CMS’s new rule for antibiotic stewardship: The case of H. pylori


The Centers for Medicare and Medicaid Services (CMS) finalized a new regulation requiring all hospitals participating in its programs to establish antimicrobial stewardship programs by March 30, 2020 (https://federalregister.gov/d/2019-20736). This welcome action was prompted by the rise in antimicrobial resistance; recent Centers for Disease Control and Prevention estimates more than 2.8 million antibiotic-resistant infections with more than 35,000 deaths occur in the United States each year (https://www.cdc.gov/drugresistance/biggest-threats.html). CMS recommended that hospitals follow stewardship guidelines established by CDC, and other nationally recognized sources (https://www.cdc.gov/antibiotic-use/healthcare/pdfs/hospital-core-elements-H.pdf). Antibiotic stewardship includes optimization of several aspects of antimicrobial therapy including the drugs, formulations, doses, and dosing intervals. It also includes obtaining and updating local, regional, and national susceptibility data to provide regularly updated guidance regarding diagnosis and therapy.

How does this new CMS rule affect gastroenterologists and what role, if any, do we play in the epidemic of antibiotic resistance? The one infectious disease that gastroenterology effectively owns is Helicobacter pylori. Treatment of this disease has the potential to be involved in the epidemic of antimicrobial resistance. Current H. pylori therapies were largely devised without considering the principles of antibiotic stewardship. Therapies for H. pylori have largely been developed using trial and error, antimicrobial susceptibility testing is rarely available, and local and regional susceptibility are not readily available or updated. Current national treatment recommendations are most often based on comparisons of regimens grouping trials containing different drugs, doses, and durations of therapy performed in populations in whom resistance was neither assessed nor taken into account. Finally, some of the most highly recommended effective regimens inevitably contain at least one antibiotic unnecessary for the outcome, and inadvertently serve to increase population antibiotic exposure.

Clarithromycin-amoxicillin-PPI triple is still the most often used legacy therapy in the United States with an average cure rate of 70%. Recent guidelines have suggested adding a fourth drug, metronidazole to produce a quadruple therapy (concomitant therapy); the premise is that although both clarithromycin and metronidazole resistance are common, dual resistance is not. However, this benefit comes at the price of every patient receiving at least one unnecessary antibiotic, and patients with treatment failures receiving three unnecessary antibiotics. The cumulative effect given the approximately 2 million treatments annually is 10s of thousands of kilograms of inappropriate antibiotic use annually with the likely consequence of increasing resistance.

How to move forward? The CDC documents regarding antimicrobial stewardship in hospitals with limited resources (https://www.cdc.gov/antibiotic-use/core-elements/resource-limited.html) suggest creation and promotion of evidence-based treatment guidelines for common clinical syndromes, tracking of antibiotic dispensing using available data, setting of national targets for improvement, and description of resistance patterns to improve treatment guidelines and identify priority pathogens. The CDC documents require creation and promotion of evidence-and susceptibility-based treatment guidelines, tracking of antibiotic dispensing and setting targets for improvement (i.e., monitoring and reporting). It is important to note that the CMS rule focused on hospitals as hospitals have traditionally been the sites where local susceptibility data are obtained and gathered to provide the regional data and updated treatment guidelines used to treat most infectious diseases.

The Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States in 2017 had several recommendations that would effectively address the CMS rule and CDC recommendations. For example, statement 15: that empiric eradication therapy for H. pylori be based on region or population-specific antibiotic susceptibility data (Grade 1B); Statement 17: that validated diagnostic testing of stool or gastric mucosal biopsy by culture and susceptibility, or molecular analysis be universally available (Grade 1); Statement 18: that antibiotics that may be routinely evaluated for susceptibility include amoxicillin, clarithromycin, levofloxacin, metronidazole, and tetracycline. (Grade 2C); and Statement 19: that professional societies provide the research needed to support evidence-based reimbursement decisions for antibiotic susceptibility testing for H. pylori (Grade 1).

Organized gastroenterology needs to join with the infectious disease community to make H. pylori an infection of joint interest. Mass eradication of H. pylori worldwide offers the promise of elimination of gastric cancer. The CMS rule should ultimately result in significant changes in the approach of treating H. pylori infections that includes improved testing and availability and implementation of knowledge of local susceptibility and resistance patterns. Therapies that reliably cure H. pylori without unnecessary antibiotics need to be used whereas regimens that fail to reliably achieve high cure rates should be abandoned. We should consider establishing quality metrics related to appropriate diagnostic testing for both the initial infection as well as posttreatment evaluations. We must add our voice to advocate for hospitals and central laboratories to offer susceptibility testing locally or as a send out for clinicians to provide locally relevant antimicrobial therapy for H. pylori infections. The CMS rule provides both the impetus and the methods to move forward and deal with H. pylori like other infectious diseases.

Dr. Graham is a professor of medicine, Baylor College of Medicine, Houston; Dr. El-Serag is chair of the department of medicine at Baylor College of Medicine, Houston. Neither had conflicts of interest related to this comment.

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