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Date Printed: June 26, 2017: 01:25 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-82000-14

Original Effective Date: 11/15/01

Reviewed: 07/28/16

Revised: 08/15/16

Subject: Salivary and Blood Hormone Testing

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Salivary hormone monitoring is being promoted as part of comprehensive hormone replacement programs. Measurements are made at baseline, during treatment, and on an annual basis. Individuals are encouraged to use salivary testing if they are currently taking “bioidentical” hormones that have been sold as natural, safer alternatives to synthetic hormone replacement therapy. Salivary testing is suggested as a means for determining adjustments to therapy dosage and thereby minimizing the risks of hormone replacement therapy. Also, salivary testing has been suggested as a way of monitoring anti-aging therapy especially if the therapy involves testosterone. The consumer may order home saliva tests over the Internet (e.g., estrogen, progesterone, testosterone, melatonin, cortisol, DHEA). A physician’s prescription is not required for these saliva tests, which are primarily promoted for the evaluation of menopause and aging.

Blood hormone panels (screening multiple hormones) are also being promoted as a way to provide a view of the overall general health of a person. Clinical applications advertised include the possible discovery of the source of a chronic condition related to abnormal hormone levels and treatment information for persons with complaints related to issues such as fatigue, migraines, and physical appearance (hair, skin).

POSITION STATEMENT:

Serial monitoring of salivary estriol levels is considered experimental or investigational, as there is insufficient clinical evidence to support the use of serial monitoring of salivary estriol levels as a technique of risk assessment for preterm labor or delivery. There is insufficient clinical evidence of safety or efficacy in published medical peer reviewed literature.

Salivary hormone testing for the screening, diagnosis or monitoring of menopause (pre and post) aging, and hormone replacement therapy (HRT) is considered experimental or investigational, as there is insufficient clinical evidence to support the use of salivary hormone testing. The data available does not support the tests clinical efficacy.

These tests may include:

Blood hormone panels are considered experimental or investigational for all indications. The evidence is insufficient to determine the effects of the testing on health outcomes.

BILLING/CODING INFORMATION:

There are no specific CPT codes for these tests.

HCPCS Coding:

S3650

Saliva test, hormone level; during menopause (investigational)

S3652

Saliva test, hormone level; to assess preterm labor risk (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Fetal Fibronectin Test, 05 86000 14

OTHER:

Other names used to report salivary and blood hormone testing:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Estriol, Salivary

Female Comprehensive Hormone Panel

Male Comprehensive Hormone Panel

SalEst™

Salivary Estriol

SpectraCell Hormone Panel

REFERENCES:

  1. American College of Obstetricians and Gynecologists (ACOG) Committee Bulletin Number 532: Compounded Bioidentical Menopausal Hormone Therapy. August 2012, reaffirmed 2016.
  2. American College of Obstetricians and Gynecologists (ACOG) News Release, ACOG Reiterates Stance on So-Called “Bioidentical” Hormones, 02/03/09.
  3. American College of Obstetricians and Gynecologists (ACOG) News Release. “SalEst Test Not Recommended as Screening Tool for Predicting Premature Labor”, 01/31/01.
  4. Blue Cross Blue Shield Association Medical Policy. Salivary Estriol as Risk Predictor for Preterm Labor (2.04.11), 08/09 (archived).
  5. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). “Salivary Estriol for the Assessment of Spontaneous Preterm Labor”, (07/99).
  6. ECRI Hotline Response. Salivary Hormone Tests for Menopause and Aging in Adult Women, updated 01/31/08.
  7. HAYES Medical Technology Directory. “Salivary Estriol Test for Preterm Labor”, (SALI0103.11, 05/14/99, Updated 10/05).
  8. HAYES, Inc, Hayes Brief, Salivary Estriol Test to Assess the Risk for Preterm Labor and Birth, 11/05.
  9. Hayes, Inc., FDA Takes Action Against Misleading Claims for Compounded Hormone Replacement Medications, 01/13/08.
  10. Kaufman, E. & Lamster, I. B. (2002). The diagnostic applications of saliva – A review. Crit Rev Oral Biol Med, 13(2): 197-212.
  11. Ressel, G, ACOG Issues Recommendations on Assessment of Risk Factors for Preterm Birth, American Family Physician, 02/02.
  12. Warren, M. P. & Stanczyk, F. Z. (2004). Custom-compounded hormone therapy: Is there science to support the claims? Council on Hormone Education, 2(4).
  13. Yoneda S, Sakai M, Sasaki Y, Shiozaki A, Hidaka T, Saito S, Interleukin-8 and Glucose In Amniotic Fluid, Fetal Fibronectin In Vaginal Secretions and Preterm Labor Index Based On Clinical Variables are Optimal Predictive Markers For Preterm Delivery In Patients With Intact Membranes, J Obstet Gynaecol Res. 2007 Feb; 33(1): 38-44.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 07/28/16.

GUIDELINE UPDATE INFORMATION:

11/15/01

New Medical Coverage Guideline.

04/15/03

Reviewed; added code S3652. Deleted code S3650.

04/15/04

Reviewed; maintain investigational status.

04/15/05

Scheduled review; no change in coverage statement. Updated references.

06/15/05

Revision to guideline; consisting of MCG name change to Salivary Hormone Testing. Updated description section to include information regarding salivary hormone monitoring. Added an investigational statement for salivary hormone testing for the screening, diagnosis and/or monitoring of menopausal (pre and post) and aging, and hormone replacement therapy (HRT). Updated references.

06/15/06

Reviewed; maintain investigational status.

06/15/07

Annual review; investigational status maintained, reformatted guideline, references updated.

05/15/08

Annual review: position statements maintained, references updated.

05/15/09

Annual review: position statements maintained, references updated.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

08/15/16

Revision; title, description, position statement, and references updated.

Date Printed: June 26, 2017: 01:25 AM