Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee requested coverage for testosterone pellet therapy. Findings:  Three physician reviewers found that the EE is diagnosed with low free testosterone and menopausal disorder.  She experienced decreased libido, decreased energy, mood swings, anxiety, poor memory, no mental clarity, and lethargy.  She had implantation of a testosterone pellet.  She indicated she had been receiving the pellet therapy previously and wished to continue treatment because she felt better when her testosterone was higher.  She reported improvement after the pellet therapy.  The enrollee indicates the testosterone pellets are derived from natural plant based ingredients and possess the exact hormonal structure of the human hormones, and a physician is required to implant the pellet in the hip.  Her physician indicates the enrollees laboratory values show significant hormone deficiency and no other form of hormone delivery can produce the consistent blood level of estrogen and testosterone that pellets can.  He states that the pellet therapy is the only method of testosterone therapy that gives sustained and consistent testosterone levels throughout the day for four to six months without a roller coaster effect.  Review of the record indicates the enrollee has normal periods and is not post-menopausal. Testosterone levels are in the normal range for females.  There is no evidence to support testosterone replacement therapy. According to the literature, there are greater uncertainties regarding testosterone therapy in women. A clinical practice guideline published by the endocrine society does not recommend the generalized use of testosterone in women, due to the lack of clear indications of use and inadequate long-term safety data.  However, its role as a treatment in both men and women remains without a unified, recommended stance. Testosterone implants are not approved by the FDA for relief of menopausal symptoms and are not approved for use in women. Proponents of the bioidentical approach claim that these preparations are effective for menopausal symptoms and are safer than commercially available preparations. However, a systematic review of the literature concluded that, while some of these products may decrease hot flashes, there is no evidence that `bioidentical` hormones have any advantage over conventional hormone therapies.  In addition, their safety has not been established.  The natural testosterone pellets are still considered unproven in this clinical scenario.Final Result: Three of the three reviewers determined that the requested services are not likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: One reviewer is board certified in obstetrics and gynecology and reproductive endocrinology, two reviewers are board certified in obstetrics and gynecology and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.