DESCRIPTIONTestosterone is an endogenous androgen. Androgens are responsible for normal growth and development of male sex organs. Testosterone is involved in the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution (e.g., beard, pubic, chest and axillary hair); laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution.
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:
POLICYPrior Authorization Requirements
Prior authorization is required for testosterone when purchased at a pharmacy.
The following information is required to complete the prior authorization process:
Testosterone replacement is considered medically necessary for the following diagnoses:
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.
POLICY EXCEPTIONSFederal Employee Program (FEP)
The State Health Plan (State and School Employees) does not require prior authorization for testosterone; however, claims for testosterone will be reviewed for medical necessity.
POLICY GUIDELINESPhysician must submit what testosterone levels are considered normal for the lab.
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.
POLICY HISTORY05/10/2011: New policy added. Approved by Medical Policy Advisory Committee.
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.
03/27/2014: Policy reviewed; no changes.
10/24/2014: Policy statement updated to remove "initial" and "first" from the first Prior Authorization Requirements policy statement. It previously stated the following: 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).
12/31/2014: Added the following new 2015 HCPCS codes to the Code Reference section: J1071, J3121, and J3145.
SOURCE(S)AACE Hypogonadism Task Force. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients - 2002 Update, ENDOCRINE PRACTICE, Vol 8 No. 6 November/December 2002
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.