Corporate Medical Policy

Transcription

1 Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: helicobacter_pylori_testing 01/01/2019 N/A 01/01/ /01/2019 Policy Effective April 1, 2019 Description of Procedure or Service Policy Definitions Helicobacter pylori is a gram negative bacteria which causes chronic inflammation (infection) in the stomach and and is associated with peptic ulcer disease, chronic gastritis, gastric adenocarcinoma, and gastric mucosa associated lymphoid tissue (MALT) lymphoma (Crowe, 2018). ***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician. BCBSNC will provide coverage for helicobacter pylori testing when it is determined to be medically necessary because the medical criteria and guidelines shown below are met. Benefits Application This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy. When Helicobacter Pylori Testing is covered 1. Urea Breath testing OR stool antigen testing for H. Pylori infection is considered medically necessary for adult patients (>18y) in the following situations: a. In the evaluation of a patient with suspected H.Pylori infection and the following symptoms: i. dyspeptic symptoms, or ii. active peptic ulcer disease (PUD), or iii. past PUD without H.Pylori history, or iv. low-grade gastric mucosa-associated lymphoid tissue (MALT) lymphoma, or v. a history of endoscopic resection of early gastric cancer (EGC), or vi. patients with uninvestigated dyspepsia who are under the age of 60 years and without alarm features, or Page 1 of 8

2 vii. Patients initiating chronic treatment with a non-steroidal anti-inflammatory drug (NSAID), or viii. Patients with unexplained iron deficiency anemia ix. In the evaluation of a patient with chronic immune thrombocytopenic purpura (ITP) and suspected H. Pylori infection. b. Re-evaluation to measure success of eradication of H. Pylori infection, at least 4 weeks post-treatment. i. Any patient with an H. pylori-associated ulcer. ii. As part of the follow-up of patients with persistent symptoms of dyspepsia following appropriate antibiotic treatment for H. Pylori. iii. In patients with Gastric MALT Lymphoma. iv. In individuals who have undergone resection of early gastric cancer 2. Urea Breath testing OR stool antigen testing for H. Pylori infection is considered medically necessary for pediatric patients (<18y) in the re-evaluation to measure success of eradication of H. Pylori infection, at least 4 weeks post-treatment 3. Biopsy-based endoscopic histology test and Rapid Urease Test or culture is considered medically necessary in pediatric patients (<18y) for the diagnosis of H. Pylori infection in following situations: a. Children with gastric or duodenal ulcers b. Children with refractory iron deficiency anemia (IDA) in which other causes have been ruled out 4. Biopsy-based endoscopic histology test and Rapid Urease Test or culture is considered medically necessary in adult patients (>18 y) undergoing endoscopic examination or in those with alarm symptoms for the diagnosis of H. Pylori infection When Helicobacter Pylori Testing is not covered 1. Urea Breath testing OR stool antigen testing for H. Pylori infection is considered not medically necessary for asymptomatic pediatric (<18y) and asymptomatic adult (>18y) patients in all other situations and adult patients with typical symptoms of gastroesophageal reflux disease (GERD) who do not have a history of peptic ulcer disease (PUD) 2. Serologic testing for H. Pylori infection is considered not medically necessary in adult and pediatric patients as it does not distinguish between currently active infection with past exposure and an infection that has been cured. 3. Biopsy-based endoscopic histology test and Rapid Urease Test or culture is considered not medically necessary in pediatric patients (<18y) for the diagnosis of H. Pylori infection in following situations: a. Children with functional abdominal pain b. As part of initial investigation in children with iron deficiency anemia c. When investigating causes of short stature 4. Testing with the Urea Breath test and/or stool antigen and/or biopsy-based testing is considered not medically necessary in patients with recent use of antibiotics, proton pump inhibitors (PPIs) or bismuth. 5. Concurrent testing with the Urea Breath test and/or stool antigen testing and/or biopsy-based testing is not considered not medically necessary as simultaneous use of both methods does not improve clinical understanding. Page 2 of 8

3 6. Polymerase chain reaction (PCR) testing for H. Pylori is considered not medically necessary as it not practical for routine diagnosis. Policy Guidelines Background Dyspepsia is identified by a variety of gastrointestinal symptoms such as heartburn, nausea, bloating, burping, and general stomach pain or discomfort. The investigation of the cause for dyspepsia includes evaluation for gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD), nonsteroidal anti-inflammatory drug (NSAID) related damage, cancer, and Helicobacter pylori (H. pylori) infection. It is estimated that 25 40% of adults suffer from dyspepsia per year, and approximately 10% of dyspepsia is due to PUD. Men have an estimated 12% lifetime prevalence of PUD and women a 9% lifetime prevalence. The costs associated with PUD are substantial at $3 billion for hospitalizations, $2 billion for physician visits, and another $1 billion of estimated decreased productivity. It is estimated that up to 95 percent of people with duodenal ulcers and 80 percent of people with gastric ulcers are infected with the gram-negative bacterium, Helicobacter Pylori (H. pylori). Infection with H. pylori is common worldwide, occurring more widely in developing countries, in rural areas, and areas with poor socioeconomic status. Prevalence in the United States is significant, estimated to be 30 40% in the general population. Transmission of H. pylori requires ingestion of the bacterium, and acute infection is typically asymptomatic or attributed to other common transient conditions. In an infected individual, H. pylori bacteria are found in within gastric mucosa or attached to stomach epithelium. In addition to PUD, H. pylori infection is associated with gastric cancers, including mucosa associated lymphoid tissue (MALT). H. pylori is not associated with GERD, and the presence of GERD may reduce the likelihood of H. pylori infection. In individuals on lowdose aspirin therapy, H. pylori infection has been shown to be an independent risk factor for upper gastrointestinal bleeding. Eradication of H. pylori infection has been shown to result in healing of peptic ulcers and reduces the risk for development of gastric cancer. Treatment for H. pylori involves a combination of antibiotics and proton-pump inhibitors. Various antibiotics are used to address potential antibiotic resistance, and treatment typically lasts for 7 to 14 days. The rate for eradication from first-line treatment is estimated to be 70-80%. Identification of H. pylori infection is accomplished with one or more of the several tests available. The choice of test is guided by the reason for the test, cost and availability of the test, the patient s age and clinical presentation, prevalence in a population, and the patient s use of certain medications. Testing for H. pylori infection is done for two main reasons: to detect active infection that will be treated, and to confirm eradication of the infection post-treatment. Although serology tests are available to detect H. pylori antibodies, they have a very low positive predictive value in populations with low or average prevalence, as the antibodies will be detected even after an infection has been treated or naturally resolved. In populations with a high prevalence of H. pylori infection, a positive serology test is assumed to indicate active infection. Tests to identify active H. pylori infection include both invasive and non-invasive approaches. Endoscopy and collection of biopsy specimens for evaluation of H. pylori infection typically is done in older individuals and those with alarm symptoms such as bleeding, unexplained anemia, Page 3 of 8

4 unexplained weight loss, progressing dysphagia, recurrent vomiting, a family history of gastrointestinal cancer, or a personal history of esophagogastric malignancy. Tissue samples can tested for H. pylori via a rapid urease test, culture, staining, fluorescent in situ hybridization, or molecular genetic testing. Each has limitations that render sensitivity, specificity, cost, and/or availability less than ideal. Non-invasive options for detection of active H. pylori infection include urea breath tests and stool antigen testing. The stool antigen test is an immunoassay that detects the presence of H. pylori in a stool sample. The test is reported to have greater than 90% sensitivity and specificity for detection of active H. pylori infection, and its use has been FDA cleared for all ages. This test may be used for initial diagnostic purposes and for post-treatment testing. Urea breath tests, which take advantage of the bacteria s urease activity, may also be used to detect active H. pylori infection. The patient ingests a solution containing either 13 C or 14 C labeled urea, after a set amount of time, the patient s breath is collected and analyzed for the presence of 13 C or 14 C labeled CO 2. If H. pylori is present it will have metabolized the labeled urea and labeled CO 2 will be detected, thus indicating infection with H. pylori. Urea breath tests have diagnostic sensitivity and specificity of 90% for initial detection of H. pylori infection, and 95% sensitivity when used for post-treatment confirmation of eradication. The urea breath test is FDA cleared for use in individuals 18 years of age and older. Some medications are known to inhibit the growth or urease activity of H. pylori, and can cause a false negative H. pylori test result. It is recommended that individuals refrain from taking PPIs, antibiotics, and bismuth-containing medications for 2 to 4 weeks prior to testing, to reduce the chance of a false negative result. To confirm that antibiotic therapy has been effective, re-testing should occur 4 weeks after completion of the treatment. Applicable Federal Regulations The Urea breath test (UBT) (CPT codes 83013, 83014) is FDA-cleared for the initial diagnosis and to confirm eradication. On Feb 24, 2012 the first FDA-cleared Urea Breath Test for children aged 3-17 was approved. Special equipment is needed for testing, patient must make an appointment, fast for 24 hours and the FDA does REQUIRE patients to be off antimicrobials, PPI, bismuth and H2 blockers for 2 weeks prior to testing. Guidelines and Recommendations The American Gastroenterological Association (AGA) (Talley, 2005) recommends that patients 55 years of age or younger without alarm features should receive H pylori test and treat followed by acid suppression if symptoms remain and note that H pylori testing is optimally performed by a 13C-urea breath test or stool antigen test. Additionally, the AGA indicates that although the yield of endoscopy is low, it is recommended for patients older than 55 years of age and for younger patients presenting with new-onset dyspepsia. They reason that endoscopy with biopsy is the preferred test for this age group because upper gastrointestinal malignancy becomes more common after age 55 years. In 2017 the ACG published a Technical review on Upper Gastrointestinal biopsy (Allen, Katzka, Robert, & Leontiadis, 2015) to evaluate dyspepsia in the absence of visible mucosal lesions and found that: In the defined population, biopsy of normal-appearing gastric mucosa can detect HP infection that would be missed on the exam if biopsies were not obtained. The quality Page 4 of 8

5 of evidence is very low. One must note that there are noninvasive methods to detect HP infection. Detection of HP infection with tissue biopsy and its eradication in patients with dyspepsia is associated with symptom improvement and reduction of risk for HPrelated comorbidities, including gastric cancer compared with no biopsy (or no eradication). The quality of evidence is moderate based on multiple RCTs that show a modest effect with a NNT of about The effect on symptom resolution is not universal and it does not appear to improve well-being. Quality of evidence for this statement is low. The American College of Gastroenterology (ACG) (Chey, Leontiadis, Howden, & Moss, 2017) guidelines recommend that: 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 mucosaassociated 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. pyloriinfection 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). Page 5 of 8

6 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 National Institute for Health and Care Excellence (NICE) (2014)recommends test for H. pylori using a carbon-13 urea breath test or a stool antigen test, or laboratory-based serology where its performance has been locally validated Perform re-testing for H. pylori using a carbon-13 urea breath test Do not use office-based serological tests for H. pylori because of their inadequate performance. NICE also recommends that individuals with positive H. pylori tests be offered therapy to eradicate the bacteria, however they note that re-testing to confirm eradication should not be routinely offered. NICE limits the recommendation for post-treatment testing to people with peptic ulcer (gastric or duodenal) 6 to 8 weeks after beginning treatment, depending on the size of the lesion. The European Helicobacter Study Group (EHSG) recommends testing for H. pylori infection also in individuals with unexplained iron deficiency anemia, unexplained idiopathic thrombocytopenia purpura, MALToma, and atrophic gastritis. EHSG also recommends testing post-gastric resection and testing of individuals who are first-degree relatives of those with gastric cancer. Additionally, EHSG recommends testing for and eradication of H. pylori in individuals with long time PPI or NSAID use. The American College of Cardiology (Bhatt et al., 2008) recommends Testing for and eradicating H. pylori in patients with a history of ulcer disease before starting chronic antiplatelet therapy. The European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) (L. Jones et al., 2017) The ESPGHAN and NASPGHAN have issued updated guidelines for management of H.pylori in children and adolescents. They have proposed 16 recommendations including recommendations for diagnosis and management of H.pylori infection in pediatric patients. They have defined pediatric patients as children and adolescents below 18 years of age. The following recommendations were stated: Recommendation 2c: We recommend against a test and treat strategy for H.pylori infection in children. (Strong, Quality-Weak, 100% agreement). The panelists explained that performing a noninvasive test to detect infection and treat is not needed because H.pylori infection usually does not cause any symptoms in the absence of peptic ulcer disease (PUD). Recommendation 3: We recommend that testing for H.pylori be performed in children with gastric or duodenal PUD. Recommendations 4, 5a and 7: They recommended against diagnostic testing for H.Pylori infection in children with functional abdominal pain, as part of the initial investigation in children with iron deficiency anemia and when investigating causes of short stature. The non-invasive diagnostic testing was indicated in children when investigating causes of chronic immune thrombocytopenic purpura (Recommendation 6) or for the assessment of anti-h.pylori therapy at least after 4 weeks of therapy (Recommendation 15). Page 6 of 8

7 The panelists recommended to base H.Pylori infection diagnosis in children on either histopathology plus at least one other positive biopsy-based test or the culture (Recommendation 9a). Finally, they recommended against serology-based testing in children (Recommendation 10). Billing/Coding/Physician Documentation Information This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at They are listed in the Category Search on the Medical Policy search page. Applicable service codes: 83009, 83013, 83014, 86677, 87081, 87077, 87181, 87186, 87205, 87338, 87339, Code Number PA Required PA Not Required Not Covered X X X X X X X X X X X X BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included. Scientific Background and Reference Sources Allen, J. I., Katzka, D., Robert, M., & Leontiadis, G. I. (2015). American Gastroenterological Association Institute Technical Review on the Role of Upper Gastrointestinal Biopsy to Evaluate Dyspepsia in the Adult Patient in the Absence of Visible Mucosal Lesions. Gastroenterology, 149(4), doi: /j.gastro Bhatt, D. L., Scheiman, J., Abraham, N. S., Antman, E. M., Chan, F. K., Furberg, C. D.,... Quigley, E. M. (2008). ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. Circulation, 118(18), doi: /circulationaha Chey, W. D., Leontiadis, G. I., Howden, C. W., & Moss, S. F. (2017). ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol, 112(2), doi: /ajg Crowe, S. (2018). Indications and diagnostic tests for Helicobacter pylori infection - UpToDate. Page 7 of 8

8 infection?search=heliobacter%20pylori%20testing&source=search_result&selectedtitle=1~150&us age_type=default&display_rank=1 NICE. (2014). National Institute for Health and Care Excellence: Clinical Guidelines. from National Institute for Health and Care Excellence (UK)Copyright (c) National Institute for Health and Care Excellence, Talley, N. J. (2005). American Gastroenterological Association medical position statement: evaluation of dyspepsia. Gastroenterology, 129(5), doi: /j.gastro Policy Implementation/Update Information 1/1/2019 New policy developed. BCBSNC will provide coverage for helicobacter pylori testing when it is determined to be medically necessary because criteria and guidelines are met. Medical Director review 1/1/2019. Policy noticed 1/1/2019 for effective date 4/1/2019. (jd) Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits and eligibility are determined before medical guidelines and payment guidelines are applied. Benefits are determined by the group contract and subscriber certificate that is in effect at the time services are rendered. This document is solely provided for informational purposes only and is based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. Medical practices and knowledge are constantly changing and BCBSNC reserves the right to review and revise its medical policies periodically. Page 8 of 8