Testosterone Cypionate (Azmiro) - Notification
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Defines medical necessity and prior authorization notification criteria for Azmiro (testosterone cypionate IM) administered by a healthcare professional for testosterone replacement and select indications; applies to Blue Cross NC membership.
Requirement for use of a self-administered formulation of testosterone unless certain criteria are met.
Requirement for trial and failure of testosterone cypionate (Depo-Testosterone).
Requirement that the patient will not be treated for age-related or late-onset hypogonadism.
Added maximum units and Site of Care medical necessity criteria.
Coverage Criteria
Laboratory documentation required
Provider must document laboratory testing before initiation and for continuation of therapy. Two early morning (AM) pretreatment testosterone levels drawn on separate days are required for patients not currently receiving testosterone replacement therapy; alternatively, patients already receiving therapy must have at least one total or free testosterone level checked within the past year. Medical record documentation of test results must be submitted with the request. If laboratory proof is not provided, the request may be denied.
- Two pretreatment early morning testosterone levels, drawn on subsequent days, with results showing either: total testosterone below the laboratory lower limit of normal or < 300 ng/dL, OR free testosterone below the laboratory lower limit of normal (medical record documentation required).
- If patient is currently receiving testosterone therapy: documentation of a total or free testosterone level checked within the past year (medical record documentation required).
- Consequences: Requests lacking required laboratory documentation may be denied or returned for additional information.
Initial Therapy
Initial Therapy — Covered when ALL of the following are met:
ALL of the following
ALL of the following
ANY of the following
- The patient is NOT currently receiving testosterone replacement therapy and has TWO pretreatment early morning testosterone levels, drawn on subsequent days, meeting one of: 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 required).
- The patient is currently receiving testosterone replacement therapy and has had a total or free serum testosterone level checked in the past year (medical record documentation required).
- Presence of symptoms of hypogonadism at the time of diagnosis, including at least ONE of: incomplete or delayed sexual development; decreased libido; decreased spontaneous erections; breast discomfort/gynecomastia; loss of axillary and/or pubic hair; very small (< 5 mL) or shrinking testes; infertility due to low sperm count; height loss due to vertebral fractures/low bone density; hot flushes or sweats.
- 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/support for assistance (medical record documentation required).
- ONE of the following: the patient has tried and had an inadequate response to testosterone cypionate (Depo-Testosterone) (medical record documentation required); OR the patient has an intolerance, FDA-labeled contraindication, or hypersensitivity to testosterone cypionate (Depo-Testosterone) (medical record documentation required).
- Requested quantity does NOT exceed the maximum units allowed for the duration of approval.
- The patient will NOT be treated for age-related or late-onset hypogonadism.
ALL of the following
- For indications other than primary hypogonadism (e.g., HIV-related hypogonadism, delayed puberty, gender dysphoria, or palliative treatment of metastatic inoperable breast cancer) specific additional criteria in the policy must be met (medical record documentation required).
ALL of the following
- Duration of approval: 365 days (1 year).
Continuation Therapy
Continuation Therapy — Covered for continuation when ALL of the following are met:
ALL of the following
- The patient was previously approved through Blue Cross NC initial criteria for approval; OR would have met initial criteria at therapy start; AND
- The patient has demonstrated a positive clinical response while using the medication; AND
ANY of the following
- The patient has a diagnosis of hypogonadism and has had a total serum or free serum testosterone level checked in the past year (medical record documentation required).
- The patient is using the agent for palliative treatment of metastatic inoperable breast cancer.
- The patient has a diagnosis of delayed puberty.
- The patient has a diagnosis of gender dysphoria and meets the policy's sex trait modification coverage criteria (medical record documentation required).
- The patient will NOT be treated for age-related or late-onset hypogonadism; AND
- The patient has a physical or cognitive limitation preventing safe use of a self-administered formulation, demonstrated by BOTH inability to self-administer AND lack of caregiver/support (medical record documentation required).
ANY of the following
- The patient has tried and had an inadequate response to testosterone cypionate (Depo-Testosterone) (medical record documentation required).
- The patient has an intolerance, FDA-labeled contraindication, or hypersensitivity to testosterone cypionate (Depo-Testosterone) (medical record documentation required).
- Requested quantity does NOT exceed the maximum units allowed for the duration of approval.
- Duration of approval: 365 days (1 year).
ALL of the following
- For requests for injection or infusion administration in inpatient or outpatient hospital settings, Site of Care Criteria applies as outlined in the policy.
Initial Therapy
inv-17: Initial Therapy
Initial approval requirements
Medical record documentation required
See policy symptom list
Gender dysphoria requires coverage for sex trait modification, age and mental health/consent requirements
Medical record documentation required
See dosing and maximum units
Continuation Therapy
inv-18: Continuation Therapy
Continuation approval requirements
Duration of approval: 365 days
Provider Actions & Documentation
Prior authorization/notification required for J1072 (Azmiro)
Prior authorization/notification is required for HCPCS J1072 (testosterone cypionate, Azmiro). Documentation must include diagnosis, required laboratory results, symptom documentation, and other criteria per the policy.
- Submit prior authorization/notification for J1072 (testosterone cypionate, intramuscular injection).
- Include diagnosis, qualifying labs, symptom documentation, and any required additional clinical records.
Document trial and inadequate response to Depo-Testosterone (or intolerance/contraindication)
Policy requires a trial and documented inadequate response to testosterone cypionate (Depo-Testosterone) before approval, unless there is documented intolerance, FDA-labeled contraindication, or hypersensitivity to Depo-Testosterone.
- Document trial and inadequate response to Depo-Testosterone in the medical record.
- Alternatively, document intolerance, FDA contraindication, or hypersensitivity to Depo-Testosterone.
Baseline labs and symptom documentation required
Medical record must document either two pretreatment early morning total testosterone levels on subsequent days meeting qualifying low thresholds (total < lab LLN or <300 ng/dL) or a low free testosterone level, and presence of at least one symptom of hypogonadism.
- Two pretreatment early-morning testosterone measurements on subsequent days are required (total or free).
- At least one hypogonadism symptom must be documented at diagnosis (e.g., decreased libido, decreased spontaneous erections, loss of body hair).
Additional clinical documentation: self‑administration limitation and product trial records
Document inability to self-administer (physical or cognitive limitation) and lack of caregiver support when claiming exemption from the self-administration requirement; also document trials, failures, or intolerance to alternatives such as Depo-Testosterone when applicable.
- Record both inability to self-administer and absence of caregiver/support to qualify for clinician-administered product.
- Provide medical record evidence of trial/failure or intolerance/contraindication to Depo-Testosterone if relying on that criterion.
Age-related (late-onset) hypogonadism is excluded — risk of denial
Requests for treatment of age-related or late-onset hypogonadism are excluded and will not meet criteria; submitting such requests risks denial.
- Do not request therapy for age-related (late-onset) hypogonadism under this policy; such requests will not meet criteria.
- Continuation approvals explicitly require that the patient will NOT be treated for age-related or late-onset hypogonadism.
Coding
| J1072 | testosterone cypionate, intramuscular injection |
Step Therapy / Prior Treatment Requirements
| Step | Requirement | Documentation required |
|---|---|---|
| 1 | Trial of testosterone cypionate (Depo-Testosterone) with documented inadequate response required prior to approval of the requested product | Medical record documentation of trial and inadequate response to Depo-Testosterone |
| 1 | Alternatively, documented intolerance, FDA-labeled contraindication, or hypersensitivity to testosterone cypionate (Depo-Testosterone) may substitute for trial | Medical record documentation of intolerance, FDA contraindication, or hypersensitivity to Depo-Testosterone |
| — | If patient has physical or cognitive limitation and lacks caregiver support, self-administration requirement may be waived | Medical record documentation demonstrating inability to self-administer AND lack of caregiver/support |
Quantity Limits
Site of Care Medical Necessity
inv-03: Site of Care Medical Necessity
Site of Care conditions
If Site of Care criteria are not met, administration should occur in office or home (with or without supervision by a certified healthcare professional)
Site-of-care rules: inpatient restricted; outpatient hospital only with qualifying criteria
Injection/infusion administration may be given inpatient only if medical necessity criteria are met and the inpatient admission is not solely for administration; outpatient hospital administration is allowed only when medical necessity criteria are met and at least one specified condition applies — otherwise administration should occur in the office or home.
- Inpatient: Admission may not be solely for the purpose of administering the injection/infusion.
- Outpatient hospital: Allowed only if medical necessity criteria are met AND one qualifying condition applies (e.g., history of severe adverse event, increased risk for severe event, inability to adhere, new to therapy, re-initiation, formulation change).
- If Site of Care criteria are not met, administer in home or physician office.
Background
Azmiro (testosterone cypionate, intramuscular) is indicated for testosterone replacement in males with deficiency or absence of endogenous testosterone, including primary hypogonadism, hypogonadotropic hypogonadism, and selected use to stimulate puberty in carefully selected males with delayed puberty. It is also indicated for palliative treatment of metastatic mammary cancer in postmenopausal women. The labeling specifies that safety and efficacy have not been established for men with age-related (late-onset) hypogonadism and for pediatric patients below 12 years, and the policy’s clinical requirements and exclusions reflect those limitations.
Definitions
Revision History
Policy became effective and instituted multiple material changes: requirement for use of a self‑administered testosterone formulation unless documented inability, requirement for trial and inadequate response to Depo‑Testosterone (testosterone cypionate), exclusion of treatment for age‑related/late‑onset hypogonadism, and addition of maximum units and Site of Care medical necessity criteria.
Policy notification issued to stakeholders advising of upcoming policy effective date and changes on 2026-07-01.
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