ModifiedUnitedHealthcarePolicy IEXD0076.06

Testosterone Replacement or Supplementation Therapy

This policy describes medical necessity criteria, coding, and coverage considerations for injectable testosterone products and testosterone pellets for replacement therapy and gender-affirming hormone therapy for adults. It applies to UnitedHealthcare medical benefit determinations for applicable members.

Policy Summary

PayerUnitedHealthcare

PolicyTestosterone Replacement or Supplementation Therapy

Policy CodePolicy IEXD0076.06

Change TypeAdded HCPCS J1072clarified follow-up lab timingremoved max dosage list

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain and document a follow-up calculated free or bioavailable testosterone level within 6 months for patients on therapy <1 year or within 12 months for patients on therapy ≥1 year.

SourceLink

POLICY UPDATE CHANGES

Azmiro (testosterone cypionate) has been added to the Review at Launch program and to the list of applicable testosterone products.

Coverage criteria were revised to add specific follow-up calculated free or bioavailable testosterone requirements for patients currently on therapy.

Continuation of therapy criteria revised to require either specific history (e.g., bilateral orchiectomy, panhypopituitarism, genetic disorder) or laboratory criteria including two early morning total testosterone measurements <300 ng/dL or a single low calculated free/bioavailable testosterone when an SHBG-altering condition is present.

HCPCS code J1072 (testosterone cypionate, Azmiro) was added to the applicable codes.

Removed list of maximum dosage requirements and maximum allowed frequencies; reference to the Medical Benefit Drug Policy titled 'Maximum Dosage and Frequency' was added.

Follow-up calculated free or bioavailable testosterone level timing specified for new and continuing therapy, and dose adjustment requirement if above upper limits.

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Coverage Criteria and Medical Necessity

Medical Necessity Criteria

Injectable testosterone and Testopel are medically necessary when ALL required elements in the applicable section are met.

Conditions Associated with a Deficiency or Absence of Endogenous Testosterone - Continuation/Replacement

ONE of
- Bilateral orchiectomy
- Panhypopituitarism
- A genetic disorder known to cause hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)
OR - Laboratory criteria
- ONE of
  - Two pre-treatment early-morning serum total testosterone levels < 300 ng/dL (< 10.4 nmol/L) or less than the reference range for the reporting lab, taken at separate times
  - Both of the following: patient has a condition that may alter sex-hormone binding globulin (SHBG) (e.g., thyroid disorder, HIV disease, liver disorder, diabetes, obesity); AND one pre-treatment calculated free or bioavailable testosterone < 50 pg/mL (< 5 ng/dL or < 0.17 nmol/L) or less than the reference range for the reporting lab

Follow-up Laboratory Monitoring

Covered when ALL of the following are met

Laboratory follow-up timing

Timing: Follow-up level drawn within the past 6 months for patients new to testosterone therapy (on therapy < 1 year) OR within the past 12 months for patients continuing testosterone therapy (on therapy \u2265 1 year).
Result interpretation: If the follow-up calculated free or bioavailable testosterone level is within or below the normal male limits of the reporting lab, the monitoring requirement is met; OR if the level is above the upper male limits of the reporting lab, documentation of a dose adjustment meets the requirement.

Compounded hormone products, including compounded testosterone, estrogen, and progesterone pellets, are not FDA approved and are not proven or medically necessary for any indication. These compounded preparations are excluded from coverage.

No additional exclusions are explicitly stated in this section of the policy.

The policy no longer lists specific maximum dosage requirements or maximum allowed frequencies. Providers should refer to the separate Medical Benefit Drug Policy titled "Maximum Dosage and Frequency" for applicable dose and frequency limits and follow that policy when requesting coverage or submitting claims.

The safety and efficacy of Testopel (testosterone pellets) in men with age-related (late-onset) hypogonadism have not been established and therefore Testopel is not supported for that indication.

Explicit lists of maximum dosages and allowed frequencies were removed from this policy. For dose and frequency limits, providers must consult the Medical Benefit Drug Policy titled "Maximum Dosage and Frequency" and ensure authorizations and claims comply with that separate policy.

Procedure, HCPCS, and Diagnosis Codes

Procedure CPTCPT

11980

Subcutaneous hormone pellet implantation

Injectable testosterone HCPCS/J-codesHCPCS

J1071	Injection, testosterone cypionate, 1 mg
J1072	Injection, testosterone cypionate (Azmiro), 1 mg
J3121	Injection, testosterone enanthate, 1 mg
J3145	Injection, testosterone undecanoate, 1 mg

Pellet HCPCSHCPCS

S0189

Testosterone pellet, 75 mg

Applicable 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

1–10 of 28

1/3

Applicable HCPCS CodesHCPCS

J1072

HCPCS code added (testosterone product billing code as specified in policy)

Applicable HCPCS Codes (added)HCPCS

J1072

Added HCPCS code J1072

Total serum testosterone (early morning) — pre-treatment threshold

Threshold (total serum testosterone, early morning)Less than 300 ng/dL (< 10.4 nmol/L) or less than the laboratory reference range

Measurement timingTwo pre-treatment early-morning serum total testosterone levels must be taken at separate times

Use in continuation criteriaTwo early-morning total testosterone measurements <300 ng/dL may satisfy continuation/replacement criteria when specified

Calculated free or bioavailable testosterone — SHBG-altered conditions

Threshold (calculated free or bioavailable testosterone)Less than 50 pg/mL (< 5 ng/dL or < 0.17 nmol/L) or less than the laboratory reference range

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for injectable testosterone (including testosterone cypionate, enanthate, undecanoate) and testosterone pellets (Testopel). Requests must include documentation of the diagnosis of hypogonadism and supporting laboratory results; dosing must be consistent with FDA‑approved labeling. Requests missing required diagnostic evidence, required laboratory results, or documentation of appropriate dosing may be returned or denied.

Required documentation must include: diagnosis of hypogonadism and one of the diagnostic pathways described in policy (e.g., two early morning total testosterone measurements < 300 ng/dL taken separately, or calculated free/bioavailable testosterone below lab reference range when SHBG–altering condition present).
For patients already on testosterone therapy: provide timing and results of follow-up calculated free or bioavailable testosterone testing (within 6 months for patients on therapy <1 year; within 12 months for patients on therapy ≥1 year).
If follow-up calculated free or bioavailable testosterone is outside the upper male limits of normal for the reporting lab, documentation must show a dose adjustment.
Authorization is limited to a maximum of 12 months per approval.
Dosing must follow FDA labeling; compounded testosterone or compounded pellets are not covered.

Clinical Background

Endogenous androgens, principally testosterone, are responsible for male sexual development and maintenance of secondary sexual characteristics. Testosterone products are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (testicular failure from causes such as cryptorchidism, torsion, orchitis, vanishing testes syndrome, or orchiectomy) and hypogonadotropic hypogonadism (gonadotropin/LHRH deficiency or pituitary–hypothalamic injury).

Definitions and Clinical Terms

Testicular failure — primary hypogonadism examples

DefinitionTesticular failure (primary hypogonadism) — conditions causing failure of the testes leading to low endogenous testosterone

ExamplesCryptorchidism (undescended testis), torsion, orchitis, orchiectomy (including bilateral orchiectomy)

ContextListed as indications for replacement therapy under FDA informational guidance

Hypogonadotropic hypogonadism — definition

DefinitionHypogonadotropic hypogonadism — gonadotropin (LHRH) deficiency or pituitary-hypothalamic injury resulting in low testosterone

CausesMay be congenital or acquired from tumors, trauma, or radiation affecting the pituitary-hypothalamic axis

Policy Summary

PayerUnitedHealthcare

PolicyTestosterone Replacement or Supplementation Therapy

Policy CodePolicy IEXD0076.06

Change TypeAdded HCPCS J1072clarified follow-up lab timingremoved max dosage list

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain and document a follow-up calculated free or bioavailable testosterone level within 6 months for patients on therapy <1 year or within 12 months for patients on therapy ≥1 year.

SourceLink

On This Page

Documentation Required

Required Laboratory Follow-up

Follow-up laboratory testing requirements: calculated free or bioavailable testosterone must be documented with the timing relative to therapy status (new to therapy vs continuing) as described above. Lack of documented follow-up testing within the required timeframe may affect coverage decisions.

New to therapy (on therapy < 1 year): follow-up calculated free or bioavailable testosterone drawn within the past 6 months.
Continuing therapy (on therapy ≥ 1 year): follow-up calculated free or bioavailable testosterone drawn within the past 12 months.
Results must be reported using the lab's male reference limits; documentation should indicate whether results are within, below, or above the male limits of normal.

Billing Rule

Billing and Prior Authorization Coding

Billing and coding: include applicable HCPCS/CPT/ICD codes on the prior authorization and claim. Use HCPCS code J1072 where applicable. Prior authorization requirements in this policy and the referenced Medical Benefit Drug Policy (Maximum Dosage and Frequency) must be followed; failure to follow the separate Medical Benefit Drug Policy may result in denial or reimbursement issues.

Applicable codes: HCPCS J1072 (added).
Refer to the Medical Benefit Drug Policy titled 'Maximum Dosage and Frequency' for dosage/frequency rules; the removed dosage list in this policy has been superseded by that policy.

Denial Risk

Provider Actions and Documentation Requirements

Documentation expectations and denial risk: requests must clearly show the diagnostic pathway used, all required laboratory values with drawing dates and lab reference ranges, and any dose adjustments when lab values exceed upper male limits of normal. Requests missing required diagnostic evidence or missing/untimely follow-up laboratory documentation may be returned for additional information or denied.

Include dates and numeric results for all testosterone tests (total and calculated free or bioavailable as applicable) and the laboratory reference ranges.
If follow-up labs are outside the upper male limits of normal, include documentation of the dose adjustment.
Incomplete requests (missing diagnosis, missing pre‑treatment labs, or missing required follow‑up calculated free/bioavailable testosterone within required timeframe) may be returned or denied.