State and School Employees' Health Insurance Plan - Testosterone Replacement Therapy

POLICY NUMBER

S.5.01.477

Aveed (testosterone undecanoate oil for injection)

Delatestryl (testosterone enanthate oil for injection)

Depo-Testosterone (testosterone cypionate for injection)

Testopel (testosterone implant pellet)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

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.

Quantity Limits

POLICY

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Testosterone replacement therapy may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The individual has a documented diagnosis of ONE of the following: 

      1. Pituitary tumor;

      2. Klinefelter’s syndrome;

      3. Kallman’s syndrome; OR

      4. Bilateral orchiectomy; OR

   2. The individual has a documented diagnosis of hypogonadism and and clinical documentation is provided to support BOTH of the following:

      1. The individual is experiencing signs and symptoms of low testosterone (i.e., malaise, fatigue, lethargy, muscle loss, depression, or decreased libido); AND

      2. Two low total testosterone levels (below the normal laboratory reference range) as evidenced by two morning samples collected between 8:00 a.m. and 10:00 a.m. and obtained on different days.

2. ONE of the following:

   1. Therapy is injectable testosterone cypionate or injectable testosterone enanthate; OR

   2. Therapy is Testopel (testosterone pellet) AND documentation submitted shows that an appropriate trial of both injectable testosterone cypionate AND an appropriate trial of injectable testosterone enanthate could not adequately raise the individual’s total testosterone to a therapeutic level within normal limits of laboratory reference range (see definition of Medication Trial in Policy Guidelines section) when collected between 8:00 a.m. and 10:00 a.m.; AND

3. The dose requested is within the program quantity limits based on FDA approved labeled dosage.

Aveed (testosterone undecanoate oil for injection) is considered not medically necessary as other formulary options exist for testosterone replacement therapy.

Testosterone replacement is considered not medically necessary if the only symptom is erectile dysfunction or impotence.

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees):  Self-administered drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a self-administered drug are not covered under the medical benefit.

POLICY GUIDELINES

Physician must submit what testosterone levels are considered normal for the lab.

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

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 dysfunction, 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 Participant's illness, injury or Mental Health Disorders, 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 Participant'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 Participant, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant's medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.

For the definition of medical necessity, “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.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

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.

Medication Trial

An adequate trial of injectable testosterone replacement therapy is defined as 3 months of treatment at appropriate doses. Two low total testosterone levels as evidenced by two morning samples collected between 8:00 a.m. and 10:00 a.m. and obtained on different days should be documented following 3 months of treatment with injectable testosterone. The results of both tests must fall below the normal laboratory reference range.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

07/01/2023: New policy added.

06/07/2024: Minor wording changes in policy section; intent unchanged.

06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria revised regarding clinical documentation and testosterone levels. Sources updated.

01/01/2026: Code Reference section updated to add new HCPCS code J1073.

SOURCE(S)

1. Aveed prescribing information. Endo USA, Inc. August 2021. Last accessed April 2025.

2. Depo-Testosterone prescribing information. Pharmacia and Upjohn Company LLC. August 2020. Last accessed April 2025.

3. Shalender B, Juan PB, Glenn RC, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2018; 103(5):1715-1744. https://doi.org/10.1210/jc.2018-00229

4. Snyder P. Clinical features and diagnosis of male hypogonadism. (2024) UpToDate. Accessed on April 9, 2025. https://www.uptodate.com/contents/clinical-features-and-diagnosis-of-male-hypogonadism

5. Testopel prescribing information. Endo USA, Inc. March 2024. Last accessed April 2025.

6. Testosterone enanthate prescribing information. Hikma Pharmaceuticals USA Inc. November 2021. Last accessed April 2025.

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

Not Medically Necessary Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.