Hypogonadism denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Testopel pellets. The Endocrine Society and American Urological Association (AUA) have published guidelines to direct treatment of hypogonadism. According to the current guidelines, patients with signs and symptoms of testosterone deficiency plus a consistently low serum total testosterone and/or free testosterone, less than 300 ng/dl for patients under 70 years of age. Documentation of low fasting morning serum testosterone on at least two occasions is required. Treatment for hypogonadism addresses adult patients who are hypogonadal as evidenced by suggestive clinical symptoms such as decreased libido, low bone mineral density, and small testes, as well as low morning serum testosterone levels.

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for the hormone implants (subcutaneous testosterone implants) for treatment of the enrollee’s hypogonadism. Findings: The physician reviewer found that the Endocrine Society guidelines recommend testosterone therapy for symptomatic men with classical androgen deficiency syndromes aimed at inducing and maintaining secondary sex characteristics and at improving their sexual function, sense of well-being, and bone mineral density.Testosterone pellets were approved by the U.S. Food and Drug Administration (FDA) and have been proven to be effective at doses up to 10-12 pellets every three to four months in well selected patients. This patient has proven low testosterone levels. In addition, the patient has not responded adequately to transdermal therapy.

Where the denial was upheld

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for testosterone gel, 1%. The enrollee has a medical history of solar urticaria, hidradenitis suppurativa, and obesity. Blood work showed a low total testosterone level below the normal range of 250 to 827. His provider reviewed the laboratory results and diagnosed the enrollee with testicular hypofunction, secondary to obesity. Weight loss for fat reduction and muscle building was discussed. AndroGel was prescribed. The enrollee indicates one of the side effects of low testosterone is its affects on the brain, which can lead to anxiety or depression. He reports he now feels depressed, upset and angry. Testosterone gel, 1%, is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for hormone implants. Findings: The physician reviewers found that the Endocrine Society recommends that the diagnosis of hypogonadism be made in men who have both consistent signs and symptoms and low total testosterone levels. Testosterone should be administered to adult males who are hypogonadal, as evidenced by clinical symptoms and signs consistent with androgen deficiency and a subnormal morning serum testosterone concentration on separate occasions. Symptoms suggestive of androgen deficiency include low libido, decreased morning erections, loss of body hair, low bone mineral density (BMD), gynecomastia, and small testes. Fatigue, depression, anemia, reduced muscle strength, and increased fat mass are less specific.

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 hypogonadism, then check the rights and deadlines that apply to your plan.