Testosterone Replacement or Supplementation Therapy
Defines UnitedHealthcare medical benefit coverage criteria for injectable testosterone products and testosterone pellets (including testosterone cypionate, enanthate, undecanoate, and Testopel) for adults, and specifies exclusions (e.g., Azmiro typically excluded, compounded pellets). Applies to UnitedHealthcare commercial plans and referenced Medicare/Community Plan contexts.
Azmiro (testosterone cypionate) is typically excluded from coverage and coverage reviews may be in place if required by law or the benefit plan.
Coverage for Depo-Testosterone, testosterone enanthate, Testopel pellets, and Aveed is contingent on criteria in the Diagnosis-Specific Requirements section.
HCPCS/HCPCS-like code J1073 (Testosterone pellet, implant, 75 mg) was added to the applicable codes list; S0189 was removed.
CMS section added to Supporting Information and References updated.
Coverage Criteria for Injectable Testosterone and Testopel
Initial and replacement therapy for hypogonadism (injectable testosterone and Testopel)
Covered when ALL of the following are met:
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Gender-affirming hormonal therapy (transgender adults)
Covered when ALL of the following are met:
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Azmiro (testosterone cypionate) is typically excluded from coverage. Coverage reviews may be required by law or the member's benefit plan; when applicable, refer to the Medical Benefit Drug Policy titled Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs and the corresponding excluded drug list with preferred alternatives. Requests for Azmiro may be denied if it is listed as an excluded product by the plan or does not meet the Diagnosis-Specific Requirements in this policy.
For injectable testosterone products and Testopel (testosterone pellets) that do require medical necessity review, coverage is contingent on meeting the Diagnosis-Specific Requirements. Dosing must follow FDA-approved labeling and, when authorized, coverage will be for no more than 12 months per authorization period.
Compounded hormone products, including but not limited to compounded testosterone, estrogen, and progesterone pellets, are not FDA approved and are considered not proven or medically necessary for any indication. These compounded products are therefore not covered under this policy.
When submitting requests, do not substitute compounded pellets or other compounded hormone preparations for FDA-approved testosterone formulations; coverage decisions will be made only for products and indications that meet the policy's Diagnosis-Specific Requirements and FDA-approved product expectations.
Initial Therapy
Initial therapy — initial coverage for injectable testosterone and Testopel when diagnostic criteria met
Initial coverage is provided when ALL diagnostic and documentation requirements below are satisfied:
Initial therapy
- A - qualifying history: Patient has history of bilateral orchiectomy OR panhypopituitarism OR a genetic disorder known to cause hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)
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- B - diagnostic laboratory confirmation: Two pre-treatment early morning serum total testosterone levels < 300 ng/dL (taken at separate times) OR when a condition that may alter SHBG is present, one pre-treatment calculated free or bioavailable testosterone < 50 pg/mLtotal T <300 ng/dL; free/bioavailable T <50 pg/mL
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- C - on-therapy documentation: If patient is currently on testosterone therapy, provide follow-up calculated free or bioavailable testosterone drawn within past 6 months (if on therapy <1 year) or within past 12 months (if on therapy ≥1 year); results within or below normal male limits or above upper male limits with documented dose adjustment support continuation/initial authorizationtiming: 6 or 12 months
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Continuation Therapy
Continuation therapy — periodic follow-up testosterone measurements and dosing adjustments required
Continuation requires periodic follow-up testing and documentation:
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Provider Actions and Documentation Requirements
Prior Authorization Required
Authorization required for injectable testosterone and Testopel (pellets). A medical necessity review is required; dosing must follow FDA-approved labeling. Authorizations will be for no more than 12 months.
- Applies to injectable testosterone products and Testopel (testosterone pellets).
- Authorization duration: up to 12 months.
- Dosing must be consistent with FDA-approved labeling.
Compounded Products Not Covered
Compounded hormone products, including but not limited to compounded testosterone, estrogen, and progesterone pellets, are not considered proven or medically necessary and are not covered. Compounded drugs (including compounded pellets) are not FDA approved and may be excluded from coverage.
- Examples: compounded testosterone pellets, compounded estrogen or progesterone pellets.
- Compounded products are not FDA approved and are not covered.
Required Clinical and Coding Documentation
Documentation must include diagnostic codes and laboratory testing as specified. For new therapy, provide two separate early-morning total serum testosterone measurements < 300 ng/dL (or below the lab reference range). If SHBG-altering conditions exist, a single pre-treatment calculated free or bioavailable testosterone < 50 pg/mL (or below lab reference) may be acceptable. For patients already on therapy, provide follow-up calculated free or bioavailable testosterone drawn within the past 6 months (if <1 year on therapy) or within 12 months (if ≥1 year on therapy); documentation of dose adjustment if levels are outside lab male limits.
- Required diagnosis: relevant ICD-10 codes (e.g., E23.0, E29.1, E89.3, F64.x, Z87.890, etc.).
- Required labs: two separate early-morning total testosterone measurements prior to initiation; or when indicated, calculated free/bioavailable testosterone thresholds as above.
- Follow-up testing: within 6 months for patients on therapy <1 year; within 12 months for patients on therapy ≥1 year.
Gender-Affirming Therapy Documentation
For gender-affirming hormone therapy, provide a DSM diagnosis of gender dysphoria by a mental health professional. Medication must be prescribed by or in consultation with an endocrinologist or a medical provider knowledgeable in transgender hormone therapy. Authorization for gender-affirming use of injectable testosterone or Testopel will be for no more than 12 months.
- DSM diagnosis of gender dysphoria documented by a mental health professional.
- Prescriber: endocrinologist or provider experienced in transgender hormone therapy.
- Authorization duration: up to 12 months for gender-affirming therapy.
Coding — Procedure, HCPCS/J-codes, and Diagnosis Codes
| 11980 | Subcutaneous hormone pellet implantation |
| E23.0 | Hypopituitarism |
| E23.3 | Hypothalamic dysfunction, not elsewhere classified |
| E29.1 | Testicular hypofunction |
| E30.0 | Delayed puberty |
| E89.3 | Postprocedural hypopituitarism |
| E89.5 | Postprocedural testicular hypofunction |
| F64.0 | Transsexualism |
| F64.1 | Dual role transvestism |
| F64.2 | Gender identity disorder of childhood |
| F64.8 | Other gender identity disorders |
Definitions
Background
Endogenous androgens, principally testosterone, are essential for male sexual development and the maintenance of secondary sex characteristics. Androgen replacement is indicated in conditions associated with deficiency or absence of endogenous testosterone such as primary hypogonadism (testicular failure from causes like cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy) and hypogonadotropic hypogonadism (gonadotropin/LHRH deficiency or pituitary–hypothalamic injury).
Approved testosterone formulations include injectable preparations and subcutaneous implants (Testopel). Product-specific dosing and administration vary: for example, injectable testosterone cypionate and enanthate are typically administered in the range of 50 mg to 400 mg every 2 to 4 weeks (not to exceed 400 mg per 14 days), Aveed (testosterone undecanoate) uses an initial 750 mg dose with a week 4 dose then maintenance every 10 weeks, and testosterone pellets (Testopel) are dosed by implanted pellets (commonly 75 mg per pellet) with total implant doses and intervals guided by replacement needs. Monitoring of therapy and adherence to FDA labeling and the policy's authorization limits (typically up to 12 months) is required.
Site of Care
Site‑of‑care — office/infusion center/hospital outpatient
This policy does not restrict site‑of‑care; however, Medicare/MA rules and member plan terms may impose site‑of‑care requirements. Verify the member’s benefit plan and applicable Medicare guidance for Part B coverage and any MAO site‑of‑care rules.
- Site‑of‑care (office, infusion center, hospital outpatient) is subject to member plan and Medicare/MA guidance — this policy does not impose a site restriction.
- For Medicare, refer to CMS guidance and applicable LCDs for Part B drug furnishing rules.
Step Therapy
| Plan / Population | Step therapy note |
|---|---|
| Medicare Advantage members | |
| Medicare Advantage members may be subject to Medicare Part B Step Therapy Programs per local coverage determinations (LCDs) and MAO policies; refer to applicable LCDs (e.g., L36569, L36538, L39086) and plan-specific MAO step therapy criteria. |
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