CurrentBlue Cross Blue Shield - OklahomaPolicy CPCPLAB009

Testosterone

This policy governs reimbursement and coding criteria for serum testosterone and related hormone testing (e.g., free testosterone, SHBG, dihydrotestosterone, estradiol) for BCBSOK products and applies to providers submitting claims for these laboratory services.

Policy Summary

PayerBlue Cross Blue Shield - Oklahoma

PolicyTestosterone

Policy CodePolicy CPCPLAB009

Change TypeAdded sample collection/assay notesliterature updates

Effective Date03/15/2024

Next Review Date

Key ActionObtain two total testosterone measurements at least 24 hours apart for initial male screening before further testing.

SourceLink

POLICY UPDATE CHANGES

Initial screening and follow-up screening language was added to #1a and sample collection/assay sensitivity notes were added.

Document updated with literature review; reimbursement information unchanged; references revised.

8Procedure codes listed

2Initial screening measurements (males)

2-3 moMonitoring freq first year

1Estradiol prior to therapy

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Coverage and Medical Necessity Criteria

Medically necessary indications

inv-01: Medically necessary indications — Covered when the following clinical indications and testing sequences are met:

ALL of the following

Measurement of serum total testosterone may be reimbursable for symptoms of androgen deficiency or androgen excess in males; initial screening requires two measurements at least 24 hours apart; if initial screening is normal but symptoms persist, follow-up testing allowed no sooner than 60 days after initial screening.
Measurement of serum total testosterone may be reimbursable for monitoring treatment response in men taking enzyme inhibitors for prostate cancer.
Measurement of serum total testosterone may be reimbursable for men receiving testosterone replacement therapy (every 2–3 months for the first year after initiation or after change in dosage; annually thereafter).
Measurement of serum total testosterone may be reimbursable for gender-dysphoric/gender-incongruent persons (baseline, during treatment, and for therapy monitoring).
Measurement of serum total testosterone may be reimbursable for symptomatic females being evaluated for conditions associated with androgen excess (e.g., PCOS, functional hypothalamic amenorrhea).
For males with total testosterone confirmed as low or borderline low and who have hypogonadism, gynecomastia, and/or other testicular hypofunction, annual measurements of serum free testosterone, SHBG, and/or albumin may be reimbursable.
For individuals suspected of disorders with altered SHBG, measurement of serum free testosterone using an accepted algorithm based on total testosterone, SHBG, and/or albumin or bioavailable testosterone may be reimbursable.
Prior to initiating testosterone therapy for males with gynecomastia, once-per-lifetime serum estradiol measurement may be reimbursable.
For individuals with ambiguous genitalia, hypospadias, or microphallus, measurement of serum dihydrotestosterone for diagnosis of 5-alpha reductase deficiency may be reimbursable.

Not Medically Necessary / Not Reimbursable

inv-02: Not medically necessary / Not reimbursable — Not reimbursable in these situations:

ALL of the following

Measurement of serum free testosterone and/or bioavailable testosterone as a primary test without prior serum total testosterone measurement is not reimbursable.
Measurement of serum total testosterone, free testosterone, and/or bioavailable testosterone for asymptomatic individuals or for individuals with non-specific symptoms is not reimbursable.
Measurement of serum testosterone for identification of androgen deficiency in women is not reimbursable.
Use of saliva for measurement of testosterone is not reimbursable.
Measurement of serum dihydrotestosterone is not reimbursable for situations not explicitly listed as reimbursable above.

Denial Risk

Provider Action / Billing Guidance

Provider action: No explicit denial triggers are stated beyond the not reimbursable situations listed above; ensure prior total testosterone measurement before ordering free or bioavailable testosterone as a primary test, avoid saliva-based testing, and document symptoms/indication when ordering tests for reimbursement consideration.

Order serum total testosterone first before obtaining free or bioavailable testosterone when used for diagnostic purposes.
Do not use saliva-based testosterone assays for reimbursement.
Document clinical symptoms or specific indications when ordering testosterone testing to support medical necessity.

Indications and Clinical Uses

inv-20: Symptoms of androgen deficiency or excess in males; monitoring of prostate cancer therapy with enzyme inhibitors; monitoring men on testosterone replacement; gender-dysphoric/gender-incongruent persons; symptomatic females evaluated for androgen excess; suspected disorders affecting SHBG; ambiguous genitalia/hypospadias/microphallus for DHT measurement.

Male indications and monitoring: Symptoms of androgen deficiency or androgen excess in males — initial screening requires two total testosterone measurements at least 24 hours apart; if initial screening is normal but symptoms persist, repeat testing may be performed no sooner than 60 days after the initial screening.two measurements, ≥24 hours apart; repeat ≥60 days if persistent symptoms

supported by chunk 3

Prostate cancer therapy monitoring: Monitoring of treatment response in men taking enzyme inhibitors for prostate cancer may be reimbursable via serum total testosterone measurement.

supported by chunk 3

Testosterone replacement monitoring:

Testing Frequency and Monitoring

inv-22: total testosterone — Two measurements for initial male screening

RequirementTwo serum total testosterone measurements for initial male screening, collected at least 24 hours apart.

PopulationMales with symptoms of androgen deficiency or androgen excess.

Timing noteSamples should be collected in the early morning after fasting (Note 1).

inv-23: total testosterone — Repeat testing if persistent symptoms

RequirementIf initial screening was normal but symptoms persist, repeat total testosterone testing is allowed no sooner than 60 days after the initial screening.

PopulationMales with persistent symptoms of androgen deficiency or excess despite a normal initial screen.

Procedure and Billing Codes

Procedure Codes (listed)CPT

82040
82642
82670
82681
84270
84402
84403
84410

Provider Responsibilities and Billing Guidance

Prior Authorization

Check plan-specific prior authorization

Not all lab management reimbursement criteria apply to every BCBSOK product; prior authorization requirements vary by plan. Providers should review the member's plan documents to determine whether prior authorization is required for laboratory services.

Prior Authorization

Prior authorization — none specified in policy

No prior authorization requirements are specified in this policy document. Determine plan-specific requirements by consulting the applicable plan documents or provider contract.

Step Therapy

Initial testing sequence — two total testosterone measurements

For initial screening of suspected androgen deficiency in males, obtain two serum total testosterone measurements at least 24 hours apart before ordering additional tests such as free or bioavailable testosterone.

How to Order and Document Tests

Billing Rule

Ordering and claims submission — review plan coverage

Review plan documents for eligible coverage and submit claims using appropriate CPT/HCPCS codes; be prepared to provide supporting documentation if requested during claim review.

Providers are responsible for submission of accurate documentation and valid code combinations from HIPAA-approved code sets.

Note

Ordering provider restrictions — none specified

This policy does not specify any restrictions on which providers may order the tests. Follow applicable plan documents and provider contracts for any ordering restrictions.

Services Not Reimbursed

Not covered tests and scenarios include: salivary testosterone testing; ordering free or bioavailable testosterone as the primary test without a prior total testosterone; and testing for asymptomatic individuals or those with non-specific symptoms. The policy update history notes that reimbursement information was unchanged while literature and clarifying notes (e.g., morning fasting collection and assay sensitivity for females) were added.

The policy update notes do not list additional specific tests or clinical indications as excluded beyond those stated in the reimbursement information.

Key Definitions and Assay Notes

inv-17: CDC HoSt/Testosterone certified assay — An assay standardized to within ±6.4% of the CDC total testosterone reference standard; strongly recommended for serum total testosterone...

DefinitionAn assay standardized to within ±6.4% of the CDC total testosterone reference standard is considered CDC HoSt/Testosterone certified.

RecommendationIt is STRONGLY RECOMMENDED that serum total testosterone measurement be performed with an assay certified by the CDC HoSt/Testosterone program.

Practical noteA list of CDC-certified assays is available on the CDC HoSt website.

inv-18: Primary test — Ordering measurement of serum free testosterone and/or bioavailable testosterone without a prior total testosterone measurement; stated as unsupported.

Policy stanceOrdering measurement of serum free testosterone and/or bioavailable testosterone as a primary test without a prior total testosterone measurement is not reimbursable.

Clinical Background and Evidence Summary

Serum total testosterone demonstrates substantial biologic variability; accordingly, the policy advises that sample collection for serum total testosterone should occur in the early morning after fasting. The policy strongly recommends using assays certified by the CDC HoSt/Testosterone program (standardized to within ±6.4% of the CDC reference). For females, the policy notes that the assay technology must be sufficiently sensitive to detect low serum total testosterone levels.

inv-21 (duplicate reference): Literature-supported indications and measurement method comparisons referenced for clinical interpretation.

Literature-supported indications and assay method considerations referenced for clinical interpretation.

Assay performance and interpretation: Selected references compare assay methods (immunoassay vs tandem mass spectrometry, salivary measures) and describe biologic variation, SHBG dynamics, and clinical cohorts; these sources support the policy’s recommendations on assay selection (CDC HoSt certification) and sample collection timing (early morning, fasting).

supported by chunks 18, 19, and 20

Policy Summary

PayerBlue Cross Blue Shield - Oklahoma

PolicyTestosterone

Policy CodePolicy CPCPLAB009

Change TypeAdded sample collection/assay notesliterature updates

Effective Date03/15/2024

Next Review Date

Key ActionObtain two total testosterone measurements at least 24 hours apart for initial male screening before further testing.

SourceLink

On This Page

Men receiving testosterone replacement therapy — monitoring with serum total testosterone every 2–3 months for the first year after initiation or after a change in therapeutic dosage; annually thereafter.

every 2–3 months for first year; annually thereafter

supported by chunk 3

Gender‑affirming care: Gender-dysphoric/gender-incongruent persons — baseline testing, during treatment, and for therapy monitoring with serum total testosterone may be reimbursable.

supported by chunk 3

Symptomatic females evaluated for androgen excess: Symptomatic females being evaluated for conditions associated with androgen excess (e.g., PCOS, functional hypothalamic amenorrhea) — serum total testosterone measurement may be reimbursable; note assays must be sensitive enough to detect low female levels.

supported by chunks 3 and 4

Disorders affecting SHBG: Suspected disorders altering SHBG — measurement of serum free testosterone calculated from total testosterone, SHBG, and/or albumin or measurement of bioavailable testosterone may be reimbursable.

supported by chunk 3

DHT for congenital/genital anomalies: Ambiguous genitalia, hypospadias, or microphallus — measurement of serum dihydrotestosterone for diagnosis of 5-alpha reductase deficiency may be reimbursable.

supported by chunk 3

inv-21: Clinical and research literature supports measurement of serum total testosterone for evaluation of hypogonadism and related conditions; references relevant to interpretation.

Clinical and research literature supports measurement of serum total testosterone for evaluation of hypogonadism and related conditions; references relevant to interpretation.

Literature and method comparisons: References include studies on associations between low testosterone and clinical conditions, dynamics of testosterone levels, and method comparisons (including salivary measurement versus tandem mass spectrometry and immunoassays). These references inform interpretation and assay selection; CDC HoSt/Testosterone-certified assays are strongly recommended for accuracy.

supported by chunks 18, 19, and 20

ReferenceFollow-up testing timing specified in initial screening guidance (≥60 days).

inv-24: total testosterone — Monitoring frequency on replacement therapy

Monitoring frequencyFor men receiving testosterone replacement therapy: every 2–3 months for the first year after initiation or after dosage change; annually thereafter.

Other indicationsAlso used for monitoring in gender-dysphoric/gender-incongruent persons (baseline, during treatment, and for therapy monitoring).

ContextApplies to serum total testosterone monitoring during therapy per reimbursement guidance.

inv-25: free testosterone/SHBG/albumin when indicated — Annual

FrequencyAnnual measurement of serum free testosterone, SHBG, and/or albumin when indicated (e.g., males with confirmed low or borderline total testosterone and hypogonadism, gynecomastia, or other testicular hypofunction).

IndicationTriggered by confirmed low/borderline total testosterone and clinical conditions affecting SHBG or testicular function.

MethodFree testosterone may be calculated using a medically accepted algorithm based on total testosterone, SHBG, and/or albumin or measured as bioavailable testosterone.

inv-26: estradiol prior to initiating testosterone therapy for males with gynecomastia — Once per lifetime

RequirementOnce-per-lifetime serum estradiol measurement prior to initiating testosterone therapy for males with gynecomastia may be reimbursable.

PopulationMales with gynecomastia being considered for testosterone therapy.

PurposeAssess estradiol prior to starting therapy to inform management decisions.

inv-27: Frequency limits — placeholder key_value (empty label/summary)

If initial screening is normal but symptoms persist, repeat testing is allowed no sooner than 60 days after the initial screening.

Step Therapy

Step therapy — none specified

No step therapy requirements are specified in the policy. Follow plan-specific utilization management rules if present.

Documentation Required

Claims documentation and coding requirements

Providers must submit accurate documentation of services performed and code claims using HIPAA-approved code sets and standard industry coding guidelines; BCBSOK may request additional documentation upon claim review.

Claims should be coded according to industry standards (CPT, HCPCS, ICD-10, UB, NCCI, etc.).
Upon request, providers should furnish additional documentation to support medical necessity.

Documentation Required

Sample collection and assay sensitivity

Collect serum total testosterone samples in the early morning after fasting. When measuring total testosterone in females, use an assay with sensitivity adequate to detect the low serum testosterone levels normally found in females.

CDC HoSt/Testosterone–certified assays are strongly recommended for serum total testosterone measurement (see Note 1).

Denial Risk

Denial triggers — none additional specified

No additional specific denial triggers are stated beyond the policy's not-reimbursable items; apply the listed not-reimbursable conditions when adjudicating claims.

ContextFree or bioavailable testosterone may be reimbursable when performed after a low or borderline total testosterone or when disorders affecting SHBG are suspected.

Denial riskRequests for free/bioavailable testosterone as the initial/primary test may be denied per reimbursement rules.

inv-19: Assay sensitivity — Assay sensitivity for females

RequirementAssay technology used for measuring serum total testosterone in females must be sensitive enough to detect the low total testosterone levels normally found in females.

Sample collectionSerum total testosterone sample collection should occur in the early morning after fasting (Note 1).

Policy updateThis sensitivity and collection guidance was added/clarified in policy updates (see 11/01/2023 and 03/15/2024).