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Contractor Name

CareFirst of Maryland INC., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LCD Database ID Number

L790

LCD Title

Breath Test for Helicobacter Pylori (H. Pylori)

Contractor's Determination Number

98-02-R5

AMA/CPT and ADA/CDT Copyright Statement

CPT codes, descriptions, and other data only are copyright 2004 American Medical Association (or such other date of publication of CPT). All rights reserved. Applicable FARS/DFARS clauses apply. CDT-4 codes and descriptions are © 2004 American Dental Association. All rights reserved.

CMS National Coverage Policy

• Establishment of national policy supersedes all previous contractor policy statements, including Local Medical Policy coverage guidelines
• Title XVIII of the Social Security Act, section 1862 (a) (7). This section excludes routine physical examinations.
• 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 for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
• Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.

Primary Geographic Jurisdiction

Maryland

Washington, DC

Secondary Geographic Jurisdiction

Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington state, and Wyoming

Oversight Region

Region III

CMS Consortium

Northeast

DMERC Region LCD Covers

N/A

Original Determination Effective Date

09/11/1998

Revision Effective Date

09/01/2004

01/22/2003

08/10/2001

04-09-2001

11/17/2000

Indications and Limitations of Coverage and/or Medical Necessity

Description

• The breath test for Helicobacter pylori is a non-invasive invasive diagnostic procedure utilizing analysis of breath samples to determine the presence of Helicobacter pylori. There are different specific tests available.
• The carbon-13 breath test consists of analysis of breath samples before and after ingestion of 13-C-urea. 13-C-urea will decompose to form 13-CO2 and NH4 in the presence of urease, which is produced by H. pylori in the stomach. The 13-CO2 is absorbed in the blood, then exhaled in the breath. The exhaled breath sample is analyzed and compared with the baseline breath sample, which was obtained before the ingestion of the 13-C-urea.
• The ^14-C-urea breath test is a radioisotope method for detecting H. pylori in the stomach. 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.

Indications and Limitations

· The tests available for the diagnosis of Helicobacter pylori infection differ with respect to sensitivity, specificity, invasiveness, cost, and in 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:

· patients 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 gastrointestinal endoscopy is planned,

· 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 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 considered not medically 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 or for whom an upper gastrointestinal endoscopy is planned,

· Patients who have non-specific dyspeptic symptoms with a negative H. pylori serum antibody test, or;

· 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. If a follow-up breath test is used to document eradication of H. pylori in the asymptomatic patient, it is expected that medical record documentation should verify the history of the previous complication.

· 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 thirty percent of patients with H. pylori infection associated with duodenal ulcer and/or gastritis/duodenitis.

· Commercially available kits for administering the 13-C-urea breath test are reimbursable based on invoice price for the kit. The kit and 13-C-urea containing drug must be approved by the FDA. Because of the precise way the 13-C-urea must be administered and the breath samples collected, 13-C-urea is not considered self-administrable.

· Services related to the explanation of the test to the patient, and supervision of the administration of the 13-C-urea, should be billed as evaluation and management services by the physician administering the test. Normally, if the test is administered during the overall evaluation of the patient for the clinical problem requiring the test, the time and effort of the physician in administering the test should be taken into consideration in determining the level of evaluation and management service to be billed.

Coverage Topics

Diagnostic Tests, X-rays, and Lab Services

Bill Type Codes

11X, 13X, 14X, 21X, 22X, 23X, 72X, 83X

Revenue Codes

30X, 34X, 636

CPT/HCPCS Codes

The AMA and CMS require the use of short descriptors for policies published on the Web. Refer to the CPT book for the long description of the following codes:

78267	Ó	Breath tst attain/anal C¹⁴
78268	Ó	Breath test analysis, C¹⁴
83013	Ó	H pylori analysis
83014	Ó	H pylori drug admin/collect

© CPT American Medical Association

Does the "CPT 30% Coding Rule" Apply?

N/A 

ICD-9 Codes that Support Medical Necessity

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider’s responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the claim is submitted.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

Medicare is establishing the following limited coverage for

Covered for:

531.00	Gastric ulcer; acute with hemorrhage; without mention of obstruction
531.01	Gastric ulcer; acute with hemorrhage; with obstruction
531.10	Gastric ulcer; acute with perforation, without mention of obstruction
531.11	Gastric ulcer; acute with perforation, with obstruction
531.20	Gastric ulcer; acute with hemorrhage and perforation; without mention of obstruction
531.21	Gastric ulcer; acute with hemorrhage and perforation; with obstruction
531.30	Gastric ulcer; acute without mention of hemorrhage or perforation; without mention of
	obstruction
531.31	Gastric ulcer; acute without mention of hemorrhage or perforation; with obstruction
531.40	Gastric ulcer; chronic or unspecified hemorrhage, without mention of obstruction
531.41	Gastric ulcer; chronic or unspecified hemorrhage, with obstruction
531.50	Gastric ulcer; chronic or unspecified with perforation, without mention of obstruction
531.51	Gastric ulcer; chronic or unspecified with perforation, with obstruction
531.60	Gastric ulcer; chronic or unspecified with hemorrhage and perforation, without mention
	of obstruction
531.61	Gastric ulcer; chronic or unspecified with hemorrhage and perforation, with obstruction
531.70	Gastric ulcer; chronic or unspecified without mention of hemorrhage and perforation,
	without mention of obstruction
531.71	Gastric ulcer; chronic or unspecified without mention of hemorrhage and perforation,
	with obstruction
531.90	Gastric ulcer; unspecified as acute or chronic, without mention of hemorrhage or
	perforation, without mention of obstruction
531.91	Gastric ulcer; unspecified as acute or chronic, without mention of hemorrhage or
	perforation, with obstruction
532.00	Duodenal ulcer, acute with hemorrhage; without mention of obstruction
532.01	Duodenal ulcer, acute with hemorrhage; with obstruction
532.10	Duodenal ulcer, acute with perforation; without mention of obstruction
532.11	Duodenal ulcer, acute with perforation; with obstruction
532.20	Duodenal ulcer, acute with hemorrhage and perforation; without mention of obstruction
532.21	Duodenal ulcer, acute with hemorrhage and perforation; with obstruction
532.30	Duodenal ulcer, acute without mention of hemorrhage or perforation; without mention
	of obstruction
532.31	Duodenal ulcer, acute without mention of hemorrhage or perforation; with obstruction
532.40	Duodenal ulcer, chronic or unspecified with hemorrhage, without mention of
	obstruction
532.41	Duodenal ulcer, chronic or unspecified with hemorrhage, with obstruction
532.50	Duodenal ulcer, chronic or unspecified with perforation, without mention of obstruction
532.51	Duodenal ulcer, chronic or unspecified with perforation, with obstruction
532.60	Duodenal ulcer, chronic or unspecified with hemorrhage and perforation, without
	mention of obstruction
532.61	Duodenal ulcer, chronic or unspecified with hemorrhage and perforation, with
	obstruction
532.70	Duodenal ulcer, chronic without mention of hemorrhage and perforation, without
	mention of obstruction
532.71	Duodenal ulcer, chronic without mention of hemorrhage and perforation, with
	obstruction
532.90	Duodenal ulcer, unspecified as acute or chronic, without mention of hemorrhage or
	perforation; without mention of obstruction
532.91	Duodenal ulcer, unspecified as acute or chronic, without mention of hemorrhage or
	perforation; with obstruction
534.00	Gastrojejunal ulcer, acute with hemorrhage; without mention of obstruction
534.01	Gastrojejunal ulcer, acute with hemorrhage; with obstruction
534.10	Gastrojejunal ulcer, acute with perforation; without mention of obstruction
534.11	Gastrojejunal ulcer, acute with perforation; with obstruction
534.20	Gastrojejunal ulcer, acute with hemorrhage and perforation; without mention of
	obstruction
534.21	Gastrojejunal ulcer, acute with hemorrhage and perforation; with obstruction
534.30	Gastrojejunal ulcer, acute without mention of hemorrhage and perforation;
	without mention of obstruction
534.31	Gastrojejunal ulcer, acute without mention of hemorrhage and perforation; with
	obstruction
534.40	Gastrojejunal ulcer, chronic or unspecified with hemorrhage, without mention of
	obstruction
534.41	Gastrojejunal ulcer, chronic or unspecified with hemorrhage, with obstruction
534.50	Gastrojejunal ulcer, chronic or unspecified with perforation, without mention of
	obstruction
534.51	Gastrojejunal ulcer, chronic or unspecified with perforation, with obstruction
534.60	Gastrojejunal ulcer, chronic or unspecified with hemorrhage and perforation, without
	mention of obstruction
534.61	Gastrojejunal ulcer, chronic or unspecified with hemorrhage and perforation, with
	obstruction
534.70	Gastrojejunal ulcer, chronic without mention of hemorrhage or perforation, without
	mention of obstruction
534.71	Gastrojejunal ulcer, chronic without mention of hemorrhage or perforation, with
	obstruction
534.90	Gastrojejunal ulcer, unspecified as acute or chronic without mention of hemorrhage or
	perforation; without mention of obstruction
534.91	Gastrojejunal ulcer, unspecified as acute or chronic without mention of hemorrhage or
	perforation; with obstruction
535.00	Acute gastritis; without mention of hemorrhage
535.01	Acute gastritis; with hemorrhage
535.10	Atrophic gastritis; without mention of hemorrhage
535.11	Atrophic gastritis; with hemorrhage
535.50	Unspecified gastritis and gastroduodenitis; without mention of hemorrhage
535.51	Unspecified gastritis and gastroduodenitis; with hemorrhage
535.60	Duodenitis; without mention of hemorrhage
535.61	Duodenitis; with hemorrhage
536.8	Dyspepsia and other specified disorders of function of stomach
789.01	Abdominal pain; right upper quadrant
789.02	Abdominal pain; left upper quadrant
789.06	Abdominal pain, epigastric

Diagnoses that Support Medical Necessity

N/A

ICD-9 Codes that DO NOT Support Medical Necessity

N/A

Diagnoses that DO NOT Support Medical Necessity

N/A

Documentation Requirements

• Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and available to Medicare upon request.
• ICD-9-CM diagnosis codes supporting medical necessity must be submitted with each claim. Claims submitted without such evidence will be denied as not medically necessary.

Utilization Guidelines

Medicare will monitor the utilization of this procedure through the Medical Review process.

Sources of Information and Basis for Decision

· TrailBlazer Carrier Advisory Committee

· TrailBlazer Medicare B Newsletter, No. 020, October 1997

· Klein, Peter D., et al. 1996. “Non-invasive Detection of Helicobacter Pylori Infection in Clinical Practice: The ¹³C-urea Breath Test.” The American Journal of Gastroenterology Vol. 91 (April): pp. 690-694.

· Slomianski, Arie, M.D., et al. 1995. “[¹³C] Urea Breath Test to Confirm Eradication of Helicobacter Pylori.” The American Journal of Gastroenterology Vol 90 (February): pp. 224-226.

Advisory Committee Notes

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final

decision rests with the contractor; this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies).

Start Date of Comment Period

03/31/1998

End Date of Comment Period

04/30/1998

Start Date of Notice Period

08/11/1998

Revision History Number

R5

R4

R3

R2

R1

Revision History

Revision Number	Revision History Explanation
R5	Addition of 83X to “Bill Types of Code.” Converted from LMRP to
	LCD format.
R-4	Descriptors changed to short descriptors, unranged ICD-9 codes.
R-3	The policy was revised to accommodate changes in CPT 2001 with the
	addition of 78267 and 78268. (See 08/10/2001 Provider Bulletin)
R-2	The policy was revised to accommodate changes in CPT 2000 with
	the addition of 83013 and 83014. (See 04/09/2001 Provider Bulletin)
R-1	Policy modified to accommodate ICD-9-CM codes 531.30-531.31,
	erroneously omitted in the original policy.

Does this LCD contain a "Least Costly Alternative" provision?

No

THIS BULLETIN SHOULD BE SHARED WITH ALL HEALTH CARE PRACTITIONERS AND MANAGERIAL MEMBERS OF THE PROVIDER/SUPPLIER STAFF. BULLETINS ISSUED AFTER OCTOBER 1, 1999 ARE AVAILABLE FROM OUR WEBSITE AT www.marylandmedicare.com

Italicized and or quoted material is excerpted from the American Medical Association Current Procedural Terminology CPT codes, descriptions and other data only are copyrighted 1999 American Medical Association (or such other publication of CPT). All rights reserved. Applicable FARS/DFARS apply.