CurrentAvMedPolicy Pub. 100-2

Testosterone Replacement Therapy (TRT) Injectables prior authorization

Medical prior-authorization and step-edit request form and clinical criteria for coverage of injectable testosterone therapies (Aveed, Azmiro, Testopel) for AvMed members; applicable to prescribing providers submitting requests.

Policy Summary

PayerAvMed

PolicyTestosterone Replacement Therapy (TRT) Injectables prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete and sign the prior authorization form and attach two morning testosterone lab results, supporting chart notes, and prior therapy documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsLength of authorization

300 ng/dLTestosterone threshold

750 mgAveed max dose

50–400 mgAzmiro dosing

6 pelletsTestopel supply

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Coverage Criteria for Injectable Testosterone Therapies

Initial coverage criteria

Covered when ALL of the following are met:

ALL of the following

Member must meet ONE of the following:
- Partial Androgen Insensitivity Syndrome with male gender identity/gender dysphoria or delayed male puberty
- Hypogonadism confirmed by BOTH of the following
  - TWO morning testosterone levels: TWO (2) MORNING (6AM to 11AM) testosterone levels obtained on different dates that are below 300 ng/dL or below the lower limit of normal for the reference range (attach lab results with reference ranges from the laboratory for both)2 measurements <300 ng/dL or below lab reference range
    Attach both lab results with laboratory reference ranges.
  - Symptom requirements
    At least one specific symptom (documented)>=1 specific symptom
    Non-Specific Symptoms (select at least two): At least two non-specific symptoms from the listed items (e.g., incomplete or delayed sexual development; reduced sexual desire (libido); decreased spontaneous erections; breast discomfort/gynecomastia; loss of body hair; small or shrinking testes; low/zero sperm count; height loss/low bone density/low trauma fracture; hot flushes/sweats; decreased energy, motivation; depressed mood; poor concentration; sleep disturbances; mild anemia (Hgb 10-11 g/dL); reduced muscle bulk/strength; increased body fat/BMI; diminished physical/work performance)>=2 non-specific symptoms
    See policy symptom list for full items.
Step therapy/previous therapy: Documentation of inadequate response, contraindication, or intolerance to both a topical agent (≥3 months) and a preferred intramuscular testosterone (≥3 months) verified by pharmacy paid claims or chart notes.
Document date/name of drug; verification via pharmacy paid claims or chart notes.

Eligibility root - operational: All clinical criteria and documentation requirements must be met and provided (labs, diagnostics, chart notes). Authorization may be delayed or denied if documentation is incomplete.

Prescribing physician must sign and print name on the request; include supporting documentation.

Testosterone therapies are subject to specific coverage exclusions. For the hypogonadism indication, testosterone drugs cannot be used in conjunction with other erectile dysfunction drugs. Additionally, testosterone replacement is excluded from coverage for sexual dysfunction when documentation shows “decreased spontaneous erections” as the only symptom (see symptom documentation requirements).

If the request documents only “decreased spontaneous erections” as the sole symptom, the request will be denied. The policy requires documentation of at least one specific symptom plus at least two non‑specific symptoms (or other qualifying diagnostic criteria); a single non‑specific symptom alone does not meet medical necessity for testosterone replacement.

Covered and Requestable Codes; Laboratory Thresholds

Covered/Requestable codesmixedCovered

J3145	Aveed (testosterone undecanoate) IM injection
J1072	Azmiro (testosterone cypionate) IM injection
J1073	Testopel (testosterone pellets)
11980	CPT code for subcutaneous hormone pellet implantation
S0189	HCPCS code for testosterone pellet, 75 mg

Morning testosterone level threshold (diagnostic criteria)

Morning testosterone diagnostic thresholdTWO (2) morning (6AM–11AM) testosterone levels obtained on different dates that are below 300 ng/dL or below the lower limit of normal for the laboratory reference range (attach lab results with reference ranges)

Timing for measurementsMorning draws between 6AM and 11AM on different dates

Documentation requiredAttach laboratory results with the laboratory reference ranges for both measurements

Provider Requirements and Prior Authorization Process

Prior Authorization

Prior Authorization Required — Submission and Completeness Risk

Prior authorization is required for physician‑administered testosterone replacement therapy (TRT) injectables listed as non‑preferred. Authorization may be delayed or denied if the request form or supporting documentation is incomplete, incorrect, illegible, or missing required elements (including physician signature and completed clinical documentation). For urgent reviews, call AvMed Pre‑Authorization if a standard review would seriously jeopardize the member's life, health, or ability to regain maximum function.

Fax completed form to 1-877-535-1391.
Prescribing physician must sign and clearly print name on the request form; preprinted stamps are not valid.
If information provided is not complete, correct, or legible, authorization can be delayed.

Step Therapy

Step Therapy Requirements

Step therapy must be documented prior to approval. Provide evidence of inadequate response, intolerance, or contraindication to both topical and preferred intramuscular testosterone agents, verified by pharmacy paid claims or chart notes.

Member must have had an inadequate response, contraindication, or intolerance to at least a 3‑month trial of a topical testosterone agent (e.g., testosterone gel, patch, topical solution, nasal gel). Document drug name and dates.
AND member must have had an inadequate response, contraindication, or intolerance to at least a 3‑month trial of a preferred intramuscular testosterone medication (e.g., testosterone cypionate, testosterone enanthate, testosterone undecanoate). Document drug name and dates.
Use of samples to initiate therapy does not meet step edit/prior authorization criteria.

Documentation Required

Documentation Requirements — Labs, Symptoms, and Prescriber Signature

Clinical documentation requirements must be attached or request may be denied. Attach laboratory reports with reference ranges and include two separate morning testosterone levels, recorded on different dates, below 300 ng/dL or below the laboratory reference range. Include chart notes documenting symptoms and prior therapy trials.

Attach TWO (2) morning (6AM–11AM) testosterone levels obtained on different dates with laboratory reference ranges for both.
Include documentation of at least one specific symptom and at least two non‑specific symptoms; if decreased spontaneous erections is the only symptom documented, the request will be denied for sexual dysfunction.
Include dates and names of prior therapies used to meet step therapy requirements and verification of pharmacy paid claims where applicable.
Length of authorization: 12 months.

Denial Risk

Incomplete Submission — Risk of Delay or Denial

Prescribers: incomplete or missing information (including missing physician signature, missing lab reports, missing step‑therapy verification, or illegible entries) increases the risk the request will be delayed or denied. Ensure all required fields are completed and supporting records are attached before submission.

Prescribing physician must sign and clearly print name (preprinted stamps not valid).
If information provided is not complete, correct, or legible, authorization can be delayed.
Fax to 1-877-535-1391; phone calls are unnecessary if form and contact information are correct.

Initial Therapy Dosing and Supply Criteria

Initial therapy dosing and supply

Agent-specific dosing and supply: Agent-specific maximum dosing and supply: Aveed — 3 mL (750 mg) IM initial, then 3 mL (750 mg) at 4 weeks, then 3 mL (750 mg) every 10 weeks; Azmiro — 50–400 mg IM every 2–4 weeks; Testopel — 75 mg implantable pellet, 6 pellets per 90-day supply (6 billable units every 90 days). CPT/HCPCS codes for pellets: 11980 (implantation) and S0189 (testosterone pellet, 75 mg).

Step Therapy Trials and Verification

Step	Requirement	Verification
1	Trial of a topical testosterone agent for at least 3 months (e.g., testosterone gel, patch, topical solution, nasal gel)	Document date and drug name; prior therapy verified by pharmacy paid claims or submitted chart notes
2	Trial of a preferred intramuscular testosterone for at least 3 months (e.g., testosterone cypionate, enanthate, or undecanoate)	Document date and drug name; verification by pharmacy paid claims or submitted chart notes
3	Exception allowed if inadequate response, contraindication, or intolerance to the above trials	Provider must indicate inadequate response, contraindication, or intolerance and supply supporting documentation (chart notes or claims)

Quantity Limits and Product-Specific Supplies

Testopel (testosterone pellets) supply/units

Testopel supply per period6 pellets per 90-day supply (6 billable units every 90 days)

Pellet strength and codeTestopel — 75 mg implantable pellet; HCPCS S0189 corresponds to 75 mg pellet

Procedure code for implantationCPT 11980 — subcutaneous hormone pellet implantation

Site of Care and Dispensing Rules

Billing Rule

Site-of-care: physician's office purchasing; physician office or specialty pharmacy may dispense

Aveed, Azmiro, and Testopel injectables must be purchased by the physician's office when indicated; medication may be provided by either the physician's office or a specialty pharmacy as indicated on the form.

Form includes checkboxes to indicate medication provided by Physician's office or Specialty Pharmacy
Aveed is labeled 'MUST be purchased by Physician's Office' on the form

Policy Background

This policy defines clinical and documentation criteria for medically necessary use of injectable testosterone formulations for hypogonadism and related androgen‑insensitivity conditions. Coverage requires biochemical confirmation with TWO morning (6AM–11AM) testosterone measurements below <300 ng/dL or below the laboratory reference range (attach lab results with reference ranges) and documented clinical symptoms consistent with low testosterone. Prior therapy requirements apply: providers must document inadequate response, contraindication, or intolerance to at least a three‑month trial of a topical agent and a three‑month trial of a preferred intramuscular testosterone unless contraindicated. Prescribing clinicians must complete and sign the prior‑authorization form and include supporting chart notes, lab reports, and prior‑therapy verification; authorizations are issued for 12 months when criteria are met.

Definitions

Confirmed hypogonadism definition

Definition of confirmed hypogonadismHypogonadism confirmed by TWO morning (6AM–11AM) testosterone levels obtained on different dates that are below 300 ng/dL or below the lower limit of normal for the laboratory reference range

Number of required measurementsTwo separate morning measurements on different dates

Laboratory reference requirementAttach lab results showing each value and the laboratory's reference ranges