Document Clinical Indication

Coverage for testosterone and related testing is contingent upon documentation of a clinical indication consistent with this policy and the member's benefits. Providers must document the patient’s symptoms, signs, and the clinical rationale for testing (for example: symptoms of androgen deficiency or excess, monitoring of testosterone therapy, evaluation of gynecomastia, suspected disorders affecting SHBG, ambiguous genitalia, or gender-affirming care). Requests for testing without an appropriate documented clinical indication may be denied.

• Document patient symptoms/signs and clinical rationale when ordering any testosterone-related test
• Verify member benefits and any applicable Medicare/Medicaid rules before ordering

Procedure Codes

Use these procedure codes as references when ordering or billing for testosterone and related assays. Confirm payer-specific billing guidance prior to claim submission.

• CPT 84403 — Testosterone; total
• CPT 84402 — Testosterone; free
• CPT 84410 — Testosterone; bioavailable, direct measurement (eg, differential precipitation)
• CPT 82642 — Dihydrotestosterone (DHT)
• CPT 82670 — Estradiol; total
• CPT 82681 — Estradiol; free, direct measurement (eg, equilibrium dialysis)
• CPT 84270 — Sex hormone binding globulin (SHBG)
• CPT 82040 — Albumin; serum, plasma or whole blood

Prior Authorization

No changes were made to prior authorization requirements after review. Follow existing payer prior authorization processes where applicable for services that require it.

• Check the member’s benefit plan for prior authorization requirements before ordering

Step Order Requirement

Total serum testosterone should be measured first. Measurement of free or bioavailable testosterone as the primary/initial diagnostic test (without a prior total testosterone) does not meet coverage criteria.

• Obtain morning, fasting total testosterone before ordering free or bioavailable testosterone
• Exceptions: follow policy-specified indications where calculated or measured free/bioavailable testing is appropriate (e.g., conditions altering SHBG or borderline total T)

Baseline & Monitoring

Baseline assessment and ongoing monitoring are required for covered testosterone therapies and diagnostic evaluations. Establish baseline total testosterone and hematocrit prior to initiating therapy. For men >40 years, obtain baseline PSA. Consider reproductive evaluation for men desiring fertility prior to treatment.

• Baseline: total testosterone and hematocrit; PSA in men >40; reproductive evaluation when fertility is a consideration
• On-therapy monitoring: assess TT and hematocrit at 3 and 6 months after initiation or dose change, then annually if stable

Monitoring Intervals

After starting testosterone therapy, monitor response and safety at specified intervals. Assess clinical response and adverse effects at approximately 3 and 6 months after therapy initiation and check serum testosterone levels and hematocrit at those times as coverage conditions.

• Assess clinical response and adverse effects at 3 and 6 months
• Measure serum testosterone and hematocrit at 3 and 6 months; then annually if stable

Guideline References

Clinical guidelines inform evaluation and monitoring approaches but do not by themselves create additional step therapy or coverage requirements beyond this policy. Use guideline recommendations (AUA, EAA, ES, EAU, CUA/CSAM, NCCN, ASRM, ACOG) to support clinical decision-making and documentation.

• Guidelines are referenced for best practices; they do not override explicit coverage criteria in this policy

Documentation & Specimen Collection

When ordering free or bioavailable testosterone tests, providers must document prior total testosterone results (when applicable), the clinical indication for additional testing, and specimen collection details (morning collection, fasting status, and collection time). Include prior test dates and values in the request.

• Document prior total testosterone result and date when ordering free/bioavailable testing
• Record specimen collection time (morning, fasting) and method on the requisition

Diagnostic Lab Documentation

Diagnostic laboratory documentation required to establish testosterone deficiency includes two separate morning total testosterone measurements and additional hormone testing when indicated to characterize the cause.

• Two morning (fasting) total testosterone measurements on separate days are required to support a diagnosis of low testosterone
• Measure LH and FSH to differentiate primary vs secondary hypogonadism; consider prolactin, ferritin or iron studies when secondary causes are suspected

Confirmatory Testing

Confirmatory testing requires fasting morning total testosterone measurements on two separate days (preferably before 11:00 AM). This confirms functional hypogonadism and is necessary before initiating testosterone therapy except in clearly defined clinical exceptions.

• Two fasting, early-morning total testosterone tests on different days (preferably before 11:00 AM)
• If initial test is normal but symptoms persist, repeat testing may be performed no sooner than 60 days after the initial screen

Reference Guidelines

Providers should cite and reference current clinical guidelines (AUA, EAA, Endocrine Society, EAU, CUA/CSAM, NCCN, ASRM, ACOG) when documenting indications, diagnostic evaluation, and monitoring plans to support medical necessity and coverage determinations.

• Include guideline references in clinical documentation when applicable to support testing or monitoring decisions

Denial Triggers

Requests for free or bioavailable testosterone as the initial diagnostic test without a prior total testosterone, testing in asymptomatic individuals, use of saliva specimens, or routine testosterone testing in women for androgen deficiency are denial triggers under this policy. Also, testing that lacks appropriate supporting clinical documentation may be denied.

• Denial triggers include: free/bioavailable T as primary test without prior total T; testing asymptomatic or non-specific symptom individuals; saliva-based testosterone measurements; routine testosterone for identifying androgen deficiency in women
• Ensure clinical documentation and prior test results are submitted to avoid denials

Assay Limitations

Direct analog-based free testosterone immunoassays and some commercial kits are discouraged due to inaccuracy. Use CDC-certified total testosterone assays, calculated free testosterone using accepted algorithms (total T, SHBG, albumin), or equilibrium dialysis methods where available. Using invalid assays may lead to incorrect clinical management and claim denial.

• Do not use direct analog-based free testosterone immunoassays for clinical decision-making
• Prefer CDC HoSt-certified assays for total testosterone and validated methods for free or bioavailable calculations

Government Policy Override

If this policy conflicts with an applicable state or federal government policy (e.g., Medicare LCD/NCD or state Medicaid rules), the government policy governs the coverage determination. Verify and follow relevant government coverage rules for the member at the time of request.

• Government coverage determinations (LCD/NCD/state Medicaid) take precedence over this policy when applicable
• Check CMS and state Medicaid resources for the most current guidance

Literature Review Conclusion

A literature review completed during the recent policy update did not necessitate changes to the coverage criteria. Existing coverage rules remain in effect; continue to follow the policy’s documentation, testing sequence, and monitoring requirements.

• Recent review (12/03/2025) concluded no modifications to coverage criteria were needed