Local Coverage Determination (LCD)

Measurement of Salivary Hormones

L36857

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L36857
Original ICD-9 LCD ID
Not Applicable
LCD Title
Measurement of Salivary Hormones
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36857
Original Effective Date
For services performed on or after 07/21/2017
Revision Effective Date
For services performed on or after 11/01/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
06/05/2017
Notice Period End Date
07/20/2017

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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Code of Federal Regulations:

42 CFR Sections 410.32(a) & 410.32(a)(3) require that clinical laboratory services be ordered and used promptly by the physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who is treating the beneficiary.

42CFR411.15 excludes from coverage examinations performed for a purpose other than treatment or diagnosis of a specific illness, symptoms, complaint, or injury with specific legislative enactments as the only exceptions.

CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, §§20.4.4 and 20.4.5.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Hormones, both endocrine and exocrine, are secreted into various bodily fluids and their measurement can often diagnose diseases or be used to follow the course of a disease. Traditionally endocrine hormones are measured in serum, plasma, or urine. Measurements of hormones at certain times of the day, or after various attempts at suppression or stimulation can be used for diagnoses of endocrine diseases. Recently some labs have attempted to develop measurement of hormones in salivary secretions. Material is collected from saliva and sent to a lab for measurement. The convenience of collection without need of arterial or venipuncture simplifies collection, but the accuracy of measurement and lack of standardization makes the values determined still investigational. Noridian Healthcare Solutions currently considers salivary cortisol collected in the evening for diagnosis of Cushing’s syndrome as the only medically necessary and reasonable hormone measurement from salivary fluid. All other determinations of salivary hormones (e.g., thyroid, testosterone, estrogen, parathyroid, growth hormone, etc.) are considered investigational.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
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Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

If requested, chart documentation would show signs, symptoms, or clinical reasons why Cushing’s syndrome was being tested for.

No comments were received for this draft LCD for comment period ending 12/15/2016.

Sources of Information
  1. Aetna, Salivary Test Policy.
  2. American Association of Clinical Endocrinologists (AACE) Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Menopause. Endocrine Practice Vol 17 (Suppl 6) November/December 2011.
  3. Blue Cross Blue Shield of Florida, Salivary and Blood Hormone Testing.
  4. Blue Cross Blue Shield of Idaho, Salivary Hormone Testing, MP 2.04.301.
  5. Blue Cross Blue Shield of North Carolina Policy, Salivary Hormone Test.
  6. Blue Cross Blue Shield of Tennessee, Salivary Testing for Steroid Hormone Levels.
  7. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.
  8. Cushing syndrome: update on testing; Endocrinol Metab Clin North Am. 2015 Mar;44(1):43-50. doi: 10.1016/j.ecl.2014.10.005. Epub 2014 Nov 4.
  9. Salivary Hormone Measurement Using LC/MS/MS: Specific and Patient-Friendly Tool for Assessment of Endocrine Function. Tatsuya Higashi. 2012 The Pharmaceutical Society of Japan.
  10. Saliva as a diagnostic tool for oral and systemic diseases. Mohammad A. Javaid, Ahad S. Ahmed, Robert Durand, Simon D. Tran. J Oral Biol Craniofac Res. 2016 Jan-Apr;6(1):66-75. doi: 10.1016/j.jobcr.2015.08.006. Epub 2015 Sep 9.
  11. Standardizing Hormone Measurements; National Center for Environmental Health Division of Laboratory Sciences. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention National Center for Environmental Health Division of Laboratory Sciences.
  12. Taking on Free Hormone Measurement and Interpretation. Joesph R. Wiencek, PhD, American Association for Clinical Chemistry (AACC), August 1, 2016, CLN Daily.
  13. Wellmark Medical Policy, Saliva Hormone Tests.
Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/01/2019 R3

The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.
    )
11/01/2019 R2

11/01/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage.

As required by CR 10901, all billing and coding information has been moved to the companion article, this article is linked to the LCD.

  • Provider Education/Guidance
  • Revisions Due To Code Removal
10/01/2017 R1

DATE (08/23/2017): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

Effective 10/1/2017, LCD is revised per the annual ICD-10-CM code update to: Add ICD-10-CM codes: E27.8

 

 

  • Revisions Due To ICD-10-CM Code Changes
N/A

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
01/29/2020 11/01/2019 - N/A Currently in Effect You are here
10/22/2019 11/01/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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