CurrentRegence BlueCross BlueShieldPolicy 81

Testosterone Testing

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This policy governs coverage of total, free, and bioavailable testosterone testing for diagnosing androgen deficiency or excess and for establishing baselines or monitoring treatment response. It applies to providers submitting testosterone testing for individuals with relevant symptoms, disorders, or specified treatments.

Policy Summary

PayerRegence BlueCross BlueShield

PolicyTestosterone Testing

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJuly 1, 2026

Last ReviewMay 1, 2026

Next Review DateMarch 1, 2027

Key ActionSubmit chart notes documenting symptoms, relevant treatment history, the reason for testing, the blood draw date, and the diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Testosterone testing CPT codes addressed

Up to 6Total testosterone tests allowed in the first therapy year

AnnuallyTesting frequency after the first therapy year

2Early-morning measurements recommended for diagnosis

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CurrentRegence BlueCross BlueShieldPolicy 81

Testosterone Testing

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Sign up for regence Policy 81 alerts

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Policy Summary

PayerRegence BlueCross BlueShield

PolicyTestosterone Testing

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJuly 1, 2026

Last ReviewMay 1, 2026

Next Review DateMarch 1, 2027

Key ActionSubmit chart notes documenting symptoms, relevant treatment history, the reason for testing, the blood draw date, and the diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Testosterone testing CPT codes addressed

Up to 6Total testosterone tests allowed in the first therapy year

AnnuallyTesting frequency after the first therapy year

2Early-morning measurements recommended for diagnosis

Initial and Monitoring Total Testosterone Testing

Total testosterone testing may be considered medically necessary when at least one of the following pathways is met.

At least one qualifying pathway

Diagnosis of androgen deficiency or excess: Testing is for diagnosing androgen deficiency or androgen excess in an individual with symptoms or a disorder known to affect testosterone levels.
Baseline or treatment monitoring
- Eligible treatment
  - The individual is receiving testosterone replacement therapy for androgen deficiency.
    Testing is covered for up to 6 tests per year during the first year, then annually.
  - The individual is receiving sex steroid hormone treatment for gender dysphoria.
  - The individual is receiving treatment for prostate cancer.

Annual Free or Bioavailable Testosterone Testing

Annual free and/or bioavailable testosterone testing may be considered medically necessary when all applicable criteria are met.

All required criteria

Prior total testosterone evaluation: Prior total testosterone testing has been performed.
Low or borderline-low total testosterone: Total serum testosterone levels are low or borderline low.280 to 300 ng/dL (9.7 to 10.4 nmol/L) is the cited lower reference range in men with signs and symptoms of testosterone deficiency.
Testicular hypofunction findings: The individual has signs or symptoms of testicular hypofunction.
Examples include gynecomastia, erectile dysfunction, infertility, loss of bone or muscle mass, delayed puberty, libido loss, fatigue, or depression.

Not Medically Necessary Testing

Testing is considered not medically necessary when the applicable medical necessity criteria are not met.

Either exclusion applies

Total testosterone exclusion: The criteria for medically necessary total testosterone testing are not met.
Applies to CPT 84403.
Free or bioavailable testosterone exclusion: The criteria for medically necessary free or bioavailable testosterone testing are not met, including testing without prior total testosterone testing.
Applies to CPT 84402 and CPT 84410.

Medically Necessary Total Testosterone Testing

Total testosterone testing may be considered medically necessary for clinically supported diagnostic or treatment-monitoring indications.

At least one qualifying indication

Testing is for diagnosis of suspected testosterone deficiency in a man with specific compatible signs and symptoms.
Testing is for evaluation of testosterone excess in a woman.
Testing is for establishing a baseline or monitoring testosterone treatment for gender dysphoria.
Testing is for monitoring hormone-treatment efficacy.
Testing is for a selected prostate cancer treatment indication, including efficacy or castrate-level assessment when clinically indicated.

Medically Necessary Free or Bioavailable Testosterone Testing

Free or bioavailable testosterone testing may be considered medically necessary only for the qualifying deficiency evaluation.

Qualifying binding-protein condition: Testing is for diagnosing testosterone deficiency when testosterone-binding protein levels are altered.

Annual testing may be considered medically necessary in this situation, generally when total testosterone is low or borderline low.

Not Medically Necessary Total Testosterone Testing

Routine total testosterone testing is not medically necessary when policy criteria or frequency limits are not met.

Either exclusion applies

Criteria not met: The medical necessity criteria for total testosterone testing are not met.
Routine testing exceeds frequency limit: Routine total testosterone testing exceeds the allowed frequency during testosterone replacement therapy.More than 6 tests during the initial year, or more than 1 test annually after the initial year.

Not Medically Necessary Free or Bioavailable Testosterone Testing

Free or bioavailable testosterone testing is not medically necessary outside the qualifying deficiency evaluation.

Unqualified indication: Testing is ordered for an indication other than diagnosing testosterone deficiency when testosterone-binding protein levels are altered.

This includes routine monitoring.

Free or bioavailable testosterone testing without prior total testosterone testing is considered not medically necessary. Prior total testosterone testing is required before free or bioavailable testing can meet the applicable coverage criterion.

Testing men for testosterone deficiency should be avoided during acute illness and while recovering from an acute illness, because these conditions can suppress testosterone concentrations and confound interpretation.

Direct analog-based free testosterone immunoassays should not be used because they are inaccurate. When free testosterone testing is indicated, use an accurate method, such as equilibrium dialysis or a calculation using total testosterone, sex hormone-binding globulin, and albumin concentrations.

Routine monitoring of serum androgens is not recommended for hyperandrogenic adolescents.

Routine screening of men in the general population for hypogonadism is not recommended. Testing should be based on compatible signs or symptoms and consistently low testosterone concentrations.

Total testosterone testing is considered not medically necessary when the applicable total testosterone medical necessity criterion is not met.

Free or bioavailable testosterone testing is considered not medically necessary when the applicable criterion is not met, including when total testosterone is not low or borderline low, qualifying signs or symptoms are absent, or prior total testosterone testing has not been performed.

Routine total testosterone testing is considered not medically necessary when performed more than six times during the initial year of testosterone replacement therapy or more than annually thereafter.

Free or bioavailable testosterone testing is considered not medically necessary for indications other than evaluating testosterone deficiency when testosterone-binding protein levels are altered. This includes routine monitoring.

Coding and Reference Thresholds

Total Testosterone TestingCPTCovered

84403

Total testosterone testing

Free and Bioavailable Testosterone TestingCPTCovered

84402	Free testosterone testing
84410	Bioavailable testosterone testing

Not Medically NecessaryCPTNot Covered

84403	Total testosterone testing
84402	Free testosterone testing
84410	Bioavailable testosterone testing

CPT CodesCPT

84402	Testosterone; free
84403	Testosterone; total

HCPCS CodesHCPCS

84410

Testosterone; bioavailable, direct measurement (eg, differential precipitation)

Lower Total Testosterone Reference Point

Reference range280 to 300 ng/dL in men with signs and symptoms of testosterone deficiency

SI-unit conversion9.7 to 10.4 nmol/L

Comparison populationLevels are compared with the normal range for healthy young men

Total Testosterone Replacement Therapy Frequency

TestTotal testosterone during testosterone replacement therapy for androgen deficiency

Initial yearUp to 6 tests per year

After initial yearTesting is covered annually

Total Testosterone Diagnostic Cutoff

GuidelineAmerican Urological Association

Diagnostic cutoffTotal testosterone below 300 ng/dL

Use of cutoffA reasonable cutoff supporting the diagnosis of low testosterone

Diagnostic Morning Measurements

Number of measurementsTwo total testosterone measurements

TimingMeasurements must be taken on separate early mornings

Fasting guidanceEndocrine Society guidance specifies that both morning measurements should be obtained while fasting

Initial-Year Replacement Therapy Testing

TestRoutine total testosterone testing during the initial year of testosterone replacement therapy

LimitMore than 6 tests in the initial year

Coverage statusMore than 6 tests is not medically necessary

Post-Initial-Year Replacement Therapy Testing

TestRoutine total testosterone testing after the initial year of testosterone replacement therapy

LimitMore than annual testing

Coverage statusMore than annual testing is not medically necessary

Documentation and Provider Actions

Documentation Required

Clinical Notes and Testing Rationale

Submit History and Physical or chart notes documenting the patient's symptoms, applicable treatment history, and the clinical reason for testosterone testing.

Include symptomology, treatment history, and the reason testing is being ordered.

Documentation Required

Specimen and Diagnosis Details

Include the blood draw date and diagnosis with the documentation submitted for review.

Blood draw date
Diagnosis

Denial Risk

Total Testosterone Criteria Not Met

Total testosterone testing (CPT 84403) is not medically necessary when the policy's total-testosterone coverage criterion is not met.

Review and document that Criterion I is satisfied before ordering or submitting total testosterone testing.

Denial Risk

Free or Bioavailable Testosterone Criteria Not Met

Free testosterone (CPT 84402) and bioavailable testosterone (CPT 84410) are not medically necessary when the applicable criterion is not met, including testing without prior total testosterone testing.

Confirm that the low or borderline-low total testosterone and related findings required by Criterion II are documented.
Do not submit free or bioavailable testosterone testing without prior total testosterone testing unless the policy criteria otherwise support it.

Documentation Required

Required Documentation Missing

Clinical documentation is required to determine whether the policy criteria are met. Missing information could affect the review and decision outcome.

History and Physical or chart notes
Symptoms and applicable treatment history
Reason for testing
Blood draw date
Diagnosis

Billing Rule

Excessive Routine Total Testosterone Testing

Routine total testosterone testing is not medically necessary when it exceeds the policy frequency limits: more than six tests during the initial year of testosterone replacement therapy or more than one test annually thereafter.

Initial year of testosterone replacement therapy: no more than six tests per year
After the initial year: no more than one test annually

Denial Risk

Unqualified Free or Bioavailable Testosterone Testing

Free or bioavailable testosterone testing is generally useful for diagnosing testosterone deficiency only when testosterone-binding protein levels are altered. Testing for other indications, including routine monitoring, is not medically necessary.

Ensure testing is part of a qualifying testosterone-deficiency evaluation.
Routine monitoring and other nonqualifying indications are not medically necessary.

Definitions

Total Testosterone Testing

What it measuresBoth free and bound forms of testosterone

Primary roleThe initial test used for diagnosing testosterone deficiency or excess

Clinical useUsed for testosterone deficiency or excess in men and testosterone excess in women

Free Testosterone Testing

What it measuresThe small fraction of circulating testosterone that is not bound to SHBG or albumin

Binding proteins excludedSex hormone-binding globulin and albumin

Potential useMay be useful for diagnosing testosterone deficiency when total testosterone is low or borderline low

Bioavailable Testosterone

DefinitionTestosterone not bound to sex hormone-binding globulin

ComponentsFree testosterone and the albumin-bound fraction

Measurement methodsMay be measured directly using precipitation or calculated from total testosterone, SHBG, and albumin levels

Low or Borderline-Low Total Testosterone

Applicable populationMen with signs and symptoms of testosterone deficiency

Reference comparisonResults may be compared with the normal range for healthy young men

Lower reference point280 to 300 ng/dL (9.7 to 10.4 nmol/L)

Free Testosterone

DefinitionThe small fraction of circulating testosterone that is not bound to SHBG or albumin

SHBG bindingFree testosterone is not bound to sex hormone-binding globulin

Albumin bindingFree testosterone is not bound to albumin

Bioavailable Testosterone

DefinitionNon-SHBG-bound testosterone

Direct measurementMeasured by a precipitation technique

Calculated measurementMay be calculated from total testosterone, SHBG, and albumin levels

Clinical Utility

DefinitionThe ability of a test to produce clinically important improvements in health outcomes

Treatment decisionsTest results guide treatment decisions that would not otherwise be made without testing

Outcome requirementThe resulting treatment decisions must lead to improved primary health outcomes

Covered Indications

Diagnosis of Androgen Deficiency or Androgen Excess

Total testosterone testing may be considered medically necessary when symptoms or a relevant disorder support evaluation of androgen status.

Clinical indication: The individual has symptoms or a disorder known to affect testosterone levels, and testing is being performed to diagnose androgen deficiency or androgen excess.

Examples of associated disorders include primary or secondary hypogonadism, polycystic ovary syndrome, congenital adrenal hyperplasia, prostate cancer, ovarian cancer, adrenal tumors, adrenal insufficiency, Turner syndrome, and pituitary dysfunction.

Baseline or Response Monitoring During Eligible Treatment

Testing may be considered medically necessary to establish a treatment baseline or monitor response during an eligible therapy.

At least one eligible treatment

The individual is receiving testosterone replacement therapy for androgen deficiency.
Testing is covered for up to 6 tests per year during the first year, then annually.
The individual is receiving sex steroid hormone treatment for gender dysphoria.
The individual is receiving treatment for prostate cancer.

Annual Free or Bioavailable Testing With Low or Borderline-Low Total Testosterone

Annual free or bioavailable testosterone testing may be considered medically necessary when all of the following are present.

All required criteria

Prior total testosterone testing has been performed.
Total serum testosterone is low or borderline low.280 to 300 ng/dL (9.7 to 10.4 nmol/L) is the cited lower reference range in men with signs and symptoms of testosterone deficiency.
The individual has signs or symptoms of testicular hypofunction.

Diagnosis of Suspected Testosterone Deficiency in Men

Diagnosis should be based on compatible clinical findings together with consistently low testosterone measurements.

Clinical and laboratory findings

The man has specific signs or symptoms compatible with testosterone deficiency.
Total testosterone is consistently low on two separate early-morning measurements.
The Endocrine Society specifies fasting morning measurements; the AUA supports two separate early-morning measurements.
The testosterone result supports the clinical diagnosis.The AUA cites a reasonable cutoff of <300 ng/dL; a lower reference range of 280 to 300 ng/dL is also cited for symptomatic men.

Evaluation of Testosterone Excess in Women

Total testosterone testing may be considered medically necessary when evaluating suspected androgen excess in women.

Clinical evaluation: The testing is performed to evaluate suspected testosterone excess in a woman.

Baseline and Monitoring Testosterone Treatment for Gender Dysphoria

Testing may be considered medically necessary to establish a baseline and monitor response to testosterone treatment for gender dysphoria.

Gender-affirming hormone treatment

The individual is receiving testosterone treatment for gender dysphoria.
Testing is being used to establish a treatment baseline or monitor treatment response.
Guideline monitoring intervals vary by treatment phase and patient population; intervals of 3 to 12 months are cited in the policy evidence.

Monitoring Testosterone Supplementation and Selected Prostate Cancer Treatment

Testing may be considered medically necessary to monitor treatment efficacy, including selected prostate cancer treatment.

At least one qualifying treatment-monitoring purpose

Testing is used to monitor testosterone supplementation treatment efficacy.
Testing is used to monitor selected prostate cancer treatment efficacy or assess castrate-level response when clinically indicated.

Free or Bioavailable Testing When Binding Proteins Are Altered

Free or bioavailable testosterone testing may be considered medically necessary for deficiency evaluation when testosterone-binding proteins are altered.

Altered testosterone binding

Testing is for diagnosis of testosterone deficiency.
Testosterone-binding protein levels are altered.
This testing is generally useful when total testosterone is low or borderline low.
The testing frequency is clinically appropriate.Annual testing may be medically necessary.

Clinical Hyperandrogenism in Functional Hypothalamic Amenorrhea Evaluation

Testosterone testing may be considered medically necessary when evaluating clinical hyperandrogenism during functional hypothalamic amenorrhea assessment.

Clinical hyperandrogenism evaluation

The patient is being evaluated for functional hypothalamic amenorrhea and has clinical hyperandrogenism.
Total testosterone and dehydroepiandrosterone sulfate (DHEA-S) levels are obtained.
An 8 AM 17-hydroxyprogesterone level is obtained when late-onset congenital adrenal hyperplasia is suspected.

Evaluation of Androgen Excess in Polycystic Ovary Syndrome

Testosterone testing may be considered as part of an evaluation for polycystic ovary syndrome when clinical and ovarian findings support the diagnosis.

PCOS diagnostic evaluation

The evaluation includes assessment for androgen excess using total, free, or bioavailable serum testosterone.
Supporting PCOS findings
- Polycystic ovaries are present.
- Ovulatory dysfunction is present.

Testosterone Testing

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Testosterone Testing

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Coverage Criteria

Coding and Reference Thresholds

Documentation and Provider Actions

Background

Definitions

Covered Indications

Frequency and Quantity Limits

Not Covered