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MP 2.04.95

Salivary Hormone Testing


 

Medical Policy    
Section
Medicine
 
Subsection Last Review Status/Date
Created with Literature search/3:2011
Issue
3:2011
Original Policy Date
3/2011
Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

 


 

Description

There remains interest in testing various hormone levels using saliva as the specimen rather than blood, plasma, or urine. Salivary testing has been viewed as potentially more advantageous due to its noninvasive nature and the relative ease and convenience of sample collection, which can be done in the home. Most steroid-based hormones, such as estrogen, progesterone, androgens, dehydroepiandrosterone (DHEA) and cortisol, are bound to carrier proteins which carry them through the blood stream.  About one to five percent are present in the blood unbound or free. The free hormones are able to enter into target tissues as well as accumulate in saliva. Thus, salivary hormone levels may reflect “free” (active) blood hormone levels.

Consumers now have the ability to order home saliva tests over the Internet for some hormones such as estrogen, progesterone, testosterone, melatonin, cortisol, and dehydroepiandrosterone (DHEA). A physician's prescription is not required for these saliva tests, which are primarily promoted for the evaluation of menopause and aging. 

 

 

 


 

Policy

Salivary hormone testing is considered investigational for all indications, including but not limited to the screening, diagnosis and/or monitoring of aging, endocrine conditions, and menopause.  Salivary hormone tests include, but are not limited to:

  • Cortisol 
  • DHEA 
  • Estrogen 
  • Melatonin 
  • Progesterone 
  • Testosterone 

 


 

Policy Guidelines

not applicable

 


 

Rationale

Hormone concentrations in saliva are subject to a number of factors, which influence their correlation with the total plasma concentration, or the unbound ('free') fraction of hormone. Such factors include: binding affinity for specific protein carriers; saliva flow; use of pharmacologic agents, which may disturb the ratio of free to bound hormone by displacing the bound hormone; metabolism of the hormone by salivary gland epithelial cells or oral bacteria; circadian rhythms; and contamination of the saliva specimen with blood, food, gingival fluid, or tissue debris. [1,2]

Despite these variables, the technical feasibility of measuring some salivary hormone levels has been demonstrated in some published studies. However, it is not clear that standardized protocols for measuring salivary hormone levels are used. [1,3]  There also continues to be a need for a protocol for sample collection and handling. Whembolua and colleagues studied the saliva sample of 19 healthy adults who provided saliva samples upon rising in the morning, rinsed their mouths with water, and donated a second specimen 10 minutes later. [4] Samples were either left untreated or passed through a 0.22-micron filter and then frozen at -80°C or incubated at room temperature for 10 days. Aliquots of each sample were cultured on agar to determine baseline and post-incubation (or freezing) bacteria load. Bacteria counts were not significantly influenced by rinsing (with water), were substantially reduced by filtration, and increased by incubation at room temperature.

Average levels of salivary testosterone and cortisol, but not DHEA, were significantly lower in samples stored at room temperature than samples frozen the day of collection. The change in bacteria count induced by storing samples at RT was associated with a change in testosterone but not cortisol or DHEA. When samples were passed through a 0.22-micron filter bacteria counts were reduced, and the association between bacteria and testosterone was reduced to nonsignificant. These findings contribute to a growing body of literature revealing that the process of sample collection, storage, and handling can dramatically influence the accuracy of information generated when salivary biomarkers are integrated into research and clinical diagnostics. Normal and abnormal values as studied in different clinical situations must be established. For accurate interpretation of study results, sensitivities, specificities, and positive and negative predictive values compared to a gold standard must be known.

There are no published studies documenting sensitivity, specificity, or positive and negative predictive values for any salivary hormones when used to diagnose, treat, or monitor menopause or aging.

The clinical utility of both positive and negative tests must be established. The clinical utility of a diagnostic technique is related to how the results of that study can be used to benefit patient management. Relevant outcomes of a negative test (ie, suspected pathology is not present) may be avoidance of more invasive diagnostic tests or avoidance of ineffective therapy. Relevant outcomes of a positive test (ie, suspected outcome is present) may also include avoidance of a more invasive test plus the institution of specific, effective therapy.

There are no published clinical trials that demonstrate how the results of salivary hormone testing can be used clinically to direct patient treatment of menopause or aging. In addition, clinical practice guidelines from the North American Menopause Society and the Institute for Clinical Systems Improvement consider evidence to be insufficient to consider salivary hormone testing reliable. [5,6] The American College of Obstetrics and Gynecologists states 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'. [7] There are no published national practice guidelines that advocate the use of salivary hormone testing in the diagnosis, treatment or monitoring of menopause or aging.

In summary, 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.

 

 

 

 

 

References:

  1. Saliva as a Diagnostic Fluid. Conference proceedings. Panama City Beach, Florida, October 22-25, 1992. Ann N Y Acad Sci. 1993 Sep 20;694:1-348.  PMID: 8105740
  2. Lawrence, HP. Salivary markers of systemic disease: noninvasive diagnosis of disease and monitoring of general health. J Can Dent Assoc. 2002 Mar;68(3):170-4.  PMID: 11911813
  3. Vining, RF, McGinley, RA. The measurement of hormones in saliva: possibilities and pitfalls. J Steroid Biochem. 1987;27(1-3):81-94.  PMID: 3320544 
  4. Whembolua, GL, Granger, DA, Singer, S, Kivlighan, KT, Marguin, JA. Bacteria in the oral mucosa and its effects on the measurement of cortisol, dehydroepiandrosterone, and testosterone in saliva. Horm Behav. 2006 Apr;49(4):478-83.  PMID: 16309679
  5. The role of testosterone therapy in postmenopausal women: position statement of The North American Menopause Society. Menopause. 2005 Sep-Oct;12(5):496-511; quiz 649.  PMID: 16145303
  6. Institute for Clinical Systems Improvement (ISCI). Menopause and hormone therapy (HT): collaborative decision-making and management. 2008;64:198. [cited 02/11/2009]; Available from: http://www.guideline.gov/summary/sum mary.aspx?doc_id=13312&nbr=006756&string=Menopause+and+%22 hormone+therapy%22
  7. ACOG News Release: ACOG Reiterates Stance on So-Called “Bioidentical” Hormones. The American College of Obstetrics and Gynecologists; 2009.   [cited 02/11/2009]; Available from: http://www.acog.org/from_home/publications/press_releases/nr02-03-09.cfm 

 

Codes

Number

Description

CPT  84999 Unlisted chemistry procedure
  82530 Cortisol;free
   82626 Dehydroepiandrosterone (DHEA)
   82670 Estradiol
   84144 Progesterone
   84402 Testosterone
HCPCS S3650 Saliva test, hormone level; during menopause

 


 

Policy History

Date

Action

Reason

3/21/11 Add to Medicine section New policy