Medical Policy: 02.04.05
Original Effective Date: May 1998
Reviewed: August 2020
Revised: August 2017
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.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
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 either females or males which can occur at any age and effect how a person feels on a daily basis. 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.
A number of 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, DHEA and cortisol) has been proposed for the screening, diagnosis, and monitoring of menopause 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.
It has been observed that salivary estriol levels surge several weeks before the onset of spontaneous preterm labor. Therefore, measurement of salivary estriol has been explored as a risk predictor for preterm labor. SalEst™ is a laboratory technique approved by the FDA for measuring salivary estriol as a risk assessment marker of preterm labor and delivery.
The use of bioidentical hormones (BHT) has escalated in recent years, along with the use of salivary hormone testing, which has been proven to be inaccurate and unreliable.
Salivary hormone level testing is recommended by many bioidentical hormone proponets 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 NAMS addressed salivary hormone testing with regards to MHT, stating that salivary hormone testing is "inaccurate and unreliable". The NAMS further notes that 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".
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. First, salivary levels do not consistently provide a reasonable representation of endogenous, circulating serum hormones. There is within patient variability in salivary hormone concentrations, especially when exogenously administered hormones are given. Salivary hormone levels vary depending on diet, time of testing, and the specific hormone being tested. Second, because the pharmacokinetics of exogenously administered compounded hormones cannot be known, it is not possible to estimate with reliability how and when to test saliva to obtain a representative result. Third, saliva contains far lower concentrations of hormone than serum and its prone to contamination with blood, infectious agents, and epithelial cells all of which may affect the level of hormone to be measured.
Although more sensitive testing is becoming available through the use of mass spectrometry, there are few indications for the measurement of hormone levels to ascertain success of therapy when treating postmenopausal women 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.
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 and other conditions and therefore is considered investigational.
The use of Saliva hormone tests including but not limited to estrogen (estradiol), progesterone, testosterone, melatonin, cortisol or dehydroepiandrosterone (DHEA) in males or females of any age is considered investigational for all indications, including but not limited to:
Based on the peer reviewed literature there is lack of clinical evidence to indicate its validity as an appropriate form of testing and also fails to demonstrate that this testing is appropriate for screening, diagnosing, or monitoring patients with menopause or other conditions and therefore, is considered investigational.
The use of salivary estriol levels as a predictor of preterm labor is considered investigational.
There are no published clinical studies that demonstrate that treatment decisions made based on the results of salivary estriol testing can be used to enhance patient management and improve beneficial health outcomes.
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