Compelling Findings on Antibiotic Resistance in Europe and Aggressive Action on the Homefront: Public Health Watch

We have no one to blame but ourselves.

That’s arguably the underlying message of an analysis of European hospitals published on July 29^th by Nature Microbiology. After assessing the genome sequences and epidemiological data of more than 1700 Klebsiella pneumoniae samples collected from patients across 244 hospitals in 32 countries, they concluded that “carbapenemase acquisition is the main cause of carbapenem resistance,” and that more than half of the hospitals that contributed carbapenemase-positive isolates likely experienced within-hospital transmission.

“[I]n the case of carbapenem-resistant K pneumoniae, our findings imply hospitals are the key facilitator of transmission,” co-author Sophia David, PhD, a postdoctoral scientist at the Centre for Genomic Pathogen Surveillance (CGPS) at the Wellcome Sanger Institute in Hinxton, UK, said in a statement. “[O]ver half of the samples carrying a carbapenemase gene were closely related to others collected from the same hospital, suggesting that the bacteria are spreading from person-to-person primarily within hospitals.”

David and her colleagues also found that inter-hospital spread of carbapenem-resistant K pneumoniae is much more common within countries, as opposed to between countries. Interestingly, 477 of 682 (69.9%) of the carbapenemase-positive isolates they studied are concentrated in 4 clonal lineages, sequence types 11, 15, 101, 258/512, and their derivatives.

The findings, although on a different continent, come at a time when the Centers for Medicare & Medicaid Services (CMS) is changing its reimbursement structure for antibiotics as well as for the treatment of antimicrobial-resistant infections in the United States. In a recent blog post for Health Affairs, CMS administrator Seema Verma, MPH, noted that, with the modifications, the agency hopes to create “an alternative pathway” for New Technology Add-On Payments (NTAPs)—without the so-called “substantial clinical improvement” (SCI) criterion—and increase the value of these payments from 50% to 75% for Qualified Infectious Disease Products (QIDPs); rework severity levels for antimicrobial resistance within clinically-relevant diagnosis-related groups; and consider policy changes that go beyond the current Inpatient Prospective Payment System model to “scale” hospital stewardship programs to enhance patient safety. Overall, the goal is to eliminate regulatory barriers and overhaul a payment structure that undervalues antibiotics.

“[Antimicrobial resistance] is both a public health crisis and a national security imperative that demands systemic policy action,” she wrote. “The agency’s realignment of inpatient payment incentives is intended to stabilize the antibiotic development pipeline in the short term and guarantee an arsenal of innovation to fight [the crisis] in the long term.”

At the same time, US Senators Johnny Isakson (R-GA) and Bob Casey (D-PA) in June introduced the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, which would increase Medicare reimbursements to hospitals when advanced antibiotics are (properly) used and require hospitals to establish antibiotic stewardship programs to improve patient outcomes, reduce inappropriate antibiotic use, and strengthen surveillance efforts. The Infectious Diseases Society of America provided guidance that informed the legislation.

“[DISARM is] an encouraging first step…but [it] can’t stand alone,” Cornelius J. Clancy, MD, Chief, Infectious Diseases, VA Pittsburgh Healthcare System and Director, XDR Pathogen Lab, University of Pittsburgh wrote in an op-ed published by the Philadelphia Inquirer on August 8^th. “Legislators should also create market entry rewards for newly approved antibiotics…[to] ensure a sustainable economic return for vital antibiotic research and development…Investing in market initiatives won’t just save lives, it’s also financially savvy. Antimicrobial resistance already costs our nation $20 billion a year. Drug-resistant superbugs will kill tens of millions of people by causing infections and by jeopardizing lifesaving medical advancements. It’s time to develop new antibiotics and more appropriately use today’s treatments.”