(Reproduced by permission from Medicare Focus, March/April, 1998, pp. 13-17.)

Medicare Part A
Local Medical Review Policy
Helicobacter Pylori/Urea Breath Test

Policy Number: A98-01

Description

The breath test for Helicobacter pylori is a non-invasive diagnostic procedure utilizing analysis of breath samples to determine the presence of Helicobacter pylori. The test is based on the presence of urease produced by Helicobacter pylori bacteria. The test is performed by the differential detection of labeled Carbon (13C and 14C) collected in baseline breath samples and test breath samples after ingestion of labeled Carbon (13C and 14C) urea.

HCPCS Codes:

83019

Helicobacter pylori, breath test (including drug and breath sample collection kit)

Type of Bill: 12X, 13X, 14X, 71X

Revenue Codes: 30X Laboratory Test

Indications and Limitations of Coverage and/or Medical Necessity

This test is a non-invasive test to detect current infection of the stomach by Helicobacter pylori. Infection with this organism is associated with duodenal ulcer, gastric ulcer, gastric cancer, atrophic gastritis, and gastric MALT (mucosa associated lymphoid tissue) Lymphoma. Helicobacter pylori is a ubiquitous infection in the adult population.

Physicians should not test patients unless they are willing to treat those who test positive if the patient is agreeable to treatment.

The following clinical scenarios are appropriate for use of the H. pylori breath test:

• Symptomatic individuals younger than 50 years of age who present with previously uninvestigated dyspepsia in whom a diagnosis of ulcer disease is possible should be tested by serology, whole blood or breath test. If the patient has previously been diagnosed with Helicobacter pylori, the urea breath test is the test of choice; and/or,
• An upper gastrointestinal contrast x-ray series has been done which shows a duodenal ulcer or significant gastritis and/or duodenitis, and no endoscopy is planned; and/or,
• There are persistent or recurrent symptoms six weeks after treatment for a documented H. pylori infection, and no endoscopy is planned.

The H. pylori breath test is not indicated for:

• Symptomatic patients older than 50 years of age with previously uninvestigated dyspepsia, or those of any age with alarm symptoms such as weight loss, bleeding, anemia or dysphagia. These patients should have an endoscopy with biopsy and urease testing (CLO test).
• Patients who are asymptomatic for gastrointestinal symptoms.
• Patients who have non-specific dyspeptic symptoms with a negative H. pylori serum antibody test.

A relative contraindication for urea breath testing includes:

1. Those patients in whom endoscopy with biopsy is planned or done within the past month.
2. Confirmation of eradication of Helicobacter pylori infection in asymptomatic previously treated patients.

Based on cure rates of H. pylori infection with the currently accepted regimens utilizing antibiotics, repeat endoscopy or H. pylori breath testing would be expected in less than 30 percent of patients with H. pylori infection associated with duodenal ulcer and/or gastritis/duodenitis.

A minimum of four weeks should have passed before urea breath testing is performed following treatment for Helicobacter pylori.

Diagnosis Codes for Coverage

One of the following covered ICD-9-CM diagnosis codes must be linked to the appropriate procedure.

ICD-9-CM Code	Description
531.00 - 531.91 532.00 - 532.91 534.00 - 534.91 535.00 - 535.11 535.60 - 535.61 536.8	Diseases of Esophagus, Stomach, and Duodenum
789.01 - 789.02 789.06	Symptoms

Category: Pathology and Laboratory

HCFA's National Policy

Title XVIII of the Social Security Act, section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary, i.e., reasonable and necessary are those tests used in the diagnosis and management of illness and injury or to improve the function of a malformed body part.

Title XVIII of the Social Security Act, section 1862(a)(7). This section excludes routine physical examinations.

Reason for Denial

Tests performed during annual physical examinations or other routine screening situations without signs, symptoms or illness will result in denial as a non-covered benefit.

Non-covered Diagnosis Codes

Any that are not listed as covered diagnosis codes in the "Covered ICD-9-CM Codes" section in this policy.

ICD-9-CM Codes: (Codes that are never covered)

V70.0 - V70.9

Sources of Information

NIH Consensus Conference (Development Panel): Helicobacter pylori in Peptic Ulcer Disease. MAMA 272: 1,65-69, 1994

Klein, et al: Non-Invasive Detection of Helicobacter pylori Infection in Clinical Practice: The 13C Urea Breath Test American Journal of Gastroenterology 91:4, 690-694, 1996

The Report of The International Update Conference on Helicobacter pylori February 1997

Coding Guidelines

Use CPT code 83019 includes all drugs, administered solutions, and the breath sample collection kit.

Documentation Required

ICD-9 diagnosis codes are required on claim.

Medical records must clearly document the medical necessity for the test and the frequency of the test.

If documentation is requested for review, submit the following:

• History and Physical
• Physician orders/progress notes
• Diagnosis/reason for test
• Test results
• Itemization of charges

Documentation supporting the medical necessity of this item, such as ICD-9-CM codes, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary.

This policy is being adapted from the Carrier policy. It does not represent the sole opinion of the Intermediary/Medical Director. This policy was developed in consultation with the medical community and the Carrier Advisory Committee.