ModifiedBlue Cross Blue Shield - North CarolinaPolicy N/A

Testosterone Cypionate (Azmiro®) “Notification” (PDF) Opens in a New Tab.

Defines medical necessity criteria, initial and continuation approval requirements, site-of-care rules, dosing/HCPCS and maximum units for testosterone cypionate (Azmiro) IM injection administered by a healthcare professional; includes limitations of use and documentation requirements.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyTestosterone Cypionate (Azmiro®) “Notification” (PDF) Opens in a New Tab.

Policy CodePolicy N/A

Change TypeCriteria added: self-admin formulation preference; Depo-Testosterone trial; age-related hypogonadism excluded; site-of-care and max units

Effective DateJul 1, 202625d

Next Review Date

Key ActionDocument two pretreatment early morning testosterone levels (or one in the prior year if already on therapy) and include documentation of prior trial/intolerance to Depo-Testosterone or inability to self-administer when applicable.

SourceLink

POLICY UPDATE CHANGES

Requirement for use of a self-administered formulation of testosterone unless certain criteria are met was added.

Requirement for trial and failure of testosterone cypionate (Depo-Testosterone) was added.

Requirement that the patient will not be treated for age-related or late-onset hypogonadism was added.

Maximum units and Site of Care medical necessity criteria were added.

Policy notification and effective date provided.

365Authorization Duration

J1072Primary HCPCS Code

10,400Maximum Units (duration)

>=2Required pretreatment testosterone draws

Coverage Summary & Scope

Azmiro (testosterone cypionate) intramuscular (IM) injection is indicated for testosterone replacement therapy in males with conditions associated with a deficiency or absence of endogenous testosterone, including primary and hypogonadotropic hypogonadism, delayed puberty in selected males, and certain uses in women (metastatic mammary cancer). Safety and efficacy have not been established for age-related or late-onset hypogonadism or for pediatric patients <12 years. The policy references the FDA label and applicable clinical guidelines to define medical necessity and documentation requirements.

Scope: This policy defines medical necessity criteria for initial and continuation approval, site-of-care rules for injection administration, HCPCS billing (J1072), dosing/maximum units limits for testosterone cypionate (Azmiro) IM injection administered by a healthcare professional, and documentation requirements (laboratory confirmation, trial/intolerance to Depo-Testosterone, and self-administration exceptions).

Key thresholds

Duration365 days (1 year)

Primary HCPCS CodeJ1072

Maximum Units10,400 (for duration of approval)

Required pretreatment testosterone draws>=2 early morning total or free testosterone levels on subsequent days

Initial Therapy Criteria (Medical Necessity)

Initial Criteria for Approval

The restricted product(s) may be considered medically necessary when the following criteria are met:

ONE of the following
- A: Established diagnosis of hypogonadism with androgen deficiency
  - Laboratory confirmation [medical record documentation required]
    Total or Free testosterone thresholds: Total serum testosterone level that is below the testing laboratory's lower limit of the normal range OR less than 300 ng/dL; OR Free serum testosterone level that is below the testing laboratory's lower limit of the normal rangeTotal < lab lower limit OR <300 ng/dL; Free < lab lower limit

Duration of Approval (Initial)

Duration of Approval (Initial): Approval duration: 365 days (1 year)365 days

Continuation Therapy Criteria

Continuation Criteria for Approval

Criteria to continue therapy after initial approval

Prior approval or retroactive eligibility: Patient was approved through Blue Cross NC initial criteria for approval OR The patient would have met initial criteria at the time they started therapy
Clinical response: The patient has demonstrated a positive clinical response while using the medication
Indication-specific continuation
- Hypogonadism: The patient has had a total serum or free serum testosterone level checked in the past year

Site-of-Care Medical Necessity Criteria

Site of Care Medical Necessity Criteria

Applies to requests for injection/infusion administration in inpatient or outpatient hospital settings

Inpatient setting: Above medical necessity criteria are met AND inpatient admission is NOT for the sole purpose of administering the injection or infusion
Outpatient hospital setting
- Severe adverse event history: History of a severe adverse event following injection/infusion (e.g., anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure)
- High-risk conditions: Conditions that cause increased risk for severe adverse event (e.g., unstable renal function, cardiopulmonary conditions, unstable vascular access)

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior authorization required — 365 day authorization

Prior authorization is required. Requests must meet the policy's initial or continuation criteria and, when approved, are authorized for 365 days. Include medical record documentation of prior trial and inadequate response to testosterone cypionate (Depo-Testosterone) or documentation of intolerance/FDA-labeled contraindication or hypersensitivity when applicable. Billing code J1072 is the primary HCPCS code referenced for testosterone cypionate.

Requests must meet initial or continuation criteria.
Authorization duration: 365 days.
Document trial and inadequate response to Depo-Testosterone or intolerance/contraindication if applicable.
HCPCS code: J1072

Documentation Required

Applicable Codes

HCPCS (drug billing)HCPCSCovered

J1072

Testosterone cypionate, per 100 mg (HCPCS code listed in policy)

Background and Clinical Evidence

Evidence and background: the policy is based on the FDA package insert for testosterone cypionate (Azmiro) and cites clinical guidelines including the Endocrine Society testosterone therapy guideline (Bhasin et al., 2018), WPATH Standards of Care Version 8 (2022), Endocrine Society transgender guideline (Hembree et al., 2017), and the IDSA/HIV Medicine Association primary care guidance update (2024).

Limitations and safety: the FDA label and policy specify dosing ranges for IM administration and HCPCS billing code J1072, and explicitly state that safety and effectiveness have not been established for men with age-related or late-onset hypogonadism and for pediatric patients below age 12. The policy also notes requirements added for trial/failure of Depo-Testosterone and for use of self-administered formulations unless documented exceptions exist.

Definitions

Term	Definition
{"text":"New to therapy","status":""},{"text":"Initial injection or infusion OR less than 3 months since initial injection or infusion.","status":""}
{"text":"Re-initiation of therapy","status":""},{"text":"First injection/infusion after 6 months of no injections for drugs with dosing interval <6 months, OR first injection after at least a 1-month gap outside approved dosing interval for drugs requiring every 6 months dosing.","status":""}

Revision History

2026-04-02policy_notification

Policy notification issued for upcoming policy effective date of 2026-07-01.

2026-07-01effective_dateLatest

Policy effective. Original medical policy criteria issued July 2026; incorporated new requirements including: requirement to use a self-administered formulation of testosterone unless documented inability exists; requirement for trial and inadequate response to testosterone cypionate (Depo-Testosterone) or documented intolerance/contraindication; explicit exclusion of treatment for age-related or late-onset hypogonadism; addition of maximum units (10,400) and Site of Care medical necessity criteria for inpatient/outpatient administration.

July 2026

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyTestosterone Cypionate (Azmiro®) “Notification” (PDF) Opens in a New Tab.

Policy CodePolicy N/A

Change TypeCriteria added: self-admin formulation preference; Depo-Testosterone trial; age-related hypogonadism excluded; site-of-care and max units

Effective DateJul 1, 202625d

Next Review Date

SourceLink

On This Page

B: Diagnosis of hypogonadism and currently receiving testosterone replacement therapy:

The patient has had a total serum or free serum testosterone level checked in the past year

C: HIV with unexplained weight loss or low BMD and low testosterone

Not currently receiving testosterone replacement therapy
- HIV testosterone thresholds: Total serum testosterone below lab lower limit OR < 300 ng/dL; OR Free serum testosterone below lab lower limit

D: Palliative treatment of metastatic inoperable breast cancer (women): Requesting agent used for palliative treatment of metastatic inoperable breast cancer

E: Delayed puberty: Diagnosis of delayed puberty

F: Gender dysphoria

Adult (>=18 years): Patient has coverage for sex trait modification; Patient is 18 years of age or older; Patient has persistent, well-documented gender dysphoria; Patient has capacity to make a fully informed decision and consent for treatment; Mental health concerns, if present, are reasonably well-controlled
Adolescent (12 to <18 years): Qualified mental health provider has confirmed persistence of gender dysphoria and addressed coexisting problems; Patient has sufficient capacity to consent; Patient informed of irreversible effects and fertility options; Patient and parents/caregivers/guardians have consented and are involved in support
Exception path: Treating clinician must submit information indicating why it would be clinically inappropriate to require the candidate to meet these criteria
medical record documentation required

Exclusion: The patient will NOT be treated for age-related or late-onset hypogonadism

Self-administration exception: The patient has a physical or cognitive limitation making self-administered formulation unsafe or not feasible, demonstrated by BOTH: inability to self-administer the medication; AND lack of caregiver or support system for assistance with administration of self-administered products

medical record documentation required

ONE of the following additional requirements

Trial and inadequate response to Depo-Testosterone: Patient has tried and had an inadequate response to testosterone cypionate (Depo-Testosterone)
medical record documentation required
Intolerance/contraindication to Depo-Testosterone: Patient has intolerance, FDA labeled contraindication, or hypersensitivity to testosterone cypionate (Depo-Testosterone)
medical record documentation required

Quantity limit: The requested quantity does NOT exceed the maximum units allowed for the duration of approvalMaximum Units = 10,400

See Maximum Units table

See Maximum Units table: the policy limits the requested quantity to a maximum of 10,400 units for the duration of approval (365 days).

Palliative breast cancer: Using agent for palliative treatment of metastatic inoperable breast cancer

Delayed puberty: Diagnosis of delayed puberty

Gender dysphoria continuation: Patient has coverage for sex trait modification

Exclusion: The patient will NOT be treated for age-related or late-onset hypogonadism

medical record documentation required

ONE of the following

Trial and inadequate response to Depo-Testosterone: Patient has tried and had an inadequate response to testosterone cypionate (Depo-Testosterone)
medical record documentation required
Intolerance/contraindication to Depo-Testosterone: Patient has intolerance, FDA labeled contraindication, or hypersensitivity to testosterone cypionate (Depo-Testosterone)
medical record documentation required

Quantity limit: The requested quantity does NOT exceed the maximum units allowed for the duration of approvalMaximum Units = 10,400

Mild adverse events not managed with pre-medication: History of mild adverse events not managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids)

Adherence inability: Inability to physically and cognitively adhere to treatment schedule and regimen complexity

New to therapy or re-initiation: New to therapy: initial injection/infusion OR < 3 months since initial injection/infusion; OR Re-initiation defined as first injection/infusion after 6 months of no injections for drugs with dosing interval <6 months OR first injection after at least a 1-month gap outside approved dosing interval for drugs requiring every 6 months dosing

Formulation change requirement: Requirement of a change in the requested restricted product formulation

If Site of Care criteria NOT met: Injection/infusion will be administered in home-based infusion or physician office setting with or without supervision by a certified healthcare professional

Billing Rule

Site of care rules for administration

If requesting inpatient administration, the inpatient admission must not be solely for the purpose of administering the injection. For outpatient hospital administration, the medical necessity criteria must be met and ONE of the listed outpatient criteria must be present (for example: history of severe adverse event to the drug, conditions increasing risk for severe adverse events, inability to adhere to regimen, new to therapy/re-initiation, requirement to change formulation, or history of mild adverse events not managed with pre-medication). If outpatient hospital criteria are not met, administration should occur in the home or physician office setting.

Inpatient admission must NOT be solely for administration.
Outpatient hospital requires one specified criterion (e.g., severe adverse event history, increased risk conditions, regimen adherence issues, new to therapy/re-initiation, formulation change, or unmanaged mild adverse events).
If Site of Care criteria are not met, administer in home-based infusion or physician office.

Laboratory confirmation required

Document two pretreatment early morning testosterone levels drawn on subsequent days that meet one of the thresholds, or if the patient is already on therapy, document one total or free testosterone level within the prior year. Thresholds: total serum testosterone below the laboratory lower limit of normal OR < 300 ng/dL; OR free serum testosterone below the laboratory lower limit of normal. Medical record documentation of these results is required.

Two early morning testosterone levels on subsequent days (pretreatment) required unless already on therapy.
If already on therapy, document one total or free testosterone level within the past year.
Total testosterone threshold: below lab lower limit OR < 300 ng/dL.
Free testosterone threshold: below lab lower limit.

Documentation Required

Self-administration requirement exception

If requesting clinic-administered intramuscular product instead of a self-administered formulation, document that the patient has a physical or cognitive limitation that makes self-administration unsafe or not feasible, demonstrated by BOTH inability to self-administer and lack of caregiver or support system to assist with administration. Medical record documentation is required.

Document inability to self-administer the medication.
Document lack of caregiver or support system to assist with self-administration.
Both elements must be documented to qualify for the exception.

Denial Risk

Age-related hypogonadism excluded

Requests for treatment of age-related or late-onset hypogonadism are excluded and will not be approved.

Documentation Required

Gender-affirming care documentation

For gender-affirming care, document required elements per age group. For adults (>=18 years): evidence of coverage for sex trait modification, persistent well-documented gender dysphoria, capacity to give informed consent, and mental health concerns reasonably well-controlled. For adolescents (12 to <18 years): a qualified mental health provider must confirm persistence of gender dysphoria, address coexisting problems, confirm sufficient capacity for informed consent; the patient must be informed of irreversible effects and fertility implications and give informed consent with parental/caregiver involvement. Treating clinician may submit justification if criteria cannot be met. Coverage for sex trait modification must be confirmed per plan.

Adults: coverage for sex trait modification, documented persistent gender dysphoria, capacity for informed consent, mental health reasonably controlled.
Adolescents (12 to <18): qualified mental health provider confirmation, informed consent, fertility counseling, parental/caregiver involvement.
Clinician may request exception with documentation if criteria are not appropriate.

Material changes added to initial and continuation criteria: requirement for self-administered formulation unless documented inability; requirement for trial and failure of Depo-Testosterone (testosterone cypionate) or intolerance/contraindication; requirement that patients will not be treated for age-related or late-onset hypogonadism; addition of maximum units and Site of Care medical necessity criteria.