CurrentColorado Rocky Mountain Health PlansPolicy 2026D0076J

Testosterone Replacement or Supplementation Therapy

Defines medical benefit coverage criteria for injectable testosterone products and testosterone pellets (Testopel) including indications, required laboratory confirmation, gender-affirming therapy criteria, and exclusion of compounded pellets for UnitedHealthcare commercial plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTestosterone Replacement or Supplementation Therapy

Policy CodePolicy 2026D0076J

Change TypeMaterial updates and coding revisions

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis and qualifying laboratory values (two early-morning total testosterone <300 ng/dL or free/bioavailable <50 pg/mL when applicable).

SourceLink

POLICY UPDATE CHANGES

Added language that Azmiro is typically excluded from coverage and that coverage reviews may be in place if required by law or the benefit plan; and referred to the excluded drug list with preferred alternatives.

Clarified that coverage for Depo-Testosterone, testosterone enanthate, Testopel, and Aveed is contingent on criteria in the Diagnosis-Specific Requirements section.

Updated list of applicable HCPCS codes to add J1073 and remove S0189.

Added a CMS section to Supporting Information and updated References.

Removed reference link to the Medical Benefit Drug Policy titled Review at Launch for New to Market Medications for Azmiro (testosterone cypionate).

12maximum authorization period

<300two pre-treatment T tests threshold

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

J1071,J1072,J1073,J3121,J3145listed HCPCS/J-codes

11980CPT pellet code

excludedcoverage stance for Azmiro

Coverage Criteria for Testosterone Products

Initial and replacement therapy criteria

Covered when ALL of the following are met

Qualifying clinical history: Either patient has history of bilateral orchiectomy, panhypopituitarism, or a genetic disorder causing hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)

Laboratory confirmation: Either two pre-treatment early morning total testosterone levels < 300 ng/dL taken at separate times; OR for patients with conditions that may alter SHBG (e.g., thyroid disorder, HIV, liver disorder, diabetes, obesity) one pre-treatment calculated free or bioavailable testosterone < 50 pg/mL; OR patient is currently on testosterone therapy with a follow-up calculated free or bioavailable testosterone level drawn within the past 6 months (if on therapy <1 year) or within 12 months (if on therapy ≥1 year) that is within or below the normal male limits for the reporting lab, or is above the upper male limit with documented dose adjustment.total T <300 ng/dL; free/bioavailable <50 pg/mL

Dosing and authorization limits: Dosing is in accordance with FDA-approved labeling; authorization limited to no more than 12 months.12 months

Gender-affirming hormone therapy (adults)

Covered when ALL of the following are met

Gender-affirming therapy requirements: Diagnosis of gender dysphoria per current DSM by a mental health professional; medication prescribed by or in consultation with an endocrinologist or a provider knowledgeable in transgender hormone therapy; authorization limited to no more than 12 months.12 months

Azmiro (testosterone cypionate) is typically excluded from coverage. Coverage reviews for Azmiro may be performed if required by law or the terms of the member’s benefit plan; when applicable, refer to the Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs policy and the corresponding excluded drug list with preferred alternatives. Requests for injectable testosterone products that require medical necessity review should be evaluated against the Diagnosis‑Specific Requirements sections of this policy.

Compounded hormone products, including but not limited to compounded testosterone pellets and other compounded estrogen or progesterone pellets, are not proven or medically necessary for any indication and are not FDA approved. The policy therefore considers compounded hormone pellets not medically necessary and excludes them from coverage.

Initial Therapy

Initial therapy

Initial therapy criteria for replacement

Clinical qualifying history or labs: Either specified clinical/surgical/genetic history consistent with primary or hypogonadotropic hypogonadism (e.g., orchiectomy, panhypopituitarism, congenital disorders) OR laboratory confirmation as defined: two early morning total testosterone < 300 ng/dL OR calculated free/bioavailable testosterone < 50 pg/mL when an SHBG‑altering condition is present.total T <300 ng/dL; free/bioavailable <50 pg/mL

Continuation Therapy and Monitoring

Continuation therapy monitoring

Continuation of therapy for patients already on testosterone

On-therapy monitoring: Follow-up calculated free or bioavailable testosterone level drawn within the past 6 months for patients on therapy <1 year, or within 12 months for patients on therapy ≥1 year, showing values within or below normal male limits for the reporting lab, or values above upper male limits with documented dose adjustment.6 or 12 months

Coding and Diagnostic Codes

Covered CPT Codes (reference)CPT

11980

Subcutaneous hormone pellet implantation

Listed 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 CodesICD-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
F64.0	Transsexualism
F64.1	Dual role transvestism
F64.2	Gender identity disorder of childhood
F64.8	Other gender identity disorders

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inv-08: Total testosterone (early morning) — threshold value for diagnostic testing

Diagnostic thresholdTwo pre-treatment early morning serum total testosterone measurements < 300 ng/dL (< 10.4 nmol/L) or below the laboratory reference range, collected at separate times

Alternate wording in policy< 300 ng/dL (or less than lab reference range)

Timing requirementBoth measurements must be early morning samples taken at separate times

inv-09: Calculated free or bioavailable testosterone — threshold when SHBG-altering condition present

Threshold when SHBG-altering condition presentOne pre-treatment calculated free or bioavailable testosterone level < 50 pg/mL (< 5 ng/dL or < 0.17 nmol/L) or below the laboratory reference range

Provider Requirements and Authorization

Prior Authorization

Prior Authorization and Excluded Products

Prior authorization is required for injectable testosterone products and Testopel (testosterone pellets). Azmiro™ (testosterone cypionate) is typically excluded from coverage; coverage reviews may occur if required by law or the benefit plan. Refer to the Medical Benefit Drug Policy titled "Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs" and the corresponding excluded drug list with preferred alternatives. Compounded hormone products (including compounded testosterone, estrogen, or progesterone pellets) are not FDA approved and are considered not proven or medically necessary.

Prior authorization required for injectable testosterone and Testopel
Azmiro™ typically excluded — coverage reviews may be required by law or plan; see excluded drug list
Compounded hormone products (e.g., pellets) and compounded drugs are not FDA approved and not medically necessary

Documentation Required

Required Documentation for Medical Necessity

Key Definitions

inv-15: Definition — Primary hypogonadism (testicular failure causes)

DefinitionPrimary hypogonadism: testicular failure due to congenital or acquired causes such as cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy

Examples (congenital)Cryptorchidism; vanishing testes syndrome

Examples (acquired)Bilateral torsion; orchitis; orchiectomy

inv-16: Definition — Hypogonadotropic hypogonadism (pituitary/hypothalamic causes)

DefinitionHypogonadotropic hypogonadism: pituitary or hypothalamic causes such as LHRH (gonadotropic) deficiency or injury from tumors, trauma, or radiation

Pathophysiology examplesLuteinizing hormone–releasing hormone (LHRH) deficiency; pituitary or hypothalamic injury

Background

Endogenous androgens, principally testosterone, are responsible for male sexual development and maintenance of secondary sex characteristics. Androgen replacement therapy is indicated for conditions associated with a deficiency or absence of endogenous testosterone such as primary hypogonadism (congenital or acquired testicular failure) and hypogonadotropic hypogonadism (pituitary or hypothalamic causes). Dosing and administration vary by formulation: for example, testosterone pellets (Testopel) for replacement are dosed in the range of 150 mg to 450 mg subcutaneously every 3 to 6 months, while injectable formulations have different schedules (e.g., testosterone cypionate/enanthate typically 50–400 mg every 2 to 4 weeks; Aveed initial 750 mg then at week 4 and every 10 weeks). Safety and efficacy of Testopel for age‑related (late‑onset) hypogonadism have not been established. Monitoring should include clinical assessment and appropriate laboratory evaluation as specified elsewhere in this policy.

Step Therapy / Medicare Guidance

Medicare Advantage (Part B) Step Therapy Applicability	Notes / Action
May apply to Medicare Advantage members receiving outpatient (Part B) testosterone products
Preferred therapy criteria for Medicare Advantage members: refer to Medicare Part B step therapy programs and applicable local coverage determinations (LCDs). See CMS guidance and plan-specific step therapy requirements.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTestosterone Replacement or Supplementation Therapy

Policy CodePolicy 2026D0076J

Change TypeMaterial updates and coding revisions

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis and qualifying laboratory values (two early-morning total testosterone <300 ng/dL or free/bioavailable <50 pg/mL when applicable).

SourceLink

On This Page

Examples of SHBG-altering conditionsThyroid disorder, HIV disease, liver disorder, diabetes, obesity (policy examples)

Use-caseApplies when patient has a condition that may alter sex-hormone binding globulin (SHBG)

For medical necessity determination, submit documentation of baseline and/or follow-up testosterone laboratory results and relevant clinical information. Acceptable laboratory confirmation includes early morning serum total testosterone levels, calculated free or bioavailable testosterone when indicated, or documented current testosterone therapy with recent follow-up levels. Ensure dosing aligns with FDA-approved labeling. Authorization will be for no more than 12 months.

Two pre-treatment early morning serum total testosterone levels < 300 ng/dL (< 10.4 nmol/L) or below lab reference range, drawn at separate times; OR
If altered SHBG suspected (e.g., thyroid disorder, HIV, liver disease, diabetes, obesity): one pre-treatment calculated free or bioavailable testosterone < 50 pg/mL (< 5 ng/dL or < 0.17 nmol/L) or below lab reference range; OR
If patient is currently on testosterone therapy: follow-up calculated free or bioavailable testosterone drawn within past 6 months (if on therapy <1 year) or within 12 months (if on therapy ≥1 year), showing values as specified in Diagnosis-Specific Requirements
Dosing must follow FDA-approved labeling; authorization limited to ≤ 12 months

Step Therapy

Medicare Step Therapy Note

For Medicare Part B and Medicare Advantage reviews, follow CMS guidance on step therapy and related program requirements. When Medicare beneficiaries are subject to step therapy, ensure documentation demonstrates adherence to any applicable Medicare step therapy protocols and provide clinical rationale when an exception is requested.

Follow CMS guidance for Medicare Part B/MA step therapy reviews
Include documentation showing prior treatment attempts or clinical rationale for step-therapy exception requests

Denial Risk

Denial Triggers

Requests lacking required laboratory confirmation, dosing consistent with FDA labeling, or those for excluded products (e.g., Azmiro™ where exclusion applies, compounded hormone products) are likely to be denied. Requests for compounded testosterone or compounded pellets should be denied as not medically necessary. Ensure all supporting clinical documentation is included to avoid denial delays.

Denial likely if pre-treatment or follow-up lab criteria are not met
Denial likely for Azmiro™ where exclusion applies unless coverage review required by law/plan permits
Denial likely for compounded hormone products (not FDA approved)

Clinical causesTumors, trauma, or radiation affecting the pituitary–hypothalamic axis