UnitedHealthcare® Commercial
Medical Policy
HELICOBACTER PYLORI SEROLOGY TESTING
Policy Number: 2017T0579B
Table of Contents
Page
INSTRUCTIONS FOR USE .......................................... 1
BENEFIT CONSIDERATIONS ...................................... 1
COVERAGE RATIONALE ............................................. 1
APPLICABLE CODES ................................................. 2
DESCRIPTION OF SERVICES ...................................... 2
CLINICAL EVIDENCE ................................................. 2
U.S. FOOD AND DRUG ADMINISTRATION .................... 3
CENTERS FOR MEDICARE AND MEDICAID SERVICES .... 3
REFERENCES ........................................................... 3
POLICY HISTORY/REVISION INFORMATION ................. 3
Effective Date: January 1, 2017
Community Plan Policy

Helicobacter Pylori Serology Testing
INSTRUCTIONS FOR USE
This Medical Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the
member specific benefit plan document must be referenced. The terms of the member specific benefit plan document
[e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ
greatly from the standard benefit plan upon which this Medical Policy is based. In the event of a conflict, the member
specific benefit plan document supersedes this Medical Policy. All reviewers must first identify member eligibility, any
federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Medical
Policy. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its
sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational
purposes. It does not constitute medical advice.
UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in
administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent
professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or
medical advice.
BENEFIT CONSIDERATIONS
Before using this policy, please check the member specific benefit plan document and any federal or state mandates,
if applicable.
Essential Health Benefits for Individual and Small Group
For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured
non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten
categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small
group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to
provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be
removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is
made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit
plan document to determine benefit coverage.
COVERAGE RATIONALE
Helicobacter pylori (H. pylori) serology testing is unproven and not medically necessary for diagnosing
infection or evaluating treatment effectiveness.
The American Gastroenterological Association (AGA) no longer recommends serology-based testing for diagnosing
infection or evaluating treatment effectiveness as it is unable to distinguish between active infection and previous
exposure to H. pylori, does not confirm eradication and has a poor positive predictive value when compared to active
infection tests such as the urea breath test or stool antigen test.
Helicobacter Pylori Serology Testing
Page 1 of 4
UnitedHealthcare Commercial Medical Policy
Effective 01/01/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
APPLICABLE CODES
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all
inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or noncovered health service. Benefit coverage for health services is determined by the member specific benefit plan
document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply
any right to reimbursement or guarantee claim payment. Other Policies and Coverage Determination Guidelines may
apply.
CPT Code
86677
Description
Antibody; Helicobacter pylori
CPT® is a registered trademark of the American Medical Association
DESCRIPTION OF SERVICES
Helicobacter pylori (H. pylori) is a common bacterium found in the lining of the stomach. H. pylori is found in about
two-thirds of the world’s population, and infection causes the majority of peptic ulcers and is a risk factor for stomach
cancer.
H. pylori infection can be diagnosed using invasive or noninvasive methods. Invasive methods require the use of
endoscopy and include rapid urease testing, histology, culture and polymerase chain reaction. During endoscopy,
biopsy specimens of the stomach and duodenum are obtained for analysis. Noninvasive methods do not use
endoscopy and include urea breath test, stool antigen test and antibody testing. The urea breath test and stool
antigen test identify active infection where the antibody test indicates only the presence of H. pylori at some time.
American College of Gastroenterology (ACG) and AGA guidelines recommend test, treat and retest to confirm
eradication with an active infection test prior to prescribing a proton pump inhibitor (PPI), and for patients under the
age of 55 with no alarm symptoms. Alarm symptoms can include gastrointestinal bleeding, anemia, early satiety,
unexplained weight loss (>10% weight loss), progressive dysphagia, odynophagia, recurrent vomiting, family history
of gastrointestinal cancer or previous esophagogastric malignancy. Noninvasive active testing methods recommended
by ACG and AGA include urea breath test and stool antigen test (Chey et al., 2007).
Serology or antibody testing measures immunoglobulin G (IgG), IgA and/or IgM antibodies specific to H. pylori in
serum, whole blood or urine. Serology testing is no longer recommended for diagnosing infection or evaluating
treatment effectiveness as it is unable to distinguish between active infection and previous exposure to H. pylori, does
not confirm eradication and has a poor positive predictive value in populations with low disease prevalence when
compared to active infection tests (Centers for Disease Control, 2006; Chey et al., 2007).
CLINICAL EVIDENCE
A meta-analysis by Loy et al. (1996) evaluated the performance characteristics of several commercially available
quantitative serological assays for H. pylori and found their overall sensitivity and specificity to be 85% and 79%,
respectively. Twenty-one studies of varying quality were included in the analysis. Test accuracy measured was
significantly higher in studies with smaller proportions of infected patients. There was little evidence to suggest that
any one test was more accurate than another. The authors reported that the overall accuracy of these tests may not
be adequate for clinical decision-making.
National Institute for Health and Care Excellence (NICE) guidelines recommend testing for H. pylori using a carbon-13
urea breath test or a stool antigen test, or laboratory-based serology where its performance has been locally validated.
The guidelines do not recommend the use of office-based serological tests because of their inadequate performance
(NICE, 2014).
Professional Societies
American Association for Clinical Chemistry (AACC)
The AACC does not recommend H. pylori antibody testing for routine diagnosis or for evaluation of treatment
effectiveness (AACC website, 2014).
American College of Gastroenterology (ACG)
ACG guidelines on the management of H. pylori infection (Chey et al., 2007) address three nonendoscopic diagnostic
testing methods: antibody test, urea breath test and stool antigen test. Antibody testing identifies an immunological
reaction to the infection while the urea breath test and stool antigen test identify the presence of active H. pylori
infection. The guidelines make the following recommendations regarding testing:
Helicobacter Pylori Serology Testing
Page 2 of 4
UnitedHealthcare Commercial Medical Policy
Effective 01/01/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.

Although antibody testing is widely available, it has a poor positive predictive value in populations with a low
prevalence of H. pylori infection, limiting its usefulness in clinical practice.
o The urea breath test and stool antigen test provide reliable means of identifying active H. pylori infection
before antibiotic therapy.
o Both the urea breath test and stool antigen test can be used to confirm eradication of H. pylori infection.
o Antibody tests are of little benefit in documenting eradication as results can remain positive for years following
successful cure of the infection.
ACG guidelines for the management of dyspepsia (Talley and Vakil, 2005a) state that dyspeptic patients more than 55
years old, or those with alarm features, should undergo prompt endoscopy to rule out peptic ulcer disease,
esophagogastric malignancy and other rare upper gastrointestinal tract disease. Alarm features include bleeding,
anemia, early satiety, unexplained weight loss (>10% body weight), progressive dysphagia, odynophagia, persistent
vomiting, a family history of gastrointestinal cancer, previous esophagogastric malignancy, previous documented
peptic ulcer, lymphadenopathy or an abdominal mass. In patients aged 55 years or younger with no alarm features,
one option is a test and treat approach for H. pylori using a validated noninvasive test. The urea breath test and stool
antigen test are the most accurate noninvasive diagnostic tools. Many serological tests have not been locally validated,
and have suboptimal sensitivity and specificity in practice
American Gastroenterological Association (AGA)
An AGA technical review on the management of dyspepsia (Talley et al., 2005b) states that tests for active H. pylori
infection (stool antigen test and urea breath test) should be used rather than serology testing for both the initial
diagnosis of infection and the confirmation of H. pylori eradication. This recommendation is based on the superior
accuracy of tests for active H. pylori infection compared with serologic testing.
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
The FDA has approved a number of serological tests for the detection of antibodies to H. pylori. See the following
website for more information (use product code LYR):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. (Accessed November 9, 2016)
CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS)
Medicare does not have a National Coverage Determination (NCD) for Helicobacter pylori (H. pylori) serology testing.
Local Coverage Determinations (LCDs) do not exist at this time.
(Accessed November 11, 2016)
REFERENCES
American Association for Clinical Chemistry (AACC). H. pylori testing. Last reviewed November 2014. Last modified
December 2015. Available at: https://labtestsonline.org/understanding/analytes/h-pylori/tab/test. Accessed
November 9, 2016.
Centers for Disease Control (CDC). Helicobacter pylori and peptic ulcer disease. September 2006. Available at:
http://www.cdc.gov/ulcer/keytocure.htm#diagnosed. Accessed November 9, 2016.
Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. Guideline on the
management of Helicobacter pylori infection. Am J Gastroenterol. 2007 Aug;102(8):1808-25.
Loy CT, Irwig LM, Katelaris PH, Talley NJ. Do commercial serological kits for Helicobacter pylori infection differ in
accuracy? A meta-analysis. Am J Gastroenterol. 1996 Jun;91(6):1138-44.
National Institute for Health and Care Excellence (NICE). CG184. Gastro-oesophageal reflux disease and dyspepsia in
adults: investigation and management. September 2014. Available at:
http://www.nice.org.uk/guidance/cg184/resources/gastrooesophageal-reflux-disease-and-dyspepsia-in-adultsinvestigation-and-management-35109812699845. Accessed November 9, 2016.
Talley NJ, Vakil N; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the
management of dyspepsia. Am J Gastroenterol. 2005a Oct;100(10):2324-37.
Talley NJ, Vakil NB, Moayyedi P. American Gastroenterological Association technical review on the evaluation of
dyspepsia. Gastroenterology. 2005b Nov;129(5):1756-80.
POLICY HISTORY/REVISION INFORMATION
Date
01/01/2017


Action/Description
Reformatted and reorganized policy; transferred content to new template
Updated supporting information to reflect the most current references; no change
Helicobacter Pylori Serology Testing
Page 3 of 4
UnitedHealthcare Commercial Medical Policy
Effective 01/01/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
Date

Action/Description
to coverage rationale or list of applicable codes
Archived previous policy version 2016T0579A
Helicobacter Pylori Serology Testing
Page 4 of 4
UnitedHealthcare Commercial Medical Policy
Effective 01/01/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.