Testosterone coverage criteria (serum and related testing)
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Governs coverage criteria for serum and related testosterone testing (total, free, bioavailable, DHT, estradiol, SHBG) and indications/limitations for individuals being evaluated or monitored for androgen-related conditions; affects providers submitting claims/authorization requests to Avalon Healthcare Solutions.
No material clinical or coverage changes in this revision.
Coverage Criteria for Testosterone and Related Tests
inv-01: Meets coverage criteria — Total testosterone and related indications
Covered when ANY of the following are met:
II.1
inv-02: Meets coverage criteria — Secondary testing in males with low/borderline TT
Covered when ALL of the following are met:
II.2
inv-03: Meets coverage criteria — Algorithm-based FT estimation for SHBG disorder suspicion
Covered when ANY of the following are met:
II.3
inv-04: Meets coverage criteria — Specific single-instance tests
Covered when the following specific single-measure conditions are met:
II.4–II.5
inv-05: Does not meet coverage criteria — Not covered in these situations:
Not covered in these situations:
II.6–II.10
The policy excludes the use of saliva for testosterone measurement. Salivary testosterone testing "DOES NOT MEET COVERAGE CRITERIA" because published scientific literature does not support its routine clinical use for diagnosis or management in the covered indications.
Routine measurement of serum estradiol is not recommended. The European Academy of Andrology specifically states, "We do not recommend routine measurement of serum estradiol," reserving estradiol testing for rare cases or when a validated mass spectrometry–based method is available.
The European Association of Urology recommends screening for late-onset hypogonadism only in symptomatic men. The EAU also advises against using structured interviews or self-reported questionnaires for systematic population screening because these tools have low specificity and may lead to inappropriate testing or diagnoses.
Measurement of serum dihydrotestosterone (DHT) is limited to the specific diagnostic contexts enumerated in the coverage criteria (for example, diagnosis of 5‑alpha reductase deficiency in individuals with ambiguous genitalia, hypospadias, or microphallus). For all other situations not explicitly listed, measurement of serum DHT "DOES NOT MEET COVERAGE CRITERIA."
Per this policy, measurement of serum testosterone for the purpose of identifying androgen deficiency in women is not medically necessary and "DOES NOT MEET COVERAGE CRITERIA." The revision history and coverage statements clarify that testosterone testing for diagnosing androgen deficiency in women is excluded from coverage.
Direct analog-based immunoassays for free testosterone are discouraged due to demonstrated inaccuracy and poor reliability. Guideline statements and the EAA advise that commercially available direct free testosterone kits "should not be used" and recommend calculated estimates (using total testosterone, SHBG, and albumin) or reference methods (e.g., equilibrium dialysis) when free testosterone assessment is required.
The document notes that many laboratories perform laboratory-developed tests (LDTs), which are regulated as high-complexity tests under CLIA but are not FDA-approved or cleared. The excerpt describes LDTs’ regulatory status rather than listing explicit "not medically necessary" conditions tied to LDT use.
Testing for serum testosterone to identify androgen deficiency in women is explicitly stated as not meeting coverage criteria in this policy. The revision history (05/23/2022) documents the addition of a coverage code clarifying that serum testosterone testing "DOES NOT MEET COVERAGE CRITERIA" for identifying androgen deficiency in women.
inv-06: Initial diagnostic criteria — Covered when ALL of the following are met (per cited guideline recommendations):
Covered when ALL of the following are met (per cited guideline recommendations):
AUA/EAA/EAU recommendations
AUA/ES guidance
Endocrine Society, EAA, CUA/CSAM recommendations
inv-08: Population-specific guidance — Special-population considerations (informational for coverage decisions):
Monitoring and continuation coverage criteria:
Document baseline values for monitoring
CUA/CSAM, ES recommendations
inv-09: Guideline-based testing and monitoring
Covered testing and follow-up when clinically indicated according to referenced guidelines:
CUA/CSAM and EAU recommendations
EAU guidance
IGHG/PCSF and CUA/CSAM recommendations
CUA/CSAM recommendations
EAU recommendation
Billing and Coding
| 82040 | Albumin; serum, plasma or whole blood. |
| 82642 | Dihydrotestosterone (DHT). |
| 82670 | Estradiol; total. |
| 82681 | Estradiol; free, direct measurement (eg, equilibrium dialysis). |
| 84270 | Sex hormone binding globulin (SHBG). |
| 84402 | Testosterone; free. |
| 84403 | Testosterone; total. |
| 84410 | Testosterone; bioavailable, direct measurement (eg, differential precipitation). |
| 83001 | Code removed (per revision history) |
| 83002 | Code removed (per revision history) |
| 83003 | Code removed (per revision history) |
| 84146 | Code removed (per revision history) |
| 84443 | Code removed (per revision history) |
| 82024 | Code removed (per revision history) |
| G2163 | Hormonal Testing in Adult Females — removed/archived (per revision history) |
Provider Documentation, Ordering, and Authorization Actions
Document and cite specific indication for testing
Coverage for serum testosterone testing is limited to specific, documented clinical indications such as symptomatic androgen deficiency or excess in males (initial screening with two measurements at least 24 hours apart), monitoring treatment response in men on enzyme inhibitors for prostate cancer, men receiving testosterone replacement therapy (every 2–3 months during the first year or after dosage change, then annually), gender‑dysphoric/gender‑incongruent persons (baseline and during treatment), and symptomatic females being evaluated for androgen excess (e.g., PCOS).
- Initial screening for symptomatic males: two measurements at least 24 hours apart; if initial normal but symptoms persist, repeat no sooner than 60 days.
- Monitoring indications include prostate cancer enzyme inhibitor therapy and routine monitoring of testosterone replacement therapy per schedule above.
- Gender‑affirming care and evaluation of symptomatic females for androgen excess are covered indications.
Confirm low total testosterone with two morning measurements
Before initiating testosterone therapy, confirm low total testosterone with two early‑morning measurements on separate occasions and obtain LH/FSH (and other workup as indicated) to establish etiology prior to treatment.
- AUA: two early‑morning total testosterone measurements on separate occasions before diagnosing low testosterone or offering therapy.
- Measure serum luteinizing hormone and follicle‑stimulating hormone to distinguish primary versus secondary hypogonadism.
Reference CPT/HCPCS codes for hormone assays
Use the listed CPT/HCPCS procedure codes as references when requesting authorization or submitting claims for testosterone‑related laboratory testing; inclusion on this list does not guarantee payment.
Verify removed or archived procedure codes before billing
Revision history documents removal/archival of specified codes; providers must verify current billable codes and any impacts on prior authorization or claims before submission.
- Revision notes list removed codes and archival of G2163; confirm up‑to‑date code sets with payer guidance.
Obtain TT first and use validated algorithms to estimate free T
Obtain total testosterone first—using two early‑morning measurements for initial screening—and, when SHBG or albumin effects are suspected, use validated calculation algorithms (based on TT, SHBG, and/or albumin) to estimate free testosterone rather than ordering direct free testosterone assays as first‑line.
- Equilibrium dialysis is gold standard but limited; Endocrine Society recommends algorithmic estimation using TT, SHBG, and/or albumin.
- Direct free/bioavailable immunoassays are inaccurate and should not be used as primary tests.
Assess response at 3 and 6 months, then annually if stable
For continued coverage of testosterone therapy, assess clinical response and adverse effects at approximately 3 and 6 months after therapy initiation, then annually if stable; document clinical response and specified laboratory monitoring including hematocrit (and PSA when indicated).
- CUA/CSAM: assess response and adverse effects at 3 and 6 months; measure testosterone and hematocrit at these intervals and annually if stable.
- Document therapy dates, clinical response, and laboratory values in the medical record.
No step therapy required
No step therapy requirements are specified in this policy section.
Document morning fasting specimen timing and assay certification
Document specimen timing (early‑morning collection, after fasting) for total testosterone tests and, when available, use and note a CDC HoSt‑certified assay on the record.
- Note 1: 'Serum total testosterone sample collection should occur in the early morning, after fasting.'
- CDC HoSt certification is strongly recommended; certified assays are traceable to the CDC reference standard (±6.4%).
Document required lab values: two morning T tests, LH/FSH, and adjuncts
Include the required laboratory documentation when submitting requests: two separate morning total testosterone values (when indicated), LH/FSH to differentiate primary vs secondary hypogonadism, and other tests as specified (SHBG, prolactin, albumin, hemoglobin/hematocrit).
- Document dates and results of the two early‑morning total testosterone measurements.
- Include LH and FSH measurements; add prolactin, SHBG, albumin, and hematocrit as clinically indicated.
Use listed lab procedure codes as reference and document indications
The policy provides CPT/HCPCS laboratory procedure codes for reference only; these codes do not guarantee payment—providers should document the specific tests performed and the clinical indication when submitting claims.
- Codes listed are illustrative and subject to updates; verify payment policies with the payer.
Record early‑morning, fasting specimen collection
Collect serum total testosterone samples in the early morning after fasting; this timing requirement is reiterated in policy notes and should be recorded when ordering and submitting tests.
- Note 1 explicitly states: 'Serum total testosterone sample collection should occur in the early morning, after fasting.'
Do not order free/bioavailable T as primary test
Ordering serum free and/or bioavailable testosterone as the primary test—without prior total testosterone measurement—does not meet coverage criteria and may result in denial.
- Policy: 'Measurement of serum free testosterone and/or bioavailable testosterone as a primary test ... DOES NOT MEET COVERAGE CRITERIA.'
Avoid testing asymptomatic or nonspecific‑symptom individuals
Testing (total, free, bioavailable testosterone) ordered for asymptomatic individuals or those with non‑specific symptoms does not meet coverage criteria and may be denied.
- Policy: 'For asymptomatic individuals or for individuals with non‑specific symptoms, measurement ... DOES NOT MEET COVERAGE CRITERIA.'
Risk of denial if two morning TT measurements are not obtained
Failure to obtain two separate early‑morning total testosterone measurements before diagnosing low testosterone or initiating therapy may risk non‑coverage or denial due to not meeting guideline‑based diagnostic criteria.
- AUA and other societies require two early‑morning measurements on separate occasions before diagnosis and therapy.
Measure baseline PSA in men per guideline ages and monitor
Obtain and document baseline PSA in men as recommended by guidelines (AUA: prior to therapy in men over 40; Endocrine Society: prior to therapy in men over 50) and monitor per guideline thresholds—failure to do so may prompt clinical review or coverage concern.
- Endocrine Society recommends PSA measurement in hypogonadal men >50 at 3 and 12 months after starting therapy and urologic referral if PSA rises >1.4 ng/mL above baseline or exceeds 4 ng/mL.
- AUA: measure PSA in men over 40 prior to commencement of testosterone therapy.
Follow government (LCD/NCD) policy when conflicts exist
When this policy conflicts with applicable government coverage policies (LCDs/NCDs), the government policy takes precedence; ensure alignment with those policies to avoid denials.
- Policy disclaimer: government coverage determinations supersede this policy in case of conflict.
Code removals noted in revision history
The revision history documents removal of several laboratory codes (83001, 83002, 83003, 84146, 84443, 82024) and archival of G2163; billing with removed codes may affect authorization and claims.
- Revision history entry lists removed codes and archived G2163; confirm current coding before claim submission.
Background and Scope
Testosterone is an androgen produced in both males and females that contributes to sexual development, libido, musculoskeletal health, and metabolic function. Disorders of testosterone production or action can present as hypogonadism (low testosterone with relevant signs/symptoms) or as androgen excess states. Clinical diagnosis relies on correlation of symptoms with biochemical testing—primarily serum total testosterone measured on morning samples—and may require adjunct hormones (LH, FSH, prolactin, SHBG) and appropriate assay selection because analytic variability affects interpretation.
Definitions and Test Methodology
Policy Revision History
Committee and ODM approvals recorded for updated background, guidelines, and evidence-based references (Committee approved 10/07/2025; ODM approved 10/23/2025).
Committee approved updates to background, guidelines, and evidence-based references (Committee approved 02/06/2025; ODM approved 03/06/2025).
Committee approved updates to background, guidelines, and evidence-based references (Committee approved 02/12/2024; ODM approved 02/29/2024).
Removed several CPT codes and archived G2163; clarified policy title and coverage criteria formatting, moved technical notes into Note 1 and Note 4, and recorded Committee and ODM approvals (Committee approved 09/18/2023; ODM approved 09/07/2023).
Updated background, guidelines, recommendations, and evidence-based references; added and renumbered coverage criteria including additions for symptomatic females and exclusions for testosterone testing in women (CC13/CC19) and other structural changes.
Policy initial effective date established (Initial Effective Date).
Initial Effective Date for the policy.
Updated background, guidelines, recommendations, and evidence-based references; added coverage criteria for symptomatic females and other renumbering and content edits.
Removed CPT codes 83001, 83002, 83003, 84146, 84443, 82024 and archived G2163; policy title and notes clarified; Committee and ODM approvals recorded.
Reviewed and updated background, guidelines, and references; literature review did not change coverage criteria; Committee approved 02/12/2024 and ODM approved 02/29/2024.
Reviewed and updated background, guidelines, and references; literature review did not change coverage criteria; Committee approved 02/06/2025 and ODM approved 03/06/2025.
Final recorded approvals for implementation (Committee approved 10/07/2025; ODM approved 10/23/2025) and implementation noted (OH MyCare FIDE).
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