ModifiedColorado Rocky Mountain Health PlansPolicy IEXD0076.07

Testosterone Replacement or Supplementation Therapy

Medical benefit drug policy governing use of testosterone products for Individual Exchange benefit plans (excludes MA, NV, NY) including diagnosis-specific coverage and preferred product criteria.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTestosterone Replacement or Supplementation Therapy

Policy CodePolicy IEXD0076.07

Change TypeMaterial edits to exclusions and codingAZMIRO exclusion clarified

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain two early-morning total testosterone levels <300 ng/dL (or appropriate free/bioavailable levels) and submit required lab documentation with authorization requests.

SourceLink

POLICY UPDATE CHANGES

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

Added language indicating Azmiro™ is typically excluded from coverage and coverage reviews may be in place if required by law or the benefit plan; refer to the Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs policy and the corresponding excluded drug list with preferred alternatives.

For requests that require medical necessity review, also refer to the Diagnosis-Specific Requirements section of the policy.

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

Updated applicable HCPCS codes list: Added J1073 and removed S0189.

Updated References section to reflect the most current information and added CMS section; archived previous policy version IEXD0076.06.

4preferred testosterone products listed

12 monthsmaximum authorization duration

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300 ng/dLtotal testosterone threshold

J1073HCPCS code added

S0189HCPCS code removed

IEXD0076.06previous policy version

Coverage Criteria for Testosterone Therapies

Replacement Therapy (Injectable/Testopel)

Covered when ALL of the following are met

Overall: Injectable testosterone and Testopel are medically necessary for replacement therapy when criteria below are met

A. Established causes: Patient has history of one of: bilateral orchiectomy; panhypopituitarism; a genetic disorder known to cause hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)

Supported by list in policy

B. Biochemical diagnosis: One of the following: two pre-treatment early-morning total testosterone levels < 300 ng/dL (or below lab reference range) taken at separate times; OR (patient has condition that may alter SHBG AND one pre-treatment calculated free or bioavailable testosterone < 50 pg/mL or below lab reference range)< 300 ng/dL or < 50 pg/mL when applicable

Alternative pathway when SHBG-altering condition present

C. Monitoring and continuation: Patient is currently on testosterone therapy AND one of the following: follow-up calculated free or bioavailable testosterone drawn within past 6 months for patients on therapy < 1 year, or within 12 months for patients on therapy ≥ 1 year, is within or below the normal male limits for the reporting lab; OR the follow-up level is above upper male limits and the dose is adjusted6 or 12 months depending on duration

Follow-up monitoring requirement

D. Dosing and duration: Dosing is in accordance with FDA-approved labeling; authorization will be for no more than 12 months<= 12 months

Gender-Affirming Hormonal Therapy (transgender adults)

Covered when ALL of the following are met

G1: Patient was male at birth

Policy requirement

G2: Diagnosis of hypogonadism

G3: Diagnosis of gender dysphoria according to current DSM (e.g., DSM-5-TR) by a mental health professional

DSM-5-TR referenced

G4: Medication is prescribed by or in consultation with an endocrinologist or a medical provider knowledgeable in transgender hormone therapy

Coverage contingent on Diagnosis-Specific Requirements

Coverage statements present in this section apply when criteria in the Diagnosis-Specific Requirements are met

Coverage contingent on diagnosis-specific criteria: Coverage for Depo-Testosterone®, testosterone enanthate, Testopel®, and Aveed® is contingent on criteria in the Diagnosis-Specific Requirements section.

Detailed criteria are in the Diagnosis-Specific Requirements section of the policy (see policy text).

Compounded hormone products, including but not limited to compounded testosterone, estrogen, and progesterone pellets, are not proven or medically necessary for any indication. These compounded preparations are not FDA approved and there has been no FDA submission for approval of compounded testosterone, estrogen, or progesterone pellets.

As a result, compounded hormone products are excluded from coverage under this policy. Providers requesting coverage should note that commercially manufactured, FDA‑approved testosterone therapies (including injectable formulations and Testopel® pellets) are addressed separately in the policy and are subject to the specific diagnostic, laboratory, dosing, monitoring, and authorization criteria described for replacement and gender‑affirming therapy.

Azmiro™ (testosterone cypionate) is typically excluded from coverage under this policy. Coverage for Azmiro™ may be reconsidered only if required by law or specific provisions of the member's benefit plan, or when coverage review procedures defined by the plan necessitate evaluation.

When Azmiro™ is excluded, clinicians should refer to the Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs policy and the corresponding excluded drug list for preferred therapeutic alternatives and guidance on prior authorization or step‑therapy requirements.

Compounded testosterone, estrogen, and progesterone pellets are not FDA approved and are not proven or medically necessary for any indication. The policy explicitly excludes these compounded pellet products from coverage.

For commercially available pellet or injectable testosterone products (for example, Testopel®, Depo‑Testosterone®, or Aveed®), coverage decisions follow the Diagnosis‑Specific Requirements and the replacement therapy criteria set forth elsewhere in this policy; compounded pellets remain non‑covered regardless of indication.

Coding and Clinical Thresholds

Covered CPT CodesCPT

11980

Subcutaneous hormone pellet implantation

Covered 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 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

1–10 of 28

1/3

Applicable HCPCS codes (edits)HCPCS

J1073	added (exact description not provided in this excerpt)
S0189	removed (exact description not provided in this excerpt)

inv-11: Total testosterone — threshold value

Total testosterone thresholdTwo pre-treatment early-morning serum total testosterone levels < 300 ng/dL (< 10.4 nmol/L) or less than the lab reference range, taken at separate times

Alternative when SHBG alteredIf condition may alter SHBG, one pre-treatment calculated free or bioavailable testosterone < 50 pg/mL may be used instead

Timing of measurementsPre-treatment measurements must be early-morning samples taken at separate times

inv-12: Calculated free or bioavailable testosterone — threshold value

Calculated free/bioavailable T thresholdOne pre-treatment calculated free or bioavailable testosterone level < 50 pg/mL (< 5 ng/dL or < 0.17 nmol/L) or less than the lab reference range

Provider Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required for Non‑Preferred Testosterone Products

Providers must obtain prior authorization for requests to continue Azmiro™ or other non-preferred testosterone products when a preferred testosterone product is available. Prior authorization is required to confirm that the member meets the Preferred Product Criteria or applicable Diagnosis-Specific Requirements before coverage will be granted for a non-preferred testosterone product.

Applies to Azmiro™ (testosterone cypionate) and other non-preferred testosterone products
Refer to Diagnosis-Specific Requirements for conditions and laboratory criteria
Coverage reviews may be required when Azmiro™ is typically excluded and exceptions are permitted only per plan or law

Billing Rule

Background

Androgens, principally testosterone, are responsible for the development and maintenance of male secondary sex characteristics and reproductive structures. Testosterone replacement therapy is indicated for conditions associated with deficiency or absence of endogenous testosterone such as primary hypogonadism (testicular failure from causes like cryptorchidism, torsion, orchitis, or orchiectomy) and hypogonadotropic hypogonadism (pituitary‑hypothalamic dysfunction or gonadotropin deficiency).

Diagnosis should be supported by biochemical testing: typically two early‑morning total testosterone measurements < 300 ng/dL or, when conditions affect sex hormone‑binding globulin, a calculated free or bioavailable testosterone < 50 pg/mL. Therapeutic products (injectable testosterone, Testopel® pellets, Aveed®) have established dosing recommendations and monitoring expectations; safety and efficacy for age‑related (late‑onset) hypogonadism are not established for Testopel® and monitoring requirements are described in the policy.

Definitions

inv-22: Primary hypogonadism definition

DefinitionTesticular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy

ClassificationPrimary hypogonadism may be congenital or acquired and is an indication for androgen replacement therapy

ExamplesIncludes causes such as bilateral orchiectomy and genetic disorders causing testicular failure

inv-23: Hypogonadotropic hypogonadism definition

DefinitionGonadotropin (luteinizing hormone-releasing hormone) deficiency or pituitary–hypothalamic injury from tumors, trauma, or radiation leading to low testosterone

ClassificationHypogonadotropic hypogonadism may be congenital or acquired and is an indication for androgen replacement therapy

Revision History and Policy Changes

2026-01-01policy revisionLatest

Added language that Azmiro™ is typically excluded from coverage (coverage reviews may occur if required by law or the benefit plan); clarified that coverage for Depo-Testosterone®, testosterone enanthate, Testopel®, and Aveed® is contingent on Diagnosis-Specific Requirements; updated applicable HCPCS codes (added J1073, removed S0189); added CMS section; updated References; archived previous version IEXD0076.06.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTestosterone Replacement or Supplementation Therapy

Policy CodePolicy IEXD0076.07

Change TypeMaterial edits to exclusions and codingAZMIRO exclusion clarified

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain two early-morning total testosterone levels <300 ng/dL (or appropriate free/bioavailable levels) and submit required lab documentation with authorization requests.

SourceLink

On This Page

Authorization will be for no more than 12 months

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

Relation to total TServes as an alternative diagnostic criterion when total testosterone measurements may be unreliable

Coding Inclusion Is Not a Coverage Guarantee

Inclusion of procedure or HCPCS codes in this policy is for reference only and does not guarantee coverage or payment. Providers should verify coverage and reimbursement by checking the member-specific benefit plan document and any applicable laws or mandates.

Listed codes (e.g., J1071, J1072, J1073, J3121, J3145, CPT 11980) are illustrative and not a guarantee of payment
Presence of a code in this policy is not a determination of member eligibility or benefit coverage

Note

Member‑Specific Benefit Plan Governs

The member-specific benefit plan governs determination of coverage. In the event of any conflict between this policy and the member’s benefit plan document or applicable federal/state mandates, the member-specific benefit plan and applicable law take precedence.

Always confirm benefits and any legal mandates with the member-specific plan document
This policy is informational and does not replace the member-specific benefit plan

Step Therapy

Step Therapy / Preferred Product Requirement

Step therapy applies: members are generally required to have a trial of preferred testosterone products (e.g., testosterone cypionate [Depo‑Testosterone®], testosterone enanthate, testosterone pellets [Testopel®], testosterone undecanoate [Aveed®]) with adequate dose and duration and clinical response documentation before Azmiro™ or other non-preferred testosterone products will be approved. Exceptions require documented intolerance, contraindication, or clinical justification per the Preferred Product Criteria.

Preferred products: Depo‑Testosterone®, testosterone enanthate, Testopel®, Aveed®
Required documentation: trial history, clinical response, or physician attestation of intolerance/contraindication
If member continues a non-preferred product, a switch to a preferred product will be required unless Preferred Product Criteria are met

Clinical contextOccurs due to dysfunction of the hypothalamic–pituitary axis causing insufficient gonadotropin stimulation of the testes

inv-24: testosterone cypionate product referenced as Azmiro™ (prescribing information added July 2025)

Product nameAzmiro™ (testosterone cypionate)

Prescribing information addedPrescribing information for Azmiro™ referenced in policy was added July 2025

Coverage stanceAzmiro™ is typically excluded from coverage; coverage reviews may occur if required by law or the member's benefit plan

Related guidanceRefer to the Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs policy and excluded drug list for preferred alternatives when Azmiro™ is excluded