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Clinical Policy Bulletin:
Salivary Hormone Tests
Number: 0608


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



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."

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes not covered for indications listed in the CPB (not all-inclusive):
82530
82533
82626
82627
82670
82671
82672
82677
82679
84144
84402
84403
84436
84437
84439
84443
84479
84480
84481
HCPCS codes not covered for indications listed in the CPB:
S3650 Saliva test, hormone level; during menopause
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
255.41 - 255.42 Corticoadrenal insufficiency
256.2 Postablative ovarian failure
256.31 Premature menopause
627.0 - 627.9 Menopausal and postmenopausal disorders
733.00 - 733.09 Osteoporosis
V07.4 Hormone replacement therapy (postmenopausal)
V49.81 Asymptomatic postmenopausal status (age-related) (natural)
V82.81 Special screening for osteoporosis


The above policy is based on the following references:
  1. American Association of Clinical Endocrinologists (AACE). Medical guidelines for clinical practice for management of menopause. Endocrine Pract. 1999;5:355-366. Available at: http://www.aace.com/clin/guides/menopause.pdf. Accessed February 15, 2002.
  2. Hodgson SF, Watts NB, Bilezikian JP, et al. .American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition, with selected updates for 2003. Endocr Pract. 2003;9(6):544-564..
  3. AACE Thyroid Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr Pract. 2002;8(6):457-469..
  4. Huppert FA, Van Niekerk JK, Herbert J. Dehydroepiandrosterone (DHEA) supplementation for cognition and well-being (Cochrane Review). In: The Cochrane Library. Issue 4, 2002. Oxford, UK: Update Software. Available at:http://www.update-software.com/abstracts/ab000304.htm. Accessed February 15, 2002.
  5. Herbert V, Kava R. The miracle of melatonin? Priorities (American Council on Science and Health). 1995;7(4). Available at: http://www.hcrc.org/contrib/acsh/articles/melaton.html. Accessed February 15, 2002.
  6. No authors listed. Melatonin: Interesting, but not miraculous. Prescrire Int. 1998;7(38):180-187.
  7. Contreras LN, Arregger AL, Persi GG, et al. A new less-invasive and more informative low-dose ACTH test: Salivary steroids in response to intramuscular corticotrophin. Clin Endocrinol (Oxf). 2004;61(6):675-682.
  8. [No authors listed.] Chronic hypoadrenalism. GPNotebook. General Practitioner Notebook. Warwickshire, UK: Oxbridge Solutions, Ltd.; 2005. Available at: http://www.gpnotebook.co.uk/simplepage.cfm?ID=2127560704. Accessed September 16, 2005.
  9. Odeke S, Nagelberg SB. Addison disease. eMedicine Endocrinology Topic 42. Omaha, NE: eMedicine.com; updated November 25, 2003. Available at: http://www.emedicine.com/med/topic42.htm. Accessed September 16, 2005.
  10. Rubin GJ, Hotopf M, Papadopoulos A, Cleare A. Salivary cortisol as a predictor of postoperative fatigue. Psychosom Med. 2005;67(3):441-447.
  11. American College of Obstetricians and Gynecologists (ACOG) Committee on Gynecologic Practice. ACOG Committee Opinion #322: Compounded bioidentical hormones. Obstet Gynecol. 2005;106(5 Pt 1):1139-1140.
  12. National Institutes of Health (NIH). NIH State-of-the-Science Conference Statement on Management of Menopause-Related Symptoms. NIH Consensus and State-of-the-Science Statements. Bethesda, MD: NIH: March 21-23; 22(1). 
  13. Institute for Clinical Systems Improvement (ICSI). Menopause and hormone therapy (HT): Collaborative decision-making and management. Bloomington, MN: ICSI; October 2006.
  14. The North American Menopause Society. The role of testosterone therapy in postmenopausal women: Position statement of The North American Menopause Society. Menopause. 2005;12(5):497-511.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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