Currentsierra health and lifePolicy 2026D0076J

Medical Benefit Drug Policy: Testosterone Replacement or Supplementation Therapy

Defines medical benefit coverage criteria for injectable testosterone products (testosterone cypionate, testosterone enanthate, testosterone pellets/Testopel, testosterone undecanoate/Aveed) including diagnosis-specific requirements, gender-affirming therapy criteria, exclusions for compounded products, applicable procedure/HCPCS/CPT/ICD-10 codes, and utilization/authorization parameters.

Policy Summary

Payersierra health and life

PolicyMedical Benefit Drug Policy: Testosterone Replacement or Supplementation Therapy

Policy CodePolicy 2026D0076J

Change TypeRevised coverage language; code list update

Effective DateJan 1, 2026

Next Review Date

Key ActionAuthorization is required for testosterone products covered under this policy and will be for no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

Added language that Azmiro is typically excluded from coverage and that coverage for testosterone cypionate (Depo-Testosterone), testosterone enanthate, testosterone pellets (Testopel), and testosterone undecanoate (Aveed) is contingent on criteria in the Diagnosis-Specific Requirements section.

5HCPCS/CPT codes listed

30+ICD-10 diagnosis codes listed

12 monthsAuthorization duration cap

Required pre-treatment total T measurements

Coverage Summary & Scope

Defines medical benefit coverage criteria for injectable testosterone products including testosterone cypionate, testosterone enanthate, testosterone pellets (Testopel), and testosterone undecanoate (Aveed). Coverage for these products is contingent on the Diagnosis-Specific Requirements which include documented diagnostic scenarios and biochemical confirmation pathways. Gender-affirming therapy criteria for transgender adults are specified and require DSM diagnosis of gender dysphoria and prescription by or consultation with an endocrinologist or a provider knowledgeable in transgender hormone therapy. Compounded hormone products (including compounded pellets) are not FDA approved and are listed as not proven or medically necessary. Applicable procedure and billing codes include HCPCS/J-codes J1071, J1072, J1073, J3121, J3145 and CPT 11980. Utilization and authorization parameters require dosing per FDA-approved labeling and authorization for no more than 12 months.

Thresholds and Authorization Duration

Total testosterone thresholdTwo early morning serum total testosterone levels < 300 ng/dL (< 10.4 nmol/L) or less than the reference range for the lab, taken on separate occasions.

Calculated free/bioavailable testosterone thresholdOne 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 lab when SHBG-altering conditions are present.

Follow-up monitoring interval — new usersFollow-up calculated free or bioavailable testosterone drawn within the past 6 months for patients on therapy < 1 year.

Follow-up monitoring interval — continuing usersFollow-up calculated free or bioavailable testosterone drawn within the past 12 months for patients on therapy ≥ 1 year.

Authorization duration capAuthorization will be for no more than 12 months.

Medically Necessary Criteria (Initial & Continuation Therapy)

Medically Necessary - Injectable Testosterone and Testopel (Initial or Continuation)

Injectable testosterone and Testopel are medically necessary when ALL of the following criteria are met:

ONE of the following baseline diagnostic scenarios

Patient has history of one of the following
- Bilateral orchiectomy: Patient has history of bilateral orchiectomy
- Panhypopituitarism: Patient has history of panhypopituitarism
- Genetic disorder causing hypogonadism: Patient has a genetic disorder known to cause hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)

Not Medically Necessary / Exclusions

The following are not proven or medically necessary:

Exclusions and not medically necessary

Azmiro exclusion: Azmiro (testosterone cypionate) is typically excluded from coverage; coverage reviews may be in place if required by law or the benefit plan. Refer to Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs and excluded drug list with preferred alternatives.
Compounded hormone products (e.g., pellets), including but not limited to compounded testosterone, estrogen, and progesterone pellets are not proven or medically necessary for any indication; compounded drugs are not FDA approved.
Testopel age-related hypogonadism informational: Safety and efficacy of Testopel in men with age-related (late-onset) hypogonadism have not been established (informational exclusion for that indication)

Applicable Procedure, HCPCS/J, and Diagnosis Codes

HCPCS / J-codes (Injectable testosterone and pellet)HCPCSCovered

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

CPT CodesCPTCovered

11980

Subcutaneous hormone pellet implantation

ICD-10 Codes (examples supporting hypogonadism or related conditions)ICD-10Covered

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

Listing of a code in this policy does not imply a right to reimbursement or guarantee claim payment; member-specific benefit plan documents and applicable laws govern coverage and payment.

Prior Authorization, Documentation & Billing Actions

Prior Authorization

Authorization required and duration limit

Authorization is required for testosterone products covered under this policy and will be for no more than 12 months.

Documentation Required

Biochemical confirmation and monitoring documentation

Provide two early morning total testosterone levels < 300 ng/dL obtained on separate occasions OR calculated free or bioavailable testosterone results when conditions that alter SHBG are present. For patients already on therapy, provide follow-up calculated free or bioavailable testosterone drawn within the past 6 months for new users (< 1 year on therapy) or within the past 12 months for continuing users (≥ 1 year on therapy), with dose adjustment if levels exceed upper male limits.

Evidence, Guidelines & Definitions

Endocrine Society guideline (2018) recommends diagnosing hypogonadism only in men with symptoms/signs consistent with testosterone deficiency using fasting early morning total testosterone concentrations with confirmation. Measurement of free testosterone is recommended when total testosterone is near the lower limit of normal or when a condition that alters sex-hormone binding globulin (SHBG) is present.

Definitions

SHBGSex-hormone binding globulin; conditions altering SHBG (e.g., thyroid disorder, HIV, liver disorder, diabetes, obesity) may necessitate measurement of free or bioavailable testosterone.

Background

This policy outlines FDA-indicated uses of androgens for replacement therapy in primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired), with dosing regimens per product labeling: testosterone pellets (Testopel) typically 150–450 mg subcutaneously every 3–6 months; Aveed (testosterone undecanoate) 750 mg initially, at week 4, then every 10 weeks; testosterone cypionate and enanthate 50–400 mg every 2–4 weeks (not to exceed 400 mg per 14 days). The policy notes that safety and efficacy of Testopel for age-related hypogonadism have not been established and that compounded hormone pellets are not FDA approved.

Policy Revision History

01/01/2026material_changeLatest

Added instruction to refer to Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs and updated references and CMS section; added J1073 and removed S0189 from applicable codes; added language that Azmiro is typically excluded and that coverage for Depo-Testosterone (testosterone cypionate), testosterone enanthate, Testopel (testosterone pellets), and Aveed (testosterone undecanoate) is contingent on Diagnosis-Specific Requirements.

Policy Summary

Payersierra health and life

PolicyMedical Benefit Drug Policy: Testosterone Replacement or Supplementation Therapy

Policy CodePolicy 2026D0076J

Change TypeRevised coverage language; code list update

Effective DateJan 1, 2026

Next Review Date

Key ActionAuthorization is required for testosterone products covered under this policy and will be for no more than 12 months.

SourceLink

On This Page

Biochemical confirmation pathway

Typical biochemical confirmation: Two pre-treatment early morning serum total testosterone levels < 300 ng/dL (< 10.4 nmol/L) or less than the reference range for the lab, obtained on separate occasionsTotal testosterone < 300 ng/dL or < lab reference
Altered SHBG pathway: Patient has condition that may alter sex-hormone binding globulin (e.g., thyroid disorder, HIV, 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 labCalculated free or bioavailable T < 50 pg/mL or < lab reference
Patients already on testosterone therapy
- Monitoring - within or below normal male limits: Follow-up calculated free or bioavailable testosterone drawn within the past 6 months for patients on therapy < 1 year, or within the past 12 months for patients on therapy ≥ 1 year, is within or below the normal male limits of the reporting labFollow-up within 6 months (new) or 12 months (continuing)
- Monitoring - outside upper male limits with dose adjustment: Follow-up calculated free or bioavailable testosterone drawn within the past 6 months (new users) or 12 months (continuing users) is above the upper male limit of normal for the reporting lab AND the dose is adjustedFollow-up within 6 months (new) or 12 months (continuing)

AND additional required criteria

Patient sex at birth: Patient was male at birth
Diagnosis of hypogonadism (examples in ICD-10 list)
Dosing per FDA labeling: Dosing is in accordance with the United States Food and Drug Administration approved labeling
Authorization duration: Authorization will be for no more than 12 months12 months

Medically Necessary - Gender-Affirming Hormonal Therapy (Injectable Testosterone and Testopel)

Injectable testosterone and Testopel may be covered for transgender adults when ALL of the following are met:

Gender-affirming hormonal therapy criteria

DSM diagnosis: Diagnosis of gender dysphoria according to the current DSM (e.g., DSM-5-TR) by a mental health professional
Prescriber or consultation: Medication is prescribed by or in consultation with an endocrinologist or a medical provider knowledgeable in transgender hormone therapy
Authorization duration: Authorization will be for no more than 12 months12 months

Compounded hormone pellets are not FDA approved. Safety and efficacy of Testopel for men with age-related (late-onset) hypogonadism have not been established (informational).

Billing Rule

Use appropriate HCPCS/J-code

Report injectable testosterone and pellets using the appropriate HCPCS / J-codes and CPT code for pellet implantation. Inclusion of a code does not guarantee payment; member benefit plan governs reimbursement.

J1071
J1072
J1073
J3121
J3145
11980

Denial Risk

Excluded/Not medically necessary compounds and Azmiro

Claims for compounded hormone pellets are not proven or medically necessary and are not FDA approved. Azmiro (testosterone cypionate) is typically excluded from coverage; such claims risk denial unless a plan or mandate requires coverage.

J1072

Documentation Required

Gender-affirming therapy requirements

For gender-affirming hormonal therapy, document a DSM diagnosis of gender dysphoria by a mental health professional and that the medication is prescribed by or in consultation with an endocrinologist or a medical provider knowledgeable in transgender hormone therapy.