Saliva Testing for Hormone Levels
DESCRIPTION
Saliva hormone tests are used as a baseline measurement to identify female hormone levels in Saliva hormone tests are used as a baseline measurement to identify female hormone levels in the blood stream of premenopausal, perimenopausal and postmenopausal women. The result of the saliva hormone test is then used to initiate hormone replacement therapy. Salivary hormone tests include but are not limited to estrogens, progesterone, testosterone, cortisol, melatonin and dehydroepiandrosterone (DHEA).
POLICY
Saliva testing for hormone replacement therapy, screening, diagnosing, or monitoring menopause (pre, peri, and post), osteoporosis, and anti-aging is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
The lack of any well-designed randomized controlled trials or studies regarding saliva testing provides little evidence of clinical efficacy.
SOURCES
AACE Reproductive Medicine Committee. (2007, July). American Association of Clinical Endocrinologists (AACE) Reproductive Medicine Committee position statement on bioidentical hormones. Retrieved February 20, 2009 from http://www.aace.com/pub/pdf/guidelines/AACEBHStatement071507.pdf.
ACOG Committee on Gynecologic Practice. (2005). ACOG Committee Opinion #322: Compounded bioidentical hormones. Obstetrics and Gynecology, 106 (5 Pt 1), 1139-1140. (198 articles and/or guidelines reviewed)
Fugh-Berman, A., & Bythrow, J. (2007). Bioidentical hormones for menopausal hormone therapy: Variation on a theme. Journal of General Internal Medicine, 22 (7), 1030-1034.
Flyckt, R. L., Liu, J., Frasure, H., Wekselman, K., Buch, A., & Kingsberg, S. A. (2009). Comparison of salivary versus serum testosterone levels in postmenopausal women receiving transdermal testosterone supplementation versus placebo. Menopause, 16 (4), 680-688. Abstract retrieved October 6, 2010 from PubMed database.
Institute for Clinical Systems Improvement (ICSI). (2008, October). Health care guideline: Menopause and hormone therapy (HT): Collaborative decision-making and management. Retrieved February 20, 2009 from http://www.icsi.org/menopause_and_hormone_therapy/menopause_and_hormone_replacement_therapy_ht___collaborative_decision_making_and_management_.html.
Kaufman, E. & Lamster, I. B. (2002). The diagnostic applications of saliva - A review. Critical Reviews in Oral Biology and Medicine, 13 (2), 197-212.
Li, Y., Denny, P., Ho, C. M., Montemagno, C., Shi, W., Qi, F., et al. (2005). The Oral Fluid MEMS/NEMS Chip (OFMNC): Diagnostic and translational applications. Advances in Dental Research, 18 (1), 3-5.
Stephenson, K. (2004). The salivary hormone profile in the clinical evaluation of women. International Journal of Pharmaceutical Compounding, 8 (6), 427-435.
U. S. Food and Drug Administration. (2004, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K041349. Retrieved February 20, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K041349.pdf.
U. S. Food and Drug Administration. (2005, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K051733. Retrieved February 20, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051733.pdf.
ORIGINAL EFFECTIVE DATE: 7/11/2009
MOST RECENT REVIEW DATE: 11/11/2010
ID_BT
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