Regulations are redundant and lack specific standards for hospital compliance, experts say.
The US Centers for Medicare and Medicaid Services (CMS) handed down a new rule regarding hospitals and antibiotic stewardship on September 26th.
The response from the infectious disease community: What took you so long?
Experts also question whether the new regulations do enough to establish minimum standards for responsible prescribing.
As part of the Omnibus Burden Reduction (Conditions of Participation) Final Rule—which is designed to eliminate Medicare requirements deemed “unnecessary, obsolete, or excessively burdensome on hospitals and other healthcare providers” by the Trump administration—CMS is now requiring all hospitals participating in its programs (ie, accepting Medicare/Medicaid patients) to establish “infection prevention and control and antibiotic stewardship programs that are not only active and facility-wide, but which also demonstrate adherence to nationally recognized guidelines for the surveillance, prevention, and control of [hospital-associated infections] and other infectious diseases, as well as best practices for the optimization of antibiotic use through stewardship in order to effectively reduce the development and transmission of antibiotic-resistant organisms.” It has been suggested that this regulation merely formalizes a process initiated several years ago when the Joint Commission approved its new “Antibiotic Stewardship Standard” in 2016.
“There is already a regulatory standard at the most widely used hospital compliance [and] regulatory [organization] in the US around antibiotic stewardship,” noted Brad Spellberg, MD, chief medical officer, Los Angeles County-University of Southern California Medical Center and associate dean, clinical affairs, Keck School of Medicine at USC. “As such, there will likely not be much of an immediate change [in hospital practices], since the work to require hospitals to do this was already begun several years ago. But the step is important in solidifying the CMS condition of participation around stewardship. Had CMS not done this, the Joint Commission and other contracted regulatory organizations would likely have revoked their standards around antibiotic stewardship.”
CMS describes its decision to enact this requirement as being part of an effort “to reduce inefficiencies and move the nation closer to a health care system that delivers value, high quality care, and better outcomes for patients at the lowest possible cost.” According to the Infectious Diseases Society of America (IDSA), which issued a statement in the immediate aftermath of the CMS rule announcement, the change “makes expert and coordinated interventions to improve the use of antimicrobial drugs mandatory in virtually all US hospitals, will help curb inappropriate use of some of our most valuable medicines, reducing risks to patients and averting increased health care costs.”
In fact, it could be argued that CMS’ action on antibiotic stewardship is a long-overdue response to a growing crisis. By now, everyone knows the US Centers for Disease Control and Prevention (CDC) statistics: that some 2 million Americans are sickened—and 23,000 die—annually as a result of infections caused by antibiotic-resistant bacteria. As Contagion® reported late last year, the Organization for Economic Cooperation and Development (OECD) estimates that, by 2050, more than 1 million Americans will have died as a result of antibiotic-resistant infections.
“While an essential step to controlling antimicrobial resistance, the rule will not on its own contain the threat,” the IDSA statement reads. “Stewardship can help limit the development of resistance, but even the necessary and appropriate use of antibiotics leads to resistance. With the evolving nature of infectious diseases, the need for a robust and renewable antibiotic pipeline capable of meeting current and future patient needs will continue. IDSA, in turn, will continue to call for additional support and investments on a federal level in research and development toward new antibiotics that reflect the value of infection-fighting medicines to individual and public health, and to the practice of modern medicine.”
And, as Spellberg told Contagion®, the new rule will “have little effect on hospitals” surveyed by the Joint Commission (the vast majority of US facilities), because they have already implemented programs to meet that organization’s regulatory standards. In addition, it may not go far enough in setting minimum standards for stewardship.
“The CMS conditions of participation do not dictate how effective these programs are,” Spellberg said. “The response to the standard has been only to require some elements of such programs, with no measures around actually implementing effective stewardship. That is what is most disappointing around these efforts. A check-box response to meet the standards will not ensure that stewardship is effectively conducted. What we need are performance measures around stewardship to ensure that antibiotic stewardship programs have teeth and can actually influence physician behavior.”