Helicobacter Pylori Testing HELICOBACTER PYLORI TESTING HS-131. Policy Number: HS-131. Original Effective Date: 9/17/2009

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Sharon Briggs
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Easy Choice Health Plan, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Inc.

WellCare Health Plans of New Jersey, Inc. WellCare Health Insurance of Arizona, Inc. WellCare of Florida, Inc.

WellCare of New York, Inc. WellCare of South Carolina, Inc. WellCare of Texas, Inc. WellCare Prescription Insurance, Inc.

9/17/2009 Revised Date(s): 9/24/2010; 9/1/2011; 9/6/2012; 8/1/2013; 8/7/2014; 7/11/2015 APPLICATION STATEMENT The application of

1 Easy Choice Health Plan, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Inc. Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc. WellCare Health Insurance of Illinois, Inc. WellCare Health Plans of New Jersey, Inc. WellCare Health Insurance of Arizona, Inc. WellCare of Florida, Inc. WellCare of Connecticut, Inc. WellCare of Georgia, Inc. WellCare of Kentucky, Inc. WellCare of Louisiana, Inc. WellCare of New York, Inc. WellCare of South Carolina, Inc. WellCare of Texas, Inc. WellCare Prescription Insurance, Inc. Windsor Health Plan Windsor Rx Medicare Prescription Drug Plan Helicobacter Pylori Testing Policy Number: Original Effective Date: 9/17/2009 Revised Date(s): 9/24/2010; 9/1/2011; 9/6/2012; 8/1/2013; 8/7/2014; 7/11/2015 APPLICATION STATEMENT The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

2 DISCLAIMER The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult for list of current LOBs. BACKGROUND H. pylori is a spiral-shaped, gram-negative bacterium found in the gastric mucosa or attached to the epithelial lining of the stomach. The organism weakens the protective mucous coating of the stomach and duodenum, allowing acid to get through to the sensitive lining beneath. Both the acid and the bacteria irritate the lining and cause the ulcer. H. pylori is able to survive in stomach acid because it secretes enzymes that neutralize the acid. Acute infection is commonly asymptomatic but may be associated with epigastric burning, abdominal distention or bloating, belching, nausea, flatulence, and/or halitosis. Almost all members infected with H. pylori who have had endoscopic biopsies are found to have histological gastritis. H. pylori infection can lead to ulceration of the gastric mucosa and duodenum and has been found to be strongly associated with the development of epithelial and lymphoid malignancies of the stomach. It has been classified by the International Agency for Research on Cancer as a group I carcinogen and a definite cause of gastric cancer in humans. Associations have been made between H. pylori and both dyspepsia and gastroesophageal reflux disease (GERD). Dyspepsia is clinically defined as nausea, epigastric pain or discomfort experienced on more than seven days of a four-week period. Factors that affect the management of dyspepsia include the patient s age, routine use of NSAIDs, and presence of any alarm symptoms. Alarm symptoms are identified as melena, hematemesis, persistent vomiting, anemia, acute onset of total dysphagia or involuntary weight loss greater than 5%. The procedure of choice for evaluation of dyspepsia is endoscopy, especially when alarm symptoms are present. For patients with a documented history of PUD who present with dyspepsia in the absence of reflux or alarm symptoms, management should begin with testing for H. pylori, followed by eradication therapy if results are positive. It has not been proven that eradication of H. pylori improves symptoms in patients with non-ulcer dyspepsia. 1 In February 2012, the FDA approved the first test for use in children ages 3 to 17 to detect Helicobacter pylori bacterial infections. (Hayes, 2012). The BreathTek Urea Blood Test (BreathTek UBT ) was first approved for adults in According to the product labeling, BreathTek UBT should not be used until at least 4 weeks after completing treatment to eradicate H. pylori, as earlier posttreatment assessment may give false-negative results. In addition, atimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingestion of these within 2 weeks prior to performing the BreathTek UBT may give false-negative results. 2 Hayes 3 also reports that a study published in Lancet suggests that, in a European population, a combination of four agents over 10 days can safely eradicate helicobacter pylori (H. pylori) infection. Most international treatment guidelines recommend a 7-day regimen of three drugs, which has been associated with a loss of efficacy due to an increase in antibiotic resistance. POSITION STATEMENT Applicable To: Medicaid All Markets Medicare All Markets The following methods are considered medically necessary for diagnosing Helicobacter pylori (H. pylori) infection: Endoscopic biopsy with urease testing, histology and/or culture Clinical Coverage Guideline page 2

3 H. pylori stool antigen (HpSA) Serology in individuals not previously treated for H. pylori infection Urea breath testing (criteria outlined below) The H. pylori urea breath test is considered medically necessary in the following circumstances: Member with uncomplicated symptoms of peptic ulcer disease for whom antibiotic therapy is planned, if H. pylori breath test is positive, and no endoscopy is planned; OR, Members who have had an upper gastrointestinal endoscopy and in whom no helicobacter testing was performed; OR, Members who have non-specific dyspeptic symptoms with a positive H. pylori serum antibody test, and no endoscopy is planned; OR, 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; OR, There are persistent or recurrent symptoms six weeks after treatment for a documented H. pylori infection, and no endoscopy is planned; OR, Anyone with complications from peptic ulcer disease after appropriate antibiotic/h3 antagonist treatment, to establish a bacterial cure. The H. pylori breath test is considered NOT medically necessary in the following circumstances: Members who are being (V74.9) screened for H. pylori infection in the absence of documented upper gastrointestinal tract symptoms and/or pathology; OR, Members 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; OR, Members who have non-specific dyspeptic symptoms with a negative H. pylori serum antibody test or a negative H. pylori stool antigen test; OR, Members who are asymptomatic after treatment of an H. pylori infection 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. CODING Covered CPT * Codes Urea Breath test, C-14, Isotopic; acquisition for analysis Urea Breath test, C-14, Isotopic; analysis Helicobacter pylori, blood test analysis for urease activity, non-radioactive isotope (C-13) H pylori; breath test analysis for unease activity, non-radioactive isotope; C H pylori; drug administration H pylori; antibody H pylori, stool ; EIA or ELISA H pylori; EIA or ELISA HCPCS Level II Codes - No applicable codes. ICD-9-CM Procedure Codes - No applicable codes. DRAFT ICD-10-PCS Codes - No applicable codes. Clinical Coverage Guideline page 3

4 Covered ICD-9 Diagnosis Codes Helicobacter Pylori [H. PYLORI] Esophageal Reflux Acute Gastric Ulcer with hemorrhage without obstruction Acute Gastric Ulcer with hemorrhage with obstruction Acute Gastric Ulcer with perforation without obstruction Acute Gastric Ulcer with perforation with obstruction Acute Gastric Ulcer with hemorrhage and perforation without obstruction Acute Gastric Ulcer with hemorrhage and perforation with obstruction Acute Gastric Ulcer without hemorrhage or perforation without obstruction Acute Gastric Ulcer without hemorrhage or perforation with obstruction Chronic or unspecified Gastric Ulcer with hemorrhage without obstruction Chronic or unspecified Gastric Ulcer with hemorrhage with obstruction Chronic or unspecified Gastric Ulcer with perforation without obstruction Chronic or unspecified Gastric Ulcer with perforation with obstruction Chronic or unspecified Gastric Ulcer with hemorrhage and perforation without obstruction Chronic or unspecified Gastric Ulcer with hemorrhage and perforation with obstruction Chronic Gastric Ulcer without hemorrhage or perforation without obstruction Chronic Gastric Ulcer without hemorrhage or perforation with obstruction Gastric Ulcer unspecified as acute or chronic without hemorrhage or perforation without obstruction Gastric Ulcer unspecified as acute or chronic without hemorrhage or perforation with obstruction Acute Duodenal Ulcer with hemorrhage without obstruction Acute Duodenal Ulcer with hemorrhage with obstruction Acute Duodenal Ulcer with perforation without obstruction Acute Duodenal Ulcer with perforation with obstruction Acute Duodenal Ulcer with hemorrhage and perforation without obstruction Acute Duodenal Ulcer with hemorrhage and perforation with obstruction Acute Duodenal Ulcer without hemorrhage or perforation without obstruction Acute Duodenal Ulcer without hemorrhage or perforation with obstruction Chronic or unspecified Duodenal Ulcer with hemorrhage without obstruction Chronic or unspecified Duodenal Ulcer with hemorrhage with obstruction Chronic or unspecified Duodenal Ulcer with perforation without obstruction Chronic or unspecified Duodenal Ulcer with perforation with obstruction Chronic or unspecified Duodenal Ulcer with hemorrhage and perforation without obstruction Chronic or unspecified Duodenal Ulcer with hemorrhage and perforation with obstruction Chronic Duodenal Ulcer without hemorrhage or perforation without obstruction Chronic Duodenal Ulcer without hemorrhage or perforation with obstruction Duodenal Ulcer unspecified as acute or chronic without hemorrhage or perforation without obstruction Duodenal Ulcer unspecified as acute or chronic without hemorrhage or perforation with obstruction Acute Peptic Ulcer of unspecified site with hemorrhage without obstruction Acute Peptic Ulcer of unspecified site with hemorrhage with obstruction Acute Peptic Ulcer of unspecified site with perforation without obstruction Acute Peptic Ulcer of unspecified site with perforation with obstruction Acute Peptic Ulcer of unspecified site with hemorrhage and perforation without obstruction Acute Peptic Ulcer of unspecified site with hemorrhage and perforation with obstruction Acute Peptic Ulcer of unspecified site without hemorrhage and perforation without obstruction Acute Peptic Ulcer of unspecified site without hemorrhage and perforation with obstruction Chronic or unspecified Peptic Ulcer of unspecified site with hemorrhage without obstruction Chronic or unspecified Peptic Ulcer of unspecified site with hemorrhage with obstruction Chronic or unspecified Peptic Ulcer of unspecified site with perforation without obstruction Chronic or unspecified Peptic Ulcer of unspecified site with perforation with obstruction Chronic or unspecified Peptic Ulcer of unspecified site with hemorrhage & perforation without obstruction Clinical Coverage Guideline page 4

5 Chronic or unspecified Peptic Ulcer of unspecified site with hemorrhage and perforation with obstruction Chronic Peptic Ulcer of unspecified site without hemorrhage or perforation without obstruction Chronic Peptic Ulcer of unspecified site without hemorrhage or perforation with obstruction Peptic Ulcer of unspecified site unspecified as acute or chronic without hemorrhage or perforation without obstruction Peptic Ulcer of unspecified site unspecified as acute or chronic without hemorrhage or perforation with obstruction Acute Gastrojejunal Ulcer with hemorrhage without obstruction Acute Gastrojejunal Ulcer with hemorrhage with obstruction Acute Gastrojejunal Ulcer with perforation without obstruction Acute Gastrojejunal Ulcer with perforation with obstruction Acute Gastrojejunal Ulcer with hemorrhage and perforation without obstruction Acute Gastrojejunal Ulcer with hemorrhage and perforation with obstruction Acute Gastrojejunal Ulcer without hemorrhage or perforation without obstruction Acute Gastrojejunal Ulcer without hemorrhage or perforation with obstruction Chronic or unspecified Gastrojejunal Ulcer with hemorrhage without obstruction Chronic or unspecified Gastrojejunal Ulcer with hemorrhage with obstruction Chronic or unspecified Gastrojejunal Ulcer with perforation without obstruction Chronic or unspecified Gastrojejunal Ulcer with perforation with obstruction Chronic or unspecified Gastrojejunal Ulcer with hemorrhage and perforation without obstruction Chronic or unspecified Gastrojejunal Ulcer with hemorrhage and perforation with obstruction Chronic Gastrojejunal Ulcer without hemorrhage or perforation without obstruction Chronic Gastrojejunal Ulcer without hemorrhage or perforation with obstruction Gastrojejunal Ulcer unspecified as acute or chronic without hemorrhage or perforation without obstruction Gastrojejunal Ulcer unspecified as acute or chronic without hemorrhage or perforation with obstruction Acute Gastritis without hemorrhage Acute Gastritis with hemorrhage Atrophic Gastritis without hemorrhage Atrophic Gastritis with hemorrhage Gastric Mucosal Hypertrophy without hemorrhage Gastric Mucosal Hypertrophy with hemorrhage Alcoholic Gastritis without hemorrhage Alcoholic Gastritis with hemorrhage Other specified Gastritis without hemorrhage Other specified Gastritis with hemorrhage Unspecified Gastritis and Gastroduodenitis without hemorrhage Unspecified Gastritis and Gastroduodenitis with hemorrhage Duodenitis without hemorrhage Duodenitis with hemorrhage Persistent vomiting Dyspepsia and other specified disorders of function of stomach Other specified disorders of stomach and duodenum 538 Gastrointestinal mucositis ulcerative Nausea with vomiting Vomiting Alone Heartburn 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 the gastrointestinal tract Clinical Coverage Guideline page 5

6 Non-Covered ICD-9-CM Diagnosis Code V74.9 Special Screen Examination for Bacterial and Spirochetal disease Covered Draft ICD-10-CM Diagnosis Codes B96.81 Helicobacter pylori (H.pylori) as the cause of disease classified elsewhere K21.9 Gastro-esophageal reflux disease without esophagitis K25.0 Acute gastric ulcer with hemorrhage K25.1 Acute gastric ulcer with perforation K25.2 Acute gastric ulcer with both hemorrhage and perforation K25.3 Acute gastric ulcer without hemorrhage or perforation K25.4 Chronic or unspecified gastric ulcer with hemorrhage K25.5 Chronic or unspecified gastric ulcer with perforation K25.6 Chronic or unspecified gastric ulcer with both hemorrhage and perforation K25.7 Chronic or unspecified gastric ulcer without hemorrhage or perforation K25.9 Gastric ulcer, unspecified as acute or chronic, without hemorrhage or perforation K26.0 Acute duodenal ulcer with hemorrhage K26.1 Acute duodenal ulcer with perforation K26.2 Acute duodenal ulcer with both hemorrhage and perforation K26.3 Acute duodenal ulcer without hemorrhage or perforation K26.4 Chronic or unspecified duodenal ulcer with hemorrhage K26.5 Chronic or unspecified duodenal ulcer with perforation K26.6 Chronic or unspecified duodenal ulcer with both hemorrhage and perforation K26.7 Chronic duodenal ulcer without hemorrhage or perforation K26.9 Duodenal ulcer, unspecified as acute or chronic, without hemorrhage or perforation K27.0 Acute peptic ulcer, site unspecified, with hemorrhage K27.1 Acute peptic ulcer, site unspecified, with perforation K27.2 Acute peptic ulcer, site unspecified, with both hemorrhage and perforation K27.3 Acute peptic ulcer, site unspecified, without hemorrhage or perforation K27.4 Chronic or unspecified peptic ulcer, site unspecified, with hemorrhage K27.5 Chronic or unspecified peptic ulcer, site unspecified, with perforation K27.6 Chronic or unspecified peptic ulcer, site unspecified, with hemorrhage and perforation K27.7 Chronic or unspecified peptic ulcer, site unspecified, without hemorrhage or perforation K27.9 Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation K28.0 Acute Gastrojejunal ulcer with hemorrhage K28.1 Acute Gastrojejunal ulcer with perforation K28.2 Acute Gastrojejunal ulcer with hemorrhage and perforation K28.3 Acute Gastrojejunal ulcer without hemorrhage or perforation K28.4 Chronic or unspecified Gastrojejunal ulcer with hemorrhage K28.5 Chronic or unspecified Gastrojejunal ulcer with perforation K28.6 Chronic or unspecified Gastrojejunal ulcer with both hemorrhage and perforation K28.7 Chronic or unspecified Gastrojejunal ulcer without hemorrhage or perforation K28.9 Gastrojejunal ulcer, unspecified as acute or chronic, without hemorrhage or perforation K29.00 Acute gastritis without bleeding K29.01 Acute gastritis with bleeding K29.20 Alcoholic gastritis without bleeding K29.21 Alcoholic gastritis with bleeding K29.30 Chronic superficial gastritis without bleeding K29.31 Chronic superficial gastritis with bleeding K29.40 Chronic atrophic gastritis without bleeding K29.41 Chronic atrophic gastritis with bleeding K29.50 Unspecified chronic gastritis without bleeding K29.51 Unspecified chronic gastritis with bleeding Clinical Coverage Guideline page 6

7 K29.60 Other gastritis without bleeding K29.61 Other gastritis with bleeding K29.70 Gastritis, unspecified, without bleeding K29.71 Gastritis, unspecified, with bleeding K29.80 Duodenitis without bleeding K29.81 Duodenitis with bleeding K29.90 Gastroduodenitis, unspecified, without bleeding K39.91 Gastroduodenitis, unspecified, with bleeding R10.10 Upper abdominal pain, unspecified R10.11 Right upper quadrant pain R10.12 Left upper quadrant pain R11.10 Vomiting, unspecified R11.11 Vomiting without nausea R11.2 Nausea with vomiting, unspecified R12 Heartburn R14.0 Abdominal distension (gaseous) R14.1 Gas pain R14.2 Eructation R14.3 Flatulence R93.3 Abnormal findings on diagnostic imaging of other parts of digestive tract Non-Covered DRAFT ICD-10-CM Diagnosis Code Z11.2 Encounter for screening for other bacterial diseases *Current Procedural Terminology (CPT ) 2015 American Medical Association: Chicago, IL. REFERENCES 1. Chey W, Wong, BCY. American College of Gastroenterology Guideline on the Management of Helicobacter pylori Infection. American Journal of Gastroenterology. 2007; 102: FDA approved first helicobacter pylori breath test for children. Hayes Directory Web site. Published February 27, Accessed August 19, Quadruple therapy for treating helicobacter pylori. Hayes Directory Website. Published May 23, Accessed August 19, MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS Date Action 7/11/2015, 8/7/2014, 8/1/2013 9/6/2012 Approved by MPC. No changes. Approved by MPC. Condensed background section. Added 2 new Hayes references re: 2012 FDA approval of testing in children and a study showing efficacy in shorter duration of treatment in eradicating H. pylori. No other substantive changes; coverage not altered. 12/1/2011 9/1/2011 New template design approved by MPC. Approved by MPC. Clinical Coverage Guideline page 7

Wireless Capsule Endoscopy

Wireless Capsule Endoscopy Harmony Behavioral Health, Inc. Harmony Behavioral Health of Florida, Inc. Harmony Health Plan of Illinois, Inc. HealthEase of Florida, Inc. Ohana Health Plan, a plan offered by WellCare Health Insurance