products furnished by the local, state or federal government. Any Prescription Drug
Product to the extent payment or benefits are provided or available from the local, state or federal
government (for example, Medicare) whether or not payment or benefits are received, except as
otherwise provided by law;

· Prescription Drug Products for any condition, Injury, Sickness or mental illness arising out of, or in the
course of, employment for which benefits are available under any workers' compensation law or other
similar laws, whether or not a claim for such benefits is made or payment or benefits are received;

· Any product dispensed for the purpose of appetite suppression or weight loss;
· A Pharmaceutical Product for which Benefits are provided in your Summary Plan Description;

· Durable Medical Equipment. Prescribed and non-prescribed outpatient supplies. This exclusion does not
apply to diabetic supplies and inhaler spacers specifically stated as covered;

· General vitamins, except the following which require a Prescription Order or Refill:

· Prenatal vitamins
· Vitamins with fluoride
· Single entity vitamins
· Unit dose packaging of Prescription Drug Products;

· Medications used for cosmetic purposes;
· Prescription Drug Products, including New Prescription Drug Products or new dosage forms, that we
determine do not meet the definition of a Covered Health Care Service;

· Prescription Drug Products as a replacement for a previously dispensed Prescription Drug Product that
was lost, stolen, broken or destroyed;

· Prescription Drug Products when prescribed to treat infertility;
· Treatment for toenail onychomycosis (toenail fungus);

· Certain prescription Drug Products for tobacco cessation;
· Diagnostic kits and products;

· Dental products, including but not limited to prescription fluoride topicals;

Page 71 Section 13 -Prescription Drug
HSA - 2017