Testosterone Deficiency denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient requested reimbursement and prospective authorization and coverage for clomiphene citrate.The American Urological Association (AUA) Guidelines on the Evaluation and Management of Testosterone Deficiency, specifically Guideline Statement 27, explains that clomiphene citrate is widely accepted as a treatment for low testosterone in males. The AUA guidelines specifically list clomiphene citrate as one of the appropriate alternative therapies commonly used to promote the endogenous production of testosterone. It further supports the use of clomiphene based on studies that showed that clomiphene citrate has outstanding biochemical and clinical efficacy, with increases in serum testosterone similar to those for testosterone gel.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for depo-testosterone, non-statin cholesterol medication, and a consultation with a urologist. Based on the available documentation, this patient should have ongoing follow-up for his symptoms with a urologist. However, there is a lack of documentation to support the need for testosterone treatment as there is no record of low testosterone levels in the records provided for review. In addition, there is a lack of evidence of statin intolerance. Thus, the requested depo-testosterone and non-statin cholesterol medication are not supported as medically necessary for treatment of the patient’s medical condition, while a consultation with a urologist is medically necessary.

Where the denial was upheld

An enrollee has requested reimbursement for the Testopel Pellets 75 mg provided, and prospective authorization and coverage for Testopel Pellets 75 mg (quantity 4 per year). Patients treated with testosterone require monitoring of serum levels and symptom management to assure the lowest effective dose is used to achieve treatment goals. However, based on the current medical literature, there is a paucity of data demonstrating that one formulation of testosterone supplementation is more effective than other preparations. Moreover, there is a lack of long-term studies that suggest a benefit with Testopel treatment over standard available therapies. Thus, the Testopel Pellets 75 mg provided, and future Testopel Pellets 75 mg (quantity 4 per year), were not and are not likely to be more beneficial for treatment of this patient’s medical condition than any available standard therapy.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Testosterone cypionate injections. Studies show that the aim of testosterone replacement therapy (TRT) is to improve symptoms and signs of testosterone deficiency including decreased libido, erectile dysfunction, depressed mood, anemia, loss of muscle and bone mass, by increasing serum testosterone levels to physiologic range a study showed. The records provided for review fail to document a recent assessment with prostate specific antigen (PSA) and rectal examination to assess the patient’s prostate cancer activity. In addition, there is a lack of report that the patient has undergone an assessment of muscle status, or the findings of a behavioral health examination. Moreover, the patient does not have evidence of muscle mass wasting.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving testosterone deficiency, then check the rights and deadlines that apply to your plan.