CAM 131

Testosterone Testing

Category:Laboratory   Last Reviewed:January 2020
Department(s):Medical Affairs   Next Review:January 2021
Original Date:January 2016    

Description/Background
The steroid hormone testosterone plays a role in development and health. Production of testosterone is controlled by the pituitary gland, specifically by luteinizing hormone (LH), via negative feedback. Most of the testosterone circulating in blood is bound to sex-hormone binding globulin (SHBG), and a lesser amount is bound loosely to albumin, while a very small fraction occurs in the biologically active or "free" form. "Bioavailable" testosterone is considered to be the combination of that which is free and that which is bound to albumin in circulation.

Low testosterone can result in delayed puberty, and can indicate testicular failure. In adults, decreases in testosterone production occur normally with age, typically starting gradually in the mid-40s, and more pronounced after 60 years of age. Significant decreases may result in symptoms such as fatigue, decreased libido, erectile dysfunction, depression, muscle weakness, and others. Unfortunately, these symptoms are not specific to testosterone deficiency. Low testosterone levels are associated with diabetes, metabolic syndrome, cardiovascular disease, obesity, sleep apnea, and other disorders. Therefore, the evaluation of patients with symptoms of testosterone deficiency should not be limited to measurement of testosterone levels. Co-morbid conditions that may be the underlying cause of the low testosterone should be investigated as well. Association of low testosterone with increased risk of death from all causes has been noted, providing additional impetus for accurate assessment and treatment.

For symptomatic individuals who are testosterone deficient, and in whom the symptoms are directly caused by low testosterone, testosterone replacement therapy may relieve symptoms and improve quality of life. However, concurrent improvements in healthy living are also recommended.

Additionally, testosterone elevations are associated with serious conditions, including tumors, hyperthyroidism, genetic disorders, including congenital adrenal hyperplasia, and polycystic ovarian syndrome (PCOS). 

Policy

  1. Testing for serum total testosterone is considered MEDICALLY NECESSARY in symptomatic individuals being evaluated for androgen deficiency.  For pre-pubescent individuals, the technology used for testing should be sensitive and specific enough to quantify accurately the low concentrations normally found in that population.
  2. Repeat testing for serum total testosterone is considered MEDICALLY NECESSARY in individuals with low initial serum testosterone results.  Sample collection should occur in early morning, and at least one week after the initial test.
  3. Measurement of serum free testosterone and/or bioavailable testosterone is considered MEDICALLY NECESSARY if total testosterone is confirmed as borderline or low.
  4. Testing for serum total testosterone is considered MEDICALLY NECESSARY in symptomatic individuals being evaluated for conditions associated with androgen excess.  For infants and pre-pubescent individuals, the technology used for testing should be sensitive and specific enough to quantify accurately the low concentrations normally found in that population.
  5. Testing for serum total testosterone is considered MEDICALLY NECESSARY in symptomatic individuals being evaluated for conditions associated with androgen excess (e.g., polycystic ovary syndrome and functional hypothalamic amenorrhea).  The technology used for testing should be sensitive enough to detect the low concentrations normally found in this population.
  6. Measurement of serum free testosterone and/or bioavailable testosterone is considered MEDICALLY NECESSARY in individuals suspected of having a disorder that is accompanied by increased or decreased SHBG levels.
  7. Testosterone measurements is considered MEDICALLY NECESSARY in monitoring treatment response in individuals taking enzyme inhibitors for prostate cancer.
  8. Testing for serum total testosterone is considered MEDICALLY NECESSARY in individuals receiving testosterone replacement therapy every 3-6 months  for the first year after initiation of therapy, and annually thereafter.
  9. Testing for serum total testosterone, free testosterone, and/or bioavailable testosterone is considered NOT MEDICALLY NECESSARY in asymptomatic individuals or in individuals with non-specific symptoms.
  10. Testing for serum testosterone is considered NOT MEDICALLY NECESSARY for the identification of androgen deficiency in biologic females.
  11. Salivary testing for testosterone is INVESTIGATIONAL.

Rationale 
The Endocrine Society recommends measurement of serum testosterone in individuals with specific symptoms such as incomplete or delayed sexual development, eunuchoidism, reduced libido, breast discomfort, shrinking testes, and others. They also recommend consideration of serum testosterone evaluation for individuals with non-specific symptoms such as fatigue, depression, poor concentration, sleep disturbance, and others. Additionally, The Endocrine Society suggests that androgen deficiency not be evaluated during acute or sub-acute illness.

The Endocrine Society recommends use of total testosterone measurement from a morning sample, with confirmation by repeat testing for results that are low or borderline, or in those suspected of abnormal SHBG levels. Repeat testing should also include measurement of free or bioavailable testosterone. They note that all testing should be performed with reliable, validated assays.

The Endocrine Society recommends against androgen deficiency screening in the general population.

For individuals receiving testosterone replacement therapy, the Endocrine Society recommends monitoring serum testosterone levels 3 to 6 months after initiation of therapy.

The American Association of Clinical Endocrinology (AACE) also recommends use of a morning sample for determination of serum total testosterone in individuals being evaluated for androgen deficiency. Additionally, AACE recommends repeat testosterone measurement and use of SHBG or free testosterone testing "if testosterone levels are low-normal and the symptoms and signs indicate hypogonadism."

For individuals receiving testosterone replacement therapy, AACE recommends measurement of serum testosterone levels every 3 - 4 months for the first year after initiation of therapy, as part of the overall monitoring of therapy effectiveness.

The British Columbia Medical Association also recommends against screening for testosterone deficiency in asymptomatic individuals, and indicates that presence of erectile dysfunction alone is not sufficient to warrant serum testosterone testing. They also recommend against serum testosterone testing in females for the purpose of identifying hypoandrogenism.

Relative to the diagnosis of PCOS, the Endocrine Society identifies three criteria that may be evaluated: androgen excess, ovulatory dysfunction, and polycystic ovaries. Two of the three criteria are sufficient for diagnosis, and if both clinical criteria are met, they do not recommend testing for androgen excess.. 

References 

  1. "Androgen deficiency in older men: Indications, advantages, and pitfalls of testosterone replacement therapy." Retrieved on January 14, 2014 from http://www.ccjm.org/content/79/11/797.full.pdf
  2. "The Role of Routine Serum Testosterone Testing: Routine Hormone Analysis Is Not Indicated as an Initial Screening Test in the Evaluation of Erectile Dysfunction." Retrieved on January 14, 2014 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1472836/pdf/RIU006004_0203.pdf, 2014.
  3. "Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline." Journal of Clinical Endocrinology & Metabolism, June 2010, Vol. 95(6):2536–2559.
  4. "American Association Of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients—2002 Update." Endocrine Practice, Vol. 8, No. 6, November/December 2002 439-456.
  5. "Diagnosis and Treatment of Polycystic Ovary Syndrome: An Endocrine Society Clinical Practice Guideline." Journal of Clinical Endocrinology & Metabolism, December 2013.
  6. "Testosterone Testing Protocol." British Columbia Medical Association, June, 2011. Accessed February, 2014 at www.BCGuidelines.ca

Coding Section 

Codes Number Description
CPT  82642 (effective 01/01/2019) Dihydrotestosterone (DHT) 
  84402 Testosterone; free
  84403 Testosterone; total 
  84410 (effective 1/1/2017)  bioavailable, direct measurement (eg, differential precipitation) 
ICD-10-CM  E28.1 Androgen excess 
  E29.0-E29.9 Testicular dysfunction 
  E30.0 Delayed puberty 
  F32.0-F33.9

Depression 

  G47.8-G47.9 Sleep disorders 
  N50.0 Atrophy of testis 
  N50.8 Other spec disorders, male genital organs 
  N50.9 Disorder of male genital organs, unspecified 
  N64.4 Breast pain 
  R41.840 Attention/concentration deficit 
  R41.9 Unspecified symptoms/signs involving cognitive functions and awareness 
  R53.81, R53.83

Fatigue 

  R68.82 Decreased libido 
  Z92.240-Z92.241 Personal history, steroid therapy 
  L70.0-L70.9 Acne 
  R63.5 Excessive weight gain 
  L68.0 Hirsutism 
  N91.0-N91.5 Absent, scanty and rare menstruation 
  N92.0-N92.6 Excessive, frequent/irregular menstruation 
  N94.89-N94.9 Specified conditions associated with female genital organs and menstrual cycle 
  N97.0-N97.9 Female infertility 
  E88.81 Metabolic syndrome (insulin resistance) 
  R73.01-R73.09 Abnormal glucose 
  E08-E13 Diabetes 
  E28.2 Polycystic Ovarian Syndrome 
  E24.0-E24.9 Cushing’s Syndrome 
  E03.9 Hypothyroidism 
  E22.0 Acromegaly 
  E05.0-E05.9 Thyrotoxicosis 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2016 Forward     

01/02/2020 

Annual review, no change to policy intent 

02/05/2019 

Annual review. Updating policy. 

01/07/2019 

Added effective date to code 82642 

12/19/2018 

Updating with 2019 codes.  

01/30/2018 

Annual review, no change to policy intent 

04/26/2017 

Updated category to Laboratory. No other changes made. 

04/10/2017 

Interim Review. Updated policy verbiage. No other changes made. 

01/25/2017 

Addition to annual review. Adding an example of what androgen excess in females would be and updating the verbiage in criteria number 7 to include enzyme inhibitors 

01/03/2017 

Annual review, no change to policy intent. 

11/30/2016 

Updated Coding Section with 2017 codes. 

01/07/2016

NEW POLICY


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