Treatment of Males with Low Testosterone

Jurisdiction: JJ Part B. States: Alabama, Georgia, Tennessee. Type: Active LCD

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. Covered Indications Treatment with testosterone is medically reasonable and necessary when prescribed for: Symptomatic hypogonadism (congenital or acquired) due to a disorder of the testicles, pituitary gland, or brain Delayed male puberty Gender dysphoria in a member who is able to make an informed decision to engage in hormone therapy This A/B MAC expects that the establishment of a diagnosis of primary hypogonadism will be undertaken with at least 2 separate fasting serum testosterone levels, taken on 2 different days, drawn prior to 10 AM, and obtained from identical laboratories. A single luteinizing hormone (LH) or follicle stimulating hormone (FSH) level will also be drawn. Elevated LH/FSH confirms primary hypogonadism and the potential need for replacement hormone. If the 2 testosterone determinations are low AND the LH/FSH level(s) are also low, pituitary disease (including a serum prolactin) or chronic diseases should be assessed. ONLY secondary hypogonadism that is due to a medical disorder of the testicles, pituitary gland, or brain will be considered reasonable and necessary for treatment with testosterone. Prescribing and monitoring parameters will include: Prostate-specific antigen (PSA) testing must be done within the last 12 months prior to prescribing testosterone AND there will be ongoing monitoring throughout therapy. Hematocrit must be evaluated prior to prescribing testosterone AND there will be ongoing monitoring throughout therapy. Digital prostate exam must be done within the last 12 months prior to prescribing testosterone AND there will be ongoing monitoring throughout therapy. Where replacement is indicated, the dose of replacement therapy should be the least amount necessary to obtain a serum testosterone in the low normal range. There will be ongoing monitoring of testosterone levels throughout therapy. Testosterone replacement can be administered by many routes. The current preferred routes are by transdermal preparations. Due to United States (U.S.) Food and Drug Administration (FDA) listed warnings about possible thromboembolic disease, increase in erythrocythemia, cardiovascular risk, and stroke, the clinical records shall reflect that these issues were discussed with the patient before initiating therapy. Documentation of the symptoms, signs, physical examination, and required laboratory tests must be available in the chart if requested. Limitations The following uses of testosterone are considered NOT medically reasonable and necessary: Patients with hypogonadism due to aging also known as late-onset hypogonadism (LOH) Idiopathic hypogonadism not due to disorder of the testicles, pituitary gland, or brain Male menopause Patients with a breast cancer diagnosis Patients with a prostate cancer diagnosis unless previously undergone a radical prostatectomy and disease free for at least 2 years Patients with thrombophilia or patients who have had a myocardial infarction (MI), cardiac revascularization, or a stroke within the past 6 months Patients with a prostate nodule or induration, a PSA > 4 ng/mL or > 3 ng/mL in men at increased risk of prostate cancer (e.g., African American men or those who have a first-degree relative with diagnosed prostate cancer) Patients with a hematocrit > 48% Patients interested in reproduction Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS National Coverage Determinations (NCDs), and all Medicare payment rules. The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this Local Coverage Determination (LCD).