ModifiedPremera BluecrossPolicy G2013

Testosterone and related laboratory testing

Defines when serum measurements of total, free, bioavailable testosterone and related hormones (SHBG, estradiol, dihydrotestosterone, albumin) are considered reimbursable and when certain tests (e.g., salivary testosterone, DHT in unspecified situations) are not reimbursable. Applies to Premera Blue Cross claims and providers ordering/testing for members.

Policy Summary

PayerPremera Bluecross

PolicyTestosterone and related laboratory testing

Policy CodePolicy G2013

Change TypeNew policy added

Effective DateFeb 6, 2026

Next Review Date

Key ActionObtain and document two separate early-morning total testosterone measurements when diagnosing testosterone deficiency.

SourceLink

POLICY UPDATE CHANGES

Measurement of serum total testosterone may be considered reimbursable for indications outlined in this policy when criteria are met.

multiplereimbursable indications listed

9codes listed

early morningrecommended sample time

2 measurementsconfirm low TT

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Feb 6, 2026effective date

Coverage Criteria for Testosterone and Related Tests

Covered indications

Measurement of serum total testosterone is reimbursable when any of the following situations apply:

Reimbursable indications for serum total testosterone: Includes: symptoms of androgen deficiency or androgen excess in individuals assigned male at birth (initial screening requires two measurements at least 24 hours apart; if initial screening normal but symptoms persist, repeat testing no sooner than 60 days after the initial screening); monitoring treatment response in individuals taking enzyme inhibitors for prostate cancer; individuals assigned male at birth receiving testosterone replacement therapy (every 2–3 months for the first year after initiation or after dose change; annually thereafter); baseline and monitoring for gender-dysphoric/gender-incongruent individuals; symptomatic individuals assigned female at birth being evaluated for androgen excess (e.g., PCOS, functional hypothalamic amenorrhea)

See chunks 3 and 4 for details.

Free/bioavailable testosterone and SHBG testing: For males with total testosterone confirmed low or borderline and who have hypogonadism, gynecomastia, or other forms of testicular hypofunction, annual measurement of serum free testosterone, SHBG, and/or albumin is reimbursable.annual

chunk 3

Testing when SHBG suspected abnormal: If a disorder that alters SHBG is suspected, measurement of free testosterone using an accepted algorithm based on total testosterone, SHBG, and/or albumin or measurement of bioavailable testosterone is reimbursable.

chunks 3 and 28

Pre-therapy estradiol: Prior to initiating testosterone therapy for individuals assigned male at birth with gynecomastia, one lifetime serum estradiol measurement is reimbursable.once per lifetime

chunk 3

DHT for congenital diagnosis: For individuals with ambiguous genitalia, hypospadias, or microphallus, measurement of serum dihydrotestosterone for diagnosis of 5-alpha reductase deficiency is reimbursable.

chunk 3

Primary testing flexibility: Measurement of serum free testosterone and/or bioavailable testosterone as a primary test (without prior total testosterone) is considered reimbursable.

chunk 4

Asymptomatic or non-specific symptoms: For asymptomatic individuals or those with non-specific symptoms, measurement of total, free, and/or bioavailable testosterone is considered reimbursable.

chunk 4

Diagnosis of testosterone deficiency

Covered when ALL of the following are met

Diagnostic confirmation: Two separate early-morning total testosterone measurements are obtained documenting low levelstwo measurements

AUA and guideline recommendations (chunks 28, 35)

Clinical correlation: Low total testosterone is accompanied by signs and/or symptoms consistent with testosterone deficiencysymptoms/signs

Diagnosis requires both low TT and clinical features (chunk 35)

Adjunct testing for etiology: Appropriate LH and FSH to distinguish primary vs secondary hypogonadism and prolactin (or iron studies) when indicated are performedas clinically indicated

Gender-affirming hormone therapy monitoring

Monitoring of transgender patients covered when

Baseline and interval monitoring: Serum testosterone measured at baseline and every 6–12 months during puberty suppression and induction protocols; measure every 3 months during induction until levels are in the target male range, then every 3–12 months thereafter. Monitor timing relative to formulation (mid-injection, peak/trough, pre-injection for long-acting agents; transdermal measurement at least 2 hours after application; parenteral undecanoate just before next injection).3-12 months per stage

chunk 31

Diagnostic and monitoring criteria for testosterone deficiency

Covered when ALL of the following are met

Confirmatory testing for hypogonadism: Total testosterone measured in a fasting morning sample on at least two separate days using a well-validated assay; calculate free testosterone or measure SHBG when total T is borderline or when conditions affecting SHBG are present.see guidance

EAA, CUA/CSAM, EAU recommend two morning measurements, validated assays, and use of calculated fT when indicated (chunks 38, 42, 44)

Differentiate primary vs secondary hypogonadism: Measure LH (and FSH) in all patients with suspected hypogonadism; measure prolactin when secondary hypogonadism or low libido is present; obtain pituitary MRI for secondary hypogonadism with elevated prolactin, mass symptoms, or severe hypogonadism (TT < 6 nmol/L).TT < 6 nmol/L for MRI consideration

EAA/EAU recommendations (chunks 38, 44)

Pre-therapy screening prior to testosterone therapy:

Gynecomastia evaluation

Covered when evaluating gynecomastia

Hormone panel for gynecomastia: Measure testosterone, estradiol, SHBG, LH, FSH, TSH, prolactin, hCG, alpha-fetoprotein (AFP), and assess liver and renal function as part of the gynecomastia workup.

EAA gynecomastia guideline (chunk 39)

Reimbursable indications (summary)

Covered when ALL of the following are met

Policy-level condition: Measurement of serum total testosterone may be considered reimbursable when criteria are met as outlined in this policy.

See full policy for detailed clinical criteria and indications (chunk 64)

The policy states that use of saliva for measurement of testosterone is not reimbursable because available published scientific literature does not confirm that salivary testing is required or beneficial for diagnosis and treatment. In addition, measurement of serum dihydrotestosterone (DHT) is not reimbursable except for the specific clinical indications enumerated elsewhere in the policy (e.g., evaluation of 5‑alpha reductase deficiency); DHT testing outside those specified situations is considered non‑reimbursable.

Professional guidelines cited in the policy discourage the use of direct analog–based free testosterone immunoassays because these commercial direct assays have poor accuracy and reliability. Clinicians are advised to determine free testosterone using an accepted calculation (total testosterone, SHBG, and albumin) or by reference methods such as equilibrium dialysis rather than relying on direct immunoassay kits for clinical decision‑making.

Routine measurement of serum estradiol is not recommended by the referenced guidance. Estradiol testing should be reserved for rare clinical scenarios or when a validated mass spectrometry–based method is available; routine screening or broad use of estradiol assays is discouraged.

This medical policy applies to Premera Blue Cross plans but does not apply to Medicare Advantage. Providers and members should consult the member benefit booklet or contact customer service to confirm specific plan applicability and any member‑level restrictions.

The policy explains the rationale for excluding salivary testosterone and routine DHT testing from reimbursement: there is insufficient published scientific evidence demonstrating that salivary testosterone measurement is required or beneficial for clinical diagnosis or management. As a result, salivary testosterone testing is considered not reimbursable. Similarly, measurement of serum DHT is limited to the specific, predefined diagnostic indications in the policy; DHT testing outside those indicated situations is not reimbursable.

The policy aligns with guideline recommendations that routine population screening for hypogonadism is not recommended. Diagnosis should be targeted to individuals with symptoms or signs consistent with testosterone deficiency and supported by biochemical testing rather than broad population screening.

For pediatric patients, the policy references guidance that clinicians should avoid ordering LH/FSH and either estradiol or testosterone for children who present only with pubic hair or body odor without other signs of puberty. Such isolated findings typically reflect premature adrenarche and do not require evaluation of the pituitary–gonadal axis with these tests.

Coding and Test Thresholds

Covered CPT CodesCPTCovered

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

CDC HoSt assay acceptance (±6.4% calibration verification)

Calibration verification acceptance limit±6.4% from the target value (CDC HoSt Program) for calibration verification of total testosterone assays

Verification frequencyCalibration is verified by analyzing serum material with assigned reference values every 6 months

Applicable method notedCDC HoSt analysis described for ID-LC-MS/MS methodology; reportable range and LOD provided by CDC guidance

Total testosterone diagnostic threshold

Diagnostic threshold (AUA)Total testosterone < 300 ng/dL is a reasonable cut-off to support diagnosis of low testosterone

Confirmatory testingDiagnosis should be made only after two total testosterone measurements taken on separate occasions in the early morning

Provider Actions, Documentation, and Billing Guidance

Documentation Required

Reimbursable tests for specified indications

Measurement of serum total testosterone, free testosterone, bioavailable testosterone, SHBG, albumin, dihydrotestosterone (when indicated), and estradiol are reimbursable when performed for the indications specified in this policy (e.g., symptoms/signs of androgen deficiency or excess, monitoring of testosterone replacement or cancer therapies, gender-affirming care, evaluation of androgen-excess conditions, suspected 5-alpha reductase deficiency, ambiguous genitalia). Providers must document clinical indication and correlation with symptoms or signs when claiming reimbursement.

Reimbursable tests (when policy criteria and clinical indication are met): TT (total testosterone), fT (free testosterone - calculated or by equilibrium dialysis), bioavailable testosterone, SHBG, albumin, DHT (for suspected 5-alpha reductase deficiency), estradiol (one-time prior to initiating therapy for gynecomastia).
Use bioavailable or calculated free testosterone (from TT, SHBG, albumin) or equilibrium dialysis rather than direct analog-based free testosterone immunoassays.

Documentation Required

Document two separate early-morning total testosterone measurements

Serum total testosterone samples should be collected in the early morning after fasting (or between 7–11 am, or within three hours after waking for shift workers) and, when used for diagnosis, should be measured on two separate early-morning occasions at least 24 hours apart. Document the timing of specimen collection, whether fasting, the assay method used, and the two separate early-morning total testosterone results as part of the diagnostic record.

Background and Clinical Context

Testosterone is produced primarily by Leydig cells in males and by the ovaries and adrenal glands in females and serves as the biochemical precursor for dihydrotestosterone (DHT) and estradiol. The policy references recommendations emphasizing measurement of serum total testosterone in morning fasting samples, typically on two separate days, and using validated assays; free testosterone can be calculated from total testosterone, SHBG, and albumin or measured by equilibrium dialysis when indicated.

Definitions and Terminology

TT — Total testosterone (terminology entry)

TT — Total testosteroneAbbreviation TT denotes total testosterone (serum total testosterone)

SHBG — Sex hormone binding globulinAbbreviation SHBG denotes sex hormone binding globulin

Equilibrium dialysisEquilibrium dialysis is the gold standard method for determining free serum testosterone (technically demanding)

Direct free testosterone immunoassaysDirect analog-based free testosterone immunoassays are inaccurate and are discouraged for clinical decision-making

Recommended sampling for TTMeasure serum total testosterone in a fasting morning sample; repeat on a separate day to confirm low levels

SHBG — Sex hormone binding globulin (terminology entry)

Policy Revision History

2025-11-01policy_approval

New policy approved October 14, 2025 and added to Routine Test Management Policy section; measurement of serum total testosterone may be considered reimbursable when criteria are met.

2026-02-06policy_effectiveLatest

Policy became effective for dates of service on or after February 6, 2026 following a 90-day provider notification period.

Policy Summary

PayerPremera Bluecross

PolicyTestosterone and related laboratory testing

Policy CodePolicy G2013

Change TypeNew policy added

Effective DateFeb 6, 2026

Next Review Date

Key ActionObtain and document two separate early-morning total testosterone measurements when diagnosing testosterone deficiency.

SourceLink

On This Page

Endocrine Society/AUA guidance for etiologic workup (chunks 28, 35)

Measure hemoglobin and hematocrit and counsel regarding polycythemia risk; measure PSA in men over 40 to exclude prostate cancer when appropriate; assess fertility desires and perform reproductive evaluation prior to therapy in men desiring fertility.

AUA and society guidance for baseline screening and monitoring (chunks 28, 35, 42)

Assay considerations: Use LC-MS/MS as the reference method when available; standardized automated immunoassays are acceptable but LC-MS/MS preferred for free testosterone accuracy; avoid direct free testosterone immunoassay kits due to poor reliability.

EAU and EAA emphasize assay choice and limitations of direct assays (chunks 44, 38)

Clinical correlation requiredLow total testosterone must be combined with symptoms and/or signs for clinical diagnosis

PSA referral thresholds during testosterone therapy (Endocrine Society)

Endocrine Society PSA monitoring triggerRefer to urology if PSA increases > 1.4 ng/mL above baseline or reaches an absolute value > 4 ng/mL during testosterone therapy

Recommended monitoring timesMeasure PSA at 3 months and 12 months after starting testosterone therapy in men over age 50 (per guideline)

Clinical noteSevere hypogonadal men may have larger PSA increases; consider baseline and expected response when interpreting changes

Free testosterone threshold (some data: <225 pmol/L)

Free testosterone threshold (data)Some data indicate free testosterone (fT) levels below 225 pmol/L are associated with hypogonadism

Assay accuracy noteLC-MS/MS provides the most accurate fT measurement; uncertainty exists about definitive fT cutoffs

Clinical implicationConsider calculated fT from TT, SHBG, and albumin when TT is borderline or SHBG-altering conditions are present

Late-onset hypogonadism threshold (EAU: 12 nmol/L)

EAU LOH diagnostic thresholdUse 12 nmol/L total testosterone (3.5 ng/mL) as a reliable threshold to diagnose late-onset hypogonadism (LOH)

Repeat measurement guidanceRepeat total testosterone on at least two separate occasions when < 12 nmol/L before starting therapy

Additional testingMeasure SHBG and calculate free testosterone when indicated; assess LH/FSH to differentiate hypogonadism type

Two early-morning total testosterone measurements on separate occasions are required to support a diagnosis of biochemical hypogonadism.
If initial screening is normal but symptoms persist, repeat testing is allowed no sooner than 60 days after the initial screening.
Document assay method (prefer CDC HoSt-certified assay or LC‑MS/MS when available) and whether free testosterone was calculated or measured by equilibrium dialysis.

Denial Risk

Use of direct analog-based free testosterone immunoassays is discouraged

Direct analog‑based free testosterone immunoassays are discouraged because they are inaccurate and may lead to inappropriate clinical decisions. When free testosterone is clinically needed, calculate it from total testosterone, SHBG, and albumin using a validated algorithm or measure by equilibrium dialysis or other validated laboratory methods.

Do not use direct analog-based free testosterone immunoassays for clinical decision-making.
Acceptable approaches: calculated free testosterone (TT+SHBG+albumin) or free testosterone by equilibrium dialysis.
Document the method used when ordering and reporting free or bioavailable testosterone.

Denial Risk

Nonreimbursable sample types and limited DHT indications

Saliva testing for testosterone is not reimbursable. Measurement of serum dihydrotestosterone (DHT) is reimbursable only for diagnosis of 5‑alpha reductase deficiency and is not reimbursable for other indications not specified in this policy.

Saliva samples for testosterone measurement — not reimbursable.
DHT measurement covered only for suspected 5‑alpha reductase deficiency; DHT for other indications — not reimbursable.

Documentation Required

Laboratory test validation requirement for LDTs

Laboratory‑developed tests (LDTs) must be validated and performed in CLIA‑certified laboratories as high‑complexity tests per CLIA '88. FDA clearance or approval is not required for clinical use, but LDTs must meet CLIA validation requirements.

LDTs are regulated under CLIA as high‑complexity tests and require appropriate validation and CLIA compliance.
Document the laboratory performing the test and CLIA status when using LDTs.

Billing Rule

Reimbursement contingent on meeting policy criteria

Reimbursement is contingent on meeting the policy criteria and appropriate documentation. Providers must document clinical indication, timing of specimen collection, assay/method used, and, when applicable, two separate early‑morning total testosterone results and follow-up monitoring plans.

Claims lacking documentation of clinical indication, specimen timing, or required repeat early‑morning TT measurements may be denied.
Verify that the test ordered aligns with one of the reimbursable indications listed in this policy before billing.

Denial Risk

Failure to obtain two morning total testosterone measurements may affect coverage

Failure to obtain two early‑morning total testosterone measurements on separate occasions may result in inadequate documentation of biochemical hypogonadism and could lead to denial of testing or therapy-related claims. Ensure both results and clinical correlation are documented in the medical record.

If only a single low TT is available, measure a second early‑morning TT and document symptoms/signs prior to initiating testosterone therapy.
For men with borderline TT or conditions affecting SHBG, include SHBG and calculated free T or equilibrium dialysis results as appropriate.

Documentation Required

Assess response and adverse effects at 3 and 6 months and repeat levels

Assess response to testosterone therapy and monitor for adverse effects at approximately 3 and 6 months after therapy onset and repeat testosterone and hematocrit levels at these intervals; thereafter, test annually if stable. Document monitoring results and any therapy adjustments.

Measure TT and hematocrit at baseline, at 3 and 6 months after initiating therapy, and annually thereafter if stable.
Document assessment of adverse effects and clinical response at 3 and 6 months.

Note

Benefit limits and member contract verification

Benefit coverage is subject to member plan terms. Providers and members should verify member benefits and any applicable limits or exclusions prior to testing and billing.

Consult the member benefit booklet or contact member/customer service to confirm coverage and any benefit limits.
Coverage and reimbursement are subject to the limits and conditions of the member's benefit plan; this policy is not applicable to Medicare Advantage.

SHBG — definitionSHBG stands for sex hormone-binding globulin; measure when conditions that alter SHBG are suspected

Clinical roleSHBG is used with total testosterone and albumin to calculate estimated free testosterone when indicated

Terminology sourceSHBG is listed in the policy terminology table as 'Sex hormone binding globulin'

Equilibrium dialysis definition

DefinitionEquilibrium dialysis uses a semipermeable membrane to separate bound from free testosterone and is considered the gold standard for free serum testosterone determination

LimitationsTechnically difficult, expensive, limited availability, and dependent on environmental conditions (pH, ionic strength, temperature)

Analytical dependencyEquilibrium dialysis relies on accurate and precise total testosterone measurements

Direct free testosterone immunoassays definition and caution

Definition and cautionDirect free testosterone immunoassays directly measure free testosterone but are inaccurate; clinicians should not use direct analog-based free testosterone immunoassays

Recommended alternativesUse calculated free testosterone based on TT, SHBG, and albumin or measure free testosterone by equilibrium dialysis when necessary

Policy rationaleCommercial direct assays have poor accuracy and reliability compared to equilibrium dialysis or validated calculations

Total testosterone (TT) — recommended morning fasting sample and repeat measurement guidance

Sample timingSerum total testosterone should be collected in the early morning after fasting (typically 7–11 am)

Repeat measurementMeasure total testosterone on at least two separate mornings to confirm low levels (two measurements at least 24 hours apart for initial screening in AMAB individuals)

DocumentationDocument timing of specimen collection and assay type/validation when reporting total testosterone

Free testosterone (fT) — calculation from TT, SHBG, albumin; direct assays discouraged

Calculation methodFree testosterone (fT) should be calculated from total testosterone, SHBG, and albumin using accepted algorithms when indicated

Discouraged direct assaysDirect commercial free testosterone assays are discouraged due to poor accuracy; use equilibrium dialysis or validated calculations instead

Assay recommendationLC-MS/MS is preferred for accurate measurement of free testosterone when available

Serum total testosterone (terminology)

Terminology entrySerum total testosterone (often abbreviated TT) — measured in a morning fasting sample and used as the primary biochemical test for diagnosing hypogonadism

Clinical useIf TT is low or borderline, calculate free testosterone or measure SHBG; confirm low TT with repeat morning measurements

Preferred methodsLC-MS/MS is the reference standard; standardized automated immunoassays are acceptable when LC-MS/MS is not available