Medical Policy: 02.04.05
Original Effective Date: May 1998
Reviewed: August 2021
Revised: August 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Saliva is produced primarily by the parotid, sublingual, and submandibular glands. Salivary fluid may contain various amounts of hormones, depending on the ability of these hormones to leave the blood, penetrate through or around the salivary cell membranes, and diffuse into the saliva. Lipid-soluble hormones can pass directly through cell membranes via passive diffusion and are commonly found in the saliva. Small, water-soluble hormones may be able to enter the saliva through the tight junctions between salivary cells in a process called ultrafiltration. Salivary cells do not appear to use active transport to place hormones into the saliva.
Salivary tests may help to identify hormonal imbalances in individuals which can occur at any age and effects how a person feels daily. The slightest dysfunction of an individual’s hormones can result in weight gain, mood changes, low libido, poor memory or concentration, depression, bone loss, migraines or headaches and sleep disorders. Salivary testing can also be used to monitor the outcomes of hormonal replacement therapy.
Several laboratory tests are now being offered to consumers as home-based testing. Among these tests, saliva testing for certain hormones (e.g., estrogen (estradiol), progesterone, testosterone, dehydroepiandrosterone (DHEA) and cortisol) has been proposed for the screening, diagnosis, and/or monitoring of menopause, preterm labor, and other conditions.
The saliva used for hormone testing may be collected in the clinic setting or by the individual at home. The sample is then sent to a laboratory for evaluation.
The results of the test may then be used to determine the need for vitamins, herbs, and phyto-hormones (e.g., phytoestrogen and phytotestosterone). These may be manufactured products (e.g., vitamins, topical creams) or products compounded specifically for the individual.
Preterm birth is a major complication of pregnancy and remains a leading cause of neonatal morbidity and mortality worldwide. Improvements in the understanding of the pathophysiology of preterm labor have led to the development of novel diagnostic tools of use to identify women at greatest risk for preterm birth. Currently two FDA-approved biochemical tests are available in the United States:
A practice bulletin from ACOG issued in 2002 (no updated bulletin found in 2021) on preterm saliva testing states the following:
The relevant population(s) of interest are patients presenting with hormone changes due to preterm labor or menopause.
The intervention includes saliva hormone tests including but not limited to estrogen (estradiol), progesterone, testosterone, melatonin, and/or dehydroepiandrosterone (DHEA) which can be used to monitor the outcomes of hormonal replacement therapy.
The comparators of interest are standard of care: serum specimen for measurement of hormones.
The outcomes of interest are to diagnose and treat the underlying condition correctly.
A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).
A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.
Serum is the standard specimen used for measurement of hormones. Because saliva is similar to a blood ultrafiltrate, it has been theorized that salivary hormone concentrations may correlate with free/unbound serum concentrations. However, the promotion of saliva testing has been criticized. Critics site a lack of scientific evidence supporting the use of salivary hormone levels for determining and monitoring hormone therapy. They also claim that hormone concentrations in saliva are highly variable and may not correlate with biological or clinical response to treatment, that salivary hormone levels may not reflect free hormone levels in blood, and that the large variability associated with salivary hormone assays makes them unreliable. Therefore, the medical literature fails to demonstrate that salivary tests are appropriate for screening, diagnosing, or monitoring patients with menopause, preterm labor, and other conditions and therefore is considered investigational.
There is no evidence that hormonal levels in saliva are biologically meaningful. In addition, whereas saliva is an ultrafiltrate of the blood and in theory should be amendable to testing for "free" (unbound) concentrations of hormones, salivary testing does not currently offer an accurate or precise method of hormone testing. There are several problems with salivary testing and monitoring of free hormone levels.
Although more sensitive testing is becoming available using mass spectrometry, there are few indications for the measurement of hormone levels to ascertain success of therapy when treating postmenopausal woman with hormones. If treatment is initiated for symptom control, subjective improvement in symptoms is the therapeutic end point, and there is no need to assess hormone levels. Hormone therapy should not be titrated to hormone levels (serum, urinary or salivary).
Compounded hormone therapy (HT) has been prescribed or dosed on the basis of salivary hormone testing; however, salivary testing for HT is considered unreliable because of differences in hormone pharmacokinetics and absorption, diurnal variation, and interindividual and intraindividual variability.
Salivary hormone testing with regards to menopausal hormone therapy, stating that salivary hormone testing is "inaccurate and unreliable". The levels in serum, saliva, and tissue are "markedly different" and alludes to the FDA’s statement that there is "no scientific basis for using saliva testing to adjust hormone levels". The recommendations for clinical care include salivary testing of reproductive hormones is inaccurate and never indicated.
Salivary hormone level testing is recommended by many bioidentical hormone proponents as a means of providing patients with "individualized" therapy. Yet these methods are not approved by either the FDA or the Clinical Laboratory Improvement Amendments (the US Health and Human Services agency regulating laboratory standards). Accurate studies have revealed large intra-subject variability in salivary hormone concentrations, which fluctuate depending on numerous variables, including diet, hydration, and circadian rhythm. These conditions are difficult to standardize. Standardized blood tests, which are available for sex steroids, are well established but have limited clinical value in evaluating menopausal hormone therapy (MHT). (Evidence Level: 4 no evidence (theory, opinion, consensus, or review).
The use of salivary testing for individuals with menopause is considered investigational for all indications.
The use of salivary testing to assess preterm labor risk is considered investigational for all indications.
Based on the peer reviewed literature there is lack of clinical evidence to indicate the treatment decisions made based on the results of salivary testing for menopause and preterm labor risk can be used to enhance patient management and improve beneficial health outcomes.
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