RetiredUnitedHealthcarePolicy CSLA2026D0076L

Testosterone Replacement or Supplementation Therapy (for Louisiana Only) Retired April 1, 2026

Medical benefit drug policy governing use of specified injectable testosterone products and Testopel pellets for replacement therapy in members of UnitedHealthcare Community Plan in Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicyTestosterone Replacement or Supplementation Therapy (for Louisiana Only) Retired April 1, 2026

Policy CodePolicy CSLA2026D0076L

Change TypeRetired (plan-level discontinuation) and HCPCS code list updated

Effective DateJanuary 1, 2026 - March 31, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis of hypogonadism, male-at-birth status, and required laboratory confirmation (two early-morning total T <300 ng/dL or alternate free/bioavailable T criteria).

SourceLink

POLICY UPDATE CHANGES

Applicable HCPCS codes list was updated to add J1073 and remove S0189.

Policy was retired and Louisiana plan membership disenrolled on April 1, 2026.

1state this policy applies to

12 momaximum authorization duration

300 ng/dLtotal testosterone threshold (pre-treatment)

J1073HCPCS code added in 2026 update

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Coverage Criteria

Compounded hormone products, including compounded testosterone, estrogen, or progesterone pellets, are not FDA-approved. These compounded pellets are considered experimental/investigational and are not covered for any indication.

The safety and efficacy of Testopel (testosterone pellets) have not been established for age-related (late-onset) hypogonadism. The policy states that Testopel’s use for this indication is not supported by evidence demonstrating safety and efficacy.

Use of compounded hormone pellets or other compounded testosterone formulations is considered experimental/investigational and therefore not medically necessary. Because these compounded products are not FDA-approved and lack demonstrated safety and efficacy, requests for coverage of compounded pellets or compounded testosterone preparations will be denied.

Coding and Clinical Thresholds

Covered CPT Codes (reference)CPT

11980

Subcutaneous hormone pellet implantation

Applicable HCPCS/J-codesHCPCS

J1071	Injection, testosterone cypionate, 1 mg
J1072	Injection, testosterone cypionate (Azmiro), 1 mg
J1073	Testosterone pellet, implant, 75 mg
J3121	Injection, testosterone enanthate, 1 mg
J3145	Injection, testosterone undecanoate, 1 mg

Relevant ICD-10 diagnosis codes (reference)ICD-10

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
N44.00	Torsion of testis, unspecified
N45.2	Orchitis
Q53.00	Ectopic testis, unspecified
Q53.01	Ectopic testis, unilateral

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inv-08: Pre-treatment total testosterone threshold

ThresholdTwo pre-treatment early morning serum total testosterone levels < 300 ng/dL (< 10.4 nmol/L) or below the lab reference range, drawn at separate times

ContextUsed to establish biochemical diagnosis of testosterone deficiency as part of coverage criteria for injectable testosterone and Testopel pellets

Measurement timingEarly morning (to reflect peak physiologic levels)

inv-09: Pre-treatment calculated free or bioavailable testosterone threshold

ThresholdOne pre-treatment calculated free or bioavailable testosterone level < 50 pg/mL (< 5 ng/dL or < 0.17 nmol/L) or below the lab reference range

When to useRequired when patient has a condition that may alter sex‑hormone binding globulin (e.g., thyroid disorder, HIV, liver disorder, diabetes, obesity)

RoleAlternate biochemical confirmation pathway when SHBG-altering conditions are present

inv-10: Follow-up free/bioavailable testosterone timing (new therapy)

Timing (new to therapy)Follow-up calculated free or bioavailable testosterone drawn within the past 6 months for patients on therapy less than one year

Acceptable resultsResult is within or below the normal male limits of the reporting lab, or is above upper male limits with documented dose adjustment

PurposeUsed to confirm therapeutic monitoring and dosing adequacy for authorization decisions

inv-11: Follow-up free/bioavailable testosterone timing (continuing therapy)

Timing (continuing therapy)Follow-up calculated free or bioavailable testosterone drawn within the past 12 months for patients on therapy one year or longer

Acceptable resultsResult is within or below the normal male limits of the reporting lab, or is above upper male limits with documented dose adjustment

PurposePeriodic monitoring to document continued biochemical control and guide dosing for ongoing authorization

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for specified testosterone products. Injectable testosterone and Testopel (testosterone pellets) require authorization when used for replacement therapy in conditions associated with testosterone deficiency (primary hypogonadism, hypogonadotropic hypogonadism) and meet clinical criteria. Authorization will be for no more than 12 months.

Affected products: Testosterone cypionate, testosterone enanthate, testosterone undecanoate (Aveed®), Testopel® pellets
Authorization duration: up to 12 months
Conditions: primary hypogonadism or hypogonadotropic hypogonadism meeting clinical/lab criteria

Step Therapy

Step Therapy / Dosing Note

No step therapy requirements are specified in this policy. Dosing and frequency should follow FDA-approved labeling and product-specific guidance (operational/provider note).

Step therapy: None specified

Background

Androgens (testosterone and related compounds) are responsible for development and maintenance of male sexual characteristics and are indicated for replacement therapy when endogenous testosterone is deficient or absent. Indications include primary hypogonadism (testicular failure from congenital or acquired causes) and hypogonadotropic hypogonadism (pituitary/hypothalamic causes). Testosterone replacement is guided by diagnosis in symptomatic men with confirmatory laboratory testing and requires monitoring of serum testosterone and other safety parameters during therapy.

Definitions

inv-17: Definition — Primary hypogonadism (testicular failure causes listed)

DefinitionPrimary hypogonadism: testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy

Etiologies (congenital or acquired)Cryptorchidism; bilateral testicular torsion; orchitis; vanishing testes syndrome; bilateral orchiectomy

Clinical relevanceIndication for testosterone replacement when associated with symptomatic testosterone deficiency and confirmatory laboratory testing

inv-18: Definition — Hypogonadotropic hypogonadism (gonadotropin deficiency causes listed)

DefinitionHypogonadotropic hypogonadism: gonadotropin deficiency from pituitary–hypothalamic injury (e.g., tumors, trauma, radiation) or LHRH deficiency

Etiologies (congenital or acquired)

Policy Summary

PayerUnitedHealthcare

PolicyTestosterone Replacement or Supplementation Therapy (for Louisiana Only) Retired April 1, 2026

Policy CodePolicy CSLA2026D0076L

Change TypeRetired (plan-level discontinuation) and HCPCS code list updated

Effective DateJanuary 1, 2026 - March 31, 2026

Next Review DateN/A

SourceLink

On This Page

Dosing/frequency: Follow FDA directions (e.g., Aveed® 750 mg initial, week 4, then every 10 weeks; cypionate/enanthate 50–400 mg every 2–4 weeks, not to exceed 400 mg per 14 days; Testopel dosing 150–450 mg every 3–6 months per labeling)

Documentation Required

Required clinical and laboratory documentation must be provided with authorization requests. Documentation should demonstrate diagnosis, sex assigned at birth, and confirmatory laboratory testing (timing and values) per criteria.

Diagnosis of hypogonadism and documentation that patient was male at birth
Either two early-morning pre-treatment serum total testosterone levels < 300 ng/dL taken on separate occasions, OR one pre-treatment calculated free or bioavailable testosterone level < 50 pg/mL when a condition affecting SHBG is present
For patients already on therapy: follow-up calculated free or bioavailable testosterone level within past 6 months (if on therapy <1 year) or within past 12 months (if on therapy ≥1 year); documentation if dose adjustment occurred when levels exceed upper male limits

Denial Risk

Compounded Products Not Covered

Compounded hormone products, including compounded testosterone and compounded pellets, are considered experimental/investigational and are not covered.

Compounded testosterone, estrogen, and progesterone pellets are not FDA approved and are not covered
Commercially manufactured Testopel® pellets (FDA-approved) are subject to the prior authorization criteria above; compounded pellets are excluded

Luteinizing hormone–releasing hormone (LHRH) deficiency; pituitary or hypothalamic injury due to tumor, trauma, or radiation

Clinical relevanceIndication for testosterone replacement when associated with symptomatic testosterone deficiency and confirmatory laboratory testing