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Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2014, 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 2014 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.

05-86000-15

Original Effective Date: 10/15/99

Reviewed: 01/28/10

Revised: 01/01/14

Subject: Helicobacter Pylori (H. Pylori) 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
 


DESCRIPTION:

The recognition of the role of the bacterium Helicobacter pylori (H. pylori) in the pathogenesis of peptic ulcer disease has revolutionized the therapy of peptic ulcer. Specifically, 80% to 95% of patients with duodenal ulcers and 70% to 90% of patients with gastric ulcers have coexisting H. pylori gastritis; eradication of H. pylori infection using a variety of combinations of antibiotics, bismuth compounds, and acid suppression therapy has emerged as a basic treatment strategy for these ulcers. The majority of patients positive for H. pylori do not develop ulcer symptoms; however recent medical literature supports an association between H. pylori and non-ulcer dyspepsia.

Dyspepsia refers to a symptom complex of epigastric pain or discomfort. While some dyspepsia symptoms, such as a postprandial gnawing or burning relieved by foods or antacids are suggestive of ulcer, others, such as belching, bloating, and fullness are referred to as non-ulcer dyspepsia. Nevertheless, there is considerable overlap between ulcer and non-ulcer dyspepsia.

Coincident with the increased understanding of the pathophysiology of H. pylori has been the development of non-invasive methods of detection of H. pylori. Invasive detection of H. pylori involves endoscopy followed by culture and either direct histologic identification of the organism, or detection of the organism using the CLO (campylobacter-like organism) test. Non-invasive methods include serologic identification of anti-H.pylori antibodies, detection of H. pylori antigens in stool, or the detection of urease enzyme via a urea breath test (UBT). Serologic tests cannot differentiate between active and past infection while both fecal antigens and a UBT provide direct evidence that H. pylori is currently present. In addition, serologic testing is less sensitive and specific than the active non-invasive tests and has a high false-positive rate. Therefore the American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG) no longer recommend using serologic testing.

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request for helicobacter pylori (h. pylori) testing to expedite the medical review process.

1. Click the link Helicobacter Pylori (H. Pylori) Testing - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

NOTE: H. pylori testing must be ordered by the treating physician.

The following methods to diagnosis helicobacter pylori (H. pylori) infection meet the definition of medical necessity:

For patients 55 years of age and younger without alarm features*:

1. H. pylori stool antigen

• Patients are not required to be off of Proton Pump Inhibitors (PPIs), Antimicrobials, and Bismuth preparations prior to testing.

2. Urea breath test

• Patients are required to be off of PPIs, Antimicrobials, and Bismuth preparations for 2 weeks prior to testing.

For patients older than 55 years OR those with alarm features*:

• Early endoscopy with biopsy for H pylori.

*Alarm Features: Age older than 55 years with new-onset dyspepsia, family history of upper gastrointestinal cancer, unintended weight loss, gastrointestinal bleeding, progressive dysphagia, odynophagia, unexplained iron-deficiency anemia, persistent vomiting, palpable mass or lymphadenopathy, jaundice.

NOTE: Screening for H. pylori infection in the absence of documented upper gastrointestinal tract symptoms or pathology is not covered.

BILLING/CODING INFORMATION:

CPT Coding:

43239

Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single or multiple

78267

Urea breath test, C-14; (isotopic); acquisition for analysis

78268

Urea breath test, C-14; analysis

83013

Helicobacter pylori, breath test analysis for urease activity, non-radioactive isotope (e.g., C-13)

83014

Helicobacter pylori, drug administration

87338

Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; Helicobacter pylori, stool

87339

Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; Helicobacter pylori

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical, physician initial assessment, attending physician visit notes, treatment plan, pathology and surgical reports.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Physician Initial Assessment

18736-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note or treatment notes

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Pathology Study Report

27898-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Physician operative note (surgical report)

28573-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

REIMBURSEMENT INFORMATION:

Serologic tests cannot differentiate between active and past infection while both fecal antigens and a UBT provide direct evidence that H. pylori is currently present. In addition, serologic testing is less sensitive and specific than the active non-invasive tests and has a high false-positive rate. Therefore the American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG) no longer recommend using serologic testing.

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 revised date

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report stool antigen testing:

HpSA®

REFERENCES:

  1. American Gastroenterological Association, Medical Position Statement: Evaluation of Dyspepsia, 11/05.
  2. Blue Cross Blue Shield Association Medical Policy, Urea Breath Test for Diagnosis of Helicobacter pylori, 2.04.06, 07/03.
  3. Chey WD, Wong BC, et al. American College of Gastroenterology Guideline on the Management of Helicobacter pylori Infection, 2007.
  4. Medicare Part B Medical Policy Procedures. Breath Test For Helicobacter Pylori (H.Pylori) #78267, 01/01/02.
  5. Vakil N, How To Test For Helicobacter Pylori In 2005, Cleveland Clinical Journal of Medicine, Volume 72, Supplement 2, May 2005.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/28/10.

GUIDELINE UPDATE INFORMATION:

10/15/99

Medical Coverage Guideline Reformatted.

01/01/02

Coding changes.

03/15/02

Multiple revisions.

09/23/03

Added diagnosis 041.86.

04/15/04

Annual review. Deleted covered statement-urea breath testing or fecal antigen testing performed as part of the work-up of patients with dyspneic symptoms and suspected H. pylori. Added rationale for when services are not covered. Added diagnoses: 532.30 – 532.31, 532.70 – 532.71, 533.00 – 533.91, and 536.8.

01/01/05

HCPCS update. Added 83009. Revised descriptor for 78267, 83013, and 83014.

09/15/07

Review, coverage statement and description section updated with AGA information and recommendations, guideline reformatted, references updated.

02/15/10

Revision: position statements, description section, and references updated.

10/15/10

Revision; formatting changes.

10/01/11

Revision; formatting changes.

02/28/12

Revision; position statement; formatting changes.

01/01/14

Annual HCPCS update. Revised code 43239. Program Exceptions section updated.

DECISION TREE

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, 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 2013 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.

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Date Printed: August 20, 2014: 08:21 PM