LCD Reference Article Response To Comments Article

Response to Comments: Helicobacter Pylori Infection Testing

A56381

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A56381
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Response to Comments: Helicobacter Pylori Infection Testing
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Response to Comments
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05/27/2019
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Noridian’s Response to Provider Recommendations for Helicobacter Pylori Infection Testing for comment period ending 04/13/2018.

Response To Comments

Number Comment Response
1

- We attached the 2017 ACG guidelines for H. pylori infections. Based on these recommendations, we would recommend consideration be given to adding the following for coverage:

- Patient with active peptic ulcer disease, or a past history of peptic ulcer disease (strong recommendation, high quality of evidence) with no biopsies results available or on PPI treatment.

- Patient with low grade gastric mucosa associated lymphoid tissue (MALT) lymphoma, or a history of endoscopic resection of early gastric cancer (Strong recommendation, low quality of evidence).

-Patient initiating chronic treatment with a non-steroidal anti-inflammatory drug (NSAID) (Strong recommendation, moderate quality of evidence).

Also may wish to consider providing coverage for H. pylori testing in patient with dyspepsia and alarm symptoms after a negative upper endoscopy and no biopsies. Breath test or stool Ag testing may be less costly than biopsies and pathology.

See Response 2

2

Sorry I wasn’t able to attend the recent California CAC meeting but I wanted to submit comments on behalf of Gastroenterology societies and for the California Medical Association on the following:

HELICOBACTER PYLORI INFECTION TESTING DL37624

  • Criteria for coverage for urea breath testing or stool antigen testing for active H. pylori infection are:

Evaluation of new onset dyspepsia in persons younger than 55 years of age without alarm symptoms; or

Evaluation of person with persistent symptoms of dyspepsia despite 2 weeks of appropriate antibiotic therapy for H. pylori; or

Before starting proton pump inhibitor therapy for dyspepsia; or

Before bariatric surgery for obesity, including endoscopic bariatric interventions; or

Recurrent dyspeptic symptoms suggest reinfection with H. pylori; or

Re-evaluation to assess success of eradication of H. pylori infection (no sooner than 4 weeks post-treatment).

  • All other H. pylori testing for any other etiology is not reasonable and necessary, and not a Medicare benefit

You specifically indicate coverage is not appropriate for: onset of new dyspepsia in person aged 55 years or older, and screening of asymptomatic person for H. pylori infection. And you state that upper GI endoscopy is indicated for persons aged 55 years or older because of increased concern for gastric neoplasia

I’d bring to your attention a recent American College of Gastroenterology guideline published by respected experts on the subject and with a large number of research studies cited.

I would note the age of 60 years is cited as a threshold for endoscopy for uninvestigated dyspepsia and would seem more appropriate, except in patients from high risk epidemiologic backgrounds.

Noridian is encouraged to add to coverage:

  • Evaluation before starting long term NSAID therapy
  • ITP
  • Patients taking long-term low-dose aspirin, particularly if other ulcerogenic risk factors are present (eg other anticoagulants, SSRI drugs which as a class have anti-platelet effects), smokers
  • Patients with credible past history of peptic ulcer disease not apparently due to NSAID use, even if asymptomatic when seen
  • Unexplained iron deficiency anemia, despite appropriate evaluation

I include a portion of the guideline below and attach a PDF with the guideline

Additionally, consider extending the otherwise broad list of covered diagnoses to include ICD-10 codes for the group of nausea/vomiting codes, iron deficiency anemia, ITP. It will not be very practical to include a list of conditions where NSAIDs or low dose aspirin, and the medical directors should strongly consider simply removing a specific ‘restrictive’ list of ICD10 codes.

I appreciate your consideration of my comments.

From:

http://gi.org/guideline/treatment-of-helicobacter-pylori-infection/

William D. Chey, MD, FACG1, Grigorios I. Leontiadis, MD, PhD2, Colin W. Howden, MD, FACG3 and Steven F. Moss, MD, FACG4

Am J Gastroenterol 2017; 112: 212–238; doi:10.1038/ajg.2016.563; published online 10 January 2017

Question 2: What Are the Indications to Test For, and to Treat, H. pylori Infection?

Recommendations

  • Since all patients with a positive test of active infection with H. pylori should be offered treatment, the critical issue is which patients should be tested for the infection (strong recommendation, quality of evidence: not applicable),
  • All patients with active peptic ulcer disease (PUD), a past history of PUD (unless previous cure of H. pylori infection has been documented), low-grade gastric mucosa-associated lymphoid tissue (MALT) lymphoma, or a history of endoscopic resection of early gastric cancer (EGC) should be tested for H. pylori infection. Those who test positive should be offered treatment for the infection (strong recommendation, quality of evidence: high for active or history of PUD, low for MALT lymphoma, low for history of endoscopic resection of EGC).
  • In patients with uninvestigated dyspepsia who are under the age of 60 years and without alarm features, non-endoscopic testing for H.pylori infection is a consideration. Those who test positive should be offered eradication therapy (conditional recommendation, quality of evidence: high for efficacy, low for the age threshold).
  • When upper endoscopy is undertaken in patients with dyspepsia, gastric biopsies should be taken to evaluate for H. pylori infection. Infected patients should be offered eradication therapy (Strong recommendation, high quality of evidence).
  • Patients with typical symptoms of gastroesophageal reflux disease (GERD) who do not have a history of PUD need not be tested for H. pylori infection. However, for those who are tested and found to be infected, treatment should be offered, acknowledging that effects on GERD symptoms are unpredictable (strong recommendation, high quality of evidence).
  • In patients taking long-term low-dose aspirin, testing for H. pylori infection could be considered to reduce the risk of ulcer bleeding. Those who test positive should be offered eradication therapy (conditional recommendation, moderate quality of evidence).
  • Patients initiating chronic treatment with a non-steroidal anti-inflammatory drug (NSAID) should be tested for H. pylori infection (strong recommendation, moderate quality of evidence). Those who test positive should be offered eradication therapy. The benefits of testing and treating H. pylori in patients already taking NSAIDs remains unclear (conditional recommendation, low quality of evidence).
  • Patients with unexplained iron deficiency (ID) anemia despite an appropriate evaluation should be tested for H. pylori infection. Those who test positive should be offered eradication therapy (conditional recommendation, high quality of evidence).
  • Adults with idiopathic thrombocytopenic purpura (ITP) should be tested for H. pylori infection. Those who test positive should be offered eradication therapy (conditional recommendation, very low quality of evidence).
  • There is insufficient evidence to support routine testing and treating of H. pylori in asymptomatic individuals with a family history of gastric cancer or patients with lymphocytic gastritis, hyperplastic gastric polyps and hyperemesis gravidarum (no recommendation, very low quality of evidence).

The ACG’s 2007 treatment guideline on the management of H. pylori infection (26) listed the following as established indications for diagnosis and treatment:

  • Active PUD (gastric or duodenal).
  • Confirmed history of PUD (not previously treated for H. pylori).
  • Gastric MALT lymphoma (low grade).
  • After endoscopic resection of EGC.

The current guideline extends the list of potential indications to test patients for H. pylori infection. There are varying levels of evidence in support of the different potential indications for testing that are listed below. For some of these, the decision to test an individual patient for H. pylori will be influenced by clinical judgment and considerations of a patient’s general medical condition. Not all of these potential indications are given a definite recommendation, so that clinicians may exercise their judgment for individual patients. There is no justification in North America for universal or population-based screening.

Both commenters directed attention to the more recently published guidance from the American College of Gastroenterology from 2017. The recommendations therein have been incorporated into the LCD as criteria for testing. Selection criteria for the proper test has not changed. The second comment mentioned other possible reasons for testing which were not substantiated with additional literature and were not supported by the guidelines. Should subsequent evidence-based peer reviewed published literature be brought to our attention Noridian will reconsider these.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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DL37624 - (MCD Archive Site)
L37624 - (MCD Archive Site)
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Keywords

  • Helicobacter
  • Pylori
  • Infection
  • Testing
  • 78267
  • 78268
  • 83013
  • 83014
  • 87338