Testosterone (Testopel, Aveed, Azmiro) Policy
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Defines coverage and prior authorization criteria for Aveed, Azmiro, and Testopel injectable/implantable testosterone products across Univera Healthcare commercial, Medicaid, Medicare Advantage, and other lines of business (except Medicare Part D where noted).
No material clinical or coverage changes in this revision.
Coverage Criteria
Coverage Duration
Coverage duration and recertification rules:
Requests for testosterone products for indications where efficacy has not been established will be denied as experimental, investigational, or unproven. Excluded indications specifically include: idiopathic hypogonadism (i.e., hypogonadism not due to primary or secondary causes), menopause (female or male), pain management in women, female sexual dysfunction / hypoactive sexual desire disorder, improvement of cognitive function in aging men, and treatment of cancers (e.g., breast, kidney, and prostate).
For Medicaid Managed Care and HARP lines of business, coverage is limited to physician‑administered drugs produced by manufacturers that participate in the Medicaid Drug Rebate Program (MDRP participation required). Products from manufacturers that do not participate in the MDRP will not be covered and will be denied. Providers may reference the CMS list of new/reinstated and terminated labelers for current participation status.
Initial Therapy — Product-specific Dosing
Recertification and Continuation Criteria
Step Therapy / Prior Trial Requirements
| Requirement | Details |
|---|---|
| Step therapy requirement | |
| Requests for Aveed, Azmiro, or Testopel require a prior trial of testosterone cypionate or testosterone enanthate for at least 3 months unless a valid exception is documented per Insurance Law § 4903(c-1) and Public Health Law § 4903(3-a). |
| HCPCS Code | Description | Preference / Utilization Management |
|---|---|---|
| J1071 | ||
| testosterone cypionate (Depo‑Testosterone) | ||
| Preferred; may be required as step therapy prior to non-preferred products or used in utilization edits | ||
| J3121 | ||
| testosterone enanthate | ||
| Preferred; may be required as step therapy prior to non-preferred products or used in utilization edits | ||
| S0189 / J3490 | ||
| Testopel (pellet) / unclassified drug code often used for Testopel | ||
| Non-preferred; may be subject to additional review or restrictive edits | ||
| J3145 / C9023 | ||
| Aveed (testosterone undecanoate) / temporary HCPCS | ||
| Non-preferred; may be subject to additional review or restrictive edits | ||
| J1072 | ||
| Azmiro | ||
| Non-preferred; may be subject to additional review or restrictive edits |
Provider Actions and Documentation Requirements
Obtain prior authorization (contract dependent)
Prior authorization is required and is contract dependent. This policy does not apply to Medicare Part D and D‑SNP pharmacy benefits; refer to the member's contract/benefit plan for applicability and exclusions.
PA applies to physician‑administered products; follow HCPCS preference
Prior authorization requirements apply to physician‑administered testosterone products; HCPCS codes are designated as preferred (J1071, J3121) and non‑preferred (S0189/J3490, J3145/C9023, J1072), which may affect coverage and PA processing.
Document ≥3‑month trial of cypionate or enanthate before approval
Document a prior trial of at least 3 months of testosterone cypionate or testosterone enanthate before requesting Aveed, Azmiro, or Testopel; exceptions require documentation of severe adverse effects or suboptimal therapeutic response.
- Minimum trial duration: ≥3 months of cypionate or enanthate
- If trial discontinued for safety or lack of effect, document severe adverse effects or suboptimal therapeutic effects
Submit documentation of prior trials and exceptions
Provide documentation of prior trials (≥3 months) of testosterone cypionate or enanthate, including evidence of severe adverse effects or suboptimal response when claiming an exception.
- Include initial and repeat (≥24 hours apart) morning total testosterone levels prior to initiating therapy
- Include specialist prescribing or consultation notes when applicable
- For recertification, provide objective evidence of ongoing benefit (therapeutic labs, symptom control, or other documentation)
Confirm eligibility and align coding/documentation with contract
Reimbursement and coverage depend on the member's subscriber contract and must align with coding and documentation submitted with the request.
- Ensure procedure coding matches the product and that submitted documentation supports medical necessity per the member's benefit design
Do not request products for experimental/unproven indications
Requests for uses considered experimental, investigational, or unproven (for example, idiopathic hypogonadism, menopause, female sexual dysfunction, cognitive improvement in aging men, and treatment of cancers) will be denied as not established.
Medicaid: deny products from non‑MDRP manufacturers
Products from manufacturers that do not participate in the Medicaid Drug Rebate Program (MDRP) will not be covered under Medicaid Managed Care/HARP lines of business; coverage will be denied for such products.
- Verify manufacturer MDRP participation before submitting requests for Medicaid Managed Care/HARP members
- Refer to the Medicaid list of terminated/new labelers for current participation status
Coding (HCPCS)
Site of Care Considerations
Site of care may affect approval timeframe
The requested site of care (office, infusion center, hospital outpatient, or home) may impact the approval timeframe and is subject to review.
- Site of care selection may affect processing time and review requirements
Office site‑of‑care may affect approval timeframe
When the office is the requested site of care, note that site‑of‑care selection may affect the approval timeframe and is subject to review.
Definitions
Background
Testosterone replacement therapy is indicated for men with primary or secondary hypogonadism and for selected adolescent males with delayed puberty. Clinical initiation is guided by the presence of symptoms consistent with testosterone deficiency and by laboratory confirmation with morning total testosterone measurements. The policy aligns with guideline expectations that diagnosis requires both compatible signs or symptoms (for example, reduced libido, decreased erections, low energy, loss of body hair, small testicular volume, infertility, or low bone density) and consistently low morning testosterone values. Therapy decisions should also consider age-related thresholds and safety: clinicians are advised to exercise caution initiating treatment in older men when benefits and risks are uncertain. Reference materials informing these expectations include product labeling for Aveed, Azmiro, and Testopel and relevant clinical guidelines.
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