The breath test for Helicobacter pylori (H. pylori) is a non-invasive diagnostic procedure utilizing analysis of breath samples to determine the presence of H. pylori in the stomach. The H. pylori breath test consists of analysis of breath samples before and after ingestion of labeled C-urea. There are two methods for labeling the urea used in the breath test. One is to use the stable heavy isotope 13C-urea and the other is to use the radioactive isotope 14C-urea. Labeled C-urea will decompose to form labeled CO2 and NH4 in the presence of urease that is produced by H. pylori in the stomach. The labeled CO2 is absorbed in the blood, and then exhaled in the breath. The exhaled breath sample is then analyzed and compared with the baseline breath sample, which was obtained before the ingestion of the labeled C-urea.
The breath test can detect H. pylori colonization with reported 95 percent accuracy. H. pylori is accepted as an etiologic factor in duodenal ulcers, peptic ulcer disease, gastric carcinoma and primary B cell gastric lymphoma.
The stool test (code 87338) describes an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. A fresh or appropriately stored stool specimen is processed and tested by enzyme immunoassay technique.
Serological testing for antibodies to H. pylori is inexpensive, convenient and simple, but, because antibody levels persist some months after treatment, it is not useful for assessing therapeutic effectiveness.
Invasive tests for H. pylori detection involve endoscopic biopsies of stomach tissue and are not addressed in this policy.
The tests available for the diagnosis of Helicobacter pylori infection differ with respect to sensitivity, specificity, invasiveness, cost and the additional information that they provide.
The appropriate choice of test depends on the clinical situation. The following clinical scenarios are appropriate for use of the H. pylori breath test:
- Patient with classic relatively uncomplicated symptoms of peptic ulcer disease for whom antibiotic therapy is planned, if the H. pylori breath test is positive, and no endoscopy is planned.
- Patients who have had an upper gastrointestinal endoscopy and in whom no helicobacter testing was performed.
- Patients who have non-specific dyspeptic symptoms with a positive H. pylori serum antibody test, and no endoscopy is planned.
- An upper gastrointestinal contrast X-ray series has been done that shows a duodenal ulcer or significant gastritis and/or duodenitis, and no endoscopy is planned.
- There are persistent or recurrent symptoms six weeks after treatment for a documented H. pylori infection, and no endoscopy is planned.
- Anyone with complications from peptic ulcer disease (i.e., bleeding ulcers, perforated ulcers), after appropriate antibiotic/H3 antagonist treatment, to establish a bacterial cure.
The H. pylori breath test is not considered reasonable and necessary in the following situations:
- Patients who are being screened for H. pylori infection in the absence of documented upper gastrointestinal tract symptoms and/or pathology.
- Patients who have had an upper gastrointestinal endoscopy within the preceding six weeks and helicobacter testing was performed, or for whom an upper gastrointestinal endoscopy is planned who have not been treated for H. pylori.
- Patients who have non-specific dyspeptic symptoms with a negative H. pylori serum antibody test or a negative H. pylori stool antigen test.
- Patients who are asymptomatic after treatment of an H. pylori infection (either proven or suspected) except in the situation of a history of a major complication of ulcer disease such as bleeding, perforation, penetration or multiple recurrences in which case an H. pylori breath test may be used to document eradication of the infection in lieu of a follow-up endoscopy.
Based on cure rates for H. pylori infection with the currently accepted regimens utilizing antibiotics, repeat endoscopy or H. pylori breath test would be expected in less than 30 percent of patients with H. pylori infection associated with duodenal ulcer and/or gastritis/duodenitis.
The serological test for H. pylori antibody is appropriate for the patient with non-specific dyspeptic symptoms in order to rule in or out H. pylori infection. Because high levels of antibody persist for months after successful or unsuccessful treatment of H. pylori infection, this test is not appropriate to determine treatment outcome.
The stool test for H. pylori antigen is also appropriate for the patient with non-specific dyspeptic symptoms. In contrast to the serum antibody test, the stool antigen test returns to normal (negative) after successful treatment, and may be used to determine treatment outcome.
The serological test for H. pylori antigen (CPT code 87339) is not recommended.
Screening services are not covered under Medicare.
Procedure codes 83013 and 83014 should be used to describe the C-13 versions of the test, and 78267 and 78268 should be used to describe the C-14 versions of the breath tests. The payment for provision of the C-13 and C-14 isotopes is included in the payment for these CPT codes. The provider may not bill separately for providing these isotopes.
CPT code 83013 should be used to report the laboratory charge for the analysis of the breath sample obtained.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
- Safe and effective.
- Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
- Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
- Furnished in a setting appropriate to the patient’s medical needs and condition.
- Ordered and furnished by qualified personnel.
- One that meets, but does not exceed, the patient’s medical need.
- At least as beneficial as an existing and available medically appropriate alternative.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 14X, 18X, 21X, 22X, 23X, 71X, 73X, 77X, 83X, 85X
Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
Breath tst attain/anal c-14
Breath test analysis, c-14
H pylori (c-13), breath
H pylori drug admin
Hpylori, stool, eia
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes 78267, 78268 (the breath tests), 83013, 83014, 86677 and 87338 (stool test):
Helicobacter pylori [H. pylori]
Gastric ulcer, acute with hemorrhage
Gastric ulcer, acute with perforation
Gastric ulcer, acute with hemorrhage and perforation
Gastric ulcer, acute without mention of hemorrhage or perforation
Gastric ulcer, chronic or unspecified with hemorrhage
Gastric ulcer, chronic or unspecified with perforation
Gastric ulcer, chronic or unspecified with hemorrhage and perforation
Gastric ulcer, chronic without mention of hemorrhage or perforation
Gastric ulcer, unspecified as acute or chronic, without mention of hemorrhage or perforation
Duodenal ulcer, acute with hemorrhage
Duodenal ulcer, acute with perforation
Duodenal ulcer, acute with hemorrhage and perforation
Duodenal ulcer, acute without mention of hemorrhage or perforation
Duodenal ulcer, chronic or unspecified with hemorrhage
Duodenal ulcer, chronic or unspecified with perforation
Duodenal ulcer, chronic or unspecified with hemorrhage and perforation
Duodenal ulcer, chronic without mention of hemorrhage or perforation
Duodenal ulcer, unspecified as acute or chronic, without mention of hemorrhage or perforation
Peptic ulcer, site unspecified, acute with hemorrhage
Peptic ulcer, site unspecified, acute with perforation
Peptic ulcer, site unspecified, acute with hemorrhage and perforation
Peptic ulcer, site unspecified, acute without mention of hemorrhage and perforation
Peptic ulcer, site unspecified, chronic or unspecified with hemorrhage
Peptic ulcer, site unspecified, chronic or unspecified with perforation
Peptic ulcer, site unspecified, chronic or unspecified with hemorrhage and perforation
Peptic ulcer, site unspecified, chronic without mention of hemorrhage or perforation
Peptic ulcer, site unspecified, unspecified as acute or chronic, without mention of hemorrhage or perforation
Gastrojejunal ulcer, acute with hemorrhage
Gastrojejunal ulcer, acute with perforation
Gastrojejunal ulcer, acute with hemorrhage and perforation
Gastrojejunal ulcer, acute without mention of hemorrhage or perforation
Gastrojejunal ulcer, chronic or unspecified with hemorrhage
Gastrojejunal ulcer, chronic or unspecified with perforation
Gastrojejunal ulcer, chronic or unspecified with hemorrhage and perforation
Gastrojejunal ulcer, chronic without mention of hemorrhage or perforation
Gastrojejunal ulcer, unspecified as acute or chronic, without mention of hemorrhage or perforation
Gastritis and duodenitis, acute gastritis
Gastritis and duodenitis, atrophic gastritis
Gastritis and duodenitis, gastric mucosal hypertrophy
Gastritis and duodenitis, alcoholic gastritis
Gastritis and duodenitis, other specified gastritis
Gastritis and duodenitis, unspecified gastritis and gastroduodenitis
Gastritis and duodenitis, duodenitis
Dyspepsia and other specified disorders of function of stomach
Other specified disorders of stomach and duodenum
Gastrointestinal mucositis (ulcerative)
Nausea with vomiting – vomiting alone
Flatulence eructation and gas pain
Abdominal pain right upper quadrant – abdominal pain left upper quadrant
Abdominal pain epigastric
Nonspecific (abnormal) findings on radiological and other examination of gastrointestinal tract
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
ICD-9-CM Codes That DO NOT Support Medical Necessity
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
When requesting a written appeal, please send all relevant documentation with the appeal request.
Sources of Information and Basis for Decision
J4 (CO, NM, OK, TX) MAC Integration
TrailBlazer adopted the Noridian Administrative Services, LLC LCD, “Helicobacter Pylori Testing,” for the Jurisdiction 4 (J4) MAC transition.
Full disclosure of information sources is found with original contractor LCDs.