Helicobactor Pylori Testing (H. Pylori)

Date of Revision: 8/2/02

DESCRIPTION:

Helicobacter pylori is a gram-negative rod that is uniquely adapted to survive in the highly acid gastric environment. H. Pylori infection of the stomach and duodenum has been causally linked to the development of chronic active gastritis, peptic ulcer disease, gastric cancer, and probably some forms of gastric lymphoma. 

However, an association between H. pylori infection and non-ulcerative dyspepsia has not been established. H. Pylori is a chronic infection, which increases in prevalence with age. Only 15%-30% of infected individuals develop peptic ulcers. Eradication of the infection results in resolution of the gastritis and a marked decrease in the recurrence rate of peptic ulcers.  

Gastric cancer develops in only 1% of patients with H. pylori-induced chronic atrophic gastritis. The pathogenesis of H. pylori-related peptic ulcers is not yet well understood. No theory explains why duodenal ulcers develop in some infected individuals, gastric ulcers develop in others, and most experience no ulcers at all. 
 

HCPCS CODES:

The following short descriptors are in accordance with the AMA copyright agreement. Please refer to the current CPT book for full descriptions. 

INDICATIONS & LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY:

Prior to date of service 10/15/1998, this test was non-covered. 

Effective with DOS 10/15/1998: 

Testing for H. pylori can be divided into direct tests (biopsy and/or culture) and indirect (gram stain, Rapid Urease Testing, serologic tests, and breath tests). The gold standard for diagnosis of active infection is biopsy with culture. Breath testing for H. pylori is considered to be a reliable proxy for active infection. At the present time, 2 types of breath tests are approved by the FDA. One utilizes ingestion of carbon 13 labeled urea (not radioactive).  

A breath sample is collected 30 minutes later and sent to a laboratory-approved f or testing. The second method involves administration of radioactive C-14, and counting the C-14 in a breath sample. The latter test can be done entirely in any facility capable of doing radionuclide procedures. A Rapid Urease Test may be done at the time of biopsy (e.g., CLO test). Serologic tests may be useful for certain situations. (See below) 

1. Indirect testing is indicated for symptomatic patients with a documented history of chronic/recurrent duodenal ulcer, gastric ulcer or chronic gastritis.

2. Indirect testing is not indicated for new onset dyspepsia responsive to conservative treatment (e.g., withdrawal of nonsteroidal anti-inflammatory drugs and/or use of anti-secretory agents).

3. However, unresponsive dyspepsia, or if associated with complications, e.g., obstruction, anemia, evidence of GI bleeding, anorexia/weight loss should be investigated further with appropriate endoscopy/barium studies.

4. The optimal testing combination depends upon whether or not endoscopy is planned:

a)     Endoscopy not planned (e.g., not indicated or patient refused)
Serologic test or urea breath test is usually performed.

b)     Endoscopy is clinically indicated and planned:
Endoscopic biopsy and rapid urease test is usually performed.
Urea breath test should not be done routinely in this subset of patients.

5. Serologic testing to H. pylori is a useful method to detect active H. pylori infection. However, it is of no clinical value in the following situations:

a)     New onset dyspepsia responsive to treatment.

b)     Dyspeptic patients who require UGI endoscopy (see #3)

c)      Patients with documented normal UGI endoscopy.

d)     Also, serologic testing for H. pylori is of limited value in monitoring response to treatment of H. pylori infection because the titers diminish slowly, and the magnitude of the decline is variable.

6. It is not necessary to do either serology or a breath test for H. pylori in the following situations:

a)     Screening for H. pylori in the absence of documented gastric or duodenal pathology.

b)     Patients who have had a normal UGI endoscopy within the prior 5 weeks or for whom upper GI endoscopy are planned, either for initial diagnosis or follow-up (e.g., gastric ulcer).

c)      patients who are asymptomatic after treatment of an H. pylori infection.

d)     Patients with new onset uncomplicated dyspeptic symptoms.

7. All testing must be performed on equipment, which is FDA, approved for the specific test. 

FOLLOW-UP TESTING

For patients who have been treated for a definitive diagnosis of H. pylori infection, clinical follow-up for the ulcer/gastritis is indicated and may require continued anti-secretory treatment. However, it is not necessary in all cases to determine if the H. pylori organism has been eradicated. The overall cure rate with current antibiotic protocols is 90%. Those in whom recurrent ulcer symptoms develop during the first 2 years after treatment should be re-evaluated by endoscopy or a breath test. Serologic tests are unreliable in determining if the infection has been eradicated. 

Confirmation of successful H. pylori cure may be necessary in patients with a history of complicated or refractory ulcers, but is controversial in patients with uncomplicated ulcers who are asymptomatic after antibiotic therapy. 

REFRACTORY CONDITIONS

A refractory duodenal ulcer is defined as unhealed after 8 weeks with anti-secretory therapy. The therapeutic response of gastric ulcers is slower and is considered refractory if still present after 12 weeks of therapy. It is essential that the urease and breath tests are performed no sooner than 1 month, and preferably longer, after discontinuing agents capable of suppressing H. pylori (e.g., bismuth, omeprazole, antibiotics). 

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Prior to date of service 10/15/1998, this test was non-covered.
Effective with DOS 10/15/1998:

 041.86

 151.0   - 151.9

 531.00 - 531.91

 532.00 - 532.91

 533.00 - 533.91

 534.00 - 534.91

 535.00 - 535.11

 535.21

 535.40 - 535.41

 535.50 - 535.51

 535.60 - 535.61

 536.8   - 558.9

 789.01 - 789.02

 789.06 - 789.07 

Reasons For Denial: 

1. Laboratory tests which are performed for screening purposes are excluded from coverage by the carriers. These services are to be identified on the claim with the "V" codes listed under "Coding Guidelines". Tests ordered for diagnoses not listed as covered in this policy or for excessive frequency will be denied as not medically necessary.
2. Limitation of liability and refund requirements apply to denials for frequency and/or medical necessity. When the advance notice is given, the service(s) must be submitted with modifier GA (advance notice has been give to the beneficiary).
3. Claims for breath tests for H. pylori will be denied as not necessary for patients who have non-specific symptoms with a negative H. pylori serum antibody test.
4. Claims for testing for H. pylori will be denied if repeated sooner than 8 weeks from previous testing.
5. Documentation does not show the patient was symptomatic.
6. Tests performed on equipment which is not FDA approved for the specific test will be denied.

Noncovered ICD-9 Codes:

Any ICD-9 code not listed in the "Covered ICD-9 Codes" section of this policy. 

Coding Guidelines: 

1. Screening tests in the absence of signs or symptoms of illness should be billed using the following ICD-9 V codes; V70.0; V70.5; V70.9; V82.6; V82.8; V82.9
2. ICD-9 codes must be used to the highest level of specificity.
3. When the C-13 test is performed, CPT 83019 should only be billed by the laboratory which performs the test. The administration of the C-13 labeled urea and collection of the breath sample should be billed as CPT 99211. The kit/supplies required for this test is included in the testing and should not be billed separately.
4. When the C-14 test is performed, the testing facility should use CPT 78990 for the provision of the radionuclide, and CPT 78999 for the scanning procedure. The procedure and the name and dose of the radionuclide must be entered into the documentation field of the claim.

Documentation Requirement:

An appropriate diagnosis code must be submitted on the claim. The patient’s medical record should indicate the signs/symptoms exhibited by the patient that required the ordering of the laboratory test. Documentation must be available to the carriers upon request.