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Testosterone 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.
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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
05/31/2016: Policy number L.5.01.477 added. Policy Guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to remove the following deleted HCPCS codes: J1070, J1080, J3140, J3120, J3130, and J3150.
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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.