CurrentCapital BluecrossPolicy AHS - G2013 - Testosterone, 1

Laboratory testing for testosterone and related hormones

Defines coverage criteria and limitations for measurement of serum total, free, bioavailable testosterone, SHBG, estradiol, dihydrotestosterone and related tests for diagnosis and monitoring of androgen deficiency/excess, hypogonadism, gender-affirming therapy, and specific congenital conditions.

Policy Summary

PayerCapital Bluecross

PolicyLaboratory testing for testosterone and related hormones

Policy CodePolicy AHS - G2013 - Testosterone, 1

Change TypeNo material change

Effective DateNov 16, 2015

Next Review DateN/A

Key ActionUse CDC-certified assays for morning fasting total testosterone samples and document assay and collection time; do not order free or bioavailable testosterone as the primary test without a prior total testosterone measurement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

MultipleGuideline Sources

10Covered/Not-covered points

8Key recommended tests

9CPT codes listed

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Policy Number: AHS - G2013 - Testosterone, 1; Status: CURRENT; Effective Date: 2015-11-16; Last Review: 2026-05-01.

Scope: Defines coverage criteria and limitations for measurement of serum total testosterone (TT), free testosterone (FT), bioavailable testosterone, sex hormone-binding globulin (SHBG), estradiol (E2), and dihydrotestosterone (DHT) for diagnosis and monitoring of androgen deficiency/excess, hypogonadism, gender-affirming therapy, and specific congenital conditions.

Coverage stance (high-level): Measurement of serum total testosterone MEETS COVERAGE CRITERIA in specified clinical situations (initial screening with two morning measurements ≥24 hours apart; follow-up testing no sooner than 60 days if initial normal but symptoms persist; monitoring during prostate enzyme inhibitor therapy; monitoring men on testosterone replacement therapy every 2–3 months for the first year or after dose change and annually thereafter; baseline and monitoring for gender-dysphoric/gender-incongruent persons; symptomatic females evaluated for androgen excess).

Additional covered tests and limits: Annual measurement of free testosterone, SHBG, and/or albumin is covered for men with confirmed low or borderline TT and hypogonadism/testicular dysfunction; FT may be measured using a medically accepted algorithm based on TT, SHBG, and albumin or by bioavailable T methods when indicated; one-time lifetime estradiol prior to testosterone therapy in males with gynecomastia; DHT measurement meets coverage for diagnosis of 5-alpha reductase deficiency in individuals with ambiguous genitalia, hypospadias, or microphallus. (Also lists situations that do NOT meet coverage, e.g., primary FT/bioavailable T testing without prior TT, saliva testing.)

Operational notes: Samples for TT should be collected in the early morning after fasting (recommendation: between 07:00–11:00 or within 3 hours after waking for shift workers); assays should be traceable to standardized reference material and it is strongly recommended to use assays certified by the CDC Hormone Standardization (HoSt) program.

Medical-Necessity Criteria

Meet Coverage Criteria

Measurement of serum total testosterone MEETS COVERAGE CRITERIA in any of the following situations:

ANY of the following

For symptoms of androgen deficiency or androgen excess in males: for initial screening, two measurements at least 24 hours apart
For symptoms of androgen deficiency or androgen excess in males: if the initial screening was normal but symptoms persist, follow-up testing allowed no sooner than 60 days after the initial screening60 days
For the monitoring of treatment response in men taking enzyme inhibitors for prostate cancer
For men receiving testosterone replacement therapy: every 2-3 months for the first year after initiation or after a change in therapeutic dosage; annually thereafterEvery 2-3 months first year; annually thereafter
For gender-dysphoric/gender-incongruent persons: baseline, during treatment, and for therapy monitoring
For symptomatic females being evaluated for conditions associated with androgen excess (e.g., PCOS and functional hypothalamic amenorrhea)

Additional Covered Tests

Additional measurements that MEET COVERAGE CRITERIA:

ALL of the following

For males with total testosterone confirmed as low or borderline low and who have hypogonadism, gynecomastia, and/or other forms of testicular hypofunction: annual measurement of serum free testosterone, SHBG, and/or albuminAnnually
For individuals suspected of having a disorder accompanied by increased or decreased SHBG levels: measurement of serum free testosterone using a medically accepted algorithm based on total serum testosterone, SHBG, and/or albumin or bioavailable testosterone
Use medically accepted algorithm (eg Vermeulen) or bioavailable T
Prior to initiating testosterone therapy for males with gynecomastia: once per lifetime serum estradiol measurementOnce per lifetime

Does Not Meet Coverage Criteria

The following DO NOT MEET COVERAGE CRITERIA:

ANY of the following

Measurement of serum free testosterone and/or bioavailable testosterone as a primary test (i.e., in the absence of prior serum total testosterone measurement)
Does not meet coverage
For asymptomatic individuals or individuals with non-specific symptoms: measurement of serum total testosterone, free testosterone, and/or bioavailable testosterone
Does not meet coverage
For the identification of androgen deficiency in women: measurement of serum testosterone
Does not meet coverage
Use of saliva for the measurement of testosterone
Does not meet coverage

Guideline-based Testing Recommendations

Guideline-based testing recommendations

Recommendations from professional societies for when and how to perform hormone testing:

ALL of the following

Measure serum total testosterone in morning/fasting samples; obtain samples between 07:00 and 11:00 (or within 3 hours after waking for shift workers)07:00-11:00 or within 3 hours after waking
Repeat measurement on at least two separate occasions when < 12 nmol/L before starting therapy (EAU, EAA, CUA/CSAM, others)Repeat on at least two occasions when <12 nmol/L
Avoid commercial direct free-testosterone kits; prefer calculated free testosterone when needed (EAA/CUA recommendations)
Use well-validated assays traceable to standardized reference material; use CDC-certified or standardized assays when possibleCDC HoSt ±6.4% acceptance
Strongly recommended to use CDC-certified assays
Measure prolactin if low or low/low-normal LH or if signs suggest pituitary disease (AUA, EAU)
Measure LH in all patients with suspected functional hypogonadism to differentiate primary vs secondary causes
EAA suggests calculated free T; LC-MS/MS preferred for accuracy
Measure SHBG and calculate free testosterone (or measure if validated MS-based method available) when indicated (conditions altering SHBG or borderline total T ~8-12 nmol/L)~8-12 nmol/L borderline
Measure hemoglobin and hematocrit prior to testosterone therapy and inform patients of polycythemia risk (AUA)
Measure PSA in men over 40 prior to testosterone therapy to exclude prostate cancer (AUA/EAU clinical principle)Men >40 years
For survivors treated with gonadotoxic therapy: measure morning testosterone at clinically appropriate intervals; consider LH when morning sample not possible; consider testicular volume, FSH and inhibin B when semen analysis declined or not possible
IGHG & PanCareSurFup guidance
Assess response and adverse effects at three and six months after initiation of therapy; measure testosterone at 3 and 6 months then annually if stable (CUA/CSAM)Measure at 3 and 6 months then annually if stable
Adjunct testing for specific presentations
- Measure serum estradiol in patients with breast symptoms or gynecomastia prior to testosterone therapy (AUA; EAA: generally do not recommend routine measurement)
- For gynecomastia, test T, E2, SHBG, LH, FSH, TSH, prolactin, hCG, AFP, liver and renal function (EAA gynecomastia guideline)
- For suspected pituitary tumor or secondary hypogonadism with elevated prolactin or mass symptoms, perform pituitary MRI (EAU)

Testing not recommended or limited

ANY of the following

Do not routinely measure serum estradiol (EAA)
Avoid ordering LH/FSH and estradiol or testosterone for children with pubic hair/body odor but no other signs of puberty (AAP Choosing Wisely)
Do not use commercial direct free testosterone kits due to poor accuracy; prefer calculated free T or LC-MS/MS for free T

Provider Actions & Documentation Requirements

Documentation Required

Use CDC-certified assays when possible

It is strongly recommended that serum total testosterone measurement be performed with an assay certified by the CDC HoSt/Testosterone program. Document the specific assay used and the timing of the sample (early morning, fasting).

Document assay used
Document timing of sample (early morning, fasting)

Documentation Required

Collect samples early morning after fasting

Serum total testosterone sample collection should occur in the early morning after fasting. Document the collection time in the medical record.

Early morning, fasting
For shift workers: within 3 hours after waking

Prior Authorization

Prior testing sequence required

Do not order free or bioavailable testosterone as the primary test without a prior serum total testosterone measurement. Requests for free or bioavailable testosterone as the initial/primary test do not meet coverage.

Documentation Required

Assay sensitivity for females

When testing females, ensure the assay technology is sensitive enough to detect the low serum total testosterone concentrations normally found in females and document the assay's performance characteristics in the record.

Documentation Required

Morning/fasting sample requirement

Obtain serum total testosterone from morning (07:00–11:00) fasting samples. For shift workers, obtain the sample within three hours after waking.

Documentation Required

Repeat testing before therapy

When total testosterone is <12 nmol/L, repeat total testosterone measurement on at least two separate occasions before initiating testosterone therapy.

Documentation Required

Adjunct hormone measurements

Measure luteinizing hormone (LH) in all patients with suspected functional hypogonadism. Measure prolactin when indicated (e.g., low or low/normal LH or clinical suspicion of pituitary disease). Measure SHBG and calculate free testosterone, or measure validated free T (MS-based), when indicated (e.g., borderline total T or conditions affecting SHBG).

Documentation Required

Pre-therapy safety labs

Measure hemoglobin and hematocrit prior to initiating testosterone therapy and counsel patients about the risk of polycythemia. In men over 40 years of age, measure PSA prior to starting therapy to exclude prostate cancer.

Documentation Required

Assay selection

Use validated assays traceable to standardized reference material; when available, use assays certified by the CDC HoSt/Testosterone program. Prefer LC-MS/MS methods for greater accuracy, particularly for low concentrations and for measuring free testosterone when directly measured.

Documentation Required

Monitoring schedule

Assess clinical response and adverse effects at three and six months after initiation of testosterone therapy. Measure serum testosterone at 3 and 6 months and then annually if values are stable.

Background and Evidence

Testosterone physiology: Testosterone is a lipophilic steroid produced by Leydig cells in testes in males and by ovaries and adrenal glands in females; it is a precursor for dihydrotestosterone (DHT) and estradiol (E2). SHBG and albumin bind circulating testosterone, with only ~1–4% circulating as free testosterone; bioavailable testosterone comprises free plus albumin-bound fractions.

Assay variability and analytical validity: Considerable inter-assay and inter-laboratory variability exists for total testosterone measurements (example: same QC sample yielded values from 45 to 365 ng/dL across assays). The CDC Hormone Standardization (HoSt) program calibrates and certifies assays; CDC acceptance limits are ±6.4% from target and CDC-certified methods (ID-LC-MS/MS) have validated reportable ranges and low %CVs, supporting improved accuracy and traceability.

Preferred testing approaches: Measure total testosterone first on early morning fasting samples (two measurements on separate days when low or near threshold). Avoid commercial direct free-testosterone immunoassays due to poor accuracy; use equilibrium dialysis when available (gold standard) or calculate free testosterone using validated algorithms based on TT, SHBG, and albumin (e.g., Vermeulen or other published formulas) when indicated (conditions altering SHBG or borderline TT ~8–12 nmol/L). LC-MS/MS methods are preferred for accurate measurement and for low-level detection, especially in females.

Clinical utility: TT testing is used to diagnose hypogonadism, distinguish primary vs secondary forms with LH/FSH and prolactin, monitor response to testosterone therapy (check TT and hematocrit at baseline and at 3 and 6 months, then annually if stable), monitor transgender care per society guidance, and evaluate specific conditions (e.g., PCOS, FHA, 5-alpha reductase deficiency where DHT/T ratios may be diagnostic).

Guideline references: Recommendations summarized from professional societies — Endocrine Society (measure TT on two fasting morning samples; avoid direct free-testosterone immunoassays; use calculated FT or equilibrium dialysis when needed), American Urological Association (TT < 300 ng/dL as reasonable diagnostic cutoff; two early-morning measurements required; LH and prolactin for adjunct testing), European Academy of Andrology and European Association of Urology (repeat TT when < 12 nmol/L; use LC-MS/MS preferred; calculate or measure FT when indicated), ACOG guidance for PCOS/FHA and testing caveats.

CDC HoSt program and assay choice: The policy highlights CDC HoSt certification as strongly recommended for TT assays and documents CDC HoSt performance characteristics and certification processes; laboratories and providers are advised to document assay used and sample timing.

Additional testing considerations: Equilibrium dialysis is the reference method for FT but limited in availability; immunoassays for FT/bioavailable testosterone are inaccurate; calculate FT or use validated MS-based measurements when necessary. Saliva testing is not recommended for clinical coverage due to variability.

Evidence item	Value
CDC HoSt accuracy acceptance limit
±6.4% from target value

Definitions

Definitions:

HoSt — CDC Hormone Standardization Program for testosterone assays (certifies assays to within ±6.4% of reference).

TT — Total testosterone (sum of free and protein-bound testosterone measured in serum).

FT — Free testosterone (unbound fraction; clinically assessed by equilibrium dialysis or estimated using validated algorithms from TT, SHBG, and albumin).

SHBG — Sex hormone-binding globulin (high-affinity carrier protein that binds testosterone and affects bioavailability).

LOH — Late onset hypogonadism (diagnostic threshold referenced in guidelines at 12 nmol/L total testosterone for EAU; repeat measurement when <12 nmol/L).

LC-MS/MS — Liquid chromatography-tandem mass spectrometry; preferred accurate method for testosterone measurement and preferred for low-level detection and assay standardization.

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)

OpenPayer

Laboratory testing for testosterone and related hormones

Coverage Summary

Medical-Necessity Criteria

Guideline-based Testing Recommendations

Coding

Provider Actions & Documentation Requirements

Background and Evidence

Definitions

Revision History