Blue Cross NC Testosterone Cypionate Coverage Update

Coverage Criteria

Documentation Required

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).

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.

Initial Therapy

inv-17: Initial Therapy

Initial approval requirements

Diagnosis and lab confirmation: Established diagnosis of hypogonadism with androgen deficiency AND diagnostic confirmation by TWO pretreatment early morning testosterone levels on subsequent days (total < lab LLN or <300 ng/dL) or low free testosterone OR patient is currently on therapy with a total or free testosterone checked in the past year2 morning levels or recent labs

Medical record documentation required

Symptom requirement: Presence of at least ONE listed symptom of hypogonadism at time of diagnosis>=1 symptom

See policy symptom list

Special indications:

Continuation Therapy

inv-18: Continuation Therapy

Continuation approval requirements

Continuation nodes: Patient previously approved or would have met initial criteria; has demonstrated positive clinical response; has ongoing lab monitoring (total or free testosterone in past year); continued non-age-related indication; self-administration limitation and prior product trial/intolerance requirements apply

Duration of approval: 365 days

Provider Actions & Documentation

Prior Authorization

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.

Step Therapy

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.

Coding

Covered HCPCS CodesHCPCSCovered

J1072

testosterone cypionate, intramuscular injection

inv-07: Total serum testosterone threshold

Threshold valueTotal serum testosterone < 300 ng/dL or below the testing laboratory's lower limit of normal

Alternative lab criterionFree serum testosterone below the laboratory lower limit of normal (accepted alternative)

Specimen timingTwo pretreatment early morning testosterone levels drawn on subsequent days required for diagnostic confirmation

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

inv-20: testosterone cypionate (Azmiro) — maximum units allowed

Maximum units allowed10,400 units per duration of approval

Duration tied to limitMaximum units apply for the duration of approval (365 days)

HCPCS code referenceAssociated HCPCS code J1072 (testosterone cypionate, intramuscular injection)

Site of Care Medical Necessity

inv-03: Site of Care Medical Necessity

Site of Care conditions

Inpatient administration: Injection/infusion may be given in an inpatient setting if the medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection/infusion

Outpatient hospital administration: Injection/infusion may be given in an outpatient hospital setting if medical necessity criteria are met AND ONE of: history of severe adverse event to the medication; conditions that increase risk for severe adverse event (e.g., unstable renal, cardiopulmonary conditions, unstable vascular access); history of mild adverse events not managed with mild pre-medication; inability to physically/cognitively adhere to regimen; new to therapy (<3 months) or re-initiation per definitions; or requirement to change formulation

If Site of Care criteria are not met, administration should occur in office or home (with or without supervision by a certified healthcare professional)

Note

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

inv-15: Primary hypogonadism — definition and examples

DefinitionPrimary hypogonadism: testicular failure (congenital or acquired) causing deficiency or absence of endogenous testosterone

Common causes/examplesCryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy

Other causesKlinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals

inv-16: Hypogonadotropic hypogonadism — definition

DefinitionHypogonadotropic hypogonadism: congenital or acquired deficiency of gonadotropin production due to pituitary-hypothalamic injury or idiopathic causes

Etiologies notedIdiopathic gonadotropin deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation

Revision History

2026-07-01Policy effective dateLatest

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.

2026-04-02Notification

Policy notification issued to stakeholders advising of upcoming policy effective date and changes on 2026-07-01.

OpenPayer

Testosterone Cypionate (Azmiro) - Notification

Coverage Criteria

Initial Therapy

Continuation Therapy

Provider Actions & Documentation

Coding

Step Therapy / Prior Treatment Requirements

Quantity Limits

Site of Care Medical Necessity

Background

Definitions

Revision History