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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.
Federal Employee Program (FEP) Members: Aveed (testosterone undecanoate injection), Delatestryl (testosterone enanthate injection), Depo-Testosterone (testosterone cypionate injection), and Testopel (testosterone propionate implant) may be considered medically necessary in male patients 18 years of age or older with deficiency of testosterone (hypogonadism); two morning testosterone levels that are less than 300ng/dL on different days; patients over 40 years of age must have baseline PSA less than 4 ng/ml and prostatectomy patients excluded from the requirement; absence of cancer and palpable prostate nodules; hematocrit level is less than 54%, and the patient will be monitored for worsening symptoms of benign prostatic hypertrophy (BPH) if there is a concurrent diagnosis and the patient has had an evaluation of cardiovascular risk for myocardial infarction, angina, stroke and there is absence of un-treated sleep apnea; no dual therapy with another testosterone product.
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. Total testosterone levels need to be below 300 ng/dL on both days in order to be considered for therapy.
Delatestryl (testosterone enanthate injection), Depo-Testosterone (testosterone cypionate injection), Testopel (testosterone propionate implant) may be considered medically necessary in male patients 12 years of age or older for treatment for delayed sexual development and/or puberty with confirmation of bone age of the hand and wrist (as determined by radiographic evidence), liver function and hematocrit tests to be monitored every 6 months.
Delatestryl (testosterone enanthate injection) is considered medically necessary when used secondarily in women with previously treated inoperable metastatic breast or mammary cancer and confirmation that the following will be monitored every 6 months: hypercalcemia and agreement to discontinue the drug if present, liver function and hematocrit tests.
Aveed (testosterone undeconate injection), Delatestryl (testosterone enanthate injection), Depo-Testosterone, Testone CIK (testosterone cypionate injection), and Testopel (testosterone propionate implant) may be considered investigational for all other indications.
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.
06/16/2015: Updated the Policy Exceptions section for Federal Employee Program (FEP) members for coverage of testosterone replacement.
08/31/2015: Medical policy revised to add ICD-10 codes.
10/28/2015: Updated the Policy Exceptions section for Federal Employee Program (FEP) members to provide coverage criteria for testosterone use in women.
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.