Testosterone Replacement Therapy

POLICY NUMBER

L.5.01.477

Androgel (testosterone gel)

Android (methyltestosterone capsule)

Aveed (testosterone undecanoate oil for injection)

Axiron (testosterone topical solution)

Delatestryl (testosterone enanthate oil for injection)

Depo-Testosterone (testosterone cypionate for injection)

Fortesta (testosterone gel)

Jatenzo (testosterone undecanoate capsule)

Kyzatrex (testosterone undecanoate capsule)

Natesto (testosterone nasal gel)

Testim (testosterone gel)

Testopel (testosterone implant pellet)

Tlando (testosterone undecanoate capsule)

Undecatrex (testosterone undecanoate capsule)

Vogelxo (testosterone gel)

Xyosted (testosterone enanthate auto-injector)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

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

Injectable formulations of testosterone cypionate and testosterone enanthate do not require prior authorization.

Prior authorization is only required for non-injectable formulations of testosterone.

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 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. Request is for Androgel (testosterone gel), Testim (testosterone gel), or Testopel (testosterone pellet);

3. The provider has submitted documentation to show 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

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

Aveed (testosterone undecanoate oil for injection), Axiron (testosterone topical solution), Fortesta (testosterone gel), Natesto (testosterone nasal gel), Vogelxo (testosterone gel), Xyosted (testosterone enanthate auto-injector), and oral testosterone products are considered not medically necessary as other formulary options exist for testosterone replacement therapy for the treatment of hypogonadism.

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 which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

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

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 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 Member'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 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 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

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 wherethe 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.

09/01/2017: Policy section updated to add that testosterone replacement is considered medically necessary for bilateral orchiectomy.

04/20/2018: Policy description updated to add drug quantity limits for testosterone.

02/12/2019: Added drug names to the top of the policy.

07/19/2019: Added drug names to the top of the policy. Policy section updated to state that Androderm and Xyosted are noncovered.

04/13/2020: Added drug names to the top of the policy. Policy statement criteria regarding the prior authorization process updated to change "patient" to "member." Sources updated.

02/02/2021: Added Aveed (testosterone undecanoate oil for injection) to the policy.

08/26/2021: Policy title changed from "Testosterone" to "Testosterone Replacement Therapy." Added Axiron (testosterone topical solution), Delatestryl (testosterone enanthate oil for injection), Natesto (testosterone nasal gel), and Tlando (testosterone undecanoate capsule) to the top of the policy. Added statement to perform a formulary drug search on the patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan. Policy section updated to state that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Revised medically necessary criteria. Added the following statements: 1) Androderm (testosterone patch), Aveed (testosterone udecanoate oil for injection), Axiron (testosterone topical solution), Natesto (testosterone nasal gel), Xyosted (testosterone enanthate auto-injector), and oral testosterone products are considered not medically necessary as other formulary options exist for testosterone replacement therapy. 2) Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and Medically Necessary" to "medical necessity." Added information regarding BCBSMS request for medical records and defined medication trial. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription 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 medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

06/07/2024: Removed Federal Employee Program policy language from the Policy Exceptions. Updated language regarding prior authorization requirements for testosterone formulations. Moved J3145 to the Not Medically Necessary Codes section.

06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to remove Androderm (testosterone patch) and Striant (testosterone buccal system) and add Fortesta (testosterone gel), Kyzatrex (testosterone undecanoate capsule), Testim (testosterone gel), Undecatrex (testosterone undecanoate capsule), and Vogelxo (testosterone gel). Policy description updated to revise Quantity Limits table. Policy statement revised to state that Injectable formulations of testosterone cypionate and testosterone enanthate do not require prior authorization. Revised policy statement 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, testosterone levels, and requests for Androgel (testosterone gel), Testim (testosterone gel), or Testopel (testosterone pellet). Policy statement revised to add Fortesta (testosterone gel) and Vogelxo (testosterone gel) as not medically necessary as other formulary options exist for testosterone replacement therapy for the treatment of hypogonadism. Sources updated.

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

SOURCE(S)

1. Androgel prescribing information. Ascend Therapeutics U.S., LLC. September 2024. Last accessed April 2025.

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

3. Axiron prescribing information. Physicians Total Care, Inc. November 2013. Last accessed April 2025.

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

5. Jatenzo prescribing information. TOLMAR, Inc. March 2025. Last accessed April 2025.

6. Kyzatrex prescribing information. Marius Pharmaceuticals. October 2023. Last accessed April 2025.

7. Methyltestosterone prescribing information. Amneal Pharmaceuticals of New York LLC. May 2019. Last accessed April 2025.

8. Natesto prescribing information. Acerus Pharmaceuticals Corporation. March 2025. Last accessed April 2025.

9. 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

10. 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

11. Testim prescribing information. Endo USA, Inc. August 2021. Last accessed April 2025.

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

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

14. Testosterone gel prescribing information. Actavis Pharma, Inc. June 2020. Last accessed April 2025.

15. Tlando prescribing information. Antares Pharma, Inc. January 2025. Last accessed April 2025.

16. Undecatrex prescribing information. Trifluent Pharma LLC. September 2022. Last accessed April 2025.

17. Vogelxo prescribing information. Upsher-Smith Laboratories, LLC. December 2022. Last accessed April 2025.

18. Xyosted prescribing information. Antares Pharma, Inc. March 2025. 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

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