Subject:
Salivary Hormone Testing for Menopause
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Many products of physiology and metabolism are known to be excreted by the body into the saliva. It has been proposed that measurement of these substances may be useful in some cases as an indicator of some disease states
For several decades, there has been interest in testing various hormone levels using saliva as the specimen rather than blood, serum, 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 at home.
Salivary hormone testing was designed to help aid in the diagnosis and treatment of menopause and other diseases related to aging. The tests measures the amount of free hormones (e.g., estrogen, progesterone, testosterone, melatonin, or dehydroepiandrosterone [DHEA]) found in the saliva of women. A physician's prescription is not required for these salivary tests, which are primarily promoted for the evaluation of menopause and aging. Most salivary hormone tests have become available to consumers over the internet. Some of these websites include a questionnaire to allow consumers to determine whether they need salivary testing, and a form that allows consumers to order these tests online. The results of these tests are purportedly used to determine the need for prescriptions of DHEA, vitamins, herbs, phytoestrogens, and other anti-aging regimens.
Salivary hormone levels may vary according to the time of day; therefore the timing of saliva collection may affect results. Salivary flow rate can also affect the concentration of certain hormones. Depending on the company providing the home salivary testing product, testing may be different, for example, obtaining several samples over a couple of weeks at specific times of the day.
For many substances the concentrations available in saliva do not correlate well with various disease states, are not as accurate as other testing methods, or have yet to be established as useful tools in the management or detection of disease.
Related policy:
Salivary Estriol as a Risk Predictor for Preterm Labor (Policy # 013 in the Pathology Section)
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Salivary hormone testing (e.g., estrogen, progesterone, testosterone, melatonin, DHEA) is considered investigational for the screening, diagnosis, treatment, or monitoring of menopause (pre-, peri-, and post) or diseases related to aging.
Medicare Coverage:
There is no National Coverage Determination (NCD) for Salivary Hormone Testing for Menopause. In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
HCPCS code S3650 is an invalid code for Medicare and is noncovered.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE:
According to the American College of Obstetricians and Gynecologists' ((ACOG) Committee Opinion # 532 (August 2012, reaffirmed 2018) on compounded bioidentical hormone therapy, "there is no evidence that hormonal levels in saliva are biologically meaningful." Salivary hormone testing used by proponents to "tailor" this therapy is not 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. and that hormone therapy does not require customized dosing. "If treatment is initiated for symptom control, subjective improvement in symptoms is the therapeutic endpoint, and there is no need to assess hormone levels."
According to the 2008 Institute for Clinical Systems Improvement (ICSI) Health Care Guideline for Menopause and Hormone Therapy, "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."
According to the 2012 North American Menopause Society's position statement on bioidentical hormone therapy (BHT), "Use of BHT has escalated in recent years, along with the use of salivary hormone testing, which has been proven to be inaccurate and unreliable.
North American Menopause Society in 2017 updated their statement: “Salivary testing for HT [hormone therapy] is considered unreliable because of differences in hormone pharmacokinetics and absorption, diurnal variation, and interindividual and intraindividual variability”.
According to the 2005 North American Menopause Society's position statement on testosterone therapy on menopausal women, salivary measurement assays have questionable reliability and accuracy, especially in the low ranges in women.... Their use in clinical practice is not recommended.
According to the 2007 American Association of Clinical Endocrinologists (AACE) Reproductive Medicine Committee Position Statement on Bioidentical Hormones, "Salivary hormone level testing is recommended by many BH (bioidentical hormone) proponents as a way of providing patients with "individualized" therapy.... The results of these tests are subsequently used to determine the type and dosage of compounded formulation. Only a few of salivary hormone testing methods are FDA/CLIA approved. In fact, the vast majority of the salivary hormone test results contain disclaimer that those tests are not FDA/CLIA approved and should be used only for research purposes. Yet, such tests are still utilized to support clinical decisions by some supporters of BH."
According to the Food and Drug Administration's (FDA) Compounded Menopausal Hormone Therapy Questions and Answers (2010), "There is no scientific basis for using saliva testing to adjust hormone levels. Instead, practitioners should adjust hormone therapy dosages based on patient symptoms."
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 diseases related to aging. There are no published national practice guidelines that support the use of salivary hormone testing in the screening, diagnosis, treatment, or monitoring of menopause and aging.
In summary, there is insufficient evidence in the published scientific literature that permits conclusions concerning the use of salivary hormone testing for the screening, diagnosis, treatment. or monitoring of menopause or diseases related to aging. Therefore, it is considered investigational.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Salivary Hormone Testing for Menopause
Salivary Hormone Test
Saliva Test
References:
1. American College of Obstetrician and Gynecologists (ACOG) Committee Opinion #532: Compounded Bioidentical Hormone Therapy. August 2012 (Reaffirmed 2014, Replaces No. 387, November 2007 and No. 322, November 2005). Available at: http://www.acog.org/-/media/Committee-Opinions/Committee-on-Gynecologic-Practice/co532.pdf?dmc=1&ts=20141120T0939385708 (accessed 11/20/14)
2. Institute for Clinical Systems Improvement (ICSI) Health Care Guideline: Menopause and Hormone Therapy (HT): Collaborative Decision-Making and Management. October 2008, Ninth Edition.
3. The North American Spine Society. Bioidentical Hormone Therapy. Updated on 4/5/2011.
4. The role of testosterone therapy in postmenopausal women: position statement of the North American Spine Society. Menopause, 2005;12(5):497-511.
5. Flyckt RL, Liu J, Frasure H et al. Comparison of salivary versus serum testosterone levels in postmenopausal women receiving transdermal testosterone supplementation versus placebo. Menopause. 2009 Jul-Aug;16(4):680-8.
5. American Association of Clinical Endocrinologists (AACE) Reproductive Medicine Committee Position Statement on Bioidentical Hormones. Updated on 07/15/07. Available at https://www.aace.com/files/position-statements/aacebhstatement071507.pdf (accessed 11/20/14).
6. Bioidentical Hormones. The Medical Letter. Volume 52, Issue 1339, May 31, 2010.
7. ECRI Institute. Hotline Response: Salivary hormone tests for menopause and aging in adult women. Published: 07/25/2011.
8. FDA. Compounded Menopausal Hormone Therapy Questions and Answers. Last updated: 02/05/2010. Available at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm183088.htm (accessed 11/20/14)
9. UpToDate. Preparation for postmenopausal hormone therapy. Topic last updated: Mar 28, 2014.
10. UpToDate. Clinical manifestations and diagnosis of menopause. Literature review current through: Oct 2015. This topic last updated: Aug 05, 2015.
11. UpToDate. Treatment of menopausal symptoms with hormone therapy. Literature review current through September 2016. Topic last updated June 8, 2016.
12. Martin KA, Barbieri RL. Treatment of menopausal symptoms with hormone therapy. In: UpToDate, Crowley WF, Martin KA (Eds), UpToDate, Waltham, MA. (Accessed on September 8, 2017.)
13. Martin KA, Barbieri RL. Preparations for menopausal hormone therapy. In: UpToDate, Snyder PJ, Crowley WF, Martin KA (Eds), UpToDate, Waltham, MA. (Accessed on September 8, 2017.)
14. Casper RF. Clinical manifestations and diagnosis of menopause. In: UpToDate, Barbieri RL, Crowley WF, Martin KA (Eds), UpToDate, Waltham, MA. (Accessed on September 8, 2017.)
15. Casper RF. Clinical manifestations and diagnosis of menopause. In: UpToDate, Barbieri RL, Crowley WF, Martin KA (Eds), UpToDate, Waltham, MA. (Accessed on August 9, 2018)
16. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause (New York, N.Y.) 2017;24(7):728-53 doi: 10.1097/gme.0000000000000921[published Online First: Epub Date]|.
17. Casper RF. Clinical manifestations and diagnosis of menopause. In: UpToDate, Barbieri RL, Crowley WF, Martin KA (Eds), UpToDate, Waltham, MA. (Accessed on August 22, 2019)
18. Casper RF. Clinical manifestations and diagnosis of menopause. In: UpToDate, Barbieri RL, Crowley WF, Martin KA (Eds), UpToDate, Waltham, MA. (Accessed on August 19, 2020)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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