Currentblue cross blue shield - tennesseePolicy N/A

Testosterone – G2013

Defines coverage criteria and limitations for measurement of serum total, free, bioavailable testosterone and related tests (SHBG, albumin, estradiol, dihydrotestosterone) for diagnosis and monitoring across indications including male hypogonadism, prostate cancer monitoring, gender-affirming care, gynecomastia, androgen excess in females, and congenital disorders.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyTestosterone – G2013

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain two serum total testosterone measurements at least 24 hours apart for initial screening of males with symptoms of androgen deficiency or excess.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes — policy content remains unchanged.

6Key covered indications listed

5Not-covered test situations listed

8CPT codes referenced

Coverage Summary

This policy provides coverage criteria for laboratory measurement of serum testosterone and related tests with a mixed coverage stance: some indications and follow-up/monitoring scenarios MEET COVERAGE CRITERIA while other uses DO NOT. Key covered populations and indications include: males with suspected hypogonadism or androgen excess, monitoring men on prostate cancer enzyme inhibitors, men receiving testosterone replacement therapy, gender-dysphoric/gender-incongruent persons for baseline and monitoring, symptomatic females evaluated for androgen excess (e.g., PCOS), evaluation of gynecomastia, and diagnosis/assessment of certain congenital disorders (e.g., 5-alpha reductase deficiency). The policy recommends using assays certified by the CDC HoSt/Testosterone program when available.

Medical-Necessity Criteria

Covered Indications (MEETS 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.
Follow-up if initial normal: If the initial screening was normal but symptoms persist, follow-up testing is allowed no sooner than 60 days after the initial screening.>= 60 days
Prostate cancer monitoring: For the monitoring of treatment response in men taking enzyme inhibitors for prostate cancer.
Testosterone replacement therapy monitoring: For men receiving testosterone replacement therapy (every 2-3 months for the first year after initiation of therapy or after a change in therapeutic dosage; annually thereafter).every 2-3 months for first year; annually thereafter
Gender-dysphoric/gender-incongruent care: For gender-dysphoric/gender-incongruent persons (baseline, during treatment, and for therapy monitoring).
Symptomatic females with androgen excess: For symptomatic females being evaluated for conditions associated with androgen excess (e.g., polycystic ovary syndrome and functional hypothalamic amenorrhea).

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Additional Covered Tests

The following measurements MEET COVERAGE CRITERIA when indicated:

ANY of the following

Annual measurement after low or borderline total testosterone: 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 albumin.annual
Free testosterone calculation or bioavailable testing: 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.
Lifetime estradiol prior to therapy for gynecomastia: Prior to initiating testosterone therapy for males with gynecomastia, once per lifetime serum estradiol measurement.

Not Covered (DOES NOT MEET COVERAGE CRITERIA)

The following testing situations do not meet coverage criteria:

ANY of the following

Free/bioavailable not primary: 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 CRITERIA.
Asymptomatic or non-specific symptoms: For asymptomatic individuals or for individuals with non-specific symptoms, measurement of serum total testosterone, free testosterone, and/or bioavailable testosterone DOES NOT MEET COVERAGE CRITERIA.
Identification of androgen deficiency in women: For the identification of androgen deficiency in women, measurement of serum testosterone DOES NOT MEET COVERAGE CRITERIA.
Saliva testing:

Provider Actions

Documentation Required

Initial total testosterone screening

Obtain two serum total testosterone measurements at least 24 hours apart for initial screening of males with symptoms of androgen deficiency or androgen excess.

84403

Documentation Required

Follow-up after normal initial test with persistent symptoms

If the initial total testosterone is normal and symptoms persist, document the persistence of symptoms and perform follow-up total testosterone testing no sooner than 60 days after the initial screening.

84403
>= 60 days

Documentation Required

Monitoring while on testosterone therapy

For men receiving testosterone replacement therapy, monitor testosterone levels every 2–3 months during the first year after initiation of therapy or after a change in therapeutic dosage, then annually thereafter; document the timing of tests, results, and any dose changes.

84403
84402
every 2-3 months for first year; annually thereafter

Prior Authorization

Assay certification recommendation

It is strongly recommended that serum total testosterone measurement be performed with an assay certified by the CDC HoSt/Testosterone program; document the assay used and the certification (CDC HoSt/Testosterone) if available.

CDC HoSt/Testosterone = CDC's Hormone Standardization program for total testosterone assays

Documentation Required

Use of free/bioavailable testosterone

Do not use free or bioavailable testosterone as the primary diagnostic test in the absence of a prior total testosterone measurement; if ordering free or bioavailable testing after total testosterone, document the indication and prior total testosterone result.

84402
84410

Background

Testosterone is produced by Leydig cells in the testes in males and by the ovaries and adrenal glands in females; it serves as a precursor for dihydrotestosterone and estradiol. Sex hormone-binding globulin (SHBG) binds testosterone in circulation and affects transport and bioavailability. Additional pituitary hormones—follicle-stimulating hormone (FSH), luteinizing hormone (LH), and prolactin—participate in the hypothalamic-pituitary-gonadal axis and are useful in diagnostic evaluation when dyshomeostasis is suspected. In this policy, terms such as male and female refer to sex assigned at birth. Recommendations are provided in the context of Endocrine Society and other clinical practice guidelines.

TermHoSt/Testosterone

DefinitionCDC's Hormone Standardization program for total testosterone assays.

The CDC HoSt/Testosterone certification indicates that certified total testosterone assays are standardized to within ±6.4% of the CDC total testosterone reference standard; the policy strongly recommends performing serum total testosterone measurement with a CDC HoSt-certified assay when available.

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

Testosterone – G2013

Coverage Summary

Medical-Necessity Criteria

Coding

Provider Actions

Background