Policy
Aetna considers salivary tests of cortisol, estrogen, progesterone, testosterone, melatonin or dehydroepiandrosterone (DHEA) experimental and investigational for the screening, diagnosis, or monitoring of menopause or diseases related to aging, or any other indications because these tests have not been proven to be valid alternatives to serum tests.
Note: In addition, laboratory tests are not covered unless they are ordered by a physician or other qualified health professional. Please check benefit plan descriptions
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Background
Salivary tests of estrogen, progesterone, testosterone, melatonin, cortisol and DHEA have become available to consumers over the Internet. Some of these websites include a questionnaire to allow consumers to determine whether they need saliva testing, and a form that allows consumers to order these tests online. The results of these tests are purportedly used to determine the need prescriptions of DHEA, vitamins, herbs, phytoestrogens, and other anti-aging regimens.
The medical literature on salivary testing correlates salivary levels with serum levels, the gold standard measurement. However, the medical literature fails to demonstrate that salivary tests are appropriate for screening, diagnosing, or monitoring patients with menopause, osteoporosis, or other consequences of aging.
Evidence-based clinical practice guidelines from the American Association of Clinical Endocrinologists outline the appropriate methods of screening and diagnosing menopause and osteoporosis. The primary test for menopause screening is serum FSH, for thyroid dysfunction serum TSH, and bone density measurement is the primary method of screening for osteoporosis. None of these guidelines indicates salivary testing as an appropriate method of screening, diagnosing, or monitoring these disorders.
According to available guidelines, primary hypoadrenalism (Addison’s disease) is suggested by a markedly elevated plasma adrenocorticotrophic hormone (ACTH) with low or normal serum cortisol. The diagnosis of adrenocortical insufficiency is established primarily by use of the rapid ACTH stimulation test, which involves assessment of the response of serum aldosterone and cortisol to ACTH infusion.
Furthermore, there is inadequate evidence of the value of measuring salivary components to guide prescription of "anti-aging" regimens. The clinical value of these tests depends not only on how well the salivary testing corresponds to some gold standard (i.e., a serum test), but also upon the evidence of the effectiveness of the particular intervention (anti-aging regimen) that would be prescribed based on the results of the salivary test. Meta-analyses of the literature have questioned the value of supplementation with DHEA and melatonin on improving patient outcomes.
According to a committee opinion by the American College of Obstetricians and Gynecologists (ACOG, 2005), there is no scientific evidence to support claims of increased safety or effectiveness for individualized estrogen or progesterone regimens prepared by compounding pharmacies. Furthermore, hormone therapy does not belong to a class of drugs with an indication for individualized dosing. The opinion by ACOG also pointed out that salivary hormone level testing used by proponents to 'tailor' this therapy isn't meaningful because salivary hormone levels vary within each woman depending on her diet, the time of day, the specific hormone being tested, and other variables.
A National Institutes of Health State-of-the-Art Conference Statement on Management of Menopausal Symptoms (2005) reached the following conclusions about salivary hormone testing and bioidential hormones: "Bioidentical hormones, often called 'natural' hormones, are treatments with individually compounded recipes of a variety of steroids in various dosage forms, with the composition and dosages based on a person’s salivary hormone concentration. These steroids may include estrone, estradiol, estriol, DHEA, progesterone, pregnenolone, and testosterone. There is a paucity of data on the benefits and adverse effects of these compounds."
An assessment by the Institute for Clinical Systems Improvement (2006) concluded: "Currently, there is insufficient evidence in the published scientific literature to permit conclusions concerning the use of salivary hormone testing for the diagnosis, treatment or monitoring of menopause and aging."
The North American Menopause Society (2005) has concluded: "Salivary testing is not considered to be a reliable measure of testosterone levels."
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