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Testosterone

 

DESCRIPTION

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:

  • 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.

 

POLICY

Prior Authorization Requirements

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

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

  1. The progress notes where the patient 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.

 

POLICY EXCEPTIONS

Federal 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 GUIDELINES

Physician 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. 
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.

 

POLICY HISTORY

05/10/2011: 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).

 

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
www.mayoclinic.com
www.encoderpro.com

 

CODE REFERENCE

This 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. 

Covered Codes

Code Number

Description

CPT-4

 

 

ICD-9 Procedure

 

 

ICD-9 Diagnosis

194.3 

Malignant neoplasm of pituitary gland and craniopharyngeal duct

227.3 

Benign neoplasm of pituitary gland and craniopharyngeal duct (pouch) 

253.4 

Other anterior pituitary disorders (Kallmann syndrome)

257.2

Other testicular hypofunction

311 

Depressive disorder, not elsewhere classified

728.2 

Muscular wasting and disuse atrophy, not elsewhere classified

758.7

Klinefelter's syndrome

780.79 

Other malaise and fatigue

799.81 

Decreased libido

HCPCS

J1070

Injection, testosterone cypionate, up to 100 mg

J1080  

Injection, testosterone cypionate, 1 cc, 200 mg

J3140 

Injection, testosterone suspension, up to 50 mg

J3120

Injection, testosterone enanthate, up to 100 mg

J3130  

Injection, testosterone enanthate, up to 200 mg

J3150 

Injection, testosterone propionate, up to 100 mg

S0189  

Testosterone pellet, 75 mg 

 

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