Benefit-dependent requirements

Application of criteria depends on the member’s benefit coverage at the time of the request; Medicare and Medicaid specifications are detailed in the ‘Applicable State and Federal Regulations’ section and take precedence when conflicts exist.

• Verify member benefit coverage and any applicable government (LCD/NCD/state Medicaid) rules before ordering or submitting claims.

Prior authorization requirement — tests that do not meet criteria

Measurement of serum total, free, or bioavailable testosterone for asymptomatic individuals or those with non‑specific symptoms, and use of saliva for testosterone measurement, DO NOT MEET CRITERIA and are subject to denial if submitted without appropriate justification.

• Do not order or authorize testosterone testing for asymptomatic or non‑specific symptom presentations without documented indication.
• Saliva-based testosterone testing is not acceptable and will be denied.

Criteria for initiating testosterone therapy (support for prior auth)

Prior authorization to initiate testosterone therapy should be supported by documentation of symptoms or signs consistent with testosterone deficiency, two separate morning total testosterone measurements on different days demonstrating low levels, evaluation for reversible causes, baseline hematocrit (and PSA when age‑appropriate), and a documented follow‑up plan (reassessment at 3 and 6 months).

• Document two morning total testosterone measurements taken on separate days (early morning, fasting).
• Measure LH/FSH (and prolactin or ferritin/iron saturation when indicated) to classify primary vs secondary hypogonadism and assess reversibility.
• Document baseline hematocrit and PSA (age‑appropriate) and planned monitoring at 3 and 6 months after therapy initiation.

Procedure codes potentially subject to authorization

The policy lists CPT/HCPCS codes relevant to testosterone and related hormone testing; verify payer-specific prior authorization requirements for these procedure codes before ordering.

• 82040, 82642, 82670, 82681, 84270, 84402, 84403, 84410 — confirm payer authorization rules for these codes.

Prior authorization not specified in this section

This section of the policy contains references and does not specify additional prior authorization processes beyond the coverage criteria and government precedence noted elsewhere.

• When in doubt, refer to the member’s benefit documents and the ‘Applicable State and Federal Regulations’ section for authorization rules.

Preferred approach before specialized testing

When free testosterone assessment is needed, use validated calculated estimates derived from total testosterone, SHBG, and albumin (per Endocrine Society/EAA guidance) rather than direct immunoassays; equilibrium dialysis or calculated methods are preferred where indicated.

• Reserve direct free/bioavailable testosterone assays only when equilibrium dialysis or validated calculation methods are not available.
• Use published algorithms (e.g., Vermeulen or equivalent) based on TT, SHBG, and albumin to estimate free testosterone.

Assess reversible or secondary causes before therapy

Assess and document reversible or secondary causes of hypogonadism (e.g., medications, obesity, systemic illness) and consider non‑pharmacologic interventions (such as weight loss) for functional hypogonadism before or alongside testosterone therapy.

• Investigate secondary causes with LH/FSH, prolactin, and iron studies as appropriate; consider pituitary imaging when indicated.
• Document consideration of reversible factors and any trials of interventions for functional hypogonadism prior to initiating therapy.

Tiered testing approach — total testosterone first

Perform a tiered testing approach: measure morning total testosterone first and reserve free or bioavailable testosterone testing (measured or calculated) for equivocal or borderline total testosterone results or when SHBG‑altering conditions are present.

• Initial TT sample should be collected in the early morning (07:00–11:00) after fasting when feasible.
• If TT is borderline or SHBG‑altering conditions exist, document calculation or measurement of free/bioavailable testosterone using validated methods.

Claims documentation and coding — billing and claims requirements

Submit accurate clinical documentation and code claims appropriately according to industry coding guidelines; failure to follow coding/billing rules may result in denial or recoupment.

• Include clinical indication and relevant laboratory/diagnostic findings in the chart and on the claim.
• Ensure CPT/HCPCS and ICD‑10 codes match the documented services and member diagnosis.

Assay documentation — report method and CDC standardization

Document the assay method and, when available, CDC HoSt/Testosterone certification or evidence the assay is traceable/standardized to CDC reference material to support analytic validity.

• Record the laboratory assay method (e.g., ID‑LC‑MS/MS) and, if available, CDC HoSt certification status.
• Include assay reportable range and limits of detection when relevant to interpretation.

Specimen timing and assay documentation — confirmatory measurements required

Document two fasting early‑morning total testosterone measurements on separate days; if total testosterone is equivocal or the patient has SHBG‑altering conditions, document free testosterone assessment using validated calculation or equilibrium dialysis.

• Ensure morning samples (preferably between 07:00–11:00 or within 3 hours after waking for shift workers) and fasting status are recorded.
• If TT is equivocal, document calculated free testosterone (TT, SHBG, albumin) or equilibrium dialysis results.

Document symptoms, signs, and adjunct labs for diagnosis

Document symptoms and/or signs that correlate with low testosterone, plus LH/FSH to differentiate primary vs secondary hypogonadism, and baseline hematocrit and PSA when appropriate prior to initiating therapy.

• Record specific symptoms/signs of androgen deficiency in the medical record.
• Include LH/FSH and, when indicated, prolactin and reproductive evaluation results to support diagnosis and treatment decisions.

Denial triggers — common reasons for denial

Tests will be denied when ordered for asymptomatic or non‑specific symptoms, when using saliva specimens for testosterone measurement, or when measuring serum DHT in situations not explicitly covered by the policy.

• Do not submit claims for saliva‑based testosterone testing; these do not meet criteria.
• Avoid ordering DHT unless the clinical scenario is one of the specific indications listed (e.g., ambiguous genitalia, hypospadias, microphallus).