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Testosterone therapy is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.  Hypogonadism may be caused by an inherited (congenital) trait or something that happens later in life (acquired), such as an injury or an infection. There are two basic types of hypogonadism:

• Primary - This type of hypogonadism, also known as primary testicular failure, originates from a problem in the testicles.
• Secondary - This type of hypogonadism indicates a problem in the hypothalamus or the pituitary gland, parts of the brain that signal the testicles to produce testosterone. The hypothalamus produces gonadotropin-releasing hormone, which signals the pituitary gland to make follicle-stimulating hormone (FSH) and luteinizing hormone. Luteinizing hormone then signals the testes to produce testosterone.

Prior authorization is required for testosterone when purchased at a pharmacy. 

The following information is required to complete the prior authorization process:

1. The initial progress notes where the patient first complained of low testosterone symptoms and his testosterone level was checked (see the Medical Necessity criteria below).
2. Two total testosterone levels (see the Medical Necessity criteria below).

Medical Necessity

Testosterone replacement is considered medically necessary for the following diagnoses:

• Pituitary tumor
• Klinefelter’s Syndrome
• Kallman’s Syndrome

Testosterone replacement is considered medically necessary for a diagnosis of hypogonadism as evidenced by total testosterone level that falls below the normal laboratory reference range AND symptoms of malaise, fatigue, lethargy, muscle loss, depression, or decreased libido.

Effective 05/10/2011, for new start prescriptions, the medical necessity requirements above must be met; however, two total testosterone levels are required to determine medical necessity of testosterone replacement. Two morning samples drawn between 8:00 a.m. and 10:00 a.m. obtained on different days are required. The results of both tests must fall below the normal laboratory reference range. 

Testosterone replacement is considered not medically necessary if the only symptom is Erectile Dysfunction or Impotence.

Effective 05/10/2011, for all new starts, only AndroGel®, testosterone injections/injectable testosterone, and testosterone pellets are covered.

Oral testosterone is not covered.

The medical records that are reviewed for the determination of medically necessity are the office progress notes and the first serum testosterone lab level when the patient first complained about symptoms of low testosterone. 
The coverage guidelines outlined in this medical policy should not be used in lieu of the Member's specific benefit plan language.
Benefits will not be provided for the following contract exclusions: 
1. Services and supplies related to infertility, artificial insemination, intrauterine insemination and in-vitro fertilization regardless of any claim of Medical Necessity.
2. For treatment related to sex transformations, sexual function, sexual dysfunctions or inadequacies regardless of Medical Necessity.

08/19/2011: Added testosterone pellets to the policy statement.  Added HCPCS code S0189  to the Covered Codes table.

10/11/2011: Removed the link to the prior authorization request form and fax number as this is now an electronic process.

03/08/2013: Policy reviewed; no changes.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

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